Medical connector with closeable male luer.
Abstract
The present invention relates to a medical connector configured to provide a permanent connection between medical devices, the medical connector comprising: a female end configured to receive a male end of a first medical device; a generally circular cover portion attached to the female end that is substantially wider than the cross section of the female end; a second end configured to connect to a second medical device; a housing extending between the female end and the second end, the housing comprising a region adjacent the covering portion that is wider than the outer diameter of the covering portion; an elastic member positioned at least partially within the housing; and an axially movable valve member; wherein: in a first stage, the female end is configured to remain stationary with respect to the housing while the male end of the first medical device is rotated over the female end, wherein the torque required to rotate the female end with relative to the housing is greater than the torque required to rotate the male end of the first medical device over the female end; in a second step, after the male end of the first medical device rotates over the female end, the female end is configured to rotate relative to the housing to inhibit disconnection of the male end of the first medical device from the female end of the medical connector; and the medical connector is configured to selectively seal fluid flow from the second end after the medical connector is disconnected from the second medical device.

Term
1.6 yearsleft in the term
Expires 15 May 2028.
- Priority
- Filed
- Granted
- Today
- Expires
14 claims: 2 independent, 12 dependent
- 1- 224 - INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIA!. REIVINDICACIONES 1. Un conector médico configurado para proporcionar una conexión permanente entre dispositivos médicos, comprendiendo el conector médico:un extremo hembra configurado para recibir un extremo macho de un primer dispositivo médico;una porción de cobertura generalmente circular unida al extremo hembra que es sustancialmente más amplia que la sección transversal del extremo hembra;un segundo extremo configurado para conectarse con un segundo dispositivo médico;un alojamiento que se extiende entre el extremo hembra y el segundo extremo, comprendiendo el alojamiento una región adyacente a la porción de cobertura que es más amplia que el diámetro exterior de la porción de cobertura;un miembro elástico colocado al menos parcialmente dentro del alojamiento;y un miembro de válvula axialmente móvil;en donde: en una primera etapa, el extremo hembra se configura para permanecer estacionario con respecto al alojamiento mientras que el extremo macho del primer dispositivo médico se gira sobre el extremo hembra, en el que el momento de torsión requerido para girar el extremo hembra con respecto al alojamiento es mayor que el momento de 225 INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIAL torsión requerido para girar el extremo macho del primer dispositivo médico sobre del extremo hembra;en una segunda etapa, después que gira el extremo macho del primer dispositivo médico sobre el extremo hembra, el extremo hembra se configura para girar con respecto al alojamiento para inhibir la desconexión del extremo macho del primer dispositivo médico del extremo hembra del conector médico;y el conector médico está configurado para sellar selectivamente el flujo de fluido del segundo extremo después que se desconecta el conector médico del segundo dispositivo médico.
- 2El conector médico de la reivindicación 1, en donde el segundo extremo comprende un miembro macho tubular rígido.
- 3El conector médico de la reivindicación 2, en donde el miembro de válvula se extiende al menos parcialmente a través del alojamiento en una dirección axial y comprende:un primer extremo abierto y un segundo extremo;un pasaje dentro del miembro de válvula;al menos una abertura cercana al segundo extremo del miembro de válvula que se extiende hacia el exterior desde el pasaje a través del miembro de válvula;un elemento de sellado dispuesto dentro del alojamiento y configurado para inhibir la comunicación de smesBceusoccsK*' IMPI INSTITUTO MEXICANO DE LA PROPIEDAD del-^lo jaiffT®M) 226 fluido a través del orificio hueco interior del miembro macho tubular y el eiife'iiiuu Ιΐΰΐΐίϋΐ alojamiento.
- 4El conector médico de la reivindicación 3, que comprende además al menos un puntal conectado al miembro de válvula y que se extiende hacia el segundo extremo del miembro de válvula, extendiéndose el al menos un puntal sustancialmente paralelo al eje central del miembro de válvula y rodeando al menos parcialmente una sección estrecha del miembro de válvula que termina en el segundo extremo.
- 5El conector médico de la reivindicación 1, en donde el miembro de válvula es rígido.
- 6El conector médico de la reivindicación 1, que comprende además al menos un puntal conectado al miembro de válvula y que se extiende hacia el segundo extremo del conector médico.
- 7El conector médico de la reivindicación 1, en donde el extremo hembra comprende una saliente configurada para romperse cuando se gira el extremo macho del primer dispositivo médico con relación al extremo hembra más allá de un punto en donde el extremo macho del primer dispositivo médico se embraga sustancial y completamente con el extremo hembra de tal manera que, cuando se ha roto la saliente, el extremo hembra se configura para girar con respecto al alojamiento para inhibir la desconexión del extremo macho del 227 INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIAL primer dispositivo médico del extremo hembra del conector médico. 8. Un equipo de dispositivo médico, que comprende:el conector médico de la reivindicación 1;y al menos uno del primer dispositivo médico que tiene un extremo macho configurado para extremo hembra del conector médico y el médico configurado para conectarse con el ser recibido por el segundo dispositivo segundo extremo del conector médico.
- 89. El conector médico de la reivindicación 1, en donde el miembro de válvula se extiende al menos parcialmente a través del alojamiento en una dirección axial y comprende:un primer extremo abierto y un segundo extremo;un pasaje dentro del miembro de válvula;al menos una abertura cercana al segundo extremo del miembro de válvula que se extiende hacia fuera desde el pasaje a través del miembro de válvula.
- 910. Un conector médico configurado para proporcionar una conexión permanente entre dispositivos médicos, el conector médico comprende:un alojamiento con una superficie de embrague exterior, un primer extremo y un segundo extremo, incluyendo dicho primer extremo una porción macho configurada para 228 INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIAL embragar un conector hembra e incluyendo dicho segundo extremo una primera abertura;un pasaje de fluido generalmente lineal entre los extremos primero y segundo del alojamiento, al menos una porción de dicho pasaje estando definida por un miembro de válvula axialmente movible que es deslizable a lo largo de un eje lineal de dicho alojamiento, y dicho pasaje siendo bloqueado en dicha porción macho cuando dicho conector médico se encuentra en una posición cerrada;en donde el miembro de válvula se extiende al menos parcialmente a través del alojamiento en una dirección axial y comprende un primer extremo abierto y un segundo extremo, un pasaje dentro del miembro de válvula, y al menos una abertura cercana al segundo extremo del miembro de válvula que se extiende hacia fuera del pasaje del miembro de válvula a través del miembro de válvula, comprendiendo además dicho primer extremo de dicho alojamiento una cubierta exterior fija con relación al alojamiento y que incluye una porción de embrague dispuesta en la pared interior de la misma;dicho segundo extremo de dicho alojamiento comprende una primera estructura generalmente tubular que se extiende desde dicha primera abertura, incluyendo dicha estructura generalmente tubular una segunda abertura que tiene un primer diámetro exterior más pequeño que el diámetro - 229 IMPI INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIAL interior de dicha primera abertura y 1ina p^^^ión do oobort-^r? que se extiende radialmente posicionada entre dicha segunda abertura y dicha primera abertura de dicho alojamiento, dicha porción de cobertura que se extiende radialmente tiene un segundo diámetro exterior más grande que dicho primer diámetro exterior, y dicha estructura tubular está configurada para girar con relación a dicho alojamiento para inhibir la desconexión del conector médico de otro dispositivo médico;y dentro de dicho alojamiento, dicho primer extremo abierto de dicho miembro de válvula rodea una porción de dicha primera estructura generalmente tubular.
- 1011. El conector médico de la reivindicación 10, en donde al menos una porción tanto de dicha porción de cobertura que se extiende radialmente como de dicha segunda abertura giran fuera de dicho alojamiento.
- 1112. El conector médico de la reivindicación 10, que comprende además al menos un puntal conectado al miembro de válvula y que se extiende hacia el segundo extremo del miembro de válvula, extendiéndose el al menos un puntal sustancialmente paralelo al eje central del miembro que inhibe el flujo de fluido y rodeando al menos parcialmente una sección estrecha del miembro de válvula que termina en el segundo extremo cerrado.
- 1213. El conector médico de la reivindicación 10, 230 INSTITUTO MEXICANO DE LA FROFIEDAD INDUSTRIAL que comprende además un elemento de sellado dispupstn dpntrn del alojamiento y configurado para inhibir la comunicación de fluido a través del pasaje de fluido del alojamiento entre una superficie interior del pasaje de fluido y una superficie 5 exterior del miembro de válvula.
- 1314. El conector médico de la reivindicación 10, en donde el miembro de válvula es rígido.
- 1415. El conector médico de la reivindicación 10, en donde el segundo extremo comprende una saliente configurada 10 para romperse cuando se gira un primer dispositivo médico con relación al segundo extremo más allá de un punto en donde el primer dispositivo médico se embraga sustancial y completamente con el segundo extremo de tal manera que, cuando se ha roto la saliente, el segundo extremo se 15 configura para girar con respecto al alojamiento para inhibir la desconexión del primer dispositivo médico del segundo extremo del conector médico. RESUMEN 231 .· ) Un conector luer que incluye un alojamiento rígido que tiene un primer extremo y un segundo extremo. El alojamiento incluye además una porción macho tubular rígida en el primer extremo, una porción hembra tubular rígida en el segundo extremo y una abertura longitudinal a través de estas. La porción macho se configura para embragarse con un conector hembra. La porción hembra se configura para embragarse con un conector macho y para evitar el desembrague del conector macho de la porción hembra. En algunas modalidades, la porción hembra se configura para mantener una posición rotacional fija cuando se rosca el conector macho con esta, pero gira con el conector macho una vez que el conector macho se ha embragado completamente con la porción hembra a fin de evitar que el conector macho se desenrosque de la porción hembra.
Independent claims14
1,580 paragraphs in 155 sections, as filed
Institute
Mexican Property
Industrial
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___I KNOW___
ΜΧΜΤΛΚΪΛ Rl fCONOMY
PATENT TITLE NO. 337063
Owner (s): ICU MEDICAL, INC.
Address:
951 Calle Amanecer, San Clemente, California, 92673, USA
Denomination: MEDICAL CONNECTOR WITH CLOSURE MALE LUER
Classification: lnt.CI.8: A61M39 / 10; A61M39 / 14; A61M39 / 26
Inventor (s): THOMAS F. FANGROW; GEORGE A. LOPEZ
APPLICATION i
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May 2 Patent Number: 314789
PRIORITY
Date:
Number:
1st: May 20, 2007, October 20, April 20, 2
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60/938,428
60/978,697 61/042,016 12/117,568
15d artteufos-e *
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Industrial Federation (DOF).
Artos imp Togables, keep r lenses on and 7 "bis 2 of h Law of the - / 05/1999,
Date of Sold
L ^ reference patent is
Dfcconfbm ......
Credit from date of defecation
Q {§en subscribes this
Industrial Ownership (Diari
2W1 / 2004, 06/16/2005, 25 ib | so a), 4 »and 12» of the Mexican Institute of Industrial Property (DOF 12/27/1999, amended ^ Tf0 / 1Ó / 2002, 07/29/2004 , 08/04/2004 and 09/13/2007); Γ, 3<sup>or </sup>and 5th subsection a) of the Agreement that delegates powers to the Deputy General Directors, Coordinator, Divisional Directors, Heads of Regional Offices, Divisional Deputy Directors, Departmental Coordinators and o ther subordinate s of the Mexican Institute of Industrial Property. (DOF 12/15/1999, amended on 02/04/2000, 07/29/2004, 08/04/2004 and 09/13/2007).
The organization with ndament in accordance with site 23 of the eydeláPtpp of presentation of the
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Fraction V. 6th fraction III, and 59 of the Law da ^ f'ibpiedad being patent has a vlgepcto will be subject to the ítuio lo h * e with foundation
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1/2006, θ · θ5 / 2009,06 / 01 / 2010,1
I and III c Regulation of the Mexican Institute 7/2004 and BMilMWMtMaóMMfMM ··
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10/1996, 12/26/1997, 04/09/2012); Articles 1 *, 3 * section Industrial V redad (DOF 12/14/1999, re-signed on
Organic
Issue Date: February 11, 2016
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NAHANNY CANAL REYES
Arenal No 550, Floor 1,
Col. Pueblo Santa María Tepepan, Xochirnilco, CP 16020,
Mexico City
Tel (55) 53 34 07 00 \ yvu- impi, eob inx
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Mxlal 2ΟΙ3> / II
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MEDICAL CONNECTOR WITH LUER MALE CERyj ^ jj j
Related Requests <sup>inst</sup>5elaSity INDUSTRIAL
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This application is a continuation of US Patent Application No. 12 / 117,568, filed May 8, 2008 which refers to, claims the benefit of, and is the non-provisional of the US Provisional Patent Application Nos. . 60 / 938,428, filed May 16, 2007, 60 / 978,697, filed October 9, 2007, and 61 / 042,016, filed April 3, 2008, each of which is incorporated by reference in its totality in the present. This application also incorporates by reference in its entirety US Provisional Patent Application No. 60 / 696,894, filed July 6, 2005, and US Provisional Patent Application No. 60 / 707,319, filed July 11, 2005. August, 2005 and US Patent Application Nos. 11 / 417,604, filed May 3, 2006 and 11 / 482,176, filed July 6, 2006.
BACKGROUND OF THE INVENTIONS
Field of Inventions
These inventions relate in general to medical connectors through which fluids flow, and in particular to medical connectors with male luers. Description of Related Technique
Connector, valve, and tubing systems are routinely used in hospitals and other
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medical facilities to facilitate the transfer of fluids to and from patients. The challenge of keeping such systems sterile and avoiding fluid leakage when the various components are engaged and disengaged is frequent.
In order to maintain a barrier to bacteria, debris, and fluid leaks, female connectors have often been provided with plugs, such as diaphragms, flexible seals, or other impediments, at their mating ends. When a male luer connector is engaged with the female connector, the plug of the female connector is temporarily open, drilled, or offset to allow fluid to flow between the two connectors. Male connectors typically employ needles or luers to open, pierce, or displace the plug in female connectors.
In many systems, only the female connectors are automatically blocked from the external environment when disengaged. Male luer connectors are generally not provided with self-closing mechanisms. Sometimes male luer connectors use additional components, such as caps, to stop the flow of fluid and prevent the entry of bacteria and debris. Because such locking mechanisms are not automatic (or not used at all), male luer connectors are sometimes left unsealed, allowing leakage of the
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY fluid. This can increase the risk of unsanitary conditions inside and outside the fluid transfer system. Also, in some medical applications such as certain chemotherapy treatments, fluids in the tubing and fittings can be harmful if released.
Additionally, in the busy environment of hospitals and other medical facilities, healthcare providers must frequently manipulate multiple medical implements quickly with one hand, making it difficult to retrieve the male luer caps and quickly attach them when disengaging the male connectors. . In addition, male luer connectors are frequently employed at the downstream end of gravity feed fluid sources such as IV bags. When connectors and tubing are initially connected to such sources, they are generally empty (ie, filled with air) and must be primed with fluid before they can be connected to a patient. During the preparation procedure, fluid is allowed to flow from the upstream end of the tubing to the male luer at the downstream end. As the fluid flows through the tubing, the air in the tubing escapes through the male connector at the downstream end to the environment. Once the fluid itself reaches the male connector, it can also leak and spill. Because the connectors
<img file="MX337063B_D0010.tif" />
Male luer usually does not close automatically after preparation, the male luer a small amount of fluid while the male connector moves rapidly towards the mating clutch with a female connector. For this reason, the male luer is generally held over a weir or trash can at the end of the setup procedure to contain the leaking fluid.
There is a need for a lockable male luer connector that opens automatically when engaged with the female connector and automatically closes when disengaged from such a connector to minimize or eliminate dripping during setup and other procedures and to improve the barrier of the delivery system. fluid transfer against bacteria and other debris. There is also a need for a closable male luer connector with a female connector having a locking facility or other facility that allows the female portion of the male luer connector to mate with a corresponding male connector portion of a male connector or other medical device. such as a syringe, but which inhibits the ability, or substantially prevents, that the female portion of the male luer connector disengages from the corresponding male luer portion of the mated component.
SUMMARY OF SOME MODALITIES
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MEXICAN INSTITUTE
PE INDUSTRIAL PROPERTY
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various modalities of
Connectors are described
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It is contemplated that the features of the various embodiments described herein may be combined to form additional embodiments. Such combinations are within the scope of this description.
In an exemplary embodiment, a male luer connector has a main housing with first and second ends. The second end of the housing comprises a male luer and a cover that surrounds at least a portion of the male luer. The cover has screw threads arranged on an internal wall thereof. A tubular valve member with a fluid path is disposed within the housing. The valve member has a point at its second end. In the region near the tip, a pair of fluid ports are located on opposite sides of the valve member. The tip is configured to closely contact an inner wall of the male luer in a region at or near the second end of the male luer. The valve member also has a pair of struts directed toward the second end. The struts extend axially through a portion of the housing, and the ends of the struts toward the second end are positioned within a space between the male luer and the cover at the second end of the housing.
It is “industrial -connects a length of medical tubing to the connector. One end of the pipe is attached to the first end of the valve member by means of adhesive, welding, or some other. An elastic, elastomeric member extends from a midsectional region outside the housing to a region at or near the first end of the valve member within the housing.
In a substantially closed state, the elastic member is configured to pull the housing and the tubular valve member together along their respective axes. In this state, the tip of the valve member is pressed into close contact with a portion of the inner wall at the second end of the male luer, and fluid flow from the medical tubing through the tubular valve member is impeded. Fluid generally cannot escape through the opening at the second end of the male luer because that opening is blocked by the tip of the valve member.
When a force is applied to separate the valve member from the housing, the elastic member extends and the tip of the valve member moves in the direction of the first end from the second end of the male luer. This separating force can be applied manually, for example, by holding the outer wall of the housing with two fingers and holding the tubing attached to the first end of the suction.
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valve member with two other fingers, and then moving the fingers in the opposite direction. The separation force can also be applied automatically by a different manual action. For example, the act of connecting the male luer to a female end of another medical implement can automatically separate the valve member from the housing. As the leading end of the female connector proceeds upward from the screw threads at the second end of the male luer connector housing, the female connector contacts and exerts a force directed toward the first end against the struts of the valve member. This force moves the valve member toward the first end against the biasing force directed toward the second end exerted by the elastic member. In this open state, fluid is allowed to flow through opposing orifices, around the tip of the valve member, and out of the connector through the opening between the tip of the valve member and the inner wall at the second end. of the male luer. In some embodiments, the valve member automatically advances in the direction of the first end when the valve member contacts the fluid conduit (eg, a pin positioned within a female connector) as the male and female connectors are brought together. female.
When the separation force is removed, for
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MEXICAN INSTfT'JTO DE LA PKOrtcL'AD INDUSTRIAL
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For example, by releasing the manual grip on the housing and tubing, or by detaching the female connector from the second end of the housing, the resilient member, once again, joins the housing and the valve member to one another. This causes the tip at the second end of the valve member to closely contact a portion of the inner wall in a region near the second end of the male luer, and prevent fluid from flowing out of the valve.
Described herein is an embodiment that prevents disengagement of the female portion of the male luer connector from the corresponding male luer portion of the mated component. Briefly, without limitation, this embodiment of a luer connector may comprise a rigid housing having a first end and a second end. The housing may further comprise a rigid tubular male portion at the first end, a rigid tubular female portion comprising a closure facility at the second end, and a longitudinal opening therethrough. The male portion is configured to engage with a female connector. The female portion is configured to engage with a male connector. The closure facility is configured to substantially allow rotation of the luer connector relative to the male connector in a first direction in such a way as to allow the female portion to engage in a manner
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I
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
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threaded with an internal thread of the male connector, and is configured for luer connector in substantially preventing rotation of the relationship to the male connector in a second direction
Described herein is another embodiment that can prevent disengagement of the female portion of the male luer connector from the corresponding male connecting portion of the mated component. Briefly, without limitation, this embodiment of a luer connector may comprise a rigid housing having a first end and a second end. The housing may further comprise a rigid tubular male portion at the first end, a rigid tubular female portion comprising a stripping facility at a second end, and a longitudinal opening therethrough. The male portion can be configured to engage with a female connector. The female portion can be configured to engage with a male connector. The detached installation can substantially prevent removal of the corresponding male connector portion of the mated component from the female portion of the luer connector.
In greater detail, but without limitation, the detached facility may be configured to allow a threaded male connector portion of the mated component to rotate relative to a threaded female portion of the luer connector in a first tightening direction until the portion
JL lvl Jl JL INSTITUTO MEXICANO D £ LA PROPERTY
<td>male connector</td><td>INDUSTRIAL of the coupled component is,</td>
substantially and fully threadedly engaged with the female portion of the luer connector. Additionally, without limitation, the detachable facility may be configured to prevent the male connector portion of the mated component from rotating relative to the female portion of the luer connector in a second out of adjustment direction after the male connector portion of the mated component has been engaged. engaging substantially completely with the female portion of the luer connector, thereby preventing the mated component from easily disengaging from the luer connector.
In some embodiments, this is accomplished as follows. As will be described in greater detail below, the female portion of the luer connector may comprise an end cap between the main housing body and the female connector. The end cap may comprise a first end cap component and a second end cap component. The second end cap component may be supported by a housing member, and the first end cap component may be supported by the second end cap component and may be partially positioned within the second end cap component. The first end cap component of the luer connector may comprise one or more tabs that protrude radially toward the portion.
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exterior from an exterior surface thereof, which can be engaged with complementary tabs projecting radially inwardly from an internal surface of the second end cap component. In a first state, the barb clutch can prevent the first end cap component of the luer connector from rotating freely within the second end cap component. The tabs that protrude outwardly from the first end cap component of the luer connector can be configured to disengage or separate when a predetermined level of torque is applied to the first end cap component of the luer connector, which, in In some embodiments, it can occur when a male luer portion of the mated component is found, substantially and fully threadedly engaged with the first end cap component of the luer connector.
Once the tabs of the first end cap component of the luer connector have detached or separated, the first end cap component of the luer connector can then rotate substantially freely within the second end cap component such that the male portion of the mating component cannot rotate relative to the first end cap component. In other words, when the male portion of the mated component rotates relative to the
5»
INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIAL luer connector, the first end cap component can rotate in unison with the male portion of the mated component in such a way as to substantially prevent the male portion of the mated component from disengaging from the first end cap component , and therefore, of the luer connector.
In some embodiments, a method is provided for engaging a medical implement with a connector, the method comprising the steps of connecting a first end of a medical implement with a first end of a connector. The connector may comprise a rigid housing with a first end configured to threadably engage the first end of the medical implement. The first end may comprise a first portion comprising at least one clutch surface and a second portion coaxially aligned with the first portion and comprising at least one clutch surface.
The first and second portions may be configured to be in a closed first configuration wherein the respective clutch surfaces of the first and second portions cooperate to prevent or prevent the first and second portions from rotating relative to each other, and a second position substantially unhindered wherein the first and second portions are capable of rotating relative to each other. The method further comprises twisting the medical implement relative to the connector to advance the end of the medical implement further.
IMPI
INSTITUTO MEXIC / tWO “pe LA ntOPlEDAD INDUSTRIAL
<img file="MX337063B_D0021.tif" />
threadedly the first past the first end of the connector until the medical implement and connector reach a point substantially and fully threadedly engaged. Further twisting of the medical implement relative to the connector in the forward direction beyond the point substantially and fully threadedly engaged, disengages the cooperating clutch surfaces of the first and second portions to allow the first portion to rotate relative to the second portion without disengaging the medical implement from the connector.
Other features and configurations for the above embodiments are also described herein, as well as additional embodiments for other lockable male luers connectors.
Such embodiments generally include means to allow or prevent fluid flow through a male luer in a connector, preferably automatically upon connection to a corresponding female connector. Such embodiments may also include features and configurations that allow the female portion of the male luer connector to mate with a corresponding male connector portion of another connector or medical device such as a syringe, while inhibiting or substantially preventing disengagement of the female portion. of the male luer connector of the connector portion
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INSTITUTO MEXICZJ DE LA ΡΚΟΡΙΙΪλ industr; corresponding male of the mated component.
Brief Description of the Drawings
Certain embodiments of these inventions will now be described in detail with reference to the following figures.
These figures are provided for illustrative purposes only, and the inventions are not limited to the subject material illustrated in the figures.
Figure 1A shows a perspective view of one embodiment of a male luer connector attached to a tubing configured to receive fluid from a bag.
Hanging gravity feed IV.
In this and other figures, the relative size of the connector and the attached tubing is increased compared to other objects to facilitate the observation of certain details.
Figure IB shows a perspective view of the connector of Figure 1A in a stretched, substantially open configuration.
Figure IC shows a perspective view of one embodiment of the connector of Figure 1A that is connected to an exemplary female connector attached to tubing inserted into a patient.
Figure 2 shows a perspective view of one embodiment of a closable male luer connector.
Figure 3 shows a perspective view of a housing portion of the connector of Figure 2.
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MEXICAN INSTITUTE
OF THE PROPERTY
INDUSTRIAL
Figure 4A shows a perspective view of a valve member portion of the connector of Figure
2.
Figure 4B shows a perspective view of another embodiment of a valve member portion of the connector of Figure 2.
Figure 4C shows a cross-sectional view of the embodiment of the valve member portion of the connector of Figure 4B.
Figure 5 shows a perspective view of an elastic member of the connector of Figure 2.
Figure 6 shows a perspective view of a sealing portion of the connector of Figure 2. The relative size of the sealing portion is increased compared to the components of the connector shown in other figures to facilitate observation.
Figure 7 shows a perspective view of certain components of the connector of Figure 2 in a partially assembled configuration. The housing portion of Figure 5 is not shown in Figure 7.
Figure 8 shows a cross-sectional view of the connector of Figure 2 adjacent to a female portion of another medical implement. In this stage, the fluid is prevented through the connector in Figure 2.
Figure 9 shows a cross-sectional view
<img file="MX337063B_D0026.tif" />
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0027.tif" />
of the clutch connector in Figure 2 with the medical implement in Figure 8.
Fluid is flowing through the clutch connectors.
Figure 10 shows a cross-sectional view of the connector of Figure 2 adjacent to another medical implement with a closable female luer connector. At this stage, fluid is prevented through the connector of Figure 2 and the female luer connector.
Figure 11 shows a cross-sectional view of the connectors of Figure 10 after the clutch. Fluid is flowing through the clutch connectors.
Figure 12 shows a perspective of the connector of Figure 2 adjacent a syringe to a male luer tip. At this stage, fluid is prevented through the connector.
Figure 13 shows a perspective view of the components of Figure 12 after the clutch. At this stage, fluid is still prevented through the connector.
Figure 14 shows a cross-sectional view of the connector and male luer tip of the syringe of Figure 13.
Figure 15 shows a perspective view of a closable male luer connector located with its first end adjacent to a syringe with the male luer tip and with its
IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0028.tif" />
second end located adjacent to a hypodermic needle in a female luer attachment portion.
Figure 16 shows a perspective view of the components of Figure 15 clutches. At this stage, fluid can flow through the connector.
Figure 17 is a cross-sectional view of the connector, the male luer tip of the syringe, and the hypodermic needle of Figure 16. At this stage, fluid can flow through the connector.
Figure 18A is a perspective view of another embodiment of a closable male luer connector.
Figure 18B is a cross-sectional view of the connector of Figure 18A.
Figure 18C is a detail of the cross-sectional view of the connector of Figure 18A.
Figure 19 is a perspective view of the connector of Figure 18A located adjacent to the syringe with a male luer tip.
Figure 20 is a perspective view of the components of Figure 19 clutches.
Figure 21 is a perspective view of another embodiment of a clutch clutch male luer connector with a syringe with a male luer tip.
Fig. 22A is a cross-sectional view of another embodiment of a closable male luer connector.
<img file="MX337063B_D0029.tif" />
Figure 22B is a detail of the cross-sectional view of the connector of Figure 22A.
Figure 23A is a side view of another embodiment of a closable male luer connector with a cover.
Figure 23B is a cross-sectional view of the connector of Figure 23A.
Figure 23C is a perspective view of one embodiment of a closable male luer connector adjacent to a closable female connector. At this stage, fluid flow is prevented through the female luer connector.
Figure 23D is a perspective view of the components of Figure 23C clutches.
Figure 24A is a perspective view of another embodiment of a closable male luer connector.
Figure 24B is a cross-sectional view of the connector of Figure 24A.
Figure 25A is a side view of another embodiment of a closable male luer connector with a cover.
Figure 25B is a cross-sectional view of the connector of Figure 25A.
Figure 26A is a perspective view of another embodiment of a closable male luer with a flexibly connected female luer connector.
τι;
<img file="MX337063B_D0030.tif" />
Figure 26B is a perspective view of another
<img file="MX337063B_D0031.tif" />
INSTITUTO MEXICANO DE LA FROríEDAD INDUSTRÍAL modality of a closable male luer with a flexibly connected female luer connector.
Figure 27 is a perspective view of another embodiment of a closable male luer connector.
<td></td><td>Figure 28 is</td><td>a</td><td>sight</td><td>in</td><td>court</td><td>cross</td><td>of</td>
<td>connector</td><td>of Figure 27.</td><td></td><td></td><td></td><td></td><td></td><td></td>
<td></td><td>Figure 29 is</td><td>other</td><td>sight</td><td>in</td><td>court</td><td>cross</td><td>of</td>
<td>connector</td><td>of Figure 27.</td><td></td><td></td><td></td><td></td><td></td><td></td>
<td></td><td>Figure 30 is</td><td>a</td><td>sight</td><td>in</td><td>court</td><td>cross</td><td>of</td>
<td>connector</td><td>from Figure 27</td><td colspan="2">clutch</td><td>with</td><td>a</td><td>syringe with</td><td>a</td>
<td>tip of</td><td>male luer. In</td><td colspan="5">this stage, the fluid flow</td><td>I know</td>
<td>prevents</td><td colspan="4">through the male luer connector.</td><td></td><td></td><td></td>
<td></td><td>Figure 31 is</td><td>a</td><td>sight</td><td>in</td><td>court</td><td>cross</td><td>with</td>
<td colspan="2">connector and syringe</td><td>of</td><td colspan="2">the figure</td><td colspan="2">30 clutches with</td><td>a</td>
<td>tube that</td><td colspan="2">has a portion of</td><td>Union</td><td>of</td><td>luer 1</td><td colspan="2">female. In this</td>
<td colspan="3">stage, fluid flow</td><td colspan="3">it is allowed to</td><td colspan="2">through this</td>
installation.
Figure 32 is another cross-sectional view of the connector, syringe, and tube of Figure 31. At this stage, the connector is in the process of being closed.
Figure 33 is a perspective view of the connector of Figure 27 before the clutch with one embodiment of a preparation cap.
Figure 34 is a perspective view of another embodiment of a closable male luer connector.
IK
PROPERTY INSTITUI
INDUSTRIAL • S
<img file="MX337063B_D0032.tif" />
Figure 35 is a cross-sectional view of the connector of Figure 34.
Figure 36 is a perspective view of another embodiment of a closable male luer connector.
Figure 37 is a cross-sectional view of the connector of Figure 36.
Figure 38 is a cross-sectional view of another embodiment of a closable male luer connector.
Figure 39 is a cross-sectional view of the Figure 38 clutch connector with a syringe with a male luer tip. At this stage, fluid flow is prevented through the male luer connector.
Figure 39A is a cross-sectional view of the connector and syringe of Figure 39 clutches with a tube having a female luer attachment portion. At this stage, fluid flow is allowed through this facility.
Figure 40 is a cross-sectional view of another embodiment of a closable male luer connector.
Figure 41 is a cross-sectional view of another embodiment of a closable male luer connector.
Figure 42 is a perspective view of one embodiment of a closable male luer in a closed position.
<img file="MX337063B_D0033.tif" />
Figure 43 is a perspective view of the closable male luer of Figure 42 in an open position.
Figure 44 is a cross-sectional view of the closable male luer of Figure 42.
Figure 45 is a cross-sectional view of the closable male luer of Figure 43 taken along the plane orthogonal to the cross-sectional plane of Figure 41.
Figure 46 is a schematic view of the closable male luer connector in perspective of Figure 42 taken along line 46-46.
Figure 47 is a perspective view of the valve member component of the closable male luer of Figure 42.
Figure 48 is a perspective view of the female connector component of the closable male luer connector of Figure
42.
The
Figure is an exploded view of the components of one embodiment of a closable male luer connector.
The
Figure is an exploded view of the components of one embodiment of a closable male luer connector.
The
Figure is a perspective view of a
<img file="MX337063B_D0034.tif" />
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0035.tif" />
Ho nn rrMnpnnpni-a one-mode clutch installation of a non-reversible lockable male luer connector.
<td></td><td></td><td>The</td><td>Figure</td><td> 52</td><td>is</td><td>a</td><td>sight</td><td>in</td><td>cross section of</td>
<td>the</td><td colspan="2">modality</td><td>of the</td><td colspan="2">Figure</td><td> 51</td><td>taken</td><td>to</td><td>along the line</td>
<td> 52-</td><td> 52.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>
<td></td><td></td><td>The</td><td>Figure</td><td> 53</td><td>is</td><td>a</td><td>sight</td><td colspan="2">side of a modality</td>
<td>of</td><td>a</td><td colspan="2">component <</td><td>of</td><td>a</td><td colspan="3">luer connector</td><td>non-closable male</td>
reversible.
<td>The</td><td>Figure</td><td> 54</td><td>it's a view</td><td>side</td><td>of</td><td>component of</td>
<td>Figure 53</td><td> •</td><td></td><td></td><td></td><td></td><td></td>
<td>The</td><td>Figure</td><td> 55</td><td>it's a view</td><td>side</td><td>of</td><td>a modality</td>
a component of a non-reversible closable male luer.
Figure 56 is a side view of the component of Figure 55.
Figure 57 is a perspective view of one embodiment of a closable male luer in a closed position.
Figure 58 is a cross-sectional view of the closable male luer of Figure 57 taken along line 58-58.
Figure 59 is a perspective view of the female connector component of the closable male luer connector of Figure 57.
Figure 60 is a side view of the female connector component shown in Figure 59.
<img file="MX337063B_D0036.tif" />
Figure 61 is a front view of the component of
<img file="MX337063B_D0037.tif" />
INSTITUTO MEXICANO DE LA ΓΚΟιΊΕμλΟ INDUSTRIAL female connector shown in Figure 59.
Figure 62 is an enlarged side view of an end cap portion of the female connector component shown in Figure 59 threadably inserted into the male connection portion of a mating component.
Figure 63 is a perspective view of another embodiment of a closable male luer connector in the closed position.
Figure 64 is a side view of the male closable luer embodiment shown in Figure 63 once again in the closed position, showing certain internal characteristics of the closable male luer connector in dotted lines.
Figure 65 is an exploded perspective view of the components of the closable male luer connector embodiment shown in Figure 63.
Figure 66 is an end view of the female end of the male closable luer connector embodiment shown in Figure 63.
Figure 67 is a cross-sectional view of the embodiment of the closable male luer connector shown in
Figure 63, taken along line 67-67 in Figure
66.
<img file="MX337063B_D0038.tif" />
MEXICAN INSTITUTE
OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0039.tif" />
Figure 68 is an enlarged cross-sectional view of the male closable luer connector embodiment shown in Figure 63, taken along line 68-68 in Figure 67.
Figure 69 is a cross-sectional view of the embodiment of the closable male luer connector shown in the
Figure 63, taken along line 69-69 in Figure 66.
Figure 70 is an enlarged cross-sectional view of the male closable luer connector embodiment shown in Figure 63, taken along curve 70-70 in Figure 69.
<td></td><td>The</td><td colspan="2">Figure 71 is a</td><td>sight</td><td>in</td><td>perspective</td><td>of</td><td>a</td>
<td>portion</td><td>of</td><td>the modality</td><td>of</td><td colspan="2">connector</td><td colspan="3">closable male luer</td>
<td>shown</td><td>in</td><td>Figure 63.</td><td></td><td></td><td></td><td></td><td></td><td></td>
<td></td><td>The</td><td>Figure 72 is</td><td>a</td><td>sight</td><td>in</td><td>perspective</td><td>of</td><td>a</td>
<td>portion</td><td>of</td><td>the modality</td><td>of</td><td colspan="2">connector</td><td colspan="3">closable male luer</td>
<td>shown</td><td>in</td><td>Figure 63.</td><td></td><td></td><td></td><td></td><td></td><td></td>
<td></td><td>The</td><td>Figure 73 is</td><td>a</td><td>sight</td><td>in</td><td>perspective</td><td>of</td><td>a</td>
<td>portion</td><td>of</td><td colspan="5">Male closable luer connector shown</td><td>in</td><td>the</td>
Figure 63.
<td></td><td>The</td><td>Figure 74 is</td><td>a</td><td>sight</td><td>side</td><td>component</td>
<td>shown</td><td>in</td><td>Figure 73.</td><td></td><td></td><td></td><td></td>
<td></td><td>The</td><td>Figure 75 is</td><td>a</td><td>sight</td><td colspan="2">in perspective of a</td>
<td>portion</td><td>of</td><td>the modality</td><td>of</td><td colspan="2">luer connector</td><td>closable plug</td>
IMPÍ
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0040.tif" />
shown in Figure 63.
Figure 76 is an end view of the component shown in Figure 75.
Figure 77 is a cross-sectional view of the component shown in the
Figure 75, taken along line 77-77 in Figure 76.
Figure 78A is a side view of an exemplified threaded clutch-coupled component, with the clutch male luer connector embodiment shown 'in FIG.
Figure 63.
Figure 78B is a side view of a substantially fully threadedly engaged component exemplified, with the male closable luer connector embodiment shown in Figure 63
Figure 78C substantially engaged and is a side view of a fully threadedly engaged component exemplified, with another embodiment of a closable male luer connector.
<td>The</td><td>figure</td><td>7 9A</td><td>is</td><td colspan="3">a view in</td><td>court</td><td>cross</td><td>of</td>
<td colspan="2">another form of a</td><td colspan="4">luer connector on</td><td colspan="2">position</td><td>closed.</td><td></td>
<td>The</td><td>Figure</td><td>7 9B</td><td>is</td><td>a</td><td>sight</td><td>in</td><td>court</td><td>cross</td><td>of</td>
<td>the modality</td><td colspan="3">of the connector</td><td>luer</td><td colspan="2">shown</td><td>on the</td><td>Figure 79A</td><td>in</td>
<td colspan="2">open position.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>
<td>The</td><td>Figure</td><td>80A</td><td>is</td><td>a</td><td>sight</td><td>in</td><td>court</td><td>cross</td><td>of</td>
another embodiment of a luer connector in the closed position.
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<td>The</td><td>Figure</td><td>80B</td><td>is</td><td>a</td><td colspan="3">cutaway view</td><td>cross</td><td>of</td>
<td>the modality</td><td colspan="3">of the connector</td><td>luer</td><td colspan="2">shown</td><td>on the</td><td>Figure 80A</td><td>in</td>
<td colspan="2">open position.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>
<td>The</td><td>Figure</td><td>81A</td><td>is</td><td>a</td><td>sight</td><td>in</td><td>court</td><td>cross</td><td>of</td>
<td colspan="2">another form of a</td><td colspan="4">luer connector on</td><td colspan="2">position</td><td>closed.</td><td></td>
<td>The</td><td>Figure</td><td>81B</td><td>is</td><td>a</td><td>sight</td><td>in</td><td>court</td><td>cross</td><td>of</td>
the embodiment of the luer connector shown in Figure 81A in the open position.
<td>The figure</td><td>82A is</td><td>a</td><td>sight</td><td>in</td><td>court</td><td>cross</td><td>of</td>
<td>another form of a</td><td colspan="3">luer connector on</td><td colspan="2">position</td><td>closed.</td><td></td>
<td>The figure</td><td>82B is</td><td>a</td><td>sight</td><td>in</td><td>court</td><td>cross</td><td>of</td>
<td colspan="2">connector mode</td><td>luer</td><td colspan="2">shown</td><td>on the</td><td>Figure 82A</td><td>in</td>
<td>open position.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>
<td>The figure</td><td>83A is</td><td>a</td><td>sight</td><td>in</td><td>court</td><td>cross</td><td>of</td>
<td>another form of a</td><td colspan="3">luer connector on</td><td colspan="2">position</td><td>closed.</td><td></td>
<td>The figure</td><td>83B is</td><td>a</td><td>sight</td><td>in</td><td>court</td><td>cross</td><td>of</td>
<td colspan="2">connector mode</td><td>luer</td><td colspan="2">shown</td><td>on the</td><td>Figure 83A</td><td>in</td>
<td>open position.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>
<td>The figure</td><td>84A is</td><td>a</td><td>sight</td><td>in</td><td>court</td><td>cross</td><td>of</td>
<td>another form of a</td><td colspan="3">luer connector on</td><td colspan="2">position</td><td>closed.</td><td></td>
<td>The figure</td><td>84B is</td><td>a</td><td>sight</td><td>in</td><td>court</td><td>cross</td><td>of</td>
<td colspan="2">connector mode</td><td>luer</td><td colspan="2">shown</td><td>on the</td><td>Figure 84A</td><td>in</td>
<td>open position.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>
<td>The figure</td><td>85A is</td><td>a</td><td>sight</td><td>in</td><td>court</td><td>cross</td><td>of</td>
another embodiment of a luer connector in the closed position.
f seen in
<img file="MX337063B_D0041.tif" />
of
Figure 85B is one embodiment of the luer connector shown
Cross-sectional print
<img file="MX337063B_D0042.tif" />
in Figure 85A in the open position.
Figure 86A is a cross-sectional view of another embodiment of a luer connector in the closed position.
Figure 86B is a cross-sectional view of the luer connector embodiment shown in Figure 86A in the open position.
Detailed Description of Some Exemplary Modalities
The following detailed description is now directed to certain specific embodiments of the description.
In some aspects of the embodiments described herein, a variety of means is shown for closing the second end of a male luer connector. In some embodiments, these closure mechanisms function to prevent and / or prevent fluid from escaping from or into the male luer, while allowing fluid flow when the male luer is manually opened or engaged with the corresponding female luer. . As used herein, terms such as "closed" or "sealed" are to be understood as obstructions or barriers to fluid flow. These terms should not be understood to require that a particular structure or configuration achieve complete fluid shutoff under all circumstances.
In Figure 1A, an embodiment of a
INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIAL Lockable male luer connector 10 in closed position -—— & luer connector 10 is attached to a fluid-filled gravity feed IV bag 9, which hangs from a pole support 11. At the bottom of To bag 9, a section of tubing 13 is attached. The opposite end of tubing 13 is connected to first end 12 of luer connector 10. A closure mechanism within the second end 14 of the luer connector 10 prevents the fluid contained within the bag 9 from flowing through.
<td colspan="5">through tubing 13 and leaking from the luer connector</td><td rowspan="2">10, a</td>
<td>as long as</td><td>the connector</td><td colspan="3">luer 10 stay on</td>
<td>setting</td><td>closed.</td><td></td><td></td><td></td><td></td>
<td>In</td><td>Figure IB,</td><td>the</td><td>connector</td><td>10 illustrated</td><td>in</td>
open position. Fluid can flow into the first end 12 of the connector 10 and out of the second end 14 of the connector 10. A healthcare provider can move the male luer connector 10 into this configuration by holding the second end of the closable male luer 10. with two fingers, holding the pipe 13 with two other fingers, and gently moving the fingers in opposite directions.
<td>The</td><td>system</td><td>of supply</td><td>Illustrated IV</td><td>in</td><td>the</td>
<td>Figures 1A</td><td>and IB</td><td>can enlist</td><td>easily</td><td>for</td><td>the</td>
<td>communication</td><td>fluent</td><td>with a patient</td><td colspan="2">In most</td><td>of</td>
circumstances, the pipe 13 fills with air when it is
JLV1 I -aINSTiTUTO MEXICANO DE LA PtA-OPltDAV industrial
<img file="MX337063B_D0043.tif" />
initially connected to IV bag 9. If the other exi ~ rp<sup>m</sup>^
M »··· * ·<sup>1</sup> IHNI line 13 is connected to a closed connector, as illustrated in Figure 1A, air cannot escape and fluid cannot enter line 13 from IV bag
9. Therefore, luer connector 10 is manually moved to the open position until all air is purged through luer 10 and fluid in IV bag 9 fills tubing 13 and connector 10. This procedure is known as setup. As soon as the fluid line and connector are properly prepared, the healthcare provider can quickly release opposing forces.
<td>applied</td><td>to the</td><td colspan="2">second extreme</td><td>14 of</td><td colspan="2">luer connector</td><td>10 and</td><td>the</td>
<td colspan="2">pipeline 13, and</td><td>the mechanism</td><td>of</td><td colspan="2">closed</td><td>of the connector</td><td>luer</td><td> 10</td>
<td colspan="2">can stop</td><td>quickly</td><td>the</td><td>flow</td><td>of</td><td colspan="2">flowed through</td><td>of</td>
<td>connector</td><td>luer</td><td> 10.</td><td></td><td></td><td></td><td></td><td></td><td></td>
<td></td><td>With</td><td>reference</td><td colspan="2">now to</td><td>the</td><td>Figure IC,</td><td>I know</td><td>he has</td>
<td>inserted</td><td>a</td><td>catheter 17 in</td><td>the</td><td>arm</td><td>of</td><td>a patient</td><td> 15.</td><td>The</td>
catheter 17 penetrates the skin of arm 15 and is preferably fluidly connected to the patient's bloodstream. Catheter 17 is also connected to a length of medical tubing 19 attached to a female medical connector 21. The example of a female medical connector 21 illustrated in Figure IC is a version of the Clave® connector manufactured by ICU Medical, Inc. , San Clemente, California. Multiple Modes of a Connector
INSTITUTO .McXiCAN'3 Dt LA ϊ'ϊΙΟΗΙΙλΟ INDUSTRIAL this type is illustrated and described in the Patent of
EU No.
5,685,866, which is incorporated herein by reference in its entirety.
It is contemplated that many of the embodiments of the male luer described herein may be used with other types of female connectors. Tubing 19, catheter 17, and female connector 21 were pre-fluidized using standard procedures.
The luer connector 10 is prepared as described above and engages with the female connector 21. As will be described in greater detail below, when the male connector 10 and the female connector 21 are engaged, fluid is allowed to flow from the bag. IV 9 towards the patient. When the male connector 10 and female connector 21 are disengaged, fluid is once again prevented from flowing out of the second end 14 of the male connector 10. In general, fluid is also prevented from flowing out of the opening in the female connector 21.
The embodiment illustrated in Figures 1A-1C is described in greater detail below. Each of the other embodiments described herein can be used in the illustrated fluid system, and in various modifications and alternatives thereof. Furthermore, it is contemplated that the various embodiments of connectors in accordance with the inventions may be used in a wide variety of additional medical fluid systems. For example, connectors
<img file="MX337063B_D0044.tif" />
MEXICAN INSTITUTE
D £ INDUSTRIAL PROPERTY
<img file="MX337063B_D0045.tif" />
described can also be used to transfer bodily fluids such as blood, urine, or insulin, nutritional fluids, and / or therapeutic fluids such as the fluids used in chemotherapy treatments. The described connectors can also be used to interconnect various other components of fluid transfer systems.
Referring now to Figures 2-9, the closable male luer of Figures 1A-1C is illustrated in greater detail. As illustrated in Figure 2, the assembled luer connector 10 comprises four portions: a housing 23, a valve member 16, an elastic member 18, and a sealing ring 20 (not visible in Figure 2). These portions are individually illustrated in Figures 3-6, and will be described in greater detail with reference to these Figures. The luer connector 10 can be constructed with more or fewer portions, and such portions can be combined in different configurations.
Figure 3 illustrates the housing 23 of the connector 10, separated from the other portions of the luer connector 10. The housing 23 is generally a tube-like structure with an axial passageway 28 extending from the first end 12 of the connector 10 through the upper housing 34, and middle portion 32, and luer tip 22, to the second end 14 of housing 23. In some embodiments, the length of housing 23 from first end 12 to
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0046.tif" />
luer tip 22 is approximately 1 1/8 inches., ....... Housing 23 is preferably, but not necessarily, less than or equal to approximately 1 1/8 inches from first end 12 to second end 14 such that the weight and volume of the connector are minimized. Housing 23 can be any length suitable for a particular application. The luer tip 22 connects to the remainder of the housing 23 at a base 25 that is surrounded by a cover 24. The end 27 of the luer tip 22 toward the second end of the luer connector 10 extends a distance beyond the edge 29 of the
<img file="MX337063B_D0047.tif" />
cover.
Cover 24 preferably has internal threads 26 on an interior wall, which help to securely attach connector 10 removably to another medical implement. In other embodiments, cover 24 may include other structures or materials to provide a releasable connection, including quick release mechanisms and other means. The cover 24 includes a plurality 20 of depressions 31 in an outer surface to assist the user to firmly grasp and twist the housing cover 24 with the fingers 23. The depressions 31 have sidewalls 33 tapered towards the top that prevent fingers slide out of connector 10. At one end toward the first end of connector 10 of each
INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIAL depression 31, the housing surface is approximately co-planar with the surface of the depression
31, while at one end towards the second end 14 of the connector 10 of each depression 31, the housing surface 23 is offset from, and preferably rests on, the surface of the depression 31. This configuration allows the fingers to be they slide snugly in a direction toward the second end 14 of the connector 10 along the housing 23 into a position to clamp or twist the connector 10.
Once the fingers are in the desired position, a tapered wall 33 at one end toward the second end of the depression connector 10
31, resists further movement of the fingers in the direction of the second end 14. A series of depressions extend around substantially the entire outer surface of the cover such that the user's fingers, when positioned on opposite sides of the connector
10, they will likely encounter depression 31 regardless of the orientation of connector 10 during use.
In the illustrated embodiment, tip 22 has an external tapered wall. The diameter of the tip gradually becomes smaller from the base towards the second end 27.
Tip 22 includes a hole at its second end 27.
At the base 25 of the luer tip
22, a
IMP
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0048.tif" />
inner bore 35 (see Figure 8) leads to a fluid passage region 28 in the middle portion 32 of the luer connector
10. The luer tip dimensions can be produced to meet applicable standards and / or regulations, such as ANSI standards.
The inner wall of luer tip 22 preferably includes a protrusion 30 that extends radially inward, toward the axis of fluid passage 28 surrounded by luer tip 22, narrowing fluid passage 28 at its second end 27 than in the region adjacent to the second end 27. In the illustrated embodiment, the surface of the protrusion 29 facing radially inward toward the central axis of the connector 10 tapers similarly to the taper of the outer surface of the tip 22 (see Figures 8 and 9). In this configuration, the inner diameter of the cover 29 tapers in a direction from the side towards the first end to the side of the projection 29 towards the second end. As described in more detail below, the protrusion 29 on the luer tip 22 helps to block and / or impede the flow of fluid through the connector 10 when the second end of the valve member 16 abuts it.
The middle portion 32 of the housing 23 rests between the cover 24 and the upper housing 34. As illustrated, the middle portion 32 has a larger outside diameter.
<img file="MX337063B_D0049.tif" />
<td></td><td></td><td colspan="2">INSTITUTO MEXICANO VMegí'Jj DE LA PROPERTY INDUSTRIAL</td>
<td>small than cover 24</td><td>or the</td><td>accommodation</td><td>34. The portion</td>
<td>mean 32 also has</td><td>two</td><td>openings</td><td>36 generally</td>
<td>rectangular arranged</td><td>in</td><td>the sides</td><td>opposites of</td>
<td>accommodation 23 to each other.</td><td>When</td><td>the connector</td><td>10 stands</td>
middle portion 32 is generally covered by an assembled, elastic member portion 18 (see, eg, Figure 2). As a result, the middle portion 32 generally does not come into contact with the fingers during use. Thus, in some embodiments, it is not necessary to use a clamping surface for the middle portion 32. The middle portion 32 may, therefore, have a smaller diameter and a smoother surface than any of the other sections of the housing 23.
The upper housing 34 is generally separated into two wall sections 45a, 45b by two openings 38 (only one is shown in Figure 3). The upper housing 34 includes a series of depressions 37 similar in shape and function to the depressions 31 in the cover 24. The upper housing 34 may also comprise one or more projections 43 that extend into the openings 38. In the assembled configuration, in a portion of the elastic member wall sections 45a, 45b embodiments, ribs 43 taper at their ends towards ribs 43 help to retain 18 between openings 38 in (see Figure 2). In some they taper from a thickness plus the first end of the connector,
INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIAL up to a greater thickness at its ends towards the second end of the connector.
The tapering of the ribs 43 aids in the insertion and retention of the portion of the elastic member 18 in a desired position and orientation, while allowing bending and twisting of the elastic member 18 during use. The ribs 43 also help prevent the valve member 16 from advancing too far in the direction of the first end as the connector 12 is moved to the open position by contacting the set of ribs 44 toward the second end of the valve member. valve 16. The tapering of the bosses 43 allows the bosses 44 of the valve member 16 to advance towards the second end during assembly in the housing 23 past the bosses 43 of the housing 23. The corners 47 towards the first end of the connector at each of the wall sections, are preferably rounded to avoid damage, scratches or other damage or irritation to the fingers or elastic member 18 during use.
As shown in Figure 3, the outer surface of the upper housing 34 includes a lower protrusion 39 and the outer surface of the cover 24 includes a protrusion 41 configured to help retain a central portion of the elastic member 18 around the housing 23 in the assembled configuration (see Figure 2). The projection 39 of the upper housing 34 is preferably
<img file="MX337063B_D0050.tif" />
IMPI
INSTITUTO MEXICANO E LA PROPERTY INDUSTRIAL substantially horizontal to avoid any sliding of the elastic member 18 in the direction of the first end of the connector. The projection 41 of the cover 41 is preferably tapered (see Figure 8) to aid in the proper positioning of the elastic member 18 in the housing 23 during the manufacture of the connector 10.
Housing 23 can be constructed of any number of different materials. In some embodiments, the housing 23 can be constructed of a relatively rigid material, such as polycarbonate or other polymeric material. Housing 23 and / or valve member 16 of this embodiment, or components of other embodiments, may also be constructed of a hydrophobic material, such as Bayer Makrolon, or any other suitable material.
Referring now to Figure 4A, the valve member 16 of the male luer 10 is illustrated separate from the other components of the connector 10. In some embodiments, the valve member 16 comprises a fluid passageway 52 of variable diameter extending from a first end 48 of the valve member 16 to the second end 56 thereof, surrounded by additional structures. Near the first end 48, the valve member 16 and the corresponding section of the fluid passage 52 are relatively wide to accommodate a section of standard diameter medical tubing inserted therein. About half
INSTITUTO MEXICANO Di LA INDUSTRIAL PROPERTY of valve member 16, a tube 40, which surrounds the portion of the fluid passage 52, is attached to the portion near the first end of the valve member 16. The tube is adjacent to two struts 42 approximately parallel along at least a portion of tube 40. Tube 40 may have a circular cross section or other appropriate cross section. Struts 42 are preferably relatively thin and roughly flat. A first end of each strut 42 connects to valve member 16 approximately in the middle section of valve member 16, and a second end of each strut extends toward second end 56 of valve member 16. Second end 56 of valve member 16 preferably extends further than the ends of the struts. Preferably, an open space is found between the inner wall of each strut 42 and the outer wall of tube 40.
From near the middle of the valve member 16 to the first end 48 thereof, the fluid passageway 52 comprises a wider region with ridges 44 along its outer surface. The projections 44 form two channels 46 (only one is shown in Figure 4A) longitudinally along opposite sides of the valve member body 16. In some embodiments, the struts 42 are circumferentially spaced from the struts.
IMPI
MEXICAN INSTITUTE <sup>OF</sup> THE INDUSTRIAL PROPERTY
<img file="MX337063B_D0051.tif" />
channels 46, as illustrated. -
Near the first end of the valve member 16 and tube 40, a circumferential channel 48 may be formed around the perimeter of the body of the valve member 16. The raised tabs 48 may be formed along the edge of the channel 48 toward the first end of the connector. , while the raised middle portion of the valve member may form the edge of the channel towards the second end of the connector. In some embodiments, the raised tabs 49 do not extend uniformly around the perimeter of the first end of the valve member 16, but instead have two larger sections that are diametrically spaced from each other.
The amount of material necessary to construct the valve member 16 can be reduced by indentations made in the outer layers of this portion. Tube 40 may have a passage 50 arranged through it. This passage 50 preferably extends from a hole 52 in the first end of valve member 16 to a pair of holes 50 (only one is shown in Figure 4A) positioned substantially adjacent to the second end of valve member 16. In the illustrated embodiment, these holes 52 are generally rectangular in shape. The region of tube 40 near the second end of the connector may also be formed with only one hole or more than
<img file="MX337063B_D0052.tif" />
<img file="MX337063B_D0053.tif" />
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0054.tif" />
two holes and can be used
<img file="MX337063B_D0055.tif" />
one or more of the holes. For example, the holes 52 may be drop-shaped (eg, narrow at one end and wider at the opposite end), which facilitates an injection molding manufacturing process. Furthermore, in some embodiments, valve member 16 can be constructed without a fluid path and function as a blocking plunger for fluid flowing around valve member 16 rather than a means to transport fluid between the first and third ends. second from connector 10.
Tube 40 of valve member 16 comprises, at its second end, a flange section 58. Flange section 58 preferably extends in the radial direction more than the adjacent portion of tube 40. In some embodiments, the flange section Flange 58 may be formed from the same or substantially the same material as the remainder of tube 40. Flange section 58 preferably tapers from the first end of valve member 16 toward the second end of tube 40. In some embodiments, the taper is formed at a 5 degree angle and has a taper substantially identical to that of the radially inward facing surface of housing boss 30 23. Other degrees of taper, or no taper, may also be used.
<img file="MX337063B_D0056.tif" />
The valve member 16, blunt housing 23 of
<img file="MX337063B_D0057.tif" />
IM
INSTITUTO MEXICANO DE LA PKQPiSOAD INDUSTRIAL Figure 3 can be constructed of a number of different materials.
Examples of such materials include polycarbonate or other polymeric materials. The valve member 16 may be approximately the same length and somewhat shorter than the housing.
23.
For example, the length of the valve member can be about 1 inch.
In some embodiments, the valve member 16 can be substantially shorter than the length of the housing 23. The valve member can be formed from the same rigid materials as the housing 23.
In certain applications, for example, it may be desirable to use semi-rigid or even more flexible materials in the valve member 16, and more particularly for the rim section 58 towards the second end of the tube 40.
Valve member 16 can be manufactured by injection molding. In some embodiments, at least two inlets are used to facilitate the distribution of the molten plastic throughout the mold. Preferably, one inlet may be located along one of the sides of the valve member 16 between the end of the struts 42 toward the first end of the connector and the raised tabs and another may preferably be located near the holes 52 in the valve member. valve 16. However the «eesewsMt
<img file="MX337063B_D0058.tif" />
The location of the other inlet locations is not fixed, and · γ * γ »can be used for the inlets on the valve member 16 when the valve member is injection molded
16.
The construction of both housing 23 and valve member 16 of this or other embodiments of the same material decreases the possibility of impaired performance of connector 10 due to thermal expansion / contraction or chemical interaction between connector 10 and its environment. .
Although the valve member 16 of the illustrated embodiment is configured as shown in Figure 4A, many other configurations are possible. In some embodiments, valve member 16 may be relatively smooth on its outer surface, and may primarily comprise tube 40 defining passage 50. In still other embodiments, different numbers of struts 42 may be provided along the sides of the valve member 16.
As can be seen in the embodiment illustrated in Figure 4B, the raised tabs 150 near the first end of the valve member 16 may also comprise an outer clutch surface 150, such as a screw thread, to removably attach a medical implement. (not shown), such as a syringe, with the first end of the valve member 16.
MEXICAN INSTITUTE>
OF PROPERTY V \ - * TMI ΛΛ industrial
In the embodiment illustrated in Figure 4C, the Channel may be further tapered along the inner SUPerPlrter. Tapering of channel 48 can result in a decrease in channel width with a greater dimension at the first end 180 of the valve member 16 and a smaller dimension towards the second end 184 of the valve member. The inner taper of channel 48 can complement and closely fit the taper of the male luer. Such internal taper can meet ANSI standards and / or regulations, such as the standard for medical syringes. In the illustrated embodiment, the tube 40 of the valve member 16 does not have a flange section 58 that extends radially outwardly beyond the wall of the tube 40, as in the embodiment of Figure 4A. Rather, the wall of tube 40 tapers radially inward in the region of the second end. The second end 27a of the luer tip 22a may have a smaller second cross-sectional portion 170 that decreases the likelihood of fluid escaping along the inner surface of the second end 27a of the luer tip 22a. Near the second end 27a of the luer tip 22a, a larger cross-sectional region 160 can transition to a smaller cross-sectional portion 170 toward the second end of the connector in many different ways, such as with an abrupt transition. of
IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0059.tif" />
staggered stages as illustrated in Figure 4C or with a gradual taper transition, or other transitions. Some samples of diameters in cross section of the
<td>opening</td><td>in</td><td colspan="2">the second extreme</td><td>27th</td><td>from luer 22a</td><td>include</td>
<td>those</td><td>of</td><td>approximately</td><td> 2</td><td>mm</td><td>or less, what</td><td>include</td>
<td colspan="3">about 0.5mm, 0.75</td><td>mm,</td><td> 1.0</td><td>mm, 1.25 mm, 1</td><td>.5 mm, and</td>
1.75 mm. The diameters of the opening at the second end 27a can also be in the ranges of 0.4 mm - 1.8 mm, 0.5 mm - 1.5 mm, and 0.5 - 1.0 mm. Other diameters can also be used, either within or outside of the listed ranges. Additionally, the second end of the valve member 16 can be appropriately sized to occupy the space in the opening of the second end 27a of the luer 22a.
As shown in Figures 4B and 4C, the closable male luer connector 10 has both a female end 180 and a male luer end 184. The closable female connector 21 of Figure 1C (referred to above) and 210 of Figures 10 and 11 (described in greater detail below), as well as other standard female connectors with similar external structure, also has both female and male ends. In many embodiments, such female connectors use seals or other fluid barriers to prevent fluid flow at the female end but not at the male end. In many of the embodiments of the closable male luer connectors illustrated herein, no seal or
<img file="MX337063B_D0060.tif" />
IMPI
INSTITUTO MEXICANO DE LA RKOrtEDAD INDUSTRIAL another fluid barrier shown on the female end. However, the female end of any of the closable male luer connectors described herein can be configured to include a closable female end. For example, the structure for selective fluid impediment with female connector 21 or 210, or with any of the other standard female connectors, could be included within the female end of any of the closable male luer connectors described herein to provide a connector that selectively seals or prevents fluid flow at both ends. In some such embodiments with closable male and female ends, it may be advantageous to place a resilient seal member in or near the female opening, as shown in US Patent No. 5,685,866. By positioning the sealing element in this manner, it is possible to clean the female opening before use, with antiseptic in a scrubbing motion to prevent a harmful accumulation of debris, bacteria, antiseptic, or other unwanted substances on the seal element and / or in the region between the seal member and the connector housing adjacent the seal member.
Referring now to Figure 5, elastic member 18 is described in greater detail. In the illustrated embodiment, the elastic member 18 is made up of two rings
60, 62 separated by two elastic members 64. The rings
<img file="MX337063B_D0061.tif" />
<img file="MX337063B_D0062.tif" />
INSTITUTO MEXICANO OSLA INDUSTRIAL PROPERTY
<img file="MX337063B_D0063.tif" />
and / or elastic members 64 may be made of a deformable material configured to exert a restoring force when extended. Thus, if rings 60, 62 are pulled in opposite directions, elastic members 64 function to restore rings 60, 62 to their unextended configuration.
The elastic members 64 can be constructed of a number of elastic materials. In some embodiments, the elastic members 64 are made of an elastic silicone rubber material. In other embodiments, the elastic members 64 can be made of a shape memory material. In still other embodiments, elastic members 64 and / or elastic member 18 may comprise springs or other structures capable of exerting restoring force.
Rings 60, 62 can also be made of a number of materials. In some embodiments, the rings 60, 62 are made of the same deformable elastic material that the elastic members 64 comprise. Thus, the rings 60, 62 can be stretched to a diameter to extend around the appropriate portion of the housing 23 to which each respective ring 60, 62 is attached. The elasticity of rings 60, 62 can function to effectively hold each ring 60, 62 in place in housing 23. In other embodiments, rings 60, 62 can be made of rigid or semi-rigid materials and, for example, understand
<img file="MX337063B_D0064.tif" />
half circles that can spring shut in and out
TT ~ iTTri ~ rrj ιι, ιιι ι · ι ·. íhj mmiw · ι »ι-τί ··· <τη» · —_π - ιι iht of position. In some embodiments, elastic member 18 may be integrated within valve member 16 or housing 23. In some embodiments, other structures and / or configurations may be used to selectively drive valve member 16 and housing 23 together differently than elastic member 18.
Referring now to Figure 6, the sealing portion 20 is described in greater detail. In some embodiments, the sealing portion 20 is substantially cylindrical and has a hole 66 extending through it. In some embodiments, the sealing portion 20 further comprises a pair of generally rectangular ribs 68 that extend from the side walls of the cylindrical portion at diametrically opposite positions. The projections 68 can have different shapes and / or positions. The sealing portion 20 may also have a generally smaller diameter middle portion 67 surrounded by two rings 69 at each end with larger diameters.
The sealing portion 20 can be made of a number of different materials. In some embodiments, the sealing portion 20 is made of a deformable silicone-based material 70. The deformable silicone-based materials are among those that form fluid-tight seals with plastics and other materials.
INSTITUTO MEXICANO DE LA PROPERTY INDUSTRIAL rigid polymeric.
The sealing portion 20 can be made of the same material as the elastic member 18.
<td colspan="4">In Figure 7,</td><td colspan="3">their show certain components of the</td>
<td>male luer</td><td> 10</td><td>of</td><td>a</td><td>modality. What</td><td>is illustrated,</td><td>the</td>
<td>accommodation</td><td> 23</td><td>I know</td><td>omit</td><td>. The member of</td><td>valve 16,</td><td>the</td>
elastic member 18, and sealing portion 20 are shown assembled in their respective locations.
Certain interconnections between the various portions of the male luer 10 will now be described in greater detail. As shown, the smaller ring 62 of the elastic member 18 fits within the circumferential channel 54 of the valve member 16. In some embodiments, the smaller ring 62 can be stretched to have a larger inside diameter than the raised tabs 49 than the first end of valve member 16. Once the smaller ring 62 has advanced into position around the circular channel 54, it can be released, such that it wraps tightly around the circular channel 54, as shown.
The larger ring 60 of the elastic member 18 extends around the middle portion 32 of the housing 23 (as shown in Figure 2), and can be stretched and positioned in a manner similar to that described above with respect to the small ring 62. elastic members 64 of elastic member 18 can then extend between the
INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIAL small ring 62 and larger ring 60 of the elastic-m-lembeo 18 and preferably extend along and within channels 46 in valve member 16. Once located within these channels, elastic members 64, in effect, are trapped by shoulders 44 along the outer walls of the channel. As seen in Figure 2, the elastic members 64 may also extend along the openings 38 in the upper housing 34 of the housing 23. The openings 38 are positioned generally above the channels 46 in the illustrated embodiment. Resilient member 18 thus provides a resilient connection between housing 23 and valve member 16, pulling valve member 16 into engagement with housing 23.
The sealing portion 20, which is partially hidden by the elastic member 18 in Figure 7, preferably fits snugly around the tube 40 and rests between the struts 42 of the valve member 16.
Figure 8 illustrates a cross section of the male luer of. the present embodiment adjacent to an exemplary female connector 92. In this cross-sectional view, the interconnections and interactions between housing 23, valve member 16, and sealing portion 20 can be seen in greater detail. Valve member 16 is
IMPI
Mexican Institute of Industrial Property
<img file="MX337063B_D0065.tif" />
configured to be positioned within housing 23. As illustrated, tube 40 of valve member 16 can be inserted into and through lumen 28. Meanwhile, struts 42 are configured to pass through corresponding longitudinally extending openings to through the middle portion 32 of the housing 23. In an assembled configuration, struts 42 are adjacent to tip 22 along two sides, and tube 40 is at least partially contained within tip 22. Ribs 44 are captured within openings 38 formed in upper housing 34 of housing 23.
A closure mechanism 56 is adapted to close the fluid passageway that extends through the closable male luer 10 from fluid communication with the external environment, preferably, when the male luer 10 is not in engagement with the female connector 92. In In the illustrated embodiment, fluid passage 52 comprises lumen 28 thus
<td colspan="3">as to the passage</td><td colspan="4">54 of the valve member 16. The mechanism</td><td rowspan="2">of the</td>
<td>closed</td><td> 56</td><td>of</td><td>the modality</td><td>illustrated</td><td colspan="2">understand so much</td>
<td>section</td><td>of</td><td colspan="2">flange 58 of</td><td>tube 40</td><td>As the</td><td colspan="2">taper</td>
<td>inside</td><td>of</td><td>the</td><td>raised portion</td><td colspan="2">29 of lumen 28.</td><td>Tailored</td><td>what</td>
10.
These two surfaces come into contact, they can form a seal at or near the second end of the male luer
<img file="MX337063B_D0066.tif" />
MEXICAN INSTITUTE
OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0067.tif" />
Internal taper surfaces. Substantially coupled from raised portion 58 of tube 40 and raised portion 29 of lumen 28, assist in providing closure for female connector 92. A relatively fluid-tight seal is preferably formed. The clutch between the raised portions 29 and 58 can also be created in a number of different ways. In some embodiments, the material of the rim section 58 and the material of the raised portion 29 of the lumen 28 are configured to fit closely together, and are made of sufficiently compatible materials, to form a fluid-tight seal. In other embodiments, rim section 58 and / or additional portions of valve member 16 may be made of a deformable material that more closely follows the contours of the inner surface of lumen 28, and lumen 28 need not have a taper. . The sealing portion 20 is configured, in some embodiments, to prevent fluid from escaping from within the male luer connector 10. When valve member 16 engages with housing 23, sealing portion 20 rests between middle portion 32 of housing 23 and tube 40. When fluid flows into lumen 28 of housing 23 and along the outer surface of tube 40, fluid is prevented from flowing past middle portion 32 by sealing portion 20, and more particularly
IMFl ^
INSTITUTE MMCAMO Vzí
DB LA VROVreDAD industrial is hosting maintained and
the by rings 69 on both ends of
20.
The sealing portion is preferably in position between the valve member 16 by the ribs 68 (see Figure 6) configured to fit within the holes 36 in the middle portion 32 of the housing 23. The ribs 68 help to hold the sealing portion 20 in proper alignment.
With reference to the embodiment illustrated in Figure 8, the structure of an exemplary female connector 92 will now be described in greater detail. The female connector 92 may comprise an elongated body 72 having a fluid passage 74 therethrough, and the female connector 92 may have a tip 76 near its distal end. In some embodiments, the tip 76 of the female connector 92 has a radially extending surface 78 disposed on its outer surface. Female connector 92 may have a fluid conduit positioned within female connector 92.
A fluid conduit compatible with the connectors 10 described herein is not included or required on all female connectors. Along a proximal inner surface 80 of female connector 92, fluid passage 74 preferably tapers such that the diameter of fluid passage 74 decreases in the distal direction.
i - ^ ga = as— ~ nr · ί | - r
<img file="MX337063B_D0068.tif" />
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0069.tif" />
As shown in Figure 8, housing 23, —---------------- -<sub>F</sub> -, - || n nipaarr <, r, <, j <
the valve member 16, the elastic member 18, and the sealing portion 20 are in an assembled configuration, in which the closing mechanism 56 forms a closing clutch between the rim section 58 and the interior of the lumen 28. In addition , the sealing portion 20 is in close clutch between the valve member 16 and the housing 23. Fluid from the passage 50 may flow through the windows 54 of the tube 40 of the valve member 16. In this position, the windows 54 communicate with the interior of the tip 22, but not yet with the external environment. Lumen 28 is closed at its second end by closing mechanism 56 and at its first end by sealing portion 20.
As shown in Figure 8, the struts 42 of the valve member 16 extend through the openings in the housing 23 such that their ends extend to positions near the end of the cover 24 toward the second end of the connector. . These struts 42 are configured to engage proximal ends 84 of female connector 92 as female connector 92 advances to engage male closable luer 10.
In Figure 8, the female and male luers are shown in a disengaged configuration. To engage the male luer 10 and female connector 92, the surface to be
IMPI
INSTITUTO MEXICANO dela rnoi'i í: The radially extending 78 of the female connector 92 is screwed into the internal threads 26 of the male luer 10.
As shown in Figure 9, the two luers can be threadedly engaged towards each other until the taper of the inner surface 80 of the female connector 92 rests adjacent the correspondingly tapered outer surface of the tip 22. In other embodiments, The two luers can be threadedly engaged until the second end of the tip 22 forms a seal with a corresponding surface (not shown) of the female connector 92.
As the male luer connector 10 and female connector 92 are threadedly engaged towards each other, the proximal end 84 of the tip of the female connector 92 contacts the struts 42 of the valve member 16. As the male luer connector 10 and the female connector 92 move further in engagement in a threaded manner, the struts 42, and thus the valve member 16, move in the direction of the first end of the male connector via the female connector 92 , displacing the valve member 16 relative to the housing 23. Thus, the flange section 58 moves from the second end of the tip 22 of the housing 23 toward the first end of the male connector. As these two tapered surfaces separate, a space forms between the
INSTITUTO MEXICANO DE LA PROPERTY INDUSTRIAL valve member 16 and housing 2.3 .. and fluid is allowed to pass through port 30 into fluid passage 74 of female connector 92, or vice versa. When used with some embodiments of female connector 92, an internal fluid conduit contacts second end of valve member 16 before female connector housing 92 contacts struts 42 to open male connector 10. . In some embodiments, the closure remains intact until the inner surface 80 of the tip of the female connector 92 forms a closing clutch with the outer surface of the tip 22 of the male luer 10. Thus, the passage 50 of the male luer 10 needs not being in fluid communication with the external environment.
As valve member 16 moves relative to housing 23, elastic members 64 (not shown in Figure 9) of elastic member 18 expand and exert a restoring force. As long as the female connector 92 is in engagement with the male luer 10, this restoring force can be resisted by the radially extending surface 78 of the female connector 92 that contacts the internal threads 26 of the housing 23. However, when female connector 92 is removed from male luer 10, elastic member 18 returns to valve member of valve member 16 in close engagement with lumen 28.
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0070.tif" />
Despite the relative movement between housing 23 and valve member 16, sealing portion 20 preferably maintains a fluid barrier. between the outer surface of the tube 40 and the inner surface 5 of the lumen 28. In some embodiments, the position of the sealing portion 20 is maintained by the shoulders 68. In other embodiments, the sealing portion 20 may be positioned by adhering the outer surface of the deformable material 70 to the inner surface of the lumen 28 of the housing 23. Other means may be used to secure the sealing portion 20.
As shown in Figure 9, in the open configuration, fluid passage 74 of female connector 92 can fluidly communicate with passage 50 of valve member 16. Fluid can thus flow from tubing 13 attached to male luer 10, into passage 50 of valve member 16, through windows 54 into lumen 28, out of lumen 28 through orifice. 30 at the second end of the tip 22 to the fluid passageway 74 of the female connector 92, and vice versa. Fluid is prevented from escaping male luer 10 through the opening between housing 23 and valve member 16 by sealing portion 20. A fluid tight seal may also be formed between the corresponding tapers 25 of the tip 22 of the housing 23 and the internal surface 80.
<img file="MX337063B_D0071.tif" />
INSTITU
<img file="MX337063B_D0072.tif" />
female connector 92. --— ........
Returning to Figure 10, the connector 10 is deployed adjacent a closable female luer connector 210. In the sample embodiment illustrated here, the closable female luer connector 210 comprises an outer housing 213, a void 212, a fluid passage 218 , a fluid conduit 216 with one or more holes 215, a compressible sealing element 214 with a proximal surface 217, and a threaded clutch region 211. The closable female connector 210 is positioned with its proximal end adjacent to the second end 56 of the male connector 10. The threaded clutch region 211 of the closable female connector 210 can conform to the standard dimension for luer connectors, such as those that meet the standards. ANSI. The compressible sealing element 214 can be comprised of a water-impermeable elastic material that can shrink in size when a force is exerted on it. Fluid conduit 216 may be comprised of a rigid material, such as polycarbonate plastic, that is capable of resisting deformation when sufficient force is exerted to compress sealing member 214 onto closable female connector 210.
Fluid passage 218 can place fluid conduit 216 in fluid communication with the second end
219 of the closable female connector 210. At least one hole
<img file="MX337063B_D0073.tif" />
INSTITUTO MEXICANO DE LA RROHEDAD INDUSTRIAL
215 in the fluid conduit 216 can be sealed by the compressible seal element 214 to prevent the fluid passage 218 from being in fluid communication with the void space 212 between the compressible seal element 214 and the internal wall of the housing 213 and / or with the exterior of housing 213. The orifice (s) 215 may be appropriately sized, small enough to allow fluid to pass between the fluid passage 218 and the void space 212 at an appropriate flow rate. Such a size for the hole (s) 215 is approximately 1mm in diameter, although irregular shapes and other sizes can be used. Holes of at least about 1mm or about 1mm to 3mm, or smaller than about 1mm, can also be used. The connector 10 can be engaged with a tube assembly 13 containing a fluid.
Referring to Figure 11, the connector 10 can be threadedly engaged with the closable female connector 210. The threaded region 211 of the closable female connector 210 can engage with the internal threading 26 of the male connector 10 to engage connectors 10, 210 , as illustrated. In the illustrated clutch, luer tip 22 advances toward closable female connector 210 compressing compressible seal member 214. As can be seen, the luer tip 22 contacts the compressible seal element
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0074.tif" />
214 on proximal surface 217 of 'Téléiftéhtó dé' SS'lhS compressible 214. The force exerted to engage connectors 10, 210, and to engage threaded regions 26, 211, is sufficient to compress seal element 214 to expose holes 215 in fluid conduit 216. With seal member 214 compressed, fluid passage 218 is in fluid communication with the interior space of luer tip 22.
<td>TO</td><td>measure</td><td>what</td><td>the</td><td>tip of</td><td>luer</td><td> 22</td><td colspan="2">get moving</td>
<td colspan="2">additionally towards</td><td>the</td><td colspan="2">female connector</td><td colspan="2">closable</td><td> 210,</td><td>the</td>
<td>conduit of</td><td>fluid 216</td><td>I know</td><td>places</td><td>in contact</td><td>with the</td><td colspan="2">extreme</td><td>of</td>
valve member 16 toward the second end of the male connector. The valve member 16 is moved toward the first end of the male connector by contact and continuous advancement of the luer tip 22. The elastic member 18 exerts a closing force in a direction toward the second end of the male connector on the member. valve 16. As a result, the tip of the valve member 16 toward the second end of the male connector generally maintains contact with the fluid conduit 216 throughout the entire clutch. As the valve member moves in a direction toward the first end of the male connector, the flange section 58 of the valve member 16 separates from the inner surface of the housing 23 through which the hole 30 passes. As a result , the Windows
<img file="MX337063B_D0075.tif" />
INSTITUTO MEXICANO DF LA INDUSTRIAL PROPERTY
<img file="MX337063B_D0076.tif" />
they open to fluid communication with the closable female connector 210. The compressed seal member 214 inhibits the flow of fluid into the closable female connector 210 past the luer tip 22. In this configuration, fluid can flow from tubing 13 at the end of valve member 16 to the second end of the male connector and into tubing 40 through windows 54, into lumen 28, out of the hole 30 in luer tip 22, into outer housing 213 of closable female connector 210, into holes 215 in fluid conduit 216, and into fluid channel 217 within fluid conduit 216. Thus, the second end of the connector 210 is placed in fluid communication with the proximal end 219 of the closable female connector 210. Additionally, the sealing portion 20 preferably maintains a fluid barrier between the outer surface of the tube 40 and the surface. lumen 28, confining fluid flow to closable female connector 210. When the surface of the valve member towards the second end of the connector is directly contacted by a female connector member such as the fluid conduit 216, the struts 42 cannot be engaged by the female connector.
The connectors 10, 210, can be disengaged from
<img file="MX337063B_D0077.tif" />
INSTITUTO MEXICANO DE LA PROPERTY INDUSTRIAL threaded way. During disengagement, the elastic member 18 may return the connector 10 to its pre-clutch state by directing the valve member 16 to engage the flange section 58 at the end of the valve member 16. towards the second end of the male connector with the inner surface of the luer tip 22. Similarly, the elastic material of which the compressible seal is composed can return to its shape in the closed position, and the proximal surface 217 can seal the proximal tip of the closable female connector 210.
Now, referring to Figure 12, the connector may be in engagement with a syringe 250. In Figure 12, the syringe 250 and the connector 10 are deployed adjacent to each other. The syringe may comprise a male luer connector 252, a plunger 258, a reservoir 260, and convenient projecting anchors 262. The luer connector 252 may further comprise an internally threaded cover 254 and a syringe luer tip 256. In the illustrated embodiment of connector 10, a threaded surface 150 is provided on the outer surface of the first end of valve member 16.
Now, referring to Figure 13, the connector may be threadedly engaged with the syringe 250. The cover 254 may be engaged with the end of the valve member toward the first end of the valve member.
INSTITUTO MEXICANO DE LA PROPERTY INDUSTRIAL connector to connect connector 10 to the syringe
<img file="MX337063B_D0078.tif" />
Reservoir 260 of syringe 250 may be placed in fluid communication with tube 40 inside valve member 16.
Returning to Figure 14, the clutch illustrated in Figure 13 is shown in cross-sectional view. Syringe 250 is threadedly engaged with connector 10 through the clutch between cover 254 and threaded surface 150 of valve member 16. Luer tip 252 of syringe 250 is extended into tube 40 of valve member. valve 16. Syringe reservoir 260, shown here with fluid in reservoir 260, is in fluid communication with the interior of valve member 16. Fluid can pass through tube 40 and into luer tip 22 of connector 10 In the illustrated embodiment, fluid cannot exit connector 10 outside of its male luer tip 22 because flange section 58 is in contact with the inner surface of lumen 28. Consequently, the hole 30 in the tip of the housing 23 towards the second end of the connector is blocked by the valve member 16. In order for the syringe 250 and the connector 10 to transition from the stage shown in Figure 12 to the stage shown in Figure 14, it may be necessary for the valve member 16 to be temporarily opened to release the air
INSTITUTO MEXICANO DE LA PRONEDAD INDUSTRIAL (as described in greater detail below).
Referring to Figure 15, the connector is shown adjacent to and between a syringe 250 and a sheathed hypodermic needle 270. Syringe 250, like that of Figure 12, may comprise a male luer connector 252, a plunger 258, a reservoir 260 and convenient projecting anchors 262. The luer connector 252 may further comprise an internally threaded cover 254 and a syringe luer tip 256. The sheathed needle 270 may comprise a
<td>housing 266 with raised fins</td><td> 264</td><td>in</td><td>the</td><td>extreme</td><td>of</td>
<td>clutch and needle 268.</td><td></td><td></td><td></td><td></td><td></td>
<td>With reference to Figure</td><td> 16,</td><td>the</td><td colspan="2">connector 10</td><td>I know</td>
<td colspan="2">shows clutch in threaded manner both</td><td>with</td><td>the</td><td>syringe</td><td> 250</td>
as with the sheathed needle 27 0. The threaded surface 150 of the valve member 16 of the connector 10 may engage with the threaded cover 154 of the syringe 250. Consequently, the luer tip 256 may protrude into the tube 40 of the member. Valve valve 16. Similarly, the raised flaps 264 may engage with the internal threading of the cover 24 of the connector 10. The luer tip 22 of the connector 10 may protrude into the housing 266 of the needle sleeve.
In Figure 17, the clutch shown in Figure 16 is illustrated in cross-sectional view. The connector is clutch by means of a 250 syringe and a needle
IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0079.tif" />
sheathed 270. Syringe 250 engages — engaged — threadedly with threaded surface 150 of valve member 16 of connector 10. Sheathed needle 270 is threadedly engaged with internal threading 26 of cover 24.
Luer tip 256 of syringe 250 exits into tube 40 of valve member 16. Reservoir 260 of syringe 250 is in fluid communication with tube 40 of valve member 16 through luer tip 256.
The connector 10 is in engagement with the sheathed needle 270. The sheathed needle housing 266 has raised fins 264 near its proximal end. Raised wings 264 threadably engage internal threading 26 to cover 24 of connector 10. As luer tip 22 advances toward housing 266 of needle 268, the proximal end of housing 266 can come into contact with the struts 42 of valve member 16. When sheathed needle 270 is fully engaged with connector 10, valve member 16 has moved a distance that separates rim section 58 from the tapered inner wall of lumen 28, sufficiently to allow fluid to flow out. of the windows 54 of the valve portion 16. The fluid can then flow out of the hole 30 in the end of the luer tip 22 and
INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIAL toward the housing 266 of the sheathed needle 270. The hollow tube 268 allows fluid to flow from within the housing 266 to the exterior of the distal tip of the needle 268. The sealing portion 20 preferably maintains a fluid barrier between the outer surface of tube 40 and the inner surface of lumen 28, confining fluid in the lumen and directing the fluid toward hole 30 in luer tip 22. Thus, at this stage, the syringe 250 is in fluid communication with the distal tip of the needle 268. As previously illustrated in Figures 13 and 14, in some embodiments, the connector 10 will generally not allow fluid to flow out. of the syringe 250 without a clutch component with the second end 14 of the connector
10. The component illustrated in Figures 15-17 is a needle with a sheath 270; however, other components may also be used, such as those that allow fluid to flow and have a female luer clutch portion.
Figure 18A displays a perspective view of another embodiment of a closable male luer. The rotary connector 300 is comprised of a housing 310, an internal passageway 322, and a seal member 330. The housing is further comprised of a luer tip 312, a luer receiver 316 at the first end of the connector 300, a portion of clutch 318, a handling portion 320, and a
IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0080.tif" />
raised portion 34 0. The element of seal 3jU piiude. Lcnui.
an opening 350 along its surface
314 in a transverse direction.
The internal passage
322 may extend from luer receiver 316 toward luer tip 312.
Housing 310 can be comprised of a waterproof material such as polycarbonate plastic.
Housing 310 can also be comprised of a hydrophobic plastic. Other examples of suitable materials for the construction of housing 310 are GE Valox 420 filled with glass or polypropylene.
Depending on the application, many other materials can also be used.
to receive
Accommodation
310 The illustrated is configured for a male luer tip on luer receiver 316 threadably engaging the male luer in its clutch portion 318.
The receiver 316 can conform to ANSI standards for a luer receiver. The illustrated manipulation portion 320 has two fins that extend radially from the central axis of housing 310. The manipulation portion 320 is configured to assist the user in grasping and rotating the connector 300.
The illustrated housing 310 is also constructed to provide a closable male luer at its second end. Luer tip
312, at the second end, can be constructed to ANSI standards for a male luer tip.
The luer tip attaches the body
INSTITUTO MEXICANO DE LA INDUSTRIAL PROPERTY main housing 310 in raised portion 340. Raised portion 340 is constructed to inhibit luer tip 312 from advancing too far toward a luer receptor. Housing 310 may also have an opening portion 340 behind raised portion 340. Luer tip 312 may also have a seal member 330 having a surface 314 toward the second end of the connector. The seal member 330 can be of any elastic waterproof material including, without limitation, silicone. The selection of the material for the seal construction can be accomplished by the person skilled in the art. The luer tip 312 may taper smaller in a direction from the raised portion 340 as it reaches its second end.
Seal member 330 may also have an opening 350 in surface 314 toward the second end of the pre-clutch connector with any other component. Aperture 350 may be a slit in a direction transverse to the longitudinal axis of housing 310. Aperture 350 may be centered across surface 314, or located at another position on surface 314. The seal member 330 may completely cover the second end of the luer tip 312, or only a portion thereof. The seal member 330 may be attached to the housing by a process of
<img file="MX337063B_D0081.tif" />
MEXICAN INSTITUTE
OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0082.tif" />
overmolding, among other joining methods. In such a process of overmolding ,. Housing 310 can be formed by injection molding in a first stage, and then, in a second stage, housing 310 can be reinserted into a mold (or remain in a mold) and an appropriately sized casting bolt (not shown) can be inserted through a wider end of housing 310, such as the second end. A silicone material can then be injected into the mold to form seal member 330. In other embodiments, seal member 330 may be glued or otherwise adhered to housing 310.
As can be seen from the embodiment illustrated in Figure 18A, seal member 330 can inhibit fluid flow through housing 310 when luer tip 312 is not engaged with another component. Thus, when a fluid-containing component (not shown) with a male luer connector is connected to luer receiver 316, connector 300 can be used to control fluid flow through its luer tip 312. For example, when a fluid-containing component, such as a syringe, engages with connector 300, it allows fluid to fill housing 310 of connector 300 by flowing through internal passage 322, but seal member 330 can substantially inhibit fluid flow out of luer tip 312. If the
<img file="MX337063B_D0083.tif" />
IM
INSTITUTO Mí DE LA PROt'IFi · / i;
INDUSTRIAL interior space of housing is filled with air or other gas before fluid enters, connector 300 may need to be opened to allow air, or other gas, to escape before fluid can enter.
In some embodiments, as described in detail below, the inner surface of seal member 330 can be adapted to increase resistance against widening of opening 350, which could allow fluid to escape when fluid (not shown) exerts a pressure against the seal element 330 from the internal passage 322. Thus, connector 300 inhibits fluid flow from a fluid-containing component, when connector 300 is attached to the male luer of the fluid-containing component, with no other component connected to luer tip 312 of connector 300.
In some modes of use, aperture 350 on surface 314 of seal member 330, normally closed in the position shown, may open when luer tip 312 contacts a suitable female connector, such as a sold Clave® connector. by ICU Medical, San Clemente, California. A clutch of this illustrated configuration is discussed in detail below. The clutch can be achieved in many other ways and with many other structures, including connectors other than the Clave (®
Figure 18B is a cross-sectional view of the
<img file="MX337063B_D0084.tif" />
connector 300 illustrated in Figure j! 8A. Connector 300 may have an internal passageway 322 that connects luer receiver 316 to luer tip 312. Clutch portion 318 may be configured to receive an internally threaded cover from a male luer connector (see Figure 19). Handling portion 320 may extend radially away from internal passage 322, as shown. Seal element 330 can extend along at least part of internal passage 322 and can be disposed through at least part of second end of connector 300. Seal element 330 can extend beyond end of luer tip 312. Seal member 330 may have a cross-sectional area approximately equal to housing 310 at the end of luer tip 312. In those embodiments in which luer tip 312 and seal member 330 are generally circular, the outer diameter of seal member 330 may be equal to the outer diameter of luer tip 312. Seal member 330 is missing. confined to a circular shape (or any other structure described herein) and other shapes may be used. In other embodiments, the seal member 330 does not extend beyond the end of the housing 310 toward the second end of the connector 300, but may have a maximum external dimension equal to the internal dimension of the luer tip 312. The seal member
<img file="MX337063B_D0085.tif" />
Seal 330 may have a closure portion 324. Seal portion 324 may allow fluid to flow through seal member 330 of connector 300, but is generally diverted to close opening 350 in seal member 330. The structure of the closure portion 324 can be adapted to resist allowing fluid (not shown) to flow out of the opening 350, when the luer tip 312 is not engaged with another component, as described in greater detail below.
As can be seen in Figure 18C, which is a detail of the cross-sectional view presented in Figure 18B, the seal member 330 may comprise the entire surface area of the second end of the connector 300. In other embodiments, the seal member 330 it may not be extended beyond housing 300. Internal passage 322 may extend into the seal at the second end of connector 300.
Figure 19 illustrates a perspective view of the
<td>connector 300</td><td>adjacent</td><td>to</td><td>The syringe</td><td> 360.</td><td>Like in</td><td>the</td>
<td>descriptions</td><td>previous,</td><td>the</td><td>syringe</td><td>can</td><td>understand</td><td>a</td>
<td>luer connector</td><td>male 362,</td><td>a</td><td>deposit of</td><td>fluid</td><td colspan="2">370, a plunger</td>
374 and projecting anchors 372. Luer receiver 316 of connector 300, which may be of an appropriate size and shape to engage standard luer connectors, is positioned to receive luer tip 364 from syringe 360.
<img file="MX337063B_D0086.tif" />
INDUSTRIAL internal threading 368 of cover 364 of syringe 360 is properly aligned for threaded connection with clutch portion 318.
receiver 316 can clutch to connector
Of this luer
362 so, the and connect the 360 syringe connector inside the
300 a with the syringe 360. Before the clutch of the connector 300, reservoir 370 is not inhibited, come out of by some physical component.
Now, with reference to a threaded view to connected that fluid, the luer tip 364
Figure 20, a perspective view of the connector
300 connected in a way to a syringe 360. Connector 300 can be found to the syringe
360, or to other medical implement, by many other means, solvent, solder such as glue, adhesive, ultrasonic, epoxy, interference fits, unit connections. Receiver 316 part of luer tip 364 luer 364 extends into intern 322.
engaged with
The mechanical and / or construction (not shown) contains at least of the syringe 360. The tip of at least partially, towards the passageway threaded portion of internal clutch 368 threaded 318 is of the cover finds
364 of the
<img file="MX337063B_D0087.tif" />
syringe 360.
Reservoir fluid
370 It can then flow freely within the housing 310 of the connector 300, through the internal passage 322. If the interior space of the housing is filled with fluid entering the connector, air or other
300 can gas before, open for
<img file="MX337063B_D0088.tif" />
<td>allow to</td><td>the</td><td>air,</td><td colspan="2">or other gas, escape before</td><td>that him</td>
<td>fluid can</td><td colspan="2">get in.</td><td>In some cases, the</td><td colspan="2">Accommodation 310</td>
<td>of the connector</td><td> 300</td><td>can</td><td>fill up with a gas,</td><td>such</td><td>like air.</td>
<td>Before</td><td>the</td><td>fluid</td><td>enter the accommodation</td><td> 310,</td><td>can be</td>
It is necessary for the connector to open to allow gas to escape before fluid can flow. The seal element 330 inhibits fluid from leaving the connector 300. The luer tip 312 of the connector 300 can be used to connect the connector-syringe combination 300, 360, to other components for controlled fluid transfer. Connector 300 may also be integrally formed with syringe 360 (not shown), such that connector housing 310 is formed by way of the end <sub>s</sub>fluid supply of the syringe. During the use of this connector-syringe combination, the male luer tip 312 of the connector 300, in effect, can replace the luer tip 364 of the syringe for connection purposes.
Certain medications, such as chemotherapy medications, are contact toxins, and skin is desirable.
Such medications are often stored in a syringe with a hypodermic needle, as depicted in Figures 15 and 16.
Under certain conditions, without the use of a closable male luer, it may be possible for toxic fluid to flow out of the syringe. Even if the stages are taken to
<img file="MX337063B_D0089.tif" />
prevent accidental fluid flow, such as orienting the syringe with the attached needle in such a way that gravity helps the retention of the medication within the syringe, the medication can also vaporize and leak out of the hypodermic needle. gaseous. The use of a closable male luer between the syringe and the hypodermic needle, inhibits the uncontrolled flow of medication, both in liquid and gaseous state. Consequently, the risk of accidental exposure to such toxic medications is minimized.
Now referring to Figure 21, the closable male luer connector 300 is illustrated in another embodiment, where the internally threaded cover 380 is disposed over the housing. The cover 380 at least partially or completely circulates the housing 310 approximately in the apertured portion 342 (visible in Figure 18A). In some embodiments, the cover 380 is not attached to the connector 300, and instead can rotate freely about the longitudinal axis of the connector 300. The raised portion 340 (visible in Figure 18A) can inhibit movement of the cover. 380 toward luer tip 312 of connector 300. Additionally, manipulation portion 320 of connector 300 can inhibit movement of cover 380 toward luer receiver 316. Cover 380 may be threaded consistent with
<img file="MX337063B_D0090.tif" />
ANSI specifications for luer connectors. Cover 380 can help luer tip 312 form a connection between connector 300 and other components (not shown).
Now referring to Figure 22A ,. The cross section of a closable male luer connector 400 with a continuously tapered internal passage 402 is illustrated. The tapered internal passage 402 of housing 404 allows for various injection molding fabrication techniques. For example, if the taper is wider at one end with a luer receiver 406, the casting bolt may taper in a corresponding manner to fit closely against the wall of internal passage 402, producing a seal 408 that is shorter than the luer. seal illustrated in Figure 18B.
Referring to Figure 22B, the seal 408, in the illustrated embodiment, has a closure portion 412 similar to the closure portion 324 in Figure 18B. In addition, the inner surface of seal 408 can be adapted to increase resistance to allowing fluid to exit opening 410, when fluid (not shown) in inner passage 402 exerts pressure against seal 408. The inner surface of the sealing portion 412 may include tapered surfaces against which such fluid presses to push the opening 410 to close more tightly.
Returning to Figure 23A, a side view of another embodiment of the connector 400 of Figure 22A is displayed. '
<img file="MX337063B_D0091.tif" />
MEXICAN INSTITUTE OF 1.Λ INDUSTRIAL PROPERTY
<td>A cover</td><td colspan="5">internally threaded 420 stands</td><td colspan="2">willing</td>
<td>about</td><td>the</td><td>outer surface</td><td>of</td><td colspan="3">accommodation 404.</td><td></td>
<td colspan="2">What</td><td>can be seen</td><td>in</td><td>the</td><td>Figure</td><td>23B,</td><td>the</td>
<td>accommodation</td><td> 404</td><td>can have a</td><td colspan="2">portion</td><td>elevated</td><td> 424</td><td>what</td>
inhibits axial movement of cover 420 toward luer tip 416. Housing 404 may also have a manipulation portion 418 that extends radially outward from the longitudinal axis of connector 400. Housing 404 also has an internal passage 428 extending from luer receptor 414 to seal member 430. Manipulation portion 418 can inhibit movement of the cover toward luer receptor 414 of connector 400. The manipulation portion can also be a convenient place for the user to position their fingers while turning the connector 400. Additionally, there may be an apertured portion 426 of the connector 400. The apertured portion 426 may be a portion of the connector 400 with an outer diameter smaller than the outer diameter of raised portion 424 of handling portion 418. Cover 420 may be disposed over connector 400 such that a narrow portion of cover 420 circulates connector 400 around opening portion 426. Cover 420 may be unattached to housing 404 and thus free to rotate. . The 422 internal threading of the cover can conform to standards
<img file="MX337063B_D0092.tif" />
ANSI for luer connectors, allowing to cover it and allow luer tip 416 to engage the female connector of another component (not shown).
Figure 23C depicts the closable male luer connector 400 of Figure 23B in proximity to a suitable female connector 450, such as a Clave® connector sold by ICU Medical, San Clemente, California. Female connector
450 It is similar to the one illustrated in Figure 10.
Figure 23D illustrates a clutch between the male luer connector 400 and the female connector 450. The internal threading of the cover 420 can be engaged with a threaded region.
451 of the female connector 450. The luer tip 416 of the male luer connector 400 can advance toward the female connector 450 compressing a compressible seal 454. As the male connector 400 advances, a stationary fluid conduit 456 from the female connector 450 can penetrate the opening 448 in seal element 430 of male connector 400. Fluid conduit 456 can advance far enough toward male connector 400 for holes 455 to advance toward internal passage 428 of male connector 400. Once holes 455 for female connector 450 are disposed within internal passage 428 of connector male, fluid can flow from luer receiver 414 of male connector 400 through internal passage 428 of male connector 400 to conduit ports 455
<img file="MX337063B_D0093.tif" />
Fluid can flow 'and into a conduit
Therefore, the fluid
- 78 fluid 456 from female connector 450. then through fluid ports 455 458 from female connector 450.
it may flow from the first end of the male connector 400 to the distal end of the female connector 450, when the two engage. When connectors 400, 450 are disengaged, fluid conduit 456 is withdrawn from internal passage 428 and seal member 430 closes, thus inhibiting fluid flow through male connector 400. Additionally, the compressible seal 411 of the female connector 450 returns to its original position, and inhibits flow through the ports 455 in the flow conduit 456.
Now, referring to Figure 24A, a closable male luer connector 500 is deployed in perspective view. The connector 500 has a housing 510 and a seal 514. The housing is comprised of a manipulation portion 512. In this exemplary illustration, the manipulation portion 512 includes wings 516. The wings 516 are adapted to provide a site for the user grasp and twist housing 510 of connector 500.
Now referring to Figure 24B, the connector 500 of Figure 23A is shown in cross section. The wings 516 are shown extending outward from the longitudinal axis of the connector 500 and toward the luer receiver.
518 connector. Internal passage 520 of housing 510
<img file="MX337063B_D0094.tif" />
I IMPI
INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIAL has a continuous taper, as described in the modality of connector 400 in Figure 22A.
Returning to Figure 25A, a side view of a closable male luer connector 600 is illustrated. Connector 600 has a housing 610, a seal element 614, and a cover 620. The housing comprises an internal passage 640, a luer tip 612 and a manipulation portion. The handling portion can be constructed to comprise two wings 630, as described in Figure 24A. The cover may have 622 internal threads, and such threads may be constructed to meet ANSI specifications for luer connectors. Seal element 614 may bias closed when no clutch is found.
Now, referring to Figure 25B, a cross-sectional view of the connector 600 of Figure 25A is displayed. cover 620 can circulate housing 610 in an open portion 652 of housing 610. A raised portion 650 can inhibit movement of cover 620 in the direction of the second end of connector 600, while manipulation portion 616 can inhibit movement. of the cover in the direction of the first end of the connector 600. The internal threading 622 of the cover 620 can be used to engage other components (not shown) when used in conjunction with the luer tip 612. The continuously tapered internal passage 640 has
<img file="MX337063B_D0095.tif" />
INSTITUTO MEXiCA.NO
OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0096.tif" />
Features that aid injection molding, c ^ m ^ deals with respect to Figure 22A.
Referring to Figure 26A, the perspective view of a closable male luer assembly 725 comprising a closable male luer 700 and a connected female luer connector 750 is deployed. The closable male luer
700 it may incorporate any number of the features and features described in this application. The female luer connector 750 is adapted to receive a standard male luer connector (not shown). Female luer connector 750 is located adjacent to and flexibly connected to male luer connector 700. The female luer connector 750 comprises an internal passageway 752, a luer receiver 754, and a clutch portion 756. Internal passageway 752 places luer receiver 754 in fluid communication with an internal passageway of closable male luer connector 700. Male closable luer connector 700 may be attached to female luer connector 750 through a flexible segment 760. In some embodiments, Such segment 760 may include a flexible accordion-like portion of an elastic material. In other embodiments, a material may be used
<td>right,.</td><td>flexible.</td><td>In</td><td>other</td><td>modalities,</td><td>so much</td><td>the segment</td>
<td>external</td><td>flexible</td><td>What</td><td colspan="2">the flexible tube,</td><td>may</td><td>be used</td>
<td colspan="2">to connect the</td><td>luer</td><td>male</td><td>closable 700</td><td>with the</td><td>female luer</td>
750.
<img file="MX337063B_D0097.tif" />
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0098.tif" />
The flexible segment 7 52 pp-cmitp the user to orient the female connector 750 of the facility 725 in a different attitude than the male closable luer connector 700. As an example, the closable male luer 700 may remain stationary against a patient's arm while that the female connector 750 is angled away from the arm, to aid in easy connection with a syringe or other component (not shown). By flexibly connecting the closable male luer 7 00 to the female luer connector 750, the moment generated by moving the female luer connector 750 is accepted at one point between the two components of the 725 rig and is less likely to be transmitted to another. component (not shown) attached to the closable male luer connector 700. Such component could include an IV site, where the angle of the connection could result in injury to the patient. Also, the moment will be less likely to bend and / or disconnect the tip of tube 40 from within lumen 28 (see, eg, Figure 28).
Figure 2-6B illustrates another embodiment of a closable male luer assembly 800 comprising a closable male luer connector 825 and a flexibly connected female luer connector 850. Connectors 825, 850 and their components are similar in many respects to the embodiment depicted in Figure 26 and may incorporate any number of the features and features described.
<img file="MX337063B_D0099.tif" />
P * INDUSTRIAL PROPERTY
<img file="MX337063B_D0100.tif" />
previously. The lockable male luer connector 825 and the female luer connector 850 are flexibly connected by a connecting member 860. The connecting member 860 places the connectors 825, 850 in fluid communication. The connecting member 860 illustrated herein comprises an accordion-shaped plastic conduit. The connecting member 860 is configured to allow the closable male connector 825 and the female luer connector 850 to be positioned in different angled orientations. By way of example, the closable male luer connector 825 may remain stationary while the female luer connector 850 may be positioned at an angle toward the closable male luer connector 825. In another example, the female luer connector 850 may remain stationary while the male closable luer connector may be positioned at an angle toward the female luer connector 850. In still another example, the male closable luer connector 825 and the female luer connector 850 may be positioned. both at an angle.
. «• I
Figures 27 through 32 illustrate another embodiment of a male closable luer connector 900 with a male end 902 and a female end 904. In some respects, the connector 900 is similar, in structure and installation, to other embodiments described and illustrated herein. . For example, connector 900 may include an outer housing 906, a cover 908, a resilient member 910, a valve member.
<img file="MX337063B_D0101.tif" />
IMPI
MEXICAN INSTITUTE
OF INDUSTRIAL PROPERTY internal 912 and an internal sealing portion 914. All descriptions, illustrations and features of each embodiment described herein may apply to other embodiments described herein.
As described below, connector 900 can be effective in preventing or minimizing potential dripping of fluid out of male end 902, when male end
902 It is in the process of closing.
As illustrated in Figures 28 and 29, valve member 912 may have an internal fluid passage 916 with a variable cross-sectional area.
In some embodiments, valve member 912 does not have an internal passageway and instead, fluid flows around the valve and generally wider generally cross-sectional member.
906, can
<td colspan="2"> 912.</td><td>As shown, the</td><td>area</td><td>sectional</td>
<td>of</td><td>a</td><td>Passage region 918</td><td> 916,</td><td>placed</td>
<td colspan="2">within</td><td>male end 902</td><td colspan="2">of the accommodation</td>
<td>to be</td><td colspan="2">relatively narrow; the</td><td>area</td><td>sectional</td>
<td>d e</td><td>a</td><td>Passage region 920</td><td> 916,</td><td>placed</td>
<td>in</td><td>the</td><td>middle part of connector</td><td> 900,</td><td>can be</td>
<td colspan="2">to have</td><td>a tapered wall, like</td><td colspan="2">it shows; a</td>
near the end
916, positioned plus region 922 of female passage 904, may have a larger internal volume than second region 920; a region 924 of passage 916 can be connected to region 922 via a narrow opening
926; and a region 928 may be connected to an ivi
<td></td><td>Mexican INSTITUTE ÍSíÚ OF THE PROPERTY CteTX'ífiU industrial</td>
<td>region 924.</td><td>In some embodiments, region 928 can</td>
be connected to region 924 via a narrow opening (not shown). In some embodiments, connector 900 may also include one or more struts 921 to facilitate opening of connector 900.
As discussed above, region 928 and female end 904 of housing 906 can be structured to include one or more components of the female closure end of connectors 21, 210 (and / or any component of other types of female connectors of closure) to allow female end 904 of connector 910 to selectively open or close to fluid flow.
An internal conduit 932 can partially or completely surround region 924 of the internal fluid passage 916. Conduit 932 can be secured to a base 934, and base 934 can be secured to female end 904 on one side and an intermediate portion 936 on the other. side. In the illustrated embodiment, the outer perimeter of base 934 extends toward the outer perimeter of housing 906, but can be configured in many other ways. The intermediate portion 936 may be secured to the remainder of the housing 906. On the end of the distal valve member of the male end 902, an inner conduit 938 may surround the region 922 of the fluid passage 916. In the illustrated embodiment, the inner conduit 938 of the valve member is larger in cross-sectional area and internal volume, than the
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0102.tif" />
duct *
internal f 932 surrounding region
940 may be located in an interface region between internal conduits 932,
938 to prevent or minimize fluid leakage out of passage 916 in such while allowing relative axial movement interface, between the conduits conduits are bent internal 932, internal 932,
938.
In some modalities,
938, are rigid and do not flex or under modal conditions,
934 and 936, contiguous.
separate and accommodation.
904 from the syrup portion the portions are normal for operation. In some external housings 906, 908, molded
In other embodiments, then joined together into a single housing they can be molded by themselves to form the
As shown in Figure 30, the female end 944 male connector
942.
In
900 it can be connected to one of another medical implements such as this one, and all other modalities described herein, any types of medical implements, can be described. In the 900 connector configuration and the 942 syringe fluid such as a medication cannot escape from the connector a variety of others join the connectors illustrated in Figure
30, he is from
900 find full chemotherapy. The with a fluid under normal conditions because it is impeded, on one side, by the
INSTITUTO MEXICANO DE LA FKOriEDAD INDUSTRIAL
<img file="MX337063B_D0103.tif" />
interface between valve member 912 and male end
902 and, on the other side, by the pressure of the fluid or the structure within the medical implement 942.
As illustrated in Figure 31, when valve member 912 is pushed away from male end 902, by attaching connector 900 to another medical implement (such as female connector housing 94 6 of a plastic IV tube), the Inner conduit 938 moves in the direction of female end 904, overlapping at least a portion of inner conduit 932. Then, fluid is allowed to flow between medical implements 942, 946 via connector 900. In this second configuration or open position, region 922 is smaller than it was in the first configuration or closed position (see Figure 30). On the other hand, regions 918, 920 and 928 generally remain approximately the same size. In some embodiments, including some in which the valve member 912 does not have an internal flow path, a region of changing volume can be provided within the connector 900 by overlapping the slip clutch structures without directing fluid flow through the valve member. valve 912. For example, if the valve member is solid, it can be advanced into and removed from conduit 932, and a suitable opening (eg, in conduit 932 or base 934) can allow fluid to flow through.
Mexican Institute of Industrial Property
<img file="MX337063B_D0104.tif" />
through housing 906 to male end 902. In some embodiments, including some in which valve member 902 does not have an internal flow path, the valve member could include a sleeve that can overlap over conduit 932 and an opening Suitable (eg, in conduit 932 or base 934) can allow fluid to flow through housing 906 to male end 902.
In some embodiments, upon disconnecting the medical implement 946 from the connector 900, the male end 902 may automatically close as the valve member 912 moves within the housing 906 toward the male end under the biasing force of the resilient member 910.
In certain circumstances, movement of a valve member within a fluid passageway could drive a small volume of fluid into the male end through the male opening and out of the connector, resulting in closure-induced dripping of the valve. valve. However, in the illustrated embodiment, such dripping is generally avoided or minimized.
As shown in Figure 32, as medical implement 946 and valve member 912 advance in the direction of arrow 950, the overlap region between internal conduits 932, 938 may decrease and the volume of the 922 region of the passage of
INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIAL fluid 916. The volume of region 922 may eventually return to its approximate original volume in the closed configuration (see Figure 30). The expanding volume of region 922 during male luer closure pushes fluid from anywhere in passage 916 to move into region 922.
In some embodiments, the increasing void in region 922 cannot be filled by fluid between region 922 and the syringe, or other medical implement 942, because movement of such fluid is prevented by the structures in medical implement 942 ( such as the stem seal inside the syringe, not shown). Also, in some embodiments, such as that shown in Figure 32, the opening 926 between region 922 and the end of female connector 904, is substantially smaller than the openings 952, 954 between regions 922, 920, and the rest. of fluid passage 916 within the male luer. In this configuration, there may be less fluid resistance within male end 902 than within female end 904. In some embodiments, the cross-sectional area of aperture 926 is less than half the cross-sectional area of aperture 954. In some embodiments, the cross-sectional area of aperture 926 is less than a quarter of the area in cross-sectional area of aperture 954. In some embodiments, the cross-sectional area of aperture 926 is less than a rwin umwwiimn il..vyrs
IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0105.tif" />
fifth of the area in transvprRai section. rio — the ahert-nra 954. This configuration makes it more likely that fluid will be drawn from the male end 902 into the connector, rather than from the female end 904.
As a result of the vacuum in region 922, fluid between valve member 912 and the inner wall of male end 902 is pushed back into connector body 900 toward region 922 rather than being pushed out of the male opening. . As connector 900 closes, the increased volume within connector 900 tends to draw fluid from opening 948 rather than allowing fluid to expel. In the illustrated embodiment, this is accomplished, in part, by providing a cross-sectional area of region 922 that is substantially larger than the cross-sectional area of opening 948. The volume in region 922 increases faster than which decreases the volume in the 948, as the valve member 912 moves toward the closed position. In some embodiments, the rigid walls of the overlapping internal conduits 938, 932, can withstand extensive repeated movement and use with minimal wear. The walls of the overlapping internal conduits 938, 932 generally do not deform or weaken, which could otherwise affect the size of the void created within the connector during closure.
<img file="MX337063B_D0106.tif" />
IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
In addition, the walls of the overpiiest internal conduits 938, 932 generally do not sag or kink under relatively high fluid pressures within the connector, and generally do not allow the valve member 912 to become misaligned within the internal cavity of the housing 906. under most conditions.
In some embodiments of a closable male luer connector described herein, it can be difficult to prepare the connector (ie, replace the air within the connector with fluid) without forcing air into one or more of the medical implements to which it is attached. the connector. In such embodiments, a separate preparation cap can be attached to the male end of the connector. The brew cap can be structured in many different ways.
Figure 33 provides an example of a 956 Prep Cap that can be used with a luer connector.
<td>closable plug</td><td>900. A set prep lid</td>
<td>adequately,</td><td>can be used with any of the</td>
<td>modalities of</td><td>male luer connectors described in the</td>
Present. In some embodiments, the preparation cap 956 may include a structure for opening the closable male luer connector 900 (such as a rigid internal conduit, not shown, to push against the valve member 912 or a female end 962 with a housing wall. 960 configured to make contact with
<img file="MX337063B_D0107.tif" />
is inside the
<img file="MX337063B_D0108.tif" />
cover 908), allowing fluid to escape from within the closable male luer connector 900. The preparation cap 956 may also include an internal fluid passageway (not shown) through which fluid from the open male luer connector 900 can pass. . The fluid passage may lead to an outlet port 964. The preparation cap 956 may also include a filter 958 through which escaping air can pass, but not the advancing liquid. In the illustrated embodiment, filter 958 is positioned in outlet port 964. Thus, air can be evacuated from male luer connector 900, through preparation cap 956, and out of outlet port 964. while the liquid generally remains within the male luer connector 900 and the preparation cap 956. When preparation is complete, the preparation cap 956 can be removed and discarded, which automatically closes the closable male luer connector 900, and another medical implement can be attached to the closable male luer connector 900. Many other structures and configurations can also be used. of preparation caps.
Figures 35-35 illustrate another embodiment of a closable male luer connector 900a with a male end 902a, a housing 906a, a female end 904a, and an elastic member 910a, and struts 921a. As the picture shows
<img file="MX337063B_D0109.tif" />
.DO NOT
35, one end 913a of the valve member
INSTITUTE <sup>υ</sup>”Industrial
<img file="MX337063B_D0110.tif" />
male end tip 902a, may have a first surface
915a with a larger cross-sectional surface area than a second surface
917a, configured to contact an inner side of the male end tip 902a.
This configuration can help create an interface that is also resistant to the 900a male luer connector through the male end of leakage.
902a
In the embodiment of Figure 35, inner conduit 938a is smaller in cross-section than inner conduit 932a. Relative movement between conduits 932a, 938a produces a change in the volume of region 922a, as in the embodiment illustrated in Figures 27 to 32. A resilient seal 940a prevents or minimizes leakage of fluid at the interface between the conduits. 932a, 938a. When the closable male luer connector 900a is in the first closed position, as shown, the volume of the region 922a is larger than when the closable male luer connector 900a is in the second open position. Internal passage 916a may have straight walls such that passage 916a maintains a relatively constant cross-sectional area. In some embodiments, the walls of passage 916a may include a taper. In many respects, the closable male luer connector 900a functions similarly to the closable male luer connector 900 of Figures 27-32.
<img file="MX337063B_D0111.tif" />
iNtJUa »λ *
<img file="MX337063B_D0112.tif" />
Figures 36-37 illustrate another lockable male luer connector 900b, with a male end 902b, a housing 906b, a female end 904b, and a resilient member 910b. This embodiment also includes an actuator 925b to manually open and close the male luer connector 900b. Many different types of manual actuators can be used, including those that employ springs, buttons, levers, and other structures. In the illustrated embodiment, valve member 912b includes at least one side face 927b that can be finger-contacted and advanced either toward male end 902b or female end 904b. In the illustrated embodiment, valve member 912b includes struts 921b within cover 908b. As such, when side face 927b is moved toward male end 902b, male luer connector 900b can be closed, unless male luer connector 900b is attached at its male end 902b to another medical implement. As the side face 927b moves toward the female end 904b, the male luer connector 900b can be opened, even when no other medical implement has yet been attached to the male end 902b of the connector 900b. As shown in Figure 36, the outer surface of the actuator 925b can be serrated or textured to prevent finger slippage, and the outer surface of the actuator 925b can be positioned slightly below the outer perimeter of the housing.
906b
<img file="MX337063B_D0113.tif" />
to prevent the. . -CTCTW'- · - ·· ** connector 900b opens or closes nrr ”'Tnfionally, especially during installation or other movement of connector 900b. In some embodiments, valve member 912b may not include struts within cover 908b.
The actuator 925b, or some other structure for manually opening and closing the connector 900b, may be particularly advantageous in some applications during the preparation of the closable male luer connector 900b. This allows the connector 900b to open while the air within the connector 900b is evacuated to the environment before attaching the connector 900b to another implement (which would otherwise cause the evacuated air to be forced to such another implement). The preparation cap may not be necessary when manual means are provided for opening and closing the connector 900b.
Figures 38 through 39A illustrate another embodiment of a closable male luer connector 900c with a male end 902c, a housing 906c, a female end 904c, and a resilient member 910c. This embodiment also includes an internal structure to prevent or stop fluid flow. A resilient cover 933c is generally positioned within region 922c. Cover 933c may include a front surface 935c, which is generally flat in the illustrated embodiment, a groove 931c, and a side wall.
<img file="MX337063B_D0114.tif" />
<img file="MX337063B_D0115.tif" />
937c. Side wall 937c can spr.cnrgugadia ρητΐΐ ^ · facilitate axial compression of cover 933c. Side wall 937c can be connected to a seal member 940c, as shown, or side wall 937c can be attached to a leading end 971c of conduit 932c. Conduit 932c may be in fluid communication with secondary conduit 939c.
As shown in Figure 39A, when valve member 912c moves toward female end 904c, an internal elbow 941c in valve member 912c contacts front surface 935c of cover 933c, causing the cover 933c is compressed or otherwise moved in the direction of female end 904c. On the other hand, the secondary conduit 939c generally remains stationary and abuts the other side of the front surface 935c of the cover 933c. Opposing forces exerted against cover 933c by elbow 941c and conduit 939c cause the cover to bend and slit 931c to open to allow fluid to flow through connector 900c. Selective opening of cover 933c (or other type of internal fluid impedance structure) can be accomplished in many other ways and in many other configurations. Selective opening within connector 900c allows the female end of region 922c to close or substantially close before the
<img file="MX337063B_D0116.tif" />
912c & gew! T'aqi »s d ....... lar of the 900c connector. With end 913c of opening valve member 948c from male end 902c expanding as a closed end and the region 922c that valve member 912c continues to move toward male end 902c, the increased volume drives fluid from male end 902c and into region 922c.
Figure 40 illustrates another embodiment of a closable male luer connector 900d with a male end 902d, a housing 906d, a female end 904d, and a resilient member 910d. As with the embodiment of Figures 38 and 39, this embodiment also includes an internal structure to prevent or stop fluid flow between the female end 904d and the internal cavity of the connector 900d. At one end of valve member 912d, a fluid chamber is positioned
963d in fluid communication within passage 916d of valve member 912d. In the closed position of the illustrated embodiment, fluid chamber 963d has an orifice 965d positioned in region 922d, and a hole 967d positioned in passage 930d between region 922d and region 928d of female end 904d. In many circumstances, fluid flow is blocked or decreased between female end 904d into connector 900d, due to the close peripheral fit between conduit 963 and passage 930d. However, when valve member 912d is advanced toward female end 904d, and tip 969d of l
IM.PI
INSTITUTE of the
INDUSTRIAL
<img file="MX337063B_D0117.tif" />
of the passage 930ri and orifice 967d is exposed
904d. Fur collar
- 97 fluid chamber 963d moves out of the direction of the female end 904d, the to the region 928d of the female end fluid communication between the female end 904d and the interior of the connector 900d. When valve member 912d is returned to its original closed position, fluid chamber 963d returns to its position within region 922d and tip 969d is positioned within passage 930d, once again preventing or preventing fluid from flowing between. the female end 904d and the interior of the connector 900d. As valve member 912d returns to its original closed position, fluid flow between female end 904d and the interior of connector 900d is generally impeded as soon as orifice 967d moves into passage 930d, preferably earlier. that the end 913d of the valve member 912d engages the opening 948d of the male end 902d of the connector 900d. With fluid flow, in region 922d in the direction of female end 904d of connector 900d, impeded, fluid is preferably drawn from male end 902d and into expansion region 922d. Many other structures and configurations can be used to achieve selective fluid communication between the female end 904d and the interior of the connector 900d.
Figure 41 illustrates another embodiment of a male closable luer connector 900e with a male end 902e, a
<img file="MX337063B_D0118.tif" />
housing 906e, a female end 904e, and a resilient member 910e. As with the modalities of Figures 38 to
40, this embodiment also includes an internal structure to prevent or stop fluid flow between the female end 904e and the internal cavity of the connector 900e. At one end of valve member 912e, a poppet valve 963e is positioned in fluid communication within passage 916e of valve member 912e. Poppet 963e may include a first end that engages an outer surface 961e of valve member 912e and a second end 969e. Alternatively, poppet valve 963e may be integrally formed with valve member 912e. the walls of poppet 963e are generally rigid and generally do not warp or weaken. In addition, the walls of the poppet 963e generally do not sag or kink under relatively high fluid pressures within the connector, nor do they generally allow the second end 969e to become out of alignment within the internal cavity of the connector 900e under most conditions. of the conditions. Many configurations of the 963e poppet are possible. For example, the walls of poppet 963e near surface 961e may include holes or slits to facilitate fluid flow therethrough. The walls can be formed of arms extending from the surface 961e with
<img file="MX337063B_D0119.tif" />
separation between the arms to facilitate<sup>1</sup> through them. In some embodiments, poppet 963e includes 3 arms. In some embodiments, poppet 963e includes 4 or more arms.
In the closed position of the illustrated embodiment, second end 969e of poppet valve 963e is positioned in passage 930e between region 922e and region 928e of female end 904e. In many circumstances, fluid flow is blocked or decreased between female end 904e into connector 900e, due to close peripheral fit between second end 969e of poppet 963e and passage 930e. However, as valve member 912e advances toward female end 904c, at least a portion of second end 969e of poppet 963e moves out of passage 930e and in the direction of female end 904e, allowing fluid communication. between the female end 904e and the inside of the connector 900e. When valve member 912e returns to its original closed position, poppet 963e returns approximately to its original position within region 922e and second end 969e is positioned within passage 930e, once again preventing or preventing flow of fluid between the female end 904e and the interior of the connector 900e. The second end 969e may include one or more ridges (not shown) that extend into
100
<img file="MX337063B_D0120.tif" />
Direction of male end 902e of run twr 90'0e r <sup>1</sup> These lips would at least partially remain within passage 930e when connector 900e is in the open position, to help maintain axial alignment of poppet 963e. As valve member 912e returns to its original position, fluid flow between female end 904e and the interior of connector 900e is generally impeded as soon as second end 969e moves into passage 930e, preferably before the end 913e of the valve member 912e engages the opening 948e of the male end 902e of the connector 900e. With fluid flow in region 922d in the direction of female end 904d of connector 900d impeded, fluid is preferably drawn from male end 902d and into expansion region 922d. Many other structures and configurations can be used to achieve selective fluid communication between female end 904e and the interior of connector 900e.
Figure 42 illustrates another embodiment of a closable male luer connector 1000. As shown in the illustrated embodiment, the closable male luer connector 1000 may have a first end 1012 and a second end 1014. The first end 1012 may comprise a luer tip. plug 1022 and a valve member 1016 (shown in greater detail in Figure 47). The 1033 luer tip and valve member
101
<img file="MX337063B_D0121.tif" />
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0122.tif" />
1016 can be supported by a housing The micnluu ~ dr ~~ valve 1016 may be attached to the housing 1023 by a resilient member 1018. An end cap 1030 may be attached to the housing 1023 near the second end 1014 of the closable male luer connector 1000. The end cap 1030 may have external threads 1036. The embodiment of a closable male luer connector 1000 shown in Figure 42 is in a closed position. In the closed position, valve member 1016 cooperates with male luer tip 1022 to prevent fluid through connector 1000.
As illustrated in Figure 42, housing 1023 may have a cover 1024 that surrounds luer tip 1022. Cover 1024 can have internal threads 1026. Internal threads 1026 and luer tip 1022 can form a male luer clutch. conforming to ANSI specifications for male luer connectors. End cap 1030 can be shaped like a receptacle that conforms to ANSI standards for female luer connectors and can receive a male luer connector. External threads 1036 may be arranged to threadably engage corresponding internal threads of a male luer connector.
Valve member 1016 may be at least partially enclosed by housing 1023. As
102
<img file="MX337063B_D0123.tif" />
MEXICAN INSTITUTE
OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0124.tif" />
Shown, housing 1023 can 'Leiiei 31 Minus one' side opening 1025, exposing at least a portion of valve member 1016 and / or allowing at least a portion of elastic member 1018 to pass into housing 1023. In some In embodiments, housing 1023 may define two side openings 1025, which may be arranged opposite each other on the sides of connector 1000. In some embodiments, side opening 1025 may extend only partially along housing 1023 (such as in a central region of housing 1023, as shown) to provide increased strength in housing near second end 1014. At the In the illustrated embodiment, elastic member 1018 is engaged with valve member 1016 near the side openings of housing 1023. The outer side walls 1027 of the housing may be profiled. For example, the outer surface of the housing may include a narrower portion closer to the central region of housing 1023, or a generally hourglass-shaped outer surface, or a larger cross-sectional portion (s) near from the extremes. These shapes can provide tactile confirmation of the proper placement of the user's finger on the connector 1000 during use and / or provide a more comfortable holding surface. In
103
<img file="MX337063B_D0125.tif" />
Some embodiments, a projection or pü-oyooeigji'ies-üTfCTgYBST '(not shown) may be incorporated onto the elastic member 1018 to provide additional or more effective clamping surfaces on the connector 1000.
Housing 1023 may include a luer tip 1022 near the first end 1012 of connector 1000. Luer tip 1022 may have a hole 1021 at the end, which may allow fluid to flow from within housing 1023 to the outside of the housing. luer tip 1022. Valve member 1016 may include a valve closure end 1044. Closure end 1044 may be engaged within luer tip 1022 to inhibit fluid flow through luer tip 1022. In some embodiments, an interference fit between valve member 1016 and housing 1023 inhibits fluid to flow out of luer tip 1022. In some embodiments, valve member 1016 may include a resilient section disposed near first end 1012 of housing 1023 to engage housing 1023 near luer tip 1022 to inhibit fluid flow therethrough.
As shown in the embodiment of connector 1000 illustrated in Figure 42, a valve closure surface 1046 may be disposed across luer tip 1022 when connector 1000 is in the
- 104
MEXICAN INSTITUTE
OF THE FXCF '. INDUSTRIAL AGE
<img file="MX337063B_D0126.tif" />
closed position. In some embodiments, valve closure surface 1046 may further extend beyond hole 1021 outside of luer tip 1022 when connector 100 is in the closed position. In some embodiments, valve closure surface 1046 is open within luer tip 1022. In some embodiments, valve closure surface 1046 is substantially fluid with the end of luer tip 1022. In some embodiments, valve closure surface 1046 is configured to be cleanable when connector 1000 is in the first or closed position.
As shown in Figure 43, the luer connector 1000 can be manipulated to a second or open position. In the open position of the illustrated embodiment, valve member 1016 retracts from luer tip 1022, thereby opening hole 1021 in tip 1022. As will be described in greater detail below, fluid can pass from the luer socket at the second end 1014, through the interior of the connector 1000, and exit the luer tip 1022 at the first end 1012, when the connector 1000 it opens. When closed, fluid passage through luer connector 1000 is prevented or blocked under normal operating conditions.
The elastic member 1018 can be constructed of a
105 ? »Β
MEXICAN INSTITUTE OF THE INDUSTRIAL PKCHEDAO
<td colspan="4">material that deforms elastically.</td><td colspan="2">Therefore._en,</td>
<td>some</td><td>modalities,</td><td>the</td><td colspan="2">accommodation 1023 may</td><td>remain</td>
<td>coupled</td><td>to the member</td><td>of</td><td>valve 1016</td><td>through</td><td>the member</td>
<td>elastic</td><td>1018, when</td><td>the</td><td>luer connector</td><td>1000 is</td><td>move to</td>
<td>position</td><td>open.</td><td></td><td></td><td></td><td></td>
In the example shown, the change in the relative positions of housing 1023 and valve member 1016 may cause at least a portion of elastic member 1018 to expand. Consequently, elastic member 1018 exerts a closing force on housing 1023 and valve member 1016, biased toward the return of luer connector 1000 to a closed state. The degree of tension contained in elastic member 1018 can be adjusted by varying the distance that housing 1023 and valve member 1016 are separated and / or by constructing elastic member 1018 from a variety of materials that have different elastic properties. . In some embodiments, the connector 1000 is configured to be difficult enough to open to prevent accidental or unintentional opening. In some embodiments, the difficulty in opening the connector is controlled, at least in part, by the tension contained in the elastic member 1018.
Figure ^ 4 illustrates a cross-sectional view of a lockable luer mache in the closed position. How can
106
<img file="MX337063B_D0127.tif" />
INSTITUTO MEXICANO CE LA INDUSTRIAL PROPERTY
<img file="MX337063B_D0128.tif" />
Valve 1044 may be luer tip 1022 for outside of the tip to be seen, the closing end pressing against the interior of the valve to inhibit fluid from passing into luer 1022. Valve member 1016 may include at least one strut 1050. In In some embodiments, the strut 1050 may extend approximately from the middle of the valve member 1016 toward the first end 1012. Connector 1000 may have two struts 1050, as illustrated, or luer connector 1000 may have more or less, as desired. Struts 1050 can be located around luer tip 1022, but within housing 1023, as shown. Struts 1050 can be located within the internal diameter of internal threads 1026, and are therefore positioned to engage at least a portion of a female luer socket as it engages luer tip 1022.
As shown in Figure 46, elastic member 1018 may have a first ring 1074 and at least one securing ring 1072. Although two securing rings 1072 are shown, one or more may be used in different embodiments of the connector 1000. The first Ring 1074 may be disposed in a serrated opening 1048 in the outer surface of housing 1023 toward first end 1012. Resilient member 1018 may be tight enough around housing 1023 to
107
<img file="MX337063B_D0129.tif" />
holding the first ring 1074 in place when a force is αίαγοα on the elastic member 1918 through a change in the relative positions of the housing 1023 and the valve member 1016. As will be described in greater detail below, the securing ring or rings 1072, can be arranged around valve member 1016 in different patterns.
A passage 1056 may extend through a portion of the valve member 1016 near the first end 1012. The passage 1056 may be circular in cross-section, as shown in the illustrated embodiment, or the passage 1056 may have other geometric shapes. The passage 1056 may have at least one port 1062 near the first end 1012. In the illustrated embodiment, two ports 1062 are located on the opposite side of valve member 1016 and are circular, although other locations and shapes may be used.
In the embodiment illustrated in Figure 44, the connector 1000 is in a closed position, and the relative positions of the valve member 1016 and the housing 1023 can create a chamber disposed between the passage 1056 and the luer receptor 1058. The chamber 1054 may be in fluid communication with passage 1056. Chamber 1054 may be wider than passage 1056, as illustrated. In some embodiments, camera 1054 may have
108 i ivi ra
INDUSTRIAL the same diameter as passage 1056 and, in = ί nr modes, chamber 1054 may have a smaller diameter than passage
1056.
Chamber 1024 can also be configured with a non-circular cross section in any other appropriate shape.
The camera
1054 It may be end-attached to the second end 1014 of housing 1023 by plunger 1070.
Plunger 1070 may be a portion of end cap 1030 that extends toward valve member 1016. Plunger 1070 may have a conduit 1094 through it. Conduit 1094 may place chamber 1054 in fluid communication with luer receiver 1058. Plunger 1070 may have sufficient external dimension to substantially close one end of chamber 1054, as shown. In the illustrated embodiment, plunger 1070 is circular to match the geometry of chamber 1054, but other geometric shapes may be used as appropriate.
Plunger 1070, while substantially sealing one end of chamber 1054, may have an external dimension that does not contact the wall of valve member 1016 creating chamber 1054. Accordingly, to inhibit leakage of fluid past plunger 1070 , an O-ring 1060 may be disposed in an opening 1069 behind the plunger 1070. The O-ring 1060
109
<img file="MX337063B_D0130.tif" />
INSTITUTO MEXICANO L'E LA INDUSTRIAL PROPERTY
<img file="MX337063B_D0131.tif" />
may contact valve member 1016, as shown, inhibiting fluid flow
1054. In some embodiments, the plunger outside the chamber
1070 is a portion of the end cap
1030. End cap 1030 may be engaged with housing 1023 by sonic welding, an adhesive, any other suitable method of engagement. In the illustrated embodiment, the end cap 1030 is attached to the housing.
1023 with sonic welds 1031.
One such weld
1031 it has a substantially triangular shape, as shown, although other shapes are also possible.
Accordingly, the plunger 1070 can be considered to be in a static position relative to the housing.
1023.
In some embodiments, the plunger 1070 is integrally formed with the housing.
1023 and end cap
1030 it is a separate piece appropriately attached to housing 1023 such as by sonic welding.
In some embodiments, end cap 1030 is integrally formed with housing 1023.
As shown in the mode illustrated in
Figure 44, fluid can flow into luer receiver 1058 and pass into conduit 1094. From conduit 1094, fluid can pass into chamber 1054 and from chamber
1054 toward passage 1056. As shown in the illustrated embodiment, when connector 1000 is in the
110
<img file="MX337063B_D0132.tif" />
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0133.tif" />
closed position, the valve closing end 1044 of the valve member 1016 can seal the hole in the luer tip 1022, preventing fluid from passing out of the end of the luer tip 1022. Generally, however, the fluid can exit passage 1056 through ports 1062 in valve member 1016. Fluid may reside within luer tip 1022, but can be prevented from flowing back to second end 1014 on the exterior of valve member 1016 by sealing ring 1020. Accordingly, when connector 1000 is in the closed position, as illustrated, there can generally be fluid communication between luer receiver 1058 and the interior of luer tip 1022, without allowing fluid to flow out of first end 1012. connector 1000.
In Figure 45, an illustration of one embodiment of the connector 1000 is shown in an open position. The connector 1000 can be switched to the open position when the female luer connector (not shown) engages the luer tip 1022 of the first end 1012 of the connector. When the female luer connector engages the first end 1012 of the connector 1000, a portion of the female luer connector can engage the internal threads 1026 and can be advanced to at least partially enclose the luer tip 1022. Accordingly, when ei female luer connector is located
111
<img file="MX337063B_D0134.tif" />
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0135.tif" />
clutch with internal threads 1026, a riai nnrmon. Female connector may engage struts 1050 and push valve member 1016 toward second end 1014 of the housing. In the embodiment illustrated in Figure 45, valve member 1016 is disposed toward second end 1014, resulting in connector 1000 being in an open state.
In some embodiments, when valve member 1016 is moved toward second end 1014, valve closure end 1044 (see Figure 44) is separated from luer tip 1022 including removal of valve sealing surface 1046 from the port 1021 in luer tip 1022. Consequently, fluid can pass out of the port in luer tip 1022 from within the housing. The sealing ring 1020 can still inhibit the outflow of fluid from the interior of the luer tip 1022 to the second end 1014 of the connector 1000. Consequently, in the open position, fluid can pass from the luer receiver 1058 through of conduit 1094, chamber 1054, passage 1056, port (s) 1062 in valve member 1016, into luer tip 1022 and out of hole 1021 at the end of luer tip 1022.
As can be seen in the illustrated embodiment, when the struts move towards the second end
112
<img file="MX337063B_D0136.tif" />
MEXICAN INSTITUTE
OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0137.tif" />
1014 of connector 1000, valve member 1016 is positioned closer to end cap 1030. Consequently, the wall portion of valve member 1016 containing the termination of passage 1056 is positioned closer to the plunger portion. 1070 from the end cap 1030. Thus, the volume of the chamber 1054 can be reduced when the connector 1000 is in the open position.
Correspondingly, when the connector 1000 changes from an open position to a closed position, the volume of the chamber 1054 increases as the valve member 1016 moves toward the first end 1012 of the connector 1000. As the volume of the chamber 1054 is increased, valve closure end 1044 of valve member 1016 advances toward first end 1012 to seal the hole in luer tip 1022. If no additional fluid is introduced into connector 1000 through luer receiver 1058, the existing fluid in luer tip 1022 can be drawn back through ports 1062, through passage 1056 into chamber 1054, via the vacuum effect created when the volume of chamber 1054 is increased. In this case, fluid can be inhibited from exiting the hole in luer tip 1022 as valve closure end 1044 is moved into place n the hole * because, instead, the
- 113 IMPI
<img file="MX337063B_D0138.tif" />
fluid can be drawn back into the chamber. In some embodiments, fluid on or near valve closure surface 1046 is encouraged to move into connector 1000 instead of remaining on the surface of closure surface 104 6 as the valve member 1016 moves toward the first end 1012 of housing 1023.
However, if still additional fluid is introduced into connector 1000 through luer receiver 1058, the additional fluid can advance into chamber 1054 and collect there as valve member 1016 moves toward first end 1012 to closing luer tip 1022. In this case, pressure from the newly introduced fluid can be inhibited from forcing flow out of luer tip 1022 as valve member 1016 seals tip 1022. Accordingly, fluid flow is allowed through connector 1000 while the female connector engages the first end 1012 of connector 1000, but is inhibited while the female connector disengages and after the female connector is disengaged.
As described in greater detail below, it is desirable to inhibit certain medicines from coming into contact with the skin. Thus, connector 1000 advantageously helps to retain fluid within connector 1000, when
- 114
IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0139.tif" />
Consequently, reducing the likelihood of fluid exiting through luer tip 1022 when disengagement occurs, results in a corresponding reduction in the possibility of exposure of the toxic medicine to the skin of a user or patient.
In Figure 46, a cutaway of a connector 1000 is shown with a portion of the housing removed. As can be seen, the elastic member 1018 may have a first ring 1074 disposed in an opening 1048 of the housing 1023. The elastic member may extend toward the second end 1014. The valve member 1016 may have a plurality of outwardly extending ribs incorporated into the connector illustrated as upper ribs 1064, lower ribs 1066, and open ribs 1068. The elastic member may have two locking rings 1072 disposed around the member. valve 1016 and held in place by one or more of the flanges 1064, 1066, and 1068.
As shown in the illustrated embodiment, the securing rings 1072 may be connected to the first ring 1074 by straps 1096. The straps 1096 may extend generally between the first end 1012 and the second end 1214, passing between the open flanges 1068 of the strap member. 1016 valve. In some embodiments, the 1Q72 belay rings may
- 115 -
<img file="MX337063B_D0140.tif" />
OF INDUSTRIAL OWNERSHIP
<img file="MX337063B_D0141.tif" />
stay in place by embroidering “CIS! Opening flange 1068, and bottom flange 1066. Securing rings 1072 may further extend toward second end 1014 from strap 1096, crossing each other, as shown in the illustrated embodiment. In some embodiments, a second strap 1096 may be used to connect the first ring 107 4 to each of the securing rings 1072.
Spacing of the belaying rings
1072 when connecting them through the first ring
1074 and separate straps
1096, can facilitate the fabrication of the connector 1000, particularly when the side slits 1025 do not fully extend toward the end of the housing 1023, near the second end 1014 of the connector 1000. The portion of the securing ring 1072 furthest from the strap 1096, it may be enclosed by upper and lower flanges 1064, 1066, securing it in place around valve member 1016, as shown. Consequently, when valve member 1016 moves toward the second end
1014 By clutching with a female connector, as described above, elastic member 1018 can exert a force on valve member 1016 pulling it toward first end 1012. In the illustrated embodiment, locking rings 1072 are shown superimposed, or structures ,
116
<img file="MX337063B_D0142.tif" />
including other o-ring installations<sup>,</sup><übKl<sup>fc</sup>lignT<sup>,</sup>aic<sup>,</sup>i'ons' - of the elastic member, having more or fewer securing rings 1072 or a first ring 1074 constructed or arranged differently may be used. As mentioned above, in some embodiments the securing rings 1072 are crossed over one another. When there are two rings 1072, crossing one over the other creates two crossing points 1075. In some embodiments, the thickness of one or both of the lock rings 1072 is reduced at the crossing points 1075 to create a substantially uniform lock ring 1072 around the valve member 1016.
Figure 47 illustrates one embodiment of valve member 1016 comprising valve closure surface 1046 at the end of valve closure end 1044. Ports 1062 may be located close to closure surface 1046 or as far apart as practical, of surface 1046, before sealing ring 1020 (see Figure 46). Ports 1062 can be circular, as illustrated, or they can have other shapes. Struts 1050 are shown extending toward first end 1012 of valve member 1016. There may be one, two, or more struts 1050. In some embodiments, connector 1000 does not include struts 1050. Rather, connector 1000 is adapted to be pleased in another way when
117
<img file="MX337063B_D0143.tif" />
placed in clutch mated with a female rnnprtnr. For example, the female connector may include a latch member (not shown) that could engage valve closure surface 1044 to open connector 1000, or a manually actuated slider or button may be appropriately configured to open connector 1000.
The apertured ribs 1068 may be comprised of two parallel shoulders from the main body of the valve member 1016, or, otherwise, appropriately sized to engage the resilient member 1018.
<td colspan="2">Bottom flange</td><td> 1066</td><td>can</td><td>to be</td><td>perpendicular</td><td>to</td><td>the</td>
<td>flanges</td><td>openings</td><td> 1068,</td><td>What</td><td>I know</td><td>illustrates. The</td><td colspan="2">flange</td>
<td>lower</td><td>1066 too</td><td>can</td><td colspan="2">understand</td><td colspan="2">more than one highlight,</td><td>what</td>
extends a shorter or greater distance from the main body of valve member 1016, as appropriate, to engage elastic member 1018. Upper rim 1064 may be parallel to lower rim 1066 and spaced, at least by a height, of a lock ring 1072 to engage ring 1072 and inhibit movement of ring 1072 under pressure to circulate to a different portion of valve member 1016.
Figure 48 illustrates one embodiment of the end cap 1030. The end cap 1030 may have a sealing portion 1098 adapted and configured to substantially seal the second end 1014 of the housing 1023.
118
MEXICAN INITIATIVE
OF THE ÍROPiEDAO
INDDST '.' JAL
<img file="MX337063B_D0144.tif" />
The luer receiver 1058 can extend by VfffS dltecciorT from the sealing portion 1098. The luer receiver 1058 can be appropriately sized to mate with a male luer portion (not shown) conforming to ANSI standards for luer devices. The luer receiver 1058 may have external threads 1036 to engage the male luer portion, as shown. In some embodiments, raised fins and other projections can be used to engage the male luer portion.
In some embodiments, plunger 1070 is at the end of a portion that extends in another direction from sealing portion 1098. Plunger 1070 may be sized and configured to substantially seal chamber 1054 within valve member 1016. A slit or aperture 1069 between sealing portion 1098, and plunger 1070, can be sized and configured to accommodate an O-ring 1060, as illustrated and described above.
Figure 49 illustrates an exploded view of the components of an example embodiment of a connector 1000. In the illustrated embodiment, elastic member 1018 is shown with overlapping locking rings 1072. End cap 1030 may be positioned toward second end 1014 of connector 1000. O-ring 1060 may be disposed around a
119 extreme 1030, and the — émhnin icnn pn ^ dp
IMPI
MEXICAN INSTITUTE
OF THE PROPERTY
INDUSTRIAL
<img file="MX337063B_D0145.tif" />
valve member 1016 entering face 1014.
portion of the lid to be placed inside it from the second
Resilient member 1018 is disposed around both housing 1023 and valve member 1016, elastically engaging each other. Seal ring 1020 is disposed around valve closure end 1044 of valve member 1016 and within housing 1023. Seal ring 1020 may have one or more projections 1019 corresponding to grooves in either valve member 1016 or housing 1023 to substantially secure seal ring 1020 in place. In the illustrated embodiment, two bosses 1019 extend out of seal ring 1020 to engage housing 1023. More or fewer bosses 1019 can be used or seal ring 1020 can be configured to secure to valve member 1016.
In another embodiment illustrated in Figure 50, the components are generally numbered similar to the previous embodiments, however an apostrophe (') has been added to the corresponding numbers. As can be seen, the illustrated connector 1000 'has a resilient member 1018', wherein the securing rings 1072 'are not superimposed, but are positioned at a separate interval. The straps 1096 'extend from the first ring 1074' to
120
<img file="MX337063B_D0146.tif" />
the securing ring 1072 ', at different distances.
Consequently, the first strap 1096a 'is shorter than the second strap 1096b'. The shorter strap 1096a 'connects to the first securing ring 1072a' positioned closest to the first end 1014 'of the connector 1000' and to the first ring 1074 '. Similarly, the longer strap 1096b 'may extend from the first ring 1074' towards the second securing ring 1072b '.
The first securing ring 1072a 'may be disposed between the apertured flanges 1068' and the lower flange 1066 '. The second securing ring 1072b ', which further extends towards the second end 1014', may be disposed between the lower flange 1066 'and the upper flange 1068'. The configuration of the elastic member 1018 'in the illustrated embodiment is carried out in a similar manner to the previous embodiments. Other configurations are also possible.
As described above, some medications, including those used during chemotherapy, can be harmful in certain forms of exposure to a patient. For example, exposure to the skin can sometimes result in a chemical burn. Inhaling aerosol forms of some medications can be harmful. Therefore, control over the content of the medication is highly desirable.
<img file="MX337063B_D0147.tif" />
i. '' ··, medications
121
<img file="MX337063B_D0148.tif" />
MSXiCANO INSTITUTE
OF INDUSTRIAL PROPERTY
Currently, some potentially harmful ones are distributed in sealed vials. The medication is withdrawn from the vial by inserting a needle and drawing the medication into a syringe. The needle is then removed from the vial and the medication can be delivered. However, by inserting the needle into the medication to draw it into the syringe, the medication is placed on the outside of the needle which can inadvertently come into contact with the skin and cause damage. Alternatively, a vial penetrating injector with a withdrawal mechanism can be used. In such an injector, the medication is withdrawn through the mechanism and passed directly to a needle for injection without the additional step of removing the mechanism from the vial. Even if such an injector is used, there is still the possibility that latent medication remains in the needle used to inject the medication or in the mechanism after the vial is uncoupled.
Additionally, some medications can be delivered by attaching a needle to a syringe with the medication located therein. The syringe clutched with the medication and the needle, are sterilized and placed in a vacuum sealed container. The container is then evacuated and sealed. This type of installation can result in the withdrawal of the medication through the syringe when the container is evacuated.
While in the container
122
Τ Μ Ρ Τ lvl 1 ϋINDUSTRIAL
<img file="MX337063B_D0149.tif" />
sealed, the medication can be aerosolized or coated on the outer surface of the components.
Additionally, when the ambient atmospheric pressure of the treatment location is different, particularly less than the internal pressure of the medication within the container, it is possible that uncontrolled spraying of the medication may occur. For example, medication can escape when a vial with an internal pressure greater than ambient atmosphere is penetrated through a needle to draw the medication into a syringe. Alternatively, the medication may escape when the needle is withdrawn from the vial before completely closing the vial seal.
A syringe coupled with a closable male luer can generally inhibit the flow of medication, except during desired applications. For example, in some embodiments, a syringe with a closable male luer attached will not leak medication when packaged for shipment, even if the package is vacuum sealed. Once the package is opened, the male luer can be engaged with a female luer on an IV tube, for example, and dispense medication only when the connection is engaged. By following the flow of medication from the syringe through the clutch connectors and into the IV tubing, the male luer connector can be disengaged from the connector
<img file="MX337063B_D0150.tif" />
<td>female luer.</td><td>As described above, the connector</td>
• β * »** ·<sup>1</sup>** · * Male luer can be closed or disengaged, preventing excess flow through the connector.
When a closable female luer connector is used, such as a Clave® connector sold by ICU Medical, San Clemente, California, flow out of the female connector is also inhibited.
Additionally, a syringe with a closable male luer can be engaged with a needle, as described above. Flow through the needle can therefore be controlled by the appropriate use of the closable male luer connector. The medication can also be disposed within a syringe with an integrally formed and / or permanently attached closable male luer. Therefore, direct exposure to the hazardous medications described can be essentially limited to the highly controlled environments where the medications are produced and packaged. Such medications can be placed in a syringe with a closable male luer connector prior to dispensing for use, minimizing the risk of inadvertent exposure of the medication during use of the medication.
Figure 51 illustrates one embodiment of the end or end cap 1030 '' with an example of a structure to prevent the female end of the connector from easily disengaging from the male luer inserted therein. This type of structure can have many modalities and
124
IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0151.tif" />
different configurations, such as —the retention tab — 1090 illustrated. Many of the components illustrated in Figure 51 are generally similar to those described above, except that a double apostrophe (<sup>w</sup>) to distinguish them.
The illustrated embodiment shows a retention tab 1090 partially circulating through luer receiver 1058 "and partially extending through receiver 1058". Retaining tab 1090 may comprise a cable having a partially circular shape through a portion of the cable, an angled section 1091, a straight section 1093, and a barb point 1092. The circular portion of the tab 1090 may correspond to the end diameter of the luer receiver 1058 ", which may be found along at least a portion of the external threads 10 ° 36". Angled section 1091 may comprise a transition in tab 1090 from a circular shape to straight section 1093, as shown in the illustrated embodiment. In the illustrated embodiment, the straight section 1093 passes through a portion of the solid wall of the luer receiver 1058 ", terminating at the barb point 1092. In some embodiments, the luer receiver 1058" includes an elongated structure. extending from the receiver wall 1058 '' and not necessarily including the other components of the illustrated tab 1090.
125
IMPI
INSTITUTO MEXICANO Dt LA PROMEDAD INDUSTRIAL
<img file="MX337063B_D0152.tif" />
As illustrated in Figures 51-5.1., N, -a in some embodiments, the tab point 1092, 1092 "may comprise an inclined tab surface 1092a, 192a". As illustrated more clearly in Figure 51, in some embodiments, the sloped tab surface 1092a may be configured to face the outer surface of the luer receiver 1058. In contrast, as illustrated more clearly in Figure 52, in some embodiments, the sloped tab surface 1092a can be configured to orient away from the outer surface of the luer receiver 1058 ''. Similarly, as illustrated most clearly in Figure 55, in some embodiments, the sloped tab surface 1092a 'can be configured to face outwardly (ie, away from the partially circular portion of the retention tab 1090'). In contrast, in some embodiments (not illustrated), the sloped tab surface 1092a 'can be configured to face inward (ie, toward the partially circular portion of the retention tab 1090'). In some embodiments, the tab 1090 is substantially symmetrical about its axis (eg, it does not have a flat sloping surface), or the tab 1090 has a flat or rounded end without a point.
In some embodiments, the tab 1090 may continue to extend around the luer receiver 1058 ''
126
<img file="MX337063B_D0153.tif" />
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0154.tif" />
without penetrating it.
In some embodiments, the tab 1090 may extend through the interior wall of the luer receiver 1058 ", and potentially may come into contact with a male luer connector inserted into the luer receiver 1058". Although a circular metal cable is shown in the illustrated embodiment, cable having other cross-sections or other materials in addition to metal cable, such as plastics or a metal foil, can also be used.
As described below, the tab point 1092 may have a number of shapes, each suitable to carry out the necessary retention.
The barb point 1092 may extend from the outer wall of the luer receiver 1058 '' or, as illustrated, the straight section
1092 it can continue for a distance before the cable forms the 1092 barb point.
A syringe 1080 is illustrated adjacent to luer receptor 1058 ''. The syringe may comprise a cover 1086 having internal syringe threads 1084. The syringe cover 1086 and threads 1084 may partially surround a syringe tip 1082, all components generally conforming to ANSI standards for luer connectors. The external threads 1036 '' can be configured to engage corresponding threads 1084 on the internal surface of the syringe cover 1086. The 1058 '' luer receiver can be configured
- 127 -
<img file="MX337063B_D0155.tif" />
to accept a 1082 syringe tip rr „iÍraaníin_asá _____. a luer connection.
Figure 52 illustrates a cross-sectional view of the end cap 1030 '' of Figure 51 taken along line 52-52. As shown, the tab 1090 may extend at least partially around the luer receiver 1058 ''. In the illustrated embodiment, tab 1090 is disposed adjacent external thread 1036 ''. Tab 1090 may partially flow into luer receiver 1058 "before extending through receiver 1058" with a straight section 1093. Tab 1092 may extend outwardly away from luer receiver 1058 "and external thread 1036". In some embodiments, the tab point 1092 may extend beyond the circular plane defined by the external threads 1036 ". In some embodiments, the tab 1090 forms an angle a with a line tangent to the outer wall of the luer receiver 1058 '. '. In some embodiments, the angle a is in the range of about 5 to about 75 degrees. In some embodiments, the angle a is in the range of about 10 to about 35 degrees. Generally the angle a is less than about 90 degrees. In some embodiments, the angle a is in the range of about 15 to about 30 degrees.
When a male luer connector, such as the syringe
128
1080, mates with 1030 '' end cap illustrated, coupling can be initiated by twisting syringe 1080 and luer receiver
1058 '' to engage threaded surfaces
As the clutch is introduced, the reed point
1092 can be angled as shown to slide along the inside of the deck
1086 of the syringe, guided by the threads 1084 of the syringe.
Tab point 1092 may be positioned tangential relative to luer receiver 1058 '', as shown, to emphasize clutch accommodation. In addition, the angle of the 1092 point can be aligned to stimulate the extension of the curvature of the luer receptor 1058 ''
After the clutch is completed and the engagement is complete, a reverse twisting motion is generally used to disengage the syringes from the luer receivers. However, when disengagement is attempted with the receiver 1058 '' illustrated, the reverse twisting movement causes the tab point 1092 to encounter at least a portion of the syringe cover 1086 and at least partially embed itself in the herself. The barb point 1092 can be angled to intersect the syringe cover 1086 when decoupling is attempted.
As the 1092 barb point pierces the 1986 syringe cover, it can substantially inhibit continuous disengagement, resulting in .4
129 a difficulty increased by
<img file="MX337063B_D0156.tif" />
industrial decoupling syringe 1080 and connector 1000.
For this reason, once the connector 1000 with the retention tab 1090 is attached to a syringe or other medical device, it may be difficult or impossible to disengage the connector without applying increased torque and / or structural damage to at least one of the devices
The
Figures 53 illustrate one embodiment of the retention tab
1090 having a sharp reed point 1092
As shown, the circular shape transits through the angled section 1091 to the straight section
1093 before terminating at tab point 1092. Although straight section 1093 may be at least partially embedded in end cap 1030 '', other configurations may be used.
In the illustrated embodiment, the tab point 1092 may be elliptically configured and / or lack an actual point. For example, the tab 1090 may have a sharp rounded edge or some other suitable structure.
The illustrated embodiment can be formed by cutting tab 1090 at an angle, resulting in point 1092 shown.
Figures 55 and 56 illustrate another embodiment of the retention tab 1090 '' ', where the component sections are substantially similar, except that
130 added a triple apostrophe
<img file="MX337063B_D0157.tif" />
In the illustrated embodiment, a tongue point surface 1095 is present at the tip of the tongue point 1092 '. The point surface 1095 can be formed by cutting the tip of the tab point 1092 'to enhance the ability of the barb 1090 to puncture a medical device during disengagement. Alternatively, dot surface 1095 may be formed by making a cut similar to that formed by tab dot 1092 in Figures 53 and 54, except that the cut does not need to completely cross the diameter of tab 1090 'prior to intersecting the end. of the cable from which the tab 1090 'is formed. In some embodiments, this can produce a flat 1095 reed point surface.
Although tab 1090 has been described to close luer connector 1000 to another medical device, many other methods can also be used to make coupling between medical devices difficult or impossible to invert.
For example, one or more appropriately formed barb points, pumps, fasteners, and / or ridges may also be used on the luer receiver 1058 or other structure.
Additionally, the retention tab or other removal-preventing structure may be used with other medical devices in addition to the closable male luer connector.
131
L * 7-kk jJ.
MEXICAN NSTITU7O DE LA l'uGPJF.DAD INDUSTRIAL
<img file="MX337063B_D0158.tif" />
1000 previously described.
The tab can be attached to any suitable medical device that has a portion adapted to connect to another luer connector. Any other suitable device can be configured to include a structure that prevents removal. For example, any of the devices described in the following US patent and patent applications, or other devices in the same or similar categories, can be configured to include structures that prevent recall: US Patent Nos. 6,428,520, issued August 6, 2002; 6,245,048, issued June 12, 2001; 6,695,817 issued February 24, 2004; 6,758,833 issued July 6, 2004;
and 6,599,273 issued July 29, 2003; US Patent Publication Nos. 2006/0161115, published July 20, 2006 and 2006/0173420, published August 3, 2006; and US Provisional Patent Application No. 60 / 854,524, filed October 25, 2006. A structure that prevents removal can be especially advantageous when the contents of a fluid container to which the connector is attached may be unsanitary, harmful and / or toxic.
Figures 57 and 58 illustrate another embodiment of a closable male luer connector 1100 wherein the end cap 1130 may comprise a structure to prevent the female end of the connector from easily disengaging from a male luer inserted therein. Male luer connector
132
<img file="MX337063B_D0159.tif" />
MEXICAN INSTITUTE
OF INDUSTRIAL TKOPIETY
<img file="MX337063B_D0160.tif" />
closable 1100 illustrated in Figures 57 ™ and -53, similar to the above-described closable male luer connector 1000, except as described below. The end cap 1130 of the closable male luer connector 1100 defines another example of a closure installation 1136 therein which, as will be described in greater detail below, is configured not only to threadably engage corresponding internal threads of a male luer connector or other component such as a syringe, It also prevents or prevents disengagement or unscrewing of the male luer connector from the corresponding male luer connector or other component to which the closable male luer connector 1100 is attached. Because the closure fixture 1136 can generally be used with any closable male luer or end cap, the following description will focus primarily on the closure fixture 1136 and not the features of the closable male luer 1100 that are similar to the features described. above for the male closable luer 1000.
End cap 1130 can be formed by plastic injection molding or any other suitable manufacturing process. End cap 1130 can be formed from a 20% glass filled polycarbonate material, but can be formed from any one or more different materials, such as polycarbonate, filled polycarbonate
133 glass, other rigid plastics,
<img file="MX337063B_D0161.tif" />
Suitable Mf INSTITUTE, or combinations thereof ^ ^ z ^ ó '^ o ^' Ta ^^ end cap 1030 of the above described male luer connector 1000, the end cap 1130 may be coupled to the housing 1123 by sonic welding, an adhesive, or any other method for suitable coupling. In the embodiment illustrated in Figure 58, end cap 1130 can be attached to housing 1123 with sonic welds.
<td>1131. A</td><td>welding</td><td>113the</td><td>such has one</td><td>form</td>
<td>substantially</td><td>triangular,</td><td>how I know</td><td>shows, though</td><td>as well</td>
<td colspan="2">other shapes are possible.</td><td></td><td></td><td></td>
<td>What</td><td>it shows</td><td>on the</td><td>Figure 59, in</td><td>some</td>
In embodiments, end cap 1130 may be formed to define plunger 1170. Plunger 1170 may be sized and configured to substantially seal chamber 1132 within valve member 1116. A slit or slit 1169 between sealing portion 1198 and plunger 1170 can be sized and configured to accommodate an O-ring or other annular sealing member, as illustrated in Figure 58. Alternatively, plunger 1170 may be configured to substantially engage sealing portion 1198 without the use of an annular sealing member. Plunger 1170 can be considered to be in a static position relative to housing 1123. In some embodiments, plunger 1170 may be formed
134
<img file="MX337063B_D0162.tif" />
integrally with housing 1123 and end cap
1130 it is a separate piece appropriately attached to housing 1123, such as by sonic welding.
In some embodiments, the end cap 1130 may be integrally formed with the housing.
1123.
Similar to the closable male luer connector 1000 described above, the closable male luer connector 1100 may have a first end 1112 and a second end 1114. The first end 1112 may comprise a male luer tip 1122 and a valve member 1116. Luer 1122 and valve member 1116 may be supported by housing 1123. Valve member 1116 may be coupled to housing 1123 by resilient member 1118. As with the 1030 end cap of the 1000 closable male luer connector, the end cap
1130 lockable male luer connector
1100 may be attached to housing 1123 near the second end
1114 lockable male luer connector
1100.
The male closable luer connector 1100 mode shown in Figure
58, is in a closed position, whereby valve closure end 1144 is positioned within hole 1121 in luer tip 1122, thus sealing hole 1121 in tip 1122
Thus, similarly to the closable male luer connector 1000 above, the valve member 1116 cooperates with that described above.
- 135 -
<img file="MX337063B_D0163.tif" />
male luer tip 1122 to prevent fluid flow through connector 1100 in the closed position.
In addition, the closable male luer connector 1100 can be manipulated into a second or open position in a manner similar to that of the closable male luer connector 1000 described above. In the open position of some embodiments, valve member 1116 and valve closure end 1144 retract from luer tip 1122, thereby opening hole 1121 in tip 1122. In the open position, fluid can pass from the luer socket at the second end 1114, through the interior of the connector 1100 and out of the luer tip 1122 at the first end 1112. As illustrated more clearly in the view at In cross section of Figure 58, a passageway 1156 may be in fluid communication with a chamber 1132 that may extend through a portion of the valve member 1116. Chamber 1132 may also be in fluid communication with luer receiver 1158 internal space through conduit 1194. Thus, as shown in the embodiment illustrated in Figure 58, fluid can flow into luer receiver 1158 and pass into conduit 1194. From conduit 1194, fluid can pass into chamber 1132 and from chamber 1132 into passage 1156. Under normal operating conditions, the passage of fluid through the luer connector 1100 is prevented or blocked.
136
<img file="MX337063B_D0164.tif" />
when connector 1100 closes, as shown in Figure 58.
The end cap 1130 may have a sealing portion 1198 formed and configured to substantially seal the second end 1114 of the housing 1123. The luer receiver 1158 may extend in an outward direction from the sealing portion 1198. The luer receiver 1158 can be appropriately sized to mate with a male luer portion (not shown) conforming to ANSI standards for luer devices or a syringe. The luer receiver 1158, illustrated herein, may have a closure facility 1136 that, in some embodiments, serves at least the following functions. The closure device 1136 may be threadedly engaged with the corresponding internal threads of a male luer connector or other component such as a syringe, when the end cap 1130 is rotated or screwed in a first direction (which may be the direction of the clockwise) to the male luer connector of that component. Additionally, the closure facility 1136 can prevent or substantially prevent rotation or unscrewing of the end cap 1130 from the female portion of the male luer connector 1100 in a second direction relative to the corresponding male luer portion of the coupling component when engaged. applies a force of
137
INSTITUTE) V:
Say the t'Tz.V - «2-JiísSkF INDUSTRIAL torsion to the end cap 1130 (which can<sup>1</sup> 'eñcoh'tráT'5'S5n<sup>i </sup>a counterclockwise direction) relative to the component to which the end cap 1130 and male luer connector 1100 are attached.
In the illustrated embodiment, the closure device 1136 may comprise a pair of oppositely disposed projections 1140, located on an outer surface 1142 of the end cap 1130. In some embodiments, the closure device 1136 may comprise only one projection 1140 located on the outer surface 1142 of the end cap 11340. In some embodiments, the closure facility 1136 may comprise three projections
1140 located on the outer surface 1142 of the end cap 1130, which may be spaced at equidistant radial positions. The projections 1140 preferably each comprise an outer surface 1146, a top surface 148, a bottom surface 1150, a minor side surface 1152, and a major side surface 1154. In some embodiments, the closure facility 1136 may comprise more than three lots of closed.
The ribs 1140 may be positioned on the end cap 1130 such that the flat bottom surface 1150 is coplanar with the flat end surface 1160 of the end cap 1130. Each shoulder 1140 can be configured such that the outer surface
138
<img file="MX337063B_D0165.tif" />
1146 define a diameter that is approximately slightly smaller than the diameter of the internal surface of the cover 1183 of the male luer connector or other component with which the end cap 1130 mates, as illustrated more clearly in Figure 62. In the embodiment Illustrated, the outer surface 1146 defines a diameter that is approximately 0.312 inches. This configuration is preferred, but not required, such that outer surface 1146 does not interfere with, or impart significant force against, the inner surface of the cover of the male luer portion of the component with which the component is engaged. end cap 1130. In some embodiments, the outer surface 1146 may be configured to provide an interference fit with the inner surface of the cover to prevent, substantially all or in part, disengagement of the end cap 1130 from the male luer portion of the component to which it is attached. is connected.
In the illustrated configuration, for each shoulder 1140, the intersection of the. bottom surface 1150 and major side surface 1154, can define a first sharp corner 1162. Similarly, the intersection of top surface 1148 and major side surface 1154 can define a second sharp corner 1164. The projected length of the side surface older 1154 may
139
<img file="MX337063B_D0166.tif" />
be slightly greater than the distance between adjacent laterally oriented pairs of the internal thread of the coupling component. In the illustrated embodiment, the projected length of the major side surface 1154 is approximately 0.08 inches (ie, the shortest distance between the second corner 1164 and the flat end surface 1160 is approximately 0.08 inches). To prevent a portion of the minor side surface 1152 from interfering with the internal threads of the coupling component, the length of the minor side surface 1152 can be less than the projected length of the major side surface 1154 and also less than the distance between the sides. laterally oriented adjacent walls of the internal thread of the coupling component.
Figure 62 is an enlarged side view of a portion of the end cap 1130 of the female connector component shown in Figure 59, threadedly inserted into a male connection portion 1180 of a mating component 1182. As previously described , the coupling component 1182 can be a male luer connector or another component such as a syringe. In Figure 62, the coupling component 1182 shown is a syringe. The coupling component 1182, or syringe, illustrated has a syringe cover 1183 that has internal syringe threads 1184. As illustrated in Figure 62,
140
INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIAL the 1183 syringe cover and 1184 threads may partially surround an 1185 syringe tip, generally all components conforming to ANSI standards for luer connectors. Luer receiver 1158 may be configured to accept syringe tip 1185, thereby creating a luer connection.
As illustrated therein, shoulder 1140 can be configured such that, when end cap 1130 is threadedly inserted into male luer portion 1180 of coupling component 1182, shoulder 1140 creates an interference fit with respect to to the internal threads 1184 of the male luer portion 1180 of the coupling component 1182 which prevents, substantially prevents, or it prevents unscrewing or disengagement of the end cap 1130 from the coupling component 1182. However, the shoulder 1140 preferably does not significantly inhibit the user's ability to screw or tighten the end cap 1130 on the coupling component 1182. In the illustrated embodiment, the first and second corners 1162, 1164, can exert a force on the side walls 1186 of the internal threads 1184 of the male luer portion 1180 of the coupling component 1182, such that either or both corners 1162, 1164, preferably sharpened, deforms and inserts elastically or plastically into the side walls 1186 of the threads
Γ p) τ.
141
INSTITUTO MEXICANO DE LA HUMEDAD INDUSTRIAL is illustrated smaller 1152 is parallel in from to, the falls but internal 1184.
In some embodiments, such as Figures 60 and 61, the lateral surface protrudes 1140, it may define a plane that is offset from, a horizontal plane (eg, plane A) intersecting the centerline axis of the end cap 1130 and line 62 -62. The larger side surface 1154 of each shoulder 1140 may define a plane that can be tilted at an angle X relative to plane A, when the end cap 1130 is oriented as shown in Figure 60. In the illustrated embodiment, the major lateral surface 1154 of each shoulder 1140 may be inclined at an angle, such as an angle that is approximately 12 °, relative to a horizontal plane, when the end cap 1130 is oriented as shown. in Figure 60. In some embodiments, the major lateral surface 1154 of each shoulder
<td colspan="7">1140 may be tilted at an angle that is</td>
<td>approximately</td><td> 0<sup>or</sup></td><td>Y</td><td>approximately</td><td>12th, or</td><td>of</td><td>Come in</td>
<td>approximately</td><td> 12°</td><td></td><td>and approximately</td><td>20th, or</td><td>of</td><td>Come in</td>
<td>approximately</td><td> 20°</td><td></td><td>and approximately</td><td>30 °, or</td><td>of</td><td>Come in</td>
<td>approximately</td><td> 30°</td><td>Y</td><td>about 40 °</td><td colspan="2">, in relation</td><td>yet</td>
horizontal plane, when the end cap 1130 is oriented as shown in Figure 60. In some embodiments (not shown), each of the two side surfaces 1152, 1154, may define a plane that intersects
142
<img file="MX337063B_D0167.tif" />
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0168.tif" />
a longitudinal centerline axis of the end cap
1130.
As illustrated more clearly in Figure 60, the top surface 1148 of each shoulder 1140 may be inclined at an angle Y relative to a vertical plane when the end cap 1130 is oriented as shown in Figure 60. In the illustrated embodiment, the top surface 1148 of each shoulder 1140 may be inclined at an angle, such as an angle of approximately 24 °, relative to a vertical plane, when the end cap 1130 is oriented as shown in FIG. 60. In some embodiments, the top surface 1148 of each shoulder 1140 may be angled at a
<td>angle that is</td><td colspan="2">find</td><td>Come in</td><td>approximately</td><td> 10°</td><td>Y</td>
<td>approximately</td><td> 24°,</td><td>or</td><td>Come in</td><td>approximately</td><td> 24°</td><td>Y</td>
<td>approximately</td><td> 401,</td><td>or</td><td>Come in</td><td>approximately</td><td> 40°</td><td>Y</td>
<td>approximately</td><td>60 °, in</td><td colspan="2">relation to</td><td>a vertical plane,</td><td colspan="2">when</td>
end cap 1130 is oriented as shown in Figure 60.
Although closure facility 1136 was described above in particular detail and illustrated and described to apply to end cap 1130 illustrated in Figures 57 to 62, the configuration of closure facility 1136 is not limited to this configuration. The closure facility 1136 can be configured from any of a wide range of
143
<img file="MX337063B_D0169.tif" />
range of materials similar to those described herein "or other materials known to those skilled in the art, which are suitable for such applications. Furthermore, the geometric configuration of the closure facility 1136 is not confined to the specific facilities illustrated and described herein. For example, ribs 1140 may be configured to comprise only one rib 1140, or they may comprise a plurality of ribs 1140. In addition, shoulder 1140 can be formed such that upper surface 1148 directly intersects lower surface 1150 (ie, such that shoulder 1140 has three sides and does not include minor side surface 1152).
The shoulder 1140 may be of any known geometric configuration that provides an interference fit with the internal threads of the coupling component in order to prevent, substantially impede, or prevent unscrewing or disengagement of the end cap 1130 from a coupling component, while it does not significantly inhibit the user's ability to screw or tighten the end cap 1130 onto the coupling component. Or, more generally, shoulder 1140 may be of any suitable geometric configuration that generally prevents, substantially impedes, or prevents unscrewing or disconnection of end cap 1130 from a
144
<img file="MX337063B_D0170.tif" />
INSTITUTO MEXICAMO DE LA PROHEDáD ¡NOUSTRl / .L
<img file="MX337063B_D0171.tif" />
coupling component, but that η, or significantly inhibits the user's ability to screw or tighten the end cap 1130 onto the coupling component. For example, outer surface 1146 can be configured such that it provides interference with the inner surface of the coupling component cover and / or such that it elastically or plastically deforms the inner surface of the coupling component cover to inhibit disengaging the end cap 1130 from the coupling component. Also, the applicability of closure device 1136 is not confined to end cap 1130. Any end cap or other component that has external threads can be configured to comprise the closure facility 1136 described herein. For example, one end of a catheter may include the closure facilities described herein in order to prevent, substantially impede, or prevent unscrewing or disengagement of the catheter from a luer closure component.
Figure 63 illustrates another embodiment of a closable male luer connector 1200 configured to prevent or inhibit the male portion of the mated component from unscrewing or disengaging from a closable male luer connector 1200. Any of the components that comprise the luer connector 1200 may comprise any of the settings,
145
<img file="MX337063B_D0172.tif" />
IMr ί
MEXICAN INSTITUTE OF PROPERTY
INDUSTRIAL characteristics, components and / or materials of any of the other luer connectors described herein or which are known to those of ordinary skill in the art. Additionally, any of the other luer connectors described above may comprise any of the configurations, features, and components of the luer connector 1200. For example, features relating to prevention or inhibition of disconnection can be used with any suitable medical or other fluid connector.
Figures 63 and 64 are a perspective view and a side view, respectively, of the closable male luer connector 1200 in a first or closed position. In Figure 64, some of the internal features of the closable male luer connector 1200 are shown in dotted lines. Figure 65 is an exploded perspective view of the components of the male closable luer connector 1200 embodiment shown in Figure 63. Referring to Figure 63 and / or Figure 64, the closable male luer connector 1200 may have a first end 1212 and a second end 1214. The first end 1212 may comprise a male luer tip 1222 and a valve member 1216 ( shown in greater detail in Figures 65 and 71). Luer tip 1222 and valve member 1216 may be supported by housing 1223. Valve member 1216 may be coupled to housing 1223
146
<img file="MX337063B_D0173.tif" />
IMPI 'NTi'lTUTO MEXICANO C £ LA PliOriF.DAO
INDUSTRIAL by means of an elastic member 1218.
An "end cap portion" 1230 (sometimes referred to herein as an end cap or female member) may be coupled to housing 1223 near second end 1214 of closable male luer connector 1200. One or more of the components of the The end cap portion 1230 may be integral or unitary with the housing. Referring to Figure 65, as will be described in greater detail below, in some embodiments, the end cap 1230 may comprise a first end cap component 1232 (sometimes referred to herein as a first member) and a second end cap component. end cap 1234 (sometimes referred to herein as a second member) that may be coupled to each other, as described below. Referring to Figure 7-6, the second end cap component 1234 may define an outer surface 1234a having a tapered, conical, or substantially conical shape. However, in some embodiments, the outer surface 1234a can be substantially cylindrical, ovular, a combination of conical and ovular, or any other desired shape. End cap 1230 may have external 1236 threads. As mentioned, the embodiment of a closable male luer connector 1200 shown in Figures 63 and 64 is in a closed position. In the closed position,
147 ins γγ uto hex i -N?
<sup>W</sup> CBLAPV.Ci'iRyAü
INDUSTl'J-'J valve member 1216 may be able to use nrrrr M punch of male luer 1222 to substantially impede fluid flow through connector 1200.
As illustrated in Figure 63, housing 1223 may have a cover 1224 that surrounds luer tip 1222. Cover 1224 may have internal threads 1226. Internal threads 1226 of luer tip 1222 can form a male luer clutch. conforming to ANSI specifications for male luer connectors. End cap 1230 can be shaped like a receptacle that conforms to ANSI standards for female luer connectors and can receive a male connector component from another connector or syringe. The external threads 1236 may be arranged to threadably engage correspondingly with the internal threads of a male connecting portion of the coupling component.
Valve member 1216 may be at least partially enclosed by housing 1223. As shown, housing 1223 may have at least one side opening 1225, exposing at least a portion of valve member 1216 and / or allowing that at least a portion of elastic member 1218 passes into housing 1223. In some embodiments, housing 1223 may define two side openings 1225 that may be arranged opposite each other on the sides of the
148
<img file="MX337063B_D0174.tif" />
INSTITUTE Μ EX ΙΌ Λ NO
OF THE PPOW.DA'J
INDUSTRIAL
<img file="MX337063B_D0175.tif" />
<img file="MX337063B_D0176.tif" />
z connector 1200. In some TndalídadPS ...... the side opening
1225 may extend only in part along the housing 1223 (such as in a central region of the housing 1223, as shown) to provide increased resistance in the housing near the second end 1214. In the illustrated embodiment, the elastic member
1218 it may be in engagement with valve member 1216 near the side openings of housing 1223. The outer outer surface 1227 of the housing may be profiled. For example, the outer surface of the housing may include a narrower portion near the central region of the housing 1223, or a generally hourglass-shaped outer surface or larger cross-sectional portion (s) near the ends. These configurations can provide tactile confirmation of the proper placement of the user's fingers on the connector 1200 during use and / or provide a more comfortable holding surface. In some embodiments, the outward projection or projections (not shown) may be incorporated into elastic member 1218 to provide additional or more effective clamping surfaces on luer connector 1200.
As in the other embodiments described herein, the luer tip 1222, near the first end
1212 Connector 1200 may have a 1221 hole in the
149
<img file="MX337063B_D0177.tif" />
MEXICAN INSTITUTE
OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0178.tif" />
<img file="MX337063B_D0179.tif" />
end, which may allow fluid to flow from within the housing to the exterior of luer tip 1222, when valve member 1216 is in the open position (not shown). The valve member 1216 may include a valve closure end 1244. The closure end 1244 may engage within the luer tip 1222 to inhibit the flow of fluid through the luer tip 1222. In some embodiments, an interference fit between valve member 1216 and housing 1223 inhibits fluid flow out of luer tip 1222. IN some embodiments, this interference fit is between closure end 1244 and port 1221 . In some embodiments, valve member 1216 may include a resilient section disposed near first end 1212 of housing 1223 to engage housing 1223 near luer tip 1222 to inhibit fluid flow therethrough.
As shown in the embodiment of the connector 1200, illustrated in Figure 63, a valve closure surface 1246 may be disposed across the luer tip 1222, when the connector 1200 is in the closed position. In some embodiments, valve closure surface 1246 may be configured to further extend beyond hole 1221 outside of luer tip 1222, when connector 1200 is in the socket.
- 150 -
<img file="MX337063B_D0180.tif" />
MEXICAN INSTITUTE
OF THE FRC-HÍ-Tm;) INDUSTRIAL
<img file="MX337063B_D0181.tif" />
closed position. In some embodiments, the SUperflCTS '..... <Ie ”valve closure 1246 may be open within luer tip 1222. In some embodiments, valve closure surface 1246 may be substantially fluid with the end of the valve tip. luer 1222. In some embodiments, valve closure surface 1246 is configured to be washable, when connector 1200 is in the first or closed position.
The luer connector 1200 can be manipulated to a second or open position. In the open position, valve member 1216 can retract from luer tip 1222, thereby opening hole 1221 in tip 1222. As will be described in greater detail below, fluid can pass from the luer socket into the second. end 1214, through the interior of connector 1200 and out of luer tip 1222 at first end 1212, when connector 1200 is opened. When closed, fluid passage through luer connector 1200 is prevented or blocked under normal operating conditions.
The elastic member 1218 can be constructed of a material that deforms elastically. Accordingly, in some embodiments, housing 1223 may remain coupled to valve member 1216 by resilient member 1218, when luer connector 1200 is moved to the
I
- 151 -
<img file="MX337063B_D0182.tif" />
open position. In the illustrated embodiment, the relative positions of housing 1223 and valve member 1216 can cause at least a portion of elastic member 1218 to extend. Consequently, elastic member 1218 exerts a closing force on housing 1223 and valve member 1216 biases toward the return of luer connector 1200 to a closed state. The degree of tension contained in elastic member 1218 can be adjusted by varying the distance by which housing 1223 and valve member 1216 are separated, increasing the thickness of elastic member 1218, and / or by constructing elastic member 1218 from a variety of materials that have different elastic properties. In some embodiments, the connector 1200 is configured to be difficult enough to open to prevent accidental or unintentional opening. In some embodiments, the difficulty in opening the connector is controlled, at least in part, by the tension contained in the elastic member 1218. In some embodiments, the elastic member 1218 may be configured as a spring positioned within the housing 1223 to deflect the valve member 1216 to the closed position. Movement of the connector 1200 to the open position can compress the spring, and movement of the connector 1200 to the closed position can allow the spring to expand to release.
152
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0183.tif" />
some or all compression.
Figures 66 through 70 show luer connector 1200 in the first or closed position. As can be seen in these Figures, valve member 1216 may comprise at least one strut 1250. In the illustrated embodiment, valve member 1216 may comprise two struts 1250. In some embodiments, valve member 1216 may comprise more than two struts 1250. In some embodiments, each strut 1250 may extend approximately from the middle of valve member 1216 toward first end 1212 of luer connector 1200. Struts 1250 may be located around luer tip 1222, but within housing 1223, as shown. shows. Struts 1250 may be located within the internal diameter of internal threads 1226, and may be positioned to engage at least a portion of the female luer socket as it engages luer tip 1222.
Referring to Figure 63, elastic member 1218 may comprise at least one ring 1274 and at least one securing ring 1272. However, in other embodiments, elastic member 1218 may comprise more than one ring 1274 or more than one ring. lock 1272. The first ring 1274 may be disposed in an indented opening 1248 in the outer surface of the
153
<img file="MX337063B_D0184.tif" />
MEXICAN INSTITUTE OF INDUSTRIAL l'ÜOnEDAD
<img file="MX337063B_D0185.tif" />
housing 1223 toward first end 1212. Resilient member 1218 may be tight enough around housing 1223 to hold first ring 1274 in place when a force is exerted on resilient member 1218 through a change in the relative positions of housing 1223 and of valve member 1216. As with the other embodiments of the luer connector described above, the securing ring (s) 1272 may be arranged around the valve member 1216 in different patterns.
As illustrated most clearly in Figure 67, a passageway 1256 may extend through a portion of valve member 1216 near first end 1212. The passageway 1256 may be circular in cross-section, as shown in the illustrated embodiment, or passage 1256 may have other geometric shapes. The passage 1256 may have at least one port 1262 near the first end 1212. In the illustrated embodiment, two ports 1262 are located on opposite sides of valve member 1216 and are circular, although other locations and shapes may be used.
In the embodiment illustrated in Figure 67, luer connector 1200 is in a closed position and the relative positions of valve member 1216 and housing 1223 can create a chamber disposed between the
- 154 -
<img file="MX337063B_D0186.tif" />
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0187.tif" />
passage 1256 and luer receiver 1258. Chamber 1254 may be in fluid communication with passage 1256. Chamber 1254 may be wider than passage 1256, as illustrated. In some embodiments, chamber 1254 may have the same diameter as passageway 1256.
In some embodiments, chamber 1254 may have a smaller diameter compared to passageway 1256.
Chamber 1224 may also be configured with a non-circular cross section in any other appropriate shape.
Chamber 1254 may be end-attached to second end 1214 of housing 1223 by plunger 1270.
Plunger 1270 may be a portion of end cap 1230 that extends toward valve member.
1216. Plunger 1270 may have a conduit 1294 through it. Conduit 1294 may place chamber 1254 in fluid communication with luer receiver 1258. Plunger 1270 may have sufficient external dimension to substantially close one end of chamber 1254, as shown. In the illustrated embodiment, plunger 1270 may be circular to accommodate the geometry of chamber 1254, but other geometric shapes may be used, as appropriate.
Plunger 1270 may have an external dimension that is comparable to the internal dimension of the wall of valve member 1216, creating chamber 1254, but not
IMPI
<img file="MX337063B_D0188.tif" />
155 have contact with such a wall to allow relative luuvimiont between the components. To inhibit fluid from escaping past plunger 1270, a 0-shaped ring 1260 may be disposed in an opening 1269 behind plunger 1270. O-ring 1260 may contact the wall of valve member 1216, such as shown, inhibiting the flow of fluid out of chamber 1254. In some embodiments, plunger 1270 is a portion of end cap 1230. End cap 1230 may be mated to housing 1223 through sonic welding, or any other suitable method of mating. In the illustrated embodiment, end cap 1230 is coupled to housing 1223 by sonic welds 1231. Such a weld 1231 has a substantially triangular shape as shown, although other shapes are possible as well. Accordingly, plunger 1270 can be considered to be in a static position relative to housing 1223. In some embodiments, plunger 1270 is integrally formed with housing 1223 and end cap 1230 is a separate piece appropriately attached to housing 1223. such as by sonic welding. In some embodiments, the second end cap component 1234 may be integrally formed with the housing 1223. However, as will be described in greater detail below, the first
156
<img file="MX337063B_D0189.tif" />
1232 end cap component can also form? ·? separately compared to second end cap component 1234 or housing 1223.
As shown more clearly in Figure 67, fluid can flow into luer receiver 1258 and pass into conduit 1294. From conduit 1294, fluid can pass into chamber 1254 and from chamber 1254 into passage 1256. As shown in the illustrated embodiment, when the connector 1200 is in the closed position, the valve closure end 1244 of the valve member
1216, can seal the hole in luer tip 1222, preventing fluid from passing out of the end of luer tip 1222. Generally, however, fluid can exit passageway 1256 through ports 1262 in the luer tip. valve 1216. Fluid may reside within luer tip 1222, but can be prevented from flowing back to second end 1214 on exterior of valve member 1216 by sealing ring 1220. Accordingly, when connector 1200 is in the closed position, as illustrated, there can generally be fluid communication between luer receiver 1258 and the interior of luer tip 1222, without allowing fluid to flow out of first end 1212. connector 1200.
The connector 1200 can be switched to the open position when the female luer connector (not shown) is
<img file="MX337063B_D0190.tif" />
157
<img file="MX337063B_D0191.tif" />
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0192.tif" />
mates with luer tip 1222 of primar ontreme; 1212 Lte ~ 3T connector- When the female luer connector engages the first end 1212 of the connector 1200, a portion of the female luer connector may engage the internal threads 1226 and can be advanced to at least partially enclose the luer tip 1222 . Accordingly, when the female luer is in engagement with the internal threads 1226, a portion of the female connector may engage with the struts 1250 and push the valve member 1216 toward the second end 1214 of the housing. Referring to Figure 63, the connector 1200 will be in an open position when the valve member 1216 is disposed toward the second end 1214.
In some embodiments, when valve member 1216 is moved toward second end 1214, valve closure end 1244 (see Figure 63) can be separated from luer tip 1222 by removing valve closure surface 1246 from port 1221 at luer tip 1222. Consequently, fluid can pass out of the hole in luer tip 1222 from within the housing. The sealing ring 1220 can inhibit the outflow of fluid from the interior of the luer tip 1222 to the second end 1214 of the connector 1200. Consequently, in the open position, fluid can pass from the luer receiver 1258 through the conduit 1294, the
158
<img file="MX337063B_D0193.tif" />
INSTITUTE r ''
FROM THE Η> Γ> ir-ÍLLJ '·. TO THE
<img file="MX337063B_D0194.tif" />
chamber 1254, passageway 1256, port or ports 12 62 <sup>pn</sup> -θ-1 valve member 1216, into the luer tip 1222 and out of the hole 1221 at the end of the luer tip 1222.
As can be seen in the illustrated embodiment, when struts 1250 are moved toward second end 1214 of connector 1200, valve member 1216 can be moved or positioned closer to end cap 1230. Consequently, the wall portion of the member valve 1216 containing the termination of passage 1256, is positioned closest to plunger portion 1270 of end cap 1230. Thus, the volume of chamber 1254 can be reduced when connector 1200 is in the open position.
Correspondingly, as the connector 1200 changes from an open position to a closed position, the volume of the chamber 1254 increases as the valve member 1216 moves toward the first end 1212 of the connector 1200. As the volume of the chamber 1254 is increased, valve closure end 1244 of valve member 1216 advances toward first end 1212 to seal the hole in luer tip 1222. If no additional fluid is introduced into the connector 1200 through the luer receiver 1258, the existing fluid in the luer tip 1222 can be drawn back through the
159
<img file="MX337063B_D0195.tif" />
<img file="MX337063B_D0196.tif" />
MEXICAN INSTITUTE
D £ THE PROPERTY
INDUSTRIAL
<img file="MX337063B_D0197.tif" />
ports 1262, through passage 1256 boiled “Id dMara 1254, by the vacuum effect created when the volume of chamber 1254 is increased. In this case, fluid can be inhibited from exiting the hole in luer tip 1222 as valve closure end 1244 moves into position in the hole, because fluid can be drawn from the hole instead. back to camera 1254. In some embodiments, fluid on or near valve closure surface 1246 is encouraged to move into connector 1200 rather than remaining on the surface of closure surface 1246 as valve member 1216 moves toward first end 1212 of housing 1223.
However, if still additional fluid is introduced into connector 1200 through luer receiver 1258, the additional fluid may advance into chamber 1254 and collect there as valve member 1216 moves toward first end 1212 to close luer tip 1222. In this case, pressure from the newly introduced fluid can be inhibited from forcing flow out of luer tip 1222 as valve member 1216 seals tip 1222. Accordingly, fluid flow is allowed through connector 1200 while a female connector engages the first end 1212 of connector 1200, but is inhibited while the female connector disengages and
160
<img file="MX337063B_D0198.tif" />
after the female connector has been disengaged — As described in greater detail below, it is desirable to inhibit certain medications from coming into contact with the skin. Thus, connector 1200 advantageously helps retain fluid within connector 1200, when disengaged from a female luer connector or other connection. Accordingly, reducing the likelihood that fluid will leak through luer tip 1222 when disengagement occurs, results in a corresponding reduction in the possibility of exposure of the toxic medicine to the skin of a user or patient. .
Figures 71, 72, and 73 are a perspective view of valve member 1216, elastic member 1218, and housing 1223, respectively, of the embodiment of the closable male luer connector 1200 shown in Figure 63. As previously discussed, elastic member 1218 may have a first ring 1274 that is disposed in opening 1248 of housing 1223. The elastic member may extend toward second end 1214. Valve member 1216 may have a plurality of outwardly extending ribs to support resilient member 1218. In particular, referring to Figure 71, valve member 1216 may comprise four opening flanges 1268. Securing ring 1272 (shown in Figure 72) can be secured around the
161
<img file="MX337063B_D0199.tif" />
valve member 1216 and hold at, = ¡1<sup>h</sup>mcdÍLiutL aperture flanges 1268. However, the configuration of valve member 1216 is not so limited. Valve member 1216 may comprise any number of beads in addition to or alternatively to opening beads 1268 for securing elastic member 1218 or securing ring 1272 of elastic member 1218 to valve member 1216. In the illustrated embodiment, the inner surfaces 1268a of the opening flanges 1268 may provide lateral support to the bands 1296 of the elastic member 1218 to prevent the bands 1296 from sliding laterally relative to the valve member 1216. Additionally, the leading surfaces 1268b of the opening flanges 1268 can prevent the locking ring 1272 of the elastic member 1218 from sliding axially in the direction of the valve sealing surface 1246 of the valve member 1216. In other embodiments, the member Elastic 1218 may comprise two or more, or essentially any number of rings or bands.
Additionally, referring to Figure 71, one or more of the ports 1262 may be located at or near the sealing surface 1246, or as far away as is practical from the surface 1246, prior to the sealing ring 1220. When one or more Ports 1262 are located in closing surface 1246, another opening mechanism may be employed
162
<img file="MX337063B_D0200.tif" />
of port such as a seal »lági-irn._. Loe-m.<sup>1 1</sup>1 71T7 * can be circular, as illustrated, or they can have other shapes. Struts 1250 are shown extending toward first end 1212 of valve member 1216. There may be one, two, or more struts 1250. In some embodiments, connector 1200 does not include struts 1250. Rather, connector 1200 can be adapted to open otherwise when placed in mating clutch with a female connector. For example, the female connector may include a clutch member such as, but not limited to, a valve pin or other projection (not shown), which could engage valve sealing surface 1244 to open connector 1200, or A manually actuated slider or button may be appropriately configured to open connector 1200.
Referring to Figures 73 and 74, the first end cap component 1232 may have a cover portion 1292 formed and configured to substantially cover and, in some embodiments, generally seal a portion of the second end 1214 of the housing 1223. The luer receptor 1258 may extend away from the cover portion 1292. The 1258 luer receiver can be roughly sized to mate with a male luer portion (see, eg, Figure 12) conforming to ANSI standards for luer devices. The receiver of
<img file="MX337063B_D0201.tif" />
- 163 -
<img file="MX337063B_D0202.tif" />
luer 1258 may have external threads 1236 on the luer portion, as shown. In some embodiments, raised tabs or other projections can be used to engage the male luer portion.
In some embodiments, plunger 1270 is at the opposite end of a portion of the first end cap component 1232 from cover portion 1292. Plunger 1270 may be sized and configured to substantially seal chamber 1254 within valve member 1216 A slit or opening 1269 between cover portion 1292 and plunger 1270 may be sized and formed to accommodate an O-ring 1260, as described above. Additionally, referring to Figures 73 and 74, the first end cap component 1232 illustrated therein may comprise a pair of protrusions or tabs 1298 (also referred to herein as closure elements or clutch surfaces) that protrude. radially outward from outer surface 1300. In some embodiments, the first end cap component 1232 may comprise a pair of tabs 1298 arranged to be diametrically opposed to each other. In some embodiments, the first end cap component 1232 may comprise only one tab 1298 protruding from the surface 1300. In some embodiments, the first end cap component 1232 may comprise more than two tabs ^
164
<img file="MX337063B_D0203.tif" />
from surface 1300.
As will be described in greater detail below, the tabs 1298 may engage or interlock with complementary tabs or projections on the second end cap component 1234 to prevent the first outer cap component 1232 from rotating relative to the second end cap component. 1234 when the two components are assembled together, as shown more clearly in Figure 64 or 69.
Additionally, the first end cap component 1232 may define an annular opening 1302 which, as will be described in greater detail below, may interact with the complementary features in the second end cap component 1234 to axially restrict the movement of the first component. end cap 1232 relative to second end cap component 1234. Furthermore, as more clearly illustrated in Figures 74, the first end cap component 1232 may also define an angled or tapered surface 1304 and a rounded surface 1306, both positioned between annular opening 1302 and plunger 1270. As will be described in greater detail below, angled or tapered surface 1304 and rounded surface 1306 can facilitate coupling or assembly of the first end cap component 1232 to the second end cap component 1234.
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<img file="MX337063B_D0204.tif" />
In some embodiments, the first end cap component 1232 may comprise only an angled or tapered surface 1304 or a rounded surface 1306. In other embodiments, the first end cap component 1232 may be configured to comprise neither of these two. characteristics. In some embodiments, the first end cap component 1232 and / or the second end cap component 1234 may comprise any suitable feature, lubricant, or material to facilitate coupling of the first end cap component 1232 and the second end cap component. end cap 1234 or, as will be discussed, to facilitate rotation of the first end cap component 1232 relative to the second end cap component 1234.
In the illustrated embodiment, the tabs 1298 are substantially rectangular in cross section. However, the geometry of the tabs 1298 is not limited. Tabs 1298 can define any suitable or desired cross-sectional geometry, such as, but not limited to, square, circular, or oval geometry. In some embodiments, for example, a plurality of tabs 1298 may be provided, each defining a circular cross section, linearly along one side of the second end cap component 1234.
With reference to Figures 74 to 76, the second
166
<img file="MX337063B_D0205.tif" />
INSTrn .; : - / -./-, l · .. la.
iNUUSRIAL .......
end cap component 1234 may comprise — a -... installation of ribs or tabs 1308 (also referred to herein as closure elements or clutch surfaces) that protrude, in a radially inward direction, from the inner surface 1310 of the second end cap component 1234 to create a radial array of depressions or channels 1309. Referring to Figure 64, the first end cap component 1232 may be assembled with the second end cap component 1234 such that each of the one or more tabs 1298 formed on the first end cap component 1232 , is located in one or more of the depressions or channels 1309 between each of the plurality of tabs 1308 formed in the second end cap component 1234. Accordingly, each of the one or more tabs 1298 can be dimensioned and configured such that the approximate width (represented by WI in Figure 74) of each of the one or more tabs 1298, formed in the surface 1300, of the first end cap component 1232, is less than the approximate width (represented by W2 in Figure 76) of the depressions or channels 1309 between each of the tabs 1308 formed in the second end cap component 1234.
In the illustrated embodiment, the tabs 1308 are
167
<img file="MX337063B_D0206.tif" />
substantially rectangular in cross section. jjx-.
However, the geometry of the tabs 1308 is not limited. Tabs 1308 can define any suitable or desired cross-sectional geometry, such as, but not limited to, square, circular, or oval geometry.
Additionally, as mentioned, each of the one or more tabs 1298 on the first end cap component 1232 can be configured to detach or detach before any of the plurality of tabs 1308 on the second component detach or separate. end cap 1234. Accordingly, in some embodiments, each of the one or more tabs 1298 on the first end cap component 1232 can be configured such that the approximate minimum amount of force or torque required to dislodge or separate each tab 1298 from the surface 1300 on the first end cap component 1232, is less than the approximate minimum amount of force required to detach or separate any of the tabs 1308 from the inner surface 1310 of the second end cap component 1234. In some embodiments, the minimum amount of force required to peel or separate each tab 1298 from surface 1300 on the first end cap component 1232, may be significantly less than the minimum amount of force required to peel or separate any of the the
168 tabs 1308 from inner surface 1310 locomponent of end cap 1234.
In some embodiments, tabs or projections that are configured to detach or separate may be formed on the second end cap component 1234 rather than on the first end cap component 1232, as described above. In other words, in some embodiments, one or more tabs formed on the second end cap component 1234 may be sized and / or configured the same as any of the tabs 1298 described above, and one or more tabs formed on the first cap component. end cap 1232 can be sized and / or configured the same as any of the tabs 1308 described above, such that the tabs formed in the second end cap component 1234 are dislodged or separated before any of the tabs formed in the first end cap component 1232. In brief, the configurations of the tabs 1298 in those described previously, they can be reversed.
tabs 1308
In general, other complementary clutch surfaces can be used. In illustrated embodiments, each of the components includes radially projecting tabs. In some embodiments, one or the other of the components may include appropriately sized openings.
169
<img file="MX337063B_D0207.tif" />
to accommodate a reed that is projected radially ^ -.—.
In some embodiments, the approximate minimum amount of force required to detach or separate each tab 12 98 from surface 1300 on the first end cap component 1232, may be less than about one-third of the approximate minimum amount of force required. to detach or separate each of the tabs 1308 from the inner surface 1310 of the second end cap component 1234. In some embodiments, the approximate minimum amount of force required to peel or separate each tab 1298 from surface 1300 on the first end cap component 1232 can be between about one-third and one-half of the approximate minimum amount of force. required to detach or separate any of the tabs 1308 from the inner surface 1310 of the second end cap component 1234.
In the illustrated embodiment, where two tabs are formed on surface 1300, the amount of twisting force required to dislodge or separate both tabs 1298 from surface 1300 on the first end cap component 1232, can be approximately 4 inches lbs. or more. In some embodiments, the amount of twisting force required to disengage or separate both tabs 1298 from surface 1300 on the first end cap component 1232,
170
<img file="MX337063B_D0208.tif" />
about 3 inch-pounds or more.
In some embodiments, the amount of twisting force required to disengage or separate both tabs 1298 from surface 1300 on first end cap component 1232 can be about 5 inch-pounds or more.
Referring to Figure 74, the cross-sectional area of each of the tabs 1298 can be based on the approximate length (represented by Ll in Figure 74) and the approximate width (represented by Wl in Figure 74) of each of the one or more tabs 1298 on the surface 1300 of the first end cap component 1232. Tab 1298 can be used to define a band around surface 1300 calculated by multiplying the length Ll of tab 1298 by the circumference of surface 1300. In some embodiments, such as the illustrated embodiment, where each of the one or more tabs 1298 is configured to detach from the surface 1300 of the first end cap component 1232, when the desired level of torque is reached, the area In aggregate cross-section of tab (s) 1298, it may be substantially smaller than the band around surface 1300.
In some modalities, the relation of the area in
<img file="MX337063B_D0209.tif" />
cross-section
<img file="MX337063B_D0210.tif" />
more reeds
171
<img file="MX337063B_D0211.tif" />
MEXICAN INSTITUTE
OF INDUSTRIAL PROPERTY
1298 to the value of the external diameter (repx'yyyil'l'ádU per 'L) l<sup>w</sup>(Figure 74), of the surface 1300 of the first end cap component 1232 from which each of the one or more tabs 1298 may be formed or attached, may be
<td>approximately</td><td>of</td><td>1st</td><td> 46</td><td>or older. The area</td><td colspan="2">sectional</td>
<td>transversal of</td><td>every</td><td>a</td><td>of</td><td>the tabs 1298</td><td>can</td><td>to be</td>
<td>any value</td><td colspan="2">suitable</td><td>what</td><td colspan="2">as a result that each</td><td>a</td>
<td>one o'clock or</td><td>plus</td><td colspan="2">tabs</td><td>1298 detach</td><td>since</td><td>the</td>
surface 1300, when the desired torque level is reached.
For example, in some modalities, the relationship
<td>can be found</td><td>Come in</td><td>about 1</td><td>to</td><td> 60</td><td>Y</td>
<td>about 1 to</td><td>30. In</td><td>some modalities,</td><td>the</td><td colspan="2">relationship</td>
<td>can be found</td><td>Come in</td><td>about 1</td><td>to</td><td> 50</td><td>Y</td>
<td>about 1 to</td><td> 40.</td><td></td><td></td><td></td><td></td>
In some embodiments, such as the illustrated embodiment, where each of the one or more tabs 1298 is configured to detach from the surface
1300 of the first outer cap component 1232 when the desired torque level is reached, the width W1 of each of the one or more tabs 1298 may be substantially smaller than the outer diameter DI of the surface 1300 of the first end cap component 1232 from which each of the one or more tabs can be formed or joined
1298. The width W1 of each of the tabs 1298 can be any suitable value that results in each
172
<img file="MX337063B_D0212.tif" />
MEXICAN INSTITUTE
OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0213.tif" />
one of the one or more tabs 1298 is dislodged from surface 1300, when the desired level of torque is reached. For example, the one or more tabs 1298 may be comparable in size to or smaller than the diameter of the fluid opening in plunger 1270 and / or luer receiver 1258. In some embodiments, the aggregate width ratio of tabs 1298 to outside diameter ID, can be from about 1 to 15 or greater. In some embodiments, the ratio can be between about 1 to 25 and about 1 to 10. In some embodiments, the ratio can be between about 1 to 16 and about 1 to 13. In some embodiments, multiple 1298 tabs can be used, wherein the widths W1 of each tab are different, but the added widths are calculated to achieve the desired level of torque to detach the tabs.
Similarly, in some embodiments, such as the illustrated embodiment, where each of the one or more tabs 1298 is configured to disengage from surface 1300 of the first outer cap component 1232 when the desired level of torque is reached, the length L1 of each of the one or more tabs 1298 may be substantially smaller than the outer diameter DI of the surface 1300 of the first end cap component 1232 from which each of the one or more can be formed or attached.
173 you
MEXICAN INSTITUTE
MIA recm; 7.0
INDUSTRIAL plus 1298 tabs. The length L1 of each xma ™ 3e ”“ Tas “'tabs 1298, can be any suitable value that results in each of the one or more tabs 1298 peeling off from the surface 1300, when it is reached desired level of torque. In some embodiments, the ratio of the added length of the tabs 1298 to the outer diameter ID can be from about 1 to 4 or greater. In some embodiments, the ratio can be between about 1 to 10 and about 1 to 12. In some embodiments, the ratio can be between about 1 to 5 and about 1 to 3. In some embodiments, multiple 1298 tabs can be used, wherein the widths W1 of each tab are different, but the added widths are calculated to achieve the desired level of torque to detach the tabs.
In some embodiments, one or more tabs 1298 may be configured such that the approximate width W1 of each of the one or more tabs 1298, may be significantly less than the approximate width (represented by W3 in Figure 7-6) of one or more of the plurality of tabs 1308 formed on the inner surface 1310 of the second end cap component 1234 to ensure that the one or more tabs 1298 are dislodged or separated before either of the tabs 1308. Therefore, in some embodiments, the approximate width
174
<img file="MX337063B_D0214.tif" />
W1 of 'each of the one or more tabs' Over 12 90, may be between about one third or less and about half or less of the approximate width W3 of each of the plurality of tabs 1308. Also, in some embodiments, there are many more tabs 1308 on the second end cap component 1234 than there are tabs 1298 on the first end cap component 1232, thus requiring more torsional force to dislodge the greater number of tabs 1308. on the second end cap component 1234.
In some embodiments, the material selected to form each of the one or more tabs 1298 may be the same or different compared to the material selected to form each of the one or more tabs 1308. The strength of the material selected to form tabs 1298, 1308, can affect the twisting force required to disengage tabs 1298, 1308. Accordingly, in some embodiments, the tab 1298, 1308 to be stripped may be formed of a weaker, softer, or less hard material compared to the material used to form the tab 1298, 1308 that is desired. remain intact. For example, in the illustrated embodiment, it is desired that the tab 1298 be dislodged from the surface 1300 on the first outer cap component 1232, when the desired level of
175
<img file="MX337063B_D0215.tif" />
MEXICAN INSTITUTE
Dk THE INDUSTRIAL AGE
<img file="MX337063B_D0216.tif" />
torsional force between the first end cap component 1232 and the second end cap component 1234. Thus, in the illustrated embodiment, the tab 1298 can be formed from the weaker material compared to the material used to form each of the tabs 1308. However, because the cross-sectional area of the tabs 1298, 1308 can also affect the amount of torque required to dislodge the tabs 1298, 1308, the material selected to form each of the tabs 1298, 1308, may be the same.
In some embodiments, as in the illustrated embodiment, as mentioned, it can be achieved to ensure that one or more of the tabs 1298 detach or separate before any of the tabs 1308, also configuring each of the one or more tabs 1298 of such that the approximate cross-sectional area of each of the one or more tabs 1298 is less than the cross-sectional area of each of the tabs 1308 to which it is adjacent and thus will make contact with each of the one or more tabs 1298. Referring to Figure 74, the cross-sectional area of each of the tabs 1298 is based on length (represented by Ll in Figure 74) and width (represented by Wl in Figure 74) of each of the one or more tabs 1298. Similarly, with reference to Figures 76 and 77, the area in
176
<img file="MX337063B_D0217.tif" />
INSTITUTO MEXICANO D £ LA PROPERTY INDUSTRIAL cross section of each of the tabs 1308 is based on the length (represented by L2 in Figure 77) and on the width (represented by W3 in Figure 76) of each of the one or more tabs 1308.
In some embodiments, regardless of differences in material, when the one or more tabs 1298 are designed to break away before any of the tabs 1308, the cross-sectional area of each of the one or more tabs 1298 can be substantially smaller than the cross-sectional area of each of the one or more tabs 1308. The ratio of the cross-sectional area of each of the one or more tabs 1298 relative to the cross-sectional area of each of the one or more tabs 1308 can be significantly less than one. For example, in some embodiments, as in the illustrated embodiment, the ratio can be from about 1 to 14 or greater. In some embodiments, the ratio can be between about 1 to 25 and about 1 to 10. In some embodiments, the ratio can be between about 1 to 16 and 1 to 12.
Furthermore, in some embodiments, such as the illustrated embodiment, the approximate length (represented by
Ll in Figure 74) of each of the one or more tabs
1298 is significantly less than the approximate length (represented by L2 in Figure 77) of each of the
<img file="MX337063B_D0218.tif" />
177
IMPI plurality of reeds 1308 formed in — the supeUlcre<sup></sup>internal 1310 of the second end cap component 1234. Accordingly, in some embodiments, the approximate length L1 of each of the one or more tabs 1298 may be between approximately one-third or less and approximately two-thirds, of the approximate length L2 of each of the plurality of tabs 1308.
In some embodiments, the second end cap component 1234 may define depressions or channels into which each of the one or more tabs 1298 formed in the first end cap component 1232 may be inserted, when the first end cap component end 1232 mates to second end cap component 1234. In some embodiments, the number of depressions or channels formed in the second end cap component 1234 may equal the number of tabs 1298 formed in the first end cap component 1232. In some embodiments, the number of depressions or channels formed in the second end cap component 1234, may be greater than the number of tabs 1298 formed in the first end cap component 1232.
Figure 78A is a side view of an exemplary mating component 1312 showing the male connection component of the partially engaging mating component 1312 threadably with the first end cap component.
178
IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0219.tif" />
1232 of the closable male luer connector 1200. Figure 78Ά illustrates the end cap 1230 before one or more of the tabs 1298 protrudes radially outward from the surface 1300 having separated. In Figure 78A, the coupled component 1312 exemplified is a syringe. However, the mated component 1312 can be any connector or medical instrument that has a male connection component. As illustrated therein, the mated component 1312 is only partially threadedly engaged with the first end cap component 1232, such that the torsional force exerted on the first end cap component 1232 by screwing the mating component 1312 onto the first end cap component 1232 is less than the minimum torque threshold required to dislodge or separate each one of the tabs 1298 from the first end cap component 1232. Thus, until the minimum torque threshold required to dislodge or separate each of the tabs 1298 is reached, the first end cap component 1232 may be rotatably attached to the second end cap component 1234 by the abutment of each. one of the one or more tabs 1298 formed on the first end cap component 1232 against one or more of the plurality of tabs 1308 formed on the second end cap component 1234.
179
IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0220.tif" />
When mated component 1312 is substantially fully threadedly engaged with first end cap component 1232, additional torque from mated component 1312 will eventually exert a torsional force on first end cap component 1232 that will exceed Minimum torque threshold required to separate tabs 1298 from first end cap component 1232. In some embodiments, the minimum torque threshold required to separate the tabs 1298 is approximately 4 inch-pounds of torque. Once the tabs 1298 have been separated from the first end cap component 1232, the first end cap component 1232 is able to rotate substantially freely within the second end cap component 1234. However, the first end cap component 1232 can still be retained in the housing by abutting the side surface 1302b against the side surface 1314b of the annular shoulder 1314. Also the 0-shaped ring 1260 can prevent fluid exchange without support the ability of the first end cap component 1232 to rotate. In this manner, the connector 1200 is prevented or inhibited from being easily disconnected from the mated component 1312, because the torsional force necessary for such disconnection would merely rotate the first end cap component 1232 relative to the housing.
180
<img file="MX337063B_D0221.tif" />
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0222.tif" />
1223 and / or to the second component of 1-Ap ^ ovt-remo 1234. Also, in some embodiments, there may be only a small amount (or no) of the external surface area on the first endcap component 1232 exposed for contact. with the fingers of a user, after attaching the mating component 1312, thus making it difficult to apply an opposing torsional force to the first end cap component 1232 and to the mating component 1312 to allow disconnection. This can effectively merge these two components together.
The use of tabs configured to detach is not required. Many other structures and configurations can be used to allow a threadable connection between the end of the housing and the mating component 1312, in a first stage, and then to allow rotation, in a second stage, to prevent or inhibit disconnection.
Figure 78B is a side view of mating component 1312, showing the male connecting component of mating component 1312 substantially and fully threadedly engaged with the first end cap component 1232 of male luer connector 1200. Figure 78B illustrates the first end cap component 1232 after the one or more tabs 1298 'have been separated by force exerted on each of the one or more tabs 1298 by one or more of the plurality of tabs 1308 formed in the
181
<img file="MX337063B_D0223.tif" />
<img file="MX337063B_D0224.tif" />
Pl
INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIAL internal surface 1310 of the second end cap component 1234 in reaction to the torsional force transferred to the first end cap component 1232 from the coupled component 1312 substantially and fully threadedly engaged. At this point, with each tab 1298 'spaced from the outer surface 1300 of the first end cap component 1232, the first end cap component 1232 will be able to rotate substantially freely within the second end cap component 1234. Any twisting movement applied to the mating member 1312 in any direction of rotation relative to the housing 1223, in this installation, will cause the first end cap component 1232 to rotate in unison with the mating member 1312. By this, the engaged member 1312 is unscrewed or otherwise disengaged from the first end cap component 1232.
Thus, in this manner, the luer connector 1200 is configured such that it cannot be withdrawn or disengaged from the mating member 1312 after the luer connector 1200 and the mating member 1312 have substantially and completely engaged one another.
After the one or more tabs 1298 'have been detached or separated from the first end cap component 1232, the cover portion 1292 of the first end cap component 1232 can prevent each from
<img file="MX337063B_D0225.tif" />
IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
182
<img file="MX337063B_D0226.tif" />
from the tabs 1298 'apart, drop the luer connector 1200, as shown more clearly in Figure 78B.
Additionally, as more clearly illustrated in Figure
68, the second end cap component 1234 may be configured to prevent the detached tab 1298 'from moving into the interior space of the housing 1223.
In particular, the second end cap component
1234 it may be configured to define an annular shoulder 1314 that can prevent the separate tab (s) 1298 'from moving into the interior space of housing 1223.
The
Figure 78C is a side view of an exemplified substantially fully threadedly engaged component 1312 with another embodiment of a closable male luer connector.
1200' .
In some embodiments, the closable male luer connector
1200 'can be identical to male closable luer connector
1200 described above, except for the following. In some embodiments, the second end cap component 1234 'may be configured to define an annular space 1238' adjacent the tabs.
1308'.
The annular space 1238 'may be sized and configured such that, when the one or more tabs 1298' have separated from the first end cap component 1232 ', the one or more tabs 1298' can fall and become contained within the annular space 1238 '.
In some modalities, the first component of
- 183 -
<img file="MX337063B_D0227.tif" />
end cap 1232 can be found coupled to second end cap component 1234, and thus coupled to luer connector 1200, as described below. After the second end cap component 1234 has been attached to housing 1223 following any of the methods described herein or any other suitable method, the first end cap component 1232 can then be coaxially aligned with the second end cap component. end 1234 and also rotatably align, such that each of the one or more tabs 1298 on the first end cap component 1232 is roughly aligned with the one or more gaps between the tabs 1308 formed on the second end cap component 1234. Once the first end cap component 1232 is approximately axially and rotatably aligned, the first end cap component 1232 can be inserted into the second end cap component 1234 by pushing the first end cap component 1232 against the second end cap component 1234, while maintaining the rough axial and rotational alignment described above. With reference to Figures 68, 74 and 77, the first end cap component
1232 can be pushed toward the inner end until the first end cap component 1234 is positioned relative to the second end cap component 1234, such
184
<img file="MX337063B_D0228.tif" />
MEXICAN INSTITUTE
OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0229.tif" />
that annular shoulder 1314 formed in end cap ^ ρ4ιηΗη — onrnponarüixi of end cap 1234 is radially adjacent (ie, axially aligned with) annular aperture 1302 formed in first end cap component 1232. In particular, in this position, the opposite side surfaces 1314a and 1314b of the annular shoulder 1314 formed in the second end cap component 1234 may optionally be positioned between the opposite side surfaces 1302a and 1302b of the annular opening 1302 formed in the second. end cap component 1234.
As shown more clearly in Figure 68, in some embodiments, the first end cap component 1232 and the second end cap component 1234 can be formed such that a small opening will exist between the generally cylindrical surface 1314c of the opening. annular 1314 and generally cylindrical surface 1302c of annular opening 1302. This configuration can facilitate the rotation of the first end cap component 1232 within the second end cap component 1234, ie, without friction between the two optionally cylindrical surfaces 1302c and 1314c, when the one or more tabs 1298 have become detached or separated. .
Additionally, with reference to Figure 68, the first end cap component 1232 and the second end cap component 1234 may be sized and
<img file="MX337063B_D0230.tif" />
185
<img file="MX337063B_D0231.tif" />
MEXICAN INSTITUTE
OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0232.tif" />
be configured such that the surface 1302b of the annular opening 1302 can overlap the side surface 1314b of the annular shoulder 1314 by an amount sufficient to prevent the first end cap component 1232 from inadvertently being removed from the second end cap component
1234. Additionally, the first end cap component 1232 and the second end cap component
1234 can be sized and configured such that, as described above, the first end cap component 1232 can be inserted into the second end cap component
1234 axially aligning and pushing the first end cap component 1232 toward the second end cap component 1234. Consequently, if the side surface 1302b of the annular opening 1302 overlaps the side surface 1314b of the annular shoulder 1314 by too much large, it may be difficult, in some configurations, to mate the first end cap component 1232 with the second end cap component 1234, as described above.
To facilitate insertion of the first end cap component 1232 into the second end cap component 1234, the first end cap component 1232 may be configured to have an angled or tapered annular surface 1304 and / or a rounded annular surface 1306.
186
<img file="MX337063B_D0233.tif" />
INSTITUTO MEXICANO DL LA PF.Oí'íEOAO INDUSTRIAL forward to the annular opening 1302, as shown more clearly in Figure 74. Similarly, the second end cap component 1234 can be configured to have an annular surface 1316 angled or tapered, to help align and essentially depress the first end cap component 1232 toward the second end cap component 1234, as shown more clearly in Figure 77.
Additionally, as shown in the illustrated embodiments, the one or more tabs 1298 and the plurality of tabs 1308 may comprise features and / or be configured to facilitate insertion of the first end cap component 1232 into the second end cap component. end 1234. For example, in some embodiments, as illustrated more clearly in Figure 74, each of the tabs 1298 may define angled or tapered front surfaces 1298a to help guide each of the tabs 1298 into the space between the tabs 1308 formed in the second end cap component 1234. Similarly, in some embodiments, as illustrated more clearly in Figures 75 and 77, the tabs 1308 on the second end cap component 1234 may define angled or tapered surfaces 1308a to help guide each of the tabs 1298. towards the space between each of the tabs
1308.
IMPI
<img file="MX337063B_D0234.tif" />
In some modalities, each of the
187
Additionally, tabs 1308 may define an angled or tapered leading edge 1308b to help at least axially align the first end cap component 1232 with the second end cap component 1234.
Any of the substantially rigid or semi-rigid components that comprise the luer connector 1200, including, but not limited to, the first end cap component 1232 and the second end cap component 1234, may comprise polycarbonate plastic, filled polycarbonates glass, and other suitable waterproof materials, or any combination thereof. The components that comprise the luer connector 1200 may also comprise a hydrophobic plastic. Other examples of suitable materials for the construction of any of the substantially rigid or semi-rigid components that comprise the luer connector 1200 are GE Valox 420 filled with glass or polypropylene. Depending on the application, many other materials can also be used.
Figure 79A is a cross-sectional view of another embodiment of a luer connector 1400 in a closed position. Figure 79B is a cross-sectional view of the luer connector 1400 embodiment shown in Figure 79A in an open position. In some embodiments, the connector
188
IMPI
MEXICAN INSTITUTE
OF THE FROrl'íDAD
INDUSTRIAL
<img file="MX337063B_D0235.tif" />
luer 1400 can have any Hp 1 to<sup>g</sup> mi nrnae—— ·· features and configurations than the embodiments of the luer connector 1000 described above and / or any of the features or configurations described herein. Additionally, luer connector 1400 may comprise any of the features, components, or configurations of any of the other luer connectors described herein.
As with the luer connector 1000 described above, the valve member 1416 may include at least one strut 1450. In some embodiments, the strut 1450 may extend from approximately the middle of the valve member 1416 toward the first end 1412. The connector 1400 it may have two struts 1450, as illustrated, or the luer connector 1400 may have more or less, as desired. Struts 1450 can be located around luer tip 1422, but within housing 1423, as shown. Struts 1450 may be located within the internal diameter of internal threads 1426 and, accordingly, are positioned to engage at least a portion of a female luer socket as it engages luer tip 1422.
As shown in the mode illustrated in
Figure 7-9A, elastic member 1418 may be a coil spring supported between end cap 1430 and a
- 189 -
<img file="MX337063B_D0236.tif" />
<td>portion</td><td colspan="2">front of</td><td>the</td><td>camera 1420.</td><td colspan="2">With reference</td><td>to</td>
<td>Figure</td><td>79A,</td><td colspan="2">Serving</td><td>front of</td><td>the camera</td><td> 1420</td><td>can</td>
<td>define</td><td>a</td><td>highlight</td><td colspan="2">override, like</td><td>it is illustrated</td><td>, or</td><td>can</td>
<td colspan="2">set up</td><td>of other</td><td colspan="3">way to bear a</td><td colspan="2">portion of</td>
end of elastic member 1418 in an axial and radial direction, such that the end portion of elastic member 1418 adjacent thereto remains substantially coaxially aligned with valve member 1416. Additionally, although not illustrated, end cap 1439 may also comprise an annular boss or depression, or may otherwise be configured to provide radial support to an end portion of elastic member 1418, such that the member Spring 1418 remains substantially coaxially aligned with end cap 1430.
With reference to Figures 79A and 79B, elastic member 1418 can be configured to bias valve member 1416 to the closed position, as illustrated in Figure 79A. When the valve member 1416 is caused to open, the elastic member 1418 can be axially compressed between the end cap 1430 and the front portion of the chamber 1420, as shown more clearly in Figure 79B. Valve member 1416 may be caused to open, for example, when the female portion of a connector or medical component 92 is engaged
190
<img file="MX337063B_D0237.tif" />
threaded with luer connector 1400 to axially displace the one or more struts 1450 in the direction of second end 1414 of luer connector 1400. Consequently, in the embodiment of luer connector 1400 illustrated in Figure 79A and 79B, the member Elastic 1418 can provide the same or similar axial force to elastic member 1018 described above, relative to luer connector 1000.
Additionally, because elastic member 1418 is substantially and completely enclosed within housing 1423 of luer connector 1400, in some embodiments, housing 1423 can be formed to define a continuous annular surface (ie, formed without any apertures or other opening in the outer surface, except for the openings that can form in either of the two axial ends). In some embodiments, the axial surface of housing 1423 may be profiled to provide tactile feedback and improved control for the user. In some embodiments, the center portion of the housing 1423 can be formed with a smaller cross-sectional diameter than the first and second ends 1412, 1414.
Figure 80A is a cross-sectional view of another embodiment of a luer connector 1400 'in a closed position. Figure 80B is a cross-sectional view of
191
<img file="MX337063B_D0238.tif" />
MEXICAN INSTITUTE
DE LA Fí <O? I? .DAD
INDUSTRIAL
<img file="MX337063B_D0239.tif" />
the mode of luer connector 1400 'shown in Figure
80A in an open position.
Referring to Figure 80B, the illustrated connector 1400 'is threadedly engaged with a closable female luer connector 210, which may be the same as the closable female luer connector 210 illustrated in FIG. 10 and described above. In the embodiment illustrated in Figure 80B, the closable female luer connector 210 may comprise an outer housing 213, a void 212, a fluid passage 218, a fluid conduit 216 with one or more ports 215, a compressible seal element 214 with a proximal surface 217 and a threaded clutch region 211. The closable female connector 210 may be positioned with its proximal end adjacent the first end 1412 'of the male connector 1400'. The threaded clutch region 211 of the closable female connector 210 can conform to the standard dimension for luer connectors, such as those meeting ANSI standards. The compressible seal member 214 can be comprised of a water-impermeable elastic material, which can move toward the housing 302 when a force is exerted on it. Fluid conduit 216 may be comprised of a rigid material, such as polycarbonate plastic, that is capable of resisting deformation when sufficient force is exerted to compress seal member 214, onto the
192
<img file="MX337063B_D0240.tif" />
INDU
INSTITUTO Mie
DE LAPRG lockable female connector 210.
Fluid passage 218 may place fluid passage 216 in fluid communication with second end 219 of closable female connector 210. At least one hole 215 in fluid passage 216 may be sealed by compressible seal element 214 to prevent it from being sealed. fluid passage 218 is in fluid communication with void space 212 between compressible seal member 214 and the inner wall of housing 213 and / or with the exterior of housing 213. The orifice (s) 215 may be appropriately sized to allow fluid to pass between the fluid passage 218 and the void space 212 at an appropriate fluid rate. One such dimension for the hole (s) 215 is approximately 1mm in diameter, although irregular shapes and other sizes can be used. Holes of at least about 1mm or about 1mm to 3mm, or less than about 1mm can also be used.
Referring to Figure 80B, the threaded region 211 of the closable female connector 210 may engage with the internal threads 1426 'of the male connector 1400' to engage connectors 1400 ', 210, as illustrated. In the illustrated clutch, the luer tip 1422 'advances toward the closable female connector 210 compressing the compressible seal element 214. As can be seen, the luer tip
193
<img file="MX337063B_D0241.tif" />
INSTITUTE Mi'XU DE LA? ΑΟ? Ι. íNu> J¿ ·
<img file="MX337063B_D0242.tif" />
luer 1422 'contacts compressible seal element 214 on proximal surface 217 of compressible seal element 214. The force exerted to engage connectors 1400', 210 and to engage threaded regions 1426 ', 211, is sufficient to compress seal member 214 to expose holes 215 in fluid conduit 126 and to open valve member 1416 ', as will be described below. With seal member 214 compressed, fluid passage 218 is in fluid communication with the interior space of luer tip 1422 '.
As luer tip 1422 'advances further toward closable female connector 210, fluid conduit 216 contacts the end of valve member 1416' adjacent first end 1412 'of male connector 1400'. Valve member 1416 'is movable toward second end 1414' of male connector 1400 'through contact and continuous advancement of luer tip 1422'. Resilient member 1418 'exerts a closing force in a direction toward first end 1412' of male connector 1400 'on valve member 1416'. As a result, the tip of valve member 1416 'generally maintains contact with fluid passage 216 throughout the entire clutch. As valve member 1416 'moves in a direction toward the second end
1414
- 194
<img file="MX337063B_D0243.tif" />
INSTITUTE ΜΓΧΙΟ'ΚΟ
FROM FR & fitDftO
INDUSTRIAL
<img file="MX337063B_D0244.tif" />
of the male connector 1400 ', the flange section 1458' of the valve member 1416 'can be separated from the interior surface of the housing 1423' or from the luer tip 1422 ', thus exposing or opening the orifice 1436'. As a result, apertures 1454 'open to fluid communication with closable female connector 210. Compressed seal member 214 can inhibit fluid flow into closable female connector 210 past luer tip 1422'. In this configuration, fluid can flow from second end 1414 'of luer connector 1400' to first end 1412 'of male connector 1400', through openings 1454 'out of hole 1436' in luer tip 1422 '. , into the outer housing 213 of the closable female connector 210, into the holes 215 of the fluid conduit 216 and into the fluid channel 217 within the fluid conduit 216.
The connectors 1400 ', 210, can be threadedly disengaged. During disengagement, the force exerted by elastic member 1418 'may return connector 1400' to its pre-clutch state, directing valve member 1416 'to engage flange section 1458' at the end of valve member 1416 '. toward the first end 1412 'of the male connector 1400' with the inner surface of the luer tip 1422 '. Similarly, the elastic material of which the
195
<img file="MX337063B_D0245.tif" />
compressible seal 214, can cause seal element 214 to return to its closed position and proximal surface 217 can seal the proximal tip of closable female connector 210. Any of the components of luer connector 1400 or 1400 'described herein , may be formed from any of the suitable materials described herein, or from any other suitable material for such components.
Figure 81Ά is a cross-sectional view of another embodiment of a luer connector 1500 in a closed position. Figure 81B is a cross-sectional view of the embodiment of the luer connector 1500 shown in Figure 81A in an open position. In some embodiments, the luer connector 1500 may have any of the same features and configurations as the embodiments of the luer connector 1000 described above and / or any of the features or configurations described herein. Additionally, luer connector 1500 may comprise any of the features, components, or configurations of any of the other luer connectors described herein.
As with luer connector 1000 described above, valve member 1516 may include at least one strut 1550. In some embodiments, strut 1550 may extend from about the middle of the member.
- 196 -
<img file="MX337063B_D0246.tif" />
Pl
INSTITUTE
DE ΙΛ PRCmDAI) INDUSTRY !.
<img file="MX337063B_D0247.tif" />
valve 1516 to the first end 1512. The connector
1500 it may have two struts 1550, as illustrated, or the luer connector 1500 may have more or less, as desired. Struts 1550 can be located around luer tip 1522, but within housing 1523, as shown. Struts 1550 may be located within the internal diameter of internal threads 1526 and, accordingly, are positioned to engage at least a portion of a female luer socket as it engages luer tip 1522.
As shown in the mode illustrated in
Figure 81A, elastic member 1518 may be of an axially elastic elastic material that is attached to and extends between an inner portion of housing 1523 and an outer surface of chamber 1520. In some embodiments, elastic member 1518 may be conical in shape. , the first end 1518a being attached to the outer surface of the chamber 1520 and the second end being attached
1518b to an internal surface of housing 1523. In some embodiments, elastic member 1518 may be formed of one or more generally rectangular-shaped tabs extending from an internal surface of the housing.
1523 to the outer surface of chamber 1520. In some embodiments, the elastic member
1518 can be found attached to valve member 1516 or housing 1523 using adhesive, n ^ ring => milar me.
may be constricted around elastic member 1518 and on the outer surface of chamber 1520 or by any other suitable attachment means or mechanism.
<img file="MX337063B_D0248.tif" />
197
<img file="MX337063B_D0249.tif" />
Mrx institute: c λ; ·;. ·)
DE LA ΡΚΟ?> Ει: λ5 INDUSTRIAL
<img file="MX337063B_D0250.tif" />
With reference to Figures 81A and 81B, elastic member 1518 can be configured to bias valve member 1516 to the closed position, as illustrated in Figure 81A. When the valve member 1516 is caused to open, the resilient member 1518 can elongate axially, as shown more clearly in Figure 8IB. The valve member 1516 may be caused to open, for example, when the female portion of a medical connector or component 92 is threadedly engaged with the luer connector 1500 in order to axially displace the one or more struts 1550 in the direction of the second end 1514 of luer connector 1500. Consequently, in the embodiment of the luer connector 1500 illustrated in Figures 81A and 81B, the elastic member 1518 provides the same or similar axial force to the valve member as compared to the elastic member 1018 described above, in conjunction with the luer connector 1000. .
Additionally, because elastic member 1518 is substantially and completely enclosed within housing 1523 of luer connector 1500, in some embodiments, housing 1523 may be formed to
198
<img file="MX337063B_D0251.tif" />
define a
MEXICAN INSTITUTE
OF INDUSTRIAL PROPERTY continuous annular surface.
I
In some embodiments, the annular surface is profiled to provide an apertured portion for holding by the user.
The
Figure
82A is a cross-sectional view of another embodiment of a luer connector
1500 'in a closed position. The figure
82B is a cross-sectional view of the embodiment of luer connector 1500 'shown in Figure
82A in an open position.
With reference to Figure
82B, the illustrated connector 1500 'is threadedly engaged with a closable female luer connector 210, which may be the same as the closable female luer connector 210 illustrated in FIG.
Figure 10 and described above.
The closable female connector
210 may be positioned with its proximal end
1500 'adjacent to first end 1512' of male connector
The threaded region 211 of the closable female connector
210 it can engage with internal threads 1526 'of male connector 1500' to engage connectors 1500 ', 210, as illustrated. In the illustrated clutch, luer tip 1522 'can advance toward closable female connector 210 compressing compressible seal element 215. As can be seen, luer tip 1522' contacts compressible seal element 215 on the proximal surface 217 of the compressible seal element 215. The r = r = acBissSRe
INSTITUTE MFx'c,<sup>v</sup>
I HEARD THE PROPERTY 'J φ
INDUSTRIAL connectors 1500 ', 210 and
199 force exerted to engage the to engage the threaded regions
1526 ', 211, is sufficient to compress seal element 215 to expose holes 215 in fluid conduit 216 and to open valve member 1516',
With seal element
218 can be found in as will be described below.
215 compressed, the fluid passage fluidly communicates with the interior space of the luer tip 1522 '.
As luer tip 1522 'advances further toward closable female connector 210, fluid conduit 216 contacts the end of valve member 1516' adjacent first end 1512 'of male connector 1500'. Valve member 1516 'is movable toward second end 1514' of male connector 1500 'through contact and continuous advancement of luer tip 1522'. The elastic member 1518 'exerts a closing force in a direction towards the first end 1512' of the male connector 1500 'on the valve member 1516'. As a result, the tip of the valve member 1516 'toward the first end 1512' of the male connector 1500 'generally maintains contact with the fluid conduit 216 throughout the entire clutch. As the valve member 1516 'is moved in a direction toward the second end 1514' of the male connector 1500 ', the flange section 1558' of the valve member 1516 'may separate from the surface.
200
<img file="MX337063B_D0252.tif" />
INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTPJAL interior of housing 1523 'or luer tip 1522', thus exposing or opening orifice 1536 '. As a result, apertures 1554 'open to fluid communication with closable female connector 210. Compressed seal member 215 inhibits fluid flow into closable female connector 210 past luer tip 1522'. In this configuration, fluid can flow from second end 1514 'of luer connector 1500' to first end 1512 'of male connector 1500', through openings 1554 'out of hole 1536' in luer tip 1522 ' , into the outer housing 213 of the closable female connector 210, into the holes 215 of the fluid conduit 216 and into the fluid channel 217 within the fluid conduit 216.
The connectors 1500 ', 210 can be threadedly disengaged. During disengagement, the force exerted by elastic member 1518 'may return connector 1500' to its pre-clutch state, directing valve member 1516 'to engage flange section 1558' at the end of valve member 1516 '. with the inner surface of the luer tip 1522 '. Similarly, the elastic material of which the compressible seal member 214 can be composed can cause the seal member 214 to return to its closed position and the proximal surface 217 can seal the proximal tip of the seal.
201
IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0253.tif" />
closable female connector 210. Any of the luer connector 1500 or 1500 'described herein may be formed from any of the suitable materials described herein, or from any other material suitable for such components.
Figure 83A is a cross-sectional view of another embodiment of a luer connector 1600 in a closed position. Figure 83B is a cross-sectional view of the embodiment of the luer connector 1600 shown in Figure 83A in an open position. In some embodiments, the luer connector 1600 may have any of the same features and configurations as the embodiments of the luer connector 1000 described above and / or any of the features or configurations described below. Additionally, luer connector 1600 may comprise any of the features, components, or configurations of any of the other luer connectors described herein.
As with the luer connector 1000 described above, the valve member 1616 may include at least one strut 1650. In some embodiments, the strut 1650 may extend from the middle portion of the valve member 1616 toward the first end 1612 of the luer connector 1600. Connector 1600 may have two struts 1650, as illustrated, or luer connector 1600 may have more or less,
202 as desired.
The struts around the luer tip housing 1623, as shown.
be located within the diameter
<img file="MX337063B_D0254.tif" />
MEXICAN INSTITUTE
DELA FRCrüT - '. D
INDUSTRIAL.
<img file="MX337063B_D0255.tif" />
1650 can be located
1622, but within the
Struts 1650 may be internal to internal threads 1626 and, consequently, are positioned to engage at least a portion of a female luer socket as it engages luer tip 1622.
As shown in the embodiment illustrated in Figure 83A, the elastic member 1618 may be of an axially elastic elastic material having a first end portion 1618a that is attached to the valve member 1616, and a second portion 1618b that is attached to the valve member 1616. secured to the outside of housing 1623. In this configuration, because the first portion 1618a of the elastic member 1618 is located within the housing and the second portion 1618b is located outside the housing, the housing 1623 can define openings through which the elastic member can pass. In some embodiments, elastic member 1618 may be fully contained within housing 1623, with a first end portion being secured to valve member 1616 and a second end portion being secured to the interior surface of the housing.
1623.
203
<img file="MX337063B_D0256.tif" />
INSTITUTO MEXICANO DE LA Fropíeoad INDUSTRIAL
<img file="MX337063B_D0257.tif" />
In some modalities, the mipinhro <sub>P</sub>ict - inn itia. it may comprise one or more bands with annular rings at either end, similar to elastic member 18 described above. In some embodiments, the elastic member 1618 may merely comprise one or more bands of generally rectangular shape, having a first end portion that is attached to the valve member 1616 and a second end portion that is attached to the interior or to the valve member 1616. exterior of housing 1623. In some embodiments, elastic member 1618 may be attached to valve member 1616 or housing 1623 using adhesive, an annular ring that can be constricted around elastic member 1618 and valve member 1616, or by any other suitable means or mechanism of attachment. Union. In addition, valve member 1616 may define depressions, ridges, or other features configured to axially secure a portion of resilient member 1618 to valve member 1616.
x With reference to Figures 83A and 83B, elastic member 1618 can be configured to bias valve member 1616 to the closed position, as illustrated in Figure 83A. When valve member 1616 is caused to open, resilient member 1618 can elongate axially, as shown more clearly in Figure 83B. Valve member 1616 may be caused to open, for i
204
<img file="MX337063B_D0258.tif" />
For example, when the female portion of the medical nn nonsctnr or mmpnnpntA is threadedly engaged with the luer connector 1600 in order to axially displace the one or more struts 1650 in the direction of the second end 1614 of the luer connector 1600. Consequently, in the embodiment of the luer connector 1600 illustrated in Figures 83A and 83B, the elastic member 1618 provides the same or similar axial force to the valve member as compared to the elastic member 1018 described above, in conjunction with the luer connector 1000. .
In addition to the seal created by the end portion of the valve member 1616, adjacent to the first end 1612 of the luer connector 1600, an additional generally fluid-tight seal may also be created by an additional generally flat seal 1626, which may be supported within a portion. cylindrical end cap 1630a from end cap 1630, as illustrated in Figure 83A. In some embodiments, seal 1626 may be flat and disc-shaped, defining a slit 1628 through a cross section thereof, as illustrated in Figures 83A and 83B. In the illustrated embodiment, slit 1628 in seal 1626 can be opened to allow fluid flow through seal 1626 as the valve member passes through seal 1626 and thus moves into position. open, as illustrated in Figure 83B. The 1626 seal can be formed of silicone rubber or any
205
IMPIC
INSTITUTO MEXICANO DE LA PROPIEDAD 1¾¾ INDUSTRIAL foldable and elastic to when the member in contact with the seal other suitable material that may be in order to self-restore valve 1616 is no longer in
1626. The redundancy of having the additional seal 1626 (ie, in addition to the seal created between the valve member 1616 and the male luer tip 1622) can provide the benefit of further decreasing the risk of any fluid leakage when the luer connector 1600 is in contact. in closed position.
Additionally, referring to Figures 83A and 83B, luer connector 1600 may comprise a seal 1632 that can be configured to provide a seal between the outer surface of chamber 1620 and end cap 1630. Seal 1632, preferably annular, may be configured to be sealed bonded to inner end portion 1630<sup>to</sup> end cap 1630 and to the outer surface of chamber 1620, in order to generally prevent any leakage of fluid into the interior space of housing 1623. In other words, seal 1632 may be generally configured to direct fluid or medication, which passes through the end cap 1630 into the internal passage 1634 of the valve member 1616, in order to prevent leakage into the interior space of the housing 1623.
Additionally, the 1632 seal can be configured to
206
<img file="MX337063B_D0259.tif" />
such that the volume of space VI defined within ...... of seal 1632, when valve member 1616 is in the closed position (with reference to Figure 83A), is greater than the volume of space V2 defined within seal 1632, when valve member 1616 is in the open position (referring to Figure 83B). In this configuration, as valve member 1616 moves toward the closed position, the volume of space within seal 1632 can be increased from VI to V2 in order to create a suction or negative pressure effect that can draw fluid from the seal. the internal passage 1634 into the volume of space (V) defined by the 1632 seal. Accordingly, similar to other embodiments described herein, this configuration of luer connector 1600 can eliminate or reduce the amount of potentially harmful drug that may otherwise leak from luer connector 1600 as the valve member closes. 1616.
Figure 84A is a cross-sectional view of another embodiment of a luer connector 1600 'in a closed position. Figure 84B is a cross-sectional view of the embodiment of the luer connector 1600 'shown in Figure 84A in an open position.
Referring to Figure 84B, the illustrated connector 1600 'is threadedly engaged with a closable female luer connector 210, which may be the same
207
<img file="MX337063B_D0260.tif" />
than the rsrrahlp 21 Q female luer connector illustrated in. — the
Figure 10 and described above.
The closable female connector 210 may be positioned with its proximal end adjacent the first end 1612 'of the male connector 1600'. The threaded region 211 of the closable female connector
210 it can engage with internal threads 1626 'of male connector 1600' to engage connectors 1600 ', 210, as illustrated. In the illustrated clutch, luer tip 1622 'can advance toward closable female connector 210 compressing compressible seal element 215. As can be seen, luer tip 1622' contacts compressible seal element 215 on the proximal surface 217 of compressible seal element 215. The force exerted to engage connectors 1600 ', 210 and to engage threaded regions 1626', 211, is sufficient to compress seal member 215 to expose holes 215 in fluid conduit 216 and to open valve member 1616 ', as will be described below. With seal member 215 compressed, fluid passage 218 is in fluid communication with the interior space of luer tip 22.
As luer tip 1622 'advances further toward closable female connector 210, fluid conduit 216 contacts the end of valve member 1616' adjacent first end 1612 '.
- 208
IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0261.tif" />
1600 'male connector. Valve member 1616 'is movable toward second end 1614' of male connector
1600 'through contact and continuous advancement of the 1622' luer tip. The elastic member 1618 'can exert a closing force in a direction toward the first end 1612' of the male connector 1600 'on the valve member 1616'. As a result, the tip of the valve member 1616 'toward the first end 1612' of the male connector 1600 'generally maintains contact with the fluid conduit 216 throughout the entire clutch. As the valve member 1616 'moves in a direction toward the second end 1614' of the male connector 1600 ', the flange section
1658 'of valve member 1616' can be detached from the inner surface of luer tip 1622 '. As a result, apertures 1654 'open to fluid communication with closable female connector 210. Compressed seal member 215 inhibits fluid flow into closable female connector 210 past luer tip 1622'. In this configuration, fluid can flow from second end 1614 'of luer connector 1600' to first end 1612 'of male connector 1600', through openings 1654 'out of hole 1636' in luer tip 1622 ' , into the outer housing 213 of the closable female connector 210, into the holes 215 of the fluid conduit 216 and into the
209 fluid
217 inside
<img file="MX337063B_D0262.tif" />
INSTITUTE M
PE LA PPOl'U INDUS'I fluid conduit 216 way down the
Threaded connectors. During elastic member
1600 ', 210, can be disengaged from the disengagement, the force exerted
1618 'can return connector
1400 'to valve its pre-clutch state, directing the member of
1616 'to engage the flange section 1658' of the end of the valve member 1616 'towards the first end 1612' of the male connector 1600 'with the inner surface of the luer tip 1622'. Similarly, the resilient material of which the compressible seal member 214 can be composed can cause the seal member 214 to return to its closed position and the proximal surface 217 can seal the proximal tip of the closable female connector 210. Any of the components of the luer connector 1600 or 1600 'described herein may be formed from any of the suitable materials described herein, or from any other material suitable for such components.
Figure 85A is a cross-sectional view of another embodiment of a luer connector 1700 in a closed position. Figure 85B is a cross-sectional view of the embodiment of the luer connector 1700 shown in Figure 85A in an open position. In some embodiments, the luer connector 1700 may have any of the same features and configurations as the embodiments of the luer.
210
<img file="MX337063B_D0263.tif" />
MEXICAN INSTITUTE
OF THE INDUSTRIAL PROl'-iEOAO
<img file="MX337063B_D0264.tif" />
luer connector 1000 described above and / or any of the features or configurations described below. Additionally, luer connector 1700 may comprise any of the features, components, or
<td>configurations</td><td>from any of the other luer connectors</td>
<td>described in the</td><td>Present.</td>
<td>What</td><td>with luer connector 1000 described</td>
Previously, valve member 1716 may include at least one strut 1750. In some embodiments, strut 1750 may extend approximately from the middle portion of valve member 1716 toward first end 1712. Connector 1700 may have two struts 1750, such as illustrated, or luer connector 1700 may have more or less, as desired. Struts 1750 can be located around luer tip 1722, but within housing 1723, as shown. Struts 1750 can be located within the internal diameter of internal threads 1726 and, accordingly, are positioned to engage at least a portion of a female luer socket as it engages luer tip 1722.
As illustrated in Figure 85A, the valve member 1716 of the luer connector 1700 may also comprise a first member (also referred to herein as a resilient member) and a second member 1720. In some embodiments, the first member 1718 may be generally of
- 211 -
<img file="MX337063B_D0265.tif" />
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0266.tif" />
tubular shape and formed of an elastic, flexible material ^ ___ substantially impervious to fluid. In the illustrated embodiment, the first member 1718 can be elastic in both the axial and radial directions. First member 1718 may define an axial opening therethrough which, when valve member 1716 is in the open position, allows fluid to flow through said first member 1718. In the illustrated embodiment, the first member
1718 may be positioned concentrically around second member 1720 so as to substantially completely surround second member 1720. First member 1718 may be configured and positioned such that a first end portion 1718a of first member 1718 abuts an internal end surface 1730a from the end cap 1730. Similarly, the first member 1718 can be configured and positioned such that a second end portion 1718b of the first member 1718 abuts an end surface 1750a of one or more valve struts 1750 at the opposite end of the first member 1718. Additionally, in the closed position, the inner surface 1718c of the first member 1718 may contact at least a portion of the second member 1720 so that the first member 1718 creates a substantially fluid-tight seal with the second member 1720 when the member is valve 1716 is located on the
212
<img file="MX337063B_D0267.tif" />
closed position (as shown in the F-ig ^ -ra-<sup>i</sup>& '5'A-)<sup>ro</sup>r<sup>,</sup>‘
The second member 1720 may be substantially rigid and, as shown in Figures 85A and 85B, may include one or more annular ridges 1725 around the perimeter of a portion of the second member 1720, although only one annular shoulder 1725 is shown. In the illustrated embodiment, annular shoulder 1725 may be configured to match the geometry of the interior of first member 1718 to provide a generally fluid-tight seal against internal surface 1718c of first member 1718, when valve member 1716 is in contact. in the closed position. Additionally, the second member 1720 may have a first opening 1724 that is formed in the first end portion of the second member 1720a (ie, the axial end portion of the second member 1720 that is closest to the first end 1712 of the luer connector 1700 ). Similarly, the second member 1720 may have a second opening 1726 that is formed in the second end portion of the second member 1720a (ie, the axial end portion of the second member 1720 that is closest to the second end 1714 of the luer connector 1700).
With reference to Figure 85A, the first member
1718 can be configured to bypass valve struts
1750 toward the first end 1712 of the luer connector 1700 of
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<img file="MX337063B_D0268.tif" />
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0269.tif" />
so that the valve struts 1750 cullllddll used to appear internal 1752. Additionally, with reference to Figure 85A, the first member 1718 may be configured to bias to the closed position (ie, such that the internal surface 1718c of the first member 1720 contacts annular shoulder 1725 to a degree sufficient to generally close the fluid passage between second end 1714 and first end 1712 of luer connector 1700). The amount of pressure exerted from the first member 1718, against the annular shoulder 1725, can be increased by increasing the size of the perimeter of the annular shoulder 1725 relative to the perimeter of the internal surface 1718c of the first member 1718, thereby increasing the sealing force between the flange. first member 1718 and second member 1720 while valve member 1716 is in the closed position. Additionally, the seal level can be increased, for example, by increasing the thickness or elasticity of the material used to form the first member 1718 or by altering its configuration.
Valve member 1717 can be caused to open, for example, when the female portion of a connector or medical component 92 (as shown in Figure 85b) is threadedly engaged with luer connector 1700 in order to axially displace the one or more struts 1750 in the direction
<img file="MX337063B_D0270.tif" />
second extreme 1714
<img file="MX337063B_D0271.tif" />
connector
<img file="MX337063B_D0272.tif" />
<img file="MX337063B_D0273.tif" />
1700.
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<img file="MX337063B_D0274.tif" />
INSTITUTO MEXICANO Oí LA EROHEDaO INDUSTRIAL
<img file="MX337063B_D0275.tif" />
The luer connector 1700 can be configured 'ΰδ CST so that, when the one or more struts 17 50 are moved toward the second end 1714 of the luer connector 1700, the struts 1750 exert an axial force on the second end portion 1718b of the first member 1718 which can cause the first member 1718 to decrease in length and roll or buckle outwardly in the middle portion thereof. When the middle portion of the first member 1718 sags outwardly, the inner surface 1718c can stretch and move radially outward away from the annular shoulder 1725. When the inner surface 1718c of the first member 1718 is no longer in contact with the annular shoulder 1725, the valve member is in an open position, as illustrated in Figure 85B.
Referring to Figure 85B, when the valve member 1716 is in the open position, a fluid or drug flowing into the second end 1714 of the luer connector 1700 may flow through the second opening 1726, into the space between the first member 1718 and second member 1720, around shoulder 1725, through first opening 1724, through passage 1756 and outward through the end of luer tip 1722.
In contrast, as the medical connector 92 is unscrewed or removed from the luer connector 1700, the i
215
<img file="MX337063B_D0276.tif" />
Axial deflection of first member 1718 can cause first member 1718 to elongate into its pre-rolled installation, causing struts 17 50 to move toward first end 1712 and, in some embodiments, contact inner wall 1752. Similarly, as medical connector 92 is unscrewed or removed from luer connector 1700, radial inward deflection of first member 1718 can cause first member 1718 to constrict and seal around annular shoulder 1725, preventing generally some fluid will flow through valve member 1716.
In some embodiments, the second member 1720 can be formed separately as compared to the luer tip 1722. However, in some embodiments, the second member 1720 can be formed integrally with the luer tip 1722. Additionally, because first member 1718 can be generally completely enclosed within housing 1723 of luer connector 1700, in some embodiments, housing 1723 can be formed to define a continuous annular surface. Any of the components of the luer connector 1700 described herein can be formed from any of the suitable materials described herein or from any of the materials suitable for such components.
Figure 8 6A is a cross-sectional view of
216
<img file="MX337063B_D0277.tif" />
I
INSTITUTE ΜΕΛΚDE LA PROl'lEuAD industrial
<img file="MX337063B_D0278.tif" />
another embodiment of a luer connector 1800 in <sup>1ina</sup> 1 '<sup>1</sup> i<sup>| X | rr</sup>~ closed. Figure 86B is a cross-sectional view of the luer connector 1800 embodiment shown in Figure 86A in an open position. In some embodiments, luer connector 1800 may have any of the same features and configurations as the embodiments of luer connector 1000 described above and / or any of the features, components, or configurations of any of the other luer connectors described herein.
As illustrated in Figure 86A, valve member 1816 may include at least one lever arm 1850. In particular, luer connector 1800 illustrated in Figure 86A comprises two opposing lever arms 1850, although luer connector 1800 may comprise any suitable number of 1850 lever arms. As illustrated therein, each lever arm 1850 may be pivotally installed about an axis 1852 that can be supported in a fixed position relative to housing 1823, but rotatable relative to housing 1823 to allow lever arm 1850 rotates relative to housing 1823. In some embodiments, such as the illustrated embodiments, the lever arms 1850 may extend outward from the housing 1823 through openings 1824 that may be formed in the housing 1824.
217
<img file="MX337063B_D0279.tif" />
IMPI
INSTITUTO MEXICANO ¿E LA FKOHEUAD 1NDUS11UAL
<img file="MX337063B_D0280.tif" />
year 1, 1823. .......
Each lever arm 1850 may be supported by housing 1823 such that first end portion 1850a of lever arm 1850 can contact chamber 1854, while second end portion 1850b may be positioned adjacent to the tip. from luer 1822. In particular, in the illustrated embodiment, the lever arm 1850 may be supported by the housing 1823 so that the lower surface 1850c of the first end portion 1850c can contact the outer surface 1854a of the chamber 1854. Similarly, in the illustrated embodiment, the lever arm 1850 may be supported by the housing 1823 so that the lower surface 1850d of the second end portion 1850b of each lever arm 1850 may be positioned generally within the housing 1823 around of the 1822 luer tip, as shown. The bottom surface 1850d of the second end portion 1850b of each lever arm 1850 can be located within the internal diameter of the internal threads 1826.
In this configuration, referring to Figure
86B, as the female portion of a medical connector 92 threadedly engages the threads 1826 of the luer connector 1800 and advances toward the second end 1814 of the connector via arrows Al
218
<img file="MX337063B_D0281.tif" />
INSTITUTO MEXICANO DE LA PROPERTY INDUSTRIAL luer 1800, as indicated
<img file="MX337063B_D0282.tif" />
Figure 86B, the distal tip
92a of the medical connector 92 may contact the lower surface 1850d of the second end portion
1850b of each lever arm
1850.
As the medical connector further advances toward the distal 92a of the connector end portion 1850b second end 1814, physician 92 can force each lever arm radially outward, as arrows A2 on the lever 1850 can the second portion at the far end. second
1850 in one is indicated by the
Figure 86B. Due to rotating around the axis that each arm
1852, to end measurement 1850b of each arm of
1850 it is forced radially outward, end 1850a of each lever arm moved radially inward, like arrows A3 shown in Figure 86B.
which lever the first
1850, can portion rotate and is indicated by
By forcing the first end portion 1850a of each lever arm 1850 inward, the bottom surface 1850c can be caused to exert a force radially inward against the outer surface 1854a of the chamber 1854, in the direction of arrows A3 shown in the Figure 86B. The lever arms 1850 and chamber 1854 can be configured such that the reaction force of the first end portion 1850a in the chamber 1854, as the first end portion 1850a
219 constricts inward against
Mexican JLhtuto of INDUSTRIAL property
<img file="MX337063B_D0283.tif" />
chamber 185 4, causes chamber 1854 and, consequently, valve member
1816, move axially toward the second end 1814 of the luer connector 1800. As the valve member 1816 moves axially toward the second end 1814 of the luer connector 1800, the valve member is caused to open such that the valve member 1816 is moved axially toward the second end 1814 of the luer connector 1800. Fluid or drugs may flow through valve member 1816 a out through opening 1856 at the distal end of luer tip 1822, as shown in Figure 86B.
An elastic member 1818, which can be formed from a coil spring, can be located between end cap 1830 and chamber 1854, as illustrated in Figures 86A and 86B. The front portion of the chamber 1854 may define an annular shoulder or may be otherwise configured to support an end portion of the elastic member 1818 in an axial and radial direction, such that the end portion of the elastic member 1818 adjacent thereto, remains substantially coaxially aligned with valve member 1816. Additionally, the end cap
1830 may also comprise an annular shoulder or depression, or be otherwise configured to provide radial support to an end portion of elastic member 1818, such that elastic member 1818 remains substantially coaxially aligned with the end cap.
220
<img file="MX337063B_D0284.tif" />
Mexican Institute of Industrial Property
<img file="MX337063B_D0285.tif" />
1813. _____ _______——
With reference to Figures 8 6A and 86B, elastic member 1818 can be configured to bias valve member 1816 to the closed position, as illustrated in Figure 86A. When valve member 1816 is caused to open, elastic member 1818 can be axially compressed between end cap 1830 and the front portion of chamber 1854, as shown more clearly in Figure 86B. Resilient member 1818 may bias chamber 1854 and valve member 1816 toward first end 1812 of luer connector 1800 in order to bias valve member 1816 toward the closed position. In this configuration, as medical connector 92 is removed from luer connector 1800, elastic member 1818 can bias valve member 1816 toward the closed position and can also bias lever arms 1850 to rotate about shaft 1852 so that the first end portion 1850a rotates radially outward.
A seal 1868 between the inner surface of the chamber 1854 and a portion of the end cap 1830 can prevent fluid from dripping through the space between the inner surface of the chamber 1854 and a portion of the end cap 1830. The chamber 1854 can be formed integrally with valve member 1816, or can be formed separately and adhered, fused, or otherwise joined to the member
221
<img file="MX337063B_D0286.tif" />
MEXICAN INSTITUTE OF INDUSTRIAL FROPicDAD
<img file="MX337063B_D0287.tif" />
valve 1816. Any of the connector components. luer 1800 described herein can be formed from any of the suitable materials described herein, or from any other material suitable for such components.
Some medications, including those used during chemotherapy, can be harmful to a patient in certain applications. For example, exposure to the skin can sometimes result in a chemical burn. Inhaling aerosolized forms of some medications can also be harmful. Therefore, control over the content of the medication is highly desirable.
Some potentially harmful medications are distributed in sealed vials. The medication is withdrawn from the vial by inserting a needle or vial adapter and drawing the medication into a syringe. If a needle is used, it is removed from the vial and medication can be dispensed. However, the removable needle with a medication residue disposed on the outside of the needle or vial adapter can include a medication residue on one or more of the exposed surfaces. This medication can inadvertently come into contact with the skin and cause damage. Or, if an injector is used to penetrate the vial with a withdrawal mechanism, the medication may
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MEXICAN INSTITUTE
OF THE PROPERTY
INDUSTRIAL
<img file="MX337063B_D0289.tif" />
be drawn through the mechanism and passed, di ronf aimtiiLc — to a syringe for injection without the additional step of removing the mechanism from the vial. However, even if such an injector is used, there is still the possibility that latent medication remains in the needle used to inject the medication or in the mechanism after uncoupling the vial, or in the mechanism after uncoupling the syringe.
Any characteristics of the embodiments shown and / or described in the Figures, which have not been expressly described in this text, such as the distances, proportions of the components, etc., are also intended to form part of this description. Additionally, although these inventions have been described in the context of various embodiments, features, aspects, and examples, it will be understood by those skilled in the art that the present inventions extend beyond the specifically described embodiments to other embodiments and / or alternative uses of the invention and to obvious modifications and equivalents thereof. Accordingly, it should be understood that various features and aspects of the described embodiments may be combined with or substituted for one another, in order to carry out the various modes of the disclosed inventions.
In addition, any used component or combination of components described in other structures herein, may or may be configurations of
- 223 IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX337063B_D0290.tif" />
medical connectors. Therefore, it is intended that the scope of the present inventions described is not limited by the particular embodiments discussed above.
As used throughout this specification, the terms first end and second end are marks of convenience that apply to either a female side or a male side of a valve, or both. Trademarks are used interchangeably herein.
By way of example, each of the structures of the embodiments described herein, to prevent or inhibit the disconnection of two medical connectors, can be employed on either the male or the female (or both) sides. Any particular use of first or second, with female or male should not be restricted to that end.
Contents155
380 sheets
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103 members in 15 offices
Members103
| Document | Office | Kind | |
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| EP1904152A2 | European Patent Office (EPO) | A2 | |
| MX2008000262A | Mexico | A | |
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| CN101500642A | China | A | |
| AR066635A1 | Argentina | A1 | |
| MX2009012270A | Mexico | A | |
| EP2150307A2 | European Patent Office (EPO) | A2 | |
| HK1133843A | Hong Kong, China | A | |
| HK1133843A1 | Hong Kong, China | A1 | |
| CN101743034A | China | A | |
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| US2018036524A1 | United States of America | A1 | |
| CN105013076B | China | B | |
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| EP3305361A1 | European Patent Office (EPO) | A1 | |
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| BRPI0811631B8 | Brazil | B8 | |
| EP3851155A1 | European Patent Office (EPO) | A1 | |
| ES2848388T3 | Spain | T3 | |
| ES2849048T3 | Spain | T3 | |
| US2021252267A1 | United States of America | A1 | |
| EP3305361B1 | European Patent Office (EPO) | B1 | |
| DK3305361T3 | Denmark | T3 | |
| ES2918073T3 | Spain | T3 |
Numbers
- Publication
- 337063
- Application
- 2013002911
Titles2
- Spanish
- CONECTOR MEDICO CON LUER MACHO CERRABLE.
- English
- MEDICAL CONNECTOR WITH CLOSURE MALE LUER.
Classification
- CPC, 11
- A61M39/1011
- A61M39/143
- A61M39/26
- A61M2039/1033
- A61M2039/1044
- A61M2039/261
- A61M2039/268
- A61M2039/1027
- A61M39/10
- A61M2039/1038
- A61M2039/1061
- IPC, 3
- A61M39 10
- A61M39 14
- A61M39 26