Antiseptic cap equipped syringe.
Abstract
A syringe assembly that includes: (1) a syringe barrel defines a chamber; (2) a piston mounted in the chamber and movable relative to the barrel; and (3) a cap support assembly containing a cap and absorbent material removably attached to the syringe.

Term
6.1 yearsleft in the term
Expires 26 October 2032.
- Priority
- Filed
- Granted
- Today
- Expires
13 claims: 4 independent, 9 dependent
- 1REIVINDICACIONES Habiéndose descrito la invención como antecede, se reclama como propiedad lo contenido en las siguientes reivindicaciones:1. Una combinación de jeringa y tapa antiséptica, caracterizada porque comprende: un montaje de soporte de tapa que comprende una tapa antiséptica colocada en un soporte de tapa y encerrada en el mismo por una cubierta;y un émbolo de jeringa que tiene una cámara en un extremo próximo, la cámara definida por una pared lateral que tiene un extremo próximo periférico que define una abertura, y un fondo distante, y en donde un borde interior en la pared lateral y fondo define al menos una abertura que proporciona acceso a la cámara, en donde el émbolo comprende adicionalmente un primer conjunto de paredes de soporte en una porción distante del émbolo, y un segundo conjunto de paredes de soporte en una porción próxima del émbolo, el segundo conjunto de paredes de soporte que incluye dos paredes que flanquean la abertura en la cámara, las dos paredes espaciadas por un ángulo mayor que 90 grados.
- 2La combinación de jeringa y tapa antiséptica de conformidad con la reivindicación 1, caracterizada porque la cámara del émbolo de jeringa comprende una pluralidad de 105 costillas circunferencialmente espaciadas.
- 3La combinación de jeringa y tapa antiséptica de conformidad con la reivindicación 2, caracterizada porque el soporte de tapa comprende una protuberancia en una superficie exterior del soporte de tapa, y la pluralidad de costillas circunferencialmente espaciadas comprenden al menos una muesca para recibir de manera removible la protuberancia.
- 4La combinación de jeringa y tapa antiséptica de conformidad con la reivindicación 3, caracterizada porque la pluralidad de costillas circunferencialmente espaciadas comprenden adicionalmente una segunda muesca colocada entre la primera muesca y un extremo próximo de la cámara.
- 5La combinación de jeringa y tapa antiséptica de conformidad con la reivindicación 1, caracterizada porque una o más de las paredes de soporte tiene un área ahuecada que se extiende longitudinalmente a lo largo de un borde periférico de las mismas.
- 6Un método para usar una tapa antiséptica colocada en un émbolo de una jeringa que tiene una cámara en un extremo próximo, caracterizado porque comprende:poner en contacto un soporte de tapa de un montaje de soporte de tapa, en una superficie de fondo del mismo, a través de una abertura en la cámara;empujar, a través de la abertura, el montaje de soporte de tapa fuera de la cámara al empujar en el fondo del soporte de tapa para mover una protuberancia del soporte de tapa fuera de una primera muesca en costillas circunferencialmente espaciadas en la cámara del émbolo;ΙΜΡΙ INSTITUTO MSXJCANO DE LA PROPIEDAD INDUSTRIAL remover el montaje de soporte de tapa del émbolo de j eringa;y almacenar el montaje de soporte de tapa para el uso en el futuro.
- 7El método de conformidad con la reivindicación 6, caracterizado porque además comprende el paso de usar el montaje de soporte de tapa al remover la cubierta del montaje de soporte de tapa, y al aplicar la tapa antiséptica a un sitio de acceso.
- 8El método de conformidad con la reivindicación 7, caracterizado porque además comprende el paso de sujetar el soporte de tapa para colocar la tapa antiséptica en el sitio de acceso, girar el borde de tapa para roscar la tapa antiséptica sobre el sitio de acceso, y jalar el soporte de tapa para retirar la tapa antiséptica del soporte de tapa.
- 9El método de conformidad con la reivindicación 6, caracterizado porque las costillas tienen una segunda muesca que recibe la protuberancia del soporte de tapa conforme el montaje de soporte de tapa progresa hacia fuera de la cámara, y en donde el paso de empujar el montaje de soporte de tapa fuera de la cámara comprende además empujar la protuberancia más allá de la segunda muesca. <««a .jUb»·» - 107
- 10Un método para usar una tapa antiséptica IMPI ΙΝ$ΠΗ/ΙΟ MEXICANO Jfc ΙΛ f iOPISOAD INDUSTRIAL colocada en un émbolo de una jeringa que tiene una cámara en un extremo próximo, caracterizado porque comprende:poner en contacto un soporte de tapa de un montaje de soporte de tapa, en una superficie de fondo del mismo, a través de una abertura en la cámara;empujar, a través de la abertura, el montaje de soporte de tapa fuera de la cámara al empujar en el fondo del soporte de tapa para mover una protuberancia del soporte de tapa fuera de una primera muesca en costillas circunferencialmente espaciadas en la cámara del émbolo;remover el montaje de soporte de tapa del émbolo de la jeringa;y aplicar la tapa antiséptica a un implemento médico.
- 11El método de conformidad con la reivindicación 10, caracterizado porque además comprende el paso de usar el montaje de soporte de tapa al remover la cubierta del montaje de soporte de tapa, y al aplicar la tapa antiséptica a un sitio de acceso.
- 12El método’ de conformidad con la reivindicación 11, caracterizado porque además comprende el paso de sujetar el soporte de tapa para colocar la tapa antiséptica en el sitio de acceso, girar el borde de tapa para roscar la tapa antiséptica sobre el sitio de acceso, y jalar el soporte de tapa para retirar la tapa antiséptica del soporte de tapa. 108 IMPI ΙΝίΤΤΠ'ΤΟ MEXICANO ΒΚ LA HtOAIMAD WBUmiAl
- 13El método de conformidad con la reivindicación 10, caracterizado porque las costillas tienen una segunda muesca que recibe la protuberancia del soporte de tapa conforme el montaje de soporte de tapa progresa hacia fuera 5 de la cámara, y en donde el paso de empujar el montaje de soporte de tapa fuera de la cámara comprende además empujar la protuberancia más allá de la segunda muesca. 109
Independent claims13
565 paragraphs in 79 sections, as filed
(54) Title: SYRINGE EQUIPPED WITH ANTISEPTIC LID.
(54) Title: ANTISEPTIC CAP EQUIPPED SYRINGE.
(57) Summary
A syringe assembly that includes: (1) a syringe barrel defines a chamber; (2) a piston mounted in the chamber and movable relative to the barrel; and (3) a cap support assembly containing a cap and absorbent material removably attached to the syringe.
(57) Abstract
A syringe assembly including: (1) a syringe barrel defining a chamber; (2) a plunger mounted in the chamber and moveable with respect to the barrel; and (3) a cap holder assembly containing a cap and an absorbent material removably attached to the syringe.
Institute
Mexican Property
Industrial
<img file="MX345307B_D0001.tif" />
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PATENT TITLE NO. 345307
EXCELSIOR MEDICAL CORPORATION
1933 HeckAvenue, Neptune, New Jersey, 07753, E LLA.
SYRINGE EQUIPPED WITH ANTISEPTIC LID.
Int.CI.8: A61M39 / 02; A61M39 / 16; A61M39 / 20; A61M5 / 315
WILLIAM ANDERSON; MARK WILSON; GARY HENNIGER; LARRY COLQUITT; CHRISTORHER E. GARDNER, CHIRAG SANJAY WALAWALKAR
REQUEST
International filing date:
MX / a / 2014/005371 October 2012
PRIORITY
Country:
Date:
Number:
US US November 2011 July 2012
13/288,529
13/547,650
Validity: Twenty years
Veneimied date: October 26, 2032
The reference patent is granted based on articles 1, 2, section V, 6, section III, and 60 of the Industrial Property Law.
In accordance with article 23 of the Industrial Property Law, this patent has a validity of 4 · twenty years, non-extendable, counted from the filing date of the international application and will be subject to the payment of the fee to keep the rights. , - ... Λ:., ·.; ·, ···, ·, ·: · / ........
Whoever signs this title does so based on the provisions of articles 6 * feaedones III and 7 bis 2 of the Industrial Property Law (Official Gazette of the Federation (DOF) 06/27/1991, amended on 02 / 08/1994, 10/25/1996, 12/26/1997. 05/17/1999. 01/26/2004, 06/16/2005, 01/25/2006, 05/06/2009, 06/01 / 2010, 06/18/2010, 08/28/2010, 01/27/2012 and 04/09/2012), articles 1 ·, 3<sup>or</sup> Section V Subsection a), 4th and 12th sections I and III of the Regulations of the Mexican Institute of Industrial Property (DOF 12/14/1999, amended on 07/01/2002, 07/15/2004, 07/28/1999 2004 and 9/7/2007); items 1<sup>or</sup>, 3<sup>or</sup>, 4<sup>or</sup>, 5<sup>or</sup> Section V subsection a), 16 sections I and III and 30 of the Organic Statute of the Mexican Institute of Industrial Property (DOF 12/27/1999, amended on 10/10/2002, 07/29/2004, 08/04/2004 and 09/13/2007); 1st. 3rd and 5th<sup>or</sup> Subsection a) of the Agreement that delegates powers to the Deputy General Directors, Coordinator, Divisional Directors, Heads of the Regional Offices, Divisional Deputy Directors, Departmental Coordinators and other subordinates 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).
Issue Date: January 25, 2017
THE DIVISIONAL DIRECTOR OF PATENTS
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NAHANNY CANAL REYES
TOi
AiN:> 550. floor T.
Col Maris Teosbsn.
CP WC20
Mexico City
MX / 2017/7420
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ΠΛΤπυτο μ me ano pi THE INDUSTÍIAL FKOPIWAD
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SYRINGE EQUIPPED WITH ANTISEPTIC LID
Field of Invention
The present invention relates to a syringe 5 equipped with an antiseptic cap, and more specifically to antiseptic caps placed on syringes.
Background of the Invention
Catheters are widely used to treat patients requiring a variety of medical procedures. The 10 catheters can be either acute, or temporary, for short-term use, or chronic for long-term treatment. Commonly, catheters are inserted into central veins (such as the vena cava) from peripheral sites of the vein) to provide access to the patient's vascular system. The 15 catheters offer many advantages for patients; For example, chronic catheters provide readily available access without repeated punctures or repeated cannulation of the vessel for administration of large volumes of fluids, nutrients, and medications and for intermittent blood withdrawal. With regard to the use of catheters for fluid infusion, examples include the infusion of drugs, electrolytes, or fluids used in chemotherapy. In chemotherapy, drug infusion catheters are used intermittently, ranging from daily to 25 weekly. Another example includes the use of catheters in the
REF: 248400 hyperalimentation treatment, where usually l> IIII .W. M— —I - WWMM —— n— «catheters are used for infusion of large volumes of fluids.
INSTnim: MEXICAN INDUSTRIAL PROPERTY
For hemodialysis catheters are commonly used three times a week for aspiration of blood for dialysis treatment and rapid return of blood to circulation after treatment. Although a preferred mode of vascular access for a hemodialysis patient involves the use of an arteriovenous (AV) fistula from either the upper or lower extremities or an arteriovenous bypass graft (typically using PTFE), the use of these access devices does not it is always possible or desirable. When either of these vascular access modes is not available, for example, due to a depletion of adequate blood vessels for AV shunt creation or due to suboptimal performance of established AV shunts, hemodialysis typically requires a catheter venous line of large orifice. Catheters used for hemodialysis usually include two relatively large diameter lumens (usually molded like a catheter) for rapid aspiration and return of blood required during the hemodialysis procedure. One lumen of this catheter is used for aspiration, or removal, of blood, while the other lumen is used for return of blood to the
<img file="MX345307B_D0004.tif" />
IMPI
INSTITUT · MEXICAN Di LA PROPERTY INDUSTRIAL blood stream of the patient. Catheter connections, such as catheter connections to dialysis machine tubing, or IV line tubing, to infusion ports, and to catheter caps, which are used to seal the end of a catheter to protect the catheter sterility and to prevent fluid loss and / or particle contamination, they are most often made using standardized Luer taper fittings from the medical industry. These accessories, which can be either male couplings or female couplings, include a tapered end of standardized dimensions. The coupling is done by the press fit of the coupling parts. A threaded lock or other type of locking mechanism is commonly used to ensure the integrity of the press fit of Luer fittings.
Catheters, especially chronic venous catheters, provide challenges in their use. One challenge is that these catheters can become occluded by a thrombus. In order to prevent coagulation of catheters in blood vessels between uses, such as for example between dialysis treatments when the catheter is essentially malfunctioning and resides within a central vein (i.e. superior vena cava, inferior vena cava, iliac , etc.), the catheter lumens are frequently filled with a blocking solution of a solution
IMPI
MEXICAN INSTITUTE OF THE MONEDAD INDUSTRIAL concentrate of the commonly used anticoagulant, heparin (up to 10,000 units of heparin per catheter lumen).
As used herein, the terms "blocking solution" or "blocking solution" refer to a solution that is injected or otherwise given by infusion into a catheter lumen with the intention of allowing a substantial portion of the solution to The blockage remains in the lumen and not in the systemic blood circulation until it is desired or required to regain access to that particular lumen, typically for further treatment, ie, fluid infusion or withdrawal. In addition, attention has been given to the development of alternative blocking solutions with the aim of improving the permeation rates of vascular catheters. For example, blocking solutions containing lower alcohols are under development, where lower alcohols include ethanol, propanol, and butanol. Optionally, antimicrobial and / or anticoagulant agents can be added to the blocking solution containing lower alcohol. Preferably, the blocking solution can remain in the lumen for a desired amount of time lasting from about 1 hour to 3 or 4 days or longer.
For the reasons stated above, significant care must be taken when drugs, nutrients, and the like are infused into a catheter, and where blocking a catheter between uses minimizes the risks associated with an implanted catheter, including the risk thrombosis or coagulation, the risk of excessive anticoagulation and the risk of infection. Syringes are typically used to administer the required amount of catheter blocking solution (determined by the catheter manufacturer) into an implanted catheter after a given use. The flushing procedures also require that care be taken to prevent backflow of blood into the catheter. Reflux in IV therapy is the term commonly used to describe fluid that is withdrawn into the catheter after a flushing procedure. The point is that the reflux fluid contains blood in solution that can cause the catheter to become occluded. To ensure reflux does not occur, the rinsing procedures suggest two techniques: 1) at the end of the rinsing solution administration, the user maintains pressure on the syringe plunger while holding the IV line; or 2) while the last 0.5 ml of the rinse solution is being administered, disconnect the syringe from the IV port or clamp the IV line. Either technique maintains a positive pressure on the fluid in the catheter to prevent backflow of fluid and blood.
The use of antiseptic caps, such as the cap manufactured and sold by Excelsior under the
<img file="MX345307B_D0005.tif" />
SwabCap trade name, it largely reduces the incidence of infections, resulting in, among other things, significant health benefits for patients and significant cost savings.
In view of the problems described above, there is a continuing need for advances in catheter locking techniques, devices and procedures to improve the safety and efficiency of catheter locking procedures and comprehensive patient care.
Brief Description of the Invention
The present invention relates to an antiseptic cap and syringe combination. The combination includes a syringe barrel that has an access point connection, and an end cap that has a proximal chamber and a distant chamber. The proximal chamber receives and releasably couples the access point connection of the syringe. The distant chamber receives and releasably engages an antiseptic cap. In one embodiment, the distal chamber has a plurality of ribs for contacting a plurality of ribs in the antiseptic cap to prevent relative rotational movement between the distal chamber and the antiseptic cap.
In one embodiment, an antiseptic cap and syringe end cap combination includes a first chamber having means for releasably coupling a syringe
IMPI 'Mexican institute
OF THE «INDUSTRIAL OPIETY connection of access points in a syringe. A second chamber is integrally formed with the first chamber. An antiseptic cap is placed within the second chamber, and the means for releasably coupling the antiseptic cap is provided in the second chamber.
A method is provided for storing an antiseptic cap from a syringe. The method includes the steps of providing a syringe having a barrel, plunger, access point connection, and end cap, providing a chamber on the syringe, and releasably fitting an antiseptic cap within the chamber.
Also provided is a method of using an antiseptic cap attached to an end cap of a syringe having a barrel, plunger, or access point connection and an end cap. The method includes the steps of removing the end cap from the syringe, and using the syringe. The method further includes the step of removing a cover on the antiseptic cap. Included are the steps of using an end cap to place the antiseptic cap at an access point, removing the end cap from the coupling with the antiseptic cap, leaving the antiseptic cap at the access point.
In one embodiment, an antiseptic cap and syringe end cap combination includes a first chamber having a means for releasably coupling <sub>8</sub> IMPI ^
MEXICAN INSTITUTE Fx<sup>-</sup>*
OF THE PRORIEDAO V ^ · INDUSTRIAL an access point connection on a syringe, and a second chamber integrally formed with the first chamber. An antiseptic cap assembly has an antiseptic cap, and the antiseptic cap assembly is removably positioned within the second chamber.
In another embodiment, an antiseptic cap and syringe combination includes a syringe barrel having an access point connection, and a plunger received at one end by the barrel. The plunger has a chamber that removably receives an antiseptic cap assembly at a second end. An end cap has a proximal chamber for releasably receiving the syringe access point connection, and a distal chamber for removably receiving a second antiseptic cap assembly.
In another embodiment, an antiseptic cap and syringe combination includes a syringe barrel having an access point connection, and a plunger received at one end by the barrel. A chamber is interconnected with the syringe barrel to removably receive an antiseptic cap assembly.
In another embodiment, an antiseptic cap and syringe combination includes a syringe barrel having an access point connection and an antiseptic cap. A flexible ring is provided to couple the access point and a chamber interconnected with the syringe barrel
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ΙΜΕΤΠΊΠΟ MEXICAN <sup>, W</sup> DETARTOMTY tNW) ST * lAL
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to removably receive an antiseptic cap. , _<sub>Λ</sub>i · '- ~<sup>—</sup>’
In another embodiment, a syringe and antiseptic cap combination includes a syringe barrel that has an access point connection and an end cap that includes a proximal chamber that releasably receives and couples the access point connection of the syringe. . A distal projection extends from the end cap, and an antiseptic cap assembly has a chamber for receiving the distal projection of the end cap at one end and an antiseptic cap at the other end.
In another embodiment, an antiseptic cap and syringe combination includes a syringe barrel that has an access point connection, an end cap that includes a proximal chamber for coupling the access point connection, and a distal junction chamber, and a cap assembly. The cap assembly includes a coupling boss for removably coupling the end tip.
Brief Description of Figures
Figure 1 is a perspective view of a syringe barrel and plunger assembly equipped with an antiseptic cap prior to connection of a syringe tip to a central venous catheter access point;
Figure 2 is a perspective view of a syringe barrel and plunger assembly equipped with an antiseptic cap with the syringe tip connected to a point of <sup>10</sup> Ih tNSTtTU
DE access to a central venous catheter;
Figure 3 is a perspective view ^ ΊΓιΓ plunger and syringe barrel assembly equipped with antiseptic cap prior to connection of the antiseptic cap to an access point to a central venous catheter;
Figure 4 is a perspective view of a syringe barrel and plunger assembly equipped with an antiseptic cap after connection of the antiseptic cap to a central venous catheter access point;
Figure 5 is an assembly drawing in perspective view of the plunger equipped with an antiseptic cap;
Figure 6 is a perspective view of a plunger equipped with an antiseptic cap in a partially assembled state;
Figure 7 is a perspective view of the antiseptic cap equipped plunger of Figure 6 with a top seal;
Figure 8 is a perspective view of a plunger equipped with the antiseptic cap of Figure 7 mounted in a lumen of a syringe barrel;
Figure 9 is a sectional side view of a plunger and syringe barrel assembly equipped with an antiseptic cap;
Figure 10 shows a view with separation of parts of a detail of Figure 9 of an embodiment of the
<img file="MX345307B_D0007.tif" />
IMPI ^
MEXICAN INSTITUTE
INDUSTRIAL PROPERTY syringe barrel assembly and plunger equipped with antiseptic cap;
Figure 11 shows a broken away view of a detail of Figure 9 of another embodiment of the syringe barrel and plunger assembly equipped with an antiseptic cap;
Figures 12-14 show various handle arrangements of the antiseptic cap equipped plunger assembly;
Figures 15-17 show various views of a syringe barrel and plunger assembly equipped with an antiseptic cap in one embodiment with a barrel lock to resist rotation of the plunger assembly relative to the syringe barrel;
Figure 18 shows another embodiment of a barrel lock to resist rotation of the plunger assembly relative to the syringe barrel;
Figures 19-20 show various views of a plunger and anti-reflux syringe barrel assembly equipped with another embodiment antiseptic cap with a barrel lock to resist rotation of the plunger assembly relative to the syringe barrel;
Figure 21 shows a perspective view of a plunger and syringe barrel assembly equipped with another embodiment antiseptic cap with a barrel latch for
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resist rotation of the plunger assembly relative to the syringe barrel;
Figures 22a-22b are respectively a perspective view of an antiseptic cap without a sponge and with a sponge;
Figures 23 and 24 are different embodiments of the antiseptic cap with various grip characteristics;
Figure 25 is a perspective view of the antiseptic cap of Figure 22b of coupling with a valve;
Figure 26 is a perspective view of the antiseptic cap of Figure 22b coupled with a valve;
Figure 27 is a sectional side view of the antiseptic cap and valve assembly shown in Figure 26;
Figures 28-30 are sectional side views of two different embodiments of the antiseptic cap;
Figures 31a-31b are, respectively, sectional side views showing an antiseptic cap with an actuating strut positioned centrally on a valve with the valve in the activated and non-activated positions;
Figures 32 and 33 are side sectional views showing two different embodiments of an antiseptic cap having a molded sponge;
<sup>13</sup> IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
Figure 34 is a sectional side view showing another embodiment of an antiseptic cap having a molded sponge attached to a valve;
Figure 35 is a sectional side view showing the step of attaching a molded sponge to an antiseptic cap;
Figure 36 is a sectional side view showing the step of dispensing an antiseptic compound to a molded sponge placed within a lid;
Figure 37 shows a sectional side view of an antiseptic cap that engages a valve with the antiseptic cap having an antiseptic coating;
Figure 38 shows a perspective view of an antiseptic cap on a blister pack;
Figure 39 is a cross-sectional side view of an antiseptic cap with a threaded cover;
Figure 40 is a cross-sectional side view of an antiseptic cap with a threaded cover;
Figure 41 is a cross-sectional side view of an antiseptic cap with a threaded cover;
Figures 42a-42b are front and rear perspective views of an antiseptic cap with a threaded cover connected to a Cardinal SMART SITE access site;
Figures 43a-43b are front and rear perspective views of an antiseptic cap without a cover
<img file="MX345307B_D0008.tif" />
<img file="MX345307B_D0009.tif" />
threaded connected to a Cardinal SMART SITE access site;
Figures 44a-44b are front and rear perspective views of an antiseptic cap with a threaded cover connected to a Hospira Access Device (ICU)
C1000 Key;
Figures 45a-45b are front and rear perspective views of an antiseptic cap without a threaded cap connected to a CIO00 Clave Hospira Access Device (ICU);
Figures 46a-46b are front and rear perspective views of an antiseptic cap with a threaded cover connected to a B. Braun ULTRASITE access device;
Figures 47a-47b are front and rear perspective views of an antiseptic cap without a threaded cap connected to a B. Braun ULTRASITE access device;
Figures 48a-48b are front and rear perspective views of an antiseptic cap with a threaded cap connected to a Rymed INVISION PLUS access device;
Figures 49a-49b are front and rear perspective views of an antiseptic cap without a threaded cover connected to a Rymed INVISION PLUS access device;
Figure 50 is a sectional side view
<img file="MX345307B_D0010.tif" />
cross section of an antiseptic cap with a threaded cover connected to a Cardinal SMARTSITE PLUS access device;
Figure 51 is a cross-sectional side view of an antiseptic cap with a threaded cap connected to a Cardinal SMARTSITE PLUS access device and the threaded cap having a reduced diameter compared to the threaded cap shown in Figure 50;
Figure 52 is a cross-sectional side view of an antiseptic cap with a threaded cover connected to a C1000 Clave Hospira Access Device (ICU) having a threaded cover with an alternate profile;
Figure 53 is an assembly view of a plunger and syringe barrel system equipped with cup holder and antiseptic cap;
Figure 54 is an assembly view of an antiseptic cup-holder-cap assembly adjacent to a syringe barrel and plunger system;
Figure 55 is a cross-sectional side view of a plunger and syringe barrel assembly equipped with an antiseptic cap and cup holder;
Figure 56a is a perspective view of a medical access device adjacent to a syringe barrel and plunger assembly equipped with an antiseptic cap with a peeled cover in preparation for docking;
ιβ IMPIAS Mexican institute w
FROM THE ΡϋΟΗΒΟΑΓ Q * »INDUSTRIAL
Figure 56b is a perspective view of a medical access device attached to a plunger and syringe barrel assembly equipped with an antiseptic cap;
Figure 56c is a perspective view of a medical access device attached to an antiseptic cap adjacent to a syringe barrel assembly;
Figure 57 is an enlarged view of an antiseptic cap and cup holder assembly adjacent to an open and empty chamber of a syringe plunger;
Figure 5-8 is an enlarged view of an antiseptic cap and cup holder assembly positioned within a chamber of a syringe plunger;
Figure 59 is a perspective view of an alternate embodiment of an antiseptic cap assembly adjacent to a syringe barrel and plunger assembly;
Figure 60 is a perspective view of an alternate embodiment of an antiseptic cap assembly coupled to a syringe barrel and plunger assembly;
Figure 61 is a perspective view of an alternate embodiment of an antiseptic cap assembly coupled to a syringe barrel and plunger assembly with an outer wall that is transparent to reveal the interior portions of the assembly;
Figure 62 is a perspective view of an end cap assembly having an antiseptic cap.
<img file="MX345307B_D0011.tif" />
attached to a syringe;
Figure 63 is a cross-sectional view of an end cap having an antiseptic cap attached to a syringe;
Figure 64 is a perspective view broken away showing an antiseptic cap and an end cap;
Figure 65 is a broken away perspective view showing an antiseptic cap holder assembly, an end cap, and a syringe;
Figure 66 is a part-cut perspective view showing an antiseptic cap holder assembly, an end cap, and a syringe;
Figure 67A is a cross-sectional view of an antiseptic cap assembly attached to a syringe;
Figure 67B is a cross-sectional view of an antiseptic cap assembly and a flexible cap;
Figure 68 is a side view of an antiseptic cap holder assembly attached to an end cap attached to a syringe;
Figure 69 is a perspective view of an antiseptic cap support assembly;
Figure 70 is a perspective view of an end cap;
Figure 71 is a cross-sectional view <sub>1β</sub> IMPI ^
INSTITUTE MÍXACAN · D £ LA FUOfILPA · INDUSTRIAL of the antiseptic cap support assembly of Figure 69 and the end cap of Figure 70 uncoupled and unlocked;
Figure 72 is a cross-sectional view of the antiseptic cap support assembly of Figure 69 and the end cap of Figure 70 engaged and secured;
Figure 73 is a perspective view of a syringe having a plunger with a cap holder assembly that can be manually removed from the plunger;
Figure 74 is a cross-sectional view of the syringe, plunger, and cap holder assembly of Figure.
73;
Figures 75 and 76 are sequential views, showing the process of manually removing the cap support assembly from a plunger chamber;
Figure 77 is a perspective view of another embodiment of a notched ribbed plunger chamber;
Figure 78 is a cross-sectional view of the chamber of Figure 77;
Figure 79 is a cross-sectional view of a lid support assembly positioned within the chamber shown in Figure 78;
Figure 80 is a cross-sectional view of a lid bracket assembly partially removed from the
<img file="MX345307B_D0012.tif" />
IMPI
MEXICAN INSTITUTE DE THE PROPERTY INDUSTRIAL chamber shown in Figure 78;
Figure 81 is a cross-sectional view of another embodiment of a ribbed plunger chamber having two sets of notches;
Figure 82 is a cross-sectional view of a lid support assembly positioned within the chamber shown in Figure 81;
Figure 83 is a cross-sectional view of a partially removed lid support assembly from the chamber shown in Figure 81;
Figure 84 is a perspective view of another embodiment of a plunger having side walls with recessed areas;
Figure 85 is a perspective view of another embodiment of a plunger having two or more side walls positioned at angles greater than ninety degrees to each other to provide access to the chamber;
Figure 86 is a perspective view of another embodiment of a syringe having a flange with receptacles for receiving a cap support assembly;
Figure 87 is a perspective view of the syringe shown in Figure 86 with a cap holder assembly positioned in a receptacle;
Figure 88 is a perspective view of a flange connector panel having a socket receptacle.
IMPI ^
MEXICAN INSTITUTE. *<sup>N</sup> CURRENCY MOUNTING LID SUPPORT AND A FLAP / fi ^ '^ groove n a side wall; ____——
Figure 89 is a top view of the tab connector panel of Figure 88 connected to a holding tab of a syringe;
Figure 90 is a perspective view of another embodiment of a flange connector panel having a flange slot in another side wall;
Figure 91 is a top view of the tab connector panel of Figure 90 connected to a holding tab of a syringe;
Figure 92 is a perspective view of another embodiment of a syringe with a clamping flange having engagement teeth;
Figure 93 is a perspective view of a flange connector panel that engages the clamp flange of Figure 92;
Figure 94 is a perspective view of another embodiment of a flange connector panel for connection to a clamp flange having a lip;
Figure 95 is a perspective view of a flange connector panel that attaches to the clamp flange of Figure 94;
Figure 96 is a perspective view of a cap and plunger bracket assembly connected by a joint
Figure 97 is a cross-sectional view
<img file="MX345307B_D0013.tif" />
fragile;
the plunger and cap bracket assembly of Figure 96;
Figure 98 is a broken away view of a plunger having a transverse opening to receive a cap support assembly;
Figure 99 is a broken away view of another embodiment of a plunger having a transverse opening for receiving a lid support assembly;
Figure 100 is a front view of the plunger of Figure 99;
Figure 101 is a side view of the plunger of Figure 99;
Figure 102 is a perspective view of another embodiment of a lid support assembly having a locking flange;
Figure 103 is a partial perspective view of a plunger having a locking chamber;
Figure 104 is a partial cross-sectional view of the cap bracket assembly of Figure 102 and the plunger of Figure 103 disengaged and unlocked;
Figure 105 is a cross-sectional view of the lid bracket of the lid bracket assembly of Figure 102 and the plunger of Figure 103 engaged and locked;
<img file="MX345307B_D0014.tif" />
IMPI MEXICAN INSTITUTE OE LA MtOMIDA »INDUSTRIAL
Figure 106 is a perspective view of another embodiment of a plunger having a locking lever and a lid support assembly positioned thereon;
Figure 107 is a cross-sectional view of the cap and plunger bracket assembly of Figure 106;
Figure 108 is a side view of the locking lever of Figures 106 and 107;
Figure 109 is a cross-sectional view of another embodiment of the cap and plunger bracket assembly including a locking lever with a dropout;
Figure 110 is a side view of the locking lever of Figure 109;
Figure 111 is a side view of the cap support assembly and a plunger each having an adhesive material thereon;
Figure 112 is a side view of a cap support assembly and plunger with compressible material in an uncompressed state;
Figure 113 is a side view of a cap support assembly and plunger with the compressible material in a compressed state;
Figure 114 is a cross-sectional view of a plunger and cap support assembly, wherein the flange of the cap support assembly is positioned at a distance away from the plunger flange;
<img file="MX345307B_D0015.tif" />
<img file="MX345307B_D0016.tif" />
MEXICAN INSTITUTE
OF INDUSTRIAL PROPERTY
Figure 115 is an exploded view of a plunger having a locking flange attached thereto and a cap bracket assembly;
Figure 116 is a perspective view of the plunger and cap bracket assembly of Figure 115 positioned on the plunger;
Figure 117 is a top view of the locking tab of Figures 115 and 116; and
Figure 118 is a top view of another embodiment of the locking tab of Figures 115 and 116.
Detailed description of the invention
While this invention is capable of many different embodiments, specific embodiments thereof are shown in the figures, and will be described in detail herein with the understanding that the present disclosure is to be considered as an example of the above. principles of the invention and is not intended to limit the invention to the specific embodiments illustrated.
Figures 1 and 2 show a syringe barrel and plunger assembly 10 equipped with an antiseptic cap having a plunger (or piston) assembly 12 equipped with an antiseptic cap and a syringe barrel 14. The barrel 14 has a side wall 16 that defines a chamber 18 and the barrel has a proximal end 20 and a distal end 22. The proximal end 20 has an opening 23 to chamber 18 and a flange <sub>24</sub> IMPI ^
MEXICAN INSTITUTE OF PROPERTY m
INDUSTRIAL extending radially outward from wall 16. Flange 24 has top and bottom surfaces 26, 28 and provides gripping surfaces for a user of mount 10. Distant end 22 of barrel 14 has end wall 30 and tip elongated 32 extending distantly therefrom and having a passageway 34 therethrough and in fluid communication with chamber 18. The distal end wall 30, in a preferred form of the invention, is generally conical in shape and, as is well known in the art, may have a locking luer collar 35 that concentrically encircles the tip 32 and has an assembly of 37 threads on an inner surface thereof. The luer collar 35 allows a needle or cannula to be attached to the syringe assembly and to mate the assembly to localized mating threads on other devices such as valves and injection sites. Figure 1 shows the syringe assembly proximate to an access site 38 having a valve 39 that controls access to a lumen of a tubing 41.
In a preferred form of the invention, chamber 18 of syringe assembly 10 will be filled with a blocking solution or a rinsing solution for use with an implanted central venous catheter. The manner of using a blocking or flushing solution with a catheter is well known in the art. Suitable blocking or flushing solutions will be discussed later. The flushing or blocking solution is injected into a fluid access site of the catheter to clean and disinfect the catheter and may be removed from the catheter or allowed to remain in a terminal portion of the catheter to serve as a barrier to entry of pathogens and contaminants.
The antiseptic cap plunger assembly 12 has an elongated shaft 40, a proximal end 42, and a distal end 44. The elongated shaft 40, in a preferred form of the invention, is generally of a cruciform transverse shape. A plug or piston 50 is connected to the distal end 44 of plunger 12. The piston 50 is made of dimensions such that when inserted into the syringe barrel chamber 18, an outer circumferential surface of the piston is in fluid-tight engagement with an inner surface 54 of the syringe barrel. The piston assembly 12 when moved proximally (or when removed) can deliver fluid to the chamber and when moved distantly (or when inserted into the syringe chamber) can draw fluid from the chamber. Figure 1 shows the piston assembly 12 partially inserted into the syringe chamber and Figure 2 shows the piston assembly fully inserted into the syringe chamber to distribute fluid to line 41.
A housing 60 is placed at the proximal end
<img file="MX345307B_D0017.tif" />
of the plunger assembly 12 and has a wall 62 defining a chamber 64 having an open end 66 that can be sealed by any suitable structure or material such as a cap or by a laminated material 68. An optional annular flange 70 extends radially outward from wall 62 and provides a surface to which the sealing structure can be attached.
Figure 5 shows a cap assembly 80 proximate chamber 64 of housing 60 and Figure 6 shows cap assembly 80 positioned within chamber 64. In a preferred form of the invention, cap assembly 80 has a cap. 82 having a wall 83 defining a chamber 84 containing an absorbent material 86, such as a sponge. The sponge 86, in a preferred form of the invention, is moistened or moistened with an agent such as an antiseptic, anticoagulant, or antimicrobial (antiseptic solution) and can be selected from the blocking and rinsing solutions discussed below or the antiseptic solutions. set out later. Cap 82 has an interior surface 87 with a set of threads 88 to mate with a set of threads at access site 38.
Figures 7 and 8 show the cap assembly 80 sealed with a laminate material or cover material 68 that can be attached to the flange 70 by any suitable method, such as by adhesives or by sealing techniques.
IMPI
MEXICAN INSTITUTE thermal inductive or conductive. Figure 7 shows the antiseptic cap piston assembly 12 and Figure 8 shows the antiseptic cap equipped piston assembly 12 inserted into the chamber of syringe barrel 14 to define the syringe barrel assembly and antiseptic cap equipped piston 10 .
Figures 3 and 4 show a possible method for using the cap assembly 80 by mating with the access device 38. Figure 3 shows the cover 68 detached from the flange 7 0 and Figure 4 shows the antiseptic cap assembly coupling 80 to valve 39. The syringe barrel is rotated clockwise or counterclockwise to engage the threads 88 of the antiseptic cap assembly 80 with the threads of the access site 38. After attachment, the barrel of syringe 14 will move away from access site 38 and antiseptic cap assembly 80 will slide out of housing 60 and remain engaged in access site 38. The antiseptic cap assembly 80 may remain attached to the valve 39 of the access site 38 for any suitable period of time from a few minutes to many hours. When antiseptic cap assembly 80 is attached to valve 39, tubing or catheter 41 is sealed to block pathogens and contaminants and a portion of the site from entering the catheter.
IMPI
<img file="MX345307B_D0018.tif" />
Access 38 is exposed to the antiseptic material in the sponge
86.
It is desirable that during rotation of the syringe barrel that the antiseptic cap assembly 80 does not rotate relative to the housing and / or optionally that the plunger assembly 12 does not rotate relative to the syringe barrel 14 so that the threads 88 of the antiseptic cap can fully engage access site threads. The present invention provides a mechanism associated with the assembly 10 to prevent rotation of the antiseptic cap assembly 80 with respect to the plunger assembly 12 and more preferably a mechanism in either the plunger assembly or in the antiseptic cap 80 to prevent the relative rotational movement between the antiseptic cap 80 and the plunger assembly 12. In a preferred form of the invention, the mechanism for preventing relative rotation of antiseptic cap 80 with respect to plunger 12 has engagement portions on both parts which when assembled cooperatively engage with each other to prevent relative rotation. It is also contemplated that a separate mechanism, device, or member may be used to secure the two parts together to achieve this purpose.
If a user of the assembly 10 is holding the assembly 10 by the antiseptic and plunger assembly 12 then the interlocking structures between the piston assembly 12 and the syringe barrel 14 will not necessarily be needed. Accordingly, Figures 5, 9-11 show example structures for securing mounting of antiseptic cap 80 within housing 60 so that these parts rotate together and one part does not rotate in one direction or at a different speed than the other. part. Additionally, Figures 15-18 show example structures for interlocking the antiseptic cap plunger assembly 12 with the syringe barrel 14.
In a preferred form of the invention, the housing 60 will have a feature or structure that forms an interference fit with an outer surface 83 of the antiseptic cap 80. Even more preferably, an inner surface 63 of the side wall 62 of the housing 60 will have a feature or structure to form an interference fit with a portion of the antiseptic cap assembly 80. In another preferred form of the invention, the antiseptic cap assembly 80 will have a feature for forming an interference fit with the housing 60 and even more preferably, the outer surface 83 of the antiseptic cap 80 will have a feature for contacting the inner surface 63 of the housing side wall 62.
In another preferred form of the invention, plunger housing 60 and cap assembly 80 will each have <sup>30</sup> IMPIAS
MEXICAN INSTITUTE OF THE PROTtl'AI INDUSTRIAL one a feature or structure that cooperatively couples one to another to prevent relative rotation of the cover assembly 80 and the housing 60. Figure 5 shows a preferred form of the invention having a plurality of circumferentially spaced and axially extending ribs 100 on the inner surface 63 of the housing side wall 62 (inner ribs 100) to engage the wall 83 of the housing. antiseptic cap 82 to secure cap assembly 80 in place to prevent rotation of cap assembly 80 when placed within housing 60. In a preferred form of the invention, the internal ribs 100 extend from a bottom wall 102 to an intermediate height of the housing side wall 62. In a preferred form of the invention, the internal ribs 100 will have a height approximately equal to a height of the lid 82. A plurality of internal grooves 108 are defined between each adjacent set of internal ribs 100. The inner ribs 100, in a preferred form of the invention, will have a width that tapers inward from a point near the bottom wall 102 to a top 104 of the inner ribs 100 such that the width of the inner ribs tapers from a bottom 106 of a rib to the top 104 of the rib. Also, it is preferred that the top of the inner ribs 100 have a generally arched profile.
IMPI ίΝΓΓΠΓυΤΟ. MEXICAN
OF THE EROEUDAD
INDUSTRIAL
<img file="MX345307B_D0019.tif" />
to act as an inlet during insertion of antiseptic cap assembly 80 into housing 60. In a preferred form of the invention, internal ribs 100 will terminate short of a top 113 of housing side wall 62 to define an annular gap 111 between the top of the rib 104 and the top 113. Also, extending radially inward from inner surface 63 of cap 82 is a retainer 109 positioned proximate to an upper portion 113 of side wall 62.
The antiseptic cap 82 has a plurality of circumferentially spaced and axially extending ribs 120 that extend along an outer surface 122 of the cap 82 (outer ribs 120) from an annular flange 123. The outer ribs 120 are dimensioned to engage a portion of the interior wall of the housing 62 to prevent relative rotation of the cap and plunger assembly 12 and to define a plurality of outer grooves one of each between each adjacent pair of outer ribs. . When cap 82 is placed within chamber 64 (Figures 9 and 11) each of the outer ribs 120 are placed within an inner slot 108 and each of the inner ribs are placed within an outer slot to secure these together. parts to ensure that the cap rotates in the same direction as the <sub>32</sub> IMPI <sup>J z</sup> MEXICAN INSTITUTE
DELA FK * '' »*?
INDUSTRIAL PLUNGER ROD. Figures 6 and 11 also show that when cap 82 is positioned within housing 60, retainer 109 contacts annular flange 123 to retain the housing cap to prevent or resist inadvertent dropping of the housing cap prior to engagement. of the lid with the access site. In a preferred form of the invention, the outer ribs 120 are specifically designed in conjunction with inner grooves 108 so that the antiseptic cap is guided out of the storage chamber 64 as the cap snaps onto the threads of the access site.
Figures 12-14 show various embodiments of clamping surfaces on housing 60 (with cover 68 removed) to facilitate use of assembly 10 or plunger assembly 12. Figure 12 shows protrusions 130 that extend axially and that are circumferentially spaced on an outer surface of the wall
<img file="MX345307B_D0020.tif" />
62. The protrusions 130 can have a number of different cross-sectional shapes including circular, polygonal, oval, and irregular, and in a preferred form of the invention, they extend from flange 70 to a bottom of the housing.
Figure 13 shows a housing 60 that does not have flange 70 and has protrusions 130 on wall 62 that extend substantially the full height of the
<img file="MX345307B_D0021.tif" />
IMPI
FNSTrruTc μη »c<sup>aN</sup>V THE PROPWDAt 'INDUSTRIAL HOUSING 60. Figure 14 shows a housing 6 0 dnnds. the outer surface of wall 62 is relatively smooth, but has a series of circumferentially spaced, axially extending protrusions 130 on a circumferential edge of flange 70.
As with the rotational locking features or structures of the cap and plunger assembly, the features or locking structure of the plunger assembly 12 and the syringe barrel 14, optional, it can be placed alone in the plunger assembly 12, or alone in the syringe barrel 14 or have cooperating structures in both the plunger assembly 12 and the syringe barrel 14. It is also contemplated that a separate mechanism, device, or member may be used to secure the two parts together to achieve this purpose.
Figures 15-18 show various embodiments for the optional feature of locking plunger assembly 12 from rotational movement relative to syringe barrel 14. In one embodiment shown in Figures 15-17 and 21 a fin 150 extends so that Axially along an outer surface of the housing side wall 62 engages a tooth 152 positioned on an inner surface of the syringe barrel at its proximal end. More preferably, the plunger assembly 12 will have more than one fin 150 with each fin being circumferentially spaced.
<img file="MX345307B_D0022.tif" />
IMPI
4 MEXICAN INSTITUTE
Μ THE PROPERTY
INDUSTRIAL one from another. In an even more preferred form of the invention, the plunger assembly will have four fins 150 spaced 90 degrees from each other. Also, in a more preferred form of the invention, the syringe barrel will have a plurality of circumferentially spaced teeth. When the plunger assembly is almost fully inserted into the syringe barrel, each of the fins will extend by a tooth to prevent rotation of the plunger assembly 12 relative to the syringe barrel 14.
Figure 18 shows another embodiment of a locking feature to prevent rotation of plunger assembly 12 with respect to syringe barrel 14 and also prevents relative translational movement of the parts. In this embodiment, an annular boss 160 positioned on an inner surface of the syringe barrel at its proximal end 20 engages an annular retainer 162 on an outer surface of the plunger rod.
Figures 19 and 20 show a plunger assembly equipped with antiseptic cap 12 and non-reflux syringe assembly 170. Non-reflux syringes are well known in the art and there are numerous methodologies for reducing reflux while having access to the site. access of a central venous catheter. In this embodiment, annular flange 70 of plunger assembly 12 abuts flange 24 of syringe barrel before piston 50 makes contact.
<img file="MX345307B_D0023.tif" />
IMPI
MEXICAN INSTITUTE
D £ INDUSTRIAL PROPERTY with an inner surface of the distant end wall 30 of the syringe.
It is contemplated that the antiseptic syringe cap assembly 80 of the present invention does not need to be coupled or combined with a syringe plunger or barrel. Figures 22a, b show a separate antiseptic cap assembly 200 having three circumferentially spaced ribs 120 for handholding of a cap assembly user. Figure 22a shows the cap 82 without an absorbent material 86 and Figure 22b shows the cap with an absorbent material. The cap 2 00 can be used for the same purposes as the cap assembly 80 described above, but will be used by hand. All other features of cap 200 are essentially the same as described above with the exception that cap 200 does not have to be sized to fit within a chamber carried by a syringe plunger. Figures 23 and 24 show varying frequencies of ribs 120 and varying shapes and sizes.
Figure 25 shows cap 200 near access site 38 and Figures 26 and 27 show cap 200 attached to access site 38.
A suitable absorbent material 86 includes medical grade materials capable of storing and releasing an antiseptic fluid, or liquid that serves other purposes.
<img file="MX345307B_D0024.tif" />
IMPI
MEXICAN INSTITUTE
OF IA INDUSTRIAL PROPERTY medical and includes materials such as sponges, breakable capsules and other materials or devices capable of serving this purpose. Suitable sponges can include any sponge suitable for use for medical purposes and can be natural or synthetic. The sponges can be die cut into suitable shapes or molded into the desired shape. It is desirable that the sponge 86 be attached to the antiseptic cap 82 to prevent the sponge 86 from inadvertently falling from the cap 82. Figure 28 shows the sponge 86 captured between the annular wall 202 and a disk 2 04 attached to the cap 82 by any suitable method, such as by ultrasonic or vibration welding or other techniques well known in the art.
Figures 29 and 30 show a variation on the cap assembly 200 of Figure 28. In this embodiment, the sponge is retained in the cap 82 with a plastic sheet 206 heat welded to the cap. In a preferred form of the invention, the sponge is attached by an adhesive or other method to form an assembly which is then attached to the lid.
Figures 31a-31b show cap 200 having coaxially positioned and axially extending drive strut 220, circumferentially encircled by sponge 86 having a centrally positioned hole to fit over strut 220. Figure 31a shows cover 200 in initial engagement, with
<img file="MX345307B_D0025.tif" />
<img file="MX345307B_D0026.tif" />
MEXICAN INSTITUTE
OF INDUSTRIAL O ERONITY the access site 38 and Figure 31b shows the mgroHa cap, at the access site 38 and the actuating strut opens the valve 39 and the antiseptic fluid is allowed to flow into the valve.
Figures 32-34 show variably shaped sponges which, in a preferred form of the invention, were molded into various desirable shapes. The sponge of Figure 34 has a central opening 230 to facilitate attachment of the sponge to the cap and to fill the sponge with antiseptic, anticoagulant or other suitable fluids discussed above. Figure 35 shows the cap having a centrally positioned energy director 231, an ultrasonic welder 232 that is brought into cooperative engagement with the sponge on one side of the sponge opposite the energy director 231. By applying ultrasonic energy, the Energy Director 231 melts and attaches the sponge to the lid. Figure Figure 36 shows a filling device 240, having a lumen 242 and a dispensing head 244 in communication for fluids with a source of antiseptic, anticoagulant or the like to dispense a metered quantity of this fluid in the interior portion of the sponge. .
Figure 37 shows an alternative embodiment of cap 200 where the sponge is replaced by an antiseptic coating on drive post 220.
Figure 38 shows the antiseptic cap 200 Mexican institute
OF THE PRUPLTDAJa '* ZZ_ industrial placed in a blister pack 233 before., Of ... sealing ~ the blister pack.
Figure 39 shows an antiseptic cap 300 with a threaded cap 302. The threaded cap 302 can be part of any of the antiseptic caps discussed herein. Threaded cover 302 is made of a deformable material capable of flexing under moderate force applied by the hand. In a preferred form of the invention, the threaded cover 302 is made of a polymeric containing material and more preferably a polymeric material having a modulus of elasticity of minus 20,000 psi.<sup>2</sup> (1406.13 kg / cm<sup>2</sup>). In another preferred form of the invention, the polymeric material will be an elastomer or plastomer or similar material. Threaded cover 302 improves the connection between antiseptic cap 300 and a device such as a valve or other access devices 38. Threaded cover 302 provides a physical barrier to the entry of pathogens, dust, or other contaminants through the mating threads antiseptic cap
300 and the access device or valve to which it is attached.
The threaded cover 302 can also prevent the antiseptic fluids from the antiseptic cap 300 from leaking through the threads. The threaded cover can be made from one part of the antiseptic cap 300 using well known techniques such as overmolding, or by joining as a separate part using<sub>39</sub> IMPI ^
INSTITUTE M1X1CANO OF THE PROPERTY C * »·
INBUSTUAL welding techniques such as conductive heat welding, induction heat welding, vibration welding, stretch or friction fit, or using a suitable adhesive.
Threaded cover 302 can provide a universal fit to most commercially available valves, connectors and access devices, or threaded cover 302 can be customized to mate with a particular access device.
Figure 39 shows, as described above, the antiseptic cap 300 having an annular wall 305 having a first end 306 and a second end 320 with the first end having a larger diametral dimension than the second end. The annular wall defines a central chamber 322 that has an open end 323. In a preferred form of the invention, chamber 322 will have a sponge 86 positioned therein as shown in Figures 5 and 6 above, although not shown in Figure 39. Threaded cover 3 02 is shown attached by a layer optional attachment 304 to first end 306 of annular wall 305. Threaded cover 302 has a first leg 308 and a second leg 310. The first leg 308 extends parallel to the annular wall 305 and the second leg 310 extends radially inward from the annular wall 305 in a direction transverse to the first leg 308 and through "ΝΠπυτυ Mexican Dt LA nOriAOAD" HDUSnUAL
IMPI of a portion of the open end 323 and defines an opening
Central RwW 312, having a reduced diameter compared to open end 323, in chamber 322. Second leg 310 terminates at a distal end 330 of a rounded outer surface 332.
Figure 40 shows an alternative embodiment of the antiseptic cap 300 having the threaded cover 302 having both the first and second legs 308, 310 attached to the first end 306 of the annular wall 305 through tie layers 304a, 304b . An upper surface 340 of the first end 306 is shown to have the same thickness or diametral dimension as the remainder of the first end but it is contemplated that the upper surface may have a radially extending flange 123, as shown in Figure 5.
Figure 41 shows an alternative embodiment of the antiseptic cap 300 that differs from the antiseptic cap shown in Figures 39 and 40 by not including a counterbore 336 shown in these Figures. Counterbore 336 provides a reduced diameter chamber and therefore will form a more tight fit with narrower outside diameter access devices compared to the cap shown in Figure 41, which does not include the counterbore. This is just one example of the modifications that can be made to the geometry of the lid.
<img file="MX345307B_D0027.tif" />
ΙΜΡΙ
ΙΝΤΓΙΤυΤ * 'MEXICAN
OF THE MOAIEDAD INDUSTRIAL antiseptic to allow connection between the lid and an access site.
Figures 42a-42b show front and rear views of the antiseptic cap 300 with the threaded cover 302 attached to a Cardinal SMART SITE 350 access site. Figures 43a-43b are front and rear perspective views of the antiseptic cap without the cover threaded 302 connected to the Cardenal SMART SITE access site.
Figures 44a-44b are front and rear perspective views of antiseptic cap 300 with threaded cover 302 connected to a C1O00 352 Hospira Access Device (ICU). Figures 45a-45b are front and rear perspective views of cap antiseptic, and without a 302 threaded cover, connected to a C1000 Hospira Access Device (ICU).
Figures 46a-46b are front and rear perspective views of antiseptic cap 3 00 with threaded cover 302 connected to a B. Braun U1TRASITE 354 access device. Figures 47a-47b are front and rear perspective views of cap antiseptic without threaded cover 302 attached to B. Braun ULTRASITE Access Device.
Figures 48a-48b are front and rear perspective views of the antiseptic cap with threaded cap 302 connected to a RyMed INVISION PLUS access device;
1MPW ΐΝΓπτυη »Mexican rk<sup>1</sup>· 04 LA ytCMLOAÍ! OR-
INDUSTRIAL
356. Figures 49a-49b are front and rear perspective views of the antiseptic cap without the threaded cap
302 connected to a RyMed INVISION PLUS access device.
Figures 50-52 show various embodiments of the threaded cover 302. Figure 50 differs from Figure 51 in that the second leg 310 extends farther through the chamber opening in Figure 51 than that shown in Figure 50 Figure 52 shows another embodiment of the threaded cover 302 having a second segmented leg 310a, b. This embodiment may be desirable to provide a more effective seal for certain access devices.
Figure 53 shows a part-cut view of an alternate embodiment 400 of the syringe barrel assemblies 10, discussed above, incorporating a cap holder 402 into the parts system. Thus, the alternate assembly and system 400 has a plunger assembly 12 'equipped with antiseptic cap and cap holder, syringe barrel 14, antiseptic cap 82 (shown with optional threaded cover 302), absorbent material 86 , and removable cover 68. FIG. 54 shows a broken away view of an antiseptic cap holder assembly 404 that includes cap holder 402 with antiseptic cap assembly 80 positioned within a chamber 406 of cap holder 402. This embodiment 400 allows for the processing, assembly and sterilization, separate <sub>4</sub>3 IMPI ^^
ΙΝίΤΠυΤΟ MEXICAN
DI LA MtomDAD C »» ^ F «4r TNUJSTIUAL of the 4 00 assembly, of the plunger assembly and the syringe barrel.
Lid bracket 402 has proximal and distal ends 408, 410, and an inner wall surface 412 and an outer wall surface 414, an opening 416 in chamber 406, and a radially outwardly extending flange 418 circumjacent to the opening 416 and extending from proximal end 408 of lid bracket 402. Lid bracket 402 will also have an optional bottom wall 419.
In a preferred form of the invention, the cap holder 402 or the antiseptic cap 82 will have a structure, element or the like that prevents relative rotation of the cap holder 402 and the antiseptic cap 82 as long as the antiseptic cap assembly 80 is attached. securely attaches to access device 38. Also, in a preferred form of the invention, the cap holder 4 02 or the plunger assembly 12 'will have a structure, element or the like to prevent relative rotation of the cap holder 402 and the plunger assembly 12' until the antiseptic cap assembly 8 0 will securely engage access device 38. Any of the anti-rotation devices discussed above for stopping the rotation of the antiseptic cap assembly 80 with the plunger assembly 12 will be suitable for these purposes. Also, it is contemplated that devices
<img file="MX345307B_D0028.tif" />
IMPI
ΙΝΠΤΠΓΓΟ MEXICAN OF THE RROHRDAD INDUSTRIAL discussed above with reference to Figures 15-21 prevent relative rotation of plunger assembly 12 and syringe barrel 14 can be incorporated into this embodiment 400.
Figure 53 shows the inner wall surface 412 of the lid bracket 402 having the inner ribs 100 and the inner grooves 108 interacting with the outer ribs and outer grooves 120, 122 of the lid 82 as described above with respect to the Figure 5.
These structures prevent or resist the relative rotation of the cap holder 402 with respect to the antiseptic cap assembly 80. The term "ribs" referred to herein are structures that are raised or extended outwardly from a surface. The term grooves refers to structures that extend below a surface or are defined between two ribs and are even lower than the ribs.
Figure 53 also shows an interlocking structure to prevent relative rotation of the cap holder 4 02, or the cap holder assembly 4 04, relative to the plunger assembly 12 '. The outer wall surface 414 has a plurality of circumferentially spaced and axially extending ribs 420 that define the grooves 424 between each pair of adjacent ribs. In a preferred form of the invention, ribs 420 generally
MEXICAN INSTITUTE OF INDUSTRIAL CURRENCY
IMPI are triangular in shape having a base portion 426 and an apex portion 428. The grooves 424 are oppositely oriented triangular-shaped areas having base portions 43 or groove extending between two apex portions 428 of rib and rib portions of groove apex 432 separating from adjacent rib base portions 426. On the inner wall surface 63 of the piston chamber 64 are similarly shaped piston ribs 434 and similarly shaped piston grooves 436. Ribs 420 are dimensioned to fit within plunger grooves 436 and grooves 424 are dimensioned to fit over and receive piston ribs 434. In this manner, when the lid support 402 or the lid support assembly 404 is inserted into the plunger chamber 64 the cap support ribs 420 interspersed with the plunger ribs 434 to prevent or resist relative rotation of the cap holder 402, or cap holder assembly 404, relative to plunger assembly 12 '.
In yet another preferred form of the invention, the cap support 402, the cap support assembly 4 04, or the plunger assembly 12 'will have a structure, a similar element that resists relative axial movement of these parts when the cap support cap 402 or cap support assembly 404 is fully positioned within plunger assembly 12 '. In a preferred form of the invention, the
<img file="MX345307B_D0029.tif" />
IMPI nmrnjTo mkicano D £ LA INDUSTRIAL FROHSTY cap holder 402 has an annular protrusion 440 which is made dimensioned to fit within an annular groove 442 in the inner wall surface 414 of the cap holder and preferably extends in line with the base portions of the piston ribs 434. A second securing structure is provided having a plurality of teeth 450 that extend axially outward from the outer wall surface 414 of the lid bracket and are positioned in the grooves 424. In a preferred form of the invention, the teeth are extend axially outward at a height beyond the height of the ribs 434. The teeth 450 may be positioned in one or more of the grooves or in each of the grooves 424 or in alternating grooves, or as shown, circumferentially spaced 90 ° from each other. The teeth 450 are preferably positioned in an intermediate portion, between the base and the apex, of a slot 424. The teeth 450 are made dimensioned to fit within a segmented annular groove 452 that extends circumferentially around the inner surface 412 that crosses through the plunger ribs 434 at an intermediate portion, between the base and the apex, of the piston ribs 434.
Figures 56a-56c respectively show the mount 400 in a ready-to-use position, a coupled position and a used position. The montage
400 it's used
IMPI ^
MEXICAN INSTITUTE OF THE MIOMEDAD INDUSTRIAL essentially the same way as described above with respect to Figures 3 and 4 except that when mount 400 is in the used position, cap bracket 402 remains in plunger mount 12 '.
The plunger and syringe barrel can be made of any material suitable for its purpose and include glass and polymeric material. Suitable polymeric materials include, but are not limited to, homopolymers, copolymers, and terpolymers formed from monomers such as olefins, cyclic olefins, amides, esters, and ethers. The polymeric material can be a mixture of more than one polymeric material and can be a monolayer structure or a multilayer structure. In a preferred form of the invention, the syringe barrel and plunger are injection molded from a polypropylene material.
Figures 59-61 show a third embodiment 500 of a syringe barrel and plunger assembly equipped with an antiseptic cap with the antiseptic cap assembly 80 and cover 68 removed for clarity. The third embodiment 500 provides upgrade from an antiseptic cap assembly 502 to a normal plunger 504. The antiseptic cap 502 has a first generally cylindrical outer wall 506 having a proximal end 508 and a distal end 510. The proximal end 508 is removably or fixedly attached to a button 512 of the plunger 504. The proximal end has an opening 514
<img file="MX345307B_D0030.tif" />
IMPI ffíSTTTUTO MEXICAN OF THE MOHEDAL 'INDUSTRIAL sized to fit around bottom 512 and has a member for attachment to the button. In a preferred form of the invention, the attachment member includes a plurality of circumferentially spaced and axially inwardly directed tabs 516 that extend from an interior wall surface 518 and the tabs engage a bottom surface of button 512 to bond the mount. antiseptic cap 502 to plunger 504.
The distal end of the antiseptic cap 502 has an upper annular flange 520 that extends radially inward from the first cylindrical wall 506 and defines a generally circular opening 522. A second cylindrical wall 524 extends axially downward from the upper annular flange 520 and is coaxially positioned within the first cylindrical wall 506. When the antiseptic cap 502 is attached to the plunger button 512, a bottom peripheral edge of the second cylindrical wall 524 will abut an upper surface of the plunger button 512, thereby capturing, by oppositely directed axial forces, the button 512 between tabs 516 and the second cylindrical wall. However, it is contemplated that a second set of tabs may be provided axially spaced from the first set of tabs and the piston button 512 may be trapped between the two sets of tabs. Additionally, it is contemplated that
INSTITUTE MtXICANt 'οε la reo? »EOAr C * ··.
INOUSTMAL may use other means of attachment that are well known in the art and the attachment member shown is exemplary only.
Second cylindrical wall 524 defines a chamber as shown in greater detail in Figure 5 above with ribs and grooves as described to engage the antiseptic cap assembly 80 to prevent relative rotational movement and to resist relative axial movement of the parts when the antiseptic cap assembly 80 is fully inserted into the chamber. Additionally, adaptation of the plunger and syringe as described above to prevent or resist relative rotational movement of the plunger relative to the barrel is contemplated.
The piston 50 can be formed of any suitable material including a polymeric material or a Silicon material. The plug can be selected from a material with a desired durometer so that reflux is reduced when the plug engages an inner surface of the distal end wall of the syringe barrel.
Suitable lock and rinse solutions include a lower alcohol selected from ethanol, propanol, and butanol. The blocking solution can be a single lower alcohol or a mixture of lower alcohols.
Suitable blocking solutions may also include a lower alcohol with an antimicrobial and / or
<img file="MX345307B_D0031.tif" />
IMPI
MEXICAN INSTITUTE
OF INDUSTRIAL PROPERTY an anticoagulant. Suitable blocking solutions can contain at least one lower alcohol in a range of 1% to
99% by volume and at least one other anti-microbial and / or anti-coagulant compound in a range of 1% to 99% by volume. The lower alcohol will usually be in aqueous solution, typically 1% to 99% by volume, usually 5% to 95% by volume. The at least one other antimicrobial is selected from the group consisting of taurolidine and triclosan, and the at least one anticoagulant is selected from the group consisting of riboflavin, sodium citrate, ethylenediamine-tetra-acetic acid, and citric acid.
In a preferred form of the invention, the syringe assembly 10 will be pre-filled with one of the blocking solutions and will be packaged by a manufacturer and shipped to a healthcare provider. A cannula or needle will be attached to the distal end of the barrel and placed in fluid communication with the fluid access site of an implanted central venous catheter. The rinse solution will be injected into the catheter to clean or secure the catheter. Subsequently, the cap assembly 80 will be removed from the plunger 17 and the cap will engage the fluid access site of the catheter.
Antiseptic solutions containing citrate salt
In one form, the antiseptic is a citrate salt solution and in another form of the invention the salt solution if IMPI
-<sup>31</sup> tNSTITUT MSXICANU
PE THE INDUSTRIAL FROFITY ---- Citrate is a hypertonic solution. The term hypertonic is used herein to refer to a fluid that has an osmotic concentration and density greater than the osmotic concentration and density of the patient's blood. The antiseptic solution preferably comprises a citrate salt with a concentration range, in weight percent, from about 1.5% to about 50% with an osmolality of from about 300 to about 6400 mOsm. More preferably, the antiseptic solution comprises citrate salt in a concentration range of about 10% to about 40%, even more preferably in a concentration range of about 20% to about 30%.
In a preferred embodiment, the antiseptic solution is prepared to retain a pH lower than that of the pH of the patient's blood. The citrate salt solution can be prepared to have a pH of less than about 6.5, more preferably about 4.5 to about 6.5. Also, the citrate salt solution can include pharmaceutically acceptable agents such as sodium chloride and sodium heparin. The citrate salt solution can also include a variety of other antibacterial, antimicrobial, and anticoagulant agents such as gentamicin, vancomycin, and mixtures of these agents. The
5 = IMPI ^ Í
MEXICAN INSTITUTE ^ Íl '^ ϊίϊ ^ Ι
OF IA MOHEDAL
INDUSTRIAL -------- Additional anticoagulant agents include, for example, heparin, urokinase, tissue plasminogen activator (Tpa), and mixtures of these agents.
By pharmaceutically acceptable, it is meant that the citrate salt solution and included salts and other additives which, within the scope of reasonable medical judgment, are suitable for use in contact with human and lower animal tissues without undue toxicity, without irritation. and no allergic response. Also, it is typically necessary for a composition to be sterilized to reduce the risk of infection.
Antiseptic solutions containing antimicrobial agents
An antiseptic solution containing antimicrobial agents of the present invention may contain at least one alcohol, at least one antimicrobial agent, and at least one chelator and / or anticoagulant. Various antimicrobial substances as described herein and those that are well known to those skilled in the art can be combined with the blocking solution in order to inhibit infection. The antimicrobial blocking solution of the present invention can be used to fill or flush a medical device such as an implanted device such as an implanted catheter. Other medical devices that are contemplated for use in the present invention are described herein.
IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX345307B_D0032.tif" />
In another preferred embodiment of the invention, the antiseptic agent can contain antibacterial agents such as those classified as aminoglycosides, beta-lactams, quinolones or fluoroquinolones, macrolides, sulfonamides, sulfamethaxozoles, tetracyclines, treptogramins, oxazolidinones (such as line rifzolid, lincomdamicines) , glycopeptides, polymyxins, lipo-peptide antibiotics, as well as pharmacologically acceptable sodium salts, pharmacologically acceptable calcium salts, pharmacologically acceptable potassium salts, lipid formulations, derivatives and / or analogs of the foregoing.
Aminoglycosides are bactericidal antibiotics that bind to the 30S ribosome and inhibit bacterial protein synthesis. They are typically active against aerobic gram-negative bacillus and bacilli and staphylococci. Exemplary aminoglycosides that can be used in some specific aspects of the invention include amikacin, kanamycin, gentamicin, tobramycin, or netilmicin.
Suitable beta-lactams are selected from a class of antibacterials that inhibit the synthesis of bacterial cell walls. The majority of clinically useful beta-lactams fall into either the penicillin group (penam) or the cephalosporin group (cephem). Beta-lactams also include carbapenems (for example,
<img file="MX345307B_D0033.tif" />
IMPI
MEXICAN INSTITUTE
FROM INDUSTRIAL PROPERTY imipenem), and monobactams (eg, aztreonam). Beta-lactamase inhibitors such as clavulanic acid and its derivatives are also included in this category.
Non-limiting examples of the group of penicillin antibiotics that can be used in the solutions of the present invention include amoxicillin, ampicillin, benzathine-penicillin G, carbenicillin, cloxacillin, dicloxacillin, piperacillin, or ticarcillin, etc. Examples of cephalosporins include ceftiofur, ceftiofur sodium, cefazolin, cefaclor, ceftibuten, ceftizoxime, cefoperazone, cefuroxime, cefprozil, ceftazidime, cefotaxime, cefadroxil, cephalexin, cefamandarol, cefaclor, ceftibuten, ceftizoxime, cefoperazone, cefuroxime, cefprozil, ceftazidime, cefotaxime, cefadroxil, cephalexin, cefamandeol, cefaclor, ceftibutenin, cefiximafoxin, cefithymafoxin, etc. . Other examples of beta-lactams include mipenem or meropenem which are extremely active parenteral antibiotics with a spectrum against almost all gram-positive and gram-negative organisms, both aerobic and anaerobic and to which Enterococci, B. fragilis, and P are particularly susceptible. aeruginosa. Suitable beta-lactamase inhibitors include clavulanate, sulbactam, or tazobactam. In some aspects of the present invention, antibacterial solutions can comprise a combination of at least one beta-lactam and at least one beta-lactamase inhibitor.
Macrolide antibodies are another class of <sub>55</sub> IMPIég
MEXICAN INSTITUTE F *. INDUSTRIAL PROPERTY ™ WS bacteriostatic agents that bind to the 50S subunit of ribosomes and inhibit bacterial protein synthesis. These drugs are active against gram-positive aerobic and anaerobic cocci, with the exception of enterococci and against gram-negative anaerobes. Exemplary macrolides include erythromycin, azithromycin, clarithromycin.
Quinolones and fluoroquinolones typically function by their ability to inhibit DNA gyrase activity. Examples include nalidixic acid, cinoxacin, trovafloxacin, ofloxacin, levofloxacin, grepafloxacin, trovafloxacin, esparfloxacin, norfloxacin, ciprofloxacin, moxifloxacin, and gatifloxacin.
The sulfonamides are synthetic bacteriostatic antibiotics with a broad spectrum against most gram-positive and many gram-negative organisms. These drugs inhibit the multiplication of bacteria by acting as competitive inhibitors of p-aminobenzoic acid in the folic acid metabolism cycle. Examples include mafenide, sulfisoxazole, sulfamethoxazole, and sulfadiazine.
The tetracycline group of antibiotics include tetracycline derivatives such as tigecycline which is an investigational new drug (IND), minocycline, doxycycline, or demeclocycline and analogs such as anhydrotetracycline, chlorotetracycline, or epioxytetracycline.
<img file="MX345307B_D0034.tif" />
IMPI
MEXICAN INSTITUTE
OF INDUSTRIAL PROPERTY
Suitable classes of streptogramin antibacterial agents include quinupristin, dalfopristin, or the combination of two streptogramins.
Drugs of the rifamycin class typically inhibit DNA-dependent RNA polymerase, leading to the suppression of RNA synthesis, and have a very broad spectrum of activity against most gram-positive and gram-negative bacteria including the species Pseudomonas aeruginosa and Mycobacterium. An example rifamycin is rifampin.
Other antibacterial drugs are glycopeptides such as vancomycin, teicoplanin, and derivatives thereof. Still other antibacterial drugs are the polymyxins which are exemplified by colistin.
In addition to these various different antibacterial agents such as prestinomycin, chloramphenicol, trimethoprim, fusidic acid, metronidazole, bacitracin, spectinomycin, nitrofurantoin, daptomycin or other leptopeptides, oritavancin, dalbavancin, ramaplamin, ketolide etc., solutions can be used in the preparation of the solutions. antiseptics described herein. Of these, metronidazole is only active against protozoa, such as Giardia lamblia, Entamoeba histolytica, and Trichomonas vaginalis, and strictly anaerobic bacteria. Spectinomycin is a bacgeriostatic antibiotic that is<sub>57</sub> IMPI ^
MEXICAN INSTITUTE Va * MU OF THE PROPERTY
INDUSTRIAL binds to the 3OS subunit of the ribosome, thus inhibiting the synthesis of bacterial proteins and nitrofurantoin is used orally for the treatment or prophylaxis of UTI since it is active against Escherichia coli species.
Klebsiella-Enterobacter, staphylococci, and enterococci.
In other embodiments, the antimicrobial agent is an antifungal agent. Some class of examples of antifungal agents include imidazoles and triazoles such as clotrimazole, miconazole, ketoconazole, econazole, butoconazole, omoconazole, oxiconazole, terconazole, itraconazole, fluconazole, voriconazole, posaconazole, ravuconazole or flutrimazole; polyene antifungals such as amphotericin B, liposomal amphoterecin B, natamycin, nystatin, and nystatin lipid formulations; cell wall active cyclic lipopeptide antifungals, including echinocandins such as caspofungin, micafungin, anidulfungin, cilofungin; LY121019; LY303366; the allylamine group of antifungals such as terbinafine. Still other non-limiting examples of antifungal agents include naftifine, tolnaftate, mediocidin, candicidin, trichomycin, hamycin, aurefungin, ascosin, aifattin, azacolutin, trichomycin, levorin, heptamycin, candimycin, griseofulvin, BF-1386, BTG-1375 pradimycins (MNS 18184), benanomycin; ambisoma; Nikomycin Z; flucytosine, or perimycin.
<sub>58</sub> IΜ ΡI
INS1TTUU; MEXICAN
FROM THE m MFBAt INDUSTRIAL ™
In another preferred form of the invention, the antimicrobial agent is an antiviral agent. Non-limiting examples of antiviral agents include cidofovir, amantadine, rimantadine, acyclovir, ganciclovir, penciclovir, famciclovir, foscamet, ribavirin, or valciclovir. In some forms of the invention, the antimicrobial agent is an innate immune protein or peptide. Some exemplary classes of innate peptides or proteins are transerrins, lactoferrins, defensins, phospholipases, lysozyme, cathelicidins, serprocydins, bacteriocidal permeability enhancing proteins, antipathic alpha-helical peptides, and other synthetic antimicrobial proteins.
In other embodiments of the invention, the antimicrobial agent is an antiseptic agent. Various antiseptic agents are known in the art and these include a taurinamide derivative, a phenol, a quaternary ammonium surfactant, a chlorine-containing agent, a quinaldine, a lactone, a dye, a thiosemicarbazone, a quinone, a carbamate, urea, salicylamide, carbanilide, a guanide, an amidine, an imidazoline bioxide, acetic acid, benzoic acid, sorbic acid, propionic acid, boric acid, dehydroacetic acid, sulfurous acid, vanillic acid, esters of p-hydroxybenzoic acid, isopropanol, propylene glycol, benzyl alcohol, chlorobutanol, phenylethyl alcohol, 2-bromo-2-nitropropan-l, 3-diol, formaldehyde
<img file="MX345307B_D0035.tif" />
IMPI
9 INSTITUTE M EXICANO
OF THE PROPERTY
INDUSTRIAL glutaraldehyde, calcium hypochlorite, potassium hypochlorite, sodium hypochlorite, iodine (in various solvents), povidone-iodine, hexamethylenetetramine, noxythioline, 1- (3-coroallyl) -3,5,7-triazo-l chloride -azoniaadamantane, taurolidine, taurultam, N (5-nitro-2-furfurylidene) -1-amino-hydantoin, 5-nitro-2-furaldehyde-semicarbazone, 3,4,4'-trichlorocarbanilide, 3,4 ', 5-tribromosalicylanilide, 3-trifluoromethyl -4,4'-dichlorocarbanilide, 8-hydroxyquinoline, l-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7- (1piperazinyl) -3-quinolinecarboxylic acid, 1,4-dihydro-lethyl-6-fluoro-4-oxo-7- (1 -piperazinyl) -3-quinolinecarboxylic, hydrogen peroxide, peracetic acid, phenol, sodium oxychlorosene, parachloromethaxylenol, 2,4,4<sup>1</sup>-trichloro-2<sup>1</sup> hydroxydiphenol, thymol, chlorhexidine, benzalkonium chloride, cetylpyridinium chloride, silver sulfadiazine, or silver nitrate.
In another preferred form of the invention, the antiseptic solution includes a basic reagent and a dye. The basic active can be a guanidium compound, a biguanide, a bipyridine, a phenoxide antiseptic, an alkyl oxide, an aryl oxide, a thiol, a halide, an alpha or an aromatic amine. In some specific aspects, the basic reagent is a guanidium compound. Non-limiting examples of guanidium compounds include chlorhexidine, alexidine, hexamidine. In other modalities
<img file="MX345307B_D0036.tif" />
IMPI
MEXICAN INSTITUTE
OF THE INDUSTRIAL MOflSTY, the basic reagent is a bipyridine. Another example of a bipyridine is octenidine. In still other aspects, the basic reagent is a phenoxide antiseptic.
The dye can be a triarylmethane dye, a monoazo dye, a diazo dye, an indigoid dye, a xanthene dye, an anthraquinone dye, a quinoline dye, an FD&C dye. Non-limiting examples of the triarylmethane dye include gentian violet, crystal violet, ethyl violet, or brilliant green. Exemplary monoazo dyes include FD&C Yellow No. 5, or FD&C Yellow No. 6. Other non-limiting examples of FD&C dyes include Blue No.
or Green No. 3. A non-limiting example of a diazo dye is D&C Red No. 17. An example of an indigoid dye is FD&C Blue No. 2. An example of a xanthene dye is FD&C Red No. 3; of an anthraquinone dye is D&C Green No. 6; and of a quinoline dye is D&C Yellow No. 1.
Other examples of antiseptics that can be used in the solutions of the invention are phenoxide antiseptics such as chlorofoctol, chloroxylenol or triclosan. Still other antiseptic examples that can be used to prepare the antimicrobial solutions of the invention are gendin, genlenol, genlosan, or genfoctol.
One skilled in the art will appreciate that one or more of the antimicrobial agents can be used including one or more antibacterial agents, and / or one or more agents.
<img file="MX345307B_D0037.tif" />
IMPI
MEXICAN INSTITUTE OF THE PRUPlbDAU INDUSTRIAL antifungal agents and / or one or more antiviral agents, and / or one or more 'antiseptic agents, and / or combinations of these.
A wide variety of chelating agents are contemplated as useful in the preparation of the antiseptic solutions of the invention. This includes chelators such as free acid EDTA, EDTA 2Na, EDTA. 3Na, EDTA 4Na, EDTA
2K, EDTA 2Li, EDTA 2NH4, EDTA 3K, Ba (II) -EDTA, Ca (II) -EDTA, Co (II) -EDTACu (II) -EDTA, Dy (III) -EDTA, Eu (III) -EDTA , Fe (III) EDTA, In (III-EDTA, La (III) -EDTA, CyDTA, DHEG, diethylenetriamine-penta-acetic acid (DTPA), DTPA-OH, EDDA, EDDP, EDDPO, EDTA-OH, EDTPO, EGTA, HBED, HDTA, HIDA, IDA, MethylEDTA, NTA, NTP, NTPO, O-Bistren, TTHA, EGTA, DMSA, deferoxamine, dimercaprol, zinc citrate, a combination of bismuth and citrate, penicillamine, succimer, or Etidronate. It is contemplated that any chelator other than barium, calcium, cerium, cobalt, copper, iron, magnesium, manganese, nickel, strontium, or zinc will be acceptable for use in the present invention.
Alternatively, at least one anticoagulant such as heparin, hirudin, EGTA, EDTA, urokinase, streptokinase, hydrogen peroxide etc. can be used in the preparation of the antimicrobial solutions of the invention.
In addition to the alcohols discussed above, a variety of alcohols are contemplated as useful in the
<img file="MX345307B_D0038.tif" />
IMPI
IKITITUTO mbxicano '“□ ÍÍAHMjmUAD
INOUSTUAJ62 preparation of the present antiseptic solution, include any antimicrobially active alcohol. Non-limiting examples of alcohols include ethanol, methanol, isopropanol, propylene glycol, benzyl alcohol, chlorobutanol, phenylethyl alcohol, and the like.
One skilled in the art will appreciate that the solutions of the present invention may comprise various combinations of at least one alcohol, at least one antimicrobial agent, and at least one chelator / anticoagulant. In some specific embodiments, the solution of the invention comprises at least one alcohol, at least one tetracycline, and at least one chelator / anticoagulant. In a specific aspect, this antimicrobial solution comprises ethanol, at least one tetracycline, and EDTA or heparin.
In other specific aspects, this solution comprises ethanol, minocycline and EDTA or heparin. In one embodiment of this aspect, the minocycline concentration is 0.001 mg / ml to 100 mg / ml. In another embodiment, the minocycline concentration is approximately 3 mg / ml. In another aspect, the EDTA concentration is in the range of 10-100 mg / ml. In one embodiment of this aspect, the EDTA concentration is approximately 30 mg / ml.
In another preferred form of the invention, the antiseptic solution including a pharmacologically acceptable solid salt, pharmacologically "IMPI ^" calcium salt
MEXICAN INSTITUTE ΠΙ LA PLONEUAO V * »- INDUSTRIAL acceptable, pharmacologically acceptable potassium salt and approximately one milligram per milliliter of polyhexamethylene-biguanide hydrochloride in an aqueous mixture. Additionally, the solution of the invention may also contain a pharmacologically acceptable salt of lactic acid.
Antiseptic solutions containing salt
A preferred antiseptic solution includes a solid pharmacologically acceptable salt such as sodium chloride or the like in a concentration of between about 820 mg to about 900 mg, a pharmacologically acceptable calcium salt, such as calcium chloride dihydrate or the like in a concentration between about 30.0 mg to about 36.0 mg, a pharmacologically acceptable potassium salt, such as potassium chloride or the like in a concentration between about 28.5 to about 31.5 mg and about one milligram per milliliter of polyhexamethylene biguanide hydrochloride in an aqueous mixture with one hundred milliliters of water for injection USP For particular applications, the solution of the invention can also be include sodium lactate at a concentration between about 290 mg and about 330 mg in the one hundred milliliter aqueous mixture. Photo-oxidant solutions
In another preferred form of the present invention,
<img file="MX345307B_D0039.tif" />
IMPI
MEXICAN INSTITUTE M LA nONEDAB INDUSTRIAL the antiseptic solution contains an anticoagulant and a photo-oxidant. In certain aspects, a photo-oxidant is selected to have a specific effect. As used herein, the term "photo-oxidant" is intended to refer to a compound (usually an organic dye) that has photo-oxidation properties, in which the compound exhibits an increased oxidative potential at the radiant energy position. such as light. The term photo-oxidant also refers to a composition that releases one or more electrons when struck by light.
In a preferred aspect of the invention, the photo-oxidant is methylene blue, which advantageously provides antibiotic and antifungal activity, and also provides a color so that the antiseptic solution is clearly identifiable. In addition to methylene blue, other photo-oxidants may include vengala rose, hypericin, methylene violet, proflavin, rivanol, acriflavin, toluid blue, trypan blue, neutral red, a variety of other dyes, or mixtures thereof. Therefore, in alternative aspects of the invention, one or more alternative photo-oxidants, preferably a colored photo-oxidant, is used in accordance with the invention in place of methylene blue.
Improved viscosity solutions
In another preferred form of the invention, the
IMPI
MEXICAN INSTITUTE
MEXICAN INSTITUTE OF THE PROPIWAD INDUSTRIAL antiseptic solution that includes a low viscosity antibacterial agent mixed with a viscosity increasing agent. Examples of antibacterial agents that can be used, in addition to those described above, include alcohols, chlorhexidine, chlorpactin, iodine, tauroline, citric acid, and soluble salts of citric acid, particularly sodium citrate, optionally mixed with water.
Suitable viscosity increasing agents include Carbopol, starch, methyl cellulose, carboxypolymethylene, carboxymethyl cellulose, hydroxypropyl cellulose, or the like. Carbopol is a cross-linked polyacrylic acid-based polymer sold by Noveon, Inc. It is preferably neutralized at about pH 7 with a base material such as tetrahydroxypropylethylene diamine, triethanolamine, or sodium hydroxide. Starch derivatives, such as hydroxyethyl starch, hydroxypropyl starch, or starch having attached organic acidic ester groups can also be used to improve compatibility with antibacterial agents such as alcohols, for example ethanol or isopropanol. These ester groups can be the reaction product of organic acids of two to twelve carbons with starch, for example. Also, the high viscosity antiseptic solution can be created by the use of a fat emulsion, or other
INSTITUTE M & XíCANO DF LA WOFIEDAD INDUSTRIAL dispersions in water / alcohol of glycerol mono- or di-esters of fatty acids, or fatty acid esters of other polyols such as sugars that have one or more attached fatty acid groups per molecule. Analogous compounds with ether linkages can also be used.
Also, other materials can be used such as alginic acid, with or without sodium citrate, or polyvinyl alcohol, with or without borax, povidone, polyethylene glycolalginate, sodium alginate and / or tragacanth. If desired, the fluid of this invention may also contain an effective amount of an antithrombogenic agent such as heparin, and a diluent such as water, along with other desired ingredients.
In a preferred form of the invention, the antiseptic solution contains a mixture of isopropyl alcohol and neutralized carbopol, with other optional ingredients that are present such as water, antithrombogenic agents such as heparin, and the like. Preferably, about 0.4 to 2 percent by weight of Carbopol is present. Citric acid is also present as an antibacterial agent, either with or as a substitute for another antibacterial agent such as isopropyl alcohol or ethanol.
In another embodiment, the antiseptic solution is a gel of an isopropyl alcohol, optionally with up to about 30 weight percent water, and about 2.2 weight percent hydroxypropyl cellulose, to form a high viscosity antiseptic solution.
<img file="MX345307B_D0040.tif" />
In yet another preferred form of the invention, the antiseptic solution contains carbohydrates and / or glucose breakdown products. Suitable carbohydrates are selected from the group of glucose and / or fructose. Suitable degradation products include 3-deoxyglucosone (3-DG), acetaldehyde, formaldehyde, acetaldehyde, glyoxal, methylglyoxal; 5-hydroxymethyl-2-furaldehyde (5-HMF), 2furaldehyde, and 3,4-dideoxyglucosono-3-ene (3,4-DGE).
Other suitable agents to be used in this embodiment of the antiseptic solution include substances that have anticoagulant properties, i.e., inhibitors of the coagulation cascade such as normal and low molecular weight heparin, fractionated heparin, synthetic inhibitors of the coagulation, Futhan as a broad protease inhibitor, complexing and chelating substances such as citrate, EDTA, EGTA, substances and mixtures used for the preservation of blood products (platelets or plasma), CDPA (citrate, sodium phosphate, dextrose, adenine), natural or synthetic substances that inhibit thrombin. Other suitable additives include fucosidan, riboflavin, vitamin E, alpha-tocopherol, folic acid and<sub>68</sub> IMPI ^ r
OF THE PROPERTY . INDUSTRIAL Ϊ5-- amino acids. Additionally, drugs can also be used. ·. i.
and anti-inflammatory compounds, for example cortison, mycophenolic acid (MPA) and derivatives thereof, sirolimus, tacrolimus and cyclosporine, diclofenac, etc.
Inhibitory peptides can also be used in the antiseptic solution such as defensins, (dermacidin), and others. Radicals, such as reactive oxygen species, NO or nitric oxide (NO) releasing systems, and peroxynitrite can also be used. A buffer composition can also be included in the antiseptic solution, and in a preferred form of the invention, the buffer contains lactate, bicarbonate, pyruvate, ethyl pyruvate, and citric acid in combination and mixtures that include pH adjustment by acetic acid, hydrochloric acid or sulfuric acid. Additionally, viscosity-improving additives can be added, such as lipids or lipid substances (also to obtain water-insoluble vitamins or complexes in a solution), nutrients in a high-density concentration gradient, for example fluids containing amino acids, polyglucose. , Icodextrin, pectin, hydroxyethyl-starch (HES), alginate, hyaluronic acid, etc.
Taurolidine Antiseptic Gels and Solutions
The antiseptic solutions of the present invention may include taurolidine and / or Taurultam to
<img file="MX345307B_D0041.tif" />
prevent coagulation and biofilm formation._or the elements can be combined with other antimicrobial agents. One embodiment of the present invention is a gel with thixotropic properties to keep the solution within the antiseptic cap and not spill during the time interval between uses. This is accomplished by producing a hydrogel matrix as a drug delivery vehicle that contains a biocompatible antimicrobial agent alone or with another active agent, which may be useful for particular purposes. The hydrogel matrix is biocompatible, and biodegradable in the bloodstream. The matrix can be a hydrogel (eg, pectin, gelatin, etc.), a protein (eg, collagen, hemoglobin, etc.), a colloid substance (eg, serum albumin, etc.), an emulsion, or other adjuvant. Preferably, the matrix should have structural integrity and be thixotropic. Thixotropy is a property, which is exhibited by certain gels. It is a property characterized by a solid or semi-solid substance that when shaken, shaken or subjected to high shear forces becomes fluid type and can flow and then return to the semi-solid state when forces and / or movement stop. Alternatively, the gel may have properties similar to those of the colloidal dispersion that resists movement, or flow, until a high shear force is imparted to the fluid and then flows.
<img file="MX345307B_D0042.tif" />
IMPI • MSTmrfo mkjucan · M LA nonWAP INDUSTRIAL easily.
Other ingredients can be added to the gel matrix to provide additional functional benefit. The preferred antimicrobial is taurolidine, which can be added to the matrix as a microparticle powder, or encapsulated in liposomes, microspheres, or nanospheres. It is to be appreciated that numerous active agents and drugs can be added to the thixotropic gel including sterilants, lysis agents (such as urokinase), image enhancers, catheter surface modifiers, antibiotics, and antimicrobial chemicals.
A hydrogel comprises a three-dimensional molecular network that contains large amounts of water that give good biocompatibility with the consistency of the material that is a soft solid type with high diffusive properties to gases, chemicals and proteins. Suitable hydrogels include natural polymers including serum albumin, collagen or alginates, polyvinyl alcohol, poly (ethylene oxide) or poly (hydroxyethylene), and poly electrolytes, such as poly (acrylic acid), poly (styrene sulfonate), and carboxymethyl cellulose ( CMC).
A preferred form of the antiseptic solution includes taurolidine with salicylic acid or sodium salicylate in an aqueous solvent. Salicylic acid and sodium salicylate are drugs that have been used with<sub>71</sub> ΙΜΤΙ 'MEXICAN INSTITUTE
OF THE PROPERTY
INDUSTRIAL antibiotic locks on catheters to enhance the biocidal action of the antibiotic alone and to inhibit the attachment of microbes to surfaces. This last attribute is especially important because the initiation of biofilm expression and growth requires that individual bacteria must first bind themselves to the underlying surface. By stopping the binding, the biofilm formation is blocked.
Sodium salicylate has been shown to have remarkable antibacterial activity, including the ability to enhance the activities of certain antibiotics. This drug inhibits adhesion, growth, and biofilm formation.
Antiseptic solutions containing EDTA
In a preferred form, the antiseptic solution of the present invention provides antimicrobial, antifungal, anti-viral and anti-amoebic properties and can also serve as an anticoagulant. The specific salts and compositions of ethylene diaminetetraacetic acid (EDTA) (CioHi<sub>2</sub>N<sub>2</sub>Na<sub>4</sub>08) are used at specified concentrations and at specified pH levels.
The EDTA formulations of the present invention are safe for human administration and are biocompatible and non-corrosive. They can also have anticoagulant properties and are thus useful for
<img file="MX345307B_D0043.tif" />
, 2 IMPI
MEXICAN INSTITUTE
OF TRONERAD
INDUSTRIAL prevent and / or treat a variety of catheter-related infections. In one embodiment, the antiseptic solutions of the present invention have at least four, and preferably at least five, of the following properties: anticoagulant properties; inhibitory and / or bactericidal activity against a broad spectrum of bacteria in a planktonic form; inhibitory and / or fungicidal activity against a spectrum of fungal pathogens; inhibitory and / or bactericidal activity against a broad spectrum of bacteria in a sessile form; inhibitory activity against protozoan infections; inhibitory activity against Acanthamoeba infections; safe and biocompatible, in at least modest volumes, in contact with a patient; safe and biocompatible, in at least modest volumes, in a patient's bloodstream; and safe and compatible with industrial objects and surfaces. The antiseptic solution may have a pH greater than physiological pH, such as pH> 8.0, or at pH> 8.5, or at pH> 9, or at pH> 9.5.
In another preferred form of the invention, the antiseptic solution contains a sodium EDTA salt (or combination of sodium salts) in solution at a pH in the range of 8.5 and 12.5 and, in another embodiment, at a pH between 9.5 and 11.5 and, in another mode, at a pH of between 10.5 and 11.5.
<img file="MX345307B_D0044.tif" />
IMPI
MEXICAN INSTITUTE
OF THE PROPERTY
INDUSTRIAL
When used herein, the term EDTA salt can refer to a single salt, such as a disodium or tri-sodium or tetra-sodium salt, or another form of EDTA salt, or it can refer to a combination of these salts. . The composition of EDTA salts depends on both the EDTA salts used to formulate the composition, and the pH of the composition. For antiseptic solutions of the present invention consisting of EDTA sodium salts, and at the desired pH ranges (specified above), EDTA sodium salts are predominantly present in both the trisodium and tetra-sodium salt forms.
In one embodiment, the antiseptic solution contains a combination of at least the trisodium and tetrasodium salts of EDTA, and more preferably solutions containing at least 10% of the EDTA in the composition is present in the form of the tetra-sodium salt. . In yet another embodiment, at least 50%, and more preferably at least 60%, of the EDTA in the composition is present in the form of the trisodium salt.
The EDTA solutions of the present invention are preferably provided in a sterile, non-pyrogenic form and can be packaged in any convenient manner. The compositions can be prepared under aseptic, sterile conditions, or they can be sterilized after preparation and / or packaging using any of
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DF IA PBOWEDAD V * a— INDlimilAl a variety of suitable sterilization techniques.
The formulation and production of antiseptic compositions of the present invention is generally straightforward. In one embodiment, desired antiseptic solutions of the present invention are formulated by dissolving one or more EDTA salts in an aqueous solvent, such as purified water, to the desired concentration and adjusting the pH of the EDTA salt solution to pH. wanted. The antiseptic solution can then be sterilized using conventional means, such as autoclaving, UV irradiation, filtration and / or ultrafiltration, and other means. The preferred range of osmolarity for EDTA solutions is 240-500 mOsM / kg, more preferably 300-420 mOsM / Kg. Solutions are preferably formulated using USP materials.
Antiseptic solutions containing sodium salts of EDTA other than tri- and tetra-sodium salts, such as disodium EDTA, are also contemplated. For example, disodium EDTA solutions can be used, but these solutions have a lower pH in solution than the desired pH range of the compositions of the present invention but, on adjusting the pH to the desired range using a pH-adjusting material, Such as sodium hydroxide, sodium acetate, and other well known pH adjusting agents, EDTA solutions prepared using disodium salts were converted to the preferred combination of solutions of
EDTA of di- and / or tri- and / or tetra-sodium salts of the present invention. Thus, different forms and combinations of EDTA salts can be used in the preparation of EDTA compositions of the present invention, provided that the pH of the composition is adjusted to the desired pH range prior to use. In one embodiment, antiseptic compositions consisting of a mixture of primarily tri- and tetra-sodium EDTA are provided by dissolving disodium EDTA in an aqueous solution, 3% -5% on a weight / volume basis, and by adding sodium hydroxide in a volume and / or concentration sufficient to provide the desired pH of> 8.5 and <12.0.
Antiseptic Solutions Containing Antibacterial Enzymes Antibacterial enzyme refers to any proteolytic, pore-forming, degrading, or inhibitory enzyme that kills or damages a particular bacterial species or strain thereof. The result can be achieved by damaging the cell wall of the bacterium, by breaking the cell membranes associated with the cell wall or within the bacteria, by inhibiting protein synthesis within the bacteria, by breaking the sugar structure or by any another mechanism attributed to a peptide or protein considered by those skilled in the art to be an antibacterial enzyme. The enzyme can be a natural wild type enzyme, modified by conventional techniques, conjugated
<img file="MX345307B_D0045.tif" />
IMPI
MEXICAN INSTITUTE
DELA INDUSTRIAL PROPERTY to other molecules, expressed recombinantly, or constructed synthetically.
An example of an antibacterial enzyme is lysostaphin. Lysostafin is important because it is effective in treating staphylococci and biofilms formed from them. Lysostaphin and lysostaphin analogs are defined as including lysostaphin (wild type), mutant or variant lysostaphin, any recombinant, or related enzyme (analogs), or any synthetic version or fragment of lysostaphin (whether synthetic or otherwise) that retains the proteolytic ability, in vivo and in vitro, to cleave cross-linked polyglycine bridges in staphylococcal cell wall peptidoglycan. Enzymes can be generated by post-translational processing of the protein (either by enzymes present in a producing strain or by means of enzymes or reagents introduced at any stage of the process) or by mutation of the structural gene. Mutations can include site insertion, insertion, domain removal, and replacement mutations.
Lysostaphin can be constructed synthetically, expressed in mammalian cells, insects, bacteria, yeast, reptiles, or fungi, expressed recombinantly from a cell culture or higher recombinant species, such as a mouse, or otherwise. This would include
IMPI
MEXICAN INSTTTUTE
OF INDUSTRIAL MOWING
<img file="MX345307B_D0046.tif" />
the activity-retaining synthetic construct that includes synthetic peptides and polypeptides or recombinant expression of portions of the enzyme lysostafin responsible for its activity against staphylococci as part of a larger protein or peptide, including chimeric proteins, that contain the active sites of one or more different antibacterial enzymes that are effective against either staphylococci or other species of biofilm-forming bacteria.
Antibacterial enzymes can also be coated on the surface of the devices described herein by immersing the device in a solution of the enzyme for a duration of time sufficient to form a coating of the enzyme, which inhibits biofilm formation, on the surface. susceptible surface. Even the smallest concentration of the enzyme will confer some protection. Typically, a concentration of from about 10 pg / ml to about 100 mg / ml can be used. With device surfaces, coatings can also be formed by covalently binding the enzyme to them. Antiseptic coatings
It is contemplated that the devices described herein may be coated with an antiseptic coating by any suitable technique, such as dipping the part in an antiseptic solution, when spray coating.
<img file="MX345307B_D0047.tif" />
IMPI
MEXICAN INSTITUTE
FROM INDUSTRIAL PROPERTY the part with the antiseptic solution, by mixing the antiseptic solution or material into the polymeric material used to manufacture the device.
In a preferred form of the invention, an amount of antimicrobial, physiological metal compound is added to the resin for direct molding of an article. Physiological, antimicrobial metals are proposed to include the precious metals, such as silver, gold and platinum, and copper and zinc. The antimicrobial physiological metal compounds used herein include oxides and salts of preferably silver and also gold, for example: silver acetate, silver benzoate, silver carbonate, silver citrate, silver chloride, silver iodide, silver nitrate, silver oxide, silver sulfadiazine, silver sulfate, gold chloride, and gold oxide. Platinum compounds such as chloroplatinic acid or its salts (eg sodium calcium chloroplatinate) can also be used. Also, copper and zinc compounds can be used, for example: copper and zinc oxides and salts, such as those indicated above for silver. Individual antimicrobial physiological metal compounds or combinations of antimicrobial physiological metal compounds can be used.
The preferred antimicrobial, physiological metal compounds used in this invention are <sub>79</sub> IMPI
MEXICAN INSTITUTE OF THE PtoFltDAD INDUSTRIAL silver acetate, silver oxide, silver sulfate, gold chloride, and a combination of silver oxide and gold chloride. The silver compound particles are sufficiently capable of being extracted to form a zone of inhibition to prevent and kill the growth of bacteria.
In another preferred form of the invention, the devices herein are impregnated with triclosan and silver compounds and triclosan and chlorhexidine.
With reference to Figures 62 and 63, a syringe having an end cap with an antiseptic cap placed thereon is generally indicated at 610. This arrangement facilitates the use of the antiseptic cap by providing the cap in a convenient location in the appropriate time that can be used. Syringe 612 includes a barrel 614 has a forward end 616. The forward end of syringe 612 is configured with an access point connection 618 for attachment to an access point to deliver a fluid or medication to a patient. Before use, the syringe access point connection 618 is covered with an end cap 620. The end cap 620 has a proximal end 621 that is attached to the syringe access point connection 612. The end cap 620 End 620 also has a distal end 641 that has an antiseptic cap 82. The antiseptic cap 82 may contain an absorbent material such as a sponge 86. The sponge 86 may be made of bonded fiber such as
<img file="MX345307B_D0048.tif" />
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DELA Μ »ΗΜ> Λ | Ρ Λύκ> INOUSTXIAL of bonded fiber material which is available from Filtrona
Porous Technologies, based in Richmond, VA. The sponge 86 can store an antiseptic liquid.
As can be seen in Figures 62 and 63, a cap assembly 680 is sealed by a cover or film 650 which is attached to the surface of the end cap 620 such as a flange 648. A pull tab 652 can be provide to facilitate removal of film 650 to provide access to antiseptic cap 82.
Referring to Figure 63, it can be seen that end cap 620 has proximal and distal chambers 622 and 642, respectively, positioned within a cylindrical or tapered side wall 624. Side wall 624 is shown to be continuous, but may have discrete areas of different sizes to accommodate cameras of different sizes. Side wall 624 may include ribs or gripping surfaces to facilitate handling thereof. Proximal chamber 622 is configured for attachment to access point connection 618 at the forward end 616 of barrel 614 of syringe 612 as is known. As shown, proximal chamber 622 of end cap 620 releasably receives and engages the central male extension of access point connection 618, as well as the annular surface extending around it. The configuration of the proximal camera 622 can be varied in accordance with what is known in the art.
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MEXICAN INSTITUTE
D £ THE PBOKBDAD TNDWHUAL **.
The proximal chamber 622 may have a base wall 626. 8 <sup>1</sup>--- rw ----. i -w.- - I -LL
Distant chamber 642 is sized and configured to receive an antiseptic cap 82. Distant chamber 642 may have a base wall 646. As with the plunger-equipped antiseptic cap previously described, antiseptic cap 82 may have one or more ribs 643, as shown in Figure 64, and the inner wall of distal chamber 642 may have corresponding ribs 645 to prevent movement. relative rotational position between distant chamber 642 and antiseptic cap 82.
In use, a syringe with an antiseptic cap 82 is provided with a fluid or drug for administration to a patient through an access point. End cap 620 is removed from syringe 612 and syringe 612 is connected to the access point and actuated to deliver the fluid or medication. Syringe 612 is then disconnected from the access point, end cap 62 0 is opened for access, and pull tab 652 is used to remove cover 650 to provide access to antiseptic cap 82. Then, holding the end cap 620, the antiseptic cap 82 is placed on the access point and the antiseptic cap 82 is pushed and / or twisted over the access point. Once the antiseptic cap 82 is attached to the point, the end cap 620 can be removed such that the antiseptic cap 82 is removed from the distant chamber 642 and remains attached to the
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INSTITUTE MEXICANC D £ LA PROPUOAD Omm INDUSTRIAL access point where it disinfects and protects the point until the next time the access point is accessed.
Figure 65 shows another aspect of an end cap 720 wherein a distal chamber 742 is configured to receive a cap support assembly 780 having an antiseptic cap. End cap 720 has proximal end 721 and distal end 741. In one aspect, distal chamber 742 is configured in accordance with the previously described plunger-equipped antiseptic cap chamber configuration and receives the plunger assembly therein. 780 bracket. The antiseptic cap can be used as discussed previously , or the cap holder assembly 780 can be removed from the end cap 720 and used directly.
Figure 66 shows another aspect of an end cap 820 wherein a distal chamber 842 is configured to receive a cap support assembly 880 having an antiseptic cap. End cap 820 has a proximal section 821 and a distal section 841. As illustrated, proximal section 821 and distal section 841 can be two discrete sections of varying size and shape. For example, proximal section 821 may have a tapered or cylindrical side wall, as shown. The discrete sections of variable size and shape can accommodate cameras of different sizes. Additionally, sections • w<sub>83</sub> IMPI ^ ° ftiSTnVTO MEJUCANO Vi *
Discrete INDUSTRIAL F ORI AGE, for example proximal section 821 and distal section 841, may include ribs 843 or gripping surfaces to facilitate handling thereof. In this regard, the end cap 820 is configured to change the geometry of the proximal section 821 to the distal section 841. Specifically, the proximal section 821 is shown to have a truncated conical shape and is configured to join the access point 618 of a syringe 612, while the distal section 841 is designed and configured to receive the cap bracket assembly 880. The 880 cap bracket assembly may have 845 ribs that co-act with the ribs
843 in the distant chamber 842 to prevent rotation of the cap support assembly 880 relative to the end cap 820. The antiseptic cap can be used as discussed previously, or the cap support assembly
880 can be removed from the 820 end cap and used directly.
Figure 67A is a cross-sectional view showing a syringe with an antiseptic cap assembly 980a positioned thereon indicated generally at 910. Syringe 912 includes a barrel 914 has a leading end 916. Leading end 916 of the syringe 912 is configured with an access point connection 918 and a cylindrical wall 919 for attachment to an access point to administer a fluid or medication to a patient. Before the
<td rowspan="2">use, point connection</td><td rowspan="2">84 access</td><td colspan="2">MEXICAN INSTITUTE OF INDUSTRIAL PROBITY</td>
<td> 918</td><td>syringe is _____</td>
<td>covers with a mount of</td><td>cap 980a</td><td>what</td><td>attach the wall</td>
<td>cylindrical 919. The assembly</td><td>Cover</td><td>980a</td><td>includes a lid</td>
<td colspan="3">982a antiseptic and a flexible ring</td><td>984A. The ring</td>
<td colspan="2">flexible 982a can be formed by</td><td>a</td><td>extension of the</td>
<td>outer surface 983 of</td><td>Assembly</td><td>top</td><td>980 o, the ring</td>
Flexible 984a may be in the form of a flexible cap having a top 985b and a circular ring 987b with a cap assembly 980b attached to the top 985b, as shown in Figure 67B. Cap assembly 980 is attached to cylindrical wall 919 of syringe 612 by stretching flexible ring 984 around cylindrical wall 919 such that flexible ring 984 is formed around and engages cylindrical wall 919. Flexible ring 984 biases toward a normal diameter that is smaller than or equal to the diameter of cylindrical wall 919, such that cap assembly 980 is secured to syringe 912.
Figure 68 is a side view showing a syringe with an antiseptic cap assembly attached to an antiseptic cap attached thereto generally indicated at 1010. Syringe 1012 includes a barrel 1014 having a leading end 1016. The end The front 1016 of the syringe 1012 is configured with an access point connection for attachment to an access point to administer a fluid or medication to a patient. Before use, connecting the<sub>35</sub> ΙΜΡΙ £
MEXICAN INSTITUTE ΟΕ Ι Α PHOUEDAP Ο «INDUSTRIAL syringe access point is covered with a 1020 end cap. The 1020 end cap has a proximal end 1021 that attaches to the 1012 syringe access point connection. End cap 1020 also has a distal end 1041 that comprises a snap-fit flange 1042. A cap bracket assembly 1080 has an antiseptic cap 1082 and includes a snap-fit chamber 1084 located at a bottom thereof. The 1084 snap-fit chamber is configured to mate with the 1042 snap-fit flange. In use, the 1082 antiseptic cap can be applied while the 1080 antiseptic cap bracket assembly attaches to the 1020 end cap. or the antiseptic cap bracket assembly 1080 can be removed from the end cap 102 0 and used separately.
Referring to Figures 69-72, a combination cap bracket and end cap assembly is indicated generally at 1110. End cap 1120 has a proximal end 1121 that is attached to the access point connection of a syringe and a distal end 1141 comprising a distal end wall 1149 having a distal locking chamber 1142 positioned therein. A cap support assembly 1180 has a proximal end 1181. The proximal end 1181 of the lid support assembly 1180 includes a locking boss 1160 comprising a stem 1162 and a flange ββ IMPI
MEXICAN INSTITUTE DE THE PROPERTY INDUSTRIAL de Blockade 1164, discussed in greater detail below.
Referring to Figures 71 and 72, it can be seen that end cap 1120 includes proximal chamber 1122 and distal locking chamber 1142 positioned within a cylindrical or tapered side wall 1124. Side wall 1124 may include ribs or surfaces. of subjection to facilitate the handling of the same. Proximal chamber 1122 is configured for attachment to an access point connection at a forward end of a barrel of a syringe as is known. The configuration of the proximal camera 1122 can be varied in accordance with what is known in the art.
The distal locking chamber 1142 comprises a circular chamber having an oblong or oval inlet 1154. The locking flange 1164 on the locking boss 1160 of the lid bracket assembly 1180 has an oblong or oval shape configured to engage the shape of the inlet 1154 of distant locking chamber 1142. Stem 1162 preferably has a wall thickness corresponding to the distal end wall 1149 of end cap 1120. This configuration allows the locking flange 1164 to be inserted into the distant locking chamber 1142. After the locking flange 1164 is inserted into the distant locking chamber 1142, the lid bracket assembly 1180 can be rotated, such as by 90 degrees, such that the locking tab 1164 rotates in the circular distant locking chamber
<img file="MX345307B_D0049.tif" />
1142,
<img file="MX345307B_D0050.tif" />
to retain locking tab 1164 in chamber
1142 such that the locking tab 1164 cannot be pulled from it due to the oblong or oval entry 1154. In this arrangement, the cap bracket assembly 1180 locks to the end cap 1120 until it rotates an additional 90 degrees. Importantly, other geometries of locking flange 1164 and gate 1154 are contemplated, and are not limited to only oblong or oval geometries. Instead, the locking flange 1164 and the inlet or cutout 1154 can be asymmetric, mating, rectangular, triangular, or any other geometric arrangement. In use, the 1182 antiseptic cap can be applied as the 1180 antiseptic cap holder assembly attaches to the 1120 end cap or the antiseptic cap holder assembly
1180 can be removed from end cap 1120 and used separately.
Referring to Figures 73-76, generally at 1210 a syringe assembly is shown having a plunger configured to removably receive an antiseptic cap. As shown in Figures 73 and 74, syringe 1210 has a barrel 1214 and a plunger 1240. Plunger 1240 has a proximal end 1242 that includes a chamber 1260, made sized to removably receive and retain a cap holder 1220. With reference to Figure 74, chamber 1260 is defined by a wall of
<img file="MX345307B_D0051.tif" />
θβ IMPI
ÍN ^ TITOTC MÉXlCAW ^ '^ DEWWtOHFDAP INDUSTRIAL background 1261, and an annular side wall 1262 having a peripheral proximal end 1266 that defines an opening 1268 through which the cap support assembly 1220 can be inserted into chamber 1260.
The cap support assembly 1220, as discussed previously herein, comprises a cap support 1222, an antiseptic cap 1282, a sponge 1286 in some cases, an antiseptic material, and a cover or film 1250. A pull tab 1252 to facilitate removal of film 1250 from cap holder 1222 to provide access to antiseptic cap 1282. Lid holder 1222 may have a distal end 1224 and one or more protrusions 1228 on outer surface 1226 to secure the lid holder 1220 mounting in chamber 1260.
Side wall 1262 of plunger 1240 includes one or more openings 1270 defined by edges 1272. The one or more openings 1270 provide access to chamber 1260 and facilitate removal of lid bracket assembly 1220 from plunger 1240 as will be described later. at the moment.
The cap bracket assembly 1220 is removable from the plunger 1240 and the process for this is shown in Figures 75 and 76. As shown in Figure 75, removal of the cap support assembly 1220 from the plunger 1240 involves placing the thumb or index finger through nails or more
IMPI
MEXICAN INSTITUTE
OF INDUSTRIAL NOPICTY
<img file="MX345307B_D0052.tif" />
openings 1270 against a bottom surface of the cap bracket 122 0. As shown in Figure 76, after pushing against the cap bracket assembly 1220 with a finger or thumb to push the cover bracket assembly 122 0 out of the chamber 1260. Finally, cap support assembly 1220 is ejected from chamber 1260. In this manner, antiseptic cap 1282 can be conveniently used at a different time than syringe 1210.
Figures 77-80 show another embodiment of a chamber 1360 of a plunger 1340 wherein an inner surface 1374 of chamber 1360 of plunger 1340 may have a plurality of circumferentially spaced ribs 1376 that contact the lid support assembly 1320. to secure cap bracket assembly 1320 to chamber 1360. As shown in Figures 77-80, ribs 1376 may each contain a first notch 1378 formed to accept protrusion 1328 of lid bracket 1322 to further secure the lid bracket assembly 1320 within chamber 1360. As such, Applying pressure to cap bracket assembly 1320 disengages boss 1328 from notch 1378, as shown in Figure 80. The additional pressure against the lid bracket assembly 1320 continues the removal process. The 1376 ribs can also be tapered to facilitate controlled removal of the support bracket assembly.<sub>9</sub>or IMPI ^
INSTITUTE MIXICANO Di LA MOMRDAD
INDUSTRIAL Atapa 132 0, and to prevent the lid support assembly
1320 ejects too fast. The ribs 1376 can provide a decreasing amount of resistance against the protrusion 1328 of the lid bracket 1322 as the lid bracket assembly 1320 is pushed out of the chamber 1360.
Figures 81-83 show another embodiment of a chamber 1460 of a plunger 1440. Like chamber 1360 of plunger 1340, chamber 1460 includes a plurality of ribs 1476. In this embodiment, ribs 1476 of chamber 1460 may contain each a first notch 1478 and a second shallow notch 1480 closer to the proximal end 1466 of the chamber 1460 and formed to accept the protrusion 1428 of the lid bracket 1422 of the lid bracket assembly 1420. As shown in Figures 82 and 83, as lid bracket assembly 142 0 is pushed out of chamber 1460, boss 1428 disengages first notch 1478, and then, after continued pressure, engages second notch 1480 , and then completely stirred. The second notch 1480 facilitates the controlled ejection of the lid bracket assembly 1420 from the chamber 1460 because less force is required to disengage the lid bracket assembly 1420 from the second notch 1480 than from the first notch 1478.
Figure 84 is a perspective view showing
<img file="MX345307B_D0053.tif" />
IMPI ηαΤΓΠΠΌ MtXlCAN *
OF THE MOREDAB tNUBTMAl shows a plunger 1540 having four support walls 1530 that extend at 90 degree angles to each other from a common point. Towards the proximal end 1542 of the plunger 1540, one or more support walls 1530 have a recessed area 1532 proximal to the one or more openings 1570 to facilitate removal of the cap support assembly, by providing more clearance for a user to place your thumb under the cap bracket assembly, as previously shown in Figures 75 and 76. The outermost edge of the recessed area 1532 is closer to the common point than the outermost edge of the remainder of the side wall 1530. The recessed area 152 3 may be defined by a flat edge 1532a, sloped edge 1532b, or both, as shown shown in Figure 84.
Figure 85 shows a plunger 1640 having a first set of four support walls 1630 at 90 degrees to each other positioned in a distal portion of the plunger, and a second set of four support walls 1634 in a proximal portion 1642, some of which are spaced at a greater angle from each other to allow for a wider opening 1670 in the side wall 1662 of chamber 1660. At least two of the support walls flank the chamber opening, facilitating access to, and removal of, the cap support assembly by providing more clearance for a finger or thumb.
<img file="MX345307B_D0054.tif" />
user or other removal tool, if any.
IMPI
ΜΕΤΤΤυΤβ MEXICAN OF THE NOHEDAD XDUST1UAL
Shown in Figures 86 and 87 is a syringe having a clamp flange 1715 with one or more storage receptacles. Specifically, the holding flange 1715 of the syringe 1710 includes one or more fully or partially joined openings 1717 capable of receiving and retaining a cap bracket assembly 172 0 and / or a precleaner 1721. The 1721 pre-cleaner can be used where an access site was not previously disinfected by an antiseptic cap of the present invention, at all. In this circumstance, the 1721 precleaner will disinfect the access site, the access site will be used, and then the antiseptic cap will be applied. The cap holder assembly 1720 can be attached within the opening by a friction fit and the flange around the cap opening may contact the syringe holding flange 1715, or the cap holder assembly may be engaged otherwise within the opening.
Referring to Figures 88-95, the flange connector panels for receiving a cap holder assembly may be attached to normal syringe clamping flanges. As shown in Figures 88 and 89, a flange connector panel 1846 may have an opening capable of receiving and retaining a lid support assembly. As shown, aperture 1817 may have a portion along
MEXICAN INSTITUTE OF THE HIOHELMD INDUSTRIAL of the outer edge of the flange connector panel 1846, which is unbonded, or the opening can be completely united by the flange connector panel 1846 (not shown). Flange connector panel 1846 includes a slot 1856 in a side wall 1854 that provides access to a sleeve portion 1848. Side wall 1848 and sleeve portion 1854 are configured to receive a portion of a syringe holding flange 1815 and thereby attach connector panel 1846 to the syringe. For example, clamp flange 1815 is curved, and sleeve portion 1848 is similarly curved. This bond can be maintained by a friction fit, or by other means. Figures 90 and 91 show a similar device having an opening 1917, where the slot 1956 that provides access to the sleeve portion 1948 to receive a portion of the fastening flange 1915 is in another side wall of the connector panel 1946.
In another embodiment, shown in Figures 92 and 93, a flange connector panel 2046 comprises an opening 2019 fully joined by flange connector panel 2046, and is capable of receiving and retaining a cap support assembly. The flange connector panel 2046 includes a slot 2056 that provides access to a sleeve portion 2048 having receptacles 2049. The receptacles 2049 correspond in shape and location to the
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MEXICAN INSTITUTE OF PROPERTY CMw—
INDUSTRIAL '^ uj mating teeth 2023 on a clamping flange 2015 extending from the perimeter of clamping flange 2015. Thus, when flange connector panel 2046 mates with clamping flange 2015, the teeth Coupling 2023 are received by receptacles 2049 to retain flange connector panel 2046 in clamp flange 2015. The clamp flange teeth 2023 may have two different sides: a gradually angled side 2029A, further away from the plunger 2040, and a steeply angled side 2029b. The sockets 2049 can have corresponding angles. The gradually angled sides 2029A of the teeth 2023 and sockets 2049 provide easy engagement of the connector panel 2046 to the clamping flange 2015, the steeply angled sides 2029b of the teeth 2023 and sockets 2049 that prevent disengagement, blocking from this way the connector panel 2046 to the fastening flange 2015.
In a further embodiment, shown in Figures 94 and 95, a clamp flange 2115 includes a lip 2125 along its outer perimeter. A flange connector panel 2146 that includes an opening 2119, a first pair of fingers 214 9a, and a second pair of fingers 214 9b extending from the bottom of the connector 2146 and configured to connect to the lip 2125 of the clamp flange 2115. The distance between the first pair of fingers 2149a and the second of
<img file="MX345307B_D0055.tif" />
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INSTITUTE<sup>1</sup> MEXICAN
Industrial di ΙΛ fingers 2149b may correspond to the width of lip 2125 of clamping flange 2115, such that the first and second pairs of fingers 2149a, 2149b are supported against lip 2125 of clamping flange 2115. The first pair of fingers 2149a may contact the upper surface of the clamping flange 2125. Second pair of fingers 2149b may be longer than first pair of fingers 2149a and comprise flanges 2151 configured to extend downwardly and contact the bottom surface of the clamp flange.
2115. Additionally, as shown, the four fingers,
2149a 2149b are in a rectangular formation. However, the fingers can be of variable numbers, of sizes (eg, length or width), and / or of variable formations, such as two fingers, six fingers, or a trapezoidal formation.
Figures 96 and 97 show a cap bracket assembly 2220 connected to the proximal end 2242 of plunger 2240 by a brittle joint 2236. The brittle junction 2236 can be made of plastic, and a user can remove the cap bracket assembly 2220 from the plunger 2240 by breaking brittle joint 2236, such as by bending or twisting. In this manner, the cap holder assembly 2220 can be conveniently used at a different time than the syringe 2210. Lid holder 2222 may have an annular protrusion 2238 extending from its distal end 2224 and surround brittle joint 2236 to protect a user from contact and injury.
Potential IMPI of brittle junction 2236 after breakdown of brittle junction 2236.
Figure 98 is a perspective view of a plunger 2340 having a socket 2333 that extends transverse to plunger 2340. As in previous embodiments, plunger 2340 has four supporting walls, 2330a, 2330b, 2330c, and 2330d that extend at 90 degree angles relative to each other from a common point. A support wall 2330b has a discontinuation defined by end walls 2335a and 2335b. Support wall 2330d on opposite sides has an internal depression defined by distal end wall 2335c, side end wall 2335d, and proximal end wall (not shown). Transverse support walls 2330a and 2330c have an inner circular wall 2335e that forms an opening that extends through walls 2330a and 2330c between the discontinuation in wall 2330b and the depression in wall 2330d, creating a pocket in the plunger. . The receptacle is shaped to receive a cap bracket assembly 2320. Date A illustrates the route of insertion of the cap bracket assembly 2320 into the receptacle on the plunger. As shown, the receptacle is circular, but the receptacle can be a variety of shapes. The side end wall 2335d of the cutout provides structure and rigidity and prevents over-insertion of the cap bracket assembly 2320. The cover bracket assembly
<img file="MX345307B_D0056.tif" />
IMPI
INOUSTWAL can retain on plunger 2340 by a cap fit 2320 by friction, or by other means.
Shown in Figures 99-101 is a plunger 2440 having a receptacle 2433 at a proximal end that extends transverse to plunger 2440. Plunger 2440 has four support walls 2430a, 2430b, 2430c, and 2430d that extend 90 degrees. one with respect to another from a common point. Support walls 2430a and 2430c define receptacle 2433 and may be square or rectangular to accommodate a square or rectangular cap mount 2420 cap mount. Arrow B illustrates the path of insertion of the plunger cap bracket assembly 242 0. The support wall 2430b has a tear that provides clearance for engagement of the cap bracket assembly 2420 with the socket 2433. The support walls 2430 They may include a cutout defining side walls 2435a and a bottom wall 2435b. As with the previous embodiment, the cutout sidewalls 2435a provide clearance for engagement of the lid bracket assembly 2420 with the socket 2433. The bottom wall 2435b of the cutout provides structure and rigidity to the plunger 2440 and prevents over-insertion of the stem assembly. Lid holder 2420. As with the previous embodiment, the lid holder assembly 242 0 may be secured in the receptacle by a friction fit, or by other means.
Referring to Figures 102-105, another embodiment of the present invention is shown, wherein a proximal end 2542 of a plunger 2540 comprises a proximal end wall 2543 having a proximal locking chamber 2547 positioned therein. Lock chamber, next 2547
<img file="MX345307B_D0057.tif" />
it comprises a circular, recessed chamber having an oblong or oval inlet 2549. Side wall 2545 may include ribs or gripping surfaces (not shown) to facilitate handling thereof.
The distal end 2524 of the lid support assembly 2522 comprises a locking boss 2588 having a circular shank 2590 and an oblong or oval locking flange 2592 that engages the inlet form 254 9 of the locking chamber, distal 2547. Stem 2590 preferably has a wall thickness that corresponds to or mates with proximal end wall 2543 of plunger 2540. This configuration allows the locking tab 2592 to align with the inlet and insert into the proximal locking chamber 2547. After the locking flange 2592 is inserted into the proximal locking chamber 2547, the lid support assembly 2520 can be rotated (eg, 90 degrees), as illustrated by arrow C, such that the flange lock 2592 rotates in the proximal, circular lock chamber 2547 to retain the lock tab 2592 in the chamber 2547 such that the lock tab 2592 cannot be
<img file="MX345307B_D0058.tif" />
IMPI INSTITUTE mejicano t * THE industrial PROPERTY pull of the same due to the oblong or oval entrance 2549.
A friction fit can be provided to prevent accidental rotation / disengagement. In this arrangement, the cap support assembly 2520 can lock the plunger 2540 until it is rotated an additional 90 degrees relative to the plunger.
Importantly, other geometries of locking flanges 2592, gate 2549, and cutter are contemplated and are not limited to just oblong or oval geometries. Instead, locking flange 2592 and gate 2549 or cutout can be asymmetric mating designs, rectangular, triangular, or any other geometric arrangement. In use, the antiseptic cap 2582 can be applied as the cap support assembly 2520 is attached to the plunger 2540 or the cap support assembly 2520 can be removed from the plunger 2540 and used separately.
Another embodiment of the present invention is shown in Figures 106-108. A side wall 2662 of a chamber 2660 of a plunger 2640 comprises a locking lever 2664 having a proximal end 2668 and a distal end 2672, and is connected to the side wall 2662 by a hinge 2666 of the same material, which acts as a fulcrum. . Proximal end 2668 comprises a locking boss 2670 that engages a notch in cap bracket 2622 of cap bracket assembly 2620, thereby locking it when the cap bracket
IMPI iNsrrrvro Mexican
DI IA PROPERTY cap 2622 is secured within chamber 2660 of plunger 2640. By pushing distal end 2672 of locking lever 2664, proximal end 2668 rotates around hinge 2666 of the same material, illustrated by lines D, making locking projection 2670 disengages from the notch in lid bracket 2622, thereby allowing removal of lid bracket assembly 262 0 from chamber 2660.
On the other hand, shown in Figures 109 and 110, the distal end 2772 of the locking lever 2764 may have a dropout 2773 to facilitate removal of the cap bracket assembly 2720 from the chamber 2760 of the plunger 2740. When the distal end 2772 of the locking lever 2764 is depressed and the proximal projection 2770 of the proximal end 2768 rotates around the hinge 2766 of the same material, illustrated by the lines E, and the cap bracket 2722 is disengaged, the dropout 2773 is pushes against cap bracket assembly 2720 and the shape of toe 2773 pushes cap mount 2720 out of chamber 2760, illustrated by line F.
Referring to Figure 111, another embodiment of the present invention is shown where a first adhesive material 2894a is attached to the distal end 2824 of a cap bracket assembly 2820 and a second adhesive material 2894b is attached to the proximal end 2842 of the plunger 2840. of the
<img file="MX345307B_D0059.tif" />
101
IMPI muucano institute
OF THE non EDA »INDUSTRIAL syringe. The two adhesive materials 2894a, 2894b can be removably bonded together. Adhesive materials
2894a, 2894b can be any suitable adhesive or it can be another type of material that can form a connection, such as hook and eye fasteners where the 2894a material can be comprised of hooks and the 2894b material can be comprised of grommets. In this manner, the cap support assembly 2820 can be repeatedly attached to the plunger 2840. Additionally, when cap assembly 2820 is attached to plunger 2840, the cap can be removed from cap assembly 2820, without first having to remove cap bracket assembly 2820 from plunger 2840.
Another embodiment is shown in Figures 112 and 113, where a proximal end of the plunger comprises an axially compressible material 2998, such as an accordion-folded foam or plastic, defining a cavity. As shown in Figure 112, a cap support assembly 2920 may be inserted into the cavity, such as by the path illustrated by arrow G, and secured therein by the radial force of friction of the compressible material 2998 against the cavity. outer surface 2926 of cap holder 2922. As shown in Figure 113, when compressible material 2998 is compressed, as illustrated by arrows H, cap holder assembly 2920 is easily grasped and removed.
Referring to Figure 114, another
<img file="MX345307B_D0060.tif" />
102
IMPI
MEXICAN INSTITUTE OF THE PEON AGE INDUSTRIAL modality of the present invention. A plunger 3040 may have an annular flange 3067 at a peripheral proximal end 3066 of a chamber 3060 and a cap holder 3022 may have an annular flange 3027. When the cap holder assembly 020 is fully inserted into chamber 3060 of plunger 3040 the two tabs 3027, 3067 are separated by a distance. The spaced distance allows a user to grasp the flange 3027 of the cap holder 3022, thus easily removing the cap holder assembly 3020 from the chamber 3060.
Figures 115-118 show another embodiment of the present invention comprising a radially compressible locking ring 3174 attached to a peripheral proximal end 3166 and a plunger 3140. The locking ring comprises diametrically opposed pressure tabs 3178 and locking tabs 3176. As shown in FIG. 116, the distance between the locking tabs 3176 is less than the diameter of the cap bracket 3122, thereby securing the cap bracket assembly 312 0 in the chamber 316 0 of the plunger 3140. When a diametrically opposite force is applied at pressure points 3178, as shown by arrows I, locking ring 3174 deforms and locking tabs 3176 separate from each other, shown by arrows J, sufficient to allow removal of cap bracket assembly 3120 from plunger chamber 3160
<img file="MX345307B_D0061.tif" />
103
3140. Figure 118 shows another mode of the ring of τ *
IMPI
INSTITUTE MKICANQ DS THE INDUSTRIAL PROPERTY 3274 lock comprising locking tabs 3276 where the lock ring 3274 is generally circular in shape, and where an applied force, illustrated by lines K, results in the tabs 3276 moving apart, illustrated by the lines of L.
From the foregoing, it will be appreciated that numerous variations and modifications can be made without departing from the spirit and scope of the invention. It is to be understood that no limitation is intended or should be inferred with respect to the specific apparatus illustrated herein. Of course, it is proposed to cover by the appended claims all such modifications as they fall within the scope of the claims.
It is noted that in relation to this date, the best method known to the applicant to carry out the present invention is the one that is clear from the present description of the invention.
104
IMPI • WDWnilAL
<img file="MX345307B_D0062.tif" />
Contents79
110 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6 Sheet 7 Sheet 8 Sheet 9 Sheet 10 Sheet 11 Sheet 12 Sheet 13 Sheet 14 Sheet 15 Sheet 16 Sheet 17 Sheet 18 Sheet 19 Sheet 20 Sheet 21 Sheet 22 Sheet 23 Sheet 24 Sheet 25 Sheet 26 Sheet 27 Sheet 28 Sheet 29 Sheet 30 Sheet 31 Sheet 32 Sheet 33 Sheet 34 Sheet 35 Sheet 36 Sheet 37 Sheet 38 Sheet 39 Sheet 40 Sheet 41 Sheet 42 Sheet 43 Sheet 44 Sheet 45 Sheet 46 Sheet 47 Sheet 48 Sheet 49 Sheet 50 Sheet 51 Sheet 52 Sheet 53 Sheet 54 Sheet 55 Sheet 56 Sheet 57 Sheet 58 Sheet 59 Sheet 60 Sheet 61 Sheet 62 Sheet 63 Sheet 64 Sheet 65 Sheet 66 Sheet 67 Sheet 68 Sheet 69 Sheet 70 Sheet 71 Sheet 72 Sheet 73 Sheet 74 Sheet 75 Sheet 76 Sheet 77 Sheet 78 Sheet 79 Sheet 80 Sheet 81 Sheet 82 Sheet 83 Sheet 84 Sheet 85 Sheet 86 Sheet 87 Sheet 88 Sheet 89 Sheet 90 Sheet 91 Sheet 92 Sheet 93 Sheet 94 Sheet 95 Sheet 96 Sheet 97 Sheet 98 Sheet 99 Sheet 100 Sheet 101 Sheet 102 Sheet 103 Sheet 104 Sheet 105 Sheet 106 Sheet 107 Sheet 108 Sheet 109 Sheet 110
94 members in 13 offices
Priority claims14
| Document | Office | Kind | Date |
|---|---|---|---|
| 13288529 | United States of America | – | |
| 201113288529 | United States of America | A | |
| 201113288529 | United States of America | A | |
| 13547650 | United States of America | – | |
| 201213547650 | United States of America | A | |
| 201213547650 | United States of America | A | |
| 2012062078 | United States of America | W | |
| 2012062078 | United States of America | W | |
| 13288529 | – | – | – |
| 13547650 | – | – | – |
| PCTUS2012062078 | – | – | – |
| US201113288529 | – | – | – |
| US201213547650 | – | – | – |
| WO2012US62078 | – | – | – |
Members94
| Document | Office | Kind | |
|---|---|---|---|
| US2008086091A1 | United States of America | A1 | |
| AU2008269133A1 | Australia | A1 | |
| BRPI0813497A2 | Brazil | A2 | |
| CA2692157A1 | Canada | A1 | |
| CA2846145A1 | Canada | A1 | |
| WO2009002474A1 | World Intellectual Property Organization (WIPO) | A1 | |
| US2009099529A1 | United States of America | A1 | |
| EP2167166A1 | European Patent Office (EPO) | A1 | |
| MX2010000171A | Mexico | A | |
| CN101801435A | China | A | |
| CO6270345A2 | Colombia | A2 | |
| HK1146813A | Hong Kong, China | A | |
| HK1146813A1 | Hong Kong, China | A1 | |
| US2011290799A1 | United States of America | A1 | |
| US8167847B2 | United States of America | B2 | |
| US2012109073A1 | United States of America | A1 | |
| US8231602B2 | United States of America | B2 | |
| US2012245531A9 | United States of America | A9 | |
| US2012283693A1 | United States of America | A1 | |
| US2012296284A1 | United States of America | A1 | |
| AU2012258435A1 | Australia | A1 | |
| NZ582395A | New Zealand | A | |
| US2013006194A1 | United States of America | A1 | |
| US2013023828A1 | United States of America | A1 | |
| US2013035667A1 | United States of America | A1 | |
| AU2013100345A4 | Australia | A4 | |
| CA2854296A1 | Canada | A1 | |
| WO2013066742A1 | World Intellectual Property Organization (WIPO) | A1 | |
| CN103191511A | China | A | |
| CN101801435B | China | B | |
| AU2013224680A1 | Australia | A1 | |
| AU2013100345B4 | Australia | B4 | |
| AU2008269133B2 | Australia | B2 | |
| NZ603404A | New Zealand | A | |
| CA2692157C | Canada | C | |
| AU2012332901A1 | Australia | A1 | |
| AU2012258435B2 | Australia | B2 | |
| MX2014005371A | Mexico | A | |
| NZ623138A | New Zealand | A | |
| CO7030941A2 | Colombia | A2 | |
| CN104023768A | China | A | |
| EP2773398A1 | European Patent Office (EPO) | A1 | |
| US8845593B2 | United States of America | B2 | |
| AU2014218397A1 | Australia | A1 | |
| JP2014532517A | Japan | A | |
| US2015018774A1 | United States of America | A1 | |
| US8968268B2 | United States of America | B2 | |
| EP2773398A4 | European Patent Office (EPO) | A4 | |
| NZ623139A | New Zealand | A | |
| NZ623141A | New Zealand | A | |
| HK1201770A | Hong Kong, China | A | |
| HK1201770A1 | Hong Kong, China | A1 | |
| NZ623136A | New Zealand | A | |
| US2015314119A1 | United States of America | A1 | |
| US9259535B2 | United States of America | B2 | |
| AU2013224680B2 | Australia | B2 | |
| NZ624449A | New Zealand | A | |
| CN103191511B | China | B | |
| CA2846145C | Canada | C | |
| AU2016219664A1 | Australia | A1 | |
| AU2014218397B2 | Australia | B2 | |
| MX345307BThis record | Mexico | B | |
| JP6087364B2 | Japan | B2 | |
| CN104023768B | China | B | |
| BR112014010805A2 | Brazil | A2 | |
| US9700676B2 | United States of America | B2 | |
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| AU2012332901B2 | Australia | B2 | |
| US2017361023A1 | United States of America | A1 | |
| EP2167166A4 | European Patent Office (EPO) | A4 | |
| MX354573B | Mexico | B | |
| AU2016219664B2 | Australia | B2 | |
| US10328207B2 | United States of America | B2 | |
| EP2167166B1 | European Patent Office (EPO) | B1 | |
| US2020121858A1 | United States of America | A1 | |
| CA2854296C | Canada | C | |
| ES2808632T3 | Spain | T3 | |
| BRPI0813497B1 | Brazil | B1 | |
| US2021093791A1 | United States of America | A1 | |
| BRPI0813497B8 | Brazil | B8 | |
| BR112014010805B1 | Brazil | B1 | |
| US11160932B2 | United States of America | B2 | |
| EP2773398B1 | European Patent Office (EPO) | B1 | |
| US11229746B2 | United States of America | B2 | |
| ES2907323T3 | Spain | T3 | |
| US2022379035A1 | United States of America | A1 | |
| US2022401652A1 | United States of America | A1 | |
| US11684720B2 | United States of America | B2 | |
| US12042640B2 | United States of America | B2 | |
| US2025099686A1 | United States of America | A1 |
1 legal event, as the office reported them to INPADOC
Events
| Event | Code | |
|---|---|---|
| Grant or registrationFG | FG |
Numbers
- Publication
- 345307
- Publication, DOCDB
- 345307
- Publication, EPODOC
- MX345307
- Application
- 2014005371
- Application, DOCDB
- 2014005371
- Application, EPODOC
- MX20140005371
Titles2
- Spanish
- JERINGA EQUIPADA CON TAPA ANTISEPTICA.
- English
- SYRINGE EQUIPPED WITH ANTISEPTIC LID.
Classification
- CPC, 17
- A61M5/31511
- A61M39/16
- A61M5/001
- A61M5/002
- A61M5/3135
- A61M5/3137
- A61M5/347
- A61M39/02
- A61M39/162
- A61M39/20
- A61M2005/3104
- A61M2005/31506
- A61M2039/1033
- A61M25/04
- A61M5/31
- A61M5/31513
- A61M2025/0019
- IPC, 4
- A61M39 02
- A61M5 315
- A61M39 16
- A61M39 20