Nestable sterility-protecting caps for separated connectors
Abstract
A pair of nesting caps is described, each of the caps being sized and shaped to provide a protective joint around a separate medical connector. The pair comprises a male cap and a female cap, each of which is configured to be joined with a complementary cap, to form a nested pair. The nested pair is sealed until separated for use, thereby maintaining the sterility of the inner surfaces of the nested pair. An absorbent pad can be impregnated with an antiseptic agent and included within the pair to further increase the sterility resulting from each cap, when used around a medical connector. One of the covers can include a cleaning chamber having a disposable liner, a pad and an antiseptic agent. In addition, a flexible tube, containing a burstable capsule, can be attached to one of the caps to provide an internal antiseptic solution to the caps.

Term
1.3 yearsleft in the term
Expires 15 January 2028.
- Priority
- Filed
- Granted
- Today
- Expires
25 claims: 9 independent, 16 dependent
- 1CLAIMS REIVINDICAÇÕES 1. Pair of nestable covers for use in providing a protective union around a separate medical connector, characterized by the fact that it comprises:1. Par de tampas aninháveis para uso em prover uma união protetora em tomo de um conector médico separado, caracterizado pelo fato de compreender: a male cap comprising a connecting geometry, whereby the male cap can be selectively coupled to a female cap or a separate female medical connector;uma tampa macho compreendendo uma geometria conectante, por meio da qual a tampa macho pode ser seletivamente acoplada a uma tampa fêmea ou um conector médico fêmea separado;a female cap comprising a connecting geometry, whereby the female cap can be selectively coupled to a male cap or a separate male medical connector;and each of the male and female lids comprises an internal surface, an external surface and an interface, the interfaces of the male and female lids provide a seal when joined together and which aseptically divides the internal and external surfaces, to ensure perpetuated sterility of the surfaces internal. uma tampa fêmea compreendendo uma geometria conectante, por meio da qual a tampa fêmea pode ser seletivamente acoplada a uma tampa macho ou um conector médico macho separado;e cada uma das tampas macho e fêmea compreende uma superfície interna, uma superfície externa e uma interface, as interfaces das tampas macho e fêmea proveem um selo quando unidas entre si e que assepticamente divide as superfícies interna e externa, para assegurar esterilidade perpetuada das superfícies internas.
- 6Method to protect the separate ends of the medical connectors, characterized by the fact that it comprises the steps of:6. Método para proteger as extremidades separadas dos conectores médicos, caracterizado pelo fato de compreender as etapas de: prover um par de tampas, cada uma das tampas dimensionada e conformada para prover uma união protetora em tomo de um conector médico separado e para ser seletivamente unidas entre si, o par compreendendo: provide a pair of caps, each of the caps sized and shaped to provide a protective union around a separate medical connector and to be selectively joined together, the pair comprising: a male cap, having a threaded projecting part with a hollow inner part, the male cap being adapted for selective coupling with a complementary female cap or a separate female medical connector;and a female cap having a threaded inner part, the female cap being adapted for selective coupling with a complementary male cap or a separate male medical connector, receiving at least a part of the separate male cap or male medical connector within its threaded inner part;uma tampa macho, tendo uma parte projetante rosqueada com uma parte interna oca, a tampa macho sendo adaptada para acoplamento seletivo com uma tampa fêmea complementar ou um conector médico fêmea separado;e uma tampa fêmea tendo uma parte interna rosqueada, a tampa fêmea sendo adaptada para acoplamento seletivo com uma tampa macho complementar ou um conector médico macho separado, recebendo pelo menos uma parte da tampa macho ou conector médico macho separado dentro de sua parte interna rosqueada;joining the male cap and the female cap together to form a nested pair;unir a tampa macho e a tampa fêmea entre si, para formar um par aninhado;process the pair to ensure that the inner surfaces are sterile;processar o par para assegurar que as superfícies internas estejam estéreis;separar um par de conectores médicos, expondo um conector fêmea não fixado e um conector macho não fixado;separate a pair of medical connectors, exposing an unsecured female connector and an unsecured male connector;torcer o par aninhado separando-os, para prover a tampa macho e tampa fêmea;twist the nested pair separating them, to provide the male cap and female cap;acoplar a tampa fêmea ao conector macho;e acoplar a tampa macho ao conector fêmea. couple the female cover to the male connector;and attach the male cap to the female connector.
- 11Pair of nestable covers for use in protecting separate medical connectors, characterized by the fact that it comprises:11. Par de tampas aninháveis para uso em proteger conectores médicos separados, caracterizado pelo fato de compreender: a first cover having an outer surface and an inner surface, the outer surface having an opening for access to the inner surface, the inner surface having a threaded part;and a second cap having an outer surface and a tapered part extending from the outer surface, an outer surface of the tapered part having a threaded part, adapted to fit the inner threaded part of the first cap, to enable the second cap to be selectively attached a and at least partially nested with the first cap. uma primeira tampa tendo uma superfície externa e uma superfície interna, a superfície externa tendo uma abertura para acesso à superfície interna, a superfície interna tendo uma parte rosqueada;e uma segunda tampa tendo uma superfície externa e uma parte troncocônica estendendo-se da superfície externa, uma superfície externa da parte troncocônica tendo uma parte rosqueada, adaptada para encaixar na parte interna rosqueada da primeira tampa, para possibilitar que a segunda tampa seja seletivamente presa a e pelo menos parcialmente aninhada com a primeira tampa.
- 15Nestable pair of caps for use in protecting separate medical connectors, characterized by the fact that it comprises:15. Par aninhável de tampas para uso na proteção de conectores médicos separados, caracterizado pelo fato de compreender: a first cap having an outer surface defining an opening for a hollow threaded inner part, the hollow inner part having an antiseptically saturated pad, the hollow inner part being adapted to receive a part of a separate medical connector;uma primeira tampa tendo uma superfície externa definindo uma abertura para uma parte interna rosqueada oca, a parte interna oca tendo uma almofada antissepticamente saturada, a parte interna oca sendo adaptada para receber uma parte de um conector médico separado;a second cap having an outer surface, an elongated part extending from it, the elongated part having an elongated hole with an antiseptically saturated pad disposed thereon, the elongated hole being adapted to receive a part of a separate medical connector and a cleaning chamber arranged there, the cleaning chamber comprising a cavity within the second lid, a coating positioned within the cavity, a pad disposed within the liner and a cover removably extending through the liner opening;uma segunda tampa tendo uma superfície externa, uma parte alongada estendendo-se dela, a parte alongada tendo um furo alongado com uma almofada antissepticamente saturada disposta nela, o furo alongado sendo adaptado para receber uma parte de um conector médico separado e uma câmara de limpeza disposta ali, a câmara de limpeza compreendendo uma cavidade dentro da segunda tampa, um revestimento posicionado dentro da cavidade, uma almofada disposta dentro do revestimento e uma cobertura removivelmente estendendo-se através da abertura do revestimento;a primeira tampa e a segunda tampa sendo adaptadas para encaixe seletivo e selante entre si, para evitar contaminação da parte interna oca da tampa macho e da parte alongada da tampa macho antes do desencaixe da primeira tampa e da segunda tampa entre si. the first cover and the second cover being adapted for selective fitting and sealing with each other, to avoid contamination of the hollow inner part of the male cover and the elongated part of the male cover before the first cover and second cover disengage from each other.
- 21Pair of nestable covers for use in protecting separate medical connectors, characterized by the fact that it comprises a female cover having a gripping part and a hollow internal part;21. Par de tampas aninháveis para uso na proteção de conectores médicos separados, caracterizado pelo fato de compreender uma tampa fêmea tendo uma parte de agarramento e uma parte interna oca;a male cap adapted for selective coupling with the female cap, the male cap having a gripping part and a tubular part, adapted to protrude into the hollow inner part of the female cap, when the male cap is coupled to the female cap, the hollow inner part and the tubular part having cooperating geometries, to facilitate secure fitting of the male and female caps;and a seal disposed between the female cap and the male cap, the seal being adapted to prevent contamination of the hollow inner part of the female cap and the tubular part of the male cap, the seal also being adapted to limit the evaporation or loss of an antiseptic agent arranged inside the pair of covers;uma tampa macho adaptada para acoplamento seletivo com a tampa fêmea, a tampa macho tendo uma parte de agarramento e uma parte tubular, adaptadas para projetarem-se dentro da parte interna oca da tampa fêmea, quando a tampa macho é acoplada à tampa fêmea, a parte interna oca e a parte tubular tendo geometrias cooperantes, para facilitar encaixe seguro da tampa macho e da tampa fêmea;e um selo disposto entre a tampa fêmea e a tampa macho, o selo sendo adaptado para evitar contaminação da parte interna oca da tampa fêmea e da parte tubular da tampa macho, o selo também sendo adaptado para limitar a evaporação ou perda de um agente antisséptico disposto dentro do par de tampas;em que a tampa fêmea e a tampa macho são adaptadas para desencaixe seletivo entre si e encaixe individual de conectores médicos separados. wherein the female cap and the male cap are adapted for selective detachment from each other and individual fit of separate medical connectors.
- 22Pair of nestable covers according to claim 22. Par de tampas aninháveis de acordo com a reivindicação 21, caracterizado pelo fato da tampa fêmea compreender ainda um tubo 5 compressível acoplado nela, o tubo compreendendo uma cápsula frágil e um orifício através do qual o conteúdo do tubo comunica-se com as partes internas da tampa fêmea. 21, characterized in that the female cap further comprises a compressible tube 5 coupled to it, the tube comprising a fragile capsule and an orifice through which the contents of the tube communicate with the internal parts of the female cap.
- 23Pair of nestable covers according to claim 23. Par de tampas aninháveis de acordo com a reivindicação 22, caracterizado pelo fato do tubo compreender ainda uma almofada de 10 material absorvente disposta nele, para obstruir o orifício. 22, characterized in that the tube also comprises a pad of 10 absorbent material arranged therein, to block the orifice.
- 24Pair of nestable covers according to claim 24. Par de tampas aninháveis de acordo com a reivindicação 23, caracterizado pelo fato da cápsula compreender ainda uma solução antisséptica, que é liberada da contenção fraturando-se a cápsula. 23, characterized by the fact that the capsule also comprises an antiseptic solution, which is released from containment by fracturing the capsule.
- 25Pair of nestable covers according to claim 25. Par de tampas aninháveis de acordo com a reivindicação 15 24, characterized by the fact that the tube is compressed to break the fragile capsule and release antiseptic solution through the cushion and orifice, thus administering the antiseptic solution to the internal surfaces of the nested pair, before twisting the nested pair separating it. 15 24, caracterizado pelo fato do tubo ser comprimido para romper a cápsula frágil e liberar solução antisséptica através da almofada e do orifício, desse modo administrando a solução antisséptica às superfícies internas do par aninhado, antes de torcer o par aninhado separando-o. 1/10 ο 1/10 ο co co
Independent claims9
73 paragraphs in 4 sections, as filed
(54) Title: PAIR OF NESTABLE COVERS, AND, METHOD FOR PROTECTING SEPARATE END OF MEDICAL CONNECTORS (30) Unionist Priority: 16/01/2007 us 60/880541 (73) Holder (s): University Of Utah Research Foundation (72 ) Inventor (s): James V. Mercer, MichaelW. Howlett (74) Attorney (s): Momsen, Leonardos & Cia.
(86) International Order: pct US2008051087 of 15/01/2008 (87) International Publication: wo 2008 / 089i96de 24/07/2008 (57) Summary: pair of nestable caps, and method to PROTECT THE SEPARATE END OF MEDICAL CONNECTORS . A pair of nesting caps is described, each of the caps being sized and shaped to provide a protective joint around a separate medical connector. The pair comprises a male cap and a female cap, each of which is configured to be joined with a complementary cap, to form a nested pair. The nested pair is sealed until separated for use, thereby maintaining the sterility of the internal surfaces of the nested pair. An absorbent pad can be impregnated with an antiseptic agent and included within the pair to further increase the sterility resulting from each cap, when used around a medical connector. One of the covers can include a cleaning chamber having a disposable liner, a pad and an antiseptic agent. In addition, a flexible tube, containing a rupturable capsule, can be attached to one of the caps to provide internal antiseptic solution to the caps.
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<sup>1</sup> ΡΙ0806801-1 “PAIR OF ANIS VEHICLE COVERS AND METHOD TO PROTECT THE SEPARATE END OF MEDICAL CONNECTORS” REFERENCE TO RELATED ORDERS
This order claims the benefit of US Provisional Order No. 60 / 880,541, entitled ANTISEPTIC PROTECTIVE CAP FOR MALE AND FEMALE SCREW-TOGETHER CONNECTORS, filed on January 16, 2007, which is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION
This invention is generally related to caps for medical connectors and specifically related to caps used to protect the sterility of separate medical fluid flow connectors.
2. RELEVANT TERMINOLOGY
Catheter-related bloodstream infections are caused by bacteria / fungi in patients with intravascular catheters. These infections are a major cause of illness and excessive medical costs. Approximately 80,000 catheter-related bloodstream infections occur in intensive care units in the US annually. In addition, such infections are associated with 2400 to 20,000 deaths per year.
The Centers for Disease Control and Prevention guidelines describe several ways to limit catheter-related bloodstream infections in hospitals, outpatients and home care settings. The guidelines address problems such as hand hygiene, care of the catheter site and preparation of the mixture. However, despite these guidelines, catheter-related blood infections continue to plague our health care system.
Impregnating the catheters with various antimicrobial agents is a way that has been implemented to prevent these infections. These catheters, however, gave less than satisfactory results. In addition, some microbes have developed resistance to the various antimicrobial agents in the system.
In another system that is commercially available in Europe, 5 a catheter cube containing an antiseptic chamber is filled with three percent iodized alcohol. Although it has been shown to be effective, the catheter hub is expensive and does not pass a formal cost-benefit analysis either.
The caps used to protect the sterility of medical connectors are well known in the medical art. Protective tip caps are commonly applied to tubing Luer connectors, IV access device, regulating valves and syringes. Many examples of such tip caps are commercially available. Most commercially available medical tubing assemblies are packed with a cap in place, to protect the tubing during handling. Caps for other types of connectors, including catheter injection holes, are less common, although they are also known in the medical cap technique.
The covers commonly used to cover medical connectors include a cover that is open at one end, closed at the other end and includes a set of spiral threads (to produce a secure, sealed Luer connection) over an associated bare connector, such as a hole injection. The inner side of the closed end can be equipped with a plastic cap, which can be broken when the cover is attached to the associated connector. Breaking the plastic capsule releases antiseptic agents stored inside the capsule, thereby applying the antiseptic agents to the accessible parts of the connector.
One of the many examples of medical connectors for which such caps are used are intravascular connectors associated with a central line. Commonly, a central line is used to intermittently administer medication to a patient. For example, a central line, which transmits fluids to the patient's bloodstream, may have one or more connectors associated with it. Each of the centerline connectors can be connected to other connectors, such as a connector associated with an IV bag. In such a situation, medical connectors, such as Luer locking connectors, are connected and disconnected several times and can remain disconnected for several minutes or hours. Medical connector covers are used to cover and protect the various medical connectors, while the connectors are disconnected from each other. When the medical connectors are disconnected from each other, there are two connectors that may require cover by a cover. Therefore, it would be advantageous to have a single set of connectors that can be used to provide protection for both ends of a separate connection.
BRIEF SUMMARY OF THE INVENTION
An embodiment of the present invention comprises a pair of nested protective caps, having a male cap and a female cap. Each cap has threads that correspond to connectors commonly used in medical devices and that are separated to access them. Such medical devices may include, but are not limited to, IV tubing assemblies, needle-free injection sites or orifices and vascular access devices. Each cap has threads that connect to a threaded end of an associated cap. As such, a pair of protective covers can be nestled together to provide a pair of covers that, before separation, keep the internal surfaces sterile. These covers can subsequently be separated and applied to protect both ends of a separate medical connection.
Each protective cover includes an associated medical device connector and prevents touch contamination, which can result in microbial contamination, colonization and infection, while the medical device connectors are separated. In addition, in some embodiments, protective caps may contain antiseptic agents, which kill microorganisms, such as bacteria, viruses and fungi, which can colonize and result in a vast body infection (e.g. IV catheter-related bloodstream infections). In such cases, the protective cap has an absorbent material to apply an antiseptic to a fixed medical device connector. The absorbent material can also provide frictional cleaning while the protective cap is being attached. Such cleaning improves microbial killing.
The “nesting” geometry of the pair of covers provides both caps and a single unit, sealed against contamination of the connecting parts, until the nested pair is separated. Usually, the nested pair is connected by the same thread geometries, which provide connection to the associated medical connection devices. When nested before use, the individual female and male caps are screwed together to form a seal, to ensure that the sterility of the inner surfaces of each cap is maintained. For this reason, the nested pair unit or device no longer requires sterilization before use, since the unit is produced and supplied as an inherently self-sealed sterile package.
For example, the male cap of the device can generally be used to cover the end of an IV tubing assembly, which is disconnected from an injection site without an IV catheter needle. Examples of needle-free injection sites, sometimes referred to as orifices, hubs and valves, include brands such as Clave (ICU Medicai), SmartSite (Cardinal) and Q-Site (Becton Dickenson). The nested pair female cap can then be used to protect the needle-free injection site itself. Importantly, once the cap has been applied, the medical device connector does not need to be re-disinfected (eg treated with an alcohol swab) before each reconnection, as it will be kept in a decontaminated state while under the cap protective.
In an exemplary embodiment, the nested pair of pre-sterilized lids is packaged, to protect against contamination, by a seal cover around the junction of the two lids. Embodiments of the nested pair, having a female part, also contain cleaning material at a closed end of the female part. The material is impregnated with an antiseptic agent. The male part screw into the corresponding threads of the female part. To ensure sterility and prevent loss of fluid, the contact edges of the male and female parts form a seal impermeable to the passage of fluid and microbes, when hermetically fixed together. Alternatively, a 0-ring can be attached around a part containing internal threads of the male cap. Such a seal reduces or prevents evaporative loss of antiseptic. A second, rolled-up seal can also or otherwise be used to provide additional protection for transportation and storage. The unscrewing, to separate the two parts, breaks each seal and cleans the male part. As indicated, the material disposed in the female part cleans the male connector of the medical device being plugged. This, in addition to preventing contamination, thus eliminates the need for friction cleaning (eg with alcohol).
Other exemplary embodiments provide nested and sealed male and female parts and an internal antiseptic source, as described above. However, to provide fresh antiseptic fluid within the nested pair prior to separation, a closed tube, containing a ruptured reservoir applicator, is aseptic and sealingly attached to the unroasted end of the female part. The burstable reservoir provides an open antiseptic transport neck, which passes into the female / male cap unit. Inside the tube there is a capsule, containing the reservoir, which is manually crushed inside the tube. In the female cap adjoining the end of the tube, a pad of absorbent material is arranged to controllably transmit fluid residing within the reservoir into the interior of the nested pair. Thus, a path is provided to release antiseptic into the material and the nested lid unit. Note that the act of twisting the male and female parts occurs naturally when the covers are separated. Such a wrench causes the pad of absorbent material to rub the exposed parts of the nested pair internally.
Still other exemplary embodiments provide nested and sealed male and female parts, as described above. In addition, at least one of the covers includes a cleaning chamber arranged at one end thereof. The cleaning chamber includes a cavity within one of the lids, a removable position of disposable liner within the cavity and a pad secured within the liner. The cushion can be saturated or impregnated with an antiseptic agent. The cleaning chamber can be used to clean and remove hazardous material from a medical connector before attaching another medical connector or one of the covers to it.
Additional aspects and advantages of the present invention will be set out in the description that follows and will in part be obvious from the description, or can be learned by practicing the invention. The aspects and advantages of the invention can be realized and obtained by means of the instruments and combinations particularly highlighted in the appended claims. These and other aspects of the present invention will become more fully evident from the following description and appended claims, or can be learned from the practice of the invention as set out below.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a side elevation of a pair of fixed medical caps, produced in accordance with the present invention;
Figure IA is a first extreme perspective view of the covers in Fig. 1;
Figure 1B is a second extreme perspective view of the covers in Figure 1;
Figure 2 is an exploded perspective view of the medical caps of Figure 1;
Figure 3 is a perspective view of a single cap portion of the attached pair seen in Figure 2, with internal threads seen therein;
Figure 4 is a perspective view of the cover seen in Figure 3, with an associated medical connector, seen close to being connected to it;
Figure 5 is a perspective view of a cover, which is complementary to the cover of Figure 3, and a Luer closure connector, to which the complementary cover can be attached;
Figure 6 is a side elevation of a fixed pair of medical caps, similar to the caps seen in Figure 1, however having an “O” ring arranged around the connecting edges of the caps;
Figure 7 is an exploded view of the cover unit seen in
Figure 6;
Figure 7A is an extreme perspective view of one of the covers seen in Figure 7, with a sealing mechanism arranged on them;
Figure 7B is an extreme perspective view of the other cover seen in Figure 7, with a sealing mechanism arranged on it;
Figure 8A is a side elevation of the interconnected cover unit, seen in Figure 6 with a flat or sheet seal partially displaced around the connecting edges of the cover unit;
Figure 8B is a side elevation of the interconnected cover unit, seen in Figure 8A with the flat or sheet seal fully in position;
Figure 9A is a side elevation of the cover part which is seen in Figure 3 and an absorbent pad being arranged there up;
Figure 9B is a side elevation of the cover and pad part seen in Figure 9A with the absorbent pad arranged within the cover part;
Figure 9C is a side elevation of the cover and cushion part, as seen in Figure 9B, with an amount of antiseptic material being administered inside the cover and cushion;
Figure 9D is a horizontal view of the cover part containing the pad as seen in Figures 9B and 9C, attached to an associated complementary cover;
Figure 10 is an exploded side elevation of a pair of complementary caps, similar to the caps seen in Figure 1, but having a tube part that is sized and shaped to fit through a hole in the female part of the nested pair;
Figure 11 is a side elevation of the complementary caps seen in Figure 10, interconnected with the tube part;
Figure 12 is a side elevation of a pair of complementary covers 15, similar to the covers seen in Figure 9D, with a second absorbent pad arranged thereon;
Figure 13 is a perspective view of a pair of complementary covers, similar to the covers seen in Figure 1, but having an additional cleaning device arranged at one end of the covers;
Figure 14 is a perspective view in cross section of the pair of caps in Figure 13.
DETAILED DESCRIPTION
In this description, the term proximal is used to indicate the segment of a device, usually closest to an object of the sentence describing its position. The term distal refers to an opposite position. Reference is now made to the embodiments illustrated in Figures 1 - 12, in which similar numerals are used to designate equal parts from beginning to end. The parts designated by numerals with base coatings are similar but not exactly the same as the parts designated by numerals only.
A unit or assembly is seen in Figures 1-1B 10 of a pair of separable covers 20 and 30, securely attached but releasably to each other, through a common interface 40. To serve a significant purpose, the internal parts and surfaces of the unit 10 must be sterile and, perhaps more importantly, be able to prevent contamination of a connector with which each cap becomes associated.
Lids 20 and 30 are seen separately in Figure 2, where lid 30 is seen to have an insertable or tongue section 50. Section 50 has an elongated part 60, which ends in an externally disposed threaded segment 70. The threaded segment 70 it comprises threads, generally numbered 72, which are sized and shaped to be inserted and threaded into the cap 20.
The cap 20, which is best seen in Figure 3, has a closed hollow interior 80, which opens outwardly at a proximal end 90, to expose an internally disposed thread segment 100. The threads 102 are one size and pitch to fit in addition to the threads 72 for a screwdriver or airtight fitting with the lid 30.
As illustrated in Figure 4, the lid 20 has an inner surface 104, an opening edge 106 and an outer surface 108, the opening edge 106 being a common connection between the inner surface 104 and an outer surface 108. In addition, the threads 102 also have a size and pitch to fit a screw segment 110 of a female connector, such as, for example, female Luer connector 112. Such connectors are generally commonly used as catheters and other fluid-tight protective connectors in medical applications. As seen in Figure 4, cover 20 provides a protective cover for connector 112, when boxed around connector 112 (moved in the direction of arrow 114), where the screw segment 110 fits and is pulled into a secure connection, but releasable with the threads 102 of the cap 20.
Also, as seen in Figure 5, the threads 72 of the lid 30 are one size and fit into the threads 122 of a male Luer-closure connector 120. The male connectors, of which the connector 120 is just a single example, they are also commonly used to protect fluid connections in the medical art. Note that the lid 30 has a medially arranged and elongated hole 124, into which a Luer 126, shaped into a frustoconical cone of connector 120, can be easily and safely inserted when the lid 30 is moved in the direction of arrow 128, to fit connector 120.
The lid 30 also has a surface 130 that continues through a circular edge 132. Furthermore, distally displaced from the circular edge 132, the surface 130 ends abruptly at a circular ring shaped edge 134, which is thereafter joined to a surface external 136. It can be seen that the opening edge 106 (see Figure 5) and the ring shaped edge 134 combine to form a common interface 40 (see Figure 1), when the lid 20 is affixed to the lid 30, to build the unit 10. It should also be noted that the surfaces of the unit 10, which contact the internal surfaces of a connector, such as connector 112 or connector 120, must be sufficiently sterile to not contaminate its internal surfaces.
For this reason, the internal parts and associated edges of the caps 20 and 30 must be pre-sterilized and thus maintained until use. Lids 20 and 30 can be injection molded using polypropylene or other material that can be sterilized and that is impermeable to contaminants, while lid 20 is fully nestled with lid 30, before being opened for use. Lids 20 and 30 can also be impregnated or coated with an antimicrobial substance. As an example, each cap 20 and cap 30 can be individually sterilized by ethylene oxide (ETO) before final assembly and aseptically paired, or unit 10 can finally be consolidated as a single unit and then sterilized, such as by radiation (p eg range). Even so, unit 10 must be kept intact until used, with the internal surfaces of nested parts 20 and 30 remaining clean and sterile until unit 10 is opened for use.
Reference is now made to Figures 6 to 7B, in which a seal, such as an “O” ring, is disposed between surfaces 106 and 134, to provide yet another barrier against contamination of the inner surface of covers 20 and 30. As seen in Figure 6, an “O” ring 140 is arranged between surfaces 106 and 134, to provide a seal in this way. While the “O” ring 140 can be moved from the covers 20 and 30, as shown in Figure 7, we anticipate that the “O” ring 140 can be adapted to remain attached to one of the covers 20 and 30. For example, as illustrated in Figure 7A, the “O” ring 140 can remain positioned adjacent to the surface 134 on the cover 30, when the covers 20 and 30 are disconnected from each other, instead of being separated when the cover 30 is displaced from the cover 20, as seen in Figure
7.
Alternatively, the “O” ring 140 can be associated with the cap 20, as seen in Figure 7B. In particular, the opening edge 106 of the lid 20 can have an annular groove 116, to receive the "O" ring 140 there. The annular groove 116 can be dimensioned and shaped so that the “O” ring 140 fits tightly on the lid 30 or on a medical connector, when the lid 20 is coupled there. We observe that the annular groove 116 can be disposed within the opening edge 106 towards the outside of the lid 20, as shown in Figure 7B, or the annular groove 116 can be disposed within the opening edge 106, towards the interior of the lid. 20. In some exemplary embodiments, the opening edge 106 or cap 20 has no annular groove 116. In such embodiments, the "O" ring 140 can be directly embedded in the opening edge 106. The “O” ring 140 can be fitted on or in the caps 20 or 30 in any suitable manner, including with the use of an adhesive, such as glue, mechanical fastener or a friction fitting.
As mentioned elsewhere here, a sealing mechanism, such as “O” ring 140, can be used to limit or prevent evaporation or loss of an antiseptic agent disposed within caps 20 and 30, when caps 20 and 30 are coupled each other. In addition, a sealing mechanism, such as "O" ring '140, can also limit or prevent evaporation or loss of an antiseptic agent disposed within caps 20 and 30, when caps 20 and 30 are coupled to separate medical connectors. In addition, a sealing mechanism, such as “O” ring 140, can also limit or prevent microbial ingress within caps 20 and 30, when coupled together, or within caps 20 and 30 when caps 20 and 30 are coupled separate medical connectors. In addition, a sealing mechanism, such as “O” ring 140, can be adapted to keep an antiseptic agent inside the caps 20 and 30, when the caps 20 and 30 are coupled together or to separate medical connectors for a predetermined time .
More security in sealing against contamination of the inner surface can be provided by a sealing tape, such as tape 150, seen in Figure 8A. Tape 150 is arranged to fully cover the exposed edges of surfaces 106 and 134. Tape 150 can, for example, be made of a flexible waterproof material, such as a metallized surface pillar. As seen in Figure 8B, tape 150 is wound around surfaces 106 and 134, to provide a secure seal. It is preferred that the tape 150 breaks evenly when the lid 20 is separated from the lid 30.
When plugging disconnected medical connectors, it is prudent to do more than just cover these connectors with covers. For this reason, an absorbent pad, such as pad 160, seen in Figure 9A, can be moved into the lid 20, as indicated by arrows 162 and 162 '. Pad 160 is seen disposed within the cap 20 in Figure 9B. An antiseptic 170 can also be disposed within the cap 20. Antiseptic 170 can be in liquid or solid form. For example, alcohol or other stable liquid antiseptic can be added as from a container 180 to the saturated pad 160 at a predetermined level. Note that once unit 10 is fully assembled, pad 160 will substantially remain at the predetermined saturated level, due to the external seals provided for unit 10, as described above. Alternatively or in addition, pad 160 may be impregnated with a dry antiseptic, such as chlorhexidine gluconate.
Note also that, once the lid 30 is firmly attached to the lid 20, as seen in Figure 9D, the pad 160 is arranged to contact at least the circular edge 132 (see also Figure 5) (In Figure 9D, parts cover 30, which are internal to the unit 10, are seen with invisible or dashed lines). Such contact provides a preferred scrubbing action to make contact with a surface before contacting an associated connector. Note also that the associated internal antiseptic or internal residual surfaces of the lid 30 can be transferred to related parts of the associated connector, for cleaning purposes.
Pad 160 may be formed of a resilient deformable material, so that when the lid 30 is attached to the lid 20, the elongated part 60 can compress the pillow 160 within the lid 20. In addition, the pillow 160 can expand to its original shape, when the lid 30 is removed from the lid 20. Similarly, the pad 160 can be compressed within the lid 20, when the lid 20 is coupled to a medical connector, such as a medical connector 112. Pad 160 may also be formed so that when a medical connector is coupled to cover 20, pad 160 is deformed so that it extends around the threads of the medical connector. For example, pad 160 can be formed so that when cap 20 is twisted over medical connector 112, pad 160 deforms around threads 110, thereby cleaning threads 110.
Similar to the pad 160 and antiseptic 170 disposed within the cap 20 and as described elsewhere here, the cap 30 may also have a pad and / or an antiseptic disposed therein. For example, a pad and / or antiseptic may be disposed within the elongated hole 124 of the lid 30 (Figure 5). Once unit 10 is fully assembled, a pad disposed within cover 30, which has been saturated with an antiseptic, will remain substantially at the predetermined saturation level, due to the external seals for unit 10, as described above. Once the covers 20 and 30 are disconnected from each other and connected to individual medical connectors, the pad and / or antiseptic disposed within the cover 30 can be transferred to related parts of the associated connector for cleaning purposes.
Under some conditions, it may be preferable to retain an antiseptic solution in a container before separating the nested lids. Reference is now made to Figures 10 - 11, in which a unit 10 'is seen to comprise a first lid 30', a second lid 20 'and a container containing antiseptic 200.
As seen in Figure 10, geometric aspects of the lid 20 'are similar to aspects of the lid 20, except for a through hole 210 of an end 212, providing access into the lid 20'. Instead of an absorbent pad 160 (see Figure 9D), an absorbent pad 160 'is resident at an open end 218 of a hollow flexible tube 220. Tube 220 is closed at an opposite end 222. Also retained within tube 220 by 160 'cushion and closed end
222 there is a breakable capsule 230, which is filled with a predetermined amount of antiseptic solution.
Note that tube 220 is sized and shaped and made of a material to fill and be adhesive and sealingly affixed to cap 20 ', to provide a seal around hole 210. A commercially available fragile reservoir tube, such as ChlorPrep Sepp Applicator provided by Enturia, can be used for container 200.
As seen in Figure 11, tube 220 is moved into hole 210 to be adhesively attached to it. As a result, container 200 becomes an integral part of unit 10 '. Before separating the cap 30 'from the cap 20', the capsule 230 is manually crushed to cause the fluid 232 contained within it to be released into the voids of the parts of the unit 10 'through the pad 160'.
As mentioned for tube 230, it is common for a cap, such as cap 30 or 30 ', to be used to protect a male Luer connector. In such a case, a 30 ”cap, seen in Figure 12, is seen to contain a hollow, frustoconically shaped, inner connector surface, 258. For further cleaning of a male Luer connector inserted there, a second pad loaded with antiseptic is placed on its deepest point, for contact with the end of the male connector.
With reference to Figures 13 and 14, another exemplary embodiment of a pair of nestable 10 ”caps is illustrated having a female cap 20 and a male cap 30”, similar to the caps previously described here. Arranged between the covers 20 and 30 ”there can be a sealing mechanism 140, as described above. Additionally, one or both of the covers 20 and 30 ”may have a cleaning chamber 300 disposed within its end. The cleaning chamber 300 can be adapted to clean and disinfect a medical connector before connecting the medical connector to another medical connector or one of the covers 20 and 30 ”.
In the illustrated embodiment, the cleaning chamber 300 is disposed within the lid 30 ”, however, we have observed that the cleaning chamber 300 can be disposed within the lid end 20. The cleaning chamber 300 comprises a cavity 310 within the end with a 30 ”cover. Positioned inside cavity 310 is a liner 320. The liner 320 can be removably trapped within the cavity 310, so that the liner 320 can be safely held in position when using the cover 30 ”and / or cleaning chamber 300, and removed after use of the cleaning chamber 300. The liner 320 can also be adapted to be removed from the cavity 310 before using the cleaning chamber 300, so that the cleaning chamber 300 can be used individually from the covers 20 or 30 ”. The removability of the liner 320 allows the cleaning chamber 300 to be used to remove potentially hazardous material, such as blood, body fluids and the like, from a medical connector and then discard the contents of the cleaning chamber 300, so that the hazardous material do not remain close to the medical connector when the cover is attached to it.
Pad 330 is disposed within the liner 320. Similar to pad 160 described above, pad 330 may be formed of a deformable material, capable of deformation, so that pad 330 extends around the opening and threads of a connector doctor. Pad 330 may also be formed of an abrasive material, which can completely break up hardened materials that have accumulated in a medical connector. In addition, pad 330 may be formed of a material that can be impregnated or saturated with an antiseptic agent, such as alcohol or chlorhexidine gluconate.
Cleaning chamber 300 may also include a removable cover 340 to include liner 320, pad 330 and any antiseptic agent within cavity 310. As illustrated in Figure 14, cover 340 can be attached to cover 30 ”in any manner that sealably keep the contents of cavity 310 there and allow prompt removal of cover 340 when cleaning chamber 300 is to be used. The cover 340 can be formed of any suitable material, such as foil, plastic and the like. In addition, cover 340 may also include a flap 342, which facilitates quick and convenient removal of cover 340, when cleaning chamber 300 is to be used.
The covers described here can be formed of or coated with various colored materials or coatings. In an exemplary embodiment, caps 20 and 30 comprise a single color. Alternatively, each of the caps 20 and 30 may have a separate color. Colored caps 20 and 30 can provide several advantages, such as prompt identification of the cap type, prompt matching of a particularly colored cap with a particular type of medical connector and the like.
The inventions described here can be embodied in other specific forms, without deviating from their spirit or essential characteristics. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive. The scope of the invention is therefore indicated by the appended claims, rather than by the preceding description. All changes that fall within the meaning and equivalence range of the claims are therefore intended to be covered within its scope.
Contents4
11 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6 Sheet 7 Sheet 8 Sheet 9 Sheet 10 Sheet 11
73 members in 9 offices
Priority claims7
| Document | Office | Kind | Date |
|---|---|---|---|
| 60880541 | United States of America | – | |
| 88054107 | United States of America | P | |
| 2008051087 | United States of America | W | |
| 2008051087 | – | – | – |
| 60880541 | – | – | – |
| US20070880541P | – | – | – |
| WO2008US51087 | – | – | – |
Members73
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| CA2675708A1 | Canada | A1 | |
| US2008177250A1 | United States of America | A1 | |
| WO2008089196A2 | World Intellectual Property Organization (WIPO) | A2 | |
| WO2008089196A3 | World Intellectual Property Organization (WIPO) | A3 | |
| US2009008393A1 | United States of America | A1 | |
| US2009062766A1 | United States of America | A1 | |
| MX2009007591A | Mexico | A | |
| EP2125074A2 | European Patent Office (EPO) | A2 | |
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| US2010047123A1 | United States of America | A1 | |
| US2010049170A1 | United States of America | A1 | |
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| US2011044850A1 | United States of America | A1 | |
| CA2778635A1 | Canada | A1 | |
| CA2995411A1 | Canada | A1 | |
| WO2011053924A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO2011066565A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO2011066586A1 | World Intellectual Property Organization (WIPO) | A1 | |
| US2011213341A1 | United States of America | A1 | |
| US2011217212A1 | United States of America | A1 | |
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| US2012039765A1 | United States of America | A1 | |
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| US2016310720A1 | United States of America | A1 | |
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| EP2493528A4 | European Patent Office (EPO) | A4 | |
| US9809355B2 | United States of America | B2 | |
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| US10213589B2 | United States of America | B2 | |
| US10493261B2 | United States of America | B2 | |
| EP2493528B1 | European Patent Office (EPO) | B1 | |
| CA2995411C | Canada | C |
2 legal events, as the office reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | |
|---|---|---|
| Lapse as no evidence of payment of the annual fee has been furnished to inpi (acc. art. 87)LapsedB08K | B08K | |
| Application fees: dismissal - article 86 of industrial property lawB08F | B08F |
Numbers
- Publication
- PI0806801
- Publication, DOCDB
- PI0806801
- Publication, EPODOC
- BRPI0806801
- Application
- 6801
- Application, DOCDB
- PI0806801
- Application, EPODOC
- BR2008PI06801
Titles2
- Portuguese
- par de tampas aninháveis, e, método para proteger as extremidades separadas dos conectores médicos
- English
- PAIR OF NESTABLE COVERS, AND, METHOD TO PROTECT THE SEPARATE END OF MEDICAL CONNECTORS
Classification
- CPC, 2
- A61M39/20
- A61M39/165
- IPC, 1
- A61M5 14