Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/20—Closure caps or plugs for connectors or open ends of tubes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/10—Tube connectors; Tube couplings
  • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/10—Tube connectors; Tube couplings
  • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
  • A61M39/162—Tube connectors; Tube couplings having provision for disinfection or sterilisation with antiseptic agent incorporated within the connector
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
  • A61L2/16—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using chemical substances
  • A61L2/18—Liquid substances
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
  • A61L2103/15—Laboratory, medical or dentistry appliances, e.g. catheters or sharps
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
  • A61L2202/10—Apparatus features
  • A61L2202/15—Biocide distribution means, e.g. nozzles, pumps, manifolds, fans, baffles, sprayers

Definitions

• the present disclosure relates generally to caps for medical connectors and, in particular, to a medical cap configured to be attached to male connectors for sealing, cleaning, and disinfecting portions of the male connectors, including luer connections.
• VAD standards of practice usually recommend flush procedures be performed after catheter placement, before fluid infusion, and before and after drug administration, blood sampling, transfusions, and/or administration of parenteral nutrition.
• Disinfection caps are disposable cap devices that contain an amount of cleaning or disinfecting solution for sterilizing portions of the port, hub, and valve. Accordingly, disinfecting caps can be both a barrier preventing microbes, particles, and debris from contacting portions of hubs, ports, or VADs that should remain sterile and disinfecting or cleaning devices configured to expose portions of the hubs, ports, and VADs to cleaning and disinfecting solutions.
• the cap also includes an outer absorbent support disposed in the housing defining a recess and a socket disposed in the recess of the outer absorbent support configured to engage the male connector for retaining the male connector within the housing.
• the cap also includes an inner absorbent support disposed in the socket configured to contain a cleaning solution for cleaning and/or disinfecting portions of the male connector engaged to the cap.
• the male connector includes a male luer connector.
• the male luer connector includes a luer stem defining a central lumen and a shield extending about the stem.
• the shield of the male luer connector includes threads on an inner surface of the shield configured to engage corresponding threads of a female luer connector for securing the male connector to the female luer connector.
• the luer stem of the male connector is inserted into the socket and an outer surface of the shield is in contact with an inner surface of the outer absorbent support.
• the housing includes a rigid thermoplastic polymer having at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.
• the housing includes a plurality of ridges or ribs extending outwardly from an outer surface of the housing (for making the housing easier to grip).
• an inner surface of the sidewall of the housing includes an inwardly sloping tapered portion, and wherein an outer surface of the outer absorbent support comprises an angled portion matching the tapered portion of the sidewall.
• the housing includes a first part, which includes the open first end of the housing, formed from a flexible material, and a second part, which includes the closed second end of the housing, formed from a rigid material.
• the first material includes a thermoplastic elastomer having at least one of silicone, polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene) and the second material comprises a rigid thermoplastic polymer, having at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.
• the outer absorbent support is axially compressible.
• the recess defined by the outer absorbent support includes a first portion having a first diameter corresponding to an outer diameter of an annular shield of the male connector and a second portion axially aligned with the first portion having a second diameter corresponding to an outer diameter of the socket.
• the first diameter is larger than the second diameter.
• the outer absorbent support includes an annular member that is axially compressible and encloses a central cylindrical recess.
• the outer absorbent support includes a thermoplastic elastomer having at least one of silicone, polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene).
• the socket includes an open first end, a second end, and a sidewall extending between the first end and the second end.
• the socket further includes a thread extending radially outward from the sidewall of the socket, the thread configured to engage threads on an inner surface of a shield of the male connector.
• the engagement between the thread of the socket and the threads of the shield of the male connector rotatably secure the male connector within the housing.
• the sidewall of the socket includes at least one opening for permitting the cleaning solution to pass through the socket to the outer absorbent support.
• the at least one opening includes a slot extending axially from the open first end of the socket.
• the second end of the socket is adhered to the second end of the housing, thereby securing the socket within the housing.
• the open first end of the socket is entirely enclosed in the housing.
• the socket includes a rigid thermoplastic polymer, having at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.
• the socket is formed from a same rigid thermoplastic polymer as the housing.
• the inner absorbent support includes a thermoplastic elastomer comprising at least one of silicone, polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene).
• the inner absorbent support includes a sponge.
• the inner absorbent support includes an open cell foam, such as a porous foam comprising a thermoplastic elastomer.
• the cleaning solution is absorbed by the inner absorbent support.
• the cleaning solution includes Isopropyl Alcohol (IPA).
• IPA Isopropyl Alcohol
• the cleaning solution includes from about 0.5% to about 3.5% chlorhexidine gluconate and about 70% IPA.
• a seal is disposed in the socket over the inner absorbent support configured to seal an open end of the male connector, thereby preventing the cleaning solution from entering a lumen of the male connector.
• the seal includes a non- porous foam, such as a closed cell foam.
• a layer of the cleaning solution is disposed over a top surface of the seal.
• the protective cover is attached to the housing by heat sealing.
• a method for attaching the previously described cap to the male connector includes a step of inserting a distal end of a stem of the male connector through the open first end of the housing causing the distal end of the stem to contact a seal disposed in the socket over the inner absorbent support.
• the method also includes a step of rotating the male connector relative to the housing causing the stem of the male connector to advance through the socket axially compressing the inner absorbent support.
• the method includes inserting a distal end of a stem of the male connector through the open first end of the housing causing the distal end of the stem to contact a seal disposed in the socket over the inner absorbent support; and rotating the male connector relative to the housing causing the stem of the male connector to advance through the socket axially compressing the inner absorbent support.
• the method includes continuing to rotate the male connector relative to the housing causing a shield of the male connector to press against and compress the outer annular support.
• the method includes advancing the stem of the male connector through the socket causes the cleaning solution to be expelled from the inner absorbent support and to move through the socket contacting an outer surface of the stem of the male connector.
• contact between the distal end of the stem and the seal seals a distal opening of the stem preventing the cleaning solution from passing into a lumen of the male connector.
• a manufacturing method for the previously described cap includes steps of inserting the inner absorbent support into the socket and inserting the socket and inner absorbent support inserted therein into the recess of the outer absorbent support. The method also includes a step of forming the housing about an outer surface of the outer absorbent support by over-molding.
• the method further includes inserting the inner absorbent support into the socket and inserting the socket and inner absorbent support inserted therein into the recess of the outer absorbent support; and forming the housing about an outer surface of the outer absorbent support by over-molding.
• the method includes forming the housing by forming a bottom part of the housing from a rigid thermoplastic polymer and forming a top part of the housing from a thermoplastic elastomer.
• the housing also includes a protrusion extending from the second end of the housing into the first recess and also having a front open end and a sidewall, which can be essentially cylindrical, extending between the front open end of the protrusion and the second end of the housing and having an inner and an outer surface defining a second cylindrical recess or cavity that is of a smaller diameter than the first recess defined by the housing.
• the protrusion is configured to engage the male connector for retaining the male connector within the housing, for example by the use of threads or luer lugs extending outward from the outer surface of the sidewall of the protrusion adjacent the front open end of the protrusion.
• the housing further includes a center post extending from the center of the second end of the housing into the second recess defined by the protrusion. The center post is configured to prevent ingress of disinfectant into the lumen of the male connector during disinfection process.
• the cap also includes an outer absorbent support that is cylindrical in shape and that defines a central cylindrical opening that is configured to be inserted into the first recess of the housing between the inner surface of the housing sidewall and the outer surface of the protrusion sidewall.
• the outer absorbent support is configured to clean and/or disinfect portions of the male connector such as the shield of a male luer connector.
• the cap also includes a cylindrical inner absorbent support that is cylindrical in shape and that defines a central cylindrical opening that is configured to be inserted into the second recess of the protrusion between the inner surface of the protrusion sidewall and the outer surface of the center post.
• the inner absorbent support is configured to contain cleaning solution for cleaning and/or disinfecting portions of the male connector engaged to the cap, including the distal end or tip of a stem of the male connector.
• a method for attaching the previously described cap to the male connector includes a step of inserting a distal end of a stem of the male connector through the open first end of the housing into the first recess formed by the housing and the second recess formed by the protrusion causing the distal end of the stem to contact a seal disposed in the protrusion and the inner absorbent support and causing the distal end of the annular shield of the male connector to contact the outer absorbent support.
• the method also includes a step of rotating the male connector relative to the housing causing the stem of the male connector to advance through the second recess axially compressing the inner absorbent support and the annular shield of the male connector to axially compress the outer absorbent support.
• a cap is configured to engage a male connector, the cap including a housing comprising an open first end, a closed second end, and a sidewall extending between the first end and the second end; a protrusion extending from the closed second end of the housing towards the open first end of the housing configured to engage the male connector for retaining the male connector within the housing and defining a first recess between the sidewall of the housing and the protrusion; a center post extending from the closed second end of the housing towards the open first end of the housing configured to engage the male connector and defining a second recess between the protrusion and the center post; an outer absorbent support disposed in the first recess configured to contain a cleaning solution for cleaning and disinfecting portions of the male connector engaged to the cap; and an inner absorbent support disposed in the second recess configured to contain a cleaning solution for cleaning and disinfecting portions of the male connector engaged to the cap.
• the male connector includes a luer stem including a tip and defining a central lumen and an annular shield extending about the stem, wherein the shield of the male luer connector comprises threads on an inner surface of the shield configured to engage corresponding threads of a female luer connector for securing the male connector to the female luer connector, and wherein the protrusion comprises an outer surface and threads on the outer surface of the protrusion configured to engage the threads on the inner surface of the shield of the male connector thereby releaseably securing the male connector to the cap.
• the luer stem of the male connector is inserted into the second recess and in contact with the inner absorbent support, the center post is inserted into the central lumen of the male connector, and the annular shield of the male connector is in contact with the outer absorbent support.
• the protrusion further includes a thread extending radially outward from the sidewall of the protrusion, the thread configured to engage threads on an inner surface of a shield of the male connector.
• the sidewall of the protrusion includes at least one opening for permitting the cleaning solution to pass from the inner absorbent support through the protrusion to the outer absorbent support.
• insertion of the male connector into the second recess formed between the protrusion and the center post causes the inner absorbent support to axially compress farther into the second recess, and wherein the axial compression of the inner absorbent support expels the cleaning solution from the inner absorbent support causing the cleaning solution to move through the second recess contacting an outer surface of a stem of the male connector inserted in the second recess including the tip of the stem of the male connector.
• the central post is configured to seal an open end of the male connector, thereby preventing the cleaning solution from entering a lumen of the male connector, and wherein the center post is positioned to permit the cleaning solution expelled from the inner absorbent member to move past the center post towards the open first end of the housing and wet the outer surfaces of the male connector when the inner absorbent member is axially compressed.
• the housing, protrusion and shield includes a rigid thermoplastic polymer including at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.
• the cap further includes a cleaning solution absorbed by the inner absorbent support, wherein the cleaning solution includes Isopropyl Alcohol (IPA).
• IPA Isopropyl Alcohol
• a method for attaching the cap to the male connector comprises inserting a distal end of a stem of the male connector through the open first end of the housing and into the second recess formed between the protrusion and the center post causing the distal end of the stem to contact the inner absorbent support and the center post to enter the central lumen in the stem of the male connector; and rotating the male connector relative to the housing causing the stem of the male connector to advance through the second recess axially compressing the inner absorbent support causing cleaning solution to be released into the second recess and thereby wetting, cleaning and disinfecting the distal end of a stem of the male connector outside of the central lumen.
• a manufacturing method for a cap including forming the housing, protrusion and center post; inserting the inner absorbent support into the first recess between the sidewall of the housing and the protrusion; inserting the inner absorbent into the second recess between the protrusion and the center post; and affixing a protective cover to seal the open first end of the housing.
• a cap is configured to engage a male connector including a central lumen and an annular shield, the cap including: a housing including an open first end, a second end, and a sidewall extending between the first end and the second end, and a protrusion including an open first end and a sidewall extending from the second end of the housing towards the open first end generally parallel to the sidewall of the housing configured to engage the male connector for retaining the male connector within the housing, and a center post extending from the center of the second end of the housing towards the center of the open first end of the housing configured to be inserted into and block the central lumen of male connector; an outer absorbent support disposed in the housing between the sidewall of the housing and the sidewall of the protrusion configured to contain a cleaning solution for cleaning and disinfecting portions of the male connector engaged to the cap including the annular shield of the male connector; and an inner absorbent support disposed between the protrusion and the center post configured to contain a cleaning solution for cleaning and
• the shield of the male connector is disposed in a recess defined by the sidewall of the housing and the sidewall of the protrusion such that the shield contacts and axially compresses the outer absorbent support thereby releasing cleaning solution from the outer absorbent support that wets and thereby cleans and disinfects the shield of the male connector;
• the threads on the inner surface of the shield engage a thread extending from the sidewall of the protrusion thereby releaseably connecting the male connector to the cap;
• the luer stem of the male connector is disposed in a recess defined by the sidewall of the protrusion and the center post such that the luer stem contacts and axially compresses the inner absorbent support thereby releasing cleaning solution from the inner absorbent support that wets and thereby cleans and disinfects the outside of the luer stem of the male connector including the tip of the luer stem; and the center post is disposed within the central lumen of
• the cleaning solution includes or comprises common disinfectants known in the field such as Isopropyl Alcohol (IPA), Chlorhexidine Gluconate (CHG), chlorhexidine, povidone-iodine, and octenidine and any combination of them.
• IPA Isopropyl Alcohol
• CHG Chlorhexidine Gluconate
• chlorhexidine chlorhexidine
• povidone-iodine chlorhexidine
• octenidine any combination of them.
• a method for attaching the cap to the male connector includes inserting a distal end of a stem of the male connector through the open first end of the housing and the open end of the protrusion causing the distal end of the stem to contact the inner absorbent support and the distal end of the shield to contact the outer absorbent support; and rotating the male connector relative to the housing causing the stem of the male connector to advance through the recess formed by the protrusion and axially compressing the inner absorbent support.
• FIG. 4C is a cross-sectional view of the cap of FIG. 2A with the male connector fully inserted into the cap.
• FIG. 6A is a perspective view of another example of a disinfecting cap for a male connector, according to an aspect of the disclosure.
• FIG. 6B is a cross-sectional view of the cap of FIG. 6A.
• FIG. 7A is a cross sectional view of the cap of FIG. 6A and a male connector, prior to inserting the male connector into the cap.
• FIG. 8A is a front view showing another example of a disinfecting cap for male connectors, prior to inserting the male connector into the cap.
• FIG. 8B is a cross-sectional view of the cap of FIG. 8A with the male connector fully inserted into the cap.
• FIG. 9A is a perspective view of a distal end of a male connector showing a seal of a disinfecting cap covering an open end of a lumen of the male connector, according to an aspect of the present disclosure.
• FIG. 10B is a perspective view of another exemplary seal that can be used with a disinfecting cap for a male connector, according to an aspect of the present disclosure.
• FIG. 11 A is a perspective view of a disinfecting cap for a male connector, according to an aspect of the present disclosure.
• FIG. 1 IB is a cross-sectional view of the cap of FIG. 11 A.
• FIG. 1 ID is an exploded view of the cap of FIG. 11 A without a protective cover.
• FIG. 12 is a perspective view of a cap of FIG. 11A without a protective cover, according to an aspect of the present disclosure.
• FIG. 13B is a cross-sectional view of the cap of FIG. 11A with the male connector fully inserted into the cap.
• FIG. 15 is a cross-sectional view of the cap of FIG. 11A with the male connector fully inserted into the cap.
• a proximal portion can refer to the portion of the catheter that remains outside of a patient’s body and is manipulated by a user.
• the distal portion of the catheter can be the portion that is inserted into the vasculature of the patient.
• the proximal end can be the end that is connected to another object or part.
• the distal end of the elongated member is opposite the proximal end and can be free from connections to other objects or parts.
• the invention may assume alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
• the present disclosure is directed to a disinfecting cap 10 configured to be connected to a male connector 110, such as a male connector of an access hub, port, or valve for a VAD, to prevent the connector, port, or VAD from being contaminated by, for example, microbes, debris, or other contaminants.
• the disinfecting cap 10 can be a male disinfecting cap for disinfecting ISO594-2 type of female threaded fluid luer connectors.
• the cap 10 can be configured to clean or disinfect portions of the connector 110 or port, ensuring that the connector 110 or port remains sterile prior to use.
• the cap 10 can be configured to remain in place on a connector 110 or port for at least seven days, which is a maximum time of recommended use permitted by many medical facility sterile practice guidelines.
• the cap 10 is a disinfecting cap for male connectors configured to engage with or be connected to different sizes, configurations, and/or types of male connectors 110.
• a “male connector” refers to a connector 110 comprising an elongated member, such as a tubular member or stem 114, configured to be inserted in a tube or opening having an inner diameter that is larger than an outermost diameter of the male connector 110.
• An exemplary male connector 110 is shown in FIG. 1A.
• the male connector 110 is configured to be connected to a hub, port, or another portion of a VAD comprising a female connector.
• the “female connector” refers to a connector 112 comprising an opening or port 116 that is configured to receive an elongated member or tubular member of another object or device in order to connect the object or device to the female connector 112.
• the female connector 112 can comprise an elongated distal end portion 108 with a cover or septum 118 over the opening 116.
• An exemplary female connector 112 including a septum 118 with a slit 120 is shown in FIG. IB.
• the female connector 112 can also include vertical ribs 132 near a proximal end of the female connector 112, which can be used to manipulate the female connector 112 making it easier to twist the female connector 112 relative to another connector or device.
• FIGS. 2A-4C illustrate portions of an exemplary disinfecting cap 10 configured to engage and/or to be connected to male connectors 110 with different shapes, sizes, dimensions, or configurations.
• FIG. 2A is a perspective view of the cap 10 prior to use with a protective cover adhered over an open top or first end of the cap 10.
• FIG. 2B is a cross-sectional view of the cap 10 after the protective cover is removed.
• FIG. 2C is an exploded view of the cap 10.
• FIG. 3A is a perspective view of a housing of the cap 10 showing an open top or first end of the housing.
• FIG. 3B is a cross-sectional view of the housing 12.
• FIGS. 4A-4C are cross-sectional views showing the male connector 110 being inserted into the disinfecting cap 10.
• the cap 10 can be provided as a single pre-packaged cap or cap assembly, such as the packaged cap shown in FIG. 2A. Further, as described in detail herein, the cap 10 includes components, such as sponges, abrasive surfaces, and/or cleaning or disinfecting solutions, for cleaning, scrubbing, and disinfecting portions of the male connectors 110 inserted into and mounted to the cap 10.
• components such as sponges, abrasive surfaces, and/or cleaning or disinfecting solutions, for cleaning, scrubbing, and disinfecting portions of the male connectors 110 inserted into and mounted to the cap 10.
• the cap 10 comprises a housing 12 comprising an open first end or top 14, a second or bottom 16, and a sidewall 18 extending between the top 14 and the bottom 16.
• the cap 10 further comprises an outer absorbent support 20 disposed in the housing 12.
• the outer absorbent support 20 can be a tubular member defining a central recess 22 or cavity sized to receive portions of the male connector 110.
• the cap 10 also comprises a socket 24 disposed in the recess 22 of the outer absorbent support 20 configured to engage the male connector 110 for retaining the male connector 110 within the housing 12.
• the stem 114 of the male connector 110 can be inserted into the socket 24 and threads 124 on the inner surface 126 of the shield 122 can engage corresponding threaded structures of the socket 24 for securing the male connector 110 to the socket 24.
• the cap 10 also includes cleaning parts, such as sponges, brushes, or porous members, disposed in the socket 24, for cleaning distal portions of the male connector 110.
• the cap 10 can comprise an inner absorbent support 26 disposed in the socket 24 configured to contain a cleaning solution for cleaning and/or disinfecting portions of the male connector 110 engaged to the cap 10.
• the outer absorbent support 20, inner absorbent support 26, and other parts of the cap 10 of the present disclosure are configured to cause the cleaning solution to contact multiple areas of the male connector 110 ensuring that the multiple areas of the male connector 110 remain sterile and free from microbes, contaminants, particles, and other debris.
• the cap 10 is configured to ensure that cleaning solution contacts not only a distal end or tip of the stem 114 of the male connector 110, but also outer surfaces of the stem 114, as well as inner and outer surfaces of the annular shield 122.
• the cleaning solution should contact both roots and crests of the threads 124 on the inner surface 126 of the shield 122 to ensure that the threads 124 remain clean, sterile, and ready for use.
• the housing 12 is a molded part formed by injection molding or other common molding processes.
• the housing 12 can also be formed by an over-molding method in which the housing 12 is molded about the outer surface of the outer absorbent support 20 after the other components of the cap 10 (e.g., the socket 24, inner absorbent support 26, and outer absorbent support 20) are assembled together.
• the housing 12 can be formed from a rigid thermoplastic polymer material, such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.
• interior portions of the housing 12 can be shaped to retain the outer annular support within the housing 12.
• the sidewall 18 of the housing 12 can comprise an annular inwardly sloping tapered portion 28.
• an outer surface of the outer absorbent support 20 can include an angled portion 30 matching the tapered portion 28 of the sidewall 18.
• the interface or friction engagement between the tapered portion 28 of the sidewall 18 and angled portion 30 of the housing 12 can be configured to ensure that the outer absorbent support 20 remains seated in the housing 12. In particular the interface or friction engagement can ensure that the outer absorbent support 20 does not lift away from the housing 12 when the male connector 110 is inserted into or removed from the housing 12.
• the housing 12 further comprises protrusions, such as axially extending ribs or ridges 32, extending outward from an outer surface of the sidewall 18 of the housing 12.
• the axial ridges 32 can be provided to increase rigidity of the housing 12 compared to if ridges 32 were not present. Also, the ridges 32 can make the housing 12 easier to grasp and manipulate improving usability of the cap 10 and, for example, making it less likely that the practitioner will drop or mishandle the cap 10 during use.
• the cap 10 further comprises the outer absorbent support 20 disposed within the housing 12, which can also be referred to as an absorber, absorbent member, cushion, padding, or sponge.
• the outer absorbent support 20 is a flexible, deformable, or compressible structure configured to compress axially when the male connector 110 is inserted into the housing 12.
• the outer absorbent support 20 is configured to compress so that the annular shield 122 of the male connector 110 can be inserted farther into the housing 12 allowing threads 124 of the shield 122 to come into contact with an engage the socket 24.
• the outer absorbent support 20 can be an annular or tubular structure defining the recess 22 having an outer diameter that substantially matches (e.g., is the same as or within about 5% or less of) an inner diameter of the housing 12.
• the outer absorbent support 20 can have a top portion with an outer diameter OD1 (shown in FIG. 2B) matching an inner diameter ID1 (shown in FIG. 3B) of the housing 12 and a bottom portion having an outer diameter OD2 (shown in FIG. 2B) matching an inner diameter ID2 (shown in FIG. 3B) of the housing 12.
• the recess 22 can be an irregular shape, such as a recess or cavity formed from different sized connected cylindrical and/or elongated cavities.
• the recess 22 can include a first section 22a or portion having a diameter ID3 (shown in FIG. 2B) corresponding to an outer diameter of an annular shield 122 of the male connector 110 and a second section 22b or portion axially aligned with the first portion 22a having a diameter ID4 (shown in FIG. 2B) corresponding to an outer diameter of the socket 24.
• the diameter ID3 of the first section 22a can be wider than the diameter ID4 of the second section 22b.
• the outer absorbent support 20 can be formed from a flexible and/or compressible material that deforms and presses against portions of the male connector 110 as the male connector 110 is inserted into the housing 12.
• the outer absorbent support 20 can be configured to axially compress as the male connector 110 is inserted to the housing 12.
• the outer absorbent support 20 can be configured to deform or bulge radially inwardly pressing against surfaces of the male connector 110.
• the outer absorbent support 20 can press against a distal end of the annular shield 122 and against an outer surface of the annular shield 122 to seal portions of the male connector 110, which prevents contamination of inner spaces enclosed by the annular shield 122.
• the outer absorbent support 20 comprises a thermoplastic elastomer, such as polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene).
• the outer absorbent support 20 can also comprise a porous foam (e.g., an open cell foam) or sponge capable of absorbing the cleaning or disinfecting solution, such as a foam or sponge comprising polyurethane.
• the foam material can be a Plastazote® foam, which is an engineered polymer foam by Zotefoams PCL.
• the cap 10 further comprises the socket 24, which engages the male connector 110, thereby securing the male connector 110 within the housing 12.
• the socket 24 can be a tubular member secured or adhered to the housing 12 comprising an open first end or top 34, a second end or bottom 36, and a sidewall 38 extending between the top 34 and the bottom 36.
• the socket 34 can include a closed bottom 36 having an outer surface that is adhered to an inner surface of the bottom 16 of the housing 12.
• the socket 34 can be entirely enclosed within the housing 12 meaning, for example, that the open top 34 of the socket 24 is recessed relative to the open top 14 of the housing 12 by a distance DI (shown in FIG. 2B).
• the socket 24 generally is formed from or comprises a rigid thermoplastic polymer material, such as the same material used to form the housing 12.
• the socket 24 can be formed from a rigid polymer material, such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.
• the socket 24 further comprises a thread 40 extending radially outward from the sidewall 38 of the socket 24.
• the thread 40 can be configured to engage threads 124 on an inner surface 126 of the annular shield 122 of the male connector 110 for securing the male connector 110 to the socket 24. Accordingly, the male connector 110 can be securely retained within the housing 12 by the threaded engagement preventing the cap 10 from being mistakenly removed from the male connector 110 at unexpected or inappropriate times.
• the socket 24 further comprises one or more openings in the sidewall of the socket 24 for permitting liquid, such as cleaning solution, to pass from an interior of the socket 24 to the outer absorbent support 20 surrounding the socket 24. For example, as shown in FIGS.
• the opening can be a slot 42 extending axially from the open top 34 of the socket 24.
• the socket 24 can include opposing slots 42 on opposite sides of the socket 24 for providing cleaning solution to different areas or regions of the outer absorbent support 20.
• the openings can be holes (e.g., square, rectangular, circular, or elliptical holes), slits, perforations, or any other openings extending through the sidewall 38 of the socket 24 for permitting the cleaning solution to pass from the interior of the socket 24 to the outer absorbent support 20.
• the cap 10 further comprises the inner absorbent support 26 disposed within the socket 24.
• the inner absorbent support 26 contains the cleaning solution for cleaning and/or disinfecting portions of the male connector 110 engaged to the cap 10.
• the inner absorbent support 26 can be disposed and held within a cylindrical interior space or cavity defined by the socket 24.
• the inner absorbent support 26 can be held in place within the socket 24 by a conventional adhesive or mechanical fastener.
• the inner absorbent support 26 can be held in place in the socket 24 by friction between an inner surface of the socket 24 and an outer surface of the inner absorbent support 26.
• the inner absorbent support 26 can be formed from the same material as the outer absorbent support 20, specifically from a material that is capable of absorbing the cleaning solution and expelling the cleaning solution from the inner absorbent support 26 when compressed.
• the inner absorbent support 26 can be formed from a thermoplastic elastomer, such as polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene).
• the inner absorbent support 26 can also comprise a porous foam (e.g., an open cell foam) or sponge capable of absorbing the cleaning or disinfecting solution, such as a foam or sponge comprising polyurethane.
• the foam material can be a Plastazote® foam, which is an engineered polymer foam by Zotefoams PCL.
• the inner absorbent support 26 can be provided (i.e., presoaked) with the cleaning or disinfecting solution.
• the cleaning or disinfecting solution can be an antimicrobial, anti-fungal, antibacterial, or antiviral solution that cleans and sterilizes surfaces of the male connector 110.
• the cleaning solution can be isopropyl alcohol (IPA), such as about 70% IPA.
• IPA isopropyl alcohol
• the cleaning solution can be about 0.5% to about 3.5% chlorhexidine gluconate in combination with about 70% IPA.
• a chlorohexidine composition may be beneficial because it has a slower evaporation rate than IPA and, therefore, provides a more persistent disinfectant activity after the cap 10 is removed from the male connector 110 and before the VAD is connected to the hub, port, or valve.
• the inner absorbent support 26 can be configured to axially compress as the stem 114 of the male connector 110 is inserted into and moves through the interior of the socket 24. Axial compression of the inner absorbent support 26 expels the cleaning solution from the inner absorbent support 26. The expelled cleaning solution moves through the interior of the socket 24 towards the open top 34 of the socket 24 contacting an outer surface of the stem 114 of the male connector 110 inserted into the socket 24. Once expelled from the inner absorbent support 26, the cleaning solution can also pass through openings, such as the slots 42, of the socket 24. After passing through the slots 42, the cleaning solution comes into contact with other parts of the male connector 110, such as the threads 124, inner surface 126, and/or outer surface of the annular shield 122. The cleaning solution can also be absorbed by the outer absorbent support 20, such that cleaning solution remains in proximity to surfaces of the annular shield 122 for cleaning and disinfecting these surfaces.
• the cap 10 further comprises a seal 44 positioned in the socket 24 over the inner absorbent support 26 (e.g., positioned between a top of the inner absorbent support 26 and the top 34 of the socket 24).
• the seal 44 can prevent fluids, such as cleaning or disinfecting solution absorbed by the inner absorbent support 26, from flowing into the lumen enclosed by the stem 114 of the male luer connector 110.
• the seal 44 can be formed from a thermoplastic elastomer comprising, for example, an elastomeric closed cell foam.
• the seal 44 can comprise an abrasive material that is capable of scrubbing or mechanically removing objects, such as microbes, dirt, particles, and other debris, from a distal surface of the stem 114, while, at the same time, limiting ingress of the cleaning solution into the lumen of the stem 114.
• the seal 44 includes a layer 46 of the cleaning solution over a top surface of the seal 44.
• the layer 46 of cleaning solution can be provided to clean and disinfect the distal end of the stem 114 of the male connector 110, contributing to the cleaning and disinfecting functionality provided by the cap 10.
• the seal 44 is sized and positioned so that cleaning solution expelled from the inner absorbent member 26 can move past the seal 44 towards the top 34 of the socket 24 and/or the top 14 of the housing 12. As previously discussed, as the cleaning solution moves through the interior of the socket 24, the cleaning solution contacts the outer surface of the stem 114 for cleaning and disinfecting the outer surface.
• an outer diameter of the seal 44 can be smaller than either an inner diameter of the socket 24 or an outer diameter of the inner annular support 26 so that the seal 44 does not prevent the cleaning solution from moving towards the top 34 of the socket 24 and coming into contact with the outer surface of the stem 114.
• the seal 44 can include holes, cut-away portions, grooves, slits, slots, and/or other openings for permitting the cleaning solution to move through the seal 44 towards the top 34 of the stem 24.
• the cap 10 can further comprise a removable and/or disposable protective cover 48 positioned over the open top 14 of the housing 12.
• the protective cover 48 can be provided to protect components and portions of the cap 10, such as the housing 12, outer absorbent support 20, socket 24, inner absorbent support 26, and seal 44, during transport and storage, as well as to prevent contamination and to prevent the cleaning or disinfecting solution from evaporating prior to use.
• the protective cover 48 can comprise a sheet, such as a polymer film, with adhesive on a first side of the sheet for removably mounting the protective cover 48 to the open top 14 of the housing 12.
• the protective cover 48 can be removably mounted to the open top 14 of the housing 12 by heat sealing.
• the protective cover 42 can be formed from a material that is impervious or substantially impervious to air, so that the layer 46 of cleaning solution on the top surface of the seal 44 and/or cleaning solution absorbed by the inner absorbent support 26 does not evaporate or dryout prior to use of the cap 10. Accordingly, the protective cover 48 can increase a shelf life of the cap 10, as well as prevent microbes and other debris from collecting in the cap 10 prior to use.
• the cap 310 differs from previous examples in that the housing 312 is formed from multiple parts.
• the housing 312 comprises a first part 350, which comprises the open top 314 of the housing 312.
• the first part 350 can be a tubular member comprising an open top, an open bottom, and a sidewall extending between the top and the bottom.
• the first part 350 of the housing 312 is formed from a flexible material, such as a thermoplastic elastomer, such as silicone, polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene).
• the first part 350 can be formed from a flexible material having a shore hardness A value less than or equal to 130 (Shore A).
• the flexible first part 350 of the housing 310 can be capable of stretching, bending, or otherwise deforming so that the cap 310 can engage different sizes and shapes of male connectors 110.
• both parts 350, 352 of the housing 312 can be formed by overmolding of other components of the cap 310.
• the second part 352 can be formed by over-molding of the rigid thermoplastic polymer about a bottom portion of the outer absorbent support 352 and socket 324.
• the first part 350 can be formed about the top portion of the outer absorbent support 320 by an over-molding method, which adheres the first part 350 to the outer absorbent support 320 and to the previously molded second part 352.
• FIGS. 8A and 8B show another example of a cap 410 that includes features of the present disclosure.
• FIG. 8A is a front view showing the male connector 110 and the cap 410, prior to insertion of the male connector 110 into the cap 410.
• FIG. 4B is a cross- sectional view showing the male connector 110 fully inserted into the cap 410.
• the cap 410 comprises the housing 412 comprising the open first end or top 414, the closed second end or bottom 416, and the sidewall 418 extending between the top 414 and the bottom 416.
• the cap 410 also includes the outer absorbent support 420 disposed in the housing 412 defining the central cavity or recess and the socket 424 disposed in the recess.
• the knob 454 can be T-shaped including a vertical leg and a horizontal part attached to the leg.
• the knob 454 can be configured to be grasped by the practitioner to facilitating manipulating the cap 10 to connect the cap 410 to and to disconnect the cap 410 from the male connector 110.
• the practitioner can grasp the knob 454 to rotate the cap 410 about the male connector 110.
• the practitioner can grasp the knob 454 to pull the cap 410 away from the male connector 110, thereby removing the cap 410 from the male connector 110.
• the caps 10, 310, 410 disclosed herein can include the seals 44, 344, 444 positioned between the inner absorbent support 26, 326, 426 and the open top 34 of the socket 24, 324, 424. Further, as previously described, the seal 44, 344, 444 can be positioned so that the cleaning solution can move upwards through the socket 24, 324, 424 in order to contact and wet the outer surface of the stem 114. In some examples, an outer diameter of the seal 44, 344, 444 can be smaller than an inner diameter of the socket 24, 324, 444 to allow the cleaning solution to move past the seal 44, 344, 444.
• the openings 556 may be the same size and shape or may be different sizes and shapes. Further, the openings 556 could be irregularly spaced about the periphery of the seal 544 in order to provide more cleaning solution to some portions of the male connector 110 and less cleaning solution to other portions of the male connector 110.
• seals 544 are not intended to be limiting of the present disclose and other configures for the seals 544 may be determined by those skilled in the art including various combinations of the holes or openings 556, lobes 558, and/or cut-outs 560 shown in FIGS. 9A-10B, as well various other shapes for openings or cut away portions for permitting the cleaning solution to move past the seal 544.
• Male disinfection cap
• FIGS. 11A-13B and 15 illustrate portions of an exemplary disinfecting cap 1010 configured to engage and/or to be connected to male connectors 110 with different shapes, sizes, dimensions, or configurations.
• FIG. 2A is a perspective view of the cap 1010 prior to use with a protective cover adhered over an open top or first end of the cap 1010.
• FIG. 1 IB is a cross-sectional view of the cap 1010 with the protective cover in place.
• FIG. 11C is a perspective cross-sectional view of the cap 1010 with the protective cover in place.
• FIG. 11D is an exploded view of the cap 1010 without the protective cover.
• FIG. 12 is a perspective view of a housing of the cap 1010 with the protective cover removed showing an open top or first end of the housing.
• FIG. 13A is a cross-sectional view of the cap 1010 and a male connector 110 before it is inserted into the cap 1010.
• FIG. 13B is a cross-sectional view showing the male connector 110 fully inserted into the disinfecting cap 1010.
• FIG. 15 is a close-up cross-sectional view showing the male connector 110 fully inserted into the disinfecting cap 1010.
• the cap 1010 can be provided as a single pre-packaged cap or cap assembly, such as the packaged cap shown in FIG. 11 A. Further, as described in detail herein, the cap 1010 includes components, such as sponges, and/or cleaning or disinfecting solutions, for cleaning, scrubbing, and disinfecting portions of the male connectors 110 inserted into and mounted to the cap 1010.
• the cap 1010 comprises a housing 1012 comprising an open first end or top 1014, a second end or bottom 1016, and a sidewall 1018 extending between the top 1014 and the bottom 1016 forming a first recess 1019.
• the housing 1012 further comprises a protrusion 1024 disposed in the first recess 1019 of the housing 1012 comprising an open first end 1021 and a sidewall 1017 extending between the open first end 1021 and the bottom 1016 forming a second recess 1015.
• the protrusion 1024 is connected, molded or attached to the second end or bottom 1016 of the housing 1012 and is configured to engage the male connector 110 for retaining the male connector 110 within the housing 1012.
• the housing 1012 also comprises a center post 1011 extending from the center of the second end or bottom 1016 of the housing 1012 into the center of the second recess 1015 formed defined by the protrusion 1024.
• the cap 1010 further comprises an outer absorbent support 1020 disposed in the first recess 1019 of the housing 1012.
• the outer absorbent support 1020 can be a tubular member defining a central recess 1022 or cavity sized to receive portions of the male connector 110.
• the cap 1010 further comprises an inner absorbent support 1026 disposed in the second recess 1015 defined by the protrusion 1024 of the housing 1012.
• the cap 1010 also includes cleaning parts, such as sponges, brushes, or porous members, disposed in the first recess 1019 defined by the housing and the second recess 1015 defined by the protrusion 1024, for cleaning distal portions of the male connector 110.
• the cap 1010 can comprise an inner absorbent support 1026 disposed in the second recess 1015 defined by the protrusion 1024 and an outer absorbent support 1020 disposed in the first recess 1019 defined by the housing 1012.
• the outer absorbent support 1020 may comprise a tubular structure with an open first end 1201, an open second end 1202, and a sidewall 1203 connecting said first end and said second end defining an opening 1205 along the central axis of the outer absorbent support 1020 as best shown in FIG. 1 ID.
• the outer absorbent support 1020 may comprise a recess 1206 proximate the open first end 1201 that is of a greater diameter than the opening 1205 and that creates an annular inner surface 1207 within the opening 1205 of the outer absorbent support 1020.
• the recess 1206 and the annular inner surface 1207 can be configured to accommodate or surround a thread or luer lug 1013 on the protrusion 1024 as shown FIGS. 11C and 13A for example.
• the inner absorbent support 1026 and the outer absorbent support 1020 are configured to contain a cleaning solution for cleaning and/or disinfecting portions of the male connector 110 engaged to the cap 1010 including the tip of the stem of the male connector.
• the outer absorbent support 1020, inner absorbent support 1026, and other parts of the cap 1010 of the present disclosure are configured to cause the cleaning solution to contact multiple areas of the male connector 110 ensuring that the multiple areas of the male connector 110 remain sterile and free from microbes, contaminants, particles, and other debris.
• the cap 1010 is configured to ensure that cleaning solution contacts not only a distal end or tip of the stem 114 of the male connector 110, but also outer surfaces of the stem 114, as well as inner and outer surfaces of the annular shield 122.
• the cleaning solution should contact both roots and crests of the threads 124 on the inner surface 126 of the shield 122 to ensure that the threads 124 remain clean, sterile, and ready for use.
• the housing 1012 is a molded part formed by injection molding or other common molding processes.
• the housing 1012 can be formed from a rigid thermoplastic polymer material, such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.
• the housing 1012 can be formed from a durable material, such as a material having a shore hardness D value of less than or equal to 95 (Shore D).
• the housing 1012 can be formed from a more flexible material, such as a material having a shore hardness A value less than or equal to 130 (Shore A).
• a flexible housing 1012 or housing 1012 including flexible portions can be capable of stretching, bending, or otherwise deforming so that the cap 1010 is capable of engaging male connectors 110 of different sizes and shapes.
• interior portions of the housing 1012 can be shaped to retain the outer absorbent support 1020 which can be annular in shape within the housing 1012 as shown in FIGS. 1 IB- 11C.
• the interface or friction engagement between the sidewall 1018 of the housing 1012, the sidewall 1017 of the protrusion 1024, and the outer absorbent support 1020 can be configured to ensure that the outer absorbent support 1020 remains seated in the first recess 1019 of housing 1012.
• the interface or friction engagement between the sidewall 1017 of the protrusion 1024, the center post 1011, and the inner absorbent support 1026 can be configured to ensure that the inner absorbent support 1026 remains seated in the second recess 1015 defined by the protrusion 1024 in the housing 1012.
• the interface or friction engagement can ensure that the outer absorbent support 20 does not lift away from the housing 1012 when the male connector 110 is inserted into or removed from the housing 1012.
• the housing 1012 further comprises protrusions, such as axially extending ribs or ridges 1032, extending outward from an outer surface of the sidewall 1018 of the housing 1012.
• the axial ridges 1032 can be provided to increase rigidity of the housing 1012 compared to if ridges 1032 were not present.
• the ridges 1032 can make the housing 1012 easier to grasp and manipulate improving usability of the cap 1010 and, for example, making it less likely that the practitioner will drop or mishandle the cap 1010 during use.
• the cap 1010 further comprises the outer absorbent support 1020 disposed within the first recess 1019 of the housing 1012, which can also be referred to as an absorber, absorbent member, cushion, padding, or sponge.
• the outer absorbent support 1020 is a flexible, deformable, or compressible structure configured to compress axially when the male connector 110 is inserted into the housing 1012.
• the outer absorbent support 1020 is configured to compress so that the annular shield 122 of the male connector 110 can be inserted farther into the housing 1012 allowing threads 124 of the shield 122 to come into contact with an engage the luer lugs 1013 of the protrusion 1024.
• the outer absorbent support 1020 can be an annular or tubular structure defining the first recess 1019 having an outer diameter that substantially matches (e.g., is the same as or within about 5% or less of) an inner diameter of the sidewall 1018 of the housing 1012.
• the recess 1019 can be an irregular shape, such as a recess or cavity formed from different sized connected cylindrical and/or elongated cavities.
• the outer absorbent support 1020 can be formed from a flexible and/or compressible material that deforms and presses against portions of the male connector 110 as the male connector 110 is inserted into the housing 1012.
• the outer absorbent support 1020 can be configured to axially compress as the male connector 110 is inserted to the housing 1012.
• the outer absorbent support 1020 can be configured to deform or bulge radially inwardly pressing against surfaces of the male connector 110.
• the outer absorbent support 1020 can press against a distal end of the annular shield 122 and against an outer surface of the annular shield 122 to seal portions of the male connector 110, which prevents contamination of inner spaces enclosed by the annular shield 122.
• the outer absorbent support 1020 can be configured to press against the outer surface of the annular shield 112 pushing into any gaps, slots, cut-away portions, channels, cavities, grooves, recessed areas, or any other spaces on the outer surface of the annular shield 122, which eliminates any spaces where contaminants, such as microbes, dirt, particles, or other debris, may collect. Accordingly, the deformable outer absorbent support 1020 contributes to forming a tight and secure connection between surfaces of the male connector 110 and interior component of the cap 1010, thereby contributing to the cleaning, disinfecting, and contamination avoiding features of the male connector 110.
• the outer absorbent support 1020 comprises a thermoplastic elastomer, such as polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene).
• the outer absorbent support 1020 can also comprise a porous foam (e.g., an open cell foam) or sponge capable of absorbing the cleaning or disinfecting solution, such as a foam or sponge comprising polyurethane.
• the foam material can be a Plastazote® foam, which is an engineered polymer foam by Zotefoams PCL.
• the cap 1010 further comprises the protrusion 1024, which engages the male connector 110, thereby securing the male connector 110 within the housing 12.
• the protrusion 1024 can be a tubular member secured or adhered to the bottom 1016 housing 1012 comprising an open first end or top 1021 and a sidewall 1017 extending between the top 1021 and the bottom 1016.
• the protrusion 1024 can be shaped as an open annular cylinder closed at the bottom by the inner surface of the bottom 1016 of the housing 1012.
• the protrusion 1024 can be entirely enclosed within the housing 1012 meaning, for example, that the open top 1021 of the protrusion 1024 is recessed relative to the open top 1014 of the housing 1012 as shown in FIGS. 11C-1 IB.
• the protrusion 1024 generally and the center post 1011 are formed from or comprise a rigid thermoplastic polymer material, such as the same material used to form the remainder of the housing 1012.
• the protrusion 1024 and center post 1011 can be formed from a rigid polymer material, such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.
• the protrusion 1024 further comprises a thread or luer lug 1013 extending radially outward from the sidewall 1017 of the protrusion 1024.
• the thread 1013 can be configured to engage threads 124 on an inner surface 126 of the annular shield 122 of the male connector 110 for securing the male connector 110 to the protrusion 1024. Accordingly, the male connector 110 can be securely retained within the housing 1012 by the threaded engagement preventing the cap 1010 from being mistakenly removed from the male connector 110 at unexpected or inappropriate times.
• the protrusion 1024 further comprises one or more openings in the sidewall 1017 of the protrusion 1024 for permitting liquid, such as cleaning solution, to pass from an interior second recess 1015 defined by the protrusion 1024 and the inner absorbent support 1026 to the outer absorbent support 1020 surrounding the protrusion 1024.
• the opening can be a slot 1042 extending axially from the open top 1021 of the protrusion 1024.
• the protrusion 1024 can include opposing slots 1042 in the sidewall 1017 of the protrusion 1024 on opposite sides of the protrusion 1024 for providing cleaning solution to different areas or regions of the outer absorbent support 1020.
• the openings can be holes (e.g., square, rectangular, circular, or elliptical holes), slits, perforations, or any other openings extending through the sidewall 1017 of the protrusion 1024 for permitting the cleaning solution to pass from the interior second recess 1015 formed by the protrusion 1024 to the outer absorbent support 1020.
• the cap 1010 further comprises the inner absorbent support 1026 disposed within second recess 1015 formed by the protrusion 1024.
• the inner absorbent support 1026 contains the cleaning solution for cleaning and/or disinfecting portions of the male connector 110 engaged to the cap 1010.
• the inner absorbent support 1026 can be disposed and held within a cylindrical interior recess or cavity 1015 defined by the protrusion 1024 and the center post 1011.
• the inner absorbent support 1026 can be held in place within the second recess 1015 formed by the protrusion 1024 and the center post 1011 by a conventional adhesive or mechanical fastener.
• the inner absorbent support 1026 can be formed from the same material as the outer absorbent support 1020, specifically from a material that is capable of absorbing the cleaning solution and expelling the cleaning solution from the inner absorbent support 1026 when compressed.
• the inner absorbent support 1026 can be formed from a thermoplastic elastomer, such as polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene).
• the inner absorbent support 1026 can also include a porous foam (e.g., an open cell foam) or sponge capable of absorbing the cleaning or disinfecting solution, such as a foam or sponge comprising polyurethane.
• the foam material can be a Plastazote® foam, which is an engineered polymer foam by Zotefoams PCL.
• the inner absorbent support 1026 can be provided (i.e., presoaked) with the cleaning or disinfecting solution.
• the cleaning or disinfecting solution can be an antimicrobial, anti-fungal, antibacterial, or antiviral solution that cleans and sterilizes surfaces of the male connector 110.
• the cleaning solution can be comprised of isopropyl alcohol (IPA).
• the cleaning solution comes into contact with other parts of the male connector 110, such as the threads 124, inner surface 126, and/or outer surface of the annular shield 122.
• the cleaning solution can also be absorbed by the outer absorbent support 1020, such that cleaning solution remains in proximity to surfaces of the annular shield 122 for cleaning and disinfecting these surfaces.
• the center post 1011 is sized and positioned so that cleaning solution expelled from the inner absorbent member 26 can move past the center post 1011 towards the open top 1021 of the protrusion 1024 and/or the top 1014 of the housing 1012. As previously discussed, as the cleaning solution moves through the interior second recess 1015 defined by the protrusion 1024, the cleaning solution contacts the outer surface of the stem 114 for cleaning and disinfecting the outer surface. In order for the cleaning solution to move past the center post 1011, the outer diameter of the center post 1011 can be smaller than an inner diameter of the protrusion 24 so that the center post 1011 does not prevent the cleaning solution from moving towards the top open end 1021 of the protrusion 1024 and coming into contact with the outer surface of the stem 114.
• the cap 1010 can further comprise a removable and/or disposable protective cover 1023 positioned over the open top 1014 of the housing 1012.
• the protective cover 1023 can be provided to protect components and portions of the cap 1010, such as the housing 1012, outer absorbent support 1020, protrusion 1024, inner absorbent support 1026, and center post 1011, during transport and storage, as well as to prevent contamination and to prevent the cleaning or disinfecting solution from evaporating prior to use.
• the protective cover 1023 can comprise a sheet, such as a polymer film, with adhesive on a first side of the sheet for removably mounting the protective cover 1023 to the open top 1014 of the housing 1012.
• the protective cover 1023 can be removably mounted to the open top 1014 of the housing 1012 by heat sealing.
• the protective cover 1023 can be formed from a material that is impervious or substantially impervious to air, so that the cleaning solution absorbed by the inner absorbent support 1026 and outer absorbent support 1020 does not evaporate or dry-out prior to use of the cap 1010. Accordingly, the protective cover 1023 can increase a shelf life of the cap 1010, as well as prevent microbes and other debris from collecting in the cap 1010 prior to use.
• the center post 1011 may prevent entry of IPA inside the lumen 128 of the male connector 110.
• the outer absorbent support or sponge 1020 disinfects the thread portion 124 external wall of the shield 122 of the male connector 110.
• the inner absorbent support or sponge 1026 disinfects the flat face or tip of the stem 114 of the male connector 110 outside of the lumen 128.
• the cap 1010 of the present disclosure is a disinfecting cap
• FIGS. 13A- 13B and FIG. 15 show the cap 1010 being connected to a male connector 110.
• FIG. 14 is a flow chart showing a method for connecting and/or disconnecting the disinfecting cap 1010 from the male connector 110.
• step 1210 in order to connect the cap 1010 to a male connector 110, the practitioner first removes any packaging from the cap 1010 and removes the protective cover 1023 from the open top 1014 of the housing 1012.
• the practitioner moves the connector 110 towards the open top 1014 of the housing 12 in a direction of arrow Al (shown in FIG. 13A).
• the stem 114 of the male connector 110 is inserted through the open top 1014 of the housing 1012 and through the open top 1021 of the protrusion 1024 causing the distal end of the stem 114 of the male connector 110 to contact the center post 1011 disposed within the second recess 1015 formed by the protrusion 1024, as shown in FIG. 13B.
• the center post 1011 can seal off the lumen 128 extending through the stem 114 preventing cleaning solution or other fluids from passing into the lumen 128 of the male connector 110.
• the center post 1011 extends into the lumen 128 through the distal end of the stem 114 thereby mechanically sealing off the lumen 128 from contact with the inner absorbent support 1026 and disinfectant and/or cleaning solution that the support may hold.
• Contact between the distal end of the stem 114 and the center post 1011 can also mechanically remove particles, such as microbes, dirt, and other debris, from the male connector 110.
• Moving the male connector 110 towards the cap 1010 also brings the annular shield 122 of the male connector 110 into contact with the protrusion 1024.
• the threads 124 of the shield 122 are brought into contact with the thread or luer lug 1013 on the outer surface of the protrusion 1024.
• step 1214 in order to move the male connector 110 farther into the housing 1012 of the cap 1010, the practitioner next rotates the male connector 110 relative to the cap 1010. Rotation of the male connector 110 relative to the housing 1012 and protrusion 1024 draws the male connector 110 farther into the cap 1010, as shown by arrow A2 in FIG. 13B, causing the distal end of the stem 114 to move through the interior of the open top 1013 and second recess 1015 formed by the protrusion 1024.
• the inner absorbent support 1026 axially compresses expelling the cleaning solution from the inner absorbent support 1026 into the interior second recess 1015 formed by the protrusion 1024.
• the cleaning solution moves from the inner absorbent support 1026 towards the open top 1021 of the protrusion 1024.
• the cleaning solution contacts the outer surface of the stem 114 cleaning and disinfecting the outer surface of the stem 114.
• the cleaning solution then passes through the slots 1042 in the sidewall 1017 of the protrusion 1024 and is absorbed by the outer absorbent support 1020.
• Rotation of the male connector 110 relative to the housing 1012 also causes the annular shield 122 to move into the top section of the first recess 1019 defined by the sidewall 1018 of the housing 1012.
• the shield 122 continues movement of the annular shield 122 into the housing 1012 causes the shield 122 to press against the outer absorbent support 1020, which compresses the outer absorbent support 1020.
• the outer absorbent support 1020 can also bulge radially inward pushing into gaps, slots, cut-away portions, channels, cavities, grooves, or any other spaces on the outer surface of the annular shield 122, which eliminates gaps or open spaces where contaminants, such as microbes, dirt, or other debris, may collect.
• the practitioner can pull the male connector 110 away from the housing 1012, thereby releasing the male connector 110 from the cap 1010.
• the practitioner can grasp the housing 1012 of the cap 1010 with one hand and the male connector 110 with the other hand. The practitioner then pulls the male connector 110 away from the cap 1010 to remove the male connector 110 from the cap 1010. Once removed, the cap 1010 can be discarded, as it is often a disposable single-use product.
• the male connector 110 can be connected to a VAD.
• the male connector 110 can be attached or inserted into a female hub, port, or valve of the VAD forming a needleless fluid- tight connection between the male connector 110 and a fluid path, channel, or lumen 128 of the VAD.

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Biomedical Technology (AREA)
• Pulmonology (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
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• Epidemiology (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Apparatus For Disinfection Or Sterilisation (AREA)

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• 2023
  • 2023-11-27 EP EP23898634.3A patent/EP4626537A2/de active Pending
  • 2023-11-27 CN CN202380081614.4A patent/CN120265332A/zh active Pending
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