Universal cap with pressure seal

Abstract

A universal cap with a pressure seal for connecting a medical connector includes a housing, a protrusion, a disinfecting sponge, and a pressure seal. The projection includes an internal thread on the inner surface sufficient to interlock with a mating feature of the female medical connector. An inner surface of the protrusion defines a second cavity. The protrusion includes an external thread on the outer surface sufficient to interlock with a mating feature of the male medical connector. And the disinfection sponge is arranged on the second cavity. A pressure seal is attached to the housing and disposed adjacent a surface of the disinfecting sponge. The pressure seal may include a flexible insert attached to an inner surface of the top wall of the housing. The pressure seal may include a combination of an elongate member and an insert slidably engaged with the elongate member.

Description

[0001] This application is a divisional application of the Chinese patent application with international application number PCT / US2020 / 044951, Chinese application number 202080056175.8, application date August 5, 2020, and name “Universal cap with pressure seal”. Technical Field

[0002] The present disclosure generally relates to a device for sterilizing and disinfecting access ports, such as male and female Luer connectors, and in particular, to a sterilizing and disinfecting device capable of accommodating multiple types of connectors. In general, embodiments herein relate to the field of threaded connectors, including medical caps and medical sterilization caps, particularly caps and / or sterilization caps used with fluid Luer connectors. Background Art

[0003] Vascular access devices (VADs) are commonly used therapeutic devices and include intravenous (IV) catheters. There are two general classifications of VADs: peripheral catheters and central venous catheters. When connected to a VAD to deliver fluids or medications, bacteria and other microorganisms may enter the patient's vascular system through the access interface and ports / valves. Each access interface (or port / valve or connection) is associated with the risk of transmitting catheter-related bloodstream infection (CRBSI), which can be costly and potentially fatal.

[0004] To reduce cases of CRBSI and ensure proper use and maintenance of VADs, standards of practice have been developed that include sterilization and cleaning procedures.

[0005] Sterile caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines, and early indications are that sterile caps will also be included in the 2016 Infusion Nurses Standards (INS) guidelines.

[0006] In developed markets, when an IV catheter is used, a needleless connector is typically used to close the system, which is then accessed to administer medications or other necessary fluids to the patient through the catheter. The INS Standard of Practice recommends the use of a needleless connector and states that it should be “continuously and thoroughly disinfected with alcohol, iodine, or a chlorhexidine gluconate / alcohol combination before each access.” Disinfection of needleless connectors is ultimately intended to help reduce bacteria that may live on surfaces and potentially cause a variety of catheter-related complications, including CRBSI. Nurses typically accomplish this disinfection task by performing a “swab-the-port” using a 70% isopropyl alcohol (IPA) pad. However, compliance with this practice is often very low. In addition to the lack of compliance with “swab-the-port,” clinician interviews noted that there was often variation in the time to scrub, the time to dry, and the number of times the needleless connector was swabbed.

[0007] Throughout the procedural sequence, there are numerous risks of exposure or contamination associated with the transmission of microorganisms that can cause CRBSI. Contamination can occur during medication mixing, cannula attachment, and insertion of access ports. Because the procedure to connect to a VAD is so common and simple, the risks associated with accessing the patient’s vascular system are often overlooked. Currently, the risk to the hospital and the patient is that clinicians are diligently performing the vital function of the connection, and this diligence is largely uncontrollable.

[0008] Currently, caps for male needleless connectors, female needleless connectors, intravenous (IV) tubing, and hemodialysis tubing use different designs and are therefore limited in the type of connector to which the cap can be attached. Currently, there are male disinfection cap devices for disinfecting ISO594-2 type female threaded fluid Luer connectors and female disinfection cap devices for disinfecting ISO594-2 type male threaded fluid Luer connectors. However, there is no single universal disinfection cap device that has features that allow it to be mated with any male or female threaded connector. Therefore, existing disinfection caps are designed to fit only one type of connector and are dedicated to a specific size and / or shape of connector. Therefore, there is a need for a disinfection device that can accommodate multiple types of connectors (including male and female connectors) to simplify the disinfection process.

[0009] In addition to providing a means for disinfection, the ingress of disinfectants must also be considered, as this can compromise patient safety. Based on toxicological criteria, the ingress of disinfectants should be reduced to non-toxic levels. Although needleless connectors have septa inside to form a closed system on their own, caps used with medical connectors (e.g., male connectors on IV tubing ends and open female Luer ports on catheters and stopcocks) need to be sterilized to minimize the ingress of disinfectants (e.g., isopropyl alcohol or chlorhexidine) into the central lumen of the connector. Summary of the invention

[0010] Aspects of the present disclosure relate to caps for use with medical connectors.

[0011] In one aspect, the cap includes: a shell, the shell including: a top wall; a basically cylindrical side wall forming a first cavity; and an open bottom formed by the cylindrical side wall, the open bottom having an opening leading to the first cavity in the shell for receiving an interface of a medical connector; and a protrusion extending from the shell and positioned in the first cavity, the protrusion having an inner surface and an outer surface, the inner surface of the protrusion defining a second cavity; an internal thread located on the inner surface of the protrusion, the internal thread being sufficient to interlock with a threaded joint of a female medical connector; and an external thread located on the outer surface of the protrusion, the external thread being sufficient to interlock with a threaded joint of a male medical connector; a sterile sponge constructed in the second cavity; and a pressure seal attached to the shell and disposed near the surface of the sterile sponge.

[0012] In one or more embodiments, when the cap is engaged with the medical connector, the disinfectant sponge contacts the edge of the inner cavity of the medical connector and the pressure seal blocks the inner cavity of the medical connector, thereby inhibiting the disinfectant from entering the inner cavity.

[0013] In one or more embodiments, the inner cavity of the medical connector is open to the cap, and a pressure seal enters the inner cavity to inhibit the sterilant from entering the inner cavity.

[0014] In one or more embodiments, when the medical connector includes a septum in the lumen, the pressure seal is positioned to avoid creating a fluid path through the septum.

[0015] In one or more embodiments, a disinfecting sponge includes: a slotted end; a substantially cylindrical sponge sidewall defining a hollow portion and an open end; and a sponge end wall.

[0016] In one or more embodiments, the slotted end of the disinfecting sponge includes slots extending into opposing portions of the sponge sidewalls.

[0017] In one or more embodiments, the grooves extend along opposing portions of the sidewall of the sponge to the open end.

[0018] In one or more embodiments, a pressure seal is disposed in the hollow portion of the disinfecting sponge.

[0019] In one or more embodiments, in an uncompressed state, the pressure seal is completely disposed within the hollow portion.

[0020] In one or more embodiments, the sponge end wall is in direct contact with the inner surface of the top wall.

[0021] In one or more embodiments, the pressure seal includes a slender member and an insert, wherein: the slender member extends from the inner surface of the top wall of the shell; the insert includes: a bottom wall and a basically cylindrical insert side wall, which forms a chamber, and the top edge of the insert side wall defines a hole; the insert is slidably engaged with the slender member.

[0022] In one or more embodiments, the inner surface of the top edge is slidably engaged with the slender member.

[0023] In one or more embodiments, the elongated member includes a shoulder section, a ramp section, and one or more sliding sections.

[0024] In one or more embodiments, the insert includes a plurality of prongs defined by portions of the insert sidewalls and top edge separated by slits.

[0025] In one or more embodiments, a face of the prong is slidably engaged with the elongated member.

[0026] In one or more embodiments, the outer geometry of the insert sidewall includes a tapered surface that effectively complements the inner surface of the lumen of the medical connector.

[0027] In one or more embodiments, the insert includes a polymer material selected from the group consisting of polyethylene, polypropylene, thermoplastic elastomer (TPE), or combinations thereof.

[0028] In one or more embodiments, the pressure seal includes a flexible insert attached to an inner surface of a top wall of the housing.

[0029] In one or more embodiments, the flexible insert comprises an elastomeric polymer material.

[0030] In one or more embodiments, the flexible insert includes a top wall, a bottom wall, and a substantially cylindrical and porous insert side wall extending between the top wall and the bottom wall.

[0031] In one or more embodiments, the top wall of the flexible insert further includes an extension that engages an upper lip of the protrusion.

[0032] In one or more embodiments, the flexible insert is breathable.

[0033] On the other hand, a cap is provided, which includes: a shell, the shell including: a top wall; a basically cylindrical side wall forming a first cavity; and an open bottom formed by the cylindrical side wall, the open bottom having an opening leading to the first cavity in the shell for accommodating an interface of a medical connector; a protrusion extending from the shell and positioned in the first cavity, the protrusion having: an inner surface and an outer surface, the inner surface of the protrusion defining a second cavity; an internal thread on the inner surface of the protrusion, the internal thread being sufficient to interlock with a matching feature of a medical connector including a female medical connector; and an external thread on the outer surface of the protrusion, the external thread being sufficient to interlock with a matching feature of a medical connector including a male medical connector; a sterile sea constructed in the second cavity. A sterile sponge comprising a slotted end; a substantially cylindrical sponge side wall defining a hollow portion and an open end; and a sponge end wall; a pressure seal disposed in the hollow portion of the sterile sponge, the pressure seal comprising: an elongated member extending from an inner surface of a top wall of the shell; and an insert comprising a bottom wall and a substantially cylindrical insert side wall, the insert side wall forming a chamber and a top edge of the insert side wall defining a hole; the insert being slidably engaged with the elongated member; wherein, when the cap is engaged with the medical connector, the sterile sponge contacts an inner cavity edge of the medical connector, and the insert of the pressure seal blocks the inner cavity of the medical connector, thereby inhibiting the disinfectant from entering the inner cavity.

[0034] In one or more embodiments, the inner surface of the top edge is slidably engaged with the slender member.

[0035] In one or more embodiments, the elongated member includes a shoulder section, a ramp section, and one or more sliding sections.

[0036] In one or more embodiments, the insert sidewall includes a plurality of prongs defined by portions of the insert sidewall and the top edge separated by the slits.

[0037] In one or more embodiments, a face of the prong is slidably engaged with the elongated member.

[0038] In one or more embodiments, the outer geometry of the insert sidewall includes a tapered surface that effectively complements the inner surface of the lumen of the medical connector.

[0039] In one or more embodiments, the insert includes a polymer material selected from the group consisting of polyethylene, polypropylene, thermoplastic elastomer (TPE), or combinations thereof.

[0040] On the other hand, a cap comprises: a shell, the shell comprising: a top wall; a substantially cylindrical side wall forming a first cavity; and an open bottom formed by the cylindrical side wall, the open bottom having an opening leading to the first cavity in the shell for accommodating an interface of a medical connector; a protrusion extending from the shell and positioned in the first cavity, the protrusion having: an inner surface and an outer surface, the inner surface of the protrusion defining a second cavity; an internal thread on the inner surface of the protrusion, the internal thread being sufficient to interlock with a mating feature of a medical connector including a female medical connector; and an external thread on the outer surface of the protrusion, the external thread being sufficient to interlock with a mating feature of a medical connector including a female medical connector; The invention relates to a medical connector comprising a cap and a second cavity, wherein the cap interlocks with the mating features of the medical connector; a sterile sponge constructed in the second cavity, the sterile sponge including a slotted end; a substantially cylindrical sponge side wall, the sponge side wall defining a hollow portion and an open end; and a sponge end wall; and a pressure seal, the pressure seal being disposed in the hollow portion of the sterile sponge, the pressure seal comprising: a flexible insert attached to the inner surface of the top wall of the shell; wherein, when the cap is engaged with the medical connector, the sterile sponge contacts the inner cavity edge of the medical connector and the pressure seal blocks the inner cavity of the medical connector, thereby inhibiting the sterilant from entering the inner cavity.

[0041] In one or more embodiments, the flexible insert comprises an elastomeric polymer material.

[0042] In one or more embodiments, the flexible insert includes a top wall, a bottom wall, and a substantially cylindrical and porous insert side wall extending between the top wall and the bottom wall.

[0043] In one or more embodiments, the top wall of the flexible insert further includes an extension that engages an upper lip of the protrusion.

[0044] In one or more embodiments, the flexible insert is breathable.

[0045] In one or more embodiments, the medical connector is selected from a male Luer connector, a female Luer connector, and a needle-free connector.

[0046] In one or more embodiments, the disinfecting sponge comprises a disinfectant, an antimicrobial agent, or a combination thereof.

[0047] In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

[0048] In one or more embodiments, the disinfectant or antimicrobial agent includes at least one of chlorhexidine gluconate and chlorhexidine diacetate.

[0049] In one or more embodiments, the protrusion is integrally formed with the housing.

[0050] In one or more embodiments, the protrusion is attached to an inner surface of the top wall of the housing.

[0051] In one or more embodiments, the protrusion is snap-fastened or adhered to the inner surface of the top wall of the housing.

[0052] In one or more embodiments, the projection includes an upper lip that engages an elongated ring extending from an inner surface of the top wall of the housing.

[0053] Another aspect is: a method for sterilizing a medical connector, the method comprising: connecting the cap of any of the foregoing embodiments to the medical connector by engaging the threads of the medical connector to the internal threads or external threads of the protrusion, so that the edge of the medical connector contacts the sterilizing sponge and the pressure seal prevents the sterilant from entering the inner cavity of the medical connector.

[0054] In one aspect, a medical assembly is provided, comprising the cap of any embodiment disclosed herein.

[0055] In one or more embodiments, the medical connector is a female medical connector having a male threaded connector, the female medical connector selected from the group consisting of: a needle-free connector, a stopcock, a female Luer connector, and a catheter connector.

[0056] In one or more embodiments, the medical connector is a male medical connector having a female threaded fitting, the male medical connector selected from the group consisting of: an intravenous tubing tip and a male Luer connector.

[0057] This Summary is provided to introduce selected concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

[0058] Additional features and advantages of the present disclosure will be set forth in the subsequent description, and in part will become apparent from the description, or may be learned through the practice of the present disclosure. The features and advantages of the present disclosure may be realized and obtained through the means and combinations specifically indicated in the appended claims. These and other features of the present disclosure will become more apparent through the following description and the appended claims, or may be learned through the practice of the present disclosure set forth below. BRIEF DESCRIPTION OF THE DRAWINGS

[0059] Figure 1 shows a perspective side view of an exemplary medical assembly according to one embodiment;

[0060] Figure 2 shows an exploded cross-sectional perspective top view of an exemplary cap according to one embodiment;

[0061] Figure 3 shows a cross-sectional perspective top view of a housing according to an exemplary embodiment;

[0062] Figure 4 Shows Figure 3 A partial cross-sectional view of a slender member.

[0063] Figure 5 shows a cross-sectional view of an insert according to one embodiment;

[0064] Figure 6 Shows Figure 5 A perspective top view of an insert;

[0065] Figure 7 shows a cross-sectional side view of an insert according to another embodiment;

[0066] Figure 8 shows a perspective top view of a disinfecting sponge according to one embodiment;

[0067] Fig. 9 Shows Figure 8 A cross-sectional perspective top view of a disinfectant sponge;

[0068] Fig.10 shows a cross-sectional perspective top view of a disinfecting sponge according to another embodiment;

[0069] Fig.11 Schematically shows the Figure 2 A cross-sectional perspective top view of a cap;

[0070] Fig.12 shows an exploded cross-sectional perspective top view of an exemplary cap according to one embodiment;

[0071] Fig.13 shows a perspective bottom view of a flexible insert according to one embodiment;

[0072] Fig.14 shows a partial perspective top view of a flexible insert according to another embodiment;

[0073] Fig.15 shows a partial perspective top view of a flexible insert according to another embodiment;

[0074] Fig.16 Schematically shows the Fig.12 A cross-sectional perspective top view of a cap;

[0075] Fig.17 An exemplary assembly according to one embodiment is shown showing a cap in a cross-sectional side view and a female medical connector in a partially schematic side view;

[0076] Fig.18 An exemplary assembly according to one embodiment is shown showing the cap in a cross-sectional side view and the male connector in a partial schematic view;

[0077] Fig.19 An exemplary assembly according to one embodiment is shown showing the cap in a cross-sectional perspective top view and the female connector in a partial side perspective view;

[0078] Fig. 20 An exemplary assembly according to one embodiment is shown showing the cap in a cross-sectional side view and the female medical connector in a partial side view;

[0079] Fig.21 An exemplary assembly according to one embodiment is shown showing the cap in a cross-sectional side view and the male connector in a partially schematic side view;

[0080] Fig. 22 An exemplary assembly according to one embodiment is shown showing a cap, and a female connector in a cross-sectional perspective top view;

[0081] Fig.23 schematically illustrates a cross-sectional side view of a cap according to one embodiment;

[0082] Fig.24 shows a perspective top view of a flexible insert according to one embodiment; and

[0083] Fig.25 Shown according to Fig.24 A perspective cross-sectional view of a flexible insert combined with a protrusion according to one embodiment. DETAILED DESCRIPTION

[0084] Embodiments of the present disclosure relate to a sterile universal cap with a pressure seal for connecting to and sterilizing a medical connector, the medical connector comprising a male connector and a female connector. The male connector and the female connector may be a male Luer connector and a female Luer connector. Embodiments of the cap include a housing, a protrusion, a sterile sponge, and a pressure seal. The cap includes a housing having a closed end and an open end. The side wall of the housing has a length extending from the closed end to the open end and defining a chamber. In one or more embodiments, the open end includes a peripheral flange extending radially outward from the open end, the peripheral flange defining an end face and an engagement surface. The protrusion has an inner surface having one or more threads to engage the male thread of a female medical connector (e.g., a female Luer connector). The outer surface of the protrusion has one or more threads to engage the female thread of a male medical connector (e.g., a male Luer connector). The sterile sponge is located in a cavity defined by the inner surface of the protrusion. The pressure seal is attached to the housing and arranged adjacent to the surface of the sterile sponge. In one embodiment, the pressure seal comprises a flexible insert attached to the inner surface of the top wall of the housing. In another embodiment, the pressure seal comprises a combination of an elongated member and an insert. The elongated member extends from the inner surface of the top wall of the housing and may be integrally formed with the housing; and the insert may be a slidable insert slidably engaged with the elongated member.

[0085] The universal sterilization caps with pressure seals disclosed herein are advantageous because the ingress of sterilants (e.g., isopropyl alcohol or chlorhexidine) into the central lumen of medical connectors is minimized by including a pressure seal. These caps can be used with medical connectors (e.g., male connectors on IV tubing ends and open female Luer ports on catheters and stopcocks).

[0086] In addition, the universal sterilization cap with pressure seal of the present invention has the advantage of being able to maintain pressure, which can mitigate and / or prevent fluid leakage, drug waste, hazardous drug spillage, and even patient blood loss when the clamp on the IV tube and / or the valve on the roller or stopcock is not fully closed, which may occur in certain circumstances, for example, due to non-compliance or accidents.

[0087] With respect to terms used in this disclosure, the following definitions are provided.

[0088] As used herein, the use of “a,” “an,” and “the” includes both the singular and the plural.

[0089] As used herein, the term "catheter-related bloodstream infection" or "CRBSI" refers to any infection caused by the presence of a catheter or IV line.

[0090] As used herein, the term "Luer connector" refers to a connecting ring that is a standard way to attach syringes, catheters, ported needles, IV tubing, etc. to each other. The Luer connector consists of male and female interlocking tubes and is slightly tapered so that even a simple press / twist fit can be better held together. The Luer connector can optionally include an additional threaded outer edge to make it more secure. The Luer connector male end is commonly associated with flush syringes and can be interlocked and connected to the female end located on a vascular access device (VAD). The Luer connector includes a distal end, a proximal end, an irregularly shaped outer wall, and a molded central channel for fluid communication from the chamber of the barrel of the syringe to the interface of the VAD. The Luer connector also has: a distal channel that releasably attaches the Luer connector to the interface of the VAD; and a proximal channel that releasably attaches the Luer connector to the barrel of the syringe.

[0091] As will be readily understood by those skilled in the relevant art, although descriptive terms such as "lock", "hole", "end", "interface", "thread", "sponge", "fork", "protrusion", "tab", "slope", "wall", "top", "side", "bottom", etc. are used throughout the specification to facilitate understanding, they are not intended to limit the various aspects of the embodiments that may be used to implement the present disclosure in combination or individually.

[0092] The matters illustrated in this description are provided to help fully understand the exemplary embodiments of the present disclosure. Therefore, those of ordinary skill in the art will recognize that various changes and modifications may be made to the embodiments described herein without departing from the scope and spirit of the present disclosure. In addition, for clarity and simplicity, descriptions of well-known functions and structures have been omitted.

[0093] Exemplary embodiments of the present disclosure provide caps that can reduce the number of device types and organizational effort currently required in hospital settings for connecting, capping and / or sterilizing male and female fluid Luer connections by approximately half by allowing them to be used with both male and female connectors by including them in a single cap or device feature.

[0094] In an exemplary embodiment of the present disclosure, the cap, connector cap, or sterilization cap includes an integrated thread or multiple threads, and other features in any and all combinations, allowing it to engage with both a male threaded connector and a female threaded connector. There is a male threaded connector on a female Luer connector. There is a female threaded connector on a male Luer connector. The threads may be sufficient to interlock with mating features (e.g., one or more protrusions, lugs, and / or threads) of the interface or end of the needleless connector, as described, for example, in related U.S. Patent Application Nos. 15 / 408,278 and 15 / 408,187, both filed on January 17, 2017.

[0095] According to yet another exemplary implementation of an embodiment of the present disclosure, both the male thread and the female thread coincide with each other on the inner surface and the outer surface of the threaded protrusion.

[0096] According to yet another exemplary implementation of an embodiment of the present disclosure, the female thread is sized and has a thread pattern to be engaged with a standard ISO594-2 type male connector, and / or the male thread is sized and has a thread pattern to be engaged with a standard ISO594-2 type female connector. An example of an ISO594-2 type connector is a Q-type connector.

[0097] According to other further exemplary implementations of embodiments of the present disclosure, the cap is compatible with an ISO 80369-7 connector.

[0098] In one or more embodiments, the female connector can be selected from the group consisting of a needleless connector, a catheter Luer connector, a stopcock, and a hemodialysis connector. In one or more embodiments, the needleless connector is selected from Q-Syte connector, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, InVision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClave Clear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, etc.

[0099] In one or more embodiments, the male connector can be an intravenous tubing tip, a stopcock, or a male lock Luer.

[0100] The cap of this article can be sterilized by integrating the disinfection sponge in the cavity of the cap when used for the Luer connector. The cap can be designed to be compatible to interact with various disinfectants. In one or more embodiments, the disinfectant of the disinfection sponge may include a variant of alcohol or chlorhexidine. In one or more embodiments, the disinfectant is selected from a group consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylhydroxyanisole (BHA), butylhydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics and a mixture thereof. In a specific embodiment, the disinfectant includes at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant is a fluid or a gel.

[0101] In use, when connected to a female Luer connector or a male Luer connector, pressing the disinfectant sponge against the top wall of the cap body allows the connector to contact the disinfectant to disinfect the female Luer connector or the male Luer connector.

[0102] Before describing several exemplary embodiments of the present disclosure, it should be understood that the present disclosure is not limited to the details of construction or process steps set forth in the following description. The present disclosure is capable of other embodiments and can be practiced or carried out in various ways.

[0103] Referring now to the drawings, wherein like reference numerals designate identical or corresponding parts throughout the several views, embodiments of the present disclosure are described as follows.

[0104] Turning to the attached figure, Figure 1 is a perspective side view of an exemplary medical assembly 20 according to one embodiment, wherein a cap 5 according to any embodiment disclosed herein is attached to a medical connector 10, which is attached to, for example, a tube 15. The caps herein are suitable for attachment to male and / or female medical connectors. The male and / or female connectors are in turn used to connect to medical devices, such as catheters and tubes.

[0105] exist Figure 2, provides an exploded cross-sectional perspective top view along the longitudinal axis "a" of an exemplary cap according to one embodiment. The cap 100 includes a housing 102, a protrusion 114, an elongated member 130, an insert 150, and a disinfecting sponge 200. In this embodiment, the pressure seal is a combination of the elongated member 130 and the insert 150, the insert 150 including a top edge 151 and a bottom wall 152, and a side wall 154 of the insert 150 spanning between the top edge 151 and the bottom wall 152. The top edge 151 of the insert 150 includes an inner surface 158. The insert 150 engages with the elongated member 130 along the inner side surface 158 of the top surface 151. In one or more embodiments, the insert 150 is snap-fitted onto the elongated member 130. When assembled, the insert 150 is located in the hollow portion 206 defined by the disinfecting sponge 200.

[0106] exist Figure 31, the housing 102 includes a top wall 104, a side wall 106, a protrusion 114, and an elongated member 130. The side wall 106 is substantially cylindrical. The side wall 106 defines a first cavity 112 and an open bottom 108, which defines an opening 110. The elongated member 130 extends from a first end 138 attached to the inner surface of the top wall 104 of the housing 102 to a second end 140. The protrusion 114 is located within the first cavity 112 and may be substantially cylindrical and coaxial with the side wall 106. The opening 110 is disposed at the open bottom 108 of the housing 102. The inner surface of the top wall 104 may form the top of the cavity 112. In one embodiment, the protrusion 114 is integrally formed with the housing 102. In another embodiment, the protrusion 114 is attached to the top wall 104 of the housing 102 by, for example, a snap-fit ​​attachment. The second cavity 120 of the housing 102 is defined by the inner surface 116 of the protrusion 114. The inner surface 116 includes an internal thread 122. The protrusion 114 also has an outer surface 118 including an external thread 124. In one or more embodiments, the internal thread 122 has a size and pitch to engage a threaded connector of a female connector (e.g., a female Luer connector). Such connectors are commonly used as catheters and other fluid-tight protective connectors in medical applications. The internal thread 122 is sufficient to interlock with the mating features of the female needleless connector, such as interlocking with a threaded connector having a male thread. The external thread 124 is sufficient to interlock with the mating features of the male needleless connector, such as interlocking with a threaded connector having a female thread. In one or more embodiments, the protrusion 114 may include one or more cantilever forks separated by one or more corresponding gaps. In one or more embodiments, at least one of the forks may be configured to be curved to facilitate an interference fit between the mating features of the protrusion and the male or female needleless connector. In one or more embodiments, the protrusion 114 can extend substantially from the inner surface of the top wall 104 toward the open bottom 108 of the housing 102. In one or more embodiments, the protrusion 114 can extend substantially parallel to the sidewall 106 of the housing.

[0107] exist Figure 4 , a partial cross-sectional view of the elongated member 130 shows an upper sliding section 136a that extends continuously from a first end 138 (not shown) into an inwardly tapered inclined section 134. The inclined section 134 terminates to merge with the shoulder section 132 of the elongated member 130. At the second end 140 of the elongated member 130 is a lower sliding section 136b. The insert is slidably engaged with the elongated member 130.

[0108] Figure 5 A cross-sectional view of an insert 150 according to one embodiment is provided. Figure 6A perspective top view of an insert 150 according to one embodiment is provided. The insert 150, which may be referred to as a slidable insert, includes a generally cylindrical body having a closed bottom wall 152 and an open top edge 151 with a side wall 154 spanning between the bottom wall 152 and the top edge 151. The top edge 151 radially depends from the insert side wall 154, thereby defining a hole 160. The side wall 154 defines a chamber 156 within the insert. A plurality of slits 164 exist radially about the top edge 151, which define a plurality of prongs 162 about the top edge 151 of the insert 150. The faces 158 of the prongs 162 are chamfered from the top edge 151 of the insert 150. The prongs 162 have bottom ends defined by the locations 166a, 166b, 166c, 166d where each slit ends. The slots 164 provide flexibility to each prong 162 so that when a force is applied along the central axis (e.g., Figure 2 "a"), for example, when a needleless connector or IV tubing end is attached to the cap, allowing the insert 150 to be moved along the elongated member (e.g., Figure 2 -3 item 130) slides. The insert can be made of plastic, or thermoplastic elastomer (TPE), or a blend of plastic (e.g., polypropylene (PP) or polyethylene (PE)) and TPE material. The insert is suitable for use in universal sterilization caps, such as universal sterilization caps used on both needleless connectors and stopcocks.

[0109] The pressure seal including the elongated member and the insert can also be included in non-male and female universal caps, including but not limited to female sterile caps, such as BD PureHub™. The pressure seal will allow the female sterile cap to be used with a stopcock. In one embodiment, the cap includes: a housing, the housing including: a top wall; a substantially cylindrical side wall forming a first cavity; and an open bottom formed by the cylindrical side wall, the open bottom having an opening to the first cavity in the housing for receiving an interface of a medical connector; an internal thread located on the inner surface of the cylindrical side wall, the internal thread being sufficient to interlock with a threaded joint of a medical connector; a sterile sponge, the sterile sponge being constructed in the first cavity; and an elongated member attached to the housing; and an insert slidably engaged with the elongated member and disposed near the surface of the sterile sponge.

[0110] Figure 7A cross-sectional view of an insert 170 according to another embodiment is provided, which includes a tapered edge. The insert 170, which may be referred to as a slidable insert, includes a generally cylindrical body having a closed bottom wall 172 and an open top edge 171 with a side wall 174 spanning between the bottom wall 172 and the top edge 171. The top edge 171 radially depends from the insert side wall 174, thereby defining a hole 180. The side wall 174 defines a chamber 176 within the insert. A plurality of slits 184 radially surround the top edge 171, which define a plurality of prongs 182 surrounding the top edge 171 of the insert 170. The faces 178 of the prongs 182 are chamfered from the top edge 171 of the insert 170. The prongs 182 have bottom ends defined by locations 186a, 186b, 186c, 186d where each slit ends. The bottom wall 172 also includes a tapered edge 188 that can be configured to complement the connector and / or medical device to create a sealing contact. In one or more embodiments, the outer geometry of the insert 150 has a tapered edge 188 that has an angular range that is substantially complementary to the Luer taper. When the insert is engaged with the open lumen of a medical Luer connector such as a catheter or stopcock, the complementary Luer inner wall exerts radial pressure on the insert to make the snap fit tighter and prevent the insert from moving along the central axis, even when subjected to pressure along the central axis.

[0111] The cap of the present disclosure includes a disinfecting sponge that allows the practitioner to simplify the disinfection process. Figure 8 A perspective top view of a substantially symmetrical disinfecting sponge according to one embodiment is provided, Fig. 9 A cross-sectional perspective top view of a substantially symmetrical disinfectant sponge according to one embodiment is provided. The disinfectant sponge 200 has a substantially cylindrical body with a sidewall 204 spanning between a slotted end 202 and an open end 208 having an end wall 210. Figures 8 to 9 In some embodiments, the groove 212 extends through the diameter of the slotted end 202 into the opposite portion of the side wall 204. In one or more embodiments, the groove 212 extends less than about halfway along the side wall 204. The side wall 204 defines a hollow portion 206. The groove allows the luer end of, for example, a male luer connector to be inserted into the hollow cylindrical cavity so that the sponge side wall can interact with the side surface of the male luer connector and release disinfectant onto the luer surface. When the male luer connector is screwed onto the cap, the groove opens and the luer opens the groove by pushing the two sides of the sponge apart.

[0112] Fig.10 A cross-sectional perspective top view of a substantially symmetrical disinfectant sponge according to another embodiment is provided. The disinfectant sponge 201 has a generally cylindrical body with a side wall 205 spanning between a slotted end 202 and an open end 209 having an end wall 211. Fig.10In the embodiment of the present invention, the groove 213 extends from the end wall 311 along the side wall 205 through the diameter of the slotted end 202. The side wall 205 defines a hollow portion 207. As desired, in one or more embodiments, the groove can have intermittent connections between portions of the side wall 205 so that the sponge is a single piece for easy handling. The groove allows the luer end of, for example, a male luer connector to be inserted into the hollow cylindrical cavity so that the side wall of the sponge can interact with the side surface of the male luer connector and release disinfectant onto the luer surface. The groove opens when the male luer connector is screwed onto the cap, and the luer opens the groove by pushing the two sides of the sponge apart.

[0113] Fig.11 Schematically shows the Figure 2 A cross-sectional perspective top view of the cap in assembled form. The cap 100 includes a housing 102, a top wall 104, a side wall 106, an open bottom 108 defining an opening 110, a projection 114, and an elongated member 130 shown with an insert 150 snap-fitted into place. The insert 150 is located in a hollow portion defined by the disinfectant sponge 200, which in turn is located in a cavity defined by the inner surface of the projection 114. The side wall 106 defines a cavity 112, which cavity 112 can be used to receive an interface of a connector. In one or more embodiments, when assembled, the disinfectant sponge 200 is in direct contact with the inner surface of the top wall 104.

[0114] In an exemplary embodiment, a peel seal may be provided to seal the opening 110 prior to use of the cap 100, for example, by being attached to a surface of an edge of the open bottom 108 of the housing 102. In one or more embodiments, the peel seal comprises an aluminum or multilayer polymer film peel top. In a specific embodiment, the peel seal is heat sealed or induction sealed to the open end of the cap. In one or more embodiments, the peel seal comprises a moisture barrier. According to an exemplary embodiment of the present disclosure, the cap 100 can receive the end or interface of the needleless connector in the cavity 112 and secure the end of the needleless connector in the cavity 112, for example, using threads, for example, after removing the peel seal that seals the cavity or when the peel seal film is pierced.

[0115] exist Fig.12, an exploded cross-sectional perspective top view along the longitudinal axis "b" of an exemplary cap according to one embodiment is provided. Cap 300 includes a shell 302, a top wall 304, a substantially cylindrical side wall 306, and a protrusion 314. The side wall 306 is substantially cylindrical. The side wall 306 defines a first cavity 312 and an open bottom 308, which defines an opening 310. The protrusion 314 is located in the first cavity 312 and can be substantially cylindrical and coaxial with the side wall 306. The opening 310 is disposed at the open bottom 308 of the shell 302. The inner surface of the top wall 304 can form the top of the cavity 312. In one embodiment, the protrusion 314 is integrally formed with the shell 302. In another embodiment, the protrusion 314 is attached to the top wall 304 of the shell 302 by, for example, a snap-fit ​​attachment. The second cavity 320 of the shell 302 is defined by the inner surface 316 of the protrusion 314. The inner surface 316 includes an internal thread 322. The protrusion 314 also has an outer surface 318 including an external thread 324. In one or more embodiments, the size and pitch of the internal thread 322 can engage the threaded connector of a female connector (e.g., a female Luer connector). Such connectors are commonly used as catheters and other fluid-tight protective connectors in medical applications. The internal thread 322 is sufficient to interlock with the mating features of the female needleless connector (e.g., a threaded connector with male threads). The external thread 324 is sufficient to interlock with the mating features of the male needleless connector (e.g., a threaded connector with female threads). In one or more embodiments, the protrusion 314 may include one or more cantilever forks separated by one or more corresponding gaps. In one or more embodiments, at least one of the forks may be configured to bend to facilitate an interference fit between the protrusion and the mating features of the male or female needleless connector. In one or more embodiments, the protrusion 314 may extend substantially from the inner surface of the top wall 304 toward the open bottom 308 of the housing 302. In one or more embodiments, the protrusion 314 may extend substantially parallel to the sidewall 306 of the housing.

[0116] In this embodiment, the pressure seal is a flexible insert 350 including a top edge 351 and a bottom wall 352, with a side wall 354 of the flexible insert 350 spanning between the top edge 351 and the bottom wall 352. The bottom wall 352 of the flexible insert 350 includes a tapered surface 355. When assembled, the insert 350 is located in the hollow portion 206 defined by the disinfecting sponge 200. In one or more embodiments, the flexible insert is completely disposed in the hollow portion when in an uncompressed state.

[0117] Fig.13A perspective bottom view of a flexible insert 350 according to one embodiment is provided. The flexible insert 350 includes a substantially cylindrical body having a bottom wall 352 that is closed and has a tapered surface 355, and a top edge 351 with a side wall 354 spanning between the bottom wall 352 and the top edge 351. The top edge 351 can be configured to fit a desired cap design. In one or more embodiments, the flexible insert 350 is attached to a top wall of a housing (e.g., Fig.12 Item 304). Fig.14 In FIG. 3 , the top edge 351 of the flexible insert 350 includes an attachment feature 357 for attaching to the inner surface of the top wall of the housing of the cap. Fig.14 , the attachment feature 357 is an opening in the center of the top wall 351. Fig.15 , the top edge 351 includes an attachment feature 359 which is a channel that runs through the diameter of the top wall 351 .

[0118] The outer geometry of the flexible insert 350 is sufficiently complementary to the open lumen Luer connector to engage. When the flexible insert 350 engages with the open lumen in a Luer connector (e.g., a catheter or stopcock), the complementary Luer inner wall exerts radial pressure on the insert to form an interference fit. The flexible insert 350 can define a chamber within the insert. The walls of the flexible insert 350 can be air permeable and / or porous, which can provide a channel, orifice, or air path to connect the inner chamber to the outside of the chamber of the insert to allow compression.

[0119] The flexible insert can be a solid material that can be soft to compress longitudinally so that it can retract toward the top wall at the closed end of the cap body when the cap is attached to a male Luer connector and a closed female Luer connector (e.g., a needleless connector and an IV tube end), but the solid material can be sufficiently stiff radially so that it can form sufficient interference with an open Luer (e.g., a catheter or stopcock).

[0120] Pressure seals including flexible inserts may also be included in non-male-female caps, including but not limited to female sterile caps, such as BD PureHub™. The pressure seal will allow the female sterile cap to be used with a stopcock. In one embodiment, the cap comprises: a housing, the housing comprising: a top wall; a substantially cylindrical side wall forming a first cavity; and an open bottom formed by the cylindrical side wall, the open bottom having an opening to the first cavity in the housing for receiving an interface of a medical connector; an internal thread on the inner surface of the cylindrical side wall, the internal thread being sufficient to interlock with a threaded connector of a medical connector; a sterile sponge constructed in the first cavity; and a flexible insert attached to the housing and arranged adjacent to the surface of the sterile sponge.

[0121] Fig.16 Schematically shows the assembled form according to Fig.12 300 is a cross-sectional perspective top view of a cap. The cap 300 is shown with a flexible insert 350 in place, the cap 300 comprising a housing 302, a top wall 304, a side wall 306, an open bottom 308 defining an opening 310. The flexible insert 350 is located in a hollow portion defined by the disinfecting sponge 200, which in turn is located in a cavity defined by the inner surface of the protrusion 314. The side wall 306 defines a cavity 312, which can be used to accommodate an interface of a connector. In one or more embodiments, when assembled, the disinfecting sponge 200 is in direct contact with the inner surface of the top wall 304.

[0122] In an exemplary embodiment, a peel seal may be provided to seal the opening 310 prior to use of the cap 300, for example, by being attached to a surface of an edge of the open bottom 308 of the housing 302. In one or more embodiments, the peel seal comprises an aluminum or multilayer polymer film peel top. In a specific embodiment, the peel seal is heat sealed or induction sealed to the open end of the cap. In one or more embodiments, the peel seal comprises a moisture barrier. According to an exemplary embodiment of the present disclosure, the cap 300 can receive the end or interface of the needleless connector in the cavity 312 and secure the end or interface of the needleless connector (e.g., by threads) in the cavity 312, for example, after the peel seal of the sealed cavity is removed or when the peel seal film is pierced.

[0123] Fig.17An exemplary assembly 400 of the cap 100 according to one embodiment is shown in a cross-sectional side view and a medical connector 450 is shown in a partial side view. The cap 100 includes: a housing 102; a projection 114; an elongated member 130; an insert 150 that snap-fits and slidably engages with the elongated member 130; and a disinfectant sponge 200. The connector 450 is a female medical connector having an open female Luer port, which can be, for example, a needleless connector, such as a catheter or a stopcock, which includes an open lumen 452, a lumen edge 454, and a male threaded connector 458. The male threaded connector 458 of the connector 450 engages with the internal threads 122 of the inner surface of the projection 114. When the insert 150 is engaged with the open lumen 452, the complementary inner wall (e.g., Luer wall) applies radial pressure to the insert 150 to make the snap fit tighter by the prongs on the insert that are bent inwardly toward the central axis and prevent the insert from moving along the central axis even when subjected to forces along the central axis. The lumen edge 454 pushes the sponge 200 toward the top wall 104 at the closed end of the housing 102, thereby allowing the disinfectant to be dispensed onto the lumen edge 454. The insert 150 inhibits and / or prevents the disinfectant from entering the lumen 452. In addition, the insert can maintain high pressure to avoid fluid leakage, for example, when the valve of the stopcock is not properly closed to avoid fluid leakage. In one or more embodiments, when the threaded connector from the female Luer connector engages the internal thread 122 of the cap 400 and forms a releasable connection with the internal thread 122 of the cap 400, the cap 400 provides a protective cover for the female Luer connector when it is engaged with the connector.

[0124] Fig.18An exemplary assembly 410 is shown according to one embodiment, which shows the cap 100 in a cross-sectional side view and the medical connector 460 in a partial schematic view. The cap 100 includes: a housing 102; a protrusion 114; a slender member 130; an insert 150 that snap-fits and slidably engages with the slender member 130; and a disinfecting sponge 200. The connector 460 is a male medical connector, which can be, for example, an IV tube end, and includes an open lumen 462, a rim 464, and a female threaded connector 468. The female threaded connector 468 of the connector 460 engages with the external threads 124 of the inner surface of the protrusion 114. When the insert 150 engages with the rim 464, the prongs on the insert 150 expand radially outward to allow the insert 150 to move along the slender member 130 and retract toward the top wall 104 at the closed end of the housing 102. The edge 464 pushes the sponge 200 toward the top wall 104 at the closed end of the housing 102, thereby allowing the disinfectant to be dispensed onto the inner cavity edge 464. The insert 150 inhibits and / or prevents the disinfectant from entering the open inner cavity 462. The bottom surface of the insert 150 can cover the open inner cavity 462 of the Luer end on the connector, thereby reducing the entry of the disinfectant. The insert can provide a sealing function to maintain pressure from the liquid in the central cavity and the fluid path to prevent leakage. In one or more embodiments, when the threaded connector from the male Luer connector engages the internal threads 122 of the cap 410 and forms a releasable connection with the internal threads 122 of the cap 410, the cap 410 provides a protective cover for the male Luer connector when it is engaged with the male Luer connector.

[0125] Fig.19An exemplary assembly 420 according to one embodiment is shown, which shows the cap 100 in a cross-sectional perspective top view and the medical connector 470 in a partial side perspective view. The cap 100 includes: a housing 102; a protrusion 114; an elongated member 130; an insert 150 that snap-fits and slidably engages with the elongated member 130; and a disinfectant sponge 200. The connector 470 is a female medical needleless connector that includes an inner cavity rim 474, a septum 476, and a male threaded connector 478. When assembled, the male threaded connector 478 of the connector 470 engages with the internal threads 22 of the inner surface of the protrusion 114. The inner cavity rim 474 pushes the sponge 200 toward the top wall 104 at the closed end of the housing 102, thereby allowing the disinfectant to be dispensed onto the inner cavity rim 474. When the cap 100 is attached to the needleless connector 470, the prongs on the insert 150 expand radially outward to allow the insert 150 to move along the elongated member 130 and retract toward the top wall 104 at the closed end of the housing 102. This movement prevents the insert 150 from pushing the septum 476 of the needleless connector 470, which avoids opening the fluid path and generating fluid leakage. In one or more embodiments, when the threaded connector from the female needleless connector engages the internal threads 122 of the cap 420 and forms a releasable connection with the internal threads 122 of the cap 420, the cap 420 provides a protective cover for the female needleless connector when engaged with the female needleless connector.

[0126] Fig. 20 An exemplary assembly 500 according to one embodiment is shown, which shows the cap 300 in a cross-sectional side view and the medical connector 450 in a partial side view. The cap 300 includes a housing 302, a protrusion 314, a flexible insert 350, and a disinfectant sponge 200. The connector 450 is a female medical connector with an open female Luer port, which can be, for example, a needleless connector, such as a catheter or a stopcock, and includes an open lumen 452, a lumen edge 454, and a male threaded connector 458. The male threaded connector 458 of the connector 450 engages with the internal threads 322 of the inner surface of the protrusion 314. When the insert 350 engages with the open lumen 452, the complementary inner wall (e.g., Luer wall) exerts radial pressure on the insert 350 to form an interference fit with the inner wall. The lumen edge 454 pushes the sponge 200 toward the top wall 304 at the closed end of the housing 302, thereby allowing the disinfectant to be dispensed onto the lumen edge 454. The insert 350 inhibits and / or prevents the disinfectant from entering the lumen 452. In addition, the insert can maintain high pressure to avoid fluid leakage, for example, when the valve of the stopcock is not properly closed. In one or more embodiments, when the threaded connector from the female Luer connector engages with the internal threads 322 of the cap 500 and forms a releasable connection with the internal threads 322 of the cap 500, the cap 500 provides a protective cover for the female Luer connector when it is engaged with the connector.

[0127] Fig.21 An exemplary assembly 510 according to one embodiment is shown, which shows the cap 300 in a cross-sectional side view and the medical connector 460 in a partially schematic side view. The cap 300 includes a housing 302, a protrusion 314, an insert 350, and a disinfectant sponge 200. The connector 460 is a male medical connector, which can be, for example, an IV tube end, which includes an open lumen 462, a rim 464, and a female threaded connector 468. The female threaded connector 468 of the connector 460 engages with the external threads 324 of the inner surface of the protrusion 314. When the insert 350 engages with the open lumen 462, the complementary inner wall exerts radial pressure on the insert 350 to form an interference fit with the inner wall. The rim 464 pushes the sponge 200 toward the top wall 304 at the closed end of the housing 302, thereby allowing the disinfectant to be dispensed to the lumen rim 464. The insert 350 inhibits and / or prevents the disinfectant from entering the open lumen 462. The bottom surface of the insert 350 can cap the open lumen 462, thereby reducing the ingress of sterilant. The insert can provide a sealing function to maintain pressure from the central lumen and the fluid in the fluid path, thereby preventing leakage.

[0128] Fig. 22 An exemplary assembly 520 according to one embodiment is shown, which shows the cap 300 and the medical connector 470 in a cross-sectional perspective top view. The cap 300 includes a housing 302, a protrusion 314, a flexible insert 350, and a disinfectant sponge 200. The connector 470 is a female medical needleless connector, which includes an inner cavity edge 474, a septum 476, and an external threaded connector 478. When assembled, the male threaded connector 478 of the connector 470 engages with the internal threads 322 of the inner surface of the protrusion 314. The inner cavity edge 474 pushes the sponge 200 toward the top wall 304 at the closed end of the housing 302, thereby allowing disinfectant to be dispensed onto the inner cavity edge 474. When the insert 350 engages with the open inner cavity 452, the complementary inner wall (e.g., Luer wall) exerts radial pressure on the insert 350 to form an interference fit with the inner wall. The insert 350 is compliant enough that it does not push on the septum 476 of the needleless connector 470, which avoids opening the fluid path and creating fluid leakage. In one or more embodiments, when the threaded connector from the female Luer connector engages with the internal threads 322 of the cap 520 and forms a releasable connection therewith, the cap 520 provides a protective cover for the female Luer connector when engaged with the connector.

[0129] Fig.23The cap 600 according to one embodiment is schematically shown in a cross-sectional side view. The cap 600 includes a housing 602, a top wall 604, a substantially cylindrical side wall 606, an open bottom 608 defining an opening 610, a protrusion 614, a flexible insert 650, and a disinfectant sponge 200. The insert 650 is located in a hollow portion defined by the disinfectant sponge 200, which is in turn located in a cavity defined by the inner surface of the protrusion 614. The side wall 606 defines a cavity 612, which can be used to receive an interface of a connector. The protrusion 614 is located in the first cavity 612 and can be substantially cylindrical and coaxial with the side wall 606. The opening 610 is disposed at the open bottom 608 of the housing 602. The inner surface of the top wall 604 can form the top of the cavity 612. In one embodiment, the protrusion 614 is formed integrally with the housing 602. In another embodiment, the protrusion 614 is attached to the top wall 604 of the housing 602 by, for example, a snap-fit ​​attachment. In this embodiment, the top wall 604 includes an elongated ring 605 having an inner surface 607. The flexible insert 650 includes a top wall 651 having an extension 653. The protrusion 614 includes an upper lip 615 having a shoulder 616 and an edge 617. The upper lip 615 of the protrusion 614 fits into the elongated ring 605, wherein the edge 617 of the upper lip 615 engages the inner surface 607 of the elongated ring 605. The extension 653 of the top wall 651 of the insert 650 is located in the shoulder 616 of the protrusion 614. In this embodiment, the protrusion 614 is formed separately from the housing 602 and snap-fits into the elongated ring 605.

[0130] In one or more embodiments, there are internal threads (not shown) on the inner surface of the protrusion 614, which have an appropriate size and pitch to engage the threaded connector of a female connector (e.g., a female Luer connector). Such connectors are commonly used as catheters and other fluid-tight protective connectors in medical applications. The internal threads are sufficient to interlock with the mating features of the female needleless connector (e.g., a threaded connector with male threads). There are also external threads 624, which are sufficient to interlock with the mating features of the male needleless connector (e.g., a threaded connector with female threads). In one or more embodiments, the protrusion 614 may include one or more cantilevered prongs separated by one or more corresponding gaps. In one or more embodiments, at least one of the prongs may be configured to bend to facilitate an interference fit between the protrusion and the mating features of the male or female needleless connector. In one or more embodiments, the protrusion 614 may extend substantially from the inner surface of the top wall 604 toward the open bottom 608 of the housing 602. In one or more embodiments, the protrusion 614 may extend substantially parallel to the side wall 606 of the housing.

[0131] In an exemplary embodiment, a peel seal may be provided to seal the opening 610 prior to use of the cap 600, for example, by being attached to a surface of an edge of the open bottom 608 of the housing 602. In one or more embodiments, the peel seal comprises an aluminum or multilayer polymer film peel-off top. In a specific embodiment, the peel seal is heat sealed or induction sealed to the open end of the cap. In one or more embodiments, the peel seal comprises a moisture barrier. According to an exemplary embodiment of the present disclosure, the cap 600 can receive the end or interface of the needleless connector in the cavity 612 and secure the end or interface of the needleless connector (e.g., by threads) in the cavity 612, for example, after the peel seal of the sealed cavity is removed or when the peel seal film is pierced.

[0132] Fig.24 A top perspective view of the flexible insert 650 is shown, Fig.25 Shows Fig.23 654 and the top edge 651. The flexible insert 650 includes a generally cylindrical body having a bottom wall 652 that is closed and has a tapered surface 655, and a top edge 651 between which a side wall 654 spans. The top edge 651 can be configured to fit the cap design as desired. In this embodiment, the flexible insert 650 includes an attachment feature 659 that is a channel that extends through the diameter of the top wall 651. The top wall 651 of the flexible insert 650 includes an extension 653 that fits into the shoulder 616 of the protrusion 614. The edge 617 of the protrusion 614 is aligned with the elongated ring ( Fig.23 Project 605) is engaged.

[0133] The outer geometry of the flexible insert 650 is sufficiently complementary to the open lumen Luer connector to engage. When the flexible insert 650 engages with the open lumen in a Luer connector (e.g., a catheter or stopcock), the complementary Luer inner wall exerts radial pressure on the insert to form an interference fit. The flexible insert 650 can define a cavity inside the insert. The walls of the flexible insert 650 can be air permeable and / or porous, which can provide a channel, orifice, or air path to connect the inner chamber to the outside of the chamber of the insert to allow compression.

[0134] The flexible insert can be a solid material that is soft to compress longitudinally so that it can retract toward the top wall at the closed end of the cap body when the cap is attached to a male Luer and a closed female Luer (e.g., a needleless connector and an IV tube end), but is radially rigid enough so that it can form sufficient interference with an open Luer (e.g., a catheter or a stopcock). The flexible insert is suitable for use with a universal male and female sterilization cap for use with various medical connectors known to those skilled in the art, including those disclosed herein.

[0135] Similar to Fig. 20 -22 embodiment, in assembly Fig.23 When the cap of the insert 650 is connected to the male or female medical connector, the edge of the inner cavity pushes the sponge 200 toward the top wall 604 at the closed end of the housing 602, thereby allowing the disinfectant to be distributed to the edge of the inner cavity. When the insert 650 is engaged with the open inner cavity, the complementary inner wall 26 (e.g., Luer wall) exerts radial pressure on the insert 650 to form an interference fit with the inner wall, which reduces and / or prevents the disinfectant from entering the inner cavity.

[0136] The caps herein (e.g., 100, 300, 600) can be made of any of a variety of types of plastic materials, such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, acrylonitrile butadiene styrene, or any other moldable plastic material that can be used in a medical device. In one or more embodiments, the cap includes a polypropylene or polyethylene material.

[0137] According to an exemplary embodiment of the present disclosure, the cap herein may further include a shell that implements the safety features and designs described in U.S. patent application No. 62 / 488,266 filed on April 21, 2017 and No. 62 / 523,506 filed on June 22, 2017, for example by modifying the top wall, side walls and / or shell.

[0138] According to another exemplary embodiment of the present disclosure, the caps herein (e.g., 100, 300, 600) can be implemented to have various ventilation features and designs described in U.S. patent applications Nos. 15 / 408,278 and 15 / 408,187, both filed on January 17, 2017, such as by modifying the shape and / or size of the protrusions, and / or the configuration of the internal and / or external threads (e.g., pitch, spacing, thickness and / or other structural features), and / or the configuration of the inner and / or outer surfaces.

[0139] In some embodiments, the medical connector includes a needleless injection site, which may sometimes be referred to as a needleless injection port, interface, valve or device, or as a needleless access site, port, interface, valve or device, and may include brands such as Clave® (available from ICU Medical), SmartSite® (available from Cardinal Health), and Q-Syte™ (available from Becton Dickinson). In some embodiments, the caps (e.g., 100, 300, 600) herein may be connected to any of a variety of different needleless injection sites, such as those listed previously. In one or more embodiments, after the cap has been connected to the connector, it is not necessary to disinfect the connector (e.g., with an alcohol swab) each time the connector is reconnected to another connector, because the connector will remain uncontaminated while connected to the cap. The use of the cap replaces the standard wiping protocol for cleaning the connector.

[0140] Another aspect of the present disclosure relates to a method for sterilizing a medical connector. The method includes connecting a cap of one or more embodiments to the medical connector, wherein the connection includes engaging threads of the medical connector to threads of an inner surface or an outer surface of a second cavity of the cap when the medical connector is inserted into the cap, so that the medical connector contacts an absorbent material and a disinfectant or antimicrobial agent.

[0141] Exemplary caps of the present disclosure enable continuous sterilization of the connector and minimize the ingress of microbial agents.

[0142] In order to avoid having to use different types of disinfection caps to clean different types of connectors, the exemplary cap (100, 300, 600) engages with a male Luer connector and a female Luer connector, thereby allowing a user to clean different types of connectors with a single device. When the exemplary cap (100, 300, 600) is mounted on the female Luer connector, the female Luer connector is inserted into the second cavity and screwed onto the internal thread of the exemplary cap. When the cap is mounted on the male Luer connector, the male Luer connector is inserted into the second cavity and screwed onto the external thread of the exemplary cap (100, 300, 600). After the female Luer connector is inserted into the second cavity of the exemplary cap (100, 300, 600), the disinfectant of the disinfection sponge contacts the female Luer connector. After the connector is inserted into the second cavity of the exemplary cap (100, 300, 600), the disinfectant of the disinfection sponge contacts the male Luer connector, the female Luer connector, and the hemodialysis connector.

[0143] Thus, the devices disclosed herein can be installed on both male and female Luer connectors, thereby meeting current needs in the art.

[0144] Another aspect of the present disclosure relates to an assembly. The assembly includes a cap connected to one or more embodiments of a medical connector. In one or more embodiments, the medical connector is selected from a male Luer connector, a female Luer connector, and a needleless connector. Example

[0145] Various numbered embodiments are listed below. It should be understood that the embodiments listed below can be combined with all aspects and other embodiments according to the scope of the present invention.

[0146] 1. A cap, comprising: a shell, the shell comprising: a top wall; a basically cylindrical side wall forming a first cavity; and an open bottom formed by the cylindrical side wall, the open bottom leading to the first cavity in the shell for receiving an interface of a medical connector; a protrusion, the protrusion extending from the shell and positioned in the first cavity, the protrusion having: an inner surface and an outer surface, the inner surface of the protrusion defining a second cavity; an internal thread on the inner surface of the protrusion, the internal thread being sufficient to interlock with a threaded joint of a female medical connector; an external thread on the outer surface of the protrusion, the external thread being sufficient to interlock with a threaded joint of a male medical connector; a sterile sponge constructed in the second cavity; a pressure seal, the pressure seal being attached to the shell and disposed near the surface of the sterile sponge.

[0147] 2. The cap according to embodiment 1, wherein when the cap is engaged with the medical connector, the disinfectant sponge contacts the edge of the inner cavity of the medical connector, and the pressure seal blocks the inner cavity of the medical connector, thereby inhibiting the disinfectant from entering the inner cavity.

[0148] 3. The cap according to embodiment 2, wherein when the inner cavity of the medical connector opens to the cap, the pressure seal enters the inner cavity to inhibit disinfectant from entering the inner cavity.

[0149] 4. The cap of embodiment 2, wherein when the medical connector includes a septum in the lumen, the pressure seal is positioned to avoid creating a fluid path through the septum.

[0150] 5. The cap of embodiment 1, wherein the disinfecting sponge comprises a slotted end; a substantially cylindrical sponge sidewall defining a hollow portion and an open end; and a sponge end wall.

[0151] 6. The cap of embodiment 5, wherein the slotted end of the disinfecting sponge includes slots extending into opposing portions of the sponge sidewalls.

[0152] 7. The cap of embodiment 6, wherein the grooves extend along opposing portions of the sponge sidewalls to the open end.

[0153] 8. The cap of embodiment 5, wherein the pressure seal is disposed in the hollow portion of the disinfectant sponge.

[0154] 9. The cap of embodiment 8, wherein in an uncompressed state, the pressure seal is completely disposed within the hollow portion.

[0155] 10. The cap of embodiment 5, wherein the sponge end wall is in direct contact with the inner surface of the top wall.

[0156] 11. A cap according to embodiment 1, wherein the pressure seal includes a slender member and an insert, wherein: the slender member extends from the inner surface of the top wall of the shell; the insert includes: a bottom wall and a substantially cylindrical insert side wall, the insert side wall forms a chamber, and the top edge of the insert side wall defines a hole; the insert is capable of slidably engaging with the slender member.

[0157] 12. The cap of embodiment 11, wherein an inner surface of the top edge is slidably engaged with the elongated member.

[0158] 13. The cap of embodiment 11, wherein the elongated member comprises a shoulder segment, an inclined segment, and one or more sliding segments.

[0159] 14. The cap of embodiment 11, wherein the insert includes a plurality of prongs defined by portions of the insert sidewalls and the top edge separated by slits.

[0160] 15. The cap of embodiment 14, wherein a face of the prong is slidably engaged with the elongated member.

[0161] 16. The cap of embodiment 11, wherein the outer geometry of the insert sidewall comprises a tapered surface that effectively complements the inner surface of the lumen of the medical connector.

[0162] 17. The cap of embodiment 11, wherein the insert comprises a polymer material selected from the group consisting of polyethylene, polypropylene, thermoplastic elastomer (TPE), or combinations thereof.

[0163] 18. The cap of embodiment 1, wherein the pressure seal comprises a flexible insert attached to an inner surface of the top wall of the housing.

[0164] 19. The cap of embodiment 18, wherein the flexible insert comprises an elastomeric polymer material.

[0165] 20. The cap of embodiment 18, wherein the flexible insert comprises a top wall, a bottom wall, and a substantially cylindrical and porous insert side wall extending between the top wall and the bottom wall.

[0166] 21. The cap of the preceding embodiment, wherein the top wall of the flexible insert further comprises an extension that engages an upper lip of the projection.

[0167] 22. The cap of any one of embodiments 18 to 21, wherein the flexible insert is breathable.

[0168] 23. A cap, the cap comprising: a shell, the shell comprising: a top wall; a basically cylindrical side wall forming a first cavity; and an open bottom formed by the cylindrical side wall, the open bottom having an opening leading to the first cavity in the shell for accommodating an interface of a medical connector; a protrusion extending from the shell and positioned in the first cavity, the protrusion having: an inner surface and an outer surface, the inner surface of the protrusion defining a second cavity; an internal thread on the inner surface of the protrusion, the internal thread being sufficient to interlock with a mating feature of the medical connector including a female medical connector; and an external thread on the outer surface of the protrusion, the external thread being sufficient to interlock with a mating feature of the medical connector including a male medical connector; a disinfectant sponge constructed in the second cavity, the The disinfectant sponge includes a grooved end; a substantially cylindrical sponge side wall, the sponge side wall defining a hollow portion and an open end; and a sponge end wall; a pressure seal, the pressure seal being disposed in the hollow portion of the disinfectant sponge, the pressure seal comprising: a slender member extending from the inner surface of the top wall of the shell; and an insert, the insert comprising a bottom wall and a substantially cylindrical insert side wall, the insert side wall forming a chamber and the top edge of the insert side wall defining a hole; the insert being slidably engaged with the slender member; wherein, when the cap is engaged with the medical connector, the disinfectant sponge contacts the inner cavity edge of the medical connector, and the insert of the pressure seal blocks the inner cavity of the medical connector, thereby inhibiting the disinfectant from entering the inner cavity.

[0169] 24. The cap of embodiment 23, wherein an inner surface of the top edge is slidably engaged with the elongated member.

[0170] 25. The cap of embodiment 23, wherein the elongated member comprises a shoulder segment, an inclined segment, and one or more sliding segments.

[0171] 26. The cap of embodiment 23, wherein the insert sidewall includes a plurality of prongs defined by portions of the insert sidewall and the top edge separated by slits.

[0172] 27. The cap of embodiment 26, wherein a face of the prong is slidably engaged with the elongated member.

[0173] 28. The cap of embodiment 23, wherein the outer geometry of the insert sidewall comprises a tapered surface that is operatively complementary to an inner surface of the lumen of the medical connector.

[0174] 29. The cap of embodiment 23, wherein the insert comprises a polymer material selected from the group consisting of polyethylene, polypropylene, thermoplastic elastomer (TPE), or combinations thereof.

[0175] 30. A cap, comprising: a shell, the shell comprising: a top wall; a substantially cylindrical side wall forming a first cavity; and an open bottom formed by the cylindrical side wall, the open bottom having an opening leading to the first cavity in the shell for receiving an interface of a medical connector; a protrusion, the protrusion extending from the shell and positioned in the first cavity, the protrusion having: an inner surface and an outer surface, the inner surface of the protrusion defining a second cavity; an internal thread on the inner surface of the protrusion, the internal thread being sufficient to interlock with a mating feature of the medical connector including a female medical connector; an external thread on the outer surface of the protrusion, the external thread Sufficient to interlock with the mating features of the medical connector including the male medical connector; a disinfectant sponge constructed in the second cavity, the disinfectant sponge including a slotted end; a substantially cylindrical sponge side wall, the sponge side wall defining a hollow portion and an open end; and a sponge end wall; a pressure seal, the pressure seal being disposed in the hollow portion of the disinfectant sponge, the pressure seal comprising: a flexible insert attached to the inner surface of the top wall of the shell; wherein, when the cap is engaged with the medical connector, the disinfectant sponge contacts the edge of the inner cavity of the medical connector, and the pressure seal blocks the inner cavity of the medical connector, thereby inhibiting disinfectant from entering the inner cavity.

[0176] 31. The cap of embodiment 30, wherein the flexible insert comprises an elastomeric polymer material.

[0177] 32. The cap of embodiment 30, wherein the flexible insert comprises a top wall, a bottom wall, and a substantially cylindrical and porous insert side wall extending between the top wall and the bottom wall.

[0178] 33. The cap of the preceding embodiment, wherein the top wall of the flexible insert further comprises an extension that engages an upper lip of the projection.

[0179] 34. The cap according to one of embodiments 30 to 33, wherein the flexible insert is breathable.

[0180] 35. The cap of any preceding embodiment, wherein the medical connector is selected from the group consisting of a male Luer connector, a female Luer connector, and a needle-free connector.

[0181] 36. The cap of any preceding embodiment, wherein the disinfecting sponge comprises a disinfectant, an antimicrobial agent, or a combination thereof.

[0182] 37. The cap of embodiment 36, wherein the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butyl alcohol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

[0183] 38. The cap of embodiment 37, wherein the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

[0184] 39. The cap of any one of embodiments 1 to 38, wherein the protrusion is formed integrally with the shell.

[0185] 40. The cap of any one of embodiments 1 to 38, wherein the protrusion is attached to an inner surface of the top wall of the shell.

[0186] 41. The cap of the preceding embodiment, wherein the protrusion is snap-fastened or adhered to the inner surface of the top wall of the shell.

[0187] 42. The cap of the preceding embodiment, wherein the projection includes an upper lip that engages an elongated ring extending from an inner surface of the top wall of the housing.

[0188] 43. A method for sterilizing a medical connector, the method comprising: connecting the cap of any one of the preceding embodiments to the medical connector by engaging the threads of the medical connector to the internal threads or the external threads of the protrusion, so that the edge of the medical connector contacts the sterilizing sponge and the pressure seal prevents sterilant from entering the inner cavity of the medical connector.

[0189] 44. A medical assembly comprising the cap of any one of embodiments 1 to 42 connected to a medical connector.

[0190] 45. The medical assembly of embodiment 44, wherein the medical connector is a female medical connector having a male threaded connector, the female medical connector selected from the group consisting of a needle-free connector, a stopcock, a female Luer connector, and a catheter connector.

[0191] 46. ​​The medical assembly of embodiment 44, wherein the medical connector is a male medical connector having a female threaded fitting, the male medical connector selected from the group consisting of: an intravenous tubing tip and a male Luer connector.

[0192] Although the present disclosure has been shown and described with reference to certain exemplary embodiments thereof, it will be appreciated by those skilled in the art that various changes may be made to the form and details thereof without departing from the spirit and scope of the embodiments of the present disclosure. For example, the disinfecting sponge may include any suitable disinfecting or other specific application material and may be made of any suitable material. In addition, the interior of the cap and / or the housing may be single shot injection molded or made by other suitable processes. In addition, any features or elements of any exemplary implementation of the embodiments of the present disclosure as described above and shown in the accompanying drawings may be implemented alone or in any combination, as will be readily appreciated by those skilled in the art, without departing from the spirit and scope of the embodiments of the present disclosure.

[0193] In addition, the included drawings further describe non-limiting examples of implementation of certain exemplary embodiments of the present disclosure and help describe the technology associated therewith. Any specific or relative dimensions or measurements other than those described above provided in the drawings are exemplary and are not intended to limit the scope or content of the present invention design or method as understood by those skilled in the art to which the present invention relates.

[0194] Other objects, advantages and salient features of the disclosure will become apparent to those skilled in the art from the details provided, which, taken in conjunction with the accompanying drawings, disclose exemplary embodiments of the disclosure.

[0195] References throughout this specification to "one embodiment," "certain embodiments," "one or more embodiments," or "an embodiment" mean that a particular feature, structure, material, or characteristic described in conjunction with the embodiment is included in at least one embodiment of the present disclosure. Thus, phrases such as "in one or more embodiments," "certain embodiments," "in one embodiment," or "in an embodiment" that appear in various places in this specification do not necessarily refer to the same embodiment of the present disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0196] Although the disclosure herein has provided a description with reference to specific embodiments, it should be understood that these embodiments are merely illustrations of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations may be made to the methods and apparatus of the present disclosure without departing from the spirit and scope of the present disclosure. Therefore, the present disclosure is intended to include modifications and variations within the scope of the appended claims and their equivalents.

Claims

1. A cap, comprising: A housing, the housing comprising: top wall; forming a substantially cylindrical sidewall of the first cavity; and an open bottom formed by the cylindrical sidewall, the open bottom having an opening leading to the first cavity in the housing for receiving an interface of a medical connector; and a protrusion extending from the housing and positioned within the first cavity, the protrusion having: an inner surface and an outer surface, the inner surface of the projection defining a second cavity, internal threads on the inner surface of the protrusion, the internal threads being sufficient to interlock with a threaded connector of a female medical connector; external threads on the outer surface of the protrusion, the external threads being sufficient to interlock with a threaded connector of a male medical connector; a disinfecting sponge configured within the second cavity; and A pressure seal is attached to the housing and disposed adjacent a surface of the disinfecting sponge.

2. The cap according to claim 1, wherein When the cap is engaged with the medical connector, the disinfectant sponge contacts the edge of the inner cavity of the medical connector, and the pressure seal blocks the inner cavity of the medical connector, thereby inhibiting disinfectant from entering the inner cavity.

3. The cap according to claim 2, wherein: When the inner cavity of the medical connector is open to the cap, the pressure seal enters the inner cavity to inhibit the sterilant from entering the inner cavity.

4. The cap according to claim 2, wherein: When the medical connector includes a septum located in the lumen, the pressure seal is positioned to prevent a fluid path from being created through the septum.

5. The cap according to claim 1, wherein The disinfecting sponge includes: a slotted end; a substantially cylindrical sponge side wall defining a hollow portion and an open end; and a sponge end wall.

6. The cap according to claim 5, wherein: The slotted end of the disinfecting sponge includes slots extending into opposing portions of the sponge sidewalls.

7. The cap according to claim 6, wherein: The grooves extend along opposing portions of the sponge sidewalls to the open end.

8. The cap according to claim 5, wherein: The pressure seal is disposed in the hollow portion of the disinfecting sponge.

9. The cap according to claim 8, wherein: In the uncompressed state, the pressure seal is completely disposed in the hollow portion.

10. The cap according to claim 5, wherein: The sponge end wall is in direct contact with the inner surface of the top wall.

11. The cap according to claim 1, wherein The pressure seal comprises an elongated member and an insert, wherein: The elongated member extends from an inner surface of the top wall of the housing; and The insert includes a bottom wall and a generally cylindrical insert side wall, the insert side wall forming a chamber, a top edge of the insert side wall defining an aperture; the insert is slidably engageable with the elongated member.

12. The cap according to claim 11, wherein An inner surface of the top edge is slidably engaged with the elongated member.

13. The cap according to claim 11, wherein The elongated member includes a shoulder section, a ramp section, and one or more sliding sections.

14. The cap according to claim 11, wherein The insert includes a plurality of prongs defined by portions of the insert sidewalls and the top edge separated by slits.

15. The cap according to claim 14, wherein The face of the prong is slidably engaged with the elongated member.

16. The cap of claim 11, wherein: The outer geometry of the insert sidewall includes a tapered surface that effectively complements the inner surface of the lumen of the medical connector.

17. The cap of claim 11, wherein: The insert includes a polymer material selected from the group consisting of polyethylene, polypropylene, thermoplastic elastomer (TPE), or combinations thereof.

18. The cap of claim 1, wherein: The pressure seal includes a flexible insert attached to an inner surface of the top wall of the housing.

19. The cap of claim 18, wherein: The flexible insert comprises an elastomeric polymer material.

20. The cap of claim 18, wherein: The flexible insert includes a top wall, a bottom wall, and a substantially cylindrical and porous insert side wall extending between the top wall and the bottom wall of the flexible insert.

21. Cap according to the preceding claim, wherein The top wall of the flexible insert also includes an extension that engages an upper lip of the projection.

22. The cap according to any one of claims 18 to 21, wherein The flexible insert is breathable.

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