Sterile caps

Abstract

A sterilization cap for connection to a medical connector is described. The cap includes a housing having a top wall and side walls forming a chamber, an open-cell foam structure disposed within the chamber, and a closed-cell foam structure disposed abutting the open-cell foam structure, the closed-cell foam structure having an interference fit between the closed-cell foam structure and the inner surface of the housing. The closed-cell foam structure may have a polygonal or star shape, wherein fluid can flow through the gap formed between the closed-cell foam structure and the inner surface of the chamber. The open-cell foam structure can be impregnated with a disinfectant, whereby compression of the open-cell foam structure during insertion into the Luer connector causes the disinfectant to be expelled.

Description

Technical Field

[0001] This disclosure relates to a sterilization cap device for sterilizing corresponding medical connectors. Generally, this disclosure relates to an apparatus for sterilizing and disinfecting the access port of a medical connector having a joint. Exemplary embodiments of this disclosure generally relate to the field of threaded or interlocking connectors, including medical caps and medical sterilization caps, and particularly caps and / or sterilization caps used with threaded fluid connectors. One or more exemplary embodiments of this disclosure relate to a male sterilization cap device for sterilizing male threaded Luer connectors. Background Technology

[0002] Vascular access devices (VADs) are commonly used therapeutic devices and include intravenous (IV) catheters. VADs are generally classified into two types: peripheral catheters and central venous catheters. When connected to a VAD to deliver fluids or medications, bacteria and other microorganisms can enter the patient's vascular system from the hub, port, or valve. Each hub, port, valve, or connection is associated with some risk of catheter-related bloodstream infection (CRBSI), which can be costly and potentially fatal. To reduce CRBSI cases and ensure the proper use and maintenance of VADs, practice standards have been developed, including disinfection and cleaning procedures. Disinfected caps have been added to the Society for Healthcare Epidemiology (SHEA) guidelines and the Infusion Care Standards (INS) guidelines.

[0003] In established markets, needleless connectors are typically used to close the system when IV catheters are in use, and are subsequently connected to administer medications or other necessary fluids to the patient via the catheter. INS Practice Standards recommend the use of needleless connectors and state that they should be “constantly and thoroughly disinfected with alcohol, iodine tincture, or a combination of chlorhexidine gluconate and alcohol before each connection.” Disinfection of the needleless connector is ultimately intended to help reduce bacteria that may be present on the surface and could lead to various catheter-related complications, including CRBSI. Nurses typically use a 70% isopropyl alcohol (IPA) pad to perform this disinfection by performing what is known as “hub scrubbing.” However, adherence to this practice is often very low. In addition to the lack of adherence to “hub scrubbing,” interviews with clinicians have revealed frequent discrepancies in scrubbing time, drying time, and the number of times the needleless connector is scrubbed.

[0004] The need for protecting both male and female Luer connectors to reduce central line-associated bloodstream infections (CLABSI) and peripheral line-associated bloodstream infections (PLABSI) is increasing. Threaded male Luer connectors on intravenous gravity kits and syringes are susceptible to contamination if not properly protected. Currently, when IV connectors are disconnected from central or peripheral lines to temporarily interrupt infusion, nurses often wrap the male Luer connector around the Y-position needleless connector or wrap it in an isopropyl alcohol (“IPA”)-soaked swab or cloth. However, this protection is very weak and does not adequately protect the Luer connector from contact contamination. Sterilized caps have become the most advanced sterilization and protection device, used for sterilization and forming a physical barrier on the male Luer connector to prevent microbial growth.

[0005] Throughout the entire procedural sequence associated with the spread of microorganisms that can lead to CRBSI, there are numerous risks of contact or contamination. For example, contamination can occur during drug mixing, cannula attachment, and insertion into the hub of the access route. Furthermore, threaded male Luer connectors have an open Luer connector in which the lumen is exposed. Because the procedure for connecting to a VAD is common and simple, the risks associated with access to the patient's vascular system are often overlooked. Currently, the risks to the hospital and the patient are substantially attributable to the due diligence of the clinician performing the connection, which is largely uncontrollable.

[0006] Due to the biotoxicity of disinfectants at high doses, disinfectants typically have a threshold limit for systemic exposure when infused into the bloodstream. A mechanism is needed to prevent disinfectants from entering the lumen and fluid pathway while providing effective disinfection of surrounding connectors or joints. Therefore, a disinfection device capable of blocking the lumen of open Luer connectors is needed to facilitate a reduction in the entry of such disinfectants into the connector, thereby lowering the risk of disinfectant entering the bloodstream. Summary of the Invention

[0007] A first aspect of this disclosure relates to a disinfection cap comprising a top wall, cylindrical sidewalls, an open bottom, an open-cell foam structure, and a closed-cell foam structure. The cylindrical sidewalls have an inner surface defining a chamber. The open bottom is formed by the cylindrical sidewalls, which have an opening into the chamber within the housing for receiving a hub of a Luer connector. The open-cell foam structure is disposed within the chamber, adjacent to the top wall of the chamber, and is impregnated with disinfectant fluid in a pre-use state. The closed-cell foam structure is disposed against the open-cell foam structure and is configured to block the hub of the Luer connector for fluid flow. The hub of the Luer connector is received within the inner surface of the chamber.

[0008] In one or more embodiments, the chamber extends substantially from the inner surface of the top wall toward the bottom of the opening of the housing.

[0009] In one or more embodiments, a closed-cell foam structure is formed in an interference fit between the closed-cell foam structure and the inner surface of the housing. In one or more embodiments, an open-cell foam structure is bonded to the closed-cell foam structure. In one or more embodiments, insertion of the Luer connector causes compression of the open-cell foam structure, thereby releasing fluid.

[0010] In one or more embodiments, the closed-cell foam structure has a polygonal shape.

[0011] In one or more embodiments, the closed-cell foam structure has corners of a plurality of corners that are joined to the inner surface of the shell in an interference fit manner.

[0012] In one or more embodiments, a gap is formed between one of the flat portions of the plurality of flat portions and the inner surface of the housing, the gap forming a channel for the flow of disinfectant when the open-cell foam structure is compressed.

[0013] In one or more embodiments, the closed-cell foam structure has a hexagonal shape. In one or more embodiments, the closed-cell foam structure has a pentagonal shape. In one or more embodiments, the closed-cell foam structure has a star shape.

[0014] In one or more embodiments, the closed-cell foam structure has a point among a plurality of points that are interference-fitted to the inner surface of the shell. In one or more embodiments, a gap is formed between an inner point among the plurality of inner points and the inner surface of the shell, the gap forming a channel for the flow of disinfectant when the open-cell foam structure is compressed.

[0015] In one or more embodiments, the closed-cell foam structure has a four-pointed star shape. In one or more embodiments, the closed-cell foam structure has a five-pointed star shape.

[0016] In one or more embodiments, the sterilization cap further includes at least one thread on the outer surface of the housing, the at least one thread being sufficient to interlock with a mating feature of a Luer connector. In one or more embodiments...

[0017] In one or more embodiments, the hub is secured within the inner surface of the chamber by interlocking at least a portion of the at least one thread with a mating feature on the hub of the Luer connector. In one or more embodiments, the inner surface of the chamber is secured by an interference fit with the hub of the Luer connector.

[0018] In one or more embodiments, a removable peelable seal covers the opening leading to the chamber.

[0019] In one or more embodiments, the open-cell foam structure has a polygonal shape. In one or more embodiments, the open-cell foam structure has a star-shaped shape.

[0020] The second aspect of this disclosure relates to a method for manufacturing a disinfection cap, comprising: bonding a closed-cell foam sheet to an open-cell foam sheet to form a bonded open-cell foam structure and a closed-cell foam structure; cutting the bonded open-cell foam structure and the closed-cell foam structure into shape; and inserting the bonded open-cell foam structure and the closed-cell foam structure into a cavity of a shell of a disinfection cap.

[0021] In one or more embodiments, the method further includes impregnating the open-cell foam structure with a disinfectant before inserting the open-cell foam structure and the closed-cell foam structure.

[0022] In one or more embodiments, the method further includes impregnating the open-cell foam structure with a disinfectant through a gap formed between a flat portion of the closed-cell foam structure and the inner surface of the cavity of the shell.

[0023] In one or more embodiments, the method further includes placing a peelable seal on the open end of the housing to seal the chamber and the disinfectant therein. Attached Figure Description

[0024] Figure 1 A front view of a disinfection cap according to an exemplary first embodiment of the present disclosure is shown;

[0025] Figure 2 It shows Figure 1 A 3D image of a disinfection cap;

[0026] Figure 3 It shows along Figure 1 A cross-sectional view of the disinfection cap taken along the axis X-X'.

[0027] Figure 4 It shows Figure 1 A transparent 3D image of the disinfection cap;

[0028] Figure 5A and 5B It shows Figure 1 Side views of the open-cell and closed-cell foam structures of the disinfection cap;

[0029] Figures 6A to 6E It shows Figure 1 A bottom view of the implementation method of the disinfection cap;

[0030] Figure 7 A front view of a second embodiment of an exemplary disinfection cap is shown; and

[0031] Figure 8A cross-sectional view of a third embodiment of an exemplary disinfection cap is shown. Detailed Implementation

[0032] Embodiments of this disclosure relate to a sterilization cap for connecting and sterilizing medical connectors, including a threaded connection. In one or more embodiments, the medical connector is a Luer connector or a pinless connector. In one or more embodiments, the medical connector is a male Luer connector. In one or more embodiments, the medical connector is a female Luer connector. This disclosure aims to provide a mechanism for preventing disinfectant from entering the fluid path of a medical connector while providing effective sterilization of the hub and surrounding periphery of the medical connector.

[0033] Before describing several exemplary embodiments of this disclosure, it should be understood that this disclosure is not limited to the details of the construction or process steps set forth in the following description. This disclosure can have other embodiments and can be practiced or performed in various ways.

[0034] For the purposes described below, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives should be associated with this disclosure as oriented in the accompanying drawings. However, it should be understood that, unless expressly stated to the contrary, this disclosure may take the form of alternative variations and sequences of steps. It should also be understood that the specific apparatus and processes shown in the drawings and described in the following specification are merely exemplary embodiments of this disclosure. Therefore, specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0035] As used in this article, the use of “a,” “one,” and “the” includes both singular and plural forms.

[0036] As used in this article, the term “catheter-related bloodstream infection” or “CRBSI” refers to any infection caused by the presence of a catheter or IV line.

[0037] As used herein, the term "Luer connector" refers to a connecting collar, a standard method for attaching syringes, catheters, needles with needle hubs, IV tubing, etc., to each other. A Luer connector consists of one or more interlocking tubes that taper slightly to remain together even with only a simple pressure / torsion fit. An additional threaded outer edge may optionally be included for added strength. Luer connectors are typically associated with flushing syringes and can interlock and connect to the end portion of a vascular access device (VAD). A Luer connector includes a distal end, a proximal end, an irregularly shaped outer wall, and a shaped central channel for fluid communication from the syringe barrel chamber to the hub of the VAD. The Luer connector also has a distal end channel for releasable attachment of the Luer connector to the hub of the VAD and a proximal end channel for releasable attachment of the Luer connector to the syringe barrel. As used herein, the term "Luer connector" refers to either a male or female Luer connector.

[0038] As used herein, the term "medical device" refers to a conventional medical device having a threaded or interlocking connection with corresponding mating elements. By way of example and not limitation, a syringe may have a threaded connection that is releasably interlocked with a second medical device, such as a catheter, IV line, or needle-free connector. The threaded connection may include an inner lumen defining a fluid path surrounded by a protruding wall having threaded means for attachment to the second medical device.

[0039] As will be readily understood by those skilled in the art, although descriptive terms such as “thread,” “recessed portion,” “plate,” “wall,” “top,” “side,” and “bottom” are used throughout this specification for ease of understanding, they are not intended to limit any components that can be used in combination or alone to implement various aspects of the embodiments of this disclosure.

[0040] Embodiments of the disinfection cap disclosed herein include a housing having a top wall defining a closed distal end, an open proximal end, and a generally cylindrical sidewall extending from the closed end to the open proximal end, the sidewall having an inner surface. A chamber is configured to receive a hub of a pinless connector. In one or more embodiments, the chamber is configured to receive a hub of a threaded pinless connector, having at least one thread on the outer surface of the cylindrical sidewall sufficient to interlock with a mating feature of a threaded connection. Embodiments of the disinfection cap disclose at least one thread of the disinfection cap engaging a mating feature of a threaded connection, more specifically a Luer connection. The cap also includes an open-cell foam structure serving as an absorbent material, configured to release disinfectant fluid upon insertion into the hub of the pinless connector. A closed-cell foam structure resistant to fluid absorption is attached to the open-cell foam structure. The closed-cell foam structure is configured to prevent disinfectant from entering a blocking feature in the fluid path of the hub of the Luer connection. The open-cell and closed-cell foam structures are further configured to be secured within the chamber in a pre-activated state. In one or more embodiments, the open proximal end includes a peripheral flange extending radially outward from the outer surface of the sidewall, defining an end face and an engagement surface for a peelable seal and / or diaphragm element to maintain the sterility of the chamber. The peelable seal reduces or prevents contamination of the chamber during transport and storage of the sterile cap. The peelable seal is typically maintained in a pre-activated state until injection and / or aspiration procedures are performed, during which the peelable seal is removed. The removable seal minimizes potential particulate hazards and also provides a substantially impermeable seal to the chamber prior to use of the sterile cap. The removable seal provides adequate sealing at a range of temperature, pressure, and humidity levels.

[0041] The sterilization cap provides a mechanical barrier for the connector and contains a sterilizing fluid or antimicrobial agent (hereinafter referred to as the "fluid"). The sterilization cap of this disclosure allows implementers to simplify the sterilization process. The matters illustrated in this specification are provided to aid in a comprehensive understanding of exemplary embodiments of this disclosure. Therefore, those skilled in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of this disclosure. Furthermore, for clarity and conciseness, descriptions of well-known functions and structures have been omitted.

[0042] In particular, the implementer can sterilize the needleless connector in a single action by inserting or screwing a sterilizing cap onto it. This causes the blocking feature to prevent fluid from entering the internal cavity of the needleless connector and the fluid path of the hub, while the insertion of the hub of the Luer connector simultaneously releases the fluid, allowing sterilization of the hub and its periphery of the Luer connector due to the compression of the open-cell foam. In one or more embodiments, the sterilizing cap can then be removed by removing or unscrewing it from the Luer connector. In one or more embodiments, the sterilizing cap can remain attached to the Luer connector until ready, thereby providing a closed environment for sterilization.

[0043] In exemplary embodiments of the embodiments disclosed herein, the sterilization cap includes an integral thread or tab and other features in any and all combinations thereof that allow it to engage with a threaded connector of a medical device. In a preferred embodiment, the sterilization cap engages with a Luer connector. Exemplary constructions of connectors, joints, ports, and adapters may include commercially available Luer locks, Luer sliding ports, locking ports, threaded connections, interlocking connections, or other common medical device connectors known in the art.

[0044] Referring now to the accompanying drawings, wherein the same reference numerals in the various views refer to the same or corresponding parts, embodiments of the present disclosure are described below.

[0045] like Figure 1 and 2 As shown, a first aspect of this disclosure relates to a sterilization cap 100, comprising a housing 110 having an upper portion 110A and a lower portion 110B. In one or more embodiments, the lower portion 110B is generally cylindrical, having a cylindrical housing 112. In one or more alternative embodiments, the lower portion 110B may have a tapered lower portion. The upper portion 110A of the housing has inwardly tapering sidewalls. In a further embodiment, the upper portion 110A and the lower portion 110B have generally cylindrical sidewalls. In one or more embodiments, the inner surface 126 of the lower portion 110B of the housing 110 defines a chamber 130 having an open bottom 116 for receiving the hub of a pinless connector or more specifically a Luer connector. In one embodiment, the upper portion 110A and the lower portion 110B are integrally formed, while other embodiments are assembled non-removably or removably using threaded connections, press-fit connections, adhesive connections, or combinations thereof.

[0046] In one or more embodiments, the chamber 130 may be configured to facilitate a loose fit between the chamber 130 and the hub of the Luer connector, wherein the sterilization cap 100 is secured by at least one thread 122 or a set of tabs included on the outer surface of the cylindrical housing 112. The at least one thread 122 on the outer surface of the cylindrical housing 112 is designed in size and thread pattern to engage with a standard ISO-2 type connector. The loose fit allows fluid to flow around the hub of the Luer connector. In a further embodiment, the chamber 130 may be configured as a Luer sliding joint to facilitate an interference fit between the chamber 130 and the hub of the Luer connector. In some embodiments, the interference fit may be configured strong enough that no threaded connection (e.g., the at least one thread 122) is required when the chamber 130 is removably secured to the Luer connector.

[0047] In one or more embodiments, when the hub of the Luer connector is received within the inner surface 126 of the chamber 130, the hub is secured within the chamber 130 of the sterilization cap 100 by interlocking at least a portion of at least one thread 122 with a mating feature on the hub of the Luer connector. In one or more embodiments, at least one thread 122 may include a beveled thread pattern. In one or more embodiments, at least one thread 122 may include a helical thread pattern. Such connectors are commonly used in needle-free connectors and more generally in connectors for sealing catheters and other fluids in medical applications. In some embodiments, the sterilization cap 100 provides a protective shield for the Luer connector when engaged with the threaded portion of the sterilization cap 100 from the Luer connector, whereby at least one thread 122 of the sterilization cap 100 engages and forms a releasable connection therewith.

[0048] Figure 3 The disinfection cap 100 is depicted along the like Figure 1 The cross-sectional view of plane X-X' shown. (See figure) Figure 2As depicted, the chamber 130 of the housing 110 extends from the bottom opening 116 to the top wall 114 of the total length of the housing 110, and the chamber 130 has a generally cylindrical shape. An open-cell foam structure 120 for absorbing and retaining disinfectant is provided within the chamber. The open-cell foam structure is impregnated with disinfectant in a pre-use state. The open-cell foam structure 120 may be configured to abut or abut against the top wall 114. The open-cell foam structure 120 is compressible in both the horizontal and vertical directions, primarily due to the longitudinal advancement of the pinless connector or Luer connector against the open-cell foam structure 120. In one or more embodiments, the open-cell foam structure 120 is dimensionally designed to form an interference fit with the inner surface 126 of the chamber 130, wherein the diameter of the open-cell foam structure 120 is larger than the diameter of the chamber 130. In a preferred embodiment, the open-cell foam structure 120 is dimensionally designed to loosely fit within the chamber, wherein the diameter of the open-cell foam structure 120 is smaller than the diameter of the chamber 130. The open-cell foam structure 120 allows fluid to be discharged as the open-cell foam structure 120 is compressed.

[0049] like Figure 3 and 4 As shown, a closed-cell foam structure 118 is provided near the open-cell foam structure 120. The closed-cell foam structure 118 resists fluid absorption and is configured to prevent disinfectant from entering the fluid path of the Luer connector hub. Figure 5A As shown, in one or more embodiments, the open-cell foam structure 120 and the closed-cell foam structure 118 are two separate monolithic structures, wherein the open-cell foam structure 120 is disposed on top of the closed-cell foam structure 118. Figure 5B As shown, in one or more embodiments, open-cell foam structure 120 and closed-cell foam structure 118 are bonded together as a single unit using adhesive layer 121. In one or more embodiments, open-cell foam structure 120 and closed-cell foam structure 118 are a single porous foam structure having both closed-cell and open-cell foam portions disposed against a top wall 114. In one or more embodiments, open-cell foam structure 120 is independent of closed-cell foam structure 118, with the open-cell foam structure initially disposed within chamber 130 against a top wall 114, and the closed-cell foam structure 118 disposed against open-cell foam structure 120. A pinless connector or Luer connector is advanced into chamber 130 in a longitudinal connection configuration, causing at least open-cell foam structure 120 and, in some embodiments, closed-cell foam structure 118 to compress against the top wall 114.

[0050] In one or more embodiments, the closed-cell foam structure 118 may be made of polyethylene or polyurethane foam. In one or more embodiments, the adhesive may be an EVA bonding layer.

[0051] The closed-cell foam structure 118 is configured to be fixed within the chamber 130 in a pre-activated state. In some embodiments, the closed-cell foam structure 118 forms an interference fit with the inner surface 126 of the chamber 130. The closed-cell foam structure 118 has a non-circular cross-sectional shape. As illustrated in the following embodiments, the non-circular cross-sectional shape is configured to form an interference fit with the inner surface 126 of the chamber 130 while still allowing fluid to flow out from the open-cell foam structure 120 disposed between the top wall 114 and the closed-cell foam structure 118 when the open-cell foam structure 120 is compressed.

[0052] Reference Figures 6A to 6E An embodiment of the cross-sectional shape is shown. For example... Figure 6A , 6B As shown in 6C, in one or more embodiments, the closed-cell foam structure 118 has a polygonal shape, such as a pentagon, hexagon, or rectangle. In such an embodiment, the corners of the plurality of corners 190 of the polygonal shape are interference-fitted to the inner surface 126 of the housing 110, wherein the distance between one or more of the corners of the plurality of corners 190 of the polygonal shape is configured to be dimensionally larger than the diameter of the chamber 130. A gap 192 is formed between the flat portions of the plurality of flat portions 194 and the inner surface 126 of the housing 110. The one or more gaps 192 are configured to allow fluid to flow between the flat portions of the plurality of flat portions 194 and the inner surface 126 of the housing 110. When the open-cell foam structure 120 is compressed and the closed-cell foam structure 118 is compressed due to the longitudinal advancement of the Luer connector 170, disinfectant is discharged from the open-cell foam structure 120 and through the gap 192, thereby disinfecting the hub 174 and the outer periphery of the Luer connector 170. The inner cavity 172 of the closed-cell foam structure 118 fluid-sealed Luer connector 170. The gap 192 forms a fluid channel for the flow of disinfectant when the open-cell foam structure is compressed.

[0053] Reference Figure 6D and 6E In one or more embodiments, the closed-cell foam structure 118 has a star shape, such as a four-pointed star or a five-pointed star. The points of the plurality of points 290 are interference-fitted into the inner surface 126 of the chamber 130, wherein the distance between one or more of the points 290 is configured to be dimensionally larger than the diameter of the chamber 130. A gap 292 is formed between a flat portion of a plurality of flat portions 294 and the inner surface 126 of the housing 110. This gap 292 is configured to allow fluid flow between the flat portions of the plurality of flat portions 294 and the inner surface 126 of the housing 110. The star shape also includes a plurality of internal points 296, thereby forming a larger gap 292 than in embodiments having flat portions 164.

[0054] In one or more embodiments, the closed-cell foam structure is elliptical. (See reference...) Figure 7 In one or more embodiments, the closed-cell foam structure 318 and the open-cell foam structure 320 have the same shape. In one or more embodiments, the closed-cell foam structure 318 and the open-cell foam structure 320 have polygonal shapes such as pentagons, hexagons, or rectangles, or star shapes such as quadrangular or pentagonal stars.

[0055] Reference Figure 8 In one or more embodiments, the sterilization cap 400 includes a housing 410 having an inner surface 426 defining a chamber 430 having an open bottom 416 for receiving a hub 472 of a Luer connector 470. In one or more embodiments, the chamber 430 may be configured to facilitate a loose fit between the chamber 430 and the hub 472 of the Luer connector 470, wherein the sterilization cap 400 is secured by at least one thread 422 or a set of tabs included on the outer surface of the housing. The at least one thread 422 provided on the outer surface of the cylindrical housing is designed in size and thread pattern to engage with a standard ISO-2 type connector of the Luer connector 470. The loose fit allows fluid to flow around the hub 472 of the Luer connector 470. In a further embodiment, the chamber 430 may be configured as a Luer sliding joint to facilitate an interference fit between the chamber 430 and the hub 472 of the Luer connector 470. The interference fit can be configured to be strong enough that it is not necessary to removably fix the chamber 430 to the threaded connection of the Luer connector 470 or the at least one thread 422.

[0056] In one or more embodiments, when the hub 472 of the Luer connector 470 is received within the inner surface 426 of the chamber 430, the hub 472 is secured within the chamber 430 of the sterilization cap 400 by interlocking at least a portion of at least one thread 422 with a mating feature or thread 474 on the hub of the Luer connector 470. In one or more embodiments, the at least one thread 422 may include a beveled thread pattern. In one or more embodiments, the at least one thread 422 may include a helical thread pattern. Such connectors are commonly used in medical applications as connectors for sealing and protecting catheters and other fluids. In some embodiments, the sterilization cap 400 provides a protective shield for the Luer connector when engaged with the thread 474 of the Luer connector 470, engaging at least one thread 422 of the sterilization cap 400 and forming a releasable connection therewith.

[0057] When the open-cell foam structure 420 disposed within the chamber 430 is compressed, and the closed-cell foam structure 418 disposed near the open-cell foam structure 420 is also compressed, disinfectant is discharged from the open-cell foam structure 420 and passes through the gap, thereby disinfecting the hub 472 and the outer periphery of the Luer connector 470. The closed-cell foam structure 418 fluid-seales the inner cavity 476 of the Luer connector 470. The gap forms a fluid channel for the disinfectant to flow through when the open-cell foam structure 420 is compressed.

[0058] Having the same shape for both open-cell and closed-cell foam structures facilitates the manufacture of sterilization caps. In manufacturing, the open-cell foam sheet bonded to the closed-cell foam can be cut into the appropriate shape in a single manufacturing step, rather than bonding pre-cut open-cell foam structures separately to the closed-cell foam structure. One manufacturing method includes bonding a closed-cell foam sheet to an open-cell foam sheet to form a bonded open-cell and closed-cell foam structure, cutting the bonded open-cell and closed-cell foam structures into shape, and inserting the bonded open-cell and closed-cell foam structures into a cavity of a molded housing. In one or more embodiments, the closed-cell and open-cell foam sheets have industrial dimensions. In one or more embodiments, the bonded open-cell and closed-cell foam structures are polygonal, star-shaped, or elliptical in shape.

[0059] In one or more embodiments, the method further includes impregnating the open-cell foam structure with a disinfectant before inserting the combined open-cell foam structure and closed-cell foam structure. In one or more embodiments, the method further includes impregnating the open-cell foam structure with a disinfectant through a gap formed between a flat portion of the closed-cell foam structure and the inner surface of the cavity of the housing.

[0060] The manufacturing method also includes placing a peelable seal at the open end of the housing to seal the chamber and the disinfectant therein.

[0061] By integrating a disinfectant into the chamber 130 of the disinfection cap 100, disinfection can be achieved when used on needle-free connectors or, more specifically, Luer connectors. The disinfectant can be directly contained within the chamber 130. The disinfection cap 100 is configured to interact compatiblely with a variety of disinfectants, antimicrobial agents, or fluids. In one or more embodiments, the disinfectant, antimicrobial agent, or fluid includes variants of alcohol or chlorhexidine.

[0062] In one or more embodiments, the disinfectant is selected from the group consisting essentially of: isopropanol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, oxytetracycline, antibiotics, and mixtures thereof. In a particular embodiment, the disinfectant or antimicrobial agent includes at least one of chlorhexidine gluconate and chlorhexidine acetate. In one or more embodiments, the disinfectant or antimicrobial agent is a fluid or gel.

[0063] In one or more embodiments, the sterilization cap 100 may include a removable peelable seal covering an opening to the chamber 130. In one or more embodiments, the peelable seal includes an aluminum or multilayer polymer film peel coating. In certain embodiments, the peelable seal is heat-sealed or inductively sealed to the open end of the sterilization cap 100. In one or more embodiments, the peelable seal includes a moisture barrier. In some embodiments, the peelable seal is thin enough to be pierced by a Luer connector, allowing the Luer connector to be advanced within the chamber 130 without first removing the peelable seal.

[0064] The sterilization cap 100 is made of any plastic material from a variety of types, such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactic acid, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the sterilization cap 100 comprises polypropylene or polyethylene material.

[0065] In one or more embodiments, the connector for the medical device may be selected from the group consisting essentially of: needleless connectors, catheter Luer connectors, stopcock valves, and hemodialysis connectors on primary IV gravity kits, secondary IV gravity kits, extension kits, and infusion or syringe pump kits. In some embodiments, the sterile cap may be connected to any of a variety of different needleless injection sites. In one or more embodiments, after the sterile cap has been connected to the connector, because the connector will remain uncontaminated when connected to the sterile cap, it is not necessary to sterilize the connector (e.g., treat it with an alcohol swab) before each reconnection to another connector. The sterile cap 100 is used instead of the standard wiping protocol for cleaning the connector.

[0066] Another aspect of this disclosure relates to a method for sterilizing a medical connector. The method includes connecting a sterilization cap 100 of one or more embodiments to a medical connector, wherein the connection includes threaded engagement of the medical connector's threads onto threads on the outer surface of a sidewall of the housing 110 of the sterilization cap when the medical connector is inserted into the sterilization cap 100, such that the medical connector contacts a blocking feature. In one or more embodiments, the blocking feature is a closed-cell foam structure 118.

[0067] It is conceivable that the disinfectant cap 100 disclosed herein and shown in the accompanying drawings can also be used with Luer connectors (including female and male Luer connectors), wherein the blocking feature can be used to block the lumen of the open Luer connector to facilitate a reduction in the entry of such disinfectant into the connector, thereby reducing the risk of disinfectant entering the bloodstream. Therefore, it is conceivable that the disinfectant cap 100 disclosed herein and shown in the accompanying drawings can be used with both male and female Luer connectors.

[0068] While this disclosure has been shown and described with reference to specific exemplary embodiments thereof, those skilled in the art will understand that various changes in form and detail may be made therein without departing from the spirit and scope of embodiments of this disclosure. Furthermore, the housing of the sterilization cap may be molded in a single piece or manufactured by other suitable processes. Moreover, any feature or element of any exemplary embodiment of the present disclosure as described above and shown in the accompanying drawings may be implemented individually or in any combination, as will be readily understood by those skilled in the art, without departing from the spirit and scope of embodiments of this disclosure.

[0069] Furthermore, the included drawings further illustrate non-limiting examples of implementations of specific exemplary embodiments of this disclosure and help describe the associated technology. Apart from the foregoing, any specific or relative dimensions or measurements provided in the drawings are exemplary and not limiting.

[0070] Throughout this specification, the terms "one embodiment," "specific embodiment," "one or more embodiments," or "embodiment" refer to a particular feature, structure, material, or characteristic described in connection with that embodiment, which is included in at least one embodiment of this disclosure. Therefore, the appearance of phrases such as "in one or more embodiments," "in a specific embodiment," "in one embodiment," or "in an embodiment" throughout this specification does not necessarily refer to the same embodiment of this disclosure. Furthermore, specific features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0071] While this disclosure has been described herein with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of this disclosure. It will be apparent to those skilled in the art that various modifications and alterations can be made to the methods and apparatus of this disclosure without departing from the spirit and scope of this disclosure. Therefore, this disclosure is intended to include modifications and alterations within the scope of the appended claims and their equivalents.

Claims

1. A disinfection cap having a housing, the disinfection cap comprising: A top wall and cylindrical sidewalls, the cylindrical sidewalls having an outer surface and an inner surface defining the chamber. The bottom of the opening formed by the cylindrical sidewall has an opening leading to the chamber inside the housing for receiving the hub of the Luer connector; An open-cell foam structure is disposed within the chamber, the open-cell foam structure being adjacent to the top wall of the chamber, and the open-cell foam structure being impregnated with disinfectant fluid in a pre-use state; as well as A closed-cell foam structure is disposed against the open-cell foam structure, the closed-cell foam structure being configured to block the hub of the Luer connector for fluid obstruction, wherein the hub of the Luer connector is received within the inner surface of the chamber, wherein the open-cell foam structure is coupled to the closed-cell foam structure, both the closed-cell foam structure and the open-cell foam structure having the same non-circular cross-sectional shape, the non-circular cross-sectional shape being configured to form an interference fit with the inner surface of the chamber, while allowing fluid to flow out from the open-cell foam structure disposed between the top wall and the closed-cell foam structure when the open-cell foam structure is compressed.

2. The disinfection cap according to claim 1, wherein, The insertion of the Luer connector causes compression of the open-cell foam structure, thereby releasing the fluid.

3. The disinfection cap according to claim 1, wherein, The closed-cell foam structure has a polygonal shape.

4. The disinfection cap according to claim 3, wherein, The closed-cell foam structure has one of a plurality of corners that are joined to the inner surface of the shell in an interference fit manner.

5. The disinfection cap according to claim 4, wherein, A gap is formed between one of the multiple flat portions and the inner surface of the housing, the gap forming a channel for the disinfectant to flow through when the open-cell foam structure is compressed.

6. The disinfection cap according to claim 3, wherein, The closed-cell foam structure has a hexagonal shape.

7. The disinfection cap according to claim 3, wherein, The closed-cell foam structure has a pentagonal shape.

8. The disinfection cap according to claim 1, wherein, The closed-cell foam structure has a star shape.

9. The disinfection cap according to claim 8, wherein, The closed-cell foam structure has one of a plurality of points that are joined to the inner surface of the shell in an interference fit manner.

10. The disinfection cap according to claim 9, wherein, A gap is formed between one of the plurality of internal cusps and the inner surface of the housing, the gap forming a channel for the flow of disinfectant when the open-cell foam structure is compressed.

11. The disinfection cap according to claim 3, wherein, The closed-cell foam structure has a four-point star shape.

12. The disinfection cap according to claim 3, wherein, The closed-cell foam structure has a five-pointed star shape.

13. The disinfection cap according to claim 1, further comprising at least one thread on the outer surface of the housing, the at least one thread being sufficient to interlock with the mating feature of the Luer connector.

14. The disinfection cap according to claim 5, wherein, The hub is secured within the inner surface of the chamber by interlocking at least a portion of at least one thread with a mating feature on the hub of the Luer connector.

15. The disinfection cap according to claim 1, wherein, A removable, peelable seal covers the opening leading to the chamber.

16. The disinfection cap according to claim 1, wherein, The open-cell foam structure has a polygonal shape.

17. The disinfection cap according to claim 1, wherein, The open-cell foam structure has a star shape.

18. A method for manufacturing a disinfection cap according to claim 1, comprising: By bonding closed-cell foam sheets to open-cell foam sheets, a combined open-cell foam structure and a closed-cell foam structure are formed. The combined open-cell foam structure and closed-cell foam structure are cut into shape. as well as The combined open-cell foam structure and closed-cell foam structure are inserted into the cavity of the housing of the sterilization cap.

19. The manufacturing method according to claim 18, further comprising: Before inserting the combined open-cell foam structure and closed-cell foam structure, the combined open-cell foam structure is impregnated with a disinfectant.

20. The manufacturing method according to claim 18, further comprising: An open-cell foam structure is formed by impregnating the gap between the flat portion of the closed-cell foam structure and the inner surface of the chamber of the shell with a disinfectant.

21. The manufacturing method according to claim 18, further comprising: A peelable seal is placed at the open end of the housing to seal the chamber and the disinfectant inside the chamber.

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