Disinfection Cap

Abstract

A disinfection cap for connecting to a medical connector is described. The disinfection cap includes a housing having a top wall and a side wall forming a cavity. In one or more embodiments, a retention rod forming a fluid reservoir is disposed within the cavity to hold a disinfectant. In one or more embodiments, a corrugated capsule is disposed within the cavity to hold the disinfectant. An increase in pressure within the cavity due to insertion of a luer connector results in the expulsion of the disinfectant, thereby disinfecting the luer connector.

Description

[Technical Field]

[0001] The present disclosure relates to a disinfection cap device for disinfecting a corresponding medical connector. The present disclosure generally relates to a device for disinfecting and sterilizing an access port of a medical connector having a fitting. In general, the present disclosure also relates to the field of threaded or interlocking fittings, including medical caps and medical disinfection caps, particularly caps or disinfection caps for use with threaded fluid connectors. The present disclosure also relates to a male disinfection cap device for disinfecting a male-threaded Luer connector. [Background technology]

[0002] 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. Bacteria and other microorganisms can enter a patient's vascular system through the access hub, port, or valve connected to the VAD for administering medical fluids or medications. Each access hub, port, valve, or connector is associated with some risk of transmitting a catheter-related bloodstream infection (CRBSI), which can be costly and potentially fatal. To reduce CRBSI cases and ensure VADs are properly used and maintained, standards of practice, including disinfection and cleaning procedures, have been developed. Antiseptic caps have been added to the Society for Healthcare Epidemiology of America (SHEA) and Infusion Nurse Standards (INS) guidelines.

[0003] In developed markets, when using IV catheters, needleless connectors are typically used to close the system, which is then accessed to administer medications or other necessary fluids to the patient via the catheter. INS practice guidelines recommend the use of needleless connectors, stating that they should be "consistently and thoroughly disinfected with alcohol, iodine tincture, or a chlorhexidine gluconate / alcohol combination before each access." Disinfection of needleless connectors is intended to help reduce bacteria that may reside on their surfaces, which could ultimately cause various catheter-related complications, including CRBSI. Nurses typically complete this disinfection process by using a 70% isopropyl alcohol (IPA) pad, a process known as "wiping the hub." However, compliance with this practice is generally very low. In addition to a lack of compliance with "wiping the hub," interviews with clinicians also revealed frequent variations in the wiping time, drying time, and number of times needleless connectors are wiped.

[0004] There is an increasing need to protect female and male Luer connectors to reduce central line-associated bloodstream infections (CLABSIs) and peripheral line-associated bloodstream infections (PLABSIs). Threaded male Luer connections on intravenous gravity sets and syringes are subject to contamination if not properly protected. Currently, when an IV connector is disconnected from a central or peripheral line to temporarily stop an infusion, nurses often loop the male Luer connector into a Y-site needleless connector or wrap the male Luer connector in a wipe or cloth saturated with isopropyl alcohol (IPA). However, such protection is very weak and does not adequately protect the Luer from contact contamination. Male disinfection caps have become the most advanced disinfection and protection device for disinfecting male Luer connectors and forming a physical barrier around the male Luer connector to prevent microbial growth.

[0005] There are many risks of contact or contamination throughout the sequence of procedures associated with the transmission of microorganisms that can result in CRBSI. As an example, contamination can occur during mixing of medications, attachment of the cannula, and insertion into the access hub. Furthermore, threaded male luer connectors are open luers with exposed lumens. Because the procedure for connecting to a VAD is so common and simple, the risks associated with entering the patient's vascular system are often overlooked. Currently, the risk to the hospital and patient is substantially a function of the diligence of the clinician making the connection, and this diligence is largely uncontrollable. Summary of the Invention [Problem to be solved by the invention]

[0006] Disinfectants generally have a threshold limit for systemic exposure upon injection into the bloodstream due to the biotoxicity of the disinfectant at high doses. Thus, a need exists for a disinfection device that can occlude the open luer lumen to facilitate mitigating the ingress of such disinfectants into connectors, thereby reducing the risk of the disinfectant entering the bloodstream. A need exists for a mechanism to prevent the disinfectant from entering the lumen and fluid pathway while providing effective disinfection of the surrounding connector or fitting. [Means for solving the problem]

[0007] overview A first aspect of the present disclosure relates to a disinfection cap having a cylindrical sidewall, a cavity, and an open bottom. The cylindrical sidewall has an inner surface that defines the cavity and a top wall. The open bottom is formed by the cylindrical sidewall with an opening to the cavity in the housing for receiving a hub of a luer connector. The disinfection cap further includes a retention rod disposed within the cavity, the retention rod having a proximal flange, a distal flange, and an elongated rod between the proximal and distal flanges, the distal flange of the retention rod abutting the top wall of the cavity. A fluid reservoir is defined between the inner surface of the housing, the proximal flange of the retention rod, and the distal flange of the retention rod. A disinfectant is disposed within the fluid reservoir, and the disinfectant is initially retained within the fluid reservoir. The hub of the luer connector is received within the inner surface of the cavity.

[0008] In one or more embodiments, the diameter of the proximal flange of the retention rod is equal to or slightly larger than the diameter of the proximal portion of the cavity and is configured to have a sufficient interference fit between the proximal flange of the retention rod and the proximal portion of the cavity to form a fluid seal.

[0009] In one or more embodiments, the diameter of the elongate rod is configured to bend to a final state upon insertion of the Luer connector hub when the Luer connector hub is received within the cavity, thereby breaking the fluid seal between the proximal flange and the proximal portion of the cavity and releasing disinfectant into the cavity to disinfect the Luer connector hub and surrounding area.

[0010] In one or more embodiments, at least one circular fin is disposed on the elongate rod, the at least one fin having a thickness configured to elastically deform, whereby an increase in pressure within the fluid reservoir due to insertion of the Luer connector results in deformation of the at least one fin.

[0011] In one or more embodiments, the diameter of the elongate rod is configured to compress upon insertion of the hub of the luer connector when the hub of the luer connector is received within the cavity.

[0012] In one or more embodiments, the diameter of the distal flange is equal to or greater than the diameter of the distal portion of the cavity and is configured to form an interference fit sufficient to removably retain the retention rod within the cavity.

[0013] In one or more embodiments, the distal flange of the retention rod is adhesively attached to the top wall of the cavity. In one or more embodiments, the distal flange of the retention rod is chemically bonded to the top wall of the cavity. In one or more embodiments, the distal flange of the retention rod is integrally formed with the top wall of the cavity.

[0014] In one or more embodiments, a luer connector hub is received within the interior surface of the cavity. In one or more embodiments, the disinfection cap is secured by at least one thread or a set of tabs included on the exterior surface of the housing, the at least one thread being sized and having a thread pattern that will engage with a standard ISO-2 type luer fitting. In one or more embodiments, when the luer connector hub is received within the interior surface of the cavity, the hub is secured within the disinfection cap cavity by interlocking at least a portion of the at least one thread with a mating structure on the luer connector hub. In one or more embodiments, the cavity is configured to facilitate a loose fit between the cavity and the luer connector hub.

[0015] A second aspect of the present disclosure relates to a disinfection cap having a cylindrical sidewall, a cavity, an open bottom, and a corrugated capsule disposed within the cavity. The cylindrical sidewall has an inner surface defining the cavity and a top wall. The open bottom is formed by the cylindrical sidewall with an opening to the cavity within the housing for receiving a hub of a luer connector. The corrugated capsule has a proximal surface, a distal surface, and an elongated body between the proximal and distal surfaces, the distal surface of the corrugated capsule abutting the top wall of the cavity, and the corrugated capsule has a fluid reservoir. A disinfectant is disposed within the fluid reservoir, and the disinfectant is initially retained within the fluid reservoir. The hub of the luer connector is received within the inner surface of the cavity.

[0016] In one or more embodiments, the elongate body further includes at least one or more corrugations configured to collapse together upon application of pressure to the proximal surface by insertion of the hub into the cavity of the housing.

[0017] In one or more embodiments, the corrugated capsule further includes a slit in fluid communication with the fluid reservoir, the slit being located on a proximal surface of the corrugated capsule. In one or more embodiments, in an initial, uncompressed state, the slit is fluidly closed and the fluid reservoir retains the disinfectant due to negative pressure within the fluid reservoir. In one or more embodiments, compression of the elongate body by insertion of the hub of the luer connector causes the at least one corrugation to collapse against one another, creating a pressure increase within the reservoir, which causes the slit to deform and open, allowing the disinfectant to be released through the slit and disinfect the hub and surrounding area of ​​the luer connector.

[0018] In one or more embodiments, the corrugated capsule further includes a plurality of perforations in fluid communication with the fluid reservoir, the plurality of perforations being disposed on the elongate body of the corrugated capsule, hi one or more embodiments, the plurality of perforations being disposed in at least one row of perforations, the at least one row of perforations being disposed longitudinally on the elongate body.

[0019] In one or more embodiments, in the initial, uncompressed state, the plurality of perforations are fluidly closed and the fluid reservoir retains the antiseptic due to negative pressure within the fluid reservoir.

[0020] In one or more embodiments, compression of the elongate body by insertion of the luer connector hub causes at least one corrugation to collapse against one another, resulting in an increase in pressure within the reservoir, which causes the multiple perforations to deform and open, releasing disinfectant from the multiple perforations to disinfect the luer connector hub and surrounding area.

[0021] In one or more embodiments, the distal surface of the corrugated capsule further includes an opening extending therethrough.

[0022] In one or more embodiments, the proximal surface of the corrugated capsule is an open proximal surface. In one or more embodiments, the disinfection cap further includes an end cap that abuts the engagement surface of the open proximal surface. In one or more embodiments, the end cap includes a plurality of apertures, the plurality of apertures configured to be disposed around the periphery of the end cap. In one or more embodiments, the plurality of apertures are disposed a fixed distance away from the center of the end cap and do not direct fluid flow into the lumen of the hub of the Luer connector.

[0023] In one or more embodiments, in the initial, uncompressed state, the plurality of apertures are configured to prevent negative pressure in the fluid reservoir from expelling the sanitizing agent, and in one or more embodiments, in the final, compressed state, an increase in pressure causes the sanitizing agent to be expelled through the plurality of apertures to sanitize the hub and surrounding area of ​​the luer connector.

[0024] A third aspect of the present disclosure relates to a disinfection cap having a cylindrical sidewall, a cavity, and a corrugated capsule disposed within the cavity. The cylindrical sidewall has an inner surface defining the cavity and a top wall. An open bottom is formed by the cylindrical sidewall with an opening to the cavity within the housing for receiving a hub of a luer connector. The corrugated capsule is disposed within the cavity, the corrugated capsule having an open proximal end, a closed distal end, and an elongated body between the open proximal end and the closed distal end, the distal end of the corrugated capsule abutting the top wall of the cavity, and the corrugated capsule has a fluid reservoir. A disinfectant is disposed within the fluid reservoir, and the disinfectant is retained within the fluid reservoir in an initial state. A piston is disposed relative to the open proximal end. The hub of the luer connector is received within the inner surface of the cavity.

[0025] In one or more embodiments, the elongate body further includes at least one corrugation configured to collapse against one another upon application of pressure to the proximal surface by insertion of the hub into the cavity of the housing.

[0026] In one or more embodiments, the housing further includes two wing-like protrusions disposed on a distal portion of the housing.

[0027] In one or more embodiments, the piston includes a proximal portion and a distal portion, the proximal portion having a diameter equal to or slightly smaller than the diameter of the corrugated capsule, the distal portion having a diameter substantially equal to the diameter of the fluid reservoir, and the distal portion having a diameter configured to be disposed within the corrugated capsule and form a fluid-tight seal.

[0028] In one or more embodiments, the piston further includes a plurality of openings extending from the distal portion of the corrugated capsule to the proximal end of the corrugated capsule, the plurality of openings being in fluid communication with the fluid reservoir and configured to release the disinfectant upon compression of the corrugated capsule.

[0029] In one or more embodiments, the piston further includes a plurality of directional channels disposed on a proximal surface of a proximal portion of the piston, the plurality of directional channels configured to direct the disinfectant toward the periphery of the luer hub of the luer connector.

[0030] In one or more embodiments, the plurality of directional channels are configured to be disposed on the periphery of the proximal face of the piston, the plurality of directional channels being disposed a distance away from the center of the proximal face so as not to direct fluid flow into the lumen of the hub of the Luer connector. [Brief explanation of the drawings]

[0031] [Figure 1] 1 is a front view of a disinfection cap according to a first exemplary embodiment of the present disclosure. FIG. [Figure 2] 2 is a side perspective front view of the disinfection cap of FIG. 1 according to the first embodiment. FIG. [Figure 3A] 2 is a cross-sectional view of a retaining rod disposed in the disinfection cap of FIG. 1 along the axis XX′ of the disinfection cap. [Figure 3B] FIG. 2 is a perspective exploded view of the disinfection cap of FIG. 1 according to the first embodiment. [Figure 4A] 2 is a perspective view of a retaining rod disposed within the disinfection cap of FIG. 1 according to a first embodiment. [Figure 4B] FIG. 2 is a side view of the retaining rod of the disinfection cap of FIG. 1. [Figure 4C] FIG. 2 is a side view of the retaining rod of the disinfection cap of FIG. 1. [Figure 4D] FIG. 2 is a side view of the retaining rod of the disinfection cap of FIG. 1. [Figure 5] FIG. 10 is a cross-sectional front view of a disinfection cap and a retaining rod disposed within the disinfection cap, according to a second exemplary embodiment of the present disclosure. [Figure 6A] FIG. 10 is a perspective view of a retaining rod according to a second embodiment of the present disclosure. [Figure 6B] 6 is a side view of the retaining rod of the disinfection cap of FIG. 5 in an initial, uncompressed state. [Figure 6C] 6 is a side view of the retaining rod of the disinfection cap of FIG. 5 in a final compressed state. [Figure 7] FIG. 10 is a side perspective cross-sectional view of a disinfection cap and a corrugated capsule disposed therein according to a third exemplary embodiment of the present disclosure. [Figure 8A] FIG. 8 is a perspective view of the corrugated capsule of the disinfection cap of FIG. 7. [Figure 8B] FIG. 8 is a perspective view of the corrugated capsule of the disinfection cap of FIG. 7. [Figure 8C] FIG. 8 is a perspective view of the corrugated capsule of the disinfection cap of FIG. 7. [Figure 9A] FIG. 10 is a side perspective cross-sectional view of a disinfection cap and a corrugated capsule disposed therein according to a fourth exemplary embodiment of the present disclosure. [Figure 9B] FIG. 9B is a perspective view of the corrugated capsule of the disinfection cap of FIG. 9A. [Figure 10] FIG. 10 is an exploded view of a disinfection cap and a corrugated capsule and end cap disposed therein according to a fifth exemplary embodiment of the present disclosure. [Figure 11A] FIG. 11 is a perspective view of the corrugated capsule of the disinfection cap of FIG. 10. [Figure 11B]FIG. 11 is a perspective view of the corrugated capsule of the disinfection cap of FIG. 10. [Figure 11C] FIG. 11 is a perspective view of the corrugated capsule of the disinfection cap of FIG. 10. [Figure 11D] FIG. 11 is a perspective view of the end cap of the disinfection cap of FIG. 10. [Figure 12] 11 is a cross-sectional view of the corrugated capsule and end cap abutting the hub of the luer connector according to the fifth embodiment of FIG. 10. FIG. [Figure 13A] FIG. 10 is a perspective view of a disinfectant cap according to a sixth exemplary embodiment of the present disclosure. [Figure 13B] FIG. 13B is a cross-sectional view of the antiseptic cap according to the sixth embodiment of FIG. 13A. [Figure 13C] 13B is an exploded view of the antiseptic cap according to the sixth embodiment of FIG. 13A. FIG. [Figure 14A] FIG. 13B is a perspective view of the piston of the disinfection cap of FIG. 13A. [Figure 14B] FIG. 13B is a perspective view of the piston of the disinfection cap of FIG. 13A. [Figure 15A] FIG. 13B is a cross-sectional view of the corrugated capsule and piston of the disinfection cap of FIG. 13A. [Figure 15B] FIG. 13B is a perspective view of the corrugated capsule and piston of the disinfection cap of FIG. 13A. DETAILED DESCRIPTION OF THE INVENTION

[0032] Detailed Description

[0003] Embodiments of the present disclosure relate to a disinfection cap for connecting to a medical connector including a threaded connection and disinfecting the medical connector. In one or more embodiments, the medical connector is a luer connector or a needleless 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. The present disclosure aims to provide a mechanism for preventing disinfectants from entering the fluid pathway of the medical connector while providing effective disinfection of the hub and surrounding periphery of the medical connector.

[0033] Before describing some example embodiments of the present disclosure, it is to be understood that the present disclosure is not limited to the details of structure or method steps set forth in the following description. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0034] For purposes of the following description, the terms "upper," "lower," "longitudinal," and derivatives thereof will refer to the present disclosure as oriented in the drawing figures. However, it should be understood that the present disclosure may contemplate alternative variations and sequences of steps, unless expressly specified to the contrary. It should also be understood that the specific devices and steps illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present disclosure. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0035] As used herein, the use of "a," "an," and "the" includes the singular and the plural.

[0036] As used herein, the term "catheter-related bloodstream infection" or "CRBSI" refers to any infection resulting from the presence of a catheter or IV line.

[0037] As used herein, the term "Luer connector" refers to a connecting collar, which is a standard method of attaching syringes, catheters, hub needles, IV tubing, etc. to one another. Luer connectors consist of one or more connecting tubes, slightly tapered to hold them together with a simple pressure / twist fit. Luer connectors optionally include an additional outer rim for threading, making them more secure. Luer connectors are commonly associated with flush syringes and can couple and connect with the end placed in a vascular access device (VAD). Luer connectors consist of a distal end, a proximal end, an irregularly shaped outer wall, and a contoured central passage for fluid communication from the chamber of the syringe barrel to the hub of the VAD. Luer connectors also have a distal end channel that releasably attaches the Luer connector to the hub of the VAD and a proximal end channel that releasably attaches the Luer connector to the syringe barrel. As used herein, the term "Luer connector" refers to a male Luer connector or a female Luer connector.

[0038] As used herein, the term "medical device" refers to a general medical device having a threaded or interlocking connection, the connection having a corresponding coupling element. By way of example and not limitation, a syringe may have a threaded connection that releasably couples with a secondary medical device, such as a needleless connector for a catheter, IV line, or the like. The threaded connection may include a lumen defining a fluid pathway surrounded by a protruding wall having threaded means for attachment to the secondary medical device.

[0039] As will be readily understood by one of ordinary skill in the relevant art, descriptive terms such as "screw," "taper," "tab," "wall," "top," "side," "bottom," and the like are used throughout this specification for ease of understanding, but are not intended to limit any components that may be used in combination or individually to implement various aspects of embodiments of the present disclosure.

[0040] An embodiment of the presently disclosed antiseptic cap includes a housing having a top wall defining a closed distal end, an open proximal end, and a substantially cylindrical sidewall extending from the closed end to the open proximal end, the sidewall having an inner surface. The cavity is configured to receive a hub of a needleless connector. In one or more embodiments, the cavity is configured to receive a hub of a threaded needleless connector. In one or more embodiments, the antiseptic cap has at least one thread on the outer surface of the cylindrical sidewall sufficient to couple with a mating structure of a threaded connection. An embodiment of the antiseptic cap discloses that the at least one thread of the antiseptic cap engages with the mating structure of the threaded connection, more specifically, a Luer connection. The cap further includes a capsule having a perforation that serves as an antiseptic liquid reservoir configured to release antiseptic liquid upon insertion of the hub of the needleless connector. The capsule is further configured as an occlusion structure for fluidly occluding the open lumen of the luer connector upon insertion into the cavity of the housing to prevent ingress of disinfectant into the open luer. In one or more embodiments, the open proximal end of the housing includes a peripheral ledge extending radially outward from the outer surface of the sidewall, defining an end face and an engagement surface for a removable seal and / or septum to maintain sterility of the cavity. The removable seal reduces or prevents contamination of the cavity during shipping and storage of the disinfection cap. The removable seal generally remains sealed in a pre-activated state until immediately prior to connection to a VAD or injection and / or aspiration procedure, at which time the peelable seal is removed. The peelable seal minimizes the intrusion of potential particulate hazards and provides a substantially impermeable enclosure for the cavity prior to use of the disinfection cap. The removable seal provides a sufficient seal over a range of temperatures, pressures, and humidity levels. In one or more embodiments, the removable seal is a peel seal.

[0041] The disinfection cap provides a mechanical barrier to the connector and contains a disinfectant or antibacterial agent (hereinafter referred to as "fluid"). The disinfection cap of the present disclosure allows practitioners to streamline the disinfection process. The matters illustrated herein are provided to facilitate a comprehensive understanding of the exemplary embodiments of the present 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 the present disclosure. Additionally, descriptions of well-known functions and structures are omitted for clarity and conciseness.

[0042] In particular, a practitioner can disinfect a needleless connector in a single action by inserting or threading a disinfection cap onto a needleless connector of a medical device, causing an occlusion to prevent fluid from entering the fluid path of the hub of the needleless connector, while inserting the hub of the luer connector simultaneously causes fluid to escape, allowing the luer connector hub and its surroundings to be disinfected. In one or more embodiments, the disinfection cap can then be removed by unscrewing or unscrewing the disinfection cap from the luer connector. In one or more embodiments, the disinfection cap can remain connected to the luer connector until ready for use, providing a disinfected, closed environment.

[0043] In exemplary implementations of embodiments of the present disclosure, the antiseptic cap includes integrated threads or tabs and other structures, in any and all combinations, that allow it to couple with a threaded fitting of a medical device. In preferred embodiments, the antiseptic cap couples with a Luer fitting. Exemplary structures of couplers, fittings, ports, and adapters may include commercially available Luer locks, Luer slip ports, locking ports, threaded connections, interlocking connections, or other common medical device fittings known in the art.

[0044] Referring now to the drawings, wherein like reference numerals indicate identical or corresponding parts throughout the several views, embodiments of the present disclosure are described below.

[0045] As depicted in FIGS. 1 , 2A, and 2B, a first embodiment of the present disclosure relates to an antiseptic cap 100 including a housing 110 having a distal portion 110A and a proximal portion 110B. In one or more embodiments, the proximal portion 110B is substantially cylindrical. In one or more embodiments, the proximal portion 110B is tapered. In one or more embodiments, the distal portion 110A of the housing is tapered. In further embodiments, the distal portion 110A and the proximal portion 110B are substantially cylindrical. In one or more embodiments, an inner surface 126 of the proximal portion 110B of the housing 110 defines a cavity 130 having an open bottom 116 for receiving a needleless connector, more specifically, a hub of a Luer connector. In one embodiment, the distal portion 110A is integrally formed with the proximal portion 110B. Further alternative embodiments are permanently or removably assembled with threaded connections, press fit connections, adhesive connections, or combinations thereof.

[0046] As shown in FIG. 3A , cavity 130 includes a proximal portion 132, a distal portion 134, and an intermediate portion 136 between proximal portion 132 and distal portion 134. In one or more embodiments, proximal portion 132 has an inwardly tapered shape, tapering inward from open bottom 116 toward intermediate portion 136. In one or more embodiments, distal portion 134 has a cylindrical shape. Intermediate portion 136 has a cylindrical shape. Distal portion 134 has a rounded or inwardly tapered shape, tapering inward from intermediate portion 136 toward top wall 114. In one or more embodiments, distal portion 134 has a rounded or chamfered transition from distal portion 134 to top wall 114.

[0047] In one or more embodiments, the cavity 130 is configured to facilitate a loose fit between the cavity 130 and the hub of a Luer connector, and the disinfection cap 100 is secured by at least one thread 122 or a set of tabs included on the exterior of the housing 110, the at least one thread 122 being located on the proximal portion 110B. The at least one thread 122 located on the exterior of the housing 110 is sized and has a thread pattern that will engage with a standard ISO-2 type Luer fitting. The loose fit allows fluid to flow around the hub of the Luer connector. In further embodiments, the cavity 130 is configured as a Luer slip fitting, facilitating an interference fit between the cavity 130 and the hub of the Luer connector. In one or more embodiments, the interference fit is configured to be sufficiently strong so that a threaded connection or at least one screw 122 is not required to removably secure the cavity 130 to the Luer connector.

[0048] In one or more embodiments, when the hub of a Luer connector is received within the inner surface 126 of the cavity 130, the hub is secured within the cavity 130 of the disinfection cap 100 by interlocking at least a portion of the at least one thread 122 with a mating structure on the hub of the Luer connector. In one or more embodiments, the at least one thread 122 can include an oblique thread pattern. In one or more embodiments, the at least one thread 122 can include a helical thread pattern. Such connectors are commonly and typically used as catheters and other fluid-tight protective connectors in medical applications. In some embodiments, the disinfection cap 100 is engaged with the connector and provides a protective cover for the Luer connector when threads from the Luer connector engage with the at least one thread 122 of the disinfection cap 100 to form a releasable connection.

[0049] FIG. 3A depicts a cross-sectional view of the disinfection cap 100 taken along the XX′ plane shown in FIG. 1 . FIG. 3B depicts an exploded view of the disinfection cap 100, which has a retention rod 150 disposed therein. As depicted in FIGS. 3A and 3B , the cavity 130 of the housing 110 extends from the open bottom 116 to the top wall 114, a portion of the overall length of the housing 110. The cavity 130 has a substantially cylindrical shape. The retention rod 150, configured as a fluid reservoir 160 for holding a disinfectant, is disposed within the cavity 130. The retention rod includes a proximal flange 152, a distal flange 154, and an elongated rod 156 extending from the proximal flange 152 and the distal flange 154. The retention rod 150 has a height from the proximal flange 152 to the distal flange 154, which is equal to or slightly less than the height of the cavity 130. In one or more embodiments, the proximal flange 152 and the distal flange 154 have equal diameters. In one or more embodiments, the diameter of the proximal flange 152 is smaller than the diameter of the distal flange 154.

[0050] 3B and 3C , the retention rod 150 is disposed within the cavity 130 of the housing 110. The distal flange 154 abuts the top wall 114. A fluid reservoir 160 is defined between the inner surface 126 of the housing 110, the proximal flange 152, and the distal flange 154. The diameter of the proximal flange 152 is equal to or slightly larger than the diameter of the proximal portion 132 of the cavity 130, forming an interference fit sufficient to form a fluid seal between the proximal flange 152 and the proximal portion 132 of the cavity 130. The diameter of the distal flange 154 is equal to or larger than the diameter of the distal portion 134, forming an interference fit sufficient to removably retain the retention rod 150 within the cavity 130. In one or more embodiments, the retention rod 150 is integrally formed with the housing 110 and connects a distal flange 154 to the top wall 114 of the housing 110. In one or more embodiments, the distal flange 154 is chemically bonded to the top wall 114 of the housing 110 with an adhesive.

[0051] As shown in FIGS. 4A-4C , elongate rod 156 is configured to bend upon insertion of the luer connector hub when the luer connector hub is received within cavity 130. In its initial, unbent state, shown in FIGS. 3A and 4B , retention rod 150 retains disinfectant within fluid reservoir 160. In its final, bent state, shown in FIG. 4C , elongate rod 156 bends and elastically deforms, thereby breaking the fluid seal between proximal flange 152 and proximal portion 132 of cavity 130. Breaking the fluid seal opens the fluid reservoir and releases disinfectant into cavity 130, disinfecting the luer connector hub and surrounding area. In one or more embodiments, proximal flange 152 flexes, thereby breaking the fluid seal between proximal flange 152 and proximal portion 132 of cavity 130, as shown in FIG. 4C .

[0052] In one or more embodiments, the proximal flange 152 fits over the hub of a male luer connector upon insertion of the male luer connector. In one or more embodiments, the elongated rod 156 bends into a toroidal configuration while the proximal flange 152 does not rotate.

[0053] In an alternative embodiment, compression of the retaining rod 150 causes the proximal flange 152 to bend and rotate, as depicted in FIG. 4D.

[0054] In some embodiments, the retaining rod 150 is made of a flexible TPE material, or more generally, a non-rigid plastic, allowing the retaining rod 150 to flex and bend upon application of pressure by insertion of the luer connector into the cavity 130.

[0055] According to a second embodiment of the present disclosure and as shown in FIGS. 5 and 6A-6C, an exemplary retention rod 250 of the second embodiment of the disinfection cap 200 is disclosed. The retention rod 250 of the second embodiment is disposed within the cavity 130 of the housing 110. The retention rod 250 includes a proximal flange 252, a distal flange 254, an elongated rod 256 extending from the proximal flange 152 and the distal flange 154, and at least one circular fin 258 disposed on the elongated rod 256. The distal flange 254 abuts the top wall 114 of the housing 110. The retention rod 250 has a height from the proximal flange 252 to the distal flange 254 that is equal to or slightly less than the height of the cavity 130. In one or more embodiments, the proximal flange 252 and the distal flange 254 have equal diameters. In one or more embodiments, the diameter of the proximal flange 252 is smaller than the diameter of the distal flange 254. The at least one circular fin 258 has a diameter that is smaller than or equal to the diameter of the intermediate portion 136 of the cavity 130.

[0056] In one or more embodiments, the diameter of the at least one circular fin 258 is configured to form an interference fit with the intermediate portion 136 of the cavity 130. In one or more embodiments, the interference fit between the at least one circular fin 258 and the intermediate portion 136 forms a fluid-tight seal. In one or more embodiments, the at least one circular fin 258 is configured to flex and elastically deform, thereby breaking the fluid-tight seal between the at least one circular fin 258 and the intermediate portion 136. In one or more embodiments, the at least one circular fin 258 provides structural support and rigidity to the retaining rod 250. In one or more embodiments, the at least one circular fin 258 is configured to be flexible enough to allow fluid to leak upon compression, but not completely block the fluid upon pressure increase. The at least one circular fin 258 is configured to increase surface area and increase surface tension to better retain fluid.

[0057] As shown in FIGS. 6A-6C, the diameter of elongate rod 256 is configured to compress upon insertion of the luer connector hub when the luer connector hub is received within cavity 130. In its initial, uncompressed state, as shown in FIGS. 5, 6A, and 6B, retention rod 250 retains antiseptic within fluid reservoir 260. In its compressed state, as shown in FIG. 6C, elongate rod 256 is compressed and elastically deforms, thereby breaking the fluid seal between proximal flange 252 and proximal portion 232 of cavity 130. Breaking the fluid seal releases the fluid reservoir and releases antiseptic into cavity 230, disinfecting the luer connector hub and surrounding area. In one or more embodiments, proximal flange 252 flexes, thereby breaking the fluid seal between proximal flange 252 and proximal portion 232 of cavity 130, as shown in FIG. 6C. The at least one fin 258 has a thickness configured to elastically deform, such that an increase in pressure within the fluid reservoir 260 results in deformation of the at least one fin 258. The retaining rod 150 is made of a flexible TPE material configured to flex and bend.

[0058] According to a third embodiment of the present disclosure, and as shown in FIGS. 7 and 8A-8C , an exemplary corrugated capsule 350 of the third embodiment of the disinfection cap 300 is disclosed. The third embodiment of the corrugated capsule 350 is disposed within the cavity 130 of the housing 110. The corrugated capsule 350 includes a proximal surface 352, a distal surface 354, and an elongated cylindrical body 356 extending from the proximal surface 352 and the distal surface 354. The distal surface 354 abuts the top wall 114 of the housing 110. The elongated body 356 includes at least one corrugation 358 configured to collapse against each other upon application of pressure to the proximal surface 352 by insertion of a luer connector hub into the cavity 130 of the housing 120. The elongated body 356 has a height from the proximal surface 352 to the distal surface 354 that is equal to or slightly less than the height of the cavity 130. In one or more embodiments, the proximal surface 352 and the distal surface 354 have equal diameters. In one or more embodiments, the diameter of the proximal surface 352 is smaller than the diameter of the distal surface 354.

[0059] 8A and 8B , the proximal surface 352 includes a slit 362 in fluid communication with a fluid reservoir 360, which is defined by a cavity within the elongated cylindrical body 356 extending from the proximal surface 352 to the distal surface 354. The slit 362 is disposed in the proximal surface 352. The distal surface 354 of the corrugated capsule 350 abuts the top wall 114 of the cavity 130 of the housing 110. In the initial, uncompressed state, the slit 362 is fluidly closed, and the fluid reservoir 360 retains antiseptic due to the negative pressure within the fluid reservoir 360. In the final, compressed state, compression of the elongated cylindrical body 356 by insertion of the hub of the Luer connector causes at least one corrugation 358 to collapse against one another, resulting in an increase in pressure within the reservoir 360. The increased pressure causes the slit 362 to deform open, allowing the disinfectant to be released through the slit 362 and disinfect the hub and surrounding area of ​​the luer connector.

[0060] 8C, distal surface 354 has a closed end. In one or more embodiments, the closed end of distal surface 354 is chamfered. In one or more embodiments, the closed end of distal surface 354 is rounded.

[0061] According to a fourth embodiment of the present disclosure and as shown in FIGS. 9A and 9B , an exemplary corrugated capsule 450 is disclosed. The corrugated capsule 450 of the fourth embodiment of the disinfection cap 400 is disposed within the cavity 130 of the housing 110. The corrugated capsule 450 includes a proximal surface 452, a distal surface 454, and an elongated cylindrical body 456 extending from the proximal surface 452 and the distal surface 454. The distal surface 454 abuts the top wall 114 of the housing 110. The elongated body 456 includes at least one corrugation 458 configured to collapse against each other upon application of pressure to the proximal surface 452 by insertion of a luer connector hub into the cavity 130 of the housing 120. The elongated body 456 has a height from the proximal surface 452 to the distal surface 454 that is equal to or slightly less than the height of the cavity 130. In one or more embodiments, the proximal surface 452 and the distal surface 454 have equal diameters. In one or more embodiments, the diameter of the proximal surface 452 is smaller than the diameter of the distal surface 454.

[0062] 9A and 9B, the elongated cylindrical body 456 includes a plurality of perforations 462 in fluid communication with a fluid reservoir 460, which is defined by a cavity within the elongated cylindrical body 456 extending from the proximal surface 452 to the distal surface 454. In an uncompressed state, the distal surface 454 of the corrugated capsule 450 abuts the top wall 114 of the cavity 130 of the housing 110. In an uncompressed state, the plurality of perforations 462 are configured to prevent fluid from escaping. Upon compression of the elongated cylindrical body 456, the at least one corrugation 458 collapses against one another, creating a pressure increase within the reservoir 460. The pressure increase causes disinfectant to escape through the plurality of perforations 462, disinfecting the hub and surrounding area of ​​the Luer connector. The plurality of perforations 462 are arranged in at least one row 464 of perforations, the at least one row being longitudinally disposed in the at least one corrugation 458. With the proximal face 452 of the corrugated capsule 450 closed, the lumen of the luer connector hub is fluidly sealed from ingress of disinfectant therein. In one or more embodiments, the plurality of perforations 462 are arranged in two or more rows 464 of perforations, the two or more rows being longitudinally disposed in the at least one corrugation 458. In one or more embodiments, the plurality of perforations 462 are comprised of a self-sealing material.

[0063] According to a fifth embodiment of the disinfection cap 500 of the present disclosure, and as shown in FIGS. 10 , 11A-11D, and 12 , an exemplary corrugated capsule 550 is disclosed. The third embodiment of the corrugated capsule 550 is disposed within the cavity 130 of the housing 110. As shown in FIG. 10 , the corrugated capsule 550 includes an end cap 570 disposed on a proximal surface 552 of the corrugated capsule 550. The corrugated capsule 550 includes a proximal surface 552, a distal surface 554, and an elongated cylindrical body 556 extending from the proximal surface 552 and the distal surface 554. The distal surface 554 abuts the top wall 114 of the housing 110. The elongated body 556 includes at least one corrugation 558 configured to collapse against each other upon application of pressure to the proximal surface 552 by insertion of a luer connector hub into the cavity 130 of the housing 110. Elongated body 556 has a height from proximal face 552 to distal face 554 that is equal to or slightly less than the height of cavity 130. In one or more embodiments, proximal face 552 and distal face 554 have equal diameters. In one or more embodiments, the diameter of proximal face 552 is less than the diameter of distal face 554. Elongated cylindrical body 556 includes a fluid reservoir 560 that is defined by a cavity within elongated cylindrical body 556 that extends from proximal face 552 to distal face 554.

[0064] As shown in FIG. 11A , the distal surface 554 of the corrugated capsule 550 has an opening 562 extending therethrough. As shown in FIGS. 11B and 11C , the proximal surface 552 of the corrugated capsule 550 is open, with the proximal surface 552 having an engagement surface that contacts the end cap 570. As shown in FIGS. 11C and 11D , the end cap 570 comprises a cylindrical body including a plurality of openings 572, which are configured to be disposed around the periphery of the end cap 570. As shown in the cross-sectional view of FIG. 12 , the plurality of openings 572 are positioned a distance away from the center of the end cap 570 so as not to direct fluid flow into the lumen 24 of the hub 22 of the luer connector 20. Thus, the discharge of disinfectant is prevented from entering the lumen 24.

[0065] In the initial, uncompressed state, the distal surface 554 of the corrugated capsule 550 abuts the top wall 114 of the cavity 130 of the housing 110. In the final, compressed state, compression of the elongated cylindrical body 556 causes the at least one corrugation 558 to collapse against one another, resulting in an increase in pressure within the reservoir 560. In the uncompressed state, the plurality of openings 572 are configured to prevent the expulsion of disinfectant due to negative pressure within the fluid reservoir 560. In the final, compressed state, the increase in pressure causes the disinfectant to be expelled through the plurality of openings 572, disinfecting the hub and surrounding area of ​​the luer connector.

[0066] As shown in FIGS. 13A-13C, 14A, and 14B, a sixth embodiment of the present disclosure relates to a disinfection cap 600 including a housing 610 having a distal portion 610A and a proximal portion 610B. In one or more embodiments, the proximal portion 610B is substantially cylindrical, with the housing 610 being cylindrical. In one or more embodiments, the distal portion 610A of the housing has two wing-like protrusions 613 for gripping the cap 600. In one or more embodiments, the distal portion 610A and the proximal portion 610B have substantially cylindrical sidewalls. In one or more embodiments, an inner surface 626 of the proximal portion 610B of the housing 610 defines a cavity 630 having an open bottom 616 for receiving the hub of a luer connector. In one embodiment, the distal portion 610A is integrally formed with the proximal portion 610B. In one or more alternative embodiments, the distal portion 610A and the proximal portion 610B are permanently or removably assembled with a threaded connection, a press-fit connection, an adhesive connection, or a combination thereof.

[0067] In one or more embodiments, the cavity 630 can be configured to facilitate a loose fit between the cavity 630 and the hub of a Luer connector, and the disinfection cap 500 is secured by at least one thread 622 or a set of tabs included on the exterior surface of the housing 610. The at least one thread 622 disposed on the exterior surface of the housing 610 is sized and has a thread pattern that engages with a standard ISO-2 type fitting. The loose fit allows fluid to flow around the hub of the Luer connector. In further embodiments, the cavity 630 is configured as a Luer slip fitting to facilitate an interference fit between the cavity 630 and the hub of the Luer connector. In some embodiments, the interference fit can be configured sufficiently strong so that a threaded connection or at least one screw 622 is not required to removably secure the cavity 630 to the Luer connector.

[0068] In one or more embodiments, when a hub of a Luer connector is received within the inner surface 626 of the cavity 630, the hub is secured within the cavity 630 of the disinfection cap 600 by interlocking at least a portion of the at least one thread 622 with a mating structure on the hub of the Luer connector. In one or more embodiments, the at least one thread 622 can include an oblique thread pattern. In one or more embodiments, the at least one thread 622 can include a helical thread pattern. Such connectors are commonly and typically used as catheters and other fluid-tight protective connectors in medical applications. In some embodiments, the disinfection cap 600 provides a protective cover for the Luer connector when engaged with the connector, with threads from the Luer connector engaging the at least one thread 622 of the disinfection cap 600 to form a releasable bond.

[0069] FIG. 13B depicts a cross-sectional view of the disinfection cap 600 along the YY′ plane shown in FIG. 13A. FIG. 13C depicts an exploded view of the disinfection cap 600, which has a corrugated capsule 650 disposed within the cavity 630. The corrugated capsule 650 includes a closed distal end 654 and an open proximal end 652 that define a fluid reservoir 660. Between the closed distal end 654 and the open proximal end 652 is an elongated cylindrical body 656. A piston 670 is disposed relative to the open proximal end 652. As depicted in FIGS. 13B and 13C, the overall length of the corrugated capsule 650 and the piston 670 is equal to or less than the length of the cavity 630 of the housing 612.

[0070] 14A and 14B , the piston 670 includes a proximal portion 674 and a distal portion 676. The proximal portion 674 has a diameter equal to or slightly smaller than the diameter of the corrugated capsule 650. The distal portion 676 has a smaller diameter than the proximal portion 674. The diameter of the distal portion 676 is equal to or smaller than the diameter of the fluid reservoir 660, such that the distal portion 676 is disposed within the fluid reservoir 660 and forms a fluid-tight seal therewith. The piston 670 further includes a plurality of openings 672 extending from the distal portion 676 of the piston 670 to the proximal portion 674 of the piston 670. The plurality of openings 672 are in fluid communication with the fluid reservoir 660 and are configured to release antiseptic upon compression of the corrugated capsule 650. The piston further includes a plurality of directional channels 678 disposed on a proximal surface 679 of the proximal portion 674 of the piston 670. The plurality of directional channels 678 are configured to direct disinfectant around the luer hub of the luer connector. The plurality of directional channels 678 are configured to be disposed on the outer periphery of the proximal surface 679 of the piston 670. The plurality of directional channels 678 are disposed a fixed distance away from the center of the proximal surface 679 so as not to direct fluid flow into the luer hub lumen of the luer connector. Thus, the discharge of disinfectant is prevented from entering the lumen.

[0071] 15A and 15B, the diameter of the proximal portion 674 of the piston 670 is equal to or slightly smaller than the diameter of the corrugated capsule 650. The diameter of the distal portion 676 of the piston 670 is smaller than the proximal portion 674. The diameter of the distal portion 676 is equal to or smaller than the diameter of the fluid reservoir 660, such that the distal portion 676 is disposed within the fluid reservoir 660 and forms a fluid-tight seal. The elongated cylindrical body 656 has at least one corrugation 658 along the elongated cylindrical body 656. In one or more embodiments, the at least one corrugation 658 defines a cross-section of the elongated cylindrical body 646 that has a sidewall thickness that is smaller than the sidewall thickness of the elongated cylindrical body 656.

[0072] In the uncompressed state, the distal end 654 of the corrugated capsule 650 abuts the top wall 614 of the cavity 630 of the housing 610. Upon compression of the elongated cylindrical body 656, the at least one corrugation 658 collapses against one another, causing an increase in pressure within the reservoir 660. In the uncompressed state, the plurality of openings 672 are configured to prevent fluid from escaping due to negative pressure within the fluid reservoir 660. The increase in pressure causes disinfectant to be expelled through the plurality of openings 672, disinfecting the hub and surrounding area of ​​the luer connector.

[0073] The corrugated capsule (350, 450, 550, 650) is made of a flexible elastomeric material. The disinfection cap (100, 200, 300, 400, 500, 600) is made from any of a number of types of plastic materials, such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, TPU, TPE, PVC, LSR, EPDM, Viton®, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the disinfection cap (100, 200, 300, 400, 500, 600) comprises a polypropylene or polyethylene material.

[0074] In one or more embodiments, the antiseptic is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylhydroxyanisole (BHA), butylhydroxytoluene, t-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In certain embodiments, the antiseptic or antibacterial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the antiseptic or antibacterial agent is a fluid or gel.

[0075] In one or more embodiments, the antiseptic cap (100, 200, 300, 400, 500, 600) may include a removable peel seal covering the opening to the cavity (130, 630). In one or more embodiments, the peelable seal includes an aluminum or multilayer polymer film peel-off lid. In specific embodiments, the peelable seal is heat-sealed or induction-sealed to the open end of the antiseptic cap (100, 200, 300, 400, 500, 600). In one or more embodiments, the peelable seal includes a moisture barrier.

[0076] In one or more embodiments, the connector of the medical device may be selected from the group consisting essentially of a needleless connector, a catheter luer connector, a stopcock, and a hemodialysis connector in a primary IV gravity set, a secondary IV gravity set, an extension set, and an infusion or syringe pump set. In some embodiments, the disinfecting cap may be connected to any of a variety of different needleless infusion sites. In one or more embodiments, after the disinfecting cap is mated with the connector, it is not necessary to disinfect the connector (e.g., treat with alcohol swabs) before each reconnection of the connector to another connector, as the connector will remain uncontaminated while mated with the disinfecting cap. The use of the disinfecting cap (100, 200, 300, 400, 500, 600) replaces standard swabbing protocols for cleaning connectors.

[0077] Yet another aspect of the present disclosure relates to a method for disinfecting a medical connector, the method comprising coupling one or more embodiments of a disinfection cap (100, 600) to the medical connector, the coupling comprising inserting the medical connector into the disinfection cap (100, 200, 300, 400, 500, 600) to engage threads of the medical connector with threads on the exterior surface of a sidewall of the disinfection cap housing (110, 610), such that the medical connector compresses the contact portion of the corrugated capsule (350, 450, 550, 650).

[0078] It is contemplated that the disinfection caps (100, 200, 300, 400, 500, 600) disclosed herein and shown in the figures may be utilized with luer connectors, including female and male luer connectors, and that the occlusion structure may be used to occlude the open luer lumen, facilitating mitigation of ingress of such disinfectant into the connector, thereby reducing the risk of the disinfectant entering the bloodstream. Thus, it is contemplated that the disinfection caps (100, 200, 300, 400, 500, 600) disclosed herein and shown in the figures may be utilized with male and female luer connectors.

[0079] Although the present disclosure has been shown and described with reference to specific exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the embodiments of the present disclosure. Also, the inner and / or outer housing of the disinfection cap may be single-shot molded or manufactured by other suitable processes. Furthermore, the structures or elements of any exemplary implementations of the embodiments of the present disclosure described above and shown in the illustrative drawings may be implemented individually or in any combination(s) that would be readily understood by those skilled in the art without departing from the spirit and scope of the embodiments of the present disclosure.

[0080] Additionally, the included depiction drawings further illustrate non-limiting examples of implementations of certain exemplary embodiments of the present disclosure and aid in the description of the technology associated therewith. Any specific or relative dimensions or measurements provided in the drawings, other than as described above, are illustrative and not intended to be limiting.

[0081] Throughout this specification, references to "one embodiment," "a particular embodiment," "one or more embodiments," or "an embodiment" mean that the particular aspect, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of phrases such as "in one or more embodiments," "a particular embodiment," "in one embodiment," or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment of the present disclosure. Furthermore, the particular aspects, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0082] Although the disclosure herein has provided a description with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed method and apparatus without departing from the spirit and scope of the present disclosure. Therefore, the present disclosure is intended to cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. 1. A disinfection cap having a housing, the housing comprising: a cylindrical sidewall having an inner surface defining a cavity and a top wall; an open bottom formed by said cylindrical sidewall with an opening to said cavity in said housing for receiving a hub of a luer connector; a retention rod disposed within the cavity, the retention rod having a proximal flange, a distal flange, and an elongated rod between the proximal and distal flanges, the distal flange of the retention rod abutting the upper wall of the cavity; a fluid reservoir defined between an inner surface of the housing, the proximal flange of the retention rod, and the distal flange of the retention rod; A disinfection cap comprising: a disinfectant disposed within the fluid reservoir, the disinfectant being initially retained within the fluid reservoir; and the hub of the Luer connector being received within the inner surface of the cavity.

2. 2. The disinfection cap of claim 1, wherein the diameter of the proximal flange of the retaining rod is equal to or slightly larger than the diameter of the proximal portion of the cavity and is configured to have an interference fit sufficient to form a fluid seal between the proximal flange of the retaining rod and the proximal portion of the cavity.

3. 3. The disinfection cap of claim 2, wherein the diameter of the elongated rod is configured such that when the hub of the luer connector is received within the cavity, the elongated rod elastically deforms and bends upon insertion of the hub of the luer connector, thereby breaking the fluid seal between the proximal flange and the proximal portion of the cavity and releasing disinfectant into the cavity to disinfect the hub and surrounding area of ​​the luer connector.

4. 4. The disinfection cap of claim 3, wherein at least one circular fin is disposed on the elongated rod, the at least one circular fin having a thickness configured to elastically deform, and an increase in pressure in the fluid reservoir due to insertion of the Luer connector results in deformation of the at least one circular fin.

5. 3. The disinfection cap of claim 2, wherein the diameter of the elongated rod is configured to be compressed upon insertion of the hub of the luer connector when the hub of the luer connector is received within the cavity.

6. 2. The disinfection cap of claim 1, wherein the diameter of the distal flange is the same as or larger than the diameter of the distal portion of the cavity and is configured to form an interference fit within the cavity sufficient to removably retain the retaining rod.

7. 10. The disinfection cap of claim 1, wherein the disinfection cap is secured by at least one thread or a set of tabs included on the exterior surface of the housing.

8. 1. A disinfection cap having a housing, the housing comprising: a cylindrical sidewall having an inner surface defining a cavity and a top wall; an open bottom formed by said cylindrical sidewall with an opening to said cavity in said housing for receiving a hub of a luer connector; a corrugated capsule disposed within the cavity, the corrugated capsule having a proximal surface, a distal surface, and an elongated body between the proximal surface and the distal surface, the distal surface of the corrugated capsule abutting the upper wall of the cavity, the corrugated capsule having a fluid reservoir; A disinfection cap comprising: a disinfectant disposed within the fluid reservoir, the disinfectant being retained within the fluid reservoir in an initial state; and the hub of the Luer connector being received within the inner surface of the cavity.

9. 9. The disinfection cap of claim 8, wherein the elongated body further includes at least one undulation configured to collapse together upon application of pressure to the proximal surface by insertion of the hub into the cavity of the housing.

10. 10. The disinfection cap of claim 9, wherein the corrugated capsule further includes a slit in fluid communication with a fluid reservoir, the slit being located on a proximal surface of the corrugated capsule.

11. 11. The disinfection cap of claim 10, wherein in an initial, uncompressed state, the slit is fluidly closed and the fluid reservoir retains disinfectant by negative pressure within the fluid reservoir.

12. 12. The disinfection cap of claim 11, wherein compression of the elongated body by insertion of the hub of the luer connector causes the at least one undulation to collapse against each other, resulting in an increase in pressure within the fluid reservoir, which causes the slit to deform and open, allowing disinfectant to be ejected from the slit and disinfect the hub and surrounding area of ​​the luer connector.

13. 10. The disinfection cap of claim 9, wherein the corrugated capsule further includes a plurality of perforations in fluid communication with the fluid reservoir, the plurality of perforations being disposed on the elongated body of the corrugated capsule.

14. 14. The disinfection cap of claim 13, wherein in an initial, uncompressed state, the plurality of perforations are fluidly closed and the fluid reservoir retains disinfectant by negative pressure within the fluid reservoir.

15. 15. The disinfection cap of claim 14, wherein upon compression of the elongated body by insertion of the hub of the luer connector, the at least one undulation collapses against each other, causing an increase in pressure within the fluid reservoir, and the increase in pressure causes the plurality of perforations to deform and open, allowing disinfectant to be ejected from the plurality of perforations and disinfect the hub and surrounding area of ​​the luer connector.

16. 9. The antiseptic cap of claim 8, wherein the distal surface of the corrugated capsule further includes an opening extending therethrough.

17. 9. The disinfection cap of claim 8, wherein the proximal surface of the corrugated capsule is an open proximal surface.

18. 18. The antiseptic cap of claim 17, further comprising an end cap abutting an engagement surface on the open proximal face.

19. 20. The disinfection cap of claim 18, wherein the end cap includes a plurality of openings, the plurality of openings being configured to be disposed around the periphery of the end cap.

20. 20. The disinfection cap of claim 19, wherein the plurality of openings are positioned at a fixed distance from the center of the end cap and do not direct fluid flow into the lumen of the hub of the Luer connector.

21. 20. The antiseptic cap of claim 19, wherein in an initial, uncompressed state, the plurality of openings are configured to prevent the expulsion of antiseptic due to negative pressure within the fluid reservoir.

22. 22. The disinfection cap of claim 21, wherein in a final, compressed state, an increase in pressure causes disinfectant to be expelled through a plurality of openings to disinfect the hub and surrounding area of ​​the luer connector.

23. 1. A disinfection cap having a housing, the housing comprising: a cylindrical sidewall having an inner surface defining a cavity and a top wall; an open bottom formed by said cylindrical sidewall with an opening to said cavity in said housing for receiving a hub of a luer connector; a corrugated capsule having a proximal surface disposed within the cavity, the corrugated capsule having an open proximal end, a closed distal end, and an elongated body between the open proximal end and the closed distal end, the closed distal end of the corrugated capsule abutting the top wall of the cavity, the corrugated capsule having a fluid reservoir; a disinfectant disposed within the fluid reservoir, the disinfectant initially being retained within the fluid reservoir; and a piston disposed against the open proximal end, the hub of the luer connector being received within the interior surface of the cavity; and A disinfection cap comprising:

24. 24. The disinfection cap of claim 23, wherein the elongated body further includes at least one undulation configured to collapse together upon application of pressure to the proximal surface by insertion of the hub into the cavity of the housing.

25. 25. The disinfection cap of claim 24, wherein the piston includes a proximal portion and a distal portion, the proximal portion having a diameter equal to or slightly smaller than the diameter of the corrugated capsule, the distal portion having a diameter smaller than or equal to the diameter of the fluid reservoir, and the distal portion having a diameter configured to be disposed within the corrugated capsule and form a fluid-tight seal.

26. 26. The disinfection cap of claim 25, wherein the piston further includes a plurality of openings extending from the distal portion of the corrugated capsule to the open proximal end of the corrugated capsule, the plurality of openings being in fluid communication with the fluid reservoir and configured to release disinfectant upon compression of the corrugated capsule.

27. 26. The disinfection cap of claim 25, wherein the piston further includes a plurality of directional channels disposed on the proximal surface of the proximal portion of the piston, the plurality of directional channels configured to direct disinfectant toward the periphery of the hub of the luer connector.

28. 28. The disinfection cap of claim 27, wherein the plurality of directional channels are configured to be arranged around the outer periphery of the proximal surface of the piston, and the plurality of directional channels are arranged at a fixed distance away from the center of the proximal surface so as not to direct fluid flow into the inner cavity of the hub of the Luer connector.

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