Disinfectant caps for medical connectors

Abstract

To provide alternative cap designs for use with a variety of medical fittings or connectors.SOLUTION: Antiseptic caps that can be used to disinfect and / or protect medical connectors are disclosed herein. In some embodiments, the antiseptic cap can include a first chamber configured to be removably attached to the medical connector.SELECTED DRAWING: Figure 4

Description

Technical Field

[0001] Incorporation by Reference This application claims priority to U.S. Provisional Patent Application No. 62 / 643,873, filed Mar. 16, 2018, which is hereby incorporated by reference in its entirety and forms a part of this disclosure. Additionally, International Application PCT / US2017 / 056407, filed Oct. 12, 2017, is hereby incorporated by reference in its entirety and forms a part of this disclosure. Any features, structures, materials, methods, or steps described and / or illustrated in the embodiments of the above patent applications may be used with or instead of any features, structures, materials, methods, or steps described and / or illustrated in the following paragraphs or the accompanying drawings of this specification.

[0002] The present invention generally relates to caps, and more specifically, to a sterilizing cap for use with a medical connector.

Background Art

[0003] Certain embodiments disclosed herein relate to caps for medical connectors, and more specifically, to caps that can be used to disinfect and prevent future contamination of unconnected medical connectors, such as connectors that can be used in a fluid flow system or a fluid delivery system.

[0004] Catheters are widely used to treat patients who require various medical procedures. Catheters can be temporary catheters for short-term use or can be catheters commonly used in long-term treatment. Catheters are typically inserted from a peripheral vein site into a central vein (such as the vena cava) to provide access to a patient's vascular system.

[0005] Catheter connections may include, for example, connections to dialysis machine tubing, IV line tubing, infusion ports, and catheter caps. These connections are used to seal the ends of the catheter to protect its sterile condition and prevent fluid loss and / or particulate contamination. Catheter connections are most often made using standardized Luer taper fittings used in the medical industry. These fittings may be either male or female connectors and have standard-sized tapered ends. Connections are made by press-fitting the mating parts. To ensure a complete press-fit of the Luer fitting, screw-locking fittings or other types of locking mechanisms are typically used. There are also other non-standard fittings that can be used to selectively connect multiple medical fluid-delivering components together.

[0006] Catheter-induced bloodstream infections (CRBSIs), which can be caused by microorganisms entering a patient's body via intravascular catheters, are a significant source of unnecessary illness, complications, and excessive healthcare costs. A considerable number of such infections occur annually in intensive care units in the United States.

[0007] Providing antibiotics to catheters is one approach to reducing these infections. However, satisfactory results are not achieved with many of these catheters. In addition, some microorganisms have developed resistance to the various antibiotics used in catheters. [Overview of the project] [Problems that the invention aims to solve]

[0008] Using germicidal caps, such as those manufactured and sold by Excelsior Medical and ICU Medical, Inc. under the SWABCAP® trademark, has been shown to significantly reduce the incidence of infections, providing substantial health benefits, particularly to patients, and resulting in substantial cost savings. However, the need remains to design alternative caps for use with various medical fittings or connectors. [Means for solving the problem]

[0009] This specification discloses germicidal caps that can prevent the entry of microorganisms into a patient's bloodstream via fluid flow or fluid delivery systems, such as medical connectors, needleless injection sites, and / or medical fluid transfer devices. In some embodiments, one or more caps can be configured for use with a medical infusion system that uses one or more Luer connectors, such as female or male medical connectors having Luer fittings. In some embodiments, the cap has a base and a dispensing material such as a germicidal material configured to carry a therapeutic liquid or gel, such as a liquid or gel-like disinfectant or antimicrobial agent (e.g., isopropyl alcohol, or chlorhexidine gluconate, or metal ions such as silver or copper ions, or one or more other agents suitable for disinfection or removal of contaminants).

[0010] In some embodiments, a disinfectant male Luer cap can be configured to attach to a medical connector having a male Luer with side walls and a distal tip. The disinfectant Luer cap may include a housing having an outer wall and a bottom wall, and a first chamber surrounded by the outer wall and bottom wall of the housing.

[0011] A male luer cap for disinfection may include an internal projection extending upward from the bottom wall of the housing. The internal projection may include an inner wall and an outer wall.

[0012] A male Luer cap for disinfection may include a second chamber formed by the inner wall of an inner projection. The second chamber may be configured to tightly receive a male Luer of a medical connector.

[0013] The male Luer cap for disinfection may contain a disinfectant material with a disinfectant solution attached to the upper end of the inner projection. The disinfectant can be placed outside the second chamber before use.

[0014] The male Luer cap for disinfection may include a lid that surrounds the first chamber and is configured to prevent leakage of the disinfectant before use.

[0015] The sterilizing material can be configured to wipe the distal tip and side walls of the male luer cap of the medical connector as the disinfectant male luer cap is advanced onto the male luer of the medical connector.

[0016] Any disinfectant male luer cap described in the preceding paragraph and / or any disinfectant cap described below may include one or more of the following features: The disinfectant male luer cap can be combined with a medical connector. Part of the disinfectant material can be configured to move into a second chamber as the disinfectant male luer cap is advanced onto the male luer of the medical connector. The diameter of the upper part of the inner projection can be smaller than the width of the disinfectant material. The length of the perforation in the disinfectant material can be less than or equal to the maximum diameter of the portion of the male luer of the medical connector that can be inserted into the inner projection, thereby configuring the disinfectant material to form a tight mating state around the male luer when the disinfectant male luer cap is attached to the medical connector.

[0017] In some embodiments, the disinfectant luer cap can be configured to attach to a medical connector with the male luer end surrounded by a shroud. The disinfectant luer cap may include a housing with a projection.

[0018] The projection may include an opening configured to receive a male Luer end of a medical connector, a distal portion having a first inner cross-sectional width, and a proximal portion having a second inner cross-sectional width.

[0019] The first inner cross-sectional width may be different from the second inner cross-sectional width.

[0020] A disinfectant male luer cap may include a sterilizing material connected to the outer surface of a protrusion, which is configured to disinfect the male luer end when the disinfectant luer cap is attached to a medical connector.

[0021] Any disinfectant male luer cap described in the paragraph above and / or any sterilization cap described below may include one or more of the following features: A first inner cross-sectional width may be greater than a second inner cross-sectional width. The first inner cross-sectional width may be dimensioned such that the distal portion is configured to receive the sterilization material and at least a portion of the male luer. The second inner cross-sectional width may be dimensioned to facilitate the attachment of the disinfectant luer cap to the male luer end. The sterilization material may have a diameter greater than the first and second inner cross-sectional widths. The sterilization material may be configured to disinfect at least the end face of the male luer end. The sterilization material may include one or more perforations configured to facilitate the passage of at least a portion of the male luer end through the sterilization material. One or more perforations may have a length shorter than the outer width of at least the portion of the male luer end described above. The length of one or more perforations may be configured to prevent the passage of fluid between the sterilization material and the male luer end. The sterilization material may include one or more flap portions. One or more flap portions may be configured to be at least partially positioned within the distal portion of the projection when a disinfectant luer cap is attached to the male luer end. One or more flap portions may include compressible material for compression between the distal portion of the projection and at least a portion of the male luer end. One or more flap portions may be configured to facilitate the attachment of the disinfectant luer cap to the male luer end. The disinfectant luer cap can be combined with a medical connector.

[0022] In some embodiments, the sterilization cap assembly may include one or more disinfectant male Luer caps and / or any of the sterilization caps described below, and an elongated cylindrical body or sleeve configured to include one or more disinfectant Luer caps.

[0023] In some embodiments, the sterilization cap assembly can include any one or more of the sterilizing male Luer caps of the above paragraphs and / or any of the sterilization caps described below, a cap holder configured to receive the sterilizing Luer cap, and a lid.

[0024] Embodiments will now be described with reference to the following drawings, provided by way of example and not limitation. Like reference numerals indicate the same or functionally similar elements. The sizes and relative proportions of all components and features shown in the drawings form a part of this disclosure but should not be construed as part of the claims unless specifically recited in the claims.

Brief Description of the Drawings

[0025] [Figure 1A] Front perspective view of the sterilization cap. [Figure 1B] Rear perspective view of the sterilization cap of FIG. 1A. [Figure 1C] Rear view of the sterilization cap of FIG. 1A. [Figure 1D] Side view of the sterilization cap of FIG. 1A. [Figure 1E] Side cross-sectional view of the sterilization cap of FIG. 1A. [Figure 2] Side cross-sectional view of the sterilization cap attached to the male Luer of the medical fluid connector. [Figure 3A] Side cross-sectional view of the sterilization cap. [Figure 3B] Top perspective view of an embodiment of the sterilization cap of FIG. 3A. [Figure 3C] Top perspective view of an embodiment of the sterilization cap of FIG. 3A. [Figure 4] Side cross-sectional view of the sterilization cap attached to the male Luer of the medical fluid connector. [Figure 5A] Front perspective view of an embodiment of the sterilization cap holder assembly. [Figure 5B] Side cross-sectional view of the sterilization cap holder assembly of FIG. 5A. [Figure 6] This is a front view of an embodiment of a dispensing bag for a sterilization cap holder assembly. [Figure 7] Figure 6 is a front perspective view of multiple distribution bags. [Figure 8A] Figure 6 is a front view of the distribution bag. [Figure 8B] Figure 6 is a rear view of the distribution bag. [Figure 9A] This is a partial front view of an embodiment of a dispensing bag for a sterilization cap holder assembly. [Figure 9B] This is a partial front view of an embodiment of a dispensing bag for a sterilization cap holder assembly. [Figure 9C] This is a partial front view of an embodiment of a dispensing bag for a sterilization cap holder assembly. [Figure 10] This is a front view of an embodiment of a dispensing bag for a sterilization cap holder assembly. [Figure 11A] This is a top view of the dispensing device of the sterilization cap holder assembly. [Figure 11B] Figure 11A is a side view of the distribution device. [Figure 11C] Figure 11A is a side cross-sectional view of the distribution device. [Figure 11D] Figure 11A is a side-exploded cross-sectional view of the distribution device. [Figure 12A] This is a front perspective view of an embodiment of a syringe assembly having a sterilization cap holder assembly. [Figure 12B] Figure 12A is a cross-sectional view of the syringe assembly and the sterilization cap holder assembly. [Modes for carrying out the invention]

[0026] Various systems, methods, and components can be used in various embodiments of the medical cap. Several embodiments are illustrated in the accompanying drawings; however, the drawings are provided for convenience only as examples and should not be construed as limiting the present invention to any particular combination of the illustrated features. Rather, any feature, structure, material, step, or component of any embodiment described and / or illustrated herein can be used by itself, or in conjunction with or in place of other features, structures, materials, steps, or components of any embodiment described and / or illustrated herein. Nothing is essential or indispensable herein. Any device, connection, or feature described and / or illustrated herein can be attached to, protected, or disinfected medical fluid connection points or devices, such as Luer connectors, in accordance with ISO standard 594 or ISO 80369 or other industry standards applicable to medical fluid connectors.

[0027] overview This disclosure relates to embodiments of disinfection caps that can be used to disinfect and / or protect medical connectors. The caps may be used with intravascular connectors associated with fluid pathways such as IV lines. All references to any type of connector in this application (e.g., male Luer connectors) should be understood to include and disclose any type of medical device that stores or transfers medical fluids or completes or facilitates the connection of medical fluid lines (e.g., fluid line connectors that can be opened or resealed, syringes, catheter connectors, vials, vial adapters, pump cartridges, or disposable medical product dispensing components, female connectors, blood line connectors, IV bags, catheter inserters, vents or priming caps, etc.). All features and principles of the invention disclosed herein are considered to apply to or be adaptable to use with both Luer and non-Luer connectors. Accordingly, all references to male Luer connectors or female Luer connectors in this specification should also be understood to refer to male or female connectors that are not Luer type, respectively.

[0028] Once established, the fluid pathways allow direct access to the patient's blood flow and can be used intermittently to administer drugs to the patient. These fluid pathways may have one or more associated medical connectors that can be connected to other medical connectors. In some embodiments, multiple corresponding connectors may have male or female connection areas, such as male or female Luer connection areas or Luer locks. The connection areas can provide a convenient way to connect to and disconnect the fluid pathways repeatedly. When a connector with connection areas is disconnected, one or more caps (e.g., Luer caps) can protect the disconnected connector from contamination, such as the accumulation of microorganisms, debris or other contaminants on the connection side, area, or surface of such connection areas. It may be advantageous for the caps to carry or contain some form of disinfectant for disinfecting the connection areas (e.g., Luer connection areas) before and / or during sealing the connector to prevent future external contamination. Any structure, step, material, or component illustrated and / or described in any embodiment herein may be used together with, or in place of, any structure, step, material, or component illustrated and / or described in any other embodiment herein. Such structures, steps, materials, or components are not essential or indispensable.

[0029] Sterilization cap with outer shroud Figures 1A to 1E are various illustrations of the sterilization cap 900 based on several embodiments. In particular, Figure 1A is a front perspective view of the sterilization cap 900, Figures 1B to 1E are a rear perspective view, rear view, side view, and side section view of the sterilization cap 900 of Figure 1A, respectively, and Figure 2 is a side section view of the sterilization cap 900 connected to a male Luer connector 800. In addition, Figures 3A to 3C and Figure 4 are various illustrations of the sterilization cap 900 including the sterilization material 940. Unless otherwise noted, the sterilization cap 900 shown in Figures 1A to 4 may include the same or substantially similar components as those in the drawings illustrated and described herein. It should be understood that the sterilization cap 900 shown in Figures 1A to 4 can be used with the embodiments described and / or discussed herein. It should also be understood that any of the embodiments described and / or discussed herein can be modified for use with the sterilization cap 900 shown in Figures 1A to 4. As with all embodiments herein, features, structures, materials, methods, or steps described and / or illustrated in the embodiments of Figures 1A to 1E may be used together with, or in place of, features, structures, steps, materials, or components described and / or illustrated in other embodiments herein.

[0030] As shown in these drawings, the cap 900 comprises a housing 910 including a first chamber 925. The first chamber 925 can be configured to be detachably attached to the medical connector 800, as shown in Figures 2 and 4. In some embodiments, for example, the first chamber 925 may have an inner surface configured to interact with a portion of the medical connector 800, such as the end region or male end of the medical connector, one or more threads of the medical connector and / or one or more other features of the medical connector. It should be understood that features, structures, materials, steps, or components of embodiments described and / or illustrated herein (such as the first chamber 84 of the sterilization cap 82 in Figures 1A to 1H of International Application PCT / US2017 / 056407) can be used together with, or instead of, other features, structures, materials, steps, or components of embodiments of the sterilization cap 900 in Figures 1A to 4.

[0031] As illustrated and in some embodiments, the housing 910 includes a skirt 920 and a projection 930. As illustrated, in some embodiments, the skirt 920 and projection 930 can be positioned and / or oriented such that, for example, the central longitudinal axes of the skirt 920 and projection 930 are substantially collinear when the projection 930 is positioned within the skirt 920. As illustrated and in some embodiments, the projection 930 has an opening or recess 932 (see Figure 1E) with a distal lip or rim 934, the distal lip or rim 934 can be positioned close to a recess within the skirt 920 such that the outer surface of the cap 900 extends further distally than the most distal tip of the projection 930. In some embodiments, the projection 930 can extend upward from the bottom wall of the housing 910 and may include an inner wall and an outer wall.

[0032] As shown in Figures 1A to 1E, the first chamber 925 can accept and / or house any suitable features. For example, in some embodiments, the cap 900 comprises a fluid delivery material such as a sterilizing material 940, as shown in Figures 3A to 3C and 4, which are described in further detail herein. Figure 2 shows a cross-sectional view of an embodiment of the cap 900 without the sterilizing material 940 connected to the medical connector 800.

[0033] Figure 2 illustrates an embodiment of a cap 900 connected to a male Luer connector 800. As shown, the male Luer connector 800 comprises a connector housing 810. In some embodiments, the connector housing 810 includes a shroud or collar 820 having an outer surface 822 and an inner surface 824. The inner surface 824 may include a connection interface 826. In some cases, the connection interface 826 may include threads 828. The connector housing 810 may include a male Luer 830 having an outer surface 832. As shown and in some embodiments, the male Luer 830 includes a fluid passage 840.

[0034] Referring further to Figures 2 and 4, when the cap 900 is connected to the male luer connector 800 as shown, the male luer 830 is received in the opening or recess 932 of the projection 930. In some embodiments, during or after connection, the inner surface 938 of the projection 930 is moved to be adjacent to or in contact with at least a portion of the outer surface 832 of the male luer 830 so that at least a portion of the male luer 830 is positioned within and / or fixed to the projection 930. In some cases, at least a portion of the male luer 830 is positioned within the chamber of the projection 930, as illustrated in Figures 2 and 4. For example, the chamber of the projection 930 can be formed by the inner wall of the projection 930 and is configured to tightly receive at least a portion of the male luer. In some embodiments, as illustrated, when the cap 900 is connected to a male luer 830, the male luer 830 can be sealed in a state where it is no longer in communication with the surrounding environment, thereby preventing the vaporization of the liquid contents inside the male luer 830 into the surrounding environment and / or the entry of contaminants from the surrounding environment into the male luer 830. As illustrated in Figure 2, in some embodiments, the interior of the projection 930 is empty or contains no fluid delivery material or therapeutic fluid or disinfectant, and / or, when the cap 900 is attached to the male luer connector 800, there is no structure or material between the male luer 830 and the proximal and / or distal ends inside the projection 930. As illustrated, in some embodiments, when the cap 900 is connected to the connector 800, there is no structure of the cap 900 configured to enter into or contact the fluid passage 840 of the connector 800.

[0035] In some embodiments, as illustrated in Figures 2 and 4, the skirt 920 contacts, covers, overlaps, or extends across at least a portion of the outer surface 822 of an end region, such as the end region of the collar 820 of the connector 800. In some embodiments, the skirt 920 may include a tapered region, such as a tapered region 922 near the distal end of the cap 900. In some embodiments, the cross-sectional width of the tapered region 922 may increase in the direction from proximal to distal. In the illustrated embodiments, the tapered region 922 facilitates connection between the cap 900 and the male luer connector 800. The tapered region 922 can facilitate connection between the skirt 920 and the collar 820. For example, the cross-sectional width of the skirt 920 decreases towards the proximal end of the skirt 920 as the end of the connector 800 is inserted into the proximal end of the skirt 920 in the proximal direction, thereby improving the airtightness of the connection, gripping, or mounting portion between the cap 900 and the connector 800.

[0036] In some embodiments, the skirt 920 may not include a tapered region 822. As illustrated in Figure 2, in some embodiments, the inner surface of the outer wall of the cap 900 is frictionally in contact with or attached to the connector at the outer surface of the connector, and / or the inner and / or outer surfaces of the outer wall of the cap 900 are not in contact with or attached within the threaded region or any region inside the collar or shroud of the connector 800. As illustrated, the outer cross-sectional width of the distal end of the cap 900 can be greater than the outer cross-sectional width of the portion of the connector 800 to which the cap 900 is configured to be attached. As illustrated in some embodiments, the cap 900 can be attached to and / or removed from the connector 800 by pressing the cap 900 against the connector 800 or pulling it out from the connector 800 in a single distal or proximal direction, axially or longitudinally, without requiring the cap 900 to be rotated on the connector 800 or screwed into the connector 800. In some embodiments, as shown in Figures 1E and 3A, the outer surface of the cap 900 has curved, or not straight, sidewalls that facilitate secure gripping of the cap 900 with fingers in a non-slip manner. As shown in Figures 1A to 1D, in some embodiments, the outer side of the cap 900 may have one or more substantially flat areas to facilitate gripping of the cap 900 with fingers. In some embodiments, as illustrated, the proximal base of the cap 900 may have a radially outward-extending surface that forms a lip to provide an area that prevents fingers from slipping when the cap 900 is removed from the connector 800 by pulling the cap 900 axially, or longitudinally, away from the connector 800. As shown in Figures 1E and 3A, the inner surface of the outer wall of the cap 900 may be smooth and without substantial protrusions or recesses or threads.

[0037] Sterilization cap equipped with sterilizing material Figures 3A to 3C are various diagrams of a sterilization cap 900 containing a sterilization material 940 based on several embodiments. In particular, Figure 3A is a side cross-sectional view of the sterilization cap 900, Figures 3B and 3C are top views of various embodiments of the sterilization cap 900 of Figure 3A, and Figure 4 is a side cross-sectional view of the sterilization cap 900 connected to a male Luer connector 800. Unless otherwise noted, the sterilization cap 900 shown in Figures 3A to 4 may include the same or substantially similar components as those in the drawings illustrated and described herein. It should be understood that the sterilization cap 900 shown in Figures 3A to 4 can be used with any of the embodiments described and / or intended throughout this specification. It should also be understood that any of the embodiments described and / or intended throughout this specification can be modified for use with the sterilization cap 900 shown in Figures 3A to 4. As with all embodiments herein, features, structures, materials, methods, or steps described and / or illustrated in the embodiments of Figures 3A to 4 may be used together with or instead of features, structures, materials, methods, or steps described and / or illustrated in other embodiments herein.

[0038] Examples of sterilization materials As shown in Figures 3A to 4, the cap 900 may be equipped with a sterilizing material 940. The sterilizing material 940 may be configured to be attached to a portion of the cap 900. In some embodiments, the sterilizing material 940 is attached to the outer surface 936 of the projection 930, etc., within the first chamber 925, and / or not attached to the inner surface 938 of the projection, and / or connected to the projection 930 such that at least a portion of the sterilizing material 940 extends beyond the lip or rim 934 of the projection 930 or extends distally beyond the lip or rim 934. For example, as shown in Figures 3A and 4, the proximal surface of the sterilizing material 940 may be configured to interact with and / or be attached to a portion of the projection 930 of the cap 900, such as the distal end face of the projection 930. In some embodiments, when the sterilizing material 940 is placed on the projection 930, the sterilizing material 940 and the projection 930 may be positioned and / or oriented such that their respective central longitudinal axes are substantially collinear. The sterilizing material 940 may be the same as or substantially similar to the liquid distribution material, fluid delivery material, absorbent material, and / or sterilizing material disclosed and / or exemplified in International Application PCT / US2017 / 056407.

[0039] The distal end face of the sterilizing material 940 may be positioned proximal to the distal end of the cap 900 such that when the cap 900 is turned upside down and placed on a horizontal surface, as shown in Figures 3B and 3C, the sterilizing material 940 is positioned close to a recessed area within the cap 900, thereby minimizing contact between the sterilizing material 940 and microorganisms or other contaminants before or during use when the cap 900 is turned upside down. In some embodiments, the sterilizing material 940 can be made from a deformable material such as foam, sponge, crosslinked matrix, gauze, cloth, woven or nonwoven fabric. In some embodiments, at least a portion of the sterilizing material 940 is expandable and contractible along the outer surface 936 of the protrusion 930.

[0040] The proximal end face of the sterilizing material 940 can be spaced distally from the inner surface of the base of the cap 900, for example, to form a gap between the proximal end face of the sterilizing material 940 and the inner surface of the base of the cap 900. As illustrated, the outer surface of the base of the cap 900 can be flat and / or planar and / or substantially flat and / or substantially planar so that the cap 900 can be placed on a horizontal plane without tipping over or rolling.

[0041] As shown in Figures 3B and 3C, and in some embodiments, the sterilization material 940 may include access areas such as tear points, dividing lines, separation points, or openings 942 to facilitate disinfection contact and cleaning of one or more portions of the male luer connector 800 (e.g., male luer 830). In some embodiments, the sterilization material 940 may have one or more features configured so that the user can create and / or expand an opening 942 to allow the male luer 830 of the connector 800 to access the internal cavity of the projection 930. The sterilization material 940 may be made from a deformable material for connection with the connecting region (e.g., male luer 830). In some embodiments, the sterilization material 940 may include a stationary or initial configuration in which the opening 942 is absent or the opening 942 has a diameter smaller than the outer diameter of the connecting portion of the connecting region (e.g., male luer 830). For example, the opening 942 is substantially closed or absent (as shown in Figures 3B and 3C) when the sterilizing material 940 is in a stationary or initial configuration; the opening 942 changes (as illustrated in Figure 4) to allow the male luer to extend through the sterilizing material 940 when the sterilizing material 940 is in an engaged configuration or a subsequent configuration. When the cap 900 is detachably attached to the medical connector 800, the sterilizing material 940 can transition from a stationary configuration to an engaged configuration. For example, at least a portion of the medical connector 800 (e.g., the male luer 830) may move at least a portion of the sterilizing material 940 from a stationary configuration to an engaged configuration.

[0042] For example, in some embodiments, the sterilizing material 940 may have one or more separation-promoting features, such as one or more dividing lines, notches, perforations, and / or cuts 942a, 942b, which can help form and create and / or define an opening 942. One or more separation-promoting features, such as perforations 942a, 942b, may allow the male luer 830 to pass through the sterilizing material 940 when the cap 900 is applied to the connector 800. The length of one or more separation-promoting features, such as perforations 942a, 942b, may vary depending on the desired features for a particular product. For example, the length of one or more perforations 942a, 942b may be approximately equal to or greater than the diameter or width of the connecting male luer 830. In this configuration, the length of one or more perforations 942a, 942b may be such that the male lure 830 can connect to the cap 900 without requiring the male lure 830 to puncture or tear the sterilizing material 940 and / or extend or lengthen the length of one or more perforations 942a, 942b when connecting to the cap 900. In some cases, the length of one or more perforations 942a, 942b may be approximately equal to or greater than the diameter or width along the length of the male lure 830. In some cases, the length of one or more perforations 942a, 942b may be approximately equal to or less than the outer diameter or width of the male lure 830, and the male lure 830 may cause radial or lateral extension or expansion of the sterilizing material 940 when the male lure 830 is inserted into the projection 930. In this configuration, the sterilizing material 940 interacts closely with the male luer 830 by substantially continuous contact along the male luer 830 axially and / or circumferentially around the male luer 830 (for example, in a tight and / or close-fitting state with the male luer 830) as the male luer 830 passes through one or more perforations 942a, 942b and opening 942 for connection with the cap 900. For example, the length of one or more perforations 942a, 942b may be less than or approximately equal to the maximum diameter along the portion of the male luer 830 configured to be inserted through the sterilizing material 940.In some embodiments, providing perforations 942a, 942b having smaller lengths can help avoid the presence of a gap between the sterilizing material 940 and the male luer 830 when the male luer 830 connects to the cap 900. The tight circumferential fit between the inserted male luer 830 and the projection 930, i.e., the absence of a gap between them, is advantageous in that it can prevent and / or stop the disinfectant solution and / or gas in the internal cavity of the projection 930 from vaporizing, evaporating, and leaking through the sterilizing material 940, and / or prevent undesirable or harmful substances such as bacteria, viruses and / or other microorganisms from entering the interior of the projection 930 and, consequently, the medical fluid through such gaps.

[0043] In some embodiments, one or more perforations 942a, 942b extend throughout the entire sterilizing material 940, thereby allowing the connecting male luer 830 to connect to the cap 900 without requiring the male luer 830 to puncture the sterilizing material 940. In some embodiments, one or more separation-promoting features do not have to extend throughout the entire sterilizing material 940, and the male luer 830 may need to puncture at least a portion of the sterilizing material 940, tear at least a portion of the sterilizing material 940 and / or separate it from another portion of the sterilizing material 940 in order to access the internal cavity of the protrusion. Figures 3B and 3C illustrate the sterilizing material 940 having two perforations, but any number of separation-promoting features that can form and / or define an opening 942 in the sterilizing material 940 may be utilized. For example, the sterilizing material 940 may have one perforation, three perforations, four perforations, or any other number of perforations configured to form and / or define an opening 942.

[0044] As illustrated in Figures 3B and 3C, in some embodiments, one or more separation-promoting features may help form one or more movable parts of the sterilizing material 940, such as one or more leaf-shaped, flower-shaped, or flap portions 940a, 940b. The flap portions 940a, 940b may be configured to move from a substantially planar orientation to a substantially proximal orientation when the cap 900 is attached to the connector 800. The flap portions 940a, 940b may substantially close the opening 942 when the sterilizing material 940 is in an initial or stationary configuration, and may substantially widen the opening 942 when the sterilizing material 940 is in an engaged or subsequent configuration. When attaching the connector 800 to the cap 900, one or more flap portions 940a, 940b may be configured to interact with the male luer 830 of the connector 800 and to facilitate cleaning of the male luer 830. Figures 3B and 3C illustrate the sterilization material 940 as having six flap sections, but any number of flap sections may be used.

[0045] In some embodiments, the sterilizing material 940 can be made from a compressible, deformable, and / or elastic material such as a foam, textile, cloth, or gauze. Any suitable material can be used as the sterilizing material 940. In some embodiments, the sterilizing material 940 (or any other fluid delivery material or liquid distribution material, such as those disclosed or illustrated in the specification or drawings of international application PCT / US2017 / 056407) is configured to carry and deliver a therapeutic liquid or gel, such as a liquid or gel-like disinfectant or antimicrobial agent. For example, the therapeutic liquid or gel can be isopropyl alcohol, or chlorhexidine gluconate, and / or metal ions such as silver or copper ions, and / or any other suitable agent for disinfecting, cleaning, and / or removing contaminants.

[0046] Exemplary method for attaching an embodiment of a sterilizing material The sterilizing material 940 may be attached to one or more parts of the cap 900 (e.g., protrusions 930). The sterilizing material 940 may be attached in any suitable way, such as by utilizing one or more of the various methods described herein.

[0047] In some embodiments, the sterilizing material 940 may be positioned substantially laterally aligned with the distal surface of the projection 930. For example, the proximal surface of the sterilizing material 940 may be positioned and / or oriented above the projection 930, so that the central longitudinal axes of the sterilizing material 940 and the projection 930 are substantially collinear, as shown in Figures 3A to 3C and 4. In some embodiments, the outer surfaces 936 of the sterilizing material 940 and the projection 930 may be circular (as illustrated); however, the sterilizing material 940 and the outer surfaces 936 may have any suitable shape. As illustrated, in some embodiments, the sterilizing material 940 may be substantially circular in shape, approximately the same size as or slightly wider than the substantially circular distal tip of the projection 930. In some embodiments, the sterilizing material 940 may have a shape in which its longitudinal length is smaller than its diameter or width. For example, as illustrated, the sterilizing material 940 may be in the form of a disc, a thin cylinder, or a sheet. One or more edges or other areas of the sterilizing material 940 may be bonded, sealed, and / or attached to the distal surface of the projection 930 to cover the opening 932 of the projection 930. Figures 3B and 3C each show different embodiments of the sterilizing material 940 having one or more mounting portions 946, 946' positioned close to the opening 942. One or more mounting portions 946, 946' may be configured to facilitate attachment of the sterilizing material 940 to the projection 930. Although Figures 3B and 3C illustrate the sterilizing material 940 having four mounting portions 946, 946', any number of mounting portions 946, 946' that facilitate attachment of the sterilizing material 940 to the projection 930 may be utilized.

[0048] Any suitable method may be used to bond, seal and / or attach the sterilizing material 940 to the projection 930 via one or more mounting portions 946, 946'. For example, in some embodiments, heat staking and / or thermal bonding may be used to bond, melt and / or seal at least one or more mounting portions 946, 946' to and / or around a portion of the periphery (e.g., edge) of the projection 930. Thermal bonding may be performed using standard thermal bonding or sealing techniques such as impulse, induction, conduction, radiation, or other thermal bonding or sealing techniques. Additionally or alternatively, one or more mounting portions 946, 946' may be sealed by utilizing ultrasonic welding, adhesive bonding, or by any suitable mechanical or friction connection such as snap-fit. In some embodiments, adhesives such as glue or solvent or adhesive, or any other suitable agent may be used.

[0049] Referring to Figure 3B, for example, one or more mounting portions 946 may have a substantially circular and / or dot shape. The sterilizing material 940 may be positioned on the upper part of the distal surface of the projection 930 to which it is attached. The dot-shaped mounting portion 946 may be made along the outer circumference of the projection 930 or incorporated into it. Additionally or alternatively, referring to Figure 3C, one or more mounting portions 946' may have a substantially elongated shape to facilitate the attachment of the sterilizing material 940 to the projection 930 by requiring lower precision in positioning the sterilizing material 940 on the projection 930 and / or lower precision in forming the mounting portion 946 that attaches the sterilizing material 940 to the projection 930. The substantially elongated shape of the mounting portion 946' may, in some cases, provide a larger mounting surface area compared to the dot-shaped mounting portion 946, increasing the chances of ensuring that one or more mounting portions 946' engage with and / or attach to the distal surface of the projection 930. For example, the substantially elongated shape of one or more mounting portions 946' can improve the efficiency of attaching the sterilizing material 940 to the projection 930, even when the sterilizing material 940 is positioned slightly off-center from the projection 930. In some embodiments, the sterilizing material 940 may include a combination of a dot-shaped mounting portion 946 and a substantially elongated mounting portion 946'.

[0050] Embodiment of a cap in which the inner cross-sectional width of the protruding portion changes As shown in Figures 3A and 4, the projection 930 can be configured to receive and / or engage at least a portion of the male luer 830 of the connector 800. In some embodiments, the inner surface 938 of the projection 930 may include a tapered region. For example, the cross-sectional width of the inner surface 938 of the projection 930 may vary (e.g., increase or decrease) from distal to proximal. The tapered region may facilitate connection between the cap 900 and the male luer 830 of the male luer connector 800. The tapered region may, in some cases, include a gradual change in the cross-sectional width of the inner surface 938.

[0051] Additionally or alternatively, the inner surface 938 may comprise one or more portions having varying inner cross-sectional widths, as shown in Figures 3A and 4. For example, as illustrated, the projection 930 may comprise a proximal portion 950 having a narrower inner cross-sectional width than the distal portion 952 of the projection 930. The distal portion 952 may be spaced distally from the proximal portion 950.

[0052] In some embodiments, as illustrated in Figure 4, the varying diameters of the wider distal portion 952 and the narrower proximal portion 950 may be dimensioned and configured to facilitate connection between the projection 930 and the male luer 830 when the cap 900 is attached to the medical connector 800. The inner cross-sectional width of the distal portion 952 of the projection 930 can be greater than the outer cross-sectional width of the outer surface 832 of the male luer 830 to which the cap 900 is attached. For example, the cross-sectional width of the inner surface 938 may decrease as the end of the male luer 830 is inserted proximal from the distal portion 952 toward the proximal portion 950, thereby increasing the tightness of the connection, grip, and / or attachment between the projection 930 and the male luer 830. In some cases, the distal portion 952 may be sized and configured to receive a male luer 830 and one or more movable parts of the sterilizing material 940, such as one or more flap portions 940a, 940b, in an orientation that extends substantially proximal when the cap 900 is attached to the connector 800 (for example, as shown in Figure 4).

[0053] In some embodiments, as illustrated in Figures 3A to 4, the varying diameters of the wider distal portion 952 and the narrower proximal portion 950 may be dimensioned and configured to facilitate connection between the projection 930 and the sterilizing material 940. The inner cross-sectional width of the distal portion 952 of the projection 930 can be smaller than the outer cross-sectional width of the sterilizing material 940 to which the projection 930 is configured to be attached, thereby facilitating the attachment of the sterilizing material 940 to the projection 930 as described herein.

[0054] Exemplary method for applying the cap embodiment The cap 900 can be attached to and / or removed from the connector 800 by pressing the cap 900 against the connector 800 or pulling it away from the connector 800 in the axial or longitudinal direction. Referring to Figure 4, when the cap 900 is connected to the male luer connector 800, the male luer 830 is received into the opening 942 of the sterilizing material 940 (e.g., an opening 942 of fixed size, or an opening 942 whose size increases when the male luer 830 is inserted, and / or an opening 942 created by the pressure of the male luer 830 on the sterilizing material 940 forming the opening 942) as shown. Once the male luer is received into the opening 942, the sterilizing material 940 can be configured to come into contact with the outer surface of the male luer 830, and to clean, wipe, and / or disinfect the outer surface. For example, when the cap 900 is connected to the male luer 830, the end face of the male luer 830 can be pressed against the sterilizing material 940 and positioned in fluid communication with the sterilizing material 940, facilitating cleaning and disinfection of the end face of the male luer 830 (e.g., the fluid passage 840) by the sterilizing material 940. The sterilizing material 940 may, in some cases, be configured to wipe the distal tip and / or side walls of the male luer 830 when the cap 900 advances onto the male luer 830. As illustrated in Figure 4, when the male luer 830 is inserted into the projection 930 and one or more movable parts (e.g., flap parts 940a, 940b) move in an orientation that extends substantially proximal, one or more movable parts of the sterilizing material 940 may have sufficient thickness to essentially completely or substantially fill the gap between the outer surface of the male luer 830 and the inner surface 938 of the distal portion 952 of the projection 930. In some embodiments, one or more flap portions 940a, 940b can be configured to compress between the outer surface of the male lure 830 and the inner surface 938 of the distal portion 952 of the projection 930, applying a substantially constant and substantially consistent force to the outer wall of the male lure 830 into which the projection 930 is inserted.

[0055] The distal portion 952 may be sized and configured to receive one or more flap portions 940a, 940b of the sterilizing material 940 when the male luer 830 of the connector 800 is attached to the cap 900. As shown in Figure 4, one or more flap portions 940a, 940b of the sterilizing material 940 may contact or engage with the connector 800 in a frictional manner on the outer surface of the male luer 830 and / or on the inner surface 938 of the distal portion 952 of the projection 930 in order to grip the male luer more tightly. For example, when the male luer 830 is inserted into the cap 900, one or more flap portions 940a, 940b of the sterilizing material 940 may contact the male luer 830. During and / or after coupling, by advancing the male lure 830 into the projection 930, one or more flap portions 940a, 940b may be moved to be adjacent to or in contact with at least a portion of the inner surface 938 of the distal portion 952, thereby positioning and / or fixing at least a portion of one or more flap portions 940a, 940b between the inner surface 938 of the distal portion 952 and the male lure 830. In some embodiments, one or more portions 940a, 940b may be configured to fold into the distal portion 952 of the projection 930. The distal portion 952 can be sized and configured to accept one or more portions 940a, 940b when the connector 800 is advanced into the projection 930 and to allow the cap 900 to grip the male lure of the connector 800 more tightly when attached. In some embodiments, at least a portion of the sterilizing material 940 is configured to move into the chamber of the projection 930 when the cap 900 is advanced onto the male luer 830.

[0056] During and / or after connection, the inner surface 938 of the proximal portion 950 of the projection 930 can move adjacent to or come into contact with at least a portion of the male luer 830 so that at least a portion of the male luer 830 is positioned within and / or fixed to the proximal portion 950. As illustrated in Figure 4, in some embodiments, the proximal portion 950 of the projection 930 is empty, i.e., there is no fluid delivery material or therapeutic fluid and / or disinfectant present, and / or, when the cap 900 is attached to the male luer connector 800, there is no structure or material between the male luer 830 and the proximal portion 950 of the projection 930. In some embodiments, by fixing the protrusion 930 or positioning the male luer 830 within the proximal portion 950 away from the sterilizing material 940, the therapeutic fluid or gel carried by the sterilizing material 940 or otherwise present in the cap 900 is not forced to enter the fluid passage 840 of the male luer 830.

[0057] In some embodiments, when the cap 900 is connected to the connector 800, as shown in Figure 4, the sterilizing material 940 of the cap 900 is positioned in direct contact with at least a portion of the collar 820 of the male luer connector 800. In some embodiments, the sterilizing material 940 is in direct contact with the threads 828 of the collar 820. In some embodiments, the sterilizing material 940 is in direct contact with the outer surface 832 of the male luer 830. In some embodiments, the sterilizing material 940 is spaced away from the male luer connector 800 and / or the connection interface 826. In some embodiments, when the sterilizing material 940 is in direct contact with the collar 820 of the male luer connector 800, the sterilizing material 940 comes into contact with the collar 820, cleaning, wiping and / or disinfecting the collar 820. In some embodiments, the sterilizing material 940 comes into contact with the threads 828 of the collar 820, cleaning, wiping and / or disinfecting the threads 828. In some embodiments, if the sterilizing material 940 comes into direct contact with the outer surface 832 of the male lure 830, the sterilizing material 940 comes into contact with the male lure 830, washes, wipes and / or disinfects it.

[0058] The cleaning or wiping methods used herein may include wiping and / or removing one or more substances or organisms from the surface of a medical connector in an amount or degree that provides a clinically significant therapeutic effect, or wiping and / or removing one or more substances or organisms in an amount set to avoid or suppress adverse medical outcomes to the patient, such as disease or infection or some other undesirable medical outcome.

[0059] Either or all of the cleaning and / or disinfecting steps may include a step of wiping along the surfaces to be cleaned and / or disinfected during connection. In some embodiments, as shown in Figure 4, the disinfectant material can simultaneously clean and / or disinfect the outer surface of the male luer 830 and the inner surface of the shroud or collar 820 by simultaneously contacting and / or wiping the outer surface of the male luer 830 and the inner surface of the shroud or collar 820. As illustrated in Figure 4, the disinfectant material 940 may have sufficient thickness to fill the gap between the outer surface of the male luer 830 and the inner surface of the shroud or collar 820 at the distal end of the male connector 800. The fluid delivery or disinfectant material 940 can be compressed between the outer surface of the male luer 830 and the inner surface of the shroud or collar 820. As shown in Figures 3A to 3C and Figure 4, a space can be provided between the outer surface of the fluid delivery or sterilization material 940 and the inner surface of the outer wall of the cap 900 or the inner surface of the skirt 920 so that the outer surface of the fluid delivery or sterilization material 940 does not come into contact with the inner surface of the outer wall of the cap 900 or the skirt 920. As shown in Figure 4, in some embodiments, at least a portion of the space can be approximately equal to and / or less than the thickness of the wall of the shroud or collar at the distal end of the connector 800, and at least a portion of the space can be less than the thickness of the wall of the shroud or collar at the distal end of the connector 800.

[0060] Delivery system This application includes several embodiments of a delivery system for disinfectant caps (e.g., syringes, dispensing surfaces, holders, containers, sleeves, etc.). While one or more drawings may illustrate a delivery system including a particular embodiment of a cap, it should be understood that any other cap or other medical device disclosed herein may be used in addition to or in place of the exemplified caps in the delivery system and / or in conjunction with the delivery system. For example, any one of the embodiments of a cap described herein with reference to one or more of Figures 1A to 4 of this application may be provided or used in conjunction with any delivery system, whether or not it is exemplified in such a delivery system. It should be understood that any of the delivery systems described herein may be used or modified for use with various embodiments of caps described and / or intended within the scope of this application.

[0061] Sterilization cap holder assembly Figures 5A and 5B are various illustrations of the sterilization cap holder assembly 404 based on several embodiments. In particular, Figure 5A is a front perspective view of the sterilization cap holder assembly 404, and Figure 5B is a side cross-sectional view of the sterilization cap holder assembly 404 of Figure 5A. Unless otherwise noted, the reference numerals in Figures 5A and 5B refer to the same or substantially similar components as those in the remaining drawings described herein. The sterilization caps 900 shown in Figures 5A and 5B are similar to the sterilization caps 900 shown in Figures 3A to 4, but it should be understood that the features described in relation to the sterilization cap holder assembly 404 shown in Figures 5A and 5B can be used with any embodiment of the sterilization cap and / or cap assembly described and / or intended herein. For example, any one of the sterilization caps 900 of Figure 1 and / or any additional caps disclosed herein can be modified to function with the sterilization cap holder assembly 404 as illustrated and described with reference to Figures 5A and 5B.

[0062] Figures 5A and 5B show a sterilization cap holder assembly 404 having a sterilization cap holder 402, and a sterilization cap 900 disposed within the cap holder 402. The cap holder 402 includes a proximal end 408, a distal end 410, an inner wall surface 412, and an outer wall surface 414 defining the chamber. In some embodiments, the cap holder 402 may include an opening 416 to the chamber 406 and a radially outward-extending flange 418 surrounding the opening 416. As shown in Figure 5A, the flange 418 may extend from the proximal end 408 of the cap holder 402. The cap holder 402 may include an optional bottom wall 419.

[0063] In some embodiments, the cap holder 402 prevents contamination of the sterilization cap 900 within the cap holder 402. For example, a user may handle the sterilization cap holder assembly 404 through one or more portions of the cap holder 402, such as a flange 418 extending outward from the cap holder 402. The cap holder 402 may also function as a protective device against user contact with the sterilization cap 900.

[0064] The cap holder 402 may comprise any suitable material (e.g., a rigid material or a semi-rigid material). In some embodiments, the cap holder 402 may comprise any suitable polymer. In some embodiments, the polymer may include an aliphatic polymer or a thermoplastic polymer such as a thermoplastic elastomer. For example, the cap holder 402 may comprise at least one of polypropylene and polyethylene (such as low, medium, or high-density polyethylene). The semi-rigid material of the cap holder 402 may have any suitable hardness (durometer). For example, in some embodiments, the cap holder 402 may have a Shore A hardness in the range of about 60 to about 1050, but any suitable hardness can be used, such as about 50, about 55, about 60, about 65, about 70, about 75, about 80, about 85, about 90, about 95, about 100, (in particular, for example, any hardness from about 50 to about 100). Please note that the cap holder 402 can have any degree of rigidity sufficient to accommodate the sterilization cap 900.

[0065] As shown in Figures 5A and 5B, in some embodiments, the sterilization cap holder assembly 404 may be sealed with foil material or a lid 450. The lid 450 can keep each sterilization cap 900 within the sterilization cap holder 402 sterile. The lid 450 may be configured to attach to one or more parts of the sterilization cap holder 402 and / or to attach directly to the sterilization cap 900. In some embodiments, the lid 450 may be sealed to the sterilization cap holder 402. For example, the lid 450 may be attached to the flange 418 by one or more adhesives or by a suitable method such as one or more conductive or induction heat sealing techniques.

[0066] Additionally or alternatively, the lid 450 may be sealed to at least a portion of the sterilization cap 900. By attaching it directly to the sterilization cap 900, the lid 450 can seal the first chamber 925 and prevent the sterilization material 940 and / or the disinfectant solution in the sterilization cap 900 from being removed. In some embodiments, the lid 450 may form a double seal if it is sealed to both the sterilization cap holder 402 and the sterilization cap 900 within the sterilization cap holder 402. For example, a double seal may provide an additional barrier to prevent contamination of the sterilization cap 900 and / or to prevent the sterilization material from leaking out of the sterilization cap 900. Advantageously, providing a double seal may improve the shelf life.

[0067] In some cases, the lid 450 may be sealed to the sterilization cap 900 without including a sterilization cap holder 402. For example, as shown in Figures 6 to 10 and described in further detail herein, the sterilization cap assembly 2004 may be formed such that the lid 450 is directly attached to the sterilization cap 900 without using a sterilization cap holder 402. Direct attachment to the sterilization cap 900 in the absence of the holder 402 ensures that the sterilization state of the sterilization cap 900 before use is maintained, while simultaneously minimizing the costs of materials, size, waste, manufacturing, and shipping associated with providing the sterilization cap assembly. As described herein, the attachment of the lid 450 to the sterilization cap 900 seals the first chamber 925, preventing or limiting the removal of the sterilization material 940 and / or sterilization fluid within the sterilization cap 900.

[0068] In some embodiments, the lid 450 may be heat-bonded to one or more of the sterilization cap holder 402 and the sterilization cap 900. The heat bonding may be induced using standard heat sealing techniques such as impulse, induction, conduction, radiation, or other heat sealing techniques. In some embodiments, the lid 450 can be attached to the sterilization cap holder 402 and / or the sterilization cap 900 by utilizing adhesive bonding or by appropriate mechanical or friction connections such as snap-fits.

[0069] The lid 450 can be made from any suitable material, such as foil, plastic, or laminate. In one embodiment, the lid 450 can be made from foil material having a thickness of about 1 to 2 mils.

[0070] The sterilization cap holder 402 and / or the sterilization cap 900 may optionally include structures, elements, etc., that prevent relative rotation of the sterilization cap holder 402 and the sterilization cap 900. In some embodiments, the structure or element may facilitate the attachment of the sterilization cap to the medical connector by engaging with the sterilization cap 900 and locking it in place, thereby preventing rotation of the sterilization cap 900 when it is positioned inside the sterilization cap holder 402. For example, in some embodiments, the inner wall surface 412 of the sterilization cap holder 402 may include internal ribs and / or internal slots. The internal ribs and / or internal slots may be configured to interact with the outer surface of the skirt 920 of the sterilization cap 900. In some embodiments, the sterilization cap 900 may have multiple ribs and / or multiple slots, which are configured to interact with the internal ribs and / or internal slots of the sterilization cap holder 402. These structures may prevent or restrain relative rotation of the sterilization cap holder 402 with respect to the sterilization cap 900. As used herein, the term "rib" refers to a structure that rises from the surface or extends outward. The term "slot" refers to a structure that extends below the surface or is located between two ribs and is at a lower height than those ribs.

[0071] In some embodiments, the sterilization cap holder 402 may have features or structures that form an interlocking fit with the outer surface of the sterilization cap 900. In some embodiments, the inner surface 412 of the sterilization cap holder 402 may have features or structures that form an interlocking fit with a portion of the sterilization cap 900. Additionally or alternatively, the sterilization cap 900 may have one or more features for forming an interlocking fit with the sterilization cap holder 402.

[0072] As shown in Figures 5A and 5B, the sterilization cap holder assembly 404 may include circumferentially spaced ribs 420 for gripping the sterilization cap holder assembly 404 by the user's hand. The sterilization cap holder assembly 404 may be used for the same purposes as described herein and may be used by hand.

[0073] The sterilization caps and / or sterilization cap holder assemblies disclosed herein may be distributed and / or packaged in a variety of suitable methods. Suitable methods include, but are not limited to, individual packages, pouch packages containing multiple sterilization caps and / or sterilization cap holder assemblies (such as the distribution bags described herein with reference to Figures 6 to 10), distribution devices (described herein with reference to Figures 11A to 11D), or syringe assemblies (described herein with reference to Figures 12A and 12B) on which the sterilization caps and / or sterilization cap holder assemblies can be attached to syringes. It should be understood that the relative sizes, as well as the distribution and / or packaging methods of the sterilization caps and / or sterilization cap holder assemblies disclosed herein, are illustrative and non-limiting. In fact, packaging can be modified for any suitable embodiment, and the relevant methods may differ in various embodiments.

[0074] Distribution bag Figures 6 to 10 are various illustrations of a delivery system for medical products in exemplary forms of a distribution bag 2000 for a sterilization cap assembly 2004 and / or sterilization cap holder assembly, based on various embodiments. In particular, Figure 6 is a front view of a distribution bag 2000 containing one or more sterilization cap assemblies 2004, and Figures 7, 8A, and 8B are a front perspective, front view, and rear view, respectively, of multiple distribution bags 2000 of Figure 6. Figures 9A to 9C are front views of various embodiments of the distribution bags 2000a to 2000c for the sterilization cap and / or sterilization cap assembly 2004. Figure 10 is a front view of a distribution bag 2100 for the sterilization cap and / or sterilization cap assembly 2004. Unless otherwise noted, the reference numerals in Figures 6 to 10 refer to the same or substantially similar components as those in the remaining drawings described herein. The sterilization cap assembly 2004 shown in Figures 6 to 10 is similar to the sterilization cap holder assembly 404 shown in Figures 5A and 5B, except for the addition of the sterilization cap holder 450. However, it should be understood that the features described with respect to the distribution bag shown in Figures 6 to 10 can be used with any embodiment of the sterilization cap and / or cap assembly described and / or intended herein. For example, any one of the sterilization caps 900 in Figures 1A and 2, 3A to 4, 5A and 5B, the sterilization cap holder assembly 404, and / or any additional caps disclosed herein can be modified to function with the distribution bag shown and described with reference to Figures 6 to 10.

[0075] In any embodiment, as illustrated, the delivery system may include a substantially elongated portion having a tube or sheath region with an internal cavity having an internal width or diameter corresponding to the external width or diameter of each of the multiple medical supplies housed within and distributed from the delivery system. For example, the internal width or diameter of the elongated portion of the delivery system may be approximately the same as or slightly larger than the external width or diameter of each of the multiple medical supplies in order to loosely house the multiple medical supplies within the elongated portion, thereby allowing the multiple medical supplies to move and / or traverse within the tube or sheath without being fixed or engaged with each other or with the tube or sheath. For example, in some embodiments, the interior of the elongated portion is shaped and configured so that when individual units of medical supplies are inserted into or loaded into the proximal opening of the delivery system, the multiple medical supplies automatically form a vertical column of single medical supplies within the elongated portion. By loosely housing the medical devices, a cascaded arrangement of medical devices within a tube or sheath can be moved toward the distribution area of ​​the delivery system (e.g., a narrowed area, i.e., an area with a smaller width) so that multiple or individual medical devices can be retrieved through the distal distribution area.

[0076] The inner width or diameter of the elongated portion of the delivery system can be made small enough so that multiple medical devices cannot all occupy the same height (e.g., vertical height) simultaneously within the elongated portion of the delivery system, thereby preventing clogging or other blockage of the elongated portion due to interference between the contained medical devices. One or more inner walls of the elongated portion may have a predetermined coefficient of friction, which is low enough (i.e., slippery) to allow for a smooth, reliable, and steady transfer of medical devices through the delivery system during use (e.g., when pushed or pulled through the delivery system by a user), and / or high enough (i.e., slip-resistant) to create an inertial position for each medical device during containment within the elongated portion to prevent the medical devices contained in the delivery system from sliding freely and accumulating in one place. To generate a low level of resistance against rapid sliding of the medical device through the tube or sheath when not pushed out or withdrawn from the delivery system by the user, one or more walls of the elongated portion may be flexible and / or foldable such that an irregular and non-smooth surface morphology (e.g., having wrinkles or folds) is generated along one or more inner walls during normal use when the elongated portion contains the medical device.

[0077] As shown in Figures 6 to 8B, the distribution bag 2000 may function as a delivery system for housing one or more disinfection devices or at least a portion of one or more disinfection devices, such as a sterilization cap 900, a sterilization cap assembly 2004, or a sterilization cap holder assembly 404. Any reference herein to the use or containment of any type of sterilization cap 900 and / or sterilization cap assembly 2004 should also be interpreted as including the additional or alternative use of sterilization caps and / or sterilization cap holders. In some embodiments, the distribution bag 2000 facilitates access to the sterilization cap assembly 2004 by advantageously allowing the removal of a single sterilization cap assembly 2004 at a time while maintaining one or more other sterilization cap assemblies 2004 within the distribution bag 2000.

[0078] Each of the cap assemblies 2004 may include any sterilization caps described herein. While the drawings show a dispensing bag 2000 containing five sterilization cap assemblies 2004, it should be understood that any number of disinfectant filling devices can be enclosed within the dispensing bag 2000. It should also be understood that the embodiments of the dispensing bag 2000 described and / or intended herein are modifiable for use with the sterilization caps described and / or intended herein.

[0079] In some embodiments, as shown in Figures 6 to 8B, the dispensing bag 2000 has a proximal portion 2008 and a distal portion 2012. The distal portion 2012 may include a chamber 2016 sized and configured to accommodate one or more sterilization cap assemblies 2004. For example, in some embodiments, the distal portion 2012 includes one or more sealed edges extending along the periphery of the distal portion 2012 to form the inner surface of the chamber 2016. In some embodiments, the inner surface may have a suitable surface texture, such as a smooth and / or rough surface texture.

[0080] Chamber 2016 may have any suitable shape and / or configuration that can accommodate at least a portion of the sterilization cap assembly 2004. For example, as shown in Figures 6 to 8B, Chamber 2016 may have a substantially cylindrical shape, but it should be understood that Chamber 2016 may have any suitable wall structure (e.g., straight and / or curved) and any suitable shape (e.g., cylindrical, tapered, conical).

[0081] As shown in Figures 6 to 8B, the width of the chamber 2016 may be greater than the width of the outer surface of the sterilization cap assembly 2004 to facilitate the accommodation of the sterilization cap assembly 2004. In some embodiments, the width of the chamber 2016 may remain constant throughout the chamber 2016. In some embodiments, the width of the chamber 2016 may vary along the length of the chamber. For example, the chamber 2016 may have a portion that is narrower than the chamber 2016. In some embodiments, the portion with the narrower width may be located adjacent to the distal end of the dispensing bag 2000 to facilitate the removal of a single sterilization cap assembly 2004 at a time.

[0082] The length of the chamber 2016 may be long enough to accommodate multiple sterilization cap assemblies 2004 and / or sterilization cap holder assemblies 404 and to prevent accidental or secondary removal of the sterilization cap assemblies 2004 and / or sterilization cap holder assemblies 404 from the chamber 2016.

[0083] In some embodiments, the inner surface of the distribution bag 2000 may be attached to one or more sterilization cap assemblies 2004 housed within the chamber 2016. The attachment may be made using adhesive bonding or by appropriate mechanical or friction connections such as snap-fits.

[0084] In some embodiments, as illustrated in Figures 6 to 8B, the dispensing bag 2000 may have one or more openings 2020. The openings 2020 may allow a user to remove one or more sterilization cap assemblies 2004 from the chamber 2016. For example, the openings 2020 provide access to the sterilization cap assemblies 2004 while allowing the dispensing bag 2000 to retain the sterilization cap assemblies 2004 remaining in the chamber 2016.

[0085] In some embodiments, the opening 2020 may be located at the distal end of the distribution bag 2000, as shown in Figures 8A and 8B. The opening 2020 may form a constriction, for example, by extending across only a portion of the distal end. For example, as shown in Figures 6 to 8B, the opening 2020 does not have to extend along the entire length of the distal end of the distribution bag 2000 (for example, as shown in Figure 9B as described herein). In some embodiments, the width of the opening 2020 may be smaller than the outer width or diameter of the medical product, such as a sterile cap assembly 2004 or cap, that is housed in the delivery system, in order to prevent the medical product from freely falling through the opening 2020 if not pushed out or pulled out by the user. In some embodiments, the width of the opening 2020 may be smaller than the outer width or diameter of the medical device, but it may also be large enough that the opening 2020 can temporarily expand elastically or flexibly to a size through which the medical device can pass without the material making up the opening 2020 being torn, irreversibly stretched, or otherwise damaged. By positioning the opening 2020 at the distal end, it is advantageous that the sterile cap assembly 2004 can be naturally positioned to extend adjacent to or partially through the opening 2020 when the distribution bag 2000 is suspended (as described in further detail below). In this configuration, the position of the opening 2020 may facilitate access to the sterile cap assembly 2004. However, it should be understood that such a position may be modified for any suitable embodiment.

[0086] The opening 2020 can have any suitable shape and / or configuration that allows access to the sterilization cap assembly 2004 while preventing the sterilization cap assembly 2004 from being accidentally removed from inside the chamber 2016. For example, Figures 9A to 9C show partial front views of various embodiments of the distribution bags 2000a to 2000c for the sterilization cap and / or sterilization cap assembly 2004.

[0087] As shown in Figure 9A, in some embodiments, the opening may be provided with one or more slits 2020a. The dispensing bag 2000c may have a fully sealed distal edge 2030a, and the slits 2020a may be formed along the side wall and extend into the chamber 2016 of the dispensing bag 2000a. The user may utilize the slits 2020a to access one or more sterile cap assemblies 2004 in the chamber 2016. In some embodiments, the slits 2020a may be pre-positioned in a closed position to prevent unintended removal of the sterile cap assemblies 2004 from the dispensing bag 2000a.

[0088] Figure 9B shows that in some embodiments, the opening 2020b may have a diameter smaller than the outer diameter of the sterilization cap assembly 2004 in order to prevent unintended removal of the sterilization cap assembly 2004 from the delivery system, or to allow only a portion of the sterilization cap assembly 2004 to extend outside the chamber 2016, while the rest of the sterilization cap assembly 2004 remains housed inside the delivery system until intentionally removed. For example, the opening 2020b may include one or more sealed edges 2040 within the chamber 2016, and / or one or more sealed edges 2030b at the distal end of the distribution bag 2000. One or more sealed edges 2040, 2030b may be tapered toward the opening 2020b. Advantageously, one or more sealed edges 2040, 2030b may allow only one sterilization cap assembly 2004 to extend through the opening 2020b. One or more sealed edges 2040, 2030b may have any suitable shape and / or configuration that can accept at least a portion of the sterilization cap assembly 2004. For example, as shown in Figure 9B, the sealed edges 2040 may have a substantially conical shape, but it should be understood that the sealed edges 2040 may have any suitable wall structure (e.g., straight and / or curved wall structures) and any suitable shape (e.g., cylindrical, tapered).

[0089] As shown in Figure 9C, in some embodiments, the opening 2020c may be located along the side edge of the distribution bag 2000. For example, the distribution bag 2000c may have a fully sealed distal edge 2030c. The sealed distal end 2030c is advantageous in that it prevents unintended removal of the sterilization cap assembly 2004 from the delivery system caused solely by downward gravity (for example, if the distribution bag is in a position where it is suspended vertically).

[0090] In embodiments where a portion of the sterilization cap assembly 2004 protrudes beyond the opening 2020, the user may remove the sterilization cap assembly 2004 from the dispensing bag 2000. In some embodiments, the opening 2020 may have the same or a larger diameter than the sterilization cap assembly 2004. It should be understood that the position and relative size of the opening 2020 shown in Figures 6 to 10 are illustrative and not limited thereto. In fact, the relative size can be modified for any suitable embodiment, and the relative ratio of the opening 2020 to the rest of the dispensing bag 2000 may differ in various embodiments. In some embodiments, the dispensing bag 2000 may not incorporate one or more openings 2020.

[0091] To remove the sterilization cap assembly 2004 from the distribution bag 2000, the user may grasp the portion of the sterilization cap assembly 2004 that is located within the distribution bag 200 or protrudes beyond the opening 2020 and apply an extraction force, such as a downward force (if the distribution bag 2000 is oriented to be suspended vertically). In some embodiments, the user may push the sterilization cap assembly 2004 through the opening 2020 by grasping at least a portion of the distribution bag 2000 and applying a pinching force or other force to the sterilization cap assembly 2004 through the distribution bag 2000 to advance the sterilization cap assembly 2004 through the opening 2020. In some embodiments, the distribution bag 2000 may advantageously eliminate the need for direct contact with the sterilization cap assembly 2004 during removal from the distribution bag 2000. In some embodiments, the distribution bag 2000 facilitates the removal of the sterilization cap assembly 2004 through an efficient process requiring only the use of one hand.

[0092] The sterilization cap assembly 2004 may be pulled out of the distribution bag 2000 such that the (e.g., downward) pull force required to pull the sterilization cap assembly 2004 out of the chamber 2016 is greater than the gravitational force acting on the preceding (most distal) sterilization cap assembly 2004 that is located in or partially located in the distribution bag, so that the sterilization cap assembly 2004 does not simply fall through the hole 2024 under gravity.

[0093] To prevent the sterilization cap assembly 2004 from being accidentally removed from the distribution bag 2000, in some embodiments the distribution bag 2000 may be made of a semi-rigid, elastic, or elastomer material that can deform when force is applied. When the sterilization cap assembly 2004 is removed from the chamber 2016, the opening 2020 may be configured to deform radially outward or in the opening direction at one or more locations where the sterilization cap assembly 2004 is in contact with or interacting with the opening 2020, the opening direction being substantially perpendicular to the longitudinal axis of the distribution bag 200. In some embodiments the opening 2020 may be configured to spring radially inward in a closing direction substantially opposite to the opening direction after the sterilization cap assembly 2004 has been removed from the distribution bag 2000 through the opening 2020. This is advantageous as it may allow the opening 2020 of the dispensing bag 2000 to be temporarily and / or permanently deformed when the opening 2020 interacts with one or more features of the sterilization cap assembly 2004. In some embodiments, the ability to deform the opening 2020 may allow the sterilization cap assembly 2004 to be removably housed in the chamber 2016. In some embodiments, the distal opening 2020 is smaller than the proximal opening of the dispensing bag, which may allow multiple sterilization cap assemblies 2004 to be rapidly and continuously loaded through the proximal opening during manufacturing, while simultaneously preventing the housed sterilization cap assemblies 2004 from unintentionally falling out of the distal opening 2020.

[0094] In some embodiments, the distribution bag 2000 may have one or more features configured to allow a user to create an opening 2020 to access one or more sterilization cap assemblies 2004 in the chamber 2016. Figure 10 shows an embodiment of the distribution bag 2000 having a sealing portion 2130 located distal to the opening 2020. In some embodiments, the sealing portion 2130 may include a sealed distal edge 2150 and at least a portion of a sealed side edge 2140. The sealed side edge 2140 may include at least a portion of the chamber 2016. The sealing portion 2130 may be removablely pulled away from the distribution bag 2000. In some embodiments, the distribution bag 2000 may have a notch and / or perforation and / or cut 2135 so that a user can tear or open or remove the sealing portion 2130 of the distribution bag 2000 to form an opening 2020 or access the opening 2020. When the sealing portion 2130 is removed, the distribution bag 2000 may include one or more sealed distal edges 2148a, 2148b defining the opening 2020. The opening 2020 may include any of the features described herein.

[0095] In some embodiments, the distribution bag 2000 may be manufactured using one or more steps described herein. To provide the surface of the distribution bag 2000, multiple material sheets, such as two sheets, may be arranged in an aligned manner. For example, a first sheet may be placed on top of a second sheet such that both the first and second sheets are substantially the same size and shape. In some embodiments, these sheets may be rectangular; however, these sheets may have any shape suitable for forming the distribution bag 2000. One or more edges or other areas of these sheets may be joined or sealed to provide the chamber 2016 of the distribution bag 2000. Any suitable method may be used to join or seal one or more edges or other areas. For example, in some embodiments, heat staking and / or thermal bonding may be used to melt and seal at least portions of the sheets together and / or around the peripheral portion (e.g., edges) of the chamber 2016. Thermal bonding may be performed using standard heat sealing techniques such as impulse, induction, conduction, radiation, or other heat sealing techniques. Additionally or alternatively, the edges may be sealed by utilizing appropriate mechanical or friction connections such as ultrasonic welding, adhesive bonding, or snap-fitting. In some embodiments, adhesives such as glue or solvents or adhesives, or any other suitable agents may be used. Referring to Figure 10, for example, the side edges 2140, 2142 may be sealed together with one or more edges 2144, 2146 located in the proximal portion 2008. In some embodiments, the resulting assembly has an opening 2020 in the distal portion 2012, together with a hollow chamber 2016 for holding the sterilization cap assembly 2004. One or more sterilization cap assemblies 2004 may be located in the chamber 2016 in any suitable manner. The opening 2020 may be formed by forming edges 2148a, 2148b in any sealing method described herein.In some embodiments where the distribution bag 2000 includes a sealing portion 2130, the distal end 2150 can be sealed along the width of the distribution bag 2000 and a notch, perforation and / or cut 2135 can be formed.

[0096] In some embodiments, the proximal portion 2008 of the distribution bag 2000 may include one or more hanging holes 2024. For example, the holes 2024 may include one or more die-cut holes. The holes 2024 may be dimensioned and configured to allow the distribution bag 2000 to be suspended from a convenient hanger. For example, a user may utilize one or more holes 2024 to suspend the distribution bag 2000 from an IV pole. The holes 2024 may have any suitable shape and / or configuration to allow the distribution bag 2000 to be suspended from a hanger. The location and relative size of the holes 2024 shown in Figures 6 to 8B are illustrative and not limited thereto. In fact, the location and relative size may be modified for any suitable embodiment, and the relative ratio of the holes 2024 to the rest of the distribution bag 2000 may differ in various embodiments. In some embodiments, the distribution bag 2000 may not incorporate one or more holes 2024.

[0097] The dispensing bag 2000 may be made of an impermeable or very impermeable material. In some embodiments, the material may be substantially chemically inert and / or non-conductive. The dispensing bag 2000 can provide an additional barrier to prevent contamination of the cap and sterilization cap assembly 2004, thereby improving the shelf life. The dispensing bag 2000 may provide protection against contamination of the sterilization cap assembly 2004 during handling. The dispensing bag 2000 can be configured to act as a physical barrier that isolates at least a portion of the sterilization cap assembly 2004 from the external environment. For example, in some embodiments, the dispensing bag 2000 can be configured to prevent contaminants from entering the chamber 2016.

[0098] In some embodiments, all or part of the dispensing bag 2000 may be made of a transparent material so that the user can easily identify the dispensing bag as a holder for a particular type of medical device (such as a sterile cap) and / or read information printed on the packaging of one or more types of medical devices inside the bag and / or determine the amount of sterile cap assembly 2004 remaining inside the dispensing bag 2000 from the outside of the bag and / or from any viewing angle (for example, to determine when the bag needs to be replaced). In some embodiments, the dispensing bag 2000 avoids some of the complexities associated with suspending the dispensing bag 2000 from the rear so that the dispensing bag can be seen and / or accessed from the front and rear, as shown in Figures 38A and 38B.

[0099] As shown in Figure 10, in an example of a method for manufacturing the distribution bag 2000, one or more (or any combination thereof) of the following steps may be performed. (a) Steps to provide flexible transparent sheets for the front and rear. (b) The step of roughly positioning the front seat on top of the rear seat. (c) A step of roughly aligning the edges of the front and rear seats. (d) The step of sealing or joining together multiple edges of these sheets, for example, each of the side edges and top edges of these sheets, in order to form a container for the distribution bag 2000. (e) Steps to temporarily leave at least one of each edge of the sheet (e.g., the lower edge) or a portion of such edges unsealed or unjoined relative to one another in order to form a temporary opening in the container. (f) Inserting multiple caps (e.g., individual caps or caps located in the cap holder 410) into the container of the distribution bag 2000 through a temporary opening. (g) After inserting the cap into the container, the step of sealing or joining any pre-sealed or unjoined ends through which the cap is inserted. (h) The step of sealing or joining portions of each sheet in order to form a constriction at the end or distribution area of ​​the distribution bag 2000. (i) A step of creating a perforation or other mark or area to facilitate the removal of a portion of the distribution bag 2000 in order to allow the removal of a cap that has been pre-inserted into the distribution bag 2000. Any of these steps may be omitted or modified, and the order of any of these steps may be changed. Various features of the distribution bag 2000 may include various exemplary dimensions and proportions that form part of this disclosure. It should be understood that these dimensions are illustrative and not limited to them. In fact, it should be understood that these dimensions may be modified for any suitable embodiment, and the relative proportions of these dimensions may differ in different embodiments.

[0100] Distribution device Figures 11A to 11D are various illustrations of a delivery system for medical products in an exemplary form of a dispensing device 600 for sterilization caps 900 and / or sterilization cap holder assemblies 404, based on several embodiments. In particular, Figure 11A is a top view of the dispensing device 600 including one or more sterilization caps 900, and Figures 11B, 11C, and 11D are a side view, a lateral section view, and a partial lateral exploded section view of the dispensing device 600 of Figure 11A, respectively. Unless otherwise noted, the reference numerals in Figures 11A to 11D refer to the same or substantially similar components in the remaining drawings described herein. The sterilization caps 900 shown in Figures 11A to 11D are similar to the sterilization caps 900 shown in Figures 3A to 4, but the features described with respect to the dispensing device shown in Figures 11A to 11D can be used with any sterilization cap and / or cap holder assemblies in embodiments described and / or intended herein. For example, any one of the sterilization caps 900 in Figure 2, the sterilization cap holder assemblies 404 in Figures 5A and 5B, and / or any additional caps disclosed herein can be modified to function with a dispensing device as shown and described with reference to Figures 11A to 11D.

[0101] Figures 11A to 11D show a dispensing device 600. The dispensing device 600 may function as a delivery system for housing one or more disinfection devices, or at least a portion of one or more disinfection devices, such as those shown in Figures 11A to 11D, sterilization caps 900 and / or sterilization cap holder assemblies 404. Any reference herein to the use or containment of any type of sterilization cap 900 should also be interpreted as including the use of sterilization cap holder assemblies 404 additionally or alternatively. In some embodiments, the dispensing device 600 facilitates access to the sterilization caps 900 and / or sterilization cap holder assemblies 404 by allowing the advantageous removal of a single sterilization cap 900 and / or sterilization cap holder assemblies 404 at a time, while maintaining one or more other sterilization caps 900 and / or sterilization cap holder assemblies 404 attached to the dispensing device 600.

[0102] Each of the sterilization caps 900 contained in the dispensing device 600 may include any sterilization cap holder and / or any sterilization cap as described herein. Figures 11A to 11D illustrate a dispensing device housing five sterilization caps 900, but any number of disinfectant filling devices can be attached to the dispensing device 600. Any embodiment of the dispensing device 600 described and / or intended herein can be modified for use with any sterilization cap described and / or intended herein.

[0103] As shown in the drawings, the dispensing device 600 may include one or more sterilization caps 900 attached to a cover, i.e., the dispensing surface 604. For example, as shown in Figures 11A to 11D, multiple sterilization caps 900 are attached to a single dispensing surface 604. Each of the sterilization caps 900 can be any cap described herein.

[0104] The distribution surface 604 has a width narrower than its length. The cap storage device may have any other suitable shape and / or configuration capable of receiving at least a portion of the sterilization cap 900 and / or the sterilization cap holder assembly 404. The cap storage device may have any suitable structure (e.g., a straight structure and / or a curved structure) and may have any suitable shape (e.g., cylindrical, tapered).

[0105] As shown in Figures 11A to 11D, the width of the distribution surface 604 may be greater than the width of the outer surface of the sterilization cap 900 to facilitate the attachment of the sterilization cap 900. In some embodiments, the width of the distribution surface 604 may remain constant throughout the distribution surface 604. In some embodiments, the width of the distribution surface 604 may vary along the length of the distribution surface 604. For example, the distribution surface 604 may include a portion having a narrowed width. In some embodiments, the portion having a narrowed width may be located adjacent to the distal end of the distribution device 600. In some embodiments, the width of the distribution surface 604 may be large enough to accommodate two or more rows of sterilization caps 900.

[0106] Figures 11A to 11D illustrate the dispensing device 600 as comprising one row of five sterilization caps 900, but the dispensing device 600 may include a length or width sufficient to accommodate multiple sterilization caps 900 and / or sterilization cap holder assemblies 400. For example, the width and length of the dispensing surface 604 may be large enough to accommodate two or more rows of sterilization caps 900, each row comprising two or more sterilization caps 900. In some embodiments, the dispensing surface 604 may include notches, perforations, and / or cuts between multiple sterilization caps 900 and / or sterilization cap holder assemblies 404. These notches allow the user to tear apart individual units or any number of units for future use and while still retaining the individual sterilization barriers of the units.

[0107] As shown in Figures 11A to 11D, a plurality of sterilization cap assemblies 404 may be sealed using a distribution surface 604. The distribution surface 604 may allow each sterilization cap 900 to remain sterile. The distribution surface 604 may be configured to seal to one or more portions of the sterilization cap 900. In some embodiments, the distribution surface 604 is sealable to the sterilization cap 900 as identified by reference numeral 608 in Figures 11A to 11D. For example, the distribution surface 604 may be attached to the sterilization cap 900 by any suitable method such as an adhesive, or by conductive or inductive heat sealing techniques as described herein.

[0108] By being directly attached to the sterilization cap 900, the distribution surface 604 can seal the first chamber 925 and prevent the extraction of the sterilization material 940 and / or sterilization fluid from within the sterilization cap 900. In some embodiments in which the distribution surface 604 is attached to one or more sterilization cap holder assemblies 404 of Figures 5A and 5B, the distribution surface 604 may form a double seal if it seals both the cap holder 402 and the sterilization cap 900 located within the cap holder 402. For example, a double seal may provide an additional barrier to prevent contamination of the sterilization cap 900 and / or to prevent the sterilization material from leaking out of the sterilization cap 900. Advantageously, providing a double seal may improve the shelf life.

[0109] As shown in Figures 11A to 11D, the distribution device 600 may include one or more suspension holes 610. For example, the holes 610 may include one or more die-cut holes. The holes 610 may be sized and configured to allow the distribution device 610 to be suspended from a convenient hanger. For example, a user may utilize one or more holes 610 to suspend the distribution device 600 from an IV pole. The holes 610 may have any suitable shape and / or configuration that allows the distribution device 600 to be suspended from a hanger. It should be understood that the location and relative size of the holes 610 shown in Figures 11A to 11D are illustrative and not limited thereto. In fact, it should be understood that the location and relative size can be modified for any suitable embodiment, and the relative ratio of the holes 610 to the rest of the distribution device 600 may differ in various embodiments. In some embodiments, the distribution device 600 may not incorporate one or more holes 610.

[0110] In some embodiments, the distribution surface 604 may be heat-bonded to one or more sterilization caps 900. The heat bonding may be induced using standard heat sealing techniques such as impulse, induction, conduction, radiation, or other heat sealing techniques. In some embodiments, the distribution surface 604 can be attached to the sterilization caps 900 by utilizing adhesive bonding or by appropriate mechanical or friction connections such as snap-fits.

[0111] To remove the sterilization cap 900 from the dispensing device 600, the user may grasp the portion of the sterilization cap holder assembly 404 that extends from the dispensing surface 604 and apply a removal force, such as a downward force (if the dispensing device 600 is positioned in a vertically suspended orientation). In some embodiments, as described herein, the user may remove at least a portion of the dispensing surface 604 by utilizing notches and / or perforations when removing the sterilization cap 900. Advantageously, this ensures that at least one seal is retained on the sterilization cap 900 when removed from the dispensing device 600. In some embodiments, the dispensing device 600 facilitates the removal of the sterilization cap 900 through an efficient process requiring only the use of one hand.

[0112] In some embodiments, it may be advantageous to include a sterilization cap holder 402 on the dispensing device 600, thereby eliminating the need for direct contact with the sterilization cap 900 during removal from the dispensing device 600. The sterilization cap holder 402 may prevent contamination of the sterilization cap 900 within the sterilization cap holder 402. For example, a user may handle the sterilization cap holder assembly 404 through one or more parts of the sterilization cap holder 402, such as a flange 418 extending from the sterilization cap holder 402. The sterilization cap holder 402 may also function as a protective device against user contact with the sterilization cap 900.

[0113] The sterilization cap 900 may be pulled out from the dispensing device 600 such that the removal force (e.g., downward) required to remove the sterilization cap 900 from the dispensing surface 604 is less than the strength of the hole 610, and so that the hole 610 is not torn when the dispensing device 600 is in a vertical suspension position. For example, the peeling force can be less than approximately 2 pounds to initiate peeling and less than 1 pound to continue peeling.

[0114] In some embodiments, the distribution surface 604 can be made from any suitable material. For example, the distribution surface 604 may comprise foil, plastic, laminate, etc. In some cases, the distribution surface 604 can be made from foil material having a thickness of about 1 to 2 mils. The distribution surface 604 may have a thick foil comprising a top coat made of PET, such as 48 gauge PET (polyethylene terephthalate), followed by a polymer coat such as PDX, which can be white, and a bottom coat made of a peelable sealing layer such as Allegro B manufactured by Rollprint Packaging Products, Inc. The sealing layer can form a peelable adhesive. The sterilization cap 900 and / or sterilization cap holder assembly 404 may be attached to the distribution surface 604 by induction heating of the foil, which melts the peelable sealing layer and adheres the sealing layer to the sterilization cap 900 and / or sterilization cap holder assembly 404.

[0115] In some embodiments, all or part of the dispensing device 600 may be made of a transparent material so that the user can easily identify the dispensing bag 600 as a holder for a particular type of medical device (such as a sterile cap and / or sterile cap holder assembly) and / or read information printed on the packaging of one or more types of medical devices in the bag and / or determine the amount of sterile cap assembly 404 remaining in the dispensing bag 600 from any viewing angle (for example, to determine when the dispensing bag 600 needs to be replaced). In some embodiments, the dispensing bag 600 avoids some of the complexities associated with suspending the dispensing bag 600 from the rear so that the dispensing bag 600 can be seen and / or accessed from the front and rear.

[0116] Various features of the distribution device 600 may have various exemplary dimensions and proportions that form part of this disclosure. It should be understood that these dimensions are illustrative and not limited to them. In fact, it should be understood that dimensions can be modified for any suitable embodiment, and their relative proportions may differ in various embodiments.

[0117] Syringe assembly Figures 12A and 12B are various illustrations of a syringe assembly 1210 including a sterilization cap assembly 1220, based on several embodiments. In particular, Figure 12A is a front perspective view of the syringe assembly 1210 including the sterilization cap assembly 1220, and Figure 12B is a side cross-sectional view of the syringe assembly 1210 of Figure 12A. Unless otherwise noted, the reference numerals in Figures 12A and 12B refer to the same or substantially similar components as those in the remaining drawings described herein. The sterilization cap assembly 1220 shown in Figures 12A and 12B is similar to the sterilization cap assembly 2004 shown in Figures 6 to 10, but it should be understood that the features described with reference to the syringe assembly 1210 shown in Figures 12A and 12B can be used with any embodiment of sterilization cap and / or cap holder assemblies described and / or intended herein. For example, any one of the sterilization caps 900 in Figures 1A to 2, 3A to 4, 5A and 5B, and / or any additional caps described herein can be modified to function with the syringe assembly 1210 as shown and described with reference to Figures 12A and 12B.

[0118] Figures 12A and 12B show a syringe barrel assembly 1210 having a syringe assembly 1240 with a sterile cap configured to removably receive a sterile cap holder assembly 1220. The syringe assembly 1210 may also include a syringe barrel 1214 and a plunger 1240. The syringe barrel 1214 may include a side wall defining a chamber and a proximal opening in fluid communication with the chamber. In some embodiments, the chamber of the syringe assembly 1210 may be filled with a locking solution or flushing solution for use with an intrinsic central venous catheter. Some examples of suitable locking or flushing solutions are described below. The flushing or locking solution is injected into the fluid access site of the catheter to cleanse and disinfect the catheter and can be withdrawn from the catheter or left on the end portion of the catheter to act as a barrier against the entry of pathogens and contaminants.

[0119] The plunger 1240 may include an elongated shaft, a proximal end 1242, and a distal end (not shown in Figures 12A and 12B). In some embodiments, the elongated shaft has a substantially cruciate cross-sectional shape. A stopper or piston may be connected to the distal end of the plunger 1240. In some embodiments, the piston is dimensioned such that, when inserted into the syringe barrel chamber, the outer surface of the piston engages liquid-tightly with the inside of the syringe barrel 1214. The piston assembly can draw fluid into the chamber when moved proximal (or withdrawn) and expel fluid from the chamber when moved distal (or inserted into the syringe chamber). Figures 12A and 12B show the piston assembly 1240 partially inserted into the syringe barrel 1214.

[0120] As shown in Figures 12A and 12B, in some embodiments, the proximal end 1242 of the plunger may include a chamber 1260 sized to receive and removably hold the sterilization cap assembly 1220. Referring to Figure 12B, the chamber 1260 may comprise a bottom wall 1261 and an annular side wall 1262 having a peripheral proximal end 1266 including an opening 1268 through which the sterilization cap assembly 1220 can be inserted into the chamber 1260. It should be understood that any embodiment of the sterilization cap and / or sterilization cap holder assembly described and / or intended herein can be modified for use with the syringe assembly shown in Figures 12A and 12B.

[0121] Figures 12A and 12B illustrate a sterilization cap assembly 1220 within the chamber 1260 of the plunger assembly 1240. The sterilization cap assembly 1220 may include any sterilization cap holder assembly disclosed herein. For example, the sterilization cap assembly may comprise a sterilization cap holder assembly 404 disclosed with reference to Figures 5A and 5B. For example, as described herein, the cap assembly 1220 may comprise one or more of the following features: a sterilization cap holder, a sterilization cap 900, a sterilization material 940, and a cover 1250. In some embodiments, a pull tab 1252 may be provided to facilitate the removal of the film 1250 to provide access to the sterilization cap 900. In some embodiments, the sterilization cap assembly 1220 can be manufactured, assembled, and sterilized separately from the plunger assembly 1240 and syringe barrel 1214 by incorporating a separate plunger assembly 1240 and sterilization cap assembly 1220.

[0122] In some embodiments, as illustrated in Figure 12A, the side wall 1262 of the plunger 1240 includes one or more openings 1270 having edges 1272. The one or more openings 1270 provide access to the chamber 1260 and facilitate the removal of the cap assembly 1220 from the plunger 1240, as described below.

[0123] The cap assembly 1220 can be removed from the plunger 1240. In some embodiments, removing the cap assembly 1220 from the plunger 1240 involves placing the user's thumb or index finger through one or more openings 1270 against the underside of the cap assembly 1220. The user may also press the cap assembly 1220 with their index finger or thumb to push it out of the chamber 1260. Finally, the cap assembly 1220 is discharged from the chamber 1260. In this way, the sterile cap 900 can be conveniently used at a different time than the syringe 1210.

[0124] In some embodiments, the chamber 1260 of the plunger 1240 may include an inner surface having a plurality of circumferentially spaced ribs. The plurality of ribs may be configured to contact the sterilization cap assembly 1220 and to secure the sterilization cap assembly 1220 within the chamber 1260. In some cases, each of these ribs may include a slot shaped to receive a corresponding rib positioned on the outer surface of the sterilization cap assembly 1220 to secure the cap holder assembly 1220 within the chamber 1260. The ribs of the chamber 1260 may also be tapered to facilitate controlled removal of the sterilization cap assembly 1220 and to prevent the sterilization cap assembly 1220 from being ejected excessively rapidly. These ribs can reduce the magnitude of the resistance force against the cap 1222 as the sterilization cap assembly 1220 is pushed out of the chamber 1260. It should also be understood that any of the embodiments described and / or intended herein may be modified for use with the chamber 1260 shown in Figures 12A and 12B.

[0125] As partially shown in Figure 12A, the plunger 1240 may include four support walls extending from a common point at 90-degree angles to each other. One or more support walls may have one or more recessed areas adjacent to one or more openings 1270 toward the proximal end 1242 of the plunger 1240 to facilitate removal of the cap assembly by providing more clearance for the user to place their thumb under the cap assembly. In some embodiments, the outermost edge of the recessed area is closer to the common point than the outermost edge of the rest of the side wall. The recessed area may have a flat edge, an inclined edge, or both.

[0126] In some embodiments, the plunger 1240 may not include a chamber, and the sterilization cap holder and / or sterilization cap assembly may be mounted to the distal end of the plunger 1240. The plunger 1204 may optionally have a button at its distal end, and the cap and / or sterilization cap assembly may be configured to engage with the button. For example, the cap and / or sterilization cap assembly may include a proximal end that is detachably or fixedly attached to the button of the plunger. The proximal end may include an opening dimensioned to fit around the button and may include a member for attachment to the button. In some embodiments, the attachment member includes a plurality of tabs spaced circumferentially and oriented axially inward, the tabs extending from the inner wall surface. In some embodiments, the tabs engage with the underside of the button to attach the cap holder and / or sterilization cap assembly to the plunger.

[0127] The syringe assembly 1210 can be manufactured from any material suitable for its purpose, including glass and polymer materials. Suitable polymer materials include, but are not limited to, homopolymers, copolymers, and terpolymers formed from monomers such as olefins, cyclic olefins, amides, esters, and ethers. The polymer material may be a mixture of multiple polymer materials and may have a monolayer or multilayer structure. In some embodiments, the syringe barrel and plunger are injection molded from polypropylene material.

[0128] Sterilization material Unless otherwise noted, the sterilizing materials described below refer to the same or substantially similar components as those described herein. It should be understood that the features described below can be used in conjunction with any of the embodiments described and / or intended herein. For example, any one of the sterilizing caps disclosed herein may be modified to include any sterilizing material as described below, elsewhere in this specification, or otherwise.

[0129] The sterilizing material may include medical-grade materials capable of storing and releasing disinfectants or other liquids having medical purposes, and may include materials such as sponges, burstable capsules, and other materials or devices that can serve this purpose. Suitable sponges may include any sponge suitable for use for medical purposes and may be natural or synthetic. The sterilizing material may be cut into appropriate shapes and molded into desired shapes. It may be desirable to attach the sterilizing material to the sterilizing cap to prevent it from accidentally falling off and / or dropping from the sterilizing cap. For example, the sterilizing material may be attached to the sterilizing cap by any suitable method such as ultrasonic or vibration welding or other suitable techniques.

[0130] The disinfectant material may comprise any material suitable for storing and / or releasing disinfectant. In some embodiments, the disinfectant material may comprise any suitable polymer. In some embodiments, the polymer may comprise a polymer foam. For example, the disinfectant material may comprise polyurethane, polyester, polycarbonate, and / or polyamide. The disinfectant material may comprise an open-cell foam. In some embodiments, the foam may have a density of at least about 0.8 to about 2.8 pounds / cubic foot or less.

[0131] In some embodiments, one or more portions of any of the sterilization caps described herein may be coated and / or impregnated with a disinfectant fluid, an anticoagulant fluid, an antimicrobial fluid, and / or other suitable therapeutic fluid. One or more portions of the sterilization cap that may be coated and / or impregnated include the inner surface of the cap wall, the threads, the outer surface of the cap wall, the inner surface of the cap wall, and / or additional features of the cap described herein.

[0132] A fungicide may comprise any substance suitable for its purpose. Suitable substances include, but are not limited to, isopropyl alcohol (IPA), chlorhexidine, one or more metal ions (e.g., silver), citrate solutions, etc. In some embodiments, the fungicide may include aminoglycosides, beta-lactams, quinolones or fluoroquinolones, macrolides, sulfonamides, sulfamethaxozol, tetracyclines, treptogramin, oxazolidinones (such as linezolid), clindamycin, lincomycin, rifamycin, glycopeptides, polymyxins, lipopeptide antibiotics, as well as antimicrobial agents classified as pharmacologically acceptable sodium salts, pharmacologically acceptable calcium salts, pharmacologically acceptable potassium salts, lipid preparations, derivatives and / or analogs thereof. In some embodiments, the fungicide may include antifungal agents. In some embodiments, the fungicide may include antiviral agents. The fungicide may be a mixture of several fungicide materials.

[0133] In some embodiments, a predetermined amount of a physiologically antimicrobial metal compound is added to a resin for direct molding of an article. Physiologically antimicrobial metals include precious metals such as silver, gold, and platinum, as well as copper and zinc. The physiologically antimicrobial metal compounds used herein may include oxides and salts of silver and gold, for example: silver acetate, silver benzoate, silver carbonate, silver citrate, silver chloride, silver iodide, silver nitrate, silver oxide, silver sulfadiazine, silver sulfate, gold chloride, and gold oxide. Platinum compounds, such as chloroplatinic acid or its salts (e.g., sodium and calcium chloroplatinate), may also be used. Copper and zinc compounds may also be used, for example: oxides and salts of copper and zinc as described above in relation to silver. A single physiologically antimicrobial metal compound or a combination of multiple physiologically antimicrobial metal compounds may be used.

[0134] In some embodiments, the physiologically antimicrobial metal compounds used may include silver acetate, silver oxide, silver sulfate, gold chloride, and combinations of silver oxide and gold chloride. Particles of the silver compound can be sufficiently extracted to form an inhibitory zone that inhibits bacterial growth and kills bacteria.

[0135] In some embodiments, the devices described herein are impregnated with triclosan and a silver compound or triclosan and chlorhexidine.

[0136] Further details regarding embodiments disclosed herein, including the sterilization cap, can be found in International Application PCT / US2017 / 056407. It should be understood that any of the functions, materials, methods, systems, and devices described and / or intended in International Application PCT / US2017 / 056407 may be modified for use with the various functions, materials, methods, systems, and devices described herein. For example, the sterilization cap may further comprise any of the embodiments described and / or intended in International Application PCT / US2017 / 056407. In addition, any of the functions, materials, methods, systems, and devices described and / or intended in this specification may be modified for use with the various functions, materials, methods, systems, and devices described and / or intended in International Application PCT / US2017 / 056407.

[0137] Other variations Although the present invention has been described in the context of specific embodiments and examples, the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or the use of the present invention and its equivalents. In addition, although several modifications of the present invention have been shown and described in detail, other modifications are also within the scope of the invention. Various combinations or secondary combinations of specific features and aspects of the embodiments may and may not fall within the scope of the invention. It should be understood that various features and aspects of the disclosed embodiments may be combined or substituted for each other to form various modes of the disclosed invention. Accordingly, the scope of the present invention disclosed herein is not intended to be limited by the specific disclosed embodiments described above, but should be determined solely by a fair reading of the following claims. Furthermore, terms such as “up to,” “at least,” “greater than,” “less than,” and “between” include the numbers listed. Numbers preceding terms such as “about,” “approximately,” and “substantially” as used herein include the numbers listed (e.g., about 10% = 10%), and also represent a quantity close to a specified amount that performs the desired function or obtains the desired result. [Explanation of Symbols]

[0138] 200 distribution bags 400 Sterilization Cap Holder Assembly 402 Sterilization Cap Holder 404 Sterilization Cap Holder Assembly 406 Chamber 408 Proximal end 410 Distal end 412 Interior wall surface 414 Exterior wall surface 416 Opening 418 Flange 419 Bottom wall 420 Rib 450 Lid 600 distribution devices 604 Distribution plane 610 holes 800 Medical Connectors 810 Connector Housing 820 Color 822 Exterior 824 Inner self 826 Connection Interfaces 828 screw thread 830 Male-type lure 832 External surface 840 Fluid passage 900 Sterilization Caps 910 Housing 920 Skirt 922 Tapered area 925 First Chamber 930 Protrusion 932 Opening 934 Rim 936 Exterior 938 Inner Self 940 Sterilization materials 940a, 940b Flap section 942 Opening 942a, 942b Notch, perforation, cut 946, 946' Mounting part 950 Proximal portion 952 Distal portion 1204 Plunger 1210 Syringe Assembly 1214 Syringe barrel 1220 Sterilization Cap Assembly 1222 Cap 1240 Plunger Assembly 1242 Proximal end 1250 cover 1252 Pull tab 1260 Chamber 1261 Bottom wall 1262 Side wall 1266 Peripheral proximal end 1268, 1270 Opening 1272 Edge

Claims

1. A disinfectant male luer cap configured to be attached to a medical connector having a male luer with a side wall and a distal tip, A housing comprising an exterior wall and a bottom wall, A first chamber surrounded by the outer wall and bottom wall of the housing, An inner projection extending upward from the bottom wall of the housing, comprising an inner wall and an outer wall, A second chamber formed by the inner wall of the inner protrusion, the second chamber configured to tightly receive the male luer of the medical connector, A sterilizing material containing a disinfectant solution attached to the upper end of the inner protrusion, the sterilizing material being placed outside the second chamber before use, A lid that surrounds the first chamber and is configured to prevent leakage of the disinfectant solution before use, It is equipped with, The sterilizing material is configured to wipe the distal tip and side walls of the male lue when the disinfecting male lue cap is advanced onto the male lue of the medical connector. The disinfectant male lure cap is characterized in that the disinfectant material comprises one or more perforations that can help form an opening in the disinfectant material, and one or more attachment portions for attaching the disinfectant material to the inner protrusion, wherein the one or more attachment portions are arranged in close proximity to the one or more perforations.

2. The combination of the disinfectant male Luer cap and the medical connector described in claim 1.

3. The disinfectant male luer cap according to claim 1, characterized in that a portion of the disinfectant material is configured to move into the second chamber when the disinfectant male luer cap is advanced onto the male luer of the medical connector.

4. The disinfectant male lure cap according to claim 1, characterized in that the diameter of the upper part of the inner protrusion is smaller than the width of the disinfecting material.

5. The disinfectant male luer cap according to claim 1, characterized in that the length of the perforations in the disinfectant material is less than or equal to the maximum diameter of the portion of the male luer of the medical connector that can be inserted into the inner protrusion, so that when the disinfectant male luer cap is attached to the medical connector, the disinfectant material forms a tight fit around the male luer.

6. The disinfectant lure cap according to claim 1, characterized in that the opening has a predetermined diameter, and the diameter is smaller than the outer diameter of at least a portion of the male lure end.

7. The disinfectant lure cap according to claim 6, characterized in that the diameter of the opening is configured to obstruct the passage of fluid between the sterilizing material and the male lure end.

8. The disinfectant lure cap according to claim 1, characterized in that the disinfectant material comprises one or more flap portions.

9. The disinfectant lure cap according to claim 8, characterized in that one or more of the flap portions are configured to be at least partially positioned within the distal portion of the protrusion when the disinfectant lure cap is attached to the male lure end.

10. The disinfectant lure cap according to claim 9, characterized in that one or more of the flap portions are made of a compressible material for compression between the distal portion of the protrusion and at least a part of the male lure end.

11. The disinfectant lure cap according to claim 9, characterized in that one or more of the flap portions are configured to facilitate the attachment of the disinfectant lure cap to the male lure end.

12. The combination of the disinfectant luer cap and the medical connector described in claim 1.

13. A sterilization cap assembly, One or more disinfectant lure caps according to claim 1, An elongated tubular body or sleeve configured to house one or more of the aforementioned disinfectant lure caps, A sterilization cap assembly characterized by comprising the following:

14. A sterilization cap assembly, A disinfectant lure cap according to claim 1, A cap holder configured to receive the aforementioned disinfectant lure cap, The lid and A sterilization cap assembly characterized by comprising the following:

15. A sterilization cap assembly, Two or more disinfectant lure caps according to claim 1, A material piece comprising two or more parts that form the lids of the two or more disinfectant luer caps, A sterilization cap assembly characterized by comprising the following:

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