Antimicrobial caps for medical connectors

Abstract

To provide an antimicrobial cap device for a medical connector that maintains a connector in an antiseptic state.SOLUTION: The antimicrobial cap device comprises: a first end configured to secure the antimicrobial cap device to a medical connector, the first end having an opening sized to receive at least an upper aperture of the medical connector; a base opposite the first end; a sidewall connecting the base to the first end, an inner surface of the sidewall defining a volume sufficient to receive at least the upper aperture of the medical connector, where, while the antimicrobial cap device is secured to the medical connector, the antimicrobial cap device and a portion of the medical connector form a closed volume comprising the internal volume of the medical connector; and an antimicrobial plug having a proximal end attached to the base and a distal end disposed outwardly therefrom, the antimicrobial plug comprising a spiral or wavy shape between the proximal end and the distal end.SELECTED DRAWING: Figure 9A

Description

[Technical Field]

[0001] Infusion therapy generally involves the administration of medications intravenously. During a typical infusion therapy, one or more infusion therapy devices (e.g., tubing sets) are used. Often, during an infusion therapy, the end of the tubing set is left with an exposed non-sterile surface, such as when a syringe is removed from the male luer end of the tubing set. For example, when the end of the tubing set is exposed, the patient or nurse may touch the end, or the end may come into contact with non-sterile bedding, a table, or a floor surface. [Background technology]

[0002] While it is necessary to sterilize the needleless connector end or hub of a tubing set, it is not necessary to sterilize the other end, which is typically a male luer. Antiseptic caps are increasingly being used to disinfect the ends of infusion therapy devices, such as needleless connectors, IV sets, or short extension tubing. These caps typically contain an alcohol-soaked foam that contacts the port surface when the cap is connected to the port. Various problems exist when using these caps. For example, the alcohol-soaked foam only contacts the outer surface of the access port. Also, once the cap is placed on the port, the alcohol in the cap quickly evaporates. Furthermore, using alcohol often results in the alcohol being forced into the IV line.

[0003] Additionally, some types of female Luer connectors trap liquids that cannot be effectively handled by conventional antiseptic caps. For example, side ports on catheter adapters are commonly used to provide rapid access to IV lines or a patient's bloodstream for IV medications or fluids, especially for rapid response in emergency situations. These ports may be accessed multiple times over the life of the catheter, sometimes for periods exceeding seven days. When a contaminated Luer access device, such as a syringe, is connected to the port, it can transfer microorganisms to the side walls and base of the side port. This can lead to microbial growth and colonization within the sides of the port, putting patients at risk for infection. Currently available antiseptic caps cannot effectively disinfect these surfaces.

[0004] Thus, while methods and systems for sterilizing needleless connectors currently exist, challenges remain. Therefore, augmenting or replacing current technology with the systems and methods discussed herein would be an improvement in the art. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent Application Publication No. 2012 / 397,760 [Patent Document 2] U.S. Patent Application Publication No. 2011 / 829,010 [Patent Document 3] US Patent Application Publication No. 2012 / 476,997 [Patent Document 4] U.S. Patent Application Publication No. 2012 / 490,235 [Patent Document 5] U.S. Patent Application Publication No. 2012 / 831,880 [Patent Document 6] US Patent Application Publication No. 2010 / 0137472 [Patent Document 7] US Patent Application Publication No. 2010 / 0135949 Summary of the Invention [Problem to be solved by the invention]

[0006] The present invention relates to a cap for a medical connector, and more particularly to an antimicrobial cap for placement over the connector, wherein various features of the antimicrobial cap maintain the connector in a disinfected state.

[0007] Some embodiments of the present invention provide an antimicrobial cap having an inner surface on which a dry, non-bonded antimicrobial material is disposed. Upon exposure to residual fluid, the dry, non-bonded antimicrobial material rapidly dissolves, thereby forming an antimicrobial solution within the closed volume of the cap. The antimicrobial solution contacts the inner surface of the cap and the outer surface of a connector inserted into the cap.

[0008] Other embodiments of the present invention provide various clip features on the exterior of the antimicrobial cap that allow the cap to be attached to a portion of IV tubing or to prevent the cap from contacting unwanted surfaces such as the ground with an IV pole. Various structures are further provided for storing and distributing the antimicrobial caps to clinicians.

[0009] Some embodiments of the present invention further include an antimicrobial cap having an antimicrobial plug that extends outward from an interior base surface of the cap and into an interior volume of the connector, the connector having an interior space through which the plug can extend. The antimicrobial plug can include a variety of shapes and configurations to maximize surface area without compromising the functionality of the cap and / or connector.

[0010] In some cases, an antimicrobial cap is provided with a removable / single-use antimicrobial plug that is inserted into the cap through a hole in the bottom of the cap opposite the cap opening, and after insertion and use, the plug can be removed to maintain adequate antimicrobial efficacy.

[0011] Some embodiments of the present invention include an antimicrobial growth material attached to the inside surface of the bottom of the cap. The growth material elutes from the material when contacted by residual fluid. The growth material is dehydrated and expands or swells when exposed to fluid.

[0012] Additionally, some embodiments of the present invention include a cap having an interior surface on which an antimicrobial lubricant is disposed. The antimicrobial lubricant is transferred to the exterior interior surface of the connector when the cap is placed thereon. When the cap is removed, the antimicrobial lubricant remains on the cap and connector surface, thereby providing an antimicrobial effect.

[0013] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the claimed subject matter.

[0014] Additional features and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the invention. The features and advantages of the invention may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features of the invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.

[0015] To explain how the above and other advantages and features of the invention are obtained, a more particular description of the invention briefly described above will be provided by reference to specific embodiments illustrated in the accompanying drawings. It should be understood that these drawings depict only exemplary embodiments of the invention and therefore should not be considered as limiting the scope of the invention; the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]

[0016] [Figure 1] 1 illustrates a cross-sectional view of an antimicrobial cap according to an exemplary embodiment of the present invention. [Figure 2] 1A and 1B show a cross-sectional view of an antimicrobial cap and a perspective view of a connector inserted therein according to an exemplary embodiment of the present invention. [Figure 3A] 1 illustrates a perspective view of a clip feature according to an exemplary embodiment of the present invention. [Figure 3B] 1 illustrates a perspective view of a clip feature according to an exemplary embodiment of the present invention. [Figure 3C] 1 illustrates a perspective view of a clip feature according to an exemplary embodiment of the present invention. [Figure 4A] 1 shows a perspective view of a storage and dispensing method and apparatus according to an exemplary embodiment of the present invention. [Figure 4B] 1 shows a perspective view of a storage and dispensing method and apparatus according to an exemplary embodiment of the present invention. [Figure 4C] 1 shows a perspective view of a storage and dispensing method and apparatus according to an exemplary embodiment of the present invention. [Figure 5A] 1 illustrates a cross-sectional view of an antimicrobial cap having an antimicrobial plug according to an exemplary embodiment of the present invention. [Figure 5B] 1 illustrates a cross-sectional view of an antimicrobial cap having an antimicrobial plug according to an exemplary embodiment of the present invention. [Figure 6A] 1 illustrates a cross-sectional view of a curved antimicrobial plug according to an exemplary embodiment of the present invention. [Figure 6B] 1 illustrates a cross-sectional view of a curved antimicrobial plug according to an exemplary embodiment of the present invention. [Figure 7A] 1 illustrates a cross-sectional view of an antimicrobial plug with a termination disk according to an exemplary embodiment of the present invention. [Figure 7B] 1 illustrates a cross-sectional view of an antimicrobial plug with a termination disk according to an exemplary embodiment of the present invention. [Figure 8] 1A-1C show cross-sectional views of an antimicrobial plug having a three-dimensional terminal shape that matches the interior shape of a side port, according to an exemplary embodiment of the present invention. [Figure 9A] 1 shows a cross-sectional view of a removable antimicrobial plug according to an exemplary embodiment of the present invention. [Figure 9B] 1 shows a cross-sectional view of a removable antimicrobial plug according to an exemplary embodiment of the present invention. [Figure 9C] 1 shows a cross-sectional view of a removable antimicrobial plug according to an exemplary embodiment of the present invention. [Figure 9D] 1 shows a cross-sectional view of a removable antimicrobial plug according to an exemplary embodiment of the present invention. [Figure 10A] 1 illustrates a cross-sectional view of an antimicrobial expandable material according to an exemplary embodiment of the present invention. [Figure 10B] 1 illustrates a cross-sectional view of an antimicrobial expandable material according to an exemplary embodiment of the present invention. [Figure 11A] 1 illustrates a cross-sectional view of a cap having an antimicrobial lubricant applied to the interior surface of the cap, according to an exemplary embodiment of the present invention. [Figure 11B] 1 illustrates a cross-sectional view of a cap having an antimicrobial lubricant applied to the interior surface of the cap, according to an exemplary embodiment of the present invention. [Figure 11C] 1 illustrates a cross-sectional view of a cap having an antimicrobial lubricant applied to the interior surface of the cap, according to an exemplary embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0017] The present invention relates to a cap for a medical connector, and more particularly to an antimicrobial cap for placement over the connector, wherein various features of the antimicrobial cap maintain the connector in a sterile condition.

[0018] As used herein, the term "connector" is understood to include any structure that is part of an infusion apparatus that allows for connection to a secondary intravenous infusion device. Non-limiting examples of connectors according to the present invention include needleless connectors, male luer connectors, female luer connectors, side port valves, y-port valves, port valves, and other similar structures.

[0019] Referring now to FIG. 1 , an antimicrobial cap 10 is shown. The antimicrobial cap 10 generally comprises a polymeric material that is safe for use in common infusion procedures with fluids and chemicals. For example, in some cases, the cap 10 comprises a polyvinyl chloride material. The cap 10 comprises an opening 12 having a diameter sufficient to receive the connector 30. In some cases, the connector 30 comprises a positive surface that can be inserted through the opening 12 of the cap 10. For example, in some cases, the connector 30 comprises a male Luer connector. In other cases, the connector 30 comprises a syringe tip. Furthermore, in some cases, the connector 30 comprises a side port or y-port of a catheter-assisted device. In other cases, the connector 30 comprises a catheter adapter, a section of IV tubing, or a catheter.

[0020] In some embodiments, cap 10 receives connector 30 via a threaded connection. For example, in some cases, cap 10 includes a set of internal or external threads that mate with a complementary set of threads located on the connector. In other cases, cap 10 receives connector 30 via a friction or interference fit.

[0021] The antimicrobial cap 10 further includes an inner surface 14 that defines a volume sufficient to receive the connector 30. The inner surface 14 is generally tubular, although in some cases the inner surface 14 tapers inwardly from the opening 12 to the cap base 16. The inner surface 14 can include any desired geometry or shape.

[0022] The volume of the cap 10 defines an interior space of the cap 10 extending from the opening 12 to the base 16. The volume is generally selected to accommodate placement of a connector 30 within the cap 10 for purposes of maintaining the cap 10 in a disinfected state. Accordingly, the antimicrobial cap 10 further includes a quantity of antimicrobial material 20 applied to the interior surface 14. The antimicrobial material 20 may include any type or form of antimicrobial material safe for use in accordance with the teachings of the present invention. For example, in some cases, the antimicrobial material 20 is selected from the group consisting of chlorhexidine diacetate, chlorhexidine gluconate, alexidine, silver sulfadiazine, silver acetate, silver citrate hydrochloride, cetrimide, cetylpyridinium chloride, benzalkonium chloride, orthophthalaldehyde, and elemental silver.

[0023] In some embodiments, the antimicrobial material 20 comprises a dry, non-bonded coating that is applied to the interior surface 14 in a known manner. For example, in some embodiments, the antimicrobial material 20 is applied to the interior surface 14 by spraying, dipping, or brushing. In other embodiments, the antimicrobial material 20 comprises a UV-cured polymer matrix having an antimicrobial substance evenly dispersed therein. The antimicrobial substance is not chemically bonded to the polymer matrix and, therefore, can be eluted from the matrix when the matrix is ​​exposed to residual fluids or becomes wet.

[0024] When the cap 10 is placed on the connector 30 , the connector 30 reduces the volume of the cap 10 .

[0025] When secured together, the connector 30 and the antimicrobial cap 10 form a closed volume between the interconnected devices. When exposed to residual liquid 32 from the connector 30, the dry, unbound antimicrobial material 20 dissolves more quickly than the residual fluid 32, thereby forming an antimicrobial solution with the residual fluid 32 within the closed volume, as shown in Figure 2. The antimicrobial solution is contained within the closed volume and is exposed to all surfaces of the needleless adapter and the interior surface 14 disposed within the closed volume.

[0026] As mentioned above, in some embodiments, the antimicrobial material 20 comprises a UV-cured hydrophilic polymer material (not shown) that forms a matrix containing a plurality of microscopic interstices in which the antimicrobial material is uniformly dispersed. Upon exposure to residual fluid 32, the polymer matrix softens and becomes permeable to the residual fluid. The antimicrobial material within the polymer matrix elutes from the matrix into the residual fluid, forming an antimicrobial solution having a desired final concentration within the enclosed volume. Examples of suitable polymer materials are described in U.S. Patent Application Nos. 12 / 397,760, 11 / 829,010, 12 / 476,997, 12 / 490,235, and 12 / 831,880, each of which is incorporated herein in its entirety.

[0027] Generally, a quantity of antimicrobial material 20 is dissolved in residual fluid 32 within the enclosed volume to provide an antimicrobial solution having the minimum concentration necessary to have sufficient antimicrobial effect within the enclosed volume. In some cases, a predetermined amount of antimicrobial material 20 is applied to interior surface 14 to provide a final concentration of from approximately 0.005% w / w to approximately 25% w / w. Thus, the amount of antimicrobial material 20 is determined based on the calculated enclosed volume of antimicrobial cap 10 and connector 30.

[0028] For example, if the volume of the antibacterial cap 10 is 1cm 3 and the volume of the part of the connector 30 inserted into the cap 10 is 0.75 cm 3 If so, the calculated closed volume of the antibacterial cap 10 is 0.25 cm 3 Therefore, the maximum possible volume of residual fluid 32 within the closed volume is 0.25 cm 3 Accordingly, to achieve a final desired concentration of antimicrobial material in the antimicrobial solution of approximately 0.005% w / w to approximately 25% w / w (within the closed volume), approximately 12.6 μg to approximately 83.3 mg of antimicrobial material 20 would need to be applied to the interior surface 14.

[0029] Residual fluid 32 can include any fluid or combination of fluids common to infusion therapy procedures. For example, in some embodiments, residual fluid 32 includes blood, medication, water, saline, urine, or a combination thereof. In some cases, residual fluid 32 leaks into antimicrobial cap 10 after connector 30 is inserted into cap 10. In other cases, residual fluid 32 is present on connector 30 before insertion into cap 10. Furthermore, in some cases, residual fluid 32 is present in connector 30 before insertion into antimicrobial cap 10.

[0030] After use of the antimicrobial cap 10, the cap 10 is removed from the connector 30 and disposed of. In some cases, the antimicrobial cap 10 is reused multiple times before being disposed of. For example, in some cases, the cap 10 is applied to the connector 30 after the connector 30 is removed from a separate connector (not shown). The antimicrobial cap 10 is again removed from the connector 30 before reconnecting the connector 30 with the separate connector, and then reapplied after removing the connector 30 from the separate connector.

[0031] In some cases, the exterior surface 18 of the antimicrobial cap 10 further comprises a clip 40 having a surface 42 for receiving at least one of an IV pole and an IV line to maintain the desired position of the antimicrobial cap 10, as shown in Figures 3A-3C. In some cases, as shown in Figure 3B, the clip 40 comprises a pair of opposing arms forming an aperture 44 having a diameter sufficient to receive the outer diameter of a portion of IV tubing 50. In other cases, as shown in Figure 3C, the clip 40 comprises a single hook 60 having a hook surface for interchangeably receiving an IV pole 52. Thus, in some embodiments, the antimicrobial cap 10 is coupled to the connector 30 and then coupled to the IV pole 52 or a portion of IV tubing 50 via the clip 40, thereby preventing undesired contact with the floor or other undesirable surfaces.

[0032] Referring to Figure 4, the present invention further includes various devices for storing and dispensing the antimicrobial caps 10. For example, in some embodiments, as shown in Figure 4, a single-use strip 70 is provided having an elongated surface 72 to which the base 16 surfaces of multiple caps 10 are temporarily adhered with a weak adhesive. Because the antimicrobial material 20 is provided in a dry state, the openings 12 can be oriented outward from the surface 72 without the need for a foil or polymer cover. The strip 70 further includes a hole 74 designed to receive the hook portion of an IV pole, thereby allowing the strip 70 to be hung in a convenient location for the clinician.

[0033] 4B, the outer surface 18 of the antimicrobial cap 10 tapers inward from the opening 12 to the base 16, with the diameter of the base 16 being smaller than the diameter of the opening 12. In this manner, the base 16 can be fitted into the opening 12 of an adjacent cap 10 by an interference fit to form a stacked configuration. Again, the dry antimicrobial material 20 does not require a foil or polymer cover for the opening 12, thus enabling a stacked configuration for storage and dispensing purposes.

[0034] Additionally, in some cases, as shown in FIG. 4C , a caddy 80 is provided having an opposing surface 82 onto which the base surfaces 16 of multiple caps 10 are temporarily adhered with a weak adhesive. Because the antimicrobial material 20 is provided in a dry state, the openings 12 can be oriented outward from the surface 82 without the need for a cover for the openings 12. The caddy 80 further includes a hole 84 designed to receive the hook portion 54 of an IV pole, thereby allowing it to be hung in a location convenient for the clinician. The caddy 80 also includes a clip 40 having an aperture 44 and a surface 42 for receiving a portion of the IV tubing.

[0035] 5-11C, in some cases, an antimicrobial cap 100 is hingedly coupled to a catheter adapter 120 and configured to provide a physical barrier for a connector with a side port 130. Although shown as hingedly integral to the catheter adapter, the features of the antimicrobial cap 100 described in connection with these embodiments may be implemented in any style or shape of antimicrobial cap configured to receive any type or style of connector.

[0036] 5A and 5B, in some cases, the antimicrobial cap 100 includes an opening 102 having a diameter sufficient to receive the side port 130. The cap 100 further includes an interior surface 104 defining a volume sufficient to receive the side port 130.

[0037] The side port 130 includes an opening or aperture 132, an interior volume 134, and a bottom 136. In some cases, as described below, the interior volume 134 may further include a unique interior shape. The side port 130 further includes a port valve 138 that forms a defeasible seal between the side port 130 and the interior lumen of the catheter adapter 120. When fluid is injected into the side port 130, the port valve 138 is temporarily disabled to break the seal, allowing the injected fluid to bypass the port valve 138 and enter the interior lumen of the catheter adapter 120. Following injection, a small amount of residual fluid is generally left in the interior volume 134 and is susceptible to microbial contamination. This residual fluid typically pools and collects at the bottom 136 of the side port 130 and contacts the exterior surface of the port valve 138. However, a larger amount of residual fluid contacts the surface of the additional interior volume 134 and can fill or substantially fill the interior volume 134.

[0038] The antimicrobial cap 100 further comprises an antimicrobial plug 110. The antimicrobial plug 110 generally comprises an antimicrobial material or coating that dissolves or elutes immediately upon contact of the plug 110 with residual fluid within the interior volume 134. In some cases, as described above, the antimicrobial plug 110 comprises a UV-cured hydrophilic material with a uniformly dispersed antimicrobial material. In other embodiments, the plug 110 comprises a solid antimicrobial material. In other cases, the plug 110 comprises a polymer tube with a polymer coating.

[0039] The antimicrobial plug 110 may have any form or shape consistent with the teachings of the present invention. For example, in some cases, the plug 110 may have a tubular shape. In other cases, the plug 110 may have a rod shape. Furthermore, in some cases, the antimicrobial plug 110 may have a non-linear shape or design, as shown and described in connection with Figures 8B-9.

[0040] The antimicrobial plug 110 has a proximal end 112 that is attached to the base 106 of the cap 100 and further has a distal end 114 that extends outward from the base 106. The plug 110 has a diameter and length sufficient to be inserted through the aperture 132 and positioned within the interior volume 134, as shown in FIG. 5B, such that the distal end 114 is positioned adjacent the bottom 136 when the cap 100 is coupled to the side port 130.

[0041] The length and diameter of plug 110 are selected to maximize the surface area of ​​plug 110 without sacrificing the ability of cap 100 to hinge closed over side port 130. In some cases, plug 110 has an outer diameter of about 0.076 inches and a substantial length of about 0.338 inches.

[0042] In some cases, it may be desirable to increase the surface area of ​​the antimicrobial plug 110 while maintaining the functionality of the hinge connection. Thus, in some embodiments, the antimicrobial plug 110 is curved, as shown in Figures 6A and 6B. The curved configuration of the plug 110 increases the overall length of the plug 110 but prevents contact between the distal end 114 and the aperture 132 when the cap 100 is hinged onto the side port 130. Thus, the overall surface area of ​​the plug 110 is increased without interfering with the normal operation of the hinged cap.

[0043] 7A and 7B, the distal end 114 further includes a disk 116 having an increased diameter that is slightly smaller than the diameter of the base 136. The disk 116 increases the overall surface area of ​​the plug 110 without interfering with the normal operation of the hinged cap. In some cases, the disk 116 is positioned within the base 136 when the cap 100 is seated in the side port 130. Thus, the increased surface area of ​​the disk 116 is positioned within a portion of the interior volume 134 that is most likely to contain residual fluid. In some cases, advancing the disk 116 toward the base 136 displaces residual fluid from the base 136, resulting in a majority of the space in the base 136 being occupied by the antimicrobial disk 116.

[0044] 8, the interior volume 134 has a unique interior shape 140 with a variety of surfaces. Thus, maximum antimicrobial effectiveness can be achieved by molding the distal end 114 to have the same shape as the interior shape 140. Thus, achieving the maximum surface area where the distal end 114 contacts the interior shape 140 provides the interior volume 134 with maximum antimicrobial effectiveness.

[0045] 9A and 9B, an embodiment of the present invention further comprises a cap 200 having a bore 220 in the base 216 of the cap. The bore 220 has a diameter configured to receive a removable and / or single-use antimicrobial plug 210. The plug 210 comprises materials and properties similar to those of the other antimicrobial components and devices previously described herein.

[0046] As shown in FIG. 9B , cap 200 is assembled by inserting distal end 214 into bore 220 and then inserting proximal end 212 through bore 220 until it is fully seated within recess 217 in base 216. In some cases, the shaft portion of antimicrobial plug 210 has a diameter slightly larger than the diameter of bore 220, thereby facilitating a fluid-tight interference fit between the two components. Antimicrobial plug 210 can then be removed from cap 200 and replaced with a new plug once the antimicrobial properties of the original plug 210 have been exhausted. In other cases, antimicrobial plug 210 is replaced at a controlled frequency to maintain antimicrobial effectiveness.

[0047] In some embodiments, multiple antimicrobial plugs are provided that a user can select and insert into holes 220. For example, in some cases, multiple plugs are provided, each with a unique or different antimicrobial agent. As shown in Figures 9C and 9D, antimicrobial plug 210 can also have various nonlinear shapes, such as a spiral or wave shape. As discussed above, these shapes increase the overall surface area of ​​plug 210 without interfering with the normal operation of cap 200.

[0048] 10A, embodiments of the present invention further include a cap 300 including a base surface 316 on which a dehydrated antimicrobial material 380 is provided. The dehydrated antimicrobial material 380 comprises a material that swells and expands when exposed to residual fluid located in the interior volume of the side port 130. For example, in some cases, the dehydrated antimicrobial material 380 comprises an open-cell nonwoven sponge. In other cases, the dehydrated antimicrobial material 380 comprises a hydrogel.

[0049] 10B, material 380 further comprises antimicrobial agent 320, or an antimicrobial coating containing an antimicrobial agent, which undergoes swelling or expansive expansion when material 380 is exposed to residual fluid 32 as the antimicrobial agent dissolves or elutes. In some cases, material 380 regains its original shape upon removal of residual fluid 32. In other cases, a change in the dimensions of material 380 indicates the presence of residual fluid 32, thereby alerting the clinician to replace cap 300 with a new cap.

[0050] 11A-11C, the inner surface 404 of the cap 400 comprises an antimicrobial lubricant 450. The antimicrobial lubricant 450 comprises a viscous or semi-viscous lubricant or gel having an antimicrobial agent that kills microorganisms that come into contact with the lubricant 450. In some cases, the antimicrobial lubricant 450 comprises a mixture of chlorhexidine acetate or chlorhexidine gluconate and silicone.

[0051] As shown in Figure 11B, some of the antimicrobial lubricant 450 is transferred to the exterior or interior surface of the side port 130 as the cap 400 is placed over the side port 130. When the cap 400 is removed from the side port 130, residual antimicrobial lubricant 450 remains on the exterior and interior surfaces of the side port 130 and the interior surface of the cap 400, as shown in Figure 11C.

[0052] Those skilled in the art will appreciate that various other embodiments of the present invention may similarly be coated with an antimicrobial lubricant, thereby further adding contact kill to the device. Thus, the features of various embodiments of the present invention may be implemented interchangeably to provide a wide variety of antimicrobial caps and other devices.

[0053] Various embodiments of the present invention can be manufactured according to known methods and procedures. In some cases, the antimicrobial component comprises an antimicrobial material. In other cases, the antimicrobial component is extruded or molded into a base polymeric material that has good bond strength with the antimicrobial material or agent, such as polycarbonate, copolyester, ABS, PVC, and polyurethane. The base polymeric structure can be coated with an adhesive-based antimicrobial material that may have elution properties. In some cases, the topology and dimensions of the base polymeric structure are optimized for microbiological efficacy, permanent elution profile, and assembly geometry constraints.

[0054] The various antimicrobial components of the present invention can be directly cast or molded into the antimicrobial material. In some cases, the antimicrobial component is cast into plastic and then coated with an antimicrobial agent. In some cases, the antimicrobial component is extended directly onto another component of the device. For example, in some cases, an antimicrobial plug is extended directly from the inner surface or base surface of the cap. This is done by first placing a peel-off sleeve over the base surface of the cap. The antimicrobial agent is deposited within the lumen formed by the sleeve. After curing is complete, the sleeve is peeled away, thereby revealing the plug at the base surface of the cap.

[0055] In other cases, the various components of the device are bonded together via adhesives or epoxies. For example, in some cases, the antimicrobial plug is cast or molded first and then coated with an antimicrobial coating or agent. The coated plug is then adhered to the base surface of the cap with the epoxy. In the case of a disk-ended antimicrobial plug, the disk and rod or tube may be cast as a single piece, or may be cast or molded separately and then bonded together.

[0056] The antimicrobial components and antimicrobial coatings of the present disclosure comprise one or more antimicrobial agents in a polymer matrix. The polymer matrix may be a solvent adhesive, with acrylate or cyanoacrylate solvent adhesives preferred for their good adhesive strength and high dissolution rate. Solvents may be added to enhance bonding. Nonlinear examples of suitable antimicrobial agent configurations are described in U.S. Patent Application Publication Nos. 2010 / 0137472 and 2010 / 0135949, each of which is incorporated herein by reference in its entirety.

[0057] The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are embraced within their scope.

Claims

1. An antimicrobial cap device for a medical connector, comprising: the medical connector having an upper aperture, a bottom, and an interior volume; The antibacterial cap device comprises: a first end configured to secure the antimicrobial cap device to the medical connector, the first end having an opening sized to receive at least the upper aperture of the medical connector; a base facing the first end; a sidewall connecting the base to the first end, the inner surface of the sidewall defining a volume sufficient to receive at least the upper aperture of the medical connector, the sidewall configured such that while the antimicrobial cap device is secured to the medical connector, the antimicrobial cap device and a portion of the medical connector form a closed volume that constitutes an interior volume of the medical connector; an antimicrobial plug having a proximal end attached to the base and a distal end disposed outwardly therefrom, the antimicrobial plug comprising a spiral or wave shape between the proximal end and the distal end; An antibacterial cap device comprising:

2. The antimicrobial cap device of claim 1 , wherein the antimicrobial plug has the spiral shape.

3. The antimicrobial cap device of claim 2, wherein the spiral shape increases the overall surface area of ​​the antimicrobial plug.

4. The antimicrobial cap device of claim 1 , wherein the antimicrobial plug has the wavy shape.

5. The antimicrobial cap device of claim 1 , wherein the antimicrobial plug comprises an antimicrobial material.

6. 6. The antibacterial cap device of claim 5, wherein the antibacterial material is selected from the group consisting of chlorhexidine diacetate, chlorhexidine gluconate, alexidine, silver sulfadiazine, silver acetate, silver citrate hydrochloride, cetrimide, cetylpyridinium chloride, benzalkonium chloride, orthophthalaldehyde, and elemental silver.

7. The antibacterial cap device of claim 1, wherein the base has a hole, the distal end of the antibacterial plug is inserted into the hole, and the proximal end of the antibacterial plug seals the hole.

8. The antimicrobial cap device of claim 1 , wherein the antimicrobial plug comprises a polymer matrix having an antimicrobial substance uniformly dispersed therein.

9. 9. The antimicrobial cap device of claim 8, wherein the antimicrobial substance is configured to elute from the polymer matrix when the antimicrobial plug comes into contact with a fluid.

Images