HK1196308A - Port and surface cleaning devices and techniques - Google Patents

Description

Port and surface cleaning apparatus and techniques

Cross Reference to Related Applications

This application claims priority from united states provisional patent application No. 61/564,206 entitled "medical devices and techniques for antibacterial, immunomodulatory, and antitumor therapy" filed on 28/11/2011, which is incorporated herein by reference in its entirety.

Background

Infection remains a big problem in today's medical industry. Infection is often caused by contamination of Intravascular (IV) lines (e.g., intravenous, intra-arterial, etc.), contamination of injection sites or blood draw sites (e.g., of veins, arteries, or capillaries), contamination of catheters, wound sites or incision sites, and many other sources of infection in medical facilities. For example, in U.S. hospitals alone, central venous catheters cause approximately 250,000 bloodstream Infections per year, incurring significant costs in terms of financial resource consumption and patient morbidity — medical doctor O' Grady et al, Guidelines for the Prevention of intravascular Catheter-Related Infections, 2011, centers for disease control, health and human services. These numbers do not include infections caused by contamination of injection sites, blood draw sites, non-venous catheters, or any other of a variety of sources of contamination in a medical facility. Infection is more problematic in developing countries, where syringes, IV lines (lines) and other instruments are often used and reused by a number of different patients.

Drawings

The present invention is described in detail below with reference to the attached drawings. In the drawings, the left-most digit(s) of a reference number identifies the figure in which the reference number first appears. The same reference numbers are used in different drawings to identify similar or identical components or features.

Fig. 1A and 1B illustrate an exemplary port protection cap.

Fig. 2A-2C illustrate a number of exemplary port protection caps, which may include different attachment mechanisms.

Fig. 3 illustrates an exemplary port cleaning cap.

Fig. 4A-4C illustrate an exemplary port cleaning system.

Fig. 5A-5C show example steps for attachment of an example port protection cap.

Fig. 6A and 6B illustrate an exemplary site cleaning and disinfecting device.

Fig. 7A and 7B show two exemplary packaging appliances of a port protection cap, a port cleaning cap and/or a site cleaning and disinfection device.

Fig. 8A and 8B illustrate an exemplary strip or kit of port protection caps, port cleaning caps, and/or site cleaning and disinfection devices.

Detailed Description

Overview

Methods of reducing and/or preventing infection are described. In one aspect, the present disclosure describes exemplary antimicrobial compositions that may be used alone or in combination with one or more medical devices to clean and/or disinfect Intravascular (IV) line ports, other IV components (e.g., syringes, lumens, valves, etc.), injection sites, blood draw sites (e.g., intravenous, arterial, or capillary), wound sites, incision sites, peritoneal dialysis sites, bladder or nephrostomy sites, other drainage sites, or any other site susceptible to infection.

Exemplary Port protection and cleaning device

Fig. 1A-5C show details of a number of exemplary Port (Port) cleaning and protective caps. Each cap may be made of, for example (but not limited to), polyethylene, polypropylene, copolymers, and/or mixtures thereof. The cap may also include a uv-protective material or medicament to maintain the integrity of the hydrogen peroxide during storage, transport, etc. The cap itself may additionally or alternatively be contained in a package containing uv-protective material to inhibit decomposition of the hydrogen peroxide.

FIGS. 1A and 1B illustrate an example of an IV port protective cap 100 designed to be screwed onto a threaded port, e.g., femaleA connector to provide a physical barrier against recontamination. As shown in fig. 1A, the protective cap 100 is hermetically sealed by a protective cap 102. The protective cap 100 is removably welded or bonded to the protective cap 100 by sonic welding, microwave welding, thermal welding, or other bonding techniques. The protective cap 102 may be made of the same or different material as the protective cap 100. To facilitate sealing of the protective cap 102 to the protective cap 100, the protective cap includes an energy director 104 disposed on a top surface of a rim 106 or flange surrounding an opening of the protective cap 100, as shown in fig. 1B. The energy director 104 comprises a raised ridge or rib having a smaller cross-section relative to the rim 106 of the protective cap 100. The small cross-section of the energy director 104 allows the energy director to melt more quickly and fuse with the protective cap 102 with less energy than is required to melt the entire edge 106 of the protective cap 100. The energy director 104 also allows the protective cover 102 to be fused to the protective cap 100 over a relatively thin area, thereby making the protective cover 102 easier to remove from the protective cap 100 (as compared to at the edge of the protective cap 100)106 over the entire area of the tube).

The edge 106 is designed as a "non-contact edge" that extends radially from the periphery of the body of the protective cap 100, thereby minimizing the possibility of a user's finger contacting the inner surface of the protective cap during use. In the illustrated embodiment, the energy director 104 is disposed radially outward of the opening of the protective cap, inward of the outer edge of the rim 106. This ensures that the portion of the rim 106 within the energy director 104 remains sterile prior to use. The non-contacting edge 106 increases the likelihood that the portion of the edge 106 within the energy director 104 remains sterile even during use. In other embodiments, the energy directors can be disposed anywhere on the rim 106 (e.g., centered, as shown, at the inner periphery of the rim adjacent the opening, or at the outer periphery of the rim).

As shown in fig. 1B, the protective cap 100 also includes an applicator material 108 (shown in exploded view in this figure for clarity). In the illustrated example, the applicator material comprises a cylindrical foam-like material having open cell (cell) regions 110 around the circumference of the sides of the cylinder and closed cell regions 112 on one or both axial ends of the cylinder. The open micro-porous areas 110 enable the applicator material 108 to absorb and carry antimicrobial components, such as those described below. The closed micro-porous region 112 is used to at least partially cover and seal the end of the IV port to prevent the IV port from leaking and to prevent a substantial amount of the antimicrobial composition from entering the IV port. Both the open microporous region 110 and the closed microporous region 112 can have an amount of texture or roughness to abrade the IV port. In some embodiments, the applicator material can include polyurethane, silicon, silicone rubber, polyethylene, polypropylene, thermoplastic elastomers, or similar materials, and mixtures thereof.

Similarly, although the applicator material 108 is shown as generally cylindrical, in other embodiments, the applicator material can have other shapes and/or sizes. Also, the coater material 108 can include various surface treatments (e.g., sipes, cracks, etc.), surface finishes (e.g., macro, micro, or nano structures, etc.), and/or contours (e.g., rounded, ribbed, raised, finger-like, etc.).

FIGS. 2A-2C illustrate various variations of IV port protective caps 200A, 200B, and 200C, respectively (generally referred to as protective caps 200), for use with IV port connections of various Outside Diameters (ODs), such as maleA connecting member. The protective caps 200 of these embodiments are slip fit caps in that they are designed to slip over and securely fit IV port connectors of different outer diameters, since not all port connectors have standardized outer diameters.

Fig. 2A shows a protective cap 200A having a stepped inner surface, including a first inner surface 202 and a second inner surface 204, the second inner surface 204 having a smaller average diameter relative to the first inner surface. The diameters of the first inner surface 202 and the second inner surface 204 are selected to match the outer diameter of a typical port on the market, or are selected to be the maximum and minimum outer diameters of a port on the market, or are based on other criteria. Also, the first and second inner surfaces 202 and 204 can each be tapered (i.e., have a draft angle θ) such that the diameter of the first and second inner surfaces is greatest proximate the opening of the protective cap 200A and decreases toward the bottom closed end of the protective cap. The draft angle of the first inner surface 202 can be equal to, greater than, or less than the draft angle of the second inner surface 204. When the protective cap 200A is positioned over the IV port, the protective cap 200A will slide over the IV port until the outer diameter of the IV port interferes with and seals against the interior surface of the protective cap 200A at either the first inner diameter 202 (where the IV port has a relatively large outer diameter) or the second inner diameter 204 (where the IV port has a relatively small outer diameter).

Fig. 2B and 2C show alternative embodiments of slip-fit protective caps 200B and 200C, respectively, having a continuous smooth inner surface. In contrast to the stepped shape shown in the embodiment of fig. 2A, protective caps 200B and 200C have a continuous smooth inner surface. Similar to the inner surface of the stepped protective cap 200, the inner surfaces of the protective caps 200B and 200C are also tapered to accommodate IV ports of different outer diameters. However, to accommodate IV ports having a greater range of outer diameters, the draft angle θ of the protective cap needs to be greater (i.e., a more pronounced taper) in the case of protective cap 200B, and/or the protective cap needs to be made deeper in the case of protective cap 200C.

Fig. 3 shows an IV port cleaning system 300 example, including a cleaning cap 302 having an applicator material 304 carrying an antimicrobial composition. The cleaning cap 302 can be used to clean the IV port 306. In the illustrated example, the IV port includes a female shapeA connecting member. However, in other embodiments, such an IV port cleaning system can be used or adapted to be used to clean a male shapeConnectors, and other types of IV and non-IV ports and/or lumens. The cleaning cap 302 can be used, for example, to sterilize the IV port 306 prior to connecting the port to a complementary (complementary) port, injecting medication, drawing blood, or otherwise using the IV port 306. After sterilization, the volatile components of the antimicrobial composition may evaporate over time, leaving behind a film or barrier 308 of ethylenediaminetetraacetic acid (EDTA) or other chelating agent that provides a constant defense against contaminants.

Once sterilized, a protective cap as described above can be applied to the IV port 306 to provide a physical barrier against recontamination. The protective cap may comprise the same or different antimicrobial or other compositions. In some embodiments, the protective cap can be securely coupled to the IV port 306 and seal the IV port. In the event that the antimicrobial composition in the protective cap dries out over time, the protective cap can still include a residual barrier to EDTA or other chelating agents that will provide further protection against contaminants. In other embodiments, the protective cap can simply be coated with a film or barrier of EDTA or other chelating agent on all or a portion of the interior and/or exterior surfaces of the protective cap.

Fig. 4A-4C illustrate the IV port cleaning and sterilizing system 300 shown in fig. 3 in more detail. In particular, fig. 4A shows the cleaning cap 302 prior to use. As shown in fig. 4A, the cleaning cap 302 can be used with a protective cap 400 to maintain the interior of the cleaning cap 302 in a sterile condition. Additionally or alternatively, the cleaning cap 302 can be packaged in another sterile package (not shown in this figure) to maintain the entire cleaning cap 302 in a sterile environment prior to use. To clean the IV port 306 using the cleaning cap 302, the protective seal can be removed, exposing the interior of the cap 302, as shown in fig. 4B. The cleaning cap 302 can then be placed over the IV port 306 and screwed or otherwise used to wipe and clean the IV port 306. Specifically, by threading and pressing the cleaning cap 302 against the IV port 306, the applicator material 304 carrying the antimicrobial composition can be used to wipe the exterior surface of the IV port 306.

If the IV port 306 becomes contaminated with bacteria, spores, parasites, viruses, bodily fluids, or other contaminants, the antimicrobial composition will begin to foam or froth 402, providing a visual indication of the contaminants. The foaming or frothing reaction is due to the interaction of hydrogen peroxide with bacteria, spores, parasitic bacteria and viruses. The hydrogen peroxide will also generate bubbles or foam in response to Fenton's reaction (Fenton reaction) with hemoglobin or platelets in the body fluid. The size and rate of bubble formation can indicate the degree of contamination, giving the medical personnel a visual indication that the device is contaminated and may need further cleaning and/or replacement to avoid infection.

Fig. 5A-5C illustrate an example of a protective cap 500, and in some embodiments, the protective cap 500 can be used in conjunction with the cleaning cap 302 of fig. 3 and 4A-4C. After the IV port 306 has been cleaned, the protective cap 502 can be removed from the protective cap 500 to expose the interior of the protective cap, as shown collectively in fig. 5A and 5B. As with the cleaning cap 302, the protective cap 500 can also be packaged in another sterile package (not shown in this figure) to maintain the sterility of the entire protective cap 500 prior to use.

The protective cap 500 can then be applied to the IV port 306 to provide a physical barrier against recontamination, as shown in fig. 5C. The protective cap 500 may include the same or different antimicrobial or other composition as the cleaning cap 302. If foaming or frothing 504 occurs while the protective cap 500 is coupled to the IV port 306, such foaming or frothing reaction will provide a visual indication to medical personnel that the IV port 306 is still contaminated and needs further cleaning and/or replacement.

In some embodiments, the antimicrobial composition in the cleaning cap 302, the protective cap 500, or both, may include a stain or colorant (to further enhance the visual indication of contaminants). When provided, the colorant or colorant in the cleaning cap 302 may be the same or a different color than the protective cap 500. For example, the color of the stain or colorant may match the color of the corresponding cap. In another example, the coloring agent or colorant may have a color that contrasts with the color of the corresponding cap.

Additional details of an exemplary IV port cleaning and protection device can be found in U.S. patent application No. 11/745,843 filed on 8/5 of 2007 by Tennican, which is incorporated herein by reference.

Exemplary site preparation device

Fig. 6A and 6B illustrate an example of a site cleaning and disinfecting device 600 that can be used to clean and/or disinfect an Intravascular (IV) line port, other IV components (e.g., syringes, lumens, valves, etc.), an injection site, a blood draw site (e.g., intravenous, arterial, or capillary), a catheter and/or catheter insertion site, a wound site, an incision site, a peritoneal dialysis site, a drainage site, or any other site susceptible to infection.

The device 600 includes a housing or cap 602 (shown in phantom in this figure to illustrate internal features of the device 600) that is sealed by a protective cover 604. The cap 602 may comprise the protective cap 100 of fig. 1A and 1B and is constructed in a similar manner as the protective cap 100 of fig. 1A and 1B. For example, the cap 602 can be configured to include a "non-contact edge". Additionally, the protective cover 604 can be sealed to the cap 602 using the same techniques described above for the protective cap 100 in fig. 1A and 1B. For example, and as described above, the protective cover 604 can be fused to the energy director to assist in removing the protective cover. Contained within the cap 602 is an applicator material 608, such as a foam or sponge material, which contains an antimicrobial composition such as those described above. When the protective cover 604 is in place (as shown in FIG. 6A), the applicator material 606 is in a compressed state such that, when the protective cover 604 is removed, the applicator material 606 expands and protrudes from the interior cavity of the cap 602 (as shown in FIG. 6B) for cleaning or disinfecting the desired site.

In some embodiments, the cap 602 can include a flexible and/or domed bottom surface 608 that can be depressed (as shown by the arrows in fig. 6B) to assist in the deployment of the applicator material 606 from the interior cavity of the cap 602.

The applicator material 606 in this embodiment may comprise an open cell foam material, a foam material comprising open cell areas and closed cell areas, a sponge material, an abrasive material, a mesh material, or any other material suitable for cleaning and disinfecting a site. In some embodiments, the applicator material may comprise polyurethane, silicone rubber, polyethylene, polypropylene, thermoplastic elastomers, and the like, and mixtures thereof. Moreover, although the coater material 606 is shown as a generally cylindrical body, in other embodiments the coater material may take on other shapes and/or sizes. Also, the coater material 606 may include various surface treatments (e.g., grooving, etc.), surface finishes (e.g., macrostructures, microstructures, or nanostructures, etc.), and/or contours (e.g., rounded, ribbed, protrusions, fingers, etc.).

Exemplary Package for a cleaning device

Any of the various port and/or site cleaning devices described above can be packaged independently or in multiple packages with multiple devices.

Figures 7A and 7B illustrate two example ways of packaging the port and/or site cleaning device described herein. As shown in fig. 7A, each device can be individually sealed in a pouch or sachet 700 by sandwiching the device between layers of thermoplastic material and sealing the material sheets to each other around the outer periphery of the device (e.g., by sonic welding, microwave welding, thermal bonding, or the like).

The method depicted in fig. 7A can be extended to package multiple devices into a strip simultaneously by placing multiple devices between sheets of thermoplastic material and then sealing the sheets of material relative to each other around the outer periphery of each device (using any of the sealing methods described above). The result is a noodle 702 that contains multiple independently sealed devices. The individual devices may then be dispensed by cutting between the devices in strip 702. Alternatively, noodle 702 may include perforations or score lines between individual devices in noodle 702.

Fig. 8A and 8B illustrate two example enclosures of a port and/or site cleaning device. As shown in fig. 8A, enclosure 800A includes a plurality of different, individually enclosed site cleaning devices that are joined together to form a strip 802A or kit. Strip 802A can be encapsulated according to the method described with reference to figures 7A and 7B or other methods. In the example shown, the enclosure 800A includes a soap pack (soap package)804, a first cap device 806A, a second cap device 806B, and a third cap device 806C (collectively referred to as cap devices 806). Soap bag 804 can be used to provide initial cleansing of the site and includes any cleanser known in the medical industry. The different cap devices can include a port cleaning cap, a protective cap, a site cleaning cap, or a combination of these caps. In some examples, the cap device 806 can correspond to caps having different antimicrobial compositions and/or different concentrations of antimicrobial compositions.

In one particular example, the first cap device 806A (e.g., yellow cap) can have a relatively high concentration of hydrogen peroxide, alcohol, and/or chelant, the second cap device 806B (e.g., blue cap) can have a lower concentration of hydrogen peroxide, alcohol, and/or chelant than the first cap device, and the third cap device 806C (e.g., green cap) can have a lower concentration of hydrogen peroxide, alcohol, and/or chelant than the second cap device. In this case, a first cap device 806A can be used to clean the site first, then a second cap device 806B, and finally a third cap device 806C. Higher concentrations of the antimicrobial component can provide a higher degree of disinfection, but may result in irritation to the patient's tissue (particularly if allowed to remain in contact with the tissue for a prolonged period of time). The above method can be used to provide a high degree of disinfection by using a first cap, and then removing a higher concentration of the antimicrobial composition from the second and third caps, thereby minimizing the risk of irritation to the patient's tissues.

Fig. 8B shows enclosure 800B, which is identical to enclosure 800A, except that enclosure 800B includes a fourth cap device 806D instead of soap pouch 804. Fourth cap device 806D may include a soap composition similar to soap bag 804 or may include an antimicrobial composition having a higher concentration of hydrogen peroxide, alcohol, and/or chelating agent than first cap 806A.

Exemplary antimicrobial compositions

In an exemplary embodiment, antimicrobial compositions that can be used in conjunction with the methods described herein can include, for example, those described in U.S. patent application No. 12/874,188 filed on 9/1 2010 by Tennican, which is incorporated herein by reference. In this case, the antimicrobial component can include water (H)₂O), concentrated and non-toxic chelating agents such as ethylenediaminetetraacetic acid (EDTA) (e.g., disodium EDTA, disodium calcium EDTA, magnesium EDTA, gallium EDTA) or sodium citrate (or EDTA or sodium citrate in acid, salt, derivative or other form), short chain monohydric alcohols (e.g., of formula C)₂H₅OH and empirical formula C₂H₆Ethanol of O), and concentrated, small molecule oxidizing agents (e.g., hydrogen peroxide (H)₂O₂)). In one particular example, the ingredient canIs essentially composed of water, EDTA, ethanol and hydrogen peroxide. However, in other examples, other antimicrobial compositions can be used in conjunction with the devices described herein.

The antimicrobial component can be, for example, in liquid form, gel form, or foam form, and can be combined with one or more carriers or diluents as desired for a particular application. For example, in applications where the antimicrobial composition is used as a hand sanitizer, the antimicrobial composition can take a gelled form. In other examples, if the antimicrobial composition is used as a cleaning agent, a rinse, or an irritant, the antimicrobial composition can be in liquid form. In such a case, the concentration of the plurality of components can be based on, for example, the degree of sterilization desired, whether the components are used directly with living tissue or medical devices, and/or to avoid irritation of tissue in which the components are to be used directly or indirectly (e.g., via a medical device to which the components are applied). In other examples, the antimicrobial composition in liquid form can be vaporized or aerosolized for use in the nasal passages or other respiratory tract of a patient. In other examples, the antimicrobial composition can include or be combined with a lubricant (e.g., glycerin), a surfactant or emulsifier (e.g., Glycerol Monolaurate (GML)), or the like, and can be used with a catheter, endotracheal tube, scope (scope), instrument, or other device for insertion into a patient.

Conclusion

Although the invention has been described with reference to specific structural features and/or methodological steps, it is to be understood that the claims are not necessarily limited to the specific features or steps described. Rather, the specific features and steps are merely illustrative of embodiments that fall within the scope of the claims of the present application.

Claims (25)

1. A medical device, comprising:

a cap, comprising:

a cylindrical cavity having an opening and a flange at the opening;

an outer surface configured to engage a user;

an inner surface in the cylindrical cavity; and

an energy director located on the flange and extending perpendicular to the opening of the cylindrical cavity.

2. The medical device of claim 1, wherein the cap comprises polypropylene, polyethylene, copolymer materials, or mixtures thereof.

3. The medical device of claim 1, wherein the flange is configured to extend radially from an outer periphery of the cylindrical cavity.

4. The medical device of claim 1, further comprising a protective cover attached to at least the energy director and covering at least a portion of the opening.

5. The medical device of claim 4, further comprising a foam insert located within the cylindrical cavity, wherein the foam insert is held in a compressed state when the protective cover is attached, and the foam insert is configured to extend outward from the opening of the cylindrical cavity when the protective cover is removed.

6. The medical device of claim 5, wherein a surface of the foam insert extending outward from the opening of the cylindrical cavity comprises a different surface treatment, finish, or contour.

7. The medical device of claim 1, further comprising an antimicrobial agent disposed in the foam insert.

8. The medical device of claim 7, wherein the antimicrobial agent comprises:

ethylenediaminetetraacetic acid (EDTA) at about 5mg/ml to about 50 mg/ml;

up to about 70% ethanol by volume;

up to about 7.5% hydrogen peroxide by volume; and

and (3) water.

9. The medical device of claim 1, wherein the inner surface of the cylindrical cavity of the cap further comprises at least one of:

a tapered step-like surface;

a tapered smooth surface;

a stepped surface;

a slip fit flange;

one or more threads;

one or more internal cracks; or

A wire mechanism to assist attachment of the cap to another object.

10. A medical device, comprising:

a cap having an inner surface with a cylindrical cavity and a flange at an opening of the cylindrical cavity for attaching a protective cover; and

a foam insert located within the cylindrical cavity of the cap, the foam insert being compressed by attachment of the protective cover and configured to extend beyond an opening of the cylindrical cavity when the protective cover is removed.

11. The medical device of claim 10, wherein the foam insert is cylindrical in shape and comprises an inner open microporous layer connecting two outer closed microporous layers at the top and bottom of the cylindrical shape.

12. The medical device of claim 11, wherein the interior open microporous layer of the foam insert comprises an antimicrobial composition.

13. The medical device of claim 12, wherein the antimicrobial component includes one or more of a surfactant, water, a low molecular weight alcohol, a peroxide generating agent, or a chelating agent.

14. The medical device of claim 11, wherein the outer closed microporous layer of the foam insert includes a walkway texture.

15. The medical device of claim 10, wherein the foam insert comprises polyurethane, silicon, silicone rubber, polyethylene, polypropylene, thermoplastic elastomer, or mixtures thereof.

16. The medical device of claim 10, wherein the flange at the opening of the cylindrical cavity further comprises a raised ridge extending distally from the cylindrical cavity, the raised ridge configured to weld with the removable protective cover.

17. A cleaning and disinfecting assembly comprising:

one or more caps, at least one cap having:

an inner surface having a cylindrical cavity and a flange at an opening of the cylindrical cavity; an energy director located on the flange and extending perpendicular to the opening of the cylindrical cavity, the energy director configured to attach to a removable protective cover; and

a foam insert located within a cylindrical cavity of the cap, the foam insert being compressed by attachment of the removable protective cover and configured to extend beyond an opening of the cylindrical cavity when the protective cover is removed; and

an enclosure for storing the one or more caps, the enclosure configured to allow the one or more caps to be stored individually and in series.

18. The apparatus of claim 17, wherein the flange at the opening of the cylindrical cavity of the cap is configured to extend radially from the outer periphery of the cylindrical cavity.

19. The apparatus of claim 17, wherein the foam insert includes an antimicrobial composition including one or more of a surfactant, water, a low molecular weight alcohol, a peroxide generator, or a chelating agent.

20. The apparatus of claim 17, wherein the foam insert comprises a walkway texture.

21. The apparatus of claim 17, wherein the cap comprises polypropylene, polyethylene, copolymer material, or mixtures thereof.

22. A method of preventing the spread of an infectious agent, comprising:

identifying a surface to be cleaned, decontaminated or disinfected; and

applying a medical applicator to the surface, thereby cleaning, decontaminating, or disinfecting the surface, the medical applicator comprising:

a cap having an inner surface with a cylindrical cavity and a flange at an opening of the cylindrical cavity;

a foam insert within the cylindrical cavity of the cap, the foam insert configured to extend beyond the opening of the cylindrical cavity when the protective cover is removed; and

a cleaning, antimicrobial or disinfectant agent disposed in the foam insert.

23. The method of claim 22, wherein the surface to be cleaned, decontaminated or disinfected is an area of human tissue or an area located on a medical device.

24. The method of claim 22, wherein the cleaning, antimicrobial or sanitizing agent comprises at least one of a surfactant, water, low molecular weight alcohol, peroxide generator, or chelating agent.

25. The method of claim 22, wherein the cap comprises an energy director located on the flange and extending perpendicular to the opening of the cylindrical cavity.