Combined cap applicators

(54) Title: COMBINED CAP APPLICATORS (57) Abstract: This disclosure describes example combine cap applicator and protective devices that may be used in combination with one or more cleansing, antimicrobial and/or antiseptic agents to reduce or eliminate contaminates on a surface. According to some embodiments, the disclosure describes that the combine cap applicators may comprise a first and second cap where each cap contains an applicator. According to some embodiments, the applicator may be coated or infused with a cleansing, antimicrobial or antiseptic agents for use on a surface.

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COMBINED CAP APPLICATORS

CROSS REFERENCE TO RELATEDAPPLICATION [0001] This application claims priority to U.S. Patent Applicant No. 13/757,465 filed on February 1, 2013 entitled Combine Cap Applicators which claims priority to U.S. Provisional Patent Application No. 61/595,635 filed on February 6, 2012 entitled Antiseptic Applicators and Protective Devices, both of which are hereby incorporated by reference in their entirety.

BACKGROUND [0002] Healthcare acquired infection (HAI) has been recognized as a significant cause of preventable mortality and morbidity. In the United States, HAI annually costs nearly 99,000 lives and billions of dollars in additional treatment and hospitalization. Klevens, et al., Estimating Health Care-Associated Infection and Deaths in U.S. Hospitals, 2002, Public Health Reports, Vol. 122, p. 160, 2007. Contamination of intravascular catheters, surgical sites and invasive procedure sites, frequently leads to device removal and replacement, prolonged parenteral antimicrobial therapy, and extended hospitalizations and rehabilitation.

[0003] The spread of multi-antimicrobial resistant organisms frequently are spread by healthcare providers' hands or medical equipment, from one colonized or infected patient to other susceptible patients. Surgical site infections may result from inadequate antiseptic preparations of the skin. Widespread use of chlorhexidine

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PCT/US2013/024651 gluconate (CHG) for routine washing and wiping of pre-operative sites, has led to the increased incidence of resistant Staphyloccus aureus, both to methicillin (MRSA) and CHG, in some hospital environments.

<td> [0004]</td><td> BRIEF DESCRIPTION OF THE DRAWINGS The detailed description is set forth with reference to the accompanying</td>

figures. In the figures, the left-most digit(s) of a reference number identifies the figure in which the reference number first appears. The use of the same reference numbers in different figures indicates similar or identical items or features.

<td> [0005]</td><td> FIGS. 1A and IB illustrate an example combine cap applicator.</td>

<td> [0006]</td><td> FIG. 2 is a flow diagram showing an example process for using an</td>

example combine cap applicator.

<td> [0007]</td><td> FIG. 3 illustrates an example protective cap device.</td>

<td> [0008]</td><td> FIG. 4 illustrates an example foam applicator of an example combine cap</td>

applicator or an example protective device.

<td> [0009]</td><td> FIGS. 5A-5C illustrate various mechanisms for attachment of an example</td>

combine cap applicator or an example protective device.

<td> [0010]</td><td> FIGS. 6A-6C illustrate various ways of packaging an example protective</td>

device.

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DETAILED DESCRIPTION

Overview [0011] This disclosure describes medical combined cap applicators and protective cap devices designed to reduce and/or prevent infections. In one embodiment, the disclosure describes example combined cap applicators. The combined cap applicators may comprise a first cap and a second cap detachably coupled together. The caps are separable to expose a receptacle or interior cavity within each cap. Each receptacle within each cap containing a permeable foam applicator material that may be coated or filled with, for example, a cleansing, antiseptic or antimicrobial composition.

[0012] In another embodiment, the disclosure describes example protective cap devices for multiple dose/use vials. The protective cap device may contain a foam material impregnated with an antimicrobial composition that, upon application of the protective cap device to a multiple dose/use vial, bathes the metal ring and elastomeric stopper ofthe vial in the antimicrobial composition. Thereby, reducing and/or preventing the presence of one or more contaminants upon a multiple dose/use vial. Furthermore, the foam material is constructed so as to prevent contamination of the contents of a multiple use/dose vial.

[0013] The detailed discussion below begins with a section entitled Example

Antimicrobial Composition, which describes in detail an example antimicrobial composition that may be included in the medical applicators and devices described herein. Next, the disclosure describes the Example Combined Cap Applicators. Next, the disclosure describes Example Process for using an example combine cap applicator.

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The next sections entitled Example Protective Cap Device and Example Packaging of

Protective Cap Device describes in detail several example capping devices for use on multiple dose/use vials. Next, the disclosure describes Other Cap Devices. Finally, the disclosure concludes with a brief Conclusion.

[0014] This overview, including section titles, is provided to introduce a selection of concepts in a simplified form that are further described below. The overview is provided for the reader's convenience and is not intended to limit the scope of the claims, nor the proceeding sections.

Example Antimicrobial Composition [0015] In one example embodiment, antimicrobial compositions that may be used in connection with the approaches described herein may include those described in, for example, U.S. Provisional Patent Application No. 61/412,375, filed November 10, 2010 to Tennican et al., which is incorporated herein by reference. For example, the antimicrobial compositions may include water (H₂0), a strong and non-toxic chelating agent such as ethylenediaminetetraacetic acid (EDTA)(e.g., disodium EDTA, calcium disodium EDTA, magnesium EDTA, potassium EDTA, gallium EDTA, ) or sodium citrate (or acids, salts, derivatives, or other forms of EDTA or sodium citrate), a shortchain monohydric alcohol (e.g., ethanol with a molecular formula of C₂HsOH and an empirical formula of C₂H₆0), and a strong, small molecule oxidizing agent such as hydrogen peroxide (H₂0₂). In one specific example, the compositions may consist essentially of water, EDTA, ethanol, and hydrogen peroxide. Additional ingredients can

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PCT/US2013/024651 include thickeners, gellants, surfactants, foamers and/or foam stabilizers. However, in other examples, other antimicrobial compositions may be used in combination with the applicators and devices described in this disclosure.

[0016] The antimicrobial compositions may be in a liquid form or a gel form, and may be combined with one or more carriers or diluents, depending on the needs of a specific application. For example, if the antimicrobial composition is used as a cleaning agent the antimicrobial composition may be in a liquid form. In that case, the concentration of the various constituents may depend on, for example, a desired level of sanitation and/or disinfection, whether the composition is being applied directly to living tissue or to a medical device, and/or to avoid irritation of tissue to which the composition will be applied directly or indirectly (e.g., via a medical device to which the composition is or was applied).

[0017] In addition to providing disinfection at the time of the application, the antimicrobial compositions may also provide a lasting barrier against contamination. For example, even after volatile constituents of the composition (e.g., water, alcohol, hydrogen peroxide, etc.) have evaporated, the chelating agent may remain on the treated surfaces (e.g., multiple use vial or port cleaning/protecting device, stethoscope, fingers, surrounding tissue, etc.) as a barrier that will provide antibacterial, antifungal or sporicidal (e.g.,. preventing germination of the spores), anti-parasitic, spermicidal or spermiostatic (e.g., decrease the motility of spermatozoon) and antiviral qualities. By robbing the environment of components (e.g., iron, magnesium, and manganese) that are needed for the bacteria, spores, parasites, fungus and viruses to reproduce, the chelating

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PCT/US2013/024651 agent provides a lasting defense to contamination even after other constituents of the antimicrobial composition have evaporated. Furthermore, the hydrogen peroxide in the antimicrobial compositions may induce a charge on a surface of materials (e.g., silicone materials) to which the antimicrobial compositions are applied, which make the materials more resistant to bacteria or other microorganisms.

[0018] In some embodiments, the antimicrobial composition described above may also provide a visual indication of contamination when applied to a surface or material, such indication may allow users to identify and clean surfaces to prevent infection.

[0019] The term about or approximate as used in context of describing the example antimicrobial composition is to be construed to include a reasonable margin of error that would be acceptable and/or known in the art.

Example Combined Cap Applicators [0020] FIGS. 1A and IB illustrate an example embodiment of a combine cap applicator in which a first cap applicator 100 may be detachably coupled to second cap applicator 102. Example materials for the composition of the first cap 100 and the second cap 102 include, but are not limited to, polypropylene, polyethylene and/or other copolymer materials. The first cap 100 and the second cap 102 may also comprise a material or agent that is UV protective to preserve the integrity of the antimicrobial composition during storage, shipping, etc. In other embodiments, the first cap 100 and the second cap 102 may comprise caps such as those described in U.S. Patent Application

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No. 13/688,044, filed November 28, 2012 to Tennican et al, entitled Port and Surface Cleaning Devices and Techniques, which is incorporated herein by reference.

[0021] FIGS. 1A and IB illustrate one example embodiment in which both the first cap 100 and second cap 102 include an applicator material 104 and 106, respectively, disposed within a receptacle or interior cavity of each cap prior to use. When the first cap 100 and second cap 102 are coupled together along figurative line 108, the applicator material 104 and 106 of each protective cap may be in a state of compression. When the first and second caps 100 and 102 are detached from one another, the applicator material 104 and 106 may expand and/or protrude from the interior cavity of each cap for use in cleaning or disinfecting a desired site as illustrated by caps 100 and 102 in FIG. IB (e.g., for disinfecting a intravascular port line, site preparation for a medical procedure or the like).

[0022] In some embodiments, the applicator material 104 and 106 housed within each cap is a permeable foam or sponge material, that may be coated or impregnated with a cleansing, antimicrobial, or antiseptic composition such as those described in the preceding section. Example materials for the composition of the applicator material 104 and 106 may include, but are not limited to starch polymer, cellulosic gel, polyurethane, silicon, silicon rubber, polyethylene, polypropylene, thermoplastic elastomer or mixtures thereof.

[0023] In some embodiments, the applicator material 104 and 106 may include, but are not limited to, different surface treatments (e.g., siping, slitting, etc.), surface finishes (e.g., macro-, micro-, or nano-structures, etc.), and/or contours (e.g., rounded,

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PCT/US2013/024651 ribbed, protrusions, fingers, etc.) to provide cleaning and/or scrubbing effectiveness. In some embodiments, the applicator material in the first cap may be configured similar to the applicator material in the second cap (e.g., with the same surface treatments, finishes and/or contours). However, in other embodiments, the applicator material in the first cap may be configured with a different surface treatments, finishes and/or contours than the applicator material in the second cap.

[0024] Further, while caps 100 and 102 and applicator material 104 and 106 are illustrated as being a generally cylindrical body, in other embodiments, the applicator material may take on other shapes and/or sizes. In some embodiments, the applicator material may have a shape that is substantially similar to the shape of the receptacle of the corresponding cap. For example, where the receptacle is cylindrical, the applicator material may also be cylindrical.

[0025] In some embodiments, the first cap 100 and the second cap 102 may be coupled together (e.g., during manufacture, packaging, assembly, etc.) by threads, a snap fit flange, a snap fit channel, a molded feature (e.g., the first cap may be custom cast in one of various shapes to uniquely correspond to the shape of the second cap thereby allowing a resin or adhesive, for example, to form a releasable seal when the first and second cap are attached), or the like. In some embodiments, the connection of the first cap 100 to the second cap 102 forms a seal to enclose the cleansing, antimicrobial, or antiseptic composition therein, thus preventing leakage or evaporation.

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PCT/US2013/024651 [0026] The first cap 100 may be removed or detached from the second cap 102 by, for example, twisting, pulling, snapping, or bending the first cap away from the second cap.

[0027] In other embodiments, each cap may be additionally sealed by a removable protective film or cover over the interior cavity that maintains the applicator material and cleansing, antimicrobial, or antiseptic composition in the respective caps. In some embodiments, each applicator material of each protective cap may contain a different cleansing, antimicrobial or antiseptic composition and/or different concentration of such composition.

[0028] In some embodiments, the first cap 100 may comprise a cap having an applicator material that protrudes from the receptacle of the cap, while the second cap 102 comprises a cap having applicator material that fits completely within and/or is recessed in a receptacle in the cap when in use. In that case, the first cap 100 with the protruding applicator material may be used to clean a surface (e.g., an intravascular line, valve, or port, an injection site, or the like) and the second cap 102 with the recessed applicator material may be used to cover and protect a port, vial, or other component (e.g., an intravascular line port, a vial, or the like).

[0029] In some embodiments, where the first or second cap may be configured to cover and/or protect a surface as described above, each of the first and second caps may have one of various example mechanisms for attaching each cap to the surface as described below in FIGS. 4C and 5A-5C.

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Example Process [0030] FIG. 2 illustrates an example process 200 for execution of the techniques described above of operating a combine cap applicator. The process 200 is illustrated as a logical flow graph. The order in which the operations are described is not intended to be construed as a limitation, and any number of the described operations can be combined in any order and/or in parallel to implement the process.

[0031] At operation 202, a device comprising a first cap detachably coupled to a second cap may be obtained. For example, such device may be any of the embodiments of the combined cap applicator as described above.

[0032] At operation 204, the first cap of the device may be detached from the second cap. In the context of FIG. 1, a user may detach the first cap by twisting, pulling, snapping or bending the first cap 100 away from the second cap 102.

[0033] At operation 206, an applicator located in the cavity of the first cap may be applied to a surface. Again, in the context of FIG. 1, the applicator 104 may be configured to extend beyond the cavity of the first cap when detached from the second cap. The applicator may be configured various surface treatments and/or contours for scrubbing, cleaning or disinfecting a surface (e.g., an intravascular line, valve, or port, an injection site, or the like).

[0034] Finally, at operation 208, the second cap may be removably secured to the surface. By securing the second cap to the surface, the surface may be protected from becoming re-contaminated by other environmental contaminants.

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Example Protective Cap Device [0035] Various example protective cap devices are described herein. Example protective cap devices are described generally with reference to FIG. 3-6.

[0036] FIG. 3 shows an illustration of an example protective cap device 300 that may attach to the neck and exposed elastomeric stopper of a multiple use/dose vial (vial) 302 after the vial is opened. The example protective cap device 300 having a cylindrical cavity that includes a foam insert 304 carrying an antimicrobial composition, such as the antimicrobial composition described in the preceding section. The example protective cap device 300 may be placed on a vial to protect the vial from microbial and particulate contamination while the vial is not in use. The example protective device may comprise caps such as those described in the preceding section.

[0037] In the illustrated example of FIG. 3, the outer surface of the example protective cap device 300 is shown to have a specific texture 306 that may aid the user in gripping the example protective cap device. However, the texture of the example protective cap device is not limited to such texture. Additionally or alternatively, the example protective cap device 300 may be any color that may, for example, aid the user in quick initial identification of the vial. For example, a vial used frequently in an emergency setting (e.g., emergency room, ambulance, etc.) may have a red protective cap. Additionally or alternatively, the size of the example protective cap device 300 can vary based in part on the size of the vial. The example protective cap device 300 is shown as having a round shape, although alternative shapes are contemplated such as, for

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PCT/US2013/024651 example, a square shape, a rectangular shape, an oval shape, a polygon shape, and the like. Generally, however, an opening of the protective cap device is shaped and sized to accommodate and protect the vial 302.

[0038] In some embodiments, the example protective cap device may include a label area for labeling by the user and/or the placement of an identification tag or tracking barcode.

[0039] As shown in FIG. 3, the inner surface within the cavity of the example protective cap device contains a foam insert 304. The foam insert 304, as shown in greater detail in FIG. 4, comprises a foam material having an open-cell region 400 around the circumference of the sides of the cylinder and a closed-cell region 402 on one or both axial ends of the cylinder. Example materials for the composition of the foam insert 304 include, but are not limited to, polyurethane, silicon, silicon rubber, polyethylene, polypropylene, and/or thermoplastic elastomer. The open-cell region 400 of the foam insert has a porous structure that allows an antimicrobial composition, such as the antimicrobial composition described above, to be disposed throughout all or part of the open-cell region 400. The closed-cell region 402 of the foam insert has a non-porous structure that is designed to interface with the metal ring and elastomeric stopper on the vial. The closed-cell region 402 of the foam insert may provide a barrier and prevent a contaminant from entering the elastomeric stopper of the vial and/or prevent contents of the vial from escaping. Furthermore, the closed-cell region prevents substantial amounts of the antimicrobial composition from entering the vial. In some embodiments, the

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PCT/US2013/024651 closed-cell region may have different surface finishes, treatments, or contours (e.g., macro-, micro-, or nano-structures, etc.) to facilitate gripping and/or scrubbing of the vial. [0040] FIGS. 4-5C illustrate several example mechanisms for attaching the example protective cap device to a vial. As shown in FIG. 4, the inner surface of the example protective cap device 404 includes threads 406 molded into the inner surface of the cavity. This attachment feature may allow the user to thread in a twisting motion the example protective cap device onto the vial. In this embodiment, the threads may be used to take advantage of and act upon the anatomical features of the neck of a vial.

[0041] FIG. 5A illustrates an example protective cap device 500A having a stepped inner surface, including a first inner surface 502 and a second inner surface 504, the second inner surface 504 having a smaller average diameter than the first inner surface. The first and second inner surfaces 502 and 504 may have diameters chosen to match outer diameter (OD) of common vials on the market, of maximum and minimum ODs of vials on the market, or based on other criteria. Further both of the first and second inner surfaces 502 and 504 may be tapered (i.e., have a draft angle Θ), such that a diameter of the first and second inner surfaces is largest closest to an opening of the example protective cap device 500A and decreases toward the bottom, closed end of the example protective cap device. A draft angle of the first inner surface 502 may be the same as, greater than, or less than a draft angle of the second inner surface 504. When the example protective cap device 500A is placed on a vial, the example protective cap device 500A will slide over the vial until an OD of the vial contacts and seals against the interior surface of the example protective cap device 500A at either the first inner

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PCT/US2013/024651 diameter 502 (in the case of a vial with a relatively large OD) or the second inner diameter 504 (in the case of a vial with a relatively small OD).

[0042] FIGS. 5B and 5C illustrate alternative embodiments of slip fit protective cap devices 500B and 500C, respectively, which have continuous, smooth inner surfaces. Rather than being stepped as in the embodiment of FIG. 5A, the protective cap devices 500B and 500C have continuous, smooth inner surfaces. The inner surfaces of the protective cap devices 500B and 500C are tapered to accommodate vials of varying OD. However, in order to accommodate vials having a wide range of ODs, the draft angle Θ of the protective cap devices needs to be larger (i.e., a more pronounced taper) as in the case of protective cap device 500B, and/or the protective cap device needs to be made deeper, as in the case of protective cap device 500C.

[0043] In other embodiments, the example protective cap device may be constructed with a flange on the inner surface at the opening of the cavity. The inner surface of the example protective cap device may otherwise have a continuous smooth surface. In this embodiment, the size of the flange may vary depending, in part, on the OD of the neck of the vial. When the example protective cap device in this embodiment is placed over the vial the flange allows the example protective cap to snap into place over the neck of the vial.

[0044] In still other embodiments, the example protective cap device may have internal slits in the cap that run from the opening of the cavity toward the closed end of the example protective cap device. The slits may expand only part way through the wall of the cap such that the cap still provides a seal to prevent contamination of the vial. The

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PCT/US2013/024651 internal slits in the example protective cap device would allow for the cap to expand enveloping a portion ofthe vial as the example protective cap device is slid over the vial. [0045] In still other embodiments, the example protective cap device may have a wire mechanism located within or around the cavity to allow for attachment to a vial. The wire mechanism may take the form of a spring. As with the example threads 406 in FIG. 4, the wire mechanism may allow a user to twist, squeeze, crimp, or otherwise fix the example protective cap device securely to the vial. Any of the above-listed attachment embodiments may be used separately or in conjunction with another to attach the example protective cap device to the vial.

Example Packaging of Protective Cap Device [0046] Any of the example protective cap devices described above may be sterilely packaged individually or in kits of multiple devices in a variety of packages. Furthermore, the protective cap devices themselves may additionally or alternatively be housed in a packaging that contains UV protective materials to inhibit breakdown of the antimicrobial composition.

[0047] FIGS. 6A-6C illustrate three example ways of packaging the example protective cap devices described herein. As shown in FIG. 6A, each protective cap device may be individually sealed in a pouch or packet 600 by sandwiching the protective cap device between multiple layers of thermoplastic material and sealing the sheets of material to each other around a periphery of the protective cap device by, for example, sonic welding, microwave welding, thermal bonding, or the like.

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PCT/US2013/024651 [0048] The approach described in FIG. 6A may be extended to simultaneously package multiple protective cap devices in a strip by placing multiple protective cap devices between sheets of thermoplastic material and then sealing the sheets of material to each other around the peripheries of each of the protective cap device using any of the sealing methods described above. The result is a strip 602, as illustrated in 6B, containing multiple individually sealed protective cap devices. Individual protective cap devices may then by dispensed by cutting between the protective cap devices in the strip 602. Alternatively, the strip 602 may include perforations or score lines between the individual protective cap devices in the strip 602.

[0049] In another embodiment, as shown in FIG. 6C, a package may include multiple protective cap devices that have the opened end of the cavity bonded directly in a tape or strip 604. The tape or strip 604 may be packaged according to the methods described with reference to FIGS. 6A and/or 6B, or other methods. In some embodiments, the multiple protective cap devices on tape or strip 604 may be of different sizes, different antimicrobial compositions and/or different concentrations of antimicrobial compositions.

Other Cap Devices [0050] In some examples, cap devices such as those described herein as well as in

U.S. Patent No. 7,763,006 to Tennican, U.S. Patent No. 7,799,010 to Tennican, and U.S. Patent No. 7,792,322 to Tennican, and/or U.S. Provisional Patent Application No. 61/564,206, filed November 28, 201 1 to Tennican et al., all of which are incorporated

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PCT/US2013/024651 herein by reference, may be used with syringe devices, such as mixing administration syringes described in U.S. Patent No. 7,635,344 to Tennican et al., U.S. Patent No. 7,731,678 to Tennican et al, U.S. Patent No. 7,7,31,679 to Tennican et al, U.S. Patent No. 7,749,189 to Tennican et al, U.S. Patent No. 7,753,891 to Tennican et al, U.S. Patent No. 7,776,01 1 to Tennican et al, U.S. Patent No. 7,985,21 1 to Tennican et al, U.S. Patent No. 8,002,737 to Tennican, U.S. Pat. App. Pub. No. 2007/0167910 filed 11/09/2006 to Tennican et al, U.S. Pat. App. Pub. No. 2007/0249996 filed 05/21/2007 to Tennican et al, and U.S. Pat. App. Pub. No. 201 1/0272310 filed 07/15/201 1to Tennican, which are also incorporated herein by reference.

[0051] For example, the cap devices may be packaged with a syringe (e.g., a mixing administration syringe) in accordance with the methods described in the preceding sections, or in other methods. The cap devices may be packaged in a sterile packaging along with a syringe in the same compartment of the sterile packaging or in a separate compartment of the sterile packaging. Alternatively, one or more cap devices may be packaged separately from the syringe.

[0052] In some examples, one or more cap devices may be coupled in, on, or to the plunger, wings, tip, or other portion of the syringe. In that case, the cap devices may be sealed directly to the syringe body, or may be sealed by a separate removable film or cover.

[0053] The cap device may be placed on the port access line or IV device after the mixing administrative syringe has been used on the port access line or IV device and/or an injection or blood draw site.

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PCT/US2013/024651 [0054] In some embodiments, a cap device may be used to clean, sanitize and/or disinfect on a surface (e.g., skin or tissue) prior to using the mixing administrative syringe. For example, the cap device may be used to clean an injection site prior to using the mixing administrative syringe at the injection site.

[0055] In some embodiments, a cap device may be placed on the mixing administrative syringe to disinfect the syringe prior to use. Additionally or alternatively, a cap device may be placed on a vial of medication or diluents to disinfect the vial prior to use, between uses, and/or during storage.

Conclusion [0056] Although the disclosure describes embodiments having specific structural features and/or methodological acts, it is to be understood that the claims are not necessarily limited to the specific features or acts described. Rather, the specific features and acts are merely illustrative some embodiments that fall within the scope of the claims of the disclosure.

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