JP2024518984A - Antimicrobial puncture site patch with post-injection safety seal - Patents.com - Google Patents

Abstract

The puncture site patch comprises an elastomeric self-sealing membrane having an outer surface and an inner surface; a spacer having an outer surface and an inner surface, the outer surface of the spacer being bonded to the inner surface of the membrane, the spacer further comprising an aperture, the aperture defining a cavity formed by the inner surface of the membrane, the spacer, and the skin when applied to a user; an adhesive film located on the inner surface of the spacer and capable of adhering to the skin; and at least one elongated tab movable between a first position and a second position, where when in the first position the at least one elongated tab extends outwardly from a periphery of the spacer and when in the second position the puncture site patch is folded such that the aperture is sealingly closed by the at least one elongated tab.

Description

Blood-borne pathogens are widely known to be a potent method of transmission of infectious diseases. In particular, medical professionals are at risk for such exposure due to the need to perform tasks that expose them directly to blood, such as puncturing a patient's skin with a needle to give an injection or draw blood. Typically, when the skin is punctured, the target area of skin is wiped with an antiseptic (e.g., an alcohol wipe) and a needle (which may further be attached to a syringe) is inserted through the skin subcutaneously or intramuscularly. After the skin is punctured, the needle is removed and a gauze or cotton pad is placed over the puncture wound to absorb any blood that may be released from the wound. The practitioner may come into contact with blood at multiple points during the procedure, such as when the needle initially punctures the skin, when the needle is removed from the skin and before the pad is positioned over the puncture wound, or after the pad is applied over the puncture site due to possible bleeding or seepage of blood from the pad. Additionally, gloves may be ineffective, placing the medical professional at even greater risk of exposure to pathogens. Therefore, it may be desirable to have a protective patch for use during an injection that contains a bactericidal, bacteriostatic, and/or antiviral agent to kill and/or reduce the infectivity of microorganisms (e.g., viruses, bacteria, fungi, etc.) that may have been exposed as a result of skin puncture.

However, the risk of exposure to blood-borne or other pathogens does not end with vaccination administration or other puncture wounds to the skin. Blood and/or other components may be contained in gauze, bandages, etc., placed over the puncture wound. These items require subsequent safe disposal. Additionally, with the growing popularity of drive-thru vaccination clinics, such as for influenza vaccines or SARS coronavirus 2 vaccines, gauze or bandages, etc., may be removed and disposed of in areas where others may be exposed to blood-borne pathogens, such as in the patient's home, restaurants, bathrooms, or parking lots.

The embodiments described herein address these and other problems associated with the art by providing a post-injection safety seal to a puncture site patch. Thus, according to one aspect of the invention, a puncture site patch comprises an elastomeric self-sealing membrane having an outer surface and an inner surface; a spacer having an outer surface and an inner surface, the outer surface of the spacer being bonded to the inner surface of the elastomeric self-sealing membrane, the spacer further comprising an aperture, the aperture forming a cavity formed by the inner surface of the elastomeric self-sealing membrane, the spacer, and the skin when applied to a user; an adhesive film over the inner surface of the spacer that adheres to the skin; and at least one elongated tab movable between a first position and a second position, where in the first position the at least one elongated tab extends outwardly from a periphery of the spacer and in the second position the puncture site patch is folded such that the aperture is sealed closed by the at least one elongated tab.

In some implementations, the at least one elongated tab is a first elongated tab and the puncture site patch further comprises a second elongated tab, the first and second elongated tabs each extending outwardly from a periphery of the spacer and disposed directly opposite one another. In some such implementations, in the second position, the first and second elongated tabs substantially overlap one another.

In some implementations, the puncture site patch further comprises an axis extending through the center of the aperture forming the first side of the spacer and the second side of the spacer, and in the second position, the puncture site patch is folded along the axis such that the first side of the spacer and the second side of the spacer substantially overlap one another, and the at least one elongated tab folds over the substantially overlapping first and second sides of the spacer to seal the first and second sides of the spacer in a closed state.

In some implementations, in the second position, at least one elongated tab is folded over the aperture to seal the cavity closed.

In some implementations, the puncture site patch further comprises a release paper in contact with and completely covering the adhesive film, the release paper being configured to be removed prior to application to the skin.

In some implementations, at least one elongated tab further comprises a reduced strength adhesive. In other implementations, the elastomeric self-sealing membrane is substantially transparent.

In some implementations, the elastomeric self-sealing membrane further comprises an antimicrobial agent. In some such implementations, the antimicrobial agent is mixed into the elastomeric self-sealing membrane during extrusion. In other such implementations, the antimicrobial agent is a coating applied to the elastomeric self-sealing membrane. In some implementations, the antimicrobial agent is a plurality of silver nanoparticles. In other implementations, the antimicrobial agent is a carvacrol agent mixed into the elastomeric self-sealing membrane at a concentration of about 0.01% to about 0.001%.

In another aspect, the puncture site patch comprises a substantially transparent elastomeric self-sealing membrane having an outer surface and an inner surface; a spacer having an outer surface and an inner surface, the outer surface of the spacer being bonded to the inner surface of the substantially transparent elastomeric self-sealing membrane, the spacer further comprising an aperture, the aperture forming a cavity formed by the inner surface of the substantially transparent elastomeric self-sealing membrane, the spacer, and the skin when applied to a user; an adhesive film located on the inner surface of the spacer and configured to adhere to the skin; an axis extending through a center of the aperture forming a first side of the spacer and a second side of the spacer; and an elongated tab moving between a first position and a second position, the elongated tab extending outward from a periphery of the spacer when in the first position, and the elongated tab folding along the axis such that the first side of the spacer and the second side of the spacer substantially overlap one another when in the second position.

In some implementations, the elongated tab folds over the substantially overlapping first and second sides of the spacer to seal the first and second sides of the spacer in a closed state.

In some implementations, the elongated tab is a first elongated tab and the puncture site patch further comprises a second elongated tab, the first and second elongated tabs each extending outwardly from a periphery of the spacer and disposed directly opposite one another, and when in the second position, the first and second elongated tabs substantially overlap one another.

In some implementations, the substantially transparent elastomeric self-sealing membrane further comprises an antimicrobial agent. In some such implementations, the antimicrobial agent is incorporated into the elastomeric self-sealing membrane during extrusion. In other such examples, the antimicrobial agent is a coating applied to the elastomeric self-sealing membrane.

In yet another aspect, a puncture site patch includes a substantially transparent elastomeric self-sealing membrane having an outer surface, an inner surface, and an antimicrobial agent; a spacer having an outer surface and an inner surface, the outer surface of the spacer being bonded to the inner surface of the substantially transparent elastomeric self-sealing membrane, the spacer further comprising an aperture, the aperture forming a cavity formed by the inner surface of the substantially transparent elastomeric self-sealing membrane, the spacer, and the skin when applied to a user; an adhesive film located on the inner surface of the spacer and adhering to the skin; an axis extending through a center of the aperture forming a first side of the spacer and a second side of the spacer; and an elongated tab configured to move between a first position and a second position, the elongated tab extending outward from a periphery of the spacer when in the first position, and the elongated tab being folded along the axis such that the first side of the spacer and the second side of the spacer substantially overlap one another when in the second position.

These and other advantages and features which are characteristic of the present invention are set forth in the claims annexed hereto and forming a further part hereof. For a better understanding of the invention and of the advantages and objects attained through its use, however, reference should be made to the drawings and accompanying description in which illustrative embodiments of the invention are set forth. This Summary is provided merely to introduce one of the concepts that is described in more detail below, and is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in limiting the scope of the claimed subject matter.

FIG. 1 is a plan view of an antimicrobial puncture site patch according to one embodiment described herein. FIG. 2 is an exploded perspective view of the patch of FIG. 1 . Figure 2 is a cross-sectional view of the patch of Figure 1, in a non-use configuration; Figure 2 is a cross-sectional view of the patch of Figure 1;Figure 3 is a cross-sectional view of the patch of Figure 1 in a disposal configuration; FIG. 2 is a perspective view of the patch of FIG. 1 positioned on a patient's arm. FIG. 2 is a perspective view of the patch of FIG. 1 positioned on a patient's arm. FIG. 2 is a plan view of an antimicrobial puncture site patch corresponding to another embodiment described herein. FIG. 6 is an exploded perspective view of the patch of FIG. 5 . Figure 6 is a cross-sectional view of the patch of Figure 5;Figure 7 is a cross-sectional view of the patch of Figure 5 in a non-use configuration; Figure 6 is a cross-sectional view of the patch of Figure 5. Figure 7 is a cross-sectional view of the patch of Figure 5 in a first disposal configuration. Figure 6 is a cross-sectional view of the patch of Figure 5. Figure 7 is a cross-sectional view of the patch of Figure 5 in a second disposal configuration. FIG. 6 is a perspective view of the patch of FIG. 5 positioned on a patient's arm. FIG. 6 is a perspective view of the patch of FIG. 5 positioned on a patient's arm. FIG. 6 is a plan view of the patch of FIG. 5 in a disposal configuration. FIG. 6 is a perspective view of a package corresponding to some embodiments described herein for containing the antimicrobial puncture site patch of FIG. FIG. 1 is a schematic diagram of a process by which the antimicrobial puncture site patch can be made.

1-3 show an antimicrobial puncture site patch device 10 (hereinafter "antimicrobial patch", "patch", etc.). The patch 10 includes a membrane 12 and a spacer 14, which further includes an aperture 16. In the illustrated embodiment, the patch device 10 is generally circular, but this is not intended to be limiting, and other shapes may also be used, including, but not limited to, square, rectangular, oval, triangular, and the like. In some examples, as shown in FIG. 2, for example, the patch 10 may further include an optional protective sheet or release paper 18. The protective sheet or release paper 18 may be used to protect the adhesive film 26 on the spacer 14 until the patch 10 is to be applied to the patient's skin. In some examples, the protective sheet or release paper 18 may be of a similar size and shape to the spacer 14, or in other examples, the protective sheet or release paper 18 may be slightly larger than the spacer 14.

In some examples, the protective sheet or release paper 18 may further comprise a first peel tab 28 ₁ and a second peel tab 28 ₂ , or other surface, to allow a user to easily remove the release paper 18 from the membrane 12 and spacer 14 to expose the adhesive film 26. In some examples, the patch 10 may further comprise a first pull tab 24 ₁ and a second pull tab 24 ₂ , which may protrude from the spacer 14. The first pull tab 24 ₁ and the second pull tab 24 ₂ may be positioned directly opposite each other across the aperture 16, such that when the antimicrobial puncture site patch device 10 is folded along axis A (as described herein), the first pull tab 24 ₁ and the second pull tab 24 ₂ may contact each other (see, e.g., FIG. 3B ) to seal the patch 10. As will be discussed below, folding the first pull tab _24-1 and the second pull tab _24-2 in this manner further seals the interior of the patch 10, thereby preventing contact with and the spread of pathogens in the post-injection environment.

Additionally, these pull tabs 24 ₁ and 24 ₂ may not include an adhesive, which may facilitate removal of the patch 10. In some instances, only one of the pull tabs 24 ₁ and 24 ₂ may not include the adhesive film 26, and in other instances, both pull tabs 24 ₁ and 24 ₂ may not include an adhesive. In some instances, this may allow a user to grasp a portion of one or both of the pull tabs 24 ₁ and 24 ₂ to remove the patch 10 from the skin, particularly if the adhesive film 26 is not present.

The membrane 12 of the antimicrobial patch 10 may be an extruded elastomeric material. In some examples, the elastomeric material may be sterile, self-sealing, non-coring, non-latex, and FDA approved for direct contact with human or animal skin. The self-sealing and non-coring properties of the elastomeric material allow needles (of various sizes) used for injection through the membrane 12 to be wiped clean of blood upon withdrawal of the needle through the membrane 12. Also, in some examples, the membrane 12 may be sufficiently transparent to allow the practitioner to observe the patient's skin 90 when the patch 10 is positioned over the intended injection site 92. The physical structure of the membrane 12 includes an outer surface 11 and an inner surface 13, the inner surface 13 facing the patient's skin 90 when the antimicrobial patch 10 is applied. Additionally, the membrane material may be selected to be chemically or structurally stable and substantially unaffected, and therefore not degrade when cleaned, disinfected, and/or sterilized with agents such as ethyl alcohol, betadine, or similar common disinfectants. The membrane 12 may have any shape convenient for adequately covering the spacer 14. In some embodiments, the perimeters of the membrane 12 and the spacer 14 may be substantially the same, and in other embodiments, the perimeters may be different.

The membrane 12 may further be infused with one or more antimicrobial agents. As will be further described with reference to FIG. 11, in some examples, this infusion may be completed during the solidification process of the elastomeric material (i.e., during the heating and extrusion of the polymer). This incorporation may be by extrusion or co-extrusion. There are a variety of antimicrobial agents, both natural and synthetic. For example, some of these antimicrobial agents may be extracted from various plants or herbs. Some examples of such antimicrobial herbs include, but are not limited to, oregano, sage, basil, fennel, garlic, lemon balm, peppermint, rosemary, echinacea, elderberry, licorice, astragalus, ginger, ginseng, and/or components of dandelion. In other embodiments, synthetic or lab-made antimicrobial agents may be used alone or in combination with each other or with any naturally occurring herbal antimicrobial agent. In yet other examples, one or more metals, such as silver or copper, may be used as the antimicrobial agent. These antimicrobial agents may provide various mechanisms of action for their respective antimicrobial activity. These agents may be effective against bacteria, viruses, and/or fungi, and may be bactericidal, virucidal, and/or fungicidal, and/or bacteriostatic, virucidal, and/or fungistatic. Any of these above listed agents may be incorporated into the elastomeric membrane 12, but an important consideration in selecting one or more antimicrobial agents is whether the agent remains active after exposure to the extrusion conditions (e.g., heat, pressure, etc.) of the elastomeric membrane 12, as described with reference to FIG. 11. Although the antimicrobial agent is described as being incorporated into the elastomeric membrane 12 via extrusion, this is not intended to be limiting, and in some examples, the antimicrobial agent may be applied as a coating, as a potentiometric film, and/or by lamination.

As a non-limiting example, carvacrol, a phenolic monoterpenoid from oregano (Origanum vulgare), may be incorporated into the elastomeric membrane 12 of the antimicrobial patch 10. In vitro studies have shown that carvacrol can reduce the activity of murine norovirus after about 15 minutes of exposure. In addition, carvacrol exhibits antiviral activity against a wide range of viruses, including herpes simplex virus, rotavirus, respiratory syncytial virus, and others. Furthermore, due to its phenolic structure, carvacrol is expected to be effective against coronaviruses, including SARS coronavirus 2. The inhibitory activity of carvacrol may be related to its hydrophobic and lipophilic tendencies, as these characteristics result in an affinity for cell membranes and insertions in the cell membranes that alter the physical and chemical properties of the membranes and alter the membrane stability. In some examples, the carvacrol agent may be incorporated into the elastomeric membrane 12 during the extrusion and/or solidification process at a concentration of about 0.01% to about 0.001%.

In other non-limiting examples, metal antimicrobial agents may be incorporated into or coated onto the elastomeric membrane 12 of the antimicrobial patch 10. These metal antimicrobial agents may cause cell destruction against microorganisms, for example, as a result of reactive oxygen species (ROS), other oxidation processes, replacement of structural metals, and/or destruction of iron-sulfur clusters. In some examples, silver nanoparticles or copper nanoparticles may be used as the metal antimicrobial agent. These metal nanoparticles may be included in the extrusion of the polymer forming the membrane 12 and/or coated onto the membrane 12. In some examples, the silver nanoparticles may be formed in situ, i.e., the polymer used to form the elastomeric membrane may be combined with a metal salt and a reducing agent, and the metal nanoparticles are formed during this combination. In other examples, pre-synthesized metal nanoparticles may be dispersed with the polymer medium. In some examples, silver may be incorporated into the membrane 12 at a concentration of about 0.1% to about 4%. In another example, silver may be incorporated into the membrane at a concentration of about 2.5%, at which concentration studies have shown silver to be effective against multiple microbial species. In one example, a silver zeolite-based antimicrobial agent is incorporated into the membrane.

The spacer 14 is a material having an outer surface 15 and an inner surface 17. The spacer 14 can be made of any material that can be sterilized and used in direct contact with human skin, such as nylon, polyurethane, polyethylene, polypropylene, isoprene, cotton, linen, or combinations thereof. Optionally, the material of the spacer 14 may be selected based on its ability to absorb blood and bodily fluids, although this is not required. In some instances where an absorbent material is used, it may be desirable, but not required, for the absorbent material to have some resistance to capillary action to minimize the risk of blood capillary action from the cavity 20 to the outer edge 19 of the spacer 14. In some instances, one or more additives may be incorporated into the extruded layer to enhance absorbency. The spacer 14 is secured at or on its outer surface 15 to the inner surface 13 of the membrane 12. Various means known in the art may be used to secure the spacer 14 to the membrane 12, such as, for example, glue, hot melt adhesive, pressure sensitive adhesive, heat sensitive adhesive, chemical bonding, acrylic cement, radio frequency welding, ultrasonic welding, or combinations thereof, or any other means known in the art. However, an important consideration in selecting a fastening means for the spacer is what interactions, if any, the selected fastening means may have on the effectiveness of the selected antimicrobial agent. In some examples, the spacer 14 may be positioned on the membrane 12 such that the membrane 12 covers the entire outer surface 15 of the spacer 14. The inner surface 17 of the spacer 14 is covered with an adhesive film 26 to hold the patch 10 against the patient's skin 90. Although various adhesives may perform the desired function, it is preferred that the adhesive used be an FDA approved material since the adhesive will be in direct contact with human skin.

The spacer 14 may further include an aperture 16. In some instances, the aperture may be substantially centrally located. The aperture 16 is of sufficient size to allow a practitioner to insert a needle through the membrane 12 and the aperture 16 without puncturing or damaging any portion of the spacer 14. When the antimicrobial patch 10 is applied to the patient's skin 90, the aperture 16 formed by the skin 90, the membrane 12, and the spacer 14 form a cavity 20 through which the needle passes during an injection or blood collection procedure. Blood expelled from the skin upon puncturing may be pooled within the cavity 20. In some instances, the blood may dry within the cavity 20, or in other instances, may be absorbed by the spacer 14. The spacer 14 may comprise or be composed of an absorbent material, and may optionally include a coagulant. In a non-limiting example, the spacer 14 may be constructed of polyethylene and may be coated with cellulose or any other suitable clotting agent for clotting blood as commonly known in the art. In some examples, the aperture 16 has a diameter of about 15 mm (0.519 inches) so that the cavity 20 thus formed may contain up to about 0.3 cc of bodily fluid. It should be understood that the dimensions of the aperture 16 and the antimicrobial patch are not limited to the dimensions described herein and may vary based on the desired application of the antimicrobial patch 10. It should also be understood that the volume that the cavity formed may contain may vary by varying the dimensions of the aperture.

4A and 4B, the antimicrobial patch 10 is shown affixed to a patient's skin 90 over an intended puncture site 92, such as an injection site. When the patch 10 is applied to the skin 90, a cavity 20 is formed between the skin 90 and the membrane 12, defined by the spacer 14. In some examples, this cavity 20 may have a depth D. The antimicrobial patch 10 may be secured and held directly to the patient's skin 90 along any portion of the inner surface 17 of the spacer 14 by an adhesive film 26. This secured attachment may be beneficial to prevent blood leakage and thus potential spread of blood-borne pathogens, but may also be problematic with respect to removal of the antimicrobial patch 10 from the skin after use. To facilitate removal, the antimicrobial patch 10 may further include a first pull tab 24 ₁ and a second pull tab 24 2 protruding on opposite sides from the spacer 14. In some examples, these pull tabs 24 ₁ and 24 ₂ may be integral with the spacer 14. As discussed above, the first pull tab 24 ₁ and/or the second pull tab 24 ₂ may or may not have adhesive on the inner surface 17, and in some instances may only partially have adhesive. In other instances, the adhesive is reduced in strength over some or all of the first pull tab _{24 1} and/or the second pull tab 24 2 so that either the practitioner or the patient can easily grasp a portion of one or both of these pull tabs 24 ₁ and 24 ₂ , such as the portion without adhesive, to remove the antimicrobial patch ₁₀ from the patient's skin.

3A-3B in particular, cross-sectional views of the antimicrobial patch 10 are presented in a first non-use configuration (FIG. 3A) and a second disposal configuration (FIG. 3B). As shown in FIG. 3A, the beginning locations of the first pull tab 24 ₁ and the second pull tab 24 ₂ extend outwardly from the spacer 14 in a position directly opposite one another. At some point after injection or other penetration of the membrane 12 and the skin, the patient, caregiver, or medical professional may wish to remove the antimicrobial patch 10. At such time, the patient, caregiver, or medical professional may simply grasp a portion of one or both of the pull tabs 24 ₁ and 24 ₂ and fold the antimicrobial patch 10 along the central axis A, thereby ensuring complete coverage of the aperture 16. When folded, the first pull tab 24 ₁ and the second pull tab 24 ₂ may substantially overlap one another. In some instances, there may be incisions, markings, or other guides so that the patient or caregiver knows exactly where to fold the patch 10. The existing adhesive film 26 on the antimicrobial patch 10 is used to form a sealed closure 40 to contain and prevent leakage of bodily fluids, pathogens, and the like, while simultaneously exposing the bodily fluids and any subsequent blood-borne pathogens to _{the embedded antimicrobial agent. In some instances, the adhesive film 26 extends over a portion (or all) of one or both of the pull tabs 24 1 and 24 2 , which may} further seal the patch 10. Once captured within the sealed enclosure 40 or collection cavity, blood, viral particles, bacteria, and the like contained therein may come into contact with the antimicrobial membrane 12. Contact with the antimicrobial membrane 12 for approximately 15 minutes or more results in the inactivation of the viral particles, thereby making the patch 10 safe for disposal.

As previously mentioned, drive-thru vaccination clinics or other high throughput vaccination clinics are becoming increasingly popular. The increase in such high throughput vaccination clinics increases the likelihood that used dressings, such as the antimicrobial puncture site patch 10, will be removed and discarded in areas such as the patient's home or other locations where others may be exposed to blood-borne pathogens. Once the antimicrobial patch 10 is in the discarded configuration shown in FIG. 3B, the patch 10 can be safely disposed of while minimizing the risk of exposing others to bodily fluids or pathogens that may be contained therein.

5-6, 7A-7C, 8A-8B, and 9-10 show another embodiment of an antimicrobial puncture site patch 110. As with the embodiments discussed above, the patch 110 may also include a membrane 112 and a spacer 114 having an aperture 116. As with the previous embodiments discussed herein, the patch 110 is substantially circular, but as explained in the previous embodiments, this is not intended to be limiting. Optionally, the patch 110 may also include a protective sheet or release paper 118 to protect the adhesive film 26 on the spacer 114. The release paper 118 may be of a similar size and shape to the spacer 114, but is not limiting and may be slightly larger than the spacer 114. The release paper 118 may further include a peel tab 128 or other surface to facilitate removal of the release paper 118 from the membrane 112 and the spacer 114. The patch 110 may also include an elongated pull tab 124 that may protrude from the spacer 114. The elongated pull tab 124 may facilitate removal of the patch 110 from the patient.

As shown in FIG. 7B, in some examples, the elongated pull tab 124 may be large enough to be folded over (e.g., over the elongated pull tab 124) onto the remainder of the adhesive film 126 such that the cavity 120 is completely enclosed (see further, e.g., FIG. 9) during the disposal process. By folding the elongated pull tab 124 over the remainder of the adhesive film 126 and enclosing the cavity 120, the antimicrobial agent on the membrane is ensured to remain in contact with contaminated blood on the adhesive layer and seal the cavity 120 from contact with bodily fluids and/or pathogens contained therein.

In another example, as shown in FIG. 7C, the antimicrobial patch 110 may be folded approximately in half along a central axis A forming a spacer first side 130 and a spacer second side 132. When the antimicrobial patch 110 is folded along the central axis A, the spacer first side 130 and the spacer second side 132 may be substantially overlapped, thereby ensuring that the cavity 120 is completely enclosed to form the closed patch 110. In some examples, there may be indentations, markings, or other guides so that the patient or caregiver knows exactly where to fold the patch 110. The elongated pull tab 124 may then be folded over the closed patch 110, and the adhesive film 126 on the elongated tab may be used to further seal the patch 110 in this closed position.

The membrane 112 of the antimicrobial patch 110 may be an elastomeric material similar to the elastomeric materials described with reference to the previous embodiment. As previously mentioned, in some instances, it may be advantageous for the membrane 112 to be sufficiently transparent to allow the practitioner to observe the patient's skin 190 when the patch 110 is positioned over the intended injection site 192. In some instances, this transparency may be determined by total transmittance measurements, haze measurements, clarity measurements, optical density, or any other known measurements. As with the previous membranes, the membrane 112 may further comprise an outer surface 111 and an inner surface 113. As previously mentioned, the membrane 112 may further be infused with one or more antimicrobial agents.

The spacer 114 has an outer surface 115 and an inner surface 117 and is made of a material that can be placed in direct contact with human skin, such as nylon, polyurethane, polyethylene, polypropylene, isoprene, cotton, linen, or a combination thereof. In some examples, the materials used in the construction of the spacer 114 may also be selected based on their ability to absorb various bodily fluids. When such absorbent materials are used, in some examples, the absorbent materials may have some resistance to capillarity to minimize the risk of blood capillarity from the cavity 120 to the outer edge 119 of the spacer 114. As with the previous embodiment, the spacer 114 may be secured to the inner surface 113 of the membrane 112 at or on its outer surface 115 by various means known in the art. However, as previously mentioned, an important factor in selecting the method of securing the spacer 114 is what interactions, if any, the selected method of securing may have on the effectiveness of the selected antimicrobial agent. The inner surface 117 of the spacer 114 may be covered with an adhesive film 126 to aid in retention of the patch 110 against the patient's skin 190. In some examples, the spacer 114 may further include a substantially centrally located aperture 116 of sufficient size to allow a practitioner to insert a needle through the membrane 112 without puncturing or damaging any portion of the spacer 114. As with the previous embodiment, the patch, once applied, is formed by the skin 190, the membrane 112, and the spacer 114, thereby forming a cavity 120. Bodily fluids expelled from the skin upon puncturing may be collected within the cavity 120.

8A and 8B, the antimicrobial patch 110 is shown as being applied to the patient's skin 190 over the intended puncture site 192, thereby forming a cavity 120 between the skin 190 and the membrane 112, as previously described, formed by the spacer 114. In some instances, the cavity 120 may have a depth D approximately equal to the combined width W of the spacer 114 and the adhesive film 126. An elongated pull tab 124 protruding from the spacer 114 may aid in removal of the antimicrobial patch 110. In some instances, the elongated pull tab 124 may not include an adhesive film, and in other instances, the elongated pull tab 124 may only be partially comprised of adhesive, such that a portion of the elongated pull tab 124 is free of adhesive. The elongated pull tab 124, or an adhesive-free portion thereof, may facilitate gripping of the elongated pull tab 124 by the practitioner or patient. In some examples, the elongated pull tab 124 may have a sufficient length and width to allow it to fold over the aperture 116 during the disposal process.

7A-7B, cross-sectional views of the antimicrobial patch 110 are shown in a non-use position (FIG. 7A) and a disposal position (FIG. 7B). In the disposal position, the elongated pull tab 124 is folded over the aperture 116, as indicated by the arrows. The original starting position of the elongated pull tab 124 (e.g., extending outward from the spacer 114) is indicated by a dashed line in FIG. 7B. In some instances, the elongated pull tab 124 has a length sufficient to cover substantially all of the adhesive film 126, which requires the elongated pull tab to have a length of approximately L1. In other instances, the elongated pull tab 124 may only have a length sufficient to cover the entire aperture 116. The lengths shown should not be considered limiting, and the elongated pull tab 124 may have any length sufficient to completely cover the aperture 116. Similarly, the width of the elongated pull tab 124 may be any length sufficient to completely cover the aperture 116. FIG. 9 illustrates a non-limiting example of a width W1 of the elongated pull tab 124. Ensuring that the aperture 116 is completely covered when the elongated pull tab 124 is folded over further ensures that the antimicrobial agent on the membrane 112 is maintained in contact with contaminated blood on the adhesive film 126 and further ensures that the cavity 120 is sealed, thereby preventing contact with bodily fluids and/or pathogens contained therein.

With the increased likelihood that dressings, such as antimicrobial puncture site patches 110 used in combination with vaccinations or other punctures, may be removed and discarded in areas such as the patient's home or other locations, disposal solutions are needed to minimize the risk of spreading blood-borne pathogens from contaminated dressings. In some embodiments, the antimicrobial patch 110 may be sterile packaged in a reusable container 60 that can be used to dispose of the patch 110 after removal from the patient. A non-limiting example of such a reusable container 60 is shown in FIG. 10.

As shown in FIG. 10, the reusable container 60 may be formed into a generally rectangular or square shape sufficient to hold a single antimicrobial patch 110. However, this is not intended to be limiting, and any shape may be utilized as long as it is sufficient to accommodate the antimicrobial patch 110. The reusable container 60 may generally take the form of a bag, constructed from one or more pieces of polymer, plastic, or the like, sealed together. In some examples, the reusable container 60 may comprise a first polymer sheet 62 and a second polymer sheet 64, the two sheets 62, 64 being sealed together to form a first edge portion 66, a second edge portion 68, and a bottom portion 70 of the reusable container 60. The first edge portion 66, the second edge portion 68, and the bottom portion 70 together form a cavity 72 between the first sheet 62 and the second sheet 64. The reusable container 60 may further include an opening 74 through which the antimicrobial patch 110 is placed within the cavity 72.

In some examples, the reusable container 60 may further include a tear line 76 having a notch (or perforation) 78 on one or both edges 66, 68 disposed near a top portion of the reusable container 60. The notch may facilitate opening the container 60 for a user, such as a healthcare provider administering a vaccine. In some examples, the reusable container 60 may further include a closure 80 to allow reinsertion of the antimicrobial patch after use and resealing of the reusable container 60. One non-limiting example of such a closure 80 may be a closure on the first sheet 62 that cooperates with a complementary closure element on the second sheet 64, as is typical of conventional "zip" type closures. Another non-limiting example of such a closure may be an adhesive strip and corresponding protective cover on the exterior of one sheet 62, 64 of the container 60.

In some examples, the reusable container 60 may further include an antimicrobial agent. In some examples, only the portion of the reusable container 60 that may be in contact with the antimicrobial patch 110, such as that contained within the cavity 72, may be infused or coated with the antimicrobial agent. In other examples, the entire reusable container 60 may be infused or coated with the antimicrobial agent. This infusion may be completed, for example, during the manufacturing process and/or solidification process of the polymer or plastic used to construct the container 60. As discussed above, there may be a variety of antimicrobial agents, both natural and synthetic, that may be incorporated into the reusable container 60. As discussed with reference to the antimicrobial patch 10, 110, one non-limiting example of such an antimicrobial agent may be carvacrol, which is a phenolic monoterpenoid of oregano (Origanum vulgare). Carvacrol may be incorporated into the polymer or plastic used to construct the reusable container 60. In some examples, the carvacrol agent may be incorporated into the elastomeric membrane 12 during the extrusion and/or solidification process at a concentration of about 0.01% to about 0.001%.

Although described and illustrated with antimicrobial patch 110, it should be understood that the reusable container 60 described and illustrated herein is not limiting and thus the disposal container may be used with antimicrobial patch 10 or any other embodiment of an antimicrobial patch contemplated herein.

Furthermore, while the present specification has been primarily discussed with reference to vaccination, this is not intended to be limiting. Various embodiments of the antimicrobial patch 10, 110 corresponding to the embodiments described herein may also be used for catheter insertion into a patient, needle biopsy, joint injection or aspiration, or any other instance in which a patient's skin may be punctured by a sharp, needle-like object. Furthermore, the cavity may contain bodily fluids other than blood, such as, for example, aspirates.

11, an example method for a continuous manufacturing process for producing the antimicrobial patch described herein is shown. Fabrication of the antimicrobial patch 10 may include forming an aperture at one or more predetermined locations along a sheet of spacer material (e.g., nylon, polyurethane, polyethylene, polypropylene, isoprene, cotton, linen) 14. As previously discussed, the aperture 16 may be substantially circular, but is not so limited. In some instances, the spacer material 14 may be pretreated with an adhesive film 26 on both sides 15, 17. In other instances, it may be necessary to apply the adhesive film 26 to the spacer material 14. The outer surface 15 of the spacer material 14 may further include a protective paper sheet 30 disposed thereon. This sheet may serve to protect the outer surface 15 prior to application of the membrane material 12 to the outer surface 15. The protective paper 30 may be removed by a take-up roller 32 as the die-cut spacer material continues its forward movement. Similarly, a release paper sheet 18 may be disposed over the inner surface 17 to protect the adhesive film 26 prior to use. The elastomeric membrane material sheet 12 may then be secured against the outer surface 15. The combination of the membrane 12, spacer member 14, and release paper 18 may be die cut 34 into the desired configuration.

The elastomeric membrane sheet infused with antimicrobial agents as described herein may be formed separately prior to incorporation into the process described with reference to FIG. 11. The elastomeric membrane 12 is a film extruded on standard plastic processing equipment by a standard extrusion process. During the extrusion process, an antimicrobial agent, such as carvacrol, may be added. The antimicrobial agent may be added at a temperature high enough to allow the chemical agent to be embedded while extruding the film, but not so high that it would inactivate or minimize the effect of the antimicrobial agent. The temperature at which the agent is added and extrusion is performed may also vary, as particular agents may differ in the temperature at which they may lose their antimicrobial effect. As a non-limiting example, carvacrol inactivates at about 214° F., so the extrusion temperature may be less than about 214° F., and more preferably less than about 200° F. In another example, the antimicrobial agent may be applied as a coating, as described herein, which may allow extrusion at higher temperatures.

As is known in the art, this process may be modified in various ways without departing from the scope of the invention, such as by applying a first adhesive to the membrane instead of the spacer sheet, applying a second adhesive to the release paper instead of the spacer sheet, using a laser to cut the layered material, adding a release paper after laminating and cutting the membrane and spacers, and combinations thereof.

While several embodiments of the present invention have been described and illustrated herein, those skilled in the art will readily envision various other means and/or structures for performing the functions described herein and/or achieving one or more of the results and/or advantages described herein. Any such variations and/or modifications are deemed to be within the scope of the embodiments of the present invention described herein. More generally, those skilled in the art will readily appreciate that any parameters, dimensions, materials, and configurations described herein are intended as examples, and that the actual parameters, dimensions, materials, and/or configurations will be determined by the particular application in which the teachings of the present invention are utilized. Those skilled in the art will recognize or be able to ascertain, using no more than routine experimentation, many equivalents to the specific embodiments of the present invention described herein. Thus, it will be appreciated that the foregoing embodiments are presented by way of example only, and that within the scope of the appended claims and their equivalents, embodiments of the present invention may be practiced otherwise than as specifically described and claimed. The inventive embodiments of the present disclosure relate to each individual feature, system, article, material, kit, and/or method described herein. Furthermore, any combination of two or more such features, systems, articles, materials, kits, and/or methods is included within the inventive scope of this disclosure to the extent that those features, systems, articles, materials, kits, and/or methods are not mutually inconsistent.

It is understood that any definitions and definitions used herein take precedence over dictionary definitions, definitions in documents incorporated by reference herein, and/or ordinary meanings of the defined terms.

The indefinite articles "a" and "an" as used herein and in the claims should be understood to mean "at least one," unless expressly stated otherwise.

When used as an adverb rather than a preposition in this specification and claims, "about" means "approximately" and includes the specified numerical value and all numerical values within 10% of that numerical value. In other words, "about 100%" includes 90% and 110% and all numerical values therebetween.

The term "and/or" as used herein and in the claims should be understood to mean "either or both" of the elements so combined, i.e., of elements presented conjunctively in some cases and disjunctively in other cases. Multiple elements listed with "and/or" should be construed in the same manner, i.e., as "one or more" of the elements so conjoined. Other elements other than the elements specifically indicated by the "and/or" clause may optionally be present, whether related to those specifically indicated elements or not. Thus, as a non-limiting example, a reference to "A and/or B", when used in combination with an open-ended term such as "comprising", may in one embodiment refer to only A (optionally including elements other than B), in another embodiment refer to only B (optionally including elements other than A), in yet another embodiment refer to A and B (optionally including other elements), and so forth.

As used herein and in the claims, "or" should be understood to have the same meaning as "and/or" as defined above. For example, when separating items included in a list, "or" or "and/or" should be interpreted as non-exclusive, i.e., including at least one of, but also including more than one, optionally additional unlisted items, of a plurality or list of elements. In contrast, clearly specified limiting terms, such as "only one of" or "exactly one of," or, when used in the claims, "consisting of," indicate the inclusion of exactly one element of a plurality or list of elements. In general, the term "or" in this specification, when accompanied by exclusivity language such as "either," "one of," "only one of," or "exactly one of," should only be construed as indicating mutually exclusive alternatives (i.e., one or the other, but not both). "Consisting essentially of," when used in the claims, shall have its ordinary meaning as used in the field of patent law.

As used herein and in the claims, the phrase "at least one" referring to a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of all elements specifically listed in the list of elements, and not excluding any combination of elements in the list of elements. This definition also allows for elements other than those specifically identified in the list of elements referred to by the phrase "at least one" to be optionally present, whether or not related to those specifically pointed out elements. Thus, as a non-limiting example, "at least one of A and B" (or equivalently "at least one of A or B" or equivalently "at least one of A and/or B") can refer in one embodiment to at least one A (optionally including two or more A's) and no B (and optionally including elements other than B), in another embodiment to at least one B (optionally including two or more B's) and no A (and optionally including elements other than A), in yet another embodiment to at least one A (optionally including two or more A's) and at least one B (optionally including two or more B's) (and optionally including other elements), etc.

In addition, unless expressly stated otherwise, in any method claimed herein that includes more than one step or action, it should be understood that the order of the method steps or actions is not necessarily limited to the order in which the method steps or actions are listed.

In the claims and in the above specification, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," and "composed of" are to be understood as open-ended, i.e., meaning including but not limited to. As set forth in the United States Patent Office Manual of Patent Examining Procedures (MPEP), Chapter 2111.03, only the transitional phrases "consisting of" and "consisting essentially of" are to be closed or semi-closed transitional phrases, respectively.

LIST OF SYMBOLS 10 antimicrobial puncture site patch device, antimicrobial puncture site patch, antimicrobial patch, patch device, patch 11 outer surface 12 membrane, antimicrobial membrane, elastomeric membrane material sheet, membrane material, elastomeric membrane 13 inner surface 14 spacer, spacer material, spacer material sheet, spacer member 15 outer surface 16 aperture 17 inner surface 18 release paper, release paper sheet 19 outer edge 20 cavity 26 adhesive film 30 protective paper, protective paper sheet 32 take-up roller 40 sealed enclosure 60 reusable container 62 first polymer sheet 64 second polymer sheet 66 first edge portion 68 second edge portion 70 bottom portion 72 cavity 74 opening 76 tear line 78 perforation 80 closure means 90 skin 92 injection site, puncture site 110 Antimicrobial puncture site patch 111 Outer surface 112 Membrane 113 Inner surface 114 Spacer 115 Outer surface 116 Aperture 117 Inner surface 118 Release paper 119 Outer edge 120 Cavity 124 Elongated pull tab 126 Adhesive film 128 Peel tab 130 First side 132 Second side 190 Skin 192 Injection site, puncture site 24 ₁ First pull tab 24 ₂ Second pull tab 28 ₁ First peel tab 28 ₂ Second peel tab

Claims (20)

A puncture site patch comprising:
an elastomeric self-sealing membrane having an outer surface and an inner surface;
1. A spacer having an outer surface and an inner surface,
the outer surface of the spacer is bonded to the inner surface of the elastomeric self-sealing membrane;
the spacer further comprising an aperture, the aperture defining a cavity defined by the inner surface of the elastomeric self-sealing membrane, the spacer, and the skin when applied to a user; and
an adhesive film overlying the interior surface of the spacer and configured to adhere to skin;
at least one elongated tab configured to move between a first position and a second position,
In the first position, at least one of the elongated tabs extends outwardly from a periphery of the spacer;
at least one elongated tab, wherein in the second position, the puncture site patch is folded such that the aperture is sealingly closed by the at least one elongated tab;
A puncture site patch comprising: The puncture site patch of claim 1, wherein at least one of the elongated tabs is a first elongated tab, and the puncture site patch further comprises a second elongated tab, the first elongated tab and the second elongated tab each extending outwardly from the periphery of the spacer and disposed directly opposite each other. The puncture site patch according to claim 2, wherein in the second position, the first elongated tab and the second elongated tab overlap each other. The puncture site patch of claim 1 further comprising an axis extending through a center of the aperture forming the first side of the spacer and the second side of the spacer, and in the second position, the puncture site patch is folded along the axis such that the first side of the spacer and the second side of the spacer overlap one another, and at least one of the elongated tabs folds over the overlapping first and second sides of the spacer to seal the first and second sides of the spacer in a closed state. The puncture site patch of claim 1, wherein in the second position, at least one of the elongated tabs is folded over the aperture to seal the cavity closed. The puncture site patch of claim 1 further comprising a release paper in contact with and completely covering the adhesive film, the release paper being configured to be removed prior to application to the skin. The puncture site patch of claim 1, wherein at least one of the elongated tabs further comprises a reduced strength adhesive. The puncture site patch of claim 1, wherein the elastomeric self-sealing membrane is transparent. The puncture site patch of claim 1, wherein the elastomeric self-sealing membrane further comprises an antimicrobial agent. The puncture site patch of claim 9, wherein the antimicrobial agent is incorporated into the elastomeric self-sealing membrane during extrusion. The puncture site patch of claim 9, wherein the antimicrobial agent is a coating applied to the elastomeric self-sealing membrane. The puncture site patch of claim 9, wherein the antibacterial agent is a plurality of silver nanoparticles. The puncture site patch of claim 9, wherein the antimicrobial agent is a carvacrol agent incorporated into the elastomeric self-sealing membrane at a concentration of about 0.01% to about 0.001%. A puncture site patch comprising:
a transparent elastomeric self-sealing membrane having an outer surface and an inner surface;
1. A spacer having an outer surface and an inner surface,
the outer surface of the spacer is bonded to the inner surface of the transparent elastomeric self-sealing membrane;
the spacer further comprising an aperture that, when applied to a user, defines a cavity formed by the inner surface of the transparent elastomeric self-sealing membrane, the spacer, and skin;
an adhesive film overlying the interior surface of the spacer and configured to adhere to skin;
an axis extending through a center of the aperture forming a first side of the spacer and a second side of the spacer;
an elongated tab configured to move between a first position and a second position,
In the first position, the elongated tab extends outwardly from a periphery of the spacer;
in the second position, the puncture site patch is folded along the axis such that the first side of the spacer and the second side of the spacer overlap one another; and
A puncture site patch comprising: The puncture site patch of claim 14, wherein the elongated tab folds over the overlapping first and second sides of the spacer to seal the first and second sides of the spacer in a closed state. The puncture site patch according to claim 14, wherein the elongated tab is a first elongated tab, the puncture site patch further comprises a second elongated tab, the first elongated tab and the second elongated tab each extend outwardly from the periphery of the spacer and are disposed directly opposite each other, and in the second position, the first elongated tab and the second elongated tab overlap each other. The puncture site patch of claim 14, wherein the transparent elastomeric self-sealing membrane further comprises an antimicrobial agent. The puncture site patch of claim 17, wherein the antimicrobial agent is incorporated into the elastomeric self-sealing membrane during extrusion. The puncture site patch of claim 17, wherein the antimicrobial agent is a coating applied to the elastomeric self-sealing membrane. A puncture site patch comprising:
a transparent elastomeric self-sealing membrane having an outer surface, an inner surface, and an antimicrobial agent;
1. A spacer having an outer surface and an inner surface,
the outer surface of the spacer is bonded to the inner surface of the transparent elastomeric self-sealing membrane;
the spacer further comprising an aperture that, when applied to a user, defines a cavity formed by the inner surface of the transparent elastomeric self-sealing membrane, the spacer, and skin;
an adhesive film overlying the interior surface of the spacer and configured to adhere to skin;
an axis extending through a center of the aperture forming a first side of the spacer and a second side of the spacer;
an elongated tab configured to move between a first position and a second position,
In the first position, the elongated tab extends outwardly from a periphery of the spacer;
in the second position, the puncture site patch is folded along the axis such that the first side of the spacer and the second side of the spacer overlap one another; and
A puncture site patch comprising:

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