Antimicrobial puncture site patch that seals securely after injection

Abstract

The puncture site patch comprises: a self-sealing elastomer membrane including an inner surface and an outer surface; a spacer including an outer surface and an inner surface, wherein the outer surface of the spacer is coupled to the inner surface of the self-sealing elastomer membrane, and the spacer further comprises a hole, wherein the hole forms a cavity defined by the inner surface of the self-sealing elastomer membrane, the spacer, and the skin when attached to a user; an adhesive film configured to adhere to the skin, the adhesive film located on the inner surface of the spacer; and at least one elongated tab configured to move between a first position and a second position, wherein at the first position, at least one elongated tab extends outward from the periphery of the spacer, and at the second position, the puncture site patch is folded such that the hole is sealed and closed by at least one elongated tab.

Description

Background Technology

[0001] A puncture site patch for adhesion to the skin is known from WO 2007 / 106068. It is widely known that bloodborne infectious agents are a significant method of infectious disease transmission. In particular, healthcare professionals are at risk of such exposure because they need to perform duties that involve direct exposure to blood, such as puncturing a patient's skin with a needle to administer injections or collect blood. Typically, when puncturing the skin, the target area of ​​the skin is wiped with an antiseptic (e.g., an alcohol wipe), and a needle (which may be additionally attached to a syringe) is inserted through the skin subcutaneously or intramuscularly. After puncturing the skin, the needle is withdrawn, and a gauze or cotton pad is placed over the wound to absorb blood from the wound. During this procedure, the physician may come into contact with blood at multiple points, for example, when the needle first punctures the skin, after removing the needle but before placing the pad over the wound, or even after the pad is attached over the puncture site, as blood may flow out or seep into the pad. In addition, gloves can be torn, which increases the risk of healthcare workers being exposed to infectious agents. Therefore, it may be desirable to have a protective patch for use during injection that contains bactericidal, bacteriostatic, and / or antiviral agents that kill and / or weaken the infectivity of microorganisms (e.g., viruses, bacteria, fungi, etc.) that may be exposed by puncturing the skin.

[0002] However, the risk of exposure to bloodborne or other infectious agents does not end with vaccination or other skin punctures. Gauze, bandages, and other materials placed over the wound site may contain blood and / or other components. These items must be safely disposed of afterward. Furthermore, the increasing popularity of drive-through vaccination clinics, for example for the flu or SARS-CoV-2 vaccine, means that gauze, bandages, and other materials may be removed and disposed of in places such as the patient's home, restaurants, bathrooms, parking lots, or other locations where an individual may be exposed to bloodborne agents.

[0003] The embodiments described herein solve these and other problems related to the technology of the present invention by providing a puncture site patch that is safely sealed after injection. Accordingly, according to one aspect of the present invention, the puncture site patch comprises: a self-sealing elastomer membrane having an inner surface and an outer surface; a spacer having an outer surface and an inner surface, wherein the outer surface of the spacer is coupled to the inner surface of the self-sealing elastomer membrane, and the spacer further comprises a hole, wherein the hole forms a cavity defined by the inner surface of the self-sealing elastomer membrane, the spacer, and the skin when attached to a user; an adhesive film configured to adhere to the skin, the adhesive film located on the inner surface of the spacer; and at least one elongated tab configured to move between a first position and a second position, wherein at the first position the at least one elongated tab extends outward from the periphery of the spacer, and at the second position the puncture site patch is folded such that the hole is sealed and closed by the at least one elongated tab.

[0004] In some embodiments, at least one elongated tab is a first elongated tab, and the puncture site patch further comprises a second elongated tab, and the first and second elongated tabs each extend outward from the periphery of the spacer and are positioned exactly opposite each other. In some such embodiments, the first and second elongated tabs substantially overlap each other at a second position.

[0005] In some embodiments, the puncture site patch further comprises an axis passing through the center of a hole defining a first side of the spacer and a second side of the spacer, and the puncture site patch is folded along the axis so that at a second position the first side of the spacer and the second side substantially overlap each other and at least one elongated tab is folded 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.

[0006] In some embodiments, at least one elongated tab at a second position is folded over the hole to close the cavity.

[0007] In some embodiments, the puncture site patch further comprises a release liner that contacts an adhesive film and completely covers the adhesive film, and the release liner is configured to be removed before attachment to the skin.

[0008] In some embodiments, at least one elongated tab further comprises an adhesive with reduced adhesiveness. In other embodiments, the self-sealing elastomer membrane is substantially transparent.

[0009] In some embodiments, the self-sealing elastomer membrane further comprises an antimicrobial agent. In some of these embodiments, the antimicrobial agent is incorporated into the self-sealing elastomer membrane during extrusion. In other of these embodiments, the antimicrobial agent is a coating applied to the self-sealing elastomer membrane.

[0010] In some embodiments, the antimicrobial agent is a plurality of silver nanoparticles. In other embodiments, the antimicrobial agent is a carvacrol agent incorporated into a self-sealing elastomer membrane at a concentration of about 0.01% to about 0.001%.

[0011] In another embodiment, the puncture site patch comprises: a substantially transparent self-sealing elastomer membrane comprising an inner surface and an outer surface; a spacer comprising an outer surface and an inner surface, wherein the outer surface of the spacer is coupled to the inner surface of the substantially transparent self-sealing elastomer membrane, and the spacer further comprises a hole, wherein the hole forms a cavity defined by the inner surface of the substantially transparent self-sealing elastomer membrane, the spacer, and the skin when attached to a user; an adhesive film configured to adhere to the skin, the adhesive film located on the inner surface of the spacer; an axis passing through the center of the hole defining the first side of the spacer and the second side of the spacer; and an elongated tab configured to move between a first position and a second position, wherein at the first position the elongated tab extends outward from the periphery of the spacer, and at 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 each other.

[0012] In some embodiments, an elongated tab is folded over the first and second sides of the spacer that are substantially overlapping to seal the first and second sides of the spacer in a closed state.

[0013] In some embodiments, the elongated tab is a first elongated tab, and the puncture site patch further includes a second elongated tab, the first and second elongated tabs each extend outward from the periphery of the spacer and are positioned exactly opposite each other, and the first and second elongated tabs substantially overlap each other at a second position.

[0014] In some embodiments, a substantially transparent self-sealing elastomer membrane further comprises an antimicrobial agent. In some of these embodiments, the antimicrobial agent is incorporated into the self-sealing elastomer membrane during extrusion. In other such cases, the antimicrobial agent is a coating applied to the self-sealing elastomer membrane.

[0015] In another embodiment, the puncture site patch comprises: a substantially transparent self-sealing elastomer membrane comprising an outer surface, an inner surface and an antimicrobial agent; a spacer comprising an outer surface and an inner surface, wherein the outer surface of the spacer is bonded to the inner surface of the substantially transparent self-sealing elastomer membrane, and the spacer further comprises a hole, wherein the hole forms a cavity defined by the inner surface of the substantially transparent self-sealing elastomer membrane, the spacer, and the skin when attached to a user; an adhesive film configured to adhere to the skin, the adhesive film located on the inner surface of the spacer; and an axis passing through the center of the hole defining the first side of the spacer and the second side of the spacer. The slender tab is configured to move between a first position and a second position, wherein at the first position the slender tab extends outward from the periphery of the spacer, and at the second position the slender tab includes a slender tab in which the puncture site patch is folded along an axis so that the first side and the second side of the spacer substantially overlap each other.

[0016] These and other advantages and features characterizing the present invention are described in the claims attached to this specification and constituting an additional part of this specification. However, to better understand the present invention and the advantages and purposes achieved through the use of the present invention, reference should be made to the drawings and the attached description illustrating exemplary embodiments of the present invention. The description of the present invention is provided merely to introduce a selection of technical ideas further described in the specific description below for carrying out the invention, and is not intended to identify any core or essential features of the claimed invention, nor is it intended to help limit the scope of the claimed invention. Brief explanation of the drawing

[0017] FIG. 1 is a plan view of an antibacterial puncture site patch according to one embodiment described in this specification. Figure 2 is an exploded perspective view of the patch of Figure 1. FIGS. 3A and FIGS. 3B are cross-sectional views of the patch of FIG. 1. FIG. 3A is a cross-sectional view of the patch of FIG. 3 in an unused form. FIG. 3B is a cross-sectional view of the patch of FIG. 3 in a discarded form. FIGS. 4a and FIGS. 4b are perspective views showing the patch of FIG. 1 positioned on the patient's arm. FIG. 5 is a plan view of an antibacterial puncture site patch according to another embodiment described in this specification. Figure 6 is an exploded perspective view of the patch of Figure 5. FIGS. 7A, FIGS. 7B, and FIGS. 7C are cross-sectional views of the patch of FIG. 5. FIG. 7A is a cross-sectional view of the patch of FIG. 5 in an unused form; FIG. 7B is a cross-sectional view of the patch of FIG. 5 in a first discarded form; and FIG. 7C is a cross-sectional view of the patch of FIG. 5 in a second discarded form. FIGS. 8A and FIGS. 8B are perspective views showing the patch of FIG. 5 positioned on the patient's arm. Figure 9 is a plan view showing the patch of Figure 5 in a discarded form. FIG. 10 is a perspective view of a package according to some embodiments described herein for accommodating the antibacterial puncture site patch of FIG. 5. Figure 11 is a schematic diagram of a process for manufacturing an antibacterial puncture site patch. Specific details for implementing the invention

[0018] FIGS. 1 to 3 illustrate an antibacterial puncture site patch device (10) (hereinafter referred to as "antibacterial patch," "patch," etc.). The patch (10) comprises a membrane (12) and a spacer (14), and the spacer (14) further comprises a hole (16). In the illustrated embodiment, the patch device (10) is generally circular. However, it is not intended to be limited to a circular shape, as other shapes including but not limited to squares, rectangles, ovals, triangles, etc., may be used. In some examples, for instance, as illustrated in FIG. 2, the patch (10) may optionally include a protective sheet or a release liner (18). Such a protective sheet or release liner (18) may be used to protect the adhesive film (26) of the spacer (14) until the patch (10) is applied to the patient's skin (as described in detail herein). In some examples, the protective sheet or release liner (18) may be similar in size and shape to the spacer (14), or in other examples, the protective sheet or release liner (18) may be slightly larger than the spacer (14).

[0019] In some examples, the protective sheet or release liner (18) may also include a first release tab (281) and a second release tab (282), or other surfaces, which allow the user to easily remove the release liner (18) from the membrane (12) and spacer (14) that expose the adhesive film (26). In some examples, the patch (10) may also include a first pull tab (241) and a second pull tab (242) that may protrude from the spacer (14). The first and second pull tabs (241, 242) may be positioned directly across the hole (16) from each other so that when the antimicrobial puncture site patch apparatus (10) is folded along the axis (A) (as described in detail herein), the first and second pull tabs (241, 242) may come into contact with each other (e.g., see FIG. 3b) to seal the patch (10). As will be discussed in this specification, by folding the first and second pull tabs (241, 242) in this way, the inside of the patch (10) can also be sealed so as to prevent contact with the infectious agent and the spread of the infectious agent in the environment after injection.

[0020] Additionally, these pull tabs (241, 242) may facilitate the removal of the patch (10) because the pull tabs do not contain adhesive. In some examples, only one of the pull tabs (241, 242) may not have an adhesive film (26), whereas in other examples, both of the pull tabs (241, 242) may not have adhesive. As a result, in some examples, the user may grasp the portion of one or both of the pull tabs (241, 242), particularly the portion that may not have an adhesive film (26), to remove the patch (10) from the skin.

[0021] The membrane (12) of the antimicrobial patch (10) may be an extruded elastomer material. In some examples, this elastomer material may be sterile, self-sealing, coreless, non-latex, and FDA approved for direct contact with human or animal skin. Due to the self-sealing and coreless nature of the elastomer material, the needle (of various sizes) used for injection through the membrane (12) can be cleanly wiped away when the needle is withdrawn through the membrane (12). Additionally, in some examples, the membrane (12) may be transparent enough so that a doctor can observe the patient's skin (90) when the patch (10) is placed at the intended injection site (92). The physical structure of the membrane (12) includes an outer surface (11) and an inner surface (13), with the inner surface facing the patient's skin (90) when the antimicrobial patch (10) is attached. Additionally, the membrane material may be selected to be stable and inherently unaffected by chemical or structural influences, and thus not degraded when washed, disinfected, and / or sterilized with agents such as ethyl alcohol, betadine, or similar general disinfectants. The membrane (12) may have any suitable shape that sufficiently covers the spacer (14). In some embodiments, the outer periphery of the membrane (12) and the spacer (14) may be substantially the same, whereas in other embodiments, the periphery may vary.

[0022] One or more antimicrobial agents may be additionally injected into the membrane (12). In some examples, this injection may be completed during the curing process of the elastomer material (i.e., during the heating and extrusion of the polymer), which is further described with reference to FIG. 11. This integration may be achieved through extrusion or co-extrusion. A variety of natural and synthetic antimicrobial agents exist. For example, some of these antimicrobial agents may be extracted from various plants or herbs. Some examples of these antimicrobial herbs include, but are not limited to, oregano, sage, basil, fennel, garlic, lemon balm, peppermint, rosemary, echinacea, sambucus, licorice, astragalus, ginger, ginseng, and / or dandelion components. In other embodiments, synthetic or laboratory-made antimicrobial agents may be used alone, in combination with each other, or in combination with any naturally occurring herbal antimicrobial agent. In another example, one or more metals, such as silver or copper, may be used as antimicrobial agents. 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, viral, and / or fungicidal, and / or bacteriostatic, viral inhibitory, and / or fungistatic. Any of the above may be incorporated into the elastomer membrane (12), but an important consideration in selecting one or more antimicrobial agents is whether the agent will retain its activity after being exposed to the extrusion conditions (e.g., heat, pressure, etc.) of the elastomer membrane (12) described with reference to FIG. 11. Although the antimicrobial agent is described as being incorporated into the elastomer membrane (12) via extrusion, it is not intended to be limited thereto, and in some examples, the antimicrobial agent may be applied as a coating, as an electrometric film, and / or through lamination.

[0023] As a non-limiting example, oregano ( Common oreganoCarvacrol, a phenolic monoterpenoid, can be incorporated into the elastomer membrane (12) of the antimicrobial patch (10). In vitro studies have shown that carvacrol can reduce the activity of rat norovirus after about 15 minutes of exposure. Additionally, carvacrol exhibits antiviral activity against a wide range of viruses, including herpes simplex virus, rotavirus, respiratory syncytial virus, etc. Furthermore, due to its phenolic structure, carvacrol is expected to be effective against coronaviruses, including SARS-CoV-2. The inhibitory action of carvacrol may be related to its hydrophobic and lipophilic tendencies, as these characteristics result in an affinity for cell membranes and inserts that alter the physical and chemical properties of the cell membrane and change the stability of the membrane. In some examples, carvacrol formulations can be incorporated into the elastomer membrane (12) at a concentration of about 0.01% to about 0.001% during the extrusion and / or curing process.

[0024] As another non-limiting example, a metal antimicrobial agent may be incorporated into or coated on the elastomer membrane (12) of the antimicrobial patch (10). For example, such a metal antimicrobial agent can cause cellular damage to microorganisms due to reactive oxygen species (ROS), other oxidation processes, structural metal exchange, and / or iron-sulfur cluster destruction. In some examples, silver nanoparticles or copper nanoparticles may be used as metal antimicrobial agents. These metal nanoparticles may be included in the extruder of the polymer forming the membrane (12) and / or coated on the surface of the membrane (12). In some examples, silver nanoparticles may be formed in situ, which means that the polymer(s) used to form the elastomer membrane may be combined with a metal salt and a reducing agent, and metal nanoparticles are formed during the combination. In other examples, pre-synthesized metal nanoparticles may be dispersed together 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 other examples, silver may be incorporated into the membrane at a concentration of about 2.5%, and studies have shown that at this concentration, silver is effective against several types of microorganisms. In one example, a silver-zeolite-based antimicrobial agent is incorporated into the membrane.

[0025] The spacer (14) is a material having an outer surface (15) and an inner surface (17). The spacer (14) may be composed 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 a combination thereof. Optionally, the material for the spacer (14) may be selected based on its ability to absorb blood and body fluids, but such absorbent properties are not required. In some examples, although not essential, using an absorbent material may be desirable to minimize the risk of blood being sucked from the cavity (20) to the outer edge (19) of the spacer (14) because the absorbent material has some resistance to suction. In some examples, one or more additives may be included in the extruded layer to add absorbency. The spacer (14) is fixed to the inner surface (13) of the membrane (12) on or above the outer surface (15). Various means known in the art of the present invention may be used to secure the spacer (14) to the membrane (12), such as adhesives, hot melt adhesives, pressure-sensitive adhesives, heat-sensitive adhesives, chemical bonding, acrylic cement, radio frequency welding, ultrasonic welding, or combinations thereof, or any other means known in the art of the present invention. However, an important consideration in selecting a means of securing the spacer is what kind of interaction the selected means of securing may have with the efficacy 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 coated with an adhesive film (26) to secure the patch (10) to the patient's skin (90). Although various adhesives may perform the desired function, since the adhesive comes into direct contact with human skin, it is preferable to use an FDA-approved material for the adhesive used.

[0026] This spacer (14) may additionally include a hole (16). In some examples, this hole may be located substantially in the center. The hole (16) has dimensions suitable to allow a physician to insert a needle through the membrane (12) and the hole (16) without penetrating or damaging any part of the spacer (14). When the antimicrobial patch (10) is attached to the patient's skin (90), the hole (16), bordered by the skin (90), the membrane (12), and the spacer (14), forms a cavity (20) through which a needle passes during an injection or blood collection process. Blood released from the skin by puncture may accumulate in the cavity (20). In some examples, the blood may dry within the cavity (20), and in other examples, it may be absorbed by the spacer (14). The spacer may include or be composed of an absorbent material and may optionally include a coagulant. In non-limiting examples, the spacer (14) may be made of polyethylene and may be coated with oxidized regenerated cellulose or any other suitable coagulant generally known in the art of the present invention to coagulate blood. In some examples, the diameter of the hole (16) is about 15 mm (0.591 inches), and the cavity (20) formed thereby may contain up to about 0.3 cc of body fluid. It should be understood that the dimensions of the hole (16) and the antimicrobial patch are not limited to the dimensions described herein and may vary depending on the desired use of the antimicrobial patch (10). It should also be understood that the volume that the formed cavity may contain may vary as the dimensions of the opening change.

[0027] Now, referring to FIGS. 4a and 4b, the antimicrobial patch (10) is illustrated as being attached to the intended puncture site (92), for example, the patient's skin (90) at the injection site. When the patch (10) is attached to the skin (90), a cavity (20) is formed between the membrane (12) and the skin (90), which are bounded by the spacer (14). In some examples, this cavity (20) may have a depth (D). The antimicrobial patch (10) may be fixed and held directly to the patient's skin (90) along any part of the inner surface (17) of the spacer (14) via an adhesive film (26). This secure attachment may be beneficial in preventing blood leakage and the subsequent spread of bloodborne infectious agents, and may also be problematic in removing the antimicrobial patch (10) from the skin after use. To enable easy removal, the antimicrobial patch (10) may additionally include first and second pull tabs (241, 242) protruding from the spacer (14) on opposite sides. In some examples, these pull tabs (241, 242) may be integral with the spacer (14). As previously discussed, the first and / or second pull tabs (241, 242) may or may not include adhesive on the inner surface (26), and in some examples, may include adhesive only partially. In other examples, the adhesive may be reduced in part or all of the first and / or second pull tabs (241, 242), so that a doctor or patient can easily grasp a part of one or both of the pull tabs (241, 242), for example, a part without adhesive, and remove the antimicrobial patch (10) from the patient's skin.

[0028] Now, referring specifically to FIGS. 3a and 3b, a cross-sectional view of the antimicrobial patch (10) is provided in a first unused form (Fig. 3a) and a second discarded form (Fig. 3b). As shown in FIG. 3a, the starting positions of the first and second pull tabs (241, 242) extend outward from the spacer (14) in opposite directions from each other. At some point after an injection or other puncture through the membrane (12) and the skin, the patient, caregiver, or medical professional may wish to remove the antimicrobial patch (10). At this point, the patient, caregiver, etc. can easily grasp a portion of one or both of the pull tabs (241, 242) and fold the antimicrobial patch (10) along the central axis (A) so that the hole (16) is completely covered. Once folded, the first and second pull tabs (241, 242) can substantially overlap each other. In some examples, there may be indentations, markings, or other guides that allow the patient or caregiver to know exactly where to fold the patch (10). The existing adhesive film (26) on the antimicrobial patch (10) is used to create a sealed enclosure (40) that traps body fluids, infectious agents, etc., and prevents leakage, while exposing the body fluids and subsequently any bloodborne infectious agents to the built-in antimicrobial agent. In some examples, the adhesive film (26) may extend over a portion (or the whole) of one or both of the pull tabs (241, 242) to further seal the patch (10). Once captured in the sealed enclosure (40) or collection cavity, any blood, virus particles, bacteria, etc. contained therein may come into contact with the antimicrobial membrane (12), and if the virus particles are in contact with the antimicrobial membrane (12) for about 15 minutes or more, the patch (10) can be safely disposed of.

[0029] As previously mentioned, drive-through vaccination clinics and other high-volume vaccination clinics have become popular. Due to the increase in high-volume clinics, there is a higher likelihood that used bandages, such as antimicrobial puncture site patches (10), will be removed and disposed of in places where individuals may be exposed to bloodborne infectious agents, such as the patient's home or other places. If the antimicrobial patch (10) is disposed of in the form shown in FIG. 3b, the patch (10) can be safely disposed of while minimizing the risk of another person being exposed to bodily fluids or infectious agents that may be contained within the patch.

[0030] FIGS. 5, FIGS. 6, FIGS. 7a through 7c, FIGS. 8a, FIGS. 8b, FIGS. 9, and FIGS. 10 illustrate other embodiments of an antibacterial puncture site patch (110). Similar to the embodiments discussed earlier, the patch (110) may also include a membrane (112) and a spacer (114) having a hole (116). Similar to the earlier embodiments discussed herein, the patch (110) is substantially circular, but as described in the earlier embodiments, this is not intended to be limiting. The patch (110) may also optionally include a protective sheet or release liner (118) that protects the adhesive film (126) of the spacer (114). The release liner (118) may be similar in size and shape to the spacer (114), but is not limited thereto, and may be slightly larger than the spacer (114). The release liner (118) may also include a release tab (128) or other surface that allows the release liner (118) to be easily removed from the membrane (112) and the spacer (114). The patch (110) may also include an elongated pull tab (124) that can protrude from the spacer (114). This elongated pull tab (124) allows the patch (110) to be easily removed from the patient.

[0031] As illustrated in FIG. 7b, in some examples, this elongated pull tab (124) may be large enough to be folded over the remainder of the adhesive film (126) (e.g., the elongated pull tab (124)) during disposal to completely wrap the cavity (120) (see also FIG. 9). Folding the elongated pull tab (124) over the remainder of the adhesive film (126) and wrapping the cavity ensures that the antimicrobial agent on the membrane remains in contact with the contaminated blood on the adhesive layer and seals the cavity (120), preventing contact with the body fluids and / or infectious agents contained within the cavity.

[0032] In another example, as illustrated in FIG. 7c, the antimicrobial patch (110) can be folded approximately in half along a central axis (A) defining the first side of the spacer (130) and the second side of the spacer (132). When the antimicrobial patch (110) is folded along the central axis (A), the first side of the spacer (130) and the second side of the spacer (132) can substantially overlap, thereby completely covering the cavity (120) to form a closed patch (110). In some examples, there may be indentations, markings, or other guides to allow the patient or caregiver to know exactly where to fold the patch (110). Then, the elongated pull tab (124) can be folded over the closed patch (110), and the adhesive film (126) of the elongated tab can be used to further seal the patch (110) in the closed position.

[0033] The membrane (112) of the antimicrobial patch (110) may be an elastomer material similar to the elastomer material described with reference to the preceding embodiment. As described above, it may be advantageous for the membrane (112) to be sufficiently transparent in some examples so that a physician can observe the patient's skin (190) when the patch (110) is placed at the intended injection site (192). In some examples, this transparency may be determined by a total transmittance measurement, a haze measurement, a clarity measurement, an optical density measurement, or other known measurements. Similar to the membrane described above, the membrane (112) may also include an outer surface (111) and an inner surface (113). As described above, one or more antimicrobial agents may be additionally injected into the membrane (112).

[0034] The spacer (114) comprises 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 material used to construct the spacer (114) may also be selected based on its ability to absorb various bodily fluids. When such an absorbent material is used, the absorbent material may be resistant to some degree of aspiration to minimize the risk of blood being aspirated from the cavity (120) to the outer edge (119) of the spacer (114) in some examples. Similar to the embodiments described above, the spacer (114) may be secured to the inner surface (113) of the membrane (112) on or above the outer surface (115) by various means known in the art to which the present invention belongs, but as mentioned above, an important factor in selecting the method of securing the spacer (114) is the interaction that the selected securing method may have with the efficacy of the selected antimicrobial agent. The inner surface (117) of the spacer (114) may be coated with an adhesive film (126) to allow the patch (110) to be easily maintained against the patient's skin (190). In some examples, the spacer (114) may additionally include a substantially centrally located hole (116), which has dimensions suitable for a physician to insert a needle through the membrane (112) without penetrating or damaging any part of the spacer (114). Similar to the preceding embodiment, once attached, the patch forms a cavity (120) bordered by skin (190), a membrane (112), and a spacer (114). Any bodily fluid released from the skin by puncture may accumulate in this cavity (120).

[0035] Now, referring to FIGS. 8a and 8b. An antimicrobial patch (110) is illustrated as being attached to the patient's skin (190) at an intended puncture site (192), and as described, this forms a cavity (120) between the membrane (112) and the skin (190) bounded by a spacer (114). In some examples, this cavity (120) may have a depth (D) that is roughly equal to the width (W) of the spacer (114) plus an adhesive film (126). An elongated pull tab (124) protruding from the spacer (114) allows the antimicrobial patch (110) to be easily removed. In some examples, the elongated pull tab (124) may not include an adhesive film, but in other examples, the elongated pull tab (124) may include only a portion of the adhesive film (126) and accordingly, a portion of the elongated pull tab (124) may be kept without adhesive. The elongated pull tab (124) or the portion of the elongated pull tab without adhesive allows a doctor or patient to easily grasp the elongated pull tab (124). In some examples, the elongated pull tab (124) may be long and wide enough to be folded to cover the entire hole (116) during the disposal process.

[0036] Now, referring to FIGS. 7a and 7b, a cross-sectional view of the antimicrobial patch (110) is illustrated in an unused form (Fig. 7a) and a discarded form (Fig. 7b). In the discarded form, the elongated pull tab (124) is folded over the hole (116), and this movement is indicated by an arrow. The original starting position of the elongated pull tab (124) (e.g., extending outward from the spacer (114)) is shown by a dashed line in FIG. 7b. In some examples, the elongated pull tab (124) is long enough to cover substantially all of the adhesive film (126), which requires the length of the elongated pull tab to be approximately L1. In other examples, the elongated pull tab (124) may be long enough to cover only the entire hole (116). The lengths shown should not be interpreted restrictively, as the length of the elongated pull tab (124) can be any length sufficient to completely cover the hole (116). Similarly, the width of the elongated pull tab (124) can also be any length sufficient to completely cover the hole (116). A non-limiting example of the width (W1) of the elongated pull tab (124) is shown in FIG. 9. Ensuring that the hole (116) is completely covered when the elongated pull tab (124) is folded also ensures that the antimicrobial agent of the membrane (112) remains in contact with the contaminated blood of the adhesive film (126) and seals the cavity (120) to prevent contact with bodily fluids and / or infectious agents contained within the cavity.

[0037] Since bandages such as antimicrobial puncture site patches (110) used with vaccination or other punctures are likely to be removed and disposed of at the patient's home or elsewhere, a disposal solution is required to minimize the risk of spreading bloodborne infectious agents through contaminated bandages. 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 (10) removed from the patient. Non-limiting examples of such reusable containers (60) are illustrated in FIG. 10.

[0038] As illustrated in FIG. 10, the reusable container (60) may be formed in a general rectangular or square shape sufficient to accommodate a single antimicrobial patch (110), but this is not intended to be a limitation, and any shape sufficient to accommodate the antimicrobial patch (110) may be used. The reusable container (60) may generally be in the form of a bag and may be composed of one or more pieces of polymer, plastic, etc. that are sealed and joined together. In some examples, the reusable container (60) may include a first polymer sheet (62) and a second polymer sheet (64), and the two sheets (62, 64) are sealed together to form a first edge (66), a second edge (68), and a bottom (70) portion of the reusable container (60). The first edge (66), the second edge (68), and the bottom (70) portion collectively 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 an antibacterial patch (110) can be placed within the cavity (72).

[0039] In some examples, the reusable container (60) may additionally include a notch (or perforation) (78) on one or both edges (66, 68) positioned close to the top portion of the reusable container (60). This notch(s) allow a user, for example, a medical professional administering the vaccine, to easily open the container (60). In some examples, the reusable container (60) may additionally include a stopper means (80) that allows the used antimicrobial patch to be reinserted and the reusable container (60) to be resealed. One non-limiting example of such a stopper (60) may be a stopper member of the first sheet (62) that works in conjunction with a stopper element of the second sheet (64), such as a standard "zipper" type stopper. Another non-limiting example of a stopper may be an adhesive strip and a corresponding protective cover on the outside of one sheet (62, 64) of the container (60).

[0040] In some examples, the reusable container (60) may additionally contain an antimicrobial agent. In some examples, the antimicrobial agent is injected or coated only on the portion of the reusable container (60) that can come into contact with the antimicrobial patch (110), such as the portion contained within the cavity (72). In other examples, the antimicrobial agent may be injected or coated over the entire reusable container (60). Such injection may be completed, for example, during the production and / or curing process of the polymer or plastic used to construct the container (60). As previously discussed, there may be various natural and synthetic antimicrobial agents that can be included in the reusable container (60). As discussed regarding the antimicrobial patch (10, 110), one non-limiting example of such antimicrobial agent is oregano ( Common oreganoIt may be carvacrol, a phenolic monoterpenoid. Carvacrol may be included in the polymer or plastic constituting the reusable container (60). In some examples, the carvacrol formulation may be incorporated into the elastomer membrane (12) at a concentration of about 0.01% to about 0.001% during extrusion and / or curing.

[0041] Although the antibacterial patch (110) has been described and illustrated, it should be understood that the reusable container (60) described and illustrated in this specification is not limited thereto and that the disposal container may be used with the antibacterial patch (10) or any other embodiment of the antibacterial patch that may be considered in this specification.

[0042] Additionally, although the present specification has primarily discussed vaccination, it is not limited thereto. Various embodiments of the antimicrobial patch (10, 110) consistent with the embodiments described in the present specification may be used in any other case where a catheter is inserted into a patient, needle biopsy, joint injection or aspiration, or where the patient's skin may be punctured by a sharp, needle-like object. Additionally, the cavity may contain body fluids other than blood, such as aspirates.

[0043] Now, referring to FIG. 11, an exemplary method of a continuous production process for producing the antimicrobial patch described herein is illustrated. The production of the antimicrobial patch (10) may include creating holes (16) at one or more predetermined locations along a spacer material (14) sheet (e.g., nylon, polyurethane, polyethylene, polypropylene, isoprene, cotton, linen). As previously discussed, these holes (16) may be substantially circular, but are not limited thereto. In some examples, the spacer material (14) may be pretreated with adhesive film (26) on both sides (15, 17). In other examples, it may be necessary to attach the adhesive film (26) to the spacer material (14). The outer surface (15) of the spacer material (14) may also include a protective sheet (30) placed on the outer surface. This sheet can serve to protect the outer surface (15) until the membrane material (12) is attached to the outer surface (15). The protective sheet (30) can be removed via a take-up roll (32) as the perforated spacer material continues to advance. Similarly, a release liner (18) sheet can be placed on the inner surface (17) to protect the adhesive film (26) until use. Then, the elastomer membrane material sheet (12) can be fixed to the outer surface (15). Then, the combination of the membrane (12), spacer member (14), and release liner (18) can be die-cut (34) into a desired configuration.

[0044] The elastomer membrane sheet(s) infused with the antimicrobial agent described herein may be formed separately before being included in the process described with reference to FIG. 11. The elastomer membrane (12) is a film extruded from standard plastic processing equipment by a standard extrusion process. An antimicrobial agent, for example, carvacrol, may be added during the extrusion process. The antimicrobial agent may be added at a temperature that is high enough to allow chemicals to be incorporated during the extrusion of the film, but not hot enough to inactivate or minimize the efficacy of the antimicrobial agent. Since the temperature at which a particular agent may lose its effectiveness as an antimicrobial agent can vary, the temperature at which the agent is added and the extrusion take place may also vary. As a non-limiting example, since carvacrol is inactivated at about 214 degrees Fahrenheit, the extrusion temperature may be less than about 214 degrees Fahrenheit, more preferably less than about 200 degrees Fahrenheit. In other examples, as described herein, the antimicrobial agent may be applied as a coating, thereby enabling extrusion at a higher temperature.

[0045] As is known in the technical field of the present invention, the process may be modified in various ways without departing from the scope of the present invention, for example, by applying a first adhesive to a membrane instead of a spacer sheet, applying a second adhesive to a release liner instead of a spacer sheet, cutting the laminated material using a laser, and laminating and cutting the membrane and spacer before adding the release liner and the combination thereof.

[0046] Although various embodiments of the present invention have been described and illustrated herein, a person skilled in the art will readily conceive of various other means and / or structures to perform a function and / or obtain one or more of the results and / or advantages described herein, and each such variation and / or modification is deemed to be within the scope of the embodiments of the present invention described herein. More generally, a person skilled in the art will readily understand that all parameters, dimensions, materials, and configurations described herein are exemplary and that actual parameters, dimensions, materials, and / or configurations may vary depending on the specific application or fields of application in which the teachings of the present invention are used. A person skilled in the art will be able to recognize or identify many equivalents to the specific embodiments of the present invention described herein by ordinary experimentation alone. Therefore, it should be understood that the embodiments described above are presented merely as examples and that embodiments of the present invention may be practiced differently from those specifically described and claimed within the scope of the appended claims and their equivalents. The disclosed embodiments of the present invention relate to each individual feature, system, article, material, kit, and / or method described herein. Additionally, any combination of two or more such features, systems, articles, materials, kits, and / or methods is included within the scope of the invention, provided that such features, systems, articles, materials, kits, and / or methods are not mutually contradictory. All definitions defined and used herein should be understood as superseding dictionary definitions, definitions in documents included by reference, and / or the general meanings of defined terms.

[0047] The indefinite articles "a" and "an" used in this specification and claims should be understood to mean "at least one" unless otherwise clearly indicated.

[0048] Where used as an adverb rather than a preposition in this specification and claims, "about" means "approximately" and includes the specified value and all values ​​within 10% of said value. That is, "about 100%" includes 90% and 110% and all values ​​in between.

[0049] The phrase "and / or" as used in this specification and claims should be understood to mean "one or both" of the combined elements, that is, elements that exist combined in some cases and separately in others. Multiple elements listed as "and / or" should be interpreted in the same way, that is, "one or more" of the elements so combined. In addition to the elements specifically identified by the phrase "and / or," other elements may optionally exist, whether or not they are related to the specifically identified elements. Thus, as a non-limiting example, when used with open language such as "comprising," a reference to "A and / or B" may refer to only A (optionally including an element other than B) in one embodiment, only B (optionally including an element other than A) in another embodiment, and both A and B (optionally including an element other than A) in yet another embodiment.

[0050] The term "or" as used in this specification and claims should be understood to have the same meaning as "and / or" as defined above. For example, when separating items from a list, "or" or "and / or" should be interpreted as inclusive, that is, including at least one of the number of elements or the list, but including two or more, and optionally including other items not in the list. Only terms explicitly indicated in contrast, such as "one of" or "exactly one of," or "constituting" as used in the claims, will refer to including exactly one of the number of elements or the list. In general, the term "or" as used in this specification should be interpreted only to indicate an exclusive alternative (i.e., "one or another, but not both") when preceded by an exclusive term such as "one of," "one of," "one of," or "exactly one of." "Essentially constituting" as used in the claims has the general meaning used in the field of patent law.

[0051] As used in this specification and claims, the phrase “at least one” in relation to a list of one or more elements means at least one element selected from one or more of the elements in the list of elements, but should be understood as not necessarily including at least one of each and all of the elements specifically listed in the list of elements, nor excluding any combination of the elements in the list of elements. This definition also allows for the optional existence of elements other than the specifically identified elements in the list of elements referred to by the phrase “at least one,” whether or not they are related to the specifically identified elements. Accordingly, by 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”) is, in one embodiment, at least one (A) which is absent from B (and may optionally include other elements other than B) and optionally includes more than one; in another embodiment, at least one (B) which is absent from A (and may optionally include other elements other than A) and optionally includes more than one; In another embodiment, it may refer to at least one (A) which optionally includes more than one (while optionally including other elements) and at least one (B) which optionally includes more than one.

[0052] Additionally, it should be understood that in any method claimed herein comprising one or more steps or actions, unless clearly indicated otherwise, the order of the steps or actions of the method is not necessarily limited to the order in which the steps or actions of the method are listed.

[0053] In the specification as well as in the claims above, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," and "composed of" should be understood as open, meaning that they include but are not limited to. As specified in Section 2111.03 of the U.S. Patent and Trademark Office's Manual of Patent Examination Procedures, only the transitional phrases "consisting of" and "consisting essentially of" are, respectively, closed or semi-closed transitional phrases.

Claims

Claim 1 A puncture site patch comprising: a self-sealing elastomer membrane including an inner surface and an outer surface; a spacer including an outer surface and an inner surface, wherein the outer surface of the spacer is coupled to the inner surface of the self-sealing elastomer membrane, and the spacer further comprises a hole, wherein the hole forms a cavity defined by the inner surface of the self-sealing elastomer membrane, the spacer, and the skin when attached to a user; and an adhesive film configured to adhere to the skin, the adhesive film located on the inner surface of the spacer. A puncture site patch comprising at least one elongated tab configured to be movable between a first position and a second position, wherein the at least one elongated tab has a length greater than the length from the point furthest in the extension direction of the elongated tab among the points on the periphery defining the hole to the base end of the elongated tab and a width greater than the width of the hole, wherein at the first position the at least one elongated tab extends outward from the periphery of the spacer, and at the second position the at least one elongated tab is folded over the hole to seal a cavity closed by said at least one elongated tab. Claim 2 In claim 1, at least one elongated tab is a first elongated tab, and the puncture site patch further comprises a second elongated tab, wherein the first and second elongated tabs each extend outward from the periphery of the spacer and are arranged opposite to each other. Claim 3 A puncture site patch according to claim 2, wherein the first and second elongated tabs overlap each other at a second position. Claim 4 A puncture site patch according to claim 1, further comprising an axis line passing through the center of a hole defining a first side of a spacer and a second side of a spacer, wherein at a second position the first side of a spacer and the second side of a spacer overlap each other and at least one elongated tab is folded over the overlapping first and second sides of a spacer to seal the first and second sides of a spacer in a closed state, such that the puncture site patch is folded along the axis line. Claim 5 delete Claim 6 A puncture site patch according to claim 1, further comprising a release liner that contacts an adhesive film and completely covers the adhesive film, wherein the release liner is configured to be removed before being attached to the skin. Claim 7 A puncture site patch according to claim 1, wherein at least one slender tab further comprises an adhesive with reduced adhesiveness. Claim 8 In claim 1, the self-sealing elastomer membrane is a transparent puncture site patch. Claim 9 A puncture site patch according to claim 1, wherein the self-sealing elastomer membrane further comprises an antimicrobial agent. Claim 10 A puncture site patch according to claim 9, wherein an antimicrobial agent is incorporated into a self-sealing elastomer membrane during extrusion. Claim 11 A puncture site patch according to claim 9, wherein the antimicrobial agent is a coating applied to a self-sealing elastomer membrane. Claim 12 In claim 9, the antimicrobial agent is a plurality of silver nanoparticles in a puncture site patch. Claim 13 In claim 9, the antimicrobial agent is a carvacrol agent incorporated into a self-sealing elastomer membrane at a concentration of 0.01% to 0.001%, in a puncture site patch. Claim 14 A puncture site patch comprising: a transparent self-sealing elastomer membrane including an inner surface and an outer surface; a spacer including an outer surface and an inner surface, wherein the outer surface of the spacer is coupled to the inner surface of the transparent self-sealing elastomer membrane, and the spacer further comprises a hole, wherein the hole forms a cavity defined by the inner surface of the transparent self-sealing elastomer membrane, the spacer, and the skin when attached to a user; an adhesive film configured to adhere to the skin, the adhesive film located on the inner surface of the spacer; and an axis passing through the center of the hole defining the first side of the spacer and the second side of the spacer. A puncture site patch configured to move between a first position and a second position, wherein the puncture site patch has a length greater than the length from the point furthest in the direction of extension of the puncture site patch among the points on the periphery defining the hole to the base end of the puncture site patch and a width greater than the width of the hole, wherein at the first position the puncture site patch extends outward from the periphery of the spacer, and at the second position the puncture site patch is folded over the axis and the hole to seal the cavity with the puncture site patch. Claim 15 delete Claim 16 In claim 14, the elongated tab is a first elongated tab, and the puncture site patch further comprises a second elongated tab, wherein the first and second elongated tabs each extend outward from the periphery of the spacer and are arranged opposite to each other, and the first and second elongated tabs overlap each other at a second position. Claim 17 A puncture site patch according to claim 14, wherein the transparent self-sealing elastomer membrane further comprises an antimicrobial agent. Claim 18 A puncture site patch according to claim 17, wherein an antimicrobial agent is incorporated into a self-sealing elastomer membrane during extrusion. Claim 19 Claim 17, a puncture site patch in which an antimicrobial agent is applied as a coating to a self-sealing elastomer membrane. Claim 20 A puncture site patch comprising: a transparent self-sealing elastomer membrane comprising an outer surface, an inner surface, and an antimicrobial agent; a spacer comprising an outer surface and an inner surface, wherein the outer surface of the spacer is bonded to the inner surface of the transparent self-sealing elastomer membrane, and the spacer further comprises a hole, wherein the hole forms a cavity defined by the inner surface of the transparent self-sealing elastomer membrane, the spacer, and the skin when attached to a user; an adhesive film configured to adhere to the skin, the adhesive film located on the inner surface of the spacer; and an axis passing through the center of the hole defining the first side of the spacer and the second side of the spacer. and includes an elongated tab configured to move between a first position and a second position, wherein the elongated tab has a length greater than the length from the point furthest in the direction of extension of the elongated tab among the points on the periphery defining the hole to the base end of the elongated tab and a width greater than the width of the hole, wherein at the first position the elongated tab extends outward from the periphery of the spacer, and at the second position the puncture site patch is folded over the axis and the hole to seal the cavity with the elongated tab.

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