초록 ▼

An elastomeric puncture site patch for adhering to skin and antiseptically covering the skin at an area where a sharp object such as a syringe needle or intravenous is to be inserted. The patch is comprised of an elastomeric transparent self-sealing membrane and a spacer having an aperture. The spa

An elastomeric puncture site patch for adhering to skin and antiseptically covering the skin at an area where a sharp object such as a syringe needle or intravenous is to be inserted. The patch is comprised of an elastomeric transparent self-sealing membrane and a spacer having an aperture. The spacer has an adhesive film on the surface opposite the membrane for adhering the patch to the skin. When the patch is applied to an area of the skin, a chamber is formed between the skin and the membrane and bounded by the spacer. In use, the skin is antiseptically cleaned and the patch applied. The syringe needle or similar device punctures the membrane and the skin. At the end of the procedure the needle is withdrawn and any blood remaining on the outside of the needle or oozing from the wound is trapped in the chamber, thus preventing contamination of the area beyond the chamber. A method of manufacturing the puncture site patch is also provided.

대표청구항 ▼

What is claimed is: 1. A puncture site patch for adhering to skin, comprising: an elastomeric, self-sealing membrane through which an injection needle can penetrate, the membrane having an exterior face and an interior face; a spacer having an outer face and an inner face, the spacer defining an ap

What is claimed is: 1. A puncture site patch for adhering to skin, comprising: an elastomeric, self-sealing membrane through which an injection needle can penetrate, the membrane having an exterior face and an interior face; a spacer having an outer face and an inner face, the spacer defining an aperture and being attached at said outer face to said interior face of said membrane, wherein said spacer comprises an absorptive material resistant to wicking; and an adhesive film for adhering to skin, said adhesive film coating said inner face of said spacer. 2. The puncture site patch of claim 1, wherein said membrane is transparent and has a surface area large enough to completely cover said aperture. 3. The puncture site patch of claim 2, wherein said membrane is a non-coring membrane. 4. The puncture site patch of claim 1, wherein said spacer is a material that can be sterilized without degrading. 5. The puncture site patch of claim 4, wherein said spacer comprises a material selected from the group consisting of nylon, polyurethane, polyethylene, polypropylene, isoprene, cotton, linen and combinations thereof. 6. The puncture site patch of claim 5, further comprising a pull tab extending from a periphery of said spacer. 7. The puncture site patch of claim 6, wherein said adhesive film coats only said spacer. 8. The puncture site patch of claim 4, wherein said spacer is polyurethane. 9. The puncture site patch of claim 4, further comprising a coagulating agent coating an edge of said spacer, said edge located adjacent said aperture. 10. The puncture site patch of claim 9, wherein said coagulating agent is oxidized regenerated cellulose. 11. The puncture site patch of claim 1 further comprising a release paper in direct contact and completely covering said adhesive film. 12. The puncture site patch of claim 11, wherein said release paper has a surface area slightly larger than a total surface area of said adhesive film so as to create a removal tab for said release paper. 13. A sterile puncture site patch for adhering to skin, consisting essentially of: an essentially transparent, self-sealing, non-coring, elastomeric membrane having an exterior face and an interior face; a spacer having an outer face and an inner face bonded at said outer face to said interior face of said membrane; an adhesive film for adhering to skin, said adhesive film coating said inner face of said spacer; and an aperture through said spacer, said aperture positioned in relation to said spacer and said membrane so that when said sterile puncture site patch is adhered to said skin a cavity is formed between said skin and said membrane and bounded by said spacer. 14. The sterile puncture site patch of claim 13, wherein said self-sealing membrane comprises a thermoplastic, non-coring, self-sealing, non-degrading by sterilization material. 15. The sterile puncture site patch of claim 13, wherein said spacer comprises a material selected from the group consisting of nylon, polyethylene, polypropylene, isoprene, cotton, linen and combinations thereof. 16. The sterile puncture site patch of claim 15, wherein said spacer is polyethylene. 17. The sterile puncture site patch of claim 13, wherein said spacer comprises an absorptive material. 18. The sterile puncture site patch of claim 17, wherein said absorptive material is resistant to wicking. 19. The sterile puncture site patch of claim 13, further comprising a coagulating agent coating an edge of said spacer, said edge located adjacent said aperture. 20. The sterile puncture site patch of claim 19, wherein said coagulating agent is oxidized regenerated cellulose. 21. A continuous production process method for manufacturing a puncture site patch, comprising: a) punching apertures at predetermined positions through a sheet of a spacer material comprising an absorptive material resistant to wicking having an inner face adhesive surface and an outer face adhesive surface, said outer face adhesive surface covered with a release liner; b) removing said protective paper from said outer face adhesive surface of said spacer material with a take up roll; c) securing a sheet of an elastomeric, self-sealing membrane material through which an injection needle can penetrate to said outer face adhesive surface; and d) die cutting said spacer material, said release liner and said secured membrane in a preferred configuration to produce a puncture site patch. 22. The continuous production process method of claim 21, further comprising: e) packaging said puncture site patch into an interior of a package; and f) sterilizing said puncture site patch and said interior of said package. 23. A puncture site patch for adhering to skin, comprising: a spacer defining an aperture and having an outer face and an inner face, the outer face adapted for being secured to a membrane and the inner face adapted for adhering to skin; a pull tab extending from a periphery of said spacer; the membrane comprising an elastomeric, self-sealing membrane, and the membrane having an exterior face and an interior face, the membrane interior face adapted for being secured to the outer face of the spacer; and whereby an injection needle can penetrate through the membrane, through the aperture and into skin. 24. A puncture site patch for adhering to skin, comprising: an elastomeric, self-sealing membrane through which an injection needle can penetrate the membrane having an exterior face and an interior face, and wherein the exterior face is completely exposed; a spacer having an outer face and an inner face secured at said outer face to said interior face of said membrane; an adhesive film for adhering to skin, said adhesive film coating said inner face of said spacer; and an aperture through said spacer. 25. The puncture site patch of claim 24, wherein said membrane is transparent and has a surface area large enough to completely cover said aperture. 26. The puncture site patch of claim 25, wherein said membrane is a non-coring membrane. 27. The puncture site patch of claim 24, wherein said spacer is a material that can be sterilized without degrading. 28. The puncture site patch of claim 27, wherein said spacer comprises a material selected from the group consisting of nylon, polyurethane, polyethylene, polypropylene, isoprene, cotton, linen and combinations thereof. 29. The puncture site patch of claim 28, further comprising a pull tab extending from a periphery of said spacer. 30. The puncture site patch of claim 28, wherein said adhesive film coats only said spacer. 31. The puncture site patch of claim 27, wherein said spacer is polyurethane. 32. The puncture site patch of claim 27, wherein said spacer comprises an absorptive material. 33. The puncture site patch of claim 32, wherein said absorptive material is resistant to wicking. 34. The puncture site patch of claim 27, further comprising a coagulating agent coating an edge of said spacer, said edge located adjacent said aperture. 35. The puncture site patch of claim 34, wherein said coagulating agent is oxidized regenerated cellulose. 36. The puncture site patch of claim 24, further comprising a release paper in direct contact and completely covering said adhesive film. 37. The puncture site patch of claim 36, wherein said release paper has a surface area slightly larger than a total surface area of said adhesive film so as to create a removal tab for said release paper. 38. A method for providing an injection, comprising: adhering a spacer to skin, the spacer defining an aperture, and the spacer having an outer face and an inner face and comprising an absorptive material resistant to wicking, the inner face being secured to the skin and the outer face having an elastomeric, self-sealing membrane secured to the outer face, the membrane comprising an exterior face that is at least substantially exposed; and injecting a needle through the membrane, through the aperture of the spacer, and into the skin. 39. A puncture site patch for adhering to skin, comprising: an elastomeric, self-sealing membrane through which an injection needle can penetrate, the membrane having an exterior face and an interior face; a spacer having an outer face and an inner face, the spacer defining an aperture and being attached at said outer face to said interior face of said membrane, wherein said spacer comprises a material that can be sterilized without degrading, which is selected from the group consisting of nylon, polyurethane, polyethylene, polypropylene, isoprene, cotton, linen and combinations thereof; an adhesive film for adhering to skin, said adhesive film coating said inner face of said spacer; and a pull tab extending from a periphery of said spacer. 40. The puncture site patch of claim 39, wherein said adhesive film coats only said spacer. 41. A sterile puncture site patch for adhering to skin, consisting essentially of: an essentially transparent, self-sealing, non-coring, elastomeric membrane having an exterior face and an interior face; a spacer having an outer face and an inner face bonded at said outer face to said interior face of said membrane, wherein said spacer comprises an absorptive material resistant to wicking; an adhesive film for adhering to skin, said adhesive film coating said inner face of said spacer; and an aperture through said spacer, said aperture positioned in relation to said spacer and said membrane so that when said sterile puncture site patch is adhered to said skin a cavity is formed between said skin and said membrane and bounded by said spacer. 42. A puncture site patch for adhering to skin, comprising: an elastomeric, self-sealing membrane through which an injection needle can penetrate the membrane having an exterior face and an interior face, and wherein the exterior face is at least substantially exposed; a spacer having an outer face and an inner face secured at said outer face to said interior face of said membrane, wherein said spacer comprises a material that can be sterilized without degrading, which is selected from the group consisting of nylon, polyurethane, polyethylene, polypropylene, isoprene, cotton, linen and combinations thereof; an adhesive film for adhering to skin, said adhesive film coating said inner face of said spacer; an aperture through said spacer; and a pull tab extending from a periphery of said spacer. 43. The puncture site patch of claim 42, wherein said adhesive film coats only said spacer. 44. A puncture site patch for adhering to skin, comprising: an elastomeric, self-sealing membrane through which an injection needle can penetrate the membrane having an exterior face and an interior face, and wherein the exterior face is at least substantially exposed; a spacer having an outer face and an inner face secured at said outer face to said interior face of said membrane, wherein said spacer comprises an absorptive material resistant to wicking that can be sterilized without degrading; an adhesive film for adhering to skin, said adhesive film coating said inner face of said spacer; and an aperture through said spacer.