Tissue patches and related delivery systems and methods

• US 8,137,338 B2
• Filed: 07/10/2008
• Issued: 03/20/2012
• Est. Priority Date: 05/05/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Pugsley, Charles H., McBride-Sakal, Marcia, Geitz, Kurt
• Primary Examiner(s): KOHARSKI, CHRISTOPHER
• Application Number:
  US12/216,789
• Publication Number:
  US 20080312751A1
• Time in Patent Office: 1,349 Days
• Field of Search: 604/890.1, 606/151, 606/154, 623/14.13, 623/15.11, 424/93.1, 424/93.7, 424/932.2, 424/443, 424/426
• US Class Current: 604/890.1
• CPC Class Codes: A61F 13/00063 comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic drug delivery dressings A61K9/70; chemical aspect of the additives A61L15/00
• CPC Class Codes: A61F 13/0213 the fluid retention member being a layer of hydrocolloid, gel forming material
• CPC Class Codes: A61F 13/0226 characterised by the support layer
• CPC Class Codes: A61F 13/0253 characterized by the adhesive material
• CPC Class Codes: A61L 15/40 containing ingredients of undetermined constitution or reaction products thereof , e.g. plant or animal extracts
• CPC Class Codes: A61L 15/64 specially adapted to be resorbable inside the body

Abstract

Endoluminally delivered tissue patches and related systems and methods for delivering the tissue patches for treating lesions of the alimentary tract are disclosed. A tissue patch includes a substrate, a tissue implant attached to the substrate, and a protective liner covering at least a portion of the tissue implant. A method includes providing a tissue patch having a tissue implant attached to a substrate and a protective liner covering at least a portion of the tissue implant. The tissue patch is formed into a contracted state and inserted into a lumen containing the lesion. The tissue patch then is positioned in the vicinity of the lesion. After removing the protective liner to reveal the tissue implant, the tissue implant is placed in the lesion.

Claims

1. A tissue patch for treatment of a lesion in an alimentary tract of a patient, comprising:

a substrate having a first surface and a second surface opposite to the first surface;

a sheet of tissue attached to the first surface of the substrate, the sheet of tissue occupying an area of the first surface, the area being less than the surface area of the first surface; and

a protective liner removably attached to at least one of the substrate and the sheet of tissue,

wherein the protective liner contacts and covers the sheet of tissue, and wherein the sheet of tissue is disposed between the substrate and the protective liner.

2. A tissue patch according to claim 1, wherein an adhesive material for attaching the protective liner occupies at least a portion of the first surface other than an area occupied by the tissue implant.

3. A tissue patch according to claim 1, further comprising an adhesive material to hold the patch proximate the lesion.

4. A tissue patch according to claim 3, wherein the adhesive material includes cyano-acrylate.

5. A tissue patch according to claim 3, wherein the protective liner is attached to the substrate via the adhesive material.

6. A tissue patch according to claim 1, wherein the protective liner is configured to be peeled away from the at least one of the substrate and the tissue implant.

7. A tissue patch according to claim 1, wherein the protective liner is removably attached to the first surface of the substrate.

8. A tissue patch according to claim 1, wherein the substrate is a bio-absorbable gel.

9. A tissue patch according to claim 8, wherein the substrate includes a bio-absorbable material having a predetermined thickness designed to last for a predetermined time period required for healing of the lesion so as to protect the sheet of tissue from conditions in the alimentary tract.

10. A tissue patch according to claim 1, wherein the substrate includes a therapeutic agent selected from a group consisting of human growth hormone, genetically engineered cells, antibiotics, analgesics, and pH sensitive or reactive chemicals.

11. A tissue patch according to claim 10, wherein the therapeutic agent is infused into the substrate.

12. A tissue patch according to claim 10, wherein the therapeutic agent is layered in a predetermined depth within the substrate so that the therapeutic agent activates at a predetermined time.

13. A tissue patch according to claim 1, wherein the patch is configured to be delivered endoluminally.

14. A tissue patch according to claim 13, wherein the patch is configured to be folded into a contracted state during delivery into the lesion.

15. A tissue patch according to claim 14, wherein the patch is capable of expanding upon deployment into the lesion.

16. A tissue patch according to claim 1, wherein the patch is configured to be rolled into a cylindrical shape.

17. A tissue patch according to claim 1, wherein the tissue implant is a genetically engineered tissue.

18. A tissue patch according to claim 1, further comprising a carrier attached to the substrate.

19. A tissue patch according to claim 18, wherein the carrier is configured to be peeled away from the substrate.

20. A tissue patch for treatment of a lesion in an alimentary tract of a patient, comprising:

a substrate having a first surface and a second surface opposite the first surface;

an implant of tissue attached to the first surface of the substrate and occupying a first area of the first surface;

a protective liner removably attached to the first surface of the substrate so that the implant of tissue is placed between the substrate and the protective liner and so that the protective liner contacts and covers the implant of tissue; and

an adhesive material for attaching the protective liner to the substrate,

wherein the adhesive material occupies a second area of the first surface that is different from the first area, wherein the second area comprises an outer edge of the first surface, and wherein each of the implant of tissue and the adhesive material is disposed between the substrate and the protective liner.

21. A tissue patch according to claim 20, wherein the adhesive material is configured to hold the patch proximate the lesion after the protective liner is removed.

22. A tissue patch according to claim 20, wherein the protective liner is configured to be peeled away from the substrate.

23. A tissue patch according to claim 20, wherein the substrate includes a therapeutic agent.

24. A tissue patch according to claim 20, wherein the patch is configured to be folded into a contracted state during delivery into the lesion.

25. A tissue patch according to claim 20, wherein the patch is capable of expanding upon deployment into the lesion.

26. A tissue patch according to claim 20, wherein the implant of tissue comprises a sheet of tissue.

27. A tissue patch for treatment of a lesion in an alimentary tract of a patient, comprising:

a substrate having a first surface and a second surface opposite to the first surface,

wherein the substrate is a bio-absorbable gel;

a sheet of tissue attached to the first surface of the substrate, the sheet of tissue occupying an area of the first surface, the area being less than the surface area of the first surface; and

a protective liner removably attached to at least one of the substrate and the sheet of tissue to cover the sheet of tissue,

wherein the sheet of tissue is disposed between the substrate and the protective liner.

28. A tissue patch according to claim 27, further comprising an adhesive material to hold the patch proximate the lesion.

29. A tissue patch according to claim 27, wherein the protective liner is configured to be peeled away from the at least one of the substrate and the tissue implant.

30. A tissue patch according to claim 27, wherein the substrate includes a bio-absorbable material having a predetermined thickness designed to last for a predetermined time period required for healing of the lesion so as to protect the sheet of tissue from conditions in the alimentary tract.

31. A tissue patch according to claim 27, wherein the substrate includes a therapeutic agent selected from a group consisting of human growth hormone, genetically engineered cells, antibiotics, analgesics, and pH sensitive or reactive chemicals.

32. A tissue patch according to claim 27, further comprising a carrier attached to the substrate.

33. A tissue patch for treatment of a lesion in an alimentary tract of a patient, comprising:

a substrate having a first surface and a second surface opposite the first surface,

wherein the substrate is a bio-absorbable gel;

an implant of tissue attached to the first surface of the substrate and occupying a first area of the first surface;

a protective liner attached to the first surface of the substrate so that the implant of tissue is placed between the substrate and the protective liner; and

an adhesive material for attaching the protective liner to the substrate,

wherein the adhesive material occupies a second area of the first surface that is different from the first area, wherein the second area comprises an outer edge of the first surface, and wherein each of the implant of tissue and the adhesive material is disposed between the substrate and the protective liner.

34. A tissue patch according to claim 33, wherein the protective liner is removably attached to the substrate.

35. A tissue patch according to claim 33, wherein the substrate includes a therapeutic agent.