Tissue patches and related delivery systems and methods

• US 20040225373A1
• Filed: 05/05/2003
• Published: 11/11/2004
• Est. Priority Date: 05/05/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Pugsley, Charles H., McBride-Sakal, Marcia
• Granted Patent: US 8,034,048 B2
• Time in Patent Office: Days
• US Class Current: 623/23.71
• 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 tissue implant imbedded in a substrate to form a first layer and a second layer of substrate on a top surface and a bottom surface of the tissue implant. A predetermined thickness of the first layer is different from a predetermined thickness of the second layer. A tissue patch may include a tissue implant imbedded in a substrate formed of a plurality of sections capable of being folded into a contracted state for endoluminal delivery to the lesion. A system for delivering a tissue implant includes a catheter having an expandable member at a distal end portion, a carrier placed around the expandable member, and the carrier configured to expand from a contracted state to an expanded state and to receive the tissue implant. The tissue implant contacts the lesion of the alimentary tract when the expandable member expands the carrier to the expandable state.

Claims

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

a tissue implant having a top surface and a bottom surface; and

a substrate surrounding the tissue implant such that the substrate forms a first layer on the top surface and a second layer on the bottom surface,

wherein the first layer has a first predetermined thickness and the second layer has a second predetermined thickness different from the first predetermined thickness.

2. A tissue patch according to claim 1, wherein the tissue implant is in the form of a cellular suspension.

3. A tissue patch according to claim 1, wherein the second layer is configured to contact the lesion while the first layer is configured to face a lumen of the alimentary tract.

4. A tissue patch according to claim 3, wherein the first predetermined thickness is greater than the second predetermined thickness.

5. A tissue patch according to claim 3, wherein the first layer is configured to remain on the top surface for a first predetermined time period, and the second layer is configured to remain on the bottom surface for a second predetermined time period.

6. A tissue patch according to claim 5, wherein the first predetermined time period is a time period required for healing of the lesion so as to protect the tissue implant from conditions in the lumen of the alimentary tract.

7. A tissue patch according to claim 5, wherein the second predetermined time period is a time period during deployment of the tissue patch to the lesion.

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

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

10. A tissue patch according to claim 9, wherein the therapeutic agent is infused into the substrate.

11. A tissue patch according to claim 9, wherein the therapeutic agent is layered in a predetermined depth within the substrate so that the therapeutic agent activates at a predetermined time.

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

13. A tissue patch according to claim 12, wherein the patch is configured to be folded into a contracted state during delivery into the lesion.

14. A tissue patch according to claim 13, wherein the patch is capable of expanding upon deployment into the lesion.

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

16. A tissue patch according to claim 15, wherein the adhesive is cyano-acrylate.

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

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

a tissue implant; and

a substrate containing the tissue implant, the substrate formed of a plurality of sections capable of being folded into a contracted state for endoluminal delivery to the lesion.

19. A tissue patch according to claim 18, wherein the tissue implant is embedded in the substrate in the form of a cellular suspension.

20. A tissue patch according to claim 19, wherein at least one of the sections include bio-adhesive material to hold the tissue patch on the lesion.

21. A tissue patch according to claim 20, wherein the plurality of sections are arranged such that sections containing the tissue implant contact like sections and sections with bio-adhesive material contact with sections with non-stick material, when the plurality of sections are folded into a contracted state.

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

23. A tissue patch according to claim 22, wherein the carrier is configured be peeled away from the substrate.

24. A tissue patch according to claim 22, wherein the carrier is made of bio-absorbable material.

25. A tissue patch according to claim 18, wherein the tissue implant forms a layer within the substrate and has a top surface and a bottom surface, the substrate forming a first layer on the top surface and a second layer on the bottom surface.

26. A tissue patch according to claim 25, wherein the first layer has a first predetermined thickness and the second layer has a second predetermined thickness different from the first predetermined thickness, the second layer configured to contact the lesion while the first layer is configured to face a lumen of the alimentary tract.

27. A tissue patch according to claim 26, wherein the first predetermined thickness is greater than the second predetermined thickness.

28. A tissue patch according to claim 25, wherein the first layer is configured to remain on the top surface for a first predetermined time period, and the second layer is configured to remain on the bottom surface for a second predetermined time period.

29. A tissue patch according to claim 28, wherein the first predetermined time period is a time period required for healing of the lesion so as to protect the tissue implant from conditions in the lumen of the alimentary tract.

30. A tissue patch according to claim 28, wherein the second predetermined time period is a time period during deployment of the tissue patch to the lesion.

31. A tissue patch according to claim 18, wherein the substrate is bio-absorbable gel.

32. A tissue patch according to claim 18, wherein the substrate includes a therapeutic agent selected from a group consisting of human growth hormone, generically engineered cells, antibiotics, analgesics, and pH sensitive or reactive chemicals.

33. A tissue patch according to claim 32, wherein the therapeutic agent is infused into the substrate.

34. A tissue patch according to claim 32, wherein the therapeutic agent is layered in a predetermined depth within the substrate.

35. A tissue patch according to claim 18, further comprising an adhesive material to hold the patch in the lesion.

36. A tissue patch according to claim 18, wherein the tissue implant is a generically engineered tissue.

37. A system for delivering a tissue implant to a lesion in an alimentary tract of a patient, comprising:

a catheter having an expandable member at a distal end portion; and

a carrier having an outer surface and an inner surface and placed around the expandable member, the carrier configured to expand from a contracted state to an expanded state and to receive the tissue implant,

wherein the tissue implant contacts the lesion of the alimentary tract when the expandable member expands the carrier to the expandable state.

38. A system according to claim 37, further comprising a retractable sleeve surrounding the carrier to protect the carrier during insertion and placement of the catheter, the sleeve configured to retract from around the carrier prior to the expandable member expanding to the expanded state.

39. A system according to claim 37, wherein the carrier is formed of a plurality of sections which are configured to be folded in the contracted state.

40. A system according to claim 39, wherein at least one of the plurality of panels comprises bio-adhesive material.

41. A system according to claim 39, wherein the carrier constitutes a substrate in which the tissue implant is embedded.

42. A system according to claim 39, wherein the tissue implant is placed on the outer surface of the carrier and configured to be folded together with the plurality of sections in the contracted state.

43. A system according to claim 41, wherein the tissue implant is embedded in a substrate to form a tissue patch on the outer surface of the carrier.

44. A system according to claim 43, wherein the substrate is a bio-absorbable gel.

45. A system according to claim 41, wherein the tissue implant is embedded in the substrate in a form of a cellular suspension.

46. A system according to claim 43, wherein the carrier is configured to be peeled away from the tissue patch once the tissue patch is securely placed.

47. A system according to claim 37, wherein the carrier is made of bio-absorbable material which dissolves over a period of time.

48. A system according to claim 37, wherein the tissue implant is an engineered tissue.

49. A method of delivering a tissue implant to a lesion in a patient'"'"'s body, comprising:

providing a catheter having an expandable member at a distal end portion;

disposing a contracted carrier around the expandable member, the carrier configured to expand to an expanded state and containing the tissue implant;

inserting the catheter and the contracted carrier into a lumen containing the lesion;

positioning the carrier and expandable member at the lesion; and

expanding the expandable member so as to expand the carrier to the expanded state to implant the tissue implant into the lesion.

50. A method according to claim 49, further comprising providing a retractable sleeve which surrounds the folded carrier to protect the folded carrier during insertion of the catheter, wherein the retractable sleeve is configured to retract from around the carrier prior to the expandable member expanding to the expanded state.

51. A method according to claim 49, wherein the carrier is formed of a plurality of sections which are configured to be folded in the contracted state.

52. A method according to claim 51, wherein at least a portion of the plurality of sections include bio-adhesive material.

53. A method according to claim 51, wherein the carrier constitutes a substrate in which the tissue implant is embedded.

54. A method according to claim 51, wherein the tissue implant is placed on the outer surface of the carrier and configured to be contracted with the plurality of sections in the contracted state.

55. A method according to claim 54, wherein the tissue implant is embedded in a substrate to form a tissue patch on the outer surface of the carrier.

56. A method according to claim 55, wherein the substrate is a bio-absorbable gel.

57. A method according to claim 53, wherein the tissue implant is embedded in the substrate in a form of a cellular suspension.

58. A method according to claim 49, wherein the carrier is configured to be peeled away from the tissue patch once the tissue patch is securely placed.

59. A method according to claim 49, wherein the carrier is made of bio-absorbable material which dissolves over a period of time.

60. A method according to claim 49, wherein the tissue implant is an engineered tissue.