Tissue patches and related delivery systems and methods

• US 8,034,048 B2
• Filed: 05/05/2003
• Issued: 10/11/2011
• 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: McBride-Sakal, Marcia, Pugsley, Charles H.
• Primary Examiner(s): KOHARSKI, CHRISTOPHER
• Application Number:
  US10/428,801
• Publication Number:
  US 20040225373A1
• Time in Patent Office: 3,081 Days
• Field of Search: 606/213, 606/151, 606152-154, 424/422, 424425-426, 424/93.1, 424/93.7, 424/93.2, 424/443, 424/447, 604/890.1, 623/14.13, 623/15.11, 623/23.72, 623/23.75
• 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

A tissue patch for treatment of a lesion in an alimentary tract of a patient includes a tissue implant having a top surface and a bottom surface. The tissue patch also includes a substrate completely surrounding the tissue implant such that the substrate forms a first layer on the top surface and a second layer on the bottom surface. At least one of the first and second layers contacts the respective top or bottom surface and is entirely bio-absorbable so that the tissue implant touches an area of the patient'"'"'s tissue upon dissolving of the at least one of the first and second layers. The first layer has a first predetermined thickness and the second layer has a second predetermined thickness different from the first predetermined thickness.

Claims

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

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

a substrate completely 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 at least one of the first and second layers contacts the respective top or bottom surface and is entirely bio-absorbable so that the tissue implant touches an area of the patient'"'"'s tissue upon dissolving of the at least one of the first and second layers,

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

wherein the second layer is configured to contact the lesion while the first layer is configured to face a lumen of the alimentary tract, and

wherein the first predetermined thickness is greater than the second 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 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.

4. A tissue patch according to claim 3, 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.

5. A tissue patch according to claim 3, wherein the second predetermined time period is a time period during deployment of the tissue patch to the lesion.

6. 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.

7. A tissue patch according to claim 6, wherein the therapeutic agent is infused into the substrate.

8. A tissue patch according to claim 6, wherein the therapeutic agent is layered in a predetermined depth within the substrate so that the therapeutic agent activates at a predetermined time.

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

10. A tissue patch according to claim 9, wherein the patch is configured to be folded into a contracted state during delivery into the lesion.

11. A tissue patch according to claim 10, wherein the patch is capable of expanding upon deployment into the lesion.

12. A tissue patch according to claim 10, wherein the tissue patch forms a hollow tube that is dimensioned to cover a circumferential area of the esophagus upon being unfolded during endoluminal delivery.

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

14. A tissue patch according to claim 13, wherein the adhesive is cyano-acrylate.

15. A tissue patch according to claim 1, wherein the entire substrate is bioabsorbable.

16. A tissue patch according to claim 1, wherein the at least one of the first and second layers is bio-absorbable gel.

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

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

a sheet of tissue having a top surface and a bottom surface; and

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

wherein at least one of the first and second layers contacts the respective top or bottom surface and is entirely bio-absorbable so that the tissue implant touches an area of the patient'"'"'s tissue upon dissolving of the at least one of the first and second layers,

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

wherein the second layer is configured to contact the lesion while the first layer is configured to face a lumen of the alimentary tract, and

wherein the first predetermined thickness is greater than the second predetermined thickness.

18. A tissue patch according to claim 17, wherein the sheet of tissue is in the form of a cellular suspension.

19. A tissue patch according to claim 17, 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.

20. A tissue patch according to claim 19, wherein the first predetermined time period is a time period required for healing of the lesion so as to protect the sheet of tissue from conditions in the lumen of the alimentary tract.

21. A tissue patch according to claim 19, wherein the second predetermined time period is a time period during deployment of the tissue patch to the lesion.

22. A tissue patch according to claim 17, 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.

23. A tissue patch according to claim 22, wherein the therapeutic agent is infused into the substrate.

24. A tissue patch according to claim 22, wherein the therapeutic agent is layered in a predetermined depth within the substrate so that the therapeutic agent activates at a predetermined time.

25. A tissue patch according to claim 24, wherein the patch is configured to be delivered endoluminally.

26. A tissue patch according to claim 25, wherein the patch is configured to be folded into a contracted state during delivery into the lesion.

27. A tissue patch according to claim 26, wherein the patch is capable of expanding upon deployment into the lesion.

28. A tissue patch according to claim 24, further comprising an adhesive material to hold the patch proximate the lesion.

29. A tissue patch according to claim 28, wherein the adhesive is cyano-acrylate.

30. A tissue patch according to claim 24, wherein the sheet of tissue comprises a genetically engineered tissue.

31. A tissue patch according to claim 17, wherein the entire substrate is bioabsorbable.

32. A tissue patch according to claim 17, wherein the at least one of the first and second layers is bio-absorbable gel.

33. A tissue patch according to claim 17, wherein the patch is configured to be delivered endoluminally to the esophagus, wherein the patch is configured to be folded into a contracted state during delivery into the lesion, and wherein the tissue patch forms a hollow tube that is dimensioned to cover a circumferential area of the esophagus upon being unfolded during endoluminal delivery.

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

a tissue implant having a bottom surface; and

a substrate completely surrounding the tissue implant such that the substrate forms a bottom layer on the bottom surface, the substrate formed of a plurality of sections such that the tissue patch is capable of being folded into a contracted state for endoluminal delivery to the lesion,

wherein the bottom layer contacts the bottom surface and is entirely bio-absorbable so that the tissue implant touches an area of the patient'"'"'s tissue upon dissolving of the bottom layer, and

wherein the tissue patch forms a hollow tube that is dimensioned to cover a circumferential area of the esophagus upon being unfolded during endoluminal delivery.

35. A tissue patch according to claim 34, wherein the tissue implant is embedded in the substrate in the form of a cellular suspension.

36. A tissue patch according to claim 35, wherein at least one of the sections includes bio-adhesive material to hold the tissue patch on the lesion.

37. A tissue patch according to claim 36, 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.

38. A tissue patch according to claim 34, further comprising a carrier attached to the substrate.

39. A tissue patch according to claim 38, wherein the carrier is configured to be peeled away from the substrate.

40. A tissue patch according to claim 38, wherein the carrier is made of bio-absorbable material.

41. A tissue patch according to claim 34, wherein the tissue implant forms a layer within the substrate and has a top surface, the substrate forming a top layer on the top surface.

42. A tissue patch according to claim 41, wherein the top layer has a first predetermined thickness and the bottom layer has a second predetermined thickness different from the first predetermined thickness, the bottom layer configured to contact the lesion while the top layer is configured to face a lumen of the alimentary tract.

43. A tissue patch according to claim 42, wherein the first predetermined thickness is greater than the second predetermined thickness.

44. A tissue patch according to claim 41, wherein the top layer is configured to remain on the top surface for a first predetermined time period, and the bottom layer is configured to remain on the bottom surface for a second predetermined time period.

45. A tissue patch according to claim 44, 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.

46. A tissue patch according to claim 44, wherein the second predetermined time period is a time period during deployment of the tissue patch to the lesion.

47. A tissue patch according to claim 34, wherein the substrate is bio-absorbable gel.

48. A tissue patch according to claim 34, 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.

49. A tissue patch according to claim 48, wherein the therapeutic agent is infused into the substrate.

50. A tissue patch according to claim 48, wherein the therapeutic agent is layered in a predetermined depth within the substrate.

51. A tissue patch according to claim 34, wherein the tissue implant is a genetically engineered tissue.

52. A tissue patch according to claim 34, wherein the substrate comprises at least one fold line between the plurality of sections, and the plurality of sections are foldable along the at least one fold line.

53. A tissue patch according to claim 34, further comprising an adhesive material to hold the patch in the lesion.

54. A tissue patch according to claim 34, wherein the entire substrate is bioabsorbable.

55. A tissue patch according to claim 34, wherein the bottom layer is bioabsorbable gel.

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

a sheet of tissue having a bottom surface; and

a substrate surrounding the sheet of tissue such that the substrate forms a bottom layer on the bottom surface, the substrate formed of a plurality of sections capable of being folded into a contracted state for endoluminal delivery to the lesion,

wherein the bottom layer contacts the bottom surface and is entirely bio-absorbable so that the tissue implant touches an area of the patient'"'"'s tissue upon dissolving of the bottom layer, and

wherein the tissue patch forms a hollow tube that is dimensioned to cover a circumferential area of the esophagus upon being unfolded during endoluminal delivery.

57. A tissue patch according to claim 56, wherein the sheet of tissue is embedded in the substrate in the form of a cellular suspension.

58. A tissue patch according to claim 57, wherein at least one of the sections includes bio-adhesive material to hold the tissue patch on the lesion.

59. A tissue patch according to claim 58, wherein the plurality of sections are arranged such that sections containing the sheet of tissue 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.

60. A tissue patch according to claim 56, further comprising a carrier attached to the substrate.

61. A tissue patch according to claim 60, wherein the carrier is configured to be peeled away from the substrate.

62. A tissue patch according to claim 60, wherein the carrier is made of bio-absorbable material.

63. A tissue patch according to claim 56, wherein the sheet of tissue forms a layer within the substrate and has a top surface, the substrate forming a top layer on the top surface.

64. A tissue patch according to claim 63, wherein the top layer has a first predetermined thickness and the bottom layer has a second predetermined thickness different from the first predetermined thickness, the bottom layer configured to contact the lesion while the top layer is configured to face a lumen of the alimentary tract.

65. A tissue patch according to claim 64, wherein the first predetermined thickness is greater than the second predetermined thickness.

66. A tissue patch according to claim 63, wherein the top layer is configured to remain on the top surface for a first predetermined time period, and the bottom layer is configured to remain on the bottom surface for a second predetermined time period.

67. A tissue patch according to claim 66, wherein the first predetermined time period is a time period required for healing of the lesion so as to protect the sheet of tissue from conditions in the lumen of the alimentary tract.

68. A tissue patch according to claim 66, wherein the second predetermined time period is a time period during deployment of the tissue patch to the lesion.

69. A tissue patch according to claim 66, wherein the substrate is bio-absorbable gel.

70. A tissue patch according to claim 56, 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.

71. A tissue patch according to claim 70, wherein the therapeutic agent is layered in a predetermined depth within the substrate.

72. A tissue patch according to claim 70, wherein the therapeutic agent is infused into the substrate.

73. A tissue patch according to claim 56, wherein the sheet of tissue comprises a genetically engineered tissue.

74. A tissue patch according to claim 56, wherein the substrate comprises at least one fold line between the plurality of sections, and the plurality of sections are foldable along the at least one fold line.

75. A tissue patch according to claim 56, further comprising an adhesive material to hold the patch in the lesion.

76. A tissue patch according to claim 56, wherein the entire substrate is bioabsorbable.

77. A tissue patch according to claim 56, wherein the bottom layer is bioabsorbable gel.