Tissue fastening devices and processes that promote tissue adhesion

• US 20030220660A1
• Filed: 01/16/2003
• Published: 11/27/2003
• Est. Priority Date: 04/24/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Weisenborn, Alan, Otano-Lata, Suzana E., McBrayer, Michael S., Stahley, William H, Kortenbach, Juergen A., Shaw, William J., Adams, Mark L., Wendlandt, Jeffrey M., DeVries, Robert B.
• Granted Patent: US 8,241,308 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61F 2002/30467 using hook and loop-type fasteners
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners

Abstract

The invention in certain aspects relates to a surgical fastener for fastening tissue segments having tissue surfaces. The fastener includes a first fastener member having a base and a piercing element connected to the base for piercing the tissue segments to be fastened, a second fastener member having an opening for receiving and retaining the piercing element of the first fastener member such that the tissue segments to be fastened are retained between the first and second fastening members, and means for promoting adhesion between the tissue surfaces. The invention also relates to related methods and devices for promoting adhesion of tissue segments and preventing fastener migration, especially in an endoscopic procedure for the treatment of GERD.

Claims

1. A surgical fastener for fastening tissue segments having tissue surfaces, the fastener comprising:

a first fastener member;

a second fastener member configured to receive and retain the first fastener member such that the tissue segments to be fastened are retained between the first and second fastener members; and

means for promoting adhesion between the tissue surfaces.

2. The fastener according to claim 1, wherein the first fastener member has a base and a piercing element connected to the base for piercing the tissue segments to be fastened.

3. The fastener according to claim 2, wherein the second fastener member has an opening to receive and retain the piercing element of the first fastener member.

4. The fastener according to claim 1, wherein the means for promoting adhesion includes a passageway in the first fastener member, wherein the passageway has an opening to receive a therapeutic agent, and wherein the passageway connects to at least one port in the first fastener member allowing delivery of the adhesion promoting substance to the tissue segments.

5. The fastener according to claim 4, wherein the therapeutic agent is an adhesion promoting agent.

6. The fastener according to claim 4, wherein the first fastener member has a base and a piercing element connected to the base for piercing the tissue segments to be fastened, and wherein the passageway is in the base and the piercing element, and the port is in the piercing element.

7. The fastener according to claim 4, further comprising a reservoir for containing the therapeutic agent.

8. The reservoir of claim 7, wherein the reservoir is crushable.

9. The reservoir of claim 7, wherein the reservoir is piercable.

10. The fastener according to claim 1, wherein the means for promoting adhesion includes an adhesion promoting substance.

11. The fastener according to claim 10, wherein the adhesion promoting substance is selected from at least one of the group of a sclerosing agent, an adhesive, an antibiotic, an anti-inflammatory agent, an anesthetic, a biological fluid, a growth factor, a tissue irritant, a solution including a biocompatible material, a gene, a protein, an enzyme, and a cell.

12. The fastener according to claim 3, wherein the piercing element includes a shaft connected to the base at one end and having a spike at the other end.

13. The fastener according to claim 12, wherein the opening of the second fastener member includes a means for contacting the spike to retain the spike in the second fastener member after the spike has passed through the opening.

14. The fastener according to claim 13, wherein the means for contacting the spike includes projections in the second fastener member.

15. The fastener according to claim 4, wherein the at least one port includes a plurality of ports along a length of the first fastener member.

16. The fastener according to claim 1, wherein the means for promoting adhesion includes a device releasably receiving one of the first and second fastening members, the device having a passageway for receiving a delivery mechanism for delivering a therapeutic substance to the tissue segments.

17. The fastener according to claim 16, wherein the therapeutic substance is an adhesion promoting substance.

18. The fastener according to claim 1, where the means for promoting tissue adhesion includes an adhesion promoting material located on at least a portion of at least one of the first and second fastener members for causing an adhesion in the tissue segments to be fastened.

19. The fastener according to claim 18, wherein the adhesion promoting material is a coating.

20. The fastener according to claim 18, wherein the adhesion promoting material is a suture material wrapped around the first fastening member.

21. The fastener according to claim 18, wherein the portion is a piercing element of the first fastener member for piercing the tissue segments to be fastened.

22. The fastener according to claim 1, wherein the means for promoting tissue adhesion includes at least one puncture member located on a base of the first fastener member.

23. The fastener according to claim 22, wherein the at least one puncture member includes a spike having a height of at least the thickness of one of the tissue segments to be fastened.

24. The fastener according to claim 22, wherein the at least one puncture member includes a blade having a height of at least the thickness of one of the tissue segments to be fastened.

25. A method of fastening surfaces of tissue segments, the method comprising the steps of:

piercing the tissue segments to be fastened with a tissue fastener;

retaining the tissue segments to be fastened between parts of the tissue fastener; and

delivering a therapeutic agent to the interface between the surfaces of the tissue segments to be joined.

26. The method of claim 25, wherein parts of the tissue fastener include a first part and a second part, piercing the tissue segments includes piercing the tissue segments with the first part, and retaining the tissue segments includes receiving the first part in the second part.

27. The method of claim 25, wherein the therapeutic agent is an adhesion promoting substance.

28. The method of claim 25, wherein the therapeutic agent is a coating on the tissue fastener.

29. The method according to claim 26, wherein the delivering step includes delivering the therapeutic agent through a passageway in the first part of the tissue fastener, wherein the passageway has a first end for receiving a source of the therapeutic agent, and wherein the passageway connects to at least one port in the first part allowing delivery of the therapeutic agent to the tissue segments.

30. The method according to claim 29, wherein delivering the therapeutic agent includes compressing a reservoir that contains the therapeutic agent.

31. The method according to claim 27, wherein the adhesion promoting substance is selected from at least one of the group of a sclerosing agent, an adhesive, an antibiotic, an anti-inflammatory agent, an anesthetic, a biological fluid, a growth factor, a tissue irritant, a solution including a biocompatible material, a gene, a protein, an enzyme, and a cell.

32. The method according to claim 29, wherein delivering the therapeutic agent includes delivery of the therapeutic agent to the passageway by a delivery tube connected to the first end of the passageway.

33. The method according to claim 25, wherein the delivering step includes delivering the therapeutic agent through a passageway in a device that releasably receives the tissue fastener.

34. A device for connecting and promoting adhesion of a first segment of lower esophageal sphincter tissue and a second segment of fundus tissue, the device comprising:

an elongate body configured for insertion into the esophagus;

an element connected to and pivoting from a distal end of the elongate body, the element having a retracted position along an axis of the elongate body and an extended position at an angle to the axis; and

means associated with at least one of the elongate body and the element for promoting adhesion of the first and second tissue segments.

35. The device according to claim 34, further comprising viewing means.

36. The device according to claim 35, wherein the viewing means includes an endoscope.

37. The device according to claim 35, wherein the elongate body includes a lumen for accommodating the viewing means.

38. The device according to claim 34, wherein the means for promoting adhesion includes means for causing trauma to at least one of the first and second tissue segments.

39. The device according to claim 38, wherein the means for causing trauma includes at least one puncture element located on at least one of the element and the elongate body.

40. The device according to claim 39, wherein the at least one puncture element is at least one spike.

41. The device according to claim 39, wherein the at least one puncture element is at least one blade.

42. The device according to claim 39, wherein the at least one puncture element has a height more than a thickness of one of the first and second tissue segments.

43. The device according to claim 34, wherein the means for promoting adhesion includes an injection needle.

44. The device according to claim 43, wherein the injection needle is configured to extend from the elongate body.

45. The device according to claim 43, wherein the injection needle is configured to extend from the element.

46. The device according to claim 43, wherein the injection needle communicates with a passage within the elongate body.

47. The device according to claim 43, wherein the injection needle is independent of the elongate body.

48. The device according to claim 34, wherein the means for promoting adhesion includes a plurality of injection needles.

49. A surgical fastener for fastening tissue segments having tissue surfaces, the fastener comprising:

a first fastener part including a plurality of protrusions; and

a second fastener part defining a plurality of holes for receiving the plurality of barbs.

50. The fastener of claim 49, wherein the first fastener part includes a base, and the plurality of protrusions include barbs extending from the base.

51. The fastener of claim 50, wherein the second fastener part includes a mesh screen.

52. A device for fastening a first segment of lower esophageal sphincter tissue to a second segment of fundus tissue, the device comprising:

a fastener having a first fastener part including a plurality of protrusions, and a second fastener part defining a plurality of holes for receiving the plurality of protrusions;

an elongate body configured for insertion into the esophagus, wherein the distal end of the elongate body is configured to hold one of the first fastener part and the second fastener part;

an element connected to and pivoting from the distal end of the elongate body, the element having a retracted position along an axis of the elongate body and an extended position at an angle to the axis, wherein the element is configured to hold the other of the first fastener part and the second fastener part; and

a mechanism capable of reciprocating within a channel of the elongate body and urge the first and second fastener parts together.

53. The device of claim 52, wherein the first fastener part includes a base, and the plurality of protrusions include barbs extending from the base.

54. The device of claim 53, wherein the second fastener part includes a mesh screen.

55. The device according to claim 52, further comprising viewing means.

56. The device according to claim 55, wherein the viewing means includes an endoscope.

57. The device according to claim 55, wherein the elongate body includes a lumen for accommodating the viewing means.

58. The device according to claim 52, wherein the mechanism includes a ramp-like structure.

59. A surgical fastener for fastening tissue segments having tissue surfaces, the fastener comprising:

a first fastener member; and

a second fastener member having a post defining an opening for receiving and retaining the first fastener member such that the tissue segments to be fastened are retained between the first and second fastening members.

60. The fastener according to claim 59, wherein the first fastener member has a base and a piercing element connected to the base for piercing the tissue segments to be fastened, and the opening receives and retains the piercing element.

61. The fastener according to claim 59, further comprising means for promoting adhesion between the tissue surfaces.

62. The fastener according to claim 61, wherein the means for promoting adhesion includes a reservoir for containing a therapeutic agent.

63. The fastener according to claim 62, wherein the therapeutic agent is a tissue adhesion promoting substance.

64. The fastener according to claim 62, wherein the reservoir is crushable.

65. The fastener according to claim 62, wherein the reservoir is piercable.

66. The fastener according to claim 62, wherein the reservoir is located proximate the opening of the post.

67. The fastener according to claim 62, wherein the reservoir is located inside the post.

68. The fastener according to claim 62, wherein the therapeutic agent is selected from one of the group of a sclerosing agent, an adhesive, an antibiotic, an anti-inflammatory agent, an anesthetic, a biological fluid, a growth factor, a tissue irritant, a solution including a biocompatible material, a gene, a protein, an enzyme, a cell.

69. The fastener according to claim 59, wherein the post includes a sharp edge.