SYSTEMS AND METHODS OF TISSUE CLOSURE

• US 20070260278A1
• Filed: 05/03/2007
• Published: 11/08/2007
• Est. Priority Date: 05/03/2006
• Status: Active Grant

• Current Assignee: Datascope Corporation (Getinge AB)
• Original Assignee: Raptor Ridge, LLC
• Inventors: Mohan, Ashik A., Wheeler, William K.
• Granted Patent: US 7,992,757 B2
• Time in Patent Office: Days
• US Class Current: 606/220
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/07214 Stapler heads
• CPC Class Codes: A61B 2017/306 holding by means of suction

Abstract

Apparatus, systems, and methods are described for closing the base of a left atrial appendage or other tissue structure. A tissue closure device comprises a pair of legs having compliant surfaces for engaging against opposite sides of the tissue structure. A plurality of axially spaced-apart tissue-penetrating fasteners are delivered from one leg to the other to pierce the intervening tissue and hold the closure device in place on the tissue structure.

Claims

1. A tissue closure device comprising:

a compression body having two opposed compliant tissue-engaging surfaces; and

one or more tissue-penetrating fasteners disposed to extend from a first one of the tissue-engaging surfaces, through tissue at a puncture site, to a second one the tissue-engaging surfaces to close the tissue structure therebetween.

2. A tissue closure device as in claim 1, wherein one of the tissue-engaging surfaces includes a stabilizing lip and is larger in area than the other tissue-engaging surface.

3. A tissue closure device as in claim 1, further comprising an open well disposed in one of the tissue-engaging surfaces adjacent the puncture site.

4. A tissue closure device as in claim 1, wherein the tissue-penetrating fasteners comprise male and female connectors aligned on the opposed tissue-engaging surfaces.

5. A tissue closure device as in claim 4, further comprising an open well disposed around a barb of the male connector extending into the first tissue-engaging surface, wherein the open well has a diameter greater than a diameter of the barb.

6. A tissue closure device as in claim 4, further comprising an open well disposed adjacent the female connector extending into the second tissue-engaging surface.

7. A tissue closure device as in claim 4, wherein the male and female connectors each include a rear-facing recess.

8. A tissue closure device as in claim 7, wherein the compression body includes wells corresponding to each recess.

9. A tissue closure device as in claim 1, wherein the entire compression body is formed of a compliant material.

10. A tissue closure device as in claim 4, wherein the male and female connectors are configured to securely engage each other and create a set distance between the tissue-engaging surfaces.

11. A tissue closure device as in claim 1, wherein the compliant surfaces of the compression body have a durometer in the range from 3 shore A to 15 shore A.

12. A tissue closure device as in claim 1, wherein the surfaces are composed at least partly of a silicone or a polyurethane.

13. A tissue closure device as in claim 1, wherein the compliant compression body comprises a pair of parallel, opposed legs, wherein each leg carries a tissue-engaging surface.

14. A tissue closure device as in claim 1, wherein each leg carries either male or female connectors.

15. A tissue closure device as in claim 13, wherein the parallel opposed legs are connected to form a continuous ring structure.

16. A tissue closure device as in claim 13, wherein the legs are joined at only one end.

17. A tissue closure device as in claim 13, wherein the legs are not joined at either end.

18. A tissue closure device as in claim 13, wherein the compression body further comprises a vacuum plenum with each leg of the compliant compression body.

19. A tissue closure device as in claim 18, wherein the vacuum plenum opens to a plurality of ports along at least one surface of the legs of the compression body, wherein the ports are oriented in a direction different than that of the tissue-penetrating fasteners.

20. A tissue closure device as in claim 19, wherein the ports are oriented at a generally perpendicular angle relative to the fasteners.

21. A tissue closure device as in claim 18, wherein the plenum has at least one port for receiving a vacuum probe.

22. A tissue closure device as in claim 1, wherein the compression body is made of a biodegradable material.

23. A tissue closure device as in claim 1, wherein the fasteners comprise a biodegradable material.

24. A tissue closure device as in claim 1, wherein the fasteners are contained wholly within the compression body prior to deployment and do not extend beyond the compression body after deployment.

25. A system for closing the base of a left atrial appendage, said system comprising:

a closure device including a compliant compression body with opposed tissue-engaging surfaces;

a closure device applicator for detachably securing and opening the closure device to place said device around or over the tissue structure;

a vacuum path through the applicator and closure device for applying a vacuum between the closure device and the tissue structure when the device is over the tissue structure to adhere the device to the tissue structure; and

a plurality of fasteners deployable from one tissue-engaging surface, through the tissue structure, into the other tissue-engaging surface to close the tissue structure therebetween.

26. A system as in claim 25, wherein the surfaces of the compliant compression body have a durometer in the range from 3 shore A to 15 shore A.

27. A system as in claim 25, wherein the surfaces are composed at least partly of a silicone or polyurethane.

28. A system as in claim 25, wherein the compliant compression body comprises a pair of legs, wherein each leg carries an opposed tissue-engaging surface.

29. A system as in claim 28, wherein the opposed legs are connected to form a continuous ring structure.

30. A system as in claim 28, wherein the legs are joined at only one end.

31. A system as in claim 28, wherein the legs are not joined at either end.

32. A system as in a claim 28, wherein the closure device applicator comprises a jaw mechanism which carries two probes, wherein each probe detachably engages one leg of the compliant compression body.

33. A system as in claim 32, wherein at least one of the probes has a lumen which provides a portion of the vacuum path.

34. A system as in claim 33, wherein the at least one probe is received in a vacuum plenum in the at least one leg of compliant compression body of the closure device.

35. A tissue closure device as in claim 34, wherein vacuum the plenum is open over at least a portion of the at least two tissue-engaging surfaces.

36. A tissue closure device as in claim 35, wherein the plenum is open through a plurality of ports distributed over the tissue-engaging surface.

37. A tissue closure device as in claim 34, wherein the plenum has a port for receiving the probe(s).

38. A system as in claim 32, wherein the probes of the jaw mechanism are joined by a mechanical spreading mechanism.

39. A system as in claim 38, wherein the mechanical spreading mechanism comprises a rack-and-pinion mechanism which opens the legs in a parallel manner.

40. A system as in claim 38, wherein the mechanical spreading mechanism comprises a pivot mechanism which pivotally opens the legs.

41. A method for closing a tissue structure, said method comprising:

positioning a compression body over the tissue structure with at least two compliant tissue-engaging surfaces engaging opposite sides of the structure;

applying a vacuum through the compression body to adhere the surfaces to the tissue structure; and

deploying fasteners from at least one of said surfaces, through the tissue, and into the other surface to close the tissue structure while the vacuum continues to be applied.

42. A method as in claim 41, wherein the tissue structure is a left atrial appendage.

43. A method as in claim 42, wherein positioning comprises intercostally advancing the compression member.

44. A method as in claim 42, wherein positioning comprises carrying the compliant compression body on an applicator, spreading the tissue-engaging surfaces using the applicator, and closing the spread legs over the tissue structure before applying the vacuum.

45. A method as in claim 41, wherein deploying fasteners comprises advancing male elements from either or both of the tissue-engaging surface(s) to female elements in the opposed tissue-engaging surface.

46. A method as in claim 41, wherein deploying fasteners comprises advanced barbed needles from one tissue-engaging surface to the other tissue-engaging surface.

47. A method as in claim 41, further comprising viewing the tissue structure through an optical scope during at least a portion of the procedure.

48. A method as in claim 41, further comprising directly viewing the tissue structure through a percutaneous opening during at least a portion of the procedure.

49. A method as in claim 41, further comprising introducing a substance to the tissue structure through the compression body.

50. A method as in claim 49, wherein the substance is an antibiotic, an antiseptic, or an anti-inflammatory.

51. A method as in claim 41, further comprising excising the tissue structure at a location above the compression body after the fasteners have been deployed.

52. A method as in claim 41, wherein the fasteners do not extend out of the compression body after deployment.

53. A method as in claim 41, wherein the fasteners are deployed to close the tissue-engaging surfaces against the tissue with a pressure in the range from 0.25 psi to 20 psi.

54. A method as in claim 53, wherein the pressure is in the range from 0.25 psi to 1.5 psi.

55. A system for closing the base of a left atrial appendage, said system comprising:

a closure device including a compression body with opposed compliant tissue-engaging surfaces;

one or more tissue-penetrating fasteners disposed to extend from a first one of the tissue-engaging surfaces, through tissue at a puncture site, to a second one of the tissue-engaging surfaces to close the tissue structure therebetween, each of the fasteners including a rear-facing recess;

a closure device applicator including a pair of jaws for installing the closure device;

a pair of alignment combs, each comb coupled with a jaw of the applicator and including one or more studs configured to releasably engage recesses of the fasteners, wherein the jaws of the applicator are configured to move the pair of combs closer together so as to cause deployment of the fasteners.

56. A system as in claim 55, wherein the pair of jaws comprises a pair of inner jaws coupled to the pair of alignment combs and a pair of outer jaws, wherein the applicator is configured to move the inner jaws apart independently of the outer jaws to release the studs from the recesses.

57. A system as in claim 55, wherein the jaws are configured to open in a parallel manner.

58. A system as in claim 55, wherein the jaws are configured to open about a pivot.

59. A system as in claim 55, wherein the tissue closure device further comprises an open well disposed in one of the tissue-engaging surfaces adjacent the puncture site.

60. A system as in claim 59, wherein the tissue-penetrating fasteners comprise a male connector and a female connector aligned on the opposed tissue-engaging surfaces.

61. A system as in claim 60, wherein the male connector includes a barb having a sharpened end configured to penetrate tissue.

62. A system as in claim 61, wherein the open well is disposed around the barb and extends into the first tissue-engaging surface, and wherein the open well has a diameter greater than a diameter of the barb.

63. A system as in claim 61, wherein the open well is disposed adjacent the female connector and extends into the second tissue-engaging surface.

64. A system as in claim 55, wherein the entire compression body is formed of a compliant material.

65. A system as in claim 55, wherein the compression body includes wells corresponding to each recess configured to allow the studs to engage the recesses.

66. A system as in claim 60, wherein the male and female connectors are configured to securely engage each other and create a set distance between the tissue-engaging surfaces.

67. A system as in claim 55, wherein the tissue-engaging surfaces have a durometer in the range from 3 shore A to 15 shore A.

68. A system as in claim 67, wherein the tissue-engaging surfaces are composed at least partly of a silicone or a polyurethane.

69. A system as in claim 60, wherein the compression body comprises a pair of parallel, opposed legs, wherein each leg carries a tissue-engaging surface and either the male or female connectors.

70. A system as in claim 55, wherein one of the tissue-engaging surfaces includes a stabilizing lip and is larger in area than the other tissue-engaging surface.

71. A system as in claim 55, wherein the compression body is made of a biodegradable material.

72. A system as in claim 55, wherein the fasteners comprise a biodegradable material.

73. A system as in claim 55, wherein the jaws are disposed in a plane offset from a plane of an applicator shaft.

74. A system as in claim 73, wherein the offset is 10 to 45 degrees.

75. A system as in claim 73, wherein the offset is 10 to 25 degrees.

76. A system as in claim 55, further comprising a lasso wire configured to deploy from a distal end of one of the jaws to be secured at a distal end of the other jaw to enclose a space between the jaws.