Systems and methods of tissue closure

• US 7,992,757 B2
• Filed: 05/03/2007
• Issued: 08/09/2011
• 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.
• Primary Examiner(s): Smith; Scott A.
• Application Number:
  US11/744,135
• Publication Number:
  US 20070260278A1
• Time in Patent Office: 1,559 Days
• Field of Search: 227/19, 227/176.1, 227/175.1, 227/180.1, 606/139, 606/219
• US Class Current: 227/176.1
• 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 compressible body comprising a pair of parallel legs having two opposed compliant tissue-engaging surfaces, wherein the legs are each comprised of a soft biologically compatible polymer; and

a plurality of tissue-penetrating fasteners spaced-apart along the legs and 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 compressible body includes wells corresponding to each recess.

9. 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.

10. A tissue closure device as in claim 1, wherein the entire compressible body is formed of the soft, biologically compatible polymer.

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 soft compliant polymer comprises a silicone or a polyurethane.

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

14. A tissue closure device as in claim 1, wherein the parallel opposed legs are connected to form a continuous ring structure.

15. A tissue closure device as in claim 1, wherein the legs are joined at only one end.

16. A tissue closure device as in claim 1, wherein the legs are not joined at either end.

17. A tissue closure device as in claim 1, wherein the compressible body further comprises a vacuum plenum with each leg of the compressible body.

18. A tissue closure device as in claim 17, wherein the vacuum plenum opens to a plurality of ports along at least one surface of the legs of the compressible body, wherein the ports are oriented in a direction different than that of the tissue-penetrating fasteners.

19. A tissue closure device as in claim 18, wherein the ports are oriented at a generally perpendicular angle relative to the fasteners.

20. A tissue closure device as in claim 17, wherein the plenum has at least one port for receiving a vacuum probe.

21. A tissue closure device as in claim 1, wherein the soft, biologically compatible polymer comprises a biodegradable material.

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

23. 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 compressible body after deployment.

24. A system as in claim 1, wherein the opposed legs are connected to form a continuous ring structure.

25. A system as in claim 1, wherein the legs are joined at only one end.

26. A system as in claim 1, wherein the legs are not joined at either end.

27. A system as in a claim 1, wherein the closure device applicator comprises a jaw mechanism which carries two probes, wherein each probe detachably engages one leg of the compressible body.

28. A system as in claim 27, wherein at least one of the probes has a lumen which provides a portion of the vacuum path.

29. A system as in claim 28, wherein the at least one probe is received in a vacuum plenum in the at least one leg of compressible body of the closure device.

30. A tissue closure device as in claim 29, wherein vacuum the plenum is open over at least a portion of the at least two tissue-engaging surfaces.

31. A tissue closure device as in claim 30, wherein the plenum is open through a plurality of ports distributed over the tissue-engaging surface.

32. A tissue closure device as in claim 29, wherein the plenum has a port for receiving the probe(s).

33. A system as in claim 27, wherein the probes of the jaw mechanism are joined by a mechanical spreading mechanism.

34. A system as in claim 33, wherein the mechanical spreading mechanism comprises a rack-and-pinion mechanism which opens the legs in a parallel manner.

35. A system as in claim 33, wherein the mechanical spreading mechanism comprises a pivot mechanism which pivotally opens the legs.

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

a closure device including a compressible body comprising a pair of parallel legs with opposed compliant tissue-engaging surfaces, wherein the legs are each comprised of a soft, biologically compatible polymer;

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

a vacuum path through the applicator and closure device for applying a vacuum between the legs of closure device and the tissue structure when the legs are 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 legs of the tissue structure therebetween.

37. A system as in claim 36, wherein the surfaces of the tissue-engaging surfaces have a durometer in the range from 3 shore A to 15 shore A.

38. A system as in claim 36, wherein the soft, biologically compatible polymer comprise a silicone or polyurethane.

39. A system as in claim 36, said system further comprising a source of a substance to be delivered to the tissue structure, said source being connect to the vacuum path so that said substance can be delivered when the vacuum is turned off.

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

a closure device including a compressible body comprising a pair of legs having opposed compliant tissue-engaging surfaces, wherein the legs are each comprised of a soft, biologically compatible polymer;

a plurality of tissue-penetrating fasteners spaced-apart along the legs and 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.

41. A system as in claim 40, 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.

42. A system as in claim 40, wherein the jaws are configured to open in a parallel manner.

43. A system as in claim 40, wherein the jaws are configured to open about a pivot.

44. A system as in claim 40, wherein the tissue closure device further comprises an open well disposed in one of the tissue-engaging surfaces adjacent the puncture site.

45. A system as in claim 44, wherein the tissue-penetrating fasteners comprise a male connector and a female connector aligned on the opposed tissue-engaging surfaces.

46. A system as in claim 45, wherein the male connector includes a barb having a sharpened end configured to penetrate tissue.

47. A system as in claim 46, 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.

48. A system as in claim 46, wherein the open well is disposed adjacent the female connector and extends into the second tissue-engaging surface.

49. A system as in claim 45, wherein the male and female connectors are configured to securely engage each other and create a set distance between the tissue-engaging surfaces.

50. A system as in claim 40, wherein the entire compressible body is formed of the soft, biologically compatible polymer.

51. A system as in claim 40, wherein the compressible body includes wells corresponding to each recess configured to allow the studs to engage the recesses.

52. A system as in claim 40, wherein the tissue-engaging surfaces have a durometer in the range from 3 shore A to 15 shore A.

53. A system as in claim 52, wherein the soft, compliant polymer comprises a silicone or a polyurethane.

54. A system as in claim 40, wherein one of the tissue-engaging surfaces includes a stabilizing lip and is larger in area than the other tissue-engaging surface.

55. A system as in claim 40, wherein the compressible body is made of a biodegradable material.

56. A system as in claim 40, wherein the fasteners comprise a biodegradable material.

57. A system as in claim 40, wherein the jaws are disposed in a plane offset from a plane of an applicator shaft.

58. A system as in claim 57, wherein the offset is 10 to 45 degrees.

59. A system as in claim 57, wherein the offset is 10 to 25 degrees.

60. A system as in claim 40, 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.