DEVICES AND METHODS FOR FORMING TRACTS IN TISSUE

• US 20100016810A1
• Filed: 07/21/2009
• Published: 01/21/2010
• Est. Priority Date: 07/21/2008
• Status: Abandoned Application

• Current Assignee: Arstasis, Inc.
• Original Assignee: Arstasis, Inc.
• Inventors: Modesitt, D. Bruce, DREWS, Michael
• Application Number:
  US12/507,043
• Publication Number:
  US 20100016810A1
• Time in Patent Office: Days
• US Class Current: 604/272
• CPC Class Codes: A61B 1/313 for introducing through surgical openings, e.g. laparoscopes
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00676 promotion of self-sealing of the puncture

Abstract

Described here are devices and methods for forming one or more tracts in tissue. The tracts may be formed in any suitable or desirable tissue, and may seal relatively quickly without the need for a supplemental closure device. In some variations, the methods may comprise clamping at least a portion of a tissue and advancing a tissue-piercing member through the clamped tissue to form a tract. The tract may, for example, provide access for one or more tools.

Claims

1. A device for forming a tract in tissue comprising:

a clamping member comprising a first elongated clamping arm and a second elongated clamping arm configured to clamp tissue therebetween; and

a tissue-piercing member configured to form a tract in at least a portion of the clamped tissue.

2. The device of claim 1, further comprising a housing.

3. The device of claim 2, wherein the tissue-piercing member is slidably disposed within the housing.

4. The device of claim 1, wherein the first and second elongated clamping arms are coupled to each other by a hinge.

5. The device of claim 1, wherein the tissue-piercing member is a needle.

6. The device of claim 5, wherein the needle is hollow.

7. A method for forming a tract in tissue of a subject comprising:

clamping at least a portion of tissue between a first elongated clamping arm and a second elongated clamping arm of a clamping member; and

advancing a tissue-piercing member in a first direction through at least a portion of the clamped tissue to form a tract in the tissue.

8. The method of claim 7, wherein the first elongated clamping arm contacts the portion of tissue while the second elongated clamping arm does not contact the portion of tissue.

9. The method of claim 8, wherein the second elongated clamping arm contacts a skin surface of the subject.

10. The method of claim 7, further comprising advancing the clamping member through an opening in the tissue prior to clamping at least a portion of the tissue with the clamping member.

11. The method of claim 10, wherein advancing the clamping member through the opening in the tissue comprises advancing the clamping member over a guidewire.

12. The method of claim 7, wherein the tissue is tissue of a vessel wall.

13. The method of claim 12, wherein the tissue is tissue of an arterial wall.

14. The method of claim 7, wherein the tissue comprises an organ.

15. The method of claim 14, wherein the organ is selected from the group consisting of an organ of the cardiovascular system, an organ of the digestive system, an organ of the respiratory system, an organ of the excretory system, an organ of the reproductive system, and an organ of the nervous system.

16. The method of claim 14, wherein the organ is an organ of the digestive system.

17. The method of claim 16, wherein the organ is a stomach.

18. The method of claim 7, wherein the tissue-piercing member enters the clamped tissue at a first location, and exits the clamped tissue at a second location, and wherein the length between the first and second locations is greater than the thickness of the tissue.

19. The method of claim 7, wherein the length of the tract is greater than the thickness of the tissue.

20. The method of claim 7, further comprising advancing one or more tools through the tract.

21. The method of claim 7, further comprising withdrawing the tissue-piercing member from the tissue.

22. The method of claim 21, wherein the tract self-seals after the tissue-piercing member has been withdrawn from the tissue.

23. The method of claim 22, wherein the tract self-seals within 15 minutes or less.

24. The method of claim 22, wherein the tract self-seals within 5 minutes or less.

25. The method of claim 22, wherein the tract self-seals within 1 minute or less.

26. A device for forming a tract in tissue comprising:

an elongated member;

a body coupled to the elongated member;

a foot portion coupled to the elongated member; and

a tissue-piercing member configured to be advanced from the body, wherein the body is configured to displace a first portion of a tissue in a first direction and the foot portion is configured to displace a second portion of the tissue in a second direction that is different from the first direction.

27. The device of claim 26, wherein the second direction is opposite the first direction.

28. The device of claim 26, wherein the tissue-piercing member is a needle.

29. A method for forming a tract in tissue comprising:

contacting a tissue with a device comprising an elongated member, a body coupled to the elongated member, and a foot portion coupled to the elongated member to displace a first portion of the tissue in a first direction and a second portion of the tissue in a second direction that is different from the first direction; and

advancing a tissue-piercing member through the displaced second portion of the tissue to form a tract in the tissue.

30. A device for forming a tract in tissue comprising:

a clamping member comprising a first expandable region and a second expandable region configured to clamp tissue therebetween; and

a tissue-piercing member configured to form a tract in at least a portion of the clamped tissue.

31. The device of claim 30, wherein the first expandable region comprises a first inflatable member.

32. The device of claim 31, wherein the second expandable region comprises a second inflatable member.

33. The device of claim 30, wherein the tissue-piercing member is a needle.

34. A method for forming a tract in tissue comprising:

clamping tissue between a first region of a clamping member and a second region of the clamping member when each of the first and second regions is in an expanded configuration; and

advancing a tissue-piercing member through at least a portion of the clamped tissue to form a tract in the tissue.

35. A device for use in forming tissue tracts comprising:

a first curved surface; and

a second curved surface opposed to the first curved surface and coupled to the first curved surface at an attachment point, the first and second curved surfaces configured to move about the attachment point between a first collapsed position and a second outwardly displaced position,

wherein the device defines a lumen configured to receive a tissue-piercing member, and wherein the first and second curved surfaces, when in the first collapsed position, are configured to clamp tissue and to position at least a portion of the tissue for piercing by a tissue-piercing member passing through the lumen.

36. The device of claim 35, further comprising a tissue-piercing member.

37. The device of claim 36, wherein the tissue-piercing member is a needle.

38. The device of claim 35, wherein the first and second curved surfaces, when in the first collapsed position, are configured to substantially surround a vessel and to position at least a portion of a wall of the vessel for piercing by a tissue-piercing member passing through the lumen.

39. A method for forming a tract in tissue using a device comprising first and second curved surfaces that are opposed to each other and coupled at an attachment point, the first and second curved surfaces configured to move about the attachment point between a first collapsed position and a second outwardly displaced position, the method comprising:

moving the first and second curved surfaces from the second outwardly displaced position to the first collapsed position to clamp tissue between the first and second curved surfaces,

wherein the first and second curved surfaces position at least a portion of the clamped tissue for piercing by a tissue-piercing member passing through a lumen defined by the device.

40. The method of claim 39, further comprising advancing a tissue-piercing member through at least a portion of the clamped tissue.

41. A method for forming a tract in tissue of a subject comprising:

clamping at least a portion of tissue; and

advancing a tissue-piercing member in a first direction through at least a portion of the clamped tissue to form a tract in the tissue,

wherein formation of the tract requires advancement of only one tissue-piercing member through the tissue, and wherein the tract is self-sealing.

42. The method of claim 41, wherein the tissue-piercing member comprises a needle.

43. The method of claim 42, wherein the needle is hollow.

44. The method of claim 41, wherein the tissue is clamped between first and second clamping portions of a clamping member.

45. The method of claim 44, wherein the first and second clamping portions comprise first and second elongated clamping arms.

46. The method of claim 44, wherein the clamping member has a first position and a second position, and wherein the first and second clamping portions are farther apart from each other in the first position than they are in the second position.

47. The method of claim 46, further comprising advancing the clamping member to the portion of tissue while the clamping member is in the second position.

48. The method of claim 47, wherein the clamping member is in the first position prior to clamping at least a portion of the tissue.

49. The method of claim 41, wherein the tissue is clamped between opposed first and second curved surfaces coupled at an attachment point and configured to move about the attachment point between a first collapsed position and a second outwardly displaced position.

50. The method of claim 41, further comprising advancing the tissue-piercing member in a second direction through at least a portion of the clamped tissue.

51. The method of claim 41, wherein the tissue comprises a vessel.

52. The method of claim 51, wherein the tissue comprises an artery, and the tract is an arteriotomy.

53. The method of claim 41, further comprising withdrawing the first tissue-piercing member from the tissue, wherein the tract seals after the first tissue-piercing member has been withdrawn.

54. The method of claim 53, wherein the tract seals within 15 minutes or less.

55. The method of claim 53, wherein the tract seals within 5 minutes or less.

56. The method of claim 53, wherein the tract seals within 1 minute or less.

57. The method of claim 41, further comprising advancing one or more tools through the tract.

58. A method for forming a tract in tissue of a subject comprising:

clamping at least a portion of tissue; and

advancing a tissue-piercing member in a first direction through at least a portion of the clamped tissue to form a single tract in the tissue,

wherein the single tract is self-sealing.

59. The method of claim 58, wherein the tissue comprises a vessel.

60. The method of claim 59, wherein the tissue comprises an artery, and the tract is an arteriotomy.

61. The method of claim 58, further comprising withdrawing the first tissue-piercing member from the tissue, wherein the tract seals after the first tissue-piercing member has been withdrawn.

62. The method of claim 61, wherein the tract seals within 15 minutes or less.

63. The method of claim 61, wherein the tract seals within 5 minutes or less.

64. The method of claim 61, wherein the tract seals within 1 minute or less.

65. A method for forming a tract in tissue of a subject comprising:

using a device to clamp at least a portion of tissue; and

forming a tract in the tissue by advancing at least one tissue-piercing member through at least a portion of the clamped tissue,

wherein formation of the tract requires advancement only of the tissue-piercing member through the tissue, and wherein the tract is self-sealing.

66. The method of claim 65, wherein the tissue comprises a vessel.

67. The method of claim 66, wherein the tissue comprises an artery, and the tract is an arteriotomy.

68. The method of claim 65, further comprising withdrawing the first tissue-piercing member from the tissue, wherein the tract seals after the first tissue-piercing member has been withdrawn.

69. The method of claim 68, wherein the tract seals within 15 minutes or less.

70. The method of claim 68, wherein the tract seals within 5 minutes or less.

71. The method of claim 68, wherein the tract seals within 1 minute or less.