SYSTEMS AND METHODS FOR PUNCTURE CLOSURE

• US 20090125056A1
• Filed: 08/15/2008
• Published: 05/14/2009
• Est. Priority Date: 08/15/2007
• Status: Active Grant

• Current Assignee: Cardiodex, Ltd.
• Original Assignee: Cardiodex, Ltd.
• Inventors: Mizrahi, Noam, Cohen, Aharon, Logan, Julie, Goldberg, Eran, Eckhouse, Shimon, Buchbinder, Maurice, Yadin, Amnon
• Granted Patent: US 8,366,706 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: B23P 6/00 Restoring or reconditioning objects straightening or restoring form of sheet metal, metal rods, metal tubes, metal profiles, or specific articles made therefrom B21D1/00, B21D3/00; repairing defective or damaged objects by casting techniques B22D19/10
• CPC Class Codes: Y10T 137/598 With repair, tapping, assembly, or disassembly means

Abstract

Systems, apparatuses and methods are provided for use in closing punctures in vessel walls. An apparatus may have various combinations of an anchoring device, a positioning device and a heating element for closing a puncture within a vessel wall. An anchoring device may be a balloon, an expansible cage, a wire operated T-anchor, and/or a floating anchor. A positioning device may be a balloon, a sponge, and/or an expansible cage. A heating element may be flexible or rigid and preferably provides heat to target tissue through conduction and convection. A heating element may be flat-ended or dome-shaped. The heating element and anchoring device may be positioned a fixed distance apart to sandwich tissue between the heating element and the anchoring device. The heating element may operate in multiple stages. An initial stage may non-permanently adhere the heating element to the tissue and the subsequent stage may close the puncture.

Claims

1. An apparatus for closing a puncture in a vessel wall comprising:

an anchor shaft,

an anchor coupled to a distal end of the anchor shaft wherein the anchor is deployed within a vessel lumen and moved into contact with an inner surface of a vessel wall,

a heating element for passing over the anchor shaft to a position a predetermined distance from the anchor, wherein the heating element is not within the vessel lumen, and

wherein tissue is compressed between the anchor and the heating element during activation of the heating element.

2. The apparatus of claim 1, wherein the anchor is selected from the group consisting of a balloon, a T-anchor, an expansible cage, a floating anchor, and combinations thereof.

3. The apparatus of claim 1, further comprising a positioning device passing over the anchor shaft.

4. The apparatus of claim 3, wherein the positioning device is selected from the group consisting of a balloon, a sponge, an expansible cage, and combinations thereof.

5. The apparatus of claim 1, wherein the heating element is selected from the group consisting of flat-ended, dome-shaped, flattened dome-shaped, and combinations thereof.

6. The apparatus of claim 1, wherein the heating element comprises a patterned conducting element.

7. The apparatus of claim 1, further comprising a coating on the heating element.

8. The apparatus of claim 7, wherein the coating on the heating element is silicone.

9. The apparatus of claim 1, wherein the heating element comprises two or more segments coupled together to create a unified heating element.

10. The apparatus of claim 1, wherein the heating element is flexible.

11. The apparatus of claim 10, wherein the heating element is positioned by movement of a shaft of an introducer, wherein the shaft retains the heating element in a compressed position until withdrawal of the introducer shaft.

12. The apparatus of claim 10, wherein the heating element is positioned by expansion of a positioning device.

13. The apparatus of claim 1, wherein the heating element is rigid.

14. The apparatus of claim 1, wherein the predetermined distance is approximately 1-2 mm.

15. A method of closing a puncture in a vessel wall comprising:

providing an apparatus comprising;

an anchor shaft,

an anchor coupled to a distal end of the anchor shaft, and

a heating element,

inserting the distal end of the anchor shaft into a vessel lumen through a puncture,

deploying the anchor within the vessel lumen,

inserting the heating element to a position a predetermined distance from the anchor, wherein the heating element is not within the vessel lumen and tissue is compressed between the anchor and the heating element,

withdrawing the anchor device through the heating element,

activating the heating element, and

withdrawing the heating element.

16. The method of claim 15, further comprising moving the anchor against an inner surface of the vessel wall proximate to the puncture prior to inserting the heating element.

17. The method of claim 15, wherein the anchor is selected from the group consisting of a balloon, a T-anchor, an expansible cage, a floating anchor, and combinations thereof.

18. The method of claim 15, further comprising inserting a positioning device over the anchor shaft.

19. The method of claim 18, wherein the positioning device is selected from the group consisting of a balloon, a sponge, an expansible cage, and combinations thereof.

20. The method of claim 15, wherein the heating element is selected from the group consisting of a flat-ended heating element, a dome-shaped heating element, a flattened dome-shaped heating element, and combinations thereof.

21. The method of claim 15, wherein the heating element comprises two or more segments coupled together to create a unified heating element.

22. The method of claim 15, wherein the heating element is flexible.

23. An apparatus for closing a puncture in a vessel wall comprising:

an anchor shaft,

an anchor coupled to a distal end of the anchor shaft wherein the anchor is deployed within a vessel lumen and moved into contact with an inner surface of a vessel wall, and

a two-stage heating element passing over the anchor shaft into proximity with an outer surface of the vessel wall opposite the anchor.

24. The apparatus of claim 23, wherein the anchor is selected from the group consisting of a balloon, a T-anchor, an expansible cage, a floating anchor, and combinations thereof.

25. The apparatus of claim 23, wherein the heating element is selected from the group consisting of a flat-ended heating element, a dome-shaped heating element, a flattened dome-shaped heating element, and combinations thereof.

26. The apparatus of claim 23, wherein the first stage of the two-stage heating element applies heat sufficient to minimally bind the vessel wall to the heating element.

27. The apparatus of claim 26, wherein the second stage of the two-stage heating element applies heat sufficient to close the vessel wall.

28. The apparatus of claim 27, wherein the anchor device is withdrawn through the heating element prior to the second stage.

29. The apparatus of claim 23, wherein the vessel wall and tissue is sandwiched between the anchor and the heating element.

30. The apparatus of claim 23, wherein the heating element is controlled by a handheld unit.

31. A method of closing a puncture in a vessel wall comprising:

providing an apparatus comprising;

an anchor shaft,

an anchor coupled to a distal end of the anchor shaft, and

a heating element,

inserting the distal end of the anchor shaft into a vessel lumen through a puncture,

deploying the anchor within the vessel lumen,

inserting the heating element into the vicinity of the puncture,

initially heating the heating element for minimally adhering tissue to the heating element,

withdrawing the anchor device through the heating element,

completely activating the heating element, and

withdrawing the heating element.

32. The method of claim 31, further comprising sandwiching tissue between the anchor and the heating element.

33. The method of claim 31, wherein the anchor is selected from the group consisting of a balloon, a T-anchor, an expansible cage, a floating anchor, and combinations thereof.

34. The method of claim 31, wherein the heating element is selected from the group consisting of a flat-ended heating element, a dome-shaped heating element, a flattened dome-shaped heating element, and combinations thereof.

35. An apparatus for closing a puncture in a vessel wall comprising:

an anchor shaft,

an anchor coupled to a distal end of the anchor shaft wherein the anchor is deployed within a vessel lumen and moved into contact with an inner surface of a vessel wall,

a heating element adapted to pass over the anchor shaft into proximity with an outer surface of the vessel wall opposite the anchor, and

a pass-through device at least partially surrounding the anchor shaft for facilitating passage of the heating element over the anchor shaft into proximity with the outer surface of the vessel wall opposite the anchor.

36. The apparatus of claim 35, wherein the anchor is selected from the group consisting of a balloon, a T-anchor, an expansible cage, a floating anchor, and combinations thereof.

37. The apparatus of claim 35, wherein the anchor is a nitinol cage covered by a membrane.

38. The apparatus of claim 37, wherein the membrane comprises at least silicone.

39. The apparatus of claim 37, wherein the nitinol cage is substantially planar in an expanded position.

40. The apparatus of claim 35, wherein the heating element is selected from the group consisting of a flat-ended heating element, a dome-shaped heating element, a flattened dome-shaped heating element, and combinations thereof.

41. The apparatus of claim 35, wherein the heating element is a two-stage heating element.

42. The apparatus of claim 41, wherein the first stage of the two-stage heating element applies heat sufficient to minimally bind the vessel wall to the heating element.

43. The apparatus of claim 42, wherein the second stage of the two-stage heating element applies heat sufficient to substantially close the vessel wall.

44. The apparatus of claim 43, wherein the anchor device is withdrawn through the heating element prior to the second stage.

45. The apparatus of claim 35, wherein the vessel wall and tissue is sandwiched between the anchor and the heating element.

46. The apparatus of claim 35, further comprising a guide wire deployed within a vessel lumen with the anchor shaft, wherein the guide wire remains within the vessel lumen after removal of the anchor.

47. The apparatus of claim 46, wherein the guide wire indicates position of the heating element relative to the vessel wall.

48. The apparatus of claim 35, wherein the pass-through device is a roll coupled to the anchor shaft.

49. The apparatus of claim 48, wherein the roll has one or more slits for allowing expansion of the roll.

50. The apparatus of claim 35, wherein pass-through device is a dilator.

51. The apparatus of claim 35, further comprising indicator marks on an anchor shaft coupled to the anchor, wherein the indicators indicate a correct position of the anchor.

52. The apparatus of claim 35, further comprising a large tip on the anchor, wherein the large tip fits flush with a distal end of the heating element when the anchor is withdrawn.

53. A method of closing a puncture in a vessel wall comprising:

providing an apparatus comprising;

an anchor shaft,

an anchor coupled to a distal end of the anchor shaft,

a pass-through device at least partially surrounding the anchor shaft, and

a heating element,

inserting the distal end of the anchor shaft into a vessel lumen through a puncture,

deploying the anchor within the vessel lumen,

inserting the heating element into the vicinity of the puncture by passing the heating element through the pass-through device,

withdrawing the pass-through device after positioning the heating element,

activating the heating element,

withdrawing the anchor, and

withdrawing the heating element.

54. The method of claim 53, wherein the pass-through device is withdrawn by applying pressure away from a distal end of the anchor shaft.

55. The method of claim 53, wherein activating the heating element comprises initially heating the heating element for minimally adhering tissue to the heating element, and secondarily heating the heating element.

56. The method of claim 55, wherein the anchor is withdrawn through the heating element between the initial heating and the secondary heating.

57. The method of claim 53, further comprising sandwiching tissue between the anchor and the heating element.

58. The method of claim 53, wherein the anchor is selected from the group consisting of a balloon, a T-anchor, an expansible cage, a floating anchor, and combinations thereof.

59. The method of claim 53, wherein the heating element is selected from the group consisting of a flat-ended heating element, a dome-shaped heating element, a flattened dome-shaped heating element, and combinations thereof.

60. The method of claim 53, further comprising inserting a guide wire into the vessel lumen with the anchor.

61. The method of claim 60, further comprising measuring position of the heating element with the guide wire.