Transvascular bybass method and system

• US 20040097973A1
• Filed: 05/15/2003
• Published: 05/20/2004
• Est. Priority Date: 03/20/2000
• Status: Abandoned Application

• Current Assignee: By-Pass Incorporated
• Original Assignee: By-Pass Incorporated
• Inventors: Feld, Tanchum, Kilemnik, Ido, Yadin, Amnon, Nativ, Ofer, Loshakove, Amir
• Application Number:
  US10/239,364
• Publication Number:
  US 20040097973A1
• Time in Patent Office: Days
• US Class Current: 606/144
• 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 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 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 17/1152 applying the staples on the outside of the lumen
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor

Abstract

An anastomosis delivery system for delivering a connector having at least one backwards spike having a bent tip, comprising: a hollow guide sheath; and a hollow, axially slotted section, fitting within said sheath, said section having a flared configuration and an unflared configuration and wherein said axially slotted section is adapted to contain at least a part of said connector and to limit axial motion of said connector when said section is in its unflared configuration.

Claims

1. An anastomosis delivery system for delivering a connector having at least one backwards spike having a bent tip, comprising:

a hollow guide sheath; and

a hollow, axially slotted section, fitting within said sheath, said section having a flared configuration and an unflared configuration and wherein said axially slotted section is adapted to contain at least a part of said connector and to limit axial motion of said connector when said section is in its unflared configuration.

2. A system according to claim 1, wherein axially moving said section selectively advances said spike.

3. A system according to claim 1, wherein axially moving said section selectively retracts said spike.

4. A system according to claim 1, wherein said slotted section maintains said bent tip in a bent configuration.

5. A system according to claim 1, wherein said slotted section includes at least one receptacle for engaging said bent tip.

6. A system according to claim 5, wherein said receptacle comprises an inner lip of said section, adapted for catching said tip.

7. A system according to claim 5, wherein said receptacle comprises a hole in said section, for engaging said tip.

8. A system according to claim 1, wherein said section comprises a second, inner tube and wherein said inner tube and said slotted section define between them a receptacle for a bent section of at least one bent spike of connector.

9. A system according to claim 8, wherein said receptacle is a space between tips of said slotted section and said inner tube.

10. A system according to claim 7, wherein said receptacle is an opening in said inner tube.

11. A system according to claim 7, wherein said slotted section and said inner tube grip between them a part of said connector.

12. A system according to any of claims 1-11 wherein said slotted section comprises a capsule closed at one end.

13. An anastomosis delivery system for delivering a connector having at least one backwards spike having a bent tip, comprising:

a hollow guide sheath;

an apertured inner tube fitting within said sheath; and

a plurality of spike locking elements disposed between said guide sheath and said apertured inner tube, wherein said spike locking elements, when extended, are adapted to grip a part of said anastomosis connector between said inner tube and said locking elements and wherein said apertures are each adapted to receive a said bent tip of said anastomosis connector.

14. An anastomosis delivery system for delivering a connector having at least one backwards spike having a bent tip, comprising:

a hollow guide sheath;

a cylindrical capsule having one open end an one closed end; and

an anastomosis connector held in said capsule.

15. A system according to claim 14, comprising a stopper arranged between a plurality of said backwards spikes and urging said spikes towards said capsule

16. A method of mounting an anastomosis connector having a plurality of bent backwards spikes including bent tips, into a delivery tube, comprising:

bending back said spikes to point backwards along an axial direction of said connector, away from a graft mounted on said connector;

maintaining said tips in a bent configuration; and

inserting said spikes into a receptacle of said delivery tube, which receptacle maintains said tips in a bent configuration.

17. A method according to claim 16, wherein bending back comprises:

mounting a thin flexible tube on each of said spikes;

threading said tube through a plurality of tip holding apertures in said receptacle; and

retracting said tubes to bend said spikes and pull them into said receptacle.

18. A method according to claim 17, comprising:

locking said connector in place; and

retracting said tubes to remove them from said spikes.

19. A method according to claim 16, wherein bending back comprises:

pushing back each spike, using a jig, into said receptacle; and

locking said spike tip in said receptacle.

20. A guided punch, comprising:

a sharp, extendible guide wire; and

a hollow punch mechanism adapted to ride on the guide wire, wherein said guide wire is adapted to extend from said punch.

21. A punch according to claim 20, wherein said guide wire has a limited extension distance of less than 3 cm.

22. A punch according to claim 21, wherein said distance is shorter than 1 cm.

23. A punch according to claim 21, wherein said distance is greater than 0.3 cm.

24. A punch according to any of claims 20-23, wherein said punch comprises a hollow tube adapted to fit between said punch mechanism and said guide wire.

25. A punch according to any of claims 20-23, wherein said punch is a rotating punch.

26. A punch according to any of claims 20-23, wherein said punch is an axially moving punch.

27. A punch according to any of claims 20-23, wherein said punch is adapted for injection of contrast material inside of said hollow of said punch mechanism.

28. A rotating punch, comprising:

a sharp, central guide wire; and

a rotating outer tube having a vascular cutting edge defined by a lip of said tube.

29. A punch according to claim 28, wherein said outer tube advances as it is rotated.

30. A punch according to claim 29, wherein said advancing is limited to less than 3 cm.

31. A punch according to claim 29, wherein said advancing is limited to less than 1 cm.

32. A punch according to claim 29, wherein said punch is adapted for a particular target vessel, by matching said advancing limitation to the target vessel.

33. A punch according to claim 28, wherein said cutting edge is smooth.

34. A punch according to claim 28, wherein said cutting edge is serrated.

35. A punch according to claim 28, wherein said guide wire is smooth.

36. A punch according to claim 28, wherein said guide wire is adapted to engage vascular tissue it is inserted into.

37. A punch according to claim 28, comprising a hollow tube adapted to be brought over said guide wire and within said rotating outer tube.

38. A punch according to claim 37, wherein said punch is adapted for injection of contrast material inside of said hollow tube.

39. A punch according to any of claims 28-37, wherein said punch is adapted for injection of contrast material between said spike and said outer tube.

40. A punch according to any of claims 28-37, wherein said outer tube is bent at a right angle, such that positioning perpendicular to a vessel wall is assisted.

41. A punch according to any of claims 28-37, wherein said outer tube has an increasing outer diameter, away from said cutting edge.

42. A punch according to any of claims 28-37, comprising a balloon distal from said cutting edge, said balloon, when inflated, having an outer diameter slightly greater than a diameter of said outer tube and about the inner diameter of a sheath associated with said punch.

43. An advancing rotating punch, comprising:

a sharp, central guide wire; and

a rotating outer tube adapted to cut a target vessel which advances relative to said wire when it rotates.

44. A catheter system, comprising:

an outside sheath having an inner volume;

a first contrast injection port communicating with the inner volume of said sheath;

at least one inner mechanism conveyed by said sheath and having an inner volume; and

a second contrast injection port communicating with the inner volume of said inner mechanism.

45. A system according to claim 44, wherein said at least one inner mechanism comprises two switchable inner mechanisms.

46. A system according to claim 44, wherein said at least one inner mechanism comprises an inner tube and said system comprises a third contrast injection port associated with said inner tube.

47. A system according to claim 44, said sheath is bent to facilitate perpendicular positioning of a tip of said sheath against an inner wall of a target blood vessel.

48. A system according to claim 47, said inner mechanism is bent to match said bend in said sheath.

49. A system according to claim 47, comprising a straight guide wire adapted to fit in said sheath and maintain said sheath straight when said sheath is guided to a target area.

50. A system according to claim 44, wherein said at least one inner mechanism comprises a punch.

51. A system according to claim 50, comprising an inner tube having a diameter that varies, along its length between a diameter of said punch and an inner diameter of said sheath.

52. A system according to claim 50, comprising balloon distal of said punch and having a diameter that varies between a diameter of said punch and an inner diameter of said sheath.

53. An anastomotic connector, comprising:

a cylinder-like body; and

at least one set of spikes, coupled to said body by twisting joints.

54. A connector according to claim 53, wherein said spikes are adapted not to penetrate tissue which the spikes contact.

55. A connector according to claim 53, wherein said twisting joints comprise at least one torsion bar.

56. A connector according to claim 53, wherein said twisting joints comprise at least one bend area.

57. A connector according to claim 53, wherein said set of spikes are bent.

58. A connector according to claim 57, wherein said set of spikes are bent at two different locations along the spikes.

59. A connector according to claim 57, wherein each spike comprises two arms that meet at a tip of the spike and are each attached to a different part of said connector.

60. A connector according to claim 59, wherein each arm is attached to a base extension of said connector, by a twisting joint.

61. A connector according to claim 60, wherein said arms and said base extensions define a continuous curve.

62. A fixating guide sheath for insertion into a blood vessel, comprising:

an inner tube; and

an outer tube, slotted near an end thereof, wherein said inner tube is retracted relative to said outer tube, said slotted outer tube flares out to prevent further retraction of said sheath. 63. A sheath according to claim 62, wherein said sheath is bent near said end.