Anastomotic connector and graft expander for mounting a graft

• US 20030208214A1
• Filed: 06/02/2003
• Published: 11/06/2003
• Est. Priority Date: 03/20/2000
• Status: Abandoned Application

• Current Assignee: By-Pass Incorporated
• Original Assignee: By-Pass Incorporated
• Inventors: Feld, Tanchum, Kilemnik, Ido, Keren, Dvir, Loshakove, Amir
• Application Number:
  US10/239,365
• Publication Number:
  US 20030208214A1
• Time in Patent Office: Days
• US Class Current: 606/153
• 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 2017/0641 having at least three legs as part of one single body
• 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

Abstract

An anastomotic connector device (102) for mounting a graft (100) in which the connector has spikes (106) defining a periphery around the base ring (104). Also a graft expander (900) having a body (906), a lower diameter tube portion (908) connected by truncated cone (910) and a finger rest (902) and plunger (904).

Claims

1. A method of mounting a graft on a spiked connector, in which the tips of the spikes define a periphery, comprising:

placing the graft, in said periphery, between tips of said spikes and a piercable element;

impaling said piercable element on said spikes, such that the graft is also impaled on said spikes; and

removing said piercable element from said spikes.

2. A method according to claim 1, comprising, pulling back impaled parts of said graft to a side of the spikes opposite said tips.

3. A method according to claim 1, wherein said piercable element is expandable, the method comprising inflating said expandable element.

4. A method according to claim 3, wherein said expansion impales said element on said spikes.

5. A method according to claim 3, wherein said expansion at least partially everts said graft.

6. A method according to claim 1, wherein said impaling comprises advancing said spike tips towards said graft.

7. A method according to claim 1, wherein said impaling comprises releasing said spike tips to advance towards said graft.

8. A method according to claim 1, comprising bending said spike tips into hooks after said impaling.

9. A method according to claim 1, comprising forming said spike tips into hooks before said impaling.

10. A method of mounting a graft on a spiked connector, comprising:

placing the graft between tips of said spikes and an element having a general outer perimeter;

advancing said spikes relative to said element such that said spikes penetrate said graft and penetrate said perimeter; and

removing said element.

11. A method according to claim 10, wherein said element is formed of a hard material and includes a plurality of depressions to receive said spikes.

12. A method according to claim 11, wherein said spikes are pre-bent and wherein said depressions guide an unbending of said spikes.

13. A method according to claim 10, wherein said element is piercable by said spikes.

14. A method according to claim 10, wherein said element is expandable.

15. A method according to claim 10, wherein said element is non-expandable.

16. A method according to any of claims 10-15, wherein advancing said spikes comprises advancing spikes that are adapted for engaging a target vessel of the anastomosis.

17. A method of mounting a graft on a connector having a plurality of spikes arranged around a central opening, said spikes having radially outward pointing hooks, comprising:

folding said spikes such that said hooks point inward into said central opening and define a periphery between them;

inserting a graft into said periphery;

advancing said hooks relative to said graft, to penetrate said graft; and

repositioning said hooks to point outward.

18. A method according to claim 17, wherein advancing said hooks comprises releasing said spikes.

19. A method according to claim 17, wherein advancing said hooks comprises moving said spikes.

20. A method according to claim 17, wherein advancing said hooks relative to said graft comprises radially expanding said graft towards said hooks.

21. A method according to claim 17, comprising, inserting a contra mandrel in said graft, to limit an advance of said hooks.

22. A method according to claim 21, wherein said contra mandrel guides said repositioning.

23. A method according to any of claims 17-22, wherein repositioning said hooks comprises unfolding said spikes.

24. A method of mounting a graft on a connector having a plurality of spikes arranged around a central opening, said spikes having radially outward pointing hooks, comprising:

inserting a graft into a periphery defined by forward ends of said spikes, in a first direction;

folding back a tip of said graft to cover said hooks; and

pulling back said graft, in a direction opposite said first direction, such that said hooks engage said folded part of said graft.

25. A method according to claim 24, wherein pulling back said graft comprises sharply pulling on said graft.

26. A method according to claim 24, comprising advancing said engaged part of said graft towards a base of said spikes, in said opposite direction.

27. A method according to any of claims 24-26, wherein said spikes define a cone, with said hooks at an apex of said cone.

28. A method of forming spike tips of an anastomotic connector, into hooks for engaging blood vessels, comprising:

providing an anastomosis connector having a plurality of straight spikes having tips;

first bending said tips at a first angle, using a first mandrel; and

second bending a furtherly distal portion of said tips using a second mandrel, to form a hook shape of said tips.

29. A method according to claim 28, comprising mounting a graft on said spikes of said connector prior to said first bending.

30. A method according to claim 28 or claim 29, wherein said first and said second mandrel have different outside diameters.

31. An anastomotic connector, comprising:

a base ring; and

a plurality of hooked spikes that pass through said base ring, which spikes include a weakening adjacent said hooks,

wherein a position of said weakening on said spikes is located on said spike so that the spikes can be torn off at said weakening by retracting said spikes relative to said hooks.

32. A connector according to claim 31, wherein said spikes include an extension perpendicular to said spike and distal of said weakening.

33. A connector according to claim 32, wherein said extension has an extent greater than apertures in said base ring through which said spikes pass.

34. A connector according to claim 32, wherein said extension is adapted to serve as a base for holding said hooks, when tearing said spikes.

35. A connector according to claim 31, wherein said spike have tips that are pre-stressed to bend when said spike is torn.

36. A connector according to claim 32, wherein said extension serves as a ratchet mechanism.

37. A connector according to claim 31, wherein said base ring comprises a plurality of apertures for said spikes.

38. A connector according to claim 37, wherein the apertures include a spring formed of said base ring.

39. An anastomotic connector, comprising:

a base ring; and

a plurality of target spikes, adapted to engage a target vessel, which target spikes pass through said ring; and

a plurality of retractable pulling spikes, having tips adapted to engage a graft placed in the lumen of said ring, and being adapted to at least partially evert a lip of said graft when said pulling spikes are retracted.

40. A connector according to claim 39, wherein said target spikes are hooked.

41. A connector according to claim 39, wherein said target spikes are inclined towards an axis of said connector.

42. A connector according to claim 39, wherein said puller spikes are provided through said base ring.

43. A connector according to claim 39, wherein said puller spikes are provided through a ring other than said base ring.

44. A connector according to claim 39, wherein said puller spikes include at least one weakened location, to facilitate tearing of said spikes.

45. A connector according to claim 39, wherein said puller spikes are adapted to be straightened by said ring, when they are retracted.

46. A method of performing an anastomosis, comprising:

engaging at least one of the vessels of a two vessel anastomosis, using a plurality of retractable spikes;

retracting said plurality of retractable spikes, to cause at least a partial eversion of said vessel.

47. A method according to claim 46, comprising, completing said anastomosis.

48. A method according to claim 46, comprising, removing said retractable spikes.

49. A method of partially everting a graft on a connector, comprising:

inserting a graft into a ring shaped anastomosis connector having a plurality of spikes; and

pulling an end of said graft radially out, so that said end abuts said spikes adjacent the spikes and extends radially out of said spikes between said spikes.

50. A method according to claim 49, wherein said pulling comprises pulling using retractable spikes.

51. A method of twisting hook-tipped spikes in a ring-type anastomotic connector so that the hooks point inward rather than outward, comprising:

arranging said spikes between two rings; and

rotating one of said rings relative to the other of said rings such that said spikes are twisted at least 120°

.

52. A method according to claim 51, wherein at least one of said rings comprises a rubber ring.

53. A method according to claim 51, comprising holding said twisted spikes in a twisted configuration, during an eversion process.

54. A method of selecting an anastomotic connector for a graft, comprising:

test everting a graft on a hollow, tubular gauge having a gauge diameter; and

if said everting succeeds, selecting a connector having a size that matches said gauge diameter.

55. A method according to claim 54, wherein said selected connector is pre-loaded in a delivery system, in a sterile package.

56. A method according to claim 55, wherein said package is color-coded to match said gauge.

57. A method according to claim 54, wherein test everting comprises comprising selecting first a larger gauge for test-everting.

58. A method according to claim 54, wherein test everting comprises selecting first a smaller gauge for test-everting, first.

59. A medical graft expander, comprising:

a body having a first diameter;

a tube having a second diameter smaller than said first diameter, mounted at an end of said body, and defining an inner chamber; and

a shaft, positioned in said body and axially advancable into said chamber, said shaft having at least one section with a diameter greater than a diameter of said chamber, such that when said section is advanced into said chamber, said tube is radially expanded.

60. An expander according to claim 59, wherein said tube is made of a soft material.

61. An expander according to claim 60, wherein said tube is made of silicone.

62. An expander according to claim 59, wherein said tube is sized to be larger than an inner diameter of a graft, when the tube is expanded.

63. An expander according to claim 59, wherein said tube is sized to match an inner diameter of a graft, when the tube is expanded.

64. A graft everting method, comprising:

mounting at least an end of said graft on an expandable tube;

expanding said tube to engage and expand said graft, and

rolling back at least a portion of said end over itself.

65. A method according to claim 64, comprising, providing a tube over said graft, so said rolling back is on to said tube.

66. A method according to claim 65, wherein said tube is pre-loaded with an anastomotic connector.