Prosthesis Fixation Apparatus and Methods

• US 20070219627A1
• Filed: 03/17/2006
• Published: 09/20/2007
• Est. Priority Date: 03/17/2006
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Chu, Jack, Morris, Jonathan, Machek, James
• Granted Patent: US 7,955,380 B2
• Time in Patent Office: Days
• US Class Current: 623/1.360
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/1157 applying the staples radially
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs

Abstract

A method of securing a prosthesis placed at a desired site in a passageway of a human body comprises delivering a fastener having a proximal piercing end portion and a distal piercing end portion to a site where a prosthesis having a tubular wall has been placed in the passageway, which has a wall, advancing the proximal piercing end portion beyond the prosthesis, penetrating the proximal piercing end portion into the wall of the passageway without passing the proximal piercing end portion through the tubular wall of the prosthesis, and passing the distal piercing end portion through the tubular wall of the prosthesis and into the wall of the passageway. One surgical fastener delivery apparatus for delivering a surgical fastener to a target site comprises a support having a first end, a second end, and a longitudinal axis and being adapted for placement in a passageway in a human body. A surgical fastener having a first piercing end portion, a second piercing end portion and a central portion extending therebetween and having a longitudinal axis is releasably mounted to the support with the central portion longitudinal axis generally parallel to the support longitudinal axis.

Claims

1. A method of securing a prosthesis placed at a desired site in a passageway of a human body comprising:

delivering a fastener having a proximal piercing end portion and a distal piercing end portion to a site where a prosthesis having a tubular wall has been placed in the passageway, which has a wall;

advancing the proximal piercing end portion beyond the prosthesis;

penetrating the proximal piercing end portion into the wall of the passageway without passing the proximal piercing end portion through the tubular wall of the prosthesis; and

passing the distal piercing end portion through the tubular wall of the prosthesis and into the wall of the passageway.

2. The method of claim 1 wherein the fastener is delivered in a tubular sheath, the proximal piercing end portion is extended from the tubular sheath before penetrating it into the wall of the passageway, and the distal piercing end portion is extended from the tubular sheath before passing it through the wall of the prosthesis and into the wall of the passageway.

3. The method of claim 2 wherein the fastener is delivered with the proximal piercing end portion leading the distal piercing portion.

4. The method of claim 1 wherein the fastener is delivered with the proximal piercing end portion leading the distal piercing portion.

5. The method of claim 1 wherein a radially expandable member is positioned in the passageway and expanded to force the piercing end portions into the wall of the passageway.

6. The method of claim 5 wherein the radially expandable member is a balloon which is positioned in the passageway and inflated to force the piercing end portions into the wall of the passageway.

7. The method of claim 5 wherein the radially expandable member is a self-expanding member.

8. The method of claim 5 wherein the piercing end portions are forced into the wall sequentially.

9. The method of claim 5 wherein the piercing end portions are forced into the wall simultaneously.

10. The method of claim 1 wherein a member having a preshaped memory configuration is positioned in the passageway in a restrained second configuration and allowed to move toward the preshaped memory configuration to force the piercing portions into the wall of the passageway.

11. The method of claim 10 wherein the piercing end portions are forced into the wall sequentially.

12. The method of claim 10 wherein the piercing end portions are forced into the wall simultaneously.

13. The method of claim 1 wherein the fastener is endoluminally delivered through a vessel.

14. The method of claim 13 wherein the fastener is positioned in a first vessel with the proximal piercing end portion upstream of a second vessel that branches from the first vessel and the distal piercing end portion downstream of the second vessel.

15. The method of claim 14 wherein the fastener is positioned in the aorta of the patient with the proximal piercing end portion upstream of a renal artery and the distal piercing end portion downstream of said renal artery.

16. The method of claim 14 wherein a plurality of said fasteners are delivered to the site and each proximal piercing end portion is exposed and penetrated into the wall of the passageway without passing through the tubular prosthesis and each distal piercing end portion is passed through the tubular wall of the prosthesis and into the passageway.

17. The method of claim 1 wherein a plurality of said fasteners are delivered to the site and each proximal piercing end portion is exposed and penetrated into the wall of the passageway without passing through the tubular prosthesis and each distal piercing end portion is passed through the tubular wall of the prosthesis and into the passageway.

18. Surgical fastener delivery apparatus for delivering a surgical fastener to a target site comprising:

a support having a first end, a second end, and a longitudinal axis and being adapted for placement in a passageway in a human body;

a surgical fastener having a first piercing end portion, a second piercing end portion and a central portion extending therebetween and having a longitudinal axis, said fastener being releasably mounted to said support with said central portion longitudinal axis generally parallel to said support longitudinal axis.

19. The delivery apparatus of claim 18 wherein said fastener is releasably locked to said support.

20. The delivery apparatus of claim 18 wherein said piercing end portions extend generally radially outward from said support.

21. The delivery apparatus of claim 18 wherein said central portion comprises a thread.

22. The delivery apparatus of claim 18 wherein said central portion comprises a suture.

23. The delivery apparatus of claim 18 wherein said central portion comprises a wire.

24. The delivery apparatus of claim 18 wherein said support comprises a radially expandable member.

25. The delivery apparatus of claim 24 wherein said radially expandable member is a balloon.

26. The delivery apparatus of claim 18 wherein said support comprises an elongated member having a portion having a preshaped curved configuration, which member can be restrained in a second configuration for delivery to the target site and released to move toward said preshaped configuration.

27. The delivery apparatus of claim 26 further including a tubular sheath surrounding said fastener and support, said tubular sheath and support being slidably movable relative to one another, and said tubular sheath retraining said elongated member in said second configuration.

28. The delivery apparatus of claim 27 wherein said support has a wall that forms a channel that extends in a direction generally parallel to said support longitudinal axis, said fastener central portion being releasably retained in said channel.

29. The delivery apparatus of claim 28 wherein said wall forms a channel opening having a first width in a first region and second region and a third width that is less than said first width in a third region, said fastener central portion having a width less than said third width and being disposed in said third region, said first and second piercing end portions extending from said first and second regions.

30. The delivery apparatus of claim 28 including a plurality of said fasteners, each fastener being releasably retained in said channel.

31. The delivery apparatus of claim 26 including a plurality of said fasteners, each being releasably mounted to said elongated member.

32. The delivery apparatus of claim 31 further including a tubular sheath said surrounding said fasteners and support, said tubular sheath and support being slidably movable relative to one another.

33. The delivery apparatus of claim 31 wherein said support includes a plurality of said elongated members.

34. The delivery apparatus of claim 33 further including a plurality of said fasteners, each being releasably mounted one of said elongated members.

35. The delivery apparatus of claim 34 wherein each elongated member has a wall that forms a channel which extends in a direction generally parallel to said support longitudinal axis, each fastener central portion being releasably retained in one of said channels.

36. The delivery apparatus of claim 35 wherein said wall forms a channel opening having a first width in a first region and second region and a third width that is less than said first width in a third region, said fastener central portion being disposed in said third region and said first and second piercing end portions extending from said first and second regions.

37. The delivery apparatus of claim 18 further including a plurality of said fasteners, each being releasably mounted to said support.

38. The delivery apparatus of claim 37 further including a tubular sheath surrounding said fasteners and support, said tubular sheath and support being slidably movable relative to one another.

39. The delivery apparatus of claim 18 further including a tubular sheath surrounding said fastener and support, said tubular sheath and support being slidably movable relative to one another.

40. The delivery apparatus of claim 39 wherein said fastener is a surgical staple.

41. Surgical fastener delivery apparatus for delivering a surgical fastener to a target site comprising:

a support having a first end, a second end, and a longitudinal axis and being adapted for placement in a passageway in a human body;

a surgical fastener having a first piercing end portion, a second piercing end portion and a central portion extending therebetween, said fastener being releasably locked to said support with said first piercing member being closer to said support first end as compared to said second piercing member; and

a tubular sheath, said support being slidably disposed in said tubular sheath with said support and sheath being movable relative to one another such that said sheath covers said fastener piercing end portions when in a first position and said fastener piercing end portions extend from said sheath when said sheath is in a second position.

42. The delivery apparatus of claim 41 wherein said surgical fastener is a surgical staple.

43. A surgical staple for securing a prosthesis to a target site comprising:

a first V-shaped end portion having a free piercing end adapted to penetrate tissue;

a second V-shaped end portion having a free piercing end adapted to penetrate tissue;

and a flexible member having a first end attached to said first end portion and a second end attached to said second end portion.

44. The surgical staple of claim 43 wherein said flexible member comprises a wire.

45. The surgical staple of claim 43 wherein said flexible member comprises a thread.

46. The surgical staple of claim 43 wherein said flexible member comprises a suture.

47. The surgical staple of claim 43 wherein said V-shaped portions form prongs.

48. The surgical staple of claim 46 further including barbs, each prong having at least one barb extending therefrom.

49. A surgical staple for securing a prosthesis to a target site comprising:

a first V-shaped end portion having a prong adapted to penetrate tissue and an apex;

a second V-shaped end portion having a prong adapted to penetrate tissue and an apex pointing is a direction generally opposite to the direction in which the first V-shaped end portion points;

and a central portion interconnecting said V-shaped portions.

50. The surgical staple of claim 49 further including barbs, each one of said prongs having at least one barb extended therefrom.