Prosthetic repair of body passages

• US 20020111665A1
• Filed: 04/08/2002
• Published: 08/15/2002
• Est. Priority Date: 06/20/1996
• Status: Active Grant

• Current Assignee: Vascutek Limited (Terumo Corporation)
• Original Assignee: Vascutek Limited (Terumo Corporation)
• Inventors: Lauterjung, Karl-Lutz
• Granted Patent: US 7,169,176 B2
• Time in Patent Office: Days
• US Class Current: 623/1.1
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/30327 differing in diameter
• CPC Class Codes: A61F 2002/30505 spring biased
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A prosthesis that resiliently engages a body passage includes an annular clamping ring which may be folded along a diametric axis for insertion into the body passage. The clamping ring is adapted to resiliently spring outwardly, once in position inside the body passage, and to be continually resiliently biased against the interior surface of the body passage. One or more of the clamping rings may be attached to opposed ends of a tubular graft. The rings and connected graft may be positioned in the body passage using a applicator which selectively permits expansion and/or in some embodiments contraction of the annular ring in position within a body passage. Alternatively a retaining member may be used to retain the annular ring in a compressed condition until it is in a desired position within a body passage. Among other potential uses, the present invention may be useful as a vascular stent for treating abdominal aortic aneurysms.

Claims

1. A device for retaining a prosthesis in a body passage comprising an annular, resilient element with an undeformed diameter greater than the diameter of said body passage.

2. The device of claim 1 wherein said annular resilient element has a circular cross-section when undeformed.

3. The device of claim 1 including a tubular graft attached to said element.

4. The device of claim 1 wherein said element is formed by wrapping a plurality of windings of wire around a common core and connecting said windings together.

5. The device of claim 4 wherein said wire is formed of a superelastic phase nickel-titanium alloy.

6. The device of claim 1 including a pair of elements, said elements connected by a tubular graft.

7. The device of claim 1 including a tubular graft, said element being connected to one end of said tubular graft, said tubular graft having a first diameter proximate to said connection to said element and a second diameter spaced away from said element, said first diameter being greater than said second diameter.

8. The device of claim 7 wherein said graft is formed from fabric.

9. The device of claim 7 wherein said element is connected to a fabric graft at only one end of said fabric graft.

10. The device of claim 1 wherein said element is situated inside a body passage in a C-shaped deformed configuration, folded about a diametric axis of said element.

11. The device of claim 1 including a bifurcated graft connected to said element, said bifurcated graft including a first tubular section connected to said element and a pair of tubular sections connected to said first tubular section, each of said pair of tubular sections having free ends, and annular resilient deformable elements connected to said free ends of said pair of tubular sections.

13. The prosthesis of claim 12 wherein said spring element has a circular cross-section when undeformed, and said element is formed by a plurality of circularly oriented wire strands formed of a resilient metal, said graft having a pair of opposed free ends, said spring element attached to one of said free ends of said graft.

14. The prosthesis of claim 12 wherein said graft has a pair of opposed free ends, said element connected to one of said free ends, the region of said graft proximate to said element having a diameter greater than the diameter of the portion of said graft spaced from that element.

15. The prosthesis of claim 12 wherein said element is attached to one of two opposed free ends of said graft, said graft having a greater diameter on the end connected to said spring element than on said end spaced from said element, said graft tapering in diameter from said end connected to said element to a reduced diameter and having a relatively constant diameter over a portion of the remainder of the graft.

16. The prosthesis of claim 12 wherein said graft is tubular and includes a pair of opposed free ends, spring elements being attached to each of said free ends.

17. The prosthesis of claim 12 wherein said graft is formed of fabric.

18. The prosthesis of claim 12 wherein said graft includes a pair of opposed ends, a spring element being attached to only one of said ends of said graft.

19. The prosthesis of claim 12 including a device for receiving a positioning wire.

20. The prosthesis of claim 19 wherein said device includes an internal passage for releasably receiving said wire.

12. A prosthesis for insertion into a body passage comprising an annular resilient spring element and a flexible, tubular graft attached to said element, said element having an undeformed diameter greater than the diameter of said graft.

21. A vascular prosthesis for repairing a diseased first vessel comprising:

a folded, resilient, annular ring having a first pair of loops extending in one direction, and a second pair of loops extending in the opposite direction, said first and second pairs of loops connected together, and

a tubular graft connected to said ring, said graft arranged to extend along the length of said first vessel, said first pair of loops arranged to extend at least partially past the point where a second vessel intersects said first vessel, one of said second pair of loops defining an opening to permit communication between said first and second vessels, at least partially past said prosthesis.

22. The prosthesis of claim 21, said second pair of loops are arranged to avoid occlusion of the renal arteries when said prosthesis is positioned in the abdominal aorta.

23. The prosthesis of claim 21, wherein said tubular graft has a diameter less than the undeformed diameter of said annular ring.

24. The prosthesis of claim 21, wherein said annular ring is formed by a plurality of strands of resilient wire having a substantially common central axis.

25. The prosthesis of claim 24 wherein said ring is circular in cross-section when undeformed.

26. The prosthesis of claim 21 wherein said tubular graft has a pair of opposed free ends, annular rings being connected to each of said free ends.

27. The prosthesis of claim 21 wherein said tubular graft has a pair of free ends and an annular ring is connected to only one of said free ends.

28. The prosthesis of claim 21 including a device for axially receiving a guide wire, said device adapted to telescopically and releasably receive said guide wire.

30. The apparatus of claim 29 wherein said device includes a guide wire catheter that extends axially through said prosthesis, said guide wire catheter adapted to releasably engage said annular ring when folded, on a diametric axis, into a C-shape and each of the loops extending outwardly from said axis so as to enable the amount of deformation of said loops relative to one another to be adjusted.

31. The apparatus of claim 30 wherein each of said connections is releasable from a remote location.

29. An apparatus for securing a prosthesis to an internal surface of a body passage comprising:

a resiliently deformable annular ring;

a tubular graft having a pair of opposed free ends, one of said free ends attached to said annular ring; and

a device adapted to enable said ring to be remotely compressed and expanded.

32. A prosthesis for insertion within a body passage comprising:

a first prosthesis section including a resiliently deformable annular spring element and a tubular graft, said tubular graft having a pair of free ends, said annular spring element connected to one of said free ends; and

a second prosthesis section arranged to engage the interior of said first prosthesis section in common axial alignment therewith, said second prosthesis section including a resiliently deformable annular spring element adapted to engage an internal surface of said tubular graft of said first prosthesis section so as to adjust the resulting length of the prosthesis.

33. The prosthesis of claim 32 wherein said second prosthesis section includes a tubular graft attached to said annular spring element, said tubular graft having a pair of free ends, one of said free ends connected to said spring element and the other of said free ends connected to a device for retaining said free end in an open configuration.

34. The prosthesis of claim 33, wherein said device includes a pair of relatively rigid elements defining a pair of independent passages into said free end of said second prosthesis section.

35. The prosthesis of claim 34 including third and fourth prosthesis sections telescopically engaging said relatively rigid elements on said free end of said second prosthesis section, each said third and fourth prosthesis sections including a pair of annular resilient deformable spring elements and a tubular graft, said spring elements attached to free ends of said tubular graft, at least one of said spring elements adapted to engage the interior of said second prosthesis section.

36. The prosthesis of claim 35 wherein said second prosthesis section includes a graft which has one end which defines a single passage and an opposite end which defines a pair of bifurcated passages which communicate with said single passage.

38. The method of claim 37 including the steps of deforming said ring prior to inserting said ring in said body passage, positioning said ring at a desired location in a body passage and causing said ring to expand and engage that body passage.

39. The method of claim 38 including the steps of selectively compressing and releasing the compression of said ring in position within a body passage using a remote actuator.

40. The method of claim 37 including the steps of inserting said prosthetic device into a desired location in a body passage by inserting said prosthetic device into the interior of a tubular catheter, positioning the catheter at a desired location within a body passage and ejecting said prosthetic device from the interior of said catheter.

37. A method for securing a prosthetic device in a body passage comprising the steps of:

folding a resilient annular ring to assume a first configuration having a cross-sectional area smaller than the cross-sectional area of said undeformed ring;

positioning said ring at a desired position within a body passage; and

allowing said ring to resiliently deform to a second configuration having a larger cross-sectional area than in said first configuration, but still having a cross-sectional area smaller then that of said undeformed ring.

41. A method for repairing a diseased vessel comprising the steps of:

folding an annular ring around its diametric axis to assume a smaller cross-sectional configuration;

forming a pair loops extending away from said axis; and

arranging said ring in said vessel with said diametric axis proximate to an intersecting vessel such that said loops extend at least partially past the intersecting vessel without occluding said intersecting vessel.

42. The method of claim 41 including the step of causing said annular ring to be resiliently biased against said diseased vessel when in place in the patient'"'"'s body.

43. A method of securing a prosthetic device inside a body passage comprising the steps of:

deforming an annular resilient spring by folding said spring along its diametric axis;

positioning said spring inside a body passage and causing said spring to expand resiliently against said body passage; and

causing said spring to continuously press outwardly against said body passage.

44. The method of claim 43 wherein said prosthetic device includes a tubular graft connected to said spring, said method further including the steps of inserting a second prosthetic device telescopically within the interior of said tubular graft and causing an annular resilient spring member to extend outwardly to engage the interior surface of said graft.

45. The method of claim 43 including the step of adjusting the length of said prosthetic device by inserting a second prosthetic device telescopically into said first prosthetic device.

46. The method of claim 44 including the step of telescopically inserting a pair of stents inside the second prosthetic device to form a passage from the iliac arteries to the abdominal aortic artery.

49. The prosthesis of claim 48 wherein said member is a wire connecting said elements.

47. A prosthetic device comprising:

a prosthetic heart valve;

a flexible tubular sleeve having a first end connectable to said valve and a second end; and

a deformable, resilient annular ring connected to said second end and arranged to connect said graft to the interior surface of a portion of the ascending aorta.

48. A prosthesis for insertion into a body passage comprising at least two annular resilient spring elements and a flexible tubular graft attached to each of said elements and a rigid member longitudinally connecting said elements, said member being less flexible than said graft.

50. A method for inserting a prosthesis into a body passage, comprising the steps of:

inserting a pair of tubular prostheses together into a body passage; and

telescopically adjusting the position of one of said prostheses within the other of said prostheses.

51. The method of claim 50 including the step of collapsing an annular resilient spring element on each of said prostheses prior to inserting them together into said passage to secure said elements to said passage and to each other.