FIXING DEVICE, IN PARTICULAR FOR FIXING TO VASCULAR WALL TISSUE

• US 20090234446A1
• Filed: 03/13/2009
• Published: 09/17/2009
• Est. Priority Date: 05/25/1999
• Status: Active Grant

• Current Assignee: Daidalos Solutions B.V.
• Original Assignee: Daidalos Solutions B.V.
• Inventors: BERREKLOUW, Eric
• Granted Patent: US 8,142,496 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/006 modular

Abstract

A device for narrowing the passage through surrounding vascular wall tissue, such as a ring prosthesis for reducing the size of the passage of a heart valve, includes a ring shaped element which is elastically contractile under influence of a resilient force for contracting the ring shaped element from an expanded, wide condition to a narrow condition to narrow the passage. A method of narrowing the passage through surrounding vascular wall tissue using such a device is also disclosed.

Claims

1. Device for narrowing the passage through surrounding vascular wall tissue, such as a ring prosthesis for reducing the size of the passage of a heart valve, comprising a ring shaped element which is elastically contractile under influence of a resilient force for contracting the ring shaped element from an expanded, wide condition to a narrow condition to narrow the said passage.

2. Device according to claim 1, wherein the ring shaped element comprises ring segments and a connecting system holding together the ring segments in circumferential direction of the ring shaped element, and wherein said connecting system is elastically contractile for said contracting the ring shaped element from said expanded, wide condition to said narrow condition.

3. Device according to claim 1, wherein the ring shaped element is expandable.

4. Device according to claim 1, wherein the ring shaped element is expandable for bringing the ring shaped element into contact with the vascular wall tissue surrounding the passage to be narrowed.

5. Device according to claim 3, further comprising an expandable instrument for expanding said ring shaped element to said expanded, wide condition upon expansion of said instrument and for allowing the ring shaped element to elastically contract to said narrow condition upon removal of said instrument.

6. Device according to claim 5, wherein the expandable instrument comprises a balloon which can be inflated for expansion of said instrument and deflated for removal of said instrument.

7. Device according to claim 1, wherein the ring shaped element comprises a super elastic metal alloy capable of returning the ring shaped element from a frozen, said expanded, wide condition into said narrow condition upon heating the ring shaped element.

8. Device according to claim 1, wherein the ring shaped element comprises a metal alloy with shape memory capable of returning the ring shaped element from a frozen, said expanded, wide condition into said narrow condition upon heating the ring shaped element.

9. Device according to claim 2, wherein the connecting system comprises a super elastic metal alloy capable of returning the connecting system from a frozen, said expanded, wide condition into said narrow condition upon heating the connecting system.

10. Device according to claim 2, wherein the connecting system comprises a metal alloy with shape memory capable of returning the connecting system from a frozen, said expanded, wide condition into said narrow condition upon heating the connecting system.

11. Device according to claim 2, wherein the connecting system comprises an individual connecting member between each adjacent ring segment.

12. Device according to claim 11, wherein said connecting member is a connecting wire.

13. Device according to claim 1, wherein the ring shaped element is an open ring, such as a C-shaped ring, having an opening in its circumference.

14. Device according to claim 13, wherein the ring shaped element can be brought into a ribbon-shaped condition for feeding the ring shaped element to said passage to be narrowed.

15. Device according to claim 1, wherein the ring shaped element can be brought into a ribbon-shaped condition for feeding the ring shaped element to said passage to be narrowed.

16. Device according to claim 1, wherein the ring shaped element is compressible to a compressed condition smaller than the narrow condition for feeding the ring shaped element to the passage to be narrowed.

17. Device according to claim 16, wherein the ring shaped element is in compressed condition and placed in a sleeve to keep the ring shaped element in the compressed condition.

18. Device according to claim 1, further comprising engagement members for anchoring said ring shaped element to the vascular wall tissue surrounding said passage.

19. Device according to claim 2, further comprising engagement members for anchoring each said ring segment to the vascular wall tissue surrounding said passage.

20. Device according to claim 18, wherein said engagement members comprise flanges provided at said ring shaped element for clamping said vascular wall tissue in between.

21. Device according to claim 18, wherein said engagement members comprise pins provided at said ring shaped element for anchoring said ring shaped element to said vascular wall tissue.

22. Device according to claim 21, wherein each pin is radially movable from an inwardly bent position, in which said pin lies, viewed in radial direction, entirely inside said ring shaped element, through an opening in said ring shaped element to an emerging position, in which the pin emerge through said opening at the radial outside of said ring shaped element.

23. Device according to claim 21, wherein the pins, when lying inside the ring shaped element, are in a pretensioned state pretensioned towards the emerging position.

24. Device according to claim 23, wherein the pins are frozen in said pretensioned state.

25. Device according to claim 22, further comprising removable impediments counteracting radial outward movement of said pins when in the inwardly bent position.

26. Device according to claim 1, wherein said device is a ring prosthesis for reducing the size of the passage of a heart valve.

27. Device according to claim 26, wherein said ring prosthesis is for a mitral heart valve, and wherein the ring segments comprise a fairly straight segment for arrangement along the inter-atrial septum and bean shaped segments.

28. Device according to claim 26, wherein said ring prosthesis is for an aortic valve and has a circular form.

29. Device according to claim 28, wherein said ring prosthesis has a sinusoidal form.

30. Device according to claim 28, wherein said ring shaped element consists of three or a multiple of three of said ring segments.

31. Method of narrowing the passage through surrounding vascular wall tissue, such as reducing the size of the passage of a heart valve, comprising successively the following steps:

applying a device according to claim 1 into said passage;

placing the ring shaped element in contact with the vascular wall tissue surrounding said passage and anchoring said ring shaped element to said tissue;

narrowing said passage by allowing the ring shaped element to contract elastically from said expanded, wide condition to said narrow condition.

32. Method according to claim 31, further comprising the step of adjusting the ring shaped element to the passage to be reduced in size.

33. Method according to claim 31, further comprising the step of adjusting the ring shaped element to the passage to be reduced in size, which adjusting step precedes the narrowing step.

34. Method according to claim 33, wherein the adjusting step comprises expanding the ring shaped element.

35. Method according to claim 31, wherein said placing and anchoring step comprises arranging an expandable instrument inside the ring shaped element and expanding said instrument, and wherein said narrowing step comprises removing said expanded instrument.

36. Method according to claim 35, wherein said expandable instrument comprises a balloon, and wherein said expanding comprises inflating said balloon, and wherein said removing comprises deflating said inflated balloon.

37. Method according to claim 31, wherein the ring shaped element comprises a super elastic metal alloy, and wherein the narrowing step heating the ring shaped element.

38. Method according to claim 31, wherein the ring shaped element comprises a metal alloy with shape memory, and wherein the narrowing step comprises heating the connecting system.

39. Method according to claim 31, wherein the narrowing step comprises removing at least one constrainer.

40. Method according to claim 31, wherein the ring shaped element comprises a super elastic metal alloy, and wherein the narrowing step comprises removing at least one constrainer.

41. Method according to claim 31, wherein the ring shaped element comprises a metal alloy with shape memory, and wherein the narrowing step comprises removing at least one constrainer.

42. Method according to claim 31, wherein the applying step comprises feeding the ring shaped element in a compressed condition to said passage to be narrowed.

43. Method according to claim 42, wherein the ring shaped element is in the compressed condition smaller than in the narrow condition.

44. Method according to claim 42, wherein the ring shaped element is inside a sleeve to keep the ring shaped element in the compressed condition.

45. Method according to claim 42, wherein the compressed condition is released before the placing step.

46. Method according to claim 31, wherein the applying step comprises feeding the ring shaped element in a ribbon-shaped condition to said passage to be narrowed.