Device And Method For Improving The Function Of A Heart Valve

• US 20090299471A1
• Filed: 09/05/2006
• Published: 12/03/2009
• Est. Priority Date: 09/07/2005
• Status: Active Grant

• Current Assignee: Medtentia International Ltd. Oy
• Original Assignee: Medtentia International Ltd. Oy
• Inventors: Keränen, Olli
• Granted Patent: US 8,128,691 B2
• Time in Patent Office: Days
• US Class Current: 623/2.37
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

A device for improving the function of a heart valve comprises: a support member formed from a shape memory material, and a restraining member providing a restraining action on a course of the support member. The support member may abut one side of the valve conforming to the shape of the valve annulus upon said shape memory material assuming an activated shape while the restraining member restrains the course of the support member. The restraining action is removable for allowing the support member to assume a desired, altered course. The restraining member may be biodegradable to be degraded within a patient or may be detachable from the support member to be withdrawn. The support member according to another embodiment presents a shape change in that an increased cross-section is associated with a shortened length of the support member. The support member according to yet another embodiment has a first and a second activated shape.

Claims

1. A device for improving the function of a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the device comprising:

a support member at least partially formed from a shape memory material operable to assume an activated shape and an inactivated shape, and

a restraining member, which is arranged to provide a restraining action on a course of the support member,

said support member being configured to abut one side of the valve and being arranged to conform to the shape of at least a part of the valve annulus upon said shape memory material assuming said activated shape while the restraining member exerts the restraining action on the course of the support member, and

the restraining member being formed of a biodegradable material to be degraded when the device is implanted in a patient, wherein degradation of the restraining member removes the restraining action and allows the support member to assume a desired, altered course.

2. The device according to claim 1, wherein the support member is arranged to be brought into the activated shape by receiving induced heating at selective portions of the support member.

3. The device according to claim 1, wherein the support member is arranged to assume a reduced radius of curvature upon the restraining action being removed.

4. The device according to claim 1, wherein the restraining member is formed so as to control the rate of degradation in a patient.

5. The device according to claim 1, wherein the support member is a first support member and the device further comprises a second support member at least partially formed from said shape memory material and connected to said first support member, said second support member being configured to abut an opposite side of the valve, whereby a portion of the valve tissue is trapped between said first and second support members upon said shape memory material assuming said activated shape.

6. The device according to claim 5, wherein the first and second support members are loop-shaped.

7. The device according to claim 6, wherein the first and second support members are D-shaped.

8. The device according to claim 5, wherein an outer boundary of the second support member is greater than an outer boundary of the first support member.

9. The device according to claim 6, wherein the first loop-shaped support member is continuous with the second loop-shaped support member to form a coil-shape.

10. A device for improving the function of a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the device comprising:

a support member being configured to abut one side of the valve and being arranged to conform to the shape of at least a part of the valve annulus,

said support member having an inherent adaptation to a shape change such that an increased cross-section of at least part of the support member is associated with a shortened length of the support member,

whereby the support member is susceptible to an expansion of a cross-section of the support member when the support member has conformed to the shape of at least part of the valve annulus such that the support member assumes a desired, altered shape.

11. The device according to claim 10, wherein the support member is arranged to assume a reduced radius of curvature in the altered shape.

12. The device according to claim 10, wherein the support member is a first support member and the device further comprises a second support member connected to said first support member, said second support member being configured to abut an opposite side of the valve and being arranged to conform to the shape of at least a part of the valve annulus, whereby a portion of the valve tissue is trapped between said first and second support members, said second support member having an inherent adaptation to a shape change such that an increased cross-section of at least part of the support member is associated with a shortened length of the support member.

13. The device according to claim 12, wherein the first and second support members are loop-shaped.

14. The device according to claim 13, wherein an outer boundary of the second support member is greater than an outer boundary of the first support member.

15. The device according to claim 13, wherein the first loop-shaped support member is continuous with the second loop-shaped support member to form a coil-shape.

16. The device according to claim 12, wherein the first and second support members are tubular.

17. The device according to claim 12, wherein the first and second support members have a U-shaped cross-section.

18. The device according to claim 16, wherein the first and second support members are adapted to receive a balloon therein for expanding the cross-section of at least part of the support member.

19. The device according to claim 12, wherein the first and second support members are belt-shaped.

20. The device according to claim 12, wherein the first and second support members are formed from a mesh-like structure.

21. A device for improving the function of a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the device comprising:

a support member at least partially formed from a shape memory material operable to assume a first activated shape, a second activated shape and an inactivated shape,

said support member being configured to abut one side of the valve and being arranged to conform to the shape of at least a part of the valve annulus upon said shape memory material assuming said first activated shape, and

said support member being configured to assume a desired, altered course for remodelling the valve annulus upon said shape memory material assuming said second activated shape,

wherein said shape memory material is arranged such that heating the shape memory material to a first temperature will bring the shape memory material to assume said first activated shape and further heating of the shape memory material to a second temperature will bring the shape memory material to assume said second activated shape.

22. The device according to claim 21, wherein the support member is arranged to assume a reduced radius of curvature in the altered shape.

23. The device according to claim 21, wherein the support member is a first support member and the device further comprises a second support member connected to said first support member, said second support member being configured to abut an opposite side of the valve and being arranged to conform to the shape of at least a part of the valve annulus upon said shape memory material assuming said first activated shape, whereby a portion of the valve tissue is trapped between said first and second support members, said second support member being configured to assume a desired, altered course for remodelling the valve annulus upon said shape memory material assuming said second activated shape.

24. The device according to claim 23, wherein the first and second support members are loop-shaped.

25. The device according to claim 24, wherein an outer boundary of the second support member is greater than an outer boundary of the first support member.

26. The device according to claim 24, wherein the first loop-shaped support member is continuous with the second loop-shaped support member to form a coil-shape.

27. A device for improving the function of a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the device comprising:

a support member at least partially formed from a shape memory material operable to assume an activated shape and an inactivated shape, and

a restraining member, which is arranged to provide a restraining action on a course of the support member,

said support member being configured to abut one side of the valve and being arranged to conform to the shape of at least a part of the valve annulus upon said shape memory material assuming said activated shape while the restraining member exerts the restraining action on the course of the support member, and

the restraining member being detachable from the support member for releasing the restrain and allowing the support member to assume a desired, altered course.

28. The device according to claim 27, wherein the support member is arranged to be brought into the activated shape by receiving induced heating at selective portions of the support member.

29. The device according to claim 27, wherein the support member is arranged to assume a reduced radius of curvature upon the restraining action being removed.

30. The device according to claim 27, wherein the support member is a first support member and the device further comprises a second support member at least partially formed from said shape memory material and connected to said first support member, said second support member being configured to abut an opposite side of the valve, whereby a portion of the valve tissue is trapped between said first and second support members upon said shape memory material assuming said activated shape.

31. The device according to claim 30, wherein the first and second support members are loop-shaped.

32. The device according to claim 31, wherein the first and second support members are D-shaped.

33. The device according to claim 31, wherein an outer boundary of the second support member is greater than an outer boundary of the first support member.

34. The device according to claim 31, wherein the first loop-shaped support member is continuous with the second loop-shaped support member to form a coil-shape.

35. The device according to claim 27, wherein said restraining member comprises one or more pins or bars extending between different positions on the support member and thus forcing these positions to be at a fixed distance to each other.

36. The device according to claim 27, wherein the support member is tubular and the restraining member is elongate and extendable through the tubular support member for exerting said restraining action.

37. A method for improving the function of a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the method comprising:

inserting an implantation device comprising a support member, said implantation device being inserted such that the support member abuts one side of the valve, the support member being arranged along a first course conforming to the shape of at least part of the valve annulus,

attaching the support member to valve tissue for fixating the position of the support member relative to the valve,

activating a shape change of the support member such that the support member assumes a desired, altered course in order to remodel the heart valve.

38. The method according to claim 37, wherein the support member is at least partially formed from a shape memory material operable to assume an activated shape and an inactivated shape, and the implantation device further comprises a restraining member, which is arranged to pro vide a restraining action on a course of the support member,

said insertion comprising bringing the shape memory material of the support member to an activated shape such that the support member is arranged along the first course while the restraining member exerts the restraining action on the support member.

39. The method according to claim 38, wherein said activating comprises removing the restraining action of the restraining member allowing the support member to assume the desired, altered course.

40. The method according to claim 39, wherein said removing comprises withdrawing the restraining member from the inserted implantation device.

41. The method according to claim 39, wherein the restraining member is biodegradable and said removing comprises leaving the support member and the restraining member in the patient in order for the restraining member to be degraded and remove the restraining action.

42. The method according to claim 37, wherein the support member has an inherent adaptation to a shape change such that an increased cross-section of at least part of the support member is associated with a shortened length of the support member, said activating comprising expanding the cross-section of the support member such that the support member is shortened and assumes the desired, altered course.

43. The method according to claim 42, wherein the support member is tubular or U-shaped, said expanding comprising bringing a balloon in contact with at least part of the support member and inflating the balloon such that the cross-section of the support member is increased.

44. The method according to claim 37, wherein the support member is a first support member and the implantation device further comprises a second support member connected to said first support member, said insertion further comprising placing said implantation device such that the second support member abuts an opposite side of the valve, the second support member being arranged along a first course conforming to the shape of at least part of the valve annulus at said opposite side.

45. The method according to claim 44, wherein the attaching partly comprises placing the first and second support members in relation to each other on opposite sides of the heart valve such that a portion of the valve tissue is trapped between said first and second support members.

46. The method according to claim 44 wherein said activating comprises activating a shape change of the second support member such that the second support member also assumes a desired, altered course in order to remodel the heart valve.

47. The method according to claim 44, wherein the step of inserting comprises

inserting a first end of the first support member through a portion of the valve tissue,

rotating the implantation device to position the first support member on a first side of the valve, and positioning the second support member on an opposite second side of the valve.

48. The method according to claim 37, wherein the step of inserting further comprises introducing the implantation device into the patient inside a catheter.