Apparatus and methods for repair of a cardiac valve

• US 20070239272A1
• Filed: 05/04/2007
• Published: 10/11/2007
• Est. Priority Date: 05/20/2003
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Chen, Ji-Feng, Navia, Jose
• Granted Patent: US 7,914,576 B2
• Time in Patent Office: Days
• US Class Current: 623/2.360
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes

Abstract

An apparatus for repairing a cardiac valve includes an annuloplasty ring having an expandable support member with oppositely disposed proximal and distal end portions and a main body portion between the end portions. The proximal end portion includes a plurality of wing members extending from the main body portion. Each of the wing members includes at least one hook member for embedding into a cardiac wall and a valve annulus to secure the annuloplasty ring therein. The apparatus also includes an energy delivery mechanism for selectively contracting the annuloplasty ring to restrict the valve annulus and correct valvular insufficiency. The energy delivery mechanism includes a detachable electrical lead having distal and proximal end portions. The distal end portion has a securing member for operably attaching the distal end portion to a portion of the expandable support member. The proximal end portion is operably connected to an energy delivery source.

Claims

1. An apparatus for repairing a cardiac valve, said apparatus comprising:

an annuloplasty ring including an expandable support member having oppositely disposed proximal and distal end portions and a main body portion between said end portions, said proximal end portion of said expandable support member comprising a plurality of wing members that extend from said main body portion;

each of said wing members including at least one hook member for embedding into a cardiac wall and the valve annulus to secure said annuloplasty ring in the annulus of the cardiac valve; and

an energy delivery mechanism for selectively contracting said annuloplasty ring and thereby restricting the valve annulus to support the annulus and correct valvular insufficiency, said energy delivery mechanism including a detachable electrical lead having distal and proximal end portions, said distal end portion having a securing member for operably attaching said distal end portion to a portion of said expandable support member and said proximal end portion being operably connected to an energy delivery source.

2. The annuloplasty ring of claim 1 wherein said hook members, when embedded into the cardiac wall and the valve annulus, extend distally from said wing members.

3. The apparatus of claim 1 further comprising a layer of biocompatible material covering at least a portion of said distal end portion and said main body portion of said expandable support member.

4. The apparatus of claim 1 wherein said expandable support member is made from a shape memory material that is responsive to changes in temperature above and below a predetermined temperature transition range, said expandable support member having a first configuration when the temperature is below said predetermined temperature transition range, said expandable support member having a second configuration when heated above said predetermined temperature transition range.

5. The apparatus of claim 4 wherein said expandable support member is insertable into the annulus of the cardiac valve in said first configuration and is thereafter heatable above said predetermined temperature transition range to change said expandable support member into said second configuration, wherein movement of said expandable support member into said second configuration causes a reduction in size of the opening defined by the valve annulus.

6. The apparatus of claim 1 wherein said inflatable balloon has an hourglass shape defined by first and second bulb sections connected by a center section having a smaller diameter than said bulb sections, said annuloplasty ring being positioned about said center section of said inflatable balloon.

7. The apparatus of claim 1 wherein at least a portion of said expandable support member is treated with at least one therapeutic agent for eluting into the blood stream and/or cardiac tissue.

8. The apparatus of claim 1 wherein a plurality of portions of said expandable support member are separately treated with a different one of said at least one therapeutic agent.

9. The apparatus of claim 8 wherein said main body portion and said wing members are each separately treated with a different one of said at least one therapeutic agent.

10. The apparatus of claim 8 wherein each of said wing members is separately treated with a different one of said at least one therapeutic agent.

11. An apparatus for repairing a cardiac valve, said apparatus comprising:

an annuloplasty ring including an expandable support member having oppositely disposed proximal and distal end portions and a main body portion between said end portions, said proximal end portion of said expandable support member comprising a plurality of wing members that extend from said main body portion;

each of said wing members including at least one hook member for embedding into a cardiac wall and the valve annulus to secure said annuloplasty ring in the annulus of the cardiac valve;

an inflatable balloon for expanding said expandable support member so that said annuloplasty ring engages the annulus of the cardiac valve; and

an energy delivery mechanism for selectively contracting said annuloplasty ring and thereby restricting the valve annulus to support the annulus and correct valvular insufficiency, said energy delivery mechanism including at least one energy delivery member operably secured to a portion of said inflatable balloon and being in contact with a portion of said expandable support member.

12. The annuloplasty ring of claim 11 wherein said hook members, when embedded into the cardiac wall and the valve annulus, extend distally from said wing members.

13. The apparatus of claim 11 further comprising a layer of biocompatible material covering at least a portion of said distal end portion and said main body portion of said expandable support member.

14. The apparatus of claim 11 wherein said expandable support member is made from a shape memory material that is responsive to changes in temperature above and below a predetermined temperature transition range, said expandable support member having a first configuration when the temperature is below said predetermined temperature transition range, said expandable support member having a second configuration when heated above said predetermined temperature transition range.

15. The apparatus of claim 14 wherein said expandable support member is insertable into the annulus of the cardiac valve in said first configuration and is thereafter heatable above said predetermined temperature transition range to change said expandable support member into said second configuration, wherein movement of said expandable support member into said second configuration causes a reduction in size of the opening defined by the valve annulus.

16. The apparatus of claim 11 wherein said inflatable balloon has an hourglass shape defined by first and second bulb sections connected by a center section having a smaller diameter than said bulb sections, said annuloplasty ring being positioned about said center section of said inflatable balloon.

17. The apparatus of claim 11 wherein at least a portion of said expandable support member is treated with at least one therapeutic agent for eluting into the blood stream and/or cardiac tissue.

18. The apparatus of claim 11 wherein a plurality of portions of said expandable support member are separately treated with a different one of said at least one therapeutic agent.

19. The apparatus of claim 18 wherein said main body portion and said wing members are each separately treated with a different one of said at least one therapeutic agent.

20. The apparatus of claim 18 wherein each of said wing members is separately treated with a different one of said at least one therapeutic agent.

21. A method for repairing a cardiac valve, said method comprising the steps of:

providing an annuloplasty ring having an expandable support member and an energy delivery mechanism, the energy delivering mechanism including a detachable electrical lead having distal and proximal end portions, the distal end portion including a securing member for attaching the distal end portion to a portion of the expandable support member and the proximal end portion being operably connected to an energy delivery source;

attaching the securing member to the portion of the expandable support member;

placing the annuloplasty ring around an inflatable balloon in a secured manner;

inserting the balloon and annuloplasty ring into an atrial chamber;

advancing the balloon until the annuloplasty ring is positioned within the annulus of the cardiac valve to be repaired;

expanding the expandable support member with the balloon so that the annuloplasty ring engages the annulus of the cardiac valve to secure the annuloplasty ring in the annulus;

delivering electrical energy to the annuloplasty ring via the energy delivery mechanism to secure the annuloplasty ring in the valve annulus;

collapsing the balloon; and

removing the balloon and the energy delivery mechanism from the atrial chamber.

22. The method of claim 21 wherein the expandable support member is made from a shape memory material that is responsive to changes in temperature above and below a predetermined temperature transition range, the expandable support member having a first configuration when the temperature is below the predetermined temperature transition range and a second configuration when heated above the predetermined temperature transition range, said method further including the step of cooling the expandable support member prior to inserting the annuloplasty ring into the annulus of the cardiac valve in order to place the expandable support member in the first configuration.

23. The method of claim 22 further comprising the step of heating the expandable support member above the predetermined temperature transition range so that the expandable support member changes into the second configuration.

24. The method of claim 23 wherein said step of heating the expandable support member is done at said step of delivering electrical energy to the annuloplasty ring, said step of heating the expandable support member contracts the annuloplasty ring and thereby restricts the valve annulus to support the annulus and correct valvular insufficiency.

25. The method of claim 21 wherein said step of inserting the inflatable balloon and annuloplasty ring into the atrial chamber is done percutaneously via an intravascular catheter.

26. The method of claim 21 wherein at least a portion of said expandable support member is treated with at least one therapeutic agent for eluting into the blood stream and/or cardiac tissue.

27. The apparatus of claim 21 wherein a plurality of portions of said expandable support member are separately treated with a different one of said at least one therapeutic agent.

28. The apparatus of claim 27 wherein said main body portion and said wing members are each separately treated with a different one of said at least one therapeutic agent.

29. The apparatus of claim 27 wherein each of said wing members is separately treated with a different one of said at least one therapeutic agent.

30. A method for repairing a cardiac valve, said method comprising the steps of:

providing an annuloplasty ring having an expandable support member, an inflatable balloon for expanding the expandable support member, and an energy delivery mechanism, the energy delivery mechanism including at least one energy delivery member secured to the inflatable balloon and being in contact with a portion of the expandable support member;

placing the annuloplasty ring around the inflatable balloon in a secured manner;

inserting the inflatable balloon and annuloplasty ring into an atrial chamber;

advancing the inflatable balloon until the annuloplasty ring is positioned within the annulus of the cardiac valve to be repaired;

expanding the expandable support member with the inflatable balloon so that the annuloplasty ring engages the annulus of the cardiac valve to secure the annuloplasty ring in the annulus;

delivering electrical energy to the annuloplasty ring via the energy delivery mechanism to secure the annuloplasty ring in the valve annulus;

collapsing the inflatable balloon; and

removing the inflatable balloon from the atrial chamber.

31. The method of claim 30 wherein the expandable support member is made from a shape memory material that is responsive to changes in temperature above and below a predetermined temperature transition range, the expandable support member having a first configuration when the temperature is below the predetermined temperature transition range and a second configuration when heated above the predetermined temperature transition range, said method further including the step of cooling the expandable support member prior to inserting the annuloplasty ring into the annulus of the cardiac valve in order to place the expandable support member in the first configuration.

32. The method of claim 31 further comprising the step of heating the expandable support member above the predetermined temperature transition range so that the expandable support member changes into the second configuration.

33. The method of claim 32 wherein said step of heating the expandable support member is done at said step of delivering electrical energy to the annuloplasty ring, said step of heating the expandable support member contracts the annuloplasty ring and thereby restricts the valve annulus to support the annulus and correct valvular insufficiency.

34. The method of claim 30 wherein said step of inserting the balloon and annuloplasty ring into the atrial chamber is done percutaneously via an intravascular catheter.

35. The method of claim 30 wherein at least a portion of said expandable support member is treated with at least one therapeutic agent for eluting into the blood stream and/or cardiac tissue.

36. The apparatus of claim 30 wherein a plurality of portions of said expandable support member are separately treated with a different one of said at least one therapeutic agent.

37. The apparatus of claim 36 wherein said main body portion and said wing members are each separately treated with a different one of said at least one therapeutic agent.

38. The apparatus of claim 36 wherein each of said wing members is separately treated with a different one of said at least one therapeutic agent.