Apparatus and methods for repair of a cardiac valve

• US 8,480,733 B2
• Filed: 03/04/2011
• Issued: 07/09/2013
• Est. Priority Date: 05/20/2003
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Navia, Jose Luis, Chen, Ji-Feng
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US13/040,394
• Publication Number:
  US 20110153009A1
• Time in Patent Office: 858 Days
• Field of Search: 623 236- 239
• US Class Current: 623/2.36
• 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. The apparatus of claim 1, wherein each of said hook members extends distally between each of said wing members and a location laterally adjacent said main body portion of said expandable support member.

12. The apparatus of claim 1, further including at least one constraining wire for temporarily holding said wing members in a flattened configuration during deployment of said apparatus.

13. 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;

wherein a layer of biocompatible material covers at least a portion of said distal end portion and said main body portion of said expandable support member.