Heart valve repair apparatus and methods

• US 8,100,964 B2
• Filed: 03/13/2009
• Issued: 01/24/2012
• Est. Priority Date: 02/02/2000
• Status: Expired due to Fees

• Current Assignee: Cardiac Lead Technologies, LLC
• Original Assignee: Cardiac Lead Technologies, LLC
• Inventors: Spence, Paul A.
• Primary Examiner(s): Matthews, William H.
• Application Number:
  US12/403,745
• Publication Number:
  US 20090177278A1
• Time in Patent Office: 1,047 Days
• Field of Search: 623/2.1, 623/2.14, 623/2.17, 623/2.18, 623 236- 238
• US Class Current: 623/2.36
• 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 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type

Abstract

Valve repair apparatus and methods for ensuring proper coaptation and operation of the leaflets of a heart valve. Main aspects of the disclosure relate to devices including a support member configured for attachment to the heart valve annulus, a post extending from the support member away from the plane of the annulus and a connector coupled with the post and configured for attachment to at least one of the leaflets. The various embodiments may include a replacement heart valve connected with the support member for facilitating full replacement as opposed to near repair of an existing native heart valve. Various other devices include support structure and one or more posts connected to opposite sides of the support structure and extending from one side of the valve annulus to another to modify the shape of the annulus.

Claims

1. An annuloplasty device for repairing a mitral valve, the mitral valve having a valve annulus, the valve annulus having an annulus anterior portion and an annulus posterior portion, the annulus posterior portion and the annulus anterior portion defining a mitral valve opening therebetween, the annulus posterior portion having a generally arcuate shape, the mitral valve having an anterior valve leaflet attached to the annulus anterior portion and a posterior valve leaflet attached to the annulus posterior portion, the anterior and posterior leaflets having respective anterior and posterior free margins, the anterior and posterior leaflets movable between a closed systolic configuration in which the free margins are in an approximated spatial relationship, and an open diastolic configuration in which the free margins are spaced apart to allow blood flow through the mitral valve opening generally along a valve-flow axis, the device comprising:

an anterior section and a posterior section coupled to the anterior section, the posterior and anterior sections divided along a first direction, the anterior and posterior sections being configured and sized for attachment to the annulus anterior and posterior portions respectively, the posterior section having a generally curvilinear shape and being permanently formed such that the posterior section is non-planar with respect to the anterior section when viewed in a direction generally parallel to the first direction, whereby when the annuloplasty device is attached to the valve annulus, the posterior section is retained after attachment of the anterior and posterior sections to the annulus to cause the posterior portion of the annulus to assume the non-planar generally curvilinear shape of the posterior section and thereby improve coaptation of the leaflet free margins in the systolic configuration,

wherein the annuloplasty device posterior section is permanently formed into first and second subsections, the first subsection being asymmetric relative to the second section about an axis bisecting the annuloplasty device along the first direction, the first direction and the axis being perpendicular to each other.

2. The device of claim 1, wherein the permanent deformation includes a bend configured to extend in the direction of normal blood flow along the valve-flow axis.

3. The device of claim 1, wherein the posterior and anterior sections together form a closed ring-shaped member configured to be attached along and in close proximity to the annulus.

4. The device of claim 3, wherein the ring shaped member is substantially “

D”

shaped when viewed in a direction parallel to the valve-flow axis, and wherein;

a substantially straight portion of the “

D”

-shape is attachable to the annulus anterior portion, and a substantially arcuate portion of the “

D”

-shape is attachable to the annulus posterior portion.

5. The device of claim 4, wherein the annuloplasty device posterior section is permanently formed into an asymmetric shape relative to an axis bisecting the annuloplasty device along the first direction, the first direction and second axesaxis being perpendicular to each other.

6. An annuloplasty device for repairing a mitral valve, the mitral valve having a valve annulus, the valve annulus having an annulus anterior portion and an annulus posterior portion, the annulus posterior portion and the annulus anterior portion defining a mitral valve opening therebetween, the annulus posterior portion having a generally arcuate shape, the mitral valve having an anterior valve leaflet attached to the annulus anterior portion and a posterior valve leaflet attached to the annulus posterior portion, the anterior and posterior leaflets having respective anterior and posterior free margins, the anterior and posterior leaflets movable between a closed systolic configuration in which the free margins are in an approximated spatial relationship, and an open diastolic configuration in which the free margins are spaced apart to allow blood flow through the mitral valve opening generally along a valve-flow axis, the device comprising:

an anterior section and a posterior section coupled to the anterior section, the posterior and anterior sections divided along a first direction, the anterior and posterior sections being configured and sized for attachment to the annulus anterior and posterior portions respectively, the posterior section having a generally curvilinear shape and being permanently formed such that the posterior section is non-planar with respect to the anterior section when viewed in a direction generally parallel to the first direction and such that a portion of the posterior section is permanently inwardly deformed toward the anterior section and valve-flow axis, whereby when the annuloplasty device is attached to the valve annulus, the non-planar generally curvilinear shape and the permanently inwardly deformed portion of the posterior section are retained after attachment of the anterior and posterior sections to the annulus to cause the posterior portion of the annulus to assume the non-planar generally curvilinear shape of the posterior section and thereby improve coaptation of the leaflet free margins in the systolic configuration.

7. The device of claim 6, wherein the annuloplasty device posterior section is permanently formed into first and second subsections, the first subsection being asymmetric relative to the second section about an axis bisecting the annuloplasty device along the first direction, the first direction and the axis being perpendicular to each other.

8. The device of claim 6, wherein the non-planar generally curvilinear shape includes a bend configured to extend in the direction of normal blood flow along the valve-flow axis.

9. The device of claim 6, wherein the posterior and anterior sections together form a closed ring-shaped member configured to be attached along and in close proximity to the annulus.

10. The method of claim 9, wherein the ring shaped member is substantially “

D”

shaped when viewed in a direction parallel to the valve-flow axis, and wherein;

a substantially straight portion of the “

D”

-shape is attachable to the annulus anterior portion, and a substantially arcuate portion of the “

D”

-shape is attachable to the annulus posterior portion.

11. The device of claim 10, wherein the annuloplasty device posterior section is permanently formed into an asymmetric shape relative to an axis bisecting the annuloplasty device along the first direction, the first direction and the axis being perpendicular to each other.