Method and apparatus for reshaping a ventricle

• US 8,029,556 B2
• Filed: 04/02/2007
• Issued: 10/04/2011
• Est. Priority Date: 10/04/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rowe, Stanton J.
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): Swaminathan; Seema
• Application Number:
  US11/695,583
• Publication Number:
  US 20080086164A1
• Time in Patent Office: 1,646 Days
• Field of Search: 623/2.1, 623/2.37, 623/2.11, 623/2.36, 623/1.11, 623/1.15, 606/108, 606/191, 606/192, 606/194, 606/198, 604/164.01, 604/164.03, 604/164.12, 604/170.02
• US Class Current: 623/1.21
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2230/0041 J-shaped

Abstract

The present disclosure concerns embodiments of a reshaping apparatus and methods for restoring the conical shape of a dilated heart ventricle, or at least reshaping the ventricle to a more conical shape to counter the effects of dilation, thereby improving pumping efficiency. In an exemplary embodiment, a reshaping apparatus comprises an implantable body that can be delivered to a dilated left ventricle via the patient'"'"'s vasculature in a minimally-invasive procedure. When deployed inside the left ventricle, the body is adapted to apply a longitudinal (downward) force against the inner surface of the left ventricle that causes the ventricle to distend or elongate downwardly relative to the base of the heart so as to at least partially restore the conical shape of the heart. In other embodiments, one or more tension members can be secured to heart tissue inside a heart chamber or on the outside of the heart and placed in tension to reshape the geometry of the heart.

Claims

1. An apparatus for reshaping a dilated left ventricle of a human heart, comprising:

an implantable body including an anchor member and an elongate pusher member comprising of a radially expandable stent having an unobstructed lumen extending therethrough, permanently fixed to the anchor member, the pusher member having a length sized to extend from a left ventricular outflow tract to an apex of the left ventricle, the anchor member having an expanded diameter sized for deployment in and permitting blood flow therethrough when implanted in the left ventricular outflow tract, the pusher member in a deployed state of the implantable body extending along a longitudinal axis from the anchor member to the apex of the left ventricle, the pusher member having a distal end portion adapted to apply a longitudinal force along the apex of the left ventricle to permanently elongate the left ventricle, thereby improving a pumping efficiency of the left ventricle;

wherein the implantable body is configured to be delivered into the left ventricle by a delivery catheter and wherein the implantable body is configured for ejection from the delivery catheter for permanent implantation in the left ventricle.

2. The apparatus of claim 1, wherein the stent is self expanding.

3. The apparatus of claim 1, wherein the pusher member consists of a single elongate wire comprising an atraumatic tip shaped for engagement with an inner surface of the left ventricle.

4. The apparatus of claim 1, wherein the distal end portion of the pusher member is curved.

5. The apparatus of claim 4, wherein the pusher member comprises a lumen and a stylet slidably received in the lumen, the stylet being slidable into and out of the distal end portion to adjust the radius of curvature of the distal end portion so as to adjust the length of the pusher member.

6. The apparatus of claim 1, wherein the expanded diameter of the anchor member is sized to apply a lateral force that urges the anterior leaflet of a mitral valve toward the posterior leaflet, thereby improving leaflet coaption.

7. An apparatus for reshaping a ventricle of a heart, comprising:

a radially expandable frame having an unobstructed lumen extending therethrough, substantially circular frame adapted to expand into contact with surrounding tissue to secure the frame at a fixed position in the heart, the frame being radially expandable about a longitudinal axis; and

an elongated pusher member permanently fixed to and extending from the frame substantially in the direction of the longitudinal axis, the pusher member having a distal end portion adapted to engage and push against an inner surface portion of the ventricle to permanently distend the heart in a direction extending from the frame to the distal end portion of the pusher member.

8. The apparatus of claim 7, wherein the frame mounts a prosthetic valve.

9. The apparatus of claim 7, wherein the pusher member is J-shaped.

10. The apparatus of claim 7, wherein the pusher member is formed from a flat strip of material.

11. A device for reshaping a dilated left ventricle of a heart comprising:

an insertion configuration and a deployed configuration;

a longitudinal axis;

an anchor member comprising a radially expandable stent having an unobstructed lumen extending therethrough, the anchor member deployable in juxtaposition with at least one of an aortic valve and a mitral valve, the anchor member permitting blood flow through the at least one of the aortic valve and the mitral valve in the deployed configuration; and

a pusher member extending longitudinally from the anchor member, the pusher member comprising a proximal end coupled to the anchor member, and a distal end, the pusher member dimensioned such that the distal end applies a longitudinal force against an inferior inner surface portion of the left ventricle in the deployed configuration.

12. The device of claim 11, wherein the stent is self-expanding.

13. The device of claim 11, wherein the stent is balloon expandable.

14. The device of claim 11, wherein the anchor member comprises at least one of nitinol and stainless steel.

15. The device of claim 11, wherein the anchor member comprises at least one of attachment elements, barbs, staples, and flanges.

16. The device of claim 11, wherein the anchor member is dimensioned for deployment at least one of just beneath the aortic valve, within the aortic valve annulus, within the mitral valve annulus, and within the left atrium.

17. The device of claim 11, wherein the anchor member comprises a prosthetic valve assembly.

18. The device of claim 11, wherein a length of the pusher member is adjustable.

19. The device of claim 11, wherein the distal end of the pusher member comprises an arcuate, atraumatic flexible tip portion.

20. The device of claim 11, wherein the distal end of the pusher member is J-shaped.

21. The device of claim 11, wherein the pusher member comprises at least one of round wire;

a flat ribbon;

an elongate tube;

a mesh;

a solid, non-perforated material;

a biocompatible material;

stainless steel; and

a polymer.

22. The device of claim 11, wherein, the device in the insertion configuration is insertable percutaneously through a peripheral artery.

23. The device of claim 11, wherein a diameter of the anchor member in the insertion configuration is smaller than a diameter of the anchor member in the deployed configuration.