METHOD AND APPARATUS FOR RESHAPING A VENTRICLE

• US 20080086164A1
• Filed: 04/02/2007
• Published: 04/10/2008
• Est. Priority Date: 10/04/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rowe, Stanton J.
• Granted Patent: US 8,029,556 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• 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 ventricle, comprising an implantable body configured to be positioned in the ventricle and to apply a force against an inner surface of the ventricle to elongate the ventricle in a direction extending from the base to the apex of the heart.

2. The apparatus of claim 1, wherein the body comprises an anchor member configured to be deployed in the left ventricular outflow tract and an elongate pusher member having a proximal end portion connected to the anchor member and a distal end portion configured to contact and push against an inner surface of the left ventricle.

3. The apparatus of claim 2, wherein the anchor member comprises a radially expandable stent.

4. The apparatus of claim 2, wherein the anchor member comprises a prosthetic valve.

5. The apparatus of claim 2, wherein the length of the pusher member is adjustable.

6. The apparatus of claim 2, wherein the distal end portion of the pusher member is curved.

7. The apparatus of claim 6, 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.

8. The apparatus of claim 2, wherein the anchor member is configured to apply a lateral force that urges the anterior leaflet of a mitral valve toward the posterior leaflet, thereby improving leaflet coaption.

9. An apparatus for reshaping a ventricle of a heart comprising:

a radially expandable frame adapted to expand into contact with surrounding tissue to secure the frame at a fixed position in the heart; and

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

10. The apparatus of claim 9, wherein the frame mounts a prosthetic valve.

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

12. The apparatus of claim 9, wherein the pusher member is formed from a fiat strip of material.

13. A device for reshaping a ventricle of a heart comprising:

anchor means for anchoring the device to tissue inside the heart;

pusher means for applying a pushing force against the inside of the ventricle to cause the apex of the heart to move away from the anchor means to distend the heart in a direction extending from the base of the heart to the apex.

14. The device of claim 13, wherein the anchor means comprises a radially expandable stent.

15. An apparatus for altering a shape of a heart comprising:

a tension member having first and second end portions;

a first anchor member connected to the first end portion of the tension member and comprising a plurality of radially sell-expanding tissue engaging members that are configured to anchor themselves to tissue of an inner wall at a first location inside the heart; and

a second anchor member connected to the second end portion of the tension member and comprising a plurality of radially self-expanding tissue engaging members that are configured to anchor themselves to tissue of an inner wall at a second location inside the heart;

wherein when the tension member is placed in tension between the first and second anchor members, the inner walls are drawn toward each other to alter a shape of the heart.

16. The apparatus of claim 15, wherein the tension member comprises a suture line.

17. The apparatus of claim 15, wherein the anchor members are self-deploying.

18. A method for reshaping a dilated ventricle of a patient comprising applying a longitudinal force against an apex portion of the ventricle to elongate the ventricle.

19. The method of claim 18, wherein the act of applying a longitudinal force against an apex portion of the ventricle comprises deploying an implantable body in the ventricle, which then applies the longitudinal force against the apex portion of the ventricle.

20. The method of claim 19, wherein the implantable body is delivered percutaneously through the patient'"'"'s vasculature into the ventricle.

21. The method of claim 20, wherein the implantable body is advanced through the patient'"'"'s vasculature while contained in a lumen of a delivery sheath and then deployed in the ventricle by advancing the implantable body through the open distal end of the delivery sheath.

22. The method of claim 19, wherein the implantable body comprises a radially expandable frame coupled to a pusher member, and deploying the implantable body causes the frame to deploy within the left ventricular outflow tract and the pusher member to push against an inner surface of the apex portion.

23. The method of claim 22, wherein the frame mounts a prosthetic valve member.

24. The method of claim 18, wherein the act of applying a longitudinal force against an apex portion of the ventricle comprises securing a first end portion of a tension member to the outer surface of the apex portion and securing a second end portion of the tension member to a body part below the apex portion to draw the apex portion toward the body part, thereby elongating the ventricle.

25. The method of claim 24, wherein the second end portion is secured to a rib.

26. The method of claim 24, wherein the first end portion of the tension member is connected to an anchor member, and securing the first end portion of the tension member comprises deploying the anchor adjacent the outer surface of the apex portion to cause expandable prongs of the anchor member to engage and become anchored to the outer surface.

27. A method for reshaping a dilated ventricle of a patient comprising:

positioning a tension member having first and second ends in the ventricle;

securing the first end of the tension member to a first inner wall of the ventricle and securing the second end of the tension member to a second inner wall of the ventricle; and

tensioning the tension member to draw the inner walls toward each other.

28. The method of claim 27, wherein the tension member comprises a suture line.

29. The method of claim 27, wherein the first and second ends of the tension member are secured to the inner walls with respective expandable anchor members.

30. The method of claim 29, wherein each anchor member comprises radially expandable prongs that grab the tissue of the inner walls to secure the ends of the tension member in place.

31. The method of claim 27, wherein:

the tension member comprises a first tension member; and

the method further comprises securing the first end of a second tension member to the first inner wall, securing a second end of the second tension member to the second inner wall, tensioning the second tension member, and connecting the first and second tension members to each other at a location between the inner walls.