Method of reshaping a ventricle

• US 8,870,936 B2
• Filed: 10/03/2011
• Issued: 10/28/2014
• 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): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US13/252,060
• Publication Number:
  US 20120029628A1
• Time in Patent Office: 1,121 Days
• Field of Search: 623/1.24, 623/2.1, 623/2.17
• US Class Current: 623/1.11
• 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

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

applying a force against an apex portion of the ventricle along a longitudinal axis extending generally from a base of the heart to the apex portion, thereby elongating the ventricle in the longitudinal direction;

wherein the act of applying a longitudinal force against the apex portion of the ventricle comprises deploying an implantable body in the ventricle, which then applies the force against the apex portion of the ventricle;

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;

wherein deploying the implantable body comprises positioning the frame within the left ventricular outflow tract immediately adjacent the aortic annulus such that during systole, blood in the left ventricle can flow through a lumen of the frame and then through the aortic annulus.

2. The method of claim 1, wherein the implantable body is delivered percutaneously through the patient'"'"'s vasculature into the ventricle.

3. The method of claim 2, 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.

4. The method of claim 1, wherein the frame mounts a prosthetic valve member.

12. The method of claim 1, wherein blood can flow into areas of the ventricle adjacent the apex.

14. The method of claim 1, wherein a distal end of the pusher member comprises an elongate J-shape that extends along a linear course from the frame to the apex portion, wherein a distal end of the pusher member comprises a flexible, atraumatic tip portion that approximates the apex portion.

15. The method of claim 1, wherein the frame is secured to a location within the left ventricular outflow tract in the vicinity of the aortic valve.

18. The method of claim 1, wherein the deploying results in the apex of the heart being moved away from the frame along the longitudinal axis.

19. The method of claim 1, wherein the frame is a self-expanding, cylindrical frame having a central axis which runs substantially parallel to the longitudinal axis.

5. A method of reshaping a left ventricle of a human heart, comprising:

delivering an implantable body into the left ventricle by a delivery catheter, the implantable body having an anchor member and an elongate pusher member 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 the left ventricular outflow tract, the pusher member in a deployed state 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;

ejecting the implantable body from the delivery catheter;

expanding the anchor member for securing the anchor member to the left ventricular outflow tract; and

deploying the pusher member for applying the longitudinal force along the apex of the left ventricle to permanently elongate the left ventricle, thereby improving a pumping efficiency of the left ventricle.

6. The method of claim 5, wherein the anchor member comprises a radially expandable stent having an unobstructed lumen extending therethrough.

7. The method of claim 5, wherein the anchor member comprises a radially expandable stent having a prosthetic valve member mounted therein.

8. The method of claim 5, further comprising sliding a substantially rigid dowel or stylet into an inner lumen of the pusher member to simultaneously lengthen and reduce curvature in the pusher member.

9. The method of claim 8, wherein the lengthening and curvature reduction occurs along the distal end portion.

10. The method of claim 5, wherein a diameter of the elongate pusher member is smaller than the expanded diameter of the anchor member.

11. The method of claim 6, wherein the stent is a self-expanding, cylindrical stent having a central axis that runs substantially parallel to the elongate pusher member.

13. A method of reshaping a dilated ventricle of a patient comprising:

applying a force against an apex portion of the ventricle along a longitudinal axis extending generally from a base of the heart to the apex portion, thereby elongating the ventricle in the longitudinal direction.,

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

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;

wherein the ventricle is permanently elongated in the longitudinal direction when the implantable body is deployed.

16. A method of reshaping a dilated ventricle of a patient comprising:

applying a force against an apex portion of the ventricle along a longitudinal axis extending generally from a base of the heart to the apex portion, thereby elongating the ventricle in the longitudinal direction;

wherein the act of applying a longitudinal force against the apex portion of the ventricle comprises deploying an implantable body in the ventricle, which then applies the force against the apex portion of the ventricle;

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;

wherein deploying the implantable body causes the frame to come into alignment with the aortic valve annulus.

17. A method of reshaping a dilated ventricle of a patient comprising:

applying a force against an apex portion of the ventricle along a longitudinal axis extending generally from a base of the heart to the apex portion, thereby elongating the ventricle in the longitudinal direction;

,

wherein the act of applying a longitudinal force against the apex portion of the ventricle comprises deploying an implantable body in the ventricle, which then applies the force against the apex portion of the ventricle,

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;

further comprising positioning the frame such that a first outer surface portion of the frame is engages the ventricular septal wall and a second outer surface portion of the frame engages tissue extending from the aortic valve adjacent the anterior portion of the mitral valve.