Percutaneous transcatheter repair of heart valves

• US 8,518,107 B2
• Filed: 08/04/2011
• Issued: 08/27/2013
• Est. Priority Date: 08/04/2010
• Status: Active Grant

• Current Assignee: ValCare Medical, Inc.
• Original Assignee: ValCare, Inc.
• Inventors: Tsukashima, Ross, Shaolian, Samuel M., Buchbinder, Maurice, Gray, Brian C., Packham, Victor S., Cao, Hung H.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US13/198,582
• Publication Number:
  US 20120123531A1
• Time in Patent Office: 754 Days
• Field of Search: None
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• 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 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers

Abstract

Apparatus, systems, and methods are provided for repairing heart valves through percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves. An annuloplasty ring includes an outer hollow member including a plurality of segments. Adjacent segments cooperate with one another to change the outer hollow member from an elongate insertion geometry to an annular operable geometry. The annuloplasty ring also includes an internal anchor member located at least partially within the outer hollow member. The internal anchor member includes a plurality of anchors configured to attach the annuloplasty ring to tissue of a heart valve annulus. The internal anchor member is configured to move the plurality of anchors with respect to a plurality of windows in the outer hollow member to selectively deploy the plurality of anchors through the respective windows.

Claims

1. An annuloplasty ring for transcatheter heart valve repair, the annuloplasty ring comprising:

an outer hollow member comprising a plurality of segments, wherein adjacent segments cooperate with one another to change the outer hollow member from an elongate insertion geometry to an annular operable geometry; and

an internal anchor member located at least partially within the outer hollow member, the internal anchor member comprising a plurality of anchors configured to attach the annuloplasty ring to tissue of a heart valve annulus, the internal anchor member configured to move the plurality of anchors with respect to a plurality of windows in the outer hollow member to selectively deploy the plurality of anchors through the plurality of windows, respectively,

wherein the internal anchor member comprises a superelastic shape memory material configured to automatically transition at least a portion of the internal anchor member from the elongate insertion geometry to the annular operable geometry upon exiting a catheter within a heart chamber,

wherein the internal anchor member comprises a first shape memory ribbon having the plurality of anchors cut therein, wherein the plurality of anchors are configured to automatically transition to a curved shape upon exiting the plurality of windows in the outer hollow member, and wherein the transition to the curved shape self-propels the plurality of anchors into the tissue of the heart valve annulus,

wherein the internal anchor further comprising a second shape memory ribbon within the outer hollow member, the second shape memory ribbon configured to reduce friction between the first shape memory ribbon and the outer hollow member to assist in deploying the anchors.

2. The annuloplasty ring of claim 1, wherein the plurality of segments allow the outer hollow member to be flexible in a first plane so as to be transitionable between the elongate insertion geometry and the annular operable geometry, and wherein the plurality of segments in the annular insertion geometry are at least semi-rigid in a second plane that is perpendicular to the first plane.

3. The annuloplasty ring of claim 1, wherein the outer hollow member comprises a first end and a second end, and wherein the first end is configured to couple to the second end in the annular operable geometry.

4. The annuloplasty ring of claim 3, further comprising:

a female snap-lock connector attached to the first end of the outer hollow member; and

a male snap-lock connector attached to the second end of the outer hollow member.

5. The annuloplasty ring of claim 4, further comprising a suture or wire including a distal end configured to draw the male snap lock connector into the female snap lock connector by applying tension to a proximal end of the suture or wire.

6. The annuloplasty ring of claim 1, further comprising a pivot configured to removably couple the annuloplasty ring to a shuttle configured to pass through the catheter, the pivot further configured to automatically rotate a plane of the annuloplasty ring upon exiting the catheter within the heart chamber.

7. The annuloplasty ring of claim 1, wherein the outer hollow member comprises a superelastic shape memory material configured to automatically transition from the elongate insertion geometry to the annular operable geometry upon exiting the catheter within the heart chamber.

8. The annuloplasty ring of claim 7, wherein the outer hollow member comprises a shape memory tube cut in a pattern to form the plurality of segments in a continuous series of connected segments.

9. The annuloplasty ring of claim 8, wherein

in the elongate insertion geometry, the cut shape memory tube include gaps partially separating adjacent connected segments, and wherein

in the annular operable geometry, one or more of the gaps close.

10. The annuloplasty ring of claim 1, wherein the second shape memory ribbon is superelastic and is configured to automatically transition from the elongate insertion geometry to the annular operable geometry upon exiting the catheter within the heart chamber.

11. The annuloplasty ring of claim 1, wherein the second shape memory ribbon comprises a selectively adjustable member configured to be activated postoperatively by application of external energy to change the shape of the annuloplasty ring.

12. The annuloplasty ring of claim 1, further comprising a suture or wire including a distal end removably coupled to the internal anchor member, the suture or wire configured to slide the internal anchor member within the outer hollow member, by applying tension to a proximal end of the suture or wire, so as to deploy the plurality of anchors from the plurality of windows.

13. The annuloplasty ring of claim 1, wherein the annular operable geometry comprises a D-shape corresponding to an anatomical geometry of a human mitral valve annulus, wherein the annuloplasty ring in the annular operable geometry comprises a first dimension corresponding to an anterior-posterior dimension of the mitral valve annulus and a second dimension corresponding to a commissure-commissure dimension of the mitral valve annulus.