Percutaneous annuloplasty system with anterior-posterior adjustment

• US 9,839,519 B2
• Filed: 02/27/2013
• Issued: 12/12/2017
• Est. Priority Date: 02/29/2012
• Status: Active Grant

• Current Assignee: ValCare Medical, Inc.
• Original Assignee: ValCare, Inc.
• Inventors: Shaolian, Samuel M., DuMontelle, Jeffrey P., Yellin, Nadav, Packham, Victor S., Cao, Hung H.
• Primary Examiner(s): Templeton, Christopher L
• Assistant Examiner(s): MANNAN, MIKAIL A
• Application Number:
  US13/779,478
• Publication Number:
  US 20130226289A1
• Time in Patent Office: 1,749 Days
• Field of Search: 623 236, 623 237, 623 238, 623 239, 623 24, 623 211
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: F04C 2270/0421 Controlled or regulated

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 body member including a plurality of regions. Adjacent regions cooperate with one another to change the body member from an elongate insertion geometry to an annular operable geometry. Adjacent regions are coupled by a biasing element or a stepped connector to allow expansion to an expanded state and contraction to a contracted state in the annular operable geometry. The annuloplasty ring also includes an internal anchor member located at least partially within the body member and having a plurality of anchors configured to attach the annuloplasty ring to tissue of a heart valve annulus. An angled ring closure lock allows coupling of the ends of an annuloplasty ring at an apex of a D-shape annular operable geometry.

Claims

1. A method of percutaneous transcatheter repair of a heart valve, the method comprising:

providing two biasing elements, a plurality of anchors, and a body member within an adjustable annuloplasty ring,

wherein the two biasing elements are disposed between a first posterior region and a second posterior region of the body member and are separated by an anterior region, the two biasing elements being configured to adjust an anterior-posterior distance of the adjustable annuloplasty ring;

positioning a catheter percutaneously into a heart;

inserting the adjustable annuloplasty ring configured in an elongate insertion geometry through the catheter and into the heart;

transitioning the annuloplasty ring from the elongate insertion geometry to an annular operable geometry;

actuating an expansion tool to expand the annuloplasty ring in the annular operable geometry to an expanded state, including expanding the two biasing elements of the annuloplasty ring, and thereby increasing the anterior-posterior distance of the annuloplasty ring,

wherein the two biasing elements bias the annuloplasty ring in the annular operable geometry toward a contracted state such that expansion of the annuloplasty ring to the expanded state stores a potential energy in the two biasing elements;

positioning the annuloplasty ring in abutment with an annulus of a target valve of the heart;

deploying the plurality of anchors fabricated on an anchor ribbon disposed within an interior of the annuloplasty ring;

engaging the plurality of anchors of the annuloplasty ring with the annulus of the target valve to fasten the annuloplasty ring to the annulus; and

releasing the expansion tool to release the two biasing elements of the annuloplasty ring and effectuate transition of the annuloplasty ring in the annular operable geometry from the expanded state to the contracted state to decrease the anterior-posterior distance of the annuloplasty ring and thereby decrease an anterior-posterior distance of the target valve to improve leaflet coaptation of the target valve and reduce regurgitation through the target valve,

wherein the two biasing elements release the stored potential energy to force movement of the first posterior region of the annuloplasty ring toward the second posterior region of the annuloplasty ring.

2. The method of claim 1, further comprising:

rotating the annuloplasty ring in the annular operable geometry to lie in a plane of the annulus of the target valve.

3. The method of claim 1, wherein transitioning the annuloplasty ring from the elongate insertion geometry to the annular operable geometry comprises drawing together first and second ends of the annuloplasty ring in the elongate insertion geometry using a suture.

4. The method of claim 3, further comprising:

snapping together the first and second ends of the annuloplasty ring with a snap mechanism.

5. The method of claim 4, wherein the snapping together the first and second ends of the annuloplasty ring occurs prior to expansion of the annuloplasty ring by the expansion tool.

6. The method of claim 4, wherein the snapping together the first and second ends occurs after deployment of the plurality of anchors to further reduce the anterior-posterior distance of the target valve.

7. The method of claim 1, wherein positioning the catheter percutaneously into the heart comprises an endovascular delivery into the heart of the patient.

8. The method of claim 1, wherein positioning the catheter percutaneously into the heart comprises percutaneously introducing the catheter into the heart using a trans-apical approach.

9. The method of claim 1, wherein the expansion tool is a balloon expansion tool and actuating the expansion tool comprises inflating the balloon expansion tool.

10. The method of claim 1, wherein the expansion tool comprises an expandable cage and actuating the expansion tool comprises expanding the cage.

11. The method of claim 1, wherein the expansion tool is one of a two-pronged expansion tool and a three-pronged expansion tool and actuating the expansion tool comprises deploying prongs of the expansion tool from a distal end of a delivery catheter to align and engage with the annuloplasty ring.

12. The method of claim 1, wherein deploying the plurality of anchors further comprises sliding the anchor ribbon disposed within the interior of the annuloplasty ring to align each of the plurality of anchors with each of a plurality of anchor deployment windows fabricated in the annuloplasty ring.