PERCUTANEOUS ANNULOPLASTY SYSTEM WITH ANTERIOR-POSTERIOR ADJUSTMENT

• US 20130226289A1
• Filed: 02/27/2013
• Published: 08/29/2013
• 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., Packham, Victor S., Cao, Hung H., Yellin, Nadav
• Granted Patent: US 9,839,519 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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

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

positioning a catheter percutaneously into a heart;

inserting an 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 a biasing element of the annuloplasty ring, and thereby increase an anterior-posterior distance of the annuloplasty ring;

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

deploying a plurality of anchors of the annuloplasty ring to engage the annulus of the target valve to fasten the annuloplasty ring to the annulus; and

releasing the expansion tool to release the biasing element of the annuloplasty ring and effectuate transition of the annuloplasty ring in the annular operable geometry from the expanded state to a 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.

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

a body member that is transitionable from an elongate insertion geometry to an annular operable geometry, the elongate insertion geometry to allow percutaneous passage of the annuloplasty ring, via a catheter, into a heart of a patient, and the annular operable geometry having an expanded state to conform to an annulus of a target valve of the heart and a contracted state to reduce a diameter of the annulus of the target valve;

a plurality of anchors percutaneously deployable from the body member in the annular operable geometry to engage the annulus of the target valve;

a biasing element disposed between a first region and a second region of the body member, the biasing element configured to be expanded to increase an anterior-posterior distance of the annuloplasty ring in the annular operable geometry to the expanded state in abutment with the annulus of the target valve, such that subsequent deployment of the plurality of anchors fastens the body member to the annulus of the target valve,

wherein the biasing element biases the annuloplasty ring in the operable geometry toward the contracted state such that expansion of the annuloplasty ring to the expanded state stores potential energy in the biasing element and releasing the biasing element releases the potential energy to force movement of the first region of the body member toward the second region of the body member to decrease the anterior-posterior distance of the annuloplasty ring to the contracted state 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.

2. The adjustable annuloplasty ring of claim 1, wherein the target valve is a mitral valve.

3. The adjustable annuloplasty ring of claim 2, wherein the percutaneous passage, via a catheter, into the heart of the patient comprises an endovascular delivery into the heart of the patient.

4. The adjustable annuloplasty ring of claim 3, wherein the endovascular delivery into the heart comprises a trans-septal approach.

5. The adjustable annuloplasty ring of claim 3, wherein the endovascular delivery into the heart comprises a retrograde approach.

6. The adjustable annuloplasty ring of claim 2, wherein the percutaneous passage, via a catheter, into the heart of the patient comprises a trans-apical approach.

7. The adjustable annuloplasty ring of claim 1, wherein the biasing element comprises an integral biasing portion of the body member.

8. The adjustable annuloplasty ring of claim 7, wherein the integral biasing portion of the body member comprises a spiral cut in a portion of the body member to form a spiral shape in the body member that is expandable to the expanded state and that is biased toward the contracted state.

9. The adjustable annuloplasty ring of claim 1, wherein the biasing element comprises a spring and the first and second regions of the body member comprises first and second segments, the biasing element disposed between the first and second segments and configured to be disposed in a relaxed state when the annuloplasty ring is in the contracted state and configured to be disposed in an extended strained state when the annuloplasty ring is in the expanded state.

10. The adjustable annuloplasty ring of claim 9, wherein the biasing element forces movement of the first segment in a telescopic manner into the second segment.

11. The adjustable annuloplasty ring of claim 1, wherein movement of the first region of the body toward the second region of the body decreases the anterior-posterior distance of the annuloplasty ring between 3 mm and 5 mm.

12. The adjustable annuloplasty ring of claim 1, wherein the annular operable geometry forms a D-shaped ring.

13. The adjustable annuloplasty ring of claim 1, further comprising a second biasing element disposed between a third region of the body member and the second region of the body member, the second biasing element configured to be expanded to increase an anterior-posterior distance of the annuloplasty ring in the annular operable geometry to the expanded state in abutment with the annulus of the target valve, wherein the second biasing element biases the annuloplasty ring in the operable geometry toward the contracted state such that expansion of the annuloplasty ring to the expanded state stores potential energy in the second biasing element and releasing the second biasing element releases the potential energy to force movement of the third region of the body member toward the second region of the body member to decrease the anterior-posterior distance of the annuloplasty ring to the contracted state.

14. The adjustable annuloplasty ring of claim 1, wherein the biasing element is configured to be actuated percutaneously by an elongate mechanical coupling extending from the biasing element, through the catheter, to a position external to a body of the patient.

15. The adjustable annuloplasty ring of claim 14, wherein the elongate mechanical coupling comprises a suture.

16. The adjustable annuloplasty ring of claim 14, wherein the mechanical coupling comprises a cable.

17. The adjustable annuloplasty ring of claim 1, wherein actuation of the biasing element comprises releasing the biasing element.

18. The adjustable annuloplasty ring of claim 1, the body member forming an outer hollow member, wherein adjacent regions of the body member cooperate with one another to change the outer hollow member from the elongate insertion geometry to the annular operable geometry, the adjustable annuloplasty ring further comprising;

an internal anchor member located at least partially within the outer hollow member, the internal anchor member comprising the plurality of anchors, and 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 corresponding windows.

20. The method of claim 19, wherein the biasing element biases the annuloplasty ring in the operable geometry toward the contracted state such that expansion of the annuloplasty ring to the expanded state stores potential energy in the biasing element and releasing the biasing element releases stored potential energy to force movement of a first region of the annuloplasty ring toward a second region of the annuloplasty ring.

21. The method of claim 19, further comprising:

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

22. The method of claim 19, 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.

23. The method of claim 22, further comprising:

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

24. The method of claim 23, 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.

25. The method of claim 23, 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.

26. The method of claim 19, wherein positioning the catheter percutaneously into the heart comprises an endovascular delivery into the heart of the patient.

27. The method of claim 19, wherein positioning the catheter percutaneously into the heart comprises percutaneously introducing the catheter into the heart using a trans-apical approach.

28. The method of claim 19, wherein the expansion tool comprises an expandable cage and actuating the expansion tool comprises expanding the cage.

29. The method of claim 19, 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.

27-1. The method of claim 19, wherein the expansion tool is a balloon expansion tool and actuating the expansion tool comprises inflating the balloon expansion tool.

30. A system for percutaneous, transcatheter heart valve repair, the system comprising:

a catheter to provide percutaneous access into a heart of a patient;

an adjustable annuloplasty ring comprising;

a body member that is transitionable from an elongate insertion geometry to an annular operable geometry, the elongate insertion geometry to allow percutaneous passage of the annuloplasty ring, via the catheter, into the heart of a patient, and the annular operable geometry having an expanded state to conform to an annulus of a target valve of the heart and a contracted state to reduce a diameter of the annulus of the target valve;

a plurality of anchors deployable in the annular operable geometry to engage the annulus of the target valve; and

a stepped connector comprising a plurality of engagement steps and disposed between a first region and a second region of the body member of the annuloplasty ring to enable multiple degrees of adjustment of the anterior-posterior distance as the annuloplasty ring is transitioned from the expanded state to the contracted state; and

a deployment handle for manipulation of the expansion tool and deployment of the adjustable annuloplasty ring, the deployment handle comprising;

a ring closure knob to close the annuloplasty ring, transitioning the annuloplasty ring from the elongate insertion geometry to the annular operable geometry;

a ring snap knob to snap together the first and second ends of the annuloplasty ring;

an anchor deployment knob to deploy anchors of the annuloplasty ring to fasten the annuloplasty ring to the annulus of the target heart valve;

an anterior-posterior distance adjustment knob to manipulate an expansion tool to expand and contract the anterior-posterior distance of the annuloplasty ring; and

a ring release knob to release the annuloplasty ring from a delivery system.