Cardiac valve repair devices configured for percutaneous delivery

• US 10,278,819 B2
• Filed: 05/27/2016
• Issued: 05/07/2019
• Est. Priority Date: 06/01/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Taylor, David M., Tran, Tri D., Chow, Sean, Hauser, David L., Ho, Pui Tong, Cooper, Alexander H.
• Primary Examiner(s): Rosen, Eric J
• Assistant Examiner(s): Igboko, Chima U
• Application Number:
  US15/167,760
• Publication Number:
  US 20160346084A1
• Time in Patent Office: 1,075 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• 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 2250/0014 having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis

Abstract

Disclosed herein are devices for improving coaption of the mitral valve leaflets to reduce or eliminate mitral valve regurgitation. The devices may be used to perform mitral valve annuloplasty, or to serve as a docking station for a transcatheter prosthetic heart valve. The various embodiments of devices are configured for percutaneous and, in some cases, transvascular delivery. Delivery systems useful for routing the devices to the mitral valve are also disclosed, including catheters, balloons and/or mechanical expansion systems. The devices themselves include at least one tissue penetrating member. Methods of delivery include partially embedding the devices in the mitral valve annulus via at least one tissue penetrating member. Tissue penetrating members may be embedded into the tissue in a simultaneous or a nearly simultaneous fashion. Upon embedding, the devices employ various expansion and/or contraction features to adjust the mitral valve diameter. Adjustments may continue until the leaflets fully coapt and the problem of mitral regurgitation is reduced or eliminated.

Claims

1. A device for improving function of a cardiac valve, comprising:

a frame configured to fit within a cardiac valve, the frame comprising an annular body having a first end, a second end, and an opening extending therebetween; and

wherein the frame comprises a pair of tissue penetrating members extending from the first end of the frame, each tissue penetrating member comprising an end portion having a sharp penetrating surface configured to pierce valvular tissue,

wherein the frame is collapsible to a first position and expandable to a second position;

wherein in the first position, the pair of tissue penetrating members are positioned such that their respective penetrating surfaces abut one another to form a blunt end; and

wherein in the second position, the pair of tissue penetrating members are spaced apart such that their respective penetrating surfaces are exposed.

2. The device of claim 1, wherein the tissue penetrating members further comprise tissue fixation mechanisms that have pointed ends positioned closer to the first end of the annular body of the frame than the penetrating surfaces of the tissue penetrating members.

3. The device of claim 1, wherein the frame is at least partially formed from a shape memory material.

4. The device of claim 1, wherein the frame comprises a plurality of intersecting struts, wherein some of the struts are made of shape memory material and some of the struts are made of non-shape memory material.

5. The device of claim 4, wherein the struts made of shape memory material and the struts made of non-shape memory material alternate along the perimeter of the frame.

6. The device of claim 1, wherein the frame is configured to retract from the second position and pull together the penetrated tissue.

7. The device of claim 1, further comprising a cinching system radially surrounding the frame and configured to adjust an overall diameter of the frame.

8. The device of claim 1, wherein the annular body of the frame comprises a plurality of intersecting struts forming a plurality of apices at the first end of the annular body, and wherein the pair of tissue penetrating members are attached to and extend axially away from one of the apices.

9. The device of claim 8, wherein the pair of tissue penetrating members are configured to pivot at the apex to which the tissue penetrating members are attached.

10. The device of claim 9, wherein each of the tissue penetrating members is an extension of one of two struts that intersect to form the apex to which the tissue penetrating members are attached.

11. The device of claim 10, wherein when the frame is expanded, the tissue penetrating surfaces pivot away from each other around a pivot axis at the apex to which the tissue penetrating members are attached.

12. The device of claim 8, wherein the frame comprises a plurality of pairs of tissue penetrating members, wherein each pair is attached to and extends axially away from a respective apex at the first end of the annular body.

13. The device of claim 1, wherein the end portion of each tissue penetrating member comprises a curved outer surface, and wherein when the frame is in the first position and the tissue penetrating surfaces are abutting one another, the curved outer surfaces form a continuous curved surface that defines the blunt end and when the frame is expanded to the second position, the curved outer surfaces are spaced from each other.

14. The device of claim 1, wherein the pair of tissue penetrating members are made of a shape memory material.

15. A method of percutaneous cardiac valve repair, the method comprising:

providing a transcatheter delivery system comprising;

a catheter;

an elongate balloon mounted along a distal end portion of the catheter, wherein the elongate balloon comprises an inflated state and an uninflated state, and wherein the elongate balloon comprises, in the inflated state, a first portion with a first diameter and a second portion with a second diameter larger than the first diameter; and

a frame surrounding at least a portion of the elongate balloon and comprising an annular body having a first end and a second end;

wherein when the elongate balloon is in the uninflated state, the frame is in a corresponding collapsed state, and when the elongate balloon is in the inflated state, the frame is expanded to an expanded state;

wherein the frame comprises a pair of tissue penetrating members extending from the first end of the annular body of the frame, each tissue penetrating member comprising a sharp penetrating surface configured to pierce valvular tissue;

wherein when the frame is in the collapsed state, the pair of tissue penetrating members are positioned relative to each other such that their penetrating surfaces abut one another to form a blunt end;

wherein when the frame is in the expanded state, the pair of tissue penetrating members are spaced apart such that their penetrating surfaces are exposed;

navigating the elongate balloon in the uninflated state and the frame in the collapsed state through the cardiovascular system of a subject via the catheter;

positioning the elongate balloon and the frame within a cardiac valve of the subject;

moving a gas or liquid through the catheter and into the elongate balloon, wherein said moving causes the elongate balloon to expand to the inflated state and the frame to expand to the expanded state, which causes the penetrating surfaces of the tissue penetrating members to move apart from each other;

applying force to the catheter in a manner that causes the penetrating surfaces of the tissue penetrating member of the frame to penetrate the valvular tissue of the subject;

deflating the elongate balloon such that the frame remains attached to the valvular tissue; and

removing the catheter and elongate balloon from the subject.

16. The method of claim 15, wherein the frame comprises a shape memory material that causes the frame to retract from the expanded state after removal of the elongate balloon.

17. The method of claim 15, wherein positioning the elongate balloon comprises positioning the elongate balloon such that the first portion is positioned between leaflets of the cardiac valve.

18. The method of claim 15, wherein the frame surrounds at least a portion of the second portion of the balloon.

19. The method of claim 15, wherein a surface of the elongate balloon comprises a plurality of friction elements configured to increase friction between the elongate balloon and the frame.

20. The method of claim 15, wherein the frame comprises a shape memory material that is shape set in the expanded state such that the frame remains at the expanded state and does not contract after removal of the elongate balloon.

21. The method of claim 20, wherein the transcatheter delivery system further comprising a sleeve place around the frame such that retraction of the sleeve enables the frame to expand into the expanded state.

22. The method of claim 15, wherein the annular body of the frame comprises a plurality of intersecting struts forming a plurality of apices at the first end of the annular body, and wherein the pair of tissue penetrating members are attached to and extend axially away from one of the apices.

23. The device of claim 22, wherein the pair of tissue penetrating members are configured to pivot away from each other around a pivot axis at the apex to which the tissue penetrating members are attached when the frame is expanded to the expanded state.

24. The device of claim 22, wherein the pair of tissue penetrating members comprises a plurality of pairs of tissue penetrating members, wherein each pair is attached to and extends axially away from a respective apex at the first end of the annular body.