Device, system, and method for transcatheter treatment of valve regurgitation

• US 8,888,843 B2
• Filed: 06/22/2012
• Issued: 11/18/2014
• Est. Priority Date: 01/28/2011
• Status: Active Grant

• Current Assignee: Polares Medical Inc. (Polares Medical SA)
• Original Assignee: Middle Peak Medical, Inc. (Boston Scientific Corporation)
• Inventors: Khairkhahan, Alex, Lesh, Michael D.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US13/531,407
• Publication Number:
  US 20130023985A1
• Time in Patent Office: 879 Days
• Field of Search: 606/151, 623/2.11, 623/2.3, 623/2.38, 623/2.36, 600/30, 600/37
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/0448 Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/042 Iron or iron alloys
• CPC Class Codes: A61L 27/06 Titanium or titanium alloys
• CPC Class Codes: A61L 27/3625 : Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/50 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

Abstract

The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation enhancement element for implantation across the valve; a system including the coaptation enhancement element and anchors for implantation; a system including the coaptation enhancement element, catheter and driver; and a method for transcatheter implantation of a coaptation element across a heart valve.

Claims

1. An implant for treating mal-coaptation of a heart valve, the heart valve having an annulus and first and second leaflets with an open configuration and a closed configuration, the implant comprising:

a coaptation assist body having a first coaptation surface, an opposed second surface, each surface bounded by a first lateral edge, a second lateral edge, an inferior edge, and a superior edge, an element arc length along the coaptation surface of the coaptation assist body between the superior edge and the inferior edge and an coaptation element length along the coaptation surface of the coaptation assist body between the most proximal point of the coaptation assist body and the inferior edge, wherein the element arc length is greater than the coaptation element length due to folding of the coaptation assist body;

a first anchor selectively deployable at a first target location of the heart near the second leaflet on the annulus and coupleable to the coaptation assist body near the superior edge; and

a second anchor selectively deployable, independently of the deployment of the first anchor, at a second location of the heart in the ventricle such that the coaptation assist body, when coupled to both the first anchor and the second anchor, extends from the first target location across the valve to the second target location.

2. The implant of claim 1 wherein the first coaptation surface is configured to coapt with the first leaflet of the valve in the closed configuration.

3. The implant of claim 2 wherein the coaptation with the first leaflet of the valve is at the level of the valve.

4. The implant of claim 1 wherein the first anchor is deployable superior to the annulus.

5. The implant of claim 1 wherein the first anchor is deployable into a wall of an atrium.

6. The implant of claim 1 wherein the first anchor is deployable into a wall of an auricle.

7. The implant of claim 1, further comprising a superior hub operably connected to the coaptation assist body near the superior edge, wherein the first anchor is coupleable to the superior hub.

8. The implant of claim 1, further comprising an inferior hub operably connected to the coaptation assist body near the inferior edge, wherein the second anchor is coupleable to the inferior hub.

9. The implant of claim 1, wherein the first coaptation surface has a concave surface that is generally conical between the first lateral edge and the second lateral edge.

10. A coaptation assist body for treating mal-coaptation of a heart valve, the heart valve having an annulus which defines a valve plane, and at least a first and a second leaflet, the coaptation assist body comprising:

a first coaptation surface and an opposed second surface;

a first lateral edge, a second lateral edge, an inferior edge, and a superior edge;

a coaptation zone on the first coaptation surface extending transversely between the inferior edge and the superior edge configured such that a leaflet of the valve may coapt against the coaptation zone;

wherein the first coaptation surface has an overall element arc length from the superior edge to the inferior edge; and

wherein the first coaptation surface is generally conical at a portion of the first coaptation surface between the first lateral edge and the second lateral edge, and wherein the first coaptation surface comprises a radially outward flare extending from the conical portion of the first coaptation surface beginning at an inflection point between the inferior edge and the superior edge.

11. The coaptation assist body of claim 10, wherein the radially outward flare is configured to overlay the second leaflet.

12. A coaptation assist body for treating mal-coaptation of a heart valve, the heart valve having an annulus and first and second leaflets with a first commissure at a first junction of the first and second leaflets and a second commissure at a second junction of the first and second leaflets, the coaptation assist body comprising:

a first coaptation surface and an opposed second surface;

a first lateral edge, a second lateral edge, an inferior edge, and a superior edge;

wherein the superior edge comprises a curve, such that the distance between the lateral margins of the superior curve is equivalent to a distance between the first commissure and the second commissure;

a coaptation element length equivalent to a distance measured perpendicularly to a valve plane defined by the annulus of the valve between a most proximal extent of the coaptation assist body and the inferior edge of the coaptation assist body;

a ventricular element length equivalent to a distance measured perpendicularly to the valve plane between the level of the annulus and the inferior edge of the coaptation assist body wherein the ventricular element length is less than the coaptation element length; and

a coaptation zone between the superior edge and inferior edge, wherein the coaptation zone has a coaptation zone curve radius measurable between the first and second lateral edges of the coaptation assist body and generally parallel to the valve plane at the general level of the heart valve wherein the first coaptation surface includes a radially outward flare extending from the coaptation zone at an inflection point between the inferior and superior edges.

13. The coaptation assist body of claim 12, further comprising a first connection element near the midpoint of the superior edge coupleable with a first anchor for deployment in a heart structure.

14. The coaptation assist body of claim 13, further comprising a second connection element at the inferior edge coupleable with a second anchor for deployment in a heart structure of the ventricle.

15. The coaptation assist body of claim 12, wherein the anterior surface and posterior surface comprise a covering that comprises one or more of the materials selected from the group consisting of:

ePTFE, polyurethane foam, polycarbonate foam, biologic tissue and silicone.

16. The coaptation assist body of claim 12, further comprising at least a one strut disposed within a covering material for maintenance of a shape of the coaptation assist body.

17. The coaptation assist body of claim 16, wherein the at least one strut is connected to the second connection element and extends toward the superior edge of the implant.

18. The coaptation assist body of claim 16, wherein the strut is composed of Nitinol, Polypropylene, or stainless steel.

19. The coaptation assist body of claim 16, wherein the strut extends from the second connection near one lateral edge to the superior edge and a second strut extends from the second connection near the second lateral edge to the superior edge of the implant such that the struts assist in maintaining the distance between the lateral margins of the superior edge.