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

• US 10,512,542 B2
• Filed: 03/10/2017
• Issued: 12/24/2019
• Est. Priority Date: 01/28/2011
• Status: Active Grant

• Current Assignee: Polares Medical Inc. (Polares Medical SA)
• Original Assignee: Polares Medical Inc. (Polares Medical SA)
• Inventors: Khairkhahan, Alex, Lesh, Michael D.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US15/455,567
• Publication Number:
  US 20170245994A1
• Time in Patent Office: 1,019 Days
• Field of Search: 623 126, 623 2368
• 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. A coaptation implant comprising:

a coaptation surface configured for an anterior leaflet of a valve to coapt against;

a superior edge, lateral edges, and an inferior edge, wherein the superior edge has a length greater than a length of the inferior edge, such that a transverse distance between the lateral edges generally decreases from the superior edge to the inferior edge of the coaptation implant;

a hub located near the superior edge;

a helical anchor configured to be rotated relative to the hub to engage tissue;

at least one strut, wherein a strut of the at least one strut extends from the hub toward the inferior edge, the at least one strut arranged to assist in maintaining the shape of the coaptation implant upon placement, while allowing the coaptation implant to assume a reduced configuration for deployment through a catheter.

2. The coaptation implant of claim 1, wherein the geometry of the coaptation implant is configured to conform substantially to a portion of the surface of a cone.

3. The coaptation implant of claim 1, wherein the shape of the coaptation implant is configured to conform substantially to a portion of the surface of a cone for about 50% to about 70% of a total height measured along the longitudinal axis of the cone, and the shape of the coaptation implant extends radially outwardly from the surface of the cone to form a radially outward flare.

4. The coaptation implant of claim 3, wherein the radially outward flare has a radius within a range of from about 5 mm to about 12 mm.

5. The coaptation implant of claim 1, wherein the at least one strut comprises two struts, wherein the two struts are relatively evenly spaced.

6. The coaptation implant of claim 1, wherein the at least one strut is disposed within a covering material for maintenance of a shape of the coaptation implant.

7. The coaptation implant of claim 1, wherein the at least one strut is composed of resiliently deformable materials or a Nitinol alloy.

8. The coaptation implant of claim 1, wherein the at least one strut is stiffer at an annular end than at a ventricular end of the coaptation implant.

9. The coaptation implant of claim 1, wherein an additional strut of the at least one strut is a transverse strut.

10. A coaptation implant comprising:

a coaptation surface configured for an anterior leaflet of a valve to coapt against;

a superior edge, lateral edges, and an inferior edge, wherein the superior edge has a length greater than a length of the inferior edge, such that a transverse distance between the lateral edges generally decreases from the superior edge to the inferior edge of the coaptation implant;

a hub located near the superior edge;

a helical anchor configured to be rotated relative to the hub to engage tissue;

a strut extending from the hub toward the inferior edge; and

one or more additional struts, wherein the one or more additional struts curve laterally toward the superior edge to assist in maintaining the shape of a proximal portion of the coaptation implant upon deployment.

11. The coaptation implant of claim 10, wherein an anterior surface or a posterior surface of the coaptation implant further comprise a covering.

12. The coaptation implant of claim 11, wherein the covering is comprised of ePTFE, polyurethane foam, polycarbonate foam, biologic tissue, porcine pericardium, or silicone.

13. The coaptation implant of claim 10, wherein the one or more additional struts assist in maintaining the distance between the lateral margins of the superior edge.

14. The coaptation implant of claim 10, wherein the one or more additional struts are composed of resiliently deformable materials or a Nitinol alloy.

15. A coaptation implant comprising:

a coaptation surface configured for an anterior leaflet of a valve to coapt against;

a superior edge, lateral edges, and an inferior edge, wherein the superior edge has a length greater than a length of the inferior edge, such that a transverse distance between the lateral edges generally decreases from the superior edge to the inferior edge of the coaptation implant;

a hub located near the superior edge;

a helical anchor configured to be rotated relative to the hub to engage tissue;

one or more struts, wherein a strut of the one or more struts is connected to the hub and extends longitudinally toward the inferior edge.

16. The coaptation implant of claim 15, wherein the one or more struts are concentrated toward the center of the coaptation implant.

17. The coaptation implant of claim 15, wherein the one or more struts are concentrated toward the lateral edges of the coaptation implant.

18. The coaptation implant of claim 15, wherein the one or more struts are composed of resiliently deformable materials or a Nitinol alloy.