Coaptation enhancement implant, system, and method

• US 10,470,883 B2
• Filed: 03/31/2017
• Issued: 11/12/2019
• 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:
  US15/475,629
• Publication Number:
  US 20170265995A1
• Time in Patent Office: 956 Days
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• 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 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0448 Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• 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 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

Implants, implant systems, and methods for treatment of mitral valve regurgitation and other valve diseases generally include a coaptation assist body which remains within the blood flow path as the leaflets of the valve move, the valve bodies often being relatively thin, elongate (along the blood flow path), and/or conformable structures which extend laterally from commissure to commissure, allowing the native leaflets to engage and seal against the large, opposed surfaces on either side of the valve body during the heart cycle phase when the ventricle contracts to empty that chamber of blood, and allows blood to pass around the valve body so that blood flows from the atrium to the ventricle during the filling phase of the heart cycle. Separate deployment of independent anchors near each of the commissures may facilitate positioning and support of an exemplary triangular valve body, with a third anchor being deployed in the ventricle. An outer surface of the valve body may accommodate tissue ingrowth or endothelialization, while a fluid-absorbing matrix can swell after introduction into the heart. The valve body shape may be selected after an anchor has been deployed, and catheter-based deployment systems may have a desirable low profile.

Claims

1. A coaptation assist system for treating mal-coaptation of a heart valve in a heart of a patient, the heart valve having a valve annulus and first and second leaflets, the valve annulus defining a valve axis extending along a blood flow path, the first and second leaflets having a coaptation zone, the coaptation assist system comprising:

a coaptation assist body having a first coaptation surface and a second, opposed surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body and longitudinally between an upstream end and a downstream end of the coaptation assist body, the coaptation assist body introducible into the heart and supportable within the heart, the coaptation assist body deployable from a first configuration to a second configuration, wherein in the second configuration the first coaptation surface is in position to coapt with the first leaflet of the heart valve;

a central atrial anchor deployable to anchor the coaptation assist body to the heart at the upstream end of the coaptation assist body; and

a lateral anchor affixed proximate to the first lateral edge at the upstream end of the coaptation assist body and deployable to fix the upstream end to the heart.

2. The system of claim 1, wherein the coaptation assist body further comprises axial struts which inhibit axial bending.

3. The system of claim 1, further comprising a catheter system including a catheter body having a proximal end and a distal end, the distal end being steerable within the heart from the proximal end.

4. The system of claim 1, further comprising one or more barbs.

5. The system of claim 1, wherein coaptation assist body is expandable within the heart.

6. The system of claim 1, wherein the coaptation assist body is sufficiently conformable that engagement between the coaptation assist body and the leaflets of the heart significantly conforms a shape of the coaptation assist body between the leaflets toward the mal-coaptation geometry of the leaflets.

7. The system of claim 1, wherein the coaptation assist body defines a channel within the coaptation assist body.

8. The system of claim 1, further comprising a tether disposed within the coaptation assist body.

9. The system of claim 8, wherein the tether comprises a suture.

10. The system of claim 8, wherein the tether is adjustable within the coaptation assist body.

11. The system of claim 1, further comprising a curvature lock configured to define a curvature of the coaptation assist body.

12. A system for treating mal-coaptation of a heart valve of a heart of a patient, the heart valve having a valve annulus and first and second leaflets, the valve annulus defining a valve axis extending along a blood flow path, the first and second leaflets having a coaptation zone, the system comprising:

a coaptation assist body having a first coaptation surface and a second, opposed surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body and longitudinally between an upstream end and a downstream end of the coaptation assist body, the coaptation assist body introducible into the heart and supportable within the heart, the coaptation assist body deployable from a first configuration to a second configuration, wherein in the second configuration the first coaptation surface is in position to coapt with the first leaflet of the heart valve;

a first anchor selectively deployable from within the heart at a first target location of the heart; and

a lateral anchor affixed proximate to the first lateral edge of an upstream end of the coaptation assist body and deployable to fix the upstream end to the heart.

13. The system of claim 12, further comprising a second anchor selectively deployable from within the heart at a second target location of the heart.

14. The system of claim 12, wherein the first anchor is affixed to the upstream end of the coaptation assist body and deployable to fix the upstream end of the coaptation assist body to the heart.

15. The system of claim 12, further comprising a second anchor affixed to the downstream end of the coaptation assist body and deployable to fix the downstream end of the coaptation assist body to a ventricular tissue of the heart.

16. The system of claim 12, comprising another lateral anchor affixed proximate to the second lateral edge of the upstream end of the coaptation assist body and deployable to fix the upstream end to the heart.

17. The system of claim 12, wherein the first anchor is selectively deployable from within the heart with a catheter system.

18. The system of claim 12, wherein the first anchor extends through a hub, the hub operably connected along an axis of the coaptation assist body.

19. A system for treating mal-coaptation of a heart valve of a heart of a patient, the heart valve having a valve annulus and first and second leaflets, the valve annulus defining a valve axis extending along a blood flow path, the first and second leaflets having a coaptation zone, the system comprising:

a coaptation assist body having a first coaptation surface and a second, opposed surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body and longitudinally between an upstream end and a downstream end of the coaptation assist body, the coaptation assist body introducible into the heart and supportable within the heart, the coaptation assist body deployable from a first configuration to a second configuration, wherein in the second configuration the first coaptation surface is in position to coapt with the first leaflet of the heart valve;

an annular anchor selectively deployable from within the heart at a first target location of the heart, the annular being disposed along a longitudinal axis of the coaptation assist body; and

a lateral anchor affixed proximate a to the first lateral edge of the upstream end of the coaptation assist body and deployable to fix the upstream end to the heart.