Coaptation enhancement implant, system, and method

• US 9,610,163 B2
• Filed: 09/29/2014
• Issued: 04/04/2017
• 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:
  US14/500,470
• Publication Number:
  US 20150112429A1
• Time in Patent Office: 918 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
• 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 method for treating mal-coaptation of a heart valve in a patient, the heart valve having an annulus and first and second leaflets, the annulus defining a valve axis extending along a blood flow path, the first and second leaflets having a coaptation zone defining a curve extending across the flow path, the method comprising:

introducing an implant into the heart while the implant is in a first configuration;

deploying the implant from the first configuration to a second configuration within the heart, the implant in the second configuration having a coaptation assist body with first and second opposed coaptation surfaces;

supporting the implant in a position in which the first coaptation surface is in position to coapt with the first leaflet of the heart valve; and

positioning a hub of the implant, wherein the hub allows relative rotation between a helical anchor and the implant.

2. The method of claim 1, wherein supporting the implant further comprises supporting the implant in a position in which the second coaptation surface is in position to coapt with the second leaflet of the heart valve.

3. The method of claim 1, wherein the coaptation assist body of the implant defines a curve extending across the blood flow path of the valve, the curve of the coaptation assist body corresponding to the curve of the coaptation zone.

4. The method of claim 1, wherein implant is deployed so that the coaptation assist body has an axial length, a thickness between the coaptation surfaces, and a commissure-to-commissure width, the thickness being less than 15% of the width.

5. The method of claim 1, wherein implant is deployed so that the coaptation assist body has an axial length, a thickness between the coaptation surfaces, and a commissure-to-commissure width, the length being at least 75% of the width.

6. The method of claim 1, wherein deploying the implant comprises removing the coaptation assist body from within a surrounding deployment catheter and laterally expanding the coaptation assist body from an insertion profile to a deployed profile.

7. The method of claim 1, wherein the mal-coaptation of the valve varies along the curve, further comprising characterizing the variation in mal-coaptation along the curve, wherein a thickness of the deployed coaptation assist body between the first coaptation surface and the second coaptation surface varies along the curve in response to the characterization of the variation in mal-coaptation.

8. The method of claim 1, further comprising rotating the helical anchor.

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

a coaptation assist body having an axis and first and second opposed major coaptation surfaces, each coaptation surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body, the coaptation assist body introducible into the heart and supportable within the heart so that the axis of the coaptation assist body extends along the axis of the valve with the first and second lateral sides of the coaptation assist body extending along the curve of the coaptation zone of the heart valve;

the coaptation assist body deployable from a first configuration to a second configuration by removing the coaptation assist body from within a surrounding deployment catheter; and

wherein the coaptation assist body has an insertion volume within the deployment catheter and a deployed volume greater than the insertion volume, and wherein the coaptation assist body is volumetrically expandable within the heart so as to increase a thickness of the coaptation assist device between the first and second coaptation surfaces.

10. The implant of claim 9, wherein coaptation assist body is deployable by laterally unrolling, unforcing, and/or unfolding the coaptation assist body within the heart.

11. The implant of claim 9, wherein the coaptation assist body comprises a permeable material, and wherein the coaptation assist body is configured to volumetrically expand when released in the heart without the coaptation assist body being inflated using inflation fluid introduced from outside a vascular system of the patient.

12. The implant of claim 11, wherein the coaptation assist body comprises a tissue-ingrowth material layer disposed over a core material, the core material expanding when released inside the heart.

13. The implant of claim 11, wherein the coaptation assist body comprises a layer of ePTFE over a foam or other liquid absorbing matrix.

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

introducing an implant having a coaptation assist body with first and second opposed coaptation surfaces into the heart valve;

supporting the implant so that the coaptation assist body is disposed within the coaptation zone;

positioning a hub of the implant, the hub comprising an outer collar and a pin extending therethrough, wherein the pin is configured to engage helical threads of an anchor passing above and below the pin adjusting a curvature of the coaptation assist body.

15. The method of claim 14, further comprising adjusting curvature of the coaptation assist body, wherein adjusting the axial curvature of the coaptation assist body further comprises:

tensioning a tether coupled to the downstream end of the coaptation assist body to cause the curvature of the coaptation assist body to change by changing a distance between the upstream and downstream ends of the coaptation assist body; and

engaging a lock of the tether at the upstream end of the coaptation assist body to constrain the distance between the upstream and downstream ends of the coaptation assist body.

16. The method of claim 14, wherein introducing the implant into the heart valve comprises introducing the implant in a first configuration, and then deploying the implant from the first configuration to a second configuration.

17. The method of claim 14, further comprising anchoring the downstream end of the coaptation assist body to ventricular tissue of the heart.

18. The method of claim 14, further comprising anchoring the upstream end of the coaptation assist body to the annulus of the heart valve.

19. The method of claim 14, further comprising anchoring the upstream end of the coaptation assist body to the heart near a first commissure of the heart valve and near a second commissure of the heart valve.

20. The method of claim 14, further comprising rotating the anchor.