DEVICE, SYSTEM, AND METHOD FOR TRANSCATHETER TREATMENT OF VALVE REGURGITATION

• US 20130023985A1
• Filed: 06/22/2012
• Published: 01/24/2013
• 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.
• Granted Patent: US 8,888,843 B2
• Time in Patent Office: Days
• US Class Current: 623/2.38
• 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, wherein the inferior edge has a length less than 10 mm, and a superior edge, the superior edge further comprising an annular curve radius, wherein the annular curve radius is concave toward the first coaptation surface and has a length in the range of 25-35 mm, and wherein the element arc length along the coaptation surface of the coaptation assist body between the superior edge and the inferior edge is in the range of 50-60 mm;

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 coapts with the first leaflet of the valve in its 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. 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 in the range of 50-60 mm; and

wherein the first coaptation surface generally conforms to a portion of a surface of a cone between the inferior edge and the coaptation zone, and wherein the first coaptation surface comprises a radially outward flare beginning at an inflection point within a range of 30-40 mm from the inferior edge of the coaptation assist body along a longitudinal axis of the cone, wherein the radially outward flare has a radius in the range of 5-12 mm.

8. 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 with a length in the range of 25-35 mm, such that the distance between the lateral margins of the superior curve is equivalent to the distance between the first commissure and the second commissure;

a coaptation element length measured perpendicular 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, wherein the coaptation element length is in the range of 35-45 mm;

a ventricular element length measured perpendicular 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 in the range of 25-35 mm; and

a coaptation zone between the superior edge and inferior edge, wherein the coaptation zone has a coaptation zone curve radius measured between the lateral edges of the coaptation assist body generally parallel to the valve plane at the general level of the heart valve, wherein the coaptation zone curve radius is in the range of 35-45 mm.

9. The coaptation assist body of claim 8, further comprising a first connection element near the midpoint of the superior edge coupleable with a first anchor for deployment in a heart structure.

10. The coaptation assist body of claim 9, further comprising a second connection element at the inferior edge coupleable with a second anchor for deployment in a heart structure of the ventricle.

11. The coaptation assist body of claim 8, 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.

12. The coaptation assist body of claim 8, further comprising at least a one strut disposed within the covering material for maintenance of a shape of the coaptation assist body.

13. The coaptation assist body of claim 12, wherein the at least one strut is connected to the second connection element and extends toward the superior edge of the implant.

14. The coaptation assist body of claim 12, wherein the strut is composed of Nitinol, Polypropylene, or stainless steel.

15. The coaptation assist body of claim 12, 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.

16. 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 first and second leaflets each comprising a proximal surface, a distal surface, a coaptation edge and an annular edge;

the annulus further defining a valve plane, the valve plane separating an atrium proximally and a ventricle distally, the method comprising;

selectively deploying a first anchor into heart tissue distal to the annulus;

selectively deploying a second anchor proximal to the annulus near a mid-point of the annular edge of the second leaflet;

coupling the first anchor and the second anchor to a coaptation assist body comprising a coaptation surface and a leaflet surface such that the coaptation assist body is suspended across the valve plane from the atrium proximally to the ventricle distally.

17. The method of claim 16, wherein the coaptation assist body is suspended such that the coaptation surface coapts with the first leaflet and the leaflet surface of the coaptation assist body overlays the second leaflet such that mal-coaptation is mitigated.