Techniques for percutaneous mitral valve replacement and sealing

• US 10,245,143 B2
• Filed: 07/19/2016
• Issued: 04/02/2019
• Est. Priority Date: 08/05/2011
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Cardiovalve Ltd.
• Inventors: Gross, Yossi, Hacohen, Gil, Miller, Eran, Zipory, Yuval, Reich, Tal, Kutzik, Meir, Neeman, Rotem
• Primary Examiner(s): Stewart, Alvin
• Application Number:
  US15/213,791
• Publication Number:
  US 20160324633A1
• Time in Patent Office: 987 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0015 differing in density or specific weight
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

Apparatus for use at a native heart valve of a subject is described. For some applications, the apparatus comprises a prosthetic valve support, configured (a) to be implanted at the native valve, (b) to facilitate, at a first period, implantation at the native valve of a first prosthetic valve, and (c) to facilitate, at a second period, implantation at the native valve of a second prosthetic valve. Other embodiments are also described.

Claims

1. Apparatus for use with a native valve of a heart of a subject, the apparatus comprising:

an overtube, transluminally advanceable to the heart;

a prosthetic valve support, having a compressed state for delivery through the overtube to the heart, and an expanded state in which the valve support comprises;

a flat annular upstream support portion;

comprising a nitinol frame and a fabric disposed over the nitinol frame,

having an inner perimeter defined by a free inner edge that defines an opening through the upstream support portion, and

having an outer perimeter that is at least 10 percent greater than the inner perimeter; and

a plurality of anchors comprising at least a first anchor and a second anchor, each anchor of the plurality of anchors being configured to anchor to a respective commissure of the native valve; and

a prosthetic valve;

having a compressed state for transluminal delivery, and

being intracorporeally couplable to the valve support by being expanded toward an expanded state of the prosthetic valve while disposed within the opening,

wherein;

(i) the valve support is configured such that upon deployment of the valve support from a distal end of the overtube, the first anchor and the second anchor anchor the valve support to the commissures by moving away from each other and into the commissures,

(ii) the first anchor and the second anchor are configured to anchor the valve support to the commissures by extending, from the upstream support portion, through the commissures to a ventricular side of the commissures, and

(iii) the valve support is configured such that, when anchored by the anchors to the commissures, and before the prosthetic valve is coupled to the valve support, the valve support allows the native valve to continue to function.

2. The apparatus according to claim 1, wherein the nitinol frame comprises a plurality of struts arranged in a repeating pattern.

3. The apparatus according to claim 1, wherein the prosthetic valve is intracorporeally couplable to the valve support by being expanded against the free inner edge of the valve support.

4. The apparatus according to claim 1, wherein the prosthetic valve does not comprise valve-anchoring elements that engage tissue of the native valve.

5. The apparatus according to claim 1, wherein, in the compressed state, the upstream support portion is cylindrical and has an upstream end and a downstream end, and wherein the valve support is configured such that expansion of the upstream support portion from the compressed state into the expanded state causes the downstream end to become the inner perimeter and the upstream end to become the outer perimeter.

6. The apparatus according to claim 1, wherein the outer perimeter is at least 50 percent greater than the inner perimeter.

7. The apparatus according to claim 1, wherein the native valve has an annulus, and wherein the upstream support portion is configured to be placed against an upstream surface of the native valve, and the prosthetic valve support is dimensioned such that when (i) the prosthetic valve support is in its expanded state, and (ii) the upstream support portion is disposed against the annulus, no part of the prosthetic valve support that circumscribes a space is disposed downstream of the annulus.

8. The apparatus according to claim 1, wherein the opening of the upstream support portion has a diameter that is less than 90 percent of a greatest diameter of an orifice of the native valve.

9. The apparatus according to claim 1, wherein the inner perimeter defines an inner diameter of the upstream support portion that is between 20 and 35 mm.

10. The apparatus according to claim 9, wherein the inner perimeter defines an inner diameter of the upstream support portion that is between 23 and 32 mm.

11. The apparatus according to claim 10, wherein the inner perimeter defines an inner diameter of the upstream support portion that is between 25 and 30 mm.

12. The apparatus according to claim 9, wherein the outer perimeter defines an outer diameter of the upstream support portion that is between 40 and 80 mm.

13. The apparatus according to claim 12, wherein the outer perimeter defines an outer diameter of the upstream support portion that is between 40 and 70 mm.

14. The apparatus according to claim 13, wherein the outer perimeter defines an outer diameter of the upstream support portion that is between 40 and 60 mm.

15. The apparatus according to claim 1, wherein the first anchor and the second anchor are each coupled to the upstream support portion via a respective hinge point.

16. The apparatus according to claim 1, wherein the valve support is configured such that, upon deployment of the valve support from the distal end of the overtube, the first anchor and the second anchor anchor the valve support to the commissures by pivoting away from each other and into the commissures.

17. The apparatus according to claim 1, wherein the valve support is configured such that, upon deployment of the valve support from the distal end of the overtube, the first anchor and the second anchor pivot with respect to the upstream support portion.

18. A method for use at a native valve of a heart of a subject, the method comprising:

advancing an overtube to the heart;

via the overtube, implanting at the native valve a prosthetic valve support that has (i) a compressed state for delivery through the overtube to the heart, and (ii) an expanded state in which the valve support includes;

a flat annular upstream support portion;

including a nitinol frame and a fabric disposed over the nitinol frame,

having an inner perimeter defined by a free inner edge that defines an opening through the upstream support portion, and

having an outer perimeter that is at least 10 percent greater than the inner perimeter; and

a plurality of anchors including at least a first anchor and a second anchor, each anchor of the plurality of anchors being configured to anchor to a respective commissure of the native valve; and

subsequently, implanting a prosthetic valve;

having a compressed state for transluminal delivery, and

being intracorporeally couplable to the valve support by being expanded toward an expanded state of the prosthetic valve while disposed within the opening,

wherein implanting the prosthetic valve support comprises implanting the prosthetic valve support such that;

(i) upon deployment of the valve support from a distal end of the overtube, the first anchor and the second anchor anchor the valve support to the commissures by moving away from each other and into the commissures,

(ii) the first anchor and the second anchor anchor the valve support to the commissures by extending, from the upstream support portion, through the commissures to a ventricular side of the commissures, and

(iii) before the prosthetic valve is coupled to the valve support, the valve support allows the native valve to continue to function.

19. Apparatus for use with a native valve of a heart of a subject, the apparatus comprising:

an overtube, transluminally advanceable to the heart;

a prosthetic valve support, having a compressed state for delivery through the overtube to the heart, and an expanded state in which the valve support comprises;

a flat annular upstream support portion;

comprising a nitinol frame and a fabric disposed over the nitinol frame,

having an inner perimeter defined by a free inner edge that defines an opening through the upstream support portion, and

having an outer perimeter that is at least 10 percent greater than the inner perimeter; and

a plurality of anchors comprising at least a first anchor and a second anchor, each anchor of the plurality of anchors being configured to anchor to a respective commissure of the native valve; and

a prosthetic valve;

having a compressed state for transluminal delivery, and

being intracorporeally couplable to the valve support by being expanded toward an expanded state of the prosthetic valve while disposed within the opening,

wherein the valve support is configured such that upon deployment of the valve support from a distal end of the overtube, the first anchor and the second anchor anchor the valve support to the commissures by moving away from each other and pressing radially outward into the commissures.