Techniques for percutaneous mitral valve replacement and sealing

• US 8,852,272 B2
• Filed: 03/06/2012
• Issued: 10/07/2014
• Est. Priority Date: 08/05/2011
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Mitraltech Ltd.
• Inventors: Gross, Yossi, Hacohen, Gil, Miller, Eran, Zipory, Yuval, Reich, Tal, Kutzik, Meir
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US13/412,814
• Publication Number:
  US 20130035759A1
• Time in Patent Office: 945 Days
• Field of Search: 623/2.18, 623/2.14, 623/1.24, 623/1.26, 606/213
• US Class Current: 623/2.18
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. 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 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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: 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 2230/0006 circular
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• 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 is described for use with a native heart valve of a subject, the apparatus including (1) a prosthetic valve support, comprising an upstream support portion, the upstream support portion having (a) a compressed configuration and an uncompressed configuration in which the upstream support portion has an inner perimeter that defines an opening; and (2) a prosthetic valve, advanceable into the opening defined by the upstream support portion, and intracorporeally couplable to the upstream support portion by being expanded within the opening defined by the upstream support portion, the apparatus being configured such that, when the prosthetic valve is expanded within the opening defined by the upstream support portion, the expansion of the prosthetic valve is restricted by the inner perimeter of the upstream support portion, without causing the prosthetic valve support to apply a radially-expansive force to the native annulus. Other embodiments are also described.

Claims

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

an overtube; and

an upstream support portion, the upstream support portion;

(a) having a compressed configuration in which the support is transcatheterally deliverable to the native valve within the overtube and in which the upstream support portion has a generally cylindrical shape, the cylindrical shape having a downstream end and an upstream end, each end having a perimeter, each perimeter of the cylindrical shape having a length and defining a free edge,

(b) having an uncompressed configuration in which the upstream support portion;

is configured to be placed against an upstream side of an annulus of the native valve,

is shaped to define an opening, and

has an outer perimeter and an inner perimeter, and

(c) being movable from the compressed configuration to the uncompressed configuration by the downstream end being deployed from the overtube before the upstream end is deployed from the overtube,

the apparatus being configured such that, upon deployment from the overtube, the upstream support portion moves from the compressed configuration to the uncompressed configuration thereof such that;

the perimeter of the downstream end of the upstream support portion in the compressed configuration thereof becomes the inner perimeter of the upstream support portion in the uncompressed configuration thereof, and

the perimeter of the upstream end of the upstream support portion in the compressed configuration thereof becomes the outer perimeter of the upstream support portion in the uncompressed configuration thereof.

2. The apparatus according to claim 1, wherein the apparatus is configured such that, when the upstream support portion moves from the compressed configuration to the uncompressed configuration thereof, the length of the perimeter of the upstream end of the upstream support portion in the compressed configuration thereof increases more than does the length of the perimeter of the downstream end of the upstream support portion in the compressed configuration thereof.

3. The apparatus according to claim 1, wherein the upstream support portion, in the uncompressed configuration thereof, is generally annular.

4. The apparatus according to claim 3, wherein the upstream support portion, in the uncompressed configuration thereof, is generally flat.

5. The apparatus according to claim 1, wherein the length of the outer perimeter is at least 10% greater than the length of the inner perimeter.

6. The apparatus according to claim 1, wherein the inner perimeter of the upstream support portion is configured to be coupled to the prosthetic valve.

7. The apparatus according to claim 1, wherein, in the uncompressed configuration thereof, any portion of the apparatus that circumscribes a space that has a perimeter greater than 60 mm has a depth of less than 2 mm.

8. The apparatus according to claim 1, wherein the upstream support portion is shaped such that the opening defined by the inner perimeter of the upstream support portion has a depth, and has a diameter that is more than 4 times greater than the depth.

9. The apparatus according to claim 1, further comprising the prosthetic valve.

10. The apparatus according to claim 1, wherein the overtube is configured to constrain the upstream support portion in the compressed configuration thereof while the upstream support portion is disposed within the overtube.

11. The apparatus according to claim 1, further comprising at least one clip, the clip comprising a plurality of clip arms, and being configured to couple the upstream support portion to the native valve.

12. The apparatus according to claim 11, wherein the clip is articulatably coupled to the upstream support portion.

13. The apparatus according to claim 11, wherein the clip has an open configuration and a closed configuration, and is movable between the open and closed configurations irrespective of a state of deployment of the upstream support portion.

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

(A) a prosthetic valve support, comprising an upstream support portion, the upstream support portion having;

a compressed configuration in which the upstream support portion is generally cylindrical, and is transcatheterally deliverable to the native valve, and

an uncompressed configuration in which the upstream support portion;

is configured to be placed against an upstream side of an annulus of the native heart valve, and

has an inner perimeter that defines an opening; and

(B) a prosthetic valve;

having a compressed configuration in which the prosthetic valve is transcatheterally deliverable to the native valve, and advanceable into the opening defined by the upstream support portion, and

being intracorporeally couplable to the upstream support portion by being expanded,

the apparatus being configured such that, when the prosthetic valve is expanded, the expansion of the prosthetic valve is restricted by the prosthetic valve support, without causing the prosthetic valve support to apply a radially-expansive force to the native annulus, and wherein;

in the uncompressed configuration thereof, the upstream support portion has an upstream side and a downstream side, and a total height from the upstream side to the downstream side,

the prosthetic valve has an upstream end and a downstream end, and a height from the upstream end to the downstream end, and

the height of the prosthetic valve is at least 1.5 times greater than the total height of the upstream support portion.

15. The apparatus according to claim 14, wherein:

the upstream support portion, in the compressed configuration thereof, has an upstream end and a downstream end, each end having a perimeter, each perimeter having a length, and

the upstream support portion is configured such that, when the upstream support portion moves from the compressed configuration toward the uncompressed configuration thereof;

the perimeter of the downstream end of the upstream support portion in the compressed configuration thereof becomes the inner perimeter of the upstream support portion in the uncompressed configuration thereof, and

the perimeter of the upstream end of the upstream support portion in the compressed configuration thereof becomes an outer perimeter of the upstream support portion in the uncompressed configuration thereof.

16. The apparatus according to claim 14, wherein the prosthetic valve is intracorporeally couplable to the upstream support portion by being expanded within the opening defined by the inner perimeter of the upstream support portion.

17. The apparatus according to claim 16, wherein the apparatus is configured such that, when the prosthetic valve is expanded, the expansion of the prosthetic valve is restricted by the inner perimeter of the upstream support portion.

18. The apparatus according to claim 14, wherein the prosthetic valve support further comprises a flexible and annular stabilizing element, shaped to define an aperture.

19. A method for use with a prosthetic valve for implantation at a native valve of a heart of a subject, the method comprising:

delivering an upstream support portion of a prosthetic valve support, in a compressed configuration thereof, to an upstream side of the native valve, the upstream support portion in the compressed configuration thereof, having a generally cylindrical shape, the cylindrical shape having a downstream end and an upstream end, each end having a perimeter that defines a free edge, each perimeter of the cylindrical shape having a length;

coupling the prosthetic valve support to the native valve; and

subsequently expanding the upstream support portion toward an uncompressed configuration thereof, such that;

the perimeter of the downstream end of the upstream support portion in the compressed configuration thereof becomes an inner perimeter of the upstream support portion in the uncompressed configuration thereof,

the perimeter of the upstream end of the upstream support portion in the compressed configuration thereof becomes an outer perimeter of the upstream support portion in the uncompressed configuration thereof, and

the inner perimeter of the upstream support portion defines an opening.

20. The method according to claim 19, wherein coupling the prosthetic valve support to the native valve comprises coupling the downstream end of the upstream support portion in the compressed configuration thereof to the native valve.

21. The method according to claim 19, wherein expanding the upstream support portion toward the uncompressed configuration thereof, comprises increasing the length of the perimeter of the upstream end of the upstream support portion more than the length of the perimeter of the downstream end of the upstream support portion.

22. The method according to claim 19, further comprising subsequently coupling the prosthetic valve to the prosthetic valve support by expanding the prosthetic valve within the opening defined by the upstream support portion.

23. The method according to claim 19, wherein coupling the prosthetic valve support to the native valve comprises coupling the prosthetic valve support to the native valve in a manner that allows the native valve to continue to function, at least in part.

24. The method according to claim 19, wherein expanding the upstream support portion toward the uncompressed configuration thereof, comprises expanding the upstream support portion such that the length of the outer perimeter is at least 10% greater than the length of the inner perimeter.