Techniques for percutaneous mitral valve replacement and sealing

• US 8,992,604 B2
• Filed: 02/24/2011
• Issued: 03/31/2015
• Est. Priority Date: 07/21/2010
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Mitraltech Ltd.
• Inventors: Gross, Yossi, Hacohen, Gil, Miller, Eran, Zipory, Yuval, Reich, Tal
• Primary Examiner(s): Dornbuscch, Dianne
• Assistant Examiner(s): LYNCH, ROBERT A
• Application Number:
  US13/033,852
• Publication Number:
  US 20120022640A1
• Time in Patent Office: 1,496 Days
• Field of Search: 623/2.1, 623/2.11, 623/2.12, 623/2.17, 623/2.18, 623/2.36, 623/2.37, 623/2.38, 623/2.4, 623/2.41, 623/2.42, 623/904
• US Class Current: 623/2.11
• 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 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/243 Deployment by mechanical expansion
• 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 2/2457 Chordae tendineae prostheses
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 : modular
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts

Abstract

Apparatus and methods are described, including one or more valve support guide members that are delivered to one or more commissures of a native atrioventricular valve of a patient. A prosthetic valve support is advanced toward the native valve along the one or more valve support guide members and placed at the native valve. A prosthetic valve is coupled to the valve support. One or more sealing elements facilitate sealing of an interface between the prosthetic valve support and the native valve. Other applications are also described.

Claims

1. A method, comprising:

placing an annular element of a prosthetic valve support against an annulus of a native atrioventricular valve of a patient;

subsequently, delivering a prosthetic valve, having a main frame and one or more snares coupled to the main frame, to the native atrioventricular valve; and

deploying the prosthetic valve at the native valve, the step of deploying comprising;

ensnaring at least one leaflet of the native valve with the one or more snares, and

expanding the prosthetic valve such that an outer surface of the main frame of the prosthetic valve defines a cross-sectional area that is not more than 90% of an area defined by an annulus of the native atrioventricular valve.

2. The method according to claim 1, further comprising:

determining the area defined by the annulus of the native atrioventricular valve of the patient; and

selecting the prosthetic valve by determining that the outer surface of the main frame of the prosthetic valve defines the cross-sectional area that is not more than 90% of the area defined by the annulus,

the selecting of the prosthetic valve facilitating sealing of the native valve with respect to the prosthetic valve by facilitating closing of leaflets of the native valve around the prosthetic valve, upon deployment of the prosthetic valve.

3. The method according to claim 2, wherein selecting the prosthetic valve comprises selecting a prosthetic valve having a material disposed on an outer surface thereof.

4. The method according to claim 3, wherein selecting the prosthetic valve comprises selecting a prosthetic valve having a material that prevents tissue growth disposed on an outer surface thereof.

5. The method according to claim 3, wherein selecting the prosthetic valve comprises selecting a prosthetic valve having a material that promotes tissue growth disposed on an outer surface thereof.

6. The method according to claim 1, wherein expanding the prosthetic valve comprises expanding the prosthetic valve such that the outer surface of the main frame of the prosthetic valve defines a cross-sectional area that is less than 80% of the area defined by the annulus.

7. The method according to claim 6, wherein expanding the prosthetic valve comprises expanding the prosthetic valve such that the outer surface of the main frame of the prosthetic valve defines a cross-sectional area that is less than 60% of the area defined by the annulus.

8. The method according to claim 2, wherein deploying the prosthetic valve comprises deploying at least a portion of the prosthetic valve within the prosthetic valve support.

9. The method according to claim 8, wherein deploying the at least the portion of the prosthetic valve within the prosthetic valve support comprises expanding the at least the portion of the prosthetic valve such that the at least the portion of the prosthetic valve applies a radial force to the prosthetic valve support.

10. The method according to claim 1, wherein the one or more snares are coupled to a downstream portion of the main frame, and wherein delivering the prosthetic valve comprises delivering the prosthetic valve having the one or more snares coupled to the downstream portion of the main frame.

11. The method according to claim 1, wherein deploying the prosthetic valve comprises expanding at least a portion of the prosthetic valve within the prosthetic valve support.

12. The method according to claim 1, wherein placing the annular element against the annulus comprises pushing the annular element against the annulus using a percutaneously-advanceable pushing element, and wherein the method further comprises:

after placing the annular element against the annulus, and during the deployment of the prosthetic valve, holding the annular element against the annulus by continuing to push the annular element against the annulus using the pushing element; and

subsequently, removing the pushing element from the annular element.