TECHNIQUES FOR PERCUTANEOUS MITRAL VALVE REPLACEMENT AND SEALING

• US 20120022640A1
• Filed: 02/24/2011
• Published: 01/26/2012
• Est. Priority Date: 07/21/2010
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Mitraltech Ltd.
• Inventors: GROSS, Yossi, HACOHEN, Gil, MILLER, Eran, REICH, Tal, ZIPORY, Yuval
• Granted Patent: US 8,992,604 B2
• Time in Patent Office: Days
• 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. Apparatus, comprising:

one or more valve support guide members configured to be delivered to one or more commissures of a native atrioventricular valve of a patient;

a prosthetic valve support configured to be advanced toward the native valve along the one or more valve support guide members and placed at the native valve;

a prosthetic valve configured to be coupled to the valve support; and

one or more sealing elements configured to facilitate sealing of an interface between the prosthetic valve support and the native valve.

2. The apparatus according to claim 1, wherein the sealing element comprises a balloon disposed circumferentially around an outer surface of the prosthetic valve support.

3. The apparatus according to claim 1, wherein the sealing element comprises one or more helices that are configured to facilitate sealing of commissures of the native valve with respect to the valve support by being wrapped around chordae tendineae of the native valve.

4. The apparatus according to claim 1, wherein the sealing element comprises grasping elements that are configured to facilitate sealing of commissures of the native valve with respect to the valve support by grasping the commissures.

5. The apparatus according to claim 1, wherein the sealing element is configured to facilitate anchoring of the support to the native valve.

8. The apparatus according to claim 1, wherein the native atrioventricular valve includes a mitral valve, and wherein the prosthetic valve comprises three prosthetic leaflets.

10. The apparatus according to claim 1, wherein the valve support is shaped so as to define a distal portion which is configured to push aside, at least in part, native leaflets of the valve of the patient.

12. The apparatus according to claim 1, wherein the one or more valve support guide members comprises one valve support guide member that is looped through first and second commissures of the atrioventricular valve in a manner in which a looped portion of the valve support guide member is disposed in a ventricle of the patient and first and second free ends of the valve support guide member are accessible from a site outside a body of the patient.

13. The apparatus according to claim 12, further comprising:

a guide wire configured to be advanced, via the native atrioventricular valve, into a ventricle of the patient, and coupled to an inner wall of the patient'"'"'s ventricle; and

a valve support guide member tube coupled to the guide wire,

wherein a distal portion of the valve support guide member is configured to loop through the valve support guide member tube, such that, in response to the valve support guide member being pushed distally, portions of the valve support guide member are pushed to respective commissures of the native valve.

14. The apparatus according to claim 1, wherein the prosthetic valve is shaped so as to define one or more protrusions configured to ensnare one or more native leaflets of the native valve of the patient.

15. The apparatus according to claim 14, wherein the protrusions are disposed in a sinusoidal configuration such that the protrusions conform with a saddle shape of the patient'"'"'s native annulus.

16. The apparatus according to claim 14, wherein the protrusions are configured to prevent the native leaflets from interfering with a left ventricular outflow tract of the patient, by sandwiching the leaflets between the protrusions and the prosthetic valve support.

6-7. -7. (canceled)

9. (canceled)

11. (canceled)

17-22. -22. (canceled)

23. Apparatus, comprising:

a prosthetic valve support configured to be advanced toward a native atrioventricular valve of a patient and placed at the native valve;

a prosthetic valve configured to be coupled to the valve support, the prosthetic valve being shaped so as to define first and second sets of one or more protrusions, each set of protrusions configured to ensnare a respective native leaflet of the native valve of the patient, the first set of protrusions being disposed within a first circumferential arc with respect to a longitudinal axis of the prosthetic valve, on a first side of a distal end of the prosthetic valve, the second set of protrusions being disposed within a second circumferential arc with respect to the longitudinal axis of the prosthetic valve, on a second side of the distal end of the prosthetic valve, the first and second sets being disposed so as to provide first and second gaps therebetween at the distal end of the prosthetic valve, at least one of the gaps having a circumferential arc of at least 20 degrees; and

one or more valve guide members configured to be delivered to one or more commissures of the native valve, and to guide the valve such that the first and second circumferential arcs are aligned with respective leaflets of the native valve and such that the first and second gaps are aligned with respective commissures of the native valve.

24. The apparatus according to claim 23, wherein the at least one of the gaps has a circumferential arc of at least 60 degrees.

25. The apparatus according to claim 23, wherein the first circumferential arc defines an angle of between 25 degrees and 90 degrees about the longitudinal axis of the prosthetic valve.

26. The apparatus according to claim 25, wherein the second circumferential arc defines an angle of between 25 degrees and 90 degrees about the longitudinal axis of the prosthetic valve.

27. The apparatus according to claim 25, wherein the first circumferential arc defines an angle of between 45 degrees and 75 degrees about the longitudinal axis of the prosthetic valve.

28. The apparatus according to claim 27, wherein the second circumferential arc defines an angle of between 45 degrees and 75 degrees about the longitudinal axis of the prosthetic valve.

29. A method, comprising:

determining an area defined by an annulus of a native atrioventricular valve of a patient;

selecting a prosthetic valve to be placed in the native valve by determining that the valve defines a cross-sectional area that is less than 90% of the area defined by the annulus; and

deploying the prosthetic valve at the native valve,

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.

30. The method according to claim 29, wherein selecting the prosthetic valve comprises selecting a prosthetic valve having a material disposed on an outer surface thereof.

31. The method according to claim 30, wherein selecting the prosthetic valve comprises selecting a prosthetic valve having a material that prevents tissue growth disposed on an outer surface thereof.

32. The method according to claim 30, wherein selecting the prosthetic valve comprises selecting a prosthetic valve having a material that promotes tissue growth disposed on an outer surface thereof.

33. The method according to claim 29, wherein selecting the prosthetic valve to be placed in the native valve comprises determining that the valve defines a cross-sectional area that is less than 80% of the area defined by the annulus.

34. The method according to claim 33, wherein selecting the prosthetic valve to be placed in the native valve comprises determining that the valve defines a cross-sectional area that is less than 60% of the area defined by the annulus.

35-132. -132. (canceled)