Valve prosthesis configured for deployment in annular spacer

• US 10,531,872 B2
• Filed: 07/20/2018
• Issued: 01/14/2020
• Est. Priority Date: 07/21/2010
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Cardiovalve Ltd.
• Inventors: Hacohen, Gil, Gross, Yossi, Reich, Tal
• Primary Examiner(s): Lynch, Robert A
• Application Number:
  US16/040,831
• Publication Number:
  US 20190015093A1
• Time in Patent Office: 543 Days
• 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 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: 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 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0041 J-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped

Abstract

Embodiments of the present disclosure are directed to prosthetic heart valves and methods of use thereof. In one implementation, a prosthetic heart valve may include an annular spacer having a spacer opening therein and a disc-shaped wall configured to obstruct blood flow. The annular spacer may be configured for engaging with a native heart valve opening, such as the orifice of a mitral valve. The spacer opening may be sized to be smaller than the native heart valve opening. The prosthetic heart valve may also include a central valve section configured for disposal within the spacer opening. The central valve section may be separate from the annular spacer and may include one or more prosthetic valve leaflets.

Claims

1. A prosthetic heart valve, comprising:

an annular spacer configured for deployment within a native heart valve, the annular spacer comprising;

a cylindrical skirt having an upstream end and a downstream end opposite from the upstream end, wherein a spacer opening extends through the cylindrical skirt between the upstream and downstream ends, and

a disc-shaped wall arranged about the upstream end of the cylindrical skirt, the disc-shaped wall being configured to obstruct blood flow, wherein the disc-shaped wall comprises;

a support stent having a plurality of struts, and

at least one opening configured to slide along a delivery mechanism, wherein a first portion of the support stent situated around the at least one opening has a different strut arrangement than a second portion of the support stent; and

a central valve section having a central lumen configured to support a valve prosthesis therein, wherein the central valve section is configured for disposal within the spacer opening of the annular spacer and includes at least one anchoring protrusion configured to extend radially outward from a downstream end of the central valve section,

wherein the central valve section is configured for deployment into the heart separately from the annular spacer, and

wherein the at least one anchoring protrusion of the central valve section is configured to extend through the downstream end of the spacer opening to prevent the central valve section from moving axially relative to the annular spacer.

2. The prosthetic heart valve of claim 1,

wherein the annular spacer is configured for engaging with an annulus of the native heart valve, and

wherein the spacer opening is sized to be smaller than the annulus of the native heart valve.

3. The prosthetic heart valve of claim 1, wherein the central valve section is configured for implantation after implantation of the annular spacer.

4. The prosthetic heart valve of claim 1, wherein the annular spacer is configured to secure the central valve section relative to an annulus of the native heart valve.

5. The prosthetic heart valve of claim 1,

wherein the cylindrical skirt is configured to extend at least partially into a ventricle of the heart, and

wherein the disc-shaped wall is configured to contact an atrial side of the native heart valve.

6. The prosthetic heart valve of claim 1, wherein an outer diameter of the disc-shaped wall is configured to be larger than an outer diameter of an upstream end of the central valve section.

7. The prosthetic heart valve of claim 1, wherein the cylindrical skirt comprises:

a second support stent having a second plurality of struts; and

a covering that covers at least a portion of the second support stent along the downstream end of the cylindrical skirt.

8. The prosthetic heart valve of claim 1, wherein the central valve section includes:

a flexible wire frame having a second plurality of struts; and

a plurality of anchoring protrusions, wherein each anchoring protrusion includes;

a proximal end secured to at least one strut of the flexible wire frame, and

a distal end opposite from the proximal end.

9. The prosthetic heart valve of claim 8, wherein the anchoring protrusions are configured such that when the central valve section is disposed within the spacer opening of the annular spacer, a circumference defined by the distal ends of the anchoring protrusions has a larger diameter than an outer diameter of the downstream end of the cylindrical skirt.

10. The prosthetic heart valve of claim 8, wherein the distal ends of the anchoring protrusions are configured to be the radially-outermost portions of the central valve section, relative to a center of the central valve section.

11. The prosthetic heart valve of claim 1, wherein the at least one anchoring protrusion is configured to extend radially outward beyond an outer diameter of the downstream end of the cylindrical skirt when the central valve section is disposed within the spacer opening of the annular spacer.

12. The prosthetic heart valve of claim 1, wherein the central valve section has a greater axial length than the annular spacer.

13. A prosthetic heart valve, comprising:

an annular spacer configured for deployment within a native heart valve, the annular spacer comprising;

a cylindrical skirt having an upstream end and a downstream end opposite from the upstream end, wherein a spacer opening extends through the cylindrical skirt between the upstream and downstream ends, and

a disc-shaped wall arranged about the upstream end of the cylindrical skirt, wherein the disc-shaped wall is configured to obstruct blood flow;

a central valve section having a central lumen configured to support a valve prosthesis therein, wherein the central valve section is configured for disposal within the spacer opening of the annular spacer and includes at least one anchoring protrusion configured to extend radially outward from a downstream end of the central valve section; and

at least one tissue anchor configured to extend through an opening of the disc-shaped wall to secure the disc-shaped wall to tissue of the native heart valve,

wherein the central valve section is configured for deployment into the heart separately from the annular spacer,

wherein the at least one anchoring protrusion of the central valve section is configured to extend through the downstream end of the spacer opening to prevent the central valve section from moving axially relative to the annular spacer, and

wherein the at least one tissue anchor is configured for deployment into the heart separately from the annular spacer and includes a plurality of leaves configured to splay outward upon implantation of the at least one tissue anchor.

14. The prosthetic heart valve of claim 13, wherein the at least one tissue anchor is configured to engage ventricular tissue of the native heart valve.

15. The prosthetic heart valve of claim 13, wherein the at least one tissue anchor is configured to be secured to the disc-shaped wall via a male-female locking arrangement.

16. A prosthetic heart valve, comprising:

an annular spacer configured for deployment within a native heart valve, the annular spacer comprising;

a cylindrical skirt having an upstream end and a downstream end opposite from the upstream end, wherein a spacer opening extends through the cylindrical skirt between the upstream and downstream ends, and

a disc-shaped wall arranged about the upstream end of the cylindrical skirt, wherein the disc-shaped wall is configured to obstruct blood flow; and

a central valve section having a central lumen configured to support a valve prosthesis therein, wherein the central valve section is configured for disposal within the spacer opening of the annular spacer and includes at least one anchoring protrusion configured to extend radially outward from a downstream end of the central valve section,

wherein the central valve section is configured for deployment into the heart separately from the annular spacer,

wherein the at least one anchoring protrusion of the central valve section is configured to extend through the downstream end of the spacer opening to prevent the central valve section from moving axially relative to the annular spacer, and

wherein the cylindrical skirt is configured to be inverted such that a first end of the cylindrical skirt is situated upstream of the disc-shaped wall after deployment of the annular spacer within the native heart valve, the first end of the cylindrical skirt being the downstream end of the cylindrical skirt when the cylindrical skirt is in a non-inverted configuration.

17. The prosthetic heart valve of claim 16, wherein the central valve section is configured to reposition the first end of the inverted cylindrical skirt such that the cylindrical skirt is moved into the non-inverted configuration.

18. The prosthetic heart valve of claim 16, configured such that native leaflets of the heart are not obstructed by the prosthetic heart valve until the central valve section is implanted and the cylindrical skirt is moved into the non-inverted configuration.

19. A prosthetic heart valve, comprising:

an annular spacer configured for deployment within a native heart valve, the annular spacer comprising;

a cylindrical skirt having an upstream end and a downstream end opposite from the upstream end, wherein a spacer opening extends through the cylindrical skirt between the upstream and downstream ends, and

a disc-shaped wall arranged about the upstream end of the cylindrical skirt, wherein the disc-shaped wall is configured to obstruct blood flow; and

a central valve section having a central lumen configured to support a valve prosthesis therein, wherein the central valve section is configured for disposal within the spacer opening of the annular spacer and includes at least one anchoring protrusion configured to extend radially outward from a downstream end of the central valve section,

wherein the central valve section is configured for deployment into the heart separately from the annular spacer,

wherein the at least one anchoring protrusion of the central valve section is configured to extend through the downstream end of the spacer opening to prevent the central valve section from moving axially relative to the annular spacer,

wherein the at least one anchoring protrusion is configured to extend radially outward beyond an outer diameter of the downstream end of the cylindrical skirt when the central valve section is disposed within the spacer opening of the annular spacer, and

wherein the at least one anchoring protrusion is configured to engage native leaflets of the heart and to compress the native leaflets of the heart against the annular spacer.