IP Library Granted Patent US 11,969,163
Granted Patent B2
US 11,969,163 · App. 17/181,961 · Granted Apr 30, 2024

Valve prosthesis configured for deployment in annular spacer

Inventors: Gil Hacohen (Ramat Gan, IL); Yossi Gross (Moshav Mazor, IL); Tal Reich (Moshav Moledet, IL)
Assignee: CARDIOVALVE LTD.
A61B17/0401A61F2/2409A61F2/2418A61F2/2436A61F2/2457A61B2017/00243A61B2017/0441A61B2017/0464A61F2/2412A61F2/2427A61F2/243A61F2/2466A61F2220/0016A61F2230/0041A61F2230/005
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Quick Facts
Patent No.
US 11,969,163
App. No.
17/181,961
Granted
Apr 30, 2024
Kind
B2
Abstract

Prosthetic heart valves and methods of use of prosthetic heart valves may be provided. In one implementation, a prosthetic heart valve may include an annular spacer configured for implantation with a native heart valve opening and a central valve section configured for disposal within the annular spacer. The central valve section may include at least one anchoring protrusion configured to anchor the central valve section against axial movement relative to the annular spacer. During deployment, the central valve section may be expanded radially within the heart into an at least partially-expanded configuration while at least a portion of the central valve section is situated outside of a space opening of the annular spacer, and moved upstream while remaining in the at least partially-expanded configuration until the anchoring protrusion engages the annular spacer.

Claims (55)

1. A prosthetic heart valve, comprising:

an annular spacer configured to engage 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 end and downstream end thereof, and

a disc-shaped wall situated about a portion of the cylindrical skirt and extending radially outward from the cylindrical skirt; and

a central valve section configured for disposal within the spacer opening of the annular spacer, the central valve section having:

a hollow valve section body configured to support a valve prosthesis therein, and

at least one anchoring protrusion configured to extend radially outward from the valve section body, the at least one anchoring protrusion being configured to prevent the central valve section from moving axially relative to the annular spacer,

wherein the central valve section is configured to:

expand radially within the heart from a delivery configuration into an at least partially-expanded configuration while at least a portion of the central valve section is situated outside of the spacer opening of the annular spacer, and

move into the spacer opening, while the central valve section remains in the at least partially-expanded configuration, until the at least one anchoring protrusion contacts the downstream end of the cylindrical skirt, and

wherein the cylindrical skirt of the annular spacer 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.

2. The prosthetic heart valve of claim 1 , wherein

the disc-shaped wall of the annular spacer is situated about the upstream end of the cylindrical skirt, and

the at least one anchoring protrusion is connected to a downstream end of the valve section body.

3. The prosthetic heart valve of claim 1 , wherein

the disc-shaped wall of the annular spacer is configured to contact an atrial side of the native heart valve and to secure the central valve section relative to an annulus of the native heart valve, and

the cylindrical skirt of the annular spacer is configured to extend at least partially into a ventricle of the heart.

4. The prosthetic heart valve of claim 1 , wherein the at least one anchoring protrusion is configured to extend through the downstream end of the spacer opening.

5. The prosthetic heart valve of claim 1 , wherein the disc-shaped wall comprises:

a support stent having a plurality of struts, and

a covering arranged upon the support stent, the covering being configured to obstruct blood flow.

6. The prosthetic heart valve of claim 1 ,

wherein the valve section body includes a flexible wire frame formed at least partially of a plurality of struts intersecting at strut junctions, and

wherein when the central valve section is disposed within the spacer opening of the annular spacer, at least one strut junction of the flexible wire frame is situated in an upstream direction from the upstream end of the cylindrical skirt.

7. The prosthetic heart valve of claim 6 , wherein the at least one anchoring protrusion is connected to a strut junction along a downstream end of the flexible wire frame.

8. 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.

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

10. A prosthetic heart valve, comprising:

an annular spacer configured to engage 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 end and downstream end thereof, and

a disc-shaped wall situated about a portion of the cylindrical skirt and extending radially outward from the cylindrical skirt,

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; and

a central valve section configured for disposal within the spacer opening of the annular spacer, the central valve section having:

a hollow valve section body configured to support a valve prosthesis therein, and

at least one anchoring protrusion configured to extend radially outward from the valve section body, the at least one anchoring protrusion being configured to prevent the central valve section from moving axially relative to the annular spacer,

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

11. The prosthetic heart valve of claim 10 , wherein

the disc-shaped wall of the annular spacer is situated about the upstream end of the cylindrical skirt, and

the at least one anchoring protrusion is connected to a downstream end of the valve section body.

12. The prosthetic heart valve of claim 10 , wherein

the disc-shaped wall of the annular spacer is configured to contact an atrial side of the native heart valve and to secure the central valve section relative to an annulus of the native heart valve, and

the cylindrical skirt of the annular spacer is configured to extend at least partially into a ventricle of the heart.

13. The prosthetic heart valve of claim 10 , wherein the at least one anchoring protrusion is configured to extend through the downstream end of the spacer opening.

14. The prosthetic heart valve of claim 10 , wherein the disc-shaped wall comprises:

a support stent having a plurality of struts, and

a covering arranged upon the support stent, the covering being configured to obstruct blood flow.

15. The prosthetic heart valve of claim 10 ,

wherein the valve section body includes a flexible wire frame formed at least partially of a plurality of struts intersecting at strut junctions, and

wherein when the central valve section is disposed within the spacer opening of the annular spacer, at least one strut junction of the flexible wire frame is situated in an upstream direction from the upstream end of the cylindrical skirt.

16. The prosthetic heart valve of claim 15 , wherein the at least one anchoring protrusion is connected to a strut junction along a downstream end of the flexible wire frame.

17. The prosthetic heart valve of claim 10 , 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.

18. The prosthetic heart valve of claim 10 , wherein the central valve section has a greater axial length than the annular spacer.

19. The prosthetic heart valve of claim 10 , wherein the central valve section is configured to:

expand radially within the heart from a delivery configuration into a deployed configuration while the central valve section is situated outside of the spacer opening of the annular spacer, and

move into the spacer opening, while the central valve section remains in the deployed configuration, until the at least one anchoring protrusion contacts the downstream end of the cylindrical skirt.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 4, 2021
From: HACOHEN, GIL; GROSS, YOSSI; REICH, TAL
To: CARDIOVALVE LTD.
Reel/Frame 057073/0445 →
SECURITY INTEREST Recorded Jun 10, 2021
From: CARDIOVALVE LTD.
To: BEST, LAWRENCE C.; OXO CAPITAL VALVE VENTURES LLC; PEREGRINE VC INVESTMENTS IV (IL) L.P.; PEREGRINE VC INVESTMENTS IV (US INVESTORS) L.P; PEREGRINE VC INVESTMENTS IV (OTHER INVESTORS) L.P.; NGN BIOMED OPPORTUNITY II, L.P.; IF A PE FUND II, LP; IF A PE FUND II US, LP
Reel/Frame 056539/0833 →
Continuity (10)
Continuation 16740659 · Jan 13, 2020
Continuation 16040831 · Jul 20, 2018
Continuation 15691032 · Aug 30, 2017
Continuation 14689608 · Apr 17, 2015
Continuation 13811308
Continuation In Part 13033852 · Feb 24, 2011
Continuation In Part 12840463 · Jul 21, 2010
Continuation In Part 12840463 · Jul 21, 2010
Provisional Application 61492449 · Jun 2, 2011
Related Publication 20210169467A1 · Jun 10, 2021
Cited By (2)
US 12,226,313 US 12,616,572