Aortic Replacement Valve

• US 20170049566A1
• Filed: 08/17/2015
• Published: 02/23/2017
• Est. Priority Date: 08/17/2015
• Status: Active Grant

• Current Assignee: Venus Medtech (Hangzhou), Inc.
• Original Assignee: Horizon Scientific Corp.
• Inventors: Zeng, Min Frank, Lo, Pham
• Granted Patent: US 9,895,222 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A heart valve assembly has a frame comprising an inflow section, an outflow section, and a connecting section that is located between the inflow section and the outflow section. The inflow section has a plurality of legs that extend radially outwardly, and the connecting section has a greater flexibility than the inner section. The assembly also includes a plurality of leaflets coupled to the connecting section, a valve skirt extending from the leaflets towards the inflow section of the frame, and a cuff section, with the legs and the cuff section together defining a cuff for engagement with a native annulus.

Claims

1. A heart valve assembly, comprising:

a frame that assumes a compressed configuration and an expanded configuration, the frame comprising an inflow section, an outflow section, and a connecting section that is located between the inflow section and the outflow section, the inflow section having a plurality of legs that extend radially outwardly in the expanded configuration, and wherein the connecting section has a greater flexibility than the inner section; and

a leaflet and skirt assembly having a plurality of leaflets coupled to the connecting section, a valve skirt extending from the leaflets towards the inflow section of the frame, and a cuff section, wherein the legs and the cuff section define a cuff in the expanded configuration for engagement with a native annulus.

2. The assembly of claim 1, wherein the frame is made of a shape memory material.

3. The assembly of claim 1, wherein each of the plurality of legs has a first part which extends vertically from the inflow section along the same plane as the frame, and then transitions to a first bend to a second part which extends radially outwardly and perpendicularly to the first part, and then transitions to a second bend to a third part which perpendicular to the second part, the third part terminating in an ear.

4. The assembly of claim 3, wherein the cuff section comprises a concealed portion that extends from the valve skirt and has a flanged inflow skirt that is folded over the ears of the legs, and defining an angled outer skirt that extends at an angle along the outer surface of the inflow section and which terminates at an annular stitch line, with an empty space is defined between the concealed portion, the outer skirt, and the inflow skirt.

5. The assembly of claim 1, wherein each of the plurality of legs has a first part which extends radially outwardly and perpendicularly to the plane of the inflow section, and then transitions to a second part which extends vertically and perpendicular to the first part such that the second part is generally parallel to the plane of the inflow section.

6. The assembly of claim 5, wherein the cuff section comprises a flanged inflow skirt that is formed by folding the inflow skirt over the first and second parts to form an outer skirt which terminates at an annular stitch line, with an empty space defined between the outer skirt and the inflow skirt.

7. The assembly of claim 1, wherein the frame is comprised of cells, with the cells in the connecting section having a different size from the cells in the inflow section.

8. The assembly of claim 1, wherein the combined length of the connecting section and the inflow section is about two-thirds the length of the entire frame.

9. A heart valve assembly, comprising:

a frame that assumes a compressed configuration and an expanded configuration, the frame comprising an inflow section, an outflow section, and a connecting section that is located between the inflow section and the outflow section, the inflow section having a plurality of legs; and

a leaflet and skirt assembly having a plurality of leaflets coupled to the connecting section, a valve skirt extending from the leaflets towards the inflow section of the frame, and a cuff section, wherein the legs and the cuff section define a cuff in the expanded configuration for engagement with a native annulus;

wherein the plurality of legs define an annular flange of legs that has the same diameter as the remainder of the frame when the frame and the legs are in the compressed configuration, and wherein the plurality of legs extend radially outwardly in the expanded configuration so that the flange of legs has a greater diameter than the remainder of the frame in the expanded configuration.

10. The assembly of claim 9, wherein the frame is made of a shape memory material.

11. The assembly of claim 9, wherein each of the plurality of legs has a first part which extends vertically from the inflow section along the same plane as the frame, and then transitions to a first bend to a second part which extends radially outwardly and perpendicularly to the first part, and then transitions to a second bend to a third part which perpendicular to the second part, the third part terminating in an ear.

12. The assembly of claim 11, wherein the cuff section comprises a concealed portion that extends from the valve skirt and has a flanged inflow skirt that is folded over the ears of the legs, and defining an angled outer skirt that extends at an angle along the outer surface of the inflow section and which terminates at an annular stitch line, with an empty space is defined between the concealed portion, the outer skirt, and the inflow skirt.

13. The assembly of claim 9, wherein each of the plurality of legs has a first part which extends radially outwardly and perpendicularly to the plane of the inflow section, and then transitions to a second part which extends vertically and perpendicular to the first part such that the second part is generally parallel to the plane of the inflow section.

14. The assembly of claim 13, wherein the cuff section comprises a flanged inflow skirt that is formed by folding the inflow skirt over the first and second parts to form an outer skirt which terminates at an annular stitch line, with an empty space defined between the outer skirt and the inflow skirt.

15. The assembly of claim 9, wherein the frame is comprised of cells, with the cells in the connecting section having a different size from the cells in the inflow section.

16. The assembly of claim 9, wherein the combined length of the connecting section and the inflow section is about two-thirds the length of the entire frame.

17. A method for deploying an aortic valve assembly at a native aortic annulus, comprising the steps of:

providing a heart valve assembly comprising a frame having an inflow section, an outflow section, and a connecting section that is located between the inflow section and the outflow section, the inflow section having a plurality of legs, and a leaflet and skirt assembly having a plurality of leaflets coupled to the connecting section, a valve skirt extending from the leaflets towards the inflow section of the frame, and a cuff section;

crimping the frame and the leaflets and skirt assembly onto a delivery device with the plurality of legs defining an annular flange of legs that has the same diameter as the remainder of the frame;

delivering the heart valve assembly to a location adjacent a native aortic annulus;

releasing the inflow section from the delivery device so that the plurality of legs expands to assume its shape memory deployed configuration and together with the cuff section defines a cuff that engages the native aortic annulus, with the flange of expanded legs having a diameter that is larger than the diameter of the remainder of the frame; and

releasing the connecting section and the outflow section from the delivery device.

18. The method of claim 17, further including:

providing the connecting section with a greater flexibility than the inner section; and

retrieving the connecting section into the delivery device during the step of releasing the connecting section.