Replacement heart valve

• US 10,555,809 B2
• Filed: 01/31/2018
• Issued: 02/11/2020
• Est. Priority Date: 06/19/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Hastings, Roger N., Jenson, Mark L.
• Primary Examiner(s): Lopez, Leslie
• Application Number:
  US15/884,464
• Publication Number:
  US 20180147058A1
• Time in Patent Office: 741 Days
• Field of Search: None
• 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 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• 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 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability

Abstract

A replacement heart valve assembly has a stent frame and a replacement valve. The replacement valve has a plurality of leaflets and a valve frame. The leaflets are attached to the valve frame. Further, the assembly has a plurality of suspension struts attached to the stent frame and the valve frame. The valve frame is suspended within the stent frame via the suspension struts. In some embodiments, the assembly further has a sealing member attached to the stent frame to prevent leakage around the replacement heart valve assembly.

Claims

1. A replacement valve assembly comprising:

a first tubular frame having a first diameter, a first end, a second end, a lumen extending from the first end to the second end, and a longitudinal axis;

a second tubular frame having a second diameter, a first end, a second end, a lumen extending from the first end of the second tubular frame to the second end of the second tubular frame, and a longitudinal axis coinciding with the longitudinal axis of the first tubular frame,

wherein the first diameter is greater than the second diameter;

a replacement valve comprising a plurality of leaflets disposed within and attached to the second tubular frame;

a plurality of struts suspending the second tubular frame at least partially within the first tubular frame,

wherein the plurality of struts directly connect the first end of the first tubular frame to the first end of the second tubular frame; and

a sealing member disposed on the first frame,

wherein the sealing member is configured to prevent leakage of blood around the first frame.

2. The replacement valve assembly of claim 1, wherein the first tubular frame has a non-uniform thickness.

3. The replacement valve assembly of claim 1 having a transverse cross-section, wherein the first tubular frame is non-circular and the second tubular frame is circular.

4. The replacement valve assembly of claim 1, wherein the replacement valve assembly is self-expanding.

5. The replacement valve assembly of claim 1, wherein the replacement valve has 3 leaflets.

6. The replacement valve assembly of claim 1, wherein the second end of the first tubular frame is an outflow end of the replacement valve assembly.

7. A replacement valve assembly, comprising:

a first frame having a first end, a second end, a lumen extending from the first end of the first frame to the second end of the first frame, and a longitudinal axis;

a second frame having a first end and a second end,

wherein the second frame is disposed within the lumen of the first frame;

a plurality of struts suspending the second frame at least partially within the lumen of the first frame,

wherein the first end of the first frame is directly connected to the first end of the second frame by the plurality of struts;

a replacement valve disposed within and connected to the second frame, wherein the replacement valve has a plurality of leaflets; and

a sealing member disposed on the first frame,

wherein the sealing member is configured to prevent leakage of blood around the first frame.

8. The replacement valve assembly of claim 7, wherein the first frame adjusts to a non-circular shape.

9. The replacement valve assembly of claim 8, wherein the non-circular shape is elliptical.

10. The replacement valve assembly of claim 7, wherein the replacement valve assembly is self-expanding.

11. The replacement valve assembly of claim 7, wherein the sealing member is attached to an inflow end of the first frame.

12. The replacement valve assembly of claim 7, wherein the plurality of leaflets are connected to the second frame.

13. The replacement valve assembly of claim 7, wherein the second end of the first frame is an outflow end of the replacement valve assembly.