Prosthetic valve with flow director

• US 10,111,749 B2
• Filed: 01/07/2016
• Issued: 10/30/2018
• Est. Priority Date: 06/11/2014
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Sheahan, Edmond, Duffy, Niall
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US14/989,839
• Publication Number:
  US 20160113764A1
• Time in Patent Office: 1,027 Days
• 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 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector

Abstract

A prosthetic valve comprising a stent frame, a valve structure, and a baffle structure. The stent frame defines a lumen. The valve structure is disposed within the lumen, and defines an inflow side and an outflow side. An outflow track is established within the lumen downstream of the outflow side and along which fluid flow from the valve structure progresses. The baffle structure is connected to the stent frame downstream of the outflow side. In some embodiments, the baffle structure directs blood flow into designated areas to encourage laminar flow and eliminate or reduce turbulence.

Claims

1. A prosthetic valve having an inflow end opposite an outflow end, the prosthetic valve comprising:

a stent frame defining a lumen;

a valve structure disposed within the lumen and configured to define an inflow side and an outflow side opposite the inflow side;

wherein an outflow track is established within the lumen downstream of the outflow side and along which fluid flow from the valve structure progresses; and

a baffle structure connected to the stent frame downstream of the outflow side;

wherein the baffle structure further includes a plurality of baffle members each projecting into the lumen.

2. The prosthetic valve of claim 1, wherein the baffle structure is configured and located to encourage laminar flow into blood flow immediately downstream of the outflow side.

3. The prosthetic valve of claim 1, wherein the baffle structure is configured to manipulate a natural flow profile of blood flow at the outflow side of the valve structure.

4. The prosthetic valve of claim 3, wherein the baffle structure is configured to disrupt at least 10% of the natural flow profile.

5. The prosthetic valve of claim 1, wherein the lumen has a diameter and further wherein the baffle structure includes a first baffle member projecting across less than an entirety of the diameter.

6. The prosthetic valve of claim 1, wherein the plurality of baffle members are located about a circumference of the stent frame.

7. The prosthetic valve of claim 6, wherein the baffle members are equidistantly spaced.

8. The prosthetic valve of claim 6, wherein the baffle members are longitudinally aligned.

9. The prosthetic valve of claim 6, wherein at least one of the baffle members is arranged at an angle relative to a longitudinal axis of the stent frame.

10. The prosthetic valve of claim 6, wherein each of the baffle members terminates in a leading edge opposite the stent frame, and further wherein the leading edge of at least one of the baffle members is curved.

11. The prosthetic valve of claim 6, wherein at least one of the baffle members is a paddle.

12. The prosthetic valve of claim 1, wherein the stent frame defines the outflow end of the prosthetic valve, and further wherein the baffle structure is located between the outflow end of the stent frame and the outflow side of the valve structure.

13. The prosthetic valve of claim 1, wherein the prosthetic valve is a prosthetic heart valve.

14. The prosthetic valve of claim 1, wherein the prosthetic valve is a prosthetic mitral valve.

15. The prosthetic valve of claim 1, wherein at least one baffle member defines a major plane and the stent frame defines a longitudinal axis;

further wherein at least one baffle member is arranged such that the major plane does not intersect the longitudinal axis of the stent frame.

16. A method of regulating fluid flow through a body vessel of a patient, the method comprising:

implanting a prosthetic valve within the body vessel, the prosthetic valve having an inflow end opposite an outflow end and including;

a stent frame defining a lumen,

a valve structure disposed within the lumen and configured to define an inflow side and an outflow side opposite the inflow side,

wherein an outflow track is established within the lumen downstream of the outflow side and along which fluid flow from the valve structure progresses,

a baffle structure connected to the stent frame downstream of the outflow side;

wherein the baffle structure further includes a plurality of baffle members each projecting into the lumen,

wherein fluid flow within the body vessel is naturally directed to the inflow side;

and further wherein the valve structure functions to alternately allow and occlude fluid flow from the inflow side to the outflow side;

and even further wherein the baffle structure functions to encourage laminar flow into fluid flow from the outflow side.

17. The method of claim 16, wherein fluid flow from the outflow side of the valve structure interfaces with the baffle structure prior to exiting from the outflow end.

18. The method of claim 16, wherein fluid flow from the outflow side of the valve structure interfaces with the baffle structure after exiting from the outflow side, and then interfaces with the stent structure after interfacing with the baffle structure.

19. The method of claim 16, wherein the body vessel includes a native mitral valve annulus.