Implantable prosthetic valve

• US 7,267,686 B2
• Filed: 11/10/2004
• Issued: 09/11/2007
• Est. Priority Date: 10/21/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: DiMatteo, Kristian, Marshall, Peter
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US10/985,534
• Publication Number:
  US 20050065594A1
• Time in Patent Office: 1,035 Days
• Field of Search: 623 121- 218
• US Class Current: 623/1.24
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: Y10T 137/7886 Internally extending mount

Abstract

A prosthetic valve for implantation within a fluid conducting lumen within a body includes an elongate generally cylindrical radially collapsible valve body scaffold defining a fluid passageway therethrough for retentive positioning within the lumen. A radially collapsible leaf valve member is supported by the scaffold includes a number of valve leafs deflectable between a closed position restricting fluid flow through the passageway and an open position permitting fluid flow through the passageway. The leaf valve member includes an interior leaf valve frame defining a valve leaf aperture which is sealed by a fluid impermeable non-thrombogenic lining to prevent fluid flow therethrough.

Claims

1. A valve, comprising:

a radially-elastic scaffold with valve leaflet frames having an open-frame construction; and

an elongate liner adjacent the radially-elastic scaffold and valve leaflet frames to provide a fluid passageway, where the elongate liner includes excess material to provide a concave shape to the elongate liner extending into the open-frame construction, and where the valve leaflet frames with the elongate liner move between a closed position to restrict fluid flow through the fluid passageway and an open position to allow fluid flow through the passageway.

2. The valve of claim 1, further including a microfilter support mesh over the open-frame construction of the valve leaflet frames to support cultured tissue cells seeded on to the elongate liner.

3. The valve of claim 1, wherein the valve leaflet frames of the radially-elastic scaffold are mechanically biased towards the open position.

4. The valve of claim 1, wherein the valve leaflet frames of the radially-elastic scaffold are mechanically biased towards the closed position.

5. The valve of claim 1, wherein the elongate liner is positioned over the radially-elastic scaffold and a second liner is positioned on the radially-elastic scaffold opposite the elongate liner.

6. The valve of claim 1, wherein the radially-elastic scaffold attaches to an interior surface of a second radially collapsible prosthetic fluid conduit.

7. The valve of claim 6, wherein the second radially collapsible prosthetic fluid conduit is a stent.

8. A valve, comprising:

a radially deformable unitary open-frame scaffold having a tubular body and valve leaflet frames; and

a liner at least partially encasing the radially deformable unitary open-frame scaffold to provide a fluid passageway, where the liner includes excess material to provide a concave shape to the liner extending into the open-frame scaffold, and where the valve leaflet frames with the liner move between a closed position to restrict fluid flow through the fluid passageway and an open position to allow fluid flow through the passageway.

9. The valve of claim 8, further including a flexible hinge supporting each of the valve leaflet frames on the tubular body.

10. The valve of claim 8, wherein the radially deformable unitary open-frame scaffold expands from a first diameter to a second radially-expanded diameter.

11. The valve of claim 10, wherein the radially deformable unitary open-frame scaffold expands through the use of a delivery balloon.

12. The valve of claim 10, wherein the radially deformable unitary open-frame scaffold is formed from a shape memory material that self-expands from the first diameter to the second radially-expanded diameter.

13. The valve of claim 8, wherein the elongate liner is positioned over the radially deformable unitary open-frame scaffold and a second liner is positioned on the radially deformable unitary open-flame scaffold opposite the elongate liner.

14. A medical system, comprising:

a valve having;

a radially-elastic scaffold with valve leaflet frames having an open-frame construction; and

an elongate liner adjacent the radially-elastic scaffold and valve leaflet frames to provide a fluid passageway, where the elongate liner includes excess material to provide a concave shape to the elongate liner extending into the open-frame construction, and where the valve leaflet frames with the elongate liner move between a closed position to restrict fluid flow through the fluid passageway and an open position to allow fluid flow through the passageway; and

a second radially collapsible prosthetic fluid conduit, wherein the radially-elastic scaffold attaches to an interior surface of the second radially collapsible prosthetic fluid conduit.

15. The medical system of claim 14, wherein the second radially collapsible prosthetic fluid conduit is a stent.

16. The medical system of claim 14, wherein the valve leaflet frames of the radially-elastic scaffold are mechanically biased towards the open position.

17. The medical system of claim 14, wherein the valve leaflet frames of the radially-elastic scaffold are mechanically biased towards the closed position.

18. The medical system of claim 14, wherein the elongate liner is positioned over the radially-elastic scaffold and a second liner is positioned on the radially-elastic scaffold opposite the elongate liner.