Method and apparatus for cardiac valve replacement

• US 20070255394A1
• Filed: 04/27/2007
• Published: 11/01/2007
• Est. Priority Date: 04/28/2006
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ryan, Timothy R.
• Application Number:
  US11/796,681
• Publication Number:
  US 20070255394A1
• Time in Patent Office: Days
• US Class Current: 623/1.240
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular

Abstract

A method of placing a valve in a tubular organ including the steps of delivering an expandable tubular adapter to a site within the tubular organ, wherein the adapter includes an enclosed volume surrounded by an outer wall that is spaced from an inner wall, and first and second end walls. The method further includes expanding the outer wall relative to the inner wall so that the outer wall contacts the tubular organ, and placing a valve within the inner wall of the adapter. The method may further include inserting material into the enclosed volume of the adapter to expand the outer wall relative to the inner wall, which material may include liquid or gel. Alternatively, the valve may be positioned within the inner wall prior to the adapter being delivered to the desired site.

Claims

1. A method of placing a valve in an organ having a greater perimeter than the valve, comprising:

delivering an expandable tubular adapter to a desired site within the organ, wherein the adapter comprises an enclosed volume surrounded by an outer cylindrical wall having a first perimeter that is spaced concentrically from an inner cylindrical wall having a second perimeter that is smaller than the first perimeter, and first and second end walls extending between the outer and inner cylindrical walls at a proximal and a distal end of the adapter, respectively;

expanding the outer cylindrical wall relative to the inner cylindrical wall so that the outer cylindrical wall contacts the organ; and

placing a valve within the inner cylindrical wall of the adapter.

2. The method of claim 1, wherein the organ is a blood vessel and wherein delivering the adapter comprises delivering the adapter to a desired site within the blood vessel and wherein expanding the adapter comprises expanding the adapter so that the outer cylindrical wall contacts the blood vessel.

3. The method of claim 2, wherein the valve is a segment of bovine jugular vein and the blood vessel is a right ventricular outflow tract, and wherein delivering the adapter comprises delivering the adapter to a desired site within the outflow tract and wherein expanding the adapter comprises expanding the adapter so that the outer cylindrical wall contacts the outflow tract.

4. The method of claim 1, wherein the step of expanding the outer and inner cylindrical walls relative to each other comprises inserting material into the enclosed volume of the adapter.

5. The method of claim 4, wherein inserting material into the closed volume of the adapter comprises injecting a liquid material into the enclosed volume of the adapter.

6. The method of claim 4, wherein inserting material into the closed volume of the adapter comprises injecting a gel material into the closed volume of the adapter.

7. The method of claim 4, further comprising the step of allowing the material within the enclosed volume to become at least partially hardened before placing the valve within the inner cylindrical wall of the adapter.

8. The method of claim 1, wherein outer and inner cylindrical walls and the first and second end walls extending between the outer and inner cylindrical walls comprise a liquid resistant material.

9. The method of claim 1, wherein the outer cylindrical wall comprises different material properties than that of the inner cylindrical wall.

10. The method of claim 9, wherein the outer cylindrical wall is more expandable than the inner cylindrical wall.

11. The method of claim 1, wherein the expandable tubular adapter comprises a continuous piece of material that extends from the inner cylindrical wall to the first and second end walls and to the outer cylindrical wall.

12. The method of claim 4, wherein placing the valve in the adapter occurs prior to inserting material into the closed volume of the adapter.

13. An apparatus for positioning a valve in a tubular organ having a greater perimeter than the valve, comprising:

an enclosed volume surrounded by an outer cylindrical wall having a first perimeter that is spaced concentrically from an inner cylindrical wall having a second perimeter that is smaller than the first perimeter, and first and second end walls extending between the outer and inner cylindrical walls at a proximal and a distal end of the adapter, respectively;

a quantity of material contained within the enclosed volume;

a valve mounted within the inner cylindrical wall of the adapter.

14. The apparatus of claim 13, wherein outer and inner cylindrical walls and the first and second end walls extending between the outer and inner cylindrical walls comprise a liquid resistant material.

15. The apparatus of claim 13, wherein the material contained within the enclosed volume is a liquid material.

16. The apparatus of claim 13, wherein the material contained within the enclosed volume is a gel material.

17. The apparatus of claim 13, wherein the material contained within the enclosed volume is at least semi-solid.

18. The apparatus of claim 13, wherein the outer cylindrical wall comprises at least one protrusion extending from its surface.

19. The apparatus of claim 13, wherein the inner cylindrical wall comprises at least one protrusion extending from its surface.

20. The apparatus of claim 19, wherein the at least one protrusion extending from the surface of the inner cylindrical wall is configured to mate with at least a portion of the valve.

21. A method of placing a valve in a tubular organ having a greater diameter than the valve, comprising:

delivering an expandable tubular adapter assembly to a desired site within the tubular organ, wherein the adapter assembly comprises

an adapter comprising an enclosed volume surrounded by an outer cylindrical wall having a first diameter that is spaced concentrically from an inner cylindrical wall having a second diameter that is smaller than the first diameter, and first and second end walls extending between the outer and inner cylindrical walls at a proximal and distal end of the adapter, respectively; and

a valve positioned within the inner cylindrical wall of the adapter; and

inserting material into the enclosed volume of the adapter to expand the outer cylindrical wall relative to the inner cylindrical wall so that the outer cylindrical wall contacts the tubular organ.

22. A method of placing a valve in a tubular organ having a greater diameter than the valve, comprising:

delivering an expandable adapter in an at least partially unexpanded condition to a desired site within the tubular organ, wherein the adapter comprises;

an enclosed volume surrounded by an outer wall having a first periphery that is spaced from an inner wall having a second periphery that is smaller than the first periphery, and first and second end walls extending between the outer and inner walls at a proximal and distal end of the adapter, respectively;

expanding the outer wall relative to the inner wall so that the outer wall contacts the tubular organ; and

placing a valve within the inner wall of the adapter.