Percutaneous aortic valve replacement

• US 6,482,228 B1
• Filed: 11/14/2000
• Issued: 11/19/2002
• Est. Priority Date: 11/14/2000
• Status: Expired due to Term

• Current Assignee: Troy R. Norred
• Original Assignee: Troy R. Norred
• Inventors: Norred, Troy R.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Matthews, William H
• Application Number:
  US09/712,121
• Time in Patent Office: 735 Days
• Field of Search: 623/2.1, 623/2.12, 623/2.13, 623/2.14, 623/2.18, 623/2.2, 623/2.22, 623/2.17
• US Class Current: 623/2.17
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical

Abstract

An aortic heart valve which is adapted to be placed percutaneously without the need for open-heart surgery is placed by a catheter and held in place with a stent system. The stent system is expanded in the ascending aorta to anchor the valve in the aortic channel above the native aortic valve.

Claims

1. An aortic valve for regulating blood flow through a channel of an aorta, the channel surrounded by an aortic wall, upon placement therein, said valve comprising:

a body member having a configuration adapted to fit within a channel of an aorta;

a membrane made of a material impervious to an aortic blood flow, said membrane having a first membrane position precluding a blood flow through the aorta and a second position for allowing a blood flow through the aorta; and

a plurality of frame members with said membrane mounted thereto, each frame member having a first end pivotally secured to said body member and a second end, said frame members pivotally responsive to a condition within the aorta between a first position wherein said membrane at said first frame member position is at said first membrane position and a said second frame member position wherein said membrane is at said second membrane position.

2. An aortic valve as claimed in claim 1 wherein said membrane extends across the aortic channel to block a blood flow at said first membrane position and extends generally along the aortic channel to allow a blood flow through the aorta at said second membrane position.

3. The aortic valve as claimed in claim 1 further comprising means for stopping pivotal movement of said second end of said frame members into contact with the aorta wall.

4. The aortic valve as claimed in claim 1 wherein said condition within the aorta is a change in blood pressure in the aorta.

5. The aortic valve as claimed in claim 1 wherein said frame members and membrane move to said second positions in response to systolic ejection of blood from the left ventricle in which the blood pressure in the left ventricle is higher than the blood pressure in the aorta.

6. The aortic valve as claimed in claim 1 wherein said frame member and membrane move to said first position in response to diastolic filling of the left ventricle and the blood pressure in the aorta is higher than the blood pressure in the left ventricle resulting in a reverse flow of blood from the aorta to the left ventricle which is stopped by said membrane at said first position.

7. An aortic valve as claimed in claim 1 wherein said body member has an exterior configuration to present a space between said body member exterior configuration and the aortic wall to allow blood flow therearound at said membrane second position.

8. The aortic valve as claimed in claim 1 wherein said body member comprises a base presenting an edge adapted to seat about the aortic wall surrounding the aortic channel;

an aperture in said base for blood flow therethrough;

a ring surrounding said aperture, said first end of said frame members pivotally mounted to said ring with said membrane mounted thereto, said second ends of said frame members being in contact at said first frame member position to cause said membrane to span said base aperture and preclude a blood flow past said second frame member ends and said membrane, said frame members pivotable about said ring to a second position wherein said second frame member ends are displaced one from the other to allow a blood flow through the aperture and past said membrane.

9. The aortic valve as claimed in claim 8 wherein said membrane presents a base opening secured about said aperture and a free end having an aperture therein, said aperture in said free end of said membrane at said second frame and membrane positions is open to allow blood to flow though said membrane between said membrane base opening and said aperture in said free end of said membrane at said membrane second position.

10. The aortic valve as claimed in claim 9 wherein said membrane free end aperture is closed at said first frame membrane and member positions to preclude blood from flowing though said membrane at said membrane first position.

11. The aortic valve as claimed in claim 1 further comprising means for maintaining said body member within the aortic channel.

12. An aortic valve for regulating blood flow through a channel of an aorta upon placement therein, said valve comprising:

a body member having a configuration adapted to fit within a channel of an aorta to allow passage of a blood flow therearound;

a membrane for traversing the aortic channel to preclude blood flow therethrough; and

at least two ribs for attachment of said membrane thereto, each rib having a first end hingedly attached to said body member and a free end extending from said body member, wherein said at least two ribs are responsive to a change in pressure in the aorta for movement between a first position wherein said membrane is unfolded so as to traverse the aortic channel and preclude a blood flow therethrough and a second collapsed position wherein said membrane is positioned relative to the aorta channel to allow a blood flow therearound.

13. The aortic valve as claimed in claim 12 wherein said at least two ribs extend radially from said body so as to traverse the aortic channel at a first rib position, said first rib position corresponding to unfold said membrane at said first position, and wherein said ribs extend generally along said aortic channel at a second rib position to collapse said membrane at said second position.

14. The aortic valve as claimed in claim 13 wherein said membrane presents an edge adapted for contact about a wall of the aortic channel in said first position, said contact seats said membrane edge against the aortic channel wall to reduce a blood flow therearound.

15. The aortic valve as claimed in claim 12 further comprising means for maintaining said body member at a selected position in the aorta.

16. An aortic valve for regulating a blood flow through an aortic channel surrounded by an aortic wall upon placement therein, said valve comprising:

a ring member having a circumference adapted to seat about an aortic wall surrounding an aortic channel, said ring including an aperture for blood flow therethrough;

a membrane having first and second spaced-apart open ends, said membrane made of a material resistant to a fluid flow therethrough; and

means for mounting said first open end of said membrane about said ring aperture with said second open end displaced therefrom, said means moving said membrane second end between a first open position to allow a blood flow therethrough and a second closed position to preclude a blood flow therethrough.

17. The aortic valve as claimed in claim 16 wherein said mounting means comprises at least one arm having a first end hingedly secured to said ring member and a free end spaced therefrom, said first end of said at least one arm secured to said first end of said membrane, said free end of said at least one arm secured to said second end of said membrane, said at least one arm responsive to a blood flow within the channel for movement with said membrane between said first open and second closed positions.

18. The aortic valve as claimed in claim 17 wherein said at least one arm extends generally along a path of said blood flow at said first open position, and generally traverses a blood flow path when at said second closed position.

19. The aortic valve as claimed in claim 16 further comprising means for maintaining said ring member in said seat about the aortic wall.

20. An aortic valve for controlling a blood flow through an aortic channel upon placement therein, said valve comprising:

a tissue valve having an interior member made of a tissue material and presenting an opening movable between open and closed positions;

a ring member surrounding said tissue valve, said ring member having an outer circumference adapted to seat said ring member about an aortic wall surrounding an aortic channel;

means for maintaining said ring member in said seated position about the aortic wall,

said tissue valve interior member responsive to changes of conditions within the aorta for movement of said opening between a first closed position and a second open position.

21. The aortic valve as claimed in claim 20 wherein said tissue valve interior member is responsive to changes in blood pressure in the aorta whereby to move said tissue valve between said first and second positions.

22. The aortic valve as claimed in claim 21 wherein said tissue valve interior member moves to said second position in response to systolic ejection of blood from the left ventricle in which the blood pressure in the left ventricle is greater than the blood pressure in the aortic channel.

23. The aortic valve as claimed in claim 21 wherein said tissue valve interior member moves to said first position in response to diastolic filling of the left ventricle whereby the blood pressure in the aortic channel is greater than the blood pressure in the left ventricle.

24. The aortic valve as claimed in claim 20 wherein said ring member contacts the wall of the aortic channel and seals said ring against the aortic channel wall to reduce blood flow therearound.