VALVE FRAME

• US 20090187241A1
• Filed: 01/22/2009
• Published: 07/23/2009
• Est. Priority Date: 01/22/2008
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Melsheimer, Jeffry S.
• Granted Patent: US 7,955,377 B2
• Time in Patent Office: Days
• US Class Current: 623/2.360
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

The disclosure relates to frames suitable for prosthetic implantable valves, and methods of treatment with such frames, to regulate blood flow and to be compliant in percutaneous delivery and, upon implantation, configured to conform to the changing shape of the body vessel or vein. The frames include at least one anchoring member attached to a support member at one or more attachments, and a valve member, preferably a monocuspid valve leaflet, attached to the support member. Preferred frames include two anchoring members with the support member in between the anchoring members. The support member preferably has a semielliptical shape and extends diagonally to sealingly contact the wall of the body vessel.

Claims

1. A frame suitable for prosthetic implantable valves comprising:

a first anchoring member and a second anchoring member together defining a fluid flow path about a longitudinal axis, the second anchoring member being longitudinally spaced from the first anchoring member;

a support member being curved in the shape of a semiellipse, the support member having a first end, a second end, and a middle region between the first and second ends including a vertex portion, where the support member is positioned between the first and second anchoring members, and a first attachment connecting the vertex portion to the first anchoring member, and a second attachment connecting one of the first end and the second end to the second anchoring member.

2. The frame of claim 1, where the frame is radially moveable about the longitudinal axis between an expanded configuration and a compressed configuration.

3. The frame of claim 2, where the support member extends diagonally across the fluid flow path in the expanded configuration.

4. The frame of claim 3, where the support member extends diagonally at an angle between about 15 degrees and about 60 degrees from the longitudinal axis in the expanded configuration.

5. The frame of claim 1, further comprising a valve member attached to the support member, the valve member being moveable to regulate fluid flow through fluid flow path of the first and second anchoring members

6. The frame of claim 5, where the valve member comprises a leaflet having a first edge and a second edge, the first edge being attached to the middle region of the support member, the second edge extending between the first end and the second end of the support member and being movable across the fluid flow path between a open position permitting a fluid to flow along the fluid flow path and a closed position reducing or preventing the fluid flow along the fluid flow path, when the frame is in the expanded configuration.

7. The frame of claim 2, where each of the first anchoring member and the second anchoring member has a proximal end and a distal end, and where the second anchoring member is longitudinally spaced proximally from the first anchoring member;

and where both the first end and the second end of the support member are separately attached to the second anchoring member.

8. The frame of claim 7, where the support member extends diagonally across at an angle between about 15 degrees and about 60 degrees from the longitudinal axis and distally from the second anchoring member to the first anchoring member in the expanded configuration.

9. The frame of claim 2, where the first attachment and the second attachment are positioned on opposite sides of the longitudinal axis in the expanded configuration and are substantially aligned with the longitudinal axis in the compressed configuration.

10. The frame of claim 1, where the second attachment connects the first end of the support member to the second anchoring member and a third attachment connects the second end to the second anchoring member;

the second attachment being opposably positioned with respect to the third attachment across the longitudinal axis.

11. The frame of claim 10, where the support member further comprises a first loop at the vertex portion, and the first attachment is formed by interconnecting a portion of the first anchoring member with the first loop to form a hinged attachment between the vertex portion of the support member and the first anchoring member.

12. The frame of claim 11, where at least one of the second attachment and the third attachment is a hinged attachment joining the first end or the second end of the support member and the second anchoring member.

13. The frame of claim 10, where the support member further comprises a second loop at the first end and a third loop at the second end;

the second attachment being a hinge formed by interconnecting a first portion of the second anchoring member positioned within the second loop, and the third attachment being a hinge formed by interconnecting a second portion of the second anchoring member positioned within the third loop.

14. The frame of claim 13, where the second loop and the third loop have a first inner diameter and the first portion of the second anchoring member and the second portion of the second anchoring member are loops having a thickness that is less than the first inner diameter of the second loop and the third loop, and the second attachment and the third attachment are formed as interconnecting loops.

15. The frame of claim 1, where each of the first anchoring member and the second anchoring member comprise an annular array of struts interconnected by a plurality of bends;

and the first anchoring member and the second anchoring member are similarly shaped and oriented in mirror symmetry to each other.

16. The frame of claim 1, where the semielliptical curved support member defines an opening and the valve member is positioned within said opening.

17. The frame of claim 1, where the first anchoring member and the second anchoring member have different diameters in the expanded configuration.

19. The implantable valve device of claim 17, where the distal means for supporting the support member is a first anchoring member and the proximal means for supporting the support member is a second anchoring member, the first anchoring member and the second anchoring member each having an annular array of struts interconnected by a plurality of bends;

and the first anchoring member, with the second anchoring member being similarly shaped and oriented in mirror symmetry to each other.

18. An intraluminally-implantable valve device radially moveable about a longitudinal axis between an expanded configuration and a compressed configuration, the valve device in the expanded configuration defining a fluid flow path extending along the longitudinal axis from a proximal end to a distal end, the valve device comprising:

a support member being curved in the shape of a semiellipse, the support member extending from a first end having a second loop to a second end having a third loop, and a middle region between the first and second ends including a vertex portion having a first loop, where the support member extends diagonally across the longitudinal axis in the expanded configuration;

a first hinge formed by a fourth loop interconnected with and moveable within the first loop, the fourth loop joined to a distal means for supporting the support member;

a second hinge and a third hinge formed by a fifth loop and a sixth loop interconnected with and moveable within the second loop and the third loop, respectively;

the second hinge and the third hinge in the expanded state being opposably positioned across a hypothetical plane containing the longitudinal axis and bisecting the first hinge;

the fifth loop and the sixth loop joined to a proximal means for supporting the support member that is longitudinally spaced from the distal means for supporting the support member; and

a valve leaflet attached to the support member, the valve leaflet having a first edge and a second edge, the first edge being attached to the middle region of the support member, the second edge extending between the first end and the second end of the support member and being movable across the fluid flow path between a open position permitting a fluid to flow along the fluid flow path and a closed position reducing or preventing the fluid flow along the fluid flow path, when the valve device is in the expanded configuration.

20. The implantable valve device of claim 18, where the support member is moveable with respect to the first anchoring member at the first hinge and the support member is moveable with respect to the second anchoring member at the second hinge and the third hinge when the valve device is moved between the expanded configuration and the compressed configuration.

21. A method for regulating fluid flow within a body vessel, the method comprising:

(a) loading an intraluminally-implantable valve device in a compressed configuration into a delivery catheter, the intraluminally-implantable valve device including

(i) a first anchoring member and a second anchoring member together defining a fluid flow path about a longitudinal axis, the second anchoring member being longitudinally spaced from the first anchoring member;

(ii) a support member being curved in the shape of a semiellipse, the support member having a first end, a second end, and a middle region between the first and second ends including a vertex portion, where the support member is positioned between the first and second anchoring members, and a first attachment connecting the vertex portion to the first anchoring member, and a second attachment connecting one of the first end and the second end to the second anchoring member; and

(iii) a valve leaflet attached to the support member, the valve leaflet being moveable to regulate fluid flow through fluid flow path of the first and second anchoring members;

(b) inserting the delivery catheter into a body vessel;

(c) translating the delivery catheter to a treatment site;

(d) deploying the intraluminally-implantable valve device by radially expanding the valve device from the compressed configuration to the expanded configuration within the body vessel and securably placing the valve device in the expanded configuration at the treatment site;

(e) withdrawing the delivery catheter from the body vessel.