Remodelable Prosthetic Valve

• US 20090138078A1
• Filed: 11/18/2008
• Published: 05/28/2009
• Est. Priority Date: 11/19/2007
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Biotech Incorporated (Cook Group Incorporated), Cook Incorporated (Cook Group Incorporated)
• Inventors: Chambers, Sean D., Johnson, Chad E., Paul, Ram H. JR.
• Granted Patent: US 7,846,199 B2
• Time in Patent Office: Days
• US Class Current: 623/2.100
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2230/0026 trapezoidal
• CPC Class Codes: A61F 2230/0095 Saddle-shaped
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts

Abstract

Prosthetic medical devices with delayed valve function and in situ remodeling of a portion thereof are provided, as well as methods of manufacturing the medical devices and methods of treatment using the medical devices. The medical devices may be adapted to initially maintain a remodelable material within a body vessel in a first configuration suitable to contact the remodelable material with a body fluid contacting the remodelable material for a first time period or a second configuration adapted to regulate the flow of body fluid contacting the remodelable material. The medical devices may include a releasable holding member configured to retain the remodelable material in the first configuration.

Claims

1. A prosthetic valve assembly comprising:

a. a support frame defining a lumen extending from a proximal end to a distal end along a longitudinal axis and being configured for implantation within a body vessel;

b. a valve leaflet including a remodelable material, the valve leaflet being attached to the support frame and oriented in a first configuration within the lumen permitting a bidirectional fluid flow through the lumen in a first direction along the longitudinal axis and a second direction opposite the first direction, the valve leaflet being moveable from the first configuration to a second configuration permitting fluid flow through the lumen in the first direction while substantially limiting fluid flow through the lumen in the direction opposite the first direction; and

c. a releasable holding member configured to restrain the valve leaflet in the first configuration and to prevent the valve leaflet from moving to the second configuration;

the valve leaflet being moveable to the second configuration within the lumen upon release of the holding member.

2. The prosthetic valve assembly of claim 1 wherein the releasable holding member is bioabsorbable.

3. The prosthetic valve assembly of claim 2, where the bioabsorbable holding member comprises a bioabsorbable polymer.

4. The prosthetic valve assembly of claim 1 wherein the releasable holding member comprises a metallic releasable holding member.

5. The prosthetic valve assembly of claim 2, where the bioabsorbable holding member includes at least one structure selected from the group consisting of:

a bioabsorbable suture, a portion of the support frame comprising a bioabsorbable polymer and a member comprising a bioabsorbable material connecting two portions of the support frame.

6. The prosthetic valve assembly of claim 1, wherein the support frame comprises a self-expanding material configured to move the valve leaflet from the first configuration to the second configuration upon release of the holding member.

7. The prosthetic valve assembly of claim 1, wherein the valve leaflet in the first configuration is substantially parallel to the longitudinal axis.

8. The prosthetic valve assembly of claim 7, wherein the valve leaflet in the first configuration is configured as a substantially flat sheet contained within the lumen defined by the support frame.

9. The prosthetic valve assembly of claim 8, wherein the valve leaflet in the second configuration extends from a base portion contacting a portion of the support frame to a free edge portion distal to the base portion, the free edge being flexibly moveable within the lumen to define at least a portion of a valve orifice moveable therein to permit the fluid flow through the lumen in the first direction while substantially limiting fluid flow through the lumen in the direction opposite the first direction.

10. The prosthetic valve assembly of claim 2, wherein bioabsorbable holding member comprises one or more bioabsorbable polymers or metals and is absorbable within about 14 days to 60 days after implantation within a blood vessel.

11. The prosthetic valve assembly of claim 10, wherein

a. the bioabsorbable holding member includes at least one structure selected from the group consisting of:

a bioabsorbable suture, a portion of the support frame comprising a bioabsorbable polymer and a member comprising a bioabsorbable material connecting two portions of the support frame; and

b. the support frame comprises a self-expanding material configured to move the valve leaflet from the first configuration to the second configuration upon release of the holding member.

12. A prosthetic valve assembly comprising:

a. a self-expandable support frame configured for implantation within a body vessel, the support frame having a longitudinal axis and being adapted to permit fluid flow along the longitudinal axis;

b. a first valve leaflet and a second valve leaflet each including a remodelable material and extending from a leaflet base to a leaflet free edge distal to the leaflet base,

i. the first valve leaflet and the second valve leaflet each being separately attached to the support frame in a substantially planar configuration oriented substantially parallel to each other along the longitudinal axis, the first valve leaflet and the second valve leaflet in the substantially parallel configuration permitting a bidirectional fluid flow along the longitudinal axis of the support frame in both a first direction and a second direction opposite the first direction;

ii. the first valve leaflet and the second valve leaflet being moveable from the planar configuration to a tilted configuration, the tilted configuration having the free edge of the first valve leaflet contact the free edge of the second valve leaflet to form at least a portion of a valve orifice, and the base of the first valve leaflet and the base of the second valve leaflet each being positioned a greater distance from the longitudinal axis in the tilted configuration than in the planar configuration;

the prosthetic valve assembly in the tilted configuration permitting fluid flow along the longitudinal axis in the first direction while substantially limiting fluid flow in the direction opposite the first direction; and

c. a releasable holding member configured to restrain the valve leaflets in the planar configuration and to simultaneously preventing each valve leaflet from moving to the tilted configuration;

the valve leaflets being moveable to the tilted configuration upon release of the holding member.

13. The prosthetic valve assembly of claim 12 wherein the releasable holding member is bioabsorbable

14. The prosthetic valve assembly of claim 12, where the support frame comprises a self-expanding material attached to the first valve leaflet, the support frame being configured to urge the first valve leaflet from the planar configuration to the tilted configuration by self-expansion of a portion of the support frame upon release of the holding member.

15. The prosthetic valve assembly of claim 13, where the bioabsorbable holding member resists the self-expansion of the support frame and includes at least one structure selected from the group consisting of:

a bioabsorbable suture, a portion of the support frame comprising a bioabsorbable polymer and a member comprising a bioabsorbable material connecting two portions of the support frame.

16. The prosthetic valve assembly of claim 13, wherein the bioabsorbable holding member comprises one or more bioabsorbable polymers or metals and is absorbable within about 14 days to 60 days after implantation within a blood vessel.

17. The prosthetic valve assembly of claim 12, wherein the support frame is a shape memory material and the holding member comprises a bioabsorbable polymer or metal.

18. A method of providing a prosthetic valve with delayed function and in situ remodeling of a portion thereof, the method comprising the steps of:

a. implanting a prosthetic assembly at a point of treatment within a body vessel, the body vessel having a longitudinal axis at a point of treatment, the prosthetic assembly comprising a substantially planar sheet of remodelable material attached to a support frame and a releasable holding member for maintaining the remodelable material within the body vessel without contacting the wall of the body vessel, the implanted prosthetic assembly permitting bidirectional fluid flow through the body vessel and in contact with the remodelable material at the point of treatment;

b. maintaining the prosthetic valve at the point of treatment for a period of time effective for an in situ remodeling of the remodelable material, the remodelable material forming a valve leaflet

c. releasing the holding member such that the leaflet contacts a portion of the body vessel upon release of the holding member for maintaining the remodelable material within the body vessel;

d. regulating fluid flow within the body vessel after the release of the holding member to permit fluid flow along the longitudinal axis in a first direction, while substantially limiting fluid flow in the opposite direction by movement of the valve leaflet within the body vessel.

19. The method of claim 18, wherein the effective period of time is at least about 14 days.

20. The method of claim 18, wherein the holding member is bioabsorbable and the release of holding member occurs when the holding member has been bioabsorbed so that the leaflet is released to substantially limit fluid flow in the opposite direction.