Monocuspid Prosthetic Valve Having a Partial Sinus

• US 20080288055A1
• Filed: 05/15/2008
• Published: 11/20/2008
• Est. Priority Date: 05/17/2007
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Paul, Ram H. JR.
• Granted Patent: US 8,403,979 B2
• Time in Patent Office: Days
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

The disclosure relates to an expandable valve prosthesis for regulating flow through a body vessel. The prosthesis comprises a frame configured to form a laterally asymmetric partial sinus and a valve member.

Claims

1. A valve prosthesis comprising:

an implantable frame radially-expandable from a compressed configuration to an expanded configuration having an interior lumen, the frame defining a laterally asymmetric partial sinus portion of the interior lumen extending around between about 10% and about 90% of the circumference of the frame in the expanded configuration; and

a valve member.

2. The valve prosthesis of claim 1, where the frame includes a proximal portion, a distal portion, and an intermediate portion;

the valve member comprising at least one leaflet operatively attached to the frame intermediate portion, the at least one leaflet having a base and a free edge adapted to modify fluid flow through the interior lumen; and

the partial sinus portion of the interior lumen being defined by a bulge of the intermediate portion in a lateral direction such that the bulge of the intermediate portion has a width greater than the width of the distal portion and the proximal portion.

3. The prosthesis of claim 2, where the proximal portion and the distal portion have a radial force that is less than the radial force of the intermediate portion.

4. The prosthesis of claim 2, where the intermediate portion has a longitudinal length at least as great as the longitudinal length of the at least one leaflet.

5. The valve prosthesis of claim 2, the leaflet free edge defining a valve orifice moveable within the interior lumen to modify fluid flow through the interior lumen by movement of the free edge between an open position permitting fluid flow through the valve orifice and a closed position engaging a portion of the frame opposite the partial sinus portion of the interior lumen to reduce fluid flow through the interior lumen.

6. The valve prosthesis of claim 5, where in the open position the valve leaflet is at least partially within the partial sinus.

7. The valve prosthesis of claim 1, where the partial sinus portion extends around between about 25% and about 75% of the circumference of the frame in the expanded configuration.

8. The valve prosthesis of claim 1, where the partial sinus portion extends around between about 40% and 60% of the circumference of the frame in the expanded configuration.

9. A valve prosthesis radially expandable between a compressed configuration and an expanded configuration defining an interior lumen adapted to conduct fluid from an annular inlet to an outlet, the valve prosthesis comprising:

a frame defining a laterally asymmetric partial sinus portion of the interior lumen forming a bulge of the frame extending in a first lateral direction with respect to the frame in the expanded configuration, and

a monocuspid valve leaflet having a base attached to the frame and a flexible edge free of the frame, the free edge moveable within the interior lumen to modify fluid flow therethrough by moving between an open configuration permitting fluid flow through the valve orifice and a closed configuration engaging a portion of the frame opposite the partial sinus portion to reduce fluid flow through the valve orifice.

10. The valve prosthesis of claim 9, where the leaflet comprises a material selected from the group consisting of a polymeric material, an extracellular matrix material, and an explanted tissue.

11. The valve prosthesis of claim 10, where polymeric material is selected from the group consisting of biocompatible polyurethane, polyethylene terephthalate, and polytetrafluoroethylene.

12. The valve prosthesis of claim 10, where the explanted tissue is pre-treated by performing at least one of the following:

a. maintaining the explanted tissue at a pH in the range from about 5.0 to about 8.0 and a temperature in the range from about 12°

C. to about 30°

C. for a sufficient amount of time sufficient to effect the degradation of at least a portion of the cells by autolytic enzymes within the cells;

b. contacting the explanted tissue with a chemical cross-linking agent and then irradiating with X-ray or gamma radiation;

c. contacting the explanted tissue with a tanning fluid including formaldehyde or glutaraldehyde;

or

d. placing tissue explanted tissue within an atmosphere of substantially unpressurized vapor of containing glutaraldehyde, and maintaining the tissue within the atmosphere of substantially unpressurized vapor in a manner sufficient to provide substantially uniform application of the fixative solution for a period of time to cause the desired fixation of said tissue.

13. The valve prosthesis of claim 10, where the extracellular matrix material is small intestine submucosa or an aortic tissue.

14. The valve prosthesis of claim 9, further comprising a graft operatively attached to the frame, the graft having an abluminal and a luminal surface.

15. The valve prosthesis of claim 14, wherein the graft comprises a polymeric material that is selected from the group consisting of biocompatible polyurethane, polyethylene terephthalate, and polytetrafluoroethylene.

16. The valve prosthesis of claim 14, where the graft comprises an extracellular matrix material or an explanted tissue pre-treated by performing at least one of the following:

a. maintaining the explanted tissue at a pH in the range from about 5.0 to about 8.0 and a temperature in the range from about 12°

C. to about 30°

C. for a sufficient amount of time sufficient to effect the degradation of at least a portion of the cells by autolytic enzymes within the cells;

b. contacting the explanted tissue with a chemical cross-linking agent and then irradiating with X-ray or gamma radiation;

c. contacting the explanted tissue with a tanning fluid including formaldehyde or glutaraldehyde;

or

d. placing tissue explanted tissue within an atmosphere of substantially unpressurized vapor of containing glutaraldehyde, and maintaining the tissue within the atmosphere of substantially unpressurized vapor in a manner sufficient to provide substantially uniform application of the fixative solution for a period of time to cause the desired fixation of said tissue.

17. The valve prosthesis of claim 12, where the graft luminal surface comprises a bioactive compound selected from the group consisting of anticoagulants, antiplatelets, fibrinolytics, and thrombolytics.

18. The valve prosthesis of claim 17, where the bioactive compound comprises heparin, hirudin, or a combination thereof.

19. A method of treating a venous valve-related condition by deploying a valve prosthesis within a body vessel, the method comprising the steps of:

a. inserting the valve prosthesis into a body vessel in a radially compressed configuration, the valve prosthesis including;

i. a frame moveable from the compressed configuration to an expanded configuration, the frame defining an interior lumen and having a proximal end, a distal end, a luminal surface, and an abluminal surface;

the frame defining a laterally asymmetric partial sinus portion of the interior lumen extending around up to one half of the circumference of the frame in the expanded configuration; and

ii. a means for regulating fluid flow through the interior lumen positioned within the interior lumen and being attached to the frame;

b. advancing the valve prosthesis within a body vessel;

c. positioning the valve prosthesis at a point of treatment within the body vessel; and

d. expanding the valve prosthesis from the compressed configuration to the expanded configuration to deploy the valve prosthesis within the body vessel, the expanded valve prosthesis laterally distending up to one half of the circumference of the body vessel.

20. The method of claim 19, wherein the means for regulating fluid flow through the interior lumen is a monocuspid valve leaflet having a base attached to the frame and a flexible free edge distal to the base, the free edge adapted to form a valve orifice moveable within the interior lumen to modify fluid flow therethrough by moving between an open configuration permitting fluid flow through the valve orifice and a closed configuration engaging a portion of the frame opposite the partial sinus portion to reduce fluid flow through the lumen;

and the valve leaflet includes an extracellular matrix material or an explanted tissue pre-treated by performing at least one of the following steps;

a. maintaining the explanted tissue at a pH in the range from about 5.0 to about 8.0 and a temperature in the range from about 12°

C. to about 30°

C. for a sufficient amount of time sufficient to effect the degradation of at least a portion of the cells by autolytic enzymes within the cells;

b. contacting the explanted tissue with a chemical cross-linking agent and then irradiating with X-ray or gamma radiation;

c. contacting the explanted tissue with a tanning fluid including formaldehyde or glutaraldehyde;

or

d. placing tissue explanted tissue within an atmosphere of substantially unpressurized vapor of containing glutaraldehyde, and maintaining the tissue within the atmosphere of substantially unpressurized vapor in a manner sufficient to provide substantially uniform application of the fixative solution for a period of time to cause the desired fixation of said tissue.