Venous valvuloplasty device and method

• US 20020099439A1
• Filed: 10/01/2001
• Published: 07/25/2002
• Est. Priority Date: 09/29/2000
• Status: Active Grant

• Current Assignee: Tricardia Ventures LLC
• Original Assignee: Tricardia Ventures LLC
• Inventors: Schwartz, Robert S., Van Tassel, Robert A.
• Granted Patent: US 6,932,838 B2
• Time in Patent Office: Days
• US Class Current: 623/1.24
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• 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 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• 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 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts

Abstract

A device 10 and method for replacing or restoring competence to incompetent valves. The device 10 is inserted percutaneously or surgically and is preferably constructed of a material capable of promoting cellular ingrowth such that, eventually, native biologic tissue completely covers the device 10 insulating the blood flow therefrom. The material is preferably bioabsorbable over time, allowing the device to harbor the regeneration of a valve structure and to later become absorbed by the body. The device is sized and arranged to mimic the valve it is replacing or repairing.

Claims

1. A method of restoring competence to a dilated venous valve comprising:

providing a constricting device, attachable to the vein, and capable of circumferentially compressing the vein;

placing the constricting device proximate the venous valve;

attaching the constricting device to the vein;

using the constricting device to compress the vein to a predetermined diameter whereby cusps of the venous valve coapt, thereby restoring competence to the venous valve.

2. The method of claim 1 wherein placing the constricting device proximate the venous valve comprises placing the constricting device around the outside of the vein.

3. The method of claim 2 wherein placing the constricting device around the outside of the vein further includes stretching the constricting device, thereby increasing an inner diameter of the constricting device such that the constricting device has a larger inside diameter than an outside diameter of the vein proximate the venous valve.

4. The method of claim 3 wherein attaching the constricting device to the vein comprises releasing the constricting device, thereby allowing the constricting device to return to an initial, predetermined diameter that is smaller than the outside diameter of the vein proximate the venous valve.

5. The method of claim 1 wherein placing the constricting device proximate the venous valve comprises percutaneously placing the constricting device proximate the venous valve.

6. The method of claim 5 wherein attaching the constricting device to the vein comprises:

providing a grabbing mechanism around an outside circumference of the constricting device;

placing an expansion device within an open center defined by the constricting device;

expanding the constricting device using the expansion device until the outside circumference of the constricting device is larger in diameter than an inner diameter of the vein, thereby forcing contact between the circumference of the constricting device and the vein.

7. The method of claim 6 wherein using the constricting device to compress the vein comprises releasing the expansion device, thereby allowing the constricting device to return to a predetermined diameter smaller than the inner diameter of the vein, thereby pulling the vein inwardly and compressing the vein to the predetermined diameter.

8. The method of claim 1 further comprising:

providing a second constricting device, attachable to the vein, and capable of circumferentially compressing the vein;

placing the second constricting device proximate the venous valve, opposite the other constricting device, such that the venous valve is juxtaposed between the two constricting devices;

attaching the second constricting device to the vein;

using the second constricting device to further compress the vein to the predetermined diameter whereby the cusps of the venous valve coapt, thereby restoring competence to the venous valve.

9. A device, useable to reduce a diameter of a vein, comprising:

a support structure defining an inner passage and an outer circumference, said support structure constructed and arranged to exhibit resiliency when said device is expanded or compressed;

a grabbing mechanism operably attached to the support structure, capable of fixing said support structure to the vein.

10. The device of claim 9 wherein said support structure comprises a zig zag spring member curled and joined to itself to form a ring, said zig zag providing said resiliency.

11. The device of claim 9 wherein said support structure comprises at least two rings joined together with a cross member.

12. The device of claim 9 wherein said grabbing mechanism comprises a plurality of projections operably disposed on said support structure, and constructed and arranged to penetrate and grip a wall of the vein.

13. The device of claim 9 wherein said grabbing mechanism comprises an adhesive operably disposed on said support structure.

14. The device of claim 9 wherein said support structure comprises a porous material, constructed and arranged to encourage cell infiltration and thrombus development.

15. The device of claim 9 wherein said support structure and said grabbing mechanism comprise a material that is bioabsorbable.

16. The device of claim 9 wherein said support structure is constructed and arranged such that when said support structure assumes a relaxed position, said inner passage closes, thereby blocking the passage of fluid therethrough.

17. The device of claim 9 further comprising at least one longitudinal finger extending from an upstream side of said structure, said finger angling outwardly and insertable behind a cusp of a venous valve, said finger thereby forming a sinus.

18. The device of claim 9 further comprising a transducer, operably attached to said support structure, and constructed and arranged to measure and transmit data.

19. The device of claim 9 further comprising a coating, operably disposed on said support structure, selected from the group consisting of fibrin, fibronectin, elastin, elastin fragments, collagen, mucopolysaccharides, glycosaminoglycans, extracellular matrix, cell-attracting biomolecules, fibroblasts, heparin, nitonol, and myofibroblasts.

20. The device of claim 9 wherein said support structure comprises at least one radiopaque fiber.

21. The device of claim 9 wherein said support structure further defines an inlet edge and an outlet edge whereby a cross sectional area of a plane near said inlet and outlet edges is greater than a cross sectional area of a plane substantially between said edges, all of said planes defined as being substantially perpendicular to a longitudinal axis of said structure, said support structure thus creating a nozzle effect when a fluid passes therethrough.

22. A prosthetic venous valve comprising:

a support structure defining an inner passage and an outer circumference, said support structure constructed and arranged to exhibit resiliency when said device is expanded or compressed;

a grabbing mechanism operably attached to the support structure, capable of fixing said support structure to the vein;

at least one cusp, operably disposed within said inner passage, constructed and arranged to allow blood flow in a first direction, while stopping blood from flowing in a second direction.

23. The valve of claim 22 wherein said at least one cusp has a thickness less than 100 micrometers.

24. The valve of claim 22 wherein said grabbing mechanism comprises a plurality of projections operably disposed on said support structure, and constructed and arranged to penetrate and grip a wall of the vein.

25. The valve of claim 22 wherein said support structure and said cusp comprise a porous material, constructed and arranged to encourage cell infiltration and thrombus development.

26. The valve of claim 22 wherein said support structure further defines a cavity behind said at least one cusp such that a sinus is formed between said cusp and said support structure even when said blood flow is present in said first direction.

27. The valve of claim 22 further comprising a transducer, operably attached to said support structure.

28. The valve of claim 22 further comprising a coating, operably disposed on said support structure, selected from the group consisting of fibrin, fibronectin, elastin, elastin fragments, collagen, mucopolysaccharides, glycosaminoglycans, extracellular matrix, cell-attracting biomolecules, fibroblasts, heparin, nitinol, and stainless steel.

29. The valve of claim 22 wherein said inner passage, defined by said structure, is contoured such that blood flowing therethrough undergoes an increase in velocity with a corresponding decrease in pressure, when said blood is flowing in said first direction.

30. The valve of claim 22 wherein said support structure comprises at least one radiopaque fiber.