Venous valvuloplasty device and method

• US 6,932,838 B2
• Filed: 10/01/2001
• Issued: 08/23/2005
• Est. Priority Date: 09/29/2000
• Status: Expired due to Fees

• Current Assignee: Tricardia Ventures LLC
• Original Assignee: Tricardia Ventures LLC
• Inventors: Schwartz, Robert S., Van Tassel, Robert A.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): SWEET, THOMAS
• Application Number:
  US09/968,301
• Publication Number:
  US 20020099439A1
• Time in Patent Office: 1,422 Days
• Field of Search: 623/1.22, 623/1.23, 623/1.24, 623/1.36, 623/66.1, 606/151, 606/158, 606/139, 606/142, 606/143, 128/898
• US Class Current: 623/1.23
• 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;

providing a grabbing mechanism on a surface of the constricting device for contacting said vein;

placing the constricting device proximate the venous valve;

attaching the constriction 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; and

wherein placing the constricting device proximate the venous valve comprises placing the constricting device around the outside of the vein.

2. The method of claim 1 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 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 to venous valve.

3. The method of claim 2 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.

4. 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;

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

percutaneously placing the constricting device proximate the venous valve;

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

expanding the constriction device using the expansion device until the outside circumference of the constriction 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; and

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.

5. The method of claim 4 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.

6. The method of claim 4, wherein providing a grabbing mechanism includes providing umbrella projections which expand after having passed through an inner wall of said vein.

7. The method of claim 4, wherein expanding the constriction device includes urging the grabbing mechanism through said inner wall of said vein.

8. The method of claim 7, wherein urging the grabbing mechanism through the vein wall includes causing the grabbing mechanism to protrude through said inner wall of said vein.

9. The method of claim 4, further comprising providing a second constricting device and using said second constricting device to also compress the vein to a predetermined diameter whereby cusps of the venous valve coapt, thereby restoring competence to the venous valve.

10. The method of claim 4, wherein expanding the expansion device includes inflating the expansion device.

11. The method of claim 4, wherein expanding the expansion device includes mechanically expanding the expansion device.

12. The method of claim 4, further comprising providing a leaflet support structure on said constricting device.

13. The method of claim 4, wherein providing a constricting device includes providing a support structure having a zig zag patterned spring member curled to form a ring.

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

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

placing the first constricting device proximate the venous valve;

attaching the constricting device proximate the venous valve; and

using the first constricting device to compress the vein to a predetermined diameter;

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 first 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.

15. The method of claim 14, wherein the attaching of said first constricting device and the attaching of said second constricting device comprises attaching said first and second constricting devices to the internal wall of said vein.

16. The method of claim 14, wherein the attaching of said first constricting device and the attaching of said second constricting device comprises attaching said first and second constricting devices to an external wall of said vein.

17. The method of claim 14, wherein the providing of said first and second constricting devices includes the first and second constricting devices being attached to each other.

18. The method of claim 14, wherein the attaching of said first and second constricting device includes expanding said first and second constricting devices against an internal wall of said vein.

19. The method of claim 14, further comprising providing a grabbing mechanism on each said first and second constricting devices.

20. The method of claim 19, wherein the attaching of said first and second constricting devices includes urging said grabbing mechanism of both said first and second constricting devices through an internal wall of said vein.