ARTIFICIAL VENOUS VALVE WITH DISCRETE SHAPING MEMBERS

• US 20080183280A1
• Filed: 01/29/2008
• Published: 07/31/2008
• Est. Priority Date: 01/29/2007
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Agnew, Charles W., Hunt, James B.
• Granted Patent: US 8,303,649 B2
• Time in Patent Office: Days
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid

Abstract

The invention relates to a prosthetic valve for regulating flow through a body lumen. The medical device comprises discrete shaping members, a flexible covering, and a valve member. The discrete shaping members are operatively attached to the flexible covering, such that the medical device may exhibit low radial force and dynamic movement.

Claims

1. A prosthetic valve for implantation in a body vessel having an expanded configuration and a compressed configuration, the prosthetic valve comprising:

a flexible covering defining an interior lumen with a proximal end, a distal end, a luminal surface, and an abluminal surface;

a plurality of discrete shaping members attached to the flexible covering; and

at least one valve member operatively connected to the flexible covering lumen, the valve member adapted to modify fluid flow through the flexible covering lumen.

2. The prosthetic valve of claim 1, where the flexible covering is a tubular member;

and the discrete shaping members comprise discrete Z-stent segments located substantially between the flexible covering proximal end and the flexible covering distal end and at least one shaping member does not extend circumferentially around the abluminal surface tubular member.

3. The prosthetic valve of claim 1, where the discrete shaping members comprise discrete struts extending from about the flexible covering proximal end to about the flexible covering distal end;

and the plurality of discrete shaping members are adapted to move circumferentially relative to one another along the abluminal surface of the flexible covering when the prosthetic valve is moved between the compressed configuration and the expanded configuration.

4. The prosthetic valve of claim 1, further comprising a first stent attached near the flexible covering proximal end and a second stent attached near the flexible covering distal end.

5. The prosthetic valve of claim 1, where at least one discrete shaping member comprises an energy-sensitive material.

6. The prosthetic valve of claim 5, where the energy-sensitive material increases in temperature when an energy source is applied thereto, the energy source selected from the group consisting of radiofrequency energy, electrical energy, ultrasound energy, laser energy, microwave energy, and electromagnetic energy.

7. The prosthetic valve of claim 1, where the flexible covering abluminal surface comprises a bioadhesive.

8. The prosthetic valve of claim 7, where the bioadhesive comprises a bioadhesive curable by ultraviolet light exposure.

9. The prosthetic valve of claim 1, where the discrete shaping members are selected from the group consisting of stainless steel, nitinol, tantalum, a nonmagnetic nickel-cobalt-chromium-molybdenum alloy, platinum, titanium, a suitable biocompatible alloy, a suitable biocompatible polymer, a suitable biocompatible material, and a combination thereof.

10. The prosthetic valve of claim 1, where the flexible covering comprises a material selected from the group consisting of biocompatible polyurethane, polyethylene terephthlate, polytetrafluoroethylene, and extracellular matrix material.

11. The prosthetic valve of claim 1, where the prosthesis further comprises anchoring devices.

12. A prosthetic valve for implantation in a body vessel having an expanded configuration and a compressed configuration, the prosthetic valve comprising:

a flexible covering defining a body region surrounding an interior lumen extending between a proximal covering end and a distal covering end, the flexible covering having a luminal surface defining an interior lumen and an abluminal surface;

a plurality of discrete shaping members which are individually attached to the flexible covering, the plurality of discrete shaping members being adapted to move circumferentially relative to one another along the abluminal surface of the flexible covering when the prosthetic valve is moved between the compressed configuration and the expanded configuration; and

at least one valve member operatively connected to the flexible covering lumen, the valve member adapted to modify fluid flow through the flexible covering lumen;

where the flexible covering interior lumen has a larger cross-sectional area in at least a portion surrounding the valve member than at the flexible covering proximal end and the flexible covering distal end.

13. The prosthetic valve of claim 12, where the discrete shaping members extend substantially between the flexible covering proximal end and the flexible covering distal end.

14. The prosthetic valve of claim 12, where the discrete shaping members comprise discrete Z-stent segments located substantially between the flexible covering proximal end and the flexible covering distal end.

15. The prosthetic valve of claim 12, further comprising a first stent attached near the flexible covering proximal end and a second stent attached near the flexible covering distal end.

17. The method of claim 15, further comprising securing the prosthetic valve in the patient by applying an energy source to at least one discrete shaping member.

20. The method of claim 15, where the prosthetic valve flexible covering abluminal surface comprises a bioadhesive and further comprising securing the prosthetic valve in the patient by curing the bioadhesive by ultraviolet light exposure.

16. A method of treating valvular insufficiency, comprising the steps of:

providing a prosthetic valve comprising a flexible covering defining an interior lumen having a proximal end, a distal end, a luminal surface, and an abluminal surface, a plurality of discrete shaping members attached to the flexible covering, and at least one valve member connected to the flexible covering lumen,

implanting the prosthetic valve into a patient in need thereof;

where the discrete shaping members are capable of dynamic movement.

18. The method of claim 16, where the energy source is selected from the group consisting of radiofrequency energy, electrical energy, ultrasound energy, laser energy, microwave energy, and electromagnetic energy.

19. The method of claim 16, where the electrical energy is between about 0.01 to about 10.0 milliamps at about 0.1 to about 10.0 volts.