Valvular prostheses having metal or pseudometallic construction and methods of manufacture

• US 7,195,641 B2
• Filed: 04/11/2002
• Issued: 03/27/2007
• Est. Priority Date: 11/19/1999
• Status: Expired due to Term

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Banas, Christopher E., Palmaz, Julio C., Sprague, Eugene A., Wiseman, Roger W., Bailey, Steven R., Marton, Denes, Boyle, Christopher T., Fuss, Cristina
• Primary Examiner(s): Stewart; Alvin J.
• Application Number:
  US10/120,728
• Publication Number:
  US 20030023303A1
• Time in Patent Office: 1,811 Days
• Field of Search: 623/2.18, 623/2.12, 623/1.26, 623/1.24
• US Class Current: 623/2.18
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

This invention relates to improvements in prosthetic cardiac and venous valves and implantable medical devices having moveable septa. The inventive prosthetic cardiac and venous valves have metallic or pseudometallic valves coupled to metallic or pseudometallic stents that permit percutaneous delivery of the devices.

Claims

1. An implantable prosthesis having a stent body at least partially covered by a graft member, the graft member forming at least one valve flap member within the stent body, the at least one valve flap member being biased towards a closed position;

wherein the graft member and the at least one valve flap member is comprised of a monolithic film layer having a substantially uniform thickness of biocompatible material selected from the group consisting of metals and pseudometals.

2. The implantable prosthesis according to claim 1, wherein the biocompatible material further comprises a plurality of layers.

3. The implantable prosthesis according to claim 1, wherein the biocompatible material is selected from the group consisting of titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silver, gold, silicon, magnesium, niobium, scandium, platinum, cobalt, palladium, manganese, molybdenum and alloys thereof, such as zirconium-titanium-tantalum alloys, nitinol, and stainless steel.

4. The implantable prosthesis according to claim 1, wherein the plurality of valve flap members are extensive from the graft member.

5. The implantable prosthesis according to claim 4, wherein the plurality of valve flap members are formed from a portion of the graft member.

6. An implantable valvular prosthesis having a stent body at least partially covered by a graft member, a biasing arm projecting from the stent body and into a central lumen of the stent body, at least one valve flap member formed from a terminal portion of the graft member, the biasing arm being coupled to the at least one valve flap member and biasing the at least one valve flap member towards a closed position within the central lumen of the stent body;

wherein the graft member and the at least one valve flap member are fabricated of a biocompatible film fabricated of a material selected from metals and pseudometals.

7. The implantable valvular prosthesis according to claim 6, wherein the biocompatible film further comprises a plurality of film layers.

8. An implantable valvular prosthesis, comprising a generally tubular stent body having a central lumen, a generally tubular graft member, a plurality of valve flap members, each being fabricated out of a biocompatible material selected from the group consisting of metals and pseudometals;

wherein the graft member is concentrically disposed relative to the generally tubular stent body and the plurality of valve flap members is disposed within the central lumen and biased toward a closed position to occlude the central lumen, further comprising a biasing arm supporting each of the plurality of valve flap members, wherein the biasing arm is attached to and extends from the generally tubular stent and biases the valve flap members towards a closed position.

9. The implantable valvular prosthesis according to claim 8, wherein the biasing arm is formed from a portion of the generally tubular stent.

10. The implantable valvular prosthesis according to claim 8, wherein the plurality of valve flap members are attached to and extend from the generally tubular graft member.

11. The implantable valvular prosthesis according to claim 10, wherein the plurality of valve flap members are formed from a portion of the generally tubular graft member.