Shape memory polymer prosthetic medical device

• US 9,119,714 B2
• Filed: 10/29/2009
• Issued: 09/01/2015
• Est. Priority Date: 10/29/2008
• Status: Expired due to Fees

• Current Assignee: EndoShape, Inc
• Original Assignee: The Board of Regents of the University of Colorado (University of Colorado System)
• Inventors: Shandas, Robin, Nelson, Avery, Rech, Bryan, Nair, Devatha P., Lyons, Michael B., Castleberry, Jeffrey Paul, Scott, Timothy Francis
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US12/608,714
• Publication Number:
  US 20100152839A1
• Time in Patent Office: 2,133 Days
• Field of Search: 623 211- 242
• US Class Current: 1/1
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: B29C 61/0608 characterised by the configuration or structure of the preforms
• CPC Class Codes: B29L 2031/7534 Cardiovascular protheses
• CPC Class Codes: Y10T 156/1031 with preshaping of lamina

Abstract

A prosthetic medical device is formed by the combination of a biological tissue a shape memory polymer structure. The biological tissue provides an in-situ physiological function of the device. The shape memory polymer provides a capability for minimizing the device profile during insertion and then deploying after placement into a memory shape that achieves suitable mechanical structure and stability within an anatomical lumen or cavity. This configuration may be applied to form various prosthetic devices including aortic, mitral, and tricuspid valves in the heart; venous valves; anti-reflux valves for the lower esophageal sphincter; and other biological valve structures. Alternatively, an entirely non-biologic implementation using only shape memory polymer-based structures may be used as a prosthetic valve device.

Claims

1. A method for making a prosthetic venous valve medical device comprising

configuring a prosthetic body from a material comprising a shape memory polymer in a first, post-transition, coil form designed to fit snugly against a wall of an anatomical venous lumen, wherein the prosthetic body further comprises

an outer body defining an interior lumen;

and

a plurality of valve flaps attached to the outer body within the interior lumen at multiple locations along a length of the coil form and arranged to resist retrograde fluid flow within the interior lumen; and

deforming the prosthetic body by elongating the coil form into a second, linear, pre-transition form that comprises a compact shape or profile relative to the first form for insertion into a delivery device for in vitro placement of the prosthetic medical device.

2. The method of claim 1, wherein

the valve flaps comprise a biological tissue;

and

the method further comprises affixing the biological tissue to the outer body within the lumen.

3. The method of claim 2, wherein the affixing operation further comprises affixing the biological tissue to the shape memory polymer body with an adhesive.

4. The method of claim 2, wherein the affixing operation further comprises polymerizing the shape memory polymer material around the biological tissue during the configuration operation.

5. The method of claim 2, wherein the affixing operation further comprises mechanically fastening the biological tissue to the prosthetic body with a mechanical fastener.