Immobilized biologically active entities containing heparin having high biological activity following mechanical manipulation

• US 9,399,085 B2
• Filed: 03/24/2009
• Issued: 07/26/2016
• Est. Priority Date: 05/12/2006
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Cleek, Robert L., Daly, Michael D., Pietrzak, Krzysztof R.
• Primary Examiner(s): Ware, Debbie K
• Assistant Examiner(s): Srivastava, Kailash C
• Application Number:
  US12/409,749
• Publication Number:
  US 20090181066A1
• Time in Patent Office: 2,681 Days
• Field of Search: 623/1.24, 623/2.18, 623/2.33, 424/423, 514/56
• US Class Current: 1/1
• CPC Class Codes: A61L 2300/222 Steroids, e.g. corticosteroids
• CPC Class Codes: A61L 2300/236 Glycosaminoglycans, e.g. heparin, hyaluronic acid, chondroitin
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: C08L 79/02 Polyamines
• CPC Class Codes: Y10T 428/31544 Addition polymer is perhalogenated

Abstract

The present invention is directed to immobilized biologically active entities that retain significant biological activity following mechanical manipulation of a substrate material to which the entities are immobilized.

Claims

1. A medical device comprising:

a medical device that is capable of being compacted and expanded;

a polymeric substrate material, wherein said polymeric substrate material is fluoropolymeric in composition;

a polymeric covering material attached to at least a portion of a surface of said substrate material;

a first plurality of heparin molecules having anti-thrombin III binding activity end point attached to at least a portion of said polymeric covering material; and

a composition comprising a second plurality of heparin molecules non-covalently combined with said first plurality of heparin molecules;

wherein said first plurality of heparin molecules have an anti-thrombin III binding activity of at least 10 picomoles anti-thrombin III per square centimeter (pmol/cm²) substrate material when measured following compaction of said medical device to 50% of said medical device'"'"'s original size and expansion of said medical device.

2. The medical device of claim 1, wherein said fluoropolymeric material is polytetrafluoroethylene.

3. The medical device of claim 1, further comprising an antiproliferative agent.

4. The medical device of claim 3, wherein said antiproliferative agent is dexamethasone.