Medical devices and applications of polyhydroxyalkanoate polymers

• US 7,553,923 B2
• Filed: 10/26/2007
• Issued: 06/30/2009
• Est. Priority Date: 03/25/1999
• Status: Expired due to Fees

• Current Assignee: Tepha Incorporated (Becton, Dickinson & Co)
• Original Assignee: Metabolix Incorporated
• Inventors: Skraly, Frank A., Martin, David P., Williams, Simon F.
• Primary Examiner(s): Boykin; Terressa M
• Application Number:
  US11/925,635
• Publication Number:
  US 20080095823A1
• Time in Patent Office: 613 Days
• Field of Search: 264/176.1, 264/211, 424/423, 523/124, 528/354, 528/272, 435/135
• US Class Current: 528/354
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61K 31/715 Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
• CPC Class Codes: A61L 17/12 Homopolymers or copolymers of glycolic acid or lactic acid
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08G 63/06 derived from hydroxycarboxylic acids
• CPC Class Codes: C08J 2201/0444 Salts
• CPC Class Codes: C08J 2201/0482 the liquid phase being organic
• CPC Class Codes: C08J 2367/04 Polyesters derived from hydroxy carboxylic acids, e.g. lactones C08J2367/06 takes precedence
• CPC Class Codes: C08J 9/26 by elimination of a solid phase from a macromolecular composition or article, e.g. leaching out
• CPC Class Codes: C08K 5/0033 Additives activating the degradation of the macromolecular compound
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C12P 7/625 Polyesters of hydroxy carboxylic acids
• CPC Class Codes: Y10S 606/911 Memory material

Abstract

Devices formed of or including biocompatible polyhydroxyalkanoates are provided with controlled degradation rates, preferably less than one year under physiological conditions. Preferred devices include sutures, suture fasteners, meniscus repair devices, rivets, tacks, staples, screws (including interference screws), bone plates and bone plating systems, surgical mesh, repair patches, slings, cardiovascular patches, orthopedic pins (including bone filling augmentation material), adhesion barriers, stents, guided tissue repair/regeneration devices, articular cartilage repair devices, nerve guides, tendon repair devices, atrial septal defect repair devices, pericardial patches, bulking and filling agents, vein valves, bone marrow scaffolds, meniscus regeneration devices, ligament and tendon grafts, ocular cell implants, spinal fusion cages, skin substitutes, dural substitutes, bone graft substitutes, bone dowels, wound dressings, and hemostats. The polyhydroxyalkanoates can contain additives, be formed of mixtures of monomers or include pendant groups or modifications in their backbones, or can be chemically modified, all to alter the degradation rates. The polyhydroxyalkanoate compositions also provide favorable mechanical properties, biocompatibility, and degradation times within desirable time frames under physiological conditions.

Claims

1. A stent graft comprising a biodegradable polyhydroxyalkanoate composition that has a degradation rate under physiological conditions, wherein the degradation rate is controlled by addition of components to the polyhydroxyalkanoate composition, selection of the chemical composition of the polyhydroxyalkanoate, selection of the weight average molecular weight of the polyhydroxyalkanoate, selection of the processing conditions of the polyhydroxyalkanoate, or selection of the form of the composition, wherein the polyhydroxyalkanoate polymer has a weight average molecular weight of between 10,000 and 10,000,000 daltons.

2. The stent graft of claim 1 wherein the stent graft is supported by a stent.

3. The stent graft of claim 2 wherein the stent is absorbable.

4. The stent graft of claim 1 wherein the stent comprises a polyhydroxyalkanoate.

5. The stent graft of claim 2 wherein the stent graft further comprises a drug, growth factor and/or other active agent.

6. The stent graft of claim 2 wherein the stent is self expanding or balloon-expandable.

7. The stent graft of claims 2 wherein part or all of the stent graft or stent degrades over time.

8. The stent graft of claim 1 wherein the stent graft is used to treat a diseased vessel.

9. The stent graft of claim 8 wherein the diseased vessel comprises an aneurysm or plaque deposit.

10. The stent graft of claim 8 wherein the stent graft delivers a drug, growth factor or other active agent when deployed.