Bioabsorbable polymeric composition and medical device background

• US 8,691,321 B2
• Filed: 10/20/2007
• Issued: 04/08/2014
• Est. Priority Date: 10/20/2006
• Status: Active Grant

• Current Assignee: OrbusNeich Medical Pte Ltd
• Original Assignee: Orbusneich Medical Incorporated (Orbusneich Medical)
• Inventors: Cottone, Robert J.
• Primary Examiner(s): SELLMAN, CACHET I
• Application Number:
  US11/875,892
• Publication Number:
  US 20080206440A1
• Time in Patent Office: 2,362 Days
• Field of Search: 427/2.24, 427/2.25, 424/426, 623/1.38, 623/1.46
• US Class Current: 427/2.24
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61L 31/041 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 31/048 obtained 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: B29C 48/022 characterised by the choice of material
• CPC Class Codes: B29C 48/10 flexible, e.g. blown foils
• CPC Class Codes: B29K 2067/046 PLA, i.e. polylactic acid or polylactide
• CPC Class Codes: B29K 2995/006 Bio-degradable, e.g. bioabsorbable, bioresorbable or bioerodible
• CPC Class Codes: B29K 2995/0088 Molecular weight
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A method for fabricating an embodiment of a medical device comprising the steps of: preparing a biodegradable polymeric structure; coating the biodegradable polymeric structure with a polymeric coat including a pharmacological or biological agent; cutting the structure into patterns configured to allow for crimping of the cut structure and expansion of the cut structure after crimping into a deployed configuration.

Claims

1. A method for fabricating a cardiovascular expandable scaffold comprising:

blending a polymer composition comprising a crystallizable composition comprising a base polymer of poly L-lactide, and/or poly D-lactide, and/or poly L-lactide-co-PEG, and/or poly D-lactide-co-PEG, linked with modifying copolymers comprising poly L (or D)-lactide-co-Tri-methylene-carbonate or poly L (or D)-lactide-co-ε

-caprolactone in the form of block copolymers or as blocky random copolymers;

molding said polymer composition to structurally configure said scaffold;

coating said polymer scaffold with a pharmaceutical composition comprising a ligand; and

cutting said scaffold to form desired patterns;

wherein the polymer scaffold is configured in the form of a continuously interconnected scaffold of struts which is crystallizable when stretched by expansion and wherein the polymer of poly L-lactide and poly D-lactide form a racemate-type cross-moiety crystallization.

2. The method of claim 1, wherein the blending further comprises blending a pharmacological and/or biological agent and/or radioopaque or radio-detectable material into the polymer composition.

3. The method of claim 2, wherein the pharmacological agent is selected from the group consisting of:

cyclosporin A, mycophenolic acid, mycophenolate mofetil acid, rapamycin, rapamycin derivatives, biolimus A9, CCI-779, RAD 001, AP23573, azathioprene, tacrolimus (FK506), tranilast, dexamethasone, corticosteroid, everolimus, pimecrolimus, retinoic acid, vitamin E, rosglitazone, simvastatins, fluvastatin, estrogen, 17β

-estradiol, hydrocortisone, acetaminophen, ibuprofen, naproxen, fluticasone, clobetasol, adalimumab, sulindac, dihydroepiandrosterone, testosterone, puerarin, platelet factor 4, basic fibroblast growth factor, fibronectin, butyric acid, butyric acid derivatives, paclitaxel, paclitaxel derivatives, LBM-642, deforolimus, and probucol.

4. The method of claim 2, wherein the biological agent is selected from the group consisting of:

antibiotics/antimicrobials, antiproliferative agents, antineoplastic agents, antioxidants, endothelial cell growth factors, smooth muscle cell growth and/or migration inhibitors, thrombin inhibitors, immunosuppressive agents, anti-platelet aggregation agents, collagen synthesis inhibitors, therapeutic antibodies, nitric oxide donors, antisense oligonucleotides, wound healing agents, therapeutic gene transfer constructs, peptides, proteins, extracellular matrix components, vasodialators, thrombolytics, anti-metabolites, growth factor agonists, antimitotics, steroids, steroidal antiinflammatory agents, chemokines, proliferator-activated receptor-gamma agonists, proliferator-activated receptor-alpha agonists proliferator-activated receptor-beta agonists, proliferator-activated receptor-alpha/beta agonists, proliferator-activated receptor-delta agonists, NFκ

β

, proliferator-activated receptor-alpha-gamma agonists, nonsteroidal antiinflammatory agents, angiotensin converting enzyme (ACE) inhibitors, free radical scavengers, inhibitors of the CX3CR1 receptor and anti-cancer chemotherapeutic agents.

5. The method of claim 1, wherein the ligand comprises a small molecule, a peptide, an antibody, an antibody fragment, or combinations thereof.

6. The method of claim 5, wherein the antibody or antibody fragment is specific for a progenitor endothelial cell surface antigen.

7. The method of claim 6, wherein the progenitor endothelial cell surface antigen is selected from the group consisting of CD34, CD45, CD133, CD14, CDw90, CD117, HLA-DR, VEGFR-1, VEGFR-2, CD146, CD130, CD131, stem cell antigen, stem cell factor 1, Tie-2, MCH-H-2Kk and MCH-HLA-DR.