Bioabsorbable Polymeric Composition and Medical Device Background

• US 20080206440A1
• Filed: 10/20/2007
• Published: 08/28/2008
• 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.
• Granted Patent: US 8,691,321 B2
• Time in Patent Office: Days
• 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

8-1. The method of claim 1 wherein in step (a) the blending further entails blending a pharmacological and/or biological agent and/or radioopaque or radio-detectable material into the polymer composition.

12. A method for fabricating a medical device comprising:

(a) preparing a biodegradable polymeric structure;

(b) coating said biodegradable polymeric structure of step (a) with a polymeric coat including a pharmacological or biological agent;

(c) after step (b) cutting said structure into patterns configured to allow for crimping of the cut structure and expansion of the cut structure after crimping into a deployed configuration.

13. A method in accord with claim 12 wherein said biodegradable polymeric structure prepared is in the form of a tube.

14. A method in accord with claim 12 wherein said polymeric coat is biodegradable.

15. A method in accord with claim 12 wherein said pharmacological agent of step (b) is at least one of 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, 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

16. A method in accord with claim 12 wherein said biological agent of step (b) is at least one of 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, nonsterodial antiinflammatory agents, angiotensin converting enzyme(ACE) inhibitors, free radical scavangers, inhibitors of the CX3CR1 receptor and anti-cancer chemotherapeutic agents.

17. A method for fabricating a medical device comprising:

(a) blending a composition comprising a base polymer of poly L-lactide or poly D-lactide 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 wherein the lactide chain length is sufficiently long enough to allow cross-moiety crystallization to form a polymer composition;

(b) extruding said polymer composition through an extrusion device;

(c) coating said extruded polymer composition of step (b) with a coating comprising a pharmacological or biological agent;

(d) cutting said coated polymer composition of step (c) to form configured patterns in said polymer composition, said patterns configured to allow for crimping of the cut structure and expansion of the cut structure after crimping into a deployed configuration.

18. A method in accord with claim 17 further comprising after step (c) the step of:

(c′

) extruding the same or another polymer composition onto the extruded polymer composition of step (b) as coated in step (c), such co-extruded polymer composition comprising a pharmacological or biological agent.

20. A method for fabricating cardiovascular expandable scaffold comprising, comprising:

blending a polymer composition comprising a crystallizable composition comprising a base polymer of poly L-lactide or poly D-lactide 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 wherein the lactide chain length is sufficiently long enough to allow cross-moiety crystallization;

molding said polymer composition to structurally configure said scaffold;

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

cutting said scaffold to form desired patterns.