Bioabsorbable polymeric composition and medical device

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.

1 . A method for making a bioabsorbable polymeric implant 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) allowing said polymer composition to solidify to forming a desired mass; and   (c) cutting said mass to form a configured implant.   
     
     
         2 . The method of claim I 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. 
     
     
         3 . A method in accord with claim I further comprising after step (a) the step of (a′) extruding said polymer composition. 
     
     
         4 . A method in accord with  claim 3  further comprising after or concurrent with step (a′), the step of: (a″) molding or casting said extruded polymer composition to form a molded polymer composition. 
     
     
         5 . A method in accord with claim I wherein said desired mass, is selected from the group consisting of: a sheet, a tube, a rod, and a block, 
     
     
         6 . A method in accord with  claim 4  further comprising a step after step (b) of: (b″) spraying said solidified mass with a spray composition. 
     
     
         7 . A method in accord with  claim 6  wherein the spray composition of step (b″) comprises a biological or pharmacological agent. 
     
     
         8 . A method in accord with  claim 6  wherein, the spray composition comprises a radioopaque or radio-detectable material. 
     
     
         9 . The method of  claim 7  wherein the pharmacological agent(s) include at least one of the group consisting of: cyclosporin 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, 17-estradiol, hydrocortisone, acetaminophen, ibuprofen, naproxen, fluticasone, clobetasol, adalimumah, 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. 
     
     
         10 . The method of  claim 7  wherein the biological agent(s) include 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, N′FK, 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. 
     
     
         11 . A method in accord with  claim 4  further comprising a step after step (b) of: (b″) dipping said solidified mass into a composition having a pharmacological and/or biological agent. 
     
     
         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, 17P-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 defbrolimus, 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, NFKP, 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-s-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. 
     
     
         19 . A method in accord with  claim 10  wherein step (c′) is repeated multiple times to produces a multi-layer extrusion. 
     
     
         20 . (canceled)