Bioabsorbable polymer compositions exhibiting enhanced crystallization and hydrolysis rates

Patent metadata

Field	Value
Publication number	US-9238094-B2
Application number	US-201313842066-A
Country	US
Kind code	B2
Filing date	Mar 15, 2013
Priority date	Dec 28, 2005
Publication date	Jan 19, 2016
Grant date	Jan 19, 2016

Abstract

A bimodal bioabsorbable polymer composition. The composition includes a first amount of a bioabsorbable polymer polymerized so as to have a first molecular weight distribution; a second amount of said bioabsorbable polymer polymerized so as to have a second molecular weight distribution having a weight average molecular weight between about 10,000 to about 50,000 Daltons, the weight average molecular weight ratio of said first molecular weight distribution to said second molecular weight distribution is at least about two to one; wherein a substantially homogeneous blend of said first and second amounts of said bioabsorbable polymer is formed in a ratio of between about 50/50 to about 95/5 weight/weight percent. Also disclosed are a medical device, a method of making a medical device and a method of melt blowing a semi-crystalline polymer blend.

First claim

What is claimed is:

1. A bimodal polymer composition, comprising:
(a) a first amount of a semi-crystalline bioabsorbable copolymer of at least two compounds selected from the group consisting of lactide, glycolide, dioxanone, ε-caprolactone, hydroxybutyrate, β-hydroxybutyrate, hydroxyvalerate, tetramethylene carbonate, and amino acids having a first crystallization rate and a first hydrolysis rate and a first molecular weight distribution; and
(b) a second amount of said semi-crystalline bioabsorbable copolymer having a second crystallization rate and a second hydrolysis rate and a second molecular weight distribution having a weight average molecular weight between about 10,000 to about 50,000 Daltons, the weight average molecular weight ratio of said first molecular weight distribution to said second molecular weight distribution is at least about two to one;
wherein a substantially homogeneous blend of said first and second amounts of said semi-crystalline bioabsorbable copolymers is formed in a ratio of between about 50/50 to about 95/5 weight/weight percent, said substantially homogeneous blend having a crystallization rate greater than each of said first crystallization rate and said second crystallization rate and a hydrolysis rate greater than each of said first hydrolysis rate and said second hydrolysis rate.

2. The bimodal polymer composition of claim 1 , having a degree of crystallinity from about 10% to about 50%.

3. The bimodal polymer composition of claim 1 , wherein said first molecular weight distribution is a weight average molecular weight from between about 50,000 to about 2,000,000 Daltons.

4. The bimodal polymer composition of claim 1 , wherein the bioabsorbable copolymer is a copolymer of lactide/glycolide, glycolide/p-dioxanone, glycolide/ε-caprolactone, lactide/ε-caprolactone, p-dioxanone/ε-caprolactone, glycolide/lactide/ε-caprolactone/tetramethylene carbonate, glycolide/p-dioxanone/tetramethylene carbonate or glycolide/tetramethylene carbonate.

5. The bimodal polymer composition of claim 1 , wherein the bioabsorbable copolymer is lactide/glycolide.

6. The bimodal polymer composition of claim 1 , wherein said first molecular weight distribution is a weight average molecular weight from between about 50,000 to about 100,000 Daltons.

7. A medical device comprising the bimodal polymer composition of claim 1 , including a suture, a clip, a staple, a pin, a screw, a fiber, a mesh, a clamp, a plate, a hook, a button, a snap, a prosthetic, a graft, an injectable polymer, a vertebrae disc, an anchoring device, a suture anchor, a septal occlusion device, an injectable defect filler, a preformed defect filler, a bone wax, a cartilage replacement, a spinal fixation device, a drug delivery device, a foam or a film.

8. The medical device of claim 7 , which is produced from a process comprising (i) the step of injection molding or extruding the medical device from a bimodal polymer composition, or (ii) the step of subjecting a medical device made from said bimodal polymer composition to a heat treatment step.

9. A bimodal polymer composition, comprising:
(a) a first amount of a semi-crystalline bioabsorbable polymer selected from the group consisting of poly(dioxanone), poly(ε-caprolactone), poly(hydroxybutyrate), poly(β-hydroxybutyrate), poly(hydroxyvalerate), poly(tetramethylene carbonate), poly(amino acids), copolymers and terpolymers thereof, having a first crystallization rate and a first hydrolysis rate and a first molecular weight distribution; and
(b) a second amount of said semi-crystalline bioabsorbable polymer having a second crystallization rate and a second hydrolysis rate and a second molecular weight distribution having a weight average molecular weight between about 10,000 to about 50,000 Daltons, the weight average molecular weight ratio of said first molecular weight distribution to said second molecular weight distribution is at least about two to one;
wherein a substantially homogeneous blend of said first and second amounts of said semi-crystalline bioabsorbable polymer is formed in a ratio of between about 50/50 to about 95/5 weight/weight percent, said substantially homogeneous blend having a crystallization rate greater than each of said first crystallization rate and said second crystallization rate and a hydrolysis rate greater than each of said first hydrolysis rate and said second hydrolysis rate.

Assignees

• Ethicon Inc

Inventors

• Andjelic Sasa
• Fitz Benjamin D
• Zhou Jianguo Jack

Classifications

• A61P29/00

  Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] · CPC title

• A61P25/04

  Centrally acting analgesics, e.g. opioids · CPC title

• A61L31/06 Primary

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)} · CPC title

• C08L2203/02

  for biomedical use · CPC title

• D01F6/625

  derived from hydroxy-carboxylic acids, e.g. lactones · CPC title