BIOABSORBABLE POLYMERIC COMPOSITION FOR A MEDICAL DEVICE

• US 20080118546A1
• Filed: 07/20/2007
• Published: 05/22/2008
• Est. Priority Date: 07/20/2006
• Status: Active Grant

• Current Assignee: OrbusNeich Medical Pte Ltd
• Original Assignee: Orbusneich Medical Incorporated (Orbusneich Medical)
• Inventors: Cottone, Robert J., Thatcher, G. Lawrence
• Granted Patent: US 7,846,361 B2
• Time in Patent Office: Days
• US Class Current: 424/426
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61K 9/10 Dispersions; Emulsions A61K9/06 takes precedence; composition of dispersions, emulsions A61K47/00
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• 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 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• 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: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: B29C 2793/0018 for making a hole
• CPC Class Codes: B29C 2793/009 after shaping
• CPC Class Codes: B29C 45/0053 combined with a final operation, e.g. shaping injection-compression moulding B29C45/561
• CPC Class Codes: B29C 48/0022 combined with cutting
• CPC Class Codes: B29C 71/0063 for changing crystallisation
• CPC Class Codes: B29K 2067/046 PLA, i.e. polylactic acid or polylactide
• CPC Class Codes: B29K 2105/0085 : Copolymers
• CPC Class Codes: B29K 2995/0041 : Crystalline
• CPC Class Codes: B29K 2995/006 : Bio-degradable, e.g. bioabsorbable, bioresorbable or bioerodible
• CPC Class Codes: B29L 2031/7534 : Cardiovascular protheses
• CPC Class Codes: C08G 63/91 : Polymers modified by chemical after-treatment
• CPC Class Codes: C08L 2203/02 : for biomedical use
• CPC Class Codes: C08L 2205/02 : containing two or more polymers of the same C08L -group
• CPC Class Codes: C08L 67/00 : Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain of polyester-amides C08L77/12; of polyester-imides C08L79/08; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: Y10T 428/1352 : Polymer or resin containing [i.e., natural or synthetic]
• CPC Class Codes: Y10T 428/139 : Open-ended, self-supporting conduit, cylinder, or tube-type article

Abstract

A biodegradable and biocompatible nontoxic polymeric composition is provided which includes a base material such as a crystallizable polymer, copolymer, or terpolymer, and a copolymer or terpolymer additive. Medical devices manufactured from the composition are also provided.

Claims

1. A crystallizable bioabsorbable polymer composition, comprising:

a base polymer selected from the group consisting of a poly (L-lactide) moiety and/or poly (D-lactide) moiety, and/or block copolymers or blocky random copolymers thereof.

2. The crystallizable bioabsorbable polymer composition of claim 1, further comprising a base polymer comprising a poly (L-lactide) moiety, and/or a poly (D-lactide) moiety linked with a modifying copolymer thereof, comprising poly (L-lactide-co-Tri-methylene-carbonate or poly (D-lactide-co-tri-methylene-carbonate) and (L-lactide-co-ε

-caprolactone) or (D-lactide-co-ε

-caprolactone) in the form of block copolymers or blocky random copolymers, wherein the lactide chain length is sufficient to effect cross-moiety crystallization.

3. The crystallizable bioabsorbable polymer composition of claim 1, wherein the polymer composition melt forms a lactide racemate stereo complex crystal structure, between the poly L and poly D lactide moieties.

4. The crystallizable bioabsorbable polymer composition of claim 1, wherein the polymer composition melt forms a lactide racemate stereo complex crystal structure, using the moieties comprising:

poly L-lactide with poly D-lactide with poly (L-lactide-co-tri-methylene-carbonate), or with poly (L-lactide-co-ε

-caprolactone);

poly D-lactide with poly (L-lactide-co-tri-methylene-carbonate), or with poly (L-lactide-co-ε

-caprolactone);

poly L-lactide with poly,(D-lactide-co-tri-methylene-carbonate), or with poly(L-lactide-co-ε

-caprolactone);

poly L-lactide with poly D-lactide with poly(D-lactide-co-tri-methylene-carbonate), or with poly (L-lactide-co-ε

-caprolactone);

poly L-lactide-co-PEG with (poly D-lactide-co-tri-methylene-carbonate), or with poly (L-lactide-co-ε

-caprolactone); and

poly D-lactide-co-PEG with poly L-lactide-co-tri-methylene-carbonate), or with poly (L-lactide-co-ε

-caprolactone).

5. The crystallizable bioabsorbable polymer composition of claim 1, wherein the base polymer is from about 70% to about 85% by weight, or from about 70% to about 80% by weight of the composition.

6. The crystallizable bioabsorbable polymer composition of claim 1, wherein the base polymer is 70% by weight of poly L-lactide with 30% by weight of modifying copolymer poly L-lactide-co-TMC.

7. The crystallizable bioabsorbable polymer composition of claim 1, wherein the modifying copolymer is not more than about 40% of the composition.

8. The crystallizable bioabsorbable polymer composition of claim 1, wherein a residual monomer concentration of the composition is less than 0.5%, or preferably less than 0.3%.

9. A bioabsorbable scaffold polymer 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.

10. The bioabsorbable scaffold polymer of claim 9, wherein the base polymer is from about 60% to about 90% by weight, or from about 70% to about 80% by weight of the composition.

11. The bioabsorbable scaffold polymer of claim 9, wherein the base polymer is 70% by weight of poly L-lactide with 30% by weight of modifying copolymer poly L-lactide-co-TMC.

12. The bioabsorbable scaffold polymer of claim 9, wherein the modifying copolymer is not more than about 40% of the composition.

13. The bioabsorbable scaffold polymer of claim 9, wherein a residual monomer concentration of the composition is less than 0.5%, or preferably less than 0.3%.

14. The bioabsorbable scaffold polymer of claim 9 wherein the composition may be constructed to structurally enclose or attach drugs in the polymeric matrix.

15. The bioabsorbable scaffold polymer of claim 9, wherein the drug or other additive may be bound by covalent bonds, non-polar bonds as well as ester or similar bioreversible attachment.

16. A polymer composition for a cardiovascular tube-shaped expandable scaffold, wherein said scaffold comprises 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.

17. The composition of claim 16, wherein said scaffold comprises a base polymer of base polymer ranging from about 60% to about 90% by weight, or from about 70% to about 80% by weight of the composition.

18. The composition of claim 16, wherein said scaffold comprises a base polymer ranging from 70% by weight of poly L-lactide with 30% by weight of modifying copolymer poly L-lactide-co-TMC.

19. The composition of claim 16, wherein the modifying copolymer is not more than about 40% of the composition.

20. The composition of claim 16, wherein the scaffold exhibits a structural resilience by combining rigidity and flexibility characteristics to allow snap-fit interaction between suitable parts of the polymeric device.

21. The composition of claim 16, wherein a residual monomer concentration of the composition is less than 0.5%, or preferably less than 0.3%.

22. A bioabsorbable polymeric implant comprising a melt-blend extrusion made in a single step a polymer composition comprising a crystallizable composition comprising a base polymer comprising a poly (L-lactide) moiety and or poly (D-lactide) moiety, and/or copolymers thereof.

23. The method for making a bioabsorbable polymeric implant of claim 22, further comprising:

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

-caprolactone) and/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 or extruding said polymer composition to said structurally tube configured implant; and

cutting said implant to form desired patterns.

24. The method according to claim 22, wherein the polymer compositions affect a structural resilience by combining rigidity and flexibility characteristics to allow snap-fit interaction between suitable parts of the polymeric device.

25. The method according to claim 22, wherein the polymer composition melt forms a lactide racemate stereo complex crystal structure, between the L-lactide and the D-lactide moieties.

26. The method according to claim 22, wherein the polymer composition forms a lactide racemate stereo complex crystal structure, between the moieties comprising:

poly L-lactide with poly D-lactide with poly (L-lactide-co-tri-methylene-carbonate), or with poly (L-lactide-co-e-caprolactone),

poly D-lactide with poly (L-lactide-co-tri-methylene-carbonate), or with poly (L-lactide-co-ε

-caprolactone),

poly L-lactide with poly (D-lactide-co-tri-methylene-carbonate), or with poly (L-lactide-co-ε

-caprolactone);

poly L-lactide with poly D-lactide with poly (D-lactide-co-tri-methylene-carbonate), or with poly (L-lactide-co-ε

-caprolactone);

poly L-lactide-co-PEG with (poly D-lactide-co-tri-methylene-carbonate), or with poly (L-lactide-co-ε

-caprolactone); and

poly D-lactide-co-PEG with poly L-lactide-co-tri-methylene-carbonate), or with poly (L-lactide-co-ε

-caprolactone).

27. The method of claim 22, wherein the modifying copolymer is not more than about 40% of the composition.

28. The method of claim 22, wherein a residual monomer concentration of the composition is less than 0.5%, or preferably less than 0.3%.