Elastomeric medical device

• US 5,468,253 A
• Filed: 01/21/1993
• Issued: 11/21/1995
• Est. Priority Date: 01/21/1993
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Bezwada, Rao S., Scopelianos, Angelo G.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US08/007,316
• Time in Patent Office: 1,034 Days
• Field of Search: 606/228-231, 525/415, 528/354, 528/357, 428/385
• US Class Current: 606/230
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/0618 elastic, e.g. stretchable for prostheses A61F2210/0057
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 17/105 Polyesters not covered by A61L17/12
• CPC Class Codes: A61L 17/12 Homopolymers or copolymers of glycolic acid or lactic acid
• 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: C08G 63/08 Lactones or lactides
• CPC Class Codes: C08G 63/64 Polyesters containing both carboxylic ester groups and carbonate groups
• CPC Class Codes: C08G 63/664 derived from hydroxy carboxylic acids
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 69/00 Compositions of polycarbonates; Compositions of derivatives of polycarbonates
• CPC Class Codes: Y10T 428/2969 Polyamide, polyimide or polyester

Abstract

Medical devices or components for medical devices formed from bioabsorbable elastomers comprising a random copolymer are disclosed. The random copolymer is a copolymer of from about 30 to about 70 weight percent of: a) ε-caprolactone, trimethylene carbonate, an ether lactone, or a mixture of these, and b) the balance being substantially glycolide, para-dioxanone, or a mixture of these. The random copolymers surprisingly exhibit elastomeric properties, and the copolymers are bioabsorbable. The combination of physical and biological properties of these elastomeric copolymers are particularly well-suited for numerous medical and surgical applications.

Claims

1. A component for a medical device formed from a bioabsorbable elastomer wherein the elastomer consists essentially of a random copolymer of:

a) from about 35 to about 45 weight percent of a first monomer selected from the group consisting of ε

-caprolactone, trimethylene carbonate, an ether lactone and combinations thereof, and b) the balance of the copolymer being substantially a second monomer selected from the group consisting of glycolide, para-dioxanone and combinations thereof, wherein the random copolymer exhibits an inherent viscosity of from about 0.6 dL/g to about 4.0 dL/g.

2. The component of claim 1 wherein the random copolymer is a copolymer of from about 40 to about 45 weight percent of ε

-caprolactone, and the balance being glycolide.

3. The component of claim 1 wherein the bioabsorbable elastomer is formed into a component for a surgical device selected from the group consisting of surgical clips, surgical staples, ligating rubber bands, films, elastomeric coatings for stents, gaskets, sealants, sleeves vascular grafts, channels for nerve regeneration, wound dressings, adhesive strips, flexible meshes, tubes, tapes, plugs, pads, cords, contact lenses, and corneal bandage lenses.

4. The component of claim 1 wherein the bioabsorbable elastomer is a drug delivery film.

5. The component of claim 1 wherein the bioabsorbable elastomer is a tube.

6. The component of claim 1 wherein the bioabsorbable elastomer is a foam.

7. The component of claim 1 wherein the random copolymer is prepared by polymerizing a first monomer and second monomer further in the presence of an initiator selected from the group consisting of a monohydric alcohol, polyhydric alcohol and hydroxy acid.

8. The component of claim 1 wherein the random copolymer is a copolymer of ε

-caprolactone and glycolide.

9. The component of claim 8 wherein the random copolymer exhibits a percent crystallinity of less than about 25 percent.

10. The component of claim 9 wherein the random copolymer exhibits an inherent viscosity of from about 1.0 g/dL to about 2.0 g/dL.

11. The component of claim 10 wherein the bioabsorbable elastomer exhibits a percent elongation greater than about 200.

12. The component of claim 11 wherein the bioabsorbable elastomer exhibits a percent elongation greater than about 500.

13. The component of claim 12 wherein the bioabsorbable elastomer exhibits a modulus less than about 40,000 psi.

14. The component of claim 13 wherein the bioabsorbable elastomer exhibits a modulus less than about 20,000.

15. The component of claim 14 wherein the bioabsorbable elastomer exhibits complete bioabsorption within one year.

16. The component of claim 15 wherein the bioabsorbable elastomer exhibits complete bioabsorption within six months.

17. The component of claim 16 wherein the bioabsorbable elastomer is a drug delivery film vehicle.

18. A medical device selected from the group consisting of surgical clips, surgical staples, elastomeric sutures, ligating rubber bands, films, elastomeric coatings for stents, gaskets, sealants, sleeves, vascular grafts, channels for nerve regeneration, wound dressings, adhesive strips flexible meshes, tubes, tapes, plugs, pads cords, contact lenses, and corneal bandage lenses formed from a bioabsorbable elastomer wherein the elastomer consists essentially of a random copolymer of:

a) from about 35 to about 45 weight percent of a first monomer selected from the group consisting of ε

-caprolactone, trimethylene carbonate, an ether lactone and combinations thereof, and b) the balance of the copolymer being substantially a second monomer selected from the group consisting of glycolide, para-dioxanone and combinations thereof, wherein the random copolymer exhibits an inherent viscosity of from about 0.6 dL/g to about 4.0 dL/g.

19. The medical device of claim 18 wherein the random copolymer is a copolymer of ε

-caprolactone and glycolide.

20. The medical device of claim 18 wherein the random copolymer is a copolymer of from about 40 to about 45 weight percent of ε

-caprolactone, and the balance being glycolide.

21. The medical device of claim 18 wherein the random copolymer exhibits an inherent viscosity of from about 1.0 g/dL to about 2.0 g/dL.

22. The medical device of claim 18 wherein the bioabsorbable elastomer is a tube.