Deformable, absorbable surgical device

• US 5,080,665 A
• Filed: 07/06/1990
• Issued: 01/14/1992
• Est. Priority Date: 07/06/1990
• Status: Expired due to Term

• Current Assignee: Sherwood Services AG
• Original Assignee: American Cyanamid Co (Pfizer Inc.)
• Inventors: Jarrett, Peter K., Peake, Steven L., Casey, Donald J.
• Primary Examiner(s): Pellegrino, Stephen O.
• Assistant Examiner(s): Jackson, Gary
• Application Number:
  US07/548,802
• Time in Patent Office: 557 Days
• Field of Search: 606/230, 606/231, 606/219, 606/76, 606/75, 528/354, 528/361, 525/414, 525/415, 524/381, 227/902
• US Class Current: 606/219
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• 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 17/58 for osteosynthesis, e.g. bone plates, screws , setting implements or the like A61B17/14, A61B17/16 take precedence
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61L 31/041 Mixtures of macromolecular compounds
• 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 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A deformable surgical repair device is manufactured from a block or graft copolymer. The copolymer comprises a plurality of first linkages selected from the group consisting of glycolic acid ester and lactic acid ester linkages, and mixtures thereof, and a plurality of second linkages selected from the group consisting of 1,3-dioxan-2-one; 1,4-dioxan-2-one and ε-caprolactone linkages. The plurality of first linkages comprises at least about 50 up to about 90 mole percent of the copolymer. In an alternative claim, the deformable surgical repair device is manufactured from a blend of a first and a second absorbable polymer. The first absorbable polymer comprises a plurality of linkages selected from the group consisting of glycolic acid ester and lactic acid ester linkages, and mixtures thereof. The second absorbable polymer comprises a plurality of linkages selected from the group consisting of 1,3-dioxan-2-one; 1,4-dioxan-2-one and ε-caprolactone linkages. The first absorbable polymer comprises at least about 50 up to about 90 weight percent of the blend. The device is useful in fracture fixation.

Claims

1. An article of manufacture comprising a deformable at ambient temperature surgical clip or staple, the deformable at ambient temperature surgical clip or staple having a flexural strain at break of greater than about 25%, a flexural strain at yield of greater than about 3% and a Young'"'"'s modulus of greater than about 200,000 psi, and manufactured from a copolymer, the copolymer selected from the group consisting of a block and graft copolymer having a hard and soft phase, the hard phase of said copolymer having a glass transition temperature above ambient temperature and comprising a plurality of first linkages selected from the group consisting of glycolic acid ester and lactic acid ester linkages, and mixtures thereof, and the soft phase of said copolymer having a glass transition temperature below ambient temperature and comprising a plurality of second linkages selected from the group consisting of 1,3-dioxan-2-one;

1,4-dioxan-2-one and ε

-caprolactone linkages, the plurality of first linkages comprising at least about 50 up to about 90 mole percent of the copolymer.

2. The article of claim 1 wherein said copolymer is a block copolymer.

3. The article of claim 2 wherein said plurality of first linkages comprises lactic acid ester linkages.

4. The article of claim 2 wherein said plurality of first linkages comprises glycolic acid ester linkages.

5. The article of claim 3 or 4 wherein said plurality of second linkages comprises 1,3-dioxan-2-one linkages.

14. The article of claims 1, 2, 3, 10, 11, 12 or 13 wherein the deformable surgical clip or staple is a clip.

15. The article of claims 1, 2, 3, 10, 11, 12 or 13 wherein the deformable surgical clip or staple is a staple.

6. An article of manufacture comprising a deformable at ambient temperature bone plate, the deformable at ambient temperature bone plate having a flexural strain at break of greater than about 25%, a flexural strain at yield of greater than about 3% and a Young'"'"'s modulus of greater than about 200,000 psi, and manufactured from a copolymer, the copolymer selected from the group consisting of a block and graft copolymer having a hard and soft phase, the hard phase of said copolymer having a glass transition temperature above ambient temperature and having a plurality of first linkages comprising lactic acid ester linkages and the soft phase of said copolymer having a glass transition temperature below ambient temperature and comprising a plurality of second linkages selected from the group consisting of 1,3-dioxan-2-one and 1,4-dioxan-2-one linkages, the plurality of lactic acid ester linkages comprising more than 50 to about 90 weight percent of the copolymer.

7. The article of claim 6 wherein said copolymer is a block copolymer.

8. The article of claim 7 wherein said plurality of lactic acid ester linkages comprises about 80 weight percent of the copolymer.

9. The article of claim 8 wherein the plurality of second linkages comprises 1,3-dioxan-2-one linkages.

10. An article of manufacture comprising a deformable at ambient temperature surgical clip or staple, the deformable at ambient temperature surgical clip or staple having a flexural strain at break of greater than about 25%, a fluxural strain at yield of greater than about 3% and a Young'"'"'s modulus of greater than about 200,000 psi, and manufactured from a blend of first, hard phase forming, absorbable polymer and a second, soft phase forming, absorbable polymer, the first absorbable polymer having a glass transition temperature above ambient temperature and comprising a plurality of linkages selected from the group consisting of glycolic acid ester and lactic acid ester linkages, and mixtures thereof, and the second absorbable polymer having a glass transition temperature below ambient temperature and comprising a plurality of linkages selected from the group consisting of 1,3-dioxan-2-one;

1,4-dioxan-2-one and ε

-caprolactone linkages, said first absorbable polymer comprising at least about 50 up to about 90 weight percent of the blend.

11. The article of claim 10 wherein said first absorbable polymer is a homopolymer.

12. The article of claim 11 wherein said first absorbable homopolymer consists essentially of lactic acid ester linkages.

13. The article of claim 12 wherein said second absorbable polymer comprises a plurality of linkages selected from the group consisting of 1,3-dioxan-2-one and 1,4-dioxan-2-one linkages.

16. The article of claim 10 wherein said first absorbable polymer is a copolymer

17. A surgical composite structure for mammalian tissue comprising:

a) a reinforcing component prepared from a plurality of fibers, the plurality of fibers manufactured from a biocompatible polymer, and

b) a deformable at ambient temperature bioabsorbable component consolidated around said plurality of fibers to form a matrix, the bioabsorbable component comprising a copolymer, the copolymer selected from the group consisting of a block and graft copolymer, the copolymer comprising a plurality of first linkages selected from the group consisting of glycolic acid ester and lactic acid ester linkages, and mixtures thereof, and a plurality of second linkages selected from the group consisting of 1,3-dioxan-2-one;

1,4-dioxan-2-one and ε

-caprolactone linkages, the plurality of first linkages comprising at least about 50 up to about 90 mole percent of the copolymer.

18. The structure of claim 17 wherein the reinforcing component is manufactured from an absorbable biocompatible polymer.

19. The structure of claim 18 wherein the absorbable biocompatible polymer is selected from the group consisting of a homopolymer or copolymer of polyglycolic acid, polylactic acid, polyhydroxy butyrate and blends of the same, and poly(d-lactic acid) blended with poly(1-lactic acid).

20. The structure of claim 17 wherein the reinforcing component is manufactured from a nonabsorbable biocompatible polymer.

21. The structure of claim 20 wherein the nonabsorbable biocompatible polymer is selected from the group consisting of polyethylene terephthalate, silk, nylon, polypropylene, polyethylene and polyoxymethylene and blends of the same.

22. The structure of claim 17, 18, 19, 20 or 21 wherein the bioabsorbable component comprises a block copolymer.

23. The structure of claim 22 wherein said plurality of first linkages in the block copolymer comprises lactic acid ester linkages.

24. The structure of claim 22 wherein said plurality of first linkages in the block copolymer comprises glycolic acid ester linkages.

25. The structure of claim 23 or 24 wherein said plurality of second linkages in said block copolymer comprises 1,3-dioxan-2-one linkages.

26. A surgical composite structure for mammalian tissue comprising:

a) a reinforcing component prepared from a plurality of fibers, the plurality of fibers manufactured from a biocompatible polymer, and

b) a deformable at ambient temperature bioabsorbable component consolidated around said plurality of fibers to form a matrix, the bioabsorbable component comprising a blend of a first and second absorbable polymer, the first absorbable polymer comprising a plurality of linkages selected from the group consisting of glycolic acid ester and lactic acid ester linkages, and mixtures thereof, and the second absorbable polymer comprising a plurality of linkages selected from the group consisting of 1,3-dioxan-2-one;

1,4-dioxan-2-one and ε

-caprolactone linkages, the first absorbable polymer comprising at least about 50 up to about 90 weight percent of the blend.

27. The structure of claim 26 wherein the reinforcing component is manufactured from an absorbable biocompatible polymer.

28. The structure of claim 27 wherein the absorbable biocompatible polymer is selected from the group consisting of a homopolymer or copolymer of polyglycolic acid, polylactic acid, polyhydroxy butyrate and blends of the same, and poly(d-lactic acid) blended with poly(1-lactic acid).

29. The structure of claim 26 wherein the reinforcing component is manufactured from a nonabsorbable biocompatible polymer.

30. The structure of claim 29 wherein the nonabsorbable biocompatible polymer is selected from the group consisting of polyethylene terephthalate, silk, nylon, polypropylene, polyethylene and polyoxymethylene and blends of the same.

31. The structure of claim 26, 27, 28, 29 or 30 wherein said first absorbable polymer in the bioabsorbable component is a homopolymer.

32. The structure of claim 31 wherein the first absorbable homopolymer in said bioabsorbable component consists essentially of lactic acid ester linkages.

33. The structure of claim 26, 27, 28, 29 or 30 wherein said first absorbable polymer in the bioabsorbable component is a copolymer.

34. The structure of claim 33 wherein said second absorbable polymer in said bioabsorbable component comprises a plurality of linkages selected from the group consisting of 1,3-dioxan-2-one and 1,4-dioxan-2-one linkages.