Polymeric surgical staple

• US 5,324,307 A
• Filed: 11/27/1991
• Issued: 06/28/1994
• Est. Priority Date: 07/06/1990
• Status: Expired due to Term

• Current Assignee: Sherwood Services AG
• Original Assignee: American Colloid Company (Minerals Technologies Incorporated)
• Inventors: Casey, Donald J., Dwyer, James W., Jarrett, Peter K., Rosati, Louis
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Jackson, Gary
• Application Number:
  US07/799,521
• Time in Patent Office: 944 Days
• Field of Search: 606/219, 528/370, 528/354-357, 524/381, 523/354, 523/359, 523/361, 523/105, 523/113, 428/395, 227/110, 525/415
• 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, resorptive for implantable prostheses A61F2210/0004
• 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 one piece surgical repair device consists essentially of a polymeric wire. The polymeric wire is comprised of an oriented, semicrystalline polymer. The surgical repair device can be a staple and is capable of permanent flexural deformation at ambient temperature.

Claims

1. An article of manufacture comprising a one piece surgical repair device consisting essentially of a polymeric wire comprised of an oriented, semicrystalline polymer and having a Young'"'"'s modulus of greater than about 600,000 psi, wherein the one piece surgical repair device is capable of permanent flexural deformation at ambient temperature.

2. The article of claim 1 wherein the polymeric wire has a diameter of about 0.005 to 0.050 inches.

3. The article of claim 2 wherein the diameter is about 0.010 to 0.025 inches.

4. The article of claim 1 wherein the Young'"'"'s modulus is greater than about 800,000 psi.

5. The article of claim 4 wherein the oriented polymer is from about 20 to 70 percent crystalline.

6. The article of claim 5 wherein said oriented polymer is up to about 60 percent crystalline.

7. The article of claim 1 wherein said oriented, semicrystalline polymer is a homopolymer of polylactic acid.

8. The article of claim 1 wherein said oriented, semicrystalline polymer is a homopolymer of polyglycolic acid.

9. The article of claim 1 wherein said oriented, semicrystalline polymer is a multi-phase polymer derived from lactide and glycolide.

10. The article of claim 1 wherein said oriented, semicrystalline polymer is a block copolymer.

11. The article of claim 10 wherein the block copolymer comprises lactic acid ester linkages.

12. The article of claim 1 wherein said block copolymer comprises linkages prepared from monomers selected from the group consisting of ε

-caprolactone and 1,3-dioxan-2-one.

13. The article of claim 12 wherein the lactic acid ester linkages comprise about 95 mole percent of said block copolymer.

14. The article of claim 13 wherein the remaining linkages are prepared from 1,3-dioxan-2-one.

15. The article of claim 12 wherein the remaining linkages are prepared from ε

-caprolactone.

16. The article in any one of claims 2, 3 or 5-5 to 17 inclusive wherein the one piece surgical repair device is a staple.

17. The article in any one of claims 2, 3 or 5-15 inclusive wherein the one piece surgical repair device is a cerclage wire or Kirschner wire.

18. The article in any one of claims 10 to 15 wherein at least one of the continuous phases has an in vivo glass transition temperature of more than about 37°

C. and comprises more than about 50 mole percent of the copolymer.

19. An article of manufacture comprising a one piece surgical staple consisting essentially of a polymeric wire comprised of an oriented, semicrystalline block copolymer having at least one continuous phase, and comprising more than about 50 mole percent of lactic acid ester linkages and the remaining linkages are prepared from ε

-caprolactone, wherein the one piece surgical staple is capable of permanent flexural deformation at ambient temperature.

20. An article of manufacture comprising a one piece, sterile surgical repair device manufactured from a polymeric wire comprising an extrusile, biocompatible polymer having at least one continuous phases, at least one of the continuous phases having an in vivo glass transition temperature of more than about 37°

C., wherein the one piece, sterile surgical repair device is capable of permanent flexural deformation at ambient temperature.

21. The article of claim 20 wherein the polymeric wire has a diameter of about 0.005 to 0.50 inches.

22. The article of claim 21 wherein the diameter is about 0.010 to 0.025 inches.

23. The article of claim 20, 21 or 22 wherein the polymeric wire has a Young'"'"'s modulus of greater than about 600,000 psi.

24. The article of claim 23 wherein the Young'"'"'s modulus is greater than about 800,000 psi.

25. The article of claim 20 wherein the extrusile, biocompatible polymer is a copolymer.

26. The article of claim 25 wherein the copolymer is a block copolymer.

27. The article of claim 25, or 26 wherein at least one of the continuous phases has an in vivo glass transition temperature of more than about 37°

C. and comprises more than about 50 mole percent of the copolymer.

28. The article of claim 20 wherein the extrusile, biocompatible polymer is a multi-phase polymer derived from two different monomers.

29. The article in any one of the claims 20 to 22 or 25 to 28 wherein the one piece surgical repair device is a staple and the polymeric wire has a Young'"'"'s modulus of greater than about 600,000 psi.

30. The article in any one of claims 20 to 22 or 25 to 28 wherein the one piece surgical repair device is a cerclage wire or Kirschner wire.

31. A one piece, sterile surgical staple useful in mammalian tissue, the staple comprising an extruded polymeric wire consisting essentially of an oriented, semicrystalline bioabsorbable polymer, or blend of at least two polymers wherein at least one polymer is a semicrystalline polymer, the oriented, semicrystalline bioabsorbable polymer or blend comprising a continuous phase having a glass transition temperature of greater than the in-vivo temperature of the mammalian tissue, wherein said staple is capable of permanent deformation in body fluids.

32. An article of manufacture comprising an irradiation sterilized, surgical staple manufactured from an extruded and drawn polymeric wire having a diameter of about 0.005 to 0.050 inches, the polymeric wire comprising a bioabsorbable polymer having at least one continuous phases, the at least one continuous phase having an in vivo glass transition temperature of more than about 37°

C., wherein the irradiation sterilized, surgical staple is capable of permanent flexural deformation, has a Young'"'"'s modulus of greater than about 800,000 psi, and maintains at least about 50 percent of its initial opening strength after 21 days in vivo.

33. The article of claim 32 wherein said irradiation sterilized, surgical staple is one piece.

34. The article of claim 33 wherein the bioabsorbable polymer is a homopolymer of polylactic acid.

35. The article of claim 32 wherein the extruded and drawn polymeric wire has a diameter of about 0.010 to 0.025 inches.

36. The article of claim 33 wherein the bioabsorbable polymer is a homopolymer of polyglycolic acid.

37. The article of claim 32 wherein the bioabsorbable polymer is a copolymer.

38. The article of claim 37 wherein the copolymer comprises more than about 50 mole percent of glycolic acid ester linkages.

39. The article of claim 38 wherein said irradiation sterilized, surgical staple maintains about 100 percent after 7 days and greater than about 70 percent after 21 days in vivo of its initial opening strength.

40. The article of claim 37 wherein the copolymer comprises lactic acid ester linkages.

41. The article of claim 40 wherein the block copolymer comprises linkages prepared from monomers selected from the group consisting of ε

-caprolactone and 1,3-dioxan-2-one.

42. The article of claim 40 wherein the copolymer is a block copolymer and comprises more than about 50 mole percent of lactic acid ester linkages.

43. The article of claim 42 wherein the remaining linkages are prepared from 1,3-dioxan-2-one.

45. The article of claim 43 or 44 wherein the lactic acid ester linkages comprise about 95 mole percent of the block copolymer.

46. The article as in any one of claims 40 to 44 wherein said irradiation sterilized, surgical staple maintains greater than about 110 percent of its initial opening strength from about 7 to 21 days in vivo.

44. An article of manufacture comprising an irradiation sterilized, surgical staple consisting essentially of an extruded and drawn polymeric wire having a diameter of about 0.005 to 0.050 inches, the polymeric wire comprising a bioabsorbable block copolymer having at least about 80 mole percent of lactic acid ester linkages and the remaining linkages are prepared from ε

-caprolactone, and comprising at least one continuous phases, the at least one continuous phase having an in vivo glass transition temperature of more than about 37°

C., wherein the irradiation sterilized, surgical staple is capable of permanent flexural deformation, has a Young'"'"'s modulus of greater than about 800,000 psi, and maintains at least about 50 percent of its initial opening strength after 21 days in vivo.