POLYLACTIDE SUTURES

• US 3,636,956 A
• Filed: 05/13/1970
• Issued: 01/25/1972
• Est. Priority Date: 05/13/1970
• Status: Expired due to Term

• Current Assignee: Allan K. Schneider
• Original Assignee: Allan K. Schneider
• Inventors: Schneider, Allan K.
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US05/036,797
• Time in Patent Office: 622 Days
• Field of Search: 128/334,335.5 260/78.3
• US Class Current: 606/224
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61L 17/12 Homopolymers or copolymers of glycolic acid or lactic acid
• CPC Class Codes: C08G 63/08 Lactones or lactides

Abstract

Absorbable surgical sutures that are dimensionally stable within the body may be prepared by the extrusion of polylactide polymer, including copolymers of L(-) lactide with up to 35 mole percent of glycolide. Said polymers are characterized by an inherent viscosity of at least 1.0, and the extruded filaments are oriented by drawing at a temperature of about 50* to about 140* at a draw ratio of up to 11x, and annealed. Sutures so prepared have a tensile strength of from 25,000 p.s.i. to 100,000 p.s.i.

Claims

2. The suture of claim 1, packaged in a dry atmosphere within a hermetically sealed container.

3. The suture of claim 1, packaged within an evacuated hermetically sealed container.

4. The suture of claim 1, wherein the polylactide polymer is a poly L(-) lactide containing up to 15 percent by weight of repeating units derived from DL-lactide.

5. The suture of claim 1, containing a minor amount of inert coloring agent and plasticizer.

6. The suture of claim 1, containing bis 2-methoxyethyl phthalate as a plasticizer.

7. A method of retaining living tissue in a desired location and relationship during a healing process which comprises:

sewing living tissue with the suture of claim 107, whereby said suture becomes imbedded in the tissue; and

leaving the suture in said tissue until said suture is absorbed by the tissue during the healing process.

8. The suture of claim 1, having a sterile needle attached to one end thereof.

9. The needle and suture combination of claim 8, packaged in a dry atmosphere within a hermetically sealed container.

10. The needle and suture combination of claim 8, packaged within an evacuated hermetically sealed container.

11. The needle and suture combination of claim 8, wherein said monofilament is a poly-L-(-) lactide containing up to 15 percent by weight of repeating units derived from DL-lactide.

12. The needle and suture combination of claim 8, wherein said monofilament is a 95/5 weight percent copolymer of L(-) lactide and DL-lactide.

13. The needle and suture combination of claim 8, wherein said monofilament contains a minor amount of inert coloring agent and plasticizer.

14. The needle and suture combination of claim 8, wherein said monofilament contains bis 2-methoxyethyl phthalate as a plasticizer.

15. A method of retaining living tissue in a desired location and relationship during a healing process which comprises:

sewing living tissue with the suture of claim 114, whereby said suture becomes imbedded in the tissue; and

leaving the suture in said tissue until said suture is absorbed by the tissue during the healing process.

16. A sterile surgical suture absorbable without causing unfavorable tissue reaction and essentially dimensionally stable within the body comprising a synthetic polylactide copolymer containing at least about 65 mole percent of repeating units derived from one antipodal species of alpha-hydroxypropionic acid and not more than about 35 mole percent of repeating units derived from alpha-hydroxyacetic acid, said polylactide being characterized by having an inherent viscosity of at least 1.2 at 0.1 percent concentration in a suitable solvent at 25* C. and by losing at least about 20 percent of its weight on treatment with boiling water for a period of 100 hours, and being further characterized by exhibiting a tensile strength of from 40,000 p.s.i. to about 100,000 p.s.i. and by having a diameter of 0.0005-0.045 inches.

17. The suture of claim 16, packaged in a dry atmosphere within a hermetically sealed container.

18. The suture of claim 16, packaged within an evacuated hermetically sealed container.

19. The suture of claim 16, wherein the polylactide copolymer contains about 35 mole percent of repeating units derived from alpha-hydroxyacetic acid.

20. The suture of claim 16, wherein the polylactide copolymer contains about 30 mole percent of repeating units derived from alpha-hydroxyacetic acid.

21. The suture of claim 16, wherein the polylactide copolymer contains about 25 mole percent of repeating units derived from alpha-hydroxyacetic acid.

22. The suture of claim 16, wherein the polylactide copolymer contains about 20 mole percent of repeating units derived from alpha-hydroxyacetic acid.

23. The suture of claim 16, wherein the polylactide copolymer contains about 15 weight percent of repeating units derived from alpha-hydroxyacetic acid.

24. The suture of claim 16, wherein the polylactide copolymer contains about 5 weight percent of repeating units derived from alpha-hydroxyacetic acid.

25. The suture of claim 16, containing a minor amount of inert coloring agent and plasticizer.

26. The suture of claim 16, containing bis 2-methoxy-ethyl phthalate as a plasticizer.

27. A method of retaining living tissue in a desired location and relationship during a healing process which comprises:

sewing living tissue with the suture of claim 16, whereby said suture becomes imbedded in the tissue; and

leaving the suture in said tissue until said suture is absorbed by the tissue during the healing process.

28. The suture of claim 16, having a sterile needle attached to one end thereof.

29. The needle and suture combination of claim 28, packaged in a dry atmosphere within a hermetically sealed container.

30. The needle and suture combination of claim 28, packaged within an evacuated hermetically sealed container.

31. The needle and suture combination of claim 28, wherein the polylactide polymer contains about 35 mole percent of repeating units derived from alpha-hydroxyacetic acid.

32. The needle and suture combination of claim 28, wherein the polyactide polymer contains about 30 mole percent of repeating units derived from alpha-hydroxyacetic acid.

33. The needle and suture combination of claim 28, wherein the polylactide polymer contains about 25 mole percent of repeating units derived from Alpha-hydroxyacetic acid.

34. The needle and suture combination of claim 28, wherein the polylactide polymer contains about 20 mole percent of repeating units derived from alpha hydroxyacetic acid.

35. The needle and suture combination of claim 28, wherein the polylactide polymer contains about 15 weight percent of repeating units derived from alpha-hydroxyacetic acid.

36. The needle and suture combination of claim 28, wherein the polylactide polymer contains about 5 weight percent of repeating units derived from alpha-hydroxyacetic acid.

37. The needle and suture combination of claim 28, wherein said monofilament contains a minor amount of inert coloring agent and plasticizer.

38. The needle and suture combination of claim 28, wherein said monofilament contains bis 2-methoxyethyl phthalate as a plasticizer.

39. A method of retaining living tissue in a desired location and relationship during a healing process which comprises:

sewing living tissue with the needle and suture combination of claim 28, whereby said suture becomes imbedded in the tissue; and

leaving the suture in said tissue until said suture is absorbed by the tissue during the healing process.

40. A sterile surgical suture absorbable without causing unfavorable tissue reaction and essentially dimensionally stable within the body in the form of a braided structure, comprising filaments of a synthetic polylactide polymer containing at least about 85 percent by weight of repeating units of one antipodal species of alpha-hydroxypropionic acid and no more than about 15 percent by weight of repeating units of the formula where R is lower alkylene, m is an integer of 0 to 1, R'"'"''"'"' is selected from the class consisting of hydrogen and lower alkyl, and R'"'"''"'"''"'"''"'"', which can be the same or different from R'"'"''"'"', is selected from the class consisting of hydrogen and alkyl group of up to 22 carbons when m is 0 and, when m is 1, R'"'"''"'"''"'"''"'"' is selected from the class consisting of hydrogen and lower alkyl, said polylactide being characterized by having an inherent viscosity of at least 1.2 at 0.1 percent concentration in benzene at 25* C. and by losing at least about 20 percent of its weight on treatment with boiling water for a period of 100 hours, at least 50 percent of the filaments making up the braided structure being oriented and the diameter of the filaments ranging from 0.00025 to 0.003 inches;

and the braided structure itself being characterized by exhibiting a tensile strength of from 40,000 p.s.i. to about 100, 000 p.s.i.

41. The suture of claim 40, packaged in a dry atmosphere within a hermetically sealed container.

42. The suture of claim 40, packaged within an evacuated hermetically sealed container.

43. The suture of claim 40, wherein the polylactide copolymer filaments that make up said braided structure contain up to 15 percent by weight of repeating units derived from DL-lactide.

44. The suture of claim 40, wherein the polylactide copolymer filaments that make up said braided structure are a 95/5 weight percent copolymer of L(-) lactide and DL-lactide.

45. The suture of claim 40, wherein the filaments that make up said braided structure contain a minor amount of inert coloring agent and plasticizer.

46. The suture of claim 40, wherein the filaments that make up said braided structure contain bis 2-methoxyethyl phthalate as a plasticizer.

47. A method of retaining living tissue in a desired location and relationship during a healing process which comprises:

sewing living tissue with the suture of claim 40, whereby said suture becomes imbedded in the tissue; and

leaving the suture in said tissue until said suture is absorbed by the tissue during the healing process.

48. The suture of claim 40, having a sterile needle attached to one eNd thereof.

49. The needle and suture combination of claim 48, packaged in a dry atmosphere within a hermetically sealed container.

50. The needle and suture combination of claim 48, packaged within an evacuated hermetically sealed container.

51. The needle and suture combination of claim 48, wherein the polylactide copolymer filaments that make up said braided structure contain up to 15 percent by weight of repeating units derived from DL-lactide.

52. The needle and suture combination of claim 48, wherein the polylactide copolymer filaments that make up said braided suture are a 95.5 weight percent copolymer of L(-) lactide and DL-lactide.

53. The needle and suture combination of claim 48, wherein the filaments that make up said braided suture contain a minor amount of inert coloring agent and plasticizer.

54. The needle and suture combination of claim 48, wherein the filaments that make up said braided suture contain bis 2-methoxyethyl phthalate as a plasticizer.

55. A method of retaining living tissue in a desired location and relationship during a healing process which comprises:

sewing living tissue with the suture and needle combination of claim 47, whereby said suture becomes imbedded in the tissue; and

leaving the suture in said tissue until said suture is absorbed by the tissue during the healing process.

56. A sterile surgical suture absorbable without causing unfavorable tissue reaction and essentially dimensionally stable within the body in the form of a braided structure comprising filaments of a synthetic polylactide copolymer containing at least 60 mole percent of repeating units derived from one antipodal species of alpha-hydroxypropionic acid and no more than 40 mole percent of repeating units derived from alpha-hydroxyacetic acid, said polylactide being characterized by having an inherent viscosity of at least 1.2 at 0.1 percent concentration in a suitable solvent at 25* C. and by losing at least about 20 percent of its weight on treatment with boiling water for a period of 100 hours, at least 50 percent of the filaments making up the braided structure being oriented, and the braided structure itself being further characterized by exhibiting a tensile strength of at least 15,000 p.s.i. 10 days following implantation in an animal body.

57. The suture of claim 56, packaged in a dry atmosphere within a hermetically sealed container.

58. The suture of claim 56, packaged within an evacuated hermetically sealed container.

59. The suture of claim 56, wherein the polylactide copolymer contains about 35 mole percent of repeating units derived from alpha-hydroxyacetic acid.

60. The suture of claim 56, wherein the polylactide copolymer contains about 30 mole percent of repeating units derived from alpha-hydroxyacetic acid.

61. The suture of claim 56, wherein the polylactide copolymer contains about 25 mole percent of repeating units derived from alpha-hydroxyacetic acid.

62. The suture of claim 56, wherein the polylactide copolymer contains about 20 mole percent of repeating units derived from alpha-hydroxyacetic acid.

63. The suture of claim 56, wherein the polylactide copolymer contains about 15 weight percent of repeating units derived from alpha-hydroxyacetic acid.

64. The suture of claim 56, wherein the polylactide copolymer contains about 5 weight percent of repeating units derived from alpha-hydroxyacetic acid.

65. The suture of claim 56, wherein the filaments that make up said braided structure contain a minor amount of inert coloring agent and plasticizer.

66. The suture of claim 56, wherein the filaments that make up said braided structure contain bis 2-methoxyethyl phthalate as a plasticizer.

67. A method of retaining living tissue in a desired location and relationship during a healing process which comprises:

sewing living tissue with the suture of clAim 56, whereby said suture becomes imbedded in the tissue; and

leaving the suture in said tissue until said suture is absorbed by the tissue during the healing process.

68. The suture of claim 56, having a sterile needle attached to one end thereof.

69. The needle and suture combination of claim 68, packaged in a dry atmosphere within a hermetically sealed container.

70. The needle and suture combination of claim 68, packaged within an evacuated hermetically sealed container.

71. The needle and suture combination of claim 68, wherein the polylactide copolymer filaments that make up said braided structure contain about 35 mole percent of repeating units derived from alpha-hydroxyacetic acid.

72. The needle and suture combination of claim 68, wherein the polylactide copolymer filaments that make up said braided structure contain about 30 mole percent of repeating units derived from alpha-hydroxyacetic acid.

73. The needle and suture combination of claim 68, wherein the polylactide copolymer filaments that make up said braided structure contain about 25 mole percent of repeating units derived from alpha-hydroxyacetic acid.

74. The suture of claim 68, wherein the polylactide copolymer filaments that make up said braided structure contain about 20 mole percent of repeating units derived from alpha-hydroxyacetic acid.

75. The needle and suture combination of claim 68, wherein the polylactide copolymer filaments that make up said braided structure contain about 15 weight percent of repeating units derived from alpha-hydroxyacetic acid.

76. The needle and suture combination of claim 68, wherein the polylactide copolymer filaments that make up said braided structure contain about 5 weight percent of repeating units derived from alpha-hydroxyacetic acid.

77. The needle and suture combination of claim 68, wherein the filaments that make up said braided structure contain a minor amount of inert coloring agent and plasticizer.

78. The needle and suture combination of claim 68, wherein the filaments that make up said braided structure contain bis 2-methoxyethyl phthalate as a plasticizer.

79. A method of retaining living tissue in a desired location and relationship during a healing process which comprises:

sewing living tissue with the needle and suture combination of claim 68, whereby said suture becomes imbedded in the tissue; and

leaving the suture in said tissue until said suture is absorbed by the tissue during the healing process.