Surgery – Instruments – Suture or ligature
Reexamination Certificate
1999-05-03
2001-03-27
Jackson, Gary (Department: 3731)
Surgery
Instruments
Suture or ligature
C606S230000, C528S354000, C528S357000, C525S408000, C525S415000, C525S411000
Reexamination Certificate
active
06206908
ABSTRACT:
TECHNICAL FIELD
Absorbable copolymers fabricated from the random copolymerization of 1,4 dioxane-2-one and 1,3 dioxane-2-one monomers, and more particularly surgical articles made totally or in part therefrom, including both monofilament and multifilament sutures are provided.
BACKGROUND
Polymers and copolymers of, and surgical devices made from lactide and/or glycolide and/or related compounds are well-known. See, e.g., U.S. Pat. Nos. 2,668,162, 2,683,136, 2,703,316, 2,758,987, 3,225,766, 3,268,486, 3,268,487, 3,297,033, 3,422,181, 3,442,871, 3,463,158, 3,468,853, 3,531,561, 3,565,869, 3,597,449, 3,620,218, 3,626,948, 3,636,956, 3,736,646, 3,739,773, 3,772,420, 3,733,919, 3,781,349, 3,784,585, 3,792,010, 3,797,499, 3,839,297, 3,846,382, 3,867,190, 3,987,937,, 3,878,284, 3,896,802, 3,902,497, 3,937,223, 3,982,543 4,033,938, 4,045,418, 4,057,537, 4,060,089, 4,137,921, 4,157,437, 4,243,775, 4,246,904, 4,273,920, 4,275,813, 4,279,249, 4,300,565, and 4,744,365, U.K. Pat. or Appln. Nos. 779,291, 1,332,505, 1,414,600 and 2,102,827, D. K. Gilding et al., “Biodegradable polymers for-use in surgery-polyglycolic/poly (lactic acid) homo-and copolymers: 1
, ”Polymer
, Volume 20, pages 1459-1464 (1979), and D. F. Williams (ed.)
Biocompatibility of Clinical Implant Materials
, Volume II, chapter 9: “Biodegradable Polymers” (1981).
Surgical devices prepared from copolymers containing dioxanone and polycarbonates are also known in the art. For example, U.S. Pat. No. 4,052,988 describes random copolymers containing dioxanone and up to 50 percent by weight of other copolymerizable monomers which produce non-toxic and absorbable copolymers.
As another example, U.S. Pat. No. 5,037,950 describes copolymers having sequential units of rho-dioxanone and sequential units of either tetramethylene carbonate, pentamethylene carbonate, hexamethylene carbonate, heptamethylene carbonate, octamethylene carbonate, nonamethylene carbonate, decamethylene carbonate, undecamethylene carbonate, and dodecamethylene carbonate, with hexamethylene carbonate being preferred. The '950 patent describes neither random copolymers nor copolymers containing trimethylene carbonate.
As yet a further example, U.S. Pat. No. 5,145,945 generically describes random copolymers of trimethylene carbonate and dioxanones other than carbonates. In addition, see U.S. Pat. Nos. 4,891,263; 4,916,193; 4,902,203; and 5,152,781.
As described above bioabsorbable sutures are known in the art. However, in the manufacture of sutures an important characteristic of a suture is the amount of effort typically required to straighten the suture upon its removal from the package in order to ready the suture for use. This effort appears to be related to the “strain energy” of the suture, i.e., the integration of the stress-strain curve for the suture measured in kilogram-mm, and is equivalent to the work expended in elongating the monofilament by a specified percentage of its original length. As the strain energy of a given size of suture decreases so, too, does the amount of effort required to straighten the suture prior to use. A decrease in strain energy also appears to relate to the perceived flexibility of the suture.
Therefore, it would be advantageous to provide a bioabsorbable suture which exhibits a desired absorption profile and improved flexibility and handling characteristics when compared to commercially available sutures having the same absorption profile, while maintaining other desired properties, such as knot-pull strength and straight-pull retention.
SUMMARY
It has now been found that absorbable surgical articles may be formed from the random copolymerization of 1,4 dioxane-2-one and 1,3 dioxane-2-one. Preferably, copolymers useful in forming surgical articles in accordance with the present disclosure include copolymers comprising a predominant component of dioxanone. A “predominant component” is a component which is present is an amount greater than 50 percent.
In a particularly useful embodiment these block copolymers of may be spun into fibers. The fibers can be fabricated into both monofilament and braided multifilament sutures. Preferably copolymers useful in this embodiment include at least about 60 mole percent dioxanone, the remainder being trimethylene carbonate.
There is also provided a process for manufacturing a suture exhibiting excellent flexibility and/or increased knot performance for a given size comprising the operations of extruding the block copolymer at an extrusion temperature of from about 80° C. to about 140° C. to provide a monofilament fiber, stretching the solidified monofilament at a temperature of from about 30° C. to about 60° C. in water (or other suitable liquid medium such as for example glycerol) or at from about 30° C. to about 95° C. in air (or other suitable gaseous medium) at a stretch ratio of from about 3:1 to about 10:1 to provide a stretched monofilament. The stretched monofilament preferably is then frozen at a temperature of from about −25° C. to about 0° C. The suture then may be annealed with or without relaxation at a temperature of from about 40° C. to about 95° C. to provide the finished suture.
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Jackson Gary
United States Surgical Corporation
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