Synthetic resins or natural rubbers -- part of the class 520 ser – Synthetic resins – Mixing of two or more solid polymers; mixing of solid...
Reexamination Certificate
1997-10-10
2001-02-20
Short, Patricia A. (Department: 1712)
Synthetic resins or natural rubbers -- part of the class 520 ser
Synthetic resins
Mixing of two or more solid polymers; mixing of solid...
C525S413000, C525S415000, C528S354000, C528S361000
Reexamination Certificate
active
06191236
ABSTRACT:
TECHNICAL FIELD
Absorbable block copolymers having one of the blocks predominantly hard phase forming monomers and another of said blocks made from randomly copolymerized soft phase forming monomers are described. Processes for making the copolymers and surgical articles made totally or in part from such copolymers, including both monofilament and multifilament sutures, are also described.
BACKGROUND
Bioabsorbable surgical devices such as, for example, sutures, made from copolymers derived from one or more of glycolide, lactide, p-dioxanone, epsilon-caprolactone and/or trimethylene carbonate are known in the art. However, filaments prepared from certain such copolymers are not dimensionally stable and require a freezing step to maintain a desired physical dimension. See, e.g. U.S. Pat. No. 5,494,620 which discloses the details of and benefits derived from a freezing operation. U.S. Pat. No. 5,403,347 discloses a block copolymer wherein one of the blocks is made from hard phase forming monomers (preferably glycolide) and another of the blocks is made from soft phase forming monomers (e.g., p-dioxanone) copolymerized with randomly intermingled units of other soft phase forming monomers (e.g., trimethylene carbonate). In each working example of U.S. Pat. No. 5,403,347, after spinning and drawing a monofilament made from the copolymers disclosed therein, the monofilament is subjected to a freezing operation. Thus, while the resulting monofilaments have excellent physical properties for use as a suture, four distinct steps are used in the working examples; namely, spinning, drawing, freezing and annealing.
It would be desirable to provide a bioabsorbable suture which exhibits good flexibility and handling characteristics while maintaining other desired characteristics, such as knot strength, knot retention and desired absorption characteristics. It would also be desirable to produce such a suture in fewer manufacturing steps than have been previously employed.
SUMMARY
It has now been found that absorbable surgical articles may be formed from a block copolymer having one of the blocks made from hard phase forming monomers and another of the blocks made from random copolymers of soft phase forming monomers without the need of a freezing step. Hard phase forming monomers include glycolide and lactide while soft phase forming monomers include 1,4 dioxane-2-one and 1,3 dioxane-2-one and caprolactone. Preferably, the block copolymers used in forming surgical articles include one block having glycolic acid ester units as a predominant component thereof. A “predominant component” is a component which is present in an amount greater than 50 mole percent.
The copolymers are prepared by copolymerizing the soft phase forming monomers to form a random copolymer. Hard phase forming monomer is then combined with the random copolymer and polymerization is carried out at a temperature of less than about 205° C.
In particularly useful embodiments, the block copolymers can be spun into fibers. The fibers can be fabricated into both monofilament and braided multifilament sutures.
A process for manufacturing a suture exhibiting excellent strain energy and/or increased knot performance for a given size is also described herein. The process includes the steps of extruding the aforementioned block copolymer, to provide a monofilament fiber, drawing the solidified monofilament at a draw ratio of from about 3:1 to about 10:1 to provide a drawn monofilament, and annealing the drawn monofilament to provide the finished suture.
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Biodegradable polymers for use in surgery—polyglycolic/poly(actic acid) home-and copolymers:1; Polymer; D.K. Gilding and A.M. Reed; Dec. 1979; vol. 20; p. 1459-1464.
Bennett Steven L.
Liu Cheng-Kung
Nebinger Darlene P.
Reinprecht Jon T.
Roby Mark S.
Short Patricia A.
United States Surgical Corporation
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