Plastic and nonmetallic article shaping or treating: processes – Forming continuous or indefinite length work – Shaping by extrusion
Patent
1984-03-13
1990-04-10
Lorin, Hubert C.
Plastic and nonmetallic article shaping or treating: processes
Forming continuous or indefinite length work
Shaping by extrusion
2642106, 264211, 26421114, D01F 102
Patent
active
049158937
DESCRIPTION:
BRIEF SUMMARY
This invention relates to a process for the manufacture of a polyester comprising filament material suitable for surgical application, as such or in woven, braided or knitted form, as well as reinforcing beads. The invention further relates to a synthetic surgical material that is biocompatible with a patient and is biodegradable.
The invented process of spinning a polyester material in the presence of a certain additive can be used in the production of highly fibrillated sutures, which due to their fibrillation exhibit a good resorption rate and flexibility important for handling the suture and tying the knot.
Regular structurization at the fibre surface, created in the present spinningprocess, and preserved in the fibre even after hotdrawing, provides to the fibre a high knot strength.
There exist a number of commercial biocompatible and biodegradable sutures based on polyglycolide (Dexon), copolymer of lactide and glycolide (Vicryl), or lactone of hydroxyethyl glycolic acid (PDS). These well known materials are convenient to handle, and have the required rate of bioresorption. However there still exists a need for new biocompatible and biodegradable suture materials.
As follows from literature data, polylactide fibers have already been produced, but the rate of degradation of these fibers is too low as compared with that of Vicryl, Dexon or PDS sutures.
While Vicryl, Dexon and PDS sutures respectively disappear after about 90, 120 and 180 days from implantation, the polylactide sutures are not resorbed until after about 8 to 17 months from implantation.
Thus although polylactide is a biocompatible, biodegradable and fiberforming polymer, the polylactide sutures have not so far found practical application in surgery.
It is an object of the present invention to provide sutures with adequate tensile strength, high dimensional stability and a rate of hydrolysis comparable to those of Vicryl, Dexon or PDS sutures. It is another object of the present invention to provide fibers which have a flexibility higher than those produced according to the standard methods, yet having high tensile strength and modulus. It is a further object of the present invention to provide sutures having a knot strength higher than that of fibers produced by standard spinning procedures.
These and other objects are attained by filament material produced by dry- or wet-spinning a spinning mixture comprising a polyester material and an additive, particularly a polyurethane material. When wet-spinning a coagulant material is needed. Preferred polyester materials are poly (L-lactide), (PLLA), poly (DL-LACTIDE) (PDLLA), and combinations thereof, having a viscosity-average molecular weight of at least about 3.times.10.sup.5 and preferably above 5.0.times.10.sup.5 Kg/kmol, as calculated according to the formule: [n]=5.45.times.10.sup.-4 M.sub.v.sup.0.73, for a viscosity measured at 25.degree. C. in trichlormethane.
Examples of additives other than polyurethane materials which can be used in preparing the filament material of this invention, are glycolide, lactide, camphor, benzoic acid-2-hydroxyacetate, hexamethylbenzene, 1,2-cyclohexandione and other low-molecular weight organic compounds which are preferably soluble in trichlormethane and/or dichlormethane and ethanol, and have a melting temperature in the range of 40.degree.to 180.degree. C.
Polyurethane is a preferred additive in the spinning mixture, and as such may be used in the form of a polyester urethane based on hexamethylene diisocyanate, 1,4-butanediol and a copolymer of lactic acid and ethylene glycol, diethylene glycol or tetramethylene glycol; hexamethylene diisocyanate, 2,4,6-tris(dimethylaminomethyl)phenol and copolymer of lactic acid and diethylene glycol, ethylene glycol, or tetramethylene glycol, a polyester urethane based on hexamethylene diisocyanate, trimethylol propane and a copolymer of polylactic acid and tetramethylene glycol or a polyester urethane based on 4,4'-diphenylmethane diisocyanate, 1,4-butanediol and polytetramethylene adipate. The concentration of th
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Gogolewski Sylwester
Pennings Albert J.
Lorin Hubert C.
Medtronic Inc.
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