A kind of manufacture method of polyester absorbable medical suture
The invention relates to a kind of polyester absorbable medical suture and manufacture method thereof, more particularly about a kind of polymeric polyglycolide-polylactide absorbable medical suture and manufacture method thereof.
Suture generally adopts synthetic fibers such as polyamide, polyester, polypropylene before the present invention, also has to adopt natural silkworm silk, catgut as stitching thread.Though these materials have better biocompatibility, intensity to keep characteristics for many years, maximum shortcoming is to need to take out stitches after the operation, and the biodegradation medical material of obviously seeking more excellent performance is imperative.
The absorbent surgical line is the product that the seventies initial stage is taken the lead in releasing by the U.S., the synthetic absorbent surgical line of this biochemistry (poly--hydroxybutyric acid PHB) has a lot of superior performances, the intensity of wherein outstanding is line is big, good hand touch, it is minimum to be used for the inside of human body rejection, does not have irritated reaction and side effect.According to the composition and the model size of line, this suture just is decomposed into nontoxic molecule at the inside of human body some months, is excreted by the excretory system of human body then.Class absorbent surgical line is very fast is accepted by medical circle for this, is used for replacing the catgut of life-time service.
This type of suture keeps its intensity to be about for 3~4 week at inside of human body, and during this period, surgical wound tentatively heals, thereby its mission finishes, and suture just begins it and decomposes the process that absorbs.Because it has the function of decomposition, this type of suture is used for subepidermal operation, the operation of mucosa top layer and vascular mostly and sews up operation.Owing to can be made of one suture and all kinds of syringe needle, make it to be used for different operations, so to the doctor, feel more convenient, the absorbent surgical line is also more and more accepted by the public.The expert thinks that by 2000,80% stitching thread will become the absorbent surgical line, and this year, U.S.'s sutures market was about 1,800,000,000 dollars.
But, up to now, do not find as yet and similar products like of the present invention and manufacture method.
One of purpose of the present invention provides a kind of polyester absorbable medical suture.
Two of purpose of the present invention provides a kind of polymeric polyglycolide-polylactide absorbable medical suture.
Three of purpose of the present invention provides a kind of manufacture method of polymeric polyglycolide-polylactide absorbable medical suture.
These and other purpose of the present invention will further be set forth and illustrate by following detailed description.
In the present invention, polyester absorbable medical suture is the polymeric polyglycolide-polylactide absorbable medical suture particularly, and its glycolide-lactide copolymer (PGA/PLA) chemical structural formula is:
(n=0.5 in the formula~0.95, m=0.5~0.05)
This stitching thread fiber linear density: 1.5-8dtex,
Fracture strength: 4.0-6.5CN/dtex,
Extension at break: 25-40%.
This polymeric polyglycolide-polylactide absorbable medical suture, in the hexafluoroisopropanol test condition, intrinsic viscosity is 1.10~1.80 in the time of 30 ℃; The mol ratio of glycolide-lactide copolymer is: Acetic acid, hydroxy-, bimol. cyclic ester is 0.5~0.95, lactide 0.05~0.5; The specification of polymeric polyglycolide-polylactide fibre bundle is 20d/8f~75d/24f.
Product of the present invention can be made by the following method:
At first with the glycolide-lactide copolymer of proportional quantity under the nitrogen protection condition through melt spinning, 200~250 ℃ of spinning temperatures, draw ratio are 4~8; Post processing makes the polymeric polyglycolide-polylactide fiber; With braider fiber is weaved into stitching thread then, coating is made absorbable medical suture, coating material can be one of chitin, polyvinyl alcohol, low-molecular-weight polymeric polyglycolide-polylactide or its mixture, wherein the low-molecular-weight polymeric polyglycolide-polylactide is in the hexafluoroisopropanol test condition, intrinsic viscosity is 0.60~0.80 in the time of 30 ℃, and the concentration expressed in percentage by weight of chitin, polyvinyl alcohol, low-molecular-weight polymeric polyglycolide-polylactide or its mixture is 0.3~3.8%.
Product of the present invention is a kind of good biodegradation suture, and it has, and intensity is higher, moderate, the avirulence of elongation, non-stimulated, good biocompatibility, pliability are good, and the absorption cycle is advantages such as 60~75 days; Need not take out stitches, not have the rejection reflection and have no side effect, exempt postoperative second time of misery; Because the organic component that its 70% material is a tissue, so be absorbed by the body after the several months, decompose, and excrete with secretions.In addition,, be easy to knotting, and tie and can freely move down owing to adopted special coating and weaving method, upwards sliding.
In the present invention, all raw materials all can be buied from market, chitin can use its derivant or modification chitin, the partial monopoly of the Chinese patent of for example can the request for utilization people before the application, applying for (the invention people waits the people clearly for Tan (a state in the Zhou Dynasty) will), and these patent applications are listed reference at this.
In the present invention, if not refer in particular to all amounts, percentage ratio all is weight percentage.
Below further specify the present invention by specific embodiment, but embodiment only be used for the explanation can not limit the scope of the invention.
Example 1
With mol ratio is that 0.9: 0.1 polymeric polyglycolide-polylactide copolymer (30 ℃ time intrinsic viscosity be 1.74) is 110 ℃ of temperature; vacuum is through 28 hours dryings under 750~760mmHg; dried polymeric polyglycolide-polylactide (moisture content should less than 80ppm) drops into the spinning feed bin rapidly; and protected with nitrogen; through the spinning-drawing machine spinning technique; 230 ℃ of spinning one district's temperature; 240 ℃ of two district's temperature; 238 ℃ of three district's temperature; spinning pressure 7MPa, the dosing pump pump is 0.5mm for amount 6cc/min with the aperture; the spinning plate in hole count 16 holes; winding speed is controlled at 300 meters/minute, and the as-spun fibre of spinning stretches 6 times through the hot plate stretching machine, and the filament number of gained fiber is 2.50dtex; fracture strength 6.0CN/dtex, extension at break 40%.This polymeric polyglycolide-polylactide fiber warp loom is woven into line, use concentration expressed in percentage by weight 0.6% polyvinyl alcohol slurry, coating 3 minutes at last, carry out nervous thermal finalization after the taking-up, make the stitching thread of different length different thicknesses at last according to suture sizes.Example 2
With mol ratio is that 0.65: 0.35 polymeric polyglycolide-polylactide copolymer (30 ℃ time intrinsic viscosity be 1.47) is 110 ℃ of temperature; vacuum is through 28 hours dryings under 750~760mmHg; dried polymeric polyglycolide-polylactide (moisture content should less than 80ppm) drops into the spinning feed bin rapidly; and protected with nitrogen; through the spinning-drawing machine spinning technique; 220 ℃ of spinning one district's temperature; 235 ℃ of two district's temperature; 230 ℃ of three district's temperature; spinning pressure 4MPa, the dosing pump pump is 0.5mm for amount 7cc/min with the aperture; the spinning plate in hole count 24 holes; winding speed is controlled at 100 meters/minute, and the as-spun fibre of spinning stretches 5.5 times through the hot plate stretching machine, and the filament number of gained fiber is 6.5dtex; fracture strength 5.0CN/dtex, extension at break 35%.This polymeric polyglycolide-polylactide fiber warp loom is woven into line, use concentration expressed in percentage by weight 0.6% chitin solution dipping, coating 3.5 minutes at last, carry out nervous thermal finalization after the taking-up, make the stitching thread of different length different thicknesses at last according to suture sizes.Example 3
With mol ratio is that 0.7: 0.3 polymeric polyglycolide-polylactide copolymer (30 ℃ time intrinsic viscosity be 1.50) is 110 ℃ of temperature; vacuum is through 36 hours dryings under 750~760mmHg; dried polymeric polyglycolide-polylactide (moisture content should less than 80ppm) drops into the spinning feed bin rapidly; and protected with nitrogen; through the spinning-drawing machine spinning technique; 225 ℃ of spinning one district's temperature; 238 ℃ of two district's temperature; 234 ℃ of three district's temperature; spinning pressure 5.7MPa, the dosing pump pump is 0.5mm for amount 9cc/min with the aperture; hole count is the spinning plate in 8 holes; winding speed is controlled at 400 meters/minute, and the as-spun fibre of spinning stretches 8 times through the hot plate stretching machine, and the filament number of gained fiber is 4.25dtex; fracture strength 4.5CN/dtex, extension at break 25%.This polymeric polyglycolide-polylactide fiber warp loom is woven into line, use low-molecular-weight polymeric polyglycolide-polylactide (30 ℃ time intrinsic viscosity be 0.70) slurry, the coating 3 minutes of concentration expressed in percentage by weight 2.5% at last, carry out nervous thermal finalization after the taking-up, make the stitching thread of different length different thicknesses at last according to suture sizes.Example 4
With mol ratio is that 0.5: 0.5 polymeric polyglycolide-polylactide (30 ℃ time intrinsic viscosity be 1.20) is 120 ℃ of temperature; vacuum is through 24 hours dryings under 750~760mmHg; dried polymeric polyglycolide-polylactide (moisture content should less than 80ppm) drops into the spinning feed bin rapidly; and protected with nitrogen; through the spinning-drawing machine spinning technique; 220 ℃ of spinning one district's temperature; 230 ℃ of two district's temperature; 225 ℃ of three district's temperature; spinning pressure 6MPa, the dosing pump pump is 0.5mm for amount 9cc/min with the aperture; the spinning plate in hole count 12 holes; winding speed is controlled at 460 meters/minute, and the as-spun fibre of spinning stretches 6 times through conventional stretching-machine, and the filament number of gained fiber is 3.38dtex; fracture strength 5.2CN/dtex, extension at break 32%.This polymeric polyglycolide-polylactide fiber warp loom is woven into line, use concentration expressed in percentage by weight 3% coating material dipping, coating 4.5 minutes at last, coating material can be 60% weight chitin, 40% weight polyvinyl solution, carry out nervous thermal finalization after the taking-up, make the stitching thread of different length different thicknesses at last according to suture sizes.