CN1125622A - Flexible suture of absobable biological material for medical use - Google Patents
Flexible suture of absobable biological material for medical use Download PDFInfo
- Publication number
- CN1125622A CN1125622A CN 94119089 CN94119089A CN1125622A CN 1125622 A CN1125622 A CN 1125622A CN 94119089 CN94119089 CN 94119089 CN 94119089 A CN94119089 A CN 94119089A CN 1125622 A CN1125622 A CN 1125622A
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- stitching thread
- complex
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- chitin
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Abstract
The medical absorbable flexible suture is made up through extracting collagen and chitin from connective tissue of mammal, optional modification, addition of natural flexibilizer, spinning and chromising modification on using, and features matching with healing period of wound, full absorption, no toxic by-effect and high wet strength for tying knots.
Description
The invention belongs to the medical surgical suture material.
At present, operation suture thread is divided into absorbable and two classes that can not absorb in the medical material both at home and abroad, its raw material has the composite made from natural material and synthetic pure natural, synthetic in absorbable stitching thread, just belongs to composite as the patent publication No. of documents 1 for the stitching thread that the CN1051510A name is called in " collagen-polyvinyl alcohol operation suture thread and preparation method thereof ".The stitching thread that the pure natural material is made is exactly the medical absorbable suture of collagen of Tianjin Textile Industry College development in addition except that catgut; (see documents 2: " Tianjin Textile Industry College journal " 1992 the 11st volumes the 3rd interim exercise question is: " development of the medical absorbable suture of collagen "); though the collagen stitching thread has overcome catgut and known sutural shortcoming thereof; but it still has weak point; that is exactly that the collagen stitching thread has degraded fast; fragility is big; flexible poor; the absorption phase is short; be flush away protection liquid before sewing up; must in aseptic normal saline solution, clean; so the wet knot strength of this line is low; knotting is easily broken during stitching; because this line absorption is fast; easily the generation wound does not heal and is absorbed; cause the edge of a knife accident of bursting apart, therefore, bring worry and worry to the doctor clinically.
Purpose of the present invention is exactly to overcome the shortcoming that the pure natural stitching thread exists, provide and add in a kind of natural collagen protein that the mammal connective tissue is extracted with enzyme digestion after an amount of chitin, softener mix, make stitching thread to strengthen sutural wet strength, to prolong the absorption phase, improve flexibility, adapt to instructions for use clinically.
The objective of the invention is to solve by following scheme:
Mammiferous connective tissue is got complex with extraction of collagen enzymatic digestion swelling solution and chitin solution mixing system, get stitching thread through being shaped crosslinked spinning, this stitching thread can be made into monofilament, membranaceous, netted.For improving sutural flexibility, can the collagen protein swelling solution with add the pure natural softener after chitin solution mixes, make complex after the mixing, softener can be Oleum Arachidis hypogaeae semen, castor oil, Oleum Glycines, Oleum Brassicae campestris or other vegetable oil.
Sutural manufacture method is: above-mentioned complex is packed in the spinning basin, with 0.5～3kg/cm
2Nitrogen pressure is clamp-oned in the coagulating bath of being made up of acetone, distilled water, ammonia, enters crosslinked bath again after twisted and plied, and after twice twisting, washing, drying, coiling spinning form monofilament, also can be made into membranaceous or netted.This stitching thread is put into mixed liquor by ethanol and glycerol again to be soaked to take out after 12～24 hours and extracts, putting into concentration is that the immersion of 75% ethanol is to be packaged, reuse concentration is 3%～10% chromium sulfate solution tanning 15～20 minutes as required, then is 1% Na with concentration
2CO
3Solution was decided chromium 40～60 minutes, packed into to fill in the nontoxic polyethylene pouch that concentration is 75% ethanol or dimethylbenzene protection liquid, sealed after reinstalling aluminide-coating bag after pouch is sealed, and used the r radiation sterilization.
For improving sutural flexibility, can in collagen protein and chitin, add softener and be mixed and made into the spinning liquid complex, its weight ratio is: collagen protein: chitin: softener=89: (7～10): (4～1); Softener can be Oleum Arachidis hypogaeae semen, castor oil, Oleum Brassicae campestris, Oleum Glycines or other vegetable oil.This complex is made the flexible suture line through system Wiring technology same as described above.
Advantage of the present invention is:
1, the stitching thread that makes of the present invention obviously improves wet knot strength, makes the absorption phase can be 7～9 days, prolongs the absorption phase, can satisfy clinical instructions for use.It is little to deposit degraded, and this stitching thread can meet and exceed the index of the 22 edition defined of American Pharmacopeia, can spin 0/9～2# line.
2, contain a certain proportion of softener in the stitching thread of the present invention, improve the stitching thread flexibility, adapt to clinical requirement better.
Prove through biological test and clinic trial that 3, it is light that the present invention has tissue reflection, can absorb fully, non-stimulated, have no side effect, mending stitch place, healing back does not have the advantage of cicatrix.
The embodiment of the invention:
At first prepare the collagen protein swelling solution; Fresh tendon Bovis seu Bubali is peelled off outside tendon bits and fat with scalpel, and the fascia and other impurity that then every tendon Bovis seu Bubali are scraped off the surface are placed in the household freezer freezing.Time spent is taken out beef tendon, being cut into thickness is the tendon sheet of 1.5 millimeter, taking by weighing 500 grams washes three times with distilled water, strain dried, add 9000 milliliters of ficin 0.5 grams, tetrasodium ethylenediamine tetraacetate 1.5 grams, distilled water then, place the incubator about 37 ℃ to cultivate 20 hours, take out the back, add 500 ml distilled waters and 5 milliliters of H again with distilled water flushing three times
2O
2, killed enzyme 1 hour.Tendon sheet behind the enzyme then adds 8000 milliliters of H with distilled water flushing three～four times extremely
2O and 12 gram dichloroacetic acid swellings are about 8 hours.Tendon sheet after the swelling was fully stirred 6 hours with food blending machine, filter, remove impurity and reach not swelling thing, then the collagen protein that makes is placed 5 ℃ of left and right sides refrigerators to preserve standby with 80 purpose stainless (steel) wires.
The preparation of chitin solution: taking by weighing and putting into concentration after 250 gram chitins are cleaned is 1.5% dichloroacetic acid solution stirring and dissolving 10 hours, filters with 120 order stainless (steel) wires, removes insoluble impurities, and it is standby to be placed in the refrigerator about 5 ℃ preservation.
To spin two kinds of lines of 0/1 line (or 0/6 line) is example, identical because of preparing sutural technical process, only has any different on proportioning, is simplified illustration, and the proportioning of 0/6 line has been drawn together with bracket, is the manufacture process of spinning 0/1 line (or 0/6 line) below:
By weight, collagen protein: chitin=92: 8 (or 80: 20) mixes formation spinning liquid complex; For improving sutural flexibility, collagen protein, chitin and Oleum Glycines to be mixed, its weight ratio is; Collagen protein: chitin: Oleum Glycines=89: 7: 4 (or 89: 10: 1); Any complex of making by said ratio fully stirred 2 hours with food blending machine, made its mix homogeneously, and at 3000 rev/mins, centrifugal 15 minutes of the centrifuge high speed below 20 ℃ is removed bubble, promptly obtains spinning solution.
The spinning solution that makes is packed in the spinning basin, use 3kg/cm
2(or 1.5kg/cm
2) nitrogen pressure spinning solution has been clamp-oned 98% acetone, 0.9% distilled water, 1.1% ammonia (or 98% acetone, 1.4% distilled water, 0.6% ammonia) be shaped 1 minute in the vertical coagulating bath, the strand that is shaped is twisted on 1500 rev/mins of twisters, enter behind the plying and fill 98% distilled water, 1.6% formaldehyde, 0.4% 0.3N NaOH (or 98% distilled water, 0.8% formaldehyde, 1.2% 0.3NNaOH) in the horizontal crosslinked bath crosslinked about 1 minute, enter rinsing bowl, through twisting for the second time, remove and anhydrate and cross-linking agent, 50 ℃ of stainless exsiccator inner dryings 1 minute, volume was scratched and is promptly got stitching thread on winding roller.
Take off winding roller, line is wrapped on the specific fixed length frame, intercept 30 centimetres, 45 centimetres, the line of 75 centimeter length respectively, it is that 95% ethanol and concentration are to soak 24 hours in 8% the glycerol mixed liquor that the line of fixed length is immersed in concentration, ethanol wherein: glycerol (volume ratio)=4: 6, with extracting after the line taking-up, putting into concentration again is that the immersion of 75% ethanol is stand-by.
To as the long used stitching thread in position of absorption phases such as oral cavity, need carry out the modification of chromium system and handle, its method is; Need in concentration for thicker line and be tanning 20 minutes in 10% chromium sulfate solution, be that tanning is after 15 minutes in 3% chromium sulfate solution that reuse concentration is 1%Na needing in concentration than fine rule
2CO
3Decide chromium in the solution 40～60 minutes, and can obtain a kind of stitching thread that matches with the wound healing phase.
One is with pin or does not put into nontoxic polyethylene pouch with the line of pin, injecting 1.5 ml concns with syringe is 75% ethanol, reinstall after sealing in the aluminum platinum pouch, on packer, seal again, with the r roentgenization sterilization that is 2,000,000 rads of packaged stitching thread dosage, promptly obtain medically absorbing, the flexible material stitching thread.
Claims (4)
1, a kind of medical absorbable biological material, flexible suture line, it is the complex that includes collagen protein, it is characterized in that:
(1) this stitching thread is the complex by collagen protein and chitin, crosslinked spinning after being shaped and getting;
(2) this stitching thread can be a monofilament, membranaceous or netted.
2, according to the stitching thread described in the claim 1, it is characterized in that also containing in this stitching thread the pure natural softener, softener is Oleum Arachidis hypogaeae semen, castor oil, Oleum Brassicae campestris, Oleum Glycines or other vegetable oil.
3, the manufacture method of a kind of medical absorbable biological material, flexible suture line, it is to use earlier the extraction of collagen enzymatic digestion swelling solution from animal connective tissue, it is characterized in that in the collagen protein swelling solution, adding chitin solution, mix in proportion, form complex (spinning stitching thread stock solution), through coagulating bath shaping, crosslinked bath, twice twisting, washing, drying, the modification of chromium system and make, making step is as follows with complex:
(1) preparation of chitin solution:
Water is cleaned chitin, is placed on concentration and is in 1.5% the dichloroacetic acid solution to dissolve, and again through agitation and filtration, removes insoluble impurities, preserves standby under 5 ℃ of left and right sides temperature;
(2) shaping of complex (spinning stitching thread stock solution), crosslinked, washing, dry run;
(2.1) complex preparation:
The chitin solution that obtains in collagen protein swelling solution and (1) is mixed in proportion, its weight ratio is: collagen protein: chitin=(80～92): (20～8), mixed liquor is stirred, and again through the high speed centrifugation de-bubbled, the complex that obtains spinning liquid is stand-by;
(2.2) shaping of complex, crosslinked, washing, dry run:
(2.1) are obtained complex pack in the spinning basin, with 0.5～3kg/cm
2Nitrogen pressure is clamp-oned in the coagulating bath that contains acetone, distilled water, ammonia, its volume ratio is: acetone: distilled water: ammonia=98: (0.9～1.4): (1.1～0.6), enter crosslinked bath after twisted and plied, and after washing, twisting, dry, reeling promptly gets stitching thread, wherein crosslinked bath is made up of distilled water, formaldehyde and sodium hydroxide, and their volume ratio is; Distilled water: formaldehyde: 0.2～0.5N NaOH solution=98: (0.8～1.6): (1.2～0.4).
(3) sutural processing:
The stitching thread that makes is cut into different length on demand, putting into concentration and be 95% ethanol and concentration is that 8% glycerol mixed solution soaked 12～24 hours, wherein in the mixed liquor by volume, ethanol: glycerol=4: 6, line after the immersion takes out and extracts, putting into concentration again is that 75% ethanol soaks, to be packaged;
(4) sutural chromium system modification:
With concentration is 3%～10% chromium sulfate solution tanning stitching thread 15～20 minutes, and reuse concentration is 1%Na
2CO
3Solution was decided chromium 40～60 minutes;
(5) packaging sterilizing:
In nontoxic polyethylene pouch, pack into band pin or not with the stitching thread of pin, implantation concentration is to seal behind 75% ethanol or the dimethylbenzene protection liquid in the pouch, and then seals in the aluminide-coating bag of packing into, with the stitching thread that installs through the r radiation sterilization.
4, according to the manufacture method described in the claim 3, the preparation that it is characterized in that the spinning liquid complex can also be by making after collagen protein, chitin and the softener mixing, its weight ratio is: collagen protein: chitin: softener=89: (7～10): (4～1), mixed liquor is stirred, again through the high speed centrifugation de-bubbled, the complex that obtains spinning liquid is stand-by, and remaining this stitching thread processing technology is identical with above-mentioned technology.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN94119089A CN1065773C (en) | 1994-12-28 | 1994-12-28 | Flexible suture of absobable biological material for medical use |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN94119089A CN1065773C (en) | 1994-12-28 | 1994-12-28 | Flexible suture of absobable biological material for medical use |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1125622A true CN1125622A (en) | 1996-07-03 |
| CN1065773C CN1065773C (en) | 2001-05-16 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN94119089A Expired - Fee Related CN1065773C (en) | 1994-12-28 | 1994-12-28 | Flexible suture of absobable biological material for medical use |
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| CN (1) | CN1065773C (en) |
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| US7513093B2 (en) | 2002-10-04 | 2009-04-07 | Ethicon, Inc. | Method of preparing a packaged antimicrobial medical device |
| US8112973B2 (en) | 2002-10-04 | 2012-02-14 | Ethicon, Inc. | Method of making a packaged antimicrobial suture |
| US8133437B2 (en) * | 2002-10-04 | 2012-03-13 | Ethicon, Inc. | Method of preparing an antimicrobial packaged medical device |
| CN102397592A (en) * | 2010-09-17 | 2012-04-04 | 卢爱军 | Dipping technology of protein strings |
| US8960422B2 (en) | 2002-10-04 | 2015-02-24 | Ethicon, Inc. | Packaged antimicrobial medical device and method of preparing same |
| CN104587522A (en) * | 2015-02-15 | 2015-05-06 | 黑龙江力海鑫生物科技股份有限公司 | Nutria tail collagen surgical suture and preparation method thereof |
| CN105251040A (en) * | 2015-10-28 | 2016-01-20 | 钊桂英 | Absorbable medical anti-infective suture line and preparation method |
| CN105251041A (en) * | 2015-10-28 | 2016-01-20 | 钊桂英 | Pure natural collagen medical suture line and preparation method |
| CN105288717A (en) * | 2015-10-28 | 2016-02-03 | 钊桂英 | Medicinal absorbable suture and preparation method |
| CN105311672A (en) * | 2015-11-19 | 2016-02-10 | 耿文真 | Medical absorbable suture and preparation method thereof |
| US9474524B2 (en) | 2002-10-04 | 2016-10-25 | Ethicon, Inc. | Packaged antimicrobial medical device having improved shelf life and method of preparing same |
| CN107970487A (en) * | 2017-12-26 | 2018-05-01 | 徐州仁和医疗科技有限公司 | A kind of novel medical operation suture |
| CN108057130A (en) * | 2017-12-26 | 2018-05-22 | 庞振方 | A kind of preparation process of medical collagen suture |
| CN108468094A (en) * | 2018-05-30 | 2018-08-31 | 南充盛达鸿科技有限公司 | A method of guiding fiber roll change and trend |
| CN109078215A (en) * | 2018-09-17 | 2018-12-25 | 佛山市禅城区诺高环保科技有限公司 | A kind of preparation method of absorbable antibacterial suture |
| US10245025B2 (en) | 2012-04-06 | 2019-04-02 | Ethicon, Inc. | Packaged antimicrobial medical device having improved shelf life and method of preparing same |
| CN113718351A (en) * | 2021-08-31 | 2021-11-30 | 清华大学 | Fiber multi-strand beam combining method |
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| CN100420488C (en) * | 2003-06-03 | 2008-09-24 | 天津市久康生物工程开发有限公司 | Absorbable medical chitin suture lines and their production |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4378017A (en) * | 1980-03-21 | 1983-03-29 | Kureha Kagaku Kogyo Kabushiki Kaisha | Composite material of de-N-acetylated chitin and fibrous collagen |
| CN1021953C (en) * | 1989-11-08 | 1993-09-01 | 中国医学科学院生物医学工程研究所 | Collagen-polyvinyl alcoholic operation sutures and manufacturing method thereof |
-
1994
- 1994-12-28 CN CN94119089A patent/CN1065773C/en not_active Expired - Fee Related
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| US9149273B2 (en) | 2002-10-04 | 2015-10-06 | Ethicon, Inc. | Packaged antimicrobial medical device |
| US8156718B2 (en) | 2002-10-04 | 2012-04-17 | Ethicon, Inc. | Method of preparing a packaged antimicrobial medical device |
| US9597067B2 (en) | 2002-10-04 | 2017-03-21 | Ethicon, Inc. | Packaged antimicrobial medical device and method of preparing same |
| US9597072B2 (en) | 2002-10-04 | 2017-03-21 | Ethicon, Inc. | Method of preparing a packaged antimicrobial medical device |
| US9474524B2 (en) | 2002-10-04 | 2016-10-25 | Ethicon, Inc. | Packaged antimicrobial medical device having improved shelf life and method of preparing same |
| US8668867B2 (en) | 2002-10-04 | 2014-03-11 | Ethicon, Inc. | Method of preparing an antimicrobial packaged medical device |
| US8960422B2 (en) | 2002-10-04 | 2015-02-24 | Ethicon, Inc. | Packaged antimicrobial medical device and method of preparing same |
| US7513093B2 (en) | 2002-10-04 | 2009-04-07 | Ethicon, Inc. | Method of preparing a packaged antimicrobial medical device |
| US8133437B2 (en) * | 2002-10-04 | 2012-03-13 | Ethicon, Inc. | Method of preparing an antimicrobial packaged medical device |
| US8112973B2 (en) | 2002-10-04 | 2012-02-14 | Ethicon, Inc. | Method of making a packaged antimicrobial suture |
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| US10245025B2 (en) | 2012-04-06 | 2019-04-02 | Ethicon, Inc. | Packaged antimicrobial medical device having improved shelf life and method of preparing same |
| US11707272B2 (en) | 2012-04-06 | 2023-07-25 | Cilag Gmbh International | Packaged antimicrobial medical device having improved shelf life and method of preparing same |
| CN104587522A (en) * | 2015-02-15 | 2015-05-06 | 黑龙江力海鑫生物科技股份有限公司 | Nutria tail collagen surgical suture and preparation method thereof |
| CN105288717A (en) * | 2015-10-28 | 2016-02-03 | 钊桂英 | Medicinal absorbable suture and preparation method |
| CN105251041A (en) * | 2015-10-28 | 2016-01-20 | 钊桂英 | Pure natural collagen medical suture line and preparation method |
| CN105251040A (en) * | 2015-10-28 | 2016-01-20 | 钊桂英 | Absorbable medical anti-infective suture line and preparation method |
| CN105311672A (en) * | 2015-11-19 | 2016-02-10 | 耿文真 | Medical absorbable suture and preparation method thereof |
| CN108057130A (en) * | 2017-12-26 | 2018-05-22 | 庞振方 | A kind of preparation process of medical collagen suture |
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| CN109078215B (en) * | 2018-09-17 | 2021-05-25 | 海南建科药业有限公司 | Preparation method of absorbable antibacterial suture line |
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