CN101703794A - Controlled degradable surgical suture thread and fabricating method thereof - Google Patents
Controlled degradable surgical suture thread and fabricating method thereof Download PDFInfo
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- CN101703794A CN101703794A CN200910223340A CN200910223340A CN101703794A CN 101703794 A CN101703794 A CN 101703794A CN 200910223340 A CN200910223340 A CN 200910223340A CN 200910223340 A CN200910223340 A CN 200910223340A CN 101703794 A CN101703794 A CN 101703794A
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Abstract
The invention discloses a controlled degradable surgical suture thread and a fabricating method thereof. The innermost part is chitosan fiber core, the middle part is collagen layer, and the outermost part is ethyloic-chitosan layer. From innermost to outermost, the thickness ratio of each layer is 2:X:(3-X), wherein X is larger than 1 and smaller than 3. The value of X is related to degradation velocity of the surgical suture thread: the larger the value, the faster the degradation velocity of the surgical suture thread, and the shorter the healing period of wound suitable to be sutured; and the smaller the value, the slower the degradation velocity of the surgical suture thread, and the longer the healing period of wound suitable to be sutured. The fabricating method of the surgical suture thread comprises: (1) preparing chitosan fiber core and collagen; (2) covering a layer of collagen outside the chitosan fiber; (3) covering a layer of ethyloic-chitosan outside the collagen cover of the chitosan fiber; (4) processing and polishing the suture thread prepared in (3) by an automatic coreless grinder, connecting with suture needles of different models to prepare into a finish product of surgical suture thread. The technical scheme of the invention has plentiful advantages: controllable degradation velocity, high tension strength, improved biocompatibility and anti-infectious property, quick wound healing, no obvious scars, good biocompatibility, etc.
Description
Technical field
The invention belongs to medical instruments field, relate to controlled degradable surgical suture thread and manufacture method thereof that a kind of human body can absorb specifically.
Background technology
Surgical sutures is one of the most basic in the surgical operation, most important material, is mainly used in the various sewing hemostasis of organizing, residual cavity locking and organize involutory.Surgical sutures mainly is divided into non-absorption stitching thread and absorbable suture two big classes, and absorbable suture is compared with non-absorption stitching thread, and its main advantages is: 1. no antigen (only producing slight tissue reaction when absorbing); 2. there is not pyrogenicity; 3. wound healing is complete; 4. need not to take out stitches, alleviated patient's misery, reduced the chance of bringing out infection; Thereby absorbable suture is the trend of surgical sutures development.Divide from making raw material, the absorbable suture of clinical practice mainly contains: 1. natural material; 2. chemical synthetic material; 3. the complex of natural material and chemical synthetic material.Wherein, because the surgical sutures of natural material manufacturing meets the social current of the consumption concept and the back to nature of environmental protection, be subjected to the support of national policy more.
In the natural material surgical sutures, collagen class stitching thread is (as applying for 03102533.1,89108465.7,200910013608.7 it is disclosed), chitin class stitching thread is (as application CN20031029976,20030603 is disclosed), chitosan class stitching thread (disclosed as applying for 03129976.8) etc. has market prospect, but large-scale application clinically not as yet, its major defect is: collagen stitching thread degradation in vivo is fast, absorb early, be unfavorable for wound healing and alleviate cicatrization (hot Flos Lonicerae. medical stitching thread Biodegradable fiber. textile technology progress, 3:12-13,2005; Fan Yaoming. the progress of suture. nonwoven techniques and fabrics for industrial use. weaving Leader, 1:58-63,2006); Though existing chitin, chitosan stitching thread have certain antibacterial ability, but degraded is fast, especially the chitosan molecule that deacetylation is lower is subjected to the more remarkable (Zhang Chunxue of Degradation of enzyme, Yuan Xiaoyan, Shengjing city. the biological medical polymer fibrous material. the macromolecule circular, 12:34-38,2006), thereby tensile strength is not high enough, particularly knot strength is poor, cause sutural degradation speed and speed of wound healing be not complementary adaptation (Zhao Jingna. present situation is used in the research of medical operation suture thread. external silk .2:26-29,2008; Yin Yan, He Xiaowei, yellow strong, Yu Shujuan. chitosan is in the application that can absorb in the operation suture thread. Chinese beet sugar industry, 4:28-31,2006).The main cause that produces above defective is, the mechanical strength of these natural materials itself is just not high, after implanting by operation stitching, can degrade under the effect of body fluid immersion and enzyme, sutural mechanical strength is reduced, miopragia or forfeiture too early.
In sum, existing collagen or chitosan class can absorb surgical sutures and have following defective: (1) degraded and absorbed speed is asynchronous with wound healing speed, the biggest problem that existing collagen or chitosan class can absorb surgical sutures is that degraded and absorbed speed and wound healing speed are difficult to synchronously, cause sutural effect to be made a discount, if degraded and absorbed speed greatly faster than wound healing speed, then can make the stitching thread effect weaken; If degraded and absorbed speed is much slower than wound healing speed, then can cause wound healing after stitching thread still remain in the human body, can induce tissue inflammatory reaction and pain; (2) tensile strength and knot strength relative deficiency because material itself, collagen or the sutural tensile strength of chitosan class and knot strength not high relatively (Zhao Jingna. present situation is used in the research of medical operation suture thread. external silk .2:26-29,2008; Yin Yan, He Xiaowei, yellow strong, Yu Shujuan. chitosan is in the application that can absorb in the operation suture thread. Chinese beet sugar industry, 4:28-31,2006); (3) chitosan class surgical sutures antibacterial ability relatively poor relatively (Yin Yan, He Xiaowei, yellow strong, Yu Shujuan. chitosan is in the application that can absorb in the operation suture thread. Chinese beet sugar industry, 4:28-31,2006; Cuero R.G.Antimicrobial action ofexogenous chitosan.EXS.87:315-333,1999).
Summary of the invention
The objective of the invention is in order to solve the existing above-mentioned defective that can absorb surgical sutures, a kind of controlled degradable surgical suture thread and manufacture method thereof by the new material made proposed, it has better anti-microbial property, significantly reduced the chance of bringing out wound infection, and wound healing is fast, do not have obvious cicatrix, in clinical practice, have broad prospects.
Realize that above-mentioned purpose technical scheme of the present invention is, the controlled degradable surgical suture thread outermost is the carboxymethyl chitosan layer, the centre is a collagen layer, the inside is the chitin fiber core, each layer thickness ratio is, chitin fiber core: collagen layer: carboxymethyl chitosan layer=2: X: (3-X), 1＜X＜3 wherein.The size of X value is relevant with the stitching thread degradation rate: the X value is big more, and the stitching thread degradation rate is fast more, and the wound healing phase that is suitable for sewing up is short more; Otherwise the X value is more little, and the stitching thread degradation rate is slow more, and the wound healing phase that is suitable for sewing up is long more.
Technical scheme of the present invention also relates to above-mentioned controlled degradable surgical suture thread manufacture method, and this method may further comprise the steps: (1) preparation chitin fiber core and collagen; (2) the outer bread one deck collagen of chitin fiber; (3) bread one deck carboxymethyl chitosan outside the collagen coating of chitin fiber; (4) stitching thread of (3) step preparation being carried out automatic coreless grinding machine processing polishing back is connected with the sewing needle of different model and makes the surgical sutures finished product.
Adopted cross-linking agent to be connected chitin fiber core and intermediary collagen layer respectively in above-mentioned steps (2) and the step (3), and intermediary collagen layer and outmost carboxymethyl chitosan layer, the cross-linking agent here can be that concentration is 0.25% glutaraldehyde.
The above-mentioned method for preparing the chitin fiber core is: (molecular weight is greater than 1.0 * 10 with chitosan
6Deacetylation is more than 90%) be dissolved in 5～6% acetic acid,diluted solution, add 2～3% carbamide, 0.3% zinc acetate as auxiliary agent, be prepared into the spinning solution that contains 2～6% chitosans, with filter, spinning solution after the vacuum outgas, be that 0.2～3mm spinning head sprays in 3～8%NaOH solution it is solidified through diameter, again through 2～5 times of stretching, wash, in 70 ℃ of dry 1h, final acquisition has the chitin fiber of sufficient mechanical strength under tension state.
The method of above-mentioned collagen preparation is: get fresh mammiferous tendon, remove fascia, fat, frozen section, with 37 ℃ of digestion of 0.5% pancreatin 36h, with the tendon sheet of digestion 0.5mol/L acetic acid swelling, mixing, add saturated NaCl precipitating collagen, dialysis precipitating liquid, purification collagen.
The method of above-mentioned collagen preparation also can be: get fresh mammiferous skin, washing, unhairing, defat are cut into the fritter of 1～3cm, add an amount of pepsin and acetum, placed 3～5 days for 4 ℃, intermittently stir, behind the extracting liquid filtering, add NaCl to ultimate density be 10%, the 1500rpm centrifugalize gets the collagen precipitation, it is used the 0.5mol/L acetate dissolution, and the TrisHCl buffer of pH7.5 and distilled water be dialysis alternately, until can not detecting Cl
-Till, get collagen purification solution.
Above-mentioned outside chitin fiber the method for bread one deck collagen be: at ambient temperature, prepare saturated collagen solution, after putting into chitin fiber immersion 3min, dry, with the glutaraldehyde cross-linking of concentration 0.25%, distilled water wash, gradient ethanol, acetone dehydration, after the drying, can dry step increase collagen layer thickness by repeating immersion.
The method of above-mentioned coated outside one deck carboxymethyl chitosan at chitin fiber collagen coating is: under heating condition, prepare saturated carboxymethyl chitosan sugar juice, after being cooled to room temperature, after putting into the chitin fiber immersion 3min of collagen coating, drying, is 0.25% glutaraldehyde cross-linking with concentration, distilled water wash, gradient ethanol, acetone dehydration after the drying, can increase carboxymethyl chitosan thickness by soaking repeatedly to dry.
The advantage that technical scheme of the present invention has comprises: 1. degradation speed is controlled, surgical sutures of the present invention is core with the chitin fiber, by special chemical reaction at the surface-crosslinked last layer collagen layer of chitin fiber, again at the crosslinked last layer carboxymethyl chitosan layer in collagen layer outside, the carboxymethyl chitosan layer, collagen layer is degraded under the different enzyme effects in human body with the chitosan core, because these three kinds of composition locus differences, the priority sequence of operation of enzyme is also different, carboxymethyl chitosan and degradation of chitosan are slow, collagen degradation is fast, mass ratio by the control three reaches the purpose of control degradation speed, makes sutural degradation rate consistent with wound healing speed; 2. the tensile strength height, pliability is good, knotting is convenient, existing chitin, the sutural tensile strength relative deficiency of chitosan, chemical crosslinking effect meeting by packaging technique improves sutural tensile strength greatly, make the easier operation of stitching thread, overcome the short and low shortcoming of wet knot strength of pure collagen stitching thread absorption phase simultaneously. surgical sutures ultimate strength＞500N of the present invention, tie ultimate strength＞300N greatly, meet the relevant regulations of 109 pages of 90 editions two appendix of Chinese Pharmacopoeia; 3. biocompatibility and anti-infection property have been improved, the present invention is by increasing the biocompatibility that collagen layer has improved chitin fiber, be positioned at the outermost carboxymethyl chitosan of stitching thread and have better anti-inflammation effect than chitosan, can to some should secondary suture wound carry out primary suture; 4. wound healing fast, do not have obvious cicatrix, chitosan and collagen all have the effect that promotes wound healing, reduces cicatrix, healing back wound surface is similar to normal structure, does not have obvious cicatrix; 5. excellent biological compatibility, zoopery of the present invention shows that stitching thread of the present invention has excellent biological compatibility (comprising histocompatibility, blood compatibility and immunity), does not have allergy, stimulation, haemolysis and inflammatory reaction, does not have other untoward reaction.
Description of drawings
Fig. 1 is the sectional structure chart of controlled degradable surgical suture thread of the present invention; 1-1, carboxymethyl chitosan layer among the figure; 1-2, collagen layer; 1-3, chitin fiber core;
Fig. 2 is each layer thickness definition figure of controlled degradable surgical suture thread of the present invention; 1-1L among the figure is carboxymethyl chitosan layer thickness (3-X), and 1-2L is collagen layer thickness (X), and 1-3L is a chitin fiber core thickness (2), also is the radius of 1-3.
Fig. 3 is the manufacturing flow chart of operation suture thread of the present invention.
The specific embodiment
Below technical scheme of the present invention is specifically described, as shown in the figure, Fig. 1 is the sectional structure chart of controlled degradable surgical suture thread of the present invention, and among the figure, the structure of controlled degradable surgical suture thread from the inside to the outside, be followed successively by, chitin fiber core 1-3, collagen layer 1-2 and carboxymethyl chitosan layer 1-1, each layer thickness ratio is, chitin fiber core: collagen layer: carboxymethyl chitosan layer=2: X: (3-X), 1＜X＜3 wherein.The size of X value is relevant with the stitching thread degradation rate: the X value is big more, and the stitching thread degradation rate is fast more, and the wound healing phase that is suitable for sewing up is short more; Otherwise the X value is more little, and the stitching thread degradation rate is slow more, and the wound healing phase that is suitable for sewing up is long more.For example,, to carry out 4 layered sutures usually and close, that is: Musclar layer (can use the of the present invention stitching thread of the model of X=1 as 3#, healing stage is 12-15 days) for soft tissue laceration or operative incision; Fascia layer (can use the of the present invention stitching thread of the model of X=0.5 as 3#, healing stage is 14-17 days); Hypodermis layer (can use the of the present invention stitching thread of the model of X=1.5 as 1#, healing stage is 10-13 days); Skin layer (can use the of the present invention stitching thread of the model of X=2 as 1#, healing stage is 8-11 days).
Fig. 2 is each layer thickness definition figure of controlled degradable surgical suture thread of the present invention, and the 1-1L among the figure is carboxymethyl chitosan layer thickness (3-X), and 1-2L is collagen layer thickness (X), and 1-3L is a chitin fiber core thickness (2), also is the radius of 1-3.
Fig. 3 is the manufacturing flow chart of controlled degradable surgical suture thread of the present invention, and when making controlled degradable surgical suture thread of the present invention, at first (relative molecular mass is greater than 1.0 * 10 with highly purified chitosan as shown in the figure
6Deacetylation is more than 90%) be raw material, adopt wet spinning process to prepare chitin fiber, use the spinning head in the different apertures of customization to prepare the chitin fiber in different apertures, stitching thread as different model is made raw material, concrete grammar is, chitosan is dissolved in 5～6% acetic acid,diluted solution, add 2～3% carbamide, 0.3% zinc acetate is as auxiliary agent, be prepared into the spinning solution that contains 2～6% chitosans, to filter, spinning solution after the vacuum outgas, through diameter is that 0.2～3mm spinning head sprays in 3～8%NaOH solution it is solidified, again through 2～5 times of stretchings, washing, in 70 ℃ of dry 1h, final acquisition has the chitin fiber of sufficient mechanical strength under tension state; Carry out the collagen preparation after finishing the chitin fiber preparation, concrete preparation method is: get fresh mammiferous tendon, remove fascia, fat, frozen section is with 37 ℃ of digestion of 0.5% pancreatin 36h, with the tendon sheet of digestion 0.5mol/L acetic acid swelling, mixing, add saturated NaCl precipitating collagen, dialysis precipitating liquid, purification collagen; The method of collagen preparation also can be: get fresh mammiferous skin, washing, unhairing, defat are cut into the fritter of 1～3cm, add an amount of pepsin and acetum, placed 3～5 days for 4 ℃, intermittently stir, behind the extracting liquid filtering, add NaCl to ultimate density be 10%, the 1500rpm centrifugalize gets the collagen precipitation, it is used the 0.5mol/L acetate dissolution, and the TrisHCI buffer of pH 7.5 and distilled water be dialysis alternately, until can not detecting Cl
-Till, get collagen purification solution.
After finishing the preparation of chitin fiber core and collagen, carry out bread one deck collagen outside chitin fiber, concrete grammar is: at ambient temperature, prepare saturated collagen solution, after putting into chitin fiber immersion 3min, dry, with the glutaraldehyde cross-linking of concentration 0.25%, distilled water wash, gradient ethanol, acetone dehydration after the drying, can be dried step increase collagen layer thickness by repeating immersion.
The 3rd step was carried out the coated outside one deck carboxymethyl chitosan at chitin fiber collagen coating, concrete grammar is: under heating condition, prepare saturated carboxymethyl chitosan sugar juice, be cooled to room temperature after, after the chitin fiber of putting into the collagen coating soaks 3min, dry, with concentration is 0.25% glutaraldehyde cross-linking, distilled water wash, gradient ethanol, acetone dehydration, after the drying, can increase carboxymethyl chitosan thickness by soaking repeatedly to dry.
At last, the controlled degradable surgical suture thread of above-mentioned manufacturing being carried out automatic coreless grinding machine processing polishing back is connected with the sewing needle of different model and makes the controlled degradable surgical suture thread finished product.
Technique scheme has only embodied the optimal technical scheme of technical solution of the present invention, those skilled in the art to some part wherein some changes that may make all embodied principle of the present invention, belong within protection scope of the present invention.
Claims (10)
1. controlled degradable surgical suture thread is characterized in that this stitching thread forms by three layers, and outermost is carboxymethyl chitosan layer (1-1), and the centre is collagen layer (1-2), and the inside is chitin fiber core (1-3).
2. controlled degradable surgical suture thread according to claim 1, it is characterized in that, the chitin fiber core, the thickness proportion of collagen layer and carboxymethyl chitosan layer is 2: X: (3-X), 1＜X＜3 wherein, the size of X value is relevant with the stitching thread degradation rate: the X value is big more, and the stitching thread degradation rate is fast more, and the wound healing phase that is suitable for sewing up is short more; Otherwise the X value is more little, and the stitching thread degradation rate is slow more, and the wound healing phase that is suitable for sewing up is long more.
3. controlled degradable surgical suture thread manufacture method according to claim 1 is characterized in that, this method may further comprise the steps:
(1) preparation chitin fiber core and collagen;
(2) the outer bread one deck collagen of chitin fiber;
(3) wrap one deck carboxymethyl chitosan again in the collagen coating outside of chitin fiber;
(4) stitching thread of (3) step preparation being carried out automatic coreless grinding machine processing polishing back is connected with the sewing needle of different model and makes the surgical sutures finished product.
4. according to the controlled degradable surgical suture thread manufacture method of claim 3, it is characterized in that, adopted cross-linking agent to be connected chitin fiber core and collagen layer respectively in step (2) and the step (3), and collagen layer and carboxymethyl chitosan layer.
5. according to the controlled degradable surgical suture thread manufacture method of claim 4, it is characterized in that cross-linking agent can be that concentration is 0.25% glutaraldehyde.
6. according to the controlled degradable surgical suture thread manufacture method of claim 3, it is characterized in that, the method for preparing the chitin fiber core is: chitosan is dissolved in 5～6% acetic acid,diluted solution, add 2～3% carbamide, 0.3% zinc acetate is as auxiliary agent, be prepared into the spinning solution that contains 2～6% chitosans, to filter, spinning solution after the vacuum outgas, through diameter is that 0.2～3mm spinning head sprays in 3～8%NaOH solution it is solidified, again through 2～5 times of stretchings, washing, in 70 ℃ of dry 1h, final acquisition has the chitin fiber of sufficient mechanical strength under tension state.
7. according to the controlled degradable surgical suture thread manufacture method of claim 3, it is characterized in that, the method of collagen preparation is: get fresh mammiferous tendon, remove fascia, fat, frozen section, with 37 ℃ of digestion of 0.5% pancreatin 36h, with the tendon sheet of digestion 0.5mol/L acetic acid swelling, mixing adds saturated NaCl precipitating collagen, dialysis precipitating liquid, purification collagen.
8. according to the controlled degradable surgical suture thread manufacture method of claim 3, it is characterized in that, the method of collagen preparation also can be: get fresh mammiferous skin, washing, unhairing, defat, be cut into the fritter of 1～3cm, add an amount of pepsin and acetum, placed 3～5 days for 4 ℃, intermittently stir, behind the extracting liquid filtering, add NaCl to ultimate density be 10%, the 1500rpm centrifugalize gets the collagen precipitation, it is used the 0.5mol/L acetate dissolution, and the TrisHCI buffer of pH 7.5 and distilled water be dialysis alternately, until can not detecting Cl
-Till, get collagen purification solution.
9. according to the controlled degradable surgical suture thread manufacture method of claim 3, it is characterized in that, the method of bread one deck collagen is outside chitin fiber: at ambient temperature, prepare saturated collagen solution, after putting into chitin fiber and soaking 3min, dry, with the glutaraldehyde cross-linking of concentration 0.25%, distilled water wash, gradient ethanol, acetone dehydration, after the drying, can dry step increase collagen layer thickness by repeating immersion.
10. according to the controlled degradable surgical suture thread manufacture method of claim 3, it is characterized in that, method at coated outside one deck carboxymethyl chitosan of chitin fiber collagen coating is: under heating condition, prepare saturated carboxymethyl chitosan sugar juice, after being cooled to room temperature, after putting into the chitin fiber immersion 3min of collagen coating, dry, it with concentration 0.25% glutaraldehyde cross-linking, distilled water wash, gradient ethanol, acetone dehydration after the drying, can increase carboxymethyl chitosan thickness by soaking repeatedly to dry.
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| CN102552964A (en) * | 2012-01-09 | 2012-07-11 | 青岛明药堂医药科技开发有限公司 | Nano silver chitosan composite antibacterial composition, adhesive bandage and preparation method of adhesive bandage |
| CN104069541A (en) * | 2013-12-04 | 2014-10-01 | 江西龙腾生物高科技有限公司 | Preparation method of collagen suture line |
| CN104173083A (en) * | 2014-09-03 | 2014-12-03 | 胡元国 | Medical suture and manufacturing method thereof |
| CN105770978A (en) * | 2016-03-21 | 2016-07-20 | 江苏广达医材集团有限公司 | Biodegradable medical abdominal surgical suture material |
| CN108273119A (en) * | 2018-03-08 | 2018-07-13 | 戴庆涛 | A kind of operation suture thread of gastrointestinal surgery and preparation method thereof |
| CN108642858A (en) * | 2018-04-26 | 2018-10-12 | 海斯摩尔生物科技有限公司 | A kind of preparation method of controlled degradation suture |
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| CN108853562A (en) * | 2018-09-13 | 2018-11-23 | 王传强 | A kind of absorbable pre-knotted operation suture thread of thoracic surgery sustained antiinfective |
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| CN201533923U (en) * | 2009-11-18 | 2010-07-28 | 中国人民解放军第二炮兵总医院 | Controllably degraded surgery suture |
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| CN104069541A (en) * | 2013-12-04 | 2014-10-01 | 江西龙腾生物高科技有限公司 | Preparation method of collagen suture line |
| CN104173083A (en) * | 2014-09-03 | 2014-12-03 | 胡元国 | Medical suture and manufacturing method thereof |
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| CN105770978A (en) * | 2016-03-21 | 2016-07-20 | 江苏广达医材集团有限公司 | Biodegradable medical abdominal surgical suture material |
| CN108273119B (en) * | 2018-03-08 | 2020-11-20 | 戴庆涛 | Surgical suture for gastrointestinal surgery and manufacturing method thereof |
| CN108273119A (en) * | 2018-03-08 | 2018-07-13 | 戴庆涛 | A kind of operation suture thread of gastrointestinal surgery and preparation method thereof |
| CN108642858A (en) * | 2018-04-26 | 2018-10-12 | 海斯摩尔生物科技有限公司 | A kind of preparation method of controlled degradation suture |
| CN108642858B (en) * | 2018-04-26 | 2020-08-21 | 海斯摩尔生物科技有限公司 | Preparation method of controllable degradable medical suture |
| CN108660737B (en) * | 2018-04-26 | 2020-08-25 | 东华大学 | Preparation method of high-strength medical suture |
| CN108660737A (en) * | 2018-04-26 | 2018-10-16 | 东华大学 | A kind of preparation method of high-strength suture |
| CN108853562A (en) * | 2018-09-13 | 2018-11-23 | 王传强 | A kind of absorbable pre-knotted operation suture thread of thoracic surgery sustained antiinfective |
| CN111134746A (en) * | 2019-12-30 | 2020-05-12 | 山东省肿瘤防治研究院（山东省肿瘤医院） | Surgical suture for gastrointestinal surgery and manufacturing method thereof |
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| CN112301496A (en) * | 2020-11-03 | 2021-02-02 | 上海普平生物科技有限公司 | Preparation method of controllable degradation surgical suture |
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