CN1241442A - Post-operation adhesion preventing method - Google Patents
Post-operation adhesion preventing method Download PDFInfo
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- CN1241442A CN1241442A CN 99115039 CN99115039A CN1241442A CN 1241442 A CN1241442 A CN 1241442A CN 99115039 CN99115039 CN 99115039 CN 99115039 A CN99115039 A CN 99115039A CN 1241442 A CN1241442 A CN 1241442A
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Abstract
The degradable and absorbable polymer or copolymer material of lactic acid-glycollic acid copolymer, poly-D,L-lactic acid, poly-L-lactic acid and polyglycollic acid is machined at 180-220 deg.C into 0.0002-0.5mm thick film. The film after being disinfected is used in preventing post-operation adhesion, and this can reduce post-operation complication, raise cure effect of the operation and reduce pain of the patient.
Description
The present invention relates to a kind of post-operation adhesion preventing method, be specifically related to adopt the method for biodegradable absorbable polymer as the postoperative antiadhesion barrier.
Tissue adhesion is that one of unsolved important topic has still been arranged since the history of operation both at home and abroad.It often can cause severe complication, as causing adhesive ileus after abdominal part, the operation on pelvis, can cause postoperative epilepsy after the operation of opening cranium, the thyroid postoperative can cause Secondary cases recurrent nerve injury etc., it also is to make the main cause that needs the second operation complication obviously to raise, as intestinal, bile duct injury, laryngeal nerve and parathyroid injury etc.In the research of prevention of postoperative adhesion, only limit to abdominal operation Film with Preventing Adhesion intestinal obstruction in the past.People once kept somewhere silicone oil with intraperitoneal, methods such as medium molecular dextran and streptokinase, but all do not have positive effect, or side effect is arranged.Silicone oil can not be absorbed by the body, although little to the body zest, owing to stay in intraperitoneal for a long time, produce to stimulate and can cause and ooze out and cause secondary adhesion.In molecule levulose acid anhydride owing to be that height oozes, tissue is had zest, make and organize congestion and edema, oozing out increases and causes adhesion.Streptokinase is to inject from keeping somewhere in Intraabdominal porous tubule, and in the hope of solution fibrin, but owing to can only inject in a small amount, pore can be blocked, and tubule transposition etc. is all multifactor, and curative effect is not remarkable yet.Up to now, there is no a kind of report of adhesion preventing method safely and effectively both at home and abroad.
The objective of the invention is to adopt a kind of new post-operation adhesion preventing method,, reach the purpose of convenience, safety, effective anti to overcome the defective of prior art.
The objective of the invention is to adopt following scheme to realize.
The present invention adopts viscosity-average molecular weight＜500,000, following biodegradable absorbable polymer: PLGA (polylactic acid---co-glycolic acid), PDLLA are (poly--D, L-lactic acid), to be processed into thickness 180～220 ℃ of temperature be 0.0002～0.5 millimeter thin film to the copolymer of any one material among PLLA (poly--L-lactic acid), the PGA (polyglycolic acid) or a kind of material and another kind of material, through sterilization, sterilization treatment is used for post-operation adhesion preventing.
The present invention can adopt various macromolecular material film forming process, with the biodegradable absorbable polymer 180～220 ℃ of temperature be processed into the operation desired thickness thin film, as blow molding technology, template forming technology etc.
The operation implementation process is: 1. routine operation is prepared; 2. routine operation operation; 3. biomembrane is cut by the area of actual needs, be covered in the surface (available in case of necessity surgical thread, fixing a little) of each layer surgical wound surface.4. conventional end operation.
Post-operation adhesion preventing method of the present invention, adopting PLGA, PGA, PDLLA, PLLA biodegradable absorbable polymer is antiadhesion barrier, proves through safety experiment and zoopery, makes thin film by these materials and has good flexibility, the degradable absorbability; The favorable tissue compatibility, be fixed in anti position wound surface, to prevent itself and peripheral organization's adhesion, not only can prevent intraperitoneal intestinal adhesion, and can prevent the liver visceral surface, the adhesion of hepatic portal liver 12 fat intestinal ligaments, the esophagus adhesion of thyroid art (pharynx constriction), the adhesion of the subarachnoid space of operation of opening cranium, the adhesion (fallopian tube of pelvic cavity viscera, the uterus ovary), the pleural adhesion in thoracic cavity etc. can effectively reduce postoperative complication, avoided operation once more, improve operative effect, reduced patient's misery, saved medical expense, really be a kind of convenience, post-operation adhesion preventing method safely and effectively.
Be embodiments of the invention below.
Embodiment one
Adopt the method for template forming, PLGA0.5kg with molecular weight 300,000, under 200 ℃ ± 5 ℃ of temperature, be processed into thickness and be 0.0002～0.5 millimeter thin film, ethane via epoxyethane sterilization, sterilization treatment, be used to prevent behind the vertebrae plate resection around the dura mater fibrosis and adhesion and operation on tendon, intestinal surgery, operation on biliary tract post-operation adhesion preventing, human body and zoopery the results are shown in Table 1～2.
Embodiment two
Adopt the method for blow molding, PLGA0.5kg with molecular weight 250,000, in 190 ℃ ± 5 ℃ scopes of temperature, be processed into thickness and be 0.0002～0.5 millimeter thin film, ethane via epoxyethane sterilization, sterilization treatment are used to prevent behind the vertebrae plate resection around the dura mater fibrosis and adhesion and operation on tendon, intestinal surgery, operation on biliary tract post-operation adhesion preventing.Human body and zoopery the results are shown in Table 1-2.
Embodiment three
Adopt the method for template forming, PDLLA0.5kg with molecular weight 200,000, in 190 ℃ ± 5 ℃ scopes of temperature, be processed into thickness and be 0.0002～0.5 millimeter thin film, ethane via epoxyethane sterilization, sterilization treatment, be used to prevent behind the vertebrae plate resection around the dura mater fibrosis and adhesion and operation on tendon, intestinal surgery, operation on biliary tract post-operation adhesion preventing, human body and zoopery the results are shown in Table 1-2.
Embodiment four
Adopt the method for blow molding, PDLLA0.5kg with molecular weight 200,000, in 210 ℃ ± 5 ℃ scopes of temperature, be processed into thickness and be 0.0002～0.5 millimeter thin film, ethane via epoxyethane sterilization, sterilization treatment, be used to prevent behind the vertebrae plate resection around the dura mater fibrosis and adhesion and operation on tendon, intestinal surgery, operation on biliary tract post-operation adhesion preventing, human body and zoopery the results are shown in Table 1-2.
Embodiment five
Adopt the method for template forming, PLLA0.5kg with molecular weight 400,000, in 205 ℃ ± 5 ℃ scopes of temperature, be processed into thickness and be 0.0002～0.5 millimeter thin film, ethane via epoxyethane sterilization, sterilization treatment, be used to prevent behind the vertebrae plate resection around the dura mater fibrosis and adhesion and operation on tendon, intestinal surgery, operation on biliary tract post-operation adhesion preventing, human body and zoopery the results are shown in Table 1-2.
Embodiment six
Adopt the method for blow molding, PLLA0.5kg with molecular weight 400,000, in 210 ℃ ± 5 ℃ scopes of temperature, be processed into thickness and be 0.0002～0.5 millimeter thin film, ethane via epoxyethane sterilization, sterilization treatment, be used to prevent behind the vertebrae plate resection around the dura mater fibrosis and adhesion and operation on tendon, intestinal surgery, operation on biliary tract post-operation adhesion preventing, human body and zoopery the results are shown in Table 1-2.
Embodiment seven
Adopt the method for template forming, PGA0.5kg with molecular weight 180,000, in 190 ℃ ± 5 ℃ scopes of temperature, be processed into thickness and be 0.0002～0.5 millimeter thin film, ethane via epoxyethane sterilization, sterilization treatment, be used to prevent behind the vertebrae plate resection around the dura mater fibrosis and adhesion and operation on tendon, intestinal surgery, operation on biliary tract post-operation adhesion preventing, human body and zoopery the results are shown in Table 1-2.
Embodiment eight
Adopt the method for blow molding, PGA0.5kg with molecular weight 180,000, under 200 ℃ ± 5 ℃ of temperature, be processed into thickness and be 0.0002～0.5 millimeter thin film, ethane via epoxyethane sterilization, sterilization treatment, be used to prevent behind the vertebrae plate resection around the dura mater fibrosis and adhesion and operation on tendon, intestinal surgery, operation on biliary tract post-operation adhesion preventing, human body and zoopery the results are shown in Table 1-2.
Embodiment nine
Molecular weight is 400,000 PDLLA-PLGA copolymer 0.8kg, adopt the method for blow molding behind the mix homogeneously, in 205 ℃ ± 5 ℃ scopes of temperature, be processed into thickness and be 0.0002～0.5 millimeter thin film, ethane via epoxyethane sterilization, sterilization treatment, carry out the experiment of human body and animal post-operation adhesion preventing, it is antiseized to the results are shown in Table 1～2.
Embodiment ten
It with molecular weight the method that adopts the template molding behind 450,000 the PLLA-PDLLA copolymer 0.6kg mix homogeneously, under 195 ℃ ± 5 ℃ of temperature, be processed into thickness and be 0.0002～0.5 millimeter thin film, handle through sterilization, carry out the experiment of human body and animal post-operation adhesion preventing, its anti-adhesion effects sees Table 1-2.
Embodiment 11
With molecular weight is that 350,000 PDLLA-PGA copolymer 0.5kg mixes the back and adopts blow molding technology, under 200 ℃ ± 5 ℃ of temperature, be processed into thickness and be 0.0002～0.5 millimeter thin film, handle through sterilization, be used for the experiment of human body and animal post-operation adhesion preventing, its effect sees Table 1-2.
Embodiment 12
With molecular weight is that 350,000 PLGA-PGA copolymer 0.5kg mixes the back and adopts blow molding technology, under 200 ℃ ± 5 ℃ of temperature, be processed into thickness and be 0.0002～0.5 millimeter thin film, handle through sterilization, be used for the experiment of human body and animal post-operation adhesion preventing, its effect sees Table 1-2.
Embodiment 13
With molecular weight is that 350,000 PLGA-PLLA copolymer 0.5kg mixes the back and adopts blow molding technology, under 200 ℃+5 ℃ of temperature, be processed into thickness and be 0.0002～0.5 millimeter thin film, handle through sterilization, be used for the experiment of human body and animal post-operation adhesion preventing, its effect sees Table 1-2.
Embodiment 14
With molecular weight is that 350,000 PGA-PLLA copolymer 0.5kg mixes the back and adopts blow molding technology, under 200 ℃ ± 5 ℃ of temperature, be processed into thickness and be 0.0002～0.5 millimeter thin film, handle through sterilization, be used for the experiment of human body and animal post-operation adhesion preventing, its effect sees Table 1-2.● zoopery
Laminectomy is one of the most frequently used modus operandi of ridge surgery, is the zoopery situation of vertebrae plate resection postoperative prevention epidural scarring adhesion below
1. materials and methods
1.1 animal grouping
Select 120 adult rabbit for use, body weight is 2kg～2.5kg, and male and female are not limit.Divide 12 groups at random, 10 every group, i.e. chitosan group, PLGA group, the PDLLA group, PLLA group, PGA group, gelatin foam group, PDLLA-PLGA group, PDLLA-PLLA group, PDLLA-PGA group, PLGA-PGA group, PLGA-PLLA group, PGA-PLLA group, self blank.
1.2 experiment material
Chitosan (it wins the production of biological preparation industrial corporation Shanghai), gelfoam (Shanghai Zhonghua Pharmaceutical Factory production), absorbable biological film (goods of the present invention).
1.3 experimental technique
1.5% pentobarbital sodium 2ml/kg rabbit ear edge intravenous injection fiber crops are broken, make rabbit lower back median incision under aseptic, appear L3, L5 vertebral plate and excision, form the damaged of two big or small 1cm * 0.5cm, and blank is made in damaged no any covering; Another damaged chitosan, absorbable biological film or gelfoam of covering respectively.Postoperative 2,4, in 6,8 and 10 weeks, 2 rabbits of every group of picked at random are put to death, and observe and detect.
1.4 observed content:
Perusal, scar tissue grading standard: 0 grade, do not see scar tissue or granulation tissue; The I level, a small amount of scar tissue or granulation tissue are film like; The II level, the scar tissue of some or granulation tissue, short texture, matter is soft separable with dura mater; The III level, scar tissue quantity is more, and matter is harder, and is with the dura mater adhesion, not easily separated; The IV level, scar tissue quantity is many, and complete filling is damaged, and quality is hard, with the extensive fine and close adhesion of dura mater.
Om observation is being put to death in animal all several, and every group is taken out the operation section spinal column that comprises musculus sacrospinalis respectively, and in fixing synchronously and 2 weeks of decalcification with 10% formalin solution, dehydration, paraffin embedding and HE dye, om observation.
Transmission electron microscope observing is got the postoperative 2,4 and the sample in the 8 weeks scar tissue near the spinal dura mater place respectively, after fixedly rinsing, embedding, makes ultrathin section, transmission electron microscope observing.
1.5 statistical procedures
The a plurality of samples of the The data that experiment obtains compare relatively rank test (Wilcoxon) in twos between (KruskaiWallis) and sample, inspection level α=0.05.
2. result
Scar tissue adhesion classification and statistical procedures (situation sees Table one)
Each is organized scar tissue adhesion classification situation and sees attached list 1.Compare in twos between every group, there was no significant difference between chitosan group and each experimental group (P＞0.05), but with gelatin foam group and each group blank significant difference (P＜0.05) is arranged relatively respectively.
Table one is respectively organized epidural scarring adhesion classification (n=120, blank 120 examples)
Adhesion classification group
0 grade of I level～II level III level～IV level chitosan group 91 0PDLLA 10 0 0PLGA 91 0PLLA 91 0PGA 82 0PDLLA-PLGA 82 0PDLLA-PLLA 91 0PDLLA-PGA 91 0PLGA-PLLA 82 0PLGA-PGA 82 0PLLA-PGA 910 gelfoams 00 10 blank 0 27 93 adds up to 96 41 103 ● human body is implemented
Adopt the absorbability biomembrane of embodiment one～embodiment 14 one by one each operative site of human body to be carried out the post-operation adhesion preventing experiment, it the results are shown in Table 2.
Clinical prerun catalog of table 2 antiadhesion barrier human body I phase
* 1:A. represents to adopt the detection method of MRl, CT; B. the detection method of B ultrasonic, X-ray is adopted in expression.* 2: except that vertebrae plate resection observing time is that other is 3 months 4 months.
Claims (1)
1. post-operation adhesion preventing method, it is characterized in that adopting viscosity-average molecular weight＜500,000, following biodegradable absorbable polymer: PLGA (polylactic acid---co-glycolic acid), PDLLA are (poly--D, L-lactic acid), to be processed into thickness under 180～220 ℃ of temperature be 0.0002～0.5 millimeter thin film to the copolymer of any one material among PLLA (poly--L-lactic acid), the PGA (polyglycolic acid) or a kind of material and another kind of material, through sterilization, sterilization treatment is used for post-operation adhesion preventing.
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| CN 99115039 CN1241442A (en) | 1999-07-27 | 1999-07-27 | Post-operation adhesion preventing method |
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| CN 99115039 CN1241442A (en) | 1999-07-27 | 1999-07-27 | Post-operation adhesion preventing method |
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Cited By (11)
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|---|---|---|---|---|
| WO2006023672A3 (en) * | 2004-08-23 | 2006-10-05 | Advanced Cardiovascular System | Biologically absorbable polymers for implantable devices having a constant rate of degradation |
| CN1331913C (en) * | 2002-02-05 | 2007-08-15 | 重庆永通信息工程实业有限公司 | Synthesis and application of post-operative adhesion-preventing material |
| CN103055354A (en) * | 2013-01-17 | 2013-04-24 | 中国科学院长春应用化学研究所 | Biodegradable medical surgery anti-adhesion membrane and preparation method thereof |
| US9694116B2 (en) | 2006-05-26 | 2017-07-04 | Abbott Cardiovascular Systems Inc. | Stents with radiopaque markers |
| US9763818B2 (en) | 2010-01-30 | 2017-09-19 | Abbott Cardiovascular Systems Inc. | Method of crimping stent on catheter delivery assembly |
| US9827119B2 (en) | 2010-01-30 | 2017-11-28 | Abbott Cardiovascular Systems Inc. | Polymer scaffolds having a low crossing profile |
| CN107962696A (en) * | 2017-12-14 | 2018-04-27 | 陈逊 | A kind of manufacturing process of polyglycolic acid resin laminated film |
| US9999527B2 (en) | 2015-02-11 | 2018-06-19 | Abbott Cardiovascular Systems Inc. | Scaffolds having radiopaque markers |
| US10070975B2 (en) | 2006-01-04 | 2018-09-11 | Abbott Cardiovascular Systems Inc. | Stents with radiopaque markers |
| US10307274B2 (en) | 2011-07-29 | 2019-06-04 | Abbott Cardiovascular Systems Inc. | Methods for uniform crimping and deployment of a polymer scaffold |
| US10610387B2 (en) | 2015-06-12 | 2020-04-07 | Abbott Cardiovascular Systems Inc. | Scaffolds having a radiopaque marker and methods for attaching a marker to a scaffold |
-
1999
- 1999-07-27 CN CN 99115039 patent/CN1241442A/en active Pending
Cited By (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1331913C (en) * | 2002-02-05 | 2007-08-15 | 重庆永通信息工程实业有限公司 | Synthesis and application of post-operative adhesion-preventing material |
| WO2006023672A3 (en) * | 2004-08-23 | 2006-10-05 | Advanced Cardiovascular System | Biologically absorbable polymers for implantable devices having a constant rate of degradation |
| US10070975B2 (en) | 2006-01-04 | 2018-09-11 | Abbott Cardiovascular Systems Inc. | Stents with radiopaque markers |
| US9694116B2 (en) | 2006-05-26 | 2017-07-04 | Abbott Cardiovascular Systems Inc. | Stents with radiopaque markers |
| US9867728B2 (en) | 2010-01-30 | 2018-01-16 | Abbott Cardiovascular Systems Inc. | Method of making a stent |
| US9763818B2 (en) | 2010-01-30 | 2017-09-19 | Abbott Cardiovascular Systems Inc. | Method of crimping stent on catheter delivery assembly |
| US9770351B2 (en) | 2010-01-30 | 2017-09-26 | Abbott Cardiovascular Systems Inc. | Crush recoverable polymer scaffolds |
| US9827119B2 (en) | 2010-01-30 | 2017-11-28 | Abbott Cardiovascular Systems Inc. | Polymer scaffolds having a low crossing profile |
| US10123894B2 (en) | 2010-01-30 | 2018-11-13 | Abbott Cardiovascular Systems Inc. | Method of crimping stent on catheter delivery assembly |
| US11324614B2 (en) | 2010-01-30 | 2022-05-10 | Abbott Cardiovascular Systems Inc. | Balloon expanded polymer stent |
| US10307274B2 (en) | 2011-07-29 | 2019-06-04 | Abbott Cardiovascular Systems Inc. | Methods for uniform crimping and deployment of a polymer scaffold |
| CN103055354B (en) * | 2013-01-17 | 2015-10-07 | 中国科学院长春应用化学研究所 | A kind of biodegradable medical surgery anti-adhesion membrane and preparation method thereof |
| CN103055354A (en) * | 2013-01-17 | 2013-04-24 | 中国科学院长春应用化学研究所 | Biodegradable medical surgery anti-adhesion membrane and preparation method thereof |
| US9999527B2 (en) | 2015-02-11 | 2018-06-19 | Abbott Cardiovascular Systems Inc. | Scaffolds having radiopaque markers |
| US10610387B2 (en) | 2015-06-12 | 2020-04-07 | Abbott Cardiovascular Systems Inc. | Scaffolds having a radiopaque marker and methods for attaching a marker to a scaffold |
| US11478370B2 (en) | 2015-06-12 | 2022-10-25 | Abbott Cardiovascular Systems Inc. | Scaffolds having a radiopaque marker and methods for attaching a marker to a scaffold |
| CN107962696A (en) * | 2017-12-14 | 2018-04-27 | 陈逊 | A kind of manufacturing process of polyglycolic acid resin laminated film |
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