CN1446544A - Anti blocking new mateial used after surgical operation - Google Patents
Anti blocking new mateial used after surgical operation Download PDFInfo
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- CN1446544A CN1446544A CN 02113514 CN02113514A CN1446544A CN 1446544 A CN1446544 A CN 1446544A CN 02113514 CN02113514 CN 02113514 CN 02113514 A CN02113514 A CN 02113514A CN 1446544 A CN1446544 A CN 1446544A
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- new material
- postoperative
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- biodegradable aliphatic
- adhesion
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Abstract
An antisticking material for surgical operation is prepared through dissolving the biodegradable aliphatic polyester (PDLLA, PLLA, or PTMC) in th e biological absorbable hydrophilic organic solvent. It is applied by coating it on the needed position.
Description
The present invention relates to surgical postoperative prevent to organize between a kind of new material of adhesion, particularly be dissolved in the organic solvent and the new material that forms by biodegradable adip cluster polyester material.
Tissue adhesion is that one of unsolved difficult medical problem has still been arranged since the history of operation both at home and abroad.A large amount of various types of operation cases are arranged every year, and nearly all operation all relates to the problem of anti between the tissue.Tissue adhesion not only can cause severe complications, as: can cause adhesive ileus after abdominal part, the operation on pelvis, cause postoperative epilepsy because of local adhesion after the operation of opening cranium, the thyroid postoperative can cause Secondary cases recurrent nerve injury etc., and be the one of the main reasons that complication obviously increases when performing the operation once more, as the damage of intestinal glandular tube, recurrent laryngeal nerve and parathyroid injury etc.Problems such as hyaluronate sodium and the chitin glue that uses clinically exists purity not high enough at present, and preventing adhesiving effect is not ideal enough, uses inconvenience, and application surface is narrow.In the research of prevention of postoperative adhesion, only limit to abdominal operation Film with Preventing Adhesion intestinal obstruction in the past.Once use methods such as the built-in silicone oil in abdominal cavity, medium molecular dextran and streptokinase, but all do not have positive effect.Silicone oil can not be absorbed by the body, although little to the body zest, is stranded in intraperitoneal for a long time, can produce stimulation and can cause and ooze out, and cause adhesion.Medium molecular dextran has zest to tissue owing to be hypertonic liquid, makes and organizes congestion and edema, and oozing out increases and cause adhesion.Streptokinase is to inject in Intraabdominal micropore tubule from being detained, in the hope of solution fibrin, but owing to can only inject in a small amount, pore easily get clogged and tubule transposition etc. all multifactor, curative effect is not remarkable yet.The new material and the new method of a kind of convenience of long-term clinically expectation, safe and effective anti are come out.Therefore, exploitation has the biological absorbable medical apparatus of extensive anti effect, solves the surgical postoperative adhesion, reduces postoperative complication, improves operative effect, reduces patient's medical expense, has huge market prospect and good social benefit.Along with the development of polymer science, macromolecular material in the application of biomedical sector more and more widely, Biodegradable Polymers particularly, in the biodegradation type macromolecular material, research at most, range of application the widest be aliphatic polyester.In aliphatic polyester, use maximum be poly-DL-lactic acid (PDLLA) poly (l-lactic acid) (PLLA) the homopolymerization of polyglycolic acid (PGA) poly-epsilon-caprolactone (PCL) PTMC (PTMC) and copolymer etc.In the work in our early stage, the membrane material that we successfully are prepared into poly-DL-lactic acid (PDLLA) be used for preventing tissue adhesion (Zhu Xiaoming, post-operation adhesion preventing method, Chinese patent, publication number: 1241442), this product goes on the market at present.Be used at the membrane material of degradable family macromolecule polymer development aspect the research of tissue adhesion control, document also has some relevant reports, (oral cavity material apparatus magazine, 1999,8,174 such as Li Chaolun; The Shanghai stomatology, 19998,36) report has carried out the experimental study with PDLLA film rat vivo degradation; Fei Qili etc. (Chinese reconstruction surgical magazine, 1992,2,65) have reported the research to polylactic acid film prevention adhesion of tendon; Zhang Zhongwen (Chinese journal of orthopedics, 1998,18,692) etc. has carried out the experimentation of polycaprolactone/polylactic acid film control adhesion of tendon; West (Biomaterials, 1995,16,1153) Polyethylene Glycol gel film, collagem membrane, polyester-medical anti-adhesive films such as ether film have carried out in contrast experiment's research and the body and/or the evaluation study of external performance curative effect etc.The bioabsorbable membrane that Hanff etc. (Journal of Hand Surgery, 1998,23,658) make with Polyethylene Glycol and copolymer of poly lactic acid is used to prevent the research of splanchnocoel postoperative intestinal adhesion formation; Rodgers etc. (Fertility and Sterility, 1998,69,403) have reported the research of the evaluation that the adhesion of polyethylene glycol film prevention Rabbit Model sidewall forms and forms.Can find out that from above-mentioned report degradation material all enters in the body with the form of thin film in the application of surgical postoperative at present, prevents tissue adhesion by barrier effect, the result of study of document and our test show that also this method is effective.But it is well-known, the organization of human body complexity, the wound surface of postoperative also has nothing in common with each other, also incomplete same at different parts to the shape and the thickness requirement of film, though can prepare the film of different size, can not address this problem fully, it would be desirable and use a kind of new material, the position that is allowed to condition at the need anti is according to the interim film forming of practical situation, and shape and the thickness that can regulate film according to the wound surface situation.
The object of the present invention is to provide a kind of new material of surgical postoperative anti, this material is made up of biodegradable aliphatic polyester and absorbable organic solvent, be gelatinous liquid form product, only need in use it is spread upon the position that needs anti, the thickness of smearing can be adjusted as required, this material is when spreading upon the position that needs anti-tissue adhesion, can need the position of anti with human body is mould (10-300 second) formation film at short notice, this film and postoperative need the position of anti to coincide very good, because what select for use is degradable polymer, polymer began degraded after about one month, finally degraded fully, thus reach the purpose of anti.
The object of the present invention is achieved like this: biodegradable aliphatic poly ester material, be dissolved in the biological absorbable hydrophilic organic solvent, be prepared into certain density gelatinous solution and be the anti new material, in use, get the position that a certain amount of gelatinous solution spreads upon needs anti as required, in this gelatinous solution because what select for use is absorbable hydrophilic organic solvent, can be absorbed by human circulation at short notice, the polymer that stays is being smeared position formation film, thereby surgical wound surface and surrounding tissue are separated, reach the purpose of anti.Used biodegradable aliphatic poly ester material mainly is DL-lactic acid (PDLLA) among the present invention, poly (l-lactic acid) (PLLA), polyglycolic acid (PGA), poly-epsilon-caprolactone (PCL), PTMC (PTMC), in the polydioxanone (Polydioxanone) any one uses or uses the blend and the copolymer of two kinds and two or more materials separately, properties of materials viscosity (dark type viscometer, chloroform solvent, 25 ℃) scope is at 0.1-5.0dl/g, wherein the best is 0.5-3, molecular weight ranges is 10000-1000000, and the best is 50000-300000.Used absorbed hydrophilic organic solvent mainly is 1-dodecyl-azepan-2-ketone, butanone, dimethyl sulfoxide, decyl methyl sulfoxide, 2-Pyrrolidone, N-N-methyl-2-2-pyrrolidone N-, ethyl acetate, methyl acetate, acetone, ethanol, dimethyl formamide, caprolactam, oxolane, dioxane, oleic acid, propylene glycol etc. among the present invention, can be wherein a kind of independent use or two kinds and two or more mixing use.The dissolving of polymer in solvent can be carried out in room temperature, also can heat or stir, in a word to be dissolved as principle fully.The concentration of degradable polymer in solvent is 0.1-90% (w/v), and wherein optium concentration is 5-60%.
Embodiments of the invention are as follows:
The intrinsic viscosity of polymer is measured with dark type viscometer, is solvent with the chloroform, 25 ℃ of mensuration.
Molecular weight is measured with chromatograph of gel permeation (GPC).
Product design is pressed amount of polymers (w)/quantity of solvent, and (v) * 100% calculates.
Embodiment one:
Get the poly-DL-lactic acid of 5 grams, intrinsic viscosity 1.2dl/g, molecular weight 280,000 with 25 milliliters of 1-dodecyl-azepans-2-ketone stirring and dissolving, promptly gets product, concentration 20% after treating to dissolve fully.Be used for surgical postoperative and prevent adhesion, animal and clinical test results confirm that formation is membranaceous after 10 seconds after spreading upon the position that needs anti, surgical wound surface and surrounding tissue is separated, thereby prevent adhesion.
Embodiment two:
Get 20 gram poly (l-lactic acid)s, intrinsic viscosity 3dl/g, molecular weight 500,000 with 50 milliliters of acetone stirring and dissolving, promptly gets product, concentration 40% after treating to dissolve fully.Be used for surgical postoperative and prevent adhesion, animal and clinical test results confirm that formation is membranaceous after 40 seconds after spreading upon the position that needs anti, surgical wound surface and surrounding tissue is separated, thereby prevent adhesion.
Embodiment three:
Get 50 gram poly-epsilon-caprolactones (PCL), intrinsic viscosity 1dl/g, molecular weight 150,000 with 60 milliliters of ethyl acetate stirring and dissolving, promptly gets product, concentration 83% after treating to dissolve fully.Be used for surgical postoperative and prevent adhesion, animal and clinical test results confirm that formation is membranaceous after 60 seconds after spreading upon the position that needs anti, surgical wound surface and surrounding tissue is separated, thereby prevent adhesion.
Embodiment four:
Get 30 gram polydioxanones (Polydioxanone), intrinsic viscosity 1.4dl/g, molecular weight 180,000 with 60 milliliters of N-N-methyl-2-2-pyrrolidone N-stirring and dissolving, promptly gets product, concentration 20% after treating to dissolve fully.Be used for surgical postoperative and prevent adhesion, animal and clinical test results confirm that formation is membranaceous after 120 seconds after spreading upon the position that needs anti, surgical wound surface and surrounding tissue is separated, thereby prevent adhesion.
Embodiment five:
Get 200 gram PTMC (PTMC), intrinsic viscosity 0.5dl/g, molecular weight 60,000 with 500 milliliters of dimethyl formamide stirring and dissolving, promptly gets product, concentration 40% after treating to dissolve fully.Be used for surgical postoperative and prevent adhesion, animal and clinical test results confirm that formation is membranaceous after 240 seconds after spreading upon the position that needs anti, surgical wound surface and surrounding tissue is separated, thereby prevent adhesion.
Embodiment six:
Get 20 gram polylactic acid-polyglycolic acid copolymers, intrinsic viscosity 4dl/g, molecular weight 600,000 with 100 milliliters of oxolane stirring and dissolving, promptly gets product, concentration 20% after treating to dissolve fully.Be used for surgical postoperative and prevent adhesion, animal and clinical test results confirm that formation is membranaceous after 300 seconds after spreading upon the position that needs anti, surgical wound surface and surrounding tissue is separated, thereby prevent adhesion.
Embodiment seven:
Get 20 gram DL-lactic acid (PDLLA), intrinsic viscosity 3.5dl/g, molecular weight 500,000 with 100 milliliters of 2-Pyrrolidones, N-N-methyl-2-2-pyrrolidone N-, ethyl acetate, and the mixed solvent stirring and dissolving of acetone, promptly gets product, concentration 20% after treating to dissolve fully.Be used for surgical postoperative and prevent adhesion, animal and clinical test results confirm that formation is membranaceous after 30 seconds after spreading upon the position that needs anti, surgical wound surface and surrounding tissue is separated, thereby prevent adhesion.
Embodiment eight:
Get 20 gram DL-lactic acid-PTMC (PTMC) copolymers, intrinsic viscosity 2.1dl/g, molecular weight 380,000 is with the mixed solvent stirring and dissolving of 100 milliliters of 1-dodecyl-azepans-2-ketone and butanone, promptly get product after treating to dissolve fully, concentration 20%.Be used for surgical postoperative and prevent adhesion, animal and clinical test results confirm that formation is membranaceous after 36 seconds after spreading upon the position that needs anti, surgical wound surface and surrounding tissue is separated, thereby prevent adhesion.
Claims (5)
1. the new material of a surgical postoperative anti, this material is made up of biodegradable aliphatic polyester and absorbable organic solvent, promptly biodegradable aliphatic poly ester material, be dissolved in the biological absorbable hydrophilic organic solvent, be prepared into certain density gelatinous solution and be the anti new material, only need in use it is spread upon the position that needs anti, the thickness of smearing can be adjusted as required, this material is when spreading upon the position that needs anti-tissue adhesion, can need the position of anti with human body is mould (10-300 second) formation film at short notice, this film and postoperative need the position of anti to coincide very good, polymer began degraded after about one month, finally degraded fully, thus reach the purpose of anti.
2. the new material of surgical postoperative anti according to claim 1, it is characterized in that biodegradable aliphatic poly ester material mainly is blend and the copolymer that in DL-lactic acid (PDLLA), poly (l-lactic acid) (PLLA), polyglycolic acid (PGA), poly-epsilon-caprolactone (PCL), PTMC (PTMC), the polydioxanone (Polydioxanone) any one used or used two kinds and two or more materials separately.
3. biodegradable aliphatic poly ester material according to claim 1 and 2, it is characterized in that, properties of materials viscosity (dark type viscometer, chloroform solvent, 25 ℃) scope is at 0.1-5.0dl/g, wherein the best is 0.5-3, and molecular weight ranges is 10000-1000000, and the best is 50000-300000.
4. the new material of surgical postoperative anti according to claim 1, it is characterized in that, biology can absorb hydrophilic organic solvent, mainly being 1-dodecyl-azepan-2-ketone, butanone, dimethyl sulfoxide, decyl methyl sulfoxide, 2-Pyrrolidone, N-N-methyl-2-2-pyrrolidone N-, ethyl acetate, methyl acetate, acetone, ethanol, dimethyl formamide, caprolactam, oxolane, dioxane, oleic acid, propylene glycol etc., can be wherein a kind of independent use or two kinds and two or more mixing use.
5. the new material of surgical postoperative anti according to claim 1 is characterized in that, the concentration of degradable polymer in solvent is 0.1-90% (w/v), and wherein optium concentration is 5-60%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02113514 CN1446544A (en) | 2002-03-27 | 2002-03-27 | Anti blocking new mateial used after surgical operation |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 02113514 CN1446544A (en) | 2002-03-27 | 2002-03-27 | Anti blocking new mateial used after surgical operation |
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| CN1446544A true CN1446544A (en) | 2003-10-08 |
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| CN 02113514 Pending CN1446544A (en) | 2002-03-27 | 2002-03-27 | Anti blocking new mateial used after surgical operation |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101804066A (en) * | 2010-03-26 | 2010-08-18 | 四川大学 | Application of MPEG-PLA (Methoxypolyethylene Glycols-Polylactic Acid) diblock copolymers in preparation of medical anti-blocking material |
| CN102058908A (en) * | 2009-11-18 | 2011-05-18 | 张博 | Absorbable anti-adhesive material and preparation method thereof |
| CN102665780A (en) * | 2009-12-28 | 2012-09-12 | 川澄化学工业株式会社 | Anti-adhesion material |
| CN101618045B (en) * | 2008-07-03 | 2013-08-07 | 汕头大学 | Anti-adhesion gel containing polyhydroxyalkanoate |
-
2002
- 2002-03-27 CN CN 02113514 patent/CN1446544A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101618045B (en) * | 2008-07-03 | 2013-08-07 | 汕头大学 | Anti-adhesion gel containing polyhydroxyalkanoate |
| CN102058908A (en) * | 2009-11-18 | 2011-05-18 | 张博 | Absorbable anti-adhesive material and preparation method thereof |
| CN102665780A (en) * | 2009-12-28 | 2012-09-12 | 川澄化学工业株式会社 | Anti-adhesion material |
| CN102665780B (en) * | 2009-12-28 | 2015-04-22 | 川澄化学工业株式会社 | Anti-adhesion material |
| CN101804066A (en) * | 2010-03-26 | 2010-08-18 | 四川大学 | Application of MPEG-PLA (Methoxypolyethylene Glycols-Polylactic Acid) diblock copolymers in preparation of medical anti-blocking material |
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