CN102284086A - Preparation method of biodegradable bracket for litholytic therapy of bile duct calculus - Google Patents
Preparation method of biodegradable bracket for litholytic therapy of bile duct calculus Download PDFInfo
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- CN102284086A CN102284086A CN2010102115800A CN201010211580A CN102284086A CN 102284086 A CN102284086 A CN 102284086A CN 2010102115800 A CN2010102115800 A CN 2010102115800A CN 201010211580 A CN201010211580 A CN 201010211580A CN 102284086 A CN102284086 A CN 102284086A
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- bile duct
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- support
- treatment calculus
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Abstract
The invention belongs to the fields of biomedicine and high molecular materials, and particularly relates to a preparation method of a biodegradable bracket for litholytic therapy of bile duct calculus. The method comprises the following specific steps of: mixing a biocompatible high molecular degradable material with a litholytic medicament together; and preparing a bile duct bracket with a required shape as required for the litholytic therapy of the bile duct calculus. A degradation product of the biodegradable material can be discharged from a body through metabolism so as to be nontoxic and harmless. The preparation method is simple, low in cost and high in practicability.
Description
Technical field: the invention belongs to biomedical sector and polymeric material field, be specifically related to treat the preparation of the biodegradation support of calculus of bile duct.
Background technology: calculus of bile duct has a very high sickness rate clinical, traditional method mainly adopts surgical operation therapy, but wound is big, complication is many and relapse rate is high, still have in addition many patients weak with age or occur together other diseases and can not tolerate surgery treatment.Along with the development of endoscopic technic, pancreatic duct is got involved the main treatment means that the technology (ERCP technology) of getting stone becomes calculus of bile duct gradually under the scope, has obtained excellent curative in recent years.But take out the calculus of bile duct (as calculus of bile duct multiple, huge, hard or that the position is special) of difficulty for some, or be difficult to tolerate the patient of long-time endoscopic technic, it is unobstructed with the assurance bile duct to take directly to insert the bile duct plastic stent, and calculus itself be there is no therapeutical effect.
Find after deliberation, mostly be bilirubin calculus or based on the mixed type calculus of bilirubin, therefore select the dissolved stone medicine should be to dissolve bilirubin in China's common bile duct or calculus of intrahepatic duct.With bile acid sodium is that the compound recipe Fructus Citri tangerinae oil sodium cholate Emulsion of main component can significantly be strengthened the solvability to bile pigment calculus, has become first cholelithiasis perfusion lithodialysis agent of examining by country of China.Other discovers, sodium cholate and edetate sodium use in conjunction have more obvious effect to the dissolution of bile pigment calculus, hepatic and renal function injure do not occur.At present these medicines can only be by the method administration of regional perfusion, can only be in surgical operation or postoperative drainage pipe approach use, can't carry out the treatment that continues for a long time.Therefore imagination is written into dissolved stone medicine in the biliary tract prosthesis, discharges in local slow after inserting bile duct, so just can form persistent litholytic effect.The external support that adopts Biodegradable material to make carried medicine sustained-release of having reported.
The material of biodegradable stent mainly adopts PGA (polyglycolic acid), PLA (polylactic acid) and PLGA (lactic-co-glycolic acid) at present.Domestic and international research shows, PLA and PLGA have reliable safety, good biodegradability and good carried medicine sustained-release effect, can make the biological support of multiple function as requested, and possess good intensity and pliability.In this patent design, above-mentioned dissolved stone medicine is written in this degradation material, has made biodegradable lithodialysis support, can directly insert in the bile duct by the scope approach.Except that the postoperative residue calculus being had preferably curative effect, primary cholelithiasis the greater or multiple calculus incarceration person, behind lithodialysis, calculus is softening dwindles, getting stone reduction difficulty and shortening time for nipple cuts, also is a kind of effective Therapeutic Method to the calculus of intrahepatic duct of getting the stone failure.
Summary of the invention:
The object of the present invention is to provide a kind of preparation method that is used for the treatment of the Biodegradable scaffold of calculus of bile duct.
The preparation method of the Biodegradable scaffold that is used for the treatment of calculus of bile duct that the present invention proposes, concrete steps are as follows:
(1) mixed by 10: 1 as required with biocompatibility macromolecule degradation material and dissolved stone medicine.
(2) mixture is extruded the piped support that forms the anatomic characteristic intermediate hollow that meets the human body bile duct with double screw extruder.
(3) make the anti-palpus of barb-like nearby at the tubular bracket two ends.
Among the present invention, described biocompatibility macromolecule degradation material is meant polylactic acid, any in polyglycolic acid or the polycaprolactone etc., or any two copolymers of these materials, perhaps three kinds copolymer.
Among the present invention, the lithodialysis material of indication is meant Calcium Disodium Versenate, or any or the mixture between them in the sodium cholate.
The present invention makes simply, and is cheap, practical.
The present invention has following characteristics:
First the litholytic medicine is written in the biological degradable material, makes biodegradable bile duct lithodialysis support; Support is inserted the back along with the degraded of material and the slow release of medicine, the dissolution that performance continues to calculus; Support can be inserted under scope repeatedly, thereby guarantees persistent litholytic effect.This invention is the combination of biomaterial for medical purpose and endoscopic interventional treatment, is a quantum jump of treatment under the calculus of bile duct scope.
Specific embodiments:
Further specify embodiments of the present invention below by embodiment, but the invention is not restricted to these examples.
Embodiment one
1. mixed by 5: 1 with Calcium Disodium Versenate or sodium cholate with polylactic acid, polyglycolic acid or polycaprolactone etc.
2. mixture is extruded the piped support that forms intermediate hollow with double screw extruder, the anatomic characteristic according to the human body bile duct of these pipes, the overall diameter of biliary tract prosthesis is designed to 8.5~10French, and interior diameter is designed to 4~6French, and length is that 7~12cm does not wait.
3. from the place of each 1.5cm of pipe two ends, cut into thick about 0.1cm to two ends, the palpus of wide about 0.3cm, must the about 0.7cm of length in (0 point, 3 points, 6 points, 9 points) four orientation.
Embodiment two
1. mix by 1: 1~100: 1 with polylactic acid, polyglycolic acid or polycaprolactone etc. and edetate sodium etc.
2. mixture is extruded with double screw extruder, form the piped support of intermediate hollow, the anatomic characteristic according to the human body bile duct of these pipes is designed to 8.5~10French with the overall diameter of biliary tract prosthesis, interior diameter is designed to 4~6French, and length is that 7~12cm does not wait.
3. from the place of each 1.5cm of pipe two ends, cut into thick about 0.1cm to two ends, the palpus of wide about 0.3cm, must the about 0.7cm of length in (0 point, 3 points, 6 points, 9 points) four orientation.
Claims (6)
1. preparation method that is used for the Biodegradable scaffold of dissolution treatment calculus of bile duct is characterized in that concrete steps are as follows:
(1) mixed by 1: 1~100: 1 as required with biocompatibility macromolecule degradation material and lithodialysis material.
(2) mixture is extruded formation with double screw extruder and meet the anatomic characteristic of human body bile duct, the piped support of intermediate hollow.
(3) make the anti-palpus of barb-like nearby at the tubular bracket two ends.
2. the preparation method of the Biodegradable scaffold of treatment calculus of bile duct according to claim 1, it is characterized in that step (1) biocompatibility macromolecule degradation material is meant polylactic acid, in polyglycolic acid or the polycaprolactone etc. any, or any two copolymers of these materials, perhaps three kinds copolymer.
3. the preparation method of the Biodegradable scaffold of treatment calculus of bile duct according to claim 1 is characterized in that the lithodialysis material of step (1) indication is meant Calcium Disodium Versenate, or any or the mixture between them in the sodium cholate.
4. the preparation method of the Biodegradable scaffold of treatment calculus of bile duct according to claim 1 is characterized in that step (1) will mix by 1: 1~100: 1 as required with biocompatibility macromolecule degradation material and lithodialysis material.
5. the preparation method of the biodegradation support of treatment calculus of bile duct according to claim 1 is characterized in that step (2) extrudes mixture with double screw extruder, forms the piped support of the anatomic characteristic intermediate hollow that meets the human body bile duct.
6. the preparation method of the biodegradation support of treatment calculus of bile duct according to claim 1 is characterized in that step (3) makes the tubular bracket two ends the anti-palpus of barb-like.
Priority Applications (1)
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CN2010102115800A CN102284086A (en) | 2010-06-19 | 2010-06-19 | Preparation method of biodegradable bracket for litholytic therapy of bile duct calculus |
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CN2010102115800A CN102284086A (en) | 2010-06-19 | 2010-06-19 | Preparation method of biodegradable bracket for litholytic therapy of bile duct calculus |
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CN2010102115800A Pending CN102284086A (en) | 2010-06-19 | 2010-06-19 | Preparation method of biodegradable bracket for litholytic therapy of bile duct calculus |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN104274867A (en) * | 2014-03-10 | 2015-01-14 | 北京阿迈特医疗器械有限公司 | Degradable polymer support as well as forming method and application thereof |
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2010
- 2010-06-19 CN CN2010102115800A patent/CN102284086A/en active Pending
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN104274867A (en) * | 2014-03-10 | 2015-01-14 | 北京阿迈特医疗器械有限公司 | Degradable polymer support as well as forming method and application thereof |
CN104274867B (en) * | 2014-03-10 | 2019-09-17 | 北京阿迈特医疗器械有限公司 | Degradable polymer bracket and its forming and machining method and application |
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Application publication date: 20111221 |