CN102727331A - Biodegradable magnesium alloy bile duct litholysis knitted bracket and preparation method thereof - Google Patents
Biodegradable magnesium alloy bile duct litholysis knitted bracket and preparation method thereof Download PDFInfo
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- CN102727331A CN102727331A CN2012100289031A CN201210028903A CN102727331A CN 102727331 A CN102727331 A CN 102727331A CN 2012100289031 A CN2012100289031 A CN 2012100289031A CN 201210028903 A CN201210028903 A CN 201210028903A CN 102727331 A CN102727331 A CN 102727331A
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- magnesium alloy
- bile duct
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- lithodialysis
- braided support
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Abstract
The invention belongs to the field of biomedicine, high molecular materials and magnesium alloy materials, and relates to a biodegradable magnesium alloy bile duct litholysis knitted bracket and a preparation method thereof. A knitted bracket is manufactured by knitting magnesium or magnesium alloy into a porous net structured or spiral tubular structured duct; and sodium cholate or/and edetate disodium containing biodegradable polymer layers is/are coated on the inner and outer surfaces of the knitted bracket to obtain the biodegradable magnesium alloy bile duct litholysis knitted bracket. Clinical using results indicate that the bracket provided by the invention is good in radial support property, capable of keeping bile duct unobstructed, capable of being degraded in a certain time to disappear and free of taking out once again; the biocompatibility is good and nearly no inflammation is generated due to in-vivo activities; and at the same time, through the sodium cholate or/and edetate disodium released by the medicine containing polymer coatings, formed stones can be dissolved and prevented from reforming.
Description
Technical field
The invention belongs to biomedicine, bioabsorbable polymer material and magnesium alloy materials field; Relate to a kind of biodegradable magnesium alloy bile duct lithodialysis braided support and method for preparing, be specifically related to a kind of drug-carried coat biodegradability support and method for preparing of treating calculus of bile duct.
Background technology
The clinical treatment statistics is arranged, and calculus of bile duct has very high sickness rate, and traditional treatment mainly adopts surgical operation therapy, but wound is big, complication many and relapse rate is high; In addition, still have 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 technology (ERCP technology) of getting stone under the scope becomes the main treatment means of calculus of bile duct gradually, and has obtained excellent curative in recent years.But; Take out the calculus of bile duct (like 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; Can only take directly to insert the bile duct plastic stent to guarantee that bile duct is unobstructed, described bile duct plastic stent does not have therapeutical effect to calculus itself.
Have research to confirm, magnesium is compared with the various metal implant materials that now dropped into clinical use as medical embedded material, has excellent biological compatibility and biodegradability, is the interior cation of cell that is only second to potassium, sodium, calcium in the human body.Magnesium is participated in protein synthesis, can swash in vivo plurality of enzymes, regulates nervimuscular activity, and simultaneously, it is compared with the biodegradable polymer material has the mechanical property excellence, and metabolite influences features of smaller to body.According to the corrosion resistance characteristic of magnesium and magnesium alloy, it has application promise in clinical practice like nail, internal fixation with aspects such as blade plate and magnesium alloy angiocarpy brackets at biological medical degradable embedded material and device, and it is used as biliary tract prosthesis and does not appear in the newspapers.The biodegradability magnesium alloy bracket can keep the support performance of support within a certain period of time; After it accomplishes its supporting role, can be organized fully to absorb, side effect is less; Its mechanical property and degradation time can be controlled through its sealer simultaneously; Compare with the biodegradable polymer support, magnesium alloy bracket has more excellent radial support performance, can reduce simultaneously because the inflammatory reaction that sour environment produces after the depolymerization; Therefore, the magnesium alloy biliary tract prosthesis has huge development potentiality in clinical practice.
Prior art discloses biodegradable polymer such as polycaprolactone, polylactic acid, has gathered hexanol acid, polylactic acid-polyglycolic acid copolymer, polycaprolactone-copolymer of poly lactic acid, gather dioxane, be collagen protein, phosphocholine, gelatin or chitosan and derivant thereof etc.; Has the good tissue compatibility; In the such environment of body fluid, degrade through ester linkage hydrolyzing; Intermediate product lactic acid is normal glycometabolic product in the body, and final metabolite is CO
2And H
2O discharges in the Yi Congti and can not assemble at vitals, therefore has excellent biodegradable absorbability.Above-mentioned material is nontoxic, nonirritant, non-immunogenicity and biocompatibility are good, can be used safely in the body, and be ideal material as medicament slow release/controlled release.
At present, discover that at China's common bile duct or mostly calculus of intrahepatic duct is bilirubin calculus or be main mixed type calculus with the bilirubin, therefore selecting dissolved stone medicine should be main with the dissolving bilirubin.Having research to show, 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 with bile acid sodium, has become first cholelithiasis perfusion lithodialysis agent of examining through country of China.Also have research to show that edetate sodium has obvious effects to the dissolution of bile pigment calculus, hepatic and renal function injure do not occur in addition.But at present said medicine can only be through the method administration of regional perfusion, can only the orthopaedic surgical operations operation in or postoperative drainage pipe approach use, can't carry out the treatment that continues for a long time.
Therefore, clinical practice presses for relevant a kind of biodegradable magnesium alloy bile duct lithodialysis braided support, and this support is written into dissolved stone medicine in the biodegradability magnesium alloy biliary tract prosthesis, discharges in local slow after inserting bile duct, can form persistent litholytic effect.
Summary of the invention
The objective of the invention is to overcome the defective and the deficiency of prior art, a kind of biodegradable magnesium alloy bile duct lithodialysis braided support is provided; This support can keep biliary tract unobstructed, simultaneously, the calculus that the dissolved stone medicine solubilized has formed with prevent that calculus from forming once more, and said support disappearances of degrading within a certain period of time do not need taking-up.
Particularly; Biodegradable magnesium alloy bile duct lithodialysis braided support of the present invention; It is characterized in that, adopt magnesium or magnesium alloy to be woven into the pipe of porous network structure or helix structure, make braided support; Inner surface and outer surface at said braided support scribbles the biodegradable polymer layer that contains dissolved stone medicine then, processes biodegradable magnesium alloy bile duct lithodialysis braided support;
In the said magnesium alloy, magnesia amount percentage composition is 85%-99.99%;
The diameter of described braided support is that 6-10mm, length are 60-120mm, and wherein, the diameter of monofilament is 0.1-2.0mm;
Described dissolved stone medicine is selected from sodium cholate or/and disodium edetate;
The mass ratio of said sodium cholate and disodium edetate is 0-10mol: 0-10mol;
Among the present invention, said magnesium alloy is magnalium gold, Mg-Fe alloy, magnesium-manganese alloy, magnesium alloy, magnesium-zinc alloy, magnesium zircaloy, magnesium rare earth-based alloy or the magnesium calcium alloy that magnesia amount percentage composition is 85%-99.99%;
Among the present invention, said biodegradable polymer is selected from polycaprolactone, polylactic acid, gathers hexanol acid, polylactic acid-polyglycolic acid copolymer, polycaprolactone-copolymer of poly lactic acid, gather dioxane, collagen protein, phosphocholine, gelatin or chitosan and derivant at least a.
Another object of the present invention provides a kind of method for preparing of biodegradable magnesium alloy bile duct lithodialysis braided support, it is characterized in that, may further comprise the steps:
(1) be raw material with the magnesium alloy, be processed into the monofilament that diameter is 0.1-2.0mm, it is that 6-10mm, length are the support of 60-120mm that monofilament is woven into diameter;
(2) in 0-300mg: the ratio of 1ml; Biodegradable polymer is dissolved in dichloromethane or chloroform or oxolane or acetone or carbon tetrachloride or the dimethyl formamide; Processing solution, is that sodium cholate and the disodium edetate of 0-10mol: 0-10mol is dispersed in the said biodegradable polymer solution with ratio, through soaking or spray treatment; Place the rack surface of above-mentioned steps (1) preparation, process biodegradable magnesium alloy bile duct lithodialysis braided support.
In the method for preparing according to the invention, magnalium gold, Mg-Fe alloy, magnesium-manganese alloy, magnesium alloy, magnesium-zinc alloy, magnesium zircaloy, magnesium rare earth-based alloy or magnesium calcium alloy that it is 85%-99.99% that magnesium alloy is selected from magnesia amount percentage composition;
In the method for preparing according to the invention, biodegradable polymer is selected from polycaprolactone, polylactic acid, gathers hexanol acid, polylactic acid-polyglycolic acid copolymer, polycaprolactone-copolymer of poly lactic acid, gather dioxane, collagen protein, phosphocholine, gelatin or chitosan and derivant at least a.
In the method for preparing according to the invention, dissolved stone medicine is selected from sodium cholate or/and disodium edetate.
Biodegradable magnesium alloy bile duct lithodialysis braided support of the present invention compared with prior art has the following advantages:
(1) this biodegradable magnesium alloy lithodialysis braided support is a raw material owing to select magnesium or magnesium alloy for use, and the radial support better performances can prevent the narrow closure of bile duct proliferation, keeps biliary tract unobstructed;
(2) this support biocompatibility is better, and effect does not almost have inflammation in the body;
(3) contain calculus that sodium cholate that the polymer coating of medicine slowly discharges and/or disodium edetate solubilized formed and prevent that calculus from forming once more;
(4) the outer layer copolymer coating of magnesium alloy bracket can delay the degradation time of magnesium alloy bracket; Reach the progressively purpose of degraded; Magnesium alloy bracket can continue to support over a period to come after polymer coating was degraded fully; After the biodegradability magnesium alloy bracket is degraded fully, excrete, do not need to take out, avoid operation and be detained deleterious impact in the body for a long time.
For the ease of understanding, through specific embodiment biodegradable magnesium alloy bile duct lithodialysis braided support of the present invention and preparation method thereof is carried out detailed description below.What need particularly point out is, specific embodiment only is in order to explain that obviously those skilled in the art can explain according to this paper, and the present invention is carried out various corrections or change, and these corrections and changing also will be included within the scope.
The specific embodiment
Embodiment 1
Preparation biodegradable magnesium alloy bile duct lithodialysis braided support:
(1) be that 99.9% magnalium is a raw material with magnesia amount content, be processed into the monofilament that diameter is 0.2mm, it is that 8mm, length are the support of 80mm that monofilament is woven into diameter;
(2) in 20mg: the ratio of 1ml; Polycaprolactone is dissolved in the acetone; Processing solution, is that sodium cholate and the disodium edetate of 1mol: 1mol is dispersed in the said polycaprolactone solution, through immersion treatment with ratio; Place the rack surface of above-mentioned steps (1) preparation, process biodegradable magnesium alloy bile duct lithodialysis braided support.
Embodiment 2
Prepare biodegradable magnesium alloy lithodialysis braided support through following steps,
(1) be that 99.0% magnesium-zinc alloy is a raw material with magnesia amount content, be processed into the monofilament that diameter is 0.25mm, it is that 10mm, length are the support of 120mm that monofilament is woven into diameter;
(2) in 30mg: the ratio of 1ml; Polylactic acid is dissolved in the dichloromethane; Processing solution, is that sodium cholate and the disodium edetate of 1mol: 2mol is dispersed in the said polylactic acid solution, through immersion treatment with ratio; Place the rack surface of above-mentioned steps (1) preparation, process biodegradable magnesium alloy lithodialysis braided support.
Embodiment 3
The method for preparing biodegradable magnesium alloy lithodialysis braided support,
At first, be that 99.5% magnesium zircaloy is a raw material with magnesia amount content, be processed into the monofilament that diameter is 0.21mm, it is that 10mm, length are the support of 80mm that monofilament is woven into diameter; Then; In the ratio of 40mg: 1ml, will gather hexanol acid and be dissolved in the chloroform, process solution; With ratio is that sodium cholate and the disodium edetate of 2mol: 1mol is dispersed in said gathering in the hexanol acid solution; Through immersion treatment, place above-mentioned rack surface, process biodegradable magnesium alloy lithodialysis braided support.
Embodiment 4
With magnesia amount content is that 98.% magnesium calcium alloy is a raw material, is processed into the monofilament that diameter is 0.3mm, and it is that 10mm, length are the support of 60mm that monofilament is woven into diameter; Ratio in 50mg: 1ml; Chitosan is dissolved in the carbon tetrachloride; Processing solution, is that sodium cholate and the disodium edetate of 2mol: 3mol is dispersed in the said chitosan solution, through immersion treatment with ratio; Place described rack surface, process biodegradable magnesium alloy lithodialysis braided support.
Embodiment 5
At first, be that 99.5% magnesium zircaloy is a raw material with magnesia amount content, be processed into the monofilament that diameter is 0.21mm, it is that 10mm, length are the support of 80mm that monofilament is woven into diameter; Then, in the ratio of 40mg: 1ml, will gather hexanol acid and be dissolved in the chloroform; Process solution, the sodium cholate of 10mol is dispersed in said gathering in the hexanol acid solution, through immersion treatment; Place above-mentioned rack surface, process biodegradable magnesium alloy lithodialysis braided support.
Embodiment 6
With magnesia amount content is that 98.% magnesium calcium alloy is a raw material, is processed into the monofilament that diameter is 0.3mm, and it is that 10mm, length are the support of 60mm that monofilament is woven into diameter; In the ratio of 50mg: 1ml, chitosan is dissolved in the carbon tetrachloride, process solution; The disodium edetate of 10mol is dispersed in the said chitosan solution; Through immersion treatment, place described rack surface, process biodegradable magnesium alloy lithodialysis braided support.
The medication coat lithodialysis biliary tract prosthesis that the foregoing description makes is tried out, and the result shows, biodegradable magnesium alloy lithodialysis braided support of the present invention; The radial support better performances; Can keep biliary tract unobstructed, the disappearance of can degrading does not within a certain period of time need to take out once more; And its biocompatibility is better, and effect does not almost have inflammation in the body; Simultaneously, contain the slow sodium cholate that discharges of polymer coating of medicine and/or the calculus that the disodium edetate solubilized has formed, prevent that calculus from forming once more.
Claims (12)
1. biodegradable magnesium alloy bile duct lithodialysis braided support; It is characterized in that; Adopt magnesium or magnesium alloy to be woven into the pipe of porous network structure or helix structure; Make braided support, inner surface and the outer surface at said braided support scribbles the biodegradable polymer layer that contains dissolved stone medicine then, processes biodegradable magnesium alloy bile duct lithodialysis braided support;
In the described magnesium alloy, magnesia amount percentage composition is 85%-99.99%;
The diameter of described braided support is that 6～10mm, length are 60～120mm, and wherein, the diameter of monofilament is 0.1～2.0mm;
Described dissolved stone medicine is selected from sodium cholate or/and disodium edetate, and its mass ratio is 0～10mol: 0～10mol.
2. biodegradable magnesium alloy bile duct lithodialysis braided support according to claim 1 is characterized in that, the diameter of described braided support is that 8mm, length are 80mm, and wherein, the diameter of monofilament is 0.2mm; The mass ratio of said sodium cholate and disodium edetate is 1mol: 1mol.
3. biodegradable magnesium alloy bile duct lithodialysis braided support according to claim 1 is characterized in that, the diameter of described braided support is that 10mm, length are 120mm, and wherein, the diameter of monofilament is 0.25mm; The mass ratio of said sodium cholate and disodium edetate is 1mol: 2mol.
4. biodegradable magnesium alloy bile duct lithodialysis braided support according to claim 1 is characterized in that, the diameter of described braided support is that 10mm, length are 80mm, and wherein, the diameter of monofilament is 0.21mm; The mass ratio of said sodium cholate and disodium edetate is 2mol: 1mol.
5. biodegradable magnesium alloy bile duct lithodialysis braided support according to claim 1 is characterized in that, the diameter of described braided support is that 10mm, length are 60mm, and wherein, the diameter of monofilament is 0.3mm; The mass ratio of said sodium cholate and disodium edetate is 2mol: 3mol.
6. biodegradable magnesium alloy bile duct lithodialysis braided support according to claim 1 is characterized in that described dissolved stone medicine is the sodium cholate of 10mol.
7. biodegradable magnesium alloy bile duct lithodialysis braided support according to claim 1 is characterized in that described dissolved stone medicine is the disodium edetate of 10mol.
8. biodegradable magnesium alloy bile duct lithodialysis braided support according to claim 1; It is characterized in that it is 85%～99.99% magnalium gold, Mg-Fe alloy, magnesium-manganese alloy, magnesium alloy, magnesium-zinc alloy, magnesium zircaloy, magnesium rare earth-based alloy or magnesium calcium alloy that described magnesium alloy is selected from magnesia amount percentage composition.
9. biodegradable magnesium alloy bile duct lithodialysis braided support according to claim 1; It is characterized in that described biodegradable polymer is selected from polycaprolactone, polylactic acid, gathers hexanol acid, polylactic acid-polyglycolic acid copolymer, polycaprolactone-copolymer of poly lactic acid, gather dioxane, be collagen protein, phosphocholine, gelatin or chitosan and derivant thereof.
10. the method for preparing of the described biodegradable magnesium alloy bile duct of claim 1 lithodialysis braided support is characterized in that it may further comprise the steps:
(1) is raw material with the magnesium alloy, is processed into monofilament, monofilament is woven into support;
(2) in 0～300mg: the ratio of 1ml; Biodegradable polymer is dissolved in dichloromethane or chloroform or oxolane or acetone or carbon tetrachloride or the dimethyl formamide; Processing solution, is that sodium cholate and the disodium edetate of 0～10mol: 0～10mol is dispersed in the said biodegradable polymer solution with ratio, through soaking or spray treatment; Place the rack surface of above-mentioned steps (1) preparation, process biodegradable magnesium alloy bile duct lithodialysis braided support.
11. method for preparing according to claim 10 is characterized in that, in the described step (1), the diameter of monofilament is 0.1～2.0mm.
12. method for preparing according to claim 10 is characterized in that, in the described step (1), the diameter of support is that 6～10mm, length are 60～120mm.
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| CN2012100289031A CN102727331A (en) | 2011-11-14 | 2012-02-09 | Biodegradable magnesium alloy bile duct litholysis knitted bracket and preparation method thereof |
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| CN201110360162.2 | 2011-11-14 | ||
| CN201110360162 | 2011-11-14 | ||
| CN2012100289031A CN102727331A (en) | 2011-11-14 | 2012-02-09 | Biodegradable magnesium alloy bile duct litholysis knitted bracket and preparation method thereof |
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| CN102908216A (en) * | 2012-10-30 | 2013-02-06 | 东南大学 | Biodegradable medical human body cavity channel inner bracket and preparation method thereof |
| CN106038011A (en) * | 2016-05-24 | 2016-10-26 | 李君久 | Self discharging biliary duct stent |
| CN108853608A (en) * | 2017-05-10 | 2018-11-23 | 上海交通大学 | A kind of biodegradable medical magnesium alloy sticking patch and its preparation method and application |
| CN112826988A (en) * | 2021-02-22 | 2021-05-25 | 复旦大学附属中山医院 | Directionally degradable self-shedding magnesium metal biliary stent and preparation method thereof |
| CN114452448A (en) * | 2022-02-18 | 2022-05-10 | 常熟致圆微管技术有限公司 | Preparation method of biodegradable medical metal magnesium stent |
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Application publication date: 20121017 |