CN100372578C - Composite stent material production method, composite stent material and composite stent - Google Patents
Composite stent material production method, composite stent material and composite stent Download PDFInfo
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- CN100372578C CN100372578C CNB2005100117798A CN200510011779A CN100372578C CN 100372578 C CN100372578 C CN 100372578C CN B2005100117798 A CNB2005100117798 A CN B2005100117798A CN 200510011779 A CN200510011779 A CN 200510011779A CN 100372578 C CN100372578 C CN 100372578C
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Abstract
The invention provides a composite stent material, a composite stent and a production method thereof. The composite scaffold material is formed by compounding high polymer materials with different degradation speeds or a degradable high polymer material and a non-degradable high polymer material. The non-degradable high polymer material or the high polymer material with slow degradation speed is made into a filamentous or net shape to be used as a framework, and the degradable high polymer material or the high polymer material with fast degradation speed is attached to the framework. The composite support is made of composite support materials, and the production method of the support comprises the steps of cutting the prepared composite support materials into long strips, winding the long strips on a mold into a spiral shape, and shaping for 0.1-48 hours at the temperature of 20-80 ℃ to prepare the spiral support. The composite scaffold material has small fragments formed in the degradation process in vivo, and can be discharged out of the body through the biliary tract or the urethra without blocking the duct.
Description
Technical field
The present invention relates to the engineering in medicine technical field, particularly relate to a kind of bio-medical composition.
Background technology
In clinical practice, often run into the narrow case of pipeline in the human body.Such as urethral stricture, biliary tract stenosis etc.Urethral stricture is that the quite common organizational structure of male is unusual, often is secondary to the infectious disease or the damage of urethra.The pathogen that infects in the urethra can involve prostate simultaneously, causes prostatic inflammation; Because the fiber voltinism urethral stricture that forms after the injury of urethra, can cause that dysuria and urine are counter to flow.Biliary tract stenosis belongs to biliary complications, and biliary tract infection also can cause biliary tract stenosis.Present Therapeutic Method mainly contains (1) non-operative treatment.Non-operative treatment mainly depends on the pipeline expansion, puts into a support at narrow section, plays effects such as keeping pipeline is unobstructed, pipeline typing, water conservancy diversion.(Journal of Endourology, 1997; 11:391) (Gastointestinal Endoscopy, 2003; 58:777) (2) operative treatment.The danger of operative treatment is big, the expense height, and also bigger to patient's wound, only under the invalid situation of non-operative treatment, just adopt operative treatment.Need implant at the treatment medium-height trestle, timbering material is in human body complex physical environment, be subjected to physics for a long time, chemistry, the influence of factors such as bio electricity, ubiquity many dynamic interactions between each tissue and organ simultaneously, therefore, timbering material must satisfy following several requirements: (1) has excellent biological compatibility and physical compatibility, the phenomenon that does not occur diminishing biology performance after the assurance material is compound, (2) has good biological stability, the structure of material does not change because of humoral effect, material is formed the biological respinse that does not cause organism simultaneously, (3) has enough intensity and toughness, can bear the mechanicals efforts of human body, the elastic modelling quantity of material therefor and tissue, hardness, anti-wear performance adapts, strengthen the body material and also must have high rigidity, elastic modelling quantity and shock resistance, (4) have good sterilization ability, guarantee biomaterial smooth application clinically.In addition, biomaterial will have good molding, processing characteristics, because of the processing and forming difficulty its application is restricted.Now Chang Yong timbering material has Nitinol, degradable high polymer material.Nitinol easily makes duct wall be worn because its hardness is big, is difficult for degraded simultaneously in vivo, and when took out the normal back of pipeline recovery, patient also will be subjected to once painful more, so be not suitable for use in the timbering material of urethra, biliary tract stenosis etc.Degradable high polymer material has solved this problem, and the later stage can become fragile but degradable macromolecule is degraded, and forms bigger fragment, stops up duct (GastointestinalEndoscopy, 2001 easily; 3:120).So degradable macromolecule has also run into difficulty as biliary tract and urethra rack material the time.So be necessary to improve the character of degradation material.
Summary of the invention
The present invention is directed to the defective of the said goods, a kind of production method and timbering material of compound support frame material is provided, the fragment that forms in its support degradation in vivo process of making is very little, can excrete by biliary tract or urethra, and unlikely blocking pipe.
A kind of production method of compound support frame material, comprise the steps: that (1) is made into slow degraded macromolecular or non-degradable macromolecule thread or netted as skeleton, (2) fast degraded macromolecular or degradable macromolecule are dissolved in the corresponding solvent, (3) solution in the step (2) is poured in the mould, add skeleton, the solvent evaporates film forming gets final product.
The manufacture method of described compound support frame material, described solution concentration are 0.000001-5g/ml, and thickness is 0.1～2mm.
The compound support frame material of the above method preparation.
Described compound support frame material, the diameter of described silk is 0.001-0.2mm.
Described compound support frame material, described degradable high polymer material are the degradable high polymer materials of synthetic degradable macromolecule, natural degradable macromolecule or gene engineering method preparation.
Described compound support frame material, described degradable macromolecule are poly-Acetic acid, hydroxy-, bimol. cyclic esters, polylactide, the copolymer of own lactide and lactide, polycaprolactone, poly-dioxane ester, PTMC, poly-beta-hydroxy-butanoic acid valerate, collagen, chitosan, gelatin, Polyethylene Glycol, hyaluronic acid, a kind of in the fibroin.
Described compound support frame material, described non-degradable macromolecular material are meant a kind of in nylon, epoxy resin, polyethylene, polymethyl methacrylate, politef, silicone rubber, the polyurethane.
A kind of support is made by described compound support frame material, and described support is a spiral type.
The production method of described support, the compound support frame material of made is slitting, on mould, be wound in spiral type, formalized 0.1-48 hour down in 20-80 ℃, make helical stent.
Compound support frame material of the present invention adopts the macromolecular material of different degradation speeds to be composited.Be that timbering material is to be composited with very fast degraded macromolecular by thread or netted slow degraded macromolecular; Perhaps be composited by thread or netted non-degradable macromolecule and degradable macromolecule.Degradable macromolecule can be divided into slow degraded macromolecular and fast degraded macromolecular according to the difference of its degradation speed.Not being both of degradation speed because due to the difference of monomer or molecular weight.The speed of degradation speed just comparatively speaking.Slow high molecular silk or the net of degradation speed is compounded in the fast macromolecular material of degradation speed, in degradation process, when the fast macromolecular material of degradation speed becomes fragile and is broken into fragment, macromolecule silk or net that degradation speed is slow can play the connection effect, avoid big clogged with fragments in pipeline.Macromolecule silk that degradation speed is slow or net become fragile and when becoming fragment, the fast macromolecule of degradation speed has become very little fragment, thereby can excrete.Simultaneously, because the fragment that slow macromolecule silk of degradation speed or net form all is a fine filaments, also excrete easily.Nondegradable high molecular silk or net are compounded in the degradable macromolecular material, in degradation process, degradable high polymer material becomes fragile and when being broken into fragment, non-degradable macromolecule silk or net can play the connection effect, avoid big clogged with fragments in the duct, until degradable macromolecule has become very little fragment, thereby can excrete.Because the nondegradable high molecular silk of selecting for use is very thin; The skeleton of the non-degradable high score subnet of selecting for use that is engraved as is also very thin, thus softer, can not independent support in pipeline, also can be excreted.
Solwution method is adopted in the molding of composite of the present invention, earlier the macromolecular material of non-degradable/slow degradation speed is made skeleton, can be thread or netted, the macromolecular material of degradable/fast degradation speed is made into the solution of variable concentrations as required, in mould,, make that the combination between the compound material is tightr with both composite moldings.
Description of drawings:
Fig. 1: helical stent
The specific embodiment:
The present invention is described in further detail at embodiment below.
(the used raw material of the present invention is commercially available material)
Embodiment 1 preparation support (polylactide (100,000)/nylon)
1. diameter is that the nylon yarn of 0.001mm is weaved into netted;
2. polylactide (molecular weight 100,000) is dissolved in the dichloromethane, is made into the solution that the quality volumetric concentration is 0.000001g/ml, stir;
3. the net in the step 1 is layered on mold bottom, and solution in the step 2 is poured in the mould.Allow the solution evaporation film forming, thickness be 0.1.Film is slitting, and wide is 6mm;
4. with the rectangular spiral type that on mould, is wound in the step 2, formalized 48 hours down, make helical stent at 35 ℃.
Embodiment 2 preparation supports (fibroin/silicone rubber)
Silk fibroin material is soluble in water 1., be mixed with the solution of 5g/ml, stir;
2. the silicone rubber silk that with diameter is 0.02mm is layered on mold bottom, and solution is poured in the mould.Allow the solution evaporation film forming, thickness be 2mm.Film is slitting, and wide is 0.1mm;
3. with the rectangular spiral type that on mould, is wound in the step 2, formalized 1 hour down, make helical stent at 50 ℃.
Embodiment 3 preparation supports (poly-dioxane ester (100,000)/poly-dioxane ester (500,000))
1. poly-dioxane ester (molecular weight 500,000) is made filament, and diameter is 0.1mm.
2. poly-dioxane ester (molecular weight 100,000) is dissolved in dichloromethane, is made into the solution that the quality volumetric concentration is 2g/ml, stirs;
3. solution is poured in the mould, volatilizees after 12 hours, the silk in the step 1 is put into mould.Allow the solution film forming of volatilizing fully, thickness is 1.5mm.Film is slitting, and wide is 0.8mm;
4. with the rectangular spiral type that on mould, is wound in the step 3, formalized 28 hours down, make helical stent at 80 ℃.
Embodiment 4 preparation supports (copolymer of own lactide and lactide (100,000)/poly-beta-hydroxy-butanoic acid valerate (100,000))
1. will gather beta-hydroxy-butanoic acid valerate (molecular weight 100,000) and make filament, diameter is 0.02mm.
2. the copolymer (molecular weight 100,000, monomer ratio 1: 1) with own lactide and lactide is dissolved in dichloromethane, is made into the solution that the quality volumetric concentration is 0.001g/ml, stirs;
3. solution is poured in the mould, volatilizees after 15 hours, the silk in the step 1 is put into mould.Allow the solution film forming of volatilizing fully, thickness is 0.2mm.Film is slitting, and wide is 1.5mm;
4. with the rectangular spiral type that on mould, is wound in the step 3, formalized 20 hours down, make helical stent at 40 ℃.
Embodiment 5 preparation supports (chitosan/PTMC (100,000))
1. PTMC (molecular weight 100,000) is made filament, and diameter is 0.03mm.
2. chitosan is dissolved in (acetic acid concentration: 1%v/v), be made into the solution that the quality volumetric concentration is 0.0001g/ml, stir in the acetic acid solution;
3. solution is poured in the mould, volatilizees after 15 hours, the silk in the step 1 is put into mould.Allow the solution film forming of volatilizing fully, thickness is 0.3mm.Film is slitting, and wide is 1mm;
4. with the rectangular spiral type that on mould, is wound in the step 3, formalized 15 hours down, make helical stent at 20 ℃.
Embodiment 6 preparation supports (gelatin/polyethylene (150,000))
1. polyethylene (molecular weight 150,000) is made filament, and diameter is 0.08mm.
2. gelatin is dissolved in (acetic acid concentration: 1%v/v), be made into the solution that the quality volumetric concentration is 0.2g/ml, stir in the acetic acid solution;
3. solution is poured in the mould, volatilizees after 18 hours, the silk in the step 1 is put into mould.Allow the solution film forming of volatilizing fully, thickness is 0.8mm.Film is slitting, and wide is 2mm;
4. with the rectangular spiral type that on mould, is wound in the step 3, formalized 42 hours down, make helical stent at 70 ℃.
Embodiment 7 preparation supports (hyaluronic acid/epoxy resin (0.5 ten thousand))
1. epoxy resin (molecular weight 0.5 ten thousand) is made filament, and diameter is 0.01mm.
2. hyaluronic acid is dissolved in (acetic acid concentration: 1%v/v), be made into the solution that the quality volumetric concentration is 0.05g/ml, stir in the acetic acid solution;
3. solution is poured in the mould, volatilizees after 8 hours, the silk in the step 1 is put into mould.Allow the solution film forming of volatilizing fully, thickness is 0.2mm.Film is slitting, and wide is 3mm;
4. with the rectangular spiral type that on mould, is wound in the step 3, formalized 35 hours down, make helical stent at 30 ℃.
Embodiment 8 preparation supports (Polyethylene Glycol/polyurethane (50,000))
1. polyurethane (molecular weight 50,000) is made filament, and diameter is 0.005mm.
2. Polyethylene Glycol is dissolved in (acetic acid concentration: 1%v/v), be made into the solution that the quality volumetric concentration is 1g/ml, stir in the acetic acid solution;
3. solution is poured in the mould, volatilizees after 12 hours, the silk in the step 1 is put into mould.Allow the solution film forming of volatilizing fully, thickness is 1mm.Film is slitting, and wide is 0.3mm;
4. with the rectangular spiral type that on mould, is wound in the step 3, formalized 40 hours down, make helical stent at 60 ℃.
Embodiment 9 preparation supports (collagen/poly tetrafluoroethylene)
1. getting thickness is the thick poly tetrafluoroethylene of 0.1mm, is engraved as netted.
2. collagen is dissolved in that (acetic acid concentration: 1%v/v), being made into the quality volumetric concentration is 0.1g/ml solution, stirs in the acetic acid solution.。
3. the politef net in the step 1 is layered on mold bottom, pours the solution of configuration in the step 2 into, the volatilization film forming, and film thickness monitoring is at 0.5mm.Film is slitting, and wide is 4mm,
4. with the rectangular spiral type that on mould, is wound in the step 3, formalized 5 hours down, make helical stent at 25 ℃.
Embodiment 10 preparation supports (polycaprolactone (300,000)/polymethyl methacrylate)
1. getting thickness is the thick polymethyl methacrylate of 0.2mm, is engraved as netted.
2. polycaprolactone (molecular weight 300,000) is dissolved in the dichloromethane, being made into the quality volumetric concentration is 0.1g/ml solution, stirs.。
3. the polymethyl methacrylate net in the step 1 is layered on mold bottom, pours the solution of configuration in the step 2 into, the volatilization film forming, and film thickness monitoring is at 0.6mm.Film is slitting, and wide is 5mm.
4. with the rectangular spiral type that on mould, is wound in the step 3, formalized 0.1 hour down, make helical stent at 20 ℃.
Claims (6)
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| CNB2005100117798A CN100372578C (en) | 2005-05-24 | 2005-05-24 | Composite stent material production method, composite stent material and composite stent |
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| CN100372578C true CN100372578C (en) | 2008-03-05 |
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Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100400115C (en) * | 2005-05-24 | 2008-07-09 | 北京奥精医药科技有限公司 | Composite stent material, composite stent and production method thereof |
| CN101428155B (en) * | 2008-11-26 | 2012-06-13 | 无锡市第四人民医院 | Composite artificial minute vessel stent and preparation method thereof |
| CN101695582B (en) * | 2009-10-23 | 2012-11-07 | 东华大学 | Method for preparing polyglycollide (PGA)-woven urethra scaffold for repairing urethral |
| CN102266594B (en) * | 2011-08-22 | 2014-04-16 | 东华大学 | Gradually degradable woven ureter scaffold tube and preparation method thereof |
| CN103028147B (en) * | 2011-10-09 | 2014-04-16 | 上海市儿童医院 | Fiber-based non-woven biodegradable ureteral stent tube and preparation method thereof |
| CN102488931A (en) * | 2011-12-08 | 2012-06-13 | 张自强 | Spiral urethral stent and production method thereof |
| CN103374208B (en) * | 2012-04-24 | 2015-11-18 | 苏州纳晶医药技术有限公司 | A kind of can the polymer materials and preparation method thereof of gradient degradation |
| CN103211671B (en) * | 2013-02-01 | 2016-08-10 | 东华大学 | Weaving multicomponent strengthens structure and progressively degrades ureter rack tube and preparation method thereof |
| US10413403B2 (en) * | 2015-07-14 | 2019-09-17 | Boston Scientific Scimed, Inc. | Prosthetic heart valve including self-reinforced composite leaflets |
| CA3027591C (en) * | 2016-06-23 | 2023-08-01 | Poly-Med, Inc. | Medical implants having managed biodegradation |
| CN106178107B (en) * | 2016-07-01 | 2019-04-30 | 浙江大学 | A kind of silk/collagen composite scaffold and its preparation and application |
| CN117758415A (en) * | 2023-11-29 | 2024-03-26 | 祥符实验室 | Gradient degradation composite fiber and its preparation method and application |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1381276A (en) * | 2002-05-10 | 2002-11-27 | 清华大学 | Nano carbon tube reinforced plastics/ceramics-base composition for repairing bone |
| CN1398643A (en) * | 2002-08-12 | 2003-02-26 | 天津大学 | Prepn process of multi-component hybridized 3D woven myotendinous rack material |
| CN1586655A (en) * | 2004-07-02 | 2005-03-02 | 清华大学 | Method for preparing multilayer medicine composite degradable biliary tract rack visible under X-ray |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1381276A (en) * | 2002-05-10 | 2002-11-27 | 清华大学 | Nano carbon tube reinforced plastics/ceramics-base composition for repairing bone |
| CN1398643A (en) * | 2002-08-12 | 2003-02-26 | 天津大学 | Prepn process of multi-component hybridized 3D woven myotendinous rack material |
| CN1586655A (en) * | 2004-07-02 | 2005-03-02 | 清华大学 | Method for preparing multilayer medicine composite degradable biliary tract rack visible under X-ray |
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Address after: 100085, Beijing, Haidian District Road, No. 5, 3, A305 Patentee after: Aojing Medical Technology Co.,Ltd. Address before: 100085, Beijing, Haidian District on the road No. 26, Zhongguancun venture building, room 719 Patentee before: Beijing Allgens Medical Science and Technology Co.,Ltd. |
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