CN100571794C - Degradable radioactive biliary stent and manufacture method thereof - Google Patents
Degradable radioactive biliary stent and manufacture method thereof Download PDFInfo
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- CN100571794C CN100571794C CNB2006101384714A CN200610138471A CN100571794C CN 100571794 C CN100571794 C CN 100571794C CN B2006101384714 A CNB2006101384714 A CN B2006101384714A CN 200610138471 A CN200610138471 A CN 200610138471A CN 100571794 C CN100571794 C CN 100571794C
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- radiosiotope
- biliary tract
- tract prosthesis
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Abstract
The present invention relates to a kind of degradable radioactive biliary stent and manufacture method thereof that tumor is used for the treatment of, the common biliary tract prosthesis that is woven into by NiTi alloy silk and covering the peritoneum that constitutes in its surperficial degradable, active material and form.The manufacture method of degradable radioactive biliary stent comprises the following steps: (1) use NiTi alloy silk craft or machine braiding biliary tract prosthesis; (2) peritoneal layer of brushing on the biliary tract prosthesis surface of above-mentioned manufacturing is made of radioactivity degradable macromolecule mixed solution, places then under the cross-linking agent and soaks; (3) can make after freezing and dry; (4) use the preceding eo sterilization that needs to use.The present invention is used for the treatment of, suppresses bile duct neointimal hyperplasia and tumor growth, normal structure is not damaged, and radiation the time was finished degradation process in its carrier collagen, gelatin or chitosan can carry out in vivo, finally participates in the metabolism of human body and is excreted.
Description
Technical field
The present invention relates to a kind of medical apparatus and instruments, relate to a kind of treat the degradable radioactive biliary stent that tumor uses and the invention of manufacture method aspect thereof or rather.
Background technology
Carrasco in 1985 has invented first and has been used for expansion metal support (the AJR Am J Roentgenol.1985 of bile duct; 145 (6): 1279-1281), obtain reasonable therapeutic effect.China also progressively introduces this technology the nineties in 20th century, common metal expandable stent use wound when the biliary drainage art is less, with the bigger support of the implantable diameter of the less carrier pipe of diameter, early stage complications is few, the operation case fatality rate is low, can be expanded to original diameter after inserting narrow bile duct position under human body temperature, narrow tube wall is produced the expansionary force of persistence, thereby the stability that keeps the common metal expandable stent is difficult for displacement.
The biliary tract prosthesis of common NiTi alloy silk braiding is the narrow better method of cancer of biliary duct for the treatment of at present, but along with support in the cancer of biliary duct Clinical Application, some drawbacks have appearred.Common biliary tract prosthesis only can play the expansion narrow positions at the stenosis of bile duct position, can not suppress and the kill tumor cell.And cause easily once more after a period of time at implant into body narrow, if the support expansionary force is less than oncothlipsis power, just narrow can formation once more.If in implant frame, carry out partial radiotherapy, can overcome above-mentioned shortcoming.Utilize radiosiotope
125I,
103Pd,
32The history of treatment human body cancer such as P and other disease is of long duration, and the killing tumor cells that it has been established that or other cause that the cell of pathological changes can be destroyed or be killed and wounded by radioisotopic directional emittance effect.The most frequently used a kind of form of radiotherapy is to select for use the short radiosiotope of radiation distance as the treatment source, and this kind method is also referred to as close-range treatment.Generally radiosiotope is combined into a certain product by suitable carriers in the clinical medicine field of using, be implanted to human tumor or diseased region, because the radiation treatment source is permanent implant into body or takes out from human body after treatment a period of time again, therefore, can cause in various degree damage to the patient.
This shows that above-mentioned existing biliary tract prosthesis still has many defectives, and the assistant officer waits to be improved.
Because the defective that above-mentioned existing biliary tract prosthesis exists, the design people is based on being engaged in this type of product design manufacturing for many years, amassing has abundant practical experience and Professional knowledge, actively studied innovation, in the hope of creating a kind of degradable radioactive biliary stent that improves molding, can improve the general molding structure of existing conventional biliary tract prosthesis on the market, make it have more competitiveness.Through constantly research, design, and after studying sample and improvement repeatedly, create the present invention who has practical value finally.
Summary of the invention
Technical problem underlying to be solved by this invention is, overcomes the defective that existing biliary tract prosthesis exists, and a kind of degradable radioactive biliary stent of new structure is provided, and makes it not only solve the problem of the biliary tract prosthesis restenosis of common NiTi alloy silk braiding.But also overcome because biliary system branch is comparatively dense, block biliary flowing between branch's bile duct and ductus choledochus after the biliary tract prosthesis that is covered with materials such as medical Polyurethane, medical grade silicon rubber, medical silica-gel is implanted bile duct, caused new biliary system disease to a certain extent.
The present invention solves its technical problem underlying and realizes by the following technical solutions.Degradable radioactive biliary stent according to the present invention proposes is characterized in that: the common biliary tract prosthesis that is woven into by NiTi alloy silk and covering the peritoneum that constitutes in its surperficial degradable, active material and form.
The present invention solves its technical problem and can also adopt following technical measures further to realize.
Preceding described degradation material can be: collagen, gelatin or chitosan.
Preceding described active material can be: P-32, Pd-103 or I-125.
The activity of preceding described active material is about 12.5 * 10
7Bq, this activity can be selected according to the cancer of biliary duct light and heavy degree.
The peritoneum that preceding described radioactive material and degradation material constitute evenly is covered in the biliary tract prosthesis surface.
Another technical problem to be solved by this invention is, a kind of method of making degradable radioactive biliary stent is provided, and it is characterized in that it comprises the following step:
(1) uses NiTi alloy silk craft or machine braiding biliary tract prosthesis;
(2) peritoneal layer on the biliary tract prosthesis surface of above-mentioned manufacturing is to be brushed by radioactivity degradable macromolecule mixed solution to make, and places immersion cross-linking agent under then;
(3) can make after freezing and dry;
(4) use the preceding eo sterilization that needs to use.
Preceding described radioactivity degradable macromolecule mixed solution is any active material in collagen, hydrochloric acid (acetic acid) and the claim 3; Or any active material in gelatin, water and the claim 3; Or any active material in chitosan, acetic acid and the claim 3; Or any active material in collagen, chitosan and the claim 3; Or any one of any active material mixed solution in gelatin, chitosan and the claim 3.
Preceding described cross-linking agent can be selected (1) ethyl-3-(3-dimethyl propyl) carbodiimide hydrochloride, (2) (N-morpholine)-ethane-sulfonic acid.
Preceding described collagen, gelatin solution can be used (1) ethyl-3-(3-dimethyl propyl) carbodiimide hydrochloride, (2) (N-morpholine)-ethane-sulfonic acid cross-linking agent.
The mixed solution of preceding described chitosan, acetate type need not carry out crosslinked.
The present invention compared with prior art has tangible advantage and beneficial effect.By above technical scheme as can be known, the present invention makes its characteristics that are more suitable for cancer of biliary duct in order to treatment, inhibition tumor or pathological tissues owing to adopt technique scheme; The radiosiotope P-32 that adopts, Pd-103, I-125 can suppress bile duct neointimal hyperplasia and tumor growth, its irradiation distance of empirical tests is short, normal structure is not damaged, radiation the time was finished degradation process in its carrier collagen, gelatin or chitosan can carry out in vivo, finally participated in the metabolism of human body and was excreted.
The present invention is on the practicality and cost benefit of structural design, use, really it is required to meet industry development fully, and disclosed structure is unprecedented innovative design, it does not see any publication, do not see more that before application that identical architectural feature is arranged is known, formerly public, and also not seeing on the market has similar products like, and has novelty really.
Structure of the present invention really has more technological progress than existing biliary tract prosthesis, and its particular structure feature and more can also be far from existing biliary tract prosthesis and can compare, more existing biliary tract prosthesis has more technical progress, and has the multinomial effect of enhancement, and creative really.
Designer of the present invention studies this series products experience of existing ten several years, quite understand for existing problem of existing biliary tract prosthesis and defective, and the present invention founds according to above-mentioned Study of Defects exploitation, it can reach its intended purposes and effect really, not only on the kenel of space, really belong to innovation, and the true accessory of more existing biliary tract prosthesis has suitable enhancement effect, and existing known product has more technological progress and practicality, and produced handy and practical good effect, and have practicality really.
In sum, the present invention really belongs to innovation on the kenel of space, and has the multinomial effect of enhancement than existing product, and simple in structure, is suitable for practicality, has the extensive value of industry.It is in limited field, technical development space, no matter structurally or bigger improvement all arranged on the function, and have large improvement technically, and produced handy and practical effect, and has the effect of enhancement really, thereby being suitable for practicality more, really is a new and innovative, progressive, practical new design.
Above-mentioned explanation only is the general introduction partly of technical solution of the present invention feature, can clearer understanding technological means of the present invention for making the professional and technical personnel, and can be implemented according to the content of description, below with preferred embodiment of the present invention describe in detail as after.
The specific embodiment
Degradable radioactive biliary stent of the present invention, the common biliary tract prosthesis that is woven into by NiTi alloy silk and by the degradation material and the P-32 of collagen, gelatin or chitosan, the peritoneum that Pd-103 or I-125 active material constitute constitutes.The peritoneum that is made of radioactive material and degradation material evenly is covered in the biliary tract prosthesis surface.
Make the method for degradable radioactive biliary stent:
Embodiment 1
(1) uses NiTi alloy silk craft or machine braiding biliary tract prosthesis;
(2) form peritoneum at biliary tract prosthesis surface brushing one deck collagen+hydrochloric acid (acetic acid)+P-32, the Pd-103 of above-mentioned manufacturing or the mixed solution of any active material among the I-125, place then under the cross-linking agent and soak;
(3) can make after freezing and dry;
(4) use the preceding eo sterilization that needs to use.
Embodiment 2
(1) uses NiTi alloy silk craft or machine braiding biliary tract prosthesis;
(2) form peritoneum at biliary tract prosthesis surface brushing one deck gelatin+water+P-32, the Pd-103 of above-mentioned manufacturing or the mixed solution of any active material of I-125, place then under the cross-linking agent and soak;
(3) can make after freezing and dry;
(4) use the preceding eo sterilization that needs to use.
Embodiment 3
(1) uses NiTi alloy silk craft or machine braiding biliary tract prosthesis;
(2) form peritoneum at biliary tract prosthesis surface brushing one deck chitosan+acetic acid+P-32, the Pd-103 of above-mentioned manufacturing or the mixed solution of any active material among the I-125, place then under the cross-linking agent and soak;
(3) can make after freezing and dry;
(4) use the preceding eo sterilization that needs to use.
Embodiment 4
(1) uses NiTi alloy silk craft or machine braiding biliary tract prosthesis;
(2) form peritoneum at biliary tract prosthesis surface brushing one deck collagen+chitosan+P-32, the Pd-103 of above-mentioned manufacturing or the mixed solution of any active material among the I-125, place then under the cross-linking agent and soak;
(3) can make after freezing and dry;
(4) use the preceding eo sterilization that needs to use.
Embodiment 5
(1) uses NiTi alloy silk craft or machine braiding biliary tract prosthesis;
(2) form peritoneum at biliary tract prosthesis surface brushing one deck gelatin+chitosan+P-32, the Pd-103 of above-mentioned manufacturing or the mixed solution of any active material among the I-125, place then under the cross-linking agent and soak;
(3) can make after freezing and dry;
(4) use the preceding eo sterilization that needs to use.
Above-mentioned cross-linking agent is for collagen, gelatin solution, and cross-linking agent can be selected (1) ethyl-3-(3-dimethyl propyl) carbodiimide hydrochloride, (2) (N-morpholine)-ethane-sulfonic acid; Mixed solution for chitosan+acetate type need not carry out crosslinked.
Radiosiotope ion of the present invention is uniformly distributed in collagen, gelatin or the chitosan.
Radiosiotope activity provided by the invention can be determined according to conditions of patients.
The present invention selects a kind of product that is more suitable for treating or suppressing cancer of biliary duct or bile duct pathological tissues.
The shortcoming that is used for the cancer of biliary duct treatment has in early days been alleviated in the present invention to a great extent, and it is to cover medical Polyurethane, silicone rubber or the silica gel that one deck contains radioactive material with naked NiTi alloy bracket or at exposed rack surface.Because biliary system branch is comparatively dense, after implanting bile duct, the biliary tract prosthesis that is covered with this kind material blocked biliary flowing between branch's bile duct and ductus choledochus, can cause new biliary system disease to a certain extent.
The activity that an advantage of the present invention is radiosiotope P-32, Pd-103 or I-125 can determine that activity is about 12.5 * 10 according to patient tumors cellular invasion degree
7Bq has guaranteed the safety and the effectiveness of therapeutic process.
The above, it only is preferred embodiment of the present invention, be not that the present invention is done any pro forma restriction, every foundation technical spirit of the present invention all still belongs in the scope of technical solution of the present invention any simple modification, equivalent variations and modification that above embodiment did.
Claims (7)
1, degradable radioactive biliary stent is characterized in that: the common biliary tract prosthesis that is woven into by NiTi alloy silk and covering in its surperficial degradation material and radiosiotope
125I,
103Pd or
32The film that P constitutes is formed.
2, degradable radioactive biliary stent according to claim 1 is characterized in that: described degradation material is: collagen, gelatin or chitosan.
3, degradable radioactive biliary stent according to claim 1 is characterized in that: described radiosiotope is:
32P,
103Pd or
125I.
4, degradable radioactive biliary stent according to claim 1 is characterized in that: wherein said radioisotopic radiation activity is 12.5 * 10
7Bq, this activity is selected according to the cancer of biliary duct light and heavy degree.
5, degradable radioactive biliary stent according to claim 1 is characterized in that: wherein said degradation material and radiosiotope
125I,
103Pd or
32The film that P constitutes evenly is covered in the biliary tract prosthesis surface.
6, the manufacture method of degradable radioactive biliary stent is characterized in that: this method comprises the following steps: successively
(1) uses NiTi alloy silk craft or machine braiding biliary tract prosthesis;
(2) rete of brushing on the biliary tract prosthesis surface that step (1) is made is made of any radioactivity degradable macromolecule mixed solution of following description:
Any radiosiotope in A collagen, hydrochloric acid or acetic acid and the claim 3; Or
Any radiosiotope in B gelatin, water and the claim 3; Or
Any radiosiotope in C chitosan, acetic acid and the claim 3; Or
Any radiosiotope in D collagen, chitosan and the claim 3; Or
Any one of any radiosiotope mixed solution in E gelatin, chitosan and the claim 3.
The rete that any radiosiotope mixed solution in described C chitosan, acetate type and claim 3 is brushed need not carry out crosslinked, A, B, D and E kind mixed solution need place immersion cross-linking agent under;
(3) can make after freezing and dry;
(4) use the preceding eo sterilization that needs to use.
7, manufacture method according to claim 6 is characterized in that: described cross-linking agent is selected (1) ethyl-3-(3-dimethyl propyl) carbodiimide hydrochloride or (2) (N-morpholine)-ethane-sulfonic acid.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006101384714A CN100571794C (en) | 2006-11-16 | 2006-11-16 | Degradable radioactive biliary stent and manufacture method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006101384714A CN100571794C (en) | 2006-11-16 | 2006-11-16 | Degradable radioactive biliary stent and manufacture method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN1961977A CN1961977A (en) | 2007-05-16 |
| CN100571794C true CN100571794C (en) | 2009-12-23 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB2006101384714A Active CN100571794C (en) | 2006-11-16 | 2006-11-16 | Degradable radioactive biliary stent and manufacture method thereof |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102727938A (en) * | 2011-10-28 | 2012-10-17 | 上海市第一人民医院 | Radioactive biodegradable bile duct stent and preparation method thereof |
| CN102727944A (en) * | 2011-11-14 | 2012-10-17 | 上海市第一人民医院 | Anti-benign and malignant biliary stricture drug eluting stent and preparation method thereof |
| CN114259609B (en) * | 2021-12-28 | 2023-02-28 | 埃恩普裕(北京)科技有限公司 | Support frame |
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Address after: Room 2902, block B, East Asian Wangjing center, Wangjing garden, Chaoyang District, Beijing, Patentee after: Shen Yang Address before: Beijing city Changping District day Chinese yuan No. 2 Building 7 unit 401 room Patentee before: Shen Yang |
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Address after: 100102, room 402, building 2902, Wangjing garden, Chaoyang District, Beijing Patentee after: Shen Yang Address before: 100102 B, room 2902, East Wangjing center, Chaoyang District District, Wangjing Park, Beijing, Patentee before: Shen Yang |
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Owner name: LIUAN JIMIN MEDICAL TECHNOLOGY CO., LTD. Free format text: FORMER OWNER: SHEN YANG Effective date: 20131028 |
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Effective date of registration: 20131028 Address after: 237000 Anhui science and Technology Development Service Center, Lu'an Economic Development Zone Patentee after: Lu'an Ji min Medical Technology Co., Ltd. Address before: 100102, room 402, building 2902, Wangjing garden, Chaoyang District, Beijing Patentee before: Shen Yang |