CN100400012C - Biological ceramic stopper and method for manufacturing the same - Google Patents

Biological ceramic stopper and method for manufacturing the same Download PDF

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Publication number
CN100400012C
CN100400012C CNB2004100511889A CN200410051188A CN100400012C CN 100400012 C CN100400012 C CN 100400012C CN B2004100511889 A CNB2004100511889 A CN B2004100511889A CN 200410051188 A CN200410051188 A CN 200410051188A CN 100400012 C CN100400012 C CN 100400012C
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China
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stopper
bioceramic
titanium
ion beam
manufacture method
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CNB2004100511889A
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CN1736345A (en
Inventor
訾振军
臧式先
冯耀庭
曾敏
吕世文
张智伟
孔祥清
蒋士良
于波
华益民
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Shenzhen Xianjian Biomaterial Technology Co ltd
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Shenzhen Xianjian Biomaterial Technology Co ltd
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Abstract

The present invention discloses a biological ceramics stopper and a preparation method thereof. Biological ceramics is sprayed on the surface of a stopper by using a plasma beam vapour deposition method, titanium nitride, titanium carbide and titanium oxide are synthesized by using inactive gas ion beams for bombarding and evaporating titanium, and nitrogen, carbon and oxygen adsorbed by the titanium, which are deposited on the surface of the stopper, in an ordinary temperature and the vacuum condition, and the surface coating of the stopper is formed. The biological ceramics can effectively promote the combination of metal and cells to form a natural isolating layer on the surface of the stopper in a short time, the plugging effect is enhanced, and the biocompatibility of the stopper is greatly improved. The biological ceramics layer on the metal surface is an effective protective layer, which can reduce various kinds of physical, chemical, biologic, etc. reaction of blood to the metal, the leakage of metal ions is reduced, and thereby, inflammatory reaction or thrombus can be avoided. In addition, the biological ceramics stopper obtained by the method can enhance the fatigue resistance and the abradability of the stopper.

Description

Bioceramic stopper and preparation method thereof
Technical field
The present invention relates to medical apparatus and instruments, particularly a kind of bioceramic stopper that is used for the congenital heart disease treatment and preparation method thereof.
Background technology
Congenital heart disease is that the mankind are threatened one of more serious heart disease.According to domestic statistics, the sickness rate of all kinds of congenital heart diseases for the highest, secondly is ventricular septal defect, patent ductus arteriosus and fallot's disease etc. with atrial septal defect.According to data from abroad, birth back survival baby's congenital heart disease sickness rate is about 0.8%~1%, and the nearest statistics of China is 0.13%~0.67%.If by nineteen ninety country census baby due rate is 2% to calculate, China has the birth of 140,000 children with congenital heart disease every year approximately.
In recent years, because the application of cardiac catheterization and cardioangiography, and the development of cardiac operation under direct vision under the extracorporeal circulation, make clinically the situation that congenital heart disease is difficult for diagnosis and lacks the treatment way that very big variation has taken place, popularizing of especially emerging interventional therapeutic technique more makes the diagnosis and treatment of congenital heart disease that very big change has been arranged.Interventional therapeutic technique is to develop a kind of rapidly clinical treatment technology in the last few years, and it has, and wound is little, safety, good effect, easy and simple to handle, advantage such as the hospital stays is short, patients ' recovery is fast.Along with updating of interventional medical device, the indication of its treatment also will constantly enlarge, because this technology has simple and direct safety, the reliable advantage of curative effect, believing in this century to have more wide application prospect.
The interventional therapy medical apparatus and instruments of existing congenital heart disease mainly contains following a few class: atrial septal defect plugging device, ventricular septal defect, patend ductus arteriosus occluder.This class interventional medical device clinically obtained good application, its danger that massive blood loss brings of can avoiding performing the operation, and the crowd who is suitable for is also increasing.
Although congenital heart disease is got involved medical product and obtained the prominent development that flies to jump suddenly, still exist a lot of problems to await further solution.At first, there is residual shunt at a specified future date in the stopper implant patient, and incidence rate on average can reach about 5%.Secondly, stopper metal surface endothelial cell growth speed is slower, is difficult for generating endodermis.In addition, common stopper is implanted its metal material of back and is directly contacted with blood, be subjected to the effect of multiple composite factors such as physics in the vital movement, chemistry, biology after implanting in the interior environment midium or long term of human body complexity, thereby often leak out a large amount of metal ions, cause symptoms such as inflammatory reaction or generation blood coagulation, blood compatibility is relatively poor, has 4% patient to have microthrombus according to statistics approximately.
Summary of the invention
Technical problem to be solved by this invention is, a kind of bioceramic stopper is provided, and can effectively promote combining of metal and cell, can not only improve stifledly to close effect, but also can improve the biocompatibility of stopper greatly.Simultaneously, the leakage of metal ion can be reduced, thereby inflammatory reaction or thrombosis can be avoided.
Adopted following technical scheme for solving the problems of the technologies described above the present invention: a kind of bioceramic stopper is provided, forms, be coated with one deck bioceramic on the surface of stopper by stopper and the choked flow film that is arranged on the stopper.
Described bioceramic is to strengthen vapour deposition process through ion beam to be coated in described stopper surface.Described bioceramic can be titanium nitride, titanium carbide or titanium oxide.
A kind of manufacture method of bioceramic stopper is provided, comprises the steps:
1) at first makes stopper;
2) then at stopper surface coating one deck bioceramic;
3) at last the choked flow film is set on the stopper that is covered with bioceramic.
Wherein, bioceramic step 2) is to adopt ion beam to strengthen CVD method to be coated in the stopper surface.It is under room temperature and vacuum condition that described ion beam strengthens CVD method, and with the titanium of inert gas ion beam bombardment hydatogenesis on the stopper surface, the reacting gas that its absorption feeds and synthesising biological pottery form the coating on stopper surface.Described reacting gas can be nitrogen, carbon or oxygen.Described stopper is to make the metal webmaster by knit wire or engraving metal tube, through heat-treating profiled, utilizes the end socket of argon arc or laser weld stopper and bolt head to form again.
And the manufacture method that a kind of bioceramic stopper is provided, comprise the steps:
1) making raw material surface coating one deck bioceramic of stopper earlier;
2) more above-mentioned raw material is processed to form stopper;
3) at last the choked flow film is set on the stopper that is provided with bioceramic.
Wherein, the bioceramic in the step 1) is to adopt ion beam to strengthen CVD method to be coated in the raw material surface.It is under room temperature and vacuum condition that described ion beam strengthens CVD method, and with the titanium of inert gas ion beam bombardment hydatogenesis on the raw material surface, the reacting gas that its absorption feeds and synthesising biological pottery form the coating on raw material surface.Described raw material is the metal tube that the braiding tinsel used of stopper or engraving stopper are used.
Bioceramic stopper among the present invention can effectively promote combining of metal and cell, and climb the cover speed of endothelium on the metal surface of its modification will be far faster than unmodified common metal.Thereby the bioceramic stopper can be expected to form the natural sealing coat of one deck on its surface within a short period of time, not only improved stifledly to close effect, and improved the biocompatibility of stopper greatly.The bioceramic layer of metal surface is the effective protective layer of one deck, and it has reduced blood to reactions such as the various physics of metal, chemistry and biologies, has reduced the leakage of metal ion, thereby can avoid inflammatory reaction or thrombosis.In addition, the bioceramic stopper that obtains through this method can also improve the fatigue resistance and the wearability of stopper.
The specific embodiment
Below in conjunction with specific embodiment the present invention is described in further detail: the bioceramic stopper is applicable to patend ductus arteriosus occluder (PDA), atrial septal defect plugging device (ASD) and the ventricular septal defect (VSD) etc. of congenital heart disease therapeutic process among the present invention, will be that example is described the present invention with patend ductus arteriosus occluder (PDA) below.In the manufacturing process of the present invention, at first make the metal webmaster by knit wire or engraving metal tube, through heat-treating profiled, utilize the end socket and the bolt head of argon arc or laser weld stopper to produce the patend ductus arteriosus occluder of not being with the choked flow film again, carry out bio-ceramic coating in its metal surface again.Under the room temperature, the patend ductus arteriosus occluder surface chemistry is cleaned, after the oven dry, put into the target chamber of ion beam enhanced depositing system.Evacuation makes target chamber base vacuum degree reach 5 * 10 -7Holder feeds high pure nitrogen then in target chamber, make target chamber vacuum reduce to 5 * 10 -6Holder feeds xenon again in ion source, be 0.8 * 10 in target chamber vacuum -5During holder, select the energy of 20Kev for use, 5 * 10 15Atomic number/cm 2The xenon ion bundle of dosage carries out pre-clean processes to the bombardment of stopper surface.Then, be the 10A/ condition of second with the deposition velocity, electron beam evaporation purity is 99% titanium at least, the nitrogen of titanium when evaporation adsorption target in the chamber.With its while, be 40Kev with energy, beam current density is that the xenon ion Shu Lianxu of 40 μ A/cm2 bombards, and synthetic titanium nitride forms the thick compact structure of 2 μ m until the stopper surface, and adhesion is firm, uniform and stable high-quality titanium nitride protective layer.Make the choked flow film at last.
This bioceramic can effectively promote combining of metal and cell, and the bioceramic stopper can be expected to form the natural sealing coat of one deck on its surface within a short period of time, has not only improved stifledly to close effect, and has improved the biocompatibility of stopper greatly.Simultaneously, reduce the leakage of metal ion, thereby can avoid inflammatory reaction or thrombosis.
In another embodiment of the present invention, also the metal tube that the braiding tinsel that use of stopper or engraving stopper can be used is coated bioceramic according to the method for the ion vapor deposited among the last embodiment on the surface, be made into the metal webmaster then, follow the various types of stoppers of heat-treating profiled acquisition, the end socket of argon arc and laser weld stopper and bolt head are made the choked flow film at last.

Claims (10)

1. a bioceramic stopper is made up of stopper and the choked flow film that is arranged on the stopper, it is characterized in that being coated with one deck bioceramic on the surface of stopper.
2. bioceramic stopper according to claim 1 is characterized in that described bioceramic is to strengthen vapour deposition process through ion beam to be coated in described stopper surface.
3. bioceramic stopper according to claim 2 is characterized in that described bioceramic is titanium nitride, titanium carbide or titanium oxide.
4. the manufacture method of a bioceramic stopper is characterized in that comprising the steps:
1) at first makes stopper;
2) then at stopper surface coating one deck bioceramic;
3) at last the choked flow film is set on the stopper that is covered with bioceramic.
5. the manufacture method of bioceramic stopper according to claim 4 is characterized in that step 2) in bioceramic be to adopt ion beam to strengthen CVD method to be coated in the stopper surface.
6. the manufacture method of bioceramic stopper according to claim 5, it is characterized in that it is under room temperature and vacuum condition that described ion beam strengthens CVD method, with the titanium of inert gas ion beam bombardment hydatogenesis on the stopper surface, the reacting gas that titanium absorption feeds and synthesising biological pottery form the coating on stopper surface; Described reacting gas is nitrogen, carbon or oxygen.
7. according to the manufacture method of any described bioceramic stopper of claim 4 to 6, it is characterized in that described stopper is to make the metal webmaster by knit wire or engraving metal tube, through heat-treating profiled, utilize the end socket of argon arc or laser weld stopper and bolt head to form again.
8. the manufacture method of a bioceramic stopper is characterized in that comprising the steps:
1) making raw material surface coating one deck bioceramic of stopper earlier;
2) more above-mentioned raw material is processed to form stopper;
3) at last the choked flow film is set on the stopper that is provided with bioceramic.
9. the manufacture method of bioceramic stopper according to claim 8 is characterized in that the bioceramic in the step 1) is to adopt ion beam to strengthen CVD method to be coated in the raw material surface.
10. the manufacture method of bioceramic stopper according to claim 9, it is characterized in that it is under room temperature and vacuum condition that described ion beam strengthens CVD method, with the titanium of inert gas ion beam bombardment hydatogenesis on the raw material surface, the reacting gas that titanium absorption feeds and synthesising biological pottery form the coating on raw material surface; Described raw material is the metal tube that the braiding tinsel used of stopper or engraving stopper are used.
CNB2004100511889A 2004-08-19 2004-08-19 Biological ceramic stopper and method for manufacturing the same Active CN100400012C (en)

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Application Number Priority Date Filing Date Title
CNB2004100511889A CN100400012C (en) 2004-08-19 2004-08-19 Biological ceramic stopper and method for manufacturing the same

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CN1736345A CN1736345A (en) 2006-02-22
CN100400012C true CN100400012C (en) 2008-07-09

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101357243B (en) * 2007-08-03 2013-03-27 东莞市拓扑光电科技有限公司 Nano vascular inner rack and preparation method thereof

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102697528B (en) * 2012-06-01 2014-02-26 姬尚义 Closure device
CN106267356B (en) * 2015-05-22 2020-01-03 先健科技(深圳)有限公司 Implanted medical device prefabricated part, implanted medical device and preparation method thereof
DE102016101856B4 (en) * 2016-02-03 2017-11-30 Ctf Solar Gmbh Method for depositing a CdTe layer on a substrate
CN108273142B (en) * 2018-03-21 2021-01-12 上海形状记忆合金材料有限公司 Preparation method of degradable occluder with controllable degradation rate

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5976174A (en) * 1997-12-15 1999-11-02 Ruiz; Carlos E. Medical hole closure device and methods of use
CN2518475Y (en) * 2001-12-27 2002-10-30 龚善石 Patent arterial duct blocking device
CN2566817Y (en) * 2002-09-12 2003-08-20 深圳市先健科技股份有限公司 Stopper for ventricular septal defect
CN2613248Y (en) * 2003-03-21 2004-04-28 龚善石 Ventricular septel defect block device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5976174A (en) * 1997-12-15 1999-11-02 Ruiz; Carlos E. Medical hole closure device and methods of use
CN2518475Y (en) * 2001-12-27 2002-10-30 龚善石 Patent arterial duct blocking device
CN2566817Y (en) * 2002-09-12 2003-08-20 深圳市先健科技股份有限公司 Stopper for ventricular septal defect
CN2613248Y (en) * 2003-03-21 2004-04-28 龚善石 Ventricular septel defect block device

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101357243B (en) * 2007-08-03 2013-03-27 东莞市拓扑光电科技有限公司 Nano vascular inner rack and preparation method thereof

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