CN105233348A - Anticoagulation medical device, and preparation method thereof - Google Patents
Anticoagulation medical device, and preparation method thereof Download PDFInfo
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- CN105233348A CN105233348A CN201410253582.4A CN201410253582A CN105233348A CN 105233348 A CN105233348 A CN 105233348A CN 201410253582 A CN201410253582 A CN 201410253582A CN 105233348 A CN105233348 A CN 105233348A
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Abstract
The invention discloses an anticoagulation medical device, and a preparation method thereof. The preparation method comprises following steps: a, a device main body of the anticoagulation medical device is prepared; and b, the surface of the device main body is coated with a positively charged polyelectrolyte and a negatively charged polyelectrolyte via alternate adsorption so as to form a coating layer and obtain the anticoagulation medical device. The preparation method also comprises a step of crosslinking of the positively charged polyelectrolyte with the negatively charged polyelectrolyte using a cross-linking agent. The preparation method is simple; preparation can be realized using a simple solution circulating device; a stable coating structure can be obtained via crosslinking; preparation can be carried out at mild aqueous environment; no toxic solvent is used; the preparation method is friendly to the environment; no special requirement on the shape structure of the anticoagulation medical device is required by the preparation method; and preparation can be realized on the surfaces of a plurality of medical devices with complex structures.
Description
Technical field
The present invention relates to medical apparatus and preparation method thereof, particularly relate to a kind of anticoagulation medical apparatus and preparation method thereof.
Background technology
Biomaterial is that a class has property, specific function, for the medical treatment such as artificial organ, surgical repair, diagnosis, inspection, disease therapy, healthcare field and can not produce dysgenic material to tissue, blood.As biomaterial, must have good biocompatibility, it comprises blood compatibility and histocompatibility.Wherein, comparatively histocompatibility is more harsh to the requirement of biomaterial for blood compatibility.
For the device with contacting blood, the artificial organs etc. such as such as extracorporeal circulation apparatus, interfere treatment system, artificial blood vessel and artificial heart, blood compatibility is particularly important.When these devices and associated materials and contacting blood can the absorption of induced protein or thrombin in the activation of material surface, cause the generation of fibrin gel and the formation of platelet thrombus, finally cause blood coagulation.
At present, people are mainly through synthesizing new anticoagulant material and the biomaterial modifying surface preparation of current material to good anticoagulant property.Because existing various biomaterial has good physical and mechanical properties and lower price usually, and be widely used in different kind organism medical apparatus, therefore by carrying out surface modification to current material, on the basis maintaining material good physical mechanical performance, improving the anticoagulant property of material, is a kind of cost-effective mode.People are mainly through technical methods such as chemical grafting treated, surface light chemical graft, Cement Composite Treated by Plasma, regulate the electric charge of material surface, hydrophilic and hydrophobic or at material surface grafting bioactive macromolecule, improve the anticoagulant property of material, and achieve good achievement.But, these surface modification means ubiquities the weakness such as solvent toxicity, preparation process complexity, controllable ability, not only greatly limit the designability of material surface, and the modification that cannot realize the medical apparatus with complex geometry profile, the needs of medical apparatus develop rapidly can not be met.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of anticoagulation medical apparatus and preparation method thereof, and preparation method is simple, and solvent-free toxicity, has environment friendly, and the anticoagulation medical apparatus prepared has good anticoagulant property.
The present invention solves the problems of the technologies described above the technical scheme adopted to be to provide a kind of anticoagulation medical apparatus, described medical apparatus comprises device body and coating, described coating formation is in the surface of described device body, and described coating is formed by positively charged polyelectrolyte and electronegative polyelectrolyte alternating sorbent.
Above-mentioned anticoagulation medical apparatus, wherein, positively charged polyelectrolyte and the electronegative polyelectrolyte of described alternating sorbent are combined by cross-linking agents.
Above-mentioned anticoagulation medical apparatus, wherein, described cross-linking agent is 1-ethyl-(3-dimethylaminopropyl) phosphinylidyne diimmonium salt hydrochlorate, glutaraldehyde or periodic acid.
Above-mentioned anticoagulation medical apparatus, wherein, described medical apparatus is the medical apparatus with contacting blood.
Above-mentioned anticoagulation medical apparatus, wherein, described medical apparatus is extracorporeal circulation apparatus, interfere treatment system or artificial organs.
Above-mentioned anticoagulation medical apparatus, wherein, described positively charged polyelectrolyte is serum albumin, human fibrinogen, anti-hCG, collagen protein, ovalbumin, legumelin or lactalbumin.
Above-mentioned anticoagulation medical apparatus, wherein, described electronegative polyelectrolyte is heparin sodium, hirudin, sodium alginate or dextran sulfate.
The present invention solves the problems of the technologies described above the preparation method that another technical scheme adopted is to provide a kind of anticoagulation medical apparatus, comprises the steps: device body a) providing medical apparatus; B) form coating at the positively charged polyelectrolyte of the surperficial alternating sorbent of described device body and electronegative polyelectrolyte, obtain anticoagulation medical apparatus.
The preparation method of above-mentioned anticoagulation medical apparatus, wherein, also comprises the polyelectrolyte generation cross-linking reaction being made the band positive and negative charge of described alternating sorbent by cross-linking agent.
The preparation method of above-mentioned anticoagulation medical apparatus, wherein, described step b) detailed process is as follows: b1) prepares positively charged polyelectrolyte citrate solution and electronegative polyelectrolyte citrate solution, positively charged polyelectrolyte solution and electronegative polyelectrolyte solution carried out supersound process respectively; B2) positively charged polyelectrolyte solution and electronegative poly-electrolytic solution alternate cycles are flow through the surface of device body, form coating on the surface of described device body.
The preparation method of above-mentioned anticoagulation medical apparatus, wherein, described step b2) comprise following process: b21) polyelectrolyte solution of the positive and negative electric charge of band is carried out supersound process respectively; B22) positively charged polyelectrolyte citrate solution is circulated through the surperficial 15-30 minute of device body, rinse by purified water again, then electronegative polyelectrolyte citrate solution is circulated through the surperficial 15-30 minute of device body, rinse by purified water again, obtain the medical apparatus of surface containing a bilayer; B23) alternately repeat above-mentioned steps b21) and b22), the polyelectrolyte of band positive and negative charge device body surperficial alternating sorbent repeatedly, obtain the anticoagulation medical apparatus of the polyelectrolyte alternating sorbent with positive and negative electric charge.
The preparation method of above-mentioned anticoagulation medical apparatus, wherein, described positively charged polyelectrolyte solution pH value is 3.5-4.5, and the pH value of described electronegative polyelectrolyte is 2.5-4.5.
The preparation method of above-mentioned anticoagulation medical apparatus, wherein, described step b23) in alternately repeated number of times be 2-5 time.
The preparation method of above-mentioned anticoagulation medical apparatus, wherein, the operating frequency of described supersound process is 25kHz, and ultrasonic time is 2-5 minute.
The preparation method of above-mentioned anticoagulation medical apparatus, wherein, described cross-linking process is as follows: preparation cross-linking agent solution; Then cross-linking agent solution is circulated through the surperficial 2-18 hour of the device body forming coating, finally rinses by purified water, obtain the anticoagulation medical apparatus that coating is crosslinked.
The preparation method of above-mentioned anticoagulation medical apparatus, wherein, the pH value of described cross-linking agent solution is 4.6-5.0.
The preparation method of above-mentioned anticoagulation medical apparatus, wherein, described cross-linking agent is 1-ethyl-(3-dimethylaminopropyl) phosphinylidyne diimmonium salt hydrochlorate, glutaraldehyde or periodic acid.
The preparation method of above-mentioned anticoagulation medical apparatus, wherein, described medical apparatus is the medical apparatus with contacting blood.
The preparation method of above-mentioned anticoagulation medical apparatus, wherein, described medical apparatus is extracorporeal circulation apparatus, interfere treatment system or artificial organs, and the material of device body can be polyethylene, polypropylene, polyurethane, cellulose acetate, polyether sulfone or polrvinyl chloride.
The preparation method of above-mentioned anticoagulation medical apparatus, wherein, described positively charged polyelectrolyte is serum albumin, human fibrinogen, anti-hCG, collagen protein, ovalbumin, legumelin or lactalbumin.
The preparation method of above-mentioned anticoagulation medical apparatus, wherein, described electronegative polyelectrolyte is heparin sodium, hirudin, sodium alginate or dextran sulfate.
The present invention contrasts prior art following beneficial effect: anticoagulation medical apparatus provided by the invention and preparation method thereof, by forming positively charged polyelectrolyte and electronegative polyelectrolyte coating at the surperficial alternating sorbent of device body, improve the anticoagulant property of medical apparatus, and preparation method technique of the present invention is simple, realize by simple solution circulating device, particularly by crosslinked action, more stable coating structure can be obtained; Secondly, preparation method of the present invention can be carried out under the aqueous environment of gentleness, solvent-free toxicity, is a kind of eco-friendly preparation method; 3rd, the shape and structure of preparation method of the present invention to medical apparatus does not have special requirement, can realize in Various Complex shape and structure medical device surface; Particularly in the inventive method, polyelectrolyte solution is after supersound process, and polyelectrolyte Dispersion of Solute Matter is good, avoids the generation of polyelectrolyte agglomeration, coating evenly.
Detailed description of the invention
Below in conjunction with embodiment, the invention will be further described.
Embodiment 1
1) prepare positively charged polyelectrolyte citrate solution, described positively charged polyelectrolyte solution pH value is preferably 3.5-4.5, and the concentration containing polyelectrolyte is preferably 0.015mg/mL-0.15mg/ml; The polyelectrolyte citrate solution of configure band negative charge, the pH value of described electronegative polyelectrolyte solution is preferably 2.5-4.5, concentration containing polyelectrolyte is preferably 0.10mg/mL-1.00mg/mL, and the polyelectrolyte solution of the positive and negative electric charge of band is carried out supersound process respectively; The operating frequency of described supersound process is preferably 25kHz, and ultrasonic time is preferably 2-5 minute.
2) positively charged polyelectrolyte citrate solution is circulated through device body surface 15-30 minute, then rinses 2 minutes by the purified water that pH value is 4.5.
3) electronegative polyelectrolyte citrate solution is circulated through device body surface 15-30 minute, then rinses by the purified water that pH value is 4.5, obtain the medical apparatus of surface containing a bilayer.
4) alternately above-mentioned steps 2 is repeated) and 3), the polyelectrolyte of band positive and negative charge at device body surface alternating sorbent repeatedly, obtains the anticoagulation medical apparatus of the polyelectrolyte alternating sorbent being with positive and negative charge.Alternately repeated number of times is preferably 2 ~ 5 times.
Finally, by cross-linking agent, the polyelectrolyte of the band positive and negative charge of described alternating sorbent is carried out cross-linking reaction.Concrete cross-linking process is as follows: first, preparation cross-linking agent solution; The pH value of described cross-linking agent solution is preferably 4.6-5.0; Concentration is preferably 0.10mg/ml-0.50mg/mL; Then cross-linking agent solution is circulated through the medical device surface 2-18 hour forming coating, finally rinses 5 minutes by purified water, obtain the anticoagulation medical apparatus that coating is crosslinked.
Obtaining after the anticoagulant biomaterial of said method process, utilizing dynamic Contact angle tester (DCA), toluidine blue solution characterizing the medical apparatus before and after coating respectively.Water contact angle is reduced to 78.8 ± 1 degree from 92.7 ± 1 before modified degree; Purple is become after modified medical apparatus Toluidine blue staining.
In the examples below, will show beneficial effect of the present invention in conjunction with recalcification time, recalcification time experiment reference literature (SCI, 2002,12,2369-2374) method is carried out.From anticoagulated blood test, the blood adopted is placed in containing 1/10 volume is the test tube of 0.109mol/L sodium citrate anti-freezing liquid, and the centrifugal 10min of 3000r/min, gets upper liquid (blood plasma, yellow).Anticoagulate plasma (the removing calcium) 0.4mL being preheated to 37 DEG C is added through coating process and one end close polyvinyl chloride pipe in, leave standstill 1min in 37 DEG C of water edges after, add the 0.025mol/L calcium chloride solution 0.4mL of preheating, a rustless steel probe is stretched in solution and evenly stirs slowly, record probe has just started the time occurring white filament, namely this is recalcification time, and recalcification time is longer, then show that anticoagulant property is better.In addition, in the examples below, the polyelectrolyte solution with positive and negative electric charge carries out supersound process respectively, does not repeat them here.
Embodiment 2
Concentration is that the albumin citrate solution (pH3.5) of 0.15mg/ml is circulated through bipolar femoral vein spile 15min by employing peristaltic pump, and then purified water (pH4.5) rinses 2min, obtains the surface of albumin physical absorption; Be that the heparin sodium citrate solution (pH4.5) of 0.10mg/ml is circulated through surface for the albuminous bipolar femoral vein spile 30min of positive charge by concentration, purified water (pH4.5) rinses 2min, obtains the surface of electronegative anticoagulation heparin; Be the bipolar femoral vein spile 15min that the albumin citrate solution (pH3.5) of 0.15mg/ml is circulated through surface band negative charge heparin sodium by concentration, purified water (pH4.5) rinses 2min, obtain the albuminous bipolar femoral vein spile of surface band positive charge, thus, positive charge albumin and negative charge heparin sodium 3 layers of alternate coatings surface are obtained; 1-ethyl-(3-dimethylaminopropyl) phosphinylidyne diimmonium salt acid salt solution (pH5.0) is circulated through 3 layers of alternate coatings surface 6h, obtains crosslinked positive charge albumin and negative charge heparin sodium 3 layers of alternate coatings surface.
Find with toluidine blue solution dyeing, bipolar femoral vein spile inner surface becomes purple, describes the surface of heparin sodium at bipolar femoral vein spile.Modified, the water contact angle of bipolar femoral vein spile obviously reduces.The recalcification time of the bipolar femoral vein spile of recalcification time display heparin coating extends more than 40min than the recalcification time of non-heparin coating bipolar femoral vein spile.
Embodiment 3
Concentration is that the albumin citrate solution (pH4.5) of 0.10mg/ml is circulated through membrane oxygenator oxygenation chamber 15min by employing peristaltic pump, then purified water (pH4.5) rinses 2min, obtains the surface of positive charge albumin physical absorption; Be that the heparin sodium citrate solution (pH4.5) of 0.15mg/ml is circulated through surface for positive charge albuminous membrane oxygenator oxygenation chamber 20min by concentration, purified water (pH4.5) rinses 2min, obtains the surface of negative charge polyanion anticoagulation heparin; Be the membrane oxygenator oxygenation chamber 15min that the albumin citrate solution (pH4.5) of 0.10mg/ml is circulated through the polyanions heparin sodium of surface band negative charge by concentration, purified water (pH4.5) rinses 2min, obtaining surface is the albuminous membrane oxygenator oxygenation chamber of positive charge, thus, albumin and heparin sodium 3 layers of alternate coatings surface are obtained; 1-ethyl-(3-dimethylaminopropyl) phosphinylidyne diimmonium salt acid salt solution (pH5.0) is circulated through 3 layers of alternate coatings surface 3h, obtains crosslinked albumin and heparin sodium 3 layers of alternate coatings surface.
Find with toluidine blue solution dyeing, membrane oxygenator oxygenation chamber surface becomes purple by white, describes the surface of heparin sodium at membrane oxygenator oxygenation chamber.The recalcification time of the membrane oxygenator oxygenation chamber of recalcification time display heparin coating extends more than 20min than the recalcification time of non-heparin coating membrane oxygenator oxygenation chamber.
To sum up, the preparation method of the anticoagulation medical apparatus provided of the present invention, tool has the following advantages: 1) preparation method technique of the present invention is simple, realizes by simple solution circulating device, and by crosslinked action, can obtain more stable coating structure; 2) manufacture method of the present invention is carried out under the aqueous environment of gentleness, solvent-free toxicity, is a kind of eco-friendly preparation method; 3) preparation method polyelectrolyte solution of the present invention is after supersound process, and polyelectrolyte Dispersion of Solute Matter is good, avoids the generation of agglomeration, coating evenly; 4) shape and structure of manufacture method of the present invention to medical apparatus does not have special requirement, can realize in the medical device surface of Various Complex shape and structure; 5) anticoagulation medical apparatus provided by the present invention medical apparatus more of the prior art, water contact angle obviously reduces, and recalcification time obviously extends.
Although the present invention discloses as above with preferred embodiment; so itself and be not used to limit the present invention, any those skilled in the art, without departing from the spirit and scope of the present invention; when doing a little amendment and perfect, therefore protection scope of the present invention is when being as the criterion of defining with claims.
Claims (18)
1. an anticoagulation medical apparatus, is characterized in that, comprises device body and coating, and described coating formation is in the surface of described device body, and described coating is formed by positively charged polyelectrolyte and electronegative polyelectrolyte alternating sorbent.
2. anticoagulation medical apparatus as claimed in claim 1, it is characterized in that, described positively charged polyelectrolyte and described electronegative polyelectrolyte are combined by cross-linking agents.
3. anticoagulation medical apparatus as claimed in claim 2, it is characterized in that, described cross-linking agent is 1-ethyl-(3-dimethylaminopropyl) phosphinylidyne diimmonium salt hydrochlorate, glutaraldehyde or periodic acid.
4. anticoagulation medical apparatus as claimed in claim 1, it is characterized in that, described medical apparatus is extracorporeal circulation apparatus, interfere treatment system or artificial organs.
5. anticoagulation medical apparatus as claimed in claim 1, it is characterized in that, described positively charged polyelectrolyte is serum albumin, human fibrinogen, anti-hCG, collagen protein, ovalbumin, legumelin or lactalbumin.
6. anticoagulation medical apparatus as claimed in claim 1, it is characterized in that, described electronegative polyelectrolyte is heparin sodium, hirudin, sodium alginate or dextran sulfate.
7. a preparation method for anticoagulation medical apparatus, is characterized in that, comprises the steps:
A) device body of described medical apparatus is provided; And
B) at the positively charged polyelectrolyte of the surperficial alternating sorbent of described device body and electronegative polyelectrolyte, to form coating.
8. the preparation method of anticoagulation medical apparatus as claimed in claim 7, is characterized in that, also comprise and make described positively charged polyelectrolyte and described electronegative polyelectrolyte generation cross-linking reaction by cross-linking agent.
9. the preparation method of anticoagulation medical apparatus as claimed in claim 8, it is characterized in that, described cross-linking agent is 1-ethyl-(3-dimethylaminopropyl) phosphinylidyne diimmonium salt hydrochlorate, glutaraldehyde or periodic acid.
10. the preparation method of anticoagulation medical apparatus as claimed in claim 8, is characterized in that, after being also included in described cross-linking reaction, uses purified water to rinse described medical apparatus.
The preparation method of 11. anticoagulation medical apparatus as claimed in claim 8, is characterized in that, the pH value of described cross-linking agent is 4.6-5.0.
The preparation method of 12. anticoagulation medical apparatus as claimed in claim 7, it is characterized in that, described step b) comprising: b1) prepare positively charged polyelectrolyte solution and electronegative polyelectrolyte solution, respectively supersound process is carried out to described positively charged polyelectrolyte solution and described electronegative polyelectrolyte solution; And, b2) make described positively charged polyelectrolyte solution and described electronegative poly-electrolytic solution alternately pass through the surface of described device body, thus form described coating on the surface of described device body.
The preparation method of 13. anticoagulation medical apparatus as claimed in claim 12, is characterized in that, described step b2) also comprise:
B21) make described positively charged polyelectrolyte solution be circulated through one period of scheduled time of surface of described device body, then rinse by purified water;
B22) make described electronegative polyelectrolyte solution be circulated through one period of scheduled time of surface of described device body, then rinse by purified water; And
B23) repeat above-mentioned steps b21) and b22), make described positively charged polyelectrolyte and described electronegative polyelectrolyte described device body surperficial alternating sorbent repeatedly, obtain described anticoagulation medical apparatus.
The preparation method of 14. anticoagulation medical apparatus as claimed in claim 12, it is characterized in that, the pH value of described positively charged polyelectrolyte solution is 3.5-4.5, the pH value of described electronegative polyelectrolyte solution is 2.5-4.5.
The preparation method of 15. anticoagulation medical apparatus as claimed in claim 12, is characterized in that, the operating frequency of described supersound process is 25kHz, and ultrasonic time is 2-5 minute.
The preparation method of 16. anticoagulation medical apparatus as claimed in claim 7, it is characterized in that, described medical apparatus is extracorporeal circulation apparatus, interfere treatment system or artificial organs.
The preparation method of 17. anticoagulation medical apparatus as claimed in claim 7, it is characterized in that, described positively charged polyelectrolyte is serum albumin, human fibrinogen, anti-hCG, collagen protein, ovalbumin, legumelin or lactalbumin.
The preparation method of 18. anticoagulation medical apparatus as claimed in claim 7, it is characterized in that, described electronegative polyelectrolyte is heparin sodium, hirudin, sodium alginate or dextran sulfate.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
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| CN201410253582.4A CN105233348A (en) | 2014-06-09 | 2014-06-09 | Anticoagulation medical device, and preparation method thereof |
| PCT/CN2015/080662 WO2015188716A1 (en) | 2014-06-09 | 2015-06-03 | Anticoagulation coating and applying method therefor |
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| CN201410253582.4A CN105233348A (en) | 2014-06-09 | 2014-06-09 | Anticoagulation medical device, and preparation method thereof |
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Cited By (5)
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| WO2020181642A1 (en) * | 2019-03-14 | 2020-09-17 | 江苏赛腾医疗科技有限公司 | Preparation method for ionic bond-covalent bond synergy-based surface heparinized anticoagulant medical device |
| CN112961393A (en) * | 2021-02-05 | 2021-06-15 | 普昂(杭州)医疗科技股份有限公司 | Anticoagulant biomaterial and use thereof on blood collection devices |
| CN113616861A (en) * | 2021-08-03 | 2021-11-09 | 广州维力医疗器械股份有限公司 | Layer-by-layer self-assembly composite anticoagulant coating, preparation method thereof and medical instrument |
| CN113786518A (en) * | 2021-09-15 | 2021-12-14 | 海思盖德(苏州)生物医学科技有限公司 | Preparation method of composite coating for surface modification of medical material |
| CN115317677B (en) * | 2022-08-24 | 2023-06-23 | 天津大学温州安全(应急)研究院 | High anticoagulation ECMO and extracorporeal circulation consumable |
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| WO2020181642A1 (en) * | 2019-03-14 | 2020-09-17 | 江苏赛腾医疗科技有限公司 | Preparation method for ionic bond-covalent bond synergy-based surface heparinized anticoagulant medical device |
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| CN113786518A (en) * | 2021-09-15 | 2021-12-14 | 海思盖德(苏州)生物医学科技有限公司 | Preparation method of composite coating for surface modification of medical material |
| CN115317677B (en) * | 2022-08-24 | 2023-06-23 | 天津大学温州安全(应急)研究院 | High anticoagulation ECMO and extracorporeal circulation consumable |
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Application publication date: 20160113 |