CN107875440A - A kind of preparation method of the intravascular stent with medication coat - Google Patents

A kind of preparation method of the intravascular stent with medication coat Download PDF

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Publication number
CN107875440A
CN107875440A CN201711222372.9A CN201711222372A CN107875440A CN 107875440 A CN107875440 A CN 107875440A CN 201711222372 A CN201711222372 A CN 201711222372A CN 107875440 A CN107875440 A CN 107875440A
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CN
China
Prior art keywords
intravascular stent
preparation
titanium alloy
medication coat
solution
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Application number
CN201711222372.9A
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Chinese (zh)
Inventor
卢晔
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Chengdu Chuangkezhijia Technology Co Ltd
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Chengdu Chuangkezhijia Technology Co Ltd
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Priority to CN201711222372.9A priority Critical patent/CN107875440A/en
Publication of CN107875440A publication Critical patent/CN107875440A/en
Withdrawn legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02Inorganic materials
    • A61L27/04Metals or alloys
    • A61L27/06Titanium or titanium alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/34Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54Biologically active materials, e.g. therapeutic substances
    • CCHEMISTRY; METALLURGY
    • C22METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22CALLOYS
    • C22C14/00Alloys based on titanium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/216Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602Type of release, e.g. controlled, sustained, slow
    • A61L2300/604Biodegradation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2420/00Materials or methods for coatings medical devices
    • A61L2420/02Methods for coating medical devices

Abstract

The invention discloses a kind of preparation method of the intravascular stent with medication coat, belongs to medical field, and intravascular stent includes rack body and medication coat, and described rack body is prepared for titanium alloy material.

Description

A kind of preparation method of the intravascular stent with medication coat
Technical field
The present invention relates to medical field.
Background technology
Cardiac stent (Stent) is also known as coronary stent, is the medicine equipment commonly used in interventional cardiac procedures, has and dredge Lead to arterial vascular effect.Main material is stainless steel, Nitinol or cochrome.
Existing metallic support easily causes reangiostenosis.In a kind of new support, by antithrombotic and anti-proliferate Medicine is wrapped on cardiac stent, and after being implanted into support, medicine slowly discharges, and can increase local drug concentration, reduces secondary make With reduction restenosis rate.
Existing pharmaceutical carrier typically has biodegradable and non-degradable high polymer material, and high polymer material is reduced in biology In, the release rate of medicine is low, and effective time is short.Existing frequently-used degradation material carrier has PLA, polyglycolic acid etc., also has More polyglutamic acid is studied recently, and compared with them, polymalic acid has the advantages of unique.PLA, polyglycolic acid etc. are all Water-insoluble, the drug molecule of crosslinking discharge in vivo very slowly, influence drug effect.The water imbibitions such as polyglutamic acid are too strong, hold Easy disintegrating, also have an impact for its drug effect.The side base of polymalic acid contains many carboxyls, soluble in water, and carboxyl can be with Combined with virose side base in medicine group, reduce its toxicity.After polymer molecule enters in vivo, carboxyl can be used as water Solve the basic point of catalysis.
But when polymalic acid is incorporated among support, because the coating of rack surface is very thin, the medicine that can be loaded Not enough, release time is short, will discharge high amount of drug in the short time..
The content of the invention
It is an object of the invention to:For above-mentioned problem, there is provided a kind of intravascular stent with medication coat, blood Pipe holder includes rack body and medication coat, and described rack body is prepared for titanium alloy material, described intravascular stent Preparation method is as follows:
Step 1: by titanium alloy support high-temperature process 1 to 2 hours in an inert atmosphere;
Step 2: being cooled to normal temperature in temperature, 1-10 hours are handled;
Step 3: titanium alloy is further heated up, by hydrochloric acid vapour under inert gas or vacuum environment, hydrochloric acid vapour is used Handle 5-10 minutes.
Step 4: above-mentioned treated titanium alloy is dropped into room temperature;
Step 5: above-mentioned titanium alloy is put into organic acid, soak, remove drying, be put among solvent, pass through ultrasound Ripple cleans 10-100 minutes, removes titanium alloy support;
Uniform solution a is carried out Step 7: polymalic acid is mixed with solvent a, rapamycin drug and solvent b are mixed to form Uniform solution b;
Step 8: using coaxial electrospray, solution a is placed in shell, and solution b is placed in sandwich layer, and it uniformly is applied into titanium alloy On support;
Step 9;Titanium alloy support after smearing is dried 2-10 days at 25-40 DEG C.
Further, the inert gas environment of the step 1 is nitrogen environment or ar gas environment.
Further, the pressure of described inert gas environment is 0.4-0.6 atmospheric pressure.
Further, the organic acid of the step 5 contains carboxyl, sulfonic group, sulfinic acid base, thionothiolic acid base.
Further, the solvent of the step 5 is one or more of mixtures of acetone, ethanol or distilled water.
Further, solution a concentration is 5% in described step eight.
Further, described solution b concentration is 5%.
Further, solution a and solution b is pressurized in spraying advance horizontal high voltage pump.
Further, the boost pressure of described high-pressure pump is 2-20MPA.
On the one hand polymalic acid disclosed by the invention has good biocompatibility and degradability, by coaxially spraying Applying, medicine is sufficiently wrapped up, is ejected on titanium alloy support, wherein titanium alloy passes through certain processing, and polymalic acid Cementability greatly improves, and in the present invention, with the degraded of polymalic acid, medicine slowly discharges, release time length, release rate It is high.By high-pressure injection, sprayed coating of the invention is about 5-20 μm.
Embodiment
In order to make the purpose , technical scheme and advantage of the present invention be clearer, with reference to embodiments, to the present invention It is further elaborated.It should be appreciated that the specific embodiments described herein are merely illustrative of the present invention, it is not used to Limit the present invention.
Specific embodiment 1:A kind of intravascular stent with medication coat, intravascular stent includes rack body and medicine applies Layer, described rack body are prepared for titanium alloy material, and the preparation method of described intravascular stent is as follows:
Step 1: by titanium alloy support high-temperature process 1 to 2 hours in an inert atmosphere;
Step 2: being cooled to normal temperature in temperature, handle 5 hours;
Step 3: titanium alloy is further heated up, by hydrochloric acid vapour under inert gas or vacuum environment, hydrochloric acid vapour is used Processing 4 minutes.
Step 4: above-mentioned treated titanium alloy is dropped into room temperature;
Step 5: above-mentioned titanium alloy is put into organic acid, soak, remove drying, be put among solvent, pass through ultrasound Ripple cleans 50 minutes, removes titanium alloy support;
Uniform solution a is carried out Step 7: polymalic acid is mixed with solvent a, rapamycin drug and solvent b are mixed to form Uniform solution b;
Step 8: using coaxial electrospray, solution a is placed in shell, and solution b is placed in sandwich layer, and it uniformly is applied into titanium alloy On support;
Step 9;Titanium alloy support after smearing is dried 2 days at 25 DEG C.
The inert gas environment of the step 1 is nitrogen environment or ar gas environment.
The pressure of described inert gas environment is 0.4 atmospheric pressure.
Intravascular stent according to claim 3 with medication coat, it is characterised in that the step 5 it is organic Acid contains carboxyl, sulfonic group, sulfinic acid base, thionothiolic acid base.
The solvent of the step 5 is acetone, and solution a concentration is 5% in described step eight.Described solution b's is dense Spend for 5%.Solution a and solution b is pressurized in spraying advance horizontal high voltage pump, and the boost pressure of described high-pressure pump is 10MPA.
Through measurement, after rapamycin is added, the rapamycin of first week 10% of stenter to implant human body is released, the After four weeks, burst size 30%, after two months, burst size 50, after three months, burst size 60%, burst size is 95 after half a year %。
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all essences in the present invention All any modification, equivalent and improvement made within refreshing and principle etc., should be included in the scope of the protection.

Claims (9)

  1. A kind of 1. preparation method of the intravascular stent with medication coat, it is characterised in that intravascular stent include rack body and Medication coat, described rack body are prepared for titanium alloy material, and the preparation method of described intravascular stent is as follows:
    Step 1: by titanium alloy support high-temperature process 1 to 2 hours in an inert atmosphere;
    Step 2: being cooled to normal temperature in temperature, 1-10 hours are handled;
    Step 3: titanium alloy is further heated up, by hydrochloric acid vapour under inert gas or vacuum environment, hydrochloric acid vapour is used Handle 5-10 minutes;
    Step 4: above-mentioned treated titanium alloy is dropped into room temperature;
    Step 5: above-mentioned titanium alloy is put into organic acid, soak, remove drying, be put among solvent, pass through ultrasound Ripple cleans 10-100 minutes, removes titanium alloy support;
    Uniform solution a is carried out Step 7: polymalic acid is mixed with solvent a, rapamycin drug and solvent b are mixed to form Uniform solution b;
    Step 8: using coaxial electrospray, solution a is placed in shell, and solution b is placed in sandwich layer, and it uniformly is applied into titanium alloy On support;
    Step 9;Titanium alloy support after smearing is dried 2-10 days at 25-40 DEG C.
  2. 2. the preparation method of the intravascular stent according to claim 1 with medication coat, it is characterised in that the step One inert gas environment is nitrogen environment or ar gas environment.
  3. 3. the preparation method of the intravascular stent according to claim 2 with medication coat, it is characterised in that described is lazy The pressure of property gaseous environment is 0.4-0.6 atmospheric pressure.
  4. 4. the preparation method of the intravascular stent according to claim 3 with medication coat, it is characterised in that the step Five organic acid contains carboxyl, sulfonic group, sulfinic acid base, thionothiolic acid base.
  5. 5. the preparation method of the intravascular stent according to claim 4 with medication coat, it is characterised in that the step Five solvent is one or more of mixtures of acetone, ethanol or distilled water.
  6. 6. the preparation method of the intravascular stent according to claim 5 with medication coat, it is characterised in that described step Solution a concentration is 5% in rapid eight.
  7. 7. the preparation method of the intravascular stent according to claim 6 with medication coat, it is characterised in that described is molten Liquid b concentration is 5%.
  8. 8. the preparation method of the intravascular stent according to claim 7 with medication coat, it is characterised in that solution a and Solution b is pressurized in spraying advance horizontal high voltage pump.
  9. 9. the preparation method of the intravascular stent according to claim 8 with medication coat, it is characterised in that described height The boost pressure of press pump is 2-20MPA.
CN201711222372.9A 2017-11-29 2017-11-29 A kind of preparation method of the intravascular stent with medication coat Withdrawn CN107875440A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201711222372.9A CN107875440A (en) 2017-11-29 2017-11-29 A kind of preparation method of the intravascular stent with medication coat

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201711222372.9A CN107875440A (en) 2017-11-29 2017-11-29 A kind of preparation method of the intravascular stent with medication coat

Publications (1)

Publication Number Publication Date
CN107875440A true CN107875440A (en) 2018-04-06

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Application Number Title Priority Date Filing Date
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Country Status (1)

Country Link
CN (1) CN107875440A (en)

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Application publication date: 20180406

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