CN108852568B - Multi-coating self-developing intravascular stent and preparation method thereof - Google Patents
Multi-coating self-developing intravascular stent and preparation method thereof Download PDFInfo
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- CN108852568B CN108852568B CN201810799134.2A CN201810799134A CN108852568B CN 108852568 B CN108852568 B CN 108852568B CN 201810799134 A CN201810799134 A CN 201810799134A CN 108852568 B CN108852568 B CN 108852568B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
- A61L31/082—Inorganic materials
- A61L31/088—Other specific inorganic materials not covered by A61L31/084 or A61L31/086
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/18—Materials at least partially X-ray or laser opaque
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/42—Anti-thrombotic agents, anticoagulants, anti-platelet agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/606—Coatings
Abstract
The invention discloses a multi-coating self-developing intravascular stent which comprises a tube body, wherein the tube body is provided with a plurality of grooves, developers are filled in the grooves, the openings of the grooves are provided with protective layers for covering the grooves, the outer wall of the tube body is also provided with an active layer, and the inner wall of the tube body is also provided with a drug-loaded layer. The method for preparing the stent comprises the following steps: (a) extruding a pipe and carving by laser; (b) preparing a gelatin solution; adding a developer into the groove, and smearing gelatin on the opening of the groove to obtain a protective layer; (c) obtaining a drug-loaded mixture; ultrasonically spraying the medicine-carrying mixture on the inner wall of the pipe body to prepare a medicine-carrying layer; (d) preparing a reagent A; preparing a reagent B; spraying a reagent B on the outer wall of the tube body; and spraying the reagent A on the outer wall of the tube body to prepare the multi-coating bracket.
Description
Technical Field
The invention belongs to the technical field of medical equipment, and particularly relates to a multi-coating self-developing intravascular stent and a preparation method thereof.
Background
The development function of the blood vessel stent is an important function, and after an operation, the condition of the blood vessel stent in a blood vessel needs to be observed, and the position of the blood vessel stent is usually determined by X-rays. Most of the existing vascular stents fix the developing agent at two ends of the stent, and although the vascular stent of the type can well display the position of the vascular stent under X-rays, the vascular stent cannot display the axial shape of the stent; patent CN201110234883.9 discloses a vascular stent with improved development performance and a method for enhancing the development performance of the vascular stent, in the patent document, based on a reticular stent, a thread-shaped development material is wound on corrugated rods of the stent, and the corrugated rods on the stent are all wound with development threads, so that the overall condition of the stent can be better displayed; but the production process of the intravascular stent of the patent is complex.
Disclosure of Invention
The invention aims to: the defects in the prior art are overcome, and the intravascular stent with the multi-coating self-development and the method for preparing the intravascular stent are provided.
In order to achieve the purpose, the invention adopts the technical scheme that: the utility model provides a blood vessel support of multicoat self-development, includes the body, the body is equipped with a plurality of recesses, and is a plurality of recess intussuseption be filled with the developer, groove opening part is equipped with and is used for covering the protective layer of recess, the outer wall of body still is equipped with the active layer, the active layer covers the protective layer, the inner wall of body still is equipped with the medicine carrying layer.
Further, the drug-loaded layer is a coating of a mixture of an antithrombotic drug and alumina hydrogel, and the weight ratio of the antithrombotic drug to the alumina hydrogel is 1: 5-10.
Further, the active layer is prepared from the following raw materials in parts by weight: 8-10 parts of gelatin, 1-2 parts of spidroin, 1-2 parts of polycaprolactone and 0.5-1 part of cross-linking agent.
Further, the thickness of protective layer is 1-3um, the thickness of medicine carrying layer is 10-20 um.
The method for preparing the multi-coating self-developing intravascular stent comprises the following steps:
(a) weighing shape memory polymer, heating and melting, adding the molten polymer into an aluminum alloy mold matched with the pipe body, cooling, demolding to obtain a pipe body blank, polishing the surface of the pipe body blank smoothly, and cleaning with alcohol for 2-3 times to obtain the pipe body with a groove;
(b) adding gelatin into deionized water at 50-60 deg.C, and stirring to obtain gelatin solution; adding a developer into the groove of the pipe body, smearing the gelatin solution on the opening of the groove to enable the opening of the groove to be loaded with the gelatin solution, and cooling and drying to obtain a protective layer;
(c) uniformly mixing the antithrombotic drug and the alumina hydrogel to obtain a drug-loaded mixture; ultrasonically spraying the medicine-carrying mixture on the inner wall of the tube body in the step (b), and drying to obtain a medicine-carrying layer;
(d) dissolving gelatin in water, adding spidroin and polycaprolactone into the solution system, and uniformly stirring to obtain a reagent A; dissolving gelatin in deionized water, ultrasonically stirring, adding a cross-linking agent into a solution system, and uniformly stirring to prepare a reagent B; spraying the prepared reagent B on the outer wall of the tube body, and drying the tube body in vacuum; and spraying the prepared reagent A on the outer wall of the tube body, and drying to obtain the multi-coating stent.
Further, in the step (a), the shape memory polymer is a polymer of polydioxanone and polylactic acid.
Further, in the step (d), the reagent A comprises 5-6 parts by weight of gelatin, 1-2 parts by weight of spidroin and 1-2 parts by weight of polycaprolactone.
Further, in the step (d), the thickness of the coating prepared by the reagent B is 10-20um, and the thickness of the coating prepared by the reagent A is 20-30 um.
Due to the adoption of the technical scheme, the invention has the beneficial effects that:
the blood vessel stent is provided with the plurality of grooves, the grooves are filled with the developer, the overall condition of the stent can be well displayed after the blood vessel is implanted, the openings of the grooves are coated with the protective layers, and the developer is encapsulated in the grooves by the protective layers to protect the developer. The inner wall coating at the body of support has the medicine carrying layer, and the medicine carrying layer releases the antithrombotic medicine, prevents to form the thrombus, and the outer wall coating of support body has the active layer, and this active layer comprises spidroin and polycaprolactone, has fine biocompatibility, reduces inflammatory reaction. The active layer of the outer wall of the stent comprises two layers, the coating prepared by the reagent B is porous, and the reagent A permeates into the pores, so that the connection strength of the two coatings is enhanced.
Drawings
FIG. 1 is a schematic cross-sectional view of a stent of the present invention;
FIG. 2 is an enlarged view of portion A of FIG. 1;
FIG. 3 is a top view of the tube of the present invention;
reference numerals: 1-tube body, 2-groove, 3-drug-carrying layer, 4-active layer, 5-developer and 6-protective layer.
Detailed Description
Embodiments of the present invention will be described in detail with reference to the accompanying drawings 1 to 3.
Example 1: the utility model provides a blood vessel support of multicoating self-development, includes body 1, and this body 1's material is the shape memory polymer, is equipped with a plurality of recesses 2 at body 1's outer wall, and a plurality of recesses 2 all extend along body 1's axial, are filled with developer 5 in every recess 2 intussuseption be equipped with and be used for covering recess 2 opening part protection layer 6, the outer wall coating of body 1 has active layer 4, the inner wall coating of body 1 has medicine carrying layer 3, and wherein, medicine carrying layer 3 covers protection layer 6.
The method for preparing the vascular stent of this example 1 was:
(a) weighing a certain amount of multi-block polymer formed by poly (p-dioxanone) and polylactic acid, heating and melting, adding the molten polymer into an aluminum alloy mould matched with the pipe body, cooling, demoulding to obtain a pipe body blank, polishing the surface of the pipe body blank smoothly, removing burrs on the surface of the pipe, and cleaning for 2-3 times by using alcohol to obtain a pipe body 1 with a groove 2;
(b) adding gelatin into deionized water at 60 ℃, and uniformly stirring to obtain a gelatin solution; adding a developer 5 into one groove 2 of the pipe body 1, filling the developer 5 into the opening of the groove 2, coating the gelatin solution on the opening of the groove 2, loading the gelatin solution on the opening of the groove 2, cooling and drying to form a gelatin solidified layer, repeating the operation, covering a gelatin film on each groove 2, and thus obtaining a protective layer 6, wherein the thickness of the protective layer 6 is 3 um;
(c) uniformly mixing 1 part of antithrombotic drug with 8 parts of alumina water-soluble gel to obtain a drug-loaded mixture; ultrasonically spraying the medicine-carrying mixture on the inner wall of the tube body 1 in the step (b) to enable the inner wall to uniformly load the medicine-carrying mixture, and drying the tube body 1 to obtain a medicine-carrying layer 3, wherein the thickness of the medicine-carrying layer 3 is 20 um;
(d) dissolving 5 parts of gelatin in water, adding 1 part of spidroin and 1 part of polycaprolactone into the solution system, and uniformly stirring to obtain a reagent A; dissolving 3 parts of gelatin in deionized water, ultrasonically stirring, adding 0.5 part of cross-linking agent into a solution system, and uniformly stirring to obtain a reagent B; spraying the prepared reagent B on the outer wall of the tube body 1, and drying the tube body 1 in vacuum to enable the prepared coating of the reagent B to be porous, wherein the thickness of the coating is 10 um; and spraying the prepared reagent A on the outer wall of the tube body 1, and drying to obtain the multi-coating support, wherein the thickness of the coating prepared by the reagent A is 30 um.
Example 2: the utility model provides a blood vessel support of multicoating self-development, includes body 1, and this body 1's material is the shape memory polymer, is equipped with a plurality of recesses 2 at body 1's outer wall, and a plurality of recesses 2 all extend along body 1's axial, are filled with developer 5 in every recess 2 intussuseption be equipped with and be used for covering recess 2 opening part protection layer 6, the outer wall coating of body 1 has active layer 4, the inner wall coating of body 1 has medicine carrying layer 3, and wherein, medicine carrying layer 3 covers protection layer 6.
The method for preparing the vascular stent of the present example 2 is:
(a) weighing a certain amount of multi-block polymer formed by poly (p-dioxanone) and polylactic acid, heating and melting, adding the molten polymer into an aluminum alloy mold matched with the pipe body, cooling, demolding to obtain a pipe body blank, polishing the surface of the pipe body blank smoothly, removing burrs on the surface of the pipe, soaking the pipe body blank in 80% alcohol solution for 20min, and obtaining a pipe body 1 with a groove 2;
(b) adding gelatin into deionized water at 50 ℃, and uniformly stirring to obtain a gelatin solution; adding a developer 5 into one groove 2 of the pipe body 1, filling the developer 5 into the opening of the groove 2, coating the gelatin solution on the opening of the groove 2, loading the gelatin solution on the opening of the groove 2, cooling and drying to form a gelatin solidified layer, repeating the operation, covering a gelatin film on each groove 2, and thus obtaining a protective layer 6, wherein the thickness of the protective layer 6 is 1 um;
(c) uniformly mixing 1 part of antithrombotic drug with 5 parts of alumina water-soluble gel to obtain a drug-loaded mixture; placing the tube body 1 in the step (b) in a drug-loaded mixed solution, rotating the tube body 1 to enable the inner wall and the outer wall of the tube body to be uniformly loaded with drug-loaded mixture, and drying the tube body 1 to obtain a drug-loaded layer 3, wherein the thickness of the drug-loaded layer 3 is 10 microns;
(d) dissolving 6 parts of gelatin in water, adding 2 parts of spidroin and 1 part of polycaprolactone into the solution system, and uniformly stirring to obtain a reagent A; dissolving 2 parts of gelatin in deionized water, ultrasonically stirring, adding 0.8 part of cross-linking agent into a solution system, and uniformly stirring to obtain a reagent B; selecting a solid tube with a diameter slightly smaller than that of the tube body 1, sleeving the tube body 1 on the solid tube, spraying the prepared reagent B on the outer wall of the tube body 1, and drying the tube body 1 in vacuum to enable the prepared coating of the reagent B to be porous, wherein the thickness of the coating is 20 microns; and spraying the prepared reagent A on the outer wall of the tube body 1, and drying to obtain the multi-coating support, wherein the thickness of the coating prepared by the reagent A is 20 um.
Example 3: the utility model provides a blood vessel support of multicoating self-development, includes body 1, and this body 1's material is the shape memory polymer, is equipped with a plurality of recesses 2 at body 1's outer wall, and a plurality of recesses 2 all extend along body 1's axial, are filled with developer 5 in every recess 2 intussuseption be equipped with and be used for covering recess 2 opening part protection layer 6, the outer wall coating of body 1 has active layer 4, the inner wall coating of body 1 has medicine carrying layer 3, and wherein, medicine carrying layer 3 covers protection layer 6.
The method for preparing the vascular stent of this example 3 was:
(a) weighing a certain amount of multi-block polymer formed by poly (p-dioxanone) and polylactic acid, heating and melting, adding the molten polymer into an aluminum alloy mould matched with the pipe body, cooling, demoulding to obtain a pipe body blank, polishing the surface of the pipe body blank smoothly, removing burrs on the surface of the pipe, and cleaning for 2-3 times by using alcohol to obtain a pipe body 1 with a groove 2;
(b) adding gelatin into deionized water at 55 ℃, and uniformly stirring to obtain a gelatin solution; adding a developer 5 into one groove 2 of the tube body 1, filling the developer 5 into the opening of the groove 2, coating the gelatin solution on the opening of the groove 2, loading the gelatin solution on the opening of the groove 2, cooling and drying to form a gelatin solidified layer film, and obtaining a protective layer 6, wherein the thickness of the protective layer 6 is 2 microns;
(c) uniformly mixing 1 part of antithrombotic drug with 10 parts of alumina water-soluble gel to obtain a drug-loaded mixture; ultrasonically spraying the medicine-carrying mixture on the inner wall of the tube body 1 in the step (b) to enable the inner wall to uniformly load the medicine-carrying mixture, and drying the tube body 1 to obtain a medicine-carrying layer 3, wherein the thickness of the medicine-carrying layer 3 is 20 um;
(d) dissolving 6 parts of gelatin in water, adding 1 part of spidroin and 2 parts of polycaprolactone into the solution system, and uniformly stirring to obtain a reagent A; dissolving 4 parts of gelatin in deionized water, ultrasonically stirring, adding 1 part of cross-linking agent into a solution system, and uniformly stirring to obtain a reagent B; selecting a solid tube with a diameter slightly smaller than that of the tube body 1, sleeving the tube body 1 on the solid tube, spraying the prepared reagent B on the outer wall of the tube body 1, and drying the tube body 1 in vacuum to enable the prepared coating of the reagent B to be porous, wherein the thickness of the coating is 10 microns; and spraying the prepared reagent A on the outer wall of the tube body 1, and drying to obtain the multi-coating support, wherein the thickness of the coating prepared by the reagent A is 30 um.
Example 4: the utility model provides a blood vessel support of multicoating self-development, includes body 1, and this body 1's material is the shape memory polymer, is equipped with a plurality of recesses 2 at body 1's outer wall, and a plurality of recesses 2 all extend along body 1's axial, are filled with developer 5 in every recess 2 intussuseption be equipped with and be used for covering recess 2 opening part protection layer 6, the outer wall coating of body 1 has active layer 4, the inner wall coating of body 1 has medicine carrying layer 3, and wherein, medicine carrying layer 3 covers protection layer 6.
The method for preparing the vascular stent of this example 4 was:
(a) weighing a certain amount of multi-block polymer formed by poly (p-dioxanone) and polylactic acid, heating and melting, adding the molten polymer into an aluminum alloy mould matched with the pipe body, cooling, demoulding to obtain a pipe body blank, polishing the surface of the pipe body blank smoothly, removing burrs on the surface of the pipe, and cleaning for 2-3 times by using alcohol to obtain a pipe body 1 with a groove 2;
(b) adding gelatin into deionized water at 50 ℃, and uniformly stirring to obtain a gelatin solution; adding a developer 5 into one groove 2 of the pipe body 1, filling the developer 5 into the opening of the groove 2, coating the gelatin solution on the opening of the groove 2, loading the gelatin solution on the opening of the groove 2, cooling and drying to form a gelatin solidified layer, repeating the operation, covering a gelatin film on each groove 2, and thus obtaining a protective layer 6, wherein the thickness of the protective layer 6 is 3 um;
(c) uniformly mixing 1 part of antithrombotic drug with 7 parts of alumina water-soluble gel to obtain a drug-loaded mixture; ultrasonically spraying the medicine-carrying mixture on the inner wall of the tube body 1 in the step (b) to enable the inner wall to be uniformly loaded with the medicine-carrying mixture, and drying the tube body 1 to obtain a medicine-carrying layer 3, wherein the thickness of the medicine-carrying layer 3 is 15 um;
(d) dissolving 6 parts of gelatin in water, adding 2 parts of spidroin and 2 parts of polycaprolactone into the solution system, and uniformly stirring to obtain a reagent A; dissolving 4 parts of gelatin in deionized water, ultrasonically stirring, adding 0.8 part of cross-linking agent into a solution system, and uniformly stirring to obtain a reagent B; spraying the prepared reagent B on the outer wall of the tube body 1, and drying the tube body 1 in vacuum to enable the prepared coating of the reagent B to be porous, wherein the thickness of the coating is 18 um; and spraying the prepared reagent A on the outer wall of the tube body 1, and drying to obtain the multi-coating support, wherein the thickness of the coating prepared by the reagent A is 25 um.
In the embodiment of the present invention, the developers 5 used are all the developers 5 of the prior art, such as gold, platinum, and the like. In other embodiments of the present invention, the tube 1 can be made of a shape memory polymer material in the prior art.
The stents of the above embodiments 1 to 4 are respectively implanted into the blood vessels of experimental animals, the position of the stent can be accurately positioned in the stent implantation process and the follow-up radiography process in the later period, and the complete stent structure can be clearly shown.
Claims (7)
1. The multi-coating self-developing intravascular stent is characterized by comprising a tube body (1), wherein a plurality of grooves (2) are formed in the outer wall of the tube body (1), a developing agent (5) is filled in the grooves (2), a protective layer (6) for covering the grooves (2) is arranged at the opening of the grooves (2), an active layer (4) is further arranged on the outer wall of the tube body (1), the active layer (4) covers the protective layer (6), and a drug-loaded layer (3) is further arranged on the inner wall of the tube body (1);
wherein the preparation method of the intravascular stent comprises the following steps,
(a) weighing shape memory polymer, heating and melting, adding the molten polymer into an aluminum alloy mold matched with the pipe body, cooling, demolding to obtain a pipe body blank, polishing the surface of the pipe body blank smoothly, and cleaning with alcohol for 2-3 times to obtain the pipe body (1) with a groove (2);
(b) adding gelatin into deionized water at 50-60 deg.C, and stirring to obtain gelatin solution; adding a developer (5) into the groove (2) of the tube body (1), coating the gelatin solution on the opening of the groove (2), loading the gelatin solution on the opening of the groove (2), cooling and drying to obtain a protective layer (6);
(c) uniformly mixing the antithrombotic drug and the alumina hydrogel to obtain a drug-loaded mixture; ultrasonically spraying the medicine-carrying mixture on the inner wall of the tube body (1) in the step (b), and drying to obtain a medicine-carrying layer (3);
(d) dissolving gelatin in water, adding spidroin and polycaprolactone into the solution system, and uniformly stirring to obtain a reagent A; dissolving gelatin in deionized water, ultrasonically stirring, adding a cross-linking agent into a solution system, and uniformly stirring to prepare a reagent B; spraying the prepared reagent B on the outer wall of the tube body (1), and drying the tube body (1) in vacuum; and spraying the prepared reagent A on the outer wall of the tube body (1), and drying to obtain the multi-coating stent.
2. The multi-coated self-visualizing vascular stent of claim 1, wherein: the drug-loaded layer (3) is a coating of a mixture of an antithrombotic drug and alumina hydrogel, and the weight ratio of the antithrombotic drug to the alumina hydrogel is 1: 5-10.
3. The multi-coated self-visualizing vascular stent of claim 1, wherein: the active layer (4) is prepared from the following raw materials in parts by weight: 8-10 parts of gelatin, 1-2 parts of spidroin, 1-2 parts of polycaprolactone and 0.5-1 part of cross-linking agent.
4. The multi-coated self-visualizing vascular stent of claim 1, wherein: the thickness of protective layer (6) is 1-3um, the thickness of medicine-carrying layer (3) is 10-20 um.
5. The multi-coated self-visualizing vascular stent of claim 1, wherein: in the step (a), the shape memory polymer is a polymer of polydioxanone and polylactic acid.
6. The multi-coated self-visualizing vascular stent of claim 1, wherein: in the step (d), the reagent A comprises 5-6 parts by weight of gelatin, 1-2 parts by weight of spidroin and 1-2 parts by weight of polycaprolactone.
7. The multi-coated self-visualizing vascular stent of claim 1, wherein: in the step (d), the thickness of the coating prepared by the reagent B is 10-20um, and the thickness of the coating prepared by the reagent A is 20-30 um.
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| CN110115649B (en) * | 2019-05-15 | 2021-05-18 | 四川兴泰普乐医疗科技有限公司 | Self-developing degradable blood vessel stent |
| CN110115650B (en) * | 2019-05-15 | 2021-05-18 | 四川兴泰普乐医疗科技有限公司 | Self-developing electrostatic spinning bracket and preparation method thereof |
| CN110420075B (en) * | 2019-06-27 | 2022-04-05 | 深圳市先健畅通医疗有限公司 | Covered stent |
| CN116549171A (en) * | 2023-07-12 | 2023-08-08 | 苏州美创医疗科技有限公司 | Artificial blood vessel |
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| CN204207881U (en) * | 2014-07-17 | 2015-03-18 | 微创神通医疗科技（上海）有限公司 | A kind of intravascular stent |
| CN106333773B (en) * | 2015-07-07 | 2018-05-08 | 先健科技(深圳)有限公司 | Intravascular stent |
| CN106039425B (en) * | 2016-07-21 | 2019-02-26 | 四川兴泰普乐医疗科技有限公司 | Degradable intravascular stent and preparation method thereof for vascular diseases treatment |
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