CN109567990A - A kind of novel biodegradable stent and its manufacturing method - Google Patents

A kind of novel biodegradable stent and its manufacturing method Download PDF

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Publication number
CN109567990A
CN109567990A CN201811495358.0A CN201811495358A CN109567990A CN 109567990 A CN109567990 A CN 109567990A CN 201811495358 A CN201811495358 A CN 201811495358A CN 109567990 A CN109567990 A CN 109567990A
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China
Prior art keywords
solution
metal base
polymer
coating
drug
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CN201811495358.0A
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CN109567990B (en
Inventor
王君毅
王国辉
赵迎红
蔡涛
张晨朝
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Feel At Ease Bioisystech Co Ltd In Shanghai Hundred
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Feel At Ease Bioisystech Co Ltd In Shanghai Hundred
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Classifications

    • 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
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • 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
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • 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
    • 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
    • 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

Abstract

The invention discloses a kind of novel biodegradable stents and its manufacturing method, it is related to implanted medical device field, including interior muscle, polymer substrate and medicine layer, wherein, the interior muscle is the metal base under X-ray machine with developing function, and the polymer substrate is mixed by polymer solution, wraps up the metal base layer by layer and reinforce it, the medicine layer is mixed by drug and polymer solution, is covered in the polymeric substrate layer surface.Existing metal alloy degradation speed, excessively slow, catabolite complexity easily leads to the problem of rejection with blood vessel, the problem of polymer biodegradable stent toughness deficiency easy fracture, develop incomplete problem after rack surface filling development object, the present invention combines two kinds of substrates, provides a kind of with good moulding, good radial support intensity, the bracket that can develop completely.The present invention also provides the manufacturing methods of the novel biodegradable stent.

Description

A kind of novel biodegradable stent and its manufacturing method
Technical field
The present invention relates to implanted medical device fields, more particularly to a kind of novel biodegradable stent and its manufacturing method.
Background technique
Bracket has obtained in cardiovascular disease field more and more wide as the important instrument for the treatment of hemadostewnosis Using.For being now widely used for clinical metallic support, since it will permanently retain in human body after completing treatment task, Weaken MRI coronarius or CT images so existing, interference surgery revascularization, the formation for hindering offshoot circulation, inhibit blood The defects of pipe positivity is remolded.Based on these problems, Biodegradable scaffold is caused as a kind of possible substitution solution The extensive concern of people.Biodegradable scaffold is made of degradable polymer material or metal material.In implantation lesion Behind position, Biodegradable scaffold can play the role of support blood vessels in a short time, realize revascularization.Treatment complete with Afterwards, the organic matter that Biodegradable scaffold can be degraded into human body environment can be absorbed by the body, be metabolized, the final bracket meeting It disappears.Further, since bracket must will undergo the storage of regular period after the completion of preparation, bracket shelf life is short also to be will affect The application of bracket.
The material of biodegradable stent generally comprises absorbable metal and polymer, polymer material autologous density very little, material Expect that the radiopacit of itself is poor, the intravascular stent prepared with polymer is in medical imaging device and digital subtraction technology It is almost invisible under auxiliary, cause in the course of surgery doctor bracket can not be accurately positioned, therefore polymer support need Developing mechanism is additionally set, developing mechanism is enable to be identified at DSA by doctor.Pass through the development with good visibility Structure makes up the deficiency of rest body visuality.
In order to solve the problems, such as that bracket is degradable, Chinese patent 2014108566258 proposes a kind of degradable iron-based conjunction Golden bracket, but iron-based bracket due to the degradation speed of itself it is excessively slow, need to adulterate C, N, O, S, P, Mn, Pd, Si, W, Ti, Co, At least one of Cr, Cu, Re can be doped into pure iron and form the medical ferrous alloy.And various polymerizations are added Object accelerates its degradable, and catabolite complexity easily generates rejection with blood vessel.
In order to improve the radial support intensity of bracket, Chinese patent 2017112132378 propose a kind of polylactic acid and its Copolymer bracket, it is height-oriented due to passing through radial direction, radial support intensity is improved, but bracket can be lost significantly simultaneously Toughness, so that bracket is easily broken after through tortuous blood vessel.
For the developing performance for improving bracket, Chinese patent 2015103951018 proposes a kind of intravascular stent, in bracket table Filling development object in face or structure, but can not accomplish that entire bracket develops completely
Therefore, those skilled in the art be dedicated to developing it is a kind of have good moulding, good radial support intensity, can The bracket to develop completely.
Summary of the invention
In view of the above drawbacks of the prior art, a kind of with good modeling the technical problem to be solved by the present invention is to develop Shape, good radial support intensity, the bracket that can develop completely use single substrate relative to traditional biodegradable stent, this Invention combines two kinds of substrates, utilizes the good radial support of polymer, it is ensured that restenosis will not occur for bracket；It is utilized The good moulding of metal base guarantees that bracket is reached after lesion struts by tortuous blood vessel and will not be broken, reaches simultaneously The purpose developed completely to entire bracket.
To achieve the above object, the present invention provides a kind of novel biodegradable stents, which is characterized in that including interior muscle, Polymer substrate and medicine layer, wherein the interior muscle is the metal base under X-ray machine with developing function, the polymer Substrate layer is mixed by polymer solution, is wrapped in the metal base periphery, is formed solid-state, with described in support effect Polymer substrate, the polymer solution are one of PLLA, PDLLA, PDLA, PLGA, PGLA, PLA, PDLGA or more Kind mixed with polymers forms, and the medicine layer is mixed by drug and polymer solution, is covered in the polymer substrate Surface, the drug are one of taxol, sirolimus, everolimus or a variety of.
Further, the metal base is one of ferrous alloy, magnesium base alloy, zinc-containing alloy and acieral.
Further, the metal base is single or more, and the metal base cross section is rectangle or circle.
Further, the metal base is single-chamber metal tube, respective independent parallel arrangement.
Further, the metal base is more, at hollow fried dough twist type assembled arrangement.
Further, 10 times or more in the metal base cross-sectional area of polymer substrate's cross-sectional area.
In addition, the present invention provides a kind of novel biodegradable stent manufacturing methods, which is characterized in that including following step It is rapid:
Step 1 selects metal base to have the metal base of developing function under X-ray machine, and selective polymer solution is One of PLLA, PDLLA, PDLA, PLGA, PGLA, PLA, PDLGA or a variety of are mixed, and select drug for taxol, west One of Luo Mosi, everolimus are a variety of, and drug solution is mixed by drug and polymer solution；
Step 2 wraps up polymer solution in the metal base periphery layer by layer, this process is repeated, until the Metal Substrate Protect wall cross-sectional area in 0.01mm in material periphery2To 0.04mm2Between, obtain polymer substrate；
Step 3 covers the drug solution in the polymeric substrate layer surface, forms medicine layer.
Further, in step 2, the polymer substrate is that have by spraying to obtain in the metallic substrate surface Body are as follows: by the polymer solution be dissolved in one of methanol, ethyl alcohol, isopropanol, acetone, tetrahydrofuran, acetonitrile, chloroform or Spray solution is formed in a variety of organic solvents, sufficiently oscillation mixes, with the spray rate of 0.01-0.06mm/min in the metal Substrate surface covers the spray solution of one layer of 10-15um thickness, then dries 10min under 20-25 DEG C, 40-60%RH；Again It is sprayed on this surface, repeatedly above-mentioned steps, is existed until polymer solution covers the metal base cross-sectional area 0.01mm2To 0.04mm2Between；The metal base for coating the spray solution is sent into an oven, control temperature is lower than described 10-20 DEG C of glass transition temperature of polymer solution material is dried, and the polymer substrate is formed.
Further, in step 3, the medicine layer is obtained by spraying drug solution in the polymeric substrate layer surface Arrive, specifically: by the drug and the polymer solution be dissolved in methanol, ethyl alcohol, isopropanol, acetone, tetrahydrofuran, acetonitrile, Drug solution is formed in one or more of chloroform organic solvent, sufficiently oscillation mixes, with the spray of 0.01-0.03mm/min Apply the drug solution that rate covers one layer of 5-10um thickness in the polymeric substrate layer surface, the polymeric substrate that will have been sprayed It is sent into an oven, 10-20 DEG C of glass transition temperature for controlling temperature lower than drug solution material is dried, and the medicine is formed Nitride layer.
Further, in step 2, the polymer substrate is obtained by metal base described in dip-coating, specifically: it will The polymer solution, which is dissolved in one or more of methanol, ethyl alcohol, isopropanol, acetone, tetrahydrofuran, acetonitrile, chloroform, to be had Dip-coating solution is formed in solvent, sufficiently oscillation mixes；The metal base is immersed in the dip-coating solution, is taken out after 1min It dries, 180 ° of the metal base is overturn after drying, the dip-coating solution is immersed in again, takes out and dry after 1min, guarantee The dip-coating solution coating at the metal base both ends is uniform；Coating thickness is 15-25um, positive and negative to be denoted as a circulation twice；So 10min is dried under 20-25 DEG C, 40-60%RH afterwards；It steps be repeated alternatively until that the metal base of dip-coating solution covering is horizontal Area of section is in 0.01mm2To 0.04mm2Between；The metal base of the dip-coating dip-coating solution is sent into baking oven, controls temperature 10-20 DEG C of glass transition temperature lower than the polymer solution material is dried, and the polymer substrate is formed.
Further, in step 3, the medicine layer is obtained by polymer substrate described in dip-coating, specifically: by institute State drug and the polymer solution be dissolved in one of methanol, ethyl alcohol, isopropanol, acetone, tetrahydrofuran, acetonitrile, chloroform or Drug solution is formed in a variety of organic solvents of person, sufficiently oscillation mixes；It is molten that the polymer substrate is immersed in the drug Liquid takes out after 1min and dries；180 ° of the polymer substrate are overturn after drying, is immersed in the drug solution again, It takes out and dries after 1min, the drug solution coating for guaranteeing the polymer substrate both ends uniformly, passes through control drug solution Concentration adjusts the thickness of dip-coating, and otherwise the bigger coating of concentration is thicker then thinner；By the Metal Substrate of the dip-coating drug solution Material is sent into baking oven, and 10-20 DEG C of glass transition temperature for controlling temperature lower than the drug solution material is dried, and forms institute State medicine layer.
The beneficial effects of the present invention are: the present invention good plasticity of combination metal biodegradable stent with polymerize Biodegradable The advantages of bracket good supportive, relative to metal material, the polymer substrate of biodegradable stent is presented after the setting Solid-state is able to bear certain pressure, so that the metal base being wrapped in polymer substrate has good radial support Property and intensity, it is ensured that Restenosis will not occur.Relative to polymer material, biodegradable stent improves plasticity and is not easy to send out Raw bracket fracture, and can develop completely.
It is described further below with reference to technical effect of the attached drawing to design of the invention, specific structure and generation, with It is fully understood from the purpose of the present invention, feature and effect.
Detailed description of the invention
Fig. 1 is the single piece of metal matrix structure schematic diagram of a preferred embodiment of the invention；
Fig. 2 is muscle structure top view in more metals of a preferred embodiment of the invention；
Fig. 3 is muscle structural side view in more metals of a preferred embodiment of the invention；
Fig. 4 is muscle structure oblique view in more metals of a preferred embodiment of the invention；
Fig. 5 is the straight frame cross section of two metal base respective arrays of a preferred embodiment of the invention.
Specific embodiment
Multiple preferred embodiments of the invention are introduced below with reference to Figure of description, keep its technology contents more clear and just In understanding.The present invention can be emerged from by many various forms of embodiments, and protection scope of the present invention not only limits The embodiment that Yu Wenzhong is mentioned.
In the accompanying drawings, the identical component of structure is indicated with same numbers label, everywhere the similar component of structure or function with Like numeral label indicates.The size and thickness of each component shown in the drawings are to be arbitrarily shown, and there is no limit by the present invention The size and thickness of each component.Apparent in order to make to illustrate, some places suitably exaggerate the thickness of component in attached drawing.
Embodiment one
As shown in Figure 1, The present invention gives the specific embodiment of single piece of metal matrix structure, selected metal base 1 can be with It, can also be by single-chamber for ferrous alloy, magnesium base alloy, zinc-containing alloy, acieral etc. with the material of developing function under X-ray machine Metal tube is cut by laser to obtain, and metal base 1 can be to be single, can also more respective arrays.
Fig. 2 show the hollow fried dough twist type assembled arrangement structure of muscle in more metals of a preferred embodiment of the invention and bows View, wherein wire 21,2 therein, wire that wire 22 is four same cross-sectionals.Preformed polymer silk 23 is by four In one metal wire (including wire 21, wire 22) is wrapped in, formed a branch of.Fig. 3 is this more interior hollow fried dough twist type groups of muscle The side view of arrangement is closed, Fig. 4 is this more interior hollow fried dough twist type assembled arrangement oblique views of muscle, and more interior muscle are in hollow fried dough twist type group Arrangement is closed, the toughness that fried dough twist type assembled arrangement can greatly improve bracket avoids bracket from being broken, but the meeting in flexibility It is lacked.The present embodiment devises a kind of hollow fried dough twist type aligning method, and each metal base is made to have independent work Dynamic space compensates for the missing in flexibility, specific implementation process are as follows: and metal base 21 and metal base 22 are in cross intersection, Junction interior design is hollow structure 23, and filling dissolves in the polymer lining core of dip-coating solution, braiding inside hollow structure 23 After the completion, entire metal base is integrally immersed in dip-coating solution, polymer lining core will dissolve, and obtain hollow twist shape knot Structure.
Embodiment two
It is the straight frame cross section of two metal base respective arrays of another preferred embodiment of the invention shown in Fig. 5, it can Manufacturing process of the invention is illustrated by this embodiment.Interior muscle be identical two metal bases of material model respectively Respective array, metal base 1 are ferrous alloy, magnesium base alloy, the zinc-containing alloy, aluminium base conjunction under X-ray machine with developing function Gold；In the polymer substrate 2 that two metal base surroundings package polymer solutions are formed, polymer solution PLLA, One of PDLLA, PDLA, PLGA, PGLA, PLA, PDLGA or a variety of, by forming polymerization in periphery package polymer solution Object substrate layer 2, the polymer substrate 2 are presented solid-state after solidifying, certain pressure are able to bear, so that being wrapped in polymer Metal base 1 in substrate layer 2 has good radial support, it is ensured that restenosis will not occur；2 periphery of polymer substrate It is covered with the medicine layer 3 of drug and polymer solution mixing.
Wherein, polymer substrate 2 can be by spraying to obtain on 1 surface of metal base, specific implementation process are as follows: by institute Stating polymer solution, to be dissolved in one or more of methanol, ethyl alcohol, isopropanol, acetone, tetrahydrofuran, acetonitrile, chloroform organic Spray solution is formed in solvent, sufficiently oscillation mixes, with the spray rate of 0.01-0.06mm/min in 1 table of metal base Face covers the spray solution of one layer of 10-15um thickness, then dries 10min under 20-25 DEG C, 40-60%RH；Again in this table It is sprayed on face, repeatedly above-mentioned steps, until polymer solution covers 1 cross-sectional area of metal base in 0.01mm2 To 0.04mm2Between；The metal base 1 for coating the spray solution is sent into an oven, control temperature is lower than the polymerization 10-20 DEG C of glass transition temperature of object solution material is dried, and the polymer substrate 2 is formed.
Medicine layer 3 can be obtained by spraying drug solution on 2 surface of polymer substrate, specific implementation process Are as follows: by the drug and the polymer solution be dissolved in methanol, ethyl alcohol, isopropanol, acetone, tetrahydrofuran, acetonitrile, in chloroform Drug solution is formed in one or more kinds of organic solvents, sufficiently oscillation mixes, and exists with the spray rate of 0.01-0.03mm/min The polymeric substrate layer surface covers the drug solution of one layer of 5-10um thickness, and the polymeric substrate sprayed is sent into baking oven Interior, 10-20 DEG C of glass transition temperature for controlling temperature lower than drug solution material is dried, and forms the medicine layer 3.
Embodiment three
In the present embodiment, polymer substrate 2 can also be obtained by metal base 1 described in dip-coating, specific implementation process Are as follows: the polymer solution is dissolved in one of methanol, ethyl alcohol, isopropanol, acetone, tetrahydrofuran, acetonitrile, chloroform or more Dip-coating solution is formed in kind organic solvent, sufficiently oscillation mixes；The metal base 1 is immersed in the dip-coating solution, 1min It takes out and dries afterwards, 1180 ° of the metal base are overturn after drying, the dip-coating solution is immersed in again, takes out and dry in the air after 1min It is dry, guarantee that the dip-coating solution coating at 1 both ends of metal base is uniform；Coating thickness is 15-25um, positive and negative to be denoted as one twice Circulation；Then 10min is dried under 20-25 DEG C, 40-60%RH；It steps be repeated alternatively until the gold of dip-coating solution covering Belong to 1 cross-sectional area of substrate in 0.01mm2To 0.04mm2Between；The metal base 1 of the dip-coating dip-coating solution is sent into and is dried Case, 10-20 DEG C of glass transition temperature for controlling temperature lower than the polymer solution material are dried, and the polymerization is formed Object substrate layer 2.In addition, polymer substrate 2 can also be obtained by metal base 1 described in 3D printing.Finally obtain polymer Substrate layer 2, the polymer substrate 2 are presented solid-state after solidifying, certain pressure are able to bear, so that being wrapped in polymer matrix Metal base 1 in material layer 2 has good radial support.
Medicine layer 3 can also be obtained by polymer substrate 2 described in dip-coating, specific implementation process are as follows: by the drug One or more of methanol, ethyl alcohol, isopropanol, acetone, tetrahydrofuran, acetonitrile, chloroform are dissolved in the polymer solution Drug solution is formed in organic solvent, sufficiently oscillation mixes；The polymer substrate is immersed in the drug solution, 1min It takes out and dries afterwards；180 ° of the polymer substrate are overturn after drying, the drug solution is immersed in again, is taken out after 1min It dries, the drug solution coating for guaranteeing the polymer substrate both ends uniformly, is adjusted by controlling the concentration of drug solution Otherwise the thickness of dip-coating, the bigger coating of concentration are thicker then thinner；The metal base 1 of the dip-coating drug solution is sent into and is dried Case, 10-20 DEG C of glass transition temperature for controlling temperature lower than the drug solution material are dried, and the medicine layer is formed 3.In addition, medicine layer 3 can also be obtained by polymer substrate 2 described in 3D printing.
The preferred embodiment of the present invention has been described in detail above.It should be appreciated that the ordinary skill of this field is without wound The property made labour, which according to the present invention can conceive, makes many modifications and variations.Therefore, all technician in the art Pass through the available technology of logical analysis, reasoning, or a limited experiment on the basis of existing technology under this invention's idea Scheme, all should be within the scope of protection determined by the claims.

Claims (10)

1. a kind of novel biodegradable stent, which is characterized in that including interior muscle, polymer substrate and medicine layer, wherein described Interior muscle is the metal base under X-ray machine with developing function, and the polymer substrate is mixed by polymer solution, is wrapped up In the metal base periphery, solid-state, the polymer substrate with support effect are formed, the polymer solution is One of PLLA, PDLLA, PDLA, PLGA, PGLA, PLA, PDLGA or multiple polymers mix, the medicine layer by Drug and polymer solution mix, and are covered in the polymeric substrate layer surface, and the drug is taxol, Xi Luomo One of department, everolimus are a variety of.
2. novel biodegradable stent as described in claim 1, which is characterized in that the metal base is ferrous alloy, magnesium One of based alloy, zinc-containing alloy and acieral.
3. novel biodegradable stent as described in claim 1, which is characterized in that the metal base is single or more, The metal base cross section is rectangle or circle.
4. novel biodegradable stent as described in claim 1, which is characterized in that the metal base is single-chamber metal tube.
5. novel biodegradable stent as described in claim 1, which is characterized in that polymer substrate's cross-sectional area At 10 times or more of the metal base cross-sectional area.
6. a kind of novel biodegradable stent manufacturing method, which is characterized in that the described method comprises the following steps:
Step 1, select in muscle be under X-ray machine with developing function metal base, selective polymer solution be PLLA, PDLLA, One of PDLA, PLGA, PGLA, PLA, PDLGA or multiple polymers mix, and select drug for taxol, Xi Luomo One of department, everolimus are a variety of, and drug solution is mixed by drug and polymer solution；
Step 2 wraps up polymer solution in the metal base periphery layer by layer, this process is repeated, until outside the metal base Protection wall cross-sectional area is enclosed in 0.01mm2To 0.04mm2Between, obtain polymer substrate；
Step 3 covers the drug solution in the polymeric substrate layer surface, forms medication coat.
7. method as claimed in claim 6, which is characterized in that the polymer substrate of the step 2 is by institute Metallic substrate surface is stated to spray to obtain, specifically: the polymer solution is dissolved in methanol, ethyl alcohol, isopropanol, acetone, tetrahydro Spray solution is formed in one or more of furans, acetonitrile, chloroform organic solvent, sufficiently oscillation mixes, with 0.01- The spray rate of 0.06mm/min covers the spray solution of one layer of 10-15um thickness in the metallic substrate surface, then in 20- 25 DEG C, 10min is dried under 40-60%RH；It is sprayed on this surface again, repeatedly above-mentioned steps, until polymer solution The metal base cross-sectional area is covered in 0.01mm2To 0.04mm2Between；The Metal Substrate of the spray solution will be coated Material is sent into an oven, and 10-20 DEG C of glass transition temperature for controlling temperature lower than the polymer solution material is dried, shape At the polymer substrate.
8. method as claimed in claim 6, which is characterized in that the medicine layer of the step 3 is by the polymerization Object substrate layer surface spraying drug solution obtain, specifically: by the drug and the polymer solution be dissolved in methanol, ethyl alcohol, Drug solution is formed in one or more of isopropanol, acetone, tetrahydrofuran, acetonitrile, chloroform organic solvent, is sufficiently vibrated It mixes, covers the medicine of one layer of 5-10um thickness in the polymeric substrate layer surface with the spray rate of 0.01-0.03mm/min The polymeric substrate sprayed is sent into an oven by object solution, and control temperature is lower than the glass transition temperature of drug solution material 10-20 DEG C of degree is dried, and the medicine layer is formed.
9. method as claimed in claim 6, which is characterized in that the polymer substrate of the step 2 is to pass through dip-coating The metal base obtains, specifically: the polymer solution is dissolved in methanol, ethyl alcohol, isopropanol, acetone, tetrahydrofuran, second Dip-coating solution is formed in one or more of nitrile, chloroform organic solvent, sufficiently oscillation mixes；The metal base is submerged It takes out and dries after the dip-coating solution, 1min, 180 ° of the metal base are overturn after drying, is immersed in the dip-coating again Solution takes out after 1min and dries, and guarantees that the dip-coating solution coating at the metal base both ends is uniform；Coating thickness is 15-25um, It is positive and negative to be denoted as a circulation twice；Then 10min is dried under 20-25 DEG C, 40-60%RH；It steps be repeated alternatively until dip-coating The metal base cross-sectional area of solution covering is in 0.01mm2To 0.04mm2Between；By the dip-coating dip-coating solution Metal base is sent into baking oven, and 10-20 DEG C of glass transition temperature for controlling temperature lower than the polymer solution material is dried It is dry, form the polymer substrate.
10. method as claimed in claim 6, which is characterized in that the medicine layer of the step 3 is by gathering described in dip-coating Object substrate layer is closed to obtain, specifically: the drug and the polymer solution are dissolved in methanol, ethyl alcohol, isopropanol, acetone, four Drug solution is formed in one or more of hydrogen furans, acetonitrile, chloroform organic solvent, sufficiently oscillation mixes；It will be described poly- It closes object substrate layer and is immersed in the drug solution, take out and dry after 1min；180 ° of the polymer substrate are overturn after drying, It is immersed in the drug solution again, takes out and dries after 1min, guarantees the drug solution coating at the polymer substrate both ends Uniformly, the thickness of dip-coating is adjusted by controlling the concentration of drug solution, otherwise the bigger coating of concentration is thicker then thinner；By dip-coating The metal base of the drug solution is sent into baking oven, and control temperature is lower than the glass transition temperature of the drug solution material 10-20 DEG C is dried, and the medicine layer is formed.
CN201811495358.0A 2018-12-07 2018-12-07 Degradable bracket and manufacturing method thereof Active CN109567990B (en)

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