CN106178139A - A kind of support and preparation method thereof - Google Patents
A kind of support and preparation method thereof Download PDFInfo
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- CN106178139A CN106178139A CN201610520157.6A CN201610520157A CN106178139A CN 106178139 A CN106178139 A CN 106178139A CN 201610520157 A CN201610520157 A CN 201610520157A CN 106178139 A CN106178139 A CN 106178139A
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- support
- coat
- core texture
- coated
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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
- A61L31/02—Inorganic materials
- A61L31/022—Metals or alloys
-
- 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
-
- 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
- A61L31/148—Materials at least partially resorbable by the body
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/216—Biologically 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
-
- 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
- A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
-
- 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
-
- 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
- A61L2300/426—Immunomodulating agents, i.e. cytokines, interleukins, interferons
Abstract
The present invention provides a kind of support and preparation method thereof, this support has the equal performance of conventional metals support and will not cause chronic inflammatory disease, this support includes constituting the metal material of core texture and being coated on the coat on described core texture surface, and described metal material and coat are respectively provided with biodegradable properties.
Description
Technical field
The invention belongs to medical instruments field, particularly relate to a kind of support.
Background technology
In recent years, along with Occidentalizing and aging of living habit, China's myocardial infarction, angina pectoris, apoplexy, tip
The arteriosclerotic diseases such as angiopathy are continuously increased.The most effective Therapeutic Method for this type of arteriosclerotic disease obtains
Arrive the most universal, the most representative heart coronary artery percutaneous coronary plasty (calling " PTCA " in the following text).PTCA
Operation refers to the intervention operation of narrow positions or the occlusion site by surgical means, expanding blood vessel.
PTCA operation refers to, by position, front end with the tubule (conduit) of balloon (sacculus), and dynamic via wrist or huckle
Arteries and veins inserts so that it is after the narrow positions of heart coronary artery, makes the sacculus at position, front end expand, supports big narrow blood vessel, make
Blood flow obtains the operation recovered.By this operation, the intravascular space of diseased region is expanded, and therefore adds and pass through blood
The blood flow of tube cavity.But, once conduit makes blood vessel wall sustain damage, and will cause the Ink vessel transfusing as blood vessel wall spontaneous recovery reaction
Film hypertrophy.In the PTCA case successfully having expanded coronary stenosis diseased region, about 30-40% there occurs restenosis.Owing to sending out
Need to perform the operation by row PTCA during raw restenosis, the task of top priority should establish its prevention method and Therapeutic Method again.
For solving this problem, in recent years, the medical apparatus and instruments of a kind of entitled support has put into use.At blood vessel, trachea, food
The tube chamber such as road, urethra occurs narrow position, implants the support maintaining expansion state.By under tiny folding shrinking state
After support inserts target site, remove its stress maintaining contraction state.To remove the difference of tension type, it is divided into self-inflated to prop up
Frame and sacculus expansion type support.Self-expansion type support is expanded with radial direction by the recuperability of support self, and is tightly fastened
Interior surface in human organ.Sacculus expansion type support makes support launch by the expansionary force of the sacculus of configuration in support.
But, in practical situation, only by by stenter to implant narrow positions, the generation of in-stent restenosis can not be completely inhibited.Typically
Thinking, the vascular site accepting PTCA operation or support indwelling art can be by wounds such as endotheliocyte stripping or elastic plate damages
Evil, thus relative to human body spontaneous recovery reaction time the longest (implant support after about 2 months).More specifically, human body is caused
The main reason of interior restenosis is that PTCA performs the operation or produced visible single ball adhesion, infiltration in 1-3 day after stenter to implant
After inflammatory process, and about 45 days, smooth muscle cell proliferation reaches the forming process of the neointimal hyperplasia that peak value is caused.
Therefore, the rack surface being made up of metal or macromolecular material has antiinflammatory and inhibitors of smooth muscle cell proliferation
Bracket for eluting medicament (drug-eluting stent) put into use, be implanted into the chronicity medicine at position for realizing tube chamber
Local release, thus reduce restenosis rate, expert imagines one after another at the surface of metallic stent body design medication coat.But with
Time, owing to these rack bodies prepared by metal material will semi-permanently be retained in body, after drug release, support
Body may result in the generation of chronic inflammatory disease to the mechanical stress that blood vessel wall produces.
Therefore, for solving the problems referred to above of metal rack, nearest expert contemplates a kind of rack body by biological absorbable
The support that property metal (biodegradability metal) or bioabsorbable polymers are made.Have in pertinent literature and recorded one
The mixture of material and polymer for the purpose for the treatment of in the surface-coated of bioabsorbable polymers rack body
Coating bracket, but, compared with metal rack, biodegradable polymer support intensity is relatively low, the problem that it needs to solve
It is, while guaranteeing certain radially support force, it is possible to the indwelling regular hour in vivo.Will be raw additionally, be documented
Thing absorbability polymer (polylactic acid) fibrage becomes the fabric of tubular or tubulose, recycles this fabric and makes arteria coronaria and prop up
The imagination of frame, but, the coronary artery bracket for making this fabric make possesses the radial direction support force equal with metal rack, it is necessary to right
Fabric thickeies, and thickness should be greater than the thickness of metal rack, limits because existing on thickness, and this imagination does not have practicality
Property.Additionally, expert also proposes magnesium alloy of a relatively high for intensity in biological degradable material is made support, can drop with biology
Solution property polymer phase ratio, magnesium alloy has higher intensity, so the thickness of its wire rod can be reduced.But, such degradable
Property metal rack (with magnesium as representative) though having intensity, but cannot avoid support dissolution metal cause chronic inflammatory disease problem.
Summary of the invention
For solving above-mentioned technical problem, it is an object of the invention to provide a kind of support and preparation method thereof, this support has
The equal performance of conventional metals support (mechanical characteristic) and chronic inflammatory disease will not be caused.
The support of the present invention, including constituting the metal material of core texture (rack body) and being coated on described core
The coat of body structure surface, described metal material and coat be respectively provided with biodegradable properties, and described metal material is for giving birth to
Thing degradable material, described coat is biodegradable coat.
Further, the covering rate on described core texture surface is 50-100%, and wherein covering rate refers to the table of core texture
The ratio of the coat that face is formed thereby.
Further, the thickness of described coat is 1-25 μm, preferably 1-20 μm.
Further, described metal material is magnesium or magnesium alloy, and described magnesium alloy includes magnesium and has with described magnesium
One or more in the rare earth element of biocompatibility, Fe, Zr, Y, Ti, Ta, Nd, Nb, Zn, Ca, Al, Li and Mn element, excellent
Choosing, the weight/mass percentage composition of each component in magnesium alloy: magnesium 50-98%, Li 0-40%, Fe 0-5%, other metals and rare earth
Cerium, lanthanum, neodymium, praseodymium 0-5% in dvielement.
Further, described coat at least includes a kind of polymer, and the molecular weight of wherein said polymer is preferably
30000-500000。
Further, described polymer is polylactic acid, poly-(lactic acid-ethanol), polyglycolic acid, polycaprolactone
(PCL) one or more, in poly-(lactic acid-6-caprolactone) and poly-(hydroxyacetic acid-ε-acid lactone), the most poly-(lactic acid-
6-caprolactone).
Further, described coat also includes pharmacy agent.Wherein, polymer is 1 with the ratio of pharmacy agent:
0.01-0.3, described pharmacy agent is vascellum endometrial hyperplasia inhibitor, anticoagulant, immunosuppressant, anticarcinogen and cholesterol
One or more in depressant, wherein said vascellum endometrial hyperplasia inhibitor is sirolimus, everolimus, biolimus
One or more in A9, Zuo Tamosi (zotarolimus), tacrolimus (tacrolimus) and paclitaxel, are preferably west
Luo Mosi.
The preparation method of the support of the present invention, comprises the following steps:
(1) polymer being used for coating is dissolved in solvent, obtains the coating solution that mass concentration is 6-8mg/ml；
(2) coating solution in step (1) is at least coated in outer surface (contacted with blood vessel wall of core texture
Face)；Also inner surface can be coated in；The mode using spraying or dipping coats, and wherein the covering rate of core texture is 50-100%,
The thickness of coat is 1-25 μm, preferably 1-20 μm.
(3) core texture after coating is dried, decompression can be used, dry, add the one hankered or compound mode is carried out
It is dried, obtains described support.
Further, in step (1), described solvent is effumability solvent, preferably alkyl alcohol, methanol, ethanol, three
Fluoroethanol, hexafluoroisopropanol, acetone, oxolane, C < 6 alkyl ester solvents (such as ethyl, methylene diacetate, butyl vinegar
Acid), the alkyl ketone solvent (such as methyl ethyl ketone) of C < 6, C < 4 halogenation carbonization water element (such as protochloride methyl, chloroform, two chloroethenes
Alkane) in one or more.
Further, in step (1), described coating solution also includes pharmacy agent.Wherein, polymer and pharmacy agent
Ratio is 1:0.01-0.3, and described pharmacy agent includes vascellum endometrial hyperplasia inhibitor, anticoagulant, immunosuppressant, anticancer
One or more in agent and cholesterol reducing agent, wherein said vascellum endometrial hyperplasia inhibitor be sirolimus, everolimus,
One or more in biolimus A9, Zuo Tamosi (zotarolimus), tacrolimus (tacrolimus) and paclitaxel,
It is preferably sirolimus；If polymer and vascellum endometrial hyperplasia inhibitor being dissolved separately in solvent, utilize dual spraying process,
I.e. two nozzles are injected on core texture simultaneously.
Further, in step (2), described coating solution is from the beginning of wherein one end of core texture and in the same direction
It is coated.
The support of the application is stent for controlled drug release, can be closed loop support, it is also possible to be open loop type support, and right
The support of all designs is the most effective.
By such scheme, the present invention at least has the advantage that
The present invention is by being devoted to coating material and the painting method of support, it is provided that have and conventional metals support congruency
Can (mechanical characteristic) and the support of chronic inflammatory disease will not be caused；Outer surface is had be made up of biodegradability metal material
With in the cylindrical core structure of inner surface, along its long axis direction, all or subregion coating biodegradability are polymerized
Thing, makes support, thus reaches to control the purpose of biodegradability metal material degradation speed, and the support of the present invention is being implanted
After blood vessel, especially intra-arterial, the drastically degraded of the core texture of biodegradability metal material is suppressed, and radially props up
Support force also can maintain certain level, can be efficiently applied to coronary stent treatment, and simultaneously to cerebral arteries, renal artery, end
The treatment of tip arterial bracket is the most effective；Owing to the decomposition of biodegradability metal material can control at required speed, support
Radial direction support force also be able to maintain certain level；The thickness range of coat is 1-25 μm, especially can give play to support
Anti-corrosion effects；During coating, the direction playing right-hand member or the left end of core texture is coated, by this coating, it is possible to
The degradation speed of control core structure, therefore, support can will not cause violent inflammatory reaction while degraded；Dissolve poly-
The solvent of compound is lower alkyl ketone, lower alkyl esters, uses this solvent that polymer-coated layer can be made to form required thickness, from
And make biodegradability metal material support possess corrosion resistance；When coat contains sirolimus (the preferable feelings of high concentration
Under condition in the micro-polymer being scattered in coating of sirolimus) and coat THICKNESS CONTROL when 1-25 μm, it is possible to make Xi Luomo
Department was released within the desired time, the pharmacological effect (suppression of intimal thickening) of sirolimus after release, i.e. west
Luo Mosi can contain the generation of in-stent restenosis effectively.
Accompanying drawing explanation
Fig. 1 is the partial plan of core texture in the present invention；
Fig. 2 is the core texture schematic diagram being applied in the present invention；
The pass that Fig. 3 is each support in the present invention (coating PLGA) between the weight survival rate after FBS solution impregnation 10 days
System；
The pass that Fig. 4 is each support in the present invention (coating PLLA) between the weight survival rate after FBS solution impregnation 10 days
System；
Fig. 5 is each support relation between core texture radially support force after FBS solution impregnation 10 days in the present invention.
Detailed description of the invention
Below in conjunction with the accompanying drawings and embodiment, the detailed description of the invention of the present invention is described in further detail.Hereinafter implement
Example is used for illustrating the present invention, but is not limited to the scope of the present invention.Support used in embodiment is as shown in Figure 1: outer
Footpath=1.6mm, internal diameter=3mm after expansion, length 18mm, total surface area=0.80cm2.Additionally, select magnesium alloy as core
The material of structure, the weight/mass percentage composition of each component in magnesium alloy: magnesium 50-98%, Li 0-40%, Fe 0-5%, other metals
And cerium, lanthanum, neodymium, praseodymium 0-5% in rare earth element.The body thickness of the core texture after processing is 105 ± 5 μm, after coating
Core texture is as shown in Figure 2.
Embodiment 1: the support of preparation covering rate 100%
(1) with poly-(lactic acid-ethanol) (PLGA, molecular weight about 40000) dosage of every support 425 μ g, 1000 are weighed
The PLGA of support consumption, is dissolved in 55ml methanol, prepares coating liquid；
(2) rack body is placed in the plug position of jet printing type plater, utilizes nozzle, the speed divided with 0.02ml/
Degree injection coating liquid, the position of 9mm below nozzle, make rack body constantly do reciprocating rotary with the speed of 120 weeks per minute
Motion, after about 3 minutes, starts to central authorities from one end of rack body, is coated it；
(3) coating terminate latter 3 minutes in support row drying under reduced pressure after, more remaining half region is coated；
To completing the support row drying under reduced pressure of all coatings, it is dried 24 hours at 60 DEG C, solvent is fully erased, prepare covering rate
The support of 100%.
Embodiment 2: the support of preparation covering rate 100%
Being substantially the same with step in embodiment 1, its difference is: with polylactic acid (PLLA, the molecule of every support 425 μ g
Amount about 140000) dosage, weigh the PLLA of 1000 support consumptions, be dissolved in 55ml methanol, prepare coating liquid.
Embodiment 3: the support of preparation covering rate 80%
Being substantially the same with step in embodiment 1, its difference is: with poly-(lactic acid-ethanol) of every support 340 microgram
(PLGA, molecular weight about 40000) dosage, weighs the PLGA of 1000 support consumptions, is dissolved in 50ml ethanol, and adds Xi Luomo
Department prepares coating liquid, and wherein PLGA is 1:0.3 with the mass ratio of sirolimus；Table from one end of rack body, to 80%
Region, face is coated.
Embodiment 4: the support of preparation covering rate 80%
Being substantially the same with step in embodiment 1, its difference is: with the polylactic acid of every support 340 microgram, (PLLA divides
Son amount about 140000) dosage, weigh the PLLA of 1000 support consumptions, be dissolved in 50ml ethanol, and it is prepared to add sirolimus
Coating liquid, wherein PLLA is that 1:0.01 prepares coating liquid with the mass ratio of sirolimus；From one end of rack body, to 80%
Region, surface be coated.
Embodiment 5: the support of preparation covering rate 50%
Being substantially the same with step in embodiment 1, its difference is: with poly-(lactic acid-ethanol) of every support 210 microgram
(PLGA, molecular weight about 40000) dosage, weighs the PLGA of 1000 support consumptions, is dissolved in 30ml acetone, prepares coating liquid；
Start to central authorities from one end of rack body, the region, surface of 50% is coated.
Embodiment 6: the support of preparation covering rate 50%
Being substantially the same with step in embodiment 1, its difference is: with the polylactic acid of every support 210 microgram, (PLLA divides
Son amount about 140000) dosage, weigh the PLLA of 1000 support consumptions, be dissolved in 30ml acetone, prepare coating liquid；From support originally
One end of body starts to central authorities, is coated the region, surface of 50%.
Each support corrosion resistance is tested:
The support prepared in embodiment 1-6 is compared with non-coated support, each support drying under reduced pressure, ethylene oxide gas
(EOG) after sterilizing, each support is put into the most airtight glass container, add hyclone (FBS) solution all to support
In the solution, the shaking test carried out in 37 DEG C of thermostats 10 days by a definite date (utilizes Japan big and science Co., Ltd. is raw dipping
CO2 gas incubator IP400 produced carries out shaking test)；Then from FBS solution, take out support, remove with oxolane glutinous
Invest the polymer on support, remove the corrosion product being attached on support with chromic acid solution.Carry out gravimetry, and calculate
The weight of corrosion resistance test (FBS solution impregnation) front core texture and weight survival rate, result such as Fig. 3, form institute in 4
Show, respectively illustrate after PLGA core texture covering rate and FBS dipping the relation between core texture weight survival rate and PLLA
Relation between core texture weight survival rate after core texture covering rate and FBS dipping.
In Fig. 3, the magnesium alloy weight survival rate of unexpanded non-coated support is 86.1 ± 0.2%, and expanded is
84.4 ± 0.4%, accordingly, when the most having expanded or be unexpanded, test confirms the corrosion process of magnesium alloy in FBS solution
Carrying out；On the other hand, compared with non-coated membrane support, the support in embodiment 1,3,5 has a mind to inhibit the corrosion of magnesium alloy；
Additionally, test clear and definite the most expanded or the most unexpanded time, it is right to exist between PLGA covering rate and magnesium alloy weight survival rate
Should be related to.Therefore, this patent support is had the characteristic that, the weight survival rate of magnesium alloy subtracts along with the reduction of covering rate
Little；Relative, when covering rate increases, magnesium alloy weight survival rate increases the most therewith.
In Fig. 4, test confirms compared with non-coated support, and the support of PLLA covering rate 100% can suppress core intentionally
The corrosion of core structure, and this point be equally applicable to PLGA, i.e. test demonstrate can by covering rate control magnesium alloy corrosion
Speed.
The radial direction support force of each support measures: after removing the polymer being attached on support, measures the footpath of this patent support
To support force；Counteracting force when what radially support force represented is that support total surface area applies pressure；Due to only to support
When a part applies pressure, it is impossible to obtain the numerical value fixed, preferably tackle full surface and apply active force.Embodiment 1-6 will be made
The support obtained compares with non-coated support, has carried out radially support force and has measured, each support drying under reduced pressure, ethylene oxide gas
(EOG) after sterilizing, each support is put into the glass container of clean sealing, add FBS solution and be immersed in solution to support entirety
In, in 37 DEG C of thermostatic containers, carry out the shaking test of 10 days by a definite date；From FBS solution, fish for support, remove with oxolane
After the polymer being attached on support, carry out radially support force and measure.Wherein, before FBS solution impregnation core structure (non-coated is propped up
Frame) radial direction support force (initial value) be about 200kPa/mm.Test result as shown in form in Fig. 5, the radial direction of non-coated support
Support force is 172.5 ± 2.1kPa/mm, have dropped about 14% than initial value, and surface carries out institute along with Corrosion Behaviors of Magnesium Alloys process
The bad phenomenon produced；On the other hand, test confirms either PLGA or PLLA, and the support of covering rate 100% maintains
Initial radial direction support force；Additionally, test specify that either PLGA or PLLA, exist between covering rate and radially support force
Corresponding relation, and indicate the dependency between magnesium alloy weight survival rate and radial direction support force, therefore, can show that this patent props up
The degradation speed of the core texture of frame is under control, and radially support force is able to maintain that the conclusion at certain level.
The above is only the preferred embodiment of the present invention, is not limited to the present invention, it is noted that for this skill
For the those of ordinary skill in art field, on the premise of without departing from the technology of the present invention principle, it is also possible to make some improvement and
Modification, these improve and modification also should be regarded as protection scope of the present invention.
Claims (10)
1. a support, including constituting the metal material of core texture and being coated on the coat on described core texture surface,
It is characterized in that: described metal material is Biodegradable material, described coat is biodegradable coat.
Support the most according to claim 1, it is characterised in that: the coverage rate of the coat on described core texture surface is
50-100%.
Support the most according to claim 1, it is characterised in that: the thickness of described coat is 1-25 μm.
Support the most according to claim 1, it is characterised in that: described metal material is magnesium or magnesium alloy.
Support the most according to claim 1, it is characterised in that: described coat at least includes a kind of polymer.
Support the most according to claim 5, it is characterised in that: described polymer is selected from polylactic acid, poly-(lactic acid-glycolic
Acid), polyglycolic acid, polycaprolactone (PCL), poly-(lactic acid-6-caprolactone) and poly-(hydroxyacetic acid-ε-acid lactone).
Support the most according to claim 5, it is characterised in that: described coat also includes pharmacy agent.
8. the preparation method of a support as claimed in claim 1, it is characterised in that comprise the following steps:
(1) polymer being used for coating is dissolved in solvent, obtains coating solution；
(2) coating solution in step (1) is at least coated in the outer surface of core texture.
(3) core texture after coating is dried, obtains described support.
9. preparation method as claimed in claim 8, it is characterised in that: in step (1), described solvent is effumability solvent.
10. preparation method as claimed in claim 8, it is characterised in that: in step (1), described coating solution also includes pharmacy
With agent.
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| CN201610520157.6A CN106178139A (en) | 2016-07-05 | 2016-07-05 | A kind of support and preparation method thereof |
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| CN201610520157.6A CN106178139A (en) | 2016-07-05 | 2016-07-05 | A kind of support and preparation method thereof |
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| CN106178139A true CN106178139A (en) | 2016-12-07 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108498875A (en) * | 2018-04-24 | 2018-09-07 | 苏州脉悦医疗科技有限公司 | A kind of Bioabsorbable medical instrument and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20090048660A1 (en) * | 2007-08-17 | 2009-02-19 | Biotronik Vi Patent Ag | Implant of a biocorrodable magnesium alloy and having a coating of a biocorrodable polyphosphazene |
| CN102014978A (en) * | 2008-03-20 | 2011-04-13 | 麦德托尼克瓦斯科尔勒公司 | Controlled degradation of magnesium stents |
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| US20090048660A1 (en) * | 2007-08-17 | 2009-02-19 | Biotronik Vi Patent Ag | Implant of a biocorrodable magnesium alloy and having a coating of a biocorrodable polyphosphazene |
| CN102014978A (en) * | 2008-03-20 | 2011-04-13 | 麦德托尼克瓦斯科尔勒公司 | Controlled degradation of magnesium stents |
| CN103889475A (en) * | 2011-08-15 | 2014-06-25 | Meko激光材料加工公司 | Resorbable stents which contain a magnesium alloy |
| CN104644297A (en) * | 2015-02-16 | 2015-05-27 | 上海微创医疗器械（集团）有限公司 | Bioabsorbable stent and preparation method thereof |
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| CN108498875A (en) * | 2018-04-24 | 2018-09-07 | 苏州脉悦医疗科技有限公司 | A kind of Bioabsorbable medical instrument and preparation method thereof |
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