CN109914036A - The preparation method of puncture-resistant artificial blood vessel material and thus obtained artificial blood vessel - Google Patents
The preparation method of puncture-resistant artificial blood vessel material and thus obtained artificial blood vessel Download PDFInfo
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- CN109914036A CN109914036A CN201910040748.7A CN201910040748A CN109914036A CN 109914036 A CN109914036 A CN 109914036A CN 201910040748 A CN201910040748 A CN 201910040748A CN 109914036 A CN109914036 A CN 109914036A
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- blood vessel
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- D—TEXTILES; PAPER
- D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
- D04H—MAKING TEXTILE FABRICS, e.g. FROM FIBRES OR FILAMENTARY MATERIAL; FABRICS MADE BY SUCH PROCESSES OR APPARATUS, e.g. FELTS, NON-WOVEN FABRICS; COTTON-WOOL; WADDING ; NON-WOVEN FABRICS FROM STAPLE FIBRES, FILAMENTS OR YARNS, BONDED WITH AT LEAST ONE WEB-LIKE MATERIAL DURING THEIR CONSOLIDATION
- D04H1/00—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres
- D04H1/70—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres characterised by the method of forming fleeces or layers, e.g. reorientation of fibres
- D04H1/72—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres characterised by the method of forming fleeces or layers, e.g. reorientation of fibres the fibres being randomly arranged
- D04H1/728—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres characterised by the method of forming fleeces or layers, e.g. reorientation of fibres the fibres being randomly arranged by electro-spinning
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/26—Mixtures of macromolecular compounds
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/507—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial blood vessels
-
- D—TEXTILES; PAPER
- D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
- D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
- D01D5/00—Formation of filaments, threads, or the like
- D01D5/0007—Electro-spinning
- D01D5/0061—Electro-spinning characterised by the electro-spinning apparatus
- D01D5/0076—Electro-spinning characterised by the electro-spinning apparatus characterised by the collecting device, e.g. drum, wheel, endless belt, plate or grid
- D01D5/0084—Coating by electro-spinning, i.e. the electro-spun fibres are not removed from the collecting device but remain integral with it, e.g. coating of prostheses
Abstract
The invention discloses a kind of preparation method of puncture-resistant artificial blood vessel material and thus obtained artificial blood vessel, the effective material of the present inventor's hematopoiesis includes two layers: internal layer is the good electrostatic spinning layer of blood compatibility, and outer layer is the compacted zone of puncture-resistant blood seepage-proofing；It is tightly combined between two membranes, it is inseparable.The effective material of the artificial blood obtains by the following method: one or more polymer being dissolved in solvent, uniform polymer solution is obtained；Then polymer solution is spun on mandrel device, obtaining fiber film inner layer；Then EFI is carried out on internal layer directly after the drying, obtains fine and close outer layer.Artificial blood vessel provided by the present invention has excellent biocompatibility, blood compatibility and flexibility, has the function of blood seepage-proofing and resistance to punctures repeatedly；Method provided by the present invention has the characteristics that easy to operate, simple production process and is easy to scale.
Description
Technical field
The present invention relates to medical material tech fields；In particular it relates to a kind of preparation of puncture-resistant artificial blood vessel material
Method and thus obtained artificial blood vessel.
Background technique
With the eutrophication of social development and people's dietary structure, cardiovascular disease, which has become, endangers human health
First killer.The number that cardiovascular and cerebrovascular disease is died of in the whole world every year is up to 15,000,000 people, and it is the first to occupy the various causes of the death.Blood vessel disease
What disease was often used at present is the treatment means of vasotransplantation, but since autologous vein source is very limited, clinically needs
Want a large amount of artificial blood vessel as graft substitute.Artificial blood vessel on the market is mostly imported product at present, at high price and property
Performance needed for ideal blood vessel capable of being reached far away.Clinical application Rend dialysis case is more, and mainstream solution is autologous vein and gathers
Tetrafluoroethene artificial blood vessel.But the puncture repeatedly of autologous vein easily leads to injury of blood vessel and difficult life, and polytetrafluoroethylene (PTFE) people
Thrombus easy to form after Vascular implantation is made, and polytetrafluoroethylene vascular prosthesis's hole after puncturing is larger is easy to produce oozing of blood.
Therefore, in the development process of small-caliber vascular, with greater need for solving, long-term patency rates, blood seepage-proofing and puncture resistance etc. are many to be asked
Topic.The polyurethane artificial blood vessel puncture-resistant and blood seepage-proofing performance occurred on the market at present is undesirable, the power after repeatedly puncturing
It is obvious to learn the larger and oozing of blood of performance decline.Wherein also there is multi-layer fiber composite vascular, but since there are biggish gaps between fiber
Blood is caused to ooze out from fibre gap, even three layers of fibre structure can not effectively reach the requirement of clinically blood seepage-proofing,
It can not meet the demand clinically punctured repeatedly；Thus, in order to obtain the artificial blood vessel haveing excellent performance, it is necessary to which blood vessel is carried out
Reasonable material simultaneously optimizes regulation to structure.
Summary of the invention
The defect when main object of the present invention is to overcome above-mentioned artificial blood vessel existing in the prior art to apply, mentions
Preparation method and thus obtained artificial blood vessel for a kind of puncture-resistant artificial blood vessel material, artificial blood vessel prepared by the present invention
With excellent blood compatibility, while there is blood seepage-proofing and puncture resistance, can be effectively used in vascular diseases treatment, especially
It is suitable for the treatment of small-caliber vascular.
To achieve the goals above, in the embodiment on basis, one aspect of the present invention provides a kind of puncture-resistant artificial blood
The preparation method of effective material, includes the following steps:
S1: dissolving a polymer in solvent, and obtaining concentration is the polymer solution that w/v is 10~70%, it is stirred at room temperature 5~
48 hours；
S2: the obtained polymer solution of step S1 is placed on mandrel device, is carried out electrostatic spinning, is obtained porous electrostatic
Spinning fibre internal layer, dry 5-48h, removes residual solvent；
S3: the internal layer that step S2 is obtained carries out first time EFI, second of electricity as receiving plane, using polymer solution
Spray ... .. n-th EFI obtains dense outer layer, forms artificial blood vessel material described in puncture-resistant；Wherein, the first time electricity
It include EFI, stopping, EFI, stopping ... .. more times circulations during spray.
In a preferred embodiment, in step S1, the polymer is selected from polycaprolactone (PCL), polyurethane
(PU) and one of polylactide (PLA) or a variety of；The solvent is selected from n,N-Dimethylformamide (DMF), N, N- diformazan
Yl acetamide (DMAC), acetone, tetrahydrofuran (THF), one of hexafluoroisopropanol (HFIP) or a variety of；
Preferably, the weight average molecular weight of the polycaprolactone, polylactide and polyurethane is 10,000~1,000,000；
It is highly preferred that the weight average molecular weight of the polycaprolactone is 60,000~300,000, the polylactide is divided equally again
Son amount is 50,000~500,000；The weight average molecular weight of the polyurethane is 100,000~600,000.
In a preferred embodiment, in step S1, in the polymer solution polycaprolactone account for≤
20wt%, polylactide account for≤20wt%, and polyurethane accounts for 60wt%~100wt%.
In a preferred embodiment, in step S2, the electrostatic spinning includes: to inject the polymer solution
In syringe, adjusting the distance between spinning head and mandrel reception device is 5~25cm；The environment temperature of spinning is 20~70
DEG C, 20~60%RH of ambient humidity adjusts voltage to 8~40kV, and the delivery rate of solution is 0.5~5mL/h, and roller revolving speed is
10~1000rad/min carries out spinning.
In a preferred embodiment, in step S2, the spinning time is 5-20h.
In a preferred embodiment, in step S3, the polymer solution that when EFI uses is selected from polycaprolactone, poly-
One or both of urethane.
In a preferred embodiment, in step S3, dwell time is 5-20min, institute in the first time spraying
The time for stating spraying for the first time, second of spraying and n-th spraying is 5-50min.
In a preferred embodiment, in step S3, value >=3 n of the n-th spraying.
In a preferred embodiment, in step S3, the n value of the n-th spraying is 3-8.Even high concentration
Spinning solution still contains a large amount of solvent, and single short time EFI micro can control the amount of solution for being attached to fiber surface.But it is single
Solute contained by secondary EFI is not enough to completely be covered on fiber surface and forms certain thickness dense film, so needing interval weight
It is multiple multiple, the solvent of EFI solution can be made to have enough time volatilization while achieving the purpose that completely to cover.
In a preferred embodiment, in step S3, the first time spraying, second of spraying and n-th spraying
The polymer concentration being respectively adopted successively increases.Solubility range must be in the range that electric jet technology is subjected to, can be by electric field
Traction sprays solution.In addition, the solution of the higher low concentration of mobility is carried out multiple EFI first, EFI liquid and fiber can be allowed
Closed seamless contact；High concentration can reduce solvent attachment while reach certain thickness cause within the lower time after EFI is dry
Close film.
Preferably, the polymer concentration that the first time spraying, second of spraying and n-th spraying use is respectively 15-
35%, 18-40% and 20-60%.
In a preferred embodiment, in step S3, the first time spraying, second of spraying and n-th spraying
Include:
Delivery rate is 0.1-5mL/h, and roller revolving speed is 50-1000rad/min；
It is highly preferred that environment temperature is 10-50 DEG C, ambient humidity 10-60%RH, voltage 5-30kV.
It is a further object to provide artificial blood vessels made from above-mentioned preparation method, comprising: electrospun fibers
Internal layer and EFI dense outer layer.
In a preferred embodiment, the fiber internal layer is with a thickness of 1 μm~1000 μm, fibre diameter 50nm
~5000nm, dense outer layer is with a thickness of 1 μm~1000 μm；
Preferably, for the fiber internal layer with a thickness of 5 μm~700 μm, fibre diameter is 50nm~3000nm, dense outer layer
With a thickness of 5 μm~700 μm；
It is highly preferred that the fiber internal layer is with a thickness of 50 μm~450 μm, fibre diameter is 800nm~3000nm, is caused
Close outer layer thickness is 10 μm~300 μm.
The present invention also provides the application of puncture-resistant artificial blood vessel made from above-mentioned preparation method, the artificial blood vessel is used for
In body vessel transfer operation or bypass surgery.
Through the above technical solutions, the effective material of the present inventor's hematopoiesis includes two layers: internal layer is good quiet of blood compatibility
Electro-spun layer, outer layer are the compacted zone of puncture-resistant blood seepage-proofing；It is tightly combined between two membranes, it is inseparable.The artificial blood is effective
Material obtains by the following method: one or more polymer being dissolved in solvent, uniform polymer solution is obtained；Then
Polymer solution is spun on mandrel device, obtaining fiber film inner layer；Then EFI is carried out on internal layer directly after the drying, obtained
Obtain fine and close outer layer.Artificial blood vessel provided by the present invention has excellent biocompatibility, blood compatibility and flexibility, tool
There are blood seepage-proofing and the resistance to function of puncturing repeatedly；Method provided by the present invention has easy to operate, simple production process and is easy to
The features such as scale.
Detailed description of the invention
Fig. 1 is the fiber morphology SEM schematic diagram of the electrostatic spinning internal layer for the artificial blood vessel that the embodiment of the present invention 1 obtains, figure
2a is the SEM schematic diagram for the artificial blood vessel that the embodiment of the present invention 1 obtains.
Fig. 2 b is the section partial enlargement diagram in Fig. 2 a at A.
Fig. 3 is strength test instrument figure after puncturing repeatedly.
Fig. 4 is the leakage test equipment figure of water.
Fig. 5 is intensity experiment Comparative result schematic diagram after three kinds of artificial blood vessels puncture repeatedly.
Fig. 6 is that 1 composite vascular prosthesis of the embodiment of the present invention repeatedly illustrate with the variation of outer layer dense layer thickness by puncture resistance
Figure.
Fig. 7 is that three kinds of artificial blood vessel water penetrations measure examination experimental result contrast schematic diagram.
Specific embodiment
In order to better understand the above technical scheme, being done below by specific embodiment to technical scheme detailed
Explanation, it should be understood that the specific features in the embodiment of the present application and embodiment be to technical scheme specifically
It is bright, rather than the restriction to technical scheme, in the absence of conflict, the skill in the embodiment of the present application and embodiment
Art feature can be combined with each other.It should be understood that term "and/or" used herein above includes listed by one of them or more
Any and all combinations of associated item out.
The endpoint of disclosed range and any value are not limited to the accurate range or value herein, these ranges or
Value should be understood as comprising the value close to these ranges or value.For numberical range, between the endpoint value of each range, respectively
It can be combined with each other between the endpoint value of a range and individual point value, and individually between point value and obtain one or more
New numberical range, these numberical ranges should be considered as specific open herein.
The artificial blood vessel that electrostatic spinning technique prepares multi-ply fibrous structure is attempted to use in the prior art.But due between fiber
And there is biggish gap between layers causes blood that can make to remove between layers after oozing out in fibre gap,
Clinically there is false aneurysm.Also some reach certain by reducing porosity for the artificial blood vessel of artificial arteriovenous fistula
Antiseep purpose, but in structure, which does not have blood seepage-proofing function and does not have the vascular wall of sufficient intensity.
Mechanical property after puncturing repeatedly is not still able to satisfy long-acting application demand clinically.
Therefore, it applicants have found that, in order to obtain the artificial blood vessel haveing excellent performance, needs rationally to select blood vessel
Material simultaneously optimizes regulation to structure.Electrostatic spinning technique be one it is easy to operate and can to material structure carry out finely regulating
Technology, regulation scale can be from nanometer to micron order, and can get the structure of class cytoskeleton matrix.Thus, using electrostatic spinning
Technology prepares the endothecium structure of composite vascular prosthesis of the embodiment of the present invention, can get and promotees the microstructure that endangium generates, from
And obtain long-term patency rates；Electrostatic spinning technique bring blood vessel unique texture remains to vascular wall after repeatedly puncturing simultaneously
Keep good mechanical property.EFI is to assemble in fiber surface, therefore can make to contact the fiber fusion in EFI layer in fibrous layer
Achieve the effect that be in close contact with inner fiber.Utilize the micro hydrojet of electric jet technology and the spy of the low solvent content of highly concentrated solution
Point enables the solution for being sprayed on inner fiber and only merges the fiber of internal layer most surface enough but cannot continue to merge internal layer deep layer
Fiber.Preliminary micro- infiltration layer is formed after EFI liquid is dry, micro- infiltration layer has been substantially reduced compared with the porosity of inner fiber at this time；So
Micro hydrojet is repeated afterwards to gradually reduce the porosity of micro- infiltration layer until elimination hole, then is increased spouting liquid and completed outside EFI densification
The structure of layer.Composite vascular prosthesis is obtained with this.In addition, can also be obtained by the rate of volatilization of solvent in control polymer solution
Obtain compound close spinning internal layer and dense outer layer structure.Dense outer layer and spinning endothecium structure can provide required for artificial blood vessel
Blood seepage-proofing and the resistance to performance punctured repeatedly.
Below with reference to the drawings and specific embodiments, the present invention will be described in detail.Material used in embodiment can lead to
Commercially available channel is crossed to obtain.
Embodiment 1
(1) preparation of solution: PCL (weight average molecular weight 100,000) and PU (weight average molecular weight 120,000) are dissolved in HFIP,
Wherein weight ratio PCL:PU=10:90,40 DEG C of heating water baths stir 12 hours, and it is molten to obtain the polymer that concentration is 10%w/v
Liquid, it is spare for Electrospun；PU (weight average molecular weight 150,000) is dissolved in N, N-dimethylformamide (DMF) and acetone (volume ratio
For in the mixed solvent 5/5), 40 DEG C of heating water baths are stirred 12 hours, obtain the EFI solution that concentration is 15,18,22%w/v,
It is spare for EFI.
(2) electrostatic spinning: (1) is obtained in the syringe of solution injection 10mL, in addition 21G stainless steel syringe needle.It adjusts
The distance between spinning head and roller are 15cm；The environment temperature of spinning be 40 DEG C, ambient humidity 40%RH, adjust voltage to
30kV, roller revolving speed are 100rad/min, and the delivery rate of solution is 1mL/h, and spinning 8h obtains the electrostatic spinning of composite vascular
Endothecium structure.
(3) tunica fibrosa for obtaining step (2) is 12 hours dry, removes excessive residual solvent.
(4) a) adjusting polymer solution concentration is 15% (w/v), delivery rate 3.0mL/h, roller revolving speed is
50rad/min, environment temperature are 50 DEG C, ambient humidity 50%RH, voltage 30kV, stop 20min after carrying out EFI 30min.To
Micro EFI liquid adheres in internal layer fiber surface and is merged with fiber, reduces fiber layer porosity.
B) stopping 20min after EFI 30min makes EFI liquid and fiber are secondary to merge and be further reduced porosity.
C) adjusting concentration is 18% (w/v), and delivery rate 4mL/h, roller revolving speed is 50rad/min, EFI 10min
It eliminates porosity and forms relatively thin fine and close EFI film.
D) adjusting concentration is 22% (w/v), and delivery rate 0.1mL/h, roller revolving speed is 80rad/min, EFI
30min makes EFI liquid form certain thickness dense outer layer in relatively thin fine and close EFI film surface aggregation, drying.
Fig. 1 is the fiber morphology SEM schematic diagram of the electrostatic spinning internal layer for the artificial blood vessel that the embodiment of the present invention 1 obtains.Figure
2a be the embodiment of the present invention 1 obtain composite vascular prosthesis SEM schematic diagram, through measuring, electrospun fibers internal layer with a thickness of
450 μm, fibre diameter 800nm, dense outer layer is with a thickness of 300 μm.Fig. 2 b is the section partial enlargement signal in Fig. 2 a at A
Figure.
Embodiment 2
(1) preparation of solution: PLA (weight average molecular weight 150,000) and PU (weight average molecular weight 120,000) are dissolved in HFIP,
Wherein weight ratio PLA:PU=5:95,40 DEG C of heating water baths stir 12 hours, obtain the electrospun solution that concentration is 15%w/v, use
It is spare in Electrospun；PU (weight average molecular weight 200,000) is dissolved in N, N-dimethylformamide (DMF) and acetone (volume ratio 6/4)
In the mixed solvent, 40 DEG C of heating water baths stir 12 hours, obtain the EFI solution that concentration is 35,40%w/v, standby for EFI
With.
(2) electrostatic spinning: (1) is obtained in the syringe of solution injection 10mL, in addition 21G stainless steel syringe needle.It adjusts
The distance between spinning head and roller are 15cm；The environment temperature of spinning be 45 DEG C, ambient humidity 40%RH, adjust voltage to
25kV, roller revolving speed are 100rad/min, and the delivery rate of solution is 1mL/h, and spinning 10h obtains the Static Spinning of composite vascular
Silk endothecium structure.
(3) tunica fibrosa for obtaining step (2) is 12 hours dry, removes excessive residual solvent.
(4) a) adjusting solution concentration be 35% (w/v), delivery rate 0.2mL/h, roller revolving speed be 800rad/min,
Environment temperature is 10 DEG C, ambient humidity 20%RH, voltage 5kV, stops 10min after carrying out EFI 15min.To micro EFI
Liquid adheres in internal layer fiber surface and is merged with fiber, reduces fiber layer porosity.
B) stopping 10min after EFI 15min makes EFI liquid and fiber are secondary to merge and be further reduced porosity.
C) adjusting concentration is 35% (w/v), and delivery rate 0.1mL/h, roller revolving speed is 300rad/min, EFI 5min
It eliminates porosity and forms relatively thin fine and close EFI film.
D) adjusting concentration is 40% (w/v), and delivery rate 1.5mL/h, roller revolving speed is 600rad/min, EFI
20min makes EFI liquid form certain thickness dense outer layer in relatively thin fine and close EFI film surface aggregation, drying.
Wherein, the fiber internal layer is with a thickness of 50 μm, and fibre diameter 3000nm, dense outer layer is with a thickness of 10 μm.
Embodiment 3
(1) preparation of solution: by PLA (weight average molecular weight 150,000), PCL (weight average molecular weight 120,000) and PU (Weight-average molecular
It measures 15 ten thousand) to be dissolved in HFIP, wherein weight ratio PLA:PCL:PU=5:5:90,40 DEG C of heating water baths stir 10 hours, obtain
Concentration is the electrospun solution of 15%w/v, spare for Electrospun；PU (weight average molecular weight 200,000) is dissolved in N, N dimethyl formyl
The in the mixed solvent of amine (DMF) and acetone (volume ratio 6/4), 40 DEG C of heating water baths stir 10 hours, obtain concentration be 35,
40, the EFI solution of 50%w/v, it is spare for EFI.
(2) electrostatic spinning: (1) is obtained in the syringe of solution injection 10mL, in addition 21G stainless steel syringe needle.It adjusts
The distance between spinning head and roller are 15cm；The environment temperature of spinning be 40 DEG C, ambient humidity 40%RH, adjust voltage to
30kV, roller revolving speed are 150rad/min, and the delivery rate of solution is 1mL/h, and spinning 10h obtains the Static Spinning of composite vascular
Silk endothecium structure.
(3) tunica fibrosa for obtaining step (2) is 12 hours dry, removes excessive residual solvent.
(4) a) is adjusted solution concentration is 35% (w/v), and delivery rate 3.5mL/h, roller revolving speed is 1000rad/
Min, environment temperature are 20 DEG C, ambient humidity 10%RH, voltage 5kV, stop 5min after carrying out EFI 20min.To micro electricity
Hydrojet is adhered in internal layer fiber surface and is merged with fiber, and fiber layer porosity is reduced.
B) stopping 5min after EFI 20min makes EFI liquid and fiber are secondary to merge and be further reduced porosity.
C) adjusting concentration is 40% (w/v), and delivery rate 2.8mL/h, roller revolving speed is 80rad/min, EFI 10min
It eliminates porosity and forms relatively thin fine and close EFI film.
D) adjusting concentration is 50% (w/v), and delivery rate 1.2mL/h, roller revolving speed is 200rad/min, EFI
30min makes EFI liquid form certain thickness dense outer layer in relatively thin fine and close EFI film surface aggregation, drying.
Through measuring, electrospun fibers internal layer is with a thickness of 100 μm, and fibre diameter 2000nm, dense outer layer is with a thickness of 80 μ
m。
Embodiment 4
(1) PU (weight average molecular weight 150,000) preparation of solution: is dissolved in N, N dimethyl acetamide (DMAC) and acetone
The in the mixed solvent of (volume ratio 5/5), 40 DEG C of heating water baths stir 12 hours, and it is molten to obtain the electrospinning that concentration is 12%w/v
Liquid, it is spare for Electrospun；PU (weight average molecular weight 150,000) is dissolved in N, N dimethyl acetamide (DMAC) and acetone (volume ratio
For in the mixed solvent 5/5), 35 DEG C of heating water baths are stirred 12 hours, obtain the electrospun solution that concentration is 25,35,50%w/v,
It is spare for EFI.
(2) electrostatic spinning: (1) is obtained in the syringe of solution injection 10mL, in addition 21G stainless steel syringe needle.It adjusts
The distance between spinning head and roller are 18cm；The environment temperature of spinning be 45 DEG C, ambient humidity 35%RH, adjust voltage to
25kV, roller revolving speed are 150rad/min, and the delivery rate of solution is 1mL/h, and spinning 8h obtains the Static Spinning of composite vascular
Silk endothecium structure.
(3) tunica fibrosa for obtaining step (2) is 12 hours dry, removes excessive residual solvent.
(4) a) adjusting solution concentration be 25% (w/v), delivery rate 0.2mL/h, roller revolving speed be 60rad/min, ring
Border temperature is 30 DEG C, ambient humidity 10%RH, voltage 30kV, stops 10min after carrying out EFI 15min.To micro EFI liquid
Adhere in internal layer fiber surface and merged with fiber, reduces fiber layer porosity.
B) stopping 10min after EFI 15min makes EFI liquid and fiber are secondary to merge and be further reduced porosity.
C) adjusting concentration is 35% (w/v), and delivery rate 1.8mL/h, roller revolving speed is 150rad/min, EFI
20min eliminates porosity and forms relatively thin fine and close EFI film.
D) adjusting concentration is 50% (w/v), and delivery rate 0.5mL/h, roller revolving speed is 700rad/min, EFI
30min makes EFI liquid form certain thickness dense outer layer in relatively thin fine and close EFI film surface aggregation, drying.
Through measuring, electrospun fibers internal layer is with a thickness of 200 μm, and fibre diameter 1000nm, dense outer layer is with a thickness of 100
μm。
Embodiment 5
(1) PLA (weight average molecular weight 200,000) and PU (weight average molecular weight 150,000) preparation of solution: are dissolved in N, N diformazan
The in the mixed solvent of yl acetamide (DMAC) and acetone (volume ratio 5/5), wherein weight ratio PLA:PU=5:95,40 DEG C of water
Bath heating stirring 12 hours obtains the electrospun solution that concentration is 12%w/v, spare for Electrospun；By PU (weight average molecular weight 12
Ten thousand) it is dissolved in N, the in the mixed solvent of N dimethyl acetamide (DMAC) and acetone (volume ratio 6/4), 35 degree of heating water bath stirrings
12 hours, the EFI solution that concentration is 30,40,60%%w/v is obtained, it is spare for EFI.
(2) electrostatic spinning: (1) is obtained in the syringe of solution injection 10mL, in addition 21G stainless steel syringe needle.It adjusts
The distance between spinning head and roller are 12cm；The environment temperature of spinning be 45 DEG C, ambient humidity 35%RH, adjust voltage to
30kV, roller revolving speed are 150rad/min, and the delivery rate of solution is 1mL/h, and spinning 8h obtains the Static Spinning of composite vascular
Silk endothecium structure.
(3) tunica fibrosa for obtaining step (2) is 12 hours dry, removes excessive residual solvent.
(4) a) adjusting solution concentration be 30% (w/v), delivery rate 0.5mL/h, roller revolving speed be 1000rad/
Min, environment temperature are 30 DEG C, ambient humidity 30%RH, voltage 10kV, stop 10min after carrying out EFI 5min.To micro
EFI liquid adheres in internal layer fiber surface and is merged with fiber, reduces fiber layer porosity.
B) stopping 10min after EFI 10min makes EFI liquid and fiber are secondary to merge and be further reduced porosity.
C) adjusting concentration is 40% (w/v), and delivery rate 3.8mL/h, roller revolving speed is 550rad/min, EFI 5min
It eliminates porosity and forms relatively thin fine and close EFI film.
D) adjusting concentration is 60% (w/v), and delivery rate 4.5mL/h, roller revolving speed is 800rad/min, EFI 5min
EFI liquid is set to form certain thickness dense outer layer in relatively thin fine and close EFI film surface aggregation, drying.
Through measuring, electrospun fibers internal layer is with a thickness of 50 μm, and electrospun fibers outer layer thickness is 50 μm, fibre diameter
For 1500nm, dense outer layer is with a thickness of 50 μm.
Embodiment 6
(1) PLA (weight average molecular weight 500,000) and PU (weight average molecular weight 600,000) preparation of solution: are dissolved in N, N diformazan
The in the mixed solvent of yl acetamide (DMAC) and acetone (volume ratio 5/5), wherein weight ratio PLA:PU=10:85,40 DEG C of water
Bath heating stirring 12 hours obtains the electrospun solution that concentration is 30% (w/v), spare for Electrospun；By PU (weight average molecular weight
Ten thousand) 50 are dissolved in N, the in the mixed solvent of N dimethyl acetamide (DMAC) and acetone (volume ratio 6/4), 35 DEG C of heating water baths stir
It mixes 12 hours, obtains the EFI solution that concentration is 50,20,35% (w/v), it is spare for EFI.
(2) electrostatic spinning: in the syringe for the electrospun solution injection 10mL that (1) is obtained, in addition 21G stainless pin
Head.Adjusting the distance between spinning head and roller is 5cm；The environment temperature of spinning is 70 DEG C, ambient humidity 60%RH, adjusts electricity
It is depressed into 40kV, roller revolving speed is 1000rad/min, and the delivery rate of solution is 5.0mL/h, and spinning 30h obtains composite vascular
Electrostatic spinning endothecium structure.
(3) tunica fibrosa for obtaining step (2) is 12 hours dry, removes excessive residual solvent.
(4) a) adjusting solution concentration be 50% (w/v), delivery rate 2.5mL/h, roller revolving speed be 800rad/min,
Environment temperature is 30 DEG C, ambient humidity 30%RH, voltage 10kV, stops 20min after carrying out EFI 40min.To micro EFI
Liquid adheres in internal layer fiber surface and is merged with fiber, reduces fiber layer porosity.
B) stopping 15min after EFI 40min makes EFI liquid and fiber are secondary to merge and be further reduced porosity.
C) adjusting concentration is 20% (w/v), and delivery rate 0.5mL/h, roller revolving speed is 100rad/min, EFI
25min eliminates porosity and forms relatively thin fine and close EFI film.
D) adjusting concentration is 35% (w/v), and delivery rate 5.0mL/h, roller revolving speed is 1000rad/min, EFI
20min makes EFI liquid form certain thickness dense outer layer in relatively thin fine and close EFI film surface aggregation, drying.
Through measuring, electrospun fibers internal layer is with a thickness of 200 μm, and electrospun fibers outer layer thickness is 300 μm, and fiber is straight
Diameter is 800nm, and dense outer layer is with a thickness of 120 μm.
Embodiment 7
(1) preparation of solution: by PLA (weight average molecular weight 50,000), PCL (weight average molecular weight 60,000) and PU (weight average molecular weight
Ten thousand) 10 are dissolved in HFIP, wherein weight ratio PLA:PCL:PU=5:10:85, and 40 DEG C of heating water baths stir 10 hours, obtain dense
Degree is the electrospun solution of 12% (w/v), spare for Electrospun；PU (weight average molecular weight 100,000) is dissolved in N, N dimethyl formyl
The in the mixed solvent of amine (DMF) and acetone (volume ratio 6/4), 40 DEG C of heating water baths stir 10 hours, obtain concentration be 35,
40, the electrospun solution of 50% (w/v), it is spare for EFI.
(2) electrostatic spinning: in the syringe for the electrospun solution injection 10mL that (1) is obtained, in addition 21G stainless pin
Head.Adjusting the distance between spinning head and roller is 25cm；The environment temperature of spinning is 20 DEG C, ambient humidity 20%RH, is adjusted
Voltage is to 8kV, and roller revolving speed is 10rad/min, and the delivery rate of solution is 0.5mL/h, and spinning 8h obtains the quiet of composite vascular
Electrospun endothecium structure.
(3) tunica fibrosa for obtaining step (2) is 12 hours dry, removes excessive residual solvent.
(4) a) adjusting solution concentration be 35% (w/v), delivery rate 5mL/h, roller revolving speed be 1000rad/min,
Environment temperature is 20 DEG C, ambient humidity 10%RH, voltage 5kV, stops 5min after carrying out EFI 20min.To micro EFI liquid
Adhere in internal layer fiber surface and merged with fiber, reduces fiber layer porosity.
B) stopping 5min after EFI 20min makes EFI liquid and fiber are secondary to merge and be further reduced porosity.
C) adjusting concentration is 40% (w/v), and delivery rate 2.8mL/h, roller revolving speed is 80rad/min, EFI 10min
It eliminates porosity and forms relatively thin fine and close EFI film.
D) adjusting concentration is 50% (w/v), and delivery rate 1.2mL/h, roller revolving speed is 200rad/min, EFI
30min makes EFI liquid form certain thickness dense outer layer in relatively thin fine and close EFI film surface aggregation, drying.
Through measuring, electrospun fibers internal layer is with a thickness of 100 μm, and electrospun fibers outer layer thickness is 50 μm, and fiber is straight
Diameter is 1800nm, and dense outer layer is with a thickness of 10 μm.
Composite vascular prosthesis, Nicast AVflo artificial blood vessel and single layer electrostatic spinning prepared by the embodiment of the present invention 1
Artificial blood vessel carries out the strength detection after puncturing repeatedly and the leakage measurement of water simultaneously.Strength test (instrument after puncturing repeatedly
See attached drawing 3) it is equal according to " People's Republic of China (PRC) pharmaceuticals industry standard YY-0500- with the leakage test (instrument is shown in attached drawing 4) of water
2004 " test and result characterization are carried out.
Strength test process after puncturing repeatedly is as follows: the test specimens of a bit of 1.6cm are intercepted from artificial blood vessel's sample
This, is accurate to scholar 0.5mm in millimeters.The outer surface of sample it is every square centimeter it is upper carry out 0,8,16 and 24 time puncture,
Puncture process should be limited in blood vessel circumference one third.Re-test hoop strength after sample is punctured repeatedly.Every kind of blood vessel is equal
3 groups are taken, every group of each 4 sample, experimental data is recorded with average value and saved.Strength test experimental result table after puncturing repeatedly
Bright: composite vascular prosthesis of the embodiment of the present invention initial radial intensity (0.0753kN/mm) that is averaged is better than Nicast artificial blood vessel
Mean intensity (0.0361kN/mm) and single layer electrostatic spinning artificial blood vessel mean intensity (0.02968kN/mm).It is punctured repeatedly
Afterwards, the average radial intensity (0.0637kN/mm) of composite vascular prosthesis is much stronger than Nicast artificial blood vessel mean intensity
(0.0294kN/mm) and single layer electrostatic spinning artificial blood vessel mean intensity (0.0204kN/mm) (see attached drawing 5).And composite artificial
Performance after the puncture repeatedly of blood vessel is reinforced as the thickness of outer layer compacted zone increases (see attached drawing 6).
The test process of water permeability is as follows: at room temperature, taking effective length 14cm artificial blood vessel sample, in millimeters
It is accurate to scholar 0.5mm.It selects 16G puncture needle with the puncture of the interval 0.5cm, carries out respectively 0,8,16 and 24 time after puncturing suitable
Under 16 kPas of hydrostatic pressing, survey in the unit time through the water seepage discharge on sample unit's area.Every kind of blood vessel takes 3 groups,
Every group of each 4 sample, experimental data are recorded with average value and are saved.The leakage test experiments of water the result shows that: through puncture after
The water penetration amount of artificial blood vessel is risen.But in identical puncture time, composite vascular prosthesis of the embodiment of the present invention
Puncture after water penetration amount lower than Nicast artificial blood vessel water penetration amount and be far below single layer electrostatic spinning fiber artificial blood vessel water
Infiltration capacity (see attached drawing 7).The results show composite vascular prosthesis puncture resistance of the present invention and blood seepage-proofing function admirable.
The preferred embodiment of the present invention has been described above in detail, and still, the present invention is not limited thereto.In skill of the invention
In art conception range, can with various simple variants of the technical solution of the present invention are made, including each technical characteristic with it is any its
Its suitable method is combined, and it should also be regarded as the disclosure of the present invention for these simple variants and combination, is belonged to
Protection scope of the present invention.
Claims (10)
1. a kind of preparation method of puncture-resistant artificial blood vessel material, characterized by the following steps:
S1: dissolving a polymer in solvent, and obtaining concentration is the polymer solution that w/v is 10~70%；
S2: the obtained polymer solution of step S1 is placed on mandrel device, is carried out electrostatic spinning, is obtained porous electrostatic spinning
Fiber internal layer, it is dry, remove residual solvent；
S3: the internal layer that step S2 is obtained carries out first time EFI, second of electricity as receiving plane, using polymer solution
Spray ... .. n-th EFI obtains dense outer layer, forms artificial blood vessel described in puncture-resistant；Wherein, the first time EFI process
In include EFI, stopping, EFI, stopping ... .. more times circulation.
2. the preparation method of puncture-resistant artificial blood vessel material according to claim 1, it is characterised in that: in step S1, institute
The polymer stated is selected from one of polycaprolactone, polyurethane and polylactide or a variety of；The solvent is selected from N, N- dimethyl
Formamide, n,N-dimethylacetamide, acetone, tetrahydrofuran, one of hexafluoroisopropanol or a variety of；
The weight average molecular weight of the polycaprolactone, polylactide and polyurethane is 10,000~1,000,000；
Preferably, the weight average molecular weight of the polycaprolactone is 60,000~300,000, and the weight average molecular weight of the polylactide is
50000~500,000；The weight average molecular weight of the polyurethane is 100,000~600,000.
3. the preparation method of puncture-resistant artificial blood vessel material according to claim 1 or claim 2, it is characterised in that: in step S1,
Polycaprolactone≤20wt% in the polymer solution, polylactide account for≤20wt%, polyurethane account for 60wt%~
100wt%.
4. the preparation method of puncture-resistant artificial blood vessel material according to claim 1, it is characterised in that: in step S2, institute
Stating electrostatic spinning includes: to inject the polymer solution in syringe, adjust between spinning head and mandrel reception device away from
From for 5~25cm；The environment temperature of spinning is 20~70 DEG C, 20~60%RH of ambient humidity, and adjusting voltage is molten to 8~40kV
The delivery rate of liquid is 0.5~5mL/h, and roller revolving speed is 10~1000rad/min, carries out spinning.
5. the preparation method of puncture-resistant artificial blood vessel material according to claim 1, it is characterised in that: in step S3, electricity
The polymer solution used when spray is selected from one or both of polycaprolactone, polyurethane.
6. the preparation method of puncture-resistant artificial blood vessel material according to claim 1, it is characterised in that: in step S3, institute
Stating dwell time in spraying for the first time is 5-20min, and the time of first time spraying, second of spraying and n-th spraying is
5-50min。
7. the preparation method of puncture-resistant artificial blood vessel material according to claim 1, it is characterised in that: in step S3, institute
State value >=3 n of n-th spraying；
Preferably, in step S3, the n value of the n-th spraying is 3-8.
8. the preparation method of puncture-resistant artificial blood vessel material according to claim 1, it is characterised in that: in step S3, institute
Stating spraying for the first time, second of spraying and n-th spraying includes:
Delivery rate is 0.1-5mL/h, and roller revolving speed is 50-1000rad/min；
Environment temperature is 10-50 DEG C, ambient humidity 10-60%RH, voltage 5-30kV.
9. artificial blood vessel made from the preparation method as described in claim any one of 1-8, it is characterised in that: include: electrostatic spinning
Fiber internal layer and EFI dense outer layer.
10. artificial blood vessel according to claim 9, it is characterised in that: the fiber internal layer is with a thickness of 1 μm~1000 μ
M, fibre diameter are 50nm~5000nm, and dense outer layer is with a thickness of 1 μm~1000 μm；
Preferably, for the fiber internal layer with a thickness of 5 μm~700 μm, fibre diameter is 50nm~3000nm, dense outer layer thickness
It is 5 μm~700 μm；
It is highly preferred that the fiber internal layer is with a thickness of 50 μm~450 μm, fibre diameter is 800nm~3000nm, dense outer layer
With a thickness of 10 μm~300 μm.
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| CN201910040748.7A CN109914036A (en) | 2019-01-16 | 2019-01-16 | The preparation method of puncture-resistant artificial blood vessel material and thus obtained artificial blood vessel |
| PCT/CN2020/072101 WO2020147733A1 (en) | 2019-01-16 | 2020-01-14 | Method for preparing material for artificial blood vessel, artificial blood vessel prepared thereby and application thereof |
| CN202010044393.1A CN111304831B (en) | 2019-01-16 | 2020-01-15 | Method for producing puncture-resistant artificial blood vessel material and artificial blood vessel produced thereby |
| US17/377,427 US20210338410A1 (en) | 2019-01-16 | 2021-07-16 | Preparation method for three-layer artificial blood vessel and application thereof |
| US17/377,424 US20210338411A1 (en) | 2019-01-16 | 2021-07-16 | Preparation method of material for puncture-resistant artificial blood vessel and artificial blood vessel prepared thereby |
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| EP1815820A4 (en) * | 2004-11-19 | 2010-03-03 | Teijin Ltd | Cylindrical member and process for producing the same |
| US20130268062A1 (en) * | 2012-04-05 | 2013-10-10 | Zeus Industrial Products, Inc. | Composite prosthetic devices |
| CN103481624B (en) * | 2013-08-09 | 2015-05-27 | 天津工业大学 | Preparation method of multilayer sandwich type electrostatic-spinning polymer nanofiber composite membrane |
| CN104638283B (en) * | 2015-02-09 | 2017-04-19 | 大连交通大学 | Electrostatic spinning method for preparing sponge-shaped Nafion membrane |
| CN106237389A (en) * | 2016-08-05 | 2016-12-21 | 江苏百优达生命科技有限公司 | A kind of composite artificial blood vessel |
| CN106512087A (en) * | 2016-12-06 | 2017-03-22 | 北京航空航天大学 | Artificial blood vessel stent with aligned fibers and manufacturing method of artificial blood vessel stent |
| CN106540327A (en) * | 2016-12-06 | 2017-03-29 | 北京航空航天大学 | A kind of three layers of artificial blood vessel bracket of imitative nature blood vessel and preparation method thereof |
| CN109172875B (en) * | 2018-09-18 | 2021-04-23 | 武汉纺织大学 | Preparation method of artificial blood vessel with micro-nano composite structure |
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