CN110279894A - Composite material and heart valve prosthesis based on fibroin fiber - Google Patents
Composite material and heart valve prosthesis based on fibroin fiber Download PDFInfo
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- CN110279894A CN110279894A CN201910565441.9A CN201910565441A CN110279894A CN 110279894 A CN110279894 A CN 110279894A CN 201910565441 A CN201910565441 A CN 201910565441A CN 110279894 A CN110279894 A CN 110279894A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2415—Manufacturing methods
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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
- 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
- A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
- A61L27/227—Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
-
- 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
- A61L27/52—Hydrogels or hydrocolloids
-
- 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
- A61L27/56—Porous materials, e.g. foams or sponges
-
- 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
- A61L27/58—Materials at least partially resorbable by the body
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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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/20—Materials or treatment for tissue regeneration for reconstruction of the heart, e.g. heart valves
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
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- Vascular Medicine (AREA)
- Dispersion Chemistry (AREA)
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- Prostheses (AREA)
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Abstract
The invention discloses a kind of composite material and heart valve prosthesis based on fibroin fiber, belongs to medical material tech field.Prosthese leaflet is prepared by fibroin fiber through electrostatic spinning process, can electrospinning provides the fibroin albumen membrane material leaflets of isotropism and Anisotropic Mechanical Properties respectively according to different collection modes.In addition, polyethylene glycol hydrogel is coated on fibroin fiber film surface to form composite material using optical cross-linking method.The spatial mesh structure of polyethylene glycol hydrogel protects fibroin albumen not degraded by biological enzyme, and has functions.Electrostatic spinning anisotropy fibroin protein film has Anisotropy, can imitate stress distribution of the human aortic valve under blood flow effect, realize and mechanical property similar in human body valve.
Description
Technical field
The present invention relates to medical material tech fields, and in particular to a kind of composite material and people based on fibroin fiber
Work heart valve.
Background technique
Heart valve disease is a kind of common disease and frequently-occurring disease, and Cardiac valve replacement is treatment latter stage heart valve
The most effective surgical means of lesion.The replacement valve clinically used at present is mainly mechanical valve prosthesis (stainless steel, pyrolyzed carbon materials
Deng) and biovalve (Pigs Hearts packet, bovine pericardial material etc.), however these materials lead to a series of ask after being chronically implanted human body
Topic and corresponding complication.Mechanical valve prosthesis material surface is easily formed thrombus, thus it is postoperative need to take anticoagulation medicine throughout one's life,
And the problems such as biovalve is also easily decayed and calcification, is shorter so as to cause its service life.In recent years, with macromolecule
The continuous development of materialogy, more and more polymer-based materials are studied the preparation that personnel are applied to heart valve prosthesis.20
Macromolecule heart valve, past successfully are implanted in the aorta petal of human body and mitral position for the first time the sixties in century
Over 50 years, the macromolecule heart valve of many different materials types is devised, has specifically included that polysiloxane-based, polyurethane
Class, polytetrafluoroethyl-ne alkenes and polyethylene glycol hydrogel class.But macromolecule valve does not obtain clinical universal, many yet up to now
High molecular material also faces the problems such as chronic fatigue tearing, fibroplasia and calcification.
Summary of the invention
The purpose of the present invention is to provide a kind of composite material and heart valve prosthesis based on fibroin fiber, utilization
Electrostatic spinning process prepares fibroin fiber, then polyethylene glycol hydrogel cladding is formed on its surface composite material, and will
Gained composite material is as heart valve prosthesis prosthese.Electrostatic spinning preparation fibroin albumen have good biocompatibility,
The characteristics of good mechanical property, meets native heart valve mechanical property requirements；Fibroin fiber material surface can coat simultaneously
Polyethylene glycol hydrogel, polyethylene glycol hydrogel has both good biocompatibility and anti-pollution effect, and can be effectively protected interior
The fibroin albumen in portion, to reach anticalcium and resistance to enzymolysis purpose.
To achieve the above object, technical scheme is as follows:
A kind of composite material based on fibroin fiber, including fibroin fiber film and polyethyleneglycol diacrylate
(poly (ethylene glycol) diacrylate, PEGDA) hydrogel has on the fibroin fiber film multiple micro-
Hole, the PEGDA hydrogel are coated in fibroin fiber film both side surface, and the hydrogel has penetration type structure,
That is: the PEGDA hydrogel in fibroin fiber film both side surface is connected by the micropore.
In the composite material, volume ratio shared by the fibroin fiber film is 80%-100% (preferably 80%-
95%), 100-700 μm of the film thickness of fibroin fiber film, average fibre diameter 200-500nm.
Micropore on the fibroin fiber film is uniformly distributed, and aperture is 100-150 μm, pitch-row 1-2mm.
The fibroin fiber film is to be prepared using silk as raw material using electrostatic spinning process, the electrostatic
In spinning technique: spinning voltage range is 1-33kV, and spinning receives distance 10-20cm, and spinning fltting speed is 0.1-0.15mm/
min；During spinning, when reception device is aluminum baffle, isotropism fibroin protein film is obtained；Reception device is aluminum roller
When (revolution: 2000-3000rpm), anisotropy fibroin protein film is obtained.
When the fibroin fiber film is isotropism fibroin fiber film, isotropism arrangement is presented in fiber；Institute
State fibroin fiber film be anisotropy fibroin fiber film when, fiber present anisotropy arrangement；The isotropism
The elasticity modulus of fibroin fiber film is 6-8MPa；In the anisotropy fibroin fiber film, it is parallel to machine direction
Elasticity modulus 13-18MPa is 1-4MPa perpendicular to machine direction elasticity modulus.
The composite material based on fibroin fiber is by photo-crosslinking method that PEGDA hydrogel is coated in fibroin
Azelon film surface obtains, which includes the following steps:
(1) pretreatment of fibroin fiber film: penetration type punching is carried out to fibroin protein film, obtains multiple be uniformly distributed
Micropore, avoid being layered and increasing its connectivity；Fibroin protein film after punching is immersed in the poly- second two containing photoinitiator
Alcohol diacrylate (poly (ethylene glycol) diacrylate, PEGDA) in advance in glue solution, be put into vacuum hold
Make to be completely filled with the pre- gelling solution of PEGDA in the fiber mesh and hole (micropore) of fibroin protein film in device；The PEGDA in advance at
In sol solution, polyethyleneglycol diacrylate concentration is 20-30wt.%, and photoinitiator is Irgacure2959 (2-hydroxy-
40- (2-hydroxyethoxy) -2-methylpropiophe-none), photoinitiator concentration 1-5g/L.
(2) dimethyl silicone polymer (polydimethylsiloxane, PDMS) template of size and thickness needed for preparing,
The PDMS template, which is placed on, a piece of to be hadOn the glass slide of coating, after then placing pretreatment in PDMS template
Fibroin fiber membrane sample, be supplemented the pre- gelling solution of PEGDA and fill up PDMS template central clear region, then in PDMS
Another is covered above template hasThe glass slide of coating seals；
(3) reaction is crosslinked using cool white light or ultraviolet light, until forming the coated fibroin of polyethylene glycol hydrogel
The composite material of protein film.
It is compound when polyethylene glycol hydrogel is coated when isotropism fibroin fiber film surface in the composite material
Elasticity modulus of materials is 4-6MPa；It is compound when polyethylene glycol hydrogel is coated when anisotropy fibroin fiber film surface
Material still maintains Anisotropy, in which: machine direction elasticity modulus 11-15MPa is parallel to, perpendicular to machine direction bullet
Property modulus be 1-4MPa.
By the composite material sewing based on fibroin fiber in internal stent, it is fine to obtain anisotropy fibroin albumen
Tie up composite material heart valve prosthesis prosthese.The heart valve prosthesis prosthese has excellent flow dynamics, effectively
Opening area 1.5-2.7cm2, backflow than < 20%.
Compared with existing heart valve prosthesis prosthese, the beneficial effects of the present invention are embodied in:
1, the present invention has biocompatibility using fibroin protein film as inner layer material and realizes similar with human body valve
Mechanical property；Cladding PEGDA hydrogel can also provide good biocompatibility and antifouling property, and protect the fibroin egg of internal layer
White fiber is not degraded by enzymes.
2, the present invention prepares fibroin fiber material with electrospinning process, wherein anisotropic fibroin protein film energy
The Anisotropic Mechanical Properties for enough imitating natural valve, enhance the radial compliance and circumferential strength of artificial leaflet, to obtain
Better flow dynamics and long-term fatigue durability.
3, the present invention can prepare diverse microcosmic appearance (fiber orientation, fibre diameter) and ruler by electrostatic spinning process
The complex layered heart valve prosthesis of very little (thickness of sample, size) is, it can be achieved that heart valve prosthesis customizes.
Detailed description of the invention
Fig. 1 is the stereoscan photograph of the double-deck fibroin fiber membrane material of electrostatic spinning preparation；Wherein: the figure left half
Portion is material upper surface (anisotropy), and right side is material lower surface (isotropism).
Fig. 2 is the anisotropy bilayer fibroin albumen composite material of the polyethylene glycol hydrogel package of preparation；Wherein: (a)
Composite structure schematic diagram is illustrated including fibroin protein film penetration type punch position schematic diagram and composite material section
Figure；(b) stereoscan photograph of composite material.
Fig. 3 is to use anisotropy bilayer fibroin fiber film and mass percent concentration for 20%PEGDA solution system
The mechanical property of standby artificial heart valve film composite material；Wherein: (a) bent along machine direction and perpendicular to the stretching of machine direction
Line；(b) along machine direction and perpendicular to the elastic mould value of machine direction.
Fig. 4 is the sewing method schematic diagram of fibroin fiber material when preparing heart valve prosthesis prosthese；Wherein: (a)
Leaflet material sewing method schematic diagram, (b) leaflet material and bracket assembled method schematic diagram.
Fig. 5 is that anisotropy bilayer fibroin protein film and mass percent concentration is used to prepare for 20%PEGDA solution
Rheokinetic curve under its external pulsation flow assay device of heart valve prosthesis prosthese；Wherein: (a) fluid dynamics are bent
Line；(b) heart valve prosthesis moving process picture.
Fig. 6 is using its external pulsation flow assay device of the heart valve prosthesis prosthese of isotropism fibroin albumen film preparation
Under rheokinetic curve.
Fig. 7 is to use the fibroin fiber membrane material prepared under the conditions of fibroin albumen concentration 20wt% and spinning voltage 23kV
The stereoscan photograph of material.
Specific embodiment
Below with reference to embodiment and attached drawing, technical scheme is described further.
The present invention prepares the process of fibroin fiber composite material and heart valve prosthesis prosthese are as follows: is with silk first
Raw material prepares fibroin fiber using electrostatic spinning process, optical cross-linking method is recycled to be coated on polyethylene glycol hydrogel
Its surface forms composite material.Heart valve prosthesis prosthese is finally made in composite material sewing on bracket.Detailed process is such as
Under:
(1) it prepares silk fibroin protein solution: natural silk is taken, after degumming, drying, dissolution, dialysis and concentration step
Silk fibroin protein solution is made.
(2) electrostatic spinning fiber material: electrospinning device is worked in peace and contentment development in science and technology Co., Ltd SS- using Beijing Yongkang
3535H type electrostatic spinning machine, electrostatic spinning process are as follows: by the silk fibroin protein solution and polyethylene oxide (molecule after concentration
Amount~300000) solution mixing system is at spinnability silk fibroin protein solution.Then prepared spinnability fibroin is drawn with syringe
Syringe is fixed in the card slot of syringe pump by protein solution, and positive high voltage power supply is connected on front end of the syringe needle metal needle,
Aluminium-foil paper is pasted in reception device and carries out fiber collection, and receiver end connects negative high voltage power source.It is carried out after setting spinning parameter
Electrostatic spinning obtains fibroin fiber film.The tunica fibrosa prepared is carefully torn from aluminium-foil paper, is immersed in methanol solution
In to obtain partially-crystallized fibroin albumen.
(3) penetration type punching is carried out to fibroin protein film using hyperfine machine table, avoids being layered and increasing its connectivity.
Fibroin protein film is immersed in the PEGDA containing photoinitiator in advance in glue solution, being put into vacuum tank makes fibroin albumen
The pre- gelling solution of PEGDA is completely filled in membrane fiber grid and hole.
(4) dimethyl silicone polymer (polydimethylsiloxane, PDMS) template of size and thickness needed for preparing,
The PDMS template, which is placed on, a piece of to be hadOn the glass slide of coating, after then placing pretreatment in PDMS template
Fibroin albumen membrane sample, be supplemented the pre- gelling solution of PEGDA and fill up PDMS template central clear region, then in PDMS template
Covering another above hasThe glass slide of coating seals；
(5) using cool white light or ultraviolet light cross-linking until forming the composite wood of the coated fibroin protein film of polyethylene glycol hydrogel
Material.
(6) fibroin protein film is cut into specific dimensions, and is sutured in internal stent with suture and the heart is made
Dirty valve prosthesis guarantees that the fit-state of three leaflets under natural conditions is good after suture.
Embodiment 1
This example uses the anisotropy fibroin fiber composite material of polyethylene glycol hydrogel cladding, prepares stent diameter
For the heart valve prosthesis prosthese of 25mm.
1. preparing silk fibroin protein solution: taking natural silk, made after degumming, drying, dissolution, dialysis and concentration step
At silk fibroin protein solution.
2. electrostatic spinning prepares fibrous material: by the silk fibroin protein solution and polyethylene oxide (molecular weight after concentration
~300000) solution mixing system is at spinnability silk fibroin protein solution.In low silk fibroin protein solution concentration, (spinnability fibroin albumen is molten
The content of silk fibroin protein solution is concentrated in liquid to carry out spinning under conditions of 10wt%), low spinning voltage (18kV), first uses roller
It is placed on baffle again after receiver (revolution 2800rpm) collection acquisition anisotropic membrane and collects isotropic membrane, it is final to obtain
Anisotropy duplicature (Fig. 1), 227.2 ± 23.0nm of average fibre diameter.
Mechanical test analysis shows, anisotropy fibroin fiber membrane material is being parallel to machine direction and perpendicular to fibre
Tieing up has apparent Anisotropy on direction, elasticity modulus is respectively 12.11 ± 0.61MPa and 3.44 ± 0.29MPa,
Close to the primary valvular elasticity modulus of human body.
3. carrying out penetration type punching to fibroin protein film using hyperfine machine table, pitch-row 2mm, aperture are about 100 μm.
Fibroin protein film is immersed in the PEGDA solution for being 20% containing photoinitiator mass fraction, is vented under vacuum, makes fibroin egg
PEGDA solution is completely filled in tunica albuginea fiber mesh and hole.
4. preparing the PDMS template that diameter is size needed for 25mm bracket, which is placed on a piece of glass slide,
Then pretreated fibroin albumen membrane sample is placed in the white space in PDMS template, then is covered on PDMS template
Another glass slide sealing；Using ultraviolet light cross-linking until forming the complex layered of the coated fibroin protein film of polyethylene glycol hydrogel
Material (Fig. 2).
Mechanical test analysis shows, anisotropy fibroin fiber composite material be parallel to machine direction and perpendicular to
In machine direction have apparent Anisotropy (Fig. 3), elasticity modulus be respectively 10.95 ± 1.09MPa and 3.55 ±
0.32MPa, close to the primary heart valve of human body.
5. fibroin albumen composite material is folded and is sutured according to mode shown in Fig. 4 (a), and will with suture
It is sutured in internal stent (diameter 25mm) and is made heart valve prosthesis 4 (b), and when suture guarantees fibroin fiber along leaflet week
To arrangement, guarantee that the fit-state of three leaflets under natural conditions is good after suture.
Fluid dynamics evaluation result shows that valve prosthesis has good flow dynamics (Fig. 5), effective vent
Area is greater than 2.6cm2, reflux ratio reaches ISO-5840 standard less than 20%.
Embodiment 2
This example uses the anisotropy fibroin fiber composite material of polyethylene glycol hydrogel cladding, prepares stent diameter
For the heart valve prosthesis prosthese of 23mm.
1. configuring fibroin albumen spinning solution: with embodiment 1.
2. electrostatic spinning prepares fibrous material: with embodiment 1.
3. coating PEGDA hydrogel: with embodiment 1.
4. fibroin albumen fiber composite material is cut out according to size needed for 23mm bracket, by fibroin fiber film according to Fig. 4
Shown mode is folded and is sutured, and is sutured in internal stent (diameter 23mm) with suture and heart valve is made
Prosthese guarantees that fibroin fiber is circumferentially arranged along leaflet, guarantees the fitting of three leaflets under natural conditions after suture when suture
It is in good condition.
Fluid dynamics evaluation result shows that valve prosthesis has good flow dynamics, effective vent area
Greater than 2.1cm2, reflux ratio reaches ISO-5840 standard less than 7.8%.
Embodiment 3
This example uses the isotropism fibroin fiber composite material of polyethylene glycol hydrogel cladding, prepares stent diameter
For the heart valve prosthesis prosthese of 25mm.
1. configuring fibroin albumen spinning solution: with embodiment 1.
2. electrostatic spinning prepares fibrous material: in low silk fibroin protein solution concentration (10wt.%), low spinning voltage (18kV)
Under the conditions of, isotropic membrane is collected with baffle.The tunica fibrosa prepared is carefully torn from aluminium-foil paper, is immersed in methanol solution
Obtain partially-crystallized fibroin protein film.
3. coating PEGDA hydrogel: with embodiment 1.
4. fibroin fiber film is cut out according to size needed for 25mm bracket, by fibroin fiber film according to shown in Fig. 4
Mode is folded and is sutured, and is sutured in internal stent (diameter 25mm) with suture and heart valve vacation is made
Body guarantees that fibroin fiber is circumferentially arranged along leaflet, guarantees the fitting shape of three leaflets under natural conditions after suture when suture
State is good.
Fluid dynamics evaluation result shows that valve prosthesis has good flow dynamics (Fig. 6), effective vent
Area is greater than 2.3cm2, reflux ratio reaches ISO-5840 standard less than 14.5%.
Embodiment 4
This example is compound using isotropism fibroin fiber made from the different spinning parameters of polyethylene glycol hydrogel cladding
Material prepares the heart valve prosthesis prosthese that stent diameter is 25mm.
1. configuring fibroin albumen spinning solution: with example 1.1.
2. in high fibroin albumen solution concentration (20wt.%), under high spinning voltage conditions (23kV), with baffle collect it is each to
Same sex film.The tunica fibrosa prepared is carefully torn from aluminium-foil paper, methanol solution is immersed in and obtains partially-crystallized fibroin egg
Tunica albuginea, 421.6 ± 151.9nm of fibroin fiber average diameter (Fig. 7).
3. coating PEGDA hydrogel: with embodiment 4.
3. sewing heart valve prosthesis: with embodiment 4.
Claims (10)
1. a kind of composite material based on fibroin fiber, it is characterised in that: the composite material includes fibroin fiber film
With PEGDA hydrogel, there are multiple micropores on the fibroin fiber film, the PEGDA hydrogel is coated on fibroin albumen
In tunica fibrosa both side surface, and the hydrogel has penetration type structure, it may be assumed that in fibroin fiber film both side surface
PEGDA hydrogel is connected by the micropore.
2. the composite material according to claim 1 based on fibroin fiber, it is characterised in that: in the composite material,
Volume ratio shared by the fibroin fiber film is 80%-100%, 100-700 μm of the film thickness of fibroin fiber film, fiber
Average diameter 200-500nm.
3. the composite material according to claim 1 based on fibroin fiber, it is characterised in that: the fibroin albumen is fine
Micropore on dimension film is uniformly distributed, and aperture is 100-150 μm, pitch-row 1-2mm.
4. the composite material according to claim 1 based on fibroin fiber, it is characterised in that: the fibroin albumen is fine
Tieing up film is to be prepared using silk as raw material using electrostatic spinning process, in the electrostatic spinning process: spinning voltage range
For 1-33kV, spinning receives distance 10-20cm, and spinning fltting speed is 0.1-0.15mm/min；During spinning, reception device
When for aluminum baffle, isotropism fibroin protein film is obtained；When reception device is aluminum roller, anisotropy fibroin albumen is obtained
Film.
5. the composite material according to claim 1 or 4 based on fibroin fiber, it is characterised in that: the fibroin egg
When white fiber film is isotropism fibroin fiber film, isotropism arrangement is presented in fiber；The fibroin fiber film is
When anisotropy fibroin fiber film, anisotropy arrangement is presented in fiber；The bullet of the isotropism fibroin fiber film
Property modulus be 6-8MPa；In the anisotropy fibroin fiber film, it is parallel to machine direction elasticity modulus 13-18MPa, is hung down
Directly in machine direction elasticity modulus be 1-4MPa.
6. the composite material according to claim 4 based on fibroin fiber, it is characterised in that: described to be based on fibroin egg
The composite material of white fiber be by photo-crosslinking method by PEGDA hydrogel it is coated in fibroin fiber film surface obtain, should
Process includes the following steps:
(1) pretreatment of fibroin fiber film: penetration type punching is carried out to fibroin protein film, is obtained multiple equally distributed micro-
Hole avoids being layered and increasing its connectivity；Fibroin protein film after punching is immersed in the pre- plastic of the PEGDA containing photoinitiator
In aqueous solution, be put into vacuum tank the fiber mesh for making fibroin protein film and be completely filled in hole (micropore) PEGDA in advance at
Sol solution；
(2) the dimethyl silicone polymer template of size and thickness needed for preparing, which, which is placed on, a piece of hasOn the glass slide of coating, pretreated fibroin fiber membrane sample is then placed in PDMS template,
It is supplemented the pre- gelling solution of PEGDA to fill up PDMS template central clear region, then cover another on PDMS template to haveThe glass slide of coating seals；
(3) reaction is crosslinked using cool white light or ultraviolet light, until forming the coated fibroin albumen of polyethylene glycol hydrogel
The composite material of film.
7. the composite material according to claim 6 based on fibroin fiber, it is characterised in that: described in step (1)
In the pre- gelling solution of PEGDA, PEGDA concentration is 20-30wt.%, photoinitiator concentration 1-5g/L, and the photoinitiator is
Irgacure2959。
8. the composite material according to claim 6 based on fibroin fiber, it is characterised in that: in the composite material,
When PEGDA hydrogel is coated when isotropism fibroin fiber film surface, Modulus of Composites 4-6MPa；When
PEGDA hydrogel is coated, and composite material still maintains Anisotropy when anisotropy fibroin fiber film surface,
In: it is parallel to machine direction elasticity modulus 11-15MPa, is 1-4MPa perpendicular to machine direction elasticity modulus.
9. using the heart valve prosthesis of the composite material production according to any one of claims 8 based on fibroin fiber, feature
It is: by the composite material sewing based on fibroin fiber in internal stent, obtains anisotropy fibroin fiber
Composite material heart valve prosthesis prosthese.
10. heart valve prosthesis according to claim 9, it is characterised in that: the heart valve prosthesis prosthese has excellent
Different flow dynamics, effective vent area 1.5-2.7cm2, backflow than < 20%.
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