CN110038159A - The preparation method of flexible composite implant material - Google Patents
The preparation method of flexible composite implant material Download PDFInfo
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- CN110038159A CN110038159A CN201910324459.XA CN201910324459A CN110038159A CN 110038159 A CN110038159 A CN 110038159A CN 201910324459 A CN201910324459 A CN 201910324459A CN 110038159 A CN110038159 A CN 110038159A
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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
- A61L27/16—Macromolecular materials obtained 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
- A61L27/18—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
- A61L27/28—Materials for coating prostheses
- A61L27/34—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
- 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
- A61L27/54—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
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic 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
- A61L2300/42—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
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/606—Coatings
-
- 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
Abstract
The preparation method of flexible composite implant material, it is related to the material for medical implant, and in particular to the preparation suitable for heart valve prosthesis or the flexible composite implant material of tissue patch.It will solve material of the existing fluoropolymer as artificial heart valve leaflet, and that there are fillers is easy to fall off, be also easy to produce plastic deformation and character changes；There is a problem of that uniformity is poor, antifatigue aging ability is weak and not easy to maintain again as the material of artificial heart valve leaflet using bovine pericardium.Method 1: one, high strength fibre are woven into film；Two, basis material infiltrates film, completes after solidification.Method 2: one, high strength fibre woven film；Two, the two sides adhesive matrix material of film, that is, complete.The flexible composite implant material prepared in the present invention, good biocompatibility, flexibility is good, and antifatigue, aging and wear resistance are strong, and structural stability is good, and long-time service is not susceptible to irreversible deformation；Simple process and low cost, it is easy to maintain.
Description
Technical field
The present invention relates to the materials for medical implant；More particularly to suitable for heart valve prosthesis or tissue patch
Flexible composite implant material preparation.
Background technique
Heart valve disease is a kind of very universal cardiac disorder, and wherein valve lesions caused by rheumatic fever are the most often
One of the reason of seeing.As aging of population aggravates, caused valvular heart disease after senile valvular heart disease and coronary heart disease, myocardial infarction
Become also increasingly common.The heart of human body is divided into four atrium sinistrum, left ventricle and atrium dextrum, right ventricle chambers of the heart, two atrium point
It is not connected with two ventricles, two ventricles and two main arteries are connected.Heart valve is just grown between atrium and ventricle, ventricle
Between main artery, play the role of one-way cock, helps blood flow unidirectional motion.Four valves of human body are referred to as two points
Valve, tricuspid valve, aorta petal and pulmonary valve.These valves just will affect the movement of blood flow if there is lesion has been arrived, thus
It causes cardiac function abnormal, eventually leads to heart failure.For there is the patient of valvulopathy such as mitral stenosis and reflux
The displacement of valve can be carried out using percutaneous transcatheter mitral valve displacement technique or progress surgery open chest surgery.
Artificial heart valve is divided into two classes: one kind is all to claim mechanical prosthetic valve made of artificial material；Another kind of is with life
Claim bioprosthetic valves made of object tissue.
The problem of mechanical prosthetic valve generally existing poor biocompatibility, high to anticoagulant requirement, anticoagulant dynamics not enough easily forms thrombus,
The anticoagulant danger for excessively having cerebral hemorrhage again.
Material using fluoropolymer as artificial heart valve leaflet, main material be PTFE or ePTFE, two
Person's material is sheet material, even if sheet material is porous structure, flexibility can also be worse than braided fiber.The filler of porous structure
Also there is the possibility that falls off, immersing blood circulation of human body after falling off can be risky.PTFE molecule has helical structure, and molecule is more stiff
Firmly, inter-molecular attraction is very faint, intermolecular easy sliding, and feedback is easy to happen irreversible deformation (plasticity shape in macroscopic view
Become).Under the more fatigue condition of number, it is easy to character occur and change to influence function.
Existing bioprosthetic valves largely use bovine pericardium to have good biofacies as the material of artificial heart valve leaflet
Capacitive has significant advantage on antithrombotic property.Bovine pericardium is derived from the connective tissue around the heart of ox, not because of biomaterial
Uniformity and individual material difference, material needed for a head of cattle only can provide 1~2 product.The fatigue life of the biomaterial
It is lower, generally 50 to ten years, calcification, fatigue aging and irreversible deformation can occur after being chronically implanted.And the material
Material can not be used directly, need to carry out tanning processing and tissue fixation could be as the raw material of artificial heart valve leaflet.Together
When, which saves with respect to other medical materials and sterilization process is also harsher.
Summary of the invention
The invention aims to solve material of the existing fluoropolymer as artificial heart valve leaflet, there is filling
Object is easy to fall off, be also easy to produce plastic deformation and character changes；Material using bovine pericardium as artificial heart valve leaflet exists again
The problem that uniformity is poor, antifatigue aging ability is weak and not easy to maintain, and the preparation method of flexible composite implant material is provided.
The preparation method of flexibility composite implant material of the invention, is realized according to the following steps:
One, high strength fibre is woven into the film with a thickness of 0.05~0.3mm；
Two, using gained film in basis material immersion step one, then solidified, gained composite material after solidification
Overall thickness is 0.2~0.6mm, that is, completes the preparation of flexible composite implant material；
Wherein high strength fibre described in step 1 is ultra high molecular weight polyethylene fiber, polyester fiber, nylon fiber, gathers
Tetrafluoroethylene fiber or polypropylene fibre；
The mode of braiding described in step 1 is plain weave, twill weave or satin weave weaving；
The high strength fibre used of braiding described in step 1 uses 1~40 strand；
Basis material described in step 2 is medical grade silicon rubber, hydrogel or fluorubber.
The preparation method of flexibility composite implant material of the invention, can also realize according to the following steps:
One, high strength fibre is woven into the film with a thickness of 0.05~0.3mm；
Two, in step 1 gained film two sides bond thickness be 0.08~0.2mm basis material, institute after bonding
The overall thickness for obtaining composite material is 0.2~0.6mm, that is, completes the preparation of flexible composite implant material；
Wherein high strength fibre described in step 1 is ultra high molecular weight polyethylene fiber, polyester fiber, nylon fiber, gathers
Tetrafluoroethylene fiber or polypropylene fibre；
The mode of braiding described in step 1 is plain weave, twill weave or satin weave weaving；
The high strength fibre used of braiding described in step 1 uses 1~40 strand；
Basis material described in step 2 is medical grade silicon rubber, hydrogel or fluorubber；
The basis material of the two sides bonding of film is same material or non-same material in step 2；
Bonding described in step 2 uses silicon rubber or hydrogel.
Film described in the step of above-mentioned second of preparation method one can also directly adopt existing commercial goods, thick
Degree is the macromolecule plastic film of 0.05~0.3mm, and material is identical as high strength fibre material.
After the preparation for completing flexible composite implant material using aforesaid way, according to actual needs, flexibility can also be planted
The surface for entering composite material carries out coating or plated film；Coating is to spray existing antibacterials or anticoagulation medicine on surface,
Coating thickness is 1~10 μm；Plated film is to use the mode deposition thickness of vacuum vapor deposition for 1~5 μm of Parylene.
Beneficial effects of the present invention:
1, the flexible composite implant material prepared in the present invention, good biocompatibility, because of the braiding of high strength fibre
The colloid structure of structure and outer layer base material is the material for the good biocompatibility being verified, and the combination of the two will not change
Become its biocompatibility.
2, in the preparation process of the flexible composite implant material of the present invention, the high strength fibre intensity of use is high, and flexibility is good；
Comparison uses material of the fluoropolymer as artificial heart valve leaflet, even if sheet material is porous structure, flexibility also can
It is worse than braided fiber；Its tear resistance and tensile strength are 5 times of the bovine pericardial material of equal thickness by contrast；If by superelevation point
Sub- weight polyethylene fiber replaces with polyester fiber, nylon fiber, polytetrafluoroethylene fibre or polypropylene fibre, in the feelings of equal thickness
Its tear resistance and tensile strength are also 1~4.5 times of the bovine pericardial material of equal thickness under condition.
3, the preparation process of flexible composite implant material is simple in the present invention, and cost is relatively low；And existing bovine pericardial material needs
To extract fresh pericardium from slaughterhouse, remove extra fat and musculature, and with 0.9% physiological saline clean to
Few 3 times, then 2~4 DEG C of preservations need with glutaraldehyde/PBS fixing process 0.5~for 24 hours, then carry out artificial screening, it is seen that technique
It is complex and costly.
4, the flexible composite implant material of preparation gained, the high strength fibre of braiding, stable structure, thickness and bullet in the present invention
Property it is uniform, have uniform mechanical property therefore be unlikely to deform；After film after infiltration wraps up medical grade silicon rubber again, then avoid
The risk for falling off and being layered；And existing valve made of cattle pericardium membrane material, as biology extract material, bovine pericardium that treated it is difficult to ensure that
Thickness is uniform.
5, the flexible composite implant material of preparation gained in the present invention, in human body under the conditions of or more stringent condition
Under, such as higher cardiac pressure working under load 400,000,000 times or more, therefore material is antifatigue, aging and wear resistance are strong, structure
Stability is good, and long-time service is not susceptible to irreversible deformation；And the average life of existing bovine pericardial material is 5~10
I.e. 1.9~3.8 hundred million times people's body-internal-circulations of year.
6, the flexible composite implant material of preparation gained in the present invention, it is only necessary to which room temperature aseptic condition saves, and sterilize work
The ethylene oxide sterilizing of standard can be selected in skill；And existing bovine pericardial material storage needs to be immersed in glutaraldehyde/PBS solution, and
It is placed under 2~4 DEG C of gnotobasis, and to replace glutaraldehyde/PBS solution on time；Sterilizing before bovine pericardial material use also without
Method is using conventional ethylene oxide sterilizing means, and also unusable high temperature and pressure, (more than 10min) can not be detached from solution for a long time
Protection, needs to impregnate 48h at 28~32 DEG C with special thimerosal, it is seen that it is not easy using preservation.
7, after the preparation for completing flexible composite implant material in the present invention, according to actual needs, flexibility can also be implanted into
The surface of composite material carries out coating or plated film；Flexible composite implant material after coating or coating film treatment, is planting
Enter to be further reduced after human body the generation of complication.
Detailed description of the invention
Fig. 1 is the schematic diagram of mold a in embodiment 1；
Fig. 2 is the schematic diagram that mold a and mold b is used after closing up as curing mold in embodiment 1, wherein 1 indicates mould
Has a, 2 indicate mold b, and 3 indicate the film after infiltration, and 4 indicate silicon rubber mixed liquor；
Fig. 3 is the schematic diagram of the flexible composite implant material of preparation gained in embodiment 1, wherein 1 indicates medical grade silicon rubber,
2 indicate the film after infiltration, and 3 indicate medical grade silicon rubber；
Fig. 4 is the shape appearance figure that existing valve made of cattle pericardium membrane material used is compared in embodiment 1；
Fig. 5 is the schematic diagram of the flexible composite implant material of preparation gained in embodiment 2, wherein 1 indicates existing commercially available sheet
Medical grade silicon rubber, 2 indicate the ultra high molecular weight polyethylene fiber of plain weaves, and 3 indicate the medical grade of existing commercially available sheets
Silicon rubber；
Fig. 6 is the schematic diagram of the flexible composite implant material of the preparation gained of embodiment 3, wherein 1 indicates existing commercially available sheet
Medical grade silicon rubber, 2 indicate existing commercially available macromolecule plastic film, and 3 indicate the medical grade silicon rubber of existing commercially available sheet.
Specific embodiment
Technical solution of the present invention is not limited to the specific embodiment of act set forth below, further include each specific embodiment it
Between any combination.
Specific embodiment 1: the preparation method of present embodiment flexibility composite implant material, is realized according to the following steps:
One, high strength fibre is woven into the film with a thickness of 0.05~0.3mm；
Two, using gained film in basis material immersion step one, then solidified, gained composite material after solidification
Overall thickness is 0.2~0.6mm, that is, completes the preparation of flexible composite implant material；
Wherein high strength fibre described in step 1 is ultra high molecular weight polyethylene fiber, polyester fiber, nylon fiber, gathers
Tetrafluoroethylene fiber or polypropylene fibre；
The mode of braiding described in step 1 is plain weave, twill weave or satin weave weaving；
The high strength fibre used of braiding described in step 1 uses 1~40 strand；
Basis material described in step 2 is medical grade silicon rubber, hydrogel or fluorubber.
Medical grade silicon rubber is bought from Nuo Xier NuSil company in present embodiment.
The flexible composite implant material prepared in present embodiment, good biocompatibility, because of the volume of high strength fibre
The colloid structure for knitting structure and outer layer base material is the material for the good biocompatibility being verified, and the combination of the two will not
Change its biocompatibility.
Specific embodiment 2: present embodiment and specific embodiment one is not both matrix material described in step 2
Material reuses after need to being pre-processed by the product description of purchased basis material before being infiltrated.Other steps and parameter
It is same as the specific embodiment one.
Specific embodiment 3: present embodiment and specific embodiment one or two be not both, it is described in step 2 solid
The temperature of change is carried out according to the product description of purchased basis material.Other steps and parameter and specific embodiment one or two-phase
Together.
Specific embodiment 4: present embodiment and one of specific embodiment one to three is not both institute in step 2
It is identical to state gained film, the thickness of film two sides basis material in basis material immersion step one.Other steps and parameter and tool
One of body embodiment one to three is identical.
Specific embodiment 5: present embodiment and one of specific embodiment one to four is not both institute in step 2
The shore hardness for stating medical grade silicon rubber is 0~40 degree.Other steps and parameter are identical as one of specific embodiment one to four.
Specific embodiment 6: the preparation method of present embodiment flexibility composite implant material, it can also be according to the following steps
It realizes:
One, high strength fibre is woven into the film with a thickness of 0.05~0.3mm；
Two, in step 1 gained film two sides bond thickness be 0.08~0.2mm basis material, institute after bonding
The overall thickness for obtaining composite material is 0.2~0.6mm, that is, completes the preparation of flexible composite implant material；
Wherein high strength fibre described in step 1 is ultra high molecular weight polyethylene fiber, polyester fiber, nylon fiber, gathers
Tetrafluoroethylene fiber or polypropylene fibre；
The mode of braiding described in step 1 is plain weave, twill weave or satin weave weaving；
The high strength fibre used of braiding described in step 1 uses 1~40 strand；
Basis material described in step 2 is medical grade silicon rubber, hydrogel or fluorubber；
The basis material of the two sides bonding of film is same material or non-same material in step 2；
Bonding described in step 2 uses silicon rubber or hydrogel.
Medical grade silicon rubber is bought from Nuo Xier NuSil company in present embodiment.
Specific embodiment 7: present embodiment is not both that film described in step 1 may be used also with specific embodiment six
Be finished product thickness be 0.05~0.3mm macromolecule plastic film.Other steps and parameter are identical as specific embodiment six.
The macromolecule plastic film that finished product thickness is 0.05~0.3mm in present embodiment is existing commercial goods.
Specific embodiment 8: present embodiment is not both with specific embodiment six or seven, matrix described in step 2
Material is existing commercially available flaky material.Other steps and parameter are identical as specific embodiment six or seven.
Specific embodiment 9: one of present embodiment and specific embodiment one to eight are not both, completed in step 2
After the preparation of flexible composite implant material, can also the surface to flexible composite implant material carry out coating or plated film.It is other
Step and parameter are identical as one of specific embodiment one to eight.
Specific embodiment 10: present embodiment is not both with specific embodiment nine, the coating is sprayed on surface
Existing antibacterials or anticoagulation medicine, coating thickness are 1~10 μm.Other steps and parameter and nine phase of specific embodiment
Together.
Specific embodiment 11: present embodiment is not both that the plated film is using vacuum with specific embodiment nine
The Parylene that the mode deposition thickness of vapor deposition is 1~5 μm.Other steps and parameter are identical as specific embodiment nine.
Beneficial effects of the present invention are verified by following embodiment:
Embodiment 1:
The preparation method of flexible composite implant material is realized according to the following steps:
One, ultra high molecular weight polyethylene fiber is woven into the film with a thickness of 0.15mm；
Two, using gained film in medical grade silicon rubber immersion step one, then solidified, gained composite wood after solidification
The overall thickness of material is 0.4mm, that is, completes the preparation of flexible composite implant material.
Ultra high molecular weight polyethylene fiber is to buy from Shanghai minimally invasive medical instrument Co., Ltd in the present embodiment step 1,
Its intensity is 3Gpa；Braiding uses plain weave in step 1；Ultra high molecular weight polyethylene fiber used is woven in step 1 to adopt
With 4 strands.
Medical grade silicon rubber is commercial goods in the present embodiment step 2, and the shore hardness that product description provides is 20
Degree, solidification temperature are 25 DEG C.
Infiltration uses the prior art to cured in the present embodiment step 2, and detailed process is as follows:
One, under room temperature, by two kinds of components of A, B of medical grade silicon rubber, 1:1 is mixed by volume, silicon rubber mixed liquor；
Two, gained film in 1 step 1 of embodiment is immersed in silicon rubber mixed liquor, is placed in vacuum equipment, taken out true
Sky stands 10~30min, the film after being infiltrated to 10~200Pa；
Three, silicon rubber mixed liquor is filled respectively in mold a and mold b, the film after infiltration is then laid in mold a
On, then solidify after mold a and mold b are closed up and compressed, it demoulds, that is, completes after 2~4h；
It is the bubble being discharged in mixed liquor that wherein step 2, which stands the purpose of 10~30min, and keeps infiltration abundant；
Step 3 mold a all has groove, and thickness phase as shown in Figure 1, the structure and size of mold a and mold b are identical
Together, the overall thickness that groove thickness is equal to required finished product subtracts the half after braiding gained film thickness；The depth of its groove, according to
Actual demand carries out mold, and material is match steel or organic glass.
Film after infiltration is laid on mold a by step 3, it is desirable that the area of the film after infiltration exceeds the four of mold
Week, and ensure no bubble after tiling；
Step 3 mold a and mold b is used after closing up as curing mold, as shown in Fig. 2, filling silicon rubber mixed liquor
The centre of mold a and mold b are the film after infiltration, and the film after the adjustment infiltration of the exterior measuring of curing mold, make its aptychus
Wrinkle.
In the preparation process of the flexible composite implant material of embodiment 1, the ultra high molecular weight polyethylene fiber braiding of use
Material, intensity is high, and flexibility is good；Comparison uses material of the fluoropolymer as artificial heart valve leaflet, even if sheet material
For porous structure, flexibility can also be worse than braided fiber；Through Experimental comparison, tear resistance and tensile strength are equal thickness
5 times of bovine pericardial material；If ultra high molecular weight polyethylene fiber is replaced with polyester fiber, nylon fiber, polytetrafluoroethylene (PTFE)
Fiber or polypropylene fibre, its tear resistance and tensile strength are also the bovine pericardial material of equal thickness in the case where equal thickness
1~4.5 times.
Existing bovine pericardial material needs extract fresh pericardium from slaughterhouse, remove extra fat and musculature,
And clean at least 3 times with 0.9% physiological saline, 2~4 DEG C of preservations, then need with glutaraldehyde/PBS fixing process 0.5~
For 24 hours, then artificial screening is carried out；Comparison need to only be bought existing as it can be seen that in embodiment 1 in the preparation process of flexible composite implant material
Have with mold cured after being infiltrated after material, preparation process is simple, and cost is relatively low.
The flexible composite implant material of preparation gained in embodiment 1, Fig. 3 are its schematic diagram, it is seen that the superelevation of plain weave point
Sub- weight polyethylene fiber, stable structure, thickness and uniform elastic have uniform mechanical property to be therefore unlikely to deform；After infiltration
After film wraps up medical grade silicon rubber again, then the risk for falling off and being layered is avoided；Existing valve made of cattle pericardium membrane material, such as Fig. 4 institute
Show, extracts material as biology, bovine pericardium that treated is it is difficult to ensure that thickness is uniform, the light transmission of bovine pericardium different location in Fig. 4
Degree is different, and brighter areas is on the contrary then thick than relatively thin, in uneven thickness, causes elastic uneven.
The flexible composite implant material of the preparation gained of embodiment 1, good biocompatibility, because ultra-high molecular weight polyethylene is fine
The braiding structure of dimension and the colloid structure of outer layer medical grade silicon rubber are the material for the good biocompatibility being verified, the two
Combination will not change its biocompatibility.
The average life of existing bovine pericardial material was in i.e. 1.9~3.8 hundred million times people's body-internal-circulations in 5~10 years；Through reality
Comparison is tested, flexibility composite implant material obtained by the preparation of embodiment 1, under the conditions of same in human body or under the conditions of more stringent, such as
Higher cardiac pressure working under load 400,000,000 times or more, therefore material is antifatigue, aging and wear resistance are strong, stable structure
Property it is good, long-time service be not susceptible to irreversible deformation.
Existing bovine pericardial material, which is stored, needs to be immersed in the gnotobasis that 2~4 DEG C are placed in glutaraldehyde/PBS solution
Under, and glutaraldehyde/PBS solution is replaced on time；Sterilizing before bovine pericardial material use is not available conventional ethylene oxide yet
Sterilizing means, also unusable high temperature and pressure, (more than 10min) can not be detached from solution protection for a long time, need with special disinfection
Liquid impregnates 48h at 28~32 DEG C；The flexible composite implant material of preparation gained in embodiment 1, it is only necessary to which room temperature aseptic condition is protected
It deposits, the ethylene oxide sterilizing of standard can be selected in sterilization process.
Embodiment 2
The preparation method of flexible composite implant material can also be realized according to the following steps:
One, ultra high molecular weight polyethylene fiber is woven into the film with a thickness of 0.2mm；
Two, in step 1 gained film two sides bond thickness be 0.1mm basis material, after bonding gained it is compound
The overall thickness of material is 0.5mm, that is, completes the preparation of flexible composite implant material；
Wherein ultra high molecular weight polyethylene fiber is purchase from Shanghai minimally invasive medical instrument Co., Ltd in step 1, strong
Degree is 3Gpa；The mode of the braiding is plain weave；Ultra high molecular weight polyethylene fiber used in the braiding uses 10 strands；
Basis material described in step 2 is medical grade silicon rubber, is existing commercially available flaky material；
The basis material of the two sides bonding of film is same material in step 2；
Bonding described in step 2 uses hydrogel.
Medical grade silicon rubber is bought from Nuo Xier NuSil company in present embodiment.
In the preparation process of the flexible composite implant material of embodiment 2, the ultra high molecular weight polyethylene fiber braiding of use
Material, intensity is high, and flexibility is good；Through Experimental comparison, tear resistance and tensile strength are the bovine pericardial materials of equal thickness
5 times；If ultra high molecular weight polyethylene fiber is replaced with polyester fiber, nylon fiber, polytetrafluoroethylene fibre or polypropylene
Fiber, its tear resistance and tensile strength are also 1~4.5 times of the bovine pericardial material of equal thickness in the case where equal thickness.
In embodiment 2 in the preparation process of flexible composite implant material, current material need to be only bought, after woven and bonding
, preparation process is simple, and cost is relatively low.
The flexible composite implant material of preparation gained in embodiment 2, Fig. 5 are its schematic diagram, in the product of sandwich structure, are put down
The ultra high molecular weight polyethylene fiber of line braiding, stable structure, thickness and uniform elastic, have uniform mechanical property to be therefore not easy
Deformation；Upper and lower level is all made of the medical grade silicon rubber of existing commercially available sheet, stable structure, thickness and uniform elastic.
The flexible composite implant material of the preparation gained of embodiment 2, good biocompatibility, because ultra-high molecular weight polyethylene is fine
The braiding structure of dimension and the colloid structure of outer layer medical grade silicon rubber are the material for the good biocompatibility being verified, the two
Combination will not change its biocompatibility.
The flexible composite implant material of the preparation gained of embodiment 2, tested in human body under the conditions of or more stringent item
Under part, such as higher cardiac pressure working under load 400,000,000 times or more, therefore material is antifatigue, aging and wear resistance are strong, knot
Structure stability is good, and long-time service is not susceptible to irreversible deformation.
The flexible composite implant material of preparation gained in embodiment 2, it is only necessary to which room temperature aseptic condition saves, sterilization process
The ethylene oxide sterilizing for the standard of can be selected.
Embodiment 3
Film described in the step of 2 preparation method of above-described embodiment one can also be the high score with a thickness of 0.05~0.3mm
Sub- plastic foil (commercial goods), material is identical as high strength fibre material；During the preparation process, current material only need to be bought,
After bonding, preparation process is simple, and cost is relatively low；The schematic diagram of the flexible composite implant material of preparation gained as shown in fig. 6,
Because being all made of existing commercially available flaky material, stable structure, thickness and uniform elastic, and good biocompatibility.
Embodiment 4
It, can also be to flexible composite implant material after above-described embodiment 1 and 2 completes the preparation of flexible composite implant material
Surface carries out coating or plated film；Coating is to spray existing antibacterials or anticoagulation medicine on surface, coating thickness is 1~
10μm；Plated film is to use the mode deposition thickness of vacuum vapor deposition for 1~5 μm of Parylene.
Flexible composite implant material after above-mentioned coating or coating film treatment can further subtract after being implanted into human body
The generation of few complication.
Claims (8)
1. the preparation method of flexible composite implant material, it is characterised in that it is realized according to the following steps:
One, high strength fibre is woven into the film with a thickness of 0.05~0.3mm；
Two, using gained film in basis material immersion step one, then solidified, the total thickness of gained composite material after solidification
Degree is 0.2~0.6mm, that is, completes the preparation of flexible composite implant material；
Wherein high strength fibre described in step 1 is ultra high molecular weight polyethylene fiber, polyester fiber, nylon fiber, polytetrafluoro
Vinyl fiber or polypropylene fibre；
The mode of braiding described in step 1 is plain weave, twill weave or satin weave weaving；
The high strength fibre used of braiding described in step 1 uses 1~40 strand；
Basis material described in step 2 is medical grade silicon rubber, hydrogel or fluorubber.
2. the preparation method of flexible composite implant material according to claim 1, it is characterised in that matrix described in step 2
Gained film, the thickness of film two sides basis material are identical in material immersion step one.
3. the preparation method of flexible composite implant material according to claim 1, it is characterised in that medical described in step 2
The shore hardness of grade silicon rubber is 0~40 degree.
4. the preparation method of flexible composite implant material, it is characterised in that it can also be realized according to the following steps:
One, high strength fibre is woven into the film with a thickness of 0.05~0.3mm；
Two, in step 1 the two sides bond thickness of gained film be 0.08~0.2mm basis material, gained is multiple after bonding
The overall thickness of condensation material is 0.2~0.6mm, that is, completes the preparation of flexible composite implant material；
Wherein high strength fibre described in step 1 is ultra high molecular weight polyethylene fiber, polyester fiber, nylon fiber, polytetrafluoro
Vinyl fiber or polypropylene fibre；
The mode of braiding described in step 1 is plain weave, twill weave or satin weave weaving；
The high strength fibre used of braiding described in step 1 uses 1~40 strand；
Basis material described in step 2 is medical grade silicon rubber, hydrogel or fluorubber；
The basis material of the two sides bonding of film is same material or non-same material in step 2；
Bonding described in step 2 uses silicon rubber or hydrogel.
5. the preparation method of flexible composite implant material according to claim 4, it is characterised in that film described in step 1
It can also be that finished product thickness is the macromolecule plastic film of 0.05~0.3mm.
6. according to claim 1 or the preparation method of the 4 flexible composite implant materials, it is characterised in that completed in step 2 soft
Property composite implant material preparation after, can also the surface to flexible composite implant material carry out coating or plated film.
7. the preparation method of flexible composite implant material according to claim 6, it is characterised in that the coating is on surface
Existing antibacterials or anticoagulation medicine are sprayed, coating thickness is 1~10 μm.
8. the preparation method of flexible composite implant material according to claim 6, it is characterised in that the plated film is using true
The Parylene that the mode deposition thickness of vapor depos is 1~5 μm.
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