CN107812252A - A kind of " W " model production method for the tip biomembrane for improving union - Google Patents

A kind of " W " model production method for the tip biomembrane for improving union Download PDF

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Publication number
CN107812252A
CN107812252A CN201711022047.8A CN201711022047A CN107812252A CN 107812252 A CN107812252 A CN 107812252A CN 201711022047 A CN201711022047 A CN 201711022047A CN 107812252 A CN107812252 A CN 107812252A
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model
biomembrane
production method
medicine
elastic layer
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王玉英
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Xishan Donggang District Yuying Operating Department Of Home Appliances
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Xishan Donggang District Yuying Operating Department Of Home Appliances
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/005Ingredients of undetermined constitution or reaction products thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/146Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/30Compounds of undetermined constitution extracted from natural sources, e.g. Aloe Vera
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412Tissue-regenerating or healing or proliferative agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412Tissue-regenerating or healing or proliferative agents
    • A61L2300/414Growth factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602Type of release, e.g. controlled, sustained, slow
    • A61L2300/604Biodegradation

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The present invention provides a kind of " W " model production method for the tip biomembrane for improving union, comprises the following steps:1)It is the model that " W " font and 2 raised spikes and fracture line section coincide to make drift angle section in advance;2)Elastic layer, the medicine layer of moistening are made respectively, the elastic layer is fine and close degradable or nondegradable biomembrane, medicine layer material be and the good degraded or non-degradable of human body bone bio-compatible, absorb do not absorb either or porosity and looseness material, be also encapsulated with the medicine for having facilitation to sclerotin healing inside medicine layer;3)The elastic layer of moistening is covered on 2 raised spikes of model, 2 raised spikes of model is wrapped and extends to model vertex both sides, then the medicine layer of moistening is covered on elastic layer, forms biological microstructure film;4)After air-drying shape fixation etc. biological microstructure film, the biological microstructure film made is peeled off from model vertex.5), it is " V " type film that " W " type film, which is cut,.

Description

A kind of " W " model production method for the tip biomembrane for improving union
Technical field
Present invention relates to a kind of " W " model production method for the tip biomembrane for improving union.
Background technology
It is attached to currently with the biological composite membrane comprising growth factor/stem cell at fracture line, to strengthen union Speed and quality, it has been the Disciplinary Frontiers of medical research.Fracture line(Concordant profipole)Blood vessel, osteocyte etc. is distributed with inner surface, Whether healing is good, depending on blood vessel, the growing state of osteocyte in fracture anastomosis line.Biomembrane is fitted in fracture anastomosis line Why surface can increase the quality of union, and its reason is the medicine of one side biomembrane encapsulated inside to fracture anastomosis The growth of blood vessel, osteocyte in line has a facilitation, and another aspect biomembrane is by tissue and fracture such as the muscle in the external world Concordant profipole is isolated, and prevents reaction of the tissue to blood vessel, bone cell growth in fracture anastomosis line.Therefore, it is biological Facilitation of the film to union, it should be embodied in and effective medicine and the isolation external world are applied with to fracture anastomosis line inner surface The tissue such as muscle.
The way of contact of existing biological composite membrane and fracture line is often by the way of being directly bonded, but this kind of mode Bring problems with:
1, biological composite membrane bulk area is bigger, and fracture area is smaller, and 2 can not effectively be bonded and be fixed on one Rise.
2, the limitation of current biological composite membrane material and manufacture craft, cause the degradation speed of biological composite membrane, carry Growth factor release active drug concentration time(The valid density duration is the key of fracture line healing quality) It can not be met clinical needs etc. performance indications.See《Growth factor slow-release system promotes the experimental study of fracture of mandible healing》; 《Growth factor/collagem membrane slow-released system promotes the research of union》.
Therefore, on the basis of existing biological composite membrane manufacture craft, new structure of composite membrane, and newly compound are explored The fitting of film and fracture line and fixed form, strengthen the speed and quality of union, into the direction of scientific and technical personnel's innovation.
The content of the invention
A kind of " W " model production method for the tip biomembrane for improving union, comprises the following steps:
1)It is the model that " W " font and 2 raised spikes and fracture line section coincide to make drift angle section in advance;
2)Elastic layer, the medicine layer of moistening are made respectively, the elastic layer is fine and close degradable or nondegradable biomembrane, Medicine layer material be and the good degraded or non-degradable of human body bone bio-compatible, absorb do not absorb either or it is porous Unconsolidated material, the medicine for having facilitation to sclerotin healing is also encapsulated with inside medicine layer;
3)The elastic layer of moistening is covered on 2 raised spikes of model, wraps 2 raised spikes of model and extension It is covered in model vertex both sides, then by the medicine layer of moistening on elastic layer, forms biological microstructure film;
4)After air-drying shape fixation etc. biological microstructure film, the biological microstructure film made is peeled off from model vertex. Model is wax, and wax and elastic layer material are immiscible from each other, is easy to peel off from wax pattern after air-drying.
5), it is " V " type film that " W " type film, which is cut,.
Further, fracture line section after in vitro people's bone artificial fracture with being made.The different people in fracture line section It is all similar.Therefore fracture line section after in vitro people's bone artificial fracture with being made.
Further, drift angle section is " V " font and the model identical with fracture line section is cast on fracture line with wax, Then wax solidification is waited to be formed model later.Wax and sclerotin are also immiscible, drift angle section be " V " font and with fracture line section Identical model is cast on fracture line with wax, then waits wax solidification to be formed model later, the model is easy to from fracture Taken off on line.
Further, biological microstructure film periphery is can not permeate the medical bio of the stimulate neuronal growth factor and stem cell Glue is closed.
Further, the elastic layer material is in PLA, collagen, fibrin, biogel, poly butyric ester One or several kinds of mixtures.
Further, the elastic layer material is that can not permeate the medical bio of the stimulate neuronal growth factor and stem cell Glue.
Further, medicine Rotating fields are and human body bone bio-compatible good fiber shape or areolation.
Further, the material of medicine layer is using the material for having facilitation after degraded to bone cell growth.
Further, medicine layer material is that either cellulose or biogel or sterilization or disappear at algal gel azelon Cytotoxic activity charcoal.
Further, the combination of growth factor either stem cell or growth factor and stem cell is encapsulated with medicine layer.
Further, medicine layer is encapsulated with degradable medicaments slow-released system.
On the structure and material inside each layer of biomembrane, in biomembrane related paper and patent document, discuss That states is perfectly clear, such as 201510716279.8 a kind of composite repairing materials for being used to bridge defect nerve and its support, 201480055424.6 compositions and delivery system, 201280027492.2 are for regenerative medicine and for tissue supports Bio-compatible and biodegradable gradient layer system.The application is characterised by the V-shaped word in section after its folding Type.The requirement for carrying medicine and delivery system that structure and material inside each layer are bonded together in satisfaction in the form of biological composite membrane Under, the various structures and material that provide can be selected in above paper and patent document.
Due to the limitation of biomembrane manufacture craft, the biomembrane one side volume of whole is larger, on the other hand real and bone The area for rolling over the contact of concordant profipole inner surface depends on the area of fracture anastomosis line inner surface.So only and fracture anastomosis line in table Medicine on the biomembrane in that block region of face contact can just contact fracture anastomosis line inner surface.Therefore, the application really needs The technical problem of solution is:
First, how in biomembrane manufacture craft(Each Rotating fields and material)On the Process ba- sis not improved further, fracturing In the case that concordant profipole inner surface area is constant, the concentration of increase biomembrane release medicine and time;
Second, how preferably biomembrane to be bonded and is fixed on fracture anastomosis line;
Third, how preferably the tissues such as the muscle in the external world and fracture anastomosis line inner surface to be mutually isolated.
For first problem, after fracture operation, fracture anastomosis line(Between between the knochenbruch surface being stitched together Gap)Formation cross-section is " V " trench structure.It is now biological if being directly bonded horizontal biomembrane on the trench structure Film and the area of fracture anastomosis line inner surface contact are only:The length of the width * trench structures of " V " trench structure upper surface.Such as Fruit fills in the biomembrane that section itself is also " V " in the trench structure inner surface, then now biomembrane and fracture anastomosis line The area of inner surface contact is at least:The length * 2 of the depth * trench structures of " V " trench structure." on ' V ' type trench structure When the width on surface " and " depth of ' V ' type trench structure " ratio are close to " 1 ", now obvious 2nd kind of biofilm structure can be Biomembrane manufacture craft(Each Rotating fields and material)On the Process ba- sis not improved further, in fracture anastomosis line inner surface face In the case that product is constant, increase biomembrane and the area of fracture anastomosis line inner surface contact.
For Second Problem, later composite biological film is folded, because its internal layer is elastic layer, outer layer is weaker zone (Medicine layer), therefore later " V " structure is folded, by the elastic reaction of internal layer elastic layer(Elastic layer material is fine and close, fold with After produce restoring force), itself has the trend expanded to both sides.Elastic force caused by certain elastic layer is very little, but It is enough inner surface of the edge " compression " at left and right sides of the top composite biological film " V " structure in fracture anastomosis line both sides.
For the 3rd problem, principle is same as above, because the edge " compression " at left and right sides of composite biological film top is being fractured The inner surface of concordant profipole both sides, hence in so that the tissue such as fracture anastomosis line inner surface and outside muscle obtain effectively every From.
Simultaneously as the elastic layer material is that can not permeate the Medical Living Creature Gum of growth factor, therefore medicine layer is encapsulated Medicine, can only be to inner side(Fracture anastomosis line inner surface)Release, can not discharge laterally(The human body tissue sides such as muscle)So that Limited entrapped drug(One of biomembrane process bottleneck is exactly the amount of entrapped drug can not be too many)Can be with targeted release to fracture Concordant profipole inner surface, reach the purpose precisely treated.
What is required emphasis is a little that the application uses outer layer as weaker zone(Medicine layer)It is direct with fracture anastomosis line inner surface The mode of contact, brings a performance more superior than traditional biological film laminating type, i.e. weaker zone can draw in bony surface Lead osteocyte to grow in the material of porosity and looseness, new osteocyte can also obtain entrapped drug in weaker zone in production process Effective nourishing and promotion.As for porosity and looseness material in itself, degradable substance can be selected to make, or even further, Made using the material for having facilitation after degraded to bone cell growth.
What is retrieved when the application submits heals applied to fracture anastomosis line closest to for documents, not retrieving Foldable structure composite biological film.Expand application field to be retrieved, CN201510716279.8 is due to proposing compound bio Film using when first pass through folding or convolution formed fibroin layer be internal layer, collagen layer is middle level, high polymer layer is outer layer Bridge grafting nerves support, belong to application field difference, but disclose more technical characteristic.But it does not still destroy the application Creativeness.It can be found from CN201510716279.8 accompanying drawing 3, the purpose for playing folding and convolution is by composite biological film Formed " concentric multi-layer cylinder structure ", change technical characteristic and the application be different, secondly its solve be " will fold or certificate Support after folding(Multi-layer cylinder structure composite biomembrane)Both ends and the nerve tract both ends blocked are sutured by surgical method " Its technical problem solved, the technique effect and the application of acquirement are entirely different, therefore do not destroy the creativeness of the application.
Brief description of the drawings
Fig. 1 is 4 in the present invention)When biology microstructure film be covered on model vertex, and wrap model vertex and Extend to the schematic diagram of model vertex both sides.
Embodiment
With reference to figure 1,1)Drift angle section is made in advance as " W " font and 2 raised spikes and fracture line section coincide Model;
2)Elastic layer, the medicine layer of moistening are made respectively, the elastic layer is fine and close degradable or nondegradable biomembrane, Medicine layer material be and the good degraded or non-degradable of human body bone bio-compatible, absorb do not absorb either or it is porous Unconsolidated material, the medicine for having facilitation to sclerotin healing is also encapsulated with inside medicine layer;
3)The elastic layer of moistening is covered on 2 raised spikes of model, wraps 2 raised spikes of model and extension It is covered in model vertex both sides, then by the medicine layer of moistening on elastic layer, forms biological microstructure film;
4)After air-drying shape fixation etc. biological microstructure film, the biological microstructure film made is peeled off from model vertex. Model is wax, and wax and elastic layer material are immiscible from each other, is easy to peel off from wax pattern after air-drying.5), by " W " It is " V " type film that type film, which is cut,.

Claims (10)

1. a kind of " W " model production method for the tip biomembrane for improving union, comprises the following steps:
1)It is the model that " W " font and 2 raised spikes and fracture line section coincide to make drift angle section in advance;
2)Elastic layer, the medicine layer of moistening are made respectively, the elastic layer is fine and close degradable or nondegradable biomembrane, Medicine layer material be and the good degraded or non-degradable of human body bone bio-compatible, absorb do not absorb either or it is porous Unconsolidated material, the medicine for having facilitation to sclerotin healing is also encapsulated with inside medicine layer;
3)The elastic layer of moistening is covered on 2 raised spikes of model, wraps 2 raised spikes of model and extension It is covered in model vertex both sides, then by the medicine layer of moistening on elastic layer, forms biological microstructure film;
4)After air-drying shape fixation etc. biological microstructure film, the biological microstructure film made is peeled off from model vertex,
5), it is " V " type film that " W " type film, which is cut,.
2. a kind of " W " model production method of tip biomembrane for improving union as claimed in claim 1, its feature For:Fracture line section after in vitro people's bone artificial fracture with being made.
3. a kind of " W " model production method of tip biomembrane for improving union as claimed in claim 2, its feature For:Drift angle section be " V " font and with fracture line section coincide model be cast in wax on fracture line, then wait wax solidification with After be formed model, then model is taken off from fracture line.
4. a kind of " W " model production method of tip biomembrane for improving union as claimed in claim 3, its feature For:4)Before, by biological microstructure film periphery so that the Medical Living Creature Gum of the stimulate neuronal growth factor and stem cell can not be permeated Closing.
5. a kind of " W " model production method of tip biomembrane for improving union as claimed in claim 4, its feature For:The elastic layer material is the one or several kinds in PLA, collagen, fibrin, biogel, poly butyric ester Mixture.
6. a kind of " W " model production method of tip biomembrane for improving union as claimed in claim 5, its feature For:The elastic layer material is that can not permeate the Medical Living Creature Gum of the stimulate neuronal growth factor and stem cell.
7. a kind of " W " model production method of tip biomembrane for improving union as claimed in claim 6, its feature For:Medicine Rotating fields be and human body bone bio-compatible good fiber shape or areolation.
8. a kind of " W " model production method of tip biomembrane for improving union as claimed in claim 7, its feature For:The material of medicine layer is using the material for having facilitation after degraded to bone cell growth.
9. a kind of " W " model production method of tip biomembrane for improving union as claimed in claim 8, its feature For:Medicine layer material is azelon either cellulose or biogel or sterilization algal gel or antimicrobial activity charcoal.
10. a kind of " W " model production method of tip biomembrane for improving union as claimed in claim 9, its feature For:The combination of growth factor either stem cell or growth factor and stem cell is encapsulated with medicine layer.
CN201711022047.8A 2017-10-26 2017-10-26 A kind of " W " model production method for the tip biomembrane for improving union Withdrawn CN107812252A (en)

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