CN106693071B - A kind of biodegradable medical nerve repairs conduit and preparation method thereof - Google Patents
A kind of biodegradable medical nerve repairs conduit and preparation method thereof Download PDFInfo
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- CN106693071B CN106693071B CN201611141092.0A CN201611141092A CN106693071B CN 106693071 B CN106693071 B CN 106693071B CN 201611141092 A CN201611141092 A CN 201611141092A CN 106693071 B CN106693071 B CN 106693071B
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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
- A61L27/50—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
-
- 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
-
- 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
- A61L27/20—Polysaccharides
-
- 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
- A61L27/14—Macromolecular materials
- A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
- A61L27/24—Collagen
-
- 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
- A61L27/56—Porous materials, e.g. foams or sponges
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L89/00—Compositions of proteins; Compositions of derivatives thereof
-
- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
- A61F2240/002—Designing or making customized prostheses
-
- 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
- A61L2430/32—Materials or treatment for tissue regeneration for nerve reconstruction
Abstract
The invention discloses a kind of biodegradable medical nerves to repair conduit and preparation method thereof,It is related to medical field,Including catheter body,The catheter body includes inner and outer tubes,Fiber film layer is equipped between the outer tube and inner tube,The fiber film layer is mixed by fibroin fiber and acid fiber by polylactic,The internal diameter of the outer tube is 0.5 1.5 millimeters,The wall thickness of outer tube is 0.01 0.05 millimeters,The internal diameter of said inner tube is 0.2 1.2 millimeters,The wall thickness of inner tube is 0.1 0.3 millimeters,The wall thickness of fiber film layer is 0.1 0.5 millimeters,The outer wall of said inner tube is equipped with several air holes,The outer tube is made of porous materials,The porous material is by trimethylene carbonate,Poly (glycolide-lactide) and fibroin composition,The invention,Both it can guarantee that medical nerve repaired conduit and has good gas permeability,It can guarantee that medical nerve repairs the intensity of conduit again,It disclosure satisfy that clinical practice requirement,And the preparation method that the present invention uses,Advantages of simple,It is time saving and energy saving,Energy conservation and environmental protection,It can ensure the quality of terminal conduit simultaneously.
Description
Technical field
The present invention relates to medical field, more particularly to a kind of biodegradable medical nerve repairs conduit and its preparation side
Method.
Background technology
Biodegradable medical nerve, which repairs conduit, has good biological degradability and excellent biocompatibility, energy
Enough degradation in vivo are for micromolecular compound and by organism metabolism, absorption or excretion, slow for embedded type medical treatment device, drug
When the clinical applications such as control delivery and tissue engineering bracket, without second operation, patient's pain can be mitigated, simplify operation journey
Sequence has the effects that improve therapeutic effect, extends patients ' lives and improve quality of life of patients.Therefore, biodegradable medical
Nerve rehabilitating tube is more and more widely used in biomedicine field, and is effectively advanced biological medicine and faced
The development of bed medicine.
But in the actual application of field of medicaments, clinical demand repairs conduit to biodegradable medical nerve
Specification, the precision requirement of the homogenization degree of microscopic pattern and size it is high, otherwise will directly influence actual clinical
Effect brings great side effect even life danger to user.
Medical nerve in the prior art repairs conduit, often there is poor air permeability, the problems such as intensity difference, in very great Cheng
It is difficult to for biodegradable polymers to be processed into the tubing that disclosure satisfy that clinical practice requirement on degree.
Except this, there is very high requirement to the processing technology of Biodegradable material, before forming end product, it is necessary to
Strictly control biodegradable polymeric machining process and technological parameter, it is ensured that the high-precision densification of tubing geometric dimension and
Material microscopic pattern it is high-homogenized.Currently, the common method of processable polymer tubing has extrusion, injection, molding, gas auxiliary
The forming methods such as injection.In above-mentioned processing method, it is necessary to using heating, pressurization, shearing and solvent or additive be added
Etc. techniques to realize the smooth implementation of processing, once implement in the process of biodegradable polymers plus stating technique,
It will certainly make biodegradable polymers that physicochemical change occur, such as thermal degradation, shear shinning, pyrohydrolysis reaction, chain tra nsfer
Equal side reactions, destroy the initial configuration of biodegradable polymers, reduce its initial molecular weight and expand molecular weight distribution index,
And then some negative effects are generated to the physically and/or chemically performance of polymer, it is difficult to ensure the quality of terminal conduit.
As application No. is 200310101675.7 to disclose a kind of conduit material of peripheral nerve reparation, the conduit for China
Material is prepared using chitosan, poly-D-lysine as raw material by rotary evaporation method, and conduit material prepared by this method has good
Good biocompatibility, however, its hydrophily raw material for using, in use hygroscopic swelling cause catheter diameter
Narrow pressuring nerve.
For another example China application No. is 201010595866.3 provide a kind of orientated nano fiber bionic nerve conduit and its
Production method prepares oriented nanofibers film layer by coaxial electrostatic spinning, and nerve trachea, this mode is made in then curling
The nerve trachea of preparation has fully considered the guiding function to nerve in microstructure, however passes through the side of pipe crimping after being first film-made
Gap is larger between layers for nerve trachea prepared by formula, will substantially reduce the mechanical strength of conduit entirety, and be easy to cause pipe
Wall collapses, and hinders nerve regneration.
For another example, application No. is 200410009259.9 to provide a kind of neural tissue engineering tubular bracket and its preparation for China
Method, it is 1-5mm semipermeability chitosan hollow pipes that this method prepares internal diameter first, and chitosan, collagen are then poured into pipe
Or the biological macromolecule solns such as gelatin, using particular manufacturing craft and Freeze Drying Technique, prepare there is 7-50 axial passage can
For the tubular bracket of repairing of neural injury, this method is disadvantageous in that, the fine structure inside nerve trachea is mixed and disorderly
It is limited to being acted on the directional guide of CO2 laser weld in nerve regeneration without chapter, and due to used in the tubular bracket
Raw material is hydrophilic biological macromolecule substance, makes it in use, absorbs body fluid and swelling set occurs, so as to cause pipe
The internal diameter of shape holder reduces, and pressuring nerve is unfavorable to nerve regneration.
Invention content
Technical problem to be solved by the invention is to provide a kind of biodegradable medical nerves to repair conduit and its system
Preparation Method repairs conduit to solve medical nerve caused by the prior art, and often there is poor air permeability, intensity difference etc. is asked
Topic, is largely difficult to for biodegradable polymers to be processed into the tubing that disclosure satisfy that clinical practice requirement, and
Preparation process is complicated, it is difficult to ensure the above-mentioned defects such as the quality of terminal conduit.
To achieve the above object, the present invention provides technical solution below：A kind of biodegradable medical nerve reparation
Conduit, including catheter body, the catheter body include inner and outer tubes, and fiber film layer is equipped between the outer tube and inner tube,
The fiber film layer is mixed by fibroin fiber and acid fiber by polylactic, and the internal diameter of the outer tube is 0.5-1.5 millimeters, outside
The wall thickness of pipe is 0.01-0.05 millimeters, and the internal diameter of said inner tube is 0.2-1.2 millimeters, and the wall thickness of inner tube is 0.1-0.3 millimeters,
The wall thickness of fiber film layer is 0.1-0.5 millimeters, and the outer wall of said inner tube is equipped with several air holes, and the outer tube is by porous material
It is made, the porous material is made of trimethylene carbonate, poly (glycolide-lactide) and fibroin.
Preferably, said inner tube is made of chitosan, collagen, lecithin and chitin.
Preferably, the raw material composition of said inner tube, is calculated as by following parts by weight：40-60 parts of chitosan, collagen 10-
20 parts, 6-10 parts of lecithin, 2-8 parts of chitin.
Preferably, the poly (glycolide-lactide) is by the hydroxyacetic acid group of the lactic acid and 10-30 weight % of 70-90 weight %
At.
A kind of biodegradable medical nerve repairs the preparation method of conduit, includes the following steps：
(1) inner tube is prepared：Mold with tubulose die cavity is placed in reactor, the raw material of inner tube is put into reactor
It is interior, and closed reactor；Under the conditions of 40-100 DEG C, 48-72h is reacted, cooling, demoulding can be obtained inner tube；
(2) inner tube set is collected mounted in electrostatic spinning on stick, and the outer wall needle of inner tube is pricked into several air holes；
(3) prepared by fiber film layer, dissolves pure fibroin protein film and polylactic acid using hexafluoroisopropanol, it is molten to obtain blend spinning
Liquid, then by electrostatic spinning process, fiber film layer is prepared；
(4) by fiber film layer on the outer wall of inner tube, the inner tube with fiber film layer is obtained；
(5) electrostatic spinning process is used, the outer surface that the inner tube with fiber film layer on stick is collected in electrostatic spinning is covered
Lid porous material is to get to the complex of inner tube and outer tube, then the complex is placed in hydrophily biological macromolecular solution and is soaked
Bubble processing 6-10 hour, then freezes under conditions of -15--90 DEG C, after freeze-dried processing, demoulds and can be obtained conduit sheet
Body.
Preferably, the technological parameter of electrostatic spinning is in the step (3) and step (5)：30 kilovolts of voltage, pole span
12-16 centimetres.
Preferably, the mass percent of hydrophily bioabsorbable polymer material is in the hydrophily biological macromolecular solution
10-20%.
Advantageous effect using the present invention：Biodegradable medical nerve prepared by the present invention repairs conduit, and existing
Technology is compared and is had the following advantages：
(1) fiber film layer preferably combines inner and outer tubes, and elasticity is good, and intensity is good, and uses biocompatibility
Prepared by good Biodegradable material, the generation of side effects such as can avoid or diminish inflammation after implanting disclosure satisfy that life
The requirement of object medicine, and can be absorbed by organisms or drain, it is taken out without second operation.
(2) fiber film layer is mixed by fibroin fiber and acid fiber by polylactic, and fibroin fiber is in natural conditions
Under can degrade, degradation final product be amino acid, harmless, the good biocompatibility of acid fiber by polylactic, also have one
Fixed fungus resistance, the two is combined, compared with prior art in the nerve trachea without adding fiber film layer have it is fine
Compatibility and fungus resistance, it is safe, it is without side-effects, in addition, surprisingly do not have adhesive attraction fibroin albumen
Fiber film layer made of fiber and acid fiber by polylactic can will be made of chitosan, collagen, lecithin and chitin in
Pipe combines with the outer tube made of trimethylene carbonate, poly (glycolide-lactide) and fibroin, greatly improves inner and outer tubes
Between bond strength.
(3) outer tube is made of porous materials, and porous material is made of trimethylene carbonate, poly (glycolide-lactide) and fibroin,
Poly (glycolide-lactide) can adjust degradation speed according to the ratio of lactic acid in component and hydroxyacetic acid；Fibroin can promote and guide
Regenerating Axons pass through, and provide suitable low resistance flow channel and regeneration microenvironment for nerve regneration, repairing effect is good；Methylene carbonic acid
Ester has elasticity well, and intensity is big, its three is combined, the outer layer of acquisition, has preferable elasticity, and intensity
Greatly, repairing effect is good.
(4) outer wall of inner tube is equipped with several air holes, and inner and outer tubes are preferably combined, passed through by fiber film layer
It acts synergistically between various components so that the present invention not only can guarantee that medical nerve repaired conduit and has good gas permeability, but also energy
Ensure that medical nerve repairs the intensity of conduit, disclosure satisfy that clinical practice requirement.
(5) preparation method that the present invention uses, advantages of simple, time saving and energy saving, energy conservation and environmental protection, while can ensure that terminal is led
The quality of pipe.
Description of the drawings
Fig. 1 is the structural schematic diagram of the present invention.
Wherein, 1- catheter bodies, 11- inner tubes, 111- air holes, 12- outer tubes, 13- fiber film layers.
Specific implementation mode
Below by the description to embodiment, specific embodiments of the present invention will be described in further detail, with side
Those skilled in the art is helped to have more complete, accurate and deep understanding to the inventive concept of the present invention, technical solution.
Embodiment 1：
Structure chart 1 shows the specific implementation mode of the present invention：A kind of biodegradable medical nerve reparation conduit, including
Catheter body 1, the catheter body 1 include inner tube 11 and outer tube 12, and fiber film layer is equipped between the outer tube 12 and inner tube 11
13, fiber film layer 13 is mixed by fibroin fiber and acid fiber by polylactic, and the internal diameter of the outer tube 12 is 0.5 millimeter, outside
The wall thickness of pipe 12 is 0.05 millimeter, and the internal diameter of said inner tube 11 is 0.2 millimeter, and the wall thickness of inner tube 11 is 0.1 millimeter, fiber film layer
Wall thickness be 0.2 millimeter, the outer wall of said inner tube 11 is equipped with several air holes 111, and the outer tube 12 is made of porous materials,
The porous material is made of trimethylene carbonate, poly (glycolide-lactide) and fibroin.
In the present embodiment, said inner tube 11 is made of chitosan, collagen, lecithin and chitin.
In the present embodiment, the raw material of said inner tube 11 forms, and is calculated as by following parts by weight：40 parts of chitosan, collagen
20 parts, 6 parts of lecithin, 8 parts of chitin.
In the present embodiment, the poly (glycolide-lactide) is by the hydroxyl of the lactic acid and 10 weight % of 90 weight %
Acetic acid forms.
A kind of biodegradable medical nerve repairs the preparation method of conduit, includes the following steps：
(1) inner tube 11 is prepared：Mold with tubulose die cavity is placed in reactor, the raw material of inner tube 11 is put into instead
It answers in device, and closed reactor；Under the conditions of 40 DEG C, 72h is reacted, cooling, demoulding can be obtained inner tube 11；
(2) inner tube 11 is sleeved on electrostatic spinning to collect on stick, and the outer wall needle of inner tube 11 is pricked into several air holes
111；
(3) prepared by fiber film layer 13, dissolves pure fibroin protein film and polylactic acid using hexafluoroisopropanol, obtains blend spinning
Solution, then by electrostatic spinning process, fiber film layer 13 is prepared；
(4) by fiber film layer 13 on the outer wall of inner tube 11, the inner tube 11 with fiber film layer 13 is obtained；
(5) electrostatic spinning process is used, the appearance of the inner tube 11 with fiber film layer 13 on stick is collected in electrostatic spinning
Face covering porous material is placed in hydrophily boiomacromolecule to get to the complex of inner tube 11 and outer tube 12, then by the complex
Immersion treatment 6 hours in solution, then freezed under conditions of -90 DEG C, after freeze-dried processing, demoulding can be obtained conduit sheet
Body 1.
In the present embodiment, the technological parameter of electrostatic spinning is in the step (3) and step (5)：30 kilovolts of voltage, pole
Away from 12 centimetres.
In the present embodiment, the mass percent of hydrophily bioabsorbable polymer material in the hydrophily biological macromolecular solution
It is 10%.
Embodiment 2：
Structure chart 1 shows the specific implementation mode of the present invention：A kind of biodegradable medical nerve reparation conduit, including
Catheter body 1, the catheter body 1 include inner tube 11 and outer tube 12, and fiber film layer is equipped between the outer tube 12 and inner tube 11
13, fiber film layer 13 is mixed by fibroin fiber and acid fiber by polylactic, and the internal diameter of the outer tube 12 is 1.5 millimeters, outside
The wall thickness of pipe 12 is 0.01 millimeter, and the internal diameter of said inner tube 11 is 1.2 millimeters, and the wall thickness of inner tube 11 is 0.2 millimeter, fiber film layer
Wall thickness be 0.1 millimeter, the outer wall of said inner tube 11 is equipped with several air holes 111, and the outer tube 12 is made of porous materials,
The porous material is made of trimethylene carbonate, poly (glycolide-lactide) and fibroin.
In the present embodiment, said inner tube 11 is made of chitosan, collagen, lecithin and chitin.
In the present embodiment, the raw material of said inner tube 11 forms, and is calculated as by following parts by weight：60 parts of chitosan, collagen
10 parts, 10 parts of lecithin, 2 parts of chitin.
In the present embodiment, the poly (glycolide-lactide) is made of the lactic acid of 70 weight % and the hydroxyacetic acid of 30 weight %.
A kind of biodegradable medical nerve repairs the preparation method of conduit, includes the following steps：
(1) inner tube 11 is prepared：Mold with tubulose die cavity is placed in reactor, the raw material of inner tube 11 is put into instead
It answers in device, and closed reactor；Under the conditions of 100 DEG C, 48h is reacted, cooling, demoulding can be obtained inner tube 11；
(2) inner tube 11 is sleeved on electrostatic spinning to collect on stick, and the outer wall needle of inner tube 11 is pricked into several air holes
111；
(3) prepared by fiber film layer 13, dissolves pure fibroin protein film and polylactic acid using hexafluoroisopropanol, obtains blend spinning
Solution, then by electrostatic spinning process, fiber film layer 13 is prepared；
(4) by fiber film layer 13 on the outer wall of inner tube 11, the inner tube 11 with fiber film layer 13 is obtained；
(5) electrostatic spinning process is used, the appearance of the inner tube 11 with fiber film layer 13 on stick is collected in electrostatic spinning
Face covering porous material is placed in hydrophily boiomacromolecule to get to the complex of inner tube 11 and outer tube 12, then by the complex
Immersion treatment 10 hours in solution, then freezed under conditions of -15 DEG C, after freeze-dried processing, demoulding can be obtained conduit
Ontology 1.
In the present embodiment, the technological parameter of electrostatic spinning is in the step (3) and step (5)：30 kilovolts of voltage, pole
Away from 16 centimetres.
In the present embodiment, the mass percent of hydrophily bioabsorbable polymer material in the hydrophily biological macromolecular solution
It is 20%.
Embodiment 3：
Structure chart 1 shows the specific implementation mode of the present invention：A kind of biodegradable medical nerve reparation conduit, including
Catheter body 1, the catheter body 1 include inner tube 11 and outer tube 12, and fiber film layer is equipped between the outer tube 12 and inner tube 11
13, fiber film layer 13 is mixed by fibroin fiber and acid fiber by polylactic, and the internal diameter of the outer tube 12 is 1 millimeter, outer tube
12 wall thickness is 0.02 millimeter, and the internal diameter of said inner tube 11 is 0.2 millimeter, and the wall thickness of inner tube 11 is 0.3 millimeter, fiber film layer
Wall thickness is 0.5 millimeter, and the outer wall of said inner tube 11 is equipped with several air holes 111, and the outer tube 12 is made of porous materials, institute
Porous material is stated to be made of trimethylene carbonate, poly (glycolide-lactide) and fibroin.
In the present embodiment, said inner tube 11 is made of chitosan, collagen, lecithin and chitin.
In the present embodiment, the raw material of said inner tube 11 forms, and is calculated as by following parts by weight：50 parts of chitosan, collagen
15 parts, 8 parts of lecithin, 5 parts of chitin.
In the present embodiment, the poly (glycolide-lactide) is made of the lactic acid of 80 weight % and the hydroxyacetic acid of 20 weight %.
A kind of biodegradable medical nerve repairs the preparation method of conduit, includes the following steps：
(1) inner tube 11 is prepared：Mold with tubulose die cavity is placed in reactor, the raw material of inner tube 11 is put into instead
It answers in device, and closed reactor；Under the conditions of 70 DEG C, 60h is reacted, cooling, demoulding can be obtained inner tube 11；
(2) inner tube 11 is sleeved on electrostatic spinning to collect on stick, and the outer wall needle of inner tube 11 is pricked into several air holes
111；
(3) prepared by fiber film layer 13, dissolves pure fibroin protein film and polylactic acid using hexafluoroisopropanol, obtains blend spinning
Solution, then by electrostatic spinning process, fiber film layer 13 is prepared；
(4) by fiber film layer 13 on the outer wall of inner tube 11, the inner tube 11 with fiber film layer 13 is obtained；
(5) electrostatic spinning process is used, the appearance of the inner tube 11 with fiber film layer 13 on stick is collected in electrostatic spinning
Face covering porous material is placed in hydrophily boiomacromolecule to get to the complex of inner tube 11 and outer tube 12, then by the complex
Immersion treatment 8 hours in solution, then freezed under conditions of -52 DEG C, after freeze-dried processing, demoulding can be obtained conduit sheet
Body 1.
In the present embodiment, the technological parameter of electrostatic spinning is in the step (3) and step (5)：30 kilovolts of voltage, pole
Away from 14 centimetres.
In the present embodiment, the mass percent of hydrophily bioabsorbable polymer material in the hydrophily biological macromolecular solution
It is 15%.
Embodiment 4：
Structure chart 1 shows the specific implementation mode of the present invention：Structure chart 1 shows the specific implementation mode of the present invention：It is a kind of
Biodegradable medical nerve repairs conduit, including catheter body 1, and the catheter body 1 includes 12 groups of inner tube 11 and outer tube
At equipped with fiber film layer 13 between the outer tube 12 and inner tube 11, fiber film layer 13 is by fibroin fiber and acid fiber by polylactic
It is mixed, the internal diameter of the outer tube 12 is 1.2 millimeters, and the wall thickness of outer tube 12 is 0.03 millimeter, and the internal diameter of said inner tube 11 is
0.7 millimeter, the wall thickness of inner tube 11 is 0.3 millimeter, and the wall thickness of fiber film layer is 0.2 millimeter, and the outer wall of said inner tube 11 is equipped with
Several air holes 111, the outer tube 12 are made of porous materials, and the porous material is handed over by trimethylene carbonate, poly- second third
Ester and fibroin composition.
In the present embodiment, said inner tube 11 is made of chitosan, collagen, lecithin and chitin.
In the present embodiment, the raw material of said inner tube 11 forms, and is calculated as by following parts by weight：45 parts of chitosan, collagen
18 parts, 7 parts of lecithin, 4 parts of chitin.
In the present embodiment, the poly (glycolide-lactide) is made of the lactic acid of 72 weight % and the hydroxyacetic acid of 28 weight %.
A kind of biodegradable medical nerve repairs the preparation method of conduit, includes the following steps：
(1) inner tube 11 is prepared：Mold with tubulose die cavity is placed in reactor, the raw material of inner tube 11 is put into instead
It answers in device, and closed reactor；Under the conditions of 90 DEG C, 50h is reacted, cooling, demoulding can be obtained inner tube 11；
(2) inner tube 11 is sleeved on electrostatic spinning to collect on stick, and the outer wall needle of inner tube 11 is pricked into several air holes
111；
(3) prepared by fiber film layer 13, dissolves pure fibroin protein film and polylactic acid using hexafluoroisopropanol, obtains blend spinning
Solution, then by electrostatic spinning process, fiber film layer 13 is prepared；
(4) by fiber film layer 13 on the outer wall of inner tube 11, the inner tube 11 with fiber film layer 13 is obtained；
(5) electrostatic spinning process is used, the appearance of the inner tube 11 with fiber film layer 13 on stick is collected in electrostatic spinning
Face covering porous material is placed in hydrophily boiomacromolecule to get to the complex of inner tube 11 and outer tube 12, then by the complex
Immersion treatment 9 hours in solution, then freezed under conditions of -70 DEG C, after freeze-dried processing, demoulding can be obtained conduit sheet
Body 1.
In the present embodiment, the technological parameter of electrostatic spinning is in the step (3) and step (5)：30 kilovolts of voltage, pole
Away from 13 centimetres.
In the present embodiment, the mass percent of hydrophily bioabsorbable polymer material in the hydrophily biological macromolecular solution
It is 18%.
Based on above-mentioned, prepared by the present invention biodegradable medical nerve reparation conduit, including inner and outer tubes, outer tube
Fiber film layer is equipped between inner tube, fiber film layer is mixed by fibroin fiber and acid fiber by polylactic, and fibroin albumen is fine
Dimension can degrade under field conditions (factors), and degradation final product is amino acid, harmless, the biocompatibility of acid fiber by polylactic
It is good, also there is certain fungus resistance, the two is combined, compared with prior art in the nerve without adding fiber film layer lead
Pipe has good compatibility and fungus resistance, safe, without side-effects；Connection knob of the fiber film layer as inner tube and outer tube
Band has good plasticity and suitable mechanical properties strength, and inner and outer tubes can link together well, structure
Stablize, needle pricks several air holes wherein in inner tube, and outer tube is made of porous material, porous material by trimethylene carbonate,
Poly (glycolide-lactide) and fibroin composition, trimethylene carbonate have elasticity well, and intensity is big, and poly (glycolide-lactide) can be according to group
The ratio of lactic acid and hydroxyacetic acid in point, adjusts degradation speed, and fibroin can promote and guide Regenerating Axons as porous material
Pass through, provides suitable low resistance flow channel and regeneration microenvironment for nerve regneration, repairing effect is good, its three is combined
Synergistic effect so that outer tube has porous feature, both can guarantee that medical nerve repaired conduit and has good gas permeability in this way,
It can guarantee that medical nerve repairs the intensity of conduit again, disclosure satisfy that clinical practice requirement, led more than CO2 laser weld in the prior art
The intensity and repairing effect of pipe are good, nerve rehabilitating tube in the prior art, although can meet basic demand, in outer layer
Without containing fibroin, repairing effect is relatively poor, and the present invention is prepared using the good Biodegradable material of biocompatibility, is planted
The generation of side effects such as can avoid or diminish inflammation after entering in vivo, disclosure satisfy that the requirement of biological medicine, and can be absorbed by organisms
Or excretion, it is taken out without second operation, in addition, the preparation method that the present invention uses, advantages of simple, time saving and energy saving, energy conservation and environmental protection,
It can ensure the quality of terminal conduit simultaneously.
What has been described above is only a preferred embodiment of the present invention, it is noted that for those of ordinary skill in the art
For, without departing from the concept of the premise of the invention, various modifications and improvements can be made, these belong to the present invention
Protection domain.
Claims (6)
1. a kind of biodegradable medical nerve repairs conduit, it is characterised in that：Including catheter body, the catheter body packet
Inner and outer tubes are included, fiber film layer are equipped between the outer tube and inner tube, the fiber film layer is by fibroin fiber and poly- breast
Sour fiber is mixed, and the internal diameter of the outer tube is 0.5-1.5 millimeters, and the wall thickness of outer tube is 0.01-0.05 millimeters, said inner tube
Internal diameter be 0.2-1.2 millimeter, the wall thickness of inner tube is 0.1-0.3 millimeters, and the wall thickness of fiber film layer is 0.1-0.5 millimeters, described
The outer wall of inner tube is equipped with several air holes, and the outer tube is made of porous materials, and the porous material is by trimethylene carbonic acid
Ester, poly (glycolide-lactide) and fibroin composition；
Said inner tube is made of chitosan, collagen, lecithin and chitin.
2. biodegradable medical nerve according to claim 1 repairs conduit, it is characterised in that：The original of said inner tube
Material composition, is calculated as by following parts by weight：40-60 parts of chitosan, 10-20 parts of collagen, 6-10 parts of lecithin, chitin 2-8
Part.
3. biodegradable medical nerve according to claim 1 repairs conduit, it is characterised in that：The poly- second third is handed over
Ester is made of the lactic acid of 70-90 weight % and the hydroxyacetic acid of 10-30 weight %.
4. a kind of biodegradable medical nerve by described in claim 1-3 any one repairs the preparation method of conduit,
It is characterized in that：Include the following steps：
(1) inner tube is prepared：Mold with tubulose die cavity is placed in reactor, the raw material of inner tube is put into reactor, and
Closed reactor；Under the conditions of 40-100 DEG C, 48-72h is reacted, cooling, demoulding can be obtained inner tube；
(2) inner tube set prepared in step (1) is collected mounted in electrostatic spinning on stick, and the outer wall needle of inner tube is pricked several thoroughly
Stomata；
(3) prepared by fiber film layer：Pure fibroin protein film and polylactic acid are dissolved using hexafluoroisopropanol, obtains spinning mixed solution,
Again by electrostatic spinning process, fiber film layer is prepared；
(4) by fiber film layer on the outer wall of inner tube, the inner tube with fiber film layer is obtained；
(5) electrostatic spinning process is used, the outer surface covering that the inner tube with fiber film layer on stick is collected in electrostatic spinning is more
Porous materials are placed in hydrophily biological macromolecular solution to get to the complex of inner tube and outer tube, then by the complex at immersion
Reason 6-10 hour, then freezes under conditions of -15--90 DEG C, after freeze-dried processing, demoulds and can be obtained catheter body.
5. biodegradable medical nerve according to claim 4 repairs the preparation method of conduit, it is characterised in that：Institute
The technological parameter for stating electrostatic spinning in step (3) and step (5) is：30 kilovolts of voltage, 12-16 centimetres of pole span.
6. biodegradable medical nerve according to claim 4 repairs the preparation method of conduit, it is characterised in that：Institute
The mass percent for stating hydrophily bioabsorbable polymer material in hydrophily biological macromolecular solution is 10-20%.
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| CN102048595B (en) * | 2010-12-21 | 2013-05-15 | 东华大学 | Degradable nerve conduit with highly-oriented tube-in-tube structure and manufacturing method thereof |
| CN102908207B (en) * | 2012-10-30 | 2015-04-22 | 南通大学 | Tissue engineering nerve graft prepared by biological printing technology and preparation method thereof |
| CN103230622A (en) * | 2013-04-19 | 2013-08-07 | 南通纺织职业技术学院 | Conduit for tissue-engineered nerve transplanting and preparation method thereof |
| CN105288730B (en) * | 2015-09-30 | 2019-01-18 | 中国人民解放军总医院 | A kind of preparation method of the neurologic defect repair materials of imitative base film tube structure |
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