CN105903073B - A kind of absorbable shape memory nerve casing and its preparation process - Google Patents
A kind of absorbable shape memory nerve casing and its preparation process Download PDFInfo
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- CN105903073B CN105903073B CN201610448506.8A CN201610448506A CN105903073B CN 105903073 B CN105903073 B CN 105903073B CN 201610448506 A CN201610448506 A CN 201610448506A CN 105903073 B CN105903073 B CN 105903073B
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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
- A61L27/26—Mixtures of macromolecular compounds
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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
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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
- A61L27/54—Biologically active materials, e.g. therapeutic substances
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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
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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
- 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
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
- A61L2300/414—Growth factors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/32—Materials or treatment for tissue regeneration for nerve reconstruction
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Abstract
The invention belongs to the field of medical instrument technology, it is related to a kind of absorbable shape memory nerve casing and its preparation process, neural casing is composed of the following raw materials in parts by weight: 40-55 parts of major ingredient, 1-5 parts of coupling agents, 5-15 parts of polyfunctional monomers, 1-3 parts of auxiliary agents, 10-20 parts of fillers, the major ingredient include polycaprolactone, poly-succinic acid-butanediol and polyanhydride；The auxiliary agent includes chitin oligosaccharide, agarose and collagen gel；Good biocompatibility is can absorb, and has shape memory function, and Memorability is stablized, and response rate is high, and turnaround time is easily controllable, greatly reduces neural restoration operating difficulty, promotes neural restoration.
Description
Technical field
The invention belongs to the field of medical instrument technology, are related to a kind of neural casing, especially a kind of absorbable shape memory
Neural casing and its preparation process.
Background technique
It is the disease frequently encountered in clinical position that peripheral nerve, which comes to harm, will lead to the forfeiture and motor function of feeling
Obstacle.Since nerve cell does not divide, no penetration power is grown, regeneration in vivo is extremely difficult.Current nerve of repairing lacks
Damage all multi-methods in, because neural sleeve technology can avoid sacrifice autologous nerve and it is identical when caused by nerve damage again due to by
Concern becomes a hot spot in peripheral nerve reparation.Neural casing can play the role of supporting neural axon migration, still
Neural casing is high to material requirements used by it due to using in vivo.
Always also under study for action to the material of neural casing at present, have using natural material, such as blood vessel, Laminin ELISA
Deng, but be difficult to produce in batches, and quality and performance are difficult to control.Also have using synthetic material, for example, by using application number
For 200610023175X a kind of biological absorptive bundling belt and its shape memory lock buckle disclosed on August 23rd, 2006, with poly-
Caprolactone is fertile material, is properly added auxiliary material and is prepared, and can be degraded and absorb by organism, but is made of above-mentioned material
Neural casing, also there is also certain problems in actual use, fall flat to the reparation of nerve.
Summary of the invention
It is an object of the invention to solve to improve one using the material select permeability of neural casing in the neural restoration of periphery
Kind absorbable shape memory nerve casing, by the improvement to material of main part and other auxiliary agents, realization can shape memory, and with it is outer
There is good compatibility between all nerves, promote the reparation of nerve, and facilitate the progress of operation.
The present invention also provides the preparation processes of above-mentioned neural casing, are joined by the technique of control processing step and each step
Number, so that the maximization of neural casing each component function, and it is able to achieve the facilitation of component to each other.
In order to achieve the above object, the present invention adopts the following technical scheme that: a kind of absorbable shape memory nerve casing,
Be composed of the following raw materials in parts by weight: 40-55 parts of major ingredient, 1-5 parts of coupling agents, 5-15 parts of polyfunctional monomers, 1-3 parts help
Agent, 10-20 parts of fillers, the major ingredient include polycaprolactone, poly-succinic acid-butanediol and polyanhydride；The auxiliary agent includes that crust is low
Glycan, agarose and collagen gel.
As a preferred embodiment of the above technical solution, raw material further includes the reparative factor of 0.5-2.5 parts by weight, is conducive to accelerate mind
The reparation of warp.
Further preferably, the reparative factor includes nerve growth factor, brain-derived neurotrophic factor, basic fibroblast
One or more of Porcine HGF and vascular endothelial growth factor mixture.
The reparation of above-mentioned several factor pair peripheral nerves has a facilitation, further preferably basic fibroblast growth because
The mass mixings such as son and vascular endothelial growth factor promote to repair, and improve to the compatibility tool of neural casing
Effect.
As a preferred embodiment of the above technical solution, in the major ingredient polycaprolactone, poly-succinic acid-butanediol and polyanhydride matter
Amount proportion is 1:0.1-0.3:0.3-0.5.
Polycaprolactone, poly-succinic acid-butanediol and polyanhydride are equal in above-mentioned technical proposal, good for biocompatibility, and can
The material of absorption；Using the combination of said ratio, absorbable characteristic not only can satisfy, but also Memorability is more stable, drawing
After the size for extending to suitable surgical procedure, response rate is high, and turnaround time is more conducive to control.
Further preferably the proportion of polycaprolactone, poly-succinic acid-butanediol and polyanhydride is 1:0.1:0.4.
As a preferred embodiment of the above technical solution, in the auxiliary agent chitin oligosaccharide, agarose and collagen gel according to 0.5-
The quality proportioning of 0.8:1:0.1-0.2 is added.
The above-mentioned auxiliary agent of addition has stabilization to the characteristic for stablizing neural casing so that neural casing not only have it is suitable
Suitable intensity, suppleness, can support nerve, and will not damage to nerve, be conducive to the reparation of nerve, and auxiliary agent
It is added, is conducive to the retention time for controlling intensity, to meet the needs of neural restoration；Auxiliary agent itself, which also has, promotes neural restoration
Effect.
As a preferred embodiment of the above technical solution, the filler is alginate fibre, calcium monohydrogen phosphate and poly(hydrobutyl ester) according to matter
Amount is than being 5-6:1.5-2.5:1.The addition of filler substantially increases the stability of material, keeps its Memorability more stable, and deformation is steady
It is fixed, controllable.
The preparation process of above-mentioned absorbable shape memory nerve casing, include the following steps: (1) by major ingredient and coupling agent,
Filler mixes by weight, obtains the first mixture；(2) polyfunctional monomer, auxiliary agent are added to the first mixing by weight
In material, 15-30min is mixed at being 55-60 DEG C in temperature, is mixed to get the second mixture；(3) by second mixture and institute
Reparative factor mixing is stated, and the hollow pipe that pipe thickness is 0.3-0.6mm is made；(4) hollow pipe is radiated, and in 50-
Expand the internal diameter of hollow pipe at a temperature of 55 ° to 2.5-4 times of hollow pipe raw material internal diameter, obtains neural casing；The dosage rate of radiation
It is 6 × 103To 8 × 103 Gy/h。
By implementing above-mentioned technical proposal, the present invention is with following the utility model has the advantages that nerve casing provided by the invention is raw
Object compatibility is good, absorbable, has shape memory function, and Memorability is stablized, and response rate is high, and turnaround time is easily controllable,
Neural restoration operating difficulty is greatly reduced, neural restoration is promoted.
Specific embodiment
Combined with specific embodiments below, invention is further described in detail.
Embodiment 1:
A kind of absorbable shape memory nerve casing, the raw material including following parts by weight: 50 parts of major ingredient, 1- parts of couplings
Agent, 15 parts of polyfunctional monomers, 2 parts of auxiliary agents, 15 parts of fillers, the major ingredient include polycaprolactone, poly-succinic acid-butanediol and gather
Acid anhydrides, the quality proportioning of three are 1:0.1:0.5；The auxiliary agent includes chitin oligosaccharide, agarose and collagen gel, according to
The quality proportioning of 0.6:1:0.1 is added；It according to mass ratio is 5 that the filler, which is alginate fibre, calcium monohydrogen phosphate and poly(hydrobutyl ester):
2.5:1；Coupling agent uses hydrocarbyloxysilane；Polyfunctional monomer uses pentaerythrite triolefin acid esters.
The preparation process of above-mentioned absorbable shape memory nerve casing, include the following steps: (1) by major ingredient and coupling agent,
Filler mixes by weight, obtains the first mixture；(2) polyfunctional monomer, auxiliary agent are added to the first mixing by weight
In material, 20min is mixed at being 55 DEG C in temperature, is mixed to get the second mixture；(3) by second mixture and the reparation
Factor mixing, and the hollow pipe that pipe thickness is 0.5mm is made；(4) hollow pipe is radiated, and expanded at 50 °C
The internal diameter of hollow pipe obtains neural casing to 3 times of hollow pipe raw material internal diameter；The dosage rate of radiation is 6 × 103 Gy/h。
Embodiment 2:
A kind of absorbable shape memory nerve casing, the raw material including following parts by weight: 55 parts of major ingredient, 5 parts of coupling agents,
10 parts of polyfunctional monomers, 3 parts of auxiliary agents, 20 parts of fillers, the major ingredient include polycaprolactone, poly-succinic acid-butanediol and polyacids
Acid anhydride, the quality proportioning of three are 1:0.2:0.3；The auxiliary agent includes chitin oligosaccharide, agarose and collagen gel, according to 0.5:
1:0.2 quality proportioning addition；It according to mass ratio is 6:2:1 that the filler, which is alginate fibre, calcium monohydrogen phosphate and poly(hydrobutyl ester),；
Coupling agent uses silane coupling agent；Polyfunctional monomer uses trimethylol-propane trimethacrylate.
The preparation process of above-mentioned absorbable shape memory nerve casing, include the following steps: (1) by major ingredient and coupling agent,
Filler mixes by weight, obtains the first mixture；(2) polyfunctional monomer, auxiliary agent are added to the first mixing by weight
In material, 15min is mixed at being 58 DEG C in temperature, is mixed to get the second mixture；(3) by second mixture and the nerve
Reparative factor mixing, and the hollow pipe that pipe thickness is 0.3mm is made；(4) hollow pipe is radiated, and at a temperature of 55 °
Expand the internal diameter of hollow pipe to 2.5 times of hollow pipe raw material internal diameter, obtains neural casing；The dosage rate of radiation is 7 × 103 Gy/
h。
Embodiment 3:
A kind of absorbable shape memory nerve casing, the raw material including following parts by weight: 40 parts of major ingredient, 4 parts of coupling agents,
5 parts of polyfunctional monomers, 1 part of auxiliary agent, 10 parts of fillers, the major ingredient include polycaprolactone, poly-succinic acid-butanediol, thermoplastic starch
Powder and polyanhydride, the quality proportioning of three are 1:0.3:0.1:0.4, and thermoplastic starch is conducive to improve the deformation plasticity of casing
Can, memory deformation performance is more stable；The auxiliary agent includes chitin oligosaccharide, agarose and collagen gel, according to 0.8:1:0.1's
Quality proportioning addition；It according to mass ratio is 5.5:1.5:1 that the filler, which is alginate fibre, calcium monohydrogen phosphate and poly(hydrobutyl ester),；It is even
Join agent and uses hydrocarbyloxysilane；Polyfunctional monomer uses pentaerythrite triolefin acid esters.
The preparation process of above-mentioned absorbable shape memory nerve casing, include the following steps: (1) by major ingredient and coupling agent,
Filler mixes by weight, obtains the first mixture；(2) polyfunctional monomer, auxiliary agent are added to the first mixing by weight
In material, 30min is mixed at being 60 DEG C in temperature, is mixed to get the second mixture；(3) by second mixture and the nerve
Reparative factor mixing, and the hollow pipe that pipe thickness is 0.6mm is made；(4) hollow pipe is radiated, and at a temperature of 52 °
Expand the internal diameter of hollow pipe to 4 times of hollow pipe raw material internal diameter, obtains neural casing；The dosage rate of radiation is 8 × 103 Gy/h。
Embodiment 4:
A kind of absorbable shape memory nerve casing, the raw material including following parts by weight: 42 parts of major ingredient, 3 parts of coupling agents,
8 parts of polyfunctional monomers, 2.5 parts of auxiliary agents, 16 parts of fillers, the major ingredient include polycaprolactone, poly-succinic acid-butanediol, thermoplasticity
Starch and polyanhydride, the quality proportioning of three are 1:0.15:0.2:0.35, and the deformation that thermoplastic starch is conducive to improve casing can
Plasticity energy, memory deformation performance are more stable；The auxiliary agent includes chitin oligosaccharide, agarose and collagen gel, according to 0.6:1:
0.15 quality proportioning addition；The filler be alginate fibre, calcium monohydrogen phosphate and poly(hydrobutyl ester) and the third fiber of acetic acid according to
Mass ratio is 5.5:2:1:1；Coupling agent uses silane coupling agent；Polyfunctional monomer uses trimethylol propane trimethyl propylene
Acid esters.
The preparation process of above-mentioned absorbable shape memory nerve casing, include the following steps: (1) by major ingredient and coupling agent,
Filler mixes by weight, obtains the first mixture；(2) polyfunctional monomer, auxiliary agent are added to the first mixing by weight
In material, 25min is mixed at being 55 DEG C in temperature, is mixed to get the second mixture；(3) by second mixture and the nerve
Reparative factor mixing, and the hollow pipe that pipe thickness is 0.4mm is made；(4) hollow pipe is radiated, and at a temperature of 54 °
Expand the internal diameter of hollow pipe to 3.5 times of hollow pipe raw material internal diameter, obtains neural casing；The dosage rate of radiation is 6 × 103 Gy/
h。
Claims (7)
1. a kind of absorbable shape memory nerve casing, which is characterized in that the raw material including following parts by weight: 40-55 parts of master
Material, 1-5 parts of coupling agents, 5-15 parts of polyfunctional monomers, 1-3 parts of auxiliary agents, 10-20 parts of fillers, the major ingredient include polycaprolactone,
Poly-succinic acid-butanediol and polyanhydride, the quality proportioning of polycaprolactone, poly-succinic acid-butanediol and polyanhydride is in the major ingredient
1:0.1-0.3:0.3-0.5；The auxiliary agent includes chitin oligosaccharide, agarose and collagen gel, and crust is oligomeric in the auxiliary agent
Sugar, agarose and collagen gel are added according to the quality proportioning of 0.5-0.8:1:0.1-0.2.
2. a kind of absorbable shape memory nerve casing according to claim 1, which is characterized in that raw material further includes 0.5-
The reparative factor of 2.5 parts by weight.
3. a kind of absorbable shape memory nerve casing according to claim 2, which is characterized in that the reparative factor includes
Nerve growth factor, brain-derived neurotrophic factor, basic fibroblast growth factor and vascular endothelial growth factor
One or more of mixture.
4. a kind of absorbable shape memory nerve casing according to claim 1, which is characterized in that the filler is that seaweed is fine
Dimension, calcium monohydrogen phosphate and poly(hydrobutyl ester) are 5-6:1.5-2.5:1 according to mass ratio.
5. a kind of preparation process of absorbable shape memory nerve casing as claimed in claim 2, which is characterized in that including as follows
Step: (1) mixing major ingredient and coupling agent, filler by weight, obtains the first mixture；(2) by polyfunctional monomer, auxiliary agent
It is added in the first mixture by weight, mixes 15-30min at being 55-60 DEG C in temperature, be mixed to get the second mixture；
(3) second mixture is mixed with the reparative factor, and hollow pipe is made；(4) hollow pipe is radiated, and
Expand the internal diameter of hollow pipe at a temperature of 50-55 DEG C to 2.5-4 times of hollow pipe raw material space, obtains neural casing.
6. a kind of preparation process of absorbable shape memory nerve casing according to claim 5, which is characterized in that the sky
The pipe thickness of heart pipe is 0.3-0.6mm.
7. a kind of preparation process of absorbable shape memory nerve casing according to claim 5, which is characterized in that step
(4) in, the dosage rate of radiation is 6 × 103To 8 × 103 Gy/h。
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| US11844879B2 (en) | 2018-03-01 | 2023-12-19 | Tepha, Inc. | Articles of poly(butylene succinate) and copolymers thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US20190269815A1 (en) | 2018-03-01 | 2019-09-05 | Tepha, Inc. | Yarns and fibers of poly(butylene succinate) and copolymers thereof, and methods of use therof |
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| FR2519992B1 (en) * | 1982-01-20 | 1986-04-04 | Lhd Lab Hygiene Dietetique | PROCESS FOR THE PREPARATION OF A NEW MEMORY THERMOPLASTIC COMPOSITION FROM POLYCAPROLACTONE AND POLYURETHANE, PRODUCT OBTAINED ACCORDING TO THIS PROCESS AND ITS USE IN PARTICULAR IN ORTHOPEDICS |
| CN1462769A (en) * | 2003-04-02 | 2003-12-24 | 西北工业大学 | Biogegradable oryic shape memory material and its preparation method |
| CN1544096A (en) * | 2003-11-27 | 2004-11-10 | 中国科学院长春应用化学研究所 | Shape memory processing biodegradating vitro fixed material for medical use and its preparation |
| CN102247623B (en) * | 2011-08-17 | 2014-07-23 | 上海微创医疗器械（集团）有限公司 | Multilayer degradable stent having shape memory and preparation method thereof |
| CN104353110B (en) * | 2014-09-29 | 2016-02-24 | 大连大学 | For the bone holder material with shape memory function and preparation method thereof of jawbone reparation |
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| US11844879B2 (en) | 2018-03-01 | 2023-12-19 | Tepha, Inc. | Articles of poly(butylene succinate) and copolymers thereof |
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