CN101474423B - Nerve conduit stent and preparation method thereof - Google Patents
Nerve conduit stent and preparation method thereof Download PDFInfo
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- CN101474423B CN101474423B CN 200910001598 CN200910001598A CN101474423B CN 101474423 B CN101474423 B CN 101474423B CN 200910001598 CN200910001598 CN 200910001598 CN 200910001598 A CN200910001598 A CN 200910001598A CN 101474423 B CN101474423 B CN 101474423B
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Abstract
The invention provides a neural catheter stent which comprises poly hydroxyl fatty acid ester. The inner wall of the neural catheter stent is a dense small poriform structure with the aperture of less than 10mum; the external wall is a loose macroporous structure with the aperture of 30-100mum. The neural catheter stent adopts the following steps: the polymers of poly hydroxyl fatty acid ester and organic solvent are mixed into uniform solution, wherein, the mixing proportion is each gram of the polymers of poly hydroxyl fatty acid ester is added with 8-20ml of organic solvent; the solution is added with water-soluble particles with different diameters and stirred uniformly, and then a round bar-shaped die is used for dipping the mixture; when the solution is solidified completely, pore-forming agent is dissolved out to obtain the porous structure. The neural catheter stent adopts the polymers of poly hydroxyl fatty acid ester as materials and has the advantages of excellent biocompatibility, wide raw material source, low production cost, simple preparing method, low requirements to equipment and wide application prospect.
Description
Technical field
The present invention relates to a kind of nerve conduit stent, specifically, relate to a kind of nerve conduit stent for the peripheral nervous defect repair and preparation method thereof, belong to biomedical material and field of tissue engineering technology.
Background technology
At modern medicine a large amount of patients that cause peripheral nerve injury because of contingency or malpractice are arranged clinically, according to incompletely statistics, annual about 469000 people of the nerve damage patient of the U.S., and Chinese population approximately is ten times of the U.S., patient group's number is also very huge.
The primary treatment mode that adopts for nerve injury clinically at present is nerve autograft, although the method can be repaired injured nerve effectively, also exists not enough greatly.On the one hand, the transplanting of autologous nerve certainly will damage the nerve for the tagma; On the other hand, some damage thick neural because can not find the graft that can mate, and can't treat and repair.Therefore, modern people gradually eye is shifted to can neuroprotective the nerve trachea of growth.
Now the degradation material commonly used in the tissue engineering nerve conduit has following several: collagen, chitosan, chitin, PLA, PLGA, PCL etc., wherein in the majority take chitosan, collagen and PLGA as Material Used of recent research.A kind of preparation method of chitosan composite nerve conduit is disclosed such as patent documentation CN1593354A; Patent documentation CN101138656A discloses neural tissue engineering tubular bracket and preparation method thereof, by the chitosan tube wall with have axial multichannel biogenetic derivation filling substrate and form, it is 1～5mm semipermeability chitosan hollow pipe that the method at first prepares internal diameter, then in pipe, pour into the biological macromolecule solns such as chitosan, collagen or gelatin, utilize particular manufacturing craft and Freeze Drying Technique, preparation has the tubular bracket that can be used for repairing of neural injury of 7～50 axial passages.
Collagen, chitosan belong to natural degradable high polymer material; has good biocompatibility; but the weak point of such material is unstable properties; because the host enzyme environmental evolution should not be reconciled degradation property; its mechanical strength and machining property are relatively poor; the problem such as its quality and performance and structural change be disproportionate in large-scale production, occurs easily being difficult to control, so product is difficult to accomplish scale production.Although and the materials such as PLA, PLGA, PCL have preferably machining property, and the source is sufficient, remains in problems at the aspects such as toxicity of cellular affinity, biocompatibility, catabolite.
Nerve trachea makes up and mainly contains electrical spinning method, phase separation method, particle leaching method etc.For improving the repair function of conduit, also there are some researcheres to utilize schwann cell and nerve growth factor to modify catheter holder.But because there is the bottleneck problem in source in schwann cell, neural factor is then expensive, is not suitable for common sufferer, and the safety issue that is implanted into of the equal body of this dual mode.Therefore support being carried out the modification of physical property, make its microstructure play the effect that promotes its growth in the protection injured nerve, is a kind of mode of more reasonable.
Summary of the invention
The purpose of this invention is to provide a kind of nerve conduit stent with good biocompatibility of being made by polyhydroxyalkanoate (PHA) series polymer.
Another object of the present invention provides the method for the above-mentioned nerve conduit stent of preparation.
In order to realize the object of the invention, a kind of nerve conduit stent of the present invention, it is made of polyhydroxyalkanoate, and the internal layer of described nerve conduit stent is fine and close small pore-like structure, and the aperture is below the 10 μ m; Outer is loose macroporous structure, and the aperture is 30-100 μ m.
The selection of the polyhydroxyalkanoate in the described nerve conduit stent material component is widely, such as poly butyric-alkyl caproate (PHBHHx), poly 3-hydroxy butyrate (PHB), 3-hydroxybutyrate valeric acid copolyesters (PHBV), or long-chain copolyesters etc. in the short chain that is obtained with the arbitrary proportion polymerization by 3-hydroxybutyrate and 3-hydroxycaproic acid, 3-hydroxyl enanthic acid, 3-Hydroxycaprylic acid, 3-hydroxyl n-nonanoic acid, 3-hydroxydecanoic acid or 3-hydroxyl dodecanoic acid, be preferably poly butyric-alkyl caproate, poly 3-hydroxy butyrate or 3-hydroxybutyrate valeric acid copolyesters.
The internal diameter of nerve conduit stent of the present invention is 1.5-5.0mm, and external diameter is 1.9-5.5mm.Its stent length can be controlled between the 1.0-100mm.
The preparation method of nerve conduit stent of the present invention, it comprises the steps:
1) with polyhydroxyalkanoate and organic solvent mix homogeneously, mixed proportion is that every gram polyhydroxyalkanoate adds the 8-20mL organic solvent;
2) then be divided into two parts, the water-soluble granular that adds respectively different-diameter mixes, and adopts mould to dip mixture and dries up molding, washes out granule again, obtains nerve conduit stent.
Wherein, described polyhydroxyalkanoate is long-chain copolyesters in poly butyric-alkyl caproate (PHBHHx), poly 3-hydroxy butyrate (PHB), 3-hydroxybutyrate valeric acid copolyesters (PHBV) or other short chain (by 3-hydroxybutyrate and 3-hydroxycaproic acid, 3-hydroxyl enanthic acid, 3-Hydroxycaprylic acid, 3-hydroxyl n-nonanoic acid, 3-hydroxydecanoic acid, the 3-hydroxyl dodecanoic acid copolyesters with the arbitrary proportion polymerization) etc., is preferably poly butyric-alkyl caproate, poly 3-hydroxy butyrate or 3-hydroxybutyrate valeric acid copolyesters.
Described organic solvent is benzene, chloroform, butyl acetate or Isosorbide-5-Nitrae-dioxane, is preferably chloroform, benzene or Isosorbide-5-Nitrae-dioxane.
Polyhydroxyalkanoate mixes so that also so easy acquisition uniform solution was preferably condensing reflux 2 hours as good in condensing reflux 0.5-4 hour 60-70 ℃ of lower stirring with organic solvent.
Described water-soluble granular is as catheter holder internal layer and outer field porogen, and for obtaining the uniform nerve conduit stent in aperture, granule mixes with solution and will fully stir.
For obtaining the conduit of heterogeneity structure, should dip internal layer support mixture with pole first, after slightly drying up, dip again catheter holder skin mixture.
Internal layer adopts the following water-soluble granular of diameter 10 μ m, and the volume mass of polyhydroxyalkanoate solution and water-soluble granular is than 1: 1-1: 3.
Outer to adopt diameter be the water-soluble granular of 30-100 μ m, and the volume mass of polyhydroxyalkanoate solution and water-soluble granular is than 1: 3-1: 5.
Described water-soluble granular is the Sal granule, and glucose granule or sucrose granules etc. are preferably the Sal granule.
Described mould is preferably stainless steel round bar, and diameter is 1.5-5mm.
In order to obtain the nerve conduit stent desired thickness, during the preparation ectonexine, mould dips mixture and can repeat 1-3 time respectively.Need carry out the air-dry processing of 5-10min at every turn.
The granule that washes out of the present invention adopts deionized water stripping granule, generally needs to place 48-96 hour, is preferably 72 hours.
Nerve conduit stent of the present invention is take the polyhydroxyalkanoate series polymer as material, utilizes the particle leaching method to make the catheter holder with heterogeneity microstructure.
This nerve conduit stent has the following advantages: 1) adopting the polyhydroxyalkanoate series polymer is material, and biocompatibility is good; 2) preparation technology is simple, and is lower to equipment requirements; 3) design inhomogenous microstructure, helped better to protect injured nerve; 4) raw material production is with low cost.The present invention will play a significant role at medical domain, have broad application prospects.
Description of drawings
Figure 1A is nerve conduit stent front view of the present invention and side view;
Figure 1B is nerve conduit stent partial enlarged drawing of the present invention.
The specific embodiment
Following examples are used for explanation the present invention, but are not used for limiting the scope of the invention.
Embodiment 1
Diameter is that 1.5mm, length are that 12mm, pipe thickness are the preparation of the PHBHHx nerve conduit stent of 0.25mm
(PHBHHx, anti-available from the Shandong, Shandong) is raw material with poly butyric-alkyl caproate, and diameter is that 1.5mm, length are that 12mm, pipe thickness are the PHBHHx nerve conduit stent of 0.25mm, may further comprise the steps:
1) in flask poly butyric-alkyl caproate and Isosorbide-5-Nitrae-dioxane is mixed, mixed proportion is that every gram poly butyric-alkyl caproate adds 10mL1, the 4-dioxane, and 60 ℃ of lower stirring in water bath heating, and about 2 hours of condensing reflux, obtain uniform solution;
2) with step 1) solution that obtains pours in two test tubes, add respectively diameter and be Sal granule below 10 microns and diameter at 50 ± 20 microns Sal granule, stir with Glass rod, thing is uniformly mixed, wherein, poly butyric-alkyl caproate solution and diameter are that the volume mass of the Sal granule below 10 microns was than 1: 1; Poly butyric-alkyl caproate solution and diameter are that 50 ± 20 microns the volume mass of Sal granule was than 1: 3.
3) stainless steel bar with diameter 1.5mm dips the Sal granulate mixture that is added with below 10 microns, dries up, and this operation repeats once.Continue to dip the Sal granulate mixture that is added with 50 ± 20 microns, dry up, this operation repeats 1 time.Placed fume hood air-dry 12 hours.Support immersed in the deionized water soaked 72 hours, wash out the Sal granule.Stainless steel bar is extracted out from type support.Pruning the support two ends with double-edged razor blade is 12mm to length, and obtaining diameter is that 1.5mm, length are that 12mm, pipe thickness are the PHBHHx nerve conduit stent (shown in Figure 1A and Figure 1B) of 0.25mm, places in the exsiccator stand-by.
After testing, the nerve conduit stent for preparing with said method has preferably cellular affinity, can protect preferably and induce nerve growth, and not cause strong inflammatory reaction.
Embodiment 2
Diameter is that 2mm, length are that 30mm, pipe thickness are the preparation of the PHB nerve conduit stent of 0.25mm
(PHB, anti-available from the Shandong, Shandong) is raw material with poly 3-hydroxy butyrate, and the preparation diameter is that 2mm, length are that 50mm, pipe thickness are the PHB nerve conduit stent of 2.5mm, may further comprise the steps:
1) in flask poly 3-hydroxy butyrate and Isosorbide-5-Nitrae-dioxane is mixed, mixed proportion is that every gram poly 3-hydroxy butyrate adds 20mL1, the 4-dioxane, and 70 ℃ of lower stirring in water bath heating, and about 0.5 hour of condensing reflux, obtain uniform solution;
2) with step 1) solution that obtains pours in two test tubes, add respectively diameter and be Sal granule below 10 microns and diameter at 60 ± 20 microns Sal granule, stir with Glass rod, thing is uniformly mixed, wherein, poly butyric-alkyl caproate solution and diameter are that the volume mass of the Sal granule below 10 microns was than 1: 2; Poly butyric-alkyl caproate solution and diameter are that 50 ± 20 microns the volume mass of Sal granule was than 1: 5.
3) stainless steel bar with diameter 2mm dips the Sal granulate mixture that is added with below 10 microns, dries up, and this operates triplicate.Continue to dip the Sal granulate mixture that is added with 60 ± 20 microns, dry up, this operation repeats 2 times.Placed fume hood air-dry 14 hours.Support immersed in the deionized water soaked 48 hours, wash out the Sal granule.Stainless steel bar is extracted out from type support.Pruning the support two ends with double-edged razor blade is 30mm to length, and obtaining diameter is that 2mm, length are that 30mm, pipe thickness are the PHBHHx nerve conduit stent of 0.25mm, places in the exsiccator stand-by.
After testing, the nerve conduit stent for preparing with said method has preferably cellular affinity, can protect preferably and induce nerve growth, and not cause strong inflammatory reaction.
Embodiment 3
Diameter is that 4mm, length are that 50mm, pipe thickness are the preparation of the PHBV nerve conduit stent of 0.25mm
(PHBV, anti-available from the Shandong, Shandong) is raw material with 3-hydroxybutyrate valeric acid copolyesters, and the preparation diameter is that 4mm, length are that 50mm, pipe thickness are the PHBV nerve conduit stent of 0.25mm, may further comprise the steps:
1) 3-hydroxybutyrate valeric acid copolyesters and Isosorbide-5-Nitrae-dioxane mix in flask, and mixed proportion is that every gram 3-hydroxybutyrate valeric acid copolyesters adds 8mL1, the 4-dioxane, and 65 ℃ of lower stirring in water bath heating, and about 4 hours of condensing reflux, obtain uniform solution;
2) with step 1) solution that obtains pours in two test tubes, add respectively diameter and be Sal granule below 10 microns and diameter at 50 ± 20 microns Sal granule (water-soluble granular all can), stir with Glass rod, thing is uniformly mixed, wherein, poly butyric-alkyl caproate solution and diameter are that the volume mass of the Sal granule below 10 microns was than 1: 3; Poly butyric-alkyl caproate solution and diameter are that 50 ± 20 microns the volume mass of Sal granule was than 1: 4.
3) stainless steel bar with diameter 4mm dips the Sal granulate mixture that is added with below 10 microns, dries up, and this operation repeats twice.Continue to dip the mixture that is added with the 30-100 micron particle, dry up, this operation repeats 3 times.Placed fume hood air-dry 18 hours.Support immersed in the deionized water soaked 96 hours, wash out granule.Stainless steel bar is extracted out from type support.Pruning the support two ends with double-edged razor blade is 50mm to length, and obtaining diameter is that 4mm, length are that 50mm, pipe thickness are the PHBV nerve conduit stent of 0.25mm, places in the exsiccator stand-by.
Embodiment 4
Basic preparation process is with embodiment 1, and different is, used organic solvent is chloroform, and water-soluble granular is sucrose granules.
Embodiment 5
Basic preparation process is with embodiment 1, different is, the copolyesters of polyhydroxyalkanoate for being polymerized by 3-hydroxybutyrate and 3-hydroxycaproic acid, 3-hydroxyl enanthic acid, 3-Hydroxycaprylic acid, 3-hydroxyl n-nonanoic acid, 3-hydroxydecanoic acid, 3-hydroxyl dodecanoic acid, used organic solvent is benzene, and water-soluble granular is the glucose granule.
After testing, the nerve conduit stent for preparing with said method has preferably cellular affinity, can protect preferably and induce nerve growth, and not cause strong inflammatory reaction.
Although above the present invention is described in detail with a general description of the specific embodiments, on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements all belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.
Claims (7)
1. a method for preparing nerve conduit stent is characterized in that it comprises the steps:
1) with polyhydroxyalkanoate and organic solvent mix homogeneously, mixed proportion is that every gram polyhydroxyalkanoate adds the 8-20mL organic solvent;
2) then be divided into two parts, the water-soluble granular that adds respectively different-diameter mixes, and adopts below the diameter 10 μ m as the water-soluble granular of internal layer, and polyhydroxyalkanoate solution compares 1:1-1:3 with the volume mass of water-soluble granular; Adopting diameter as outer field water-soluble granular is 30-100 μ m, and polyhydroxyalkanoate solution compares 1:3-1:5 with the volume mass of water-soluble granular; Adopt mould to dip mixture and dry up molding, wash out again granule, obtain nerve conduit stent;
Described nerve conduit stent is made of polyhydroxyalkanoate, and the internal layer of described nerve conduit stent is fine and close small pore-like structure, and the aperture is below the 10 μ m; Outer is loose macroporous structure, and the aperture is 30-100 μ m; The internal diameter of described nerve conduit stent is 1.5-5.0mm, and external diameter is 1.9-5.5mm.
2. the preparation method of described nerve conduit stent according to claim 1 is characterized in that described organic solvent is benzene, chloroform, butyl acetate or Isosorbide-5-Nitrae-dioxane.
3. the preparation method of described nerve conduit stent according to claim 2 is characterized in that, the mixing condition of described polyhydroxyalkanoate and organic solvent is 60-70 ℃ of lower the stirring and condensing reflux 0.5-4 hour.
4. the preparation method of described nerve conduit stent according to claim 1 is characterized in that described water-soluble granular is Sal granule, glucose granule or sucrose granules.
5. the preparation method of described nerve conduit stent according to claim 1 is characterized in that, the described granule that washes out adopts deionized water stripping granule.
6. the preparation method of described nerve conduit stent according to claim 1, it is characterized in that, described polyhydroxyalkanoate is poly butyric-alkyl caproate, poly 3-hydroxy butyrate, 3-hydroxybutyrate valeric acid copolyesters, or long-chain copolyesters in the short chain that is obtained with the arbitrary proportion polymerization by 3-hydroxybutyrate and 3-hydroxycaproic acid, 3-hydroxyl enanthic acid, 3-Hydroxycaprylic acid, 3-hydroxyl n-nonanoic acid, 3-hydroxydecanoic acid or 3-hydroxyl dodecanoic acid.
7. the preparation method of described nerve conduit stent according to claim 6 is characterized in that described polyhydroxyalkanoate is poly butyric-alkyl caproate, poly 3-hydroxy butyrate or 3-hydroxybutyrate valeric acid copolyesters.
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| CN 200910001598 CN101474423B (en) | 2008-10-24 | 2009-01-15 | Nerve conduit stent and preparation method thereof |
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| CN200810224190.X | 2008-10-24 | ||
| CN200810224190 | 2008-10-24 | ||
| CN 200910001598 CN101474423B (en) | 2008-10-24 | 2009-01-15 | Nerve conduit stent and preparation method thereof |
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| CN101474423B true CN101474423B (en) | 2013-02-27 |
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Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8758374B2 (en) | 2010-09-15 | 2014-06-24 | University Of Utah Research Foundation | Method for connecting nerves via a side-to-side epineurial window using artificial conduits |
| US10842494B2 (en) | 2011-10-17 | 2020-11-24 | University Of Utah Research Foundation | Methods and devices for connecting nerves |
| US9931121B2 (en) | 2011-10-17 | 2018-04-03 | University Of Utah Research Foundation | Methods and devices for connecting nerves |
| CN103654999B (en) * | 2013-12-04 | 2016-07-20 | 上海纳米技术及应用国家工程研究中心有限公司 | Nerve rehabilitating tube support of multiple structure and preparation method thereof |
| CN103692578B (en) * | 2013-12-11 | 2015-10-21 | 武汉大学 | A kind of method of twice shaping structure multichannel sponge nerve trachea and particular manufacturing craft |
| CN107261217A (en) * | 2017-07-25 | 2017-10-20 | 新乡医学院三全学院 | A kind of biological absorbable macromolecule nerve conduit stent and preparation method |
| CN114425101B (en) * | 2022-01-21 | 2022-07-22 | 北京大学口腔医学院 | Micro-nano double-layer structure antibacterial bracket and preparation method and application thereof |
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| CN1729949A (en) * | 2005-07-15 | 2006-02-08 | 清华大学 | Multi-channel nerve rehabilitating tube, its preparation process and dedicated mold |
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| CN1729949A (en) * | 2005-07-15 | 2006-02-08 | 清华大学 | Multi-channel nerve rehabilitating tube, its preparation process and dedicated mold |
| CN1778904A (en) * | 2005-10-20 | 2006-05-31 | 清华大学 | Use of poly-3-hydroxy-butanoic acid hydroxy-acetic acid ester |
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