WO2016107106A1 - 一种内置可降解金属丝的实芯神经支架 - Google Patents
一种内置可降解金属丝的实芯神经支架 Download PDFInfo
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- WO2016107106A1 WO2016107106A1 PCT/CN2015/082154 CN2015082154W WO2016107106A1 WO 2016107106 A1 WO2016107106 A1 WO 2016107106A1 CN 2015082154 W CN2015082154 W CN 2015082154W WO 2016107106 A1 WO2016107106 A1 WO 2016107106A1
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- Prior art keywords
- nerve
- metal wire
- stent
- degradable metal
- scaffold
- Prior art date
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- 210000005036 nerve Anatomy 0.000 title claims abstract description 38
- 229910052751 metal Inorganic materials 0.000 title claims abstract description 20
- 239000002184 metal Substances 0.000 title claims abstract description 20
- 239000000463 material Substances 0.000 claims abstract description 14
- 239000007787 solid Substances 0.000 claims description 11
- 239000011148 porous material Substances 0.000 claims description 8
- 230000001737 promoting effect Effects 0.000 abstract description 2
- 239000012528 membrane Substances 0.000 abstract 3
- 230000004766 neurogenesis Effects 0.000 abstract 1
- 230000035771 neuroregeneration Effects 0.000 abstract 1
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 4
- 208000014674 injury Diseases 0.000 description 4
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical group [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 3
- 208000010886 Peripheral nerve injury Diseases 0.000 description 3
- 229910052749 magnesium Inorganic materials 0.000 description 3
- 239000011777 magnesium Substances 0.000 description 3
- 210000000578 peripheral nerve Anatomy 0.000 description 3
- 230000008929 regeneration Effects 0.000 description 3
- 238000011069 regeneration method Methods 0.000 description 3
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- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 2
- 229920001661 Chitosan Polymers 0.000 description 2
- 102000008186 Collagen Human genes 0.000 description 2
- 108010035532 Collagen Proteins 0.000 description 2
- 208000028389 Nerve injury Diseases 0.000 description 2
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 2
- 239000000956 alloy Substances 0.000 description 2
- 229910045601 alloy Inorganic materials 0.000 description 2
- 210000004204 blood vessel Anatomy 0.000 description 2
- 229910052791 calcium Inorganic materials 0.000 description 2
- 239000011575 calcium Substances 0.000 description 2
- 229920001436 collagen Polymers 0.000 description 2
- 239000002131 composite material Substances 0.000 description 2
- 230000018109 developmental process Effects 0.000 description 2
- 229910052588 hydroxylapatite Inorganic materials 0.000 description 2
- 210000000936 intestine Anatomy 0.000 description 2
- 229910052742 iron Inorganic materials 0.000 description 2
- 210000001365 lymphatic vessel Anatomy 0.000 description 2
- 210000003205 muscle Anatomy 0.000 description 2
- 230000008764 nerve damage Effects 0.000 description 2
- 210000000276 neural tube Anatomy 0.000 description 2
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 2
- 229920000747 poly(lactic acid) Polymers 0.000 description 2
- 239000004626 polylactic acid Substances 0.000 description 2
- 229910052725 zinc Inorganic materials 0.000 description 2
- 239000011701 zinc Substances 0.000 description 2
- 206010029174 Nerve compression Diseases 0.000 description 1
- 206010033799 Paralysis Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 210000003050 axon Anatomy 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000007659 motor function Effects 0.000 description 1
- 231100000878 neurological injury Toxicity 0.000 description 1
- 239000002516 radical scavenger Substances 0.000 description 1
- 230000001172 regenerating effect Effects 0.000 description 1
- 230000037152 sensory function Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
Images
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Definitions
- the utility model relates to the technical field of medical instruments, in particular to a solid core nerve stent with a built-in degradable metal wire.
- Peripheral nerve damage or breakage due to various trauma causes a decrease or loss of sensory and motor function. Severe peripheral nerve injury often leads to paralysis or permanent loss of labor. Peripheral nerve injury has a high incidence in China. According to statistics, in trauma patients, nerve injury of the extremities accounts for about 10% of the total number of trauma, and about 60% of the fractures of firearm injuries have neurological injuries. To this end, we need to find the ideal treatment for peripheral nerve injury. For peripheral nerve fractures, if the fracture gap is large, the fractured peripheral nerve must be regenerated and repaired by bridging the graft.
- nerve conduits made of biodegradable materials can bridge the defected nerve after implantation in the body, but these products only provide a bridge or channel for the growth of regenerative axons and do not promote nerve growth.
- the present invention provides a solid core nerve stent with a degradable metal wire, which not only has the three-dimensional structure required for nerve regeneration, but also promotes and guides nerve growth, and has good mechanical properties.
- Biodegradable which has far-reaching significance for nerve repair.
- the technical scheme of the utility model is as follows: a solid core nerve stent with a built-in degradable metal wire, and a package a scaffold film and a scavenger-coated degradable metal wire; the scaffold film is a biodegradable material having a three-dimensional pore structure; the degradable metal wire is distributed along a lateral direction and a longitudinal direction of the nerve scaffold.
- the nerve scaffold is cylindrical, elongated or flaky.
- the nerve stent has a length of 4-30 mm.
- the occupancy of the three-dimensional pore structure of the nerve scaffold is 10-65%.
- the main component of the degradable metal wire is magnesium, zinc, calcium, iron or an alloy thereof.
- the scaffold film is a biodegradable material such as collagen, polylactic acid, chitosan, hydroxyapatite or a composite thereof.
- the source of the scaffold film is a material obtained by chemically decellularizing blood vessels, lymphatic vessels, neural tubes, intestines or muscles of an animal source.
- the utility model has the beneficial effects that the solid core nerve stent with the built-in magnesium wire of the utility model not only has the three-dimensional structure required for nerve regeneration, but also can promote and guide nerve growth, has good mechanical properties, biodegradable, and nerve repair. Has far-reaching significance.
- FIG. 1 is a schematic structural view of a solid core nerve stent with a degradable metal wire according to the present invention.
- FIG. 2 is a schematic structural view of a solid core nerve stent with a degradable metal wire according to the present invention.
- a solid core nerve stent with a degradable metal wire includes a stent film 1 and a degradable metal wire 2 wrapped by a stent film 1.
- the degradable wire 2 is distributed transversely and longitudinally along the stent.
- the nerve stent has a length of 4-30 mm.
- the stent can be prepared into various shapes according to the needs of use, and is generally in the form of a sheet, a strip or a cylinder.
- Figure 1 shows a cylindrical shape.
- Figure 2 shows the sheet shape.
- the nerve support of the present invention is not limited to the above shape, and the shape of the nerve support can be flexible and varied to meet the needs of the user without departing from the basic idea of the present invention.
- the stent film material is a biodegradable material having a three-dimensional pore structure.
- the scaffold film is a biodegradable material such as collagen, polylactic acid, chitosan, hydroxyapatite or a composite thereof. It can also be a material obtained by chemically decellularizing blood vessels, lymphatic vessels, neural tubes, intestines or muscles of animal origin.
- the stent film has a three-dimensional pore structure, and the occupation ratio of the three-dimensional pore structure is 10-65%.
- the three-dimensional pore structure provides space for nerve regeneration.
- the main component of the degradable metal wire 2 is magnesium, zinc, calcium, iron or an alloy thereof. Studies have shown that degradable wires can guide nerve growth and have the effect of promoting nerve growth.
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- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
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- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
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- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Dispersion Chemistry (AREA)
- Neurology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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- Molecular Biology (AREA)
- Biophysics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Abstract
一种内置可降解金属丝的实芯神经支架,包括支架膜料(1)以及支架膜料(1)包裹的可降解金属丝(2),支架膜料(1)为生物可降解材料,具有三维空隙结构,可降解金属丝(2)沿所述神经支架的横向和纵向分布。该神经支架不仅具有神经再生所需要的三维结构,而且能够促进和引导神经生长,力学性能良好,生物可降解。
Description
本实用新型涉及医疗器械技术领域,具体地,涉及一种内置可降解金属丝的实芯神经支架。
由于各种外伤原因导致的周围神经损伤或断裂造成伤者感觉和运动功能的下降或丧失。严重的外周神经损伤往往导致患者瘫痪或永久丧失劳动力。外周神经损伤在我国发病率较高,据统计,在外伤患者中,四肢神经伤约占外伤总数的10%,火器伤骨折中约有60%的合并神经伤。为此,需寻找理想的外周神经伤治疗手段。对于外周神经断裂类损伤,若断裂缺口较大,就须借助对缺口进行桥接移植手术才能使断裂的周围神经得到再生修复。
目前,常用的移植体有自体移植体和人工神经支架。自体移植体来源有限且会带来供体后遗症。人工神经支架方面,由于非降解导管材料可能导致神经压迫和二次手术的风险,近年来研究的主要趋向于生物可降解支架材料的开发和研究。当前,美国已经批准多种品牌,如,NeuraGen、SaluBridge,Neurolac等的神经导管用于临床。
然而,可降解的生物材料制成的神经导管在植入体内后能桥接缺损的神经,但这类产品仅仅为再生神经轴突的生长提供了一条桥梁或通道,并没有促进神经生长的作用。
实用新型内容
为了克服现有技术的不足,本实用新型提供了一种内置可降解金属丝的实芯神经支架,该神经支架不仅具有神经再生所需要的三维结构,而且能够促进和引导神经生长,力学性能良好,生物可降解,对神经修复具有深远的意义。
本实用新型的技术方案如下:一种内置可降解金属丝的实芯神经支架,包
括支架膜料以及支架膜料包裹的可降解金属丝;所述支架膜料为生物可降解材料,具有三维孔隙结构;所述可降解金属丝沿所述神经支架的横向和纵向分布。
所述神经支架为圆柱状,长条状或片状。
所述神经支架的长度为4-30mm。
所述神经支架的三维孔隙结构的占有率为10-65%。
所述可降解金属丝的主要成分为镁,锌,钙,铁或其合金。
所述支架膜料为胶原蛋白,聚乳酸,壳聚糖,羟基磷灰石等生物可降解材料或其复合物。
所述支架膜料的来源为动物源血管,淋巴管,神经管、肠道或肌肉经化学去细胞后所得的物料。
本实用新型的有益效果为:本实用新型所述内置镁丝的实芯神经支架不仅具有神经再生所需要的三维结构,而且能够促进和引导神经生长,力学性能良好,生物可降解,对神经修复具有深远的意义。
图1为本实用新型所述内置可降解金属丝的实芯神经支架的结构示意图。
图2为本实用新型所述内置可降解金属丝的实芯神经支架的结构示意图。
下面结合附图和优选实施例对本实用新型作进一步的描述,但本实用新型的实施方式不限于此。
参照图1,一种内置可降解金属丝的实芯神经支架,包括支架膜料1以及支架膜料1包裹的可降解金属丝2。所述可降解金属丝2沿所述支架横向和纵向分布。所述神经支架的长度为4-30mm。
所述支架可以根据使用需要制备成各种形状,一般为片状,长条状或圆柱状。图1所示为圆柱状。图2所示为片状。当然,本实用新型所述神经支架并不限于上述形状,在不脱离本实用新型基本构思的情况下,所述神经支架形状可以灵活多变,满足使用者的需求。
所述支架膜料为生物可降解材料,具有三维孔隙结构。所述支架膜料为胶原蛋白,聚乳酸,壳聚糖,羟基磷灰石等生物可降解材料或其复合物。也可以为动物源血管,淋巴管,神经管、肠道或肌肉经化学去细胞后所得的物料。
所述支架膜料具有三维孔隙结构,所述三维孔隙结构的占有率为10-65%。三维孔隙结构为神经的再生提供了空间。
所述可降解金属丝2的主要成分为镁,锌,钙,铁或其合金。研究表明可降解金属丝可以引导神经生长,具有促进神经生长的作用。
以上内容是结合具体的优选实施方式对本实用新型所作的进一步详细说明,不能认定本实用新型的具体实施只局限于这些说明。对于本实用新型所属技术领域的普通技术人员来说,在不脱离本实用新型构思的前提下,其架构形式能够灵活多变,可以派生系列产品。只是做出若干简单推演或替换,都应当视为属于本实用新型由所提交的权利要求书确定的专利保护范围。
Claims (4)
- 一种内置可降解金属丝的实芯神经支架,其特征在于,包括支架膜料以及支架膜料包裹的可降解金属丝;所述支架膜料为生物可降解材料,具有三维孔隙结构;所述可降解金属丝沿所述神经支架的横向和纵向分布。
- 如权利要求1所述的内置可降解金属丝的实芯神经支架,其特征在于,所述神经支架为圆柱状,长条状或片状。
- 如权利要求1所述的内置可降解金属丝的实芯神经支架,其特征在于,所述神经支架的长度为4-30mm。
- 如权利要求1所述的内置可降解金属丝的实芯神经支架,其特征在于,所述神经支架的三维孔隙结构的占有率为10-65%。
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CN204394742U (zh) * | 2014-12-29 | 2015-06-17 | 东莞颠覆产品设计有限公司 | 一种内置可降解金属丝的实芯神经支架 |
US10413403B2 (en) * | 2015-07-14 | 2019-09-17 | Boston Scientific Scimed, Inc. | Prosthetic heart valve including self-reinforced composite leaflets |
WO2020210704A1 (en) * | 2019-04-11 | 2020-10-15 | The Regents Of The University Of California | Biomimetic scaffold for peripheral nerve injuries |
CN112716653A (zh) * | 2021-01-14 | 2021-04-30 | 东莞立德生物医疗有限公司 | 一种助修复可降解自发电场的神经支架 |
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