CN108451672A - 一种用于治疗平足的距下关节制动器及其制作方法 - Google Patents
一种用于治疗平足的距下关节制动器及其制作方法 Download PDFInfo
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Abstract
本发明公开了一种用于治疗平足的距下关节制动器及其制作方法，该距下关节制动器包括本体和设置在本体表面的摩擦层，在本体末端开设有与手术器械配套的接口，接口在放置距下关节制动器时起到与手术器械防旋、防脱位的作用，安装距下关节制动器完毕后，起到手术器械与距下关节制动器分离的作用。本发明的距下关节制动器减缓了患者的疼痛感，增加了单次手术的有效时长，降低了并发症的发生；另外，本发明采用聚醚醚酮或其衍生物作为植入材料，降低了植入物在使用过程中的对跟骨与距骨的磨损，缓解了并发症的发生。
Description
技术领域
本发明涉及医用假体领域，特别涉及一种用于治疗平足的距下关节制动器及其制作方法。
背景技术
平足症中畸形严重者，需要采用手术治疗，例如软组织和骨的重建手术，以重建足弓位置。近年来开展较多的距下关节稳定术通过在跗骨管内放置一种叫做距下关节制动器的植入体，可有效复位并稳定距骨，通过对机体的塑形改造，重建足弓。具体步骤为：局部麻醉后在跗骨窦外侧中央做切口，选择合适大小的距下关节制动器插入跗骨管，术中透视显示该植入体位于距下关节之前，手术完毕缝合皮肤。
但是，目前的植入体为锥形螺纹等规则的几何形态，选择相对匹配的螺纹尺寸，通过将锥形螺纹旋转，将其逐步旋入，且为金属材料，与人体的解剖学不能匹配，在旋入过程中与跟骨、距骨之间发生摩擦，损伤跟骨与距骨，患者在术后会产生强烈的疼痛感，且金属制动器的弹性模量和人体骨不匹配，制动器与人体骨接触时，受力面积处于螺纹处，受力面积小，增快了受力处人骨的损伤；长期使用会出现一系列并发症，并发症包括：跗骨窦疼痛、内植物脱位、滑膜炎、感染(表浅/深部)、过度纠正/纠正不足、异物反应、腓骨肌痉挛、内植物断裂、距骨/跟骨骨折、距骨囊肿及距下关节炎等。其中，跗骨窦疼痛与制动器的尺寸、设计和材质密切相关，关节错位、制动器脱位及局部骨折与产品材料、手术精度密切相关。现有金属植入体硬度大，植入后容易出现脱位、松动和骨溶解等并发症，制动器沉陷、力线不当、制动器磨损或降解碎片引起异物反应及制动器断裂，导致手术失败。1974年Subotnick第一代制动器由医用塑料制成，强度不够，只能用于部分儿童。第二代金属的制动器，取出率高达40％。
发明内容
针对以上现有技术存在的缺陷，本发明的主要目的在于克服现有技术的不足之处，公开了一种用于治疗平足的距下关节制动器，包括本体和设置在所述本体表面的摩擦层，在所述本体末端开设有与手术器械配套的接口，所述接口在放置距下关节制动器时起到与所述手术器械防旋、防脱位的作用，安装所述距下关节制动器完毕后，起到所述手术器械与所述距下关节制动器分离的作用。
进一步地，所述摩擦层为棘突、螺纹、锥形、棱台形中的一种或至少两种组合。
进一步地，所述摩擦层为多孔仿生骨小梁结构。
进一步地，所述多孔仿生骨小梁结构为规则立体分布、规则四边、规则五边、规则星形中的一种或至少两种组合。
进一步地，所述本体和所述摩擦层由聚醚醚酮或其衍生物构成。
进一步地，所述本体和所述摩擦层由钛、钛合金、钽中的一种构成。
进一步地，所述多孔仿生骨小梁的空隙尺寸为1-1000μm,并且平均孔隙尺寸为100-500μm，孔隙率为50-70％。
一种用于治疗扁平足的距下关节制动器的制作方法，该方法包括如下步骤：
S1、获取患者跟骨和距骨的三维模型以及骨质边界；
S2、基于获取的三维模型，判断患者距骨是否塌陷，如果未塌陷，则通过3D打印技术打印距下关节制动器；如果出现塌陷，通过三维成像，调整距骨位置，重建正常足的足跟和距骨的相对位置，重建正常的跗骨窦和跗骨管形状，基于重建的正常骨骼解剖形态，选择起点与终点，调整所述距下关节制动器的边界，接着再使用3D打印技术打印距下关节制动器。
进一步地，S1中获取患者跟骨和距骨三维模型以及骨质边界的步骤进一步包括：
通过CT扫描或者通过MIR影像建立跟骨和距骨的模型。
进一步地，S2的步骤进一步包括：
基于三维模型通过3D打印技术将跟骨、距骨以及距下关节制动器打印出来，通过实体匹配进一步地调整跟骨与距骨的相对位置，进而调整距下关节制动器的尺寸。
本发明取得的有益效果：
(1)采用聚醚醚酮(PEEK)或其衍生物作为植入材料，弹性模量与人体的自然骨骼更加匹配，减轻了应力遮挡问题，在运动中起到一定缓冲作用，降低了植入物在使用过程中的对跟骨与距骨的磨损，缓解了并发症的发生。
(2)摩擦层采用多孔仿生骨小梁结构的设计，即增加了距下关节制动器与跟骨、距骨之间的摩擦，又维持制动器在跗骨管内的稳定性。
(3)本发明的距下关节制动器减缓了患者的疼痛感，增加了单次手术的有效时长，降低了并发症的发生。
附图说明
图1为本发明的一种用于治疗平足的距下关节制动器安装位置示意图；
图2为图1另一视角的示意图；
图3为本发明的一种用于治疗平足的距下关节制动器的结构示意图；
图4为规则立体分布的结构示意图；
图5为规则四边的结构示意图；
图6为规则五边的结构示意图；
图7为规则星形的结构示意图；
附图标记如下：
1、距下关节制动器，11、本体，12、摩擦层，13、接口，21、跟骨，22、距骨。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，下面结合附图及实施例对本发明作进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本发明，并不用于限定本发明。
本发明的一种用于治疗平足的距下关节制动器，如图1-3所示，该距下关节制动器1包括本体11和设置在本体11表面的摩擦层12，在本体11末端开设有与手术器械配套的接口13，接口13在放置距下关节制动器1时起到与手术器械防旋、防脱位的作用，安装距下关节制动器1完毕后，起到手术器械与距下关节制动器1分离的作用。手术器械可以是打入器，该接口13可以是螺纹接口，匹配的，打入器一端具有与螺纹接口匹配的螺纹，将打入器对准螺纹接口后旋紧，而后将距下关节制动器1放入跟骨21和距骨22回见的跗骨管中，放置完毕后，反向旋转打入器，使其与距下关节制动器1分离；当然，接口13也可以为卡扣，打入器的一端具有与卡扣匹配，先将打入器插入卡扣内，是其与距下关节制动器1固定，而后放入跗骨管内，再将卡扣打开，使打入器与距下关节制动器1分离。
优选的，摩擦层12为棘突、螺纹、锥形、棱台形中的一种或至少两种组合，例如，摩擦层12为棘突、螺纹、锥形、棱台形中的任意一种，也可以为棘突与螺纹的组合、锥形与棱台的组合、棘突与棱台的组合，还可以为棘突、螺纹与锥形的组合或者螺纹、锥形和棱台的组合等方式。该设计能够增加距下关节制动器1与跟骨21、距骨22之间的摩擦，防止在尝试使用时发生移位等现象，提高单次手术的有效时长。
优选的，摩擦层12为多孔仿生骨小梁结构。多孔仿生骨小梁的空隙尺寸为1-1000μm,并且平均孔隙尺寸为100-500μm，孔隙率为50-70％。该结构既能增加距下关节制动器1与跟骨21、距骨22之间的摩擦，又与跟骨21与距骨22紧密接触，部分骨骼能够长入多孔仿生骨小梁中，维持距下关节制动器1在跗骨管内的稳定性。
优选的，如图4-7所示，图4示出的是规则立体分布的结构图，图5示出的是规则四边的结构图，图6示出的是规则五边的结构图，图7示出的是规则星形的结构图，多孔仿生骨小梁结构为规则立体分布、规则四边、规则五边、规则星形中的一种或至少两种组合。例如，为规则立体分布、规则四边、规则五边、规则星形中单独的一种形状，也可以是规则四边与规则五边的组合，还可以是规则立体分布、规则四边和规则星形的组合。
优选的，本体11和摩擦层12由聚醚醚酮或其衍生物构成。弹性模量与人体的自然骨骼更加匹配，减轻了应力遮挡问题，在运动中起到一定缓冲作用，降低了植入物在使用过程中的对跟骨21与距骨22的磨损，缓解了并发症的发生。
另外，本体11和摩擦层12还可以由钛、钛合金、钽中的一种构成。上述材质具有良好的耐腐蚀性和合理的弹性模量，而且结构稳定，能够增加增加单次手术的有效时长。
根据本发明的另一个实施例，一种用于治疗扁平足的距下关节制动器的制作方法，该方法包括如下步骤：
S1、获取患者跟骨21和距骨22的三维模型以及骨质边界；
S2、基于获取的三维模型，判断患者距骨22是否塌陷，如果未塌陷，则通过3D打印技术打印距下关节制动器；如果出现塌陷，通过三维成像，调整距骨22位置，重建正常足的足跟和距骨22的相对位置，重建正常的跗骨窦和跗骨管形状，基于重建的正常骨骼解剖形态，根据跗骨管的形状，选择起点与终点，调整距下关节制动器的边界，接着再使用3D打印技术打印距下关节制动器。
优选的，S1中获取患者跟骨21和距骨22三维模型以及骨质边界的步骤进一步包括：
通过CT扫描或者通过MIR影像建立跟骨21和距骨22的模型。
优选的，S2的步骤进一步包括：
基于三维模型通过3D打印技术将跟骨21、距骨22以及距下关节制动器打印出来，通过实体匹配进一步地调整跟骨21与距骨22的相对位置，进而调整距下关节制动器的尺寸。
结合图1-2阐述距下关节制动器1安装入人体的步骤为：
在患者脚部开设1-2cm的创口，通过扩张器将跟骨21与距骨22张开，以增加跗骨管的大小，而后，通过打入器将距下关节制动器1放入跗骨管内，放开扩张器使跟骨21、距骨22复位，将打入器与距下关节制动器1分离，最后缝合伤口。
本发明取得的有益效果：
(1)采用聚醚醚酮(PEEK)或其衍生物作为植入材料，弹性模量与人体的自然骨骼更加匹配，减轻了应力遮挡问题，在运动中起到一定缓冲作用，降低了植入物在使用过程中的对跟骨与距骨的磨损，缓解了并发症的发生。
(2)摩擦层采用多孔仿生骨小梁结构的设计，即增加了距下关节制动器与跟骨21、距骨22之间的摩擦，又维持制动器在跗骨管内的稳定性。
(3)本发明的距下关节制动器减缓了患者的疼痛感，增加了单次手术的有效时长，降低了并发症的发生。
以上仅为本发明的较佳实施例，并非用来限定本发明的实施范围；如果不脱离本发明的精神和范围，对本发明进行修改或者等同替换，均应涵盖在本发明权利要求的保护范围当中。
Claims (10)
1.一种用于治疗平足的距下关节制动器，其特征在于，包括本体和设置在所述本体表面的摩擦层，在所述本体末端开设有与手术器械配套的接口，所述接口在放置距下关节制动器时起到与所述手术器械防旋、防脱位的作用，安装所述距下关节制动器完毕后，起到所述手术器械与所述距下关节制动器分离的作用。
2.根据权利要求1所述的一种用于治疗平足的距下关节制动器，其特征在于，所述摩擦层为棘突、螺纹、锥形、棱台形中的一种或至少两种组合。
3.根据权利要求1所述的一种用于治疗平足的距下关节制动器，其特征在于，所述摩擦层为多孔仿生骨小梁结构。
4.根据权利要求3所述的一种用于治疗平足的距下关节制动器，其特征在于，所述多孔仿生骨小梁结构为规则立体分布、规则四边、规则五边、规则星形中的一种或至少两种组合。
5.根据权利要求1所述的一种用于治疗平足的距下关节制动器，其特征在于，所述本体和所述摩擦层由聚醚醚酮或其衍生物构成。
6.根据权利要求1所述的一种用于治疗平足的距下关节制动器，其特征在于，所述本体和所述摩擦层由钛、钛合金、钽中的一种构成。
7.根据权利要求3所述的一种用于治疗平足的距下关节制动器，其特征在于，所述多孔仿生骨小梁的空隙尺寸为1-1000μm,并且平均孔隙尺寸为100-500μm，孔隙率为50-70％。
8.权利要求1-7任意一项所述的一种用于治疗扁平足的距下关节制动器的制作方法，该方法包括如下步骤：
S1、获取患者跟骨和距骨的三维模型以及骨质边界；
S2、基于获取的三维模型，判断患者距骨是否塌陷，如果未塌陷，则通过3D打印技术打印距下关节制动器；如果出现塌陷，通过三维成像，调整距骨位置，重建正常足的足跟和距骨的相对位置，重建正常的跗骨窦和跗骨管形状，基于重建的正常骨骼解剖形态，选择起点与终点，调整所述距下关节制动器的边界，接着再使用3D打印技术打印距下关节制动器。
9.根据权利要求8所述的一种用于治疗扁平足的距下关节制动器的制作方法，其特征在于，S1中获取患者跟骨和距骨三维模型以及骨质边界的步骤进一步包括：
通过CT扫描或者通过MIR影像建立跟骨和距骨的模型。
10.根据权利要求8所述的一种用于治疗扁平足的距下关节制动器的制作方法，其特征在于，S2的步骤进一步包括：
基于三维模型通过3D打印技术将跟骨、距骨以及距下关节制动器打印出来，通过实体匹配进一步地调整跟骨与距骨的相对位置，进而调整距下关节制动器的尺寸。
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