CN113100897A - 脊椎康复状态监测的智能外固定夹具及监测方法 - Google Patents
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Abstract
一种脊椎康复状态监测的智能外固定夹具及监测方法,主要由支撑杆1,椎弓根螺钉2、3,外固定夹具4、5,三轴加速度计模块6、7,加速度计固定模块8、9组成。当患者进行手术时,使用椎弓根螺钉2、3植入患者体内,然后安装固定夹具,通过螺柱10、11分别将椎弓根螺钉2、3与外固定家具4、5固定,通过螺柱12、13分别将外固定夹具4、5与支撑杆1固定。固定夹具安装完成后,开始安装监测装置,通过锁紧螺母14、15分别将加速度计固定模块8、9与椎弓根螺钉2、3固定。
Description
技术领域
本发明总体上涉及一种脊椎康复状态监测的智能外固定夹具及监测方法,并且更具体地涉及一种可以固定到病人的脊椎,用于对诸如脊柱侧弯之类的病症进行前外侧手术矫正的过程,所述脊柱侧弯也称为脊柱弯曲。
背景技术
由于许多不同的原因,可能会出现胸腰椎病,如脊柱骨折,脊柱肿瘤,后凸畸形和脊柱侧凸。例如,脊柱侧弯可能由于脊髓灰质炎,神经肌肉病因学麻痹性疾病或脊柱损伤等疾病而发生。然而,脊柱侧凸的最常见原因是脊柱的基因决定的生长异常,当儿童从童年后期过渡到***时,脊柱的最常见特征是导致曲线发展。这种情况被称为特发性脊柱侧凸。
自二十世纪五十年代中期以来,标准的脊柱侧凸手术治疗一直是“仪器化脊柱融合术”,其通常涉及在曲线的每一端植入金属制品例如钩或螺钉到脊柱,然后将保持杆附接到金属制品,然后用手术器械矫正脊柱(通过扭曲脊柱或将其顶起),然后将杆连接到钩或螺钉上并固定到位以维持脊柱在加长,伸直和矫正位置的位置可以使用前外侧入路进行手术,其中从患者的前方或侧面进行椎骨的矫正或矫正椎骨的后方。
为了防止植入物随后松动和失去矫正畸形,脊柱的仪器化部分的脊柱融合实际上总是与仪器同时进行。这意味着骨碎片沿着未被植入物覆盖的脊柱部分放置。这些骨碎片或移植物诱导作为曲率一部分的椎骨在数周至数月至数年的时间内一起生长。这种融合保持了通过使用器械而实现的脊柱畸形的矫正。多年来,脊柱器械的主要手术方法倾向于不完全矫正弯曲,并且典型地是仪器化和融合脊柱的长段,最通常是7-14段。这种程序对患者来说是不可避免的创伤,需要很长的恢复时间,有时甚至超过一年,且病人康复状态无法被检测。
发明内容
为解决现在脊椎手术后病人康复状态无法被检测的问题,本发明提出一种脊椎康复状态监测的智能外固定夹具,该智能外固定夹具主要包括支撑杆1,第一椎弓根螺钉2、第二椎弓根螺钉3,第一外固定夹具4、第二外固定夹具5,第一加速度计模块6、第二加速度计模块7,第一加速度计固定模块8、第二加速度计固定模块9。
当患者进行手术时,如图1所示,使用第一椎弓根螺钉2、第二椎弓根螺钉3植入患者体内,然后安装固定夹具,通过第一螺柱10、第二螺柱11分别将第一椎弓根螺钉2、第二椎弓根螺钉3与第一外固定夹具4、第二外固定夹具5固定,通过第三螺柱12、第四螺柱13分别将第一外固定夹具4、第二外固定夹具5与支撑杆1固定。固定夹具安装完成后,开始安装监测装置,通过第一锁紧螺母14、第二锁紧螺母15分别将第一加速度计固定模块8、第二加速度计固定模块9与第一椎弓根螺钉2、第二椎弓根螺钉3固定。第一加速度计模块6、第二加速度计模块7由于模块下方为球形,可以在一定范围内自由转动,调整第一加速度计模块6、第二加速度计模块7位置,使得前后两加速度计输出数值一致后,通过第四螺柱16、第五螺柱17分别固定调整好后的第一加速度计模块6、第二加速度计模块7由于受到地心引力的作用,三轴加速度计将输出患者受到的地心加速度,加速度计的输出值通过无线传输模块传入手机中,在APP中对数据进行处理,将两加速度计输入值作对比,如果两加速度计输入值差距大于设定的阈值,则判断为目前患者的姿势处于不健康姿势,手机APP发送消息提醒患者。如果患者姿势处于健康状态下,则通过算法根据加速度计的输出值统计患者的行走步数,对患者的运动量进行统计。
外固定夹具如图2所示,加速度计固定模块与加速度计模块如图3所示。
附图说明
图1为外固定夹具整体结构示意图;
图2为外固定夹具示意图;
图3为加速度计固定模块与加速度计模块示意图;
图4为椎弓根螺钉分层结构示意图;
图5为姿势判断流程图。
具体实施方式
下面结合实施例对本发明作进一步阐述。
为使本发明的目的、技术优点更清晰,一下结合附图,对本发明进行详细说明。
一种脊椎康复状态监测的智能外固定夹具,该智能外固定夹具主要包括支撑杆1,第一椎弓根螺钉2、第二椎弓根螺钉3,第一外固定夹具4、第二外固定夹具5,第一加速度计模块6、第二加速度计模块7,第一加速度计固定模块8、第二加速度计固定模块9。
当患者进行手术时,如图1所示,使用第一椎弓根螺钉2、第二椎弓根螺钉3植入患者体内,然后安装固定夹具,通过第一螺柱10、第二螺柱11分别将第一椎弓根螺钉2、第二椎弓根螺钉3与第一外固定夹具4、第二外固定夹具5固定,通过第三螺柱12、第四螺柱13分别将第一外固定夹具4、第二外固定夹具5与支撑杆1固定。固定夹具安装完成后,开始安装监测装置,通过锁紧螺母14、15分别将第一加速度计固定模块8、第二加速度计固定模块9与第一椎弓根螺钉2、第二椎弓根螺钉3固定。第一加速度计模块6、第二加速度计模块7由于模块下方为球形,可以在一定范围内自由转动,调整第一加速度计模块6、第二加速度计模块7位置,使得前后两加速度计输出数值一致后,通过螺柱16、17分别固定调整好后的第一加速度计模块6、第二加速度计模块7,由于受到地心引力的作用,三轴加速度计将输出患者受到的地心加速度,加速度计的输出值通过无线传输模块传入手机中,在APP中对数据进行处理,将两加速度计输入值作对比,如果两加速度计输入值差距大于设定的阈值,则判断为目前患者的姿势处于不健康姿势,手机APP发送消息提醒患者。如果患者姿势处于健康状态下,则通过算法根据加速度计的输出值统计患者的行走步数,对患者的运动量进行统计。
三轴加速度计的输出为A=[ax ay az]T,总加速度即为
当支架固定后,记录此时两个加速度计的输出值,记为[ax1 ay1 az1]T与[ax2 ay2az2]T,对原始加速度计进行一次低通滤波处理和一次滑动平均滤波处理,低通滤波用于消除一些硬件产生的干扰,滑动平均滤波用于处理一些伪波峰。当前时刻低通滤波输出值为
z(n)=(1-a)z(n-1)+ax(n)
上式中a为滤波系数,x(n)为本次采值,z(n)为本次低通滤波值,y(n)为滑动滤波输出值。数据经滤波处理后输出为Y1=[yx1 yy1 yz1]T与Y2=[yx2 yy2 yz2]T,为判定姿态前后变化,需要设定阈值th作为判断姿态相对改变依据,判断流程如图5所示。
脊椎康复状态监测的智能外固定夹具的部件可由适用于医疗应用的生物学上可接受的材料制成,包括金属、合成聚合物、陶瓷和骨材料和/或它们的复合材料。例如,脊椎康复状态监测的智能外固定夹具的部件,单独地或共同地,可以由诸如不锈钢合金、纯钛、钛合金、超弹性钛合金、钴铬合金、超弹性金属的材料制成。合金、陶瓷及其复合物,例如磷酸钙,热塑性塑料例如聚芳醚酮,包括聚醚醚酮(PEEK)、聚醚酮酮(PEKK)、聚醚酮(PEK)、碳-PEEK复合材料、PEEK-BaSO4聚合物橡胶、聚对苯二甲酸乙二醇酯(PET)、织物、硅树脂、聚氨酯、硅氧烷-聚氨酯共聚物、聚合物橡胶、聚烯烃橡胶、水凝胶、半刚性和刚性材料、弹性体、橡胶、热塑性弹性体、热固性弹性体、弹性体复合材料,聚合物包括聚亚苯基,聚酰胺,聚酰亚胺,聚醚酰亚胺,聚乙烯,环氧树脂。还可以是自体移植物的骨材料,同种异体移植物,异种移植物或转基因皮质和/或皮质松质骨,以及组织生长或分化因子,部分可再吸收的材料,例如,复合物金属和钙基陶瓷,PEEK和钙基陶瓷的复合材料,PEEK与可再吸收聚合物的复合材料,完全可再吸收的材料,例如钙基陶瓷,例如磷酸钙,磷酸三钙(TCP),羟基磷灰石(HA)-TCP,硫酸钙或其它可再吸收的聚合物,例如聚乙交酯,聚乙交酯,聚酪氨酸碳酸酯,聚羧酸和它们的组合。
脊椎康复状态监测的智能外固定夹具的部件可具有材料复合物,包括上述材料,以实现各种所需特性,例如强度,刚度,弹性,顺应性,生物力学性能,耐久性和射线可透性或成像偏好。脊椎康复状态监测的智能外固定夹具的部件单独地或共同地也可以由异质材料制成,例如两种或更多种上述材料的组合。脊椎康复状态监测的智能外固定夹具的部件可以整体形成,整体连接或包括紧固元件和/或器械。
脊椎康复状态监测的智能外固定夹具可以是开放式或微型开放式,最小入口和/或微创,包括经皮外科技术,以输送和引入仪器和/或脊柱植入物,例如生长棒。患者体内的手术部位,其包括例如单层或多层脊椎。脊柱植入物包括伸缩结构,伸缩结构包括电机、相互匹配的丝杆和螺母。多个固定螺钉和/或超角度放置以抵抗从椎骨组织的拉出。在一些实施例中,脊柱植入物可包括脊柱构造、一个或多个骨紧固件、椎体间植入物、脊柱杆、系绳和/或连接器。
脊椎康复状态监测的智能外固定夹具允许动态支撑脊椎。动态支撑脊椎可控地减小了小面关节上的负载,同时增加椎骨间距和椎间孔间距,这是椎间盘置换可能无法解决的问题。脊椎康复状态监测的智能外固定夹具的某些实施例基于原生脊柱节段的原理,通过监测重力参数的变化控制稳定性。因此植入物装置补充了脊柱的重力监测***,并且可以在脊柱扭转,延伸,侧向弯曲和弯曲中重新分配与脊柱段的载荷。例如,支撑杆1可以被控制伸缩,伸缩触发的因素包括人为控制和/或基于第一加速度计模块6、第二加速度计模块7监测数据的自动控制。
优选的,如图4所示椎弓根螺钉包括分层结构,从外到内依次是防护层18、密封层、相变层19、密封层、中心层20;防护层可以是钛、钛合金、不锈钢、钴铬或其任何组合;密封层通常是薄膜材料;相变层包括相变材料,在固态、液态/玻璃态之间切换,优选的,在20℃以下为固态,在30℃以上为液态/玻璃态,手术阶段保持固态,为病人脊椎提供足够的刚度支撑,手术结束后慢慢变成液态/玻璃态,为病人提供更好的舒适度。
优选的,椎弓根螺钉和/或丝杆的表层包覆有双层薄膜,双层薄膜上设置有微孔,双层薄膜内部填充有帮助骨骼快速生长的多种药剂或治疗药物。
本申请虽然已以较佳实施例公开如上,但其并不是用来限定本发明,任何本领域技术人员在不脱离本申请的精神和范围内,都可以利用上述揭示的方法和技术内容对本发明技术方案做出可能的变动和修改,因此,凡是未脱离本申请技术方案的内容,依据本申请的技术实质对以上实施例所作的任何简单修改、等同变化及修饰,均属于本申请技术方案的保护范围。
Claims (4)
1.一种脊椎康复状态监测的智能外固定夹具,其特征在于:包括支撑杆(1)、第一椎弓根螺钉(2)、第二椎弓根螺钉(3)、第一外固定夹具(4)、第二外固定夹具(5)、第一加速度计模块(6)、第二加速度计模块(7)、第一加速度计固定模块(8)、第二加速度计固定模块(9)、第一螺柱(10)、第二螺柱(11),第一螺柱(10)将第一椎弓根螺钉(2)与第一外固定夹具(4)固定,第二螺柱(11)将第二椎弓根螺钉(3)与第二外固定夹具(5)固定,第三螺柱(12)将第一外固定夹具(4)与支撑杆(1)固定,第四螺柱(13)将第二外固定夹具(5)与支撑杆(1)固定,第一锁紧螺母(14)将第一加速度计固定模块(8)与第一椎弓根螺钉(2)固定,第二锁紧螺母(15)将第二加速度计固定模块(9)与第二椎弓根螺钉(3)固定,第一加速度计模块(6)、第二加速度计模块(7)的底部为球形,第一加速度计模块(6)、第二加速度计模块(7)的输出值通过传输模块传入手机中。
2.根据权利要求1所述的一种脊椎康复状态监测的智能外固定夹具,其特征在于:第一螺柱(10)与第三螺柱(12)位于同一水平面,方向相互垂直,第一螺柱(10)依次穿过第一外固定夹具(4)和支撑杆(1);第三螺柱(12)依次穿过第二外固定夹具(5)和支撑杆(1);第一外固定夹具(4)与第二外固定夹具(5)分别位于支撑杆(1)的两端。
3.根据权利要求1-2所述的一种脊椎康复状态监测的智能外固定夹具,其特征在于:第一锁紧螺母(14)位于第一外固定夹具(4)的上端面,第二锁紧螺母(15)位于第二外固定夹具(5)的上端面,第一加速度计固定模块(8)位于第一锁紧螺母(14)的上端面,第二加速度计固定模块(9)位于第二锁紧螺母(15)的上端面。
4.根据权利要求1所述的脊椎康复状态监测的智能外固定夹具监测方法,其特征在于:第一加速度计模块(6)、第二加速度计模块(7)将输出患者受到的地心加速度,第一加速度计模块(6)、第二加速度计模块(7)的输出值通过无线传输模块传入手机中,在APP中对数据进行处理,将第一加速度计模块(6)、第二加速度计模块(7)输入值作对比,如果第一加速度计模块(6)、第二加速度计模块(7)输入值差距大于设定的阈值,则判断为目前患者的姿势处于不健康姿势,手机APP发送消息提醒患者;如果患者姿势处于健康状态下,则通过算法根据加速度计的输出值统计患者的行走步数,对患者的运动量进行统计。
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