技术领域Technical Field
本发明涉及医疗假体技术领域，特别涉及一种在体服役运动和受力状态个性化自监测智能仿生椎间盘。The present invention relates to the technical field of medical prostheses, and in particular to an intelligent bionic intervertebral disc with personalized self-monitoring of in-vivo motion and stress states.
背景技术Background Art
椎间盘退行性疾病，作为脊柱健康的重大威胁，在全球范围内广泛存在，严重影响着患者的生活质量。针对这一顽疾，人工椎间盘置换术因其能够有效恢复脊柱稳定性和减轻患者疼痛的作用而成为一种备受推崇的治疗方案。然而，尽管取得了一定的成效，但当前的人工椎间盘设计仍存在一定的局限性。Degenerative disc disease, as a major threat to spinal health, is widespread worldwide and seriously affects the quality of life of patients. For this stubborn disease, artificial disc replacement has become a highly respected treatment option because it can effectively restore spinal stability and relieve patients' pain. However, despite certain achievements, the current artificial disc design still has certain limitations.
具体而言，传统人工椎间盘多依赖于机械关节与单一材料，难以精准复现生物椎间盘的复杂运动特性，导致植入后与脊柱的自然运动模式难以完全匹配，进而可能诱发假体松动、下沉或移位等并发症。为了克服上述局限，仿生椎间盘应运而生。仿生椎间盘通过模拟生物椎间盘的解剖结构和生物力学特性，提高了与脊柱的相容性和运动匹配性，降低了并发症的风险。Specifically, traditional artificial intervertebral discs mostly rely on mechanical joints and single materials, which makes it difficult to accurately reproduce the complex motion characteristics of biological intervertebral discs, resulting in difficulty in fully matching the natural motion pattern of the spine after implantation, which may induce complications such as prosthesis loosening, sinking or displacement. In order to overcome the above limitations, bionic intervertebral discs came into being. By simulating the anatomical structure and biomechanical properties of biological intervertebral discs, bionic intervertebral discs improve compatibility and motion matching with the spine and reduce the risk of complications.
尽管仿生椎间盘在设计和功能上取得了进步，但仍然面临着一个关键问题——缺乏自主的动态智能监测能力与反馈机制。当前，患者术后康复复查高度依赖成本高昂的医学影像检查（如X光、CT），这些手段要求患者频繁就医，不仅存在X线辐射超量风险，且受限于特定时间点的静态评估，无法实现仿生椎间盘在患者体内运动和受力状态的连续、动态、个性化监控。申请号为202410575100.0的发明专利申请公开了“一种力学各向异性仿生椎间盘”，该发明仅仅从仿生椎间盘的力学结构上做出了改进，并没有自主的动态智能监测能力与反馈机制。Although bionic intervertebral discs have made progress in design and function, they still face a key problem - the lack of autonomous dynamic intelligent monitoring capabilities and feedback mechanisms. Currently, patients' postoperative rehabilitation review is highly dependent on costly medical imaging examinations (such as X-rays and CT scans). These methods require patients to seek medical treatment frequently. Not only is there a risk of excessive X-ray radiation, but they are also limited to static evaluations at specific time points, and cannot achieve continuous, dynamic, and personalized monitoring of the movement and stress state of the bionic intervertebral disc in the patient's body. The invention patent application with application number 202410575100.0 discloses "a mechanically anisotropic bionic intervertebral disc". This invention only makes improvements to the mechanical structure of the bionic intervertebral disc, and does not have autonomous dynamic intelligent monitoring capabilities and feedback mechanisms.
综上所述，亟需开发一种具备实时连续监测功能（包括方向、角度及外部载荷变化）的智能仿生椎间盘，这对于全椎间盘置换患者的个性化智能康复具有重要的科学意义和临床使用价值。通过对仿生椎间盘在患者体内的运动方向及角度的监测，为患者实时提供个性化的康复训练指导，准确识别并调整位姿变化；另外，通过对椎间应力应变的监测，及时预警术后康复进程中的异常椎间运动和受力，进而实现患者的个性化智能监测与康复促进。In summary, there is an urgent need to develop an intelligent bionic intervertebral disc with real-time continuous monitoring function (including direction, angle and external load changes), which has important scientific significance and clinical use value for the personalized intelligent rehabilitation of patients with total disc replacement. By monitoring the movement direction and angle of the bionic intervertebral disc in the patient's body, the patient can be provided with personalized rehabilitation training guidance in real time, and the posture changes can be accurately identified and adjusted; in addition, by monitoring the intervertebral stress and strain, the abnormal intervertebral movement and force in the postoperative rehabilitation process can be warned in time, thereby realizing personalized intelligent monitoring and rehabilitation promotion for patients.
发明内容Summary of the invention
本发明的目的是为了解决现有仿生椎间盘缺乏自主的动态智能监测能力与反馈机制的问题，而提供一种在体服役运动和受力状态个性化自监测智能仿生椎间盘。The purpose of the present invention is to solve the problem that the existing bionic intervertebral disc lacks autonomous dynamic intelligent monitoring capability and feedback mechanism, and to provide an intelligent bionic intervertebral disc with personalized self-monitoring of in-vivo motion and stress state.
一种在体服役运动和受力状态个性化自监测智能仿生椎间盘，包括上终板、椎间盘核心和下终板；An intelligent bionic intervertebral disc with personalized self-monitoring of in-vivo motion and stress states, comprising an upper end plate, an intervertebral disc core and a lower end plate;
所述的上终板上设置有上终板固定齿；The upper end plate is provided with upper end plate fixing teeth;
所述的椎间盘核心包括纤维环和髓核；纤维环作为椎间盘核心的外围结构，形成封闭的内腔，髓核嵌入在纤维环的内腔中，模拟天然髓核的弹性；The intervertebral disc core includes an annulus fibrosus and a nucleus pulposus; the annulus fibrosus is the peripheral structure of the intervertebral disc core, forming a closed inner cavity, and the nucleus pulposus is embedded in the inner cavity of the annulus fibrosus to simulate the elasticity of the natural nucleus pulposus;
所述的纤维环由胶原纤维基质层和胶原纤维组成；胶原纤维呈圆柱形，倾斜排列设置于胶原纤维基质层内，相邻两排的胶原纤维倾斜方向相反，胶原纤维与纤维环上下表面的夹角为10-80度；胶原纤维基质层和胶原纤维采用3D打印；The annulus fibrosus is composed of a collagen fiber matrix layer and collagen fibers; the collagen fibers are cylindrical, obliquely arranged in the collagen fiber matrix layer, the two adjacent rows of collagen fibers are inclined in opposite directions, and the angles between the collagen fibers and the upper and lower surfaces of the annulus fibrosus are 10-80 degrees; the collagen fiber matrix layer and the collagen fibers are 3D printed;
所述的下终板包括下终板基底和数个传感器，传感器固定设置在下终板基底外侧，传感器外侧固定设置有下终板固定齿。The lower end plate comprises a lower end plate base and a plurality of sensors. The sensors are fixedly arranged on the outer side of the lower end plate base, and lower end plate fixing teeth are fixedly arranged on the outer side of the sensors.
所述的上终板、椎间盘核心和下终板的横截面为“3D”型。The cross-sections of the upper endplate, the intervertebral disc core and the lower endplate are of a "3D" type.
所述的胶原纤维与纤维环上下表面的夹角为45度。The angle between the collagen fibers and the upper and lower surfaces of the annulus fibrosus is 45 degrees.
所述的胶原纤维基质层和胶原纤维分别采用3D打印出，将胶原纤维交叉排列穿套在胶原纤维基质层内。The collagen fiber matrix layer and the collagen fibers are respectively 3D printed, and the collagen fibers are cross-arranged and inserted into the collagen fiber matrix layer.
所述的胶原纤维基质层和胶原纤维采用双喷头3D打印机，同步打印成一体。The collagen fiber matrix layer and the collagen fibers are printed synchronously into one piece using a double-nozzle 3D printer.
所述的下终板的传感器为三组，分别为第一传感器、第二传感器和第三传感器；第一传感器、第二传感器和第三传感器上设置有数个凸起，下终板基底上开设有数个通孔，凸起和通孔大小及数量相应，传感器和下终板基底通过凸起和通孔的过盈固定设置在一起。The sensors of the lower end plate are divided into three groups, namely the first sensor, the second sensor and the third sensor; the first sensor, the second sensor and the third sensor are provided with several protrusions, and the base of the lower end plate is provided with several through holes, the size and number of the protrusions and the through holes correspond, and the sensors and the base of the lower end plate are fixed together by the interference fit of the protrusions and the through holes.
所述的上终板、胶原纤维基质层、胶原纤维和髓核采用聚合物材料制备。The upper end plate, collagen fiber matrix layer, collagen fibers and nucleus pulposus are made of polymer materials.
所述的下终板的传感器采用导电聚合物材料制备。The sensor of the lower end plate is made of conductive polymer material.
所述的下终板的传感器的材料或为掺杂炭黑的聚乳酸或为掺杂炭黑的碳纤或为掺杂炭黑的丙烯腈-苯乙烯-丁二烯共聚物。The material of the sensor of the lower end plate is polylactic acid doped with carbon black, carbon fiber doped with carbon black, or acrylonitrile-styrene-butadiene copolymer doped with carbon black.
本发明的工作过程和工作原理：Working process and working principle of the present invention:
在人体静止、站立或坐立状态下，本发明的上终板、椎间盘核心以及下终板受垂直压力作用，引发椎间盘核心一定方向的压缩变形，随后保持结构稳定。这一过程中，胶原纤维基质层与胶原纤维之间发生一定范围内的接触面积变化，基于摩擦起电与静电感应的耦合效应，电子在接触界面间发生转移，形成电势差。当处于稳定状态时，胶原纤维基质层与胶原纤维间的电荷随之处于静电平衡状态，电压信号维持恒定。When the human body is still, standing or sitting, the upper end plate, the intervertebral disc core and the lower end plate of the present invention are subjected to vertical pressure, which causes the intervertebral disc core to compress and deform in a certain direction, and then maintains structural stability. In this process, the contact area between the collagen fiber matrix layer and the collagen fibers changes within a certain range. Based on the coupling effect of friction electrification and electrostatic induction, electrons are transferred between the contact interfaces to form a potential difference. When in a stable state, the charge between the collagen fiber matrix layer and the collagen fibers is in an electrostatic equilibrium state, and the voltage signal remains constant.
当进入运动状态时，脊柱的复杂运动（包括前屈后伸、侧向弯屈、轴向旋转及平移）导致外部载荷作用于上终板或下终板，进而引发椎间盘核心的受压膨胀。在微观层面上，这种形变促使胶原纤维基质层与胶原纤维之间发生更紧密的接触，基于摩擦起电与静电感应的耦合效应，电子在接触界面间发生转移，形成电势差并输出脉冲信号。此过程中，压力与电势差之间呈现出线性正比关系，即压力增大导致接触面积增加，进而产生更多的电荷积累，形成更大的感应电势差。因此，可以通过开路电压峰值推导出当前所受外部载荷的数值。When entering the motion state, the complex movement of the spine (including flexion and extension, lateral bending, axial rotation and translation) causes external loads to act on the upper or lower endplate, which in turn causes the compression and expansion of the intervertebral disc core. At the microscopic level, this deformation causes the collagen fiber matrix layer to come into closer contact with the collagen fibers. Based on the coupling effect of friction electrification and electrostatic induction, electrons are transferred between the contact interfaces, forming a potential difference and outputting a pulse signal. In this process, there is a linear proportional relationship between pressure and potential difference, that is, an increase in pressure leads to an increase in contact area, which in turn generates more charge accumulation and forms a larger induced potential difference. Therefore, the value of the current external load can be derived from the peak open circuit voltage.
为实现对脊柱运动状态的全方向动态监测，胶原纤维与数个传感器分区域对应相连。这些传感器利用材料的导电特性，实时传输来自不同区域的电压信号。通过对比分析这些电压信号的差异，可以准确识别脊柱的运动方向。此外，脊柱屈伸的角度与开路电压峰值之间也建立了线性正比关系，使得通过测量电压峰值即可推算出脊柱的屈伸角度。同时，脊柱运动的频率与开路电压的脉冲频率相对应，通过计数脉冲频率可记录脊柱的屈伸次数。上述过程所产生的电能完全由人体运动过程中所产生的机械能转化。In order to achieve omnidirectional dynamic monitoring of the movement state of the spine, the collagen fibers are connected to several sensors in corresponding regions. These sensors use the conductive properties of the material to transmit voltage signals from different regions in real time. By comparing and analyzing the differences in these voltage signals, the movement direction of the spine can be accurately identified. In addition, a linear proportional relationship is established between the angle of spinal flexion and extension and the peak value of the open circuit voltage, so that the flexion and extension angle of the spine can be calculated by measuring the peak voltage. At the same time, the frequency of spinal movement corresponds to the pulse frequency of the open circuit voltage, and the number of flexion and extension of the spine can be recorded by counting the pulse frequency. The electrical energy generated by the above process is completely converted from the mechanical energy generated during the human body movement.
多个传感器间的脉冲信号差异，可以用来识别脊柱的运动方向，包括静止压缩、前屈后伸、侧向弯曲、轴向旋转及平移。The difference in pulse signals between multiple sensors can be used to identify the direction of spinal movement, including static compression, flexion and extension, lateral bending, axial rotation and translation.
所提取的信号根据上述与外部载荷、方向、屈伸角度及屈伸次数的匹配关系，可经信号处理装置处理后转换为数字化信息，实现上述参数的动态监测，相关参数可以在显示屏内进行显示，也可以发送至终端设备，供患者或医生随时查看。The extracted signal can be converted into digital information after being processed by a signal processing device according to the matching relationship with the external load, direction, flexion and extension angle and flexion and extension times, so as to realize dynamic monitoring of the above parameters. The relevant parameters can be displayed on the display screen or sent to the terminal device for patients or doctors to view at any time.
脉冲信号与当前椎间盘所受外部载荷呈现线性正比关系。The pulse signal is linearly proportional to the external load on the current intervertebral disc.
脉冲信号与脊柱屈伸角度呈现线性正比关系。The pulse signal is linearly proportional to the spinal flexion and extension angle.
脉冲信号的脉冲频率与脊柱运动频率呈现线性正比关系。The pulse frequency of the pulse signal is linearly proportional to the spinal movement frequency.
其中，信号处理装置的核心组件包括但不限于各类微控制器（MCU），如51系列、STM32系列等广泛应用的单片机，以及其他具备类似处理能力的集成电路。处理后的数据可通过集成的显示屏直接展示，显示屏与信号处理装置之间的连接可采用有线或无线方式，确保数据传输的高效与稳定。The core components of the signal processing device include but are not limited to various microcontrollers (MCUs), such as the 51 series, STM32 series and other widely used single-chip microcomputers, and other integrated circuits with similar processing capabilities. The processed data can be directly displayed on the integrated display screen, and the connection between the display screen and the signal processing device can be wired or wireless to ensure efficient and stable data transmission.
此外，也可以将数据远程发送至终端设备，如智能手机、平板电脑等，该方式包括但不限于蓝牙（Bluetooth）、LoRa（Long Range Radio）、RF24L01等无线通信模块，以及未来可能出现的其他高效、低功耗的无线通信技术。考虑到信号处理装置的模块化和可扩展性，除单一配置外，显示屏与无线通信模块也可以同时配置。In addition, data can also be sent remotely to terminal devices such as smartphones, tablets, etc. This method includes but is not limited to wireless communication modules such as Bluetooth, LoRa (Long Range Radio), RF24L01, and other high-efficiency, low-power wireless communication technologies that may appear in the future. Considering the modularity and scalability of the signal processing device, in addition to a single configuration, the display screen and the wireless communication module can also be configured at the same time.
这一全向动态监测功能为医生提供了个性化的康复训练指导依据，同时也帮助患者实时掌握自身康复状态，及时发现并预警潜在的异常或复发风险，从而采取早期干预措施，促进康复进程。This omnidirectional dynamic monitoring function provides doctors with personalized rehabilitation training guidance. It also helps patients understand their own recovery status in real time, promptly discover and warn of potential abnormalities or recurrence risks, so as to take early intervention measures and promote the recovery process.
本发明的有益效果：Beneficial effects of the present invention:
1、本发明在脊柱静止压缩、前屈后伸、侧向弯屈、轴向旋转以及平移运动过程中，胶原纤维基质层和胶原纤维间基于摩擦起电与静电感应耦合原理发生电荷转移，通过终板与外部负载间电气连接转换为高灵敏度的电压信号，从而有效感知脊柱活动中椎间盘的多向受力情况。相较于已有人工椎间盘或仿生椎间盘，无需额外附加或封装传感器。1. In the process of static compression, flexion and extension, lateral bending, axial rotation and translation of the spine, charge transfer occurs between the collagen fiber matrix layer and the collagen fibers based on the principle of friction electrification and electrostatic induction coupling, and is converted into a highly sensitive voltage signal through the electrical connection between the end plate and the external load, thereby effectively sensing the multi-directional force of the intervertebral disc during spinal movement. Compared with existing artificial intervertebral discs or bionic intervertebral discs, no additional sensors are required or packaged.
2、本发明通过下终板划分传感区域，解耦仿生椎间盘的各项传感异性特征。2. The present invention divides the sensing area by the lower end plate to decouple various sensing anisotropic characteristics of the bionic intervertebral disc.
3、本发明所产生的电信号，均为人体脊柱运动过程中所产生的机械能转换而来，无需额外的电源或化学电池供电。3. The electrical signals generated by the present invention are all converted from the mechanical energy generated during the movement of the human spine, and no additional power source or chemical battery is required.
4、本发明具有良好的生物相容性，且制造成本低，材料简单易得，工艺步骤简单，容易个性化。4. The present invention has good biocompatibility, low manufacturing cost, easy-to-obtain materials, simple process steps, and easy personalization.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
图1 为本发明实施例的结构示意图。FIG1 is a schematic structural diagram of an embodiment of the present invention.
图2为本发明实施例上终板结构示意图。FIG. 2 is a schematic diagram of the structure of the upper end plate according to an embodiment of the present invention.
图3为本发明实施例椎间盘核心的结构示意图。FIG. 3 is a schematic structural diagram of an intervertebral disc core according to an embodiment of the present invention.
图4为本发明实施例纤维环的结构示意图。FIG. 4 is a schematic structural diagram of a fiber ring according to an embodiment of the present invention.
图5为本发明实施例下终板的结构示意仰视图。FIG. 5 is a bottom view showing the structure of the lower end plate according to an embodiment of the present invention.
图6为本发明实施例的结构拆解示意图。FIG. 6 is a schematic diagram of the structural disassembly of an embodiment of the present invention.
图7为本发明实施例脉冲信号与当前椎间盘所受外部载荷的关系曲线图。FIG. 7 is a graph showing the relationship between the pulse signal and the external load currently applied to the intervertebral disc according to an embodiment of the present invention.
图8为本发明实施例脉冲信号与脊柱屈伸角度的关系曲线图。FIG8 is a graph showing the relationship between the pulse signal and the spinal flexion and extension angle according to an embodiment of the present invention.
图9为本发明实施例脉冲信号的脉冲频率与脊柱运动频率的关系曲线图。FIG. 9 is a graph showing the relationship between the pulse frequency of the pulse signal and the spinal movement frequency according to an embodiment of the present invention.
具体实施方式DETAILED DESCRIPTION
请参阅图1至图9所示，为本发明的实施例。Please refer to FIG. 1 to FIG. 9 , which are embodiments of the present invention.
一种在体服役运动和受力状态个性化自监测智能仿生椎间盘，包括上终板1、椎间盘核心2和下终板3；上终板1、椎间盘核心2和下终板3的横截面为“D”型。An intelligent bionic intervertebral disc with personalized self-monitoring of in-vivo motion and stress states comprises an upper end plate 1, an intervertebral disc core 2 and a lower end plate 3; the cross-sections of the upper end plate 1, the intervertebral disc core 2 and the lower end plate 3 are "D" shaped.
所述的上终板1上设置有上终板固定齿11，上终板固定齿11用于与相邻椎体连接固定，预防下沉；上终板1采用聚乳酸制备；The upper end plate 1 is provided with an upper end plate fixing tooth 11, which is used to connect and fix with the adjacent vertebral body to prevent sinking; the upper end plate 1 is made of polylactic acid;
所述的椎间盘核心2包括纤维环21和髓核22；纤维环21作为椎间盘核心2的外围结构，形成封闭的内腔，髓核22嵌入在纤维环21的内腔中，模拟天然髓核的弹性；髓核22采用热塑性聚氨酯弹性体87A制备；The intervertebral disc core 2 includes an annulus fibrosus 21 and a nucleus pulposus 22; the annulus fibrosus 21 is the peripheral structure of the intervertebral disc core 2, forming a closed inner cavity, and the nucleus pulposus 22 is embedded in the inner cavity of the annulus fibrosus 21 to simulate the elasticity of a natural nucleus pulposus; the nucleus pulposus 22 is made of thermoplastic polyurethane elastomer 87A;
所述的纤维环21由胶原纤维基质层211和胶原纤维212组成；胶原纤维212呈圆柱形，倾斜排列设置于胶原纤维基质层211内，相邻两排的胶原纤维212倾斜方向相反，胶原纤维212与纤维环21上下表面的夹角为45度；胶原纤维基质层211采用热塑性聚氨酯弹性体95A；胶原纤维212采用掺杂炭黑的聚乳酸，使用双喷头3D打印机，同步打印成一体。The annulus fibrosus 21 is composed of a collagen fiber matrix layer 211 and collagen fibers 212; the collagen fibers 212 are cylindrical and arranged obliquely in the collagen fiber matrix layer 211, and the two adjacent rows of collagen fibers 212 are inclined in opposite directions, and the angle between the collagen fibers 212 and the upper and lower surfaces of the annulus fibrosus 21 is 45 degrees; the collagen fiber matrix layer 211 is made of thermoplastic polyurethane elastomer 95A; the collagen fibers 212 are made of polylactic acid doped with carbon black, and are printed simultaneously into one piece using a dual-nozzle 3D printer.
所述的下终板3包括下终板基底31和三个传感器32，分别为第一传感器321、第二传感器322和第三传感器323；The lower end plate 3 includes a lower end plate base 31 and three sensors 32, namely a first sensor 321, a second sensor 322 and a third sensor 323;
第一传感器321、第二传感器322和第三传感器323固定设置在下终板基底31外侧，第一传感器321、第二传感器322和第三传感器323的外侧固定设置有下终板固定齿33，下终板固定齿33用于与相邻椎体连接固定，预防下沉.The first sensor 321, the second sensor 322 and the third sensor 323 are fixedly arranged on the outer side of the lower end plate base 31, and the lower end plate fixing teeth 33 are fixedly arranged on the outer side of the first sensor 321, the second sensor 322 and the third sensor 323, and the lower end plate fixing teeth 33 are used to connect and fix with the adjacent vertebral body to prevent sinking.
第一传感器321、第二传感器322和第三传感器323上设置有数个凸起324，下终板基底31上开设有数个通孔311，凸起324和通孔311大小及数量相应，第一传感器321、第二传感器322、第三传感器323分别和下终板基底31通过凸起324和通孔311的过盈固定设置在一起。第一传感器321、第二传感器322和第三传感器323的材料采用掺杂炭黑的聚乳酸制备。三个传感器的材料具备导电特性，与胶原纤维212构成导电通路。Several protrusions 324 are provided on the first sensor 321, the second sensor 322 and the third sensor 323, and several through holes 311 are provided on the lower end plate base 31. The protrusions 324 and the through holes 311 are of corresponding size and number. The first sensor 321, the second sensor 322 and the third sensor 323 are respectively fixed to the lower end plate base 31 through the interference fit between the protrusions 324 and the through holes 311. The materials of the first sensor 321, the second sensor 322 and the third sensor 323 are made of polylactic acid doped with carbon black. The materials of the three sensors have conductive properties and form a conductive path with the collagen fibers 212.
下终板基底31采用聚乳酸制备，防止三个传感器间发生电信号干扰。The lower end plate substrate 31 is made of polylactic acid to prevent electrical signal interference between the three sensors.
胶原纤维基质层211、胶原纤维212和髓核22采用聚合物材料制备。The collagen fiber matrix layer 211 , the collagen fibers 212 and the nucleus pulposus 22 are made of polymer materials.
本实施例的工作过程和工作原理：The working process and working principle of this embodiment:
在人体静止、站立或坐立状态下，本实施例的上终板1、椎间盘核心2以及下终板3受垂直压力作用，引发椎间盘核心2一定方向的压缩变形，随后保持结构稳定。这一过程中，胶原纤维基质层211与胶原纤维212之间发生一定范围内的接触面积变化，基于摩擦起电与静电感应的耦合效应，电子在接触界面间发生转移，形成电势差。当处于稳定状态时，胶原纤维基质层211与胶原纤维212间的电荷随之处于静电平衡状态，电压信号维持恒定。When the human body is still, standing or sitting, the upper end plate 1, the intervertebral disc core 2 and the lower end plate 3 of this embodiment are subjected to vertical pressure, which causes the intervertebral disc core 2 to compress and deform in a certain direction, and then maintains structural stability. In this process, the contact area between the collagen fiber matrix layer 211 and the collagen fiber 212 changes within a certain range. Based on the coupling effect of friction electrification and electrostatic induction, electrons are transferred between the contact interfaces to form a potential difference. When in a stable state, the charge between the collagen fiber matrix layer 211 and the collagen fiber 212 is in an electrostatic equilibrium state, and the voltage signal remains constant.
当进入运动状态时，脊柱的复杂运动（包括前屈后伸、侧向弯屈、轴向旋转及平移）导致外部载荷作用于上终板1或下终板3，进而引发椎间盘核心2的受压膨胀。在微观层面上，这种形变促使胶原纤维基质层211与胶原纤维212之间发生更紧密的接触，基于摩擦起电与静电感应的耦合效应，电子在接触界面间发生转移，形成电势差。此过程中，压力与电势差之间呈现出线性正比关系，即压力增大导致接触面积增加，进而产生更多的电荷积累，形成更大的感应电势差。因此，可以通过开路电压峰值推导出当前所受外部载荷的数值。When entering the motion state, the complex movement of the spine (including flexion and extension, lateral bending, axial rotation and translation) causes external loads to act on the upper end plate 1 or the lower end plate 3, thereby causing the intervertebral disc core 2 to be compressed and expanded. At the microscopic level, this deformation causes the collagen fiber matrix layer 211 and the collagen fiber 212 to have a closer contact. Based on the coupling effect of friction electrification and electrostatic induction, electrons are transferred between the contact interfaces to form a potential difference. In this process, there is a linear proportional relationship between pressure and potential difference, that is, an increase in pressure leads to an increase in contact area, which in turn generates more charge accumulation and forms a larger induced potential difference. Therefore, the value of the current external load can be derived from the open circuit voltage peak.
为实现对脊柱运动状态的全方向动态监测，胶原纤维212与第一传感器321、第二传感器322和第三传感器323分区域对应相连。这三个传感器利用材料的导电特性，实时传输来自不同区域的电压信号。通过对比分析这些电压信号的差异，可以准确识别脊柱的运动方向。例如，在后伸运动中，第三传感器323区域因形变较大而输出较高的电压信号；在左侧屈时，则是第一传感器321区域信号更为显著。In order to realize the dynamic monitoring of the movement state of the spine in all directions, the collagen fiber 212 is connected to the first sensor 321, the second sensor 322 and the third sensor 323 in different regions. These three sensors use the conductive properties of the material to transmit voltage signals from different regions in real time. By comparing and analyzing the differences in these voltage signals, the movement direction of the spine can be accurately identified. For example, in the extension movement, the third sensor 323 area outputs a higher voltage signal due to the larger deformation; when in left flexion, the signal of the first sensor 321 area is more significant.
此外，脊柱屈伸的角度与开路电压峰值之间也建立了线性正比关系，使得通过测量电压峰值即可推算出脊柱的屈伸角度。同时，脊柱运动的频率与开路电压的脉冲频率相对应，通过计数脉冲频率可记录脊柱的屈伸次数。上述过程所产生的电能完全由人体运动过程中所产生的机械能转化。In addition, a linear proportional relationship is established between the angle of spinal flexion and extension and the peak value of the open circuit voltage, so that the angle of spinal flexion and extension can be calculated by measuring the peak voltage. At the same time, the frequency of spinal movement corresponds to the pulse frequency of the open circuit voltage, and the number of spinal flexion and extension can be recorded by counting the pulse frequency. The electrical energy generated by the above process is completely converted from the mechanical energy generated during human body movement.
需要说明的是，所提取的信号根据上述与外部载荷、方向、屈伸角度及屈伸次数的匹配关系，可经信号处理装置处理后转换为数字化信息，实现上述参数的动态监测，相关参数可以在显示屏内进行显示，也可以发送至终端设备，供患者或医生随时查看。其中，信号处理装置的核心组件包括但不限于各类微控制器（MCU），如但不限于51系列、STM32系列等广泛应用的单片机，以及其他具备类似处理能力的集成电路。处理后的数据可通过集成的显示屏直接展示，显示屏与信号处理装置之间的连接可采用有线或无线方式，确保数据传输的高效与稳定。此外，也可以将数据远程发送至终端设备，如智能手机、平板电脑等，该方式包括但不限于蓝牙（Bluetooth）、LoRa（Long Range Radio）、RF24L01等无线通信模块，以及未来可能出现的其他高效、低功耗的无线通信技术。考虑到信号处理装置的模块化和可扩展性，除单一配置外，显示屏与无线通信模块也可以同时配置。It should be noted that the extracted signal can be converted into digital information after being processed by the signal processing device according to the above matching relationship with the external load, direction, flexion and extension angle and flexion and extension times, so as to realize the dynamic monitoring of the above parameters. The relevant parameters can be displayed on the display screen or sent to the terminal device for patients or doctors to view at any time. Among them, the core components of the signal processing device include but are not limited to various microcontrollers (MCUs), such as but not limited to the widely used single-chip microcomputers such as the 51 series and the STM32 series, and other integrated circuits with similar processing capabilities. The processed data can be directly displayed through the integrated display screen, and the connection between the display screen and the signal processing device can be wired or wireless to ensure efficient and stable data transmission. In addition, the data can also be sent remotely to terminal devices such as smart phones, tablets, etc., which includes but is not limited to wireless communication modules such as Bluetooth, LoRa (Long Range Radio), RF24L01, and other efficient and low-power wireless communication technologies that may appear in the future. Considering the modularity and scalability of the signal processing device, in addition to a single configuration, the display screen and the wireless communication module can also be configured at the same time.
这一全向动态监测功能为医生提供了个性化的康复训练指导依据，同时也帮助患者实时掌握自身康复状态，及时发现并预警潜在的异常椎间运动和受力，进而实现患者的个性化智能监测与康复促进。This omnidirectional dynamic monitoring function provides doctors with personalized rehabilitation training guidance. It also helps patients to understand their own rehabilitation status in real time, promptly detect and warn of potential abnormal intervertebral movement and force, thereby realizing personalized intelligent monitoring and rehabilitation promotion for patients.
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| CN202411413673.XACN118902703B (en) | 2024-10-11 | 2024-10-11 | In-vivo service sport and stress state personalized self-monitoring intelligent bionic intervertebral disc |
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