技术领域Technical Field
本发明涉及医疗器械技术领域，尤其涉及一种经椎间孔穿刺的背根神经节电刺激系统，分类号为A61N。The present invention relates to the technical field of medical devices, and in particular to a dorsal root ganglion electrical stimulation system via intervertebral foramen puncture, with the classification number being A61N.
背景技术Background Art
背根神经节电刺激（dorsal root ganglion stimulation，DRGS）是一种神经调控技术，用于治疗慢性疼痛和神经病变引起的疼痛。它是通过在背根神经节（dorsal rootganglion，DRG）附近植入电极，对神经信号进行电刺激，从而减轻或阻断疼痛传递。Dorsal root ganglion stimulation (DRGS) is a neuromodulation technology used to treat chronic pain and pain caused by neuropathy. It is done by implanting electrodes near the dorsal root ganglion (DRG) to electrically stimulate nerve signals, thereby reducing or blocking pain transmission.
背根神经节是位于脊髓背根与脊神经之间的结构，其中包含了感觉神经元的细胞体。这些感觉神经元通过背根神经节将外周组织和器官的感觉信息传递到脊髓和大脑。在疼痛感知中，背根神经节起着重要的作用，它们接收和传递疼痛信号，使我们感受到疼痛。The dorsal root ganglia are structures located between the dorsal roots of the spinal cord and the spinal nerves, which contain the cell bodies of sensory neurons. These sensory neurons transmit sensory information from peripheral tissues and organs to the spinal cord and brain through the dorsal root ganglia. In pain perception, the dorsal root ganglia play an important role, receiving and transmitting pain signals, making us feel pain.
通过背根神经节电刺激技术，电极被植入到背根神经节附近，通过应用电流刺激这些神经元，可以干扰和调节神经传递的过程。具体来说，电刺激可以改变疼痛信号在神经元之间的传递，干扰疼痛信号到达脊髓和大脑的路径，从而减轻疼痛感知。Through dorsal root ganglion electrical stimulation technology, electrodes are implanted near the dorsal root ganglion and by applying electric current to stimulate these neurons, the process of neurotransmission can be disturbed and modulated. Specifically, electrical stimulation can change the transmission of pain signals between neurons, interfere with the path of pain signals to the spinal cord and brain, and thus reduce pain perception.
背根神经节电刺激技术相对于传统的脊髓电刺激技术具有一些优势。首先，背根神经节电刺激可以更精确地靶向感觉神经元，因为植入电极位于神经元细胞体附近。其次，由于刺激电极与脊髓没有直接接触，背根神经节电刺激可以减少脊髓电刺激引起的副作用和并发症。此外，背根神经节电刺激技术还可以通过调节刺激参数来个体化治疗，提高治疗效果和患者的生活质量。背根神经节电刺激可应用于复杂性区域疼痛综合征、糖尿病周围神经病变、腹股沟区疼痛、术后疼痛、残肢痛和幻肢痛、带状疱疹后神经痛等疾病治疗中，相关研究表明背根神经节电刺激术感染风险较低，安全性较高。背根神经节电刺激是下肢I型或II型复杂性区域疼痛综合征的有效疗法，且优于SCS的治疗。Dorsal root ganglion stimulation technology has some advantages over traditional spinal cord stimulation technology. First, dorsal root ganglion stimulation can target sensory neurons more accurately because the implanted electrodes are located near the neuronal cell bodies. Second, since the stimulating electrodes are not in direct contact with the spinal cord, dorsal root ganglion stimulation can reduce the side effects and complications caused by spinal cord stimulation. In addition, dorsal root ganglion stimulation technology can also individualize treatment by adjusting the stimulation parameters to improve the treatment effect and the patient's quality of life. Dorsal root ganglion stimulation can be used in the treatment of complex regional pain syndrome, diabetic peripheral neuropathy, inguinal pain, postoperative pain, residual limb pain and phantom limb pain, postherpetic neuralgia and other diseases. Relevant studies have shown that dorsal root ganglion stimulation has a lower risk of infection and a higher safety. Dorsal root ganglion stimulation is an effective treatment for complex regional pain syndrome type I or II in the lower limbs, and is superior to SCS treatment.
DRGS要求疼痛区域固定且相对局限，位于1~4支脊神经皮节支配区，一般以少于4支神经区域为佳。周围神经损伤造成的局灶性NP是DRGS的最佳适应证。目前美国FDA批准的DRGS适应证限于与CRPS或周围性灼烧痛相关的慢性神经病理性疼痛，植入的解剖区域仅限于骶骨、腰椎等T10以下区域。FDA批准的背根神经节电刺激设备脉冲频率的可编程范围为4~80 Hz，默认值为20 Hz。有研究表明在背根神经节电刺激中，使用低频电刺激（<20 Hz）也可取得良好的治疗效果，将刺激频率逐渐减少到4 Hz，即在极低频状态下时，治疗效果仍然稳定。DRGS requires that the pain area is fixed and relatively limited, located in the innervation area of 1 to 4 spinal nerve dermatomes, and generally less than 4 nerve areas are preferred. Focal NP caused by peripheral nerve injury is the best indication for DRGS. Currently, the DRGS indications approved by the US FDA are limited to chronic neuropathic pain associated with CRPS or peripheral burning pain, and the anatomical area of implantation is limited to the sacrum, lumbar spine and other areas below T10. The programmable range of the pulse frequency of the FDA-approved dorsal root ganglion electrical stimulation device is 4 to 80 Hz, and the default value is 20 Hz. Studies have shown that in dorsal root ganglion electrical stimulation, the use of low-frequency electrical stimulation (<20 Hz) can also achieve good therapeutic effects. The therapeutic effect remains stable when the stimulation frequency is gradually reduced to 4 Hz, that is, in the extremely low frequency state.
CN105477779A公开一种应用于背根神经节的电刺激器，用以电刺激至少一个背根神经节，以使疼痛感降低而不会产生异常感觉。电刺激器包括有至少一个电刺激单元。电刺激单元包括至少一个第一电极及至少一个第二电极，电刺激单元发出高频电刺激信号，使第一电极与第二电极产生电场，电场范围涵盖背根神经节，且电场强度的范围介于100 V/m～1000 V/m。CN105477779A discloses an electrical stimulator applied to a dorsal root ganglion, for electrically stimulating at least one dorsal root ganglion to reduce pain without causing abnormal sensation. The electrical stimulator includes at least one electrical stimulation unit. The electrical stimulation unit includes at least one first electrode and at least one second electrode, and the electrical stimulation unit emits a high-frequency electrical stimulation signal to generate an electric field between the first electrode and the second electrode, the electric field range covers the dorsal root ganglion, and the electric field strength ranges from 100 V/m to 1000 V/m.
现有的电刺激装置通常被配置为一个孤立的治疗仪器，仅可通过人机交互端口实现对治疗方案的调整，该方式比较适用于患者刚植入电刺激装置后的初期治疗过程，在该过程中患者需要留院观察一段时间，医护人员可以及时根据患者的反应通过人机交互端口对治疗方案进行调节，以使得电刺激装置可以被调整至最佳治疗参数。然而在结束初期治疗过程之后，患者需要离开医院进行居家治疗，在该过程中因为多种因素的影响会使得以最佳治疗参数进行治疗操作的电刺激装置的治疗效果不佳，而患者本身缺乏调整治疗方案的理论基础和常识，容易出现调整后的治疗方案不合理或不清楚如何调整治疗方案的情况。如果一旦出现上述情况就需要前往医院进行复查，也会对患者的日常生活造成不便。Existing electrical stimulation devices are usually configured as an isolated treatment instrument, and the treatment plan can only be adjusted through the human-computer interaction port. This method is more suitable for the initial treatment process after the patient has just implanted the electrical stimulation device. During this process, the patient needs to stay in the hospital for observation for a period of time. Medical staff can adjust the treatment plan through the human-computer interaction port in time according to the patient's response, so that the electrical stimulation device can be adjusted to the optimal treatment parameters. However, after the initial treatment process, the patient needs to leave the hospital for home treatment. During this process, due to the influence of various factors, the treatment effect of the electrical stimulation device operated with the optimal treatment parameters will be poor. The patient himself lacks the theoretical basis and common sense for adjusting the treatment plan, and it is easy for the adjusted treatment plan to be unreasonable or unclear how to adjust the treatment plan. If the above situation occurs, you need to go to the hospital for a follow-up examination, which will also cause inconvenience to the patient's daily life.
此外，一方面由于对本领域技术人员的理解存在差异；另一方面由于申请人做出本发明时研究了大量文献和专利，但篇幅所限并未详细罗列所有的细节与内容，然而这绝非本发明不具备这些现有技术的特征，相反本发明已经具备现有技术的所有特征，而且申请人保留在背景技术中增加相关现有技术之权利。In addition, on the one hand, there are differences in understanding among those skilled in the art; on the other hand, the applicant studied a large number of documents and patents when making the present invention, but due to space limitations, not all details and contents are listed in detail. However, this does not mean that the present invention does not have the characteristics of these prior arts. On the contrary, the present invention already has all the characteristics of the prior art, and the applicant reserves the right to add relevant prior art to the background technology.
发明内容Summary of the invention
现有技术已经提供诸多用于背根神经节的电刺激装置。例如， CN105477779A公开了一种应用于背根神经节的电刺激系统，通过电刺激单元发出高频电刺激信号以使第一电极与第二电极产生范围涵盖背根神经节的电场。该技术方案仅涉及用于执行背根神经节电刺激的硬件结构，相关的电刺激参数的调整需要通过专业的医护人员根据患者实际的治疗需求进行适应性调整，患者无法依赖专业的医疗指导自行进行调整，只能根据病情的变化及时到专业医疗机构进行更新，这对于患者的居家治疗过程来说是极为不便的。现有技术为了增强医患之间的医疗数据交互，已经开发出了诸多通过多终端设备进行病症数据共享以提高患者在社区或居家护理效果的系统。例如，CN114188010A公开了一种多载体实时共享反馈症状系统，包括用户端、互联网端和服务端，其中的用户端包括通过互联网端与医务人员端实现数据交互的症状自我报告模块，症状自我报告模块用于患者向医务人员反馈患者实时健康状况。然而，该技术方案实质上提供的是一种信息沟通平台，其目的是为了提高医患之间的沟通实时性，其中并不涉及根据多终端的数据交互来实现刺激装置执行参数的远程更新过程。与常规外科手术不同，经椎间孔穿刺的背根神经节电刺激装置的植入手术完成只是治疗的开始，术后需要通过程控（程序控制）来获得并维持良好的疗效。术后的电刺激装置程控过程需要根据患者的实时病情发展以及专业的医疗指导进行针对性调整，这就要求医护人员与患者最好处于同一时空下才便于进行上述调整过程，这与患者的居家治疗需求是相违背的。为此，本申请通过远程程控的方式来解决这一技术问题，以实现更高效、更经济的长期疾病管理效果。The prior art has provided many electrical stimulation devices for dorsal root ganglia. For example, CN105477779A discloses an electrical stimulation system for dorsal root ganglia, which emits a high-frequency electrical stimulation signal through an electrical stimulation unit so that the first electrode and the second electrode generate an electric field covering the dorsal root ganglia. This technical solution only involves the hardware structure for performing electrical stimulation of dorsal root ganglia. The adjustment of the relevant electrical stimulation parameters needs to be adaptively adjusted by professional medical staff according to the actual treatment needs of the patient. The patient cannot rely on professional medical guidance to make adjustments on his own, and can only go to a professional medical institution for updates in time according to the changes in the condition, which is extremely inconvenient for the patient's home treatment process. In order to enhance the medical data interaction between doctors and patients, the prior art has developed many systems that share disease data through multiple terminal devices to improve the patient's community or home care effect. For example, CN114188010A discloses a multi-carrier real-time sharing feedback symptom system, including a user end, an Internet end and a service end, wherein the user end includes a symptom self-reporting module that realizes data interaction with the medical staff end through the Internet end, and the symptom self-reporting module is used for the patient to feedback the patient's real-time health status to the medical staff. However, this technical solution essentially provides an information communication platform, the purpose of which is to improve the real-time communication between doctors and patients. It does not involve the remote update process of the execution parameters of the stimulation device based on data interaction of multiple terminals. Unlike conventional surgical operations, the completion of the implantation surgery of the dorsal root ganglion electrical stimulation device through intervertebral foraminal puncture is only the beginning of treatment. After the operation, programming (program control) is required to obtain and maintain good therapeutic effects. The programming process of the postoperative electrical stimulation device needs to be adjusted in a targeted manner according to the patient's real-time disease progression and professional medical guidance. This requires that medical staff and patients are preferably in the same time and space to facilitate the above adjustment process, which is contrary to the patient's home treatment needs. To this end, the present application solves this technical problem through remote programming to achieve more efficient and economical long-term disease management effects.
针对现有技术之不足，本发明提供了一种经椎间孔穿刺的背根神经节电刺激系统，以解决上述至少部分技术问题。In view of the deficiencies of the prior art, the present invention provides a dorsal root ganglion electrical stimulation system via intervertebral foramen puncture to solve at least part of the above-mentioned technical problems.
本发明公开了一种经椎间孔穿刺的背根神经节电刺激系统，其包括：刺激装置，用于对患者的目标组织施加电刺激，该目标组织为背根神经节；由患者和/或医护人员使用的用户端；与用户端通讯连接的医院端。The present invention discloses a dorsal root ganglion electrical stimulation system for transforaminal puncture, which comprises: a stimulation device for applying electrical stimulation to a patient's target tissue, the target tissue being the dorsal root ganglion; a user end used by the patient and/or medical staff; and a hospital end connected to the user end for communication.
刺激装置配置的控制单元能够与患者和/或医护人员使用的用户端通讯连接，通过控制单元上配置的操作部件和/或用户端输入待调节的刺激指令，控制单元能够核验该刺激指令上是否附带有医院端下发的验证信息，用户端在接收到控制单元发出的未附带有医院端的验证信息的反馈后能够将包含该刺激指令在内的数据信息上传至医院端，以实现自动地和/或利用医护人员手动地对刺激指令的判断，其中，待调节的刺激指令包括对刺激的频率、脉宽、时长和强度以及治疗持续时间和间隔中的一个或多个参数的调节。The control unit configured for the stimulation device can be connected to a communication with a user terminal used by patients and/or medical staff. The stimulation instructions to be adjusted are input through the operating components configured on the control unit and/or the user terminal. The control unit can verify whether the stimulation instructions are accompanied by verification information issued by the hospital side. After receiving feedback from the control unit that is not accompanied by verification information from the hospital side, the user terminal can upload data information including the stimulation instructions to the hospital side, so as to realize automatic and/or manual judgment of the stimulation instructions by medical staff, wherein the stimulation instructions to be adjusted include adjustments to one or more parameters in the frequency, pulse width, duration and intensity of the stimulation, as well as the duration and interval of the treatment.
与现有技术不同的是，本发明的刺激装置上配置有能够与患者和/或医护人员使用的用户端通讯连接的控制单元，在控制单元上的操作部件和/或用户端输入的刺激指令能够用于调整刺激装置的工作参数，同时，控制单元能够对该刺激指令上是否附带有医院端下发的验证信息进行核验，如果核验不通过，则能够进一步通过用户端将包含该刺激指令在内的数据信息上传至医院端以判断该刺激指令的有效性。基于上述区别技术特征，本发明要解决的问题可以包括：如何提高待调节的刺激指令的准确性与安全性，以确保获得预期的治疗效果。具体地，本系统通过构建用户端和医院端之间的通讯连接以及用户端和控制单元之间的通讯连接，使患者能在家中进行治疗。这显著提高了治疗的便利性，使患者无需频繁往返医院，极大提高了病人的生活质量。本发明通过允许医护人员或患者在用户端调整刺激指令（包括频率、脉宽、时长、强度、治疗持续时间和间隔等），以根据患者的病情变化进行实时的治疗参数调整，优化治疗效果。待调节的刺激指令需要经过医院端的验证信息核验，增强了系统的安全性，防止了错误或不恰当的电刺激参数的应用，从而保护患者免受潜在的风险。例如，患者由于仅凭主观感受认为疼痛感加重，希望增加刺激装置的工作参数以提高疼痛减轻的作用效果，如果不设限地将刺激指令的控制权限下放至患者端，一方面存在因患者主观感受误差所带来的刺激装置参数调整错误，另一方面也存在患者因过度调整而造成患者“成瘾式”的治疗依赖，这些都是对患者健康的长期疼痛管理过程不利的。本发明刺激指令的核验过程能够确保刺激装置的电刺激参数在专业的医疗指导下与患者实际的治疗需求相匹配。通过允许患者在一定程度上参与到治疗过程中，能够提高病人的治疗依从性，同时也可以提升病人的治疗满意度。自动化的验证和反馈机制减少了因人为错误导致的医疗错误，提高了治疗的准确性和可靠性。通过远程管理和调整治疗方案，可以减少患者的就医次数，节约医疗资源，同时也减轻了医护人员的工作压力。Different from the prior art, the stimulation device of the present invention is equipped with a control unit that can be connected to the user end used by the patient and/or medical staff. The operating components on the control unit and/or the stimulation instructions input by the user end can be used to adjust the working parameters of the stimulation device. At the same time, the control unit can verify whether the stimulation instruction is accompanied by the verification information issued by the hospital end. If the verification fails, the data information including the stimulation instruction can be further uploaded to the hospital end through the user end to determine the validity of the stimulation instruction. Based on the above-mentioned distinguishing technical features, the problems to be solved by the present invention may include: how to improve the accuracy and safety of the stimulation instructions to be adjusted to ensure the expected treatment effect. Specifically, the system enables patients to receive treatment at home by constructing a communication connection between the user end and the hospital end and a communication connection between the user end and the control unit. This significantly improves the convenience of treatment, so that patients do not need to frequently go back and forth to the hospital, which greatly improves the quality of life of patients. The present invention allows medical staff or patients to adjust the stimulation instructions (including frequency, pulse width, duration, intensity, treatment duration and interval, etc.) at the user end to adjust the treatment parameters in real time according to the changes in the patient's condition and optimize the treatment effect. The stimulation instructions to be adjusted need to be verified by the verification information of the hospital side, which enhances the security of the system and prevents the application of erroneous or inappropriate electrical stimulation parameters, thereby protecting patients from potential risks. For example, because the patient believes that the pain is aggravated based on subjective feelings alone, he hopes to increase the working parameters of the stimulation device to improve the effect of pain relief. If the control authority of the stimulation instructions is delegated to the patient side without restrictions, on the one hand, there are stimulation device parameter adjustment errors caused by the patient's subjective feeling errors, and on the other hand, there are patients who are "addicted" to treatment due to excessive adjustments, which are all unfavorable to the patient's long-term pain management process. The verification process of the stimulation instructions of the present invention can ensure that the electrical stimulation parameters of the stimulation device match the actual treatment needs of the patient under professional medical guidance. By allowing patients to participate in the treatment process to a certain extent, the patient's treatment compliance can be improved, and the patient's treatment satisfaction can also be improved. The automated verification and feedback mechanism reduces medical errors caused by human errors and improves the accuracy and reliability of treatment. By remotely managing and adjusting treatment plans, the number of patients' medical visits can be reduced, medical resources can be saved, and the work pressure of medical staff can also be reduced.
根据一种优选实施方式，刺激装置包括电极单元，电极单元包括电极引线和位于电极引线远端的刺激电极，其中，电极引线可植入目标组织中或与目标组织相邻，电极单元被配置为经脊柱外侧穿刺进入椎间孔。According to a preferred embodiment, the stimulation device includes an electrode unit, which includes an electrode lead and a stimulation electrode located at the distal end of the electrode lead, wherein the electrode lead can be implanted in or adjacent to the target tissue, and the electrode unit is configured to enter the intervertebral foramen through an extravertebral puncture.
常规的背根神经节电刺激技术在植入刺激电极时通常是先经过椎板间隙穿刺，然后再经椎管内、硬膜背侧进入椎间孔。刺激电极在经过椎板间隙穿刺时，需穿过两个骨性狭窄区域，刺激电极在该区域的断裂率较高，据统计约有9%的断裂率。而且尤其是对于椎管狭窄的患者，刺激电极无法通过狭窄的椎管进入椎间孔。本发明的刺激电极可经脊柱外侧穿刺进入椎间孔，以减少刺激电极断裂率，并降低穿刺难度。以上述方式植入患者目标组织中或与目标组织相邻的刺激电极可尤其适用于椎管狭窄的患者。Conventional dorsal root ganglion electrical stimulation technology usually involves first puncturing the intervertebral space when implanting the stimulating electrode, and then entering the intervertebral foramen through the spinal canal and the dorsal side of the dura mater. When puncturing the intervertebral space, the stimulating electrode needs to pass through two areas of bony stenosis. The fracture rate of the stimulating electrode in this area is relatively high, and according to statistics, the fracture rate is about 9%. Moreover, especially for patients with spinal stenosis, the stimulating electrode cannot enter the intervertebral foramen through the narrow spinal canal. The stimulating electrode of the present invention can enter the intervertebral foramen through puncture on the outside of the spine to reduce the fracture rate of the stimulating electrode and reduce the difficulty of puncture. The stimulating electrode implanted in the patient's target tissue or adjacent to the target tissue in the above manner is particularly suitable for patients with spinal stenosis.
根据一种优选实施方式，刺激装置包括脉冲发生单元，脉冲发生单元能够耦合到电极引线的近端，其中，脉冲发生单元包括可编程控制器，该可编程控制器被配置为响应于控制单元传输的刺激指令并经由设置在电极引线上的一个或多个刺激电极提供电刺激。According to a preferred embodiment, the stimulation device includes a pulse generating unit, which can be coupled to the proximal end of the electrode lead, wherein the pulse generating unit includes a programmable controller, which is configured to respond to stimulation instructions transmitted by the control unit and provide electrical stimulation via one or more stimulation electrodes arranged on the electrode lead.
本发明的脉冲发生单元可被配置为植入式脉冲发生器（IPG），该器件能够为患者提供连续或按需的电刺激，无需频繁访问医疗机构进行治疗，极大地提高了治疗的便捷性，同时也减少了患者的心理和经济负担。借助可编程控制器，脉冲发生单元可以根据患者具体的医疗需求和反应，调整电刺激的参数（如频率、脉宽、强度等），实现个性化治疗方案。这种个性化的治疗方法能够更有效地应对各种疼痛条件，提高治疗的有效性。The pulse generating unit of the present invention can be configured as an implantable pulse generator (IPG), which can provide patients with continuous or on-demand electrical stimulation without the need to frequently visit medical institutions for treatment, greatly improving the convenience of treatment and reducing the psychological and economic burden on patients. With the help of a programmable controller, the pulse generating unit can adjust the parameters of electrical stimulation (such as frequency, pulse width, intensity, etc.) according to the patient's specific medical needs and reactions to achieve a personalized treatment plan. This personalized treatment method can more effectively cope with various pain conditions and improve the effectiveness of treatment.
根据一种优选实施方式，刺激电极的背根神经节电刺激治疗靶点能够利用影像学和电生理学测试确定得到，其中，在进行测试时能够以逐步增加射频能量的方式对多个背根神经节进行比较，当异感完全覆盖疼痛区域时，能够借此判断受累的神经节段。According to a preferred embodiment, the dorsal root ganglion electrical stimulation treatment target of the stimulation electrode can be determined by imaging and electrophysiological testing, wherein multiple dorsal root ganglia can be compared by gradually increasing radio frequency energy during the test, and when the abnormal sensation completely covers the painful area, the affected nerve segment can be determined.
医护人员可根据临床经验和辅助检查结果判断出病人疼痛区域对应的神经节段，再利用影像学和电生理学测试确定背根神经节电刺激治疗靶点。优选地，医护人员可以收集患者的全面医疗病史，包括但不限于慢性疼痛的性质、持续时间、以往的治疗响应情况和任何伴随症状。进一步地，在辅助检查时，通过详细的体格检查和相关的神经诊断测试可确定疼痛的确切来源。Medical staff can determine the nerve segment corresponding to the patient's pain area based on clinical experience and auxiliary examination results, and then use imaging and electrophysiological tests to determine the dorsal root ganglion electrical stimulation treatment target. Preferably, medical staff can collect the patient's comprehensive medical history, including but not limited to the nature, duration, previous treatment response and any accompanying symptoms of chronic pain. Furthermore, during the auxiliary examination, the exact source of the pain can be determined through a detailed physical examination and relevant neurodiagnostic tests.
根据一种优选实施方式，在初期治疗的过程中，刺激装置在初始化后能够基于输入的初始治疗参数执行相应的治疗操作，并能够受控于医护人员基于专业监测仪器的监测结果而执行的调控，以获取最佳治疗参数，其中，专业监测仪器包括生物电测量仪器、神经电生理测量仪器和/或生命体征监测仪器。According to a preferred embodiment, during the initial treatment, the stimulation device can perform corresponding treatment operations based on the input initial treatment parameters after initialization, and can be controlled by medical staff based on the monitoring results of professional monitoring instruments to obtain optimal treatment parameters, wherein the professional monitoring instruments include bioelectric measuring instruments, neuroelectrophysiological measuring instruments and/or vital signs monitoring instruments.
由于患者通常需要永久性植入刺激装置，因此，在患者进行居家治疗之前，通常需要住院观察一段时间以接收初期治疗，在此期间，医护人员可以随时观察患者的反应并配合医院的专业监测仪器的监测结果，以便及时对初始治疗参数进行调节，从而获取最佳治疗参数。Since patients usually need to have a permanent implant of a stimulation device, they usually need to be hospitalized for a period of time to receive initial treatment before they can receive home treatment. During this period, medical staff can observe the patient's response at any time and cooperate with the monitoring results of the hospital's professional monitoring equipment to adjust the initial treatment parameters in time to obtain the best treatment parameters.
根据一种优选实施方式，佩戴有已调节至最佳治疗参数的刺激装置的患者在居家治疗的过程中，能够通过用户端将数据信息上传至医院端，以使得医院端能够根据上传的数据信息判断输入的刺激指令的合理性和/或生成符合要求的建议的刺激指令，其中，上传至医院端的数据信息包括输入的刺激指令和/或患者的反馈信息，该反馈信息包括疼痛级别、生活质量指标、心理社会因素中的一个或多个。According to a preferred embodiment, during home treatment, a patient wearing a stimulation device adjusted to optimal treatment parameters can upload data information to a hospital through a user terminal, so that the hospital can determine the rationality of input stimulation instructions and/or generate recommended stimulation instructions that meet the requirements based on the uploaded data information, wherein the data information uploaded to the hospital includes input stimulation instructions and/or feedback information from the patient, and the feedback information includes one or more of pain levels, quality of life indicators, and psychosocial factors.
本发明的背根神经节电刺激系统可以将处理器设置于医院端，使得医院端可以被用于处理各患者的与刺激指令调节相关的数据运算，降低了各刺激装置的配置成本，即在各刺激装置上无需配置高性能的处理单元，即可实现对刺激指令的合理性的判断。医院端可以判断输入的刺激指令的合理性，这对于预防过度或欠缺刺激、避免产生副作用等非常有帮助。The dorsal root ganglion electrical stimulation system of the present invention can set the processor at the hospital end, so that the hospital end can be used to process the data calculation related to the stimulation instruction adjustment of each patient, reducing the configuration cost of each stimulation device, that is, there is no need to configure a high-performance processing unit on each stimulation device to achieve the judgment of the rationality of the stimulation instruction. The hospital end can judge the rationality of the input stimulation instruction, which is very helpful for preventing excessive or insufficient stimulation and avoiding side effects.
根据一种优选实施方式，医院端能够根据患者通过用户端上传的数据信息中的反馈信息提取若干类型的评分，并能够根据各类型评分之间的关联关系建立基础模型，以计算得到用于反映患者当前治疗效果的实际状态评分，其中，医院端能够根据实际状态评分以及各类型的评分生成建议的刺激指令或将该患者的数据信息发送至对应医护人员的用户端，以启动人工校核。According to a preferred embodiment, the hospital side can extract several types of scores based on the feedback information in the data information uploaded by the patient through the user side, and can establish a basic model based on the correlation between the various types of scores to calculate the actual status score that reflects the current treatment effect of the patient, wherein the hospital side can generate recommended stimulation instructions based on the actual status score and each type of score or send the patient's data information to the user side of the corresponding medical staff to initiate manual verification.
通过从患者上传的数据中提取多种类型的评分，并根据这些评分之间的关联关系建立基础模型来计算得到反映患者当前治疗效果的实际状态评分，医院端可以得到一个更为精确和全面的治疗效果评估。这种评估方式可以更有效地捕捉患者在治疗过程中的细微变化，从而提供更为精确的治疗调整依据。基于实际状态评分及各类型的评分，医院端可以生成建议的刺激指令，从而实现治疗方案的动态调整。这种调整是基于患者当前的实际反应进行的，能够更好地适应患者的实际需要，提高治疗的个性化和精确性。By extracting multiple types of scores from the data uploaded by patients and establishing a basic model based on the correlation between these scores to calculate the actual status score that reflects the current treatment effect of the patient, the hospital can obtain a more accurate and comprehensive evaluation of the treatment effect. This evaluation method can more effectively capture the subtle changes in patients during the treatment process, thereby providing a more accurate basis for treatment adjustment. Based on the actual status score and various types of scores, the hospital can generate recommended stimulation instructions to achieve dynamic adjustment of the treatment plan. This adjustment is based on the patient's current actual response, which can better meet the patient's actual needs and improve the personalization and accuracy of treatment.
根据一种优选实施方式，医院端能够通过对比输入的刺激指令与建议的刺激指令之间的偏差来判断输入的刺激指令的合理性，其中，当输入的刺激指令符合要求，医院端则下发相应的验证信息，用户端能够将验证信息发送至控制单元以实现核验；当输入的刺激指令不符合要求，医院端则给出建议的刺激指令并为建议的刺激指令附带相应的验证信息，用户端将附带有验证信息的建议的刺激指令替换原始输入的刺激指令，并发送至控制单元以实现核验。According to a preferred embodiment, the hospital side can judge the rationality of the input stimulation instruction by comparing the deviation between the input stimulation instruction and the recommended stimulation instruction, wherein, when the input stimulation instruction meets the requirements, the hospital side will issue corresponding verification information, and the user side can send the verification information to the control unit for verification; when the input stimulation instruction does not meet the requirements, the hospital side will give a recommended stimulation instruction and attach corresponding verification information to the recommended stimulation instruction, and the user side will replace the original input stimulation instruction with the recommended stimulation instruction attached with the verification information, and send it to the control unit for verification.
通过对刺激指令的实时核验，医院端能够更有效地对病患进行管理。这不仅可以提高医院的工作效率，也有助于提高病患的满意度。医院端在判断输入的刺激指令后，会即时给出反馈。这样的实时反馈能够帮助医护人员及时了解并调整治疗方案，使得治疗的实施更为高效和精确。当输入的刺激指令不符合要求时，医院端会提供建议的刺激指令并附带相应的验证信息。这样做既确保了指令的合理性，又增强了治疗的安全性。By verifying the stimulation instructions in real time, the hospital can manage patients more effectively. This can not only improve the work efficiency of the hospital, but also help improve patient satisfaction. After judging the input stimulation instructions, the hospital will give feedback immediately. Such real-time feedback can help medical staff understand and adjust the treatment plan in a timely manner, making the implementation of treatment more efficient and accurate. When the input stimulation instructions do not meet the requirements, the hospital will provide recommended stimulation instructions with corresponding verification information. This ensures the rationality of the instructions and enhances the safety of treatment.
根据一种优选实施方式，当出现如下任一情况时，医院端能够将该患者的数据信息发送至对应医护人员的用户端，以启动人工校核：各类型的评分中存在一项评分超出相应的预设阈值；实际状态评分超出预设阈值；患者根据医院端提供的建议的刺激指令执行电刺激后反馈效果不佳。According to a preferred embodiment, when any of the following situations occurs, the hospital side can send the patient's data information to the user side of the corresponding medical staff to initiate manual verification: one of the scores of each type exceeds the corresponding preset threshold; the actual status score exceeds the preset threshold; the patient feedback is not good after executing electrical stimulation according to the recommended stimulation instructions provided by the hospital side.
通过将重要的数据信息发送至对应医护人员的用户端，医院可以快速启动人工校核过程，这不仅加快了医疗响应速度，也提高了处理复杂或临界情况的效率。自动化的数据监控和异常报告机制减少了医护人员对数据的手动审查需求，使他们能够更高效地管理患者状况并集中精力于临床决策和患者照顾上。By sending important data information to the user end of the corresponding medical staff, the hospital can quickly start the manual verification process, which not only speeds up the medical response, but also improves the efficiency of handling complex or critical situations. Automated data monitoring and abnormal reporting mechanisms reduce the need for medical staff to manually review data, allowing them to manage patient conditions more efficiently and focus on clinical decision-making and patient care.
根据一种优选实施方式，医院端在构建的基础模型之上，通过引入交叉项的方式来捕捉不同类型的评分之间的相互作用，以拟合得到扩展模型，根据拟合的扩展模型，以估算交叉项的系数，从而得到改良后的实际状态评分的模型。According to a preferred embodiment, the hospital introduces cross terms on top of the constructed basic model to capture the interaction between different types of scores so as to fit an extended model, and estimates the coefficients of the cross terms based on the fitted extended model to obtain an improved model of actual status scores.
利用数据分析和模型建立，该方案允许医院端持续优化和调整治疗方法，根据患者的实时数据和反馈调整治疗策略，从而在长期内持续提升治疗效果和患者满意度。通过在基础模型上引入交叉项，医院端能更好地捕捉和理解不同类型评分间的相互作用。这通常会导致更准确的实际状态评分，因为它允许模型包括一些评分之间的非线性关系，这些关系在没有交叉项的模型中可能会被忽视。交叉项的引入可以帮助医院端了解哪些评分类型是相互影响的，以及它们是如何相互影响的。这为医生提供了更深入的理解，有助于识别和解决可能影响患者治疗效果的因素。拟合得到的扩展模型可以用来更精确地估算交叉项的系数，从而改良实际状态评分的模型。这种改良的评分模型可以提供更准确的治疗反馈，从而更精准地调整和优化治疗方案。Using data analysis and model building, the solution allows hospitals to continuously optimize and adjust treatment methods, adjust treatment strategies based on patients' real-time data and feedback, and thus continuously improve treatment outcomes and patient satisfaction in the long term. By introducing cross-terms to the basic model, hospitals can better capture and understand the interactions between different types of scores. This often leads to more accurate actual status scores because it allows the model to include some nonlinear relationships between scores that may be ignored in models without cross-terms. The introduction of cross-terms can help hospitals understand which types of scores influence each other and how they influence each other. This provides doctors with a deeper understanding and helps identify and address factors that may affect patient treatment outcomes. The extended model obtained by fitting can be used to more accurately estimate the coefficients of cross-terms, thereby improving the model of actual status scores. This improved scoring model can provide more accurate treatment feedback, thereby more accurately adjusting and optimizing treatment plans.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
图1是本发明提供的背根神经节电刺激系统的硬件连接图；FIG1 is a hardware connection diagram of a dorsal root ganglion electrical stimulation system provided by the present invention;
图2是本发明提供的背根神经节电刺激系统的控制逻辑图；FIG2 is a control logic diagram of the dorsal root ganglion electrical stimulation system provided by the present invention;
图3是本发明提供的背根神经节电刺激系统的刺激装置的结构示意图。FIG3 is a schematic diagram of the structure of a stimulation device of the dorsal root ganglion electrical stimulation system provided by the present invention.
附图标记列表Reference numerals list
100：刺激装置；110：控制单元；111：操作部件；120：电极单元；121：电极引线；122：刺激电极；130：脉冲发生单元；200：用户端；300：医院端。100: stimulation device; 110: control unit; 111: operating component; 120: electrode unit; 121: electrode lead; 122: stimulation electrode; 130: pulse generating unit; 200: user end; 300: hospital end.
具体实施方式DETAILED DESCRIPTION
下面结合附图进行详细说明。The following is a detailed description with reference to the accompanying drawings.
如图1~图3所示，本发明公开了一种经椎间孔穿刺的背根神经节电刺激系统，其配置有用于对患者施加电刺激的刺激装置100，其中，刺激装置100可包括电极单元120、脉冲发生单元130和控制单元110。As shown in Figures 1 to 3, the present invention discloses a dorsal root ganglion electrical stimulation system via intervertebral foramen puncture, which is equipped with a stimulation device 100 for applying electrical stimulation to a patient, wherein the stimulation device 100 may include an electrode unit 120, a pulse generating unit 130 and a control unit 110.
优选地，电极单元120可包括具有近端和远端的电极引线121和位于电极引线121远端的刺激电极122，其中，电极引线121被配置为植入目标组织中或与目标组织相邻。Preferably, the electrode unit 120 may include an electrode lead 121 having a proximal end and a distal end and a stimulation electrode 122 located at the distal end of the electrode lead 121, wherein the electrode lead 121 is configured to be implanted in or adjacent to the target tissue.
常规的背根神经节电刺激技术在植入刺激电极122时通常是先经过椎板间隙穿刺，然后再经椎管内、硬膜背侧进入椎间孔。椎板间隙是指人体脊椎骨（脊柱）中相邻两个椎骨之间的空隙或间隔。在脊椎解剖学中，椎板（vertebral body）是构成脊柱的主要骨骼结构之一，它们位于椎骨的前部，呈圆柱形，堆叠在一起形成了整个脊柱。椎板之间的间隙通常由两个相邻椎骨之间的椎间盘（intervertebral disc）和椎间孔（intervertebralforamen）组成。因此，刺激电极122在经过椎板间隙穿刺时，需穿过两个骨性狭窄区域，刺激电极122在该区域的断裂率较高，据统计约有9%的断裂率。而且尤其是对于椎管狭窄的患者，刺激电极122无法通过狭窄的椎管进入椎间孔，其中，椎管狭窄的患者可分为先天性椎管狭窄和后天性椎管狭窄，先天性椎管狭窄是由于在脊柱的生长形成中包括营养外伤等因素造成椎管发育的先天性狭窄致病，后天性椎管狭窄是由于椎间盘突出、椎体增生、椎体滑脱以及后纵韧带、黄韧带增生肥厚、钙化或骨化等刺激脊髓神经及周围血管，造成神经血管发生炎症粘连、充血、水肿，从而导致椎管狭窄的发生。Conventional dorsal root ganglion electrical stimulation technology usually involves first puncturing the intervertebral space when implanting the stimulation electrode 122, and then entering the intervertebral foramen through the spinal canal and the dorsal side of the dura mater. The intervertebral space refers to the space or interval between two adjacent vertebrae in the human spine (spine). In spinal anatomy, the lamina (vertebral body) is one of the main bone structures that make up the spine. They are located in the front of the vertebrae, are cylindrical, and are stacked together to form the entire spine. The space between the lamina is usually composed of an intervertebral disc and an intervertebral foramen between two adjacent vertebrae. Therefore, when the stimulation electrode 122 is punctured through the intervertebral space, it needs to pass through two bony narrow areas. The fracture rate of the stimulation electrode 122 in this area is relatively high, and according to statistics, the fracture rate is about 9%. Moreover, especially for patients with spinal stenosis, the stimulation electrode 122 cannot pass through the narrow spinal canal into the intervertebral foramen. Among them, patients with spinal stenosis can be divided into congenital spinal stenosis and acquired spinal stenosis. Congenital spinal stenosis is caused by congenital stenosis of the spinal canal development due to factors such as nutritional trauma during the growth and formation of the spine. Acquired spinal stenosis is caused by intervertebral disc herniation, vertebral hyperplasia, vertebral slippage, and hyperplasia, thickening, calcification or ossification of the posterior longitudinal ligament and yellow ligament, which stimulate the spinal nerves and surrounding blood vessels, causing inflammation, adhesion, congestion and edema of the nerves and blood vessels, thereby leading to the occurrence of spinal stenosis.
优选地，如图3所示，本发明的刺激电极122可经脊柱外侧穿刺进入椎间孔，以减少刺激电极122断裂率，并降低穿刺难度。以上述方式植入患者目标组织中或与目标组织相邻的刺激电极122可尤其适用于椎管狭窄的患者。Preferably, as shown in Fig. 3, the stimulation electrode 122 of the present invention can be inserted into the intervertebral foramen via the lateral vertebral column to reduce the fracture rate of the stimulation electrode 122 and reduce the difficulty of puncture. The stimulation electrode 122 implanted in the patient's target tissue or adjacent to the target tissue in the above manner is particularly suitable for patients with spinal stenosis.
优选地，脉冲发生单元130可被配置为植入式脉冲发生器（IPG），其可耦合到电极引线121的近端，其中，脉冲发生单元130具有可编程控制器，可编程控制器被配置为经由设置在电极引线121上的一个或多个刺激电极122提供电刺激。Preferably, the pulse generating unit 130 may be configured as an implantable pulse generator (IPG) which may be coupled to the proximal end of the electrode lead 121 , wherein the pulse generating unit 130 has a programmable controller configured to provide electrical stimulation via one or more stimulation electrodes 122 disposed on the electrode lead 121 .
优选地，控制单元110可被配置为将刺激指令传输到脉冲发生单元130，使得脉冲发生单元130中的可编程控制器能够响应于刺激指令，以根据编程数据通过刺激电极122刺激目标组织。Preferably, the control unit 110 may be configured to transmit the stimulation instruction to the pulse generating unit 130 , so that the programmable controller in the pulse generating unit 130 can respond to the stimulation instruction to stimulate the target tissue through the stimulation electrode 122 according to the programming data.
优选地，控制单元110可具有操作部件111，以利用操作部件111输入刺激指令，其中，操作部件111可例如是触控按键、触控面板、实体按键或上述组合。进一步地，控制单元110在使用前可先进行初始化，再利用操作部件111将初始治疗参数输入至控制单元110，其中，初始治疗参数为医护人员针对相应患者生成的最佳治疗方案所确定的初始参数。优选地，接收到刺激指令的控制单元110可以直接地或经过预处理地将刺激指令传输到脉冲发生单元130，使得脉冲发生单元130可以根据刺激指令驱动刺激电极122对目标组织施加电刺激。Preferably, the control unit 110 may have an operating component 111, so as to input a stimulation instruction using the operating component 111, wherein the operating component 111 may be, for example, a touch button, a touch panel, a physical button, or a combination thereof. Furthermore, the control unit 110 may be initialized before use, and then the initial treatment parameters may be input into the control unit 110 using the operating component 111, wherein the initial treatment parameters are initial parameters determined by the medical staff for the optimal treatment plan generated for the corresponding patient. Preferably, the control unit 110 that receives the stimulation instruction may transmit the stimulation instruction to the pulse generating unit 130 directly or after preprocessing, so that the pulse generating unit 130 may drive the stimulation electrode 122 to apply electrical stimulation to the target tissue according to the stimulation instruction.
优选地，刺激装置100可在医院由专业的医护人员配置完成，其中，医护人员可根据临床经验和辅助检查结果判断出病人疼痛区域对应的神经节段，以确定背根神经节电刺激治疗靶点（即目标组织）。Preferably, the stimulation device 100 can be configured by professional medical staff in a hospital, wherein the medical staff can determine the nerve segment corresponding to the patient's pain area based on clinical experience and auxiliary examination results to determine the dorsal root ganglion electrical stimulation treatment target (i.e., target tissue).
优选地，医护人员执行经过椎间孔穿刺的步骤可包括：Preferably, the steps of performing transforaminal puncture by medical personnel may include:
S1、患者体位摆放：将患者置于俯卧位，确保患者舒适并保持稳定的姿势；调整手术床，使患者脊柱处于自然状态，便于操作。S1. Patient positioning: Place the patient in a prone position, ensuring that the patient is comfortable and maintains a stable posture; adjust the operating table so that the patient's spine is in a natural state for easy operation.
S2、体表定位与划线：利用体表解剖标志进行定位，确定穿刺点；在患者皮肤上进行划线，标记穿刺路径，确保穿刺点的准确性。S2. Body surface positioning and marking: Use body surface anatomical landmarks for positioning and determining the puncture point; draw lines on the patient's skin to mark the puncture path to ensure the accuracy of the puncture point.
S3、局部麻醉：在确定的穿刺点进行局部麻醉，以减少患者在穿刺过程中的疼痛感。S3. Local anesthesia: Local anesthesia is performed at the determined puncture point to reduce the patient's pain during the puncture process.
S4、C臂引导穿刺：使用C臂X射线机进行实时影像引导，确保穿刺针准确进入椎间孔；调整穿刺角度和深度，避免损伤周围组织和神经结构。S4. C-arm guided puncture: Use C-arm X-ray machine for real-time image guidance to ensure that the puncture needle enters the intervertebral foramen accurately; adjust the puncture angle and depth to avoid damage to surrounding tissues and neural structures.
S5、植入鞘管：沿穿刺针植入鞘管，确保鞘管稳定地位于椎间孔内；透视确认鞘管位置，确保其正确无误。S5. Implant the sheath: Implant the sheath along the puncture needle to ensure that the sheath is stably located in the intervertebral foramen; confirm the position of the sheath by fluoroscopy to ensure that it is correct.
S6、植入电极：通过鞘管将刺激电极122植入椎间孔，利用刺激电极122的倒刺结构固定于椎旁肌；调整刺激电极122位置，确保刺激电极122处于最佳刺激位置；使用记忆金属弹簧作为缓冲，固定电极倒刺与刺激点之间的连接，以确保刺激电极122稳定，避免因身体活动导致刺激电极122移位。S6. Implanting electrodes: implant the stimulation electrode 122 into the intervertebral foramen through the sheath, and fix it to the paravertebral muscle using the barb structure of the stimulation electrode 122; adjust the position of the stimulation electrode 122 to ensure that the stimulation electrode 122 is in the optimal stimulation position; use a memory metal spring as a buffer to fix the connection between the electrode barb and the stimulation point to ensure the stability of the stimulation electrode 122 and avoid displacement of the stimulation electrode 122 due to body activity.
S7、透视确认与调整：利用透视技术再次确认电极的位置和稳定性；如有需要，进行微调以优化电极的位置和功能。S7. Fluoroscopic confirmation and adjustment: Use fluoroscopic technology to reconfirm the position and stability of the electrode; if necessary, make fine adjustments to optimize the position and function of the electrode.
S8、术后处理：完成电极植入后，进行必要的术后处理，包括关闭穿刺点和敷料固定；观察患者反应，确保没有立即的并发症。S8. Postoperative care: After electrode implantation, perform necessary postoperative care, including closing the puncture site and fixing with dressings; observe the patient's reaction to ensure there are no immediate complications.
优选地，医护人员可以收集患者的全面医疗病史，包括但不限于慢性疼痛的性质、持续时间、以往的治疗响应情况和任何伴随症状。进一步地，在辅助检查时，通过详细的体格检查和相关的神经诊断测试可确定疼痛的确切来源。优选地，医护人员还可以对患者的心理状况进行评估，这是因为患者的心理状况很可能影响治疗响应，例如，慢性疼痛与焦虑和抑郁等心理状况有很高的共病率，然而现有技术在对患者进行背根神经节电刺激时往往忽略了这些影响。优选地，根据上述的至少部分信息，医护人员可以针对性地为相应患者生成个性化的最佳治疗方案，其中，该最佳治疗方案可包括刺激装置100的参数设定，例如刺激的频率、脉宽、时长和强度。进一步地，除了上述参数之外，根据患者病情的严重程度还可对治疗持续时间和间隔进行调节。Preferably, the medical staff can collect the patient's comprehensive medical history, including but not limited to the nature, duration, previous treatment response and any accompanying symptoms of the chronic pain. Further, during the auxiliary examination, the exact source of the pain can be determined through a detailed physical examination and related neurodiagnostic tests. Preferably, the medical staff can also evaluate the patient's psychological condition, because the patient's psychological condition is likely to affect the treatment response. For example, chronic pain has a high comorbidity rate with psychological conditions such as anxiety and depression, but the prior art often ignores these effects when performing dorsal root ganglion electrical stimulation on patients. Preferably, based on at least part of the above information, the medical staff can generate a personalized optimal treatment plan for the corresponding patient, wherein the optimal treatment plan may include parameter settings of the stimulation device 100, such as the frequency, pulse width, duration and intensity of the stimulation. Further, in addition to the above parameters, the duration and interval of the treatment can also be adjusted according to the severity of the patient's condition.
优选地，确定治疗方案的步骤可包括：Preferably, the step of determining a treatment regimen may include:
前期评估：利用影像学和电生理学测试确定适合背根神经节电刺激的神经节位置；Preliminary evaluation: Use imaging and electrophysiological testing to determine the location of the ganglion suitable for dorsal root ganglion electrical stimulation;
试刺激期：在进行永久植入前，通过一段时间的试验刺激来评估疗效；Trial stimulation period: Before permanent implantation, a period of trial stimulation is performed to evaluate the efficacy;
植入期：如果试刺激有效，则植入电极单元120（例如永久的刺激电极122和电极引线121）和脉冲发生单元130（例如植入式脉冲发生器）；Implantation period: if the trial stimulation is effective, the electrode unit 120 (e.g., permanent stimulation electrode 122 and electrode lead 121) and the pulse generating unit 130 (e.g., implantable pulse generator) are implanted;
参数调节：根据患者的反应调整电刺激的参数；Parameter adjustment: adjust the parameters of electrical stimulation according to the patient's response;
定期随访：监测患者的治疗进展并根据需要调整治疗方案。Regular follow-up: Monitor the patient's treatment progress and adjust the treatment plan as needed.
优选地，医护人员在进行前期评估时可将射频套管针置于椎间孔背侧靠近背根神经节的位置，以逐步增加射频能量的方式同时测试多个背根神经节并进行比较，其中，当异感完全覆盖疼痛区域时，可以借此判断受累的神经节段。优选地，不同的疼痛区域常选择的刺激节段见表1，其中，表中数字越大，代表建议程度越高。Preferably, medical staff can place the radiofrequency cannula needle on the dorsal side of the intervertebral foramen near the dorsal root ganglion during preliminary evaluation, and test multiple dorsal root ganglia at the same time by gradually increasing the radiofrequency energy and comparing them. When the abnormal sensation completely covers the painful area, the affected nerve segment can be determined. Preferably, the stimulation segments commonly selected for different pain areas are shown in Table 1, where the larger the number in the table, the higher the degree of recommendation.
表1 不同疼痛区域常用刺激节段的建议程度Table 1 Recommended levels of commonly used stimulation segments in different pain areas
优选地，在确定背根神经节电刺激治疗靶点（目标组织）后，医护人员可以在可视化设备的辅助下利用穿刺套件将电极单元120植入目标组织中或与目标组织相邻，其中，电极单元120可经脊柱外侧穿刺进入椎间孔。Preferably, after determining the dorsal root ganglion electrical stimulation treatment target (target tissue), medical personnel can use a puncture kit with the assistance of a visualization device to implant the electrode unit 120 into or adjacent to the target tissue, wherein the electrode unit 120 can enter the intervertebral foramen through an external puncture of the spine.
优选地，在植入刺激装置100后，医护人员可利用操作部件111将初始治疗参数输入至控制单元110，以便进行参数调节，其中，在输入初始治疗参数时，可至少确定刺激模式，其中，刺激模式可包括连续刺激模式、脉冲刺激模式和锁相刺激模式等。进一步地，在连续刺激模式下，电刺激波形持续不断地以恒定的频率进行刺激，这种模式适用于需要持续刺激的疼痛病症；在脉冲刺激模式下，电刺激以脉冲的形式进行刺激，脉冲宽度和频率可以根据患者的需要进行调节；在锁相刺激模式下，电刺激与患者的神经信号进行同步刺激，这种模式可以根据患者的生理信号来调节刺激的时机，以提供更精确的治疗效果。优选地，初始治疗参数可包括刺激的频率、脉宽、时长和强度，进一步地还可包括治疗持续时间和间隔，其中，刺激的频率是指电刺激波形的重复率，即每秒钟刺激波形重复的次数；刺激的脉宽是指每个电刺激脉冲的持续时间；刺激的时长是指每次刺激的持续时间；刺激的强度是指电刺激的幅度或能量；治疗持续时间是指每天或每次治疗的总时长；治疗间隔是指每次治疗之间的时间间隔。Preferably, after implanting the stimulation device 100, the medical staff can use the operating component 111 to input the initial treatment parameters into the control unit 110 for parameter adjustment, wherein at least the stimulation mode can be determined when the initial treatment parameters are input, wherein the stimulation mode can include a continuous stimulation mode, a pulse stimulation mode, and a phase-locked stimulation mode, etc. Further, in the continuous stimulation mode, the electrical stimulation waveform continuously stimulates at a constant frequency, and this mode is suitable for pain conditions that require continuous stimulation; in the pulse stimulation mode, the electrical stimulation is stimulated in the form of pulses, and the pulse width and frequency can be adjusted according to the needs of the patient; in the phase-locked stimulation mode, the electrical stimulation is synchronized with the patient's neural signal, and this mode can adjust the timing of the stimulation according to the patient's physiological signal to provide a more precise treatment effect. Preferably, the initial treatment parameters may include the frequency, pulse width, duration and intensity of stimulation, and may further include the treatment duration and interval, wherein the stimulation frequency refers to the repetition rate of the electrical stimulation waveform, that is, the number of times the stimulation waveform is repeated per second; the stimulation pulse width refers to the duration of each electrical stimulation pulse; the stimulation duration refers to the duration of each stimulation; the stimulation intensity refers to the amplitude or energy of the electrical stimulation; the treatment duration refers to the total duration of each treatment per day or each time; the treatment interval refers to the time interval between each treatment.
优选地，在初期治疗的过程中，患者通常需要住院观察一段时间，在此期间，医护人员可以随时观察患者的反应并配合医院的专业监测仪器的监测结果，以便及时对初始治疗参数进行调节，从而获取最佳治疗参数。示例性地，专业监测仪器可包括生物电测量仪器、神经电生理测量仪器和/或生命体征监测仪器，其中，生物电测量仪器可例如是心电图仪、脑电图仪和肌电图仪等，可以用来监测和记录患者的心电图、脑电图和肌电活动，这些数据可以提供关于患者的心脑肌肉功能状态的信息，有助于评估治疗效果和调整电刺激参数；神经电生理测量仪器可例如是神经传导速度测量仪和脑干听觉诱发电位测量仪等，可以用来评估患者的神经功能状态，这些仪器可以提供关于神经传导速度、反应时间和神经异常的信息，可用于指导电刺激参数的调节；生命体征监测仪器可例如是血压计、心率监测仪和血氧饱和度仪等，可以用来监测患者的生命体征，如血压、心率和血氧水平，这些生理数据可以提供关于患者整体健康状况的信息，有助于评估治疗效果和调整电刺激参数。Preferably, during the initial treatment, the patient usually needs to be hospitalized for observation for a period of time. During this period, medical staff can observe the patient's response at any time and cooperate with the monitoring results of the hospital's professional monitoring equipment to adjust the initial treatment parameters in time to obtain the best treatment parameters. Exemplarily, professional monitoring instruments may include bioelectric measuring instruments, neuroelectrophysiological measuring instruments and/or vital signs monitoring instruments, wherein the bioelectric measuring instruments may be, for example, electrocardiographs, electroencephalographs and electromyographs, etc., which can be used to monitor and record the patient's electrocardiogram, electroencephalogram and electromyographic activity, and these data can provide information about the patient's cardio-cerebral-muscle functional state, which is helpful in evaluating the therapeutic effect and adjusting the electrical stimulation parameters; the neuroelectrophysiological measuring instruments may be, for example, nerve conduction velocity measuring instruments and brainstem auditory evoked potential measuring instruments, etc., which can be used to evaluate the patient's neurological functional state, and these instruments can provide information about nerve conduction velocity, reaction time and nerve abnormalities, which can be used to guide the adjustment of electrical stimulation parameters; the vital signs monitoring instruments may be, for example, sphygmomanometers, heart rate monitors and blood oxygen saturation meters, etc., which can be used to monitor the patient's vital signs, such as blood pressure, heart rate and blood oxygen level, and these physiological data can provide information about the patient's overall health status, which is helpful in evaluating the therapeutic effect and adjusting the electrical stimulation parameters.
优选地，在初期治疗结束后，刺激装置100的参数已调节至最佳治疗参数，佩戴该刺激装置100的患者可以离开医院并进行居家治疗，在此期间，医护人员需要定期地对患者进行随访调查，以监测患者的治疗进展并根据需要调整治疗方案。Preferably, after the initial treatment, the parameters of the stimulation device 100 have been adjusted to the optimal treatment parameters, and the patient wearing the stimulation device 100 can leave the hospital and receive home treatment. During this period, medical staff need to conduct regular follow-up surveys on the patient to monitor the patient's treatment progress and adjust the treatment plan as needed.
优选地，背根神经节电刺激系统可包括若干用户端200和与各用户端200通讯连接的医院端300，其中，医院端300可被配置为服务器，从而使得用户可以操作各自的用户端200并与医院端300实现数据交互。优选地，操作用户端200的用户可包括患者和医护人员。优选地，患者和医护人员可以具有各自的账号，医院端300可为不同的账号赋予相应的操作权限，以使得患者和医护人员通过各自的输入了相应账号的用户端200连接至医院端300时，仅能够执行在其操作权限范围内的相关操作。优选地，医院端300可以根据就诊记录将配对的医护人员与患者所使用的账号进行关联，从而使得医院端300在与各用户端200进行数据交互时，登录有具有关联关系的账号的多个用户端200之间可以通过医院端300实现数据共享。优选地，医护人员可通过其使用的用户端200将刺激电极122的穿刺方式上传至医院端300。Preferably, the dorsal root ganglion electrical stimulation system may include several user terminals 200 and hospital terminals 300 that are communicatively connected to each user terminal 200, wherein the hospital terminal 300 may be configured as a server, so that users can operate their respective user terminals 200 and achieve data interaction with the hospital terminal 300. Preferably, the users operating the user terminals 200 may include patients and medical staff. Preferably, the patients and medical staff may have their own accounts, and the hospital terminal 300 may grant corresponding operation permissions to different accounts, so that when the patients and medical staff are connected to the hospital terminal 300 through their respective user terminals 200 that have entered the corresponding accounts, they can only perform relevant operations within the scope of their operation permissions. Preferably, the hospital terminal 300 can associate the paired medical staff with the account used by the patient according to the medical record, so that when the hospital terminal 300 interacts with each user terminal 200, multiple user terminals 200 logged in with accounts having an associated relationship can achieve data sharing through the hospital terminal 300. Preferably, medical staff can upload the puncture method of the stimulation electrode 122 to the hospital end 300 through the user end 200 used by them.
优选地，刺激装置100的控制单元110可以通讯连接于用户端200，该用户端200可以为医护人员使用的用户端200，也可以为患者使用的用户端200。进一步地，刺激装置100的控制单元110在同一时段内可以仅与一个用户端200通讯连接，以实现与该用户端200进行独立的数据交互。示例性地，在初期治疗的过程中，医护人员可以直接掌握患者的实时情况，并基于患者情况对治疗方案进行调整，此时控制单元110可以与医护人员使用的用户端200通讯连接，从而可将治疗方案的调整记录发送给医护人员使用的用户端200，以通过医护人员使用的用户端200上传至医院端300；在居家治疗的过程中，患者会根据自身情况对治疗方案进行调整，此时控制单元110可以与患者使用的用户端200通讯连接，从而可将治疗方案的调整记录发送给患者使用的用户端200，以通过患者使用的用户端200上传至医院端300。优选地，与控制单元110通讯连接的用户端200可以直接将刺激指令发送给控制单元110，控制单元110仅需将是否按照刺激指令执行的确认信息反馈至用户端200，用户端200即可将记录的刺激指令上传至医院端300。优选地，医院端300可以对刺激指令进行判断，以确认指令输入的合理性，其中，医院端300可以在居家治疗期间对患者输入的刺激指令进行判断，以避免患者因误操作等情况而错误地调整治疗方案。进一步地，当刺激指令超出医院端300的判断能力时，医院端300可将患者通过用户端200上传的包含刺激指令在内的数据信息发送给对应医护人员所使用的用户端200，以启动人工校核。Preferably, the control unit 110 of the stimulation device 100 can be connected to the user terminal 200 by communication, and the user terminal 200 can be a user terminal 200 used by medical staff or a user terminal 200 used by patients. Further, the control unit 110 of the stimulation device 100 can be connected to only one user terminal 200 by communication in the same period of time to achieve independent data interaction with the user terminal 200. Exemplarily, during the initial treatment process, the medical staff can directly grasp the real-time situation of the patient and adjust the treatment plan based on the patient's situation. At this time, the control unit 110 can be connected to the user terminal 200 used by the medical staff by communication, so that the adjustment record of the treatment plan can be sent to the user terminal 200 used by the medical staff, so as to be uploaded to the hospital end 300 through the user terminal 200 used by the medical staff; during the home treatment process, the patient will adjust the treatment plan according to his own situation. At this time, the control unit 110 can be connected to the user terminal 200 used by the patient by communication, so that the adjustment record of the treatment plan can be sent to the user terminal 200 used by the patient, so as to be uploaded to the hospital end 300 through the user terminal 200 used by the patient. Preferably, the user terminal 200 that is communicatively connected to the control unit 110 can directly send the stimulation instruction to the control unit 110, and the control unit 110 only needs to feed back the confirmation information of whether the stimulation instruction is executed to the user terminal 200, and the user terminal 200 can upload the recorded stimulation instruction to the hospital terminal 300. Preferably, the hospital terminal 300 can judge the stimulation instruction to confirm the rationality of the instruction input, wherein the hospital terminal 300 can judge the stimulation instruction input by the patient during home treatment to avoid the patient from incorrectly adjusting the treatment plan due to misoperation and the like. Furthermore, when the stimulation instruction exceeds the judgment ability of the hospital terminal 300, the hospital terminal 300 can send the data information including the stimulation instruction uploaded by the patient through the user terminal 200 to the user terminal 200 used by the corresponding medical staff to start manual verification.
优选地，在居家治疗的过程中，刺激装置100的控制单元110所执行的任一刺激指令需附带有医院端300的验证信息，控制单元110可以对该验证信息进行核验，只有包含该验证信息的刺激指令才可以被控制单元110所执行。优选地，患者在通过操作部件111和/或用户端200对控制单元110输入刺激指令时，控制单元110可以判断该刺激指令是否附带有医院端300的验证信息，若未附带有医院端300的验证信息，可以发出提示和/或反馈至用户端200。进一步地，不论是通过操作部件111还是用户端200输入刺激指令，控制单元110与患者使用的用户端200都可处于通讯连接的状态，且当前输入的刺激指令可同时存储于控制单元110与患者使用的用户端200中，用户端200在接收到控制单元110发出的未附带有医院端300的验证信息的反馈后可以将包含该刺激指令在内的数据信息上传至医院端300，以实现自动地和/或利用医护人员手动地对刺激指令的判断。进一步地，当输入的刺激指令符合要求，医院端300则下发相应的验证信息，用户端200可以仅将验证信息发送至控制单元110以实现核验；当输入的刺激指令不符合要求，医院端300则可以给出建议的刺激指令并为建议的刺激指令附带相应的验证信息，用户端200可以将附带有验证信息的建议的刺激指令替换原始输入的刺激指令，并发送至控制单元110以实现核验。Preferably, during the home treatment process, any stimulation instruction executed by the control unit 110 of the stimulation device 100 must be accompanied by verification information from the hospital end 300, and the control unit 110 can verify the verification information, and only the stimulation instruction containing the verification information can be executed by the control unit 110. Preferably, when the patient inputs a stimulation instruction to the control unit 110 through the operating component 111 and/or the user end 200, the control unit 110 can determine whether the stimulation instruction is accompanied by verification information from the hospital end 300, and if it is not accompanied by verification information from the hospital end 300, a prompt and/or feedback can be issued to the user end 200. Further, whether the stimulation instruction is input through the operating component 111 or the user terminal 200, the control unit 110 and the user terminal 200 used by the patient can be in a communication connection state, and the currently input stimulation instruction can be stored in the control unit 110 and the user terminal 200 used by the patient at the same time. After receiving the feedback issued by the control unit 110 without the verification information of the hospital terminal 300, the user terminal 200 can upload the data information including the stimulation instruction to the hospital terminal 300, so as to automatically and/or manually determine the stimulation instruction by medical staff. Further, when the input stimulation instruction meets the requirements, the hospital terminal 300 issues the corresponding verification information, and the user terminal 200 can only send the verification information to the control unit 110 for verification; when the input stimulation instruction does not meet the requirements, the hospital terminal 300 can give a suggested stimulation instruction and attach the corresponding verification information to the suggested stimulation instruction, and the user terminal 200 can replace the original input stimulation instruction with the suggested stimulation instruction with the verification information, and send it to the control unit 110 for verification.
优选地，患者使用的用户端200上传至医院端300的数据信息除了输入的刺激指令之外，还可包括患者的反馈信息，该反馈信息用于证明患者需要对治疗方案进行调整的动机，医院端300可以根据患者的反馈信息对输入的刺激指令的合理性进行判断，从而确定是否下发验证信息。进一步地，部分患者虽然感觉当前的治疗方案效果较差（例如明显感觉减轻疼痛的程度不够），但可能由于缺乏经验等因素而不知道该如何对治疗方案进行调节，即不知道该输入何种刺激指令，此时，患者可以通过用户端200仅上传反馈信息，以使得医院端300可以根据患者的反馈信息生成符合要求的建议的刺激指令。优选地，医院端300可以通过对比输入的刺激指令与建议的刺激指令之间的偏差来判断输入的刺激指令的合理性。Preferably, the data information uploaded to the hospital end 300 by the user end 200 used by the patient may include the patient's feedback information in addition to the input stimulation instructions. The feedback information is used to prove the patient's motivation to adjust the treatment plan. The hospital end 300 can judge the rationality of the input stimulation instructions based on the patient's feedback information, thereby determining whether to issue verification information. Furthermore, although some patients feel that the current treatment plan is less effective (for example, they obviously feel that the degree of pain relief is not enough), they may not know how to adjust the treatment plan due to factors such as lack of experience, that is, they do not know what kind of stimulation instructions to input. At this time, the patient can upload only the feedback information through the user end 200, so that the hospital end 300 can generate the recommended stimulation instructions that meet the requirements based on the patient's feedback information. Preferably, the hospital end 300 can judge the rationality of the input stimulation instructions by comparing the deviation between the input stimulation instructions and the recommended stimulation instructions.
优选地，患者的反馈信息可包括疼痛级别、生活质量指标、心理社会因素中的一个或多个。Preferably, the patient's feedback information may include one or more of pain level, quality of life indicators, and psychosocial factors.
优选地，疼痛级别可使用视觉类比量表（VAS）或其他疼痛量表进行评估。视觉类比量表（VAS）是一种常用的疼痛评估工具，它是一个无刻度的直线，长度通常为10厘米（cm）。一端标记为“无疼痛”，另一端标记为“最严重的疼痛”。患者被要求在直线上标记出他们感受到的疼痛程度所对应的点。VAS评分是通过测量从“无疼痛”端到患者标记点的距离（以厘米为单位）来确定的，分数范围从0（无疼痛）到10（最严重的疼痛）。VAS简单易用，容易被患者理解，是评估疼痛强度的有效工具。除此之外，其他疼痛量表可包括：数字评分量表（NRS）、麦吉尔疼痛问卷（MPQ）等，其中，数字评分量表（NRS）要求患者根据一个数字范围（通常是0到10）来评估他们的疼痛程度，其中0代表“无疼痛”，10代表“最严重的疼痛”。患者选择一个数字来表示他们当前的疼痛强度。NRS可以是口头的（患者口头报告疼痛等级）或书面的（患者在纸上标记疼痛等级）；麦吉尔疼痛问卷（MPQ）不仅评估疼痛的强度，还评估疼痛的性质和影响。MPQ包括一系列描述疼痛特征的词语，患者根据自己的疼痛感受选择相应的词语。此外，MPQ还包括一个VAS或NRS，用于评估疼痛强度。Preferably, the pain level can be assessed using a visual analog scale (VAS) or other pain scales. The visual analog scale (VAS) is a commonly used pain assessment tool, which is an unscaled straight line, usually 10 centimeters (cm) in length. One end is marked as "no pain" and the other end is marked as "worst pain". Patients are asked to mark the point on the line corresponding to the degree of pain they feel. The VAS score is determined by measuring the distance (in centimeters) from the "no pain" end to the patient's marked point, and the score ranges from 0 (no pain) to 10 (worst pain). VAS is simple to use and easy for patients to understand, and is an effective tool for assessing pain intensity. In addition, other pain scales may include: Numerical Rating Scale (NRS), McGill Pain Questionnaire (MPQ), etc., among which the Numerical Rating Scale (NRS) requires patients to rate their pain level based on a numerical range (usually 0 to 10), where 0 represents "no pain" and 10 represents "worst pain". Patients choose a number to represent their current pain intensity. NRS can be verbal (patients report pain levels verbally) or written (patients mark pain levels on paper); The McGill Pain Questionnaire (MPQ) assesses not only the intensity of pain, but also the nature and impact of pain. The MPQ includes a series of words that describe the characteristics of pain, and patients choose the corresponding words based on their pain experience. In addition, the MPQ includes a VAS or NRS to assess pain intensity.
优选地，生活质量指标可通过特定的问卷来评估，如疼痛残疾指数（PDI），其中，疼痛残疾指数是用于评估疼痛如何影响个体日常功能的一种工具。进一步地，PDI是一个简单的问卷，被设计用来评估疼痛对个体生活各个方面的影响，其中，它包含7个项目，每个项目代表生活的一个不同领域：家庭/家务、娱乐、社交活动、职业、性生活、自我照顾和生活支持活动。每个项目的评分范围从0（无残疾）到10（完全残疾），根据疼痛对该领域活动的影响程度进行评分。总分是各项分数的总和，最高可能得分为70分。分数越高，表示疼痛对个体生活质量的负面影响越大。Preferably, quality of life indicators can be assessed by a specific questionnaire, such as the Pain Disability Index (PDI), which is a tool used to assess how pain affects an individual's daily functioning. Further, the PDI is a simple questionnaire designed to assess the impact of pain on various aspects of an individual's life, wherein it contains 7 items, each representing a different area of life: family/housework, entertainment, social activities, occupation, sex life, self-care, and life support activities. Each item is scored on a scale from 0 (no disability) to 10 (complete disability), based on the degree of pain's impact on activities in that area. The total score is the sum of the scores for each item, with a maximum possible score of 70 points. The higher the score, the greater the negative impact of pain on the individual's quality of life.
优选地，心理社会因素可通过特定的问卷来评估，如焦虑和抑郁量表（HADS），其中，HADS是一种自评量表，用于评估焦虑和抑郁水平。它由14个项目组成，其中7个用于评估焦虑，另外7个用于评估抑郁。每个项目包含一个描述性陈述，患者需要根据他们目前的感受选择最符合他们情况的答案。每个项目的评分范围为0到3分，总分分别为焦虑得分和抑郁得分。总分的范围是0到21分，得分越高，表示焦虑或抑郁症状越严重。本发明将HADS应用于慢性疾病和疼痛管理中，以用于筛查和监测焦虑和抑郁症状，从而有助于了解个体的心理状态并提供相应的支持和治疗。Preferably, psychosocial factors can be assessed by a specific questionnaire, such as the Anxiety and Depression Scale (HADS), wherein HADS is a self-assessment scale for assessing anxiety and depression levels. It consists of 14 items, 7 of which are used to assess anxiety and the other 7 are used to assess depression. Each item contains a descriptive statement, and patients need to choose the answer that best suits their situation based on their current feelings. The score range for each item is 0 to 3 points, and the total score is the anxiety score and depression score, respectively. The total score ranges from 0 to 21 points, and the higher the score, the more severe the anxiety or depression symptoms. The present invention applies HADS to chronic disease and pain management for screening and monitoring anxiety and depression symptoms, thereby helping to understand the individual's mental state and provide corresponding support and treatment.
优选地，除了患者的反馈信息，医院端300还可接入医院信息系统（HIS），以获取包括患者药物使用情况的数据信息，其中，患者的药物使用情况被记录在医院信息系统中，其包括用药类型、剂量和频率等信息。进一步地，若患者有服用未被记录在医院信息系统中的药物的情况，患者可通过用户端200将该特殊情况附在反馈信息中。优选地，医院端300可将患者的药物使用记录发送至医护人员使用的用户端200，以评估治疗的效果和可能的药物副作用。Preferably, in addition to the patient's feedback information, the hospital terminal 300 can also access the hospital information system (HIS) to obtain data information including the patient's drug usage, wherein the patient's drug usage is recorded in the hospital information system, including information such as the type, dosage and frequency of medication. Furthermore, if the patient has taken a drug that is not recorded in the hospital information system, the patient can attach the special situation to the feedback information through the user terminal 200. Preferably, the hospital terminal 300 can send the patient's drug usage record to the user terminal 200 used by medical staff to evaluate the effect of treatment and possible drug side effects.
优选地，医院端300可以通过结合疼痛级别评分（VAS）、生活质量指标评分（PDI）和心理社会因素评分（HADS）来计算患者的实际状态评分。进一步地，通过收集样本数据并运用线性回归或多元回归分析方法，将实际状态评分作为因变量，VAS评分、PDI评分和HADS评分作为自变量，拟合得到一个基础模型，根据该基础模型可在医院端300内预先为VAS、PDI和HADS设置相应权重。优选地，VAS权重（βVAS）可设置为0.3至0.5，PDI权重（βPDI）可设置为0.2至0.4，HADS权重（βHADS）可设置为0.2至0.4，其中，权重的配比可以根据治疗目标和患者实际情况在允许的范围内进行适应性调节。进一步优选地，权重配比被设定为：VAS权重=0.4，PDI权重=0.3，HADS权重=0.3。优选地，为了确保三项评分可以在同一尺度上进行比较和计算，可对各评分进行标准化处理，例如，可以将每项评分转换为0到100的标准分数。进一步地，实际状态评分可以通过以下公式计算：Preferably, the hospital end 300 can calculate the actual state score of the patient by combining the pain level score (VAS), the quality of life index score (PDI) and the psychosocial factor score (HADS). Further, by collecting sample data and applying linear regression or multiple regression analysis methods, the actual state score is used as the dependent variable, and the VAS score, PDI score and HADS score are used as independent variables to fit a basic model, and the corresponding weights can be set for VAS, PDI and HADS in advance in the hospital end 300 according to the basic model. Preferably, the VAS weight (βVAS ) can be set to 0.3 to 0.5, the PDI weight (βPDI ) can be set to 0.2 to 0.4, and the HADS weight (βHADS ) can be set to 0.2 to 0.4, wherein the weight ratio can be adaptively adjusted within the allowable range according to the treatment goal and the actual situation of the patient. Further preferably, the weight ratio is set as: VAS weight = 0.4, PDI weight = 0.3, HADS weight = 0.3. Preferably, in order to ensure that the three scores can be compared and calculated on the same scale, each score can be standardized, for example, each score can be converted into a standard score from 0 to 100. Further, the actual status score can be calculated by the following formula:
实际状态评分=βVAS·VAS+βPDI·PDI+βHADS·HADS。Actual status score=βVAS ·VAS+βPDI ·PDI+βHADS ·HADS.
示例性地，如果一个患者的VAS评分是70（转换后的标准分），PDI评分是50（转换后的标准分），HADS评分是60，则实际状态评分计算如下：For example, if a patient's VAS score is 70 (converted to standard score), PDI score is 50 (converted to standard score), and HADS score is 60, the actual status score is calculated as follows:
实际状态评分=(70×0.4)+(50×0.3)+(60×0.3)=61，Actual status score = (70×0.4)+(50×0.3)+(60×0.3)=61,
即，该患者的实际状态评分为61分。That is, the patient's actual status score is 61 points.
在利用上述公式计算实际状态评分时，可能出现VAS评分、PDI评分和HADS评分均不相同的两个患者实际状态评分相同的情况，如果仅考虑实际状态评分，此时采用同一标准给出的建议的刺激指令具有较差的针对性。因此，对于同一实际状态评分或同一等级的实际状态评分，根据VAS评分、PDI评分和HADS评分各自所处的数值范围，可以形成多种不同的建议的刺激指令。换言之，同一实际状态评分或同一等级的实际状态评分可以对应多种不同的建议的刺激指令，每种建议的刺激指令可以分别对应三种评分的一个数值范围，医院端300通过查表的方式即可确定当前最佳的建议的刺激指令。优选地，当VAS评分、PDI评分和HADS评分中存在一项评分高于相应的预设阈值和/或实际状态评分高于预设阈值时，医院端300可以将该患者的数据信息发送至对应医护人员的用户端200，以启动人工校核。优选地，当患者根据医院端300提供的建议的刺激指令执行电刺激后反馈效果不佳时，接收到反馈的医院端300可以将该患者的数据信息发送至对应医护人员的用户端200，以启动人工校核。When the actual state score is calculated using the above formula, it is possible that two patients with different VAS scores, PDI scores and HADS scores have the same actual state score. If only the actual state score is considered, the stimulation instructions recommended by the same standard at this time have poor pertinence. Therefore, for the same actual state score or the same level of actual state score, a variety of different recommended stimulation instructions can be formed according to the numerical ranges of the VAS score, PDI score and HADS score. In other words, the same actual state score or the same level of actual state score can correspond to a variety of different recommended stimulation instructions, and each recommended stimulation instruction can correspond to a numerical range of the three scores respectively. The hospital end 300 can determine the current best recommended stimulation instruction by looking up a table. Preferably, when there is a score higher than the corresponding preset threshold value and/or the actual state score is higher than the preset threshold value among the VAS score, PDI score and HADS score, the hospital end 300 can send the patient's data information to the user end 200 of the corresponding medical staff to start manual verification. Preferably, when the patient receives poor feedback after performing electrical stimulation according to the recommended stimulation instructions provided by the hospital end 300, the hospital end 300 that receives the feedback can send the patient's data information to the user end 200 of the corresponding medical staff to initiate manual verification.
优选地，在基础模型之上，还可通过引入交叉项的方式来捕捉不同评分之间的相互作用，从而提供更细致的评分差异。如此设置可使得实际状态评分更具备针对性，更难以出现VAS评分、PDI评分和HADS评分均不相同的两个患者实际状态评分相同的情况，以便更细致地区分患者的实际状态，从而为每位患者提供更加个性化的治疗建议。优选地，引入的交叉项为VAS与PDI、VAS与HADS、PDI与HADS的乘积，将上述三个乘积作为额外的自变量，以拟合得到一个扩展的模型。进一步地，根据拟合的扩展模型，估算交叉项的系数，即βVAS×PDI、βVAS×HADS、βPDI×HADS。因此，改良后的实际状态评分的模型为：Preferably, on top of the basic model, the interaction between different scores can be captured by introducing cross terms, thereby providing more detailed score differences. Such a setting can make the actual status score more targeted, and it is more difficult for two patients with different VAS scores, PDI scores and HADS scores to have the same actual status score, so as to more finely distinguish the actual status of the patient, thereby providing more personalized treatment recommendations for each patient. Preferably, the introduced cross terms are the products of VAS and PDI, VAS and HADS, and PDI and HADS, and the above three products are used as additional independent variables to fit an extended model. Furthermore, according to the fitted extended model, the coefficients of the cross terms are estimated, namely βVAS×PDI , βVAS×HADS , βPDI×HADS . Therefore, the improved model of the actual status score is:
实际状态评分=α+βVAS·VAS+βPDI·PDI+βHADS·HADS+βVAS×PDI·(VAS×PDI)+βVAS×HADS·(VAS×HADS)+βPDI×HADS·(PDI×HADS)，Actual state score=α+βVAS ·VAS+βPDI ·PDI+βHADS ·HADS+βVAS×PDI ·(VAS×PDI)+βVAS×HADS ·(VAS×HADS)+βPDI×HADS ·(PDI ×HADS),
其中，α是模型的截距，βVAS，βPDI和βHADS分别是VAS评分、PDI评分和HADS评分的权重系数，βVAS×PDI，βVAS×HADS和βPDI×HADS分别是VAS与PDI交叉项、VAS与HADS交叉项、以及PDI与HADS交叉项的系数，(VAS×PDI)，(VAS×HADS)和(PDI×HADS)分别是VAS评分和PDI评分的交叉项、VAS评分和HADS评分的交叉项以及PDI评分和HADS评分的交叉项。Among them, α is the intercept of the model, βVAS , βPDI and βHADS are the weight coefficients of VAS score, PDI score and HADS score, respectively, βVAS×PDI , βVAS×HADS and βPDI×HADS are the coefficients of the intersection term between VAS and PDI, the intersection term between VAS and HADS, and the intersection term between PDI and HADS, respectively, and (VAS×PDI), (VAS×HADS) and (PDI×HADS) are the intersection terms of VAS score and PDI score, the intersection terms of VAS score and HADS score, and the intersection terms of PDI score and HADS score, respectively.
优选地，医护人员在判断患者的治疗效果存在异常时，可以告知患者前往医院进行复查。优选地，复查的项目可包括神经生理功能监测，其可通过与刺激装置100连接的内置有神经生理监测软件的神经监测设备来实现，其中，神经监测设备可例如是神经电生理监测仪。具体地，神经监测设备通过电极在患者身上记录神经信号，包括感觉和运动神经信号。这些信号被传输到计算机上进行分析和记录，以评估电刺激对神经功能的影响。在治疗过程中，医护人员可安装电极并连接到神经监测设备。神经监测设备会实时记录神经信号的变化，医护人员可根据监测结果调整电刺激参数。Preferably, when the medical staff determines that there is an abnormality in the treatment effect of the patient, they can inform the patient to go to the hospital for a reexamination. Preferably, the items of the reexamination may include neurophysiological function monitoring, which can be achieved by a neural monitoring device connected to the stimulation device 100 and equipped with neurophysiological monitoring software, wherein the neural monitoring device may be, for example, a neuroelectrophysiological monitor. Specifically, the neural monitoring device records neural signals, including sensory and motor neural signals, on the patient through electrodes. These signals are transmitted to a computer for analysis and recording to evaluate the effect of electrical stimulation on neural function. During the treatment process, the medical staff can install the electrodes and connect them to the neural monitoring device. The neural monitoring device will record the changes in neural signals in real time, and the medical staff can adjust the electrical stimulation parameters according to the monitoring results.
需要注意的是，上述具体实施例是示例性的，本领域技术人员可以在本发明公开内容的启发下想出各种解决方案，而这些解决方案也都属于本发明的公开范围并落入本发明的保护范围之内。本领域技术人员应该明白，本发明说明书及其附图均为说明性而并非构成对权利要求的限制。本发明的保护范围由权利要求及其等同物限定。本发明说明书包含多项发明构思，诸如“优选地”或“根据一种优选实施方式”均表示相应段落公开了一个独立的构思，申请人保留根据每项发明构思提出分案申请的权利。在全文中，“优选地”所引导的特征仅为一种可选方式，不应理解为必须设置，故此申请人保留随时放弃或删除相关优选特征之权利。It should be noted that the above-mentioned specific embodiments are exemplary, and those skilled in the art can come up with various solutions inspired by the disclosure of the present invention, and these solutions also belong to the disclosure scope of the present invention and fall within the protection scope of the present invention. Those skilled in the art should understand that the present invention specification and its drawings are illustrative and do not constitute a limitation on the claims. The scope of protection of the present invention is defined by the claims and their equivalents. The present invention specification contains multiple inventive concepts, such as "preferably" or "according to a preferred embodiment", which means that the corresponding paragraph discloses an independent concept, and the applicant reserves the right to file a divisional application based on each inventive concept. Throughout the text, the features guided by "preferably" are only an optional method and should not be understood as a must-have setting. Therefore, the applicant reserves the right to abandon or delete the relevant preferred features at any time.
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