A dorsal root ganglion electrical stimulation system via intervertebral foraminal puncture

Abstract

The present invention relates to a dorsal root ganglion electrical stimulation system for transforaminal puncture, which comprises: a stimulation device for applying electrical stimulation to a patient's dorsal root ganglion; a user end used by the patient and / or medical staff; and a hospital end communicatively connected to the user end. The control unit configured by the stimulation device can be communicatively connected to the user end, and the stimulation instruction to be adjusted is input through the operating components configured on the control unit and / or the user end. The control unit can verify whether the stimulation instruction is accompanied by verification information issued by the hospital end. After receiving feedback from the control unit that is not accompanied by verification information from the hospital end, the user end can upload data information including the stimulation instruction to the hospital end, so as to automatically and / or manually determine the stimulation instruction by medical staff, wherein the stimulation instruction to be adjusted includes adjustment of 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.

Description

Technical Field

[0001] 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. Background Art

[0002] 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.

[0003] 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.

[0004] 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.

[0005] 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.

[0006] 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 damage 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.

[0007] CN105477779A discloses an electrical stimulator applied to a dorsal root ganglion, which is used to electrically stimulate 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. 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.

[0008] 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.

[0009] 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. Summary of the invention

[0010] 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.

[0011] 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.

[0012] 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.

[0013] 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.

[0014] 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 long-term pain management process of the patient's health. 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 the treatment plan, 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.

[0015] 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.

[0016] 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.

[0017] 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.

[0018] 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 specific medical needs and reactions of the patient to achieve a personalized treatment plan. This personalized treatment method can more effectively cope with various pain conditions and improve the effectiveness of treatment.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] 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.

[0023] 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 side through a user side, so that the hospital side can judge the rationality of the 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 side includes the 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.

[0024] 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.

[0025] 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.

[0026] 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 patient's current treatment effect, 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.

[0027] According to a preferred embodiment, the hospital side can judge the rationality of the input stimulation instructions by comparing the deviation between the input stimulation instructions and the recommended stimulation instructions, wherein, when the input stimulation instructions meet 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 instructions do not meet the requirements, the hospital side will give recommended stimulation instructions and attach corresponding verification information to the recommended stimulation instructions, and the user side will replace the original input stimulation instructions with the recommended stimulation instructions attached with the verification information, and send them to the control unit for verification.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 It is a hardware connection diagram of the dorsal root ganglion electrical stimulation system provided by the present invention;

[0034] Figure 2 It is a control logic diagram of the dorsal root ganglion electrical stimulation system provided by the present invention;

[0035] Figure 3 It is a schematic diagram of the structure of a stimulation device of a dorsal root ganglion electrical stimulation system provided by the present invention.

[0036] Reference numerals list

[0037] 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. DETAILED DESCRIPTION

[0038] The following is a detailed description with reference to the accompanying drawings.

[0039] like Figure 1~Figure 3 As shown, 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.

[0040] 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.

[0041] 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.

[0042] Preferably, if Figure 3 As shown, the stimulation electrode 122 of the present invention can be inserted into the intervertebral foramen via the lateral spinal puncture to reduce the fracture rate of the stimulation electrode 122 and reduce the difficulty of puncture. The stimulation electrode 122 implanted in or adjacent to the target tissue of the patient in the above manner is particularly suitable for patients with spinal stenosis.

[0043] 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 .

[0044] 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.

[0045] 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.

[0046] 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).

[0047] Preferably, the steps of performing transforaminal puncture by medical personnel may include:

[0048] 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.

[0049] 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.

[0050] S3. Local anesthesia: Local anesthesia is performed at the determined puncture point to reduce the patient's pain during the puncture process.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] Preferably, the step of determining a treatment regimen may include:

[0058] Preliminary evaluation: Use imaging and electrophysiological testing to determine the location of the ganglion suitable for dorsal root ganglion electrical stimulation;

[0059] Trial stimulation period: Before permanent implantation, a period of trial stimulation is used to evaluate the efficacy;

[0060] 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;

[0061] Parameter adjustment: adjust the parameters of electrical stimulation according to the patient's response;

[0062] Regular follow-up: Monitor the patient's treatment progress and adjust the treatment plan as needed.

[0063] 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.

[0064] Table 1 Recommended levels of commonly used stimulation segments in different pain areas

[0065]

[0066] 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.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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 terminal 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 terminal 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.

[0072] Preferably, during the home treatment, any stimulation instruction executed by the control unit 110 of the stimulation device 100 must be accompanied by verification information of 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 of the hospital end 300, and if it is not accompanied by verification information of 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 judge 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.

[0073] 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.

[0074] Preferably, the patient's feedback information may include one or more of pain level, quality of life indicators, and psychosocial factors.

[0075] 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.

[0076] 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. The higher the score, the greater the negative impact of pain on the individual's quality of life.

[0077] 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.

[0078] 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.

[0079] Preferably, the hospital end 300 can calculate the patient's actual status score by combining the pain level score (VAS), the quality of life index score (PDI) and the psychosocial factor score (HADS). Furthermore, by collecting sample data and applying linear regression or multiple regression analysis methods, the actual status 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. According to the basic model, corresponding weights can be set in advance for VAS, PDI and HADS in the hospital end 300. Preferably, the VAS weight (β VAS ) can be set from 0.3 to 0.5, and the PDI weight (β PDI ) can be set to 0.2 to 0.4, and the HADS weight (β HADS ) can be set to 0.2 to 0.4, wherein the weight ratio can be adaptively adjusted within the permitted 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:

[0080] Actual state score = β VAS VAS+β PDI PDI+β HADS ·HADS.

[0081] 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:

[0082] Actual status score = (70×0.4)+(50×0.3)+(60×0.3)=61,

[0083] That is, the patient's actual status score is 61 points.

[0084] 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.

[0085] Preferably, on top of the basic model, a cross term can be introduced to capture the interaction between different scores, thereby providing more detailed score differences. This 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 each patient with more personalized treatment recommendations. Preferably, the introduced cross term is the product of VAS and PDI, VAS and HADS, and PDI and HADS. The above three products are used as additional independent variables to fit an extended model. Furthermore, according to the fitted extended model, the coefficient of the cross term is estimated, that is, β VAS×PDI , β VAS×HADS , β PDI×HADS Therefore, the improved model of actual status score is:

[0086] Actual status score = α + β VAS VAS+β PDI PDI+β HADS HADS+β VAS×PDI (VAS × PDI) + β VAS×HADS (VAS × HADS) + β PDI×HADS (PDI × HADS),

[0087] Among them, α is the intercept of the model, β VAS , β PDI and β HADS are the weight coefficients of VAS score, PDI score and HADS score, β VAS×PDI , β VAS×HADS and β PDI×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. (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.

[0088] 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.

[0089] 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 of 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.

Claims

1. A dorsal root ganglion electrical stimulation system via intervertebral foraminal puncture, characterized in that: It includes: A stimulation device (100) for applying electrical stimulation to a target tissue of a patient, the target tissue being a dorsal root ganglion; A user terminal (200) used by patients and / or medical staff; a hospital terminal (300) in communication connection with the user terminal (200), The control unit (110) configured in the stimulation device (100) can be connected to the user terminal (200) used by the patient and / or medical staff, and the stimulation instruction to be adjusted is input through the operating component (111) configured on the control unit (110) and / or the user terminal (200). The control unit (110) can verify whether the stimulation instruction is accompanied by the verification information issued by the hospital terminal (300). After receiving the feedback issued by the control unit (110) that is not accompanied by 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) to realize the automatic and / or manual judgment of the stimulation instruction by the medical staff, wherein the stimulation instruction to be adjusted includes the adjustment of one or more parameters of the stimulation frequency, pulse width, duration and intensity, and the duration and interval of treatment; When the stimulation instruction exceeds the judgment capability of the hospital end (300), the hospital end (300) can extract several types of scores according to the feedback information in the data information uploaded by the patient through the user end (200), and can establish a basic model according to the correlation between the scores of each type, so as to calculate the actual state score reflecting the current treatment effect of the patient, wherein the hospital end (300) can generate a recommended stimulation instruction according to the actual state score and the scores of each type, or send the data information of the patient to the user end (200) of the corresponding medical staff to start manual verification; The hospital end (300) calculates the patient's actual status score by combining the pain level score (VAS), the quality of life index score (PDI) and the psychosocial factor score (HADS). The actual status score is calculated by the following formula: Actual state score = β VAS VAS+β PDI PDI+β HADS HADS; among them, β VAS , β PDI and β HADS These are the corresponding weights of VAS, PDI and HADS respectively.

2. The dorsal root ganglion electrical stimulation system according to claim 1, characterized in that: The stimulation device (100) comprises an electrode unit (120), wherein the electrode unit (120) comprises an electrode lead (121) implanted in or adjacent to a target tissue and a stimulation electrode (122) located at the distal end of the electrode lead (121), wherein the electrode unit (120) is configured to enter an intervertebral foramen via an extravertebral puncture.

3. The dorsal root ganglion electrical stimulation system according to claim 2, characterized in that: The stimulation device (100) comprises a pulse generating unit (130) which can be coupled to the proximal end of the electrode lead (121), wherein the pulse generating unit (130) comprises a programmable controller which is configured to respond to stimulation instructions transmitted by the control unit (110) and provide electrical stimulation via one or more stimulation electrodes (122) arranged on the electrode lead (121).

4. The dorsal root ganglion electrical stimulation system according to claim 2, characterized in that: The dorsal root ganglion electrical stimulation treatment target of the stimulation electrode (122) 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.

5. The dorsal root ganglion electrical stimulation system according to claim 1, characterized in that: During the initial treatment, the stimulation device (100) 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.

6. The dorsal root ganglion electrical stimulation system according to claim 5, characterized in that: During home treatment, a patient wearing the stimulation device (100) adjusted to optimal treatment parameters can upload data information to the hospital side (300) via the user side (200), so that the hospital side (300) can judge the rationality of the 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 side (300) includes the input stimulation instructions and / or the patient's feedback information, and the feedback information includes one or more of pain level, quality of life indicators, and psychosocial factors.

7. The dorsal root ganglion electrical stimulation system according to claim 6, characterized in that: The hospital end (300) 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 end (300) issues corresponding verification information, and the user end (200) can send the verification information to the control unit (110) for verification; when the input stimulation instruction does not meet the requirements, the hospital end (300) gives a recommended stimulation instruction and attaches corresponding verification information to the recommended stimulation instruction, and the user end (200) replaces the original input stimulation instruction with the recommended stimulation instruction attached with the verification information, and sends it to the control unit (110) for verification.

8. The dorsal root ganglion electrical stimulation system according to claim 6, characterized in that: When any of the following situations occurs, the hospital end (300) can send the patient's data information to the user end (200) of the corresponding medical staff to initiate manual verification: One of the scores in each category exceeds the corresponding preset threshold; The actual status score exceeds the preset threshold; After the patient performed electrical stimulation according to the recommended stimulation instructions provided by the hospital end (300), feedback was poor.

9. The dorsal root ganglion electrical stimulation system according to claim 6, characterized in that: The hospital side (300) captures the interaction between different types of scores by introducing cross terms on top of the constructed basic model 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.

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