Intelligent sacral nerve stimulation system, rehabilitation system and six-contact electrode sacral nerve stimulation system based on real-time monitoring of six-contact electrodes and real-time dynamic adjustment of positive and negative electrode combinations

Abstract

The present application discloses an intelligent sacral nerve stimulation system, a rehabilitation system, and a six-contact electrode sacral nerve stimulation system based on real-time monitoring of six-contact electrodes and real-time dynamic adjustment of positive and negative electrode combinations, wherein the sacral nerve stimulation autonomous adjustment system includes: a six-contact electrode sacral nerve stimulation unit and an adjustment control unit, the six-contact electrode sacral nerve stimulation unit is electrically connected to the adjustment control unit, the adjustment control unit is used to respond to the adjustment request at the current moment, generate a stimulation signal in the stimulation channel according to the six-contact electrode sacral nerve stimulation unit; determine a second neural signal that matches the first neural signal in response to the stimulation signal; and output an adjustment control instruction according to the second neural signal to control the autonomous adjustment of the six-contact electrode sacral nerve stimulation unit. Through the present application, on the one hand, sacral nerve stimulation self-adjustment can be achieved periodically, and on the other hand, the accuracy of sacral nerve stimulation can be improved. The present application also provides a rehabilitation system.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices and rehabilitation systems, and in particular to an intelligent sacral nerve stimulation system, a rehabilitation system, and a six-contact electrode sacral nerve stimulation system based on real-time monitoring of six-contact electrodes and real-time dynamic adjustment of positive and negative electrode combinations. Background Art

[0002] Sacral nerve stimulation technology can effectively treat patients with severe overactive bladder and improve their quality of daily life.

[0003] The therapeutic effect of sacral nerve stimulation technology depends on the contact site between the sacral nerve and the stimulation electrode. In related technologies, the sacral nerve system is equipped with multiple stimulation electrode contacts to improve the accuracy of the stimulation site. Doctors observe the effect of stimulation by changing different stimulation sites and select the appropriate stimulation scheme. After the sacral stimulation system is implanted in the patient, slight displacement of the electrodes is often caused by various reasons such as patient movement and external collisions, resulting in a decrease in the effectiveness of the original stimulation scheme and reducing the long-term effectiveness of the stimulation system. The patient must return to the hospital for the doctor to test the new stimulation scheme. However, for multi-channel stimulation electrodes, there are many optional combinations of electrode stimulation schemes. Coupled with changes in other stimulation parameters such as stimulation voltage and stimulation pulse width, the actual stimulation schemes that need to be tested have seriously increased the workload of doctors and affected the actual feasibility. Summary of the Invention

[0004] The embodiments of the present application provide an intelligent sacral nerve stimulation system, a rehabilitation system, and a six-contact electrode sacral nerve stimulation system based on real-time monitoring of six-contact electrodes and real-time dynamic adjustment of the positive and negative electrode combinations. The system has an autonomous adjustment function, which can periodically achieve self-adjustment of sacral nerve stimulation and improve the accuracy of sacral nerve stimulation.

[0005] The embodiments of this application adopt the following technical solutions:

[0006] In a first aspect, an embodiment of the present application provides an intelligent sacral nerve stimulation system based on real-time monitoring of six-contact electrodes and real-time dynamic adjustment of positive and negative electrode combinations, wherein the system includes: a six-contact electrode sacral nerve stimulation unit and a regulation control unit, the six-contact electrode sacral nerve stimulation unit is electrically connected to the regulation control unit, and the regulation control unit is used to

[0007] In response to the current adjustment request, the six-contact electrode sacral nerve stimulation unit generates a stimulation signal in the stimulation channel;

[0008] In response to the stimulation signal, determining a second neural signal that matches the first neural signal; and

[0009] According to the second neural signal output adjustment control instruction, the six-contact electrode sacral nerve stimulation unit is controlled to adjust autonomously,

[0010] Among them, the first neural signal is used to represent the electrical signal parameter value calibrated after sacral nerve stimulation at the previous moment; the second neural signal is used as the electrical signal parameter value corresponding to the target stimulation target.

[0011] In some embodiments, in response to the current adjustment request, determining a second neural signal that matches the first neural signal within an automatic adjustment threshold range includes:

[0012] Generate a stimulation electrical signal according to a periodic sacral nerve stimulation adjustment request, wherein the stimulation electrical signal is generated by a plurality of stimulation channels, and each stimulation channel includes at least one stimulation site;

[0013] When the stimulation electrical signal is within the automatic adjustment threshold range, the sacral nerve electrical signal parameter value corresponding to the target stimulation point is determined according to the sacral nerve electrical signal parameter value calibrated after the sacral nerve stimulation at the previous moment.

[0014] In some embodiments, the system further comprises:

[0015] In the first adjustment stage, the stimulation site and stimulation parameters of the patient receiving sacral nerve stimulation are obtained;

[0016] In response to the stimulation site and the stimulation parameters, acquiring a stimulation target point closest to the stimulation site;

[0017] The excitation signal of the local nerve caused by stimulating the sacral nerve corresponding to the stimulation target point closest to the stimulation site is used as the first nerve signal.

[0018] In some embodiments, determining the second neural signal that matches the first neural signal within the auto-adjustment threshold range includes:

[0019] In the second conditioning phase, the stimulation site and the acquisition site were selected and used as stimulation pairs;

[0020] In response to the stimulation instruction of the six-contact electrode sacral nerve stimulation unit, an action point is generated at least to one side at the stimulation site and a nerve signal is recorded at the acquisition site to obtain the second nerve signal matching the first nerve signal, and the second adjustment stage is no earlier than the first adjustment stage.

[0021] In some embodiments, a charging power supply unit is further included to provide power to the six-contact electrode sacral nerve stimulation unit and the adjustment control unit respectively, so that a stimulation electrical signal is generated in the six-contact electrode sacral nerve stimulation unit and a stimulation control signal is generated in the adjustment control unit.

[0022] In some embodiments, the first adjustment phase includes a sacral nerve stimulation test treatment phase in which the patient first participates, and the second adjustment phase includes a sacral nerve stimulation adjustment treatment phase in which the patient is not first participating.

[0023] In some embodiments, the characteristic parameters of the first neural signal and the second neural signal include at least one of the following: amplitude, frequency, power spectrum, and time-frequency information; the stimulation parameters used to generate the stimulation parameters include at least one of the following: stimulation amplitude, stimulation pulse width, stimulation frequency, stimulation waveform, current stimulation mode, and voltage stimulation mode.

[0024] In some embodiments, the six-contact electrode sacral nerve stimulation unit further includes a plurality of test points and a plurality of collection points. The six-contact electrode sacral nerve stimulation unit is also used to:

[0025] Providing a stimulation site corresponding to the second neural signal matching the first neural signal according to the multiple test points and the multiple acquisition points;

[0026] and / or,

[0027] A stimulation site group corresponding to the second neural signal matching the first neural signal is provided based on the multiple test points and the multiple acquisition points in the single channel and the multiple channels.

[0028] In a second aspect, an embodiment of the present application further provides a rehabilitation system for patients with overactive bladder, wherein the intelligent sacral nerve stimulation system based on real-time monitoring of six-contact electrodes and real-time dynamic adjustment of positive and negative electrode combinations as described in the first aspect is adopted.

[0029] In a third aspect, an embodiment of the present application further provides a six-contact electrode sacral nerve stimulation system, wherein the intelligent sacral nerve stimulation system based on real-time monitoring of six-contact electrodes and real-time dynamic adjustment of positive and negative electrode combinations described in the first aspect is adopted.

[0030] In a fourth aspect, an embodiment of the present application further provides an electronic device, comprising: a processor; and a memory arranged to store computer-executable instructions, wherein the executable instructions, when executed, enable the processor to perform the above method.

[0031] In a fifth aspect, an embodiment of the present application further provides a computer-readable storage medium, which stores one or more programs. When the one or more programs are executed by an electronic device including multiple applications, the electronic device executes the above method.

[0032] At least one of the above-mentioned technical solutions adopted in the embodiment of the present application can achieve the following beneficial effects: the system includes: a six-contact electrode sacral nerve stimulation unit and an adjustment control unit, and the six-contact electrode sacral nerve stimulation unit is electrically connected to the adjustment control unit. The adjustment control unit is used to respond to the adjustment request at the current moment, generate a stimulation signal in the stimulation channel according to the six-contact electrode sacral nerve stimulation unit; determine a second neural signal that matches the first neural signal in response to the stimulation signal; and output an adjustment control instruction according to the second neural signal to control the autonomous adjustment of the six-contact electrode sacral nerve stimulation unit. Through the above-mentioned system, the stimulation site and stimulation parameters can be automatically adjusted, which can effectively improve the efficiency of testing new stimulation schemes, reduce the number of patient visits to the hospital, and effectively maintain the long-term therapeutic effect of the system. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] The drawings described herein are used to provide a further understanding of the present application and constitute a part of the present application. The illustrative embodiments of the present application and their descriptions are used to explain the present application and do not constitute an improper limitation on the present application. In the drawings:

[0034] Figure 1 Schematic diagram of the internal structure of the intelligent sacral nerve stimulation system based on real-time monitoring of six-contact electrodes and real-time dynamic adjustment of the positive and negative electrode combinations in an embodiment of the present application;

[0035] Figure 2 This is a schematic diagram of the internal structure of a rehabilitation system for patients with overactive bladder according to an embodiment of the present application;

[0036] Figure 3 This is a schematic diagram of the internal structure of the six-contact electrode sacral nerve stimulation system in an embodiment of the present application;

[0037] Figure 4 This is one of the schematic diagrams of the electrodes and stimulation and data collection at the electrode contacts in the sacral nerve stimulation and autonomic regulation system in an embodiment of the present application;

[0038] Figure 5 This is a second schematic diagram of the electrodes of the sacral nerve stimulation and autonomic regulation system and the stimulation and data collection at the electrode contacts in an embodiment of the present application;

[0039] Figure 6 This is a third schematic diagram of the electrodes of the sacral nerve stimulation and autonomic regulation system and the stimulation and data collection at the electrode contacts in an embodiment of the present application;

[0040] Figure 7 This is a fourth schematic diagram of the electrodes of the sacral nerve stimulation and autonomic regulation system and the stimulation and data collection at the electrode contacts in an embodiment of the present application;

[0041] Figure 8 This is a fifth schematic diagram of the electrodes of the sacral nerve stimulation and autonomic regulation system and the stimulation and data collection at the electrode contacts in an embodiment of the present application;

[0042] Figure 9 This is a sixth schematic diagram of the electrodes of the sacral nerve stimulation and autonomic regulation system and the stimulation and data collection at the electrode contacts in an embodiment of the present application;

[0043] Figure 10 This is the seventh schematic diagram of the electrodes of the sacral nerve stimulation and autonomic regulation system and the stimulation and data collection at the electrode contacts in the embodiment of the present application. DETAILED DESCRIPTION

[0044] To make the purpose, technical solutions, and advantages of this application more clear, the technical solutions of this application will be clearly and completely described below in conjunction with the specific embodiments of this application and the corresponding drawings. Obviously, the embodiments described are only part of the embodiments of this application, not all of them. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0045] The following describes in detail the technical solutions provided by various embodiments of the present application in conjunction with the accompanying drawings.

[0046] The embodiment of the present application provides an intelligent sacral nerve stimulation system 10 based on real-time monitoring of six contact electrodes and real-time dynamic adjustment of positive and negative electrode combinations, such as Figure 1 As shown, a schematic diagram of the internal structure of the sacral nerve stimulation autonomous regulation system in an embodiment of the present application is provided, wherein the system includes: a six-contact electrode sacral nerve stimulation unit 101 and an adjustment control unit 102, wherein the six-contact electrode sacral nerve stimulation unit 101 is electrically connected to the adjustment control unit 102, and the adjustment control unit 102 is used to respond to the adjustment request at the current moment and generate a stimulation signal in the stimulation channel according to the six-contact electrode sacral nerve stimulation unit; determine a second neural signal that matches the first neural signal in response to the stimulation signal; and output an adjustment control instruction according to the second neural signal to control the autonomous regulation of the six-contact electrode sacral nerve stimulation unit, wherein the first neural signal is used to represent the monitored electrical signal parameter value calibrated after sacral nerve stimulation at the previous moment; and the second neural signal is used as the modulated electrical signal parameter value corresponding to the target stimulation target.

[0047] The six-contact electrode sacral nerve stimulation unit 101 uses a six-contact electrode and realizes automatic detection by utilizing the positive (+) and negative (-) combination of the six contacts, wherein the electrode includes at least one. The adjustment control unit 102 is electrically connected to the six-contact electrode sacral nerve stimulation unit 101 and can be implanted in the patient's body together. The adjustment control unit 102 serves as the core functional module of the sacral nerve stimulation autonomic regulation system 10, and the six-contact electrode sacral nerve stimulation unit 101 serves as the stimulation executor of the sacral nerve stimulation autonomic regulation system 10. The patient's sacral nerve serves as the carrier. Sacral nerve stimulation technology can effectively treat patients with severe overactive bladder. The six-contact electrode sacral nerve stimulation unit 101 uses multiple stimulation electrode contacts to improve the accuracy of the stimulation site.

[0048] The regulation control unit is specifically configured to generate a stimulation signal in the stimulation channel according to the six-contact electrode sacral nerve stimulation unit in accordance with the regulation request. The "current moment" refers to the moment when the patient periodically requests regulation after implanting the sacral nerve stimulation autonomic regulation system. The closer the multiple stimulation electrode contacts are deployed, the better the effect of using sacral nerve stimulation technology to effectively treat patients with severe overactive bladder. In other words, the closer the electrode contacts are, the better the effect.

[0049] Then, based on the stimulation signal generated by the six-contact electrode sacral nerve stimulation unit in the stimulation channel, a second neural signal that matches the first neural signal is determined. It should be noted that the "second neural signal" is used as the modulated electrical signal parameter value corresponding to the target stimulation target, that is, the "electrical signal parameter value" has corresponding stimulation points and stimulation parameters on the electrodes in the six-contact electrode sacral nerve stimulation unit. The "first neural signal" is used to characterize the monitored electrical signal parameter value calibrated after sacral nerve stimulation at the previous moment, that is, the "electrical signal parameter value" has standard stimulation points and standard stimulation parameters on the electrodes in the six-contact electrode sacral nerve stimulation unit. The "standard" here can be considered as the optimal stimulation scheme obtained by the doctor on the electrode after adjustment and combination with the patient's feelings.

[0050] The "modulation electrical signal parameter value" not only has a corresponding detection electrode stimulation combination, but also the optimal stimulation scheme obtained on the electrode is the electrode modulation combination corresponding to the control stimulation;

[0051] Furthermore, based on the determined second neural signal, an adjustment control instruction is output to control the autonomous adjustment of the six-contact electrode sacral nerve stimulation unit. The autonomous adjustment process is to make the "first neural signal" as close as possible to the "second neural signal." By regularly or continuously providing the test electrode combination corresponding to the second neural signal, the neural signal closest to the "first neural signal" can be found.

[0052] The use of six-contact electrodes not only allows for more possible combinations than traditional four-contact electrodes, allowing the positive and negative electrode combinations to be closer to the nerve roots, but also makes the autonomous adjustment system much easier than manual adjustment, aligning with intelligent selection and making it easier to find the combination closest to the nerve root.

[0053] The system generates a stimulation signal in the stimulation channel based on the six-contact electrode sacral nerve stimulation unit in response to a current adjustment request. In response to the stimulation signal, a second neural signal that matches the first neural signal is determined. The system autonomously completes this process and matches the second neural signal based on the predetermined first neural signal. Adjustment requests can be periodically initiated, and a new neural signal is updated after each request. The new neural signal then outputs an adjustment control instruction to control the autonomous adjustment of the six-contact electrode sacral nerve stimulation unit.

[0054] In this system, the first neural signal, representing the electrical signal parameter values ​​calibrated after sacral nerve stimulation at the last moment, can be considered to represent the electrode contacts and stimulation parameters configured by the patient's doctor in the hospital. The second neural signal, representing the electrical signal parameter values ​​corresponding to the target stimulation point, can be considered to represent the electrode contacts and stimulation parameters automatically configured by the system after the patient leaves the hospital to best fit the target stimulation point.

[0055] Through the above system, the six-contact electrode sacral nerve stimulation unit uses multiple stimulation electrode contacts to improve the accuracy of the stimulation site, which is more accurate than a single or four electrode contacts, and improves the expected effect of the stimulation program. In the related art, if the patient can no longer feel the sacral nerve stimulation, he needs to go to the hospital to have the doctor readjust the method differently. The above system can satisfy the patient's need to "feel" the sacral nerve stimulation at any time. And there is no need for an external programmer, only need to test once according to the interval period, and then compare the two adjustment results.

[0056] Unlike related art, where, after implantation, the patient's sacral stimulation system often experiences slight electrode displacement due to various factors, such as movement and external impact, which can reduce the effectiveness of the original stimulation program, the above-described system can generate a stimulation signal in the stimulation channel based on the six-contact electrode sacral nerve stimulation unit in response to the current adjustment request. In response to the stimulation signal, a second neural signal that matches the first neural signal is determined, thereby controlling the autonomous adjustment of the six-contact electrode sacral nerve stimulation unit.

[0057] Unlike related technologies, where multiple channels of stimulation electrodes require optional electrode stimulation schemes, coupled with variations in other stimulation parameters such as stimulation voltage and pulse width, the need for debugging these schemes has significantly increased the workload of physicians. The aforementioned system can autonomously match stimulation electrode contacts and stimulation parameters corresponding to the second neural signal, and output adjustment control instructions to autonomously control the six-contact electrode sacral nerve stimulation unit.

[0058] In one embodiment of the present application, the response to the adjustment request at the current moment, determining the second neural signal that matches the first neural signal within the automatic adjustment threshold range, includes: generating a stimulation electrical signal based on a periodic sacral nerve stimulation adjustment request, the stimulation electrical signal being generated by multiple stimulation channels, and each of the stimulation channels including at least one stimulation site; when the stimulation electrical signal is within the automatic adjustment threshold range, determining the sacral nerve electrical signal parameter value corresponding to the target stimulation target based on the sacral nerve electrical signal parameter value calibrated after sacral nerve stimulation at the previous moment.

[0059] The periodic sacral nerve stimulation adjustment request can be configured according to the actual patient condition and acts on the sacral nerve stimulation autonomic regulation system. According to the periodic sacral nerve stimulation adjustment request, a stimulation electrical signal generated by multiple stimulation channels is generated, and each stimulation channel includes at least one stimulation site. The stimulation point is a point selected relative to the electrode contact on the electrode, or in other words, the stimulation point is information recorded in the sacral nerve stimulation autonomic regulation system, and the electrode contact on the electrode is the information of the electrode itself. The two have a corresponding relationship. It can be understood that in the sacral nerve stimulation scheme, if the patient is far away from the nerve root, he or she is likely to have no feeling / feel weak, and if the patient is close to the nerve root, the patient's feeling is more obvious.

[0060] When it is determined that the stimulation electrical signal is within the range of the automatic adjustment threshold, the sacral nerve electrical signal parameter value corresponding to the target stimulation target is determined based on the sacral nerve electrical signal parameter value calibrated after the sacral nerve stimulation at the previous moment. When the patient moves, is hit by an external collision, or other reasons cause slight displacement of the electrode, resulting in different stimulation sites and stimulation parameters, by obtaining the excited nerve signal collected and transmitted upstream in this case, and by analyzing the consistency of the nerve excitation signal characteristics with the nerve excitation signal under typical parameters, the stimulation site and stimulation parameter with higher consistency are automatically selected as the new stimulation scheme, that is, the sacral nerve electrical signal parameter value corresponding to the target stimulation target is determined. If an electrode combination with a lower threshold than the current electrode combination is found, it means that the electrode has changed compared to the last time, and the system automatically corrects to obtain a lower threshold potential as the new electrode combination.

[0061] It should be noted that the downstream nerve excitation signal and its characteristics under typical stimulation parameters can be obtained in advance, that is, used as the first nerve signal to represent the electrical signal parameter value calibrated after sacral nerve stimulation at the previous moment.

[0062] In one embodiment of the present application, the method further includes: in a first adjustment stage, obtaining the stimulation site and stimulation parameters of the patient receiving sacral nerve stimulation; in response to the stimulation site and the stimulation parameters, acquiring the stimulation target closest to the stimulation site; and using the local nerve excitation signal caused by stimulating the sacral nerve corresponding to the stimulation target closest to the stimulation site as the first nerve signal.

[0063] The first adjustment phase refers to the sacral nerve one-stage surgical test treatment phase.

[0064] During the first-stage surgical test treatment of the sacral nerve, the doctor selects the appropriate stimulation site and stimulation parameters based on the patient's clinical response. After the parameters (i.e., typical stimulation parameters) are determined, the sacral nerve stimulation system turns on the stimulation under the typical stimulation parameters and collects and records the nearby nerve excitation signals. Figure 4 As shown, taking the stimulation site as electrode contact No. 0 as an example, the system sets electrode contact No. 2 as the collection site.

[0065] The sacral nerves are locally stimulated to cause nerve excitation. Since nerve cells have a refractory period after excitation, the propagation of pathological sacral nerve signals is interrupted, thereby producing a therapeutic effect.

[0066] It can be understood that the typical stimulation parameters are derived from the appropriate stimulation parameters selected by the doctor during the first phase of surgery based on the patient's clinical response.

[0067] In one embodiment of the present application, determining the second neural signal that matches the first neural signal within the automatic adjustment threshold range includes: in the second adjustment stage, selecting a stimulation site and an acquisition site as a stimulation pair; in response to the stimulation instruction of the six-contact electrode sacral nerve stimulation unit, generating an action point that propagates to at least one side at the stimulation site and recording the neural signal at the acquisition site to obtain the second neural signal that matches the first neural signal, and the second adjustment stage is no earlier than the first adjustment stage.

[0068] The second conditioning phase is when the patient is fully implanted with the sacral nerve stimulation system.

[0069] After the patient is fully implanted with the sacral nerve stimulation system, the doctor sets the automatic adjustment time node, and an adjustment request is initiated each time the automatic adjustment time node is reached. Figure 4As shown in the figure, the sacral nerve stimulation autonomic regulation system traverses the electrode contacts. Taking the six-contact electrode as an example, assuming that the stimulation site is 0, the system sets the acquisition site to 2, sends a stimulation instruction, stimulates the nerve at site 0, activates the local nerve, generates a nerve signal that propagates to both sides, and records the nerve excitation signal propagated by the nerve at site 2. Figure 5 and 6 As shown in the figure, the stimulation sites are changed to 1, 2, and 3 in sequence, and the acquisition sites are shifted to the right to 3, 4, and 5 accordingly, and the propagated neural excitation signals are recorded in sequence. Figure 6 As shown, when the stimulation site is 4 or 5, although there are no equally spaced collection sites on the right side, since the propagation of neural signals on the sacral nerve axons is bidirectional, the sacral nerve stimulation autonomic regulation system sets sites 2 and 3 as the collection sites corresponding to sites 4 and 5, respectively, and records the propagated neural excitation signals at the same time.

[0070] It can be understood that when the sacral nerve is locally electrically stimulated, neural excitation will be generated, and this neural excitation will propagate to both sides along the sacral nerve, so that the propagated neural excitation signal can be measured near the stimulation site.

[0071] In one embodiment of the present application, a charging power supply unit is further included to provide power to the six-contact electrode sacral nerve stimulation unit and the adjustment control unit respectively, so that a stimulation electrical signal is generated in the six-contact electrode sacral nerve stimulation unit and a stimulation control signal is generated in the adjustment control unit.

[0072] A charging power supply unit is used to provide power to the six-contact electrode sacral nerve stimulation unit and the adjustment control unit respectively, and a stimulation electrical signal is generated in the six-contact electrode sacral nerve stimulation unit, and a stimulation control signal is generated in the adjustment control unit.

[0073] Preferably, a low power consumption strategy can be adopted to reduce power consumption.

[0074] In one embodiment of the present application, the first adjustment phase includes a sacral nerve stimulation test treatment phase in which the patient first participates, and the second adjustment phase includes a sacral nerve stimulation adjustment treatment phase in which the patient does not participate for the first time.

[0075] The first adjustment phase is the primary surgical test treatment phase for the sacral nerve. During this phase, the physician selects appropriate stimulation sites and parameters based on the patient's clinical response. The second adjustment phase occurs when the patient is fully implanted with the sacral nerve stimulation system. After the patient is fully implanted with the sacral nerve stimulation system, the physician sets the automatic adjustment time points, and an adjustment request is initiated each time the automatic adjustment time points are reached.

[0076] In one embodiment of the present application, the characteristic parameters of the first neural signal and the second neural signal include at least one of the following: amplitude, frequency, power spectrum, and time-frequency information; the stimulation parameters used to generate the stimulation parameters include at least one of the following: stimulation amplitude, stimulation pulse width, stimulation frequency, stimulation waveform, stimulation current mode, and stimulation voltage mode.

[0077] The excitatory neural signal features of the first neural signal and the second neural signal include but are not limited to amplitude, frequency, power spectrum, and time-frequency information.

[0078] It is understandable that those skilled in the art can adjust the neural signal input by adjusting the amplitude, frequency, power spectrum, time-frequency, etc.

[0079] Optional stimulation parameters include but are not limited to stimulation voltage, stimulation current, stimulation amplitude, stimulation pulse width, stimulation frequency, stimulation waveform, etc.

[0080] In one embodiment of the present application, the six-contact electrode sacral nerve stimulation unit further includes a plurality of test points and a plurality of acquisition points. The six-contact electrode sacral nerve stimulation unit is further used to provide stimulation sites corresponding to the second neural signal that matches the first neural signal based on the plurality of test points and the plurality of acquisition points; and / or to provide a group of stimulation sites corresponding to the second neural signal that matches the first neural signal based on the plurality of test points and the plurality of acquisition points in a single channel and multiple channels.

[0081] The stimulation electrodes of the sacral nerve stimulation autonomic regulation system should contain at least six electrode contacts, each of which is an independent stimulation or acquisition channel.

[0082] After the patient is fully implanted with the sacral nerve stimulation system, the physician sets the automatic adjustment time node. Each time the automatic adjustment time node is reached, the system traverses the electrode contacts. This detailed explanation is provided using a six-contact electrode as an example.

[0083] First, assume that the stimulation site is 0. The sacral nerve stimulation autonomic regulation system sets the acquisition site to 2. The nerve stimulation module sends a stimulation instruction to stimulate the nerve at site 0, activates the local nerve, and generates a nerve signal that propagates to both sides. The nerve signal acquisition module records the nerve excitation signal propagated by the nerve at site 2.

[0084] Then, the stimulation sites 1, 2, and 3 are changed in sequence, and the acquisition site is correspondingly shifted to the right to the stimulation sites 3, 4, and 5, and the propagated neural excitation signals are recorded in sequence.

[0085] Finally, when the stimulation site is 4 or 5, although there are no equally spaced collection sites on the right side, since the propagation of neural signals on the sacral nerve axons is bidirectional, the sacral nerve stimulation autonomic regulation system sets sites 2 and 3 as the collection sites corresponding to 4 and 5, respectively, to record the propagated neural excitation signals.

[0086] The sacral nerve stimulation autonomic regulation system compares the excitation signal characteristics of the six sites with the excitation signal characteristics under the typical stimulation parameters in the first regulation stage, and selects the stimulation site with the highest signal characteristic consistency that exceeds a certain threshold as the new stimulation site.

[0087] When the excitation signal characteristics corresponding to all six stimulation sites are less consistent than the excitation signal characteristics under typical stimulation parameters, it indicates that adjusting the stimulation sites under the current stimulation parameters is not sufficient for therapeutic efficacy. The system then automatically adjusts the stimulation parameters, using stimulation voltage as an example (increasing stimulation voltage is often used clinically to enhance stimulation efficacy). The system sets a voltage step based on the current voltage and increases the voltage according to the step. This process repeats the following steps: (After the patient is fully implanted with the sacral nerve stimulation system, the physician sets an automatic adjustment time node.) Each time the automatic adjustment time node is reached, the system traverses the electrode contacts, obtains the excitation signal characteristics of the six sites after the voltage increase, and compares them again with the excitation signal characteristics under typical parameters. The stimulation site with the highest consistency that exceeds a certain threshold is selected as the new stimulation site, and the stimulation parameters are set accordingly. If therapeutic efficacy is still not achieved, the voltage signal is increased again within the safe voltage range, and the process repeats until therapeutic efficacy is achieved. (After the patient is fully implanted with the sacral nerve stimulation system, the physician sets an automatic adjustment time node.) Each time the automatic adjustment time node is reached, the system traverses the electrode contacts and compares the signal characteristics.

[0088] It can be understood that the stimulation parameters that can be adjusted by the sacral nerve stimulation autonomous regulation system include but are not limited to stimulation, stimulation current, stimulation pulse width, stimulation frequency, stimulation waveform, etc.

[0089] Furthermore, when one stimulation parameter adjustment cannot meet the needs, the system can also be set to change two stimulation variables at the same time, and repeat. When the patient is fully implanted with the sacral nerve stimulation system, the doctor sets the automatic adjustment time node. Each time the automatic adjustment time node is reached, the system traverses the electrode contacts and the sacral nerve stimulation autonomous adjustment system compares the excitation signal characteristics of the six sites with the consistency of the excitation signal characteristics under the typical stimulation parameters in the first adjustment stage, and selects the stimulation site with the highest signal characteristic consistency and exceeding a certain threshold as the new stimulation site. The excitation signal characteristics of the six stimulation sites when the two stimulation variables change are obtained, and the appropriate stimulation site and corresponding stimulation parameters are selected by comparison.

[0090] like Figure 7 and 8 As shown in Figure 1, using two channels for stimulation is also a way to achieve sacral nerve stimulation, usually a combination of one positive and one negative. This stimulation method can also be evaluated. Select channels 0 and 1 as positive and negative, respectively. In this case, site 3 is used as the acquisition channel. Figure 9 and 10 As shown, the channels at positions 1 and 2, 2 and 3, 3 and 4, and 4 and 5 are rotated in turn as positive and negative poles, respectively. The consistency of signal characteristics under typical stimulation parameters is compared to select the appropriate stimulation sites and possible corresponding stimulation parameters.

[0091] Alternatively, a multi-contact stimulation and collection integrated electrode may be used, and the stimulation site and the collection site are always kept at a certain distance apart.

[0092] Optionally, the stimulation signal is a limited number of stimulation pulses with time intervals, and the time intervals can be divided into equal intervals and unequal intervals. Different pulse and interval modes can help adjust the output mode of the stimulation signal.

[0093] Alternatively, the intensity curves or surfaces of the neural signals corresponding to different stimulation parameters can be obtained through interpolation and fitting, thereby evaluating the stimulation effects of different stimulation parameters at the stimulation site. The stimulation effects of different stimulation sites can be evaluated by comparing the characteristic values ​​of the curves or surfaces of the relationship between the stimulation parameters and the neural signals at different stimulation sites.

[0094] Specifically, the sacral nerve stimulation autonomic regulation system obtains all the nerve excitation signals at six sites, removes the noise signals through power frequency filtering, bandpass filtering, and band-stop filtering, and then obtains the amplitude, frequency, spectral density, time-frequency information and other characteristics of the excitation signals at the six sites after analysis.

[0095] like Figure 2 As shown, in an embodiment of the present application, a rehabilitation system for patients with overactive bladder is also provided, wherein the sacral nerve stimulation automatic regulation system is adopted. The sacral nerve stimulation automatic regulation system comprises: a six-contact electrode sacral nerve stimulation unit and a regulation control unit, wherein the six-contact electrode sacral nerve stimulation unit is electrically connected to the regulation control unit, and the regulation control unit is used to

[0096] In response to the current adjustment request, the six-contact electrode sacral nerve stimulation unit generates a stimulation signal in the stimulation channel;

[0097] In response to the stimulation signal, determining a second neural signal that matches the first neural signal; and

[0098] According to the second neural signal output adjustment control instruction, the six-contact electrode sacral nerve stimulation unit is controlled to adjust autonomously,

[0099] Among them, the first neural signal is used to represent the electrical signal parameter value calibrated after sacral nerve stimulation at the previous moment; the second neural signal is used as the electrical signal parameter value corresponding to the target stimulation target.

[0100] In some embodiments, in response to the current adjustment request, determining a second neural signal that matches the first neural signal within an automatic adjustment threshold range includes:

[0101] Generate a stimulation electrical signal according to a periodic sacral nerve stimulation adjustment request, wherein the stimulation electrical signal is generated by a plurality of stimulation channels, and each stimulation channel includes at least one stimulation site;

[0102] When the stimulation electrical signal is within the automatic adjustment threshold range, the sacral nerve electrical signal parameter value corresponding to the target stimulation point is determined according to the sacral nerve electrical signal parameter value calibrated after the sacral nerve stimulation at the previous moment.

[0103] In some embodiments, the method further comprises:

[0104] In the first adjustment stage, the stimulation site and stimulation parameters of the patient receiving sacral nerve stimulation are obtained;

[0105] In response to the stimulation site and the stimulation parameters, acquiring a stimulation target point closest to the stimulation site;

[0106] The excitation signal of the local nerve caused by stimulating the sacral nerve corresponding to the stimulation target point closest to the stimulation site is used as the first nerve signal.

[0107] In some embodiments, determining the second neural signal that matches the first neural signal within the auto-adjustment threshold range includes:

[0108] In the second conditioning phase, the stimulation site and the acquisition site were selected and used as stimulation pairs;

[0109] In response to the stimulation instruction of the six-contact electrode sacral nerve stimulation unit, an action point is generated at least to one side at the stimulation site and a nerve signal is recorded at the acquisition site to obtain the second nerve signal matching the first nerve signal, and the second adjustment stage is no earlier than the first adjustment stage.

[0110] In some embodiments, a charging power supply unit is further included to provide power to the six-contact electrode sacral nerve stimulation unit and the adjustment control unit respectively, so that a stimulation electrical signal is generated in the six-contact electrode sacral nerve stimulation unit and a stimulation control signal is generated in the adjustment control unit.

[0111] In some embodiments, the first adjustment phase includes a sacral nerve stimulation test treatment phase in which the patient first participates, and the second adjustment phase includes a sacral nerve stimulation adjustment treatment phase in which the patient is not first participating.

[0112] In some embodiments, the characteristic parameters of the first neural signal and the second neural signal include at least one of the following: amplitude, frequency, power spectrum, and time-frequency information; the stimulation parameters used to generate the stimulation parameters include at least one of the following: stimulation amplitude, stimulation pulse width, stimulation frequency, stimulation waveform, current stimulation mode, and voltage stimulation mode.

[0113] In some embodiments, the six-contact electrode sacral nerve stimulation unit further includes a plurality of test points and a plurality of collection points. The six-contact electrode sacral nerve stimulation unit is also used to:

[0114] Providing a stimulation site corresponding to the second neural signal matching the first neural signal according to the multiple test points and the multiple acquisition points;

[0115] and / or,

[0116] A stimulation site group corresponding to the second neural signal matching the first neural signal is provided based on the multiple test points and the multiple acquisition points in the single channel and the multiple channels.

[0117] Through the rehabilitation system for patients with overactive bladder, the self-regulation of sacral nerve stimulation is periodically achieved while improving the accuracy of sacral nerve stimulation.

[0118] like Figure 3 As shown, in the embodiment of the present application, a six-contact electrode sacral nerve stimulation system is also provided, wherein the sacral nerve stimulation automatic adjustment system is adopted. The sacral nerve stimulation automatic adjustment system comprises: a six-contact electrode sacral nerve stimulation unit and a regulation control unit, wherein the six-contact electrode sacral nerve stimulation unit is electrically connected to the regulation control unit, and the regulation control unit is used to

[0119] In response to the current adjustment request, the six-contact electrode sacral nerve stimulation unit generates a stimulation signal in the stimulation channel;

[0120] In response to the stimulation signal, determining a second neural signal that matches the first neural signal; and

[0121] According to the second neural signal output adjustment control instruction, the six-contact electrode sacral nerve stimulation unit is controlled to adjust autonomously,

[0122] Among them, the first neural signal is used to represent the electrical signal parameter value calibrated after sacral nerve stimulation at the previous moment; the second neural signal is used as the electrical signal parameter value corresponding to the target stimulation target.

[0123] In some embodiments, in response to the current adjustment request, determining a second neural signal that matches the first neural signal within an automatic adjustment threshold range includes:

[0124] Generate a stimulation electrical signal according to a periodic sacral nerve stimulation adjustment request, wherein the stimulation electrical signal is generated by a plurality of stimulation channels, and each stimulation channel includes at least one stimulation site;

[0125] When the stimulation electrical signal is within the automatic adjustment threshold range, the sacral nerve electrical signal parameter value corresponding to the target stimulation point is determined according to the sacral nerve electrical signal parameter value calibrated after the sacral nerve stimulation at the previous moment.

[0126] In some embodiments, the method further comprises:

[0127] In the first adjustment stage, the stimulation site and stimulation parameters of the patient receiving sacral nerve stimulation are obtained;

[0128] In response to the stimulation site and the stimulation parameters, acquiring a stimulation target point closest to the stimulation site;

[0129] The excitation signal of the local nerve caused by stimulating the sacral nerve corresponding to the stimulation target point closest to the stimulation site is used as the first nerve signal.

[0130] In some embodiments, determining the second neural signal that matches the first neural signal within the auto-adjustment threshold range includes:

[0131] In the second conditioning phase, the stimulation site and the acquisition site were selected and used as stimulation pairs;

[0132] In response to the stimulation instruction of the six-contact electrode sacral nerve stimulation unit, an action point is generated at least to one side at the stimulation site and a nerve signal is recorded at the acquisition site to obtain the second nerve signal matching the first nerve signal, and the second adjustment stage is no earlier than the first adjustment stage.

[0133] In some embodiments, a charging power supply unit is further included to provide power to the six-contact electrode sacral nerve stimulation unit and the adjustment control unit respectively, so that a stimulation electrical signal is generated in the six-contact electrode sacral nerve stimulation unit and a stimulation control signal is generated in the adjustment control unit.

[0134] In some embodiments, the first adjustment phase includes a sacral nerve stimulation test treatment phase in which the patient first participates, and the second adjustment phase includes a sacral nerve stimulation adjustment treatment phase in which the patient is not first participating.

[0135] In some embodiments, the characteristic parameters of the first neural signal and the second neural signal include at least one of the following: amplitude, frequency, power spectrum, and time-frequency information; the stimulation parameters used to generate the stimulation parameters include at least one of the following: stimulation amplitude, stimulation pulse width, stimulation frequency, stimulation waveform, current stimulation mode, and voltage stimulation mode.

[0136] In some embodiments, the six-contact electrode sacral nerve stimulation unit further includes a plurality of test points and a plurality of collection points. The six-contact electrode sacral nerve stimulation unit is also used to:

[0137] Providing a stimulation site corresponding to the second neural signal matching the first neural signal according to the multiple test points and the multiple acquisition points;

[0138] and / or,

[0139] A stimulation site group corresponding to the second neural signal matching the first neural signal is provided based on the multiple test points and the multiple acquisition points in the single channel and the multiple channels.

[0140] Through the six-contact electrode sacral nerve stimulation system, the sacral nerve stimulation can be periodically self-regulated while improving the accuracy of sacral nerve stimulation.

[0141] The foregoing is merely an embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various changes and variations. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present application should all be included within the scope of the claims of the present application.

Claims

1. An intelligent sacral nerve stimulation system based on real-time monitoring of six-contact electrodes and real-time dynamic adjustment of positive and negative electrode combinations, wherein: The system includes: a six-contact electrode sacral nerve stimulation unit and a regulation control unit, wherein the six-contact electrode sacral nerve stimulation unit is electrically connected to the regulation control unit, and the six-contact electrode sacral nerve stimulation unit uses six-contact electrodes and realizes automatic detection by utilizing the positive and negative combinations of the six contacts; the regulation control unit is used to In response to the current adjustment request, the six-contact electrode sacral nerve stimulation unit generates a stimulation signal in the stimulation channel; In response to the stimulation signal, determining a second neural signal that matches the first neural signal; and According to the second neural signal output adjustment control instruction, the six-contact electrode sacral nerve stimulation unit is controlled to adjust autonomously, Wherein, the first neural signal is used to represent the monitored electrical signal parameter value calibrated after sacral nerve stimulation at the previous moment; the second neural signal is used as the modulated electrical signal parameter value corresponding to the target stimulation target; wherein, the electrical signal parameter value has a standard stimulation point and standard stimulation parameter on the electrode in the six-contact electrode sacral nerve stimulation unit, and the modulated electrical signal parameter value not only has a corresponding detection electrode stimulation combination, but also the optimal stimulation scheme obtained on the electrode is the electrode modulation combination corresponding to the control stimulation; During the first adjustment phase of the sacral nerve stimulation test treatment phase in which the patient first participates, the stimulation site and stimulation parameters of the patient receiving sacral nerve stimulation are obtained; in response to the stimulation site and the stimulation parameters, a stimulation target closest to the stimulation site is acquired; and an excitation signal of a local nerve caused by stimulation of the sacral nerve corresponding to the stimulation target closest to the stimulation site is used as the first nerve signal; In the second adjustment stage, which is not the first time that the patient participates in the sacral nerve stimulation adjustment treatment stage, a stimulation site and a collection site are selected and used as a stimulation pair; in response to the stimulation instruction of the six-contact electrode sacral nerve stimulation unit, an action point is generated at least to one side at the stimulation site and a nerve signal is recorded at the collection site to obtain the second nerve signal that matches the first nerve signal. The second adjustment stage is no earlier than the first adjustment stage.

2. The system of claim 1, wherein: The step of determining, in response to the current adjustment request, a second neural signal matching the first neural signal within an automatic adjustment threshold range includes: Generate a stimulation electrical signal according to a periodic sacral nerve stimulation adjustment request, wherein the stimulation electrical signal is generated by a plurality of stimulation channels, and each stimulation channel includes at least one stimulation site; When the stimulation electrical signal is within the automatic adjustment threshold range, the sacral nerve electrical signal parameter value corresponding to the target stimulation point is determined according to the sacral nerve electrical signal parameter value calibrated after the sacral nerve stimulation at the previous moment.

3. The system as described in claim 1 further includes a charging power supply unit for providing power to the six-contact electrode sacral nerve stimulation unit and the adjustment control unit respectively, so that the six-contact electrode sacral nerve stimulation unit generates a stimulation electrical signal and the adjustment control unit generates a stimulation control signal.

4. The system of claim 1, wherein: The characteristic parameters of the first neural signal and the second neural signal include at least one of the following: amplitude, frequency, power spectrum, and time-frequency information; the stimulation parameters used to generate the stimulation parameters include at least one of the following: stimulation amplitude, stimulation pulse width, stimulation frequency, stimulation waveform, stimulation current mode, and stimulation voltage mode.

5. The system of claim 1, wherein: The six-contact electrode sacral nerve stimulation unit further includes a plurality of test points and a plurality of collection points. The six-contact electrode sacral nerve stimulation unit is also used to: Providing a stimulation site corresponding to the second neural signal matching the first neural signal according to the multiple test points and the multiple acquisition points; and / or, A stimulation site group corresponding to the second neural signal matching the first neural signal is provided based on the multiple test points and the multiple acquisition points in the single channel and the multiple channels.

6. A rehabilitation system for patients with overactive bladder, wherein: An intelligent sacral nerve stimulation system based on real-time monitoring of six-contact electrodes and real-time dynamic adjustment of positive and negative electrode combinations as described in any one of claims 1 to 5 is used.

7. A six-contact electrode sacral nerve stimulation system, wherein: An intelligent sacral nerve stimulation system based on real-time monitoring of six-contact electrodes and real-time dynamic adjustment of positive and negative electrode combinations as described in any one of claims 1 to 5 is used.

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