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

Abstract

The invention discloses an intelligent sacral nerve stimulation system based on six-contact electrode real-time monitoring and positive and negative electrode combination real-time dynamic adjustment, a rehabilitation system and a six-contact electrode sacral nerve stimulation system.The sacral nerve stimulation autonomous adjustment system comprises a six-contact electrode sacral nerve stimulation unit and an adjustment control unit, the six-contact electrode sacral nerve stimulation unit is electrically connected with the adjustment control unit, and the adjustment control unit is used for responding to an adjustment request at the current moment and generating a stimulation signal in a stimulation channel according to the six-contact electrode sacral nerve stimulation unit; in response to the stimulation signal, determining a second neural signal matched with the first neural signal; and outputting an adjustment control instruction according to the second neural signal so as to control the six-contact electrode sacral nerve stimulation unit to autonomously adjust. On one hand, sacral nerve stimulation self-adjustment can be periodically realized, and on the other hand, sacral nerve stimulation accuracy is improved. The invention further provides a rehabilitation system.

Description

Technical Field

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

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

[0003] The therapeutic effect of the sacral nerve stimulation technology depends on the contact sites between the sacral nerves and the stimulating electrodes. In related technologies, the sacral nerve system is equipped with multiple stimulating electrode contacts to improve the accuracy of the stimulating sites. Doctors observe the stimulating effects by changing different stimulating sites and select a suitable stimulating scheme. After the sacral stimulation system is implanted into a patient's body, due to various reasons such as the patient's movement and external collision, the electrodes are often slightly displaced, resulting in a decline in the effect of the original stimulating scheme and reducing the long-term effectiveness of the stimulating system. The patient must return to the hospital for the doctor to test a new stimulating scheme. However, for multi-channel stimulating electrodes, there are many combination methods of optional electrode stimulating schemes. Coupled with the changes in other stimulating parameters such as stimulating voltage and stimulating pulse width, the actual stimulating 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 listening of six-contact electrodes and real-time dynamic adjustment of positive and negative electrode combinations, which have an autonomous adjustment function to periodically realize self-adjustment of sacral nerve stimulation and improve the accuracy of sacral nerve stimulation.

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

[0006] In a first aspect, the embodiments of the present application provide an intelligent sacral nerve stimulation system based on real-time listening of six-contact electrodes and real-time dynamic adjustment of positive and negative electrode combinations. Among them, the 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 for

[0007] responding to an adjustment request at the current moment, and generating a stimulation signal in the stimulation channel according to the six-contact electrode sacral nerve stimulation unit;

[0008] responding to the stimulation signal, determining a second nerve signal that matches the first nerve signal; and

[0009] Output a regulation control instruction according to the second nerve signal to control the autonomous regulation of the six-contact electrode sacral nerve stimulation unit.

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

[0011] In some embodiments, the determining the second nerve signal matching the first nerve signal within the automatic regulation threshold range in response to a regulation request at the current moment includes:

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

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

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

[0015] In the first regulation stage, obtain the stimulation site and stimulation parameters of a patient receiving sacral nerve stimulation;

[0016] In response to the stimulation site and the stimulation parameters, collect the stimulation target closest to the stimulation site;

[0017] Use the excitatory signal of the local nerve caused by stimulating the sacral nerve corresponding to the stimulation target closest to the stimulation site as the first nerve signal.

[0018] In some embodiments, the determining the second nerve signal matching the first nerve signal within the automatic regulation threshold range includes:

[0019] In the second regulation stage, select a stimulation site and a collection site as a stimulation pair;

[0020] In response to the stimulation instruction of the six-contact electrode sacral nerve stimulation unit, generate an action potential propagating at least to one side at the stimulation site and record a nerve signal at the collection site to obtain the second nerve signal matching the first nerve signal, and the second regulation stage is not earlier than the first regulation stage.

[0021] In some embodiments, it further includes a charging and power supply unit for respectively providing power to the six-contact electrode sacral nerve stimulation unit and the adjustment and control unit, so as to generate a stimulation electrical signal in the six-contact electrode sacral nerve stimulation unit and generate a stimulation control signal in the adjustment and control unit.

[0022] In some embodiments, the first adjustment stage includes the stage where the patient first participates in the sacral nerve stimulation test and treatment, and the second adjustment stage includes the stage where the patient participates in the sacral nerve stimulation adjustment and treatment non-first.

[0023] In some embodiments, the characteristic parameters of the first nerve signal and the second nerve signal at least include one of the following: amplitude, frequency, power spectrum, time-frequency information; the stimulation parameters used to generate the stimulation parameters at least include one of the following: stimulation amplitude, stimulation pulse width, stimulation frequency, stimulation waveform, current stimulation mode, 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 acquisition points, and the six-contact electrode sacral nerve stimulation unit is further used for

[0025] providing a stimulation site corresponding to the second nerve signal matching the first nerve signal according to the plurality of test points and the plurality of acquisition points;

[0026] and / or

[0027] providing a group of stimulation sites corresponding to the second nerve signal matching the first nerve signal according to the plurality of test points and the plurality of acquisition points in a single channel and 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 listening with six-contact electrodes and real-time dynamic adjustment of the positive and negative electrode combination 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 listening with six-contact electrodes and real-time dynamic adjustment of the positive and negative electrode combination described in the first aspect is adopted.

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

[0031] Fifth aspect, an embodiment of the present application further provides a computer-readable storage medium storing one or more programs, which, when executed by an electronic device including a plurality of application programs, cause the electronic device to execute the above method.

[0032] The above at least one technical solution 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 configured to, in response to an adjustment request at the current moment, generate a stimulation signal in a stimulation channel according to the six-contact electrode sacral nerve stimulation unit; determine a second nerve signal matching the first nerve signal in response to the stimulation signal; and output an adjustment control instruction according to the second nerve signal to control the six-contact electrode sacral nerve stimulation unit to perform autonomous adjustment. Through the above system, the stimulation site and stimulation parameters can be automatically adjusted, the efficiency of testing new stimulation programs can be effectively improved, the number of patient visits to the hospital can be reduced, and the long-term treatment effect of the system can be effectively maintained. 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 and descriptions thereof of the present application are used to explain the present application, and do not constitute an improper limitation of the present application. In the drawings:

[0034] Figure 1 is a schematic internal structure diagram of an intelligent sacral nerve stimulation system based on real-time listening with a six-contact electrode and real-time dynamic adjustment of the positive and negative electrode combination in an embodiment of the present application;

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

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

[0037] Figure 4 is one of the schematic diagrams of the electrodes and stimulation and acquisition at the electrode contacts in the sacral nerve stimulation autonomous adjustment system in an embodiment of the present application;

[0038] Figure 5 is another schematic diagram of the electrodes and stimulation and acquisition at the electrode contacts in the sacral nerve stimulation autonomous adjustment system in an embodiment of the present application;

[0039] Figure 6 is a third schematic diagram of the electrodes and stimulation and acquisition at the electrode contacts in the sacral nerve stimulation autonomous adjustment system in an embodiment of the present application;

[0040] Figure 7 This is the fourth schematic diagram of the electrode of the sacral nerve stimulation autonomous regulation system in the embodiments of the present application and the stimulation and acquisition at the electrode contacts;

[0041] Figure 8 This is the fifth schematic diagram of the electrode of the sacral nerve stimulation autonomous regulation system in the embodiments of the present application and the stimulation and acquisition at the electrode contacts;

[0042] Figure 9 This is the sixth schematic diagram of the electrode of the sacral nerve stimulation autonomous regulation system in the embodiments of the present application and the stimulation and acquisition at the electrode contacts;

[0043] Figure 10 This is the seventh schematic diagram of the electrode of the sacral nerve stimulation autonomous regulation system in the embodiments of the present application and the stimulation and acquisition at the electrode contacts. Detailed implementation manners

[0044] To make the objectives, technical solutions and advantages of the present application clearer, the technical solutions of the present application will be clearly and completely described below in conjunction with the specific embodiments of the present application and the corresponding drawings. Apparently, the described embodiments are only a part of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without making creative efforts shall fall within the protection scope of the present application.

[0045] The technical solutions provided by the embodiments of the present application will be described in detail below in conjunction with the drawings.

[0046] The embodiments of the present application provide an intelligent sacral nerve stimulation system 10 based on real-time listening with a six-contact electrode and real-time dynamic adjustment of the positive and negative electrode combinations, as Figure 1 shown, which provides a schematic diagram of the internal structure of the sacral nerve stimulation autonomous regulation system in the embodiments of the present application. The system includes: a six-contact electrode sacral nerve stimulation unit 101 and a regulation and control unit 102. The six-contact electrode sacral nerve stimulation unit 101 is electrically connected to the regulation and control unit 102. The regulation and control unit 102 is configured to respond to a regulation 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 nerve signal that matches the first nerve signal in response to the stimulation signal; and output a regulation control instruction according to the second nerve signal to control the autonomous regulation of the six-contact electrode sacral nerve stimulation unit, where the first nerve signal is used to represent the calibrated listening electrical signal parameter value after sacral nerve stimulation at the previous moment; the second nerve signal is used as the modulation 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 (-) combinations of the six contacts, where 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 into the patient's body together. The adjustment control unit 102 serves as the core functional module of the sacral nerve stimulation autonomous adjustment system 10, and the six-contact electrode sacral nerve stimulation unit 101 serves as the stimulation executor of the sacral nerve stimulation autonomous adjustment system 10. With the patient's sacral nerve as the carrier, the sacral nerve stimulation technology can effectively treat patients with severe overactive bladder. Multiple stimulating electrode contacts are used in the six-contact electrode sacral nerve stimulation unit 101 to improve the accuracy of the stimulation site.

[0048] The adjustment control unit is specifically configured to generate a stimulation signal in the stimulation channel according to the adjustment request and based on the six-contact electrode sacral nerve stimulation unit. "The current moment" refers to the moment when the patient periodically requests adjustment after implanting and wearing the sacral nerve stimulation autonomous adjustment system. The closer the multiple stimulating electrode contacts are deployed, the better the effect of using the sacral nerve stimulation technology to effectively treat patients with severe overactive bladder. Or rather, the closer the electrode contacts are, the better the effect.

[0049] Furthermore, according to the stimulation signal generated by the six-contact electrode sacral nerve stimulation unit in the stimulation channel, a second nerve signal matching the first nerve signal is determined. It should be noted that the "second nerve signal" is used as the modulation electrical signal parameter value corresponding to the target stimulation target point. That is to say, at this "electrical signal parameter value", there are corresponding stimulation points and stimulation parameters on the electrodes in the six-contact electrode sacral nerve stimulation unit. The "first nerve signal" is used to represent the detected listening electrical signal parameter value calibrated after sacral nerve stimulation at the previous moment. That is to say, at this "electrical signal parameter value", there are standard stimulation points and standard stimulation parameters on the electrodes in the six-contact electrode sacral nerve stimulation unit. Here, "standard" can be considered as the optimal stimulation scheme obtained by the doctor through adjustment and in combination with the patient's feelings on the electrodes.

[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 electrodes is the electrode modulation combination corresponding to the regulated stimulation;

[0051] Further, according to the determined second nerve signal, an adjustment control instruction is output to control the autonomous adjustment of the six-contact electrode sacral nerve stimulation unit. The process of autonomous adjustment is a process of making the "first nerve signal" as close as possible to the "second nerve signal". By periodically or continuously giving the test electrode combination corresponding to the second nerve signal, the nerve signal closest to the "first nerve signal" can be found.

[0052] The use of a six-contact electrode not only offers more combination possibilities compared to traditional four-contact electrodes, enabling the positive and negative electrode combinations to be closer to the nerve root position. The autonomous adjustment system is much easier compared to manual adjustment, meeting the intelligent choice and making it easier to find the combination closest to the nerve root.

[0053] Through the above system, in response to an adjustment request at the current moment, a stimulation signal is generated in the stimulation channel according to the six-contact electrode sacral nerve stimulation unit; in response to the stimulation signal, a second nerve signal matching the first nerve signal is determined. The above process is autonomously completed by the system and the second nerve signal is matched according to the pre-determined first nerve signal. The adjustment request can be initiated periodically and a new nerve signal is obtained after each request, and then an adjustment control instruction is output from the new nerve signal to control the autonomous adjustment of the six-contact electrode sacral nerve stimulation unit.

[0054] Through the above system, for the first nerve signal used to represent the calibrated electrical signal parameter values after sacral nerve stimulation at the previous moment, it can be considered as the electrode contacts and stimulation parameters adjusted and configured by a doctor for the patient in the hospital. For the second nerve signal used as the electrical signal parameter values corresponding to the target stimulation target, it can be considered as the electrode contacts and stimulation parameters of the most suitable target stimulation target automatically adjusted and configured by the system after the patient leaves the hospital.

[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 precise than single or four electrode contacts, improving the expected effect of the stimulation scheme. Different from the related technology where when a patient can no longer feel sacral nerve stimulation, they need to go to the hospital for the doctor to readjust, through the above system, it can satisfy the patient's ability to "feel" sacral nerve stimulation at any time. And there is no need for an external programmer, only need to perform a test once at an interval period and then compare the two adjustment results.

[0056] Different from the related technology where after the patient's sacral stimulation system is implanted into the body, it often causes slight displacement of the electrode due to various reasons such as movement and external collision, resulting in a decline in the effect of the original stimulation scheme. Through the above system, it can 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; in response to the stimulation signal, determine the second nerve signal matching the first nerve signal, thereby controlling the autonomous adjustment of the six-contact electrode sacral nerve stimulation unit.

[0057] Different from the related art, for multi-channel stimulating electrodes, with the optional electrode stimulation schemes and the variations of other stimulation parameters such as stimulation voltage and stimulation pulse width, the actual stimulation schemes that need to be debugged have seriously increased the workload of doctors. Through the above system, the stimulating electrode contacts and stimulation parameters corresponding to the second nerve signal can be automatically matched, and an adjustment control instruction can be output to control the six-contact electrode sacral nerve stimulation unit to adjust autonomously.

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

[0059] The periodic sacral nerve stimulation adjustment request can be configured according to the actual patient conditions and act on the sacral nerve stimulation autonomous adjustment system. According to the periodic sacral nerve stimulation adjustment request, a stimulating electrical signal generated by a plurality of stimulating channels is generated, and each of the stimulating channels includes at least one stimulating site. The stimulating site is a site selected relative to the electrode contact on the electrode, or rather, the stimulating site is the information recorded in the sacral nerve stimulation autonomous adjustment 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 distance from the nerve root is far, the patient is likely to have no sensation / weak sensation, and if the distance from the nerve root is close, the patient's sensation is more obvious.

[0060] When it is determined that the stimulating electrical signal is within the automatic adjustment threshold range, the sacral nerve electrical signal parameter value corresponding to the target stimulating target is determined according to the sacral nerve electrical signal parameter value calibrated after the sacral nerve stimulation at the previous moment. When the electrode is slightly displaced due to various reasons such as the patient's movement or external collision, resulting in different stimulating sites and stimulation parameters, the excited nerve signal propagated downstream in this case is acquired, and by analyzing the characteristics of the nerve excitation signal and comparing its consistency with the nerve excitation signal under typical parameters, the stimulating sites and stimulation parameters with higher consistency are automatically selected as the new stimulation scheme, that is, the sacral nerve electrical signal parameter value corresponding to the target stimulating target is determined. If an electrode combination with a lower threshold than the current electrode combination is found, it indicates that the electrode has changed compared with the previous 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 characterize the calibrated electrical signal parameter value after sacral nerve stimulation at the previous moment.

[0062] In an embodiment of the present application, the method further includes: in the first adjustment stage, obtaining the stimulation site and stimulation parameters of a patient receiving sacral nerve stimulation; in response to the stimulation site and the stimulation parameters, collecting the stimulation target closest to the stimulation site; using the excitation signal of the local nerve 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 stage refers to the test treatment stage of the first stage of sacral nerve surgery.

[0064] In the test treatment stage of the first stage of sacral nerve surgery, the doctor selects appropriate stimulation sites and stimulation parameters according to 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 adjacent nerve excitation signals. As Figure 4 shown, taking the 0th electrode contact as the stimulation site as an example, the system sets the 2nd electrode contact as the collection site.

[0065] The sacral nerve is 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 stage of the operation according to the patient's clinical response.

[0067] In an embodiment of the present application, determining the second nerve signal matching the first nerve signal within the automatic adjustment threshold range includes: in the second adjustment stage, selecting the stimulation site and the collection site as a stimulation pair; in response to the stimulation instruction of the six-contact electrode sacral nerve stimulation unit, generating an action potential propagating at least to one side at the stimulation site and recording the nerve signal at the collection site, obtaining the second nerve signal matching the first nerve signal, and the second adjustment stage is not earlier than the first adjustment stage.

[0068] The second adjustment stage 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 a regulation request will be initiated each time the automatic adjustment time node is reached. As Figure 4As shown, the sacral nerve stimulation self-regulating system traverses the electrode contacts. Taking a six-contact electrode as an example, assuming the stimulation site is 0 and the system sets the acquisition site to 2, a stimulation instruction is sent to stimulate the nerve at the 0 site, activating the local nerve and generating nerve signals that propagate to both sides. The nerve excitation signals propagated by the nerve are recorded at the 2 site. As Figure 5 and 6 shown, the stimulation site is sequentially changed to 1, 2, and 3, and the acquisition site is correspondingly translated to the right to 3, 4, and 5, and the propagated nerve excitation signals are sequentially recorded. As Figure 6 shown, when the stimulation site is 4 or 5, although there are no equally spaced acquisition sites on the right side, since the propagation of nerve signals on the sacral nerve axon is bidirectional, the sacral nerve stimulation self-regulating system sets the 2 site and the 3 site as the acquisition sites corresponding to the 4 site and the 5 site respectively, and simultaneously records the propagated nerve excitation signals.

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

[0071] In an embodiment of the present application, a charging and power supply unit is further included, which is used to supply power to the six-contact electrode sacral nerve stimulation unit and the regulation and control unit respectively, so as to generate a stimulation electrical signal in the six-contact electrode sacral nerve stimulation unit and generate a stimulation control signal in the regulation and control unit.

[0072] The charging and power supply unit is used to supply power to the six-contact electrode sacral nerve stimulation unit and the regulation and control unit respectively, and generate a stimulation electrical signal in the six-contact electrode sacral nerve stimulation unit and generate a stimulation control signal in the regulation and control unit.

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

[0074] In an embodiment of the present application, the first regulation stage includes the stage where the patient participates in the sacral nerve stimulation test treatment for the first time, and the second regulation stage includes the stage where the patient participates in the sacral nerve stimulation regulation treatment non-first time.

[0075] The first regulation stage refers to the test treatment stage of the first-stage sacral nerve surgery. In the test treatment stage of the first-stage sacral nerve surgery, the doctor selects appropriate stimulation sites and stimulation parameters according to the patient's clinical response. The second regulation stage is that the patient is completely implanted with the sacral nerve stimulation system. After the patient is completely implanted with the sacral nerve stimulation system, the doctor sets the automatic regulation time node, and a regulation request will be initiated each time the automatic regulation time node is reached.

[0076] In one embodiment of the present application, the characteristic parameters of the first nerve signal and the second nerve signal include at least one of the following: amplitude, frequency, power spectrum, 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, stimulation voltage mode.

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

[0078] It can be understood that those skilled in the art can adjust the input of nerve signals 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, and the six-contact electrode sacral nerve stimulation unit is further configured to provide a stimulation site corresponding to the second nerve signal matching the first nerve signal according to the plurality of test points and the plurality of acquisition points; and / or, provide a group of stimulation sites corresponding to the second nerve signal matching the first nerve signal according to the plurality of test points and the plurality of acquisition points in a single channel and multiple channels.

[0081] The stimulation electrode of the sacral nerve stimulation automatic regulation system should include at least six electrode contacts, and each electrode contact is an independent stimulation or acquisition channel.

[0082] When the patient is fully implanted with the sacral nerve stimulation system, the doctor sets the automatic regulation time node, and each time the automatic regulation time node is reached, the system traverses the electrode contacts. Taking the six-contact electrode as an example, a detailed description is given.

[0083] First, assume that the stimulation site is 0. The sacral nerve stimulation automatic regulation system sets the acquisition site to 2, and the nerve stimulation module sends a stimulation instruction to stimulate the nerve at the 0 site, activate the local nerve, generate nerve signals propagating to both sides, and the nerve signal acquisition module records the nerve excitation signals of the nerve propagation at the 2 site.

[0084] Then, the stimulation sites 1, 2, and 3 are changed in sequence, and the acquisition sites are shifted to the right to the stimulation sites 3, 4, and 5 correspondingly, and the nerve excitation signals of the propagation are recorded in sequence.

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

[0086] The sacral nerve stimulation autoregulation system selects the stimulation site with the highest signal characteristic consistency and exceeding a certain threshold as the new stimulation site by comparing the consistency of the excitation signal characteristics of the six sites this time with the excitation signal characteristics under the typical stimulation parameters in the first regulation stage.

[0087] When the consistency of the excitation signal characteristics corresponding to all six stimulation sites with the excitation signal characteristics under the typical stimulation parameters is lower than the critical threshold, it indicates that adjusting the stimulation site under the current stimulation parameters cannot meet the treatment effect. At this time, the system automatically adjusts the stimulation parameters. Taking the adjustment of the stimulation voltage as an example (clinically, the stimulation effect is often enhanced by increasing the stimulation voltage), the system takes the current voltage as the benchmark, sets the voltage step, increases the voltage according to the step, and repeats the steps of when the patient is fully implanted with the sacral nerve stimulation system, the doctor sets the automatic adjustment time node, and each time the automatic adjustment time node is reached, the system traverses the electrode contacts to obtain the excitation signal characteristics of the six sites after the voltage increase, and compares them with the excitation signal characteristics under the typical parameters again, selects the stimulation site with the highest consistency and exceeding a certain threshold as the new stimulation site, and sets this stimulation parameter as the new stimulation parameter. If the treatment requirement is still not met, continue to increase the voltage signal within the safe voltage range, repeat the steps of when the patient is fully implanted with the sacral nerve stimulation system, the doctor sets the automatic adjustment time node, and each time the automatic adjustment time node is reached, the system traverses the electrode contacts, and compares the signal characteristics until the treatment effect is met.

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

[0089] Furthermore, when the adjustment of one stimulation parameter cannot meet the requirements, the system can also set to change two stimulation variables simultaneously, repeat the steps of when the patient is fully implanted with the sacral nerve stimulation system, the doctor sets the automatic adjustment time node, and each time the automatic adjustment time node is reached, the system traverses the electrode contacts and the steps that the sacral nerve stimulation autoregulation system selects the stimulation site with the highest signal characteristic consistency and exceeding a certain threshold as the new stimulation site by comparing the consistency of the excitation signal characteristics of the six sites this time with the excitation signal characteristics under the typical stimulation parameters in the first regulation stage, obtain the excitation signal characteristics of the six stimulation sites when the two stimulation variables change, and select the appropriate stimulation site and corresponding stimulation parameters by comparison.

[0090] Such asFigure 7 and 8 As shown in 8 , using two channels for stimulation is also an implementation of sacral nerve stimulation, usually a combination of positive and negative, and this stimulation method can also be evaluated. Select channels 0 and 1 as the positive and negative poles respectively, and use site 3 as the acquisition channel at this time. As Figure 9 and 10 shown, rotate the channels at positions 1 and 2, 2 and 3, 3 and 4, 4 and 5 as the positive and negative poles in sequence, compare the consistency of signal characteristics under typical stimulation parameters, select suitable stimulation sites, and possible corresponding stimulation parameters.

[0091] Optionally, a multi-contact stimulation and acquisition integrated electrode can be used, and there is always a certain distance interval between the stimulation site and the acquisition site.

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

[0093] Optionally, the intensity curve or surface of the corresponding nerve signal under different stimulation parameters can also be obtained through difference and fitting, etc., so as to evaluate the stimulation effect of different stimulation parameters at this stimulation site. By comparing the characteristic values of the curve or surface relationship between the stimulation parameters and the nerve signal among different stimulation sites, the stimulation effects of different stimulation sites are evaluated.

[0094] Specifically, the sacral nerve stimulation autonomous regulation system obtains all nerve excitation signals of six sites, removes noise signals through power frequency filtering, band-pass filtering, and band-stop filtering, and then analyzes the characteristics such as the amplitude, frequency, spectral density, and time-frequency information of the excitation signals of the six sites.

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

[0096] responding to a regulation request at the current moment, generating a stimulation signal in the stimulation channel according to the six-contact electrode sacral nerve stimulation unit;

[0097] responding to the stimulation signal, determining a second nerve signal that matches the first nerve signal; and

[0098] outputting a regulation control instruction according to the second nerve signal to control the six-contact electrode sacral nerve stimulation unit for autonomous regulation.

[0099] Wherein, the first nerve signal is used to characterize the calibrated electro-signal parameter value after sacral nerve stimulation at the previous moment; the second nerve signal is used as the electro-signal parameter value corresponding to the target stimulation target point.

[0100] In some embodiments, determining the second nerve signal matching the first nerve signal within the automatic adjustment threshold range in response to the adjustment request at the current moment includes:

[0101] Generating a stimulation electro-signal according to the periodic sacral nerve stimulation adjustment request, where the stimulation electro-signal is generated by a plurality of stimulation channels, and each of the stimulation channels includes at least one stimulation site;

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

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

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

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

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

[0107] In some embodiments, determining the second nerve signal matching the first nerve signal within the automatic adjustment threshold range includes:

[0108] In the second adjustment stage, selecting a stimulation site and a collection site and using them as a stimulation pair;

[0109] In response to the stimulation instruction of the six-contact electrode sacral nerve stimulation unit, generating at least an action potential propagating to one side at the stimulation site and recording a nerve signal at the collection site to obtain the second nerve signal matching the first nerve signal, where the second adjustment stage is not earlier than the first adjustment stage.

[0110] In some embodiments, it further includes a charging and power supply unit for respectively providing power to the six-contact electrode sacral nerve stimulation unit and the adjustment control unit, so as to generate a stimulation electro-signal in the six-contact electrode sacral nerve stimulation unit and generate a stimulation control signal in the adjustment control unit.

[0111] In some embodiments, the first adjustment stage includes the stage where the patient first participates in the sacral nerve stimulation test treatment, and the second adjustment stage includes the stage where the patient participates in the sacral nerve stimulation adjustment treatment non-first time.

[0112] In some embodiments, the characteristic parameters of the first nerve signal and the second nerve signal at least include one of the following: amplitude, frequency, power spectrum, time-frequency information; the stimulation parameters used to generate the stimulation parameters at least include one of the following: stimulation amplitude, stimulation pulse width, stimulation frequency, stimulation waveform, current stimulation mode, 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 acquisition points, and the six-contact electrode sacral nerve stimulation unit is further configured to,

[0114] According to the plurality of test points and the plurality of acquisition points, provide a stimulation site corresponding to the second nerve signal that matches the first nerve signal;

[0115] And / or,

[0116] According to the plurality of test points and the plurality of acquisition points in a single channel and multiple channels, provide a group of stimulation sites corresponding to the second nerve signal that matches the first nerve signal.

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

[0118] As Figure 3 shown, in an embodiment of the present application, a six-contact electrode sacral nerve stimulation system is further provided, wherein the sacral nerve stimulation automatic adjustment system as described above is adopted. The sacral nerve stimulation self-regulation 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, and the adjustment control unit is used for

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

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

[0121] Output an adjustment control instruction according to the second nerve signal to control the self-regulation of the six-contact electrode sacral nerve stimulation unit,

[0122] Wherein, the first nerve signal is used to represent the calibrated electro-signal parameter value after sacral nerve stimulation at the previous moment; the second nerve signal is used as the electro-signal parameter value corresponding to the target stimulation target.

[0123] In some embodiments, the determining the second nerve signal matching the first nerve signal within the automatic adjustment threshold range in response to the adjustment request at the current moment includes:

[0124] Generating a stimulation electrical signal according to a periodic sacral nerve stimulation adjustment request, the stimulation electrical signal being generated by a plurality of stimulation channels, and each of the stimulation channels including at least one stimulation site;

[0125] 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 according to the sacral nerve electrical signal parameter value calibrated after sacral nerve stimulation at the previous moment.

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

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

[0128] In response to the stimulation site and the stimulation parameters, collecting the stimulation target closest to the stimulation site;

[0129] Taking the excitation signal of the local nerve caused by stimulating the sacral nerve at the stimulation target closest to the stimulation site as the first nerve signal.

[0130] In some embodiments, the determining the second nerve signal matching the first nerve signal within the automatic adjustment threshold range includes:

[0131] In the second adjustment stage, selecting a stimulation site and a collection site and using them as a stimulation pair;

[0132] In response to the stimulation instruction of the six-contact electrode sacral nerve stimulation unit, generating at least one action potential propagating to one side at the stimulation site and recording a nerve signal at the collection site to obtain the second nerve signal matching the first nerve signal, and the second adjustment stage is not earlier than the first adjustment stage.

[0133] In some embodiments, it further includes a charging and power supply unit for respectively providing power to the six-contact electrode sacral nerve stimulation unit and the adjustment control unit, so as to generate a stimulation electrical signal in the six-contact electrode sacral nerve stimulation unit and generate a stimulation control signal in the adjustment control unit.

[0134] In some embodiments, the first adjustment stage includes the stage where the patient first participates in the sacral nerve stimulation test treatment, and the second adjustment stage includes the stage where the patient participates in the sacral nerve stimulation adjustment treatment non-first time.

[0135] In some embodiments, the characteristic parameters of the first nerve signal and the second nerve signal include at least one of the following: amplitude, frequency, power spectrum, 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, 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 acquisition points, and the six-contact electrode sacral nerve stimulation unit is further configured to,

[0137] According to the plurality of test points and the plurality of acquisition points, provide a stimulation site corresponding to the second nerve signal that matches the first nerve signal;

[0138] and / or,

[0139] According to the plurality of test points and the plurality of acquisition points in a single channel and multiple channels, provide a group of stimulation sites corresponding to the second nerve signal that matches the first nerve signal.

[0140] Through the six-contact electrode sacral nerve stimulation system, the self-regulation of sacral nerve stimulation is periodically realized while improving the accuracy of sacral nerve stimulation.

[0141] The above are only the embodiments of the present application and are not used to limit the present application. For those skilled in the art, various changes and modifications can be made to the present application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall 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 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 In response to the adjustment request at the current moment, the sacral nerve stimulation unit generates a stimulation signal in the stimulation channel according to the six-contact electrode; 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, Among them, 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.

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 comprises: 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 of the stimulation channels 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 last moment.

3. The system of claim 2, further comprising: In the first adjustment stage, 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, acquiring a stimulation target point closest to the stimulation site; 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.

4. The system of claim 3, wherein: The step of determining a second neural signal matching the first neural signal within the automatic adjustment threshold range includes: In the second conditioning phase, stimulation sites and acquisition sites were selected and used as stimulation pairs; In response to the stimulation instruction of the six-contact electrode sacral nerve stimulation unit, an action point propagating at least to one side is generated 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 regulation stage is no earlier than the first regulation stage.

5. 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 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.

6. The system of claim 4, wherein: 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 first participate.

7. 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.

8. The system of claim 1, wherein: The six-contact electrode sacral nerve stimulation unit also 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, According to the multiple test points and the multiple acquisition points in the single channel and the multiple channels, a stimulation site group corresponding to the second neural signal matching the first neural signal is provided.

9. 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 8 is used.

10. 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 8 is used.

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