Sacral nerve multi-target point synergistic stimulation system and parameter configuration method

By optimizing the multi-target synergistic stimulation system and parameters, the problem of insufficient overall stimulation intensity of the sacral nerve stimulation system was solved, and combined stimulation of the S2, S3 and S4 nerves was achieved, thus improving the therapeutic effect.

CN120189637BActive Publication Date: 2025-11-11HANGZHOU GERIATRICS HOSPITAL +1
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Patent Information

Application Number
CN202510670228.X
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-05-23
Publication Date
2025-11-11
Estimated Expiration
2045-05-23

AI Technical Summary

Technical Problem

Existing sacral nerve stimulation systems provide insufficient overall stimulation intensity to the subjects, failing to meet the needs of some individuals and resulting in poor treatment outcomes.

Method used

A multi-target synergistic stimulation system is adopted, in which multiple independent electrode branches of stimulation electrodes are implanted into the target sites of the S2, S3 and S4 nerves. Stimulation current is provided by the stimulator, and the stimulation parameters are adjusted in real time to optimize the stimulation effect through the cooperation of the programmer and the stimulator.

Benefits of technology

This approach achieves comprehensive and combined stimulation of the sacral nerves, improving the overall stimulation intensity and therapeutic effect, ensuring the accuracy and reliability of the stimulation current, and increasing the effectiveness of treating overactive bladder.

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Abstract

This application relates to a sacral nerve multi-target synergistic stimulation system and parameter configuration method. The system includes: a stimulating electrode and a stimulator; the first end of the stimulating electrode has multiple independent electrode branches, and the outer wall of each independent electrode branch is provided with multiple electrode contacts; when each independent electrode branch is implanted into a corresponding sacral nerve target site, the electrode contacts can contact the sacral nerve target site; the stimulator, connected to the second end of the stimulating electrode, is used to provide stimulating current to each independent electrode branch in the stimulating electrode; the stimulating current acts on the sacral nerve target site via the electrode contacts on the independent electrode branches. This application solves the problem of insufficient overall stimulation intensity for the stimulated subject in sacral nerve stimulation systems.
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Description

Technical Field

[0001] This application relates to the field of sacral nerve stimulation, and in particular to a sacral nerve multi-target synergistic stimulation system and parameter configuration method. Background Technology

[0002] Sacral nerve stimulation (SNS) is a neuromodulation technique used to treat refractory overactive bladder. It works by stimulating the S3 nerve to inhibit abnormal nerve transmission, thereby suppressing overactive bladder. In related techniques, the common target site for SNS nerve implantation is the unilateral S3 nerve. However, while this method alleviates symptoms to some extent, some patients remain insensitive to S3 nerve stimulation. If the stimulation system continues to maintain the generally set stimulation parameters, it cannot meet the stimulation intensity requirements of these individuals, resulting in insufficient overall stimulation intensity and thus affecting the stimulation effect.

[0003] Currently, no effective solution has been proposed to address the issue of insufficient overall stimulation intensity of the sacral nerve stimulation system on the stimulated subject in related technologies. Summary of the Invention

[0004] This application provides a sacral nerve multi-target synergistic stimulation system and parameter configuration method to at least solve the problem of insufficient overall stimulation intensity of the sacral nerve stimulation system on the stimulated object in related technologies.

[0005] In a first aspect, embodiments of this application provide a sacral nerve multi-target synergistic stimulation system, comprising: stimulation electrodes and a stimulator;

[0006] The first end of the stimulation electrode has multiple independent electrode branches, and the outer wall of each independent electrode branch is provided with multiple electrode contacts; when each independent electrode branch is implanted into the corresponding sacral nerve target site, the electrode contacts can contact the sacral nerve target site.

[0007] The stimulator is connected to the second end of the stimulating electrode and is used to provide stimulating current to each individual electrode branch in the stimulating electrode; the stimulating current acts on the sacral nerve target site via the electrode contacts on the individual electrode branches.

[0008] In some embodiments, the multi-target synergistic stimulation system further includes a programmer;

[0009] The programmable controller is communicatively connected to the stimulator and is used to transmit the acquired initial stimulation parameters to the stimulator.

[0010] The stimulator is also used to collect neural signal parameters of the sacral nerve target site and generate signal comparison results based on the neural signal parameters.

[0011] The stimulator is also used to adjust the initial stimulation parameters based on the signal comparison results, generate optimized stimulation parameters, and provide new stimulation current to the independent electrode branches based on the optimized stimulation parameters.

[0012] In some embodiments, the programmable controller further includes a display and interaction module;

[0013] The display interaction module is used to acquire the input initial stimulation parameters and display the stimulator state information and neural signal parameters received from the stimulator.

[0014] In some embodiments, the second end of the stimulation electrode includes multiple end faces; each end face is provided with multiple electrode contacts; when the second end of the stimulation electrode is connected to the stimulator, the electrode contacts can contact the elastic contact sheet inside the stimulator.

[0015] In some embodiments, the second end of the stimulation electrode is further provided with a directional pointing marker component;

[0016] The outer shell of the stimulator is also provided with an insertion direction indicator component;

[0017] When the second end of the stimulation electrode is connected to the stimulator, the directional pointing marker component is adapted to the insertion direction indicating marker component.

[0018] In some embodiments, the stimulating electrode includes a first stimulating electrode and a second stimulating electrode;

[0019] The multiple independent electrode branches of the first stimulation electrode and / or the multiple independent electrode branches of the second stimulation electrode are further provided with electrode barbs;

[0020] The distance between the location of the electrode barbs and the location of the plurality of electrode contacts is within a preset distance range.

[0021] In some embodiments, the stimulator includes a main control module and a stimulation acquisition module. The stimulation acquisition module includes a control unit, a stimulation unit, and a switching unit. The switching unit includes a first switching subunit.

[0022] The main control module is used to generate a stimulation command that indicates at least one first target electrode branch; the first target electrode branch is the branch among the individual electrode branches to which a stimulation current is to be applied.

[0023] The control unit is configured to determine the stimulation electrode contact from the electrode contacts on the first target electrode branch, and in response to the stimulation command, control the first switching subunit to connect the stimulation pathway where the stimulation electrode contact on the first target electrode branch is located.

[0024] The stimulation unit is used to provide the stimulation current to the first target electrode branch through the stimulation pathway; the stimulation current acts on the sacral nerve target site via the stimulation electrode contact.

[0025] In some embodiments, the stimulus acquisition module further includes an acquisition unit, and the switching unit further includes a second switching subunit;

[0026] The main control module is also used to generate a collection command indicating at least one second target electrode branch; the second target electrode branch is the branch of each of the independent electrode branches from which neural signal parameters are to be collected;

[0027] The control unit is used to determine the acquisition electrode contact from the electrode contacts on the second target electrode branch, and in response to the acquisition command, control the second switching subunit to connect the acquisition path where the acquisition electrode contact is located.

[0028] The acquisition unit is used to receive neural signal parameters of the sacral nerve target site acquired by the acquisition electrode contacts through the acquisition path.

[0029] In some embodiments, the switching unit further includes a third switching subunit;

[0030] The third switching subunit is used to switch the connection status of the stimulation pathway and the acquisition pathway.

[0031] Secondly, embodiments of this application provide a parameter configuration method applied to the sacral nerve multi-target synergistic stimulation system as described in the first aspect above, the method comprising:

[0032] The stimulation parameters are acquired, parameter configuration processing is performed based on the stimulation parameters, and a stimulation current is provided to at least one independent electrode branch of the stimulation electrode; the stimulation current is applied to the sacral nerve target site via the electrode contact on the independent electrode branch.

[0033] Compared to related technologies, the sacral nerve multi-target synergistic stimulation system and parameter configuration method provided in this application embodiment include: a stimulation electrode and a stimulator; the first end of the stimulation electrode has multiple independent electrode branches, and the outer wall of each independent electrode branch is provided with multiple electrode contacts; when each independent electrode branch is implanted into the corresponding sacral nerve target site, the electrode contacts can contact the sacral nerve target site; the stimulator is connected to the second end of the stimulation electrode and is used to provide stimulation current to each independent electrode branch in the stimulation electrode; the stimulation current acts on the sacral nerve target site through the electrode contacts on the independent electrode branches.

[0034] Based on this, combined stimulation of the sacral nerve at multiple target points was achieved, avoiding the problem of insufficient overall stimulation intensity of the sacral nerve stimulation system due to the insensitivity of some patients when stimulating a single nerve. At the same time, it ensured the accuracy and reliability of the stimulation current delivery when stimulating multiple target points in synergistic stimulation, effectively improving the therapeutic efficacy of the sacral nerve regulation mechanism.

[0035] Details of one or more embodiments of this application are set forth in the following drawings and description to make other features, objects and advantages of this application more readily apparent. Attached Figure Description

[0036] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments and are used to explain this application, but do not constitute an undue limitation of this application. In the drawings:

[0037] Figure 1 This is a hardware structure block diagram of a terminal according to a parameter configuration method according to an embodiment of this application;

[0038] Figure 2 This is a structural block diagram of a sacral nerve multi-target synergistic stimulation system according to an embodiment of this application;

[0039] Figure 3 This is a schematic diagram of the structure of a stimulation electrode according to an embodiment of this application;

[0040] Figure 4 This is a schematic diagram of the structure of a stimulus acquisition module according to an embodiment of this application;

[0041] Figure 5 This is a schematic diagram of the structure of a switching unit according to an embodiment of this application;

[0042] Figure 6 This is a schematic diagram of the structure of a multi-target synergistic stimulation system according to an embodiment of this application;

[0043] Figure 7 This is a structural block diagram of a multi-target synergistic stimulation system according to an embodiment of this application;

[0044] Figure 8 This is a schematic diagram of the structure of another stimulation electrode according to an embodiment of this application;

[0045] Figure 9A This is a schematic diagram of the connection structure between a stimulation electrode and a stimulator according to an embodiment of this application;

[0046] Figure 9B yes Figure 9A Internal structure diagram of the part where the central stimulation electrode is connected to the stimulator;

[0047] Figure 10 This is a schematic diagram of a stimulating electrode implanted at a sacral nerve target site according to an embodiment of this application. Detailed Implementation

[0048] To make the objectives, technical solutions, and advantages of this application clearer, the application is described and illustrated below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the application. All other embodiments obtained by those skilled in the art based on the embodiments provided in this application without inventive effort are within the scope of protection of this application. Furthermore, it is understood that although the efforts made in such a development process may be complex and lengthy, for those skilled in the art related to the content disclosed in this application, modifications to design, manufacturing, or production based on the technical content disclosed in this application are merely conventional technical means and should not be construed as insufficient disclosure of the content of this application.

[0049] In this application, the reference to "embodiment" means that a specific feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places in the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment that is mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described in this application may be combined with other embodiments without conflict.

[0050] Unless otherwise defined, the technical or scientific terms used in this application shall have the ordinary meaning understood by one of ordinary skill in the art to which this application pertains. The terms “a,” “an,” “an,” “the,” and similar words used in this application do not indicate quantity limitation and may indicate singular or plural. The terms “comprising,” “including,” “having,” and any variations thereof used in this application are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or device that includes a series of steps or modules (units) is not limited to the listed steps or units, but may also include steps or units not listed, or may include other steps or units inherent to these processes, methods, products, or devices. The terms “connected,” “linked,” “coupled,” and similar words used in this application are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. “Multiple” used in this application means two or more. “And / or” describes the relationship between related objects, indicating that three relationships may exist; for example, “A and / or B” can represent: A alone, A and B simultaneously, and B alone. The terms “first,” “second,” “third,” etc., used in this application are merely to distinguish similar objects and do not represent a specific ordering of the objects.

[0051] The method embodiments provided in this example can be executed on a terminal, computer, or similar computing device. Taking running on a terminal as an example, Figure 1 This is a hardware structure block diagram of a terminal according to a parameter configuration method based on an embodiment of this application. For example... Figure 1 As shown, a terminal may include one or more ( Figure 1 Only one is shown in the diagram. A processor 102 (which may include, but is not limited to, a microprocessor MCU or a programmable logic device FPGA, etc.) and a memory 104 for storing data are also shown. Optionally, the terminal may further include a transmission device 106 for communication functions and an input / output device 108. Those skilled in the art will understand that... Figure 1 The structure shown is for illustrative purposes only and does not limit the structure of the terminal described above. For example, the terminal may also include components that are more... Figure 1 The more or fewer components shown, or having the same Figure 1 The different configurations shown.

[0052] The memory 104 can be used to store computer programs, such as application software programs and modules, like the computer program corresponding to the parameter configuration method in this embodiment. The processor 102 executes various functional applications and data processing by running the computer program stored in the memory 104, thus implementing the above-described method. The memory 104 may include high-speed random access memory and non-volatile memory, such as one or more magnetic storage devices, flash memory, or other non-volatile solid-state memory. In some instances, the memory 104 may further include memory remotely located relative to the processor 102, and these remote memories can be connected to the terminal via a network. Examples of such networks include, but are not limited to, the Internet, corporate intranets, local area networks, mobile communication networks, and combinations thereof.

[0053] The transmission device 106 is used to receive or send data via a network. Specific examples of the network described above may include a wireless network provided by the terminal's communication provider. In one example, the transmission device 106 includes a Network Interface Controller (NIC), which can connect to other network devices via a base station to communicate with the Internet. In another example, the transmission device 106 may be a Radio Frequency (RF) module, used for wireless communication with the Internet.

[0054] It should be noted that in related technologies, the common implantation site for sacral nerves is mainly the unilateral S3 nerve. However, considering that the three branches of the sacral nerves, S2, S3, and S4, are all components of the lower urinary tract nerves, stimulating the S3 nerve alone is insufficient to treat all abnormalities in the six branches of the S2, S3, and S4 nerves on both sides. Furthermore, existing single-implantation-site sacral nerve stimulation systems cannot provide more treatment options, resulting in insufficient overall stimulation intensity for the patient.

[0055] Based on this, this embodiment provides a sacral nerve multi-target synergistic stimulation system. Figure 2 This is a structural block diagram of a sacral nerve multi-target synergistic stimulation system according to an embodiment of this application, such as... Figure 2 As shown, the system consists of a stimulation electrode 22 and a stimulator 21.

[0056] The first end of the stimulation electrode 22 has multiple independent electrode branches 221, and the outer wall of each independent electrode branch 221 is provided with multiple electrode contacts 222; when each independent electrode branch 221 is implanted into the corresponding sacral nerve target site, the electrode contacts 222 can contact the sacral nerve target site.

[0057] The first end of the aforementioned stimulation electrode 22 refers to the end that first enters the body of the target body when the stimulation electrode 22 is implanted into the sacral nerve target site; it can be considered as the distal end of the stimulation electrode. The number of stimulation electrodes 22 and the number of independent electrode branches 221 included in each stimulation electrode can be configured according to actual needs. For example, if a maximum of six nerves (S2, S3, and S4) on both sides need to be stimulated, the stimulation electrode 22 can be configured as two stimulation electrodes, each with three independent electrode branches 221 at its first end, for a total of six independent electrode branches 221. In this way, during system operation, the six independent electrode branches 221 can be implanted into the S2, S3, and S4 foramina (i.e., the aforementioned sacral nerve target sites) on both sides to synergistically stimulate these six nerves. Alternatively, the stimulation electrode 22 can be configured as three stimulation electrodes 22, each with two independent electrode branches 221 at its first end, or even with six independent electrode branches 221 at the first segment of a single stimulation electrode 22; there is no limitation on this. It should also be understood that although multiple independent electrode branches 221 are designed in this embodiment, if only some nerves need to be stimulated in actual work, the corresponding independent electrode branches 221 can be directly implanted into the target location of the nerves that need to be stimulated, while the other independent electrode branches 221 are left unattended, or the openings of other stimulation electrodes 22 that do not need to be implanted into the body of the stimulated object can be sealed.

[0058] Multiple electrode contacts 222 are arranged sequentially along the electrode branch leads on the outer wall of each independent electrode branch 221 at intervals; the distance between each electrode contact 222 can be the same or different. The number of electrode contacts 222 is not limited, but at least two are required. Each contact can be used as both a stimulation and acquisition contact, switching between the two. Specifically, if each independent electrode branch 221 has two electrode contacts 222, in actual operation, the application of stimulation current to the sacral nerve target site and the acquisition of nerve signals can be achieved through these two electrode contacts 222. For example, in the stimulation phase, contact 0 is used as the anode (+) and contact 1 as the cathode (-) to apply stimulation current; in the acquisition phase, the stimulation circuit is disconnected, and the electrophysiological signals of the sacral nerve root or surrounding tissues are acquired through contact 0 / 1. Alternatively, the number of electrode contacts 222 arranged on each independent electrode branch 221 can be appropriately increased to allow for different contact combinations.

[0059] Specifically, please refer to Figure 3The figure shows a schematic diagram of a stimulation electrode. The first end of the electrode has three independent electrode branches 221, designated as branch a, branch b, and branch c. Each independent electrode branch 221 has six equally spaced electrode contacts 222 arranged sequentially at its tip. Taking branch a, which is implanted at the target site of the S2 nerve on one side, as an example, when the stimulation current output by the stimulator is transmitted to branch a, the stimulation current acts on the S2 nerve target site through two of the six electrode contacts 222 (contact 0 and contact 1), or collects the nerve signal parameters of the S2 nerve target site through the other two electrode contacts 222 (contact 2 and contact 3). Furthermore, the remaining two contacts in branch a (contact 4 and contact 5) can be used as alternative contacts.

[0060] The aforementioned stimulator 21 is connected to the second end of the stimulating electrode 22 and is used to provide stimulating current to each independent electrode branch 221 in the stimulating electrode 22. The stimulating current flows through the electrode contacts 222 on the independent electrode branches 221 and acts on the sacral nerve target point. The second end of the stimulating electrode 22 is the other end that is arranged opposite to the first end of the stimulating electrode 22, and can also be regarded as the proximal end of the electrode that is relatively close to the stimulator 21.

[0061] The output port of the stimulator 21 is rigidly connected to the second end of the stimulating electrode 22. When the stimulator 21 applies stimulation, the stimulating electrode 22 and one or more sacral nerve target points to be stimulated are predetermined. The stimulator 21 outputs a stimulation current that meets the preset stimulation parameters. This stimulation current flows from the second end of the stimulating electrode 22 at the connection point, through the first end of the stimulating electrode 22, and is transmitted to one or more independent electrode branches 221 corresponding to the sacral nerve target point to be stimulated. Finally, the current acts on the sacral nerve target point through the electrode contacts 222 provided on the independent electrode branches 221 to stimulate the sacral nerve at that point. Therefore, during the operation of the stimulator 21 stimulating the sacral nerve, in the above-described manner, one independent electrode branch 221 can apply a stimulation current to a certain sacral nerve target point, or multiple independent electrode branches 221 can simultaneously stimulate multiple sacral nerve target points in a coordinated manner, thereby effectively improving the overall stimulation intensity of the sacral nerve of the stimulated object.

[0062] Therefore, considering the synergistic effect of the S2, S3, and S4 nerves in regulating various muscles and tissues of the lower urinary tract, the system is equipped with six independent stimulation electrodes 22, which act on the left and right sides of the S2, S3, and S4 nerves respectively. By stimulating the six nerve branches independently or in combination, the system aims to treat overactive bladder. Simultaneously, considering the mutual influence of the S2, S3, and S4 nerves, when the system stimulates one of the six nerves, it can collect nerve signals from the remaining nerve branches to observe the effect of stimulation on other nerve branches, providing more information for the system's synergistic stimulation of the S2, S3, and S4 nerves.

[0063] In the aforementioned sacral nerve multi-target synergistic stimulation system, multiple independent electrode branches 221 are set at the first end of the stimulation electrode 22. Each independent electrode branch 221 is implanted into a different sacral nerve target site, and the stimulator 21 provides stimulation current to each independent electrode branch 221. Finally, the stimulation current is applied to the corresponding sacral nerve through each independent electrode branch 221, thereby realizing a combined stimulation scheme for multiple target sites of the sacral nerve. This avoids the problem that some patients are not sensitive when stimulating a single nerve, and the stimulation system can only apply current stimulation to a single nerve, resulting in insufficient overall stimulation intensity for the stimulated subject. At the same time, it also ensures the accuracy and reliability of stimulation current delivery during multi-target synergistic stimulation, effectively improving the therapeutic efficacy of the sacral nerve modulation mechanism.

[0064] In some embodiments, the stimulator includes a main control module and a stimulation acquisition module. The stimulation acquisition module includes a control unit, a stimulation unit, and a switching unit. The switching unit includes a first switching subunit.

[0065] The main control module is used to generate stimulation commands indicating at least one first target electrode branch; the first target electrode branch is the branch among the various independent electrode branches to which stimulation current is to be applied, and the electrode contacts on each independent electrode branch can be configured as stimulation electrode contacts; the control unit is used to determine the stimulation electrode contacts from the electrode contacts on the first target electrode branch, and in response to the stimulation command, control the first switching subunit to connect the stimulation pathway where the stimulation electrode contact on the first target electrode branch is located; the stimulation unit is used to provide stimulation current to the first target electrode branch through the stimulation pathway; the stimulation current acts on the sacral nerve target site via the stimulation electrode contact.

[0066] The main control module, acting as the system's command center, is responsible for analyzing treatment parameters (such as stimulation frequency, pulse width, and amplitude) and electrode distribution information, generating stimulation commands containing identifiers for one or more target electrode branches. For example, when activating the S3 segment of the left sacral nerve, the main control module designates an independent electrode branch as the first target electrode branch and generates a corresponding stimulation parameter package. Upon receiving the command, the control unit in the stimulation acquisition module randomly selects two electrode contacts from the first target electrode branch as stimulation electrode contacts, or selects two default electrode contacts. It then uses an address decoder to analyze the physical location of the target electrode branch and drives the multiplexer array in the first switching subunit. This subunit employs a high-precision relay matrix, which can quickly close the pathway where the target stimulation electrode contact is located while simultaneously disconnecting other non-target pathways to prevent current leakage. The stimulation unit is designed based on a constant current source and monitors the output current in real time through a feedback loop to ensure the stability of the stimulation amplitude. Once the pathway is connected, the stimulation unit generates square or triangular wave current pulses according to preset parameters, which are then applied directly to the sacral nerve target location via the stimulation electrode contacts. The current waveform can be dynamically adjusted by the main control module to simulate the time-domain characteristics of natural neural signals (such as cluster discharge patterns).

[0067] For example, when the stimulation unit is in operation, the stimulation electrodes and target sites are predetermined. The operator can choose between two modes: multi-branch stimulation and single-branch stimulation, depending on the clinical effect. In single-branch stimulation, the operator can select the electrodes corresponding to the S2, S3, and S4 nerves, and then select two contacts as the positive and negative electrodes, respectively. In multi-branch stimulation, the operator can simultaneously select two to six nerve branches for stimulation and configure the positive and negative electrodes for each branch.

[0068] The above embodiments provide a hierarchical architecture of a main control module and a stimulation acquisition module (including a control unit, a stimulation unit, and a switching unit). The main control module generates dynamic stimulation commands, which drive the control unit and the stimulation unit in the stimulation acquisition module to work together. Finally, the switching unit delivers the stimulation current to the target electrode branch in a directional manner, thereby enabling precise electrical stimulation of the sacral nerve target point.

[0069] In some embodiments, the stimulation acquisition module further includes an acquisition unit, and the switching unit further includes a second switching subunit; the main control module is further configured to generate an acquisition command indicating at least one second target electrode branch; the second target electrode branch is a branch among various independent electrode branches from which neural signal parameters are to be acquired, and the electrode contacts on each independent electrode branch can be configured as acquisition electrode contacts; the control unit is configured to determine the acquisition electrode contacts from the electrode contacts on the second target electrode branch, and in response to the acquisition command, control the second switching subunit to connect the acquisition path where the acquisition electrode contacts on the second target electrode branch are located; the acquisition unit is configured to receive neural signal parameters of the sacral nerve target point acquired by the acquisition electrode contacts through the acquisition path.

[0070] Specifically, the main control module, acting as the system's command center, has added a data acquisition command generation function. When it is necessary to acquire neural signal parameters from sacral nerve target points, the main control module will specify the second target electrode branch (such as S4) among the independent electrode branches and generate an acquisition command containing acquisition parameters (such as sampling rate and filtering range). For example, when evaluating the stimulation effect, the main control module can simultaneously specify the left S3 as the stimulation electrode branch and the right S4 as the acquisition electrode branch, achieving synchronous "stimulation-acquisition" operation.

[0071] The control unit in the stimulation acquisition module randomly selects two electrode contacts from the second target electrode branch as acquisition electrode contacts, or selects two default electrode contacts as acquisition electrode contacts. Upon responding to the acquisition command, it drives the multiplexer array in the second switching subunit. This subunit uses a relay matrix independent of the first switching subunit, which can quickly close the acquisition path where the target acquisition electrode contact is located, while simultaneously disconnecting other non-target paths to avoid signal interference. The acquisition unit is based on a high-precision analog front-end design, receiving neural signal parameters (such as amplitude, frequency, and spectral density) of the sacral nerve target location acquired by the acquisition electrode contacts through the acquisition path. The acquisition unit has a built-in programmable gain amplifier and anti-aliasing filter, supports multi-channel synchronous acquisition, and can transmit the raw data to the main control module for real-time analysis.

[0072] For example, when the acquisition unit is working, the acquisition electrodes and acquisition sites are predetermined, and the operator can choose between two modes: multi-branch acquisition and single-branch acquisition. In single-branch acquisition, the operator can select one of the S2, S3, or S4 nerves from either side, and then select two sites on the corresponding electrode as the positive and negative electrodes, respectively. In multi-branch acquisition, the operator can simultaneously select two to six nerve branches for acquisition and configure the positive and negative electrodes for each acquisition site.

[0073] When stimulation and acquisition are performed simultaneously, and different electrode branches are used for stimulation and acquisition respectively, taking 1 electrode a branch for stimulation and 1 electrode b branch for acquisition (or 2 electrodes a branch) as an example, first select two sites on electrode a as the positive and negative electrodes for stimulation, and then select two sites on electrode b (2 electrodes a) as the positive and negative electrodes for acquisition. Furthermore, the system supports modes where multiple stimulation electrodes and multiple acquisition electrodes can be selected simultaneously. When stimulation and acquisition are performed separately on the same electrode branch, taking 1 electrode a branch for acquisition and stimulation as an example, first select two of the six contacts on branch a as the positive and negative electrodes for stimulation, and then select two of the remaining four contacts on branch a as the positive and negative electrodes for acquisition.

[0074] Through the above embodiments, an acquisition unit and a second switching subunit are introduced. The main control module generates dual-mode instructions (stimulation instructions and acquisition instructions) to drive the control unit, stimulation unit and acquisition unit in the stimulation acquisition module to work together. Finally, the switching unit realizes the independent switching and efficient reuse of the stimulation pathway and acquisition pathway, thereby constructing a "stimulation-acquisition" dual-pathway collaborative mechanism, realizing the dynamic monitoring and precise control of sacral nerve target points.

[0075] In some embodiments, the switching unit further includes a third switching subunit; the third switching subunit is used to switch the connection state of the stimulation pathway and the acquisition pathway. The hardware implementation of the third switching subunit can be based on a high-speed analog switch matrix, which internally contains independent stimulation pathway control groups and acquisition pathway control groups, each control group consisting of multiple high-speed switch pairs. The main control module sends a pathway switching command to the third switching subunit, the command containing the target electrode branch number and the target pathway type (stimulation / acquisition). The first and second switching subunits manage the initial switching of the stimulation pathway and the acquisition pathway, respectively, while the third switching subunit is responsible for dynamically connecting them. For example, when stimulation of contacts 0 and 1 is required, the main control module first opens paths 0 and 1 in the first switching subunit, and simultaneously instructs the third switching subunit to connect contacts 0 and 1 to the stimulation pathway. In a stimulation and acquisition synchronization scenario, the third switching subunit can manage the connection state of multiple contacts simultaneously. For example, when contacts 0 and 1 are used for stimulation, and contacts 2 and 3 are used for acquisition, the third switching subunit connects contacts 0 and 1 to the stimulation pathway, and contacts 2 and 3 to the acquisition pathway. The same contact point can alternate between stimulation and acquisition operations, while different contacts can work synchronously or asynchronously. For example, after contact 0 completes stimulation, the third switching subunit can quickly switch it to the acquisition path, while contacts 1, 2, and 3 can continue to perform other operations.

[0076] Through the above embodiments, a third switching subunit is further introduced to construct a dynamic switching mechanism between the stimulation path and the acquisition path. Through the dynamic switching of the third switching subunit, the same contact can be reused as a stimulation contact or an acquisition contact, reducing hardware resource overhead, realizing hardware-level isolation between the stimulation path and the acquisition path, avoiding direct interference of the stimulation current to the acquisition signal, and supporting rapid switching of any contact between stimulation and acquisition modes, thereby helping to achieve flexible reuse of electrode resources and a significant improvement in system efficiency.

[0077] Please see Figure 4 The aforementioned stimulation acquisition module is divided into 6 independent stimulation units, 6 independent acquisition units, and 6 switching units. Specifically, the stimulation unit for electrode 1 includes stimulation units corresponding to the three independent electrode branches of electrode 1 (stimulation 1-0, stimulation 1-1, and stimulation 1-2); the stimulation unit for electrode 2 includes stimulation units corresponding to the three independent electrode branches of electrode 2 (stimulation 2-0, stimulation 2-1, and stimulation 2-2); the acquisition unit for electrode 1 includes acquisition units corresponding to the three independent electrode branches of electrode 1 (acquisition 1-0, acquisition 1-1, and acquisition 1-2); and the acquisition unit for electrode 2 includes acquisition units corresponding to the three independent electrode branches of electrode 2 (acquisition 2-0, acquisition 2-1, and acquisition 2-2). Each stimulation unit, acquisition unit, and switching unit is responsible for stimulating and acquiring the six contacts of one electrode branch. For example, stimulation 1-0 and acquisition 1-0, plus a switching unit, handle the operation of the six contacts of the a branch of electrode 1; stimulation 2-2 and acquisition 2-2, plus a switching unit, handle the operation of the six contacts of the c branch of electrode 2. These six sub-modules operate independently of each other, and can function either synchronously or asynchronously. Each stimulation site on each independent branch of the sacral nerve stimulation electrode has both stimulation and acquisition functions. Stimulation and acquisition functions at stimulation sites within the same independent branch operate alternately, while stimulation and acquisition functions at stimulation sites in different independent branches can operate synchronously or alternately.

[0078] Further, please refer to Figure 5The aforementioned switching unit is divided into a first switching subunit (i.e., a stimulation switching subunit for controlling the stimulation pathway), a second switching subunit (i.e., a acquisition switching subunit for controlling the acquisition pathway), and six third switching subunits (i.e., stimulation and acquisition switching subunits). Taking stimulation 2-2 and acquisition 2-2 and their acquisition-stimulation switching combination module as an example, stimulation 2-2 is connected to a stimulation switching module, acquisition 2-2 is connected to an acquisition switching module, and the stimulation switching module and acquisition switching module are sequentially connected to six acquisition-stimulation switching modules. The six acquisition-stimulation switching modules are connected to the six contacts of the c branch of electrode 2. The stimulation switching module, acquisition switching module, and acquisition-stimulation switching module are all controlled by the acquisition-stimulation control module. At the same time, the acquisition-stimulation control module can open one stimulation switching module, two paths of the acquisition switching module, and one path of the acquisition-stimulation switching module. When stimulating only, taking the opening of contacts 0 and 1 as an example, the acquisition and stimulation control module opens both channels 0 and 1 in the stimulation switching module, and simultaneously opens the stimulation pathways corresponding to contacts 0 and 1 in the acquisition and stimulation control module. When acquiring only, taking the opening of contacts 0 and 1 as an example, the acquisition and stimulation control module opens both channels 0 and 1 in the acquisition switching module, and simultaneously opens the acquisition pathways corresponding to contacts 0 and 1 in the acquisition and stimulation switching module. When stimulation and acquisition are synchronized, taking the stimulation of contacts 0 and 1 and the acquisition of contacts 2 and 3 as an example, the acquisition and stimulation control module opens both channels 0 and 1 in the stimulation switching module, and both channels 2 and 3 in the acquisition switching module, and simultaneously opens the stimulation pathways corresponding to contacts 0 and 1 in the acquisition and stimulation switching module, and the acquisition pathways corresponding to contacts 2 and 3 in the acquisition and stimulation switching module. Stimulation and acquisition of the same contact can be performed alternately, and stimulation and acquisition of different contacts can be performed synchronously or asynchronously.

[0079] In some embodiments, the aforementioned sacral nerve multi-target synergistic stimulation system further includes a programmer; this programmer, communicatively connected to the stimulator, is used to transmit the acquired initial stimulation parameters to the stimulator. The programmer, acting as the system's control terminal, establishes a communication connection with the stimulator, and its main function is to transmit the acquired initial stimulation parameters to the stimulator, thereby achieving the initial setting of the stimulator's stimulation parameters. Please refer to [link / reference]. Figure 6 The figure shows a schematic diagram of a multi-target synergistic stimulation system for the sacral nerve. In this system, the programmable controller and the stimulator communicate wirelessly. This communication method offers advantages such as high flexibility and ease of installation, avoiding the problems of complex wiring and limited mobility that can arise from wired connections, making the system more convenient and adaptable in practical applications. It should also be noted that the wireless communication link between the programmable controller and the stimulator can adopt a star network topology, with the programmable controller acting as the master node and communicating synchronously or asynchronously with multiple stimulators.

[0080] The aforementioned stimulator is also used to acquire neural signal parameters at the sacral nerve target site and generate signal comparison results based on these parameters. Furthermore, the stimulator is used to adjust the initial stimulation parameters based on the signal comparison results, generating optimized stimulation parameters, and providing new stimulation currents to the independent electrode branches based on these optimized parameters. As the core execution component of the system, the stimulator undertakes several key tasks. On one hand, it receives the initial stimulation parameters transmitted by the programmable controller; on the other hand, it acquires neural signal parameters at the sacral nerve target site, generates signal comparison results based on these parameters (the neural signal parameters used for signal comparison may include amplitude, frequency, spectral density, and time-frequency information); and, based on the results, it adjusts the initial stimulation parameters to generate optimized stimulation parameters, thereby providing new stimulation currents to the independent electrode branches.

[0081] More specifically, the stimulator connects to multiple independent electrode branches, which are implanted at different target sites on the sacral nerve (such as the S3 / S4 sacral foramina), achieving synergistic stimulation through different contact combinations. For example, a six-contact electrode can provide 30 stimulation combinations, significantly improving the precision of modulation. In addition, the stimulator has a built-in neural signal acquisition unit (such as a bioelectrical amplifier and an analog-to-digital converter) to acquire real-time neurophysiological signals (such as amplitude, frequency, spectral density, and time-frequency information) at the target sites. Through embedded algorithms (such as threshold comparison and machine learning models), it generates signal comparison results to assess the neural response state, and then dynamically adjusts the stimulation parameters based on the signal characteristics to improve the stimulation effect and avoid overstimulation.

[0082] The following section further explains the process of adjusting the initial stimulation parameters based on the signal comparison results:

[0083] First, for each independent electrode branch, the correlation between parameters such as amplitude, frequency, spectral density, and time-frequency information is calculated. For example, the Pearson correlation coefficient between amplitude and frequency, and the mutual information between spectral density and time-frequency information, are calculated for electrode branch a. The correlations of corresponding parameters between different independent electrode branches are compared. For example, the amplitude-frequency correlation and spectral density-time-frequency information correlation of electrode branch a and branch b are compared. Next, based on a preset correlation threshold, it is determined whether the signal parameter correlation of each independent electrode branch is better than that of other branches. For example, if the correlation threshold is set to 0.8, and the amplitude-frequency correlation coefficient of electrode branch a is greater than 0.8 and higher than the corresponding correlation coefficient of branch b, then the signal parameter correlation of branch a is determined to be better than that of branch b. Considering the correlation comparison results of multiple parameters, the overall signal quality of each independent electrode branch is determined. For example, if branch a is better than branch b in the correlation comparison of multiple parameters such as amplitude, frequency, spectral density, and time-frequency information, then the overall signal quality of branch a can be considered better.

[0084] It should also be noted that the above signal comparison process can be specifically executed by the signal comparison unit further included in the stimulus acquisition module of the stimulator. Please refer to [link / reference]. Figure 4 The stimulation acquisition module also includes a signal comparison unit, and may further include a parameter scanning unit and a signal processing unit. For example, the sacral nerve signal acquired by electrode 2 is sent to a second signal processing unit, which performs delinearization and power frequency filtering on the signal. The processed data is then sent to a second signal comparison unit, and the stimulation parameter scanning module also sends the stimulation parameters to the second signal comparison unit. The second signal comparison unit compares the processed nerve signals on the three branches of electrode 2 and returns the optimized stimulation parameters to the control unit of the stimulation acquisition module. The first and second signal comparison units can further send the data to a third signal comparison unit, which compares the signals acquired by the two electrodes, optimizes the bilateral stimulation parameters, and returns them to the control unit. The first and second signal processing units can also directly send the processed data to the main control module, which then sends it to a programmable controller for data analysis by relevant technicians.

[0085] Through the above embodiments, the sacral nerve multi-target synergistic stimulation system has achieved a leap from static parameter setting to dynamic adaptive adjustment, realizing dynamic optimization of stimulation parameters, which is conducive to improving treatment efficacy and safety.

[0086] In some embodiments, the aforementioned programmable controller further includes a display and interaction module; the display and interaction module is used to acquire the input initial stimulation parameters and display the stimulator status information and neural signal parameters received from the stimulator.

[0087] The interactive module provides users with a convenient parameter input interface. This module also includes a built-in parameter validation mechanism, which checks the format, range, and rationality of parameters in real time during user input. If the input does not meet the requirements, such as parameters exceeding the set range or having incorrect formatting, the system will immediately display a prompt message guiding the user to make corrections. After the parameters are entered, the user clicks the confirmation button. The module then encapsulates the input parameters and, through the communication protocol with the stimulator, accurately and stably transmits them to the stimulator, providing the foundation for subsequent stimulation therapy.

[0088] Furthermore, during actual operation, the display interaction module maintains real-time communication with the stimulator, continuously receiving status information sent by the stimulator. This information covers the stimulator's operating status (such as normal operation, standby, malfunction, etc.), connection status (successful connection, failed connection, interrupted connection), and battery status (remaining power, charging status), etc. The display interaction module can also display this information using a combination of graphics and text, allowing users to quickly and intuitively understand the stimulator's current status through different icons, colors, and text descriptions. For example, a green icon indicates normal operation, while a red icon indicates a malfunction. Simultaneously, the display interaction module updates the status information in real time, ensuring that the information received by the user is always up-to-date.

[0089] The above embodiments enable efficient interaction between the user and the stimulator, providing an important guarantee for the stable operation and precise treatment of the multi-target synergistic stimulation system.

[0090] It should also be noted that, please refer to Figure 7 In addition to the aforementioned display and interaction module, the programmable controller may also include a battery module, an MCU module, and a wireless communication module. The MCU module receives control input from the display and interaction module and sends it to the wireless communication module, and receives signals from the wireless communication module and transmits them to the display and interaction module. The display and interaction module inputs stimulus acquisition commands and parameters, and displays the system status and stimulus acquisition parameters. The wireless communication module receives instructions from the MCU and sends them to the stimulator, and receives signals from the stimulator. The battery module powers the other parts of the programmable controller.

[0091] In addition, please see Figure 7 The stimulator comprises a stimulation acquisition module, a main control module, a wireless communication module, and a wireless charging module. The stimulation acquisition module configures the stimulation and acquisition channels, outputs stimulation according to specified stimulation parameters, and acquires neural signals from various sites according to instructions. The main control module receives and processes signals from the wireless communication module, sends stimulation commands and parameters, and acquisition commands to the stimulation acquisition module, receives acquired data, and sends it back to the wireless communication module. The wireless communication module communicates with the programmable controller, receiving and sending information to it. The wireless charging module charges the internal battery, which then powers the other modules of the stimulator. The stimulation parameters of the stimulator and programmable controller include, but are not limited to, frequency, pulse width, stimulation waveform, amplitude, and voltage / current mode.

[0092] In some embodiments, the second end of the stimulation electrode includes multiple end faces; each end face is provided with multiple electrode contacts; when the second end of the stimulation electrode is connected to the stimulator, the electrode contacts can contact the elastic contact sheet inside the stimulator.

[0093] The second end of this stimulation electrode features a multi-faceted design, with multiple electrode contacts carefully arranged on each face. For an example of the proximal connection of a common triangular prism electrode, please refer to [link to relevant documentation]. Figure 8 Its three sides serve as end faces, each with six electrode contacts 81, corresponding one-to-one with the six electrode contacts of the three independent electrode branches. This multi-end-face, multi-contact layout greatly increases the contact area and number of contact points between the electrodes and the stimulator, laying the foundation for efficient signal transmission.

[0094] When the second end of the stimulating electrode is connected to the stimulator, the electrode contact plate comes into contact with the elastic contact plate inside the stimulator. The elastic contact plate has excellent elasticity and conductivity. During insertion, the electrode contact plate applies pressure to the elastic contact plate, causing it to undergo elastic deformation. This deformation allows the elastic contact plate to tightly wrap around the electrode contact plate, forming a stable electrical connection.

[0095] This contact method offers several advantages. Firstly, it effectively reduces contact resistance, minimizing energy loss during signal transmission and ensuring that the stimulation signal is delivered to nerve tissue with minimal attenuation. Secondly, the adaptive properties of the elastic contact pad allow it to adapt to certain insertion errors and vibration environments. Even with slight electrode position shifts or external vibration interference during use, the elastic contact pad maintains good contact and stable signal transmission.

[0096] Through the above embodiments, the multi-faceted design provides greater flexibility for the installation and use of the stimulation electrodes, thereby enabling a stable and reliable connection between the electrodes and the stimulator through reasonable structural design and ingenious working principle, providing a strong guarantee for the efficient implementation of nerve stimulation therapy.

[0097] In some embodiments, the second end of the stimulation electrode is further provided with a directional pointing mark component; the outer shell of the stimulator is further provided with an insertion direction indicating mark component; wherein, when the second end of the stimulation electrode is connected to the stimulator, the directional pointing mark component and the insertion direction indicating mark component are adapted to each other.

[0098] The second end of the stimulation electrode employs a multi-faceted design, with multiple electrode contacts on each face to increase the contact area with the stimulator and expand the signal transmission channel. Furthermore, a directional marking component is specifically incorporated. This component typically features a specific shape, color, or pattern, such as an arrow-shaped protrusion or groove, and its position and orientation are carefully designed to match the layout of the electrode contacts within the electrode. For an example, please refer to [link to example]. Figure 8A directional pointing marker assembly 82 with a raised structure is provided on the outside of the second end of the stimulation electrode. In addition, a sealing ring 83 is designed between the electrode contact 81 and the directional pointing marker assembly 82 for sealing the stimulation electrode and the stimulator.

[0099] The stimulator's outer shell is equipped with an insertion direction indicator component. This component can be a groove, a protrusion that matches the directional marking component of the stimulation electrode, or a scribed line or symbol with specific markings. When the second end of the stimulation electrode is about to be inserted into the stimulator, the user can quickly and accurately determine the insertion direction of the electrode by observing these two marking components.

[0100] Specifically, when the second end of the stimulating electrode is inserted into the stimulator in the correct direction, the directional marking component matches the insertion direction indicator marking component. During insertion, the electrode contact gradually contacts and tightly adheres to the elastic contact plate inside the stimulator. Due to the precise positioning function of the marking component, the electrode contact can accurately align with the elastic contact plate of the corresponding channel of the stimulator, forming a reliable electrical connection.

[0101] More specifically, please refer to the connection structure between the stimulating electrode and the stimulator. Figure 9A The stimulator housing has access holes for connecting two stimulation electrodes, each with a strip-shaped insertion direction indicator component 91 on one side. Additionally, the top of the stimulator housing is equipped with a screw-type waterproof seal 92. Further details can be found in the following section. Figure 9B The image is Figure 9A The diagram shows the internal structure of the stimulator where the stimulation electrode is connected. The stimulator has 36 feedthrough channels 93, each connecting to one of the three end faces of the second end of the stimulation electrode, consisting of six electrode contacts each, for a total of 36 electrode contacts. After the stimulation electrode is inserted into the stimulator, it is secured with electrode locking screws 94. The screws have a waterproof seal, and each electrode contact is in contact with the elastic contact plate 95 of the stimulator.

[0102] Through the above embodiments, the ingenious cooperation between the directional pointing marker component and the insertion direction indicator component achieves precise docking between the stimulation electrode and the stimulator, greatly reducing the problem of incorrect connection between the electrode contact and the stimulator channel due to incorrect insertion direction, avoiding the risk of abnormal signal transmission or equipment damage, improving the efficiency and accuracy of electrode insertion, and reducing operation time and difficulty.

[0103] In some embodiments, the stimulation electrodes include a first stimulation electrode and a second stimulation electrode. Each of the first and second stimulation electrodes may have three independent electrode branches, each branch having six stimulation sites, and each stimulation site of each independent electrode branch has both stimulation and acquisition functions. These two stimulation electrodes can be connected to three sacral nerve target sites on the left and three sacral nerve target sites on the right, respectively. It should be noted that this application also supports unilateral sacral nerve multi-electrode access, stimulation, and acquisition; please refer to [link to relevant documentation]. Figure 10 The three independent electrode branches of the first stimulating electrode are inserted into the three sacral nerve target points S2, S3, and S4 on the right side, respectively. At this time, the opening at the second stimulating electrode is sealed.

[0104] The multiple independent electrode branches of the first stimulating electrode and / or the multiple independent electrode branches of the second stimulating electrode are further provided with electrode barbs; wherein, the distance between the location of the electrode barbs and the location of the multiple electrode contacts is within a preset distance range, and when the independent electrode branches are implanted into the corresponding sacral nerve target sites, the distance between the location of the electrode barbs and the sacral nerve target site is greater than the distance between the location of each electrode contact and the sacral nerve target site. For example, please refer to... Figure 3 The stimulating electrode is divided into three independent electrode branches 221 in the middle section, referred to as branch a, branch b, and branch c, respectively. Each branch has six independent electrode contacts, numbered sequentially from the closest position to the distal end as contacts 0, 1, 2, 3, 4, and 5. A short distance from the electrode contacts 222 are electrode barbs 31, used for fixing the stimulating electrode to the sacral foramen.

[0105] This embodiment also provides a parameter configuration method applied to the sacral nerve multi-target synergistic stimulation system as described in any of the above embodiments. The process includes the following steps:

[0106] The system acquires stimulation parameters, performs parameter configuration processing based on these parameters, and provides a stimulation current to at least one independent electrode branch of the stimulation electrode. The stimulation current acts on the sacral nerve target site via electrode contacts on the independent electrode branch. The stimulator is used to configure the stimulation and acquisition channels and output stimulation according to the specified stimulation parameters.

[0107] It should be noted that the steps shown in the above process or in the flowchart of the accompanying figures can be executed in a computer system such as a set of computer-executable instructions, and although a logical order is shown in the flowchart, in some cases the steps shown or described may be executed in a different order than that shown here.

[0108] The user information (including but not limited to user device information, user personal information, etc.) and data (including but not limited to data used for analysis, data stored, data displayed, etc.) involved in this application are all information and data authorized by the user or fully authorized by all parties.

[0109] Those skilled in the art will understand that all or part of the processes in the above embodiments can be implemented by a computer program instructing related hardware. The computer program can be stored in a non-volatile computer-readable storage medium. When executed, the computer program can include the processes of the embodiments described above. Any references to memory, databases, or other media used in the embodiments provided in this application can include at least one of non-volatile and volatile memory. Non-volatile memory can include read-only memory (ROM), magnetic tape, floppy disk, flash memory, optical memory, high-density embedded non-volatile memory, resistive random access memory (ReRAM), magnetic random access memory (MRAM), ferroelectric random access memory (FRAM), phase change memory (PCM), graphene memory, etc. Volatile memory can include random access memory (RAM) or external cache memory, etc. By way of illustration and not limitation, RAM can take many forms, such as Static Random Access Memory (SRAM) or Dynamic Random Access Memory (DRAM). The databases involved in the embodiments provided in this application may include at least one type of relational database and non-relational database. Non-relational databases may include, but are not limited to, blockchain-based distributed databases. The processors involved in the embodiments provided in this application may be general-purpose processors, central processing units, graphics processing units, digital signal processors, programmable logic devices, quantum computing-based data processing logic devices, etc., and are not limited to these.

[0110] Those skilled in the art should understand that the technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments have been described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0111] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A sacral nerve multi-target synergistic stimulation system, characterized in that, The system, applied to sacral nerve modulation, includes: stimulating electrodes, a stimulator, and a programmer. The first end of the stimulation electrode has multiple independent electrode branches, and the outer wall of each independent electrode branch is provided with multiple electrode contacts; when each independent electrode branch is implanted into the corresponding sacral nerve target site, the electrode contacts can contact the sacral nerve target site. The stimulator is connected to the second end of the stimulating electrode and is used to provide stimulating current to each individual electrode branch in the stimulating electrode; the stimulating current acts on the sacral nerve target site via the electrode contacts on the individual electrode branches; The second end of the stimulation electrode includes multiple end faces; each end face is provided with multiple electrode contacts; when the second end of the stimulation electrode is connected to the stimulator, the electrode contacts can contact the elastic contact sheet inside the stimulator; wherein, the second end of the stimulation electrode is triangular prism-shaped, the three sides of the triangular prism are used as end faces, and the six electrode contacts on each end face correspond one-to-one with the six electrode contacts of the three independent electrode branches; The programmable controller is communicatively connected to the stimulator and is used to transmit the acquired initial stimulation parameters to the stimulator. The stimulator is also used to acquire neural signal parameters at the sacral nerve target site, wherein the neural signal parameters are electrophysiological signals of the sacral nerve root or surrounding tissues; and to generate signal comparison results based on the neural signal parameters, including, for each independent electrode branch, calculating the correlation between amplitude, frequency, spectral density and time-frequency information, wherein the correlation includes the Pearson correlation coefficient between amplitude and frequency, and the mutual information between spectral density and time-frequency information; comparing the correlation of corresponding parameters between different independent electrode branches, and determining whether the correlation of signal parameters of each independent electrode branch is better than that of other branches according to a preset correlation threshold, thereby obtaining the signal comparison results; The stimulator is also used to adjust the initial stimulation parameters based on the signal comparison results, generate optimized stimulation parameters, and provide new stimulation current to the independent electrode branches based on the optimized stimulation parameters.

2. The sacral nerve multi-target synergistic stimulation system according to claim 1, characterized in that, The programmable controller also includes a display and interaction module; The display interaction module is used to acquire the input initial stimulation parameters and display the stimulator state information and neural signal parameters received from the stimulator.

3. The sacral nerve multi-target synergistic stimulation system according to claim 1, characterized in that, The second end of the stimulation electrode is also provided with a directional pointing marker component; The outer shell of the stimulator is also provided with an insertion direction indicator component; When the second end of the stimulation electrode is connected to the stimulator, the directional pointing marker component is adapted to the insertion direction indicating marker component.

4. The sacral nerve multi-target synergistic stimulation system according to claim 1, characterized in that, The stimulating electrode includes a first stimulating electrode and a second stimulating electrode. The multiple independent electrode branches of the first stimulation electrode and / or the multiple independent electrode branches of the second stimulation electrode are further provided with electrode barbs; The distance between the location of the electrode barbs and the location of the plurality of electrode contacts is within a preset distance range.

5. The sacral nerve multi-target synergistic stimulation system according to any one of claims 1 to 4, characterized in that, The stimulator includes a main control module and a stimulation acquisition module. The stimulation acquisition module includes a control unit, a stimulation unit, and a switching unit. The switching unit includes a first switching subunit. The main control module is used to generate a stimulation command that indicates at least one first target electrode branch; the first target electrode branch is the branch among the individual electrode branches to which a stimulation current is to be applied. The control unit is configured to determine the stimulation electrode contact from the electrode contacts on the first target electrode branch, and in response to the stimulation command, control the first switching subunit to connect the stimulation pathway where the stimulation electrode contact is located. The stimulation unit is used to provide the stimulation current to the first target electrode branch through the stimulation pathway; the stimulation current acts on the sacral nerve target site via the stimulation electrode contact.

6. The sacral nerve multi-target synergistic stimulation system according to claim 5, characterized in that, The stimulus acquisition module further includes an acquisition unit, and the switching unit further includes a second switching subunit; The main control module is also used to generate a collection command indicating at least one second target electrode branch; the second target electrode branch is the branch of each of the independent electrode branches from which neural signal parameters are to be collected; The control unit is used to determine the acquisition electrode contact from the electrode contacts on the second target electrode branch, and in response to the acquisition command, control the second switching subunit to connect the acquisition path where the acquisition electrode contact is located. The acquisition unit is used to receive neural signal parameters of the sacral nerve target site acquired by the acquisition electrode contacts through the acquisition path.

7. The sacral nerve multi-target synergistic stimulation system according to claim 6, characterized in that, The switching unit further includes a third switching subunit; The third switching subunit is used to switch the connection status of the stimulation pathway and the acquisition pathway.

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