Detailed Description
The present application will be described and illustrated with reference to the accompanying drawings and examples in order to make the objects, technical solutions and advantages of the present application more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the application. All other embodiments, which can be made by a person of ordinary skill in the art based on the embodiments provided by the present application without making any inventive effort, are intended to fall within the scope of the present application. Moreover, it should be appreciated that while such a development effort might be complex and lengthy, it would nevertheless be a routine undertaking of design, fabrication, or manufacture for those of ordinary skill having the benefit of this disclosure, and thus should not be construed as having the benefit of this disclosure.
Reference in the specification to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment may be included in at least one embodiment of the application. The appearances of such phrases in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. It is to be expressly and implicitly understood by those of ordinary skill in the art that the described embodiments of the application can be combined with other embodiments without conflict.
Unless defined otherwise, technical or scientific terms used herein should be given the ordinary meaning as understood by one of ordinary skill in the art to which this application belongs. The terms "a," "an," "the," and similar referents in the context of the application are not to be construed as limiting the quantity, but rather as singular or plural. The terms "comprises," "comprising," "includes," "including," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, article, or apparatus that comprises a list of steps or modules (elements) is not limited to only those steps or elements but may include other steps or elements not expressly listed or inherent to such process, method, article, or apparatus. The terms "connected," "coupled," and the like in connection with the present application are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. The term "plurality" as used herein means greater than or equal to two. "and/or" describes the association relationship of the association object, and indicates that three relationships may exist, for example, "a and/or B" may indicate that a exists alone, a and B exist simultaneously, and B exists alone. The terms "first," "second," "third," and the like, as used herein, are merely distinguishing between similar objects and not representing a particular ordering of objects.
The method embodiment provided in this embodiment may be executed in a terminal, a computer or a similar computing device. Taking the operation on a terminal as an example, fig. 1 is a block diagram of a hardware structure of a terminal according to a parameter configuration method according to an embodiment of the present application. As shown in fig. 1, the terminal may include one or more processors 102 (only one is shown in fig. 1) (the processor 102 may include, but is not limited to, a microprocessor MCU or a processing device such as a programmable logic device FPGA) and a memory 104 for storing data, and optionally, a transmission device 106 for communication functions and an input-output device 108. It will be appreciated by those skilled in the art that the structure shown in fig. 1 is merely illustrative and not limiting on the structure of the terminal described above. For example, the terminal may also include more or fewer components than shown in fig. 1, or have a different configuration than shown in fig. 1.
The memory 104 may be used to store a computer program, for example, a software program of application software and a module, such as a computer program corresponding to a parameter configuration method in an embodiment of the present application, and the processor 102 executes the computer program stored in the memory 104 to perform various functional applications and data processing, that is, implement the above-mentioned method. Memory 104 may include high-speed random access memory, and may also include non-volatile memory, such as one or more magnetic storage devices, flash memory, or other non-volatile solid-state memory. In some examples, the memory 104 may further include memory remotely located relative to the processor 102, which may be connected to the terminal via a network. Examples of such networks include, but are not limited to, the internet, intranets, local area networks, mobile communication networks, and combinations thereof.
The transmission device 106 is used to receive or transmit data via a network. The specific example of the network described above may include a wireless network provided by a communication provider of the terminal. In one example, the transmission device 106 includes a network adapter (Network Interface Controller, simply referred to as a NIC) that can connect to other network devices through a base station to communicate with the internet. In one example, the transmission device 106 may be a Radio Frequency (RF) module for communicating with the internet wirelessly.
It should be noted that, in the related art, a common sacral nerve implantation point is mainly a unilateral sacral 3 nerve. However, considering that the three branches of the sacral nerve, namely the sacral 2, the sacral 3 and the sacral 4, are all parts of the lower urinary tract nerve, the sacral 3 nerve is difficult to be stimulated alone to treat all abnormal conditions in the six branches of the sacral 2, the sacral 3 and the sacral 4 on the left side and the right side, and the existing single implantation point sacral nerve stimulation system cannot provide more treatment schemes, so that the overall stimulation intensity of the sacral nerve stimulation system to the stimulated object is insufficient.
Based on this, this embodiment provides a sacral nerve multi-target co-stimulation system, and fig. 2 is a block diagram of a sacral nerve multi-target co-stimulation system according to an embodiment of the application, as shown in fig. 2, which includes a stimulation electrode 22 and a stimulator 21.
The first end of the stimulating electrode 22 is provided with a plurality of independent electrode branches 221, the outer wall of each independent electrode branch 221 is provided with a plurality of electrode contacts 222, and when each independent electrode branch 221 is implanted into a corresponding sacral nerve target point, the electrode contacts 222 can be contacted with the sacral nerve target point.
The first end of the stimulating electrode 22 refers to the end that first enters the body of the subject to be stimulated when the stimulating electrode 22 is implanted at the target site of the sacral nerve, and can be regarded as the distal end of the stimulating electrode. The number of the stimulating electrodes 22 and the number of the independent electrode branches 221 included in each stimulating electrode may be configured according to actual requirements. For example, if at most six nerves, namely, left and right sacral 2, sacral 3 and sacral 4 nerves, are required to be stimulated, the stimulating electrodes 22 may be provided as two stimulating electrodes, the first end of each stimulating electrode 22 is respectively provided with three independent electrode branches 221, and the total of six independent electrode branches 221, so that, when the system works, the six independent electrode branches 221 may be respectively implanted at the sacral 2, sacral 3 and sacral 4 sites (i.e., the above-mentioned sacral nerve target sites) on the left and right sides, so as to cooperatively stimulate the six nerves. Alternatively, the stimulating electrodes 22 may be configured as three stimulating electrodes 22, where the first end of each stimulating electrode 22 is provided with two independent electrode branches 221, or the first section of one stimulating electrode 22 is configured as six independent electrode branches 221, which is not limited herein. It should be further understood that although the multiple independent electrode branches 221 are designed in the present embodiment, if only a part of the nerves need to be stimulated in actual operation, the corresponding part of the independent electrode branches 221 may be directly implanted to the target point where the nerves to be stimulated are located, and the other independent electrode branches 221 are suspended in the air, or the openings of the other stimulation electrodes 22 that do not need to be implanted into the stimulated body may be sealed.
The electrode contacts 222 provided on the outer wall of each of the independent electrode branches 221 are sequentially arranged along the electrode branch leads at intervals, and the distances between the electrode contacts 222 may be the same or different. The number of the electrode contacts 222 may be at least two without limitation. Each contact can be used as a stimulation and acquisition contact, both of which are switched in use. Specifically, if the number of the electrode contacts 222 arranged on each independent electrode branch 221 is two, in the actual working process, two processes of applying the stimulation current to the sacral nerve target point and collecting the nerve signals can be realized through switching of the two electrode contacts 222. For example, in the stimulation phase, contact 0 is used as anode (+) and contact 1 is used as cathode (-), a stimulation current is applied, and in the acquisition phase, the stimulation circuit is disconnected, and electrophysiological signals of sacral nerve roots or surrounding tissues are acquired through contact 0/1. Or the number of electrode contacts 222 arranged on each individual electrode branch 221 may be increased appropriately to operate with different contact combinations.
Specifically, referring to FIG. 3, a schematic structural diagram of a stimulation electrode is shown, wherein the stimulation electrode has three independent electrode branches 221 at a first end, denoted as branch a, branch b and branch c, respectively. The top end of each individual electrode branch 221 is provided with 6 electrode contacts 222 which are arranged equidistantly in sequence. Taking the branch a implanted at the target point of the sacral 2 nerve at one side as an example, when the stimulating current output by the stimulator is transmitted to the branch a, the stimulating current acts on the target point of the sacral 2 nerve through two electrode contacts (contact 0 and contact 1) in the 6 electrode contacts 222, or the nerve signal parameters of the target point of the sacral 2 nerve are collected through the other two electrode contacts (contact 2 and contact 3) in the 6 electrode contacts 222 of the branch a. Furthermore, the remaining two contacts in branch a (contact 4 and contact 5) can be engaged as alternative contacts.
The stimulator 21 is connected to the second end of the stimulating electrode 22, and is configured to supply a stimulating current to each of the individual electrode branches 221 of the stimulating electrode 22, where the stimulating current flows through the electrode contact 222 on the individual electrode branch 221 and acts on the sacral nerve target site. The second end of the stimulating electrode 22 is the other end opposite to the first end of the stimulating electrode 22, and may be regarded as the electrode proximal end relatively close to the stimulator 21.
The output port of the stimulator 21 is hard-wired to the second end of the stimulating electrode 22. When the stimulator 21 applies stimulation, the stimulation electrode 22 and one or more sacral nerve target points to be stimulated are predetermined, and a stimulation current meeting the preset stimulation parameter configuration is output by the stimulator 21, and the stimulation current flows from the second end of the stimulation electrode 22 at the connection, flows through the first end of the stimulation electrode 22, and is transmitted to one or more independent electrode branches 221 corresponding to the sacral nerve target points to be stimulated, and finally acts on the sacral nerve target points through electrode contacts 222 arranged on the independent electrode branches 221 to stimulate the sacral nerves of the points. Therefore, in the operation process of applying the stimulation to the sacral nerve by the stimulator 21, the stimulation current can be applied to a certain sacral nerve target site by one independent electrode branch 221 in the above manner, or the multiple sacral nerve target sites can be simultaneously co-stimulated by multiple independent electrode branches 221, so that the overall stimulation intensity of the sacral nerve of the stimulated object can be effectively improved.
Therefore, in consideration of the synergistic effect of the sacral 2, sacral 3 and sacral 4 nerves in each muscle and tissue of the urinary tract system under regulation, the system is provided with six independent stimulation electrodes 22 which respectively act on the sacral 2, sacral 3 and sacral 4 nerves on the left side and the right side, and the purpose of treating overactive bladder is achieved by independently or jointly stimulating six nerve branches. Meanwhile, considering the mutual influence of the sacrum 2, the sacrum 3 and the sacrum 4 nerves, when the system stimulates one of the six nerves, the system can collect nerve signals of the rest nerve branches so as to observe the influence of the nerve branches on other nerve branches when the nerve branches are stimulated, and more information is provided for the system to cooperatively stimulate the sacrum 2, the sacrum 3 and the sacrum 4 nerves.
In the sacral nerve multi-target point collaborative stimulation system, the first end of the stimulation electrode 22 is provided with the plurality of independent electrode branches 221, each independent electrode branch 221 is respectively implanted into different sacral nerve target points, the stimulator 21 provides the stimulation current transmitted to each independent electrode branch 221, and finally the stimulation current is applied to the corresponding sacral nerve through each independent electrode branch 221, so that a sacral nerve combined stimulation scheme integrating a plurality of target points is realized, partial patients are not sensitive during single nerve stimulation, the problem that the stimulation system only aims at the problem that the whole stimulation intensity of the stimulation system to the stimulated object is insufficient due to single nerve current application stimulation is solved, the accuracy and the reliability of the stimulation current transmission during multi-target point collaborative stimulation are ensured, and the treatment efficiency of a sacral nerve regulation mechanism is effectively improved.
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;
The device comprises a main control module, a control unit, a stimulation unit and a stimulation unit, wherein the main control module is used for generating a stimulation instruction for indicating at least one first target electrode branch, the first target electrode branch is a branch to which stimulation current is to be applied in each independent electrode branch, electrode contacts on each independent electrode branch can be configured as stimulation electrode contacts, the control unit is used for determining the stimulation electrode contacts from the electrode contacts on the first target electrode branch and responding to the stimulation instruction, the first switching subunit is controlled to be connected with a stimulation channel where the stimulation electrode contacts on the first target electrode branch are located, and the stimulation unit is used for providing stimulation current for the first target electrode branch through the stimulation channel, and the stimulation current acts on a sacral nerve target point through the stimulation electrode contacts.
The main control module is used as a system command center and is responsible for analyzing treatment parameters (such as stimulation frequency, pulse width and amplitude) and electrode distribution information to generate a stimulation instruction containing one or more target electrode branch identifiers. For example, when the left sacral nerve S3 segment is to be activated, the main control module designates the independent electrode branch as the first target electrode branch and generates a corresponding stimulation parameter packet. After receiving the instruction, the control unit in the stimulation acquisition module randomly selects two electrode contacts from the first target electrode branch to serve as stimulation electrode contacts, or selects two default electrode contacts to serve as stimulation electrode contacts, and analyzes the physical position of the target electrode branch through the address decoder to drive the multiplexer array in the first switching subunit. The subunit adopts a high-precision relay matrix, can rapidly close the passage where the contact of the target stimulation electrode is located, and simultaneously opens other non-target passages to avoid current leakage. The stimulation unit monitors output current in real time through a feedback loop based on the constant current source design, and ensures the stability of stimulation amplitude. After the passage is connected, the stimulation unit generates square wave or triangular wave current pulse according to preset parameters, and the square wave or triangular wave current pulse directly acts on the sacral nerve target point position through the stimulation electrode contact. The current waveform can be dynamically adjusted by the main control module to simulate the time domain characteristics (such as clustered discharge mode) of the natural nerve signals.
For example, when the stimulation unit works, the stimulation electrode and the stimulation target point are predetermined, and an operator can select two modes of multi-nerve branch stimulation and single-nerve branch stimulation, and particularly judge according to clinical effects. When the single nerve branches are stimulated, an operator can select electrodes corresponding to the sacral 2, sacral 3 and sacral 4 nerves respectively, and then select two contacts to serve as positive electrodes and negative electrodes for stimulation respectively. Multiple nerve branches are stimulated, an operator can select two to six nerve branches simultaneously for stimulation, and positive and negative electrodes of each electrode branch stimulation site are configured.
Through the embodiment, a layered architecture of the main control module and the stimulation acquisition module (comprising the control unit, the stimulation unit and the switching unit) is provided, a dynamic stimulation instruction is generated through the main control module, the control unit in the stimulation acquisition module is driven to work cooperatively with the stimulation unit, and finally, the stimulation current is directionally conveyed to the target electrode branch through the switching unit, so that accurate electrical stimulation on the sacral nerve target point position can be realized.
In some embodiments, the stimulation acquisition module further comprises an acquisition unit, the switching unit further comprises a second switching subunit, the main control module is further used for generating an acquisition instruction for indicating at least one second target electrode branch, the second target electrode branch is a branch of nerve signal parameters to be acquired in each independent electrode branch, the electrode contacts on each independent electrode branch can be configured as acquisition electrode contacts, the control unit is used for determining the acquisition electrode contacts from the electrode contacts on the second target electrode branch and controlling the second switching subunit to switch on an acquisition passage where the acquisition electrode contacts on the second target electrode branch are located in response to the acquisition instruction, and the acquisition unit is used for receiving the nerve signal parameters of the sacral nerve target points acquired by the acquisition electrode contacts through the acquisition passage.
Specifically, the main control module is used as a system command center, and a collection instruction generating function is newly added. When the nerve signal parameters of the sacral nerve target point position need to be acquired, the main control module designates a second target electrode branch (S4) in the independent electrode branches, and generates an acquisition instruction containing the acquisition parameters (such as sampling rate and filtering range). For example, when the stimulation effect is evaluated, the main control module can simultaneously designate the left side S3 as the stimulation electrode branch and the right side S4 as the acquisition electrode branch, so as to realize the synchronous operation of stimulation and acquisition.
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, and drives the multiplexer array in the second switching subunit after responding to the acquisition instruction. The subunit adopts a relay matrix independent of the first switching subunit, can rapidly close the acquisition passage where the target acquisition electrode contact is located, and simultaneously opens other non-target passages to avoid signal interference. The acquisition unit is based on high-precision analog front end design, and receives the nerve signal parameters (such as amplitude, frequency and frequency spectrum density) of the sacral nerve target point position acquired by the acquisition electrode contact through the acquisition channel. The acquisition unit is internally provided with a programmable gain amplifier and an anti-aliasing filter, supports multichannel synchronous acquisition, and can transmit original data to the main control module for real-time analysis.
For example, when the acquisition unit is in operation, the acquisition electrode and the acquisition site are predetermined, and the operator can select two modes, namely, multi-nerve branch acquisition and single-nerve branch acquisition. During single nerve acquisition, an operator can select one of the left and right sacral 2, sacral 3 and sacral 4 nerves, and then select two positions of the corresponding electrodes as the acquired positive electrode and negative electrode respectively. When multiple nerve branches are collected, an operator can select two to six nerve branches to collect at the same time, and each electrode branch is configured to carry out positive and negative electrodes of a collection site.
When the stimulation collection works simultaneously, and different electrode branches respectively perform stimulation and collection, taking 1 electrode a branch stimulation and 1 electrode b branch collection (or 2 electrode a branch) as an example, two positions of an a electrode are selected to serve as a positive electrode and a negative electrode of the stimulation respectively, and two positions of a b (2 electrode a) electrode branch are selected to serve as a positive electrode and a negative electrode of the collection respectively. In addition, the system supports selection of a mode in which multiple stimulation electrodes and multiple acquisition electrodes are operated simultaneously. When the same electrode branch is used for stimulation and collection respectively, taking the 1 electrode a branch for collection and stimulation as an example, two of the 6 contacts of the a branch are selected as positive and negative electrodes for stimulation, and two of the remaining 4 contacts of the a branch are selected as positive and negative electrodes for collection.
Through the embodiment, the acquisition unit and the second switching subunit are introduced, the main control module generates a dual-mode instruction (a stimulation instruction and an acquisition instruction), the control unit, the stimulation unit and the acquisition unit in the stimulation acquisition module are driven to work cooperatively, and finally, the independent switching and the efficient multiplexing of the stimulation channel and the acquisition channel are realized through the switching unit, so that a 'stimulation-acquisition' dual-channel cooperative mechanism is constructed, and the dynamic monitoring and the accurate regulation and control of the sacral nerve target point position are realized.
In some embodiments, the switching unit further comprises a third switching subunit, and the third switching subunit is used for switching the connection state of the stimulation channel and the acquisition channel. The hardware implementation of the third switching subunit may be based on a high-speed analog switch matrix, which includes an independent stimulation channel control group and an acquisition channel control group, where each group control group is composed of a plurality of high-speed switch pairs. The main control module sends a channel switching instruction to the third switching subunit, wherein the instruction comprises a target electrode branch number and a target channel type (stimulation/acquisition). The first switching subunit and the second switching subunit respectively manage primary switching of the stimulation channel and the acquisition channel, and the third switching subunit is responsible for dynamic connection between the two. For example, when the contacts 0 and 1 need to be stimulated, the main control module firstly opens two paths 0 and 1 in the first switching subunit, and simultaneously instructs the third switching subunit to connect the contacts 0 and 1 to the stimulation paths. In a stimulation and acquisition synchronization scenario, the third switching subunit may manage the connection states of multiple contacts simultaneously. For example, contacts 0, 1 are used for stimulation, contacts 2,3 are used for harvesting, the third switching subunit connects 0 and 1 to the stimulation path, and contacts 2 and 3 to the harvesting path. The same contact may alternate stimulation and harvesting operations and different contacts may operate synchronously or asynchronously, e.g., contact 0 may quickly switch it to the harvesting path after stimulation is completed, while contacts 1,2,3 may continue with other operations.
Through the embodiment, a third switching subunit is further introduced, a dynamic switching mechanism of the stimulation channel and the acquisition channel is constructed, the same contact can be reused as the stimulation contact or the acquisition contact through the dynamic switching of the third switching subunit, the hardware resource expenditure is reduced, the isolation of the stimulation channel and the acquisition channel on the hardware level is realized, the direct interference of stimulation current on acquisition signals is avoided, and the rapid switching of any contact between the stimulation and the acquisition modes can be supported, so that the flexible reuse of electrode resources and the remarkable improvement of the system efficiency are facilitated.
Referring to fig. 4, the above-mentioned stimulation acquisition module is divided into 6 independent stimulation units, 6 independent acquisition units and 6 switching units. The electrode 1 stimulation unit comprises stimulation units corresponding to three independent electrode branches (1-0, 1-1 and 1-2) of the electrode 1, the electrode 2 stimulation unit comprises stimulation units corresponding to three independent electrode branches (2-0, 2-1 and 2-2) of the electrode 2, the electrode 1 acquisition unit comprises acquisition units corresponding to three independent electrode branches (1-0, 1-1 and 1-2) of the electrode 1, and the electrode 2 acquisition unit comprises acquisition units corresponding to three independent electrode branches (2-0, 2-1 and 2-2) of the electrode 2. One stimulation unit, one acquisition unit and one switching unit are responsible for the stimulation and acquisition of the 6 contacts of one electrode branch, for example, the stimulation 1-0 and the acquisition 1-0, one switching unit is responsible for the operation of the 6 contacts of the a branch of the electrode 1, the stimulation 2-2 and the acquisition 2-2, and one switching unit is responsible for the operation of the 6 contacts of the c branch of the electrode 2. The six sub-modules work independently of each other, and can work synchronously or asynchronously. Wherein each stimulation site of each individual branch of the sacral nerve stimulation electrode has stimulation and acquisition functions. The stimulation site stimulation and collection functions of the same independent branch work alternately, and the stimulation site stimulation and collection functions of different independent branches can work synchronously or alternately.
Further, referring to fig. 5, the switching units are divided into a first switching subunit (i.e., a stimulation switching subunit for controlling a stimulation channel), a second switching subunit (i.e., an acquisition switching subunit for controlling an acquisition channel), and six third switching subunits (i.e., stimulation and acquisition switching subunits). Taking stimulus 2-2, collection 2-2 and a collection stimulus switching combination module thereof as an example, the stimulus 2-2 is connected with a stimulus switching module, the collection 2-2 is connected with a collection switching module, the stimulus switching module and the collection switching module are sequentially connected with 6 collection stimulus switching modules, and the 6 collection stimulus switching modules are connected with 6 contacts of a c branch of the electrode 2. The stimulation switching module and the acquisition switching module, and the acquisition stimulation switching module are controlled by the acquisition and stimulation control module, the same time acquisition and stimulation control module can open two paths of one stimulation switching module and one acquisition switching module, and one path of one acquisition stimulation switching module is opened. When only stimulating, taking the example of opening the contacts 0 and 1, the acquisition and stimulation control module opens the two paths of 0 and 1 in the stimulation switching module, and simultaneously opens the stimulation paths corresponding to the contacts 0 and 1 in the acquisition and stimulation control module, when only collecting, taking the example of opening the contacts 0 and 1, the acquisition and stimulation control module opens the two paths of 0 and 1 in the acquisition switching module, and simultaneously opens the acquisition paths corresponding to the contacts 0 and 1 in the acquisition and stimulation switching module, when stimulating and acquiring are synchronous, taking the example of stimulating the contacts 0 and 1, and the acquisition of the contacts 2 and 3 in the acquisition and stimulation control module opens the two paths of 0 and 1 in the stimulation switching module, and simultaneously opens the stimulation paths corresponding to the contacts 0 and 1 in the acquisition and stimulation switching module, and the acquisition paths corresponding to the contacts 2 and 3 in the acquisition and stimulation switching module, wherein the same contact stimulation and acquisition can be alternately performed, and the different contact stimulation and acquisition can be synchronously or asynchronously performed.
In some embodiments, the sacral nerve multi-target co-stimulation system further comprises a programmable controller communicatively coupled to the stimulator for transmitting the acquired initial stimulation parameters to the stimulator. The program control instrument is used as a control end of the system and is in communication connection with the stimulator, and the main function of the program control instrument is to transmit the acquired initial stimulation parameters to the stimulator, so that the initial setting of the stimulation parameters of the stimulator is realized. Referring to fig. 6, a schematic structural diagram of a sacral nerve multi-target co-stimulatory system is shown, wherein wireless communication transmission is performed between a program control device and a stimulator. The communication mode has the advantages of high flexibility, convenience in installation and the like, and the problems of complex wiring, limited movement and the like possibly caused by wired connection are avoided, so that the system has more convenience and adaptability in practical application. It should be further noted that the wireless communication link between the programmable controller and the stimulators may adopt a star network topology, and the programmable controller is used as a master node to communicate with a plurality of stimulators synchronously or asynchronously.
The stimulator is also used for adjusting the initial stimulation parameters according to the signal comparison result to generate optimized stimulation parameters and providing new stimulation current for the independent electrode branches based on the optimized stimulation parameters. The stimulator is used as a core execution component of the system and bears a plurality of key tasks. On the one hand, initial stimulation parameters transmitted by a program control instrument are received, on the other hand, nerve signal parameters of the sacral nerve target point are collected, signal comparison results are generated according to the parameters, the nerve signal parameters used for signal comparison can comprise amplitude, frequency spectrum density, time-frequency information and the like, the initial stimulation parameters are adjusted according to the results, optimized stimulation parameters are generated, and then new stimulation currents are provided for independent electrode branches.
More specifically, the stimulator is connected with a plurality of independent electrode branches, is respectively implanted into different target sites (such as S3/S4 sacral foramina) of the sacral nerve, and realizes collaborative stimulation through different contact combinations. For example, a six-contact electrode can provide 30 stimulation combination schemes, and the regulation and control precision is remarkably improved. In addition, a nerve signal acquisition unit (such as a biopotential amplifier and an analog-to-digital converter) is arranged in the stimulator, nerve electrophysiological signals (such as amplitude, frequency, spectral density, time-frequency information and the like) of the target point position are acquired in real time, a signal comparison result is generated through an embedded algorithm (such as threshold comparison and a machine learning model), the nerve response state is evaluated, and then the stimulation parameters are dynamically adjusted according to the signal characteristics, so that the stimulation effect is improved, and overstimulation is avoided.
The process of adjusting the initial stimulation parameters based on the signal comparison results is further described below:
First, for each individual electrode branch, the correlation between its parameters such as amplitude, frequency, spectral density and time-frequency information is calculated, respectively. For example, the pearson correlation coefficient between the amplitude and frequency of the branch a of the electrode 1 and the mutual information between the spectral density and the time-frequency information are calculated. And carrying out correlation comparison on corresponding parameters among different independent electrode branches. For example, the amplitude-frequency correlation, spectral density-time-frequency information correlation, etc. of the branches a and b of the comparison electrode 1. And then, judging whether the signal parameter correlation of each independent electrode branch is better than that of other branches according to a preset correlation threshold value. For example, the correlation threshold is set to 0.8, and if the amplitude-frequency correlation coefficient of branch a of electrode 1 is greater than 0.8 and higher than the corresponding correlation coefficient of branch b, it is determined that the signal parameter correlation of branch a is better than that of branch b. And comprehensively considering correlation comparison results of a plurality of parameters, and determining the overall signal quality of each independent electrode branch. For example, if branch a is better than branch b in correlation comparisons of multiple parameters such as amplitude, frequency, spectral density, and time-frequency information, the overall signal quality of branch a may be considered better.
It should be further noted that the above signal comparison process may be specifically performed by a signal comparison unit further included in the stimulus acquisition module of the stimulator. Referring to fig. 4, the stimulus acquisition module further includes a signal comparison unit, and may further include a parameter scanning unit and a signal processing unit. For example, the sacral nerve signals collected by the electrode 2 collection unit are sent to the second signal processing unit, the second signal processing unit performs processing such as nonlinear and power frequency filtering on the signals, the processed data are further sent to the 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 the electrode 2 and returns the optimized stimulation parameters to the control unit of the stimulation acquisition module. The first signal comparison unit and the second signal comparison unit can further send data to the third signal comparison unit, the signals collected by the two electrodes are compared by the signal comparison unit, and the optimized stimulation parameters of the two sides are returned to the control unit. The first signal processing unit and the second signal processing unit can also directly send the processed data to the main control module, and the main control module sends the processed data to the program control instrument for relevant technicians to analyze the data.
Through the embodiment, the sacral nerve multi-target point collaborative stimulation system realizes spanning from static parameter setting to dynamic self-adaptive adjustment, and realizes dynamic optimization of stimulation parameters, thereby being beneficial to improving treatment effect and safety.
In some embodiments, the program control instrument further comprises a display interaction module, wherein the display interaction module is used for acquiring input initial stimulation parameters and displaying stimulator state information and nerve signal parameters sent by the received stimulator.
The display interaction module provides a convenient parameter input interface for a user. The module can also be internally provided with a parameter checking mechanism, and the format, the range and the rationality of the parameters can be checked in real time in the input process of a user. If the input is not in accordance with the requirements, if the parameters exceed the set range or the format is wrong, the system can immediately pop up the prompt message to guide the user to correct. After the parameter input is completed, the user clicks the confirmation button, the module encapsulates the input parameter, and the parameter is accurately and stably transmitted to the stimulator through a communication protocol between the module and the stimulator, so that basic setting is provided for subsequent stimulation treatment.
In the actual working process, the display interaction module is communicated with the stimulator in real time, and continuously receives the state information sent by the stimulator. Such information includes the operational status of the stimulator (e.g., normal operation, standby, malfunction, etc.), the connection status (connection success, connection failure, connection interruption), and the battery status (remaining power, state of charge). The display interaction module can also display the information in a mode of combining graphics and texts, and a user can quickly and intuitively know the current condition of the stimulator through different icons, colors and text descriptions. For example, a green icon indicates normal operation and a red icon indicates failure occurrence. Meanwhile, the display interaction module can update the state information in real time, so that the information acquired by the user is always up to date.
Through the embodiment, the high-efficiency interaction between the user and the stimulator is realized, and important guarantee is provided for the stable operation and the accurate treatment of the multi-target collaborative stimulation system.
It should be noted that, referring to fig. 7, the program control apparatus may further include a battery module, an MCU module and a wireless communication module in addition to the display interaction module. The MCU module is used for receiving control input of the display interaction module, sending the control input to the wireless communication module, receiving signals of the wireless communication module and transmitting the signals to the display interaction module, the display interaction module is used for inputting stimulation acquisition commands and parameters and displaying system states and stimulation acquisition parameters, the wireless communication module is used for receiving instructions of the MCU and sending the instructions to the stimulator and receiving signals from the stimulator, and the battery module supplies power for other parts of the program control instrument.
In addition, referring to fig. 7, the stimulator includes a stimulus acquisition module, a main control module, a wireless communication module, and a wireless charging module. The main control module is used for receiving and processing signals of the wireless communication module, sending a stimulation command, parameters and a collection command to the stimulation collection module, receiving collected data and sending the data to the wireless communication module. The wireless communication module is used for communicating with the program control instrument and receiving or sending information to the program control instrument. The wireless charging module is used for charging the internal battery, and the internal battery supplies power for other modules of the stimulator. The stimulus parameters of the stimulator and the programmer include, but are not limited to, frequency, pulse width, stimulus waveform, amplitude, voltage-current mode, and the like.
In some embodiments, the second end of the stimulating electrode includes a plurality of end surfaces, each end surface is provided with a plurality of electrode contacts, and when the second end of the stimulating electrode is connected to the stimulator, the electrode contacts can be contacted with elastic contact pieces inside the stimulator.
The second end of the stimulating electrode adopts a multi-end face design, and a plurality of electrode contact pieces are carefully arranged on each end face. Taking a common joint of the proximal ends of the triangular prism-shaped electrodes as an example, please refer to fig. 8, three sides of the joint are taken as end faces, and each side is provided with six electrode contacts 81, which are respectively in one-to-one correspondence with six electrode contacts of three independent electrode branches. The layout of multiple end surfaces and multiple contact plates greatly increases the contact area and the number of contact points between the electrodes and the stimulator, and lays a foundation for efficient transmission of signals.
When the second end of the stimulating electrode is connected to the stimulator, the electrode contact piece is contacted with the elastic contact piece inside the stimulator. The elastic contact piece has excellent elasticity and electric conductivity. During the insertion process, the electrode contact piece applies pressure to the elastic contact piece so as to enable the elastic contact piece to elastically deform. This deformation allows the elastic contact pads to tightly wrap around the electrode pads, forming a stable electrical connection.
This manner of contact has a number of advantages. On one hand, the device effectively reduces contact resistance, reduces energy loss of signals in the transmission process, and ensures that stimulation signals can be transmitted to nerve tissues with less attenuation. On the other hand, the self-adaptive nature of the resilient contact strip enables it to accommodate certain insertion errors and vibration environments. Even if the electrode position is slightly deviated or disturbed by external vibration in the use process, the elastic contact piece can still keep a good contact state and maintain stable signal transmission.
Through the embodiment, the multi-terminal surface design provides greater flexibility for the installation and the use of the stimulation electrode, so that the stable and reliable connection between the electrode and the stimulator can be realized by utilizing reasonable structural design and ingenious working principle, and powerful guarantee is provided for the efficient implementation of nerve stimulation treatment.
In some embodiments, the second end of the stimulating electrode is further provided with a directional pointing marker component, the housing of the stimulator is further provided with an insertion direction indicator component, and the directional pointing marker component is matched with the insertion direction indicator component when the second end of the stimulating electrode is connected to the stimulator.
The second end of the stimulating electrode adopts a multi-end surface design, and a plurality of electrode contact pieces are arranged on each end surface so as to increase the contact area with the stimulator and the signal transmission channel. On this basis, a directional pointing indicia component is specifically provided. The assembly is typically presented in a specific shape, color or pattern, such as an arrow-shaped protrusion or recess, positioned and oriented to match the electrode contact layout within the electrode. Illustratively, referring to FIG. 8, a directional pointing indicia assembly 82 of raised configuration is provided externally of the stimulation electrode second end. In addition, a sealing ring 83 is also designed between the electrode contact 81 and the directional pointing indicia assembly 82 for sealing the stimulating electrode to the stimulator.
The outer shell of the stimulator is correspondingly provided with an insertion direction indication mark component. The element may be a groove, a protrusion, or a score line, symbol, etc. with a specific identification that is compatible with the directional pointing indicia element of the stimulation electrode. When the second end of the stimulation electrode is ready to be connected to the stimulator, the user can quickly and accurately judge the insertion direction of the electrode by observing the two marking components.
In particular, the directional pointing indicia assembly is adapted to insert the direction indicating indicia assembly when the second end of the stimulation electrode is inserted into the stimulator in the correct direction. During the insertion process, the electrode contact pieces are gradually contacted with and tightly attached to the elastic contact pieces inside the stimulator. Due to the accurate positioning action of the marking assembly, the electrode contact can be accurately aligned with the elastic contact of the corresponding channel of the stimulator, so that reliable electrical connection is formed.
More specifically, referring to fig. 9A, in the connection structure between the stimulation electrodes and the stimulator, access holes capable of being respectively connected to two stimulation electrodes are reserved in the outer casing of the stimulator, and one side of each access hole is respectively provided with a strip-shaped insertion direction indication mark assembly 91. The stimulator housing top end is also provided with a screw waterproof seal 92. Further, referring to fig. 9B, the internal structure of the stimulating electrode access to the stimulator in fig. 9A is shown, wherein thirty-six channel feedthroughs 93 are provided in the stimulator to connect to 6 electrode contacts on three end surfaces of the second end of the stimulating electrode respectively, and total 36 electrode contacts are shown. After the stimulating electrode is inserted into the stimulator, the stimulating electrode can be fixed by an electrode locking screw 94, a layer of screw is arranged on the screw to be waterproof and sealed, and each electrode contact piece is contacted with an elastic contact piece 95 of the stimulator.
Through the above-mentioned embodiment, through the ingenious cooperation of directional mark subassembly and direction of insertion indicator subassembly, realized the accurate butt joint of stimulating electrode and stimulator, greatly reduced the incorrect problem of electrode contact and stimulator passageway connection because of the direction of insertion mistake leads to, avoided signal transmission unusual or the risk of equipment damage, improved electrode insert's efficiency and accuracy, reduced operating time and degree of difficulty.
In some embodiments, the stimulation electrodes include a first stimulation electrode and a second stimulation electrode. The first stimulation electrode and the second stimulation electrode can be respectively provided with three independent electrode branches, each branch has six stimulation sites, and each stimulation site of each independent electrode branch of the stimulation electrode has stimulation and acquisition functions. The two stimulation electrodes can be respectively connected to the three sacral nerve target points on the left side and the three sacral nerve target points on the right side. It should be noted that the present application also supports unilateral sacral nerve multi-electrode access, stimulation and collection, referring to fig. 10, three independent electrode branches of the first stimulation electrode are inserted into three sacral nerve target sites of S2, S3, S4 on the right side, respectively. At this time, the opening at the second stimulation electrode is sealed.
The electrode branches of the first stimulation electrode and/or the electrode branches of the second stimulation electrode are also provided with electrode barbs, wherein the distance between the positions of the electrode barbs and the positions of the electrode contacts is within a preset distance range, and when the independent electrode branches are implanted into corresponding sacral nerve target points, the distance between the positions of the electrode barbs and the sacral nerve target points is larger than the distance between the positions of the electrode contacts and the sacral nerve target points. For example, referring to fig. 3, the stimulation electrode is split into three separate electrode branches 221, denoted branch a, branch b and branch c, respectively, with six separate electrode contacts on each branch, numbered from the nearest location at the distal end, in turn numbered 0, 1,2, 3,4, 5 contacts. At a distance from the electrode contact 222 is an electrode barb 31 for securing between the stimulation electrode and the sacral foramen.
The embodiment also provides a parameter configuration method applied to the sacral nerve multi-target point co-stimulation system according to any one of the embodiments, wherein the process includes the following steps:
The method comprises the steps of obtaining stimulation parameters, carrying out parameter configuration processing based on the stimulation parameters, providing stimulation current for at least one independent electrode branch of a stimulation electrode, and enabling the stimulation current to act on a sacral nerve target point through electrode contacts on the independent electrode branch. The stimulator is used for configuring the stimulation and acquisition channels and outputting stimulation according to the designated stimulation parameters.
It should be noted that the steps illustrated in the above-described flow or flow diagrams of the figures may be performed in a computer system, such as a set of computer-executable instructions, and that, although a logical order is illustrated in the flow diagrams, in some cases, the steps illustrated or described may be performed in an order other than that illustrated herein.
The user information (including but not limited to user equipment information, user personal information, etc.) and data (including but not limited to data for analysis, stored data, presented data, etc.) referred to by the present application are both information and data authorized by the user or sufficiently authorized by the parties.
Those skilled in the art will appreciate that implementing all or part of the above described methods may be accomplished by way of a computer program stored on a non-transitory computer readable storage medium, which when executed, may comprise the steps of the embodiments of the methods described above. Any reference to memory, database, or other medium used in embodiments provided herein may include at least one of non-volatile and volatile memory. The nonvolatile Memory may include Read-Only Memory (ROM), magnetic tape, floppy disk, flash Memory, optical Memory, high density embedded nonvolatile Memory, resistive random access Memory (ReRAM), magneto-resistive random access Memory (Magnetoresistive Random Access Memory, MRAM), ferroelectric Memory (Ferroelectric Random AccessMemory, FRAM), phase change Memory (PHASE CHANGE Memory, PCM), graphene Memory, and the like. Volatile memory can include random access memory (Random Access Memory, RAM) or external cache memory, and the like. By way of illustration, and not limitation, RAM can be in various forms such as static random access memory (StaticRandom Access Memory, SRAM) or dynamic random access memory (Dynamic Random Access Memory, DRAM), etc. The databases referred to in the embodiments provided herein may include at least one of a relational database and a non-relational database. The non-relational database may include, but is not limited to, a blockchain-based distributed database, and the like. The processor referred to in the embodiments provided in the present application may be a general-purpose processor, a central processing unit, a graphics processor, a digital signal processor, a programmable logic unit, a data processing logic unit based on quantum computing, or the like, but is not limited thereto.
It should be understood by those skilled in the art that the technical features of the above-described embodiments may be combined in any manner, and for brevity, all of the possible combinations of the technical features of the above-described embodiments are not described, however, they should be considered as being within the scope of the description provided herein, as long as there is no contradiction between the combinations of the technical features.
The above examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the application. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application. Accordingly, the scope of protection of the present application is to be determined by the appended claims.