Detailed Description
In order that those skilled in the art will better understand the present invention, a detailed description of the embodiments of the present disclosure will be provided with reference to the accompanying drawings, wherein it is apparent that the embodiments described are only some, but not all, of the embodiments of the present disclosure. All other embodiments, which can be made by those skilled in the art based on the embodiments of the present invention without making any inventive effort, shall fall within the scope of the present invention.
It should be noted that the terms "first," "second," and the like in the description and the claims of the present invention and the above figures are used for distinguishing between similar objects and not necessarily for describing a particular sequential or chronological order. It is to be understood that the data so used may be interchanged where appropriate such that the embodiments of the invention described herein may be implemented in sequences other than those illustrated or otherwise described herein. The cases of "target", "original", etc. are similar and will not be described in detail herein. Furthermore, the terms "comprises," "comprising," and "having," and any variations 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 elements is not necessarily limited to those steps or elements that are expressly listed or inherent to such process, method, article, or apparatus.
It will be appreciated that prior to using the technical solutions disclosed in the embodiments of the present disclosure, the user should be informed and authorized of the type, usage range, usage scenario, etc. of the personal information related to the present disclosure in an appropriate manner according to the relevant legal regulations.
Before the embodiments of the present disclosure are described, technical fields and related terms applied to program control devices, current program control device schemes, and reasons for the problem that the accuracy of the adopted stimulation parameters is not high are described in an exemplary manner, so that the reasons that the accuracy of the adopted stimulation parameters can be improved by the program control device schemes provided by the embodiments of the present disclosure are better understood.
Implantable medical systems may include implantable neurostimulation systems, implantable cardiac electrical stimulation systems (also known as cardiac pacemakers), implantable drug infusion systems (Implantable Drug DELIVERY SYSTEM, IDDS), lead switching systems, and the like. The implantable neural electrical stimulation system may be, for example, DBS, implantable cerebral cortex stimulation system (Cortical Nerve Stimulation, CNS), implantable spinal cord electrical stimulation system (Spinal Cord Stimulation, SCS), implantable sacral nerve electrical stimulation system (SACRAL NERVE Stimulation, SNS), and/or implantable vagal nerve electrical stimulation system (Vagus Nerve Stimulation, VNS), etc. An implantable neural electrical stimulation system includes a stimulator (i.e., an implantable neural stimulator) implanted in a subject and a programmable device disposed outside the subject, that is, the stimulator is a medical device, or the medical device includes a stimulator. The related nerve regulation technology mainly implants an electrode (the electrode is presented in the form of an electrode wire for example) at a specific part (namely a target point, also called a target nucleus) of a tissue of an organism through stereotactic surgery, and delivers electrical stimulation to the target point through the electrode to regulate and control the electrical activity and functions of a corresponding nerve structure and network.
The DBS may include an implantable pulse generator (Implantable Pulse Generator, IPG) connected to the electrode lead via an extension lead, and an electrode lead, the IPG may be implanted in the subject, for example, in the chest or other body part of the subject, and the DBS may further include an IPG and a lead body directly connected to the lead body, the IPG may be implanted in the head of the subject, for example, by slotting the skull of the subject, and then mounted in the slot of the skull, in which case the IPG may not protrude from the outer surface of the skull, or may protrude partially from the outer surface of the skull. The IPG can respond to a program control instruction sent by program control equipment, provide controllable electric stimulation treatment (or electric stimulation energy) for internal tissues of a target object by means of a sealed battery and a circuit, deliver one or more controllable specific electric stimulation for specific areas of the internal tissues through the lead body, and the extension lead is matched with the IPG to be used as a transmission medium of the electric stimulation to transmit the electric stimulation generated by the IPG to the lead body.
The electrical stimulation may be delivered in the form of a pulsed signal or may be delivered in the form of a non-pulsed signal, e.g., the electrical stimulation may be delivered as a signal having various waveform shapes, frequencies, and amplitudes, and thus the electrical stimulation in the form of a non-pulsed signal may be a continuous signal, which may have a sinusoidal waveform or other continuous waveform. The lead body delivers electrical stimulation to a specific region of tissue in the body through the plurality of electrode contacts upon receiving the electrical stimulation delivered by the IPG or extension lead. The stimulator is provided with one or more single-sided or double-sided lead bodies, on which a plurality of electrode contacts are provided, which may be uniformly arranged or non-uniformly arranged in the circumferential direction of the lead bodies. The electrode contacts may be arranged in a 4 row and 3 column array (12 electrode contacts in total) in the circumferential direction of the lead body, and may include stimulation electrode contacts and/or collection electrode contacts, which may take the shape of, for example, a sheet, ring, dot, or the like.
The stimulated in vivo tissue may be brain tissue of the target subject, the stimulated site may be a specific site of brain tissue, the stimulated sites of different target subjects may generally be different, the number of stimulation contacts (single or multiple sources) used, the application of one or more (single or multiple channels) specific electrical stimuli, and the stimulation parameters (values) may also be different. The type of target tissue to which the stimulation is applicable is not limited, and may be Deep Brain Stimulation (DBS), spinal Cord Stimulation (SCS), sacral nerve stimulation, gastric stimulation, peripheral nerve stimulation, and/or functional electrical stimulation, among others.
At present, in the DBS process, an operation object directly selects a stimulation parameter according to the individual condition of a target object to optimize the stimulation effect, but this way lacks an intuitive and accurate stimulation parameter feedback mechanism, so that the accuracy of the stimulation parameter adopted by the electrical stimulation may not be high, and further the electrical stimulation range of the electrical stimulation to the target object may be too large or too small, so that the stimulation effect of the electrical stimulation to the target object may be influenced, and even side effects may be generated.
In view of this, the embodiment of the disclosure may display the target electric field model generated according to the target stimulation parameter, so that the operation object may accurately adjust the target stimulation parameter based on the displayed target electric field model, thereby improving the accuracy of the adopted stimulation parameter. This will be explained in detail below.
Fig. 1 is a block diagram of a program control apparatus according to an embodiment of the present disclosure. The embodiment is applicable to the case of electrically stimulating a target object.
Referring to fig. 1, a programming device 110 of an embodiment of the present disclosure is communicatively connected to a stimulator 120 implanted within a target object, the programming device 110 comprising a display interface 1101 and a processor 1102;
The display interface 1101 includes a display unit 11011 displaying at least a post-operative brain model of the target subject, an operation unit 11012 for the subject to perform parameter selection, and a program control unit 11013 delivering a stimulation instruction to the stimulator, wherein,
The processor 1102 is configured to generate a target electric field model superimposed on the postoperative brain model displayed on the display unit 11011 based on the target stimulation parameter selection of the operation subject on the operation unit 11012, for the operation subject to adjust the target stimulation parameter on the operation unit 11012 based on the target electric field model displayed on the display unit 11011, and to send the target stimulation parameter to the stimulator 120 in a soft output mode in case the operation subject triggers the program control unit 11013.
In the embodiment of the present disclosure, the program control device 110 may include a doctor program control device (i.e., the program control device 110 used by a doctor) and/or a user program control device (i.e., the program control device used by a patient), and the program control device in the present disclosure may be a doctor program control device, and accordingly, a doctor who operates the program control device 110 may be referred to as an operation object. The doctor program control device is, for example, an intelligent terminal device such as a tablet computer, a notebook computer, a desktop computer and/or a mobile phone loaded with program control software.
In the embodiment of the present disclosure, the programmable device 110 may be communicatively connected to the stimulator 120 implanted in the target object, that is, the programmable device 110 may be used to adjust one or more stimulation parameters of the stimulator 120 (or one or more stimulation parameters of the pulse generator, where the electrical stimulation corresponding to different stimulation parameters is different), so that the stimulator 120 delivers the electrical stimulation to the implanted electrode according to the adjusted stimulation parameters to electrically stimulate the target object.
The target object may be understood as a subject to which the stimulator 120 is implanted to perform electrical stimulation, and may be a patient, and symptoms of different patients may be different, and positions of the implanted electrodes implanted in the patient may be different.
The display interface 1101 can be understood as an interface having a display function.
The processor 1102 may be understood as a processor 1102 having processing functions.
The post-operative brain model is understood to be a model corresponding to the brain of the target subject after the operation in which the implant electrode is implanted.
In the disclosed embodiment, the processor 1102 may read a medical image of a target object such as magnetic resonance imaging (Magnetic Resonance Imaging, MRI) or computed tomography (Computed Tomography, CT) image data of the target object, and convert the medical image into a three-dimensional space coordinate system to obtain coordinate data, automatically identify a brain tissue (such as a nucleus, cerebrospinal fluid, and the like) in the medical image by an image processing algorithm, and determine a location of the brain tissue in the medical image according to the identification result, wherein the brain tissue includes at least a target nucleus associated with a patient condition, the target nucleus can be understood as a region of the target object where the brain needs to be electrically stimulated, determine at least one of coordinates and shapes of the brain tissue in the three-dimensional space coordinate system according to the location and the coordinate data, determine position data of the brain tissue in the brain according to the coordinates and shapes of the brain tissue in the three-dimensional space coordinate system, wherein the position of the target nucleus represented by the position data has a certain matching relationship with a position of an implanted electrode in the brain, thereby ensuring that the electrical stimulation can accurately act on the target nucleus, and the target nucleus can be generated according to the medical coordinate system, the position data and the nuclear data can include a target nucleus, and a model can be further accurately displayed after the current model, and the current model can be generated, and a target model can be further accurately displayed.
It should be understood that the post-operation medical image of the patient may include some features of the implanted electrode, and of course, the features that may be included in different slices of the CT image may be different, and the post-operation brain model of the patient may be obtained by performing electrode feature simulation on the medical image to obtain an electrode model of the implanted electrode (including the electrode lead and the electrode contact) in the brain of the patient, and registering and fusing the electrode model and the brain tissue module of the patient.
The display unit 11011 may be understood as a unit for displaying at least a brain model after operation, and may display at least one of a target electric field model, an initial electric field model, a coincidence rate display frame, etc. in addition to the brain model after operation, so that an operator can learn more information through the content displayed by the display unit, thereby being beneficial to more accurately adjusting or setting parameters related to electrical stimulation.
The operation object may be understood as an object to operate the program control apparatus 110.
Parameter selection may be understood as a selection operation to select a target stimulation parameter.
The operation unit 11012 can be understood as a unit that can be operated by an operation object.
Stimulation instructions may be understood as instructions that are delivered to stimulator 120 to cause stimulator 120 to electrically stimulate a target object.
The programmed unit 11013 may be understood as a unit that delivers stimulation instructions to the stimulator 120.
The target stimulation parameters may be understood as parameters involved in causing the stimulator 120 to stimulate the target subject. The target stimulation parameters may include at least one of an electrode contact combination for delivering electrical stimulation (which may include at least one electrode contact identifier, such as a 2# electrode contact and a 3# electrode contact) and an electrode stimulation parameter, and the electrode stimulation parameters may include at least one of a frequency (e.g., number of electrical stimulation pulses per time unit of 1s, in Hz), a pulse width (duration of each pulse, in mus), an amplitude (typically expressed in voltage, i.e., intensity of each pulse, in V), a timing (e.g., a sequential or clustered, meaning a discontinuous timing behavior of multiple processes), a stimulation mode (including one or more of a current mode, a voltage mode, a timed stimulation mode, and a cyclic stimulation mode), an upper and lower control limit (the range of the control object) and an upper and lower control limit (the range of the target object may be autonomously adjusted).
The target electric field model may be understood as an electric field model generated based on the target stimulation parameters, and the target electric field model may be understood as a model corresponding to the spatial distribution of the characterization of the activated tissue volume (Volume of Activated Tissue, VTA) representing the range of influence of the electric field generated by the electrical stimulation on the brain tissue of the brain under the electrical stimulation corresponding to the target stimulation parameters.
In an embodiment of the present disclosure, the processor 1102 may generate a target electric field model superimposed on the post-operative brain model displayed on the display unit 11011 based on the target stimulation parameter selection of the operation subject on the operation unit 11012 for the operation subject to adjust the target stimulation parameter on the operation unit 11012 based on the target electric field model displayed on the display unit 11011. The process of generating the target electric field model may be, for example, the processor 1102 may calculate, according to target stimulation parameters, a spatial distribution of the VTA under the electrical stimulation (for example, by physical model principles, according to the positions of the implanted electrodes in the brain, the target stimulation parameters, and the brain structures, dynamically calculate the spatial distribution), generate, according to the spatial distribution, a target electric field model (for example, may be represented in the form of a three-dimensional VTA range), and may further, for example, obtain personalized data of the target object (the personalized data may include, for example, at least one of a medical image of the brain, a three-dimensional coordinate of a target nucleus in a three-dimensional coordinate system, and a position of the implanted electrodes implanted in the brain, etc.), electrode parameters (the electrode parameters may include, for example, at least one of a model number of implanted electrodes, a polarity, a size, a material, an electrode spacing, etc.), and brain tissue characteristics (at least one of tissue conductivity, a dielectric constant, an anisotropic characteristic of the brain, etc.), determine at least one candidate stimulation parameter according to the target stimulation parameters, the personalized data, the electrode parameters, and the brain tissue characteristics, and generate, and display the target electric field model superimposed on the display unit 11011.
In the embodiment of the present disclosure, the target stimulation parameters selected by the operation subject on the operation unit 11012 may be acquired before the processor 1102 generates the target electric field model processor 1102. It should be noted that the target stimulation parameter may be selected by the operator from at least one to-be-selected stimulation parameter displayed on the operation unit 11012, and the selection manner of the target stimulation parameter may be helpful for the operator to efficiently select the target stimulation parameter, or may be directly input by the operator through the operation unit 11012, and the selection manner of the target stimulation parameter may be helpful for obtaining the target stimulation parameter that meets the requirement of the operator.
In the embodiment of the present disclosure, after the target electric field model displayed on the display unit 11011 is adjusted on the operation unit 11012 by the operation object, the target electric field model superimposed on the postoperative brain model displayed on the display unit 11011 may be updated in real time based on the target stimulation parameter, so that the operation object may adjust the target stimulation parameter on the operation unit 11012 based on the updated target electric field model displayed on the display unit 11011, and the step of updating the target electric field model superimposed on the postoperative brain model displayed on the display unit 11011 based on the target stimulation parameter is repeatedly performed until the operation object considers that the target stimulation parameter is accurate, and the target stimulation parameter is not adjusted any more.
In the embodiment of the present disclosure, the display unit 11011 may further display a change of the target electric field model displayed under different target stimulation parameters (for example, the target stimulation parameters corresponding to each of the adjustment before and after the adjustment or the selected multiple groups of different target stimulation parameters waiting), so as to provide more information for the operation object to adjust the target stimulation parameters.
In embodiments of the present disclosure, the selection and/or adjustment of the target stimulation parameters may be performed in a current mode or a voltage mode, so that the voltage or current of the electrical stimulation delivered to the patient is more accurate through the selection and/or adjustment of the target stimulation parameters.
The Soft Output Mode (Soft Output Mode) can be understood as a Mode of gradually outputting the target stimulation parameters, because when the electric stimulation is delivered to the nuclear tissue of the brain of the patient, if the electric stimulation is suddenly delivered at a higher stimulation intensity, the electric stimulation can be delivered to the patient in a progressive manner through the Soft Output module, so that the electric stimulation can be gradually adapted to the stimulation intensity of the patient, and the treatment experience of the patient is improved.
In the disclosed embodiment, the processor 1102 may send the target stimulation parameters to the stimulator 120 in a soft output mode in case the subject triggers the programming unit 11013.
The processor 1102 may generate a target electric field model to be displayed on the display unit 11011 in a superimposed manner according to target stimulation parameters selected by the operation subject through the operation unit 11012, the display unit 11011 may display the post-operation brain model and the target electric field model to be superimposed on the post-operation brain model, so that the operation subject may adjust the target stimulation parameters (or may not adjust the target stimulation parameters if the operation subject considers that the target stimulation parameters are accurate based on the target electric field model displayed on the display unit 11011 through the operation unit 11012) based on the target electric field model displayed on the display unit 11011, and the processor 1102 may send the target stimulation parameters to the stimulator 120 in a soft output mode through a stimulation command if the operation subject triggers the program control unit 11013, so that the stimulator 120 electrically stimulates the target subject according to the target stimulation parameters.
In an embodiment of the present disclosure, the processor 1102 may be further configured to sense the electrophysiological activity of the target subject through the stimulator 120 to acquire electrophysiological signals, and adjust the target stimulation parameters according to the electrophysiological activity and the electrophysiological signals to achieve closed-loop control (or adaptive adjustment) of the target stimulation parameters.
The scheme of the embodiment of the disclosure can be applied to the field of biomedical engineering, and particularly can be applied to the medical fields of nerve regulation, electrical stimulation treatment and the like.
The program control device 110 of the embodiment of the present disclosure may provide a high-efficiency and intuitively friendly display interface 1101 for an operation object, support the operation object to freely adjust target stimulation parameters and view real-time electric field model feedback, so as to help the operation object understand specific effects of electric stimulation on brain tissues through the displayed target electric field model, thereby enabling the operation object to accurately adjust target stimulation parameters based on the displayed target electric field model, improving accuracy of the adopted stimulation parameters, avoiding excessive or insufficient electric stimulation, reducing unnecessary side effects, and ensuring safety and effectiveness of electric stimulation.
Optionally, the operation unit 11012 includes at least a stimulation parameter adjustment control to adjust the target stimulation parameter by the stimulation parameter adjustment control, the adjusted target stimulation parameter including at least one of frequency, pulse width, and amplitude.
The stimulation parameter adjustment control is understood to be a control for adjusting the target stimulation parameter.
In the embodiment of the present disclosure, the operation unit 11012 includes at least a stimulation parameter adjustment control to adjust a target stimulation parameter through the stimulation parameter adjustment control, where the adjusted target stimulation parameter includes at least one of a frequency, a pulse width, and an amplitude of the electrical stimulation, so as to provide an adjustment function for at least one of the frequency, the pulse width, and the amplitude of the electrical stimulation, and the adjustment for at least one of the frequency, the pulse width, and the amplitude of the electrical stimulation can achieve an effective adjustment in an intensity dimension of the electrical stimulation, thereby improving a therapeutic experience of a patient.
According to the technical scheme, the program control equipment can be in communication connection with a stimulator implanted in a target object, and comprises a display interface and a processor, wherein the display interface comprises a display unit for displaying at least a postoperative brain model of the target object, an operation unit for the operation object to execute parameter selection and a program control unit for delivering a stimulation instruction to the stimulator, and the processor can generate a target electric field model which is overlapped and displayed on the display unit based on the target stimulation parameter selection of the operation object on the operation unit, so that the operation object can adjust the target stimulation parameter on the operation unit based on the target electric field model displayed on the display unit, and the target stimulation parameter is sent to the stimulator in a soft output mode under the condition that the operation object triggers the program control unit, so that the target object is electrically stimulated. According to the technical scheme, the target electric field model generated according to the target stimulation parameters can be displayed, so that an operation object can accurately adjust the target stimulation parameters based on the displayed target electric field model, and the accuracy of the adopted stimulation parameters is improved.
An alternative technical scheme is that at least one implantation electrode is implanted at a target nucleus of a brain of a target object, a stimulator is configured to deliver electrical stimulation to at least part of the implantation electrodes, target stimulation parameters comprise an electrode contact combination and electrode stimulation parameters, and a processor is specifically configured to generate a target electric field model which is superimposed and displayed on a postoperative brain model displayed on a display unit based on target stimulation parameter selection of the operating object on the operation unit, so that the operating object can adjust the target stimulation parameters on the operation unit based on the target electric field model displayed on the display unit, and the electrode contact combination and the electrode stimulation parameters are sent to the stimulator in a soft output mode when the operating object triggers a program control unit, so that the stimulator delivers the electrical stimulation to the implantation electrode corresponding to the electrode contact combination according to the electrode stimulation parameters, and the electrical stimulation is performed on the target nucleus.
The implanted electrode is understood to be an electrode implanted at a target nucleus of a brain of a target object, and the electrical stimulation of the target object can be achieved by the implanted electrode implanted in the brain.
The electrode contact combination is understood to be a combination of contacts on an implanted electrode which is required to deliver the electrical stimulation, and the range of influence of an electric field generated by the electrical stimulation on brain tissues of the brain is different by adopting different electrode contact combinations.
The electrode stimulation parameters may be understood as parameters employed for the electrical stimulation, and may include, for example, at least one of current intensity, frequency, pulse width, amplitude, etc. of the electrical stimulation.
In an embodiment of the disclosure, at least one implant electrode is implanted at a target nucleus, a stimulator is configured to deliver electrical stimulation to at least part of the implant electrodes, the target stimulation parameters include an electrode contact combination and electrode stimulation parameters, a target electric field model superimposed and displayed on a post-operative brain model displayed on a display unit is generated by a processor based on target stimulation parameter selection of an operation object on the operation unit, the operation object adjusts the target stimulation parameters on the operation unit based on the target electric field model displayed on the display unit, and the electrode contact combination and the electrode stimulation parameters are sent to the stimulator in a soft output mode when the operation object triggers a program control unit, so that the stimulator delivers electrical stimulation to the implant electrode corresponding to the electrode contact combination according to the electrode stimulation parameters to perform electrical stimulation on the target nucleus. According to the technical scheme, the target nucleus can be electrically stimulated more accurately through the target stimulation parameters including the electrode contact combination and the electrode stimulation parameters.
In addition to the above, in another optional aspect, the display unit further includes a coincidence rate display frame configured to display a coincidence rate between the target electric field model and the target nucleus.
In which, for example, referring to fig. 2, a coincidence display box is understood to be a box that displays the coincidence, which can be in the form of a bullet box, without affecting the display of the target nuclei and the target electric field model.
The coincidence rate can be understood as the coincidence rate between the target electric field model and the target nucleus, and the doctor can be rapidly reminded of the influence degree of the current stimulation parameters on the target nucleus through the display of the coincidence rate, so that the rapid adjustment of the stimulation parameters is facilitated, and the program control efficiency and convenience are improved.
In the embodiment of the disclosure, the postoperative brain model may include a target nucleus, and the target nucleus may also be displayed under the condition that the display unit displays the postoperative brain model, on this basis, the display unit may further display a superposition area between the target nucleus and the target electric field model, so as to display the VTA range of the electric stimulus represented by the target electric field model and the relationship between the VTA range and the target nucleus on the display interface in an intuitive manner, so that an operator can clearly know the size and shape of the target electric field model and the spatial superposition condition between the VTA and the target nucleus, and provide a basis for the operator to adjust the target stimulation parameters.
In the embodiment of the disclosure, the display unit may further display a coverage area of the target electric field model, a position of the target nucleus, a correlation between the target nucleus and the target electric field model, and so on, so that the operation object can know more relevant information capable of representing whether the target stimulation parameter is accurate, thereby being beneficial to more accurately adjusting the target stimulation parameter.
In the embodiment of the present disclosure, the processor may be further configured to perform adjustment such as rotation or scaling corresponding to the operation instruction on the content displayed by the display unit when the operation object triggers an operation instruction such as rotation or scaling triggered by the display unit, so that the operation object may more accurately view, in real time, spatial contrast between the target nucleus and the target electric field model, so as to further optimize and adjust the target stimulation parameter.
In an embodiment of the present disclosure, the display unit may include a coincidence rate display frame, and the coincidence rate display frame may display a coincidence rate between the target electric field model and the target nuclei. According to the technical scheme, the basis can be provided for more accurately adjusting the target stimulation parameters for the operation object through the display of the coincidence rate.
In still another alternative solution, the processor is further configured to send the adjusted target stimulation parameter to the stimulator in a soft output mode when the target stimulation parameter is adjusted on the operation unit according to the second object feedback of the target object, so that the stimulator adjusts the electrical stimulation performed on the target object according to the adjusted target stimulation parameter.
The second object feedback may be understood as a feedback related to the target object, and the second object feedback may include, for example, a physiological index and/or subjective feeling of the target object.
In the embodiment of the disclosure, the processor may send the adjusted target stimulation parameter to the stimulator in the soft output mode under the condition that the target stimulation parameter is adjusted on the operation unit according to the second object feedback by the operation object, so that the stimulator adjusts the electrical stimulation performed on the target object according to the adjusted target stimulation parameter. According to the technical scheme, the electric stimulation to the target object can be realized, the actual situation of the target object is more met, and particularly, the target stimulation parameters can be timely adjusted under the condition that the second object feedback characterizes the discomfort exists in the target object, so that the electric stimulation is more met to the actual situation of the target object, and the discomfort is avoided.
Fig. 3 is a block diagram of another program control apparatus according to an embodiment of the present disclosure. The present embodiment is optimized based on the above technical solutions. In this embodiment, optionally, the processor is further configured to update the initial stimulation parameters according to the initial stimulation parameters and the parameter adjustment rate if the initial stimulation parameters of the stimulator are less than or equal to the target stimulation parameters before sending the target stimulation parameters to the stimulator in the soft output mode, send the initial stimulation parameters to the stimulator in the soft output mode to cause the stimulator to electrically stimulate the target subject according to the initial stimulation parameters, and repeatedly perform the step of updating the initial stimulation parameters according to the initial stimulation parameters and the parameter adjustment rate if the initial stimulation parameters of the stimulator are less than or equal to the target stimulation parameters. Wherein, the explanation of the same or corresponding terms as the above embodiments is not repeated herein.
Specifically, referring to FIG. 3, the programming device 210 of the present embodiment, in communication with a stimulator 220 implanted within a subject, includes a display interface 2101 and a processor 2102;
the display interface includes a display unit 21011 displaying at least a post-operation brain model of the target object, an operation unit 21012 for performing parameter selection by the operation object, and a program control unit 21013 delivering a stimulation instruction to the stimulator,
A processor 2102 configured to generate a target electric field model superimposed on the postoperative brain model displayed on the display unit 21011 based on target stimulation parameter selection of the operation subject on the operation unit 21012, for the operation subject to adjust the target stimulation parameters on the operation unit 21012 based on the target electric field model displayed on the display unit 21011, and to transmit the target stimulation parameters to the stimulator 220 in a soft output mode in case the operation subject triggers the program control unit 21013;
The processor 2102 is further configured to update the initial stimulation parameters according to the initial stimulation parameters and the parameter adjustment rate if the initial stimulation parameters of the stimulator are less than or equal to the target stimulation parameters before transmitting the target stimulation parameters to the stimulator 220 in the soft output mode, transmit the initial stimulation parameters to the stimulator 220 in the soft output mode to cause the stimulator 220 to electrically stimulate the target subject according to the initial stimulation parameters, and repeatedly perform the step of updating the initial stimulation parameters according to the initial stimulation parameters and the parameter adjustment rate if the initial stimulation parameters of the stimulator 220 are less than or equal to the target stimulation parameters.
The initial stimulation parameters may be understood as stimulation parameters used by the stimulator to initially electrically stimulate the target object, and the initial stimulation parameters may be understood as stimulation parameters used by the stimulator to electrically stimulate the target object before electrically stimulating the target object with the target stimulation parameters.
The parameter adjustment rate can be understood as the rate of adjusting the initial stimulation parameters, the parameter adjustment rate can be understood as the rate of changing the electrical stimulation in the process of gradually delivering the electrical stimulation to the patient, and the electrical stimulation can be gradually delivered to the patient according to the proper speed by setting the proper parameter adjustment rate, so that the patient can gradually adapt to the strength of the stimulation, and the treatment experience of the patient is improved.
It should be noted that, in the embodiment of the present disclosure, the initial stimulation parameter is determined to be less than or equal to the target stimulation parameter, and the initial stimulation parameter is adjusted, the determined or adjusted stimulation parameter may not be all the stimulation parameters, and in particular, the determined or adjusted stimulation parameter may be at least one parameter that may be determined by adjusting and comparing the current intensity, frequency, pulse width, amplitude, and the like in the initial stimulation parameter.
According to the technical scheme, before the target stimulation parameter is sent to the stimulator in the soft output mode, the initial stimulation parameter is updated according to the initial stimulation parameter and the parameter adjustment rate when the initial stimulation parameter of the stimulator is smaller than or equal to the target stimulation parameter, the initial stimulation parameter is sent to the stimulator in the soft output mode, so that the stimulator electrically stimulates the target object according to the initial stimulation parameter, and finally, the step of updating the initial stimulation parameter according to the initial stimulation parameter and the parameter adjustment rate when the initial stimulation parameter of the stimulator is smaller than or equal to the target stimulation parameter is repeatedly executed. According to the technical scheme, a mechanism capable of gradually adjusting the stimulation parameters can be added through the initial stimulation parameters and the parameter adjustment rate, the initial stimulation parameters for electrically stimulating the target object are gradually adjusted until the target stimulation parameters are reached, the process of electric stimulation adaptation can be provided for the target object, and discomfort or side effects brought to the target object due to direct stimulation of the target object according to electric stimulation corresponding to the target stimulation parameters are avoided.
In an alternative technical scheme, the processor is further configured to generate an initial electric field model superimposed and displayed on the postoperative brain model displayed on the display unit based on the initial stimulation parameter before updating the initial stimulation parameter according to the initial stimulation parameter and the parameter adjustment rate when the initial stimulation parameter of the stimulator is smaller than or equal to the target stimulation parameter, and adjust the initial electric field model displayed on the display unit based on the initial stimulation parameter after updating the initial stimulation parameter according to the initial stimulation parameter and the parameter adjustment rate.
Wherein the initial electric field model may be understood as an electric field model generated based on the initial stimulation parameters.
In the embodiment of the disclosure, in the case that the initial stimulation parameter of the stimulator is smaller than or equal to the target stimulation parameter, the processor generates an initial electric field model superimposed and displayed on the postoperative brain model displayed on the display unit based on the initial stimulation parameter before updating the initial stimulation parameter according to the initial stimulation parameter and the parameter adjustment rate, and adjusts the initial electric field model displayed on the display unit based on the initial stimulation parameter after updating the initial stimulation parameter according to the initial stimulation parameter and the parameter adjustment rate, so that the progressive enhanced visualized initial electric field model can be provided for the operation object, so that the operation object can know the electric stimulation degree of the target object.
In another alternative solution, the processor is further configured to update the parameter adjustment rate according to an adjustment result obtained by the adjustment when the operation object adjusts the parameter adjustment rate on the operation unit according to the first object feedback of the target object.
The first subject feedback may be understood as a feedback related to the target subject itself in the case of being electrically stimulated according to the initial stimulation parameters, and may include, for example, physiological indicators and/or subjective feelings, etc.
In the embodiment of the disclosure, when the operating object adjusts the parameter adjustment rate on the operating unit according to the first object feedback, the processor updates the parameter adjustment rate according to the adjustment result, so that the controllability of the electrical stimulation change process can be increased, and when the first object feedback characterizes that the target object has discomfort, the parameter adjustment rate can be updated in time, so as to avoid discomfort or side effects caused by the parameter adjustment rate which does not meet the requirement of the target object as the target object.
Fig. 4 is a block diagram of still another program control apparatus provided in an embodiment of the present disclosure. The present embodiment is optimized based on the above technical solutions. In this embodiment, optionally, the processor is further configured to determine at least one similar case similar to the target case of the target object from the at least one alternative case, and determine the to-be-selected stimulation parameters respectively corresponding to the at least one similar case displayed on the operation unit, so that the operation object selects the target stimulation parameters from the at least one to-be-selected stimulation parameters on the operation unit. Wherein, the explanation of the same or corresponding terms as the above embodiments is not repeated herein.
Specifically, referring to FIG. 4, the programming device 310 of the present embodiment, which is communicatively connected to a stimulator 320 implanted in a subject, includes a display interface 3101 and a processor 3102;
The display interface 3101 includes a display unit 31011 that displays at least a post-operation brain model of the target object, an operation unit 31012 for the operation object to perform parameter selection, and a program-controlled unit 31013 that delivers a stimulation instruction to the stimulator, wherein,
A processor 3102 configured to generate a target electric field model superimposed on the postoperative brain model displayed on the display unit 31011 based on target stimulation parameter selection of the operation subject on the operation unit 31012, for the operation subject to adjust the target stimulation parameters on the operation unit 31012 based on the target electric field model displayed on the display unit 31011, and to send the target stimulation parameters to the stimulator 320 in a soft output mode in case the operation subject triggers the program control unit;
The processor 3102 is further configured to determine at least one similar case similar to the target case of the target object from the at least one alternative case, and determine the selected stimulation parameters respectively corresponding to the at least one similar case displayed on the operation unit 31012, for the operation object to select the target stimulation parameters from the at least one selected stimulation parameters on the operation unit 31012.
The candidate case may be understood as a case that is candidate as a similar case, and the candidate case may be, for example, a case of the candidate subject that has been electrically stimulated.
The target case may be understood as a case of the target object.
Similar cases may be understood as alternative cases similar to the target case.
In an embodiment of the present disclosure, the processor 3102 may determine at least one similar case from the at least one alternative case that is similar to the target case of the target object. For example, the processor 3102 may retrieve, in at least one alternative case in the electrical stimulation parameter database, at least one similar case that is similar to the target case of the target object.
The stimulation parameters to be selected may be understood as the stimulation parameters used when the candidate object corresponding to the similar case is electrically stimulated.
It will be appreciated that, since the similar proportion is similar to the target case, the selected stimulation parameters adopted by the similar case also have target stimulation parameters that are more likely to be used as the target case, and thus the processor 3102 may determine the selected stimulation parameters respectively corresponding to the at least one similar case displayed on the operation unit 31012, so that the operation subject may select the target stimulation parameters from the at least one selected stimulation parameters on the operation unit 31012.
In the embodiment of the present disclosure, it may further determine at least one similar case corresponding to the case stimulation parameters displayed on the operation unit 31012, determine a stimulation parameter range according to the at least one similar case corresponding to the case stimulation parameters, and determine at least one to-be-selected stimulation parameter according to the stimulation parameter range, so that the operation object may select the target stimulation parameter from the at least one to-be-selected stimulation parameters on the operation unit 31012, and determine the at least one to-be-selected stimulation parameter on the basis of the stimulation parameter range, so that it may be avoided that the number of the at least one similar case corresponding to the case stimulation parameters is too small or too discrete, and it is difficult to provide more and more comprehensive options selectable by the operation object.
In the embodiment of the present disclosure, the processor 3102 may further determine, for each candidate stimulation parameter, a candidate electric field model displayed on the display unit 31011 according to the candidate stimulation parameter, so that the operation object may learn an influence range of the electrical stimulation under each candidate stimulation parameter on the brain, so that the operation object selects, on the operation unit 31012, a target stimulation parameter from at least one candidate stimulation parameter based on the candidate electric field model respectively corresponding to the displayed at least one candidate stimulation parameter.
According to the technical scheme of the embodiment of the disclosure, the processor determines at least one similar case similar to the target case from at least one alternative case, and determines the to-be-selected stimulation parameters respectively corresponding to the at least one similar case displayed on the operation unit, so that the operation object can select the target stimulation parameters from the at least one to-be-selected stimulation parameters on the operation unit. According to the technical scheme, at least one optimal stimulation parameter to be selected can be provided according to individual differences of the target object, so that the accuracy of the adopted stimulation parameters can be further improved.
An optional technical scheme, the processor is further configured to determine a similar electric field model of the similar case for each of the at least one similar case, superimpose the similar electric field model into the post-operation brain model of the framed reference electric field region, determine a rate of overlap between the similar electric field model superimposed onto the post-operation brain model and the reference electric field region, determine a target candidate case from the at least one similar case according to the respective rates of overlap of the at least one similar case, and update the at least one similar case according to the target candidate case.
Wherein the similar electric field model may be understood as an electric field model generated based on the corresponding candidate stimulation parameters of the similar case.
The reference electric field region may be understood as a framed region of the brain requiring electrical stimulation corresponding to a region in a post-operative brain model.
The overlap ratio is understood to be the overlap ratio between the similar electric field model and the reference electric field region.
In the embodiment of the disclosure, the processor may determine a similar electric field model of the similar case for each similar case, for example, the processor may determine the similar electric field model according to the selected stimulation parameter, the individuation data, the electrode parameter and the brain tissue characteristic corresponding to the similar case, superimpose the similar electric field model into the post-operation brain model framed with the reference electric field region, determine the overlapping rate, for example, superimpose the similar electric field model into the post-operation brain model framed with the reference electric field region and presented in a three-dimensional voxel grid, and calculate the overlapping rate of voxels between the voxel volume corresponding to the similar electric field model and the voxel volume corresponding to the reference electric field region.
The target candidate case may be understood as a similar case for updating at least one similar case, and the number of target candidate cases may be at least one.
In the embodiment of the disclosure, the processor may determine the target candidate case from the at least one similar case according to the overlapping rate corresponding to the at least one similar case, for example, a preset number (for example, 3-5) of similar cases with the highest overlapping rate in the at least one similar case, or similar cases with overlapping rate greater than the preset overlapping rate may be used as the target candidate case, so as to ensure that the coverage of the subsequent target electric field model is as accurate as possible, and update the at least one similar case according to the target candidate case.
In embodiments of the present disclosure, the processor may update at least one similar case based on the target candidate case, e.g., may update the target candidate case to at least one similar case,
In the embodiment of the disclosure, the display unit may further display the matching degree (which may be determined according to the overlapping rate corresponding to the stimulation parameters to be selected) between the at least one stimulation parameter to be selected and the reference electric field region, so that the operation object may select the target stimulation parameter from the at least one stimulation parameter to be selected based on the displayed matching degree corresponding to the at least one stimulation parameter to be selected, and the display of the matching degree may be used to prompt the operation object whether the stimulation parameters to be selected and the reference electric field region match.
For example, referring to table 1 below, the display unit may display at least one candidate stimulation parameter (current intensity in table 1) and a matching degree corresponding to the at least one candidate stimulation parameter, respectively, for the operation object to select, on the operation unit, a target stimulation parameter most suitable for the target object from the at least one candidate stimulation parameter based on the content displayed by the display unit.
Table 1 content displayed by display unit
| Options |
Amperage (mA) |
Degree of matching |
| 1 |
1.2 |
92% |
| 2 |
2.0 |
88% |
| 3 |
1.8 |
95% |
| 4 |
2.5 |
85% |
In the embodiment of the disclosure, for each similar case, determining a similar electric field model of the similar case, overlapping the similar electric field model into a post-operation brain model of a framed reference electric field region, determining an overlapping rate, determining a target candidate case from at least one similar case according to the overlapping rate respectively corresponding to the at least one similar case, and updating the at least one similar case according to the target candidate case. According to the technical scheme, the similar cases of the brain regions corresponding to the reference electric field regions which can meet the electric stimulation frame can be determined, so that the provision of at least one to-be-selected stimulation parameter of the brain regions corresponding to the reference electric field regions which can meet the electric stimulation frame is facilitated, and the accuracy of the adopted stimulation parameters is further improved.
On the basis of the above aspect, in another optional technical aspect, the display unit is further configured to display the post-operation brain model before the similar electric field model is superimposed into the post-operation brain model of which the reference electric field area has been determined, so that the operation subject frames the reference electric field area in the displayed post-operation brain model.
In the embodiment of the disclosure, the reference electric field area may be manually framed in the displayed postoperative brain model by the operation object, for example, the processor may divide the postoperative brain model or the medical image into a plurality of voxels (voxels) according to the spatial resolution according to the individuation data such as the position where the implantation electrode is implanted into the brain, so as to obtain an interactable three-dimensional Voxel grid corresponding to the brain displayed on the operation unit, so that the operation object may frame or adjust the reference electric field area (the reference electric field area generally covers the target nucleus) in the three-dimensional Voxel grid displayed on the operation unit through the mouse or the touch screen operation based on clinical experience, specific stimulation requirements or specific neuroanatomy, and each Voxel represents a tiny volume unit of the brain tissue of the brain, which can be used for fine electric field calculation, and the size and number of the voxels are closely related to the resolution of the postoperative brain model or the medical image.
In the embodiment of the disclosure, the post-operation brain model can be displayed by the display unit before the similar electric field model is overlapped into the post-operation brain model with the determined reference electric field region, so that the operation object frames the reference electric field region in the displayed post-operation brain model, and a function for frames the reference electric field region can be provided for the operation object.
For a better understanding of the technical solutions of the embodiments of the present disclosure, an alternative example is provided herein. Illustratively, the programming device may provide two modes for operating the object selection, the two modes including a mode one and a mode two, depending on the target object having different stimulation requirements and adaptations.
In the case of the first operation object selection mode, referring to fig. 5, the left part of the (User Interface, UI) view operation unit in the display Interface may be used for the operation object to select an electrode contact combination in a suitable target stimulation parameter; the display unit can display a Three-Dimensional (3D) view postoperative brain model, under the condition that an operation object selects an electrode contact combination, the display unit can display the activation effect of a corresponding implanted electrode in a superposition mode, the right part of the UI view operation unit can be used for the operation object to adjust electrode stimulation parameters in target stimulation parameters, after the electrode contact combination is selected, the operation object can manually adjust the electrode stimulation parameters through the operation unit, the display unit can display a 3D view target electric field model, which is generated according to the electrode contact combination and the electrode stimulation parameters, under the condition that the target stimulation parameters are adjusted, the display unit can update the displayed target electric field model in real time so that the operation object can immediately see the change of the range of the target electric field model, whether the current target stimulation parameters meet the requirement or not is judged, the UI view program control unit can be used for generating stimulation under the condition that the operation object considers the range of the target electric field model to be higher than the target nuclear group coincidence rate, under the condition that the operation object can program control the 'program control' button on the program control unit, under the condition that the operation object can automatically send the current target stimulation parameters and the target VTA range to the VTA according to the electrode stimulation parameters, the current target stimulation parameters and the target VTA range can be represented by the processor, the display the current target electric field model and the target electric field model can be immediately changed according to the real-time observation command, and the target electric field can be applied to the target electric field model is displayed under the condition that the operation object is changed, and judging whether adjustment is needed, if so, the operation object can continuously adjust the target stimulation parameters through the operation unit, and execute the step of sending the current target stimulation parameters and the VTA range represented by the target electric field model to the stimulator until the optimal electric stimulation effect is achieved.
In the case of the operation object selecting the mode two, referring to fig. 6, the function realized by the display interface in the mode two is the same as that of the mode one, in addition, after the operation object clicks the program control button on the program control unit, the processor gradually increases the current intensity and/or other stimulation parameters in the initial stimulation parameters on the basis of the initial stimulation parameters, sends the increased initial stimulation parameters to the stimulator so as to ensure that the electric stimulation intensity is lower in the initial stage of the electric stimulation, and gradually increases the amplification control within an adaptation range, so as to ensure that the target object can adapt to the physiological change caused by the electric stimulation, wherein the current intensity and/or other stimulation parameters increase rate can be adjusted based on the displayed initial electric field model and the first object feedback of the target object, thereby increasing the controllability of the process of applying the electric stimulation to avoid discomfort or side effect caused by sudden stimulation intensity change, and the display unit can display the initial electric field model of the 3D view, which can gradually increase along with the progressive increase of the electric field model, gradually reach the shape of the target electric field model so that the target object has enough time to adapt to the electric stimulation and side effect.
Fig. 7 is a block diagram of a medical system provided in an embodiment of the present disclosure. The embodiment is applicable to the case of electrically stimulating a target object.
Referring to fig. 7, a medical system of an embodiment of the present disclosure includes a stimulator 410 implanted within a body of a target subject;
at least one implant electrode 420, at least a portion of each implant electrode 420 being implanted into a target nucleus of a brain of a target subject, the implant electrode 420 being connected to the stimulator 410 and configured to deliver electrical stimulation to the target nucleus;
the programming device 430 provided by any embodiment of the present disclosure, the programming device 430 being communicatively coupled to the stimulator 410.
The technical scheme of the embodiment of the disclosure comprises a stimulator, at least one implantation electrode, at least one program-controlled device and a program-controlled device, wherein the stimulator is implanted into a body of a target object, at least part of each implantation electrode is implanted into a target nucleus of the brain of the target object, the implantation electrode is connected with the stimulator and is configured to deliver electric stimulation to the target nucleus, and the program-controlled device is provided by any embodiment of the disclosure and is in communication connection with the stimulator. According to the technical scheme, through the program control equipment which can display the target electric field model generated according to the target stimulation parameters so that an operation object can accurately adjust the target stimulation parameters based on the displayed target electric field model, the accuracy of the adopted stimulation parameters is improved.
The above embodiments do not limit the scope of the present invention. It will be apparent to those skilled in the art that various modifications, combinations, sub-combinations and alternatives are possible, depending on design requirements and other factors. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the scope of the present invention.