Method and programmed device for setting nerve stimulation parameters

Abstract

The application provides a nerve stimulation parameter setting method and a programmed device. The method comprises the following steps: obtaining at least one standard VTA three-dimensional model selected by a user from a plurality of standard VTA three-dimensional models; determining an actual VTA three-dimensional model according to the position and shape setting of the selected standard VTA three-dimensional model by the user; determining an electrode contact and calculating the working parameters of the electrode contact according to the shape of the actual VTA three-dimensional model and the position relationship between the actual VTA three-dimensional model and an electrode model, wherein the determined electrode contact and the working parameters thereof can generate a VTA consistent with the actual VTA three-dimensional model.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to a method for setting nerve stimulation parameters and a programming device. Background Technology

[0002] Neurostimulation therapy can be used to treat a variety of diseases. For example, deep brain stimulation is an effective treatment for Parkinson's disease, essential tremor, dystonia, obsessive-compulsive disorder, and other diseases. Vagus nerve stimulation can be used to treat epilepsy and suppress epileptic seizures. Similarly, there are spinal cord nerve stimulation therapy, sacral nerve stimulation therapy, and so on.

[0003] Neurostimulation therapy involves implanting a pulse generator, extension leads, and electrodes into the body. These are then controlled by an external device to deliver electrical pulses to specific areas, controlling disease symptoms. During stimulation, external devices are used to adjust stimulation parameters to achieve different effects. For example, adjusting the polarity of the contacts changes the stimulation location, while modifying the amplitude, pulse width, and frequency alters the range of influence.

[0004] After a device is implanted in the human body, it needs to be programmed by a doctor. VTA (Volume of Tissue Activation) refers to the range of neural tissue that electrical stimulation can affect under set parameters. This range is closely related to the electrode polarity configuration and the values ​​of the stimulation parameters. Existing technology can simulate the corresponding VTA based on the electrode configuration, allowing doctors to adjust the stimulation parameters to obtain a more ideal stimulation effect.

[0005] Neurostimulation devices have multiple electrode contacts, usually at least four. If they are directional electrode contacts, the number may be three times or more than that of ordinary electrode contacts. These electrode contacts will produce different VTAs under various combined effects and different parameter settings. Even experienced doctors need to try multiple configurations repeatedly to get the desired results, which shows that this setup process is extremely complex. Summary of the Invention

[0006] In view of this, this application provides a method for setting neural stimulation parameters, including:

[0007] Obtain at least one standard VTA 3D model selected by the user from a set of preset standard VTA 3D models;

[0008] The actual VTA 3D model is determined based on the user's settings for the position and shape of the selected standard VTA 3D model.

[0009] Based on the shape of the actual VTA 3D model and its positional relationship with the electrode model, the electrode contacts are determined and the operating parameters of the electrode contacts are calculated. The determined electrode contacts and their operating parameters can generate a VTA that matches the actual VTA 3D model.

[0010] Optionally, the preset multiple standard VTA 3D models include at least two different types of VTA 3D models.

[0011] Optionally, the user can configure the morphology of the selected standard VTA 3D model by enlarging or reducing its overall volume.

[0012] Optionally, the user's position settings for the selected standard VTA 3D model include adjusting the angle and position of the standard VTA 3D model relative to the electrode model.

[0013] Optionally, the plurality of standard VTA three-dimensional models each correspond to standard stimulus parameters under at least one stimulus type;

[0014] In the step of calculating working parameters, the stimulus type selected by the user is obtained, and the actual stimulus parameters are calculated based on the stimulus parameters corresponding to the standard VTA three-dimensional model contained in the actual VTA three-dimensional model under the stimulus type selected by the user.

[0015] Optionally, the operating parameters include the amplitude, pulse width, and frequency of the stimulation signal.

[0016] The present invention also provides a programmable control device, comprising: an interaction unit, a communication unit, and a processing unit; wherein the processing unit is used to determine the electrode contacts and their operating parameters using the above-described parameter setting method;

[0017] The interactive unit is used to present an interactive interface and receive user operations. The interactive interface includes a model display area and a model setting area. The model setting area is used to receive user selection and setting operations for the standard VTA model. The model display area is used to display the electrode model, the standard VTA three-dimensional model, and the actual VTA three-dimensional model.

[0018] The communication unit is used to send information about the determined stimulation contact points and their operating parameters to the implantable neurostimulation device, so that the electrodes send stimulation signals to the stimulation object and generate corresponding VTA.

[0019] Optionally, the model settings area includes a standard VTA selection area, which displays graphic examples of optional standard VTA 3D models; the graphic examples are configured as operable objects, and when the graphic example is selected by the user, the corresponding standard VTA 3D model is displayed at a set position in the model display area.

[0020] Optionally, the model settings area includes operation buttons for adjusting the shape, position, and angle of the standard VTA 3D model displayed in the model display area.

[0021] Optionally, the interactive interface also includes a parameter display area for displaying information about the determined stimulation points and their operating parameters.

[0022] According to the method for setting nerve stimulation parameters provided by the present invention, users can adjust or combine a standard VTA three-dimensional model to create a desired actual VTA three-dimensional model. Then, based on the shape of the actual VTA three-dimensional model and its positional relationship with the electrode model, the electrode contacts are determined and the working parameters of the electrode contacts are calculated. This achieves the purpose of using a personalized VTA to infer stimulation parameters, assisting doctors in performing programming more efficiently.

[0023] The external programming device of the nerve stimulation device can be used to execute this parameter setting method. The programming device provides a display interface and receives user operations through the interactive unit. Doctors can operate the programming device to edit the actual VTA three-dimensional model, and then calculate the contact information and working parameters. After that, the communication unit sends the information to the nerve stimulation device in the patient's body, and then makes adjustments based on the patient's feedback, thereby shortening the programming time. Attached Figure Description

[0024] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0025] Figure 1 This is a schematic diagram of the programmable control device in an embodiment of the present invention;

[0026] Figure 2 The interactive interface provided by the programmable control device in the embodiments of the present invention;

[0027] Figure 3 This invention provides an interactive interface for users after setting up an actual VTA model in this embodiment.

[0028] Figure 4 This is the interactive interface after the user sets another actual VTA model in this embodiment of the invention;

[0029] Figure 5 This is the interactive interface after the user sets the third actual VTA model in this embodiment of the invention. Detailed Implementation

[0030] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0031] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0032] This invention provides a programmable control device, such as... Figure 1 As shown, the device includes an interaction unit, a communication unit, and a processing unit. The interaction unit is used to present an interactive interface and receive user operations; specifically, it can be a touchscreen or a combination of a screen and physical buttons. Figure 2 An interactive interface is shown, including a model display area 21 and a model setting area 22. When no further settings are made by the user, the model display area 21 can display an electrode model 211 of the neural stimulation electrode. In optional embodiments, it can also display a model of the stimulation object, such as a human brain model, thereby more clearly showing the position of the electrode within the human body.

[0033] The model setting area 22 is used to receive user selection and setting operations for the standard VTA model. The standard VTA model is pre-stored locally, for example, allowing users to select the desired standard VTA model through an option menu and set its position and size. In this embodiment, the position of the standard VTA model refers to its position in the three-dimensional space displayed in the model display area 21. Users can drag the standard VTA model in this area to move its position, or stretch and shrink its size.

[0034] As a preferred embodiment, such as Figure 2 The model setup area 22 shown includes a standard VTA selection area 221, which displays graphical examples of optional standard VTA 3D models (such as 2D examples of models). This embodiment provides three examples: a circle (as a 2D example of a spherical VTA 3D model), an ellipse (as a 2D example of an ellipsoidal VTA 3D model), and an intersecting circle. In other embodiments, more or at least two other different shapes of optional standard models may be provided.

[0035] These two-dimensional graphic examples are configured as operable objects. When a user selects a particular two-dimensional graphic example, the corresponding standard VTA 3D model is displayed at a set position in the model display area 21. Specifically, the standard VTA 3D model can be displayed first at a preset fixed position, and then the user can adjust its position; or the user can select a two-dimensional graphic example and drag it to a position in the model display area 21, at which point the corresponding standard VTA 3D model is displayed, and then the user can directly drag its position and direction, and use gestures to zoom in or out in the model display area 21. Another optional setting is to configure each electrode contact on the electrode model 211 as a selectable object. The user can first click on an electrode contact, and then click on a two-dimensional graphic example. The selected contact and the corresponding standard VTA 3D model are automatically aligned and displayed in the model display area 21. The user can then fine-tune the position, size, and orientation of the VTA 3D model, thereby reducing manual operation by the user.

[0036] To allow users to configure VTA 3D models more precisely, the model setting area 22 in this embodiment also includes operation buttons for adjusting the shape, position, and angle of the standard VTA 3D model displayed in the model display area 21. For example... Figure 2 As shown, this embodiment includes zoom in and zoom out buttons. When the user clicks these buttons, the volume of the currently displayed standard VTA 3D model is adjusted by a set amount. "X", "Y", and "Z" refer to the coordinate axes of the display space. "Coordinate +" and "Coordinate -" indicate overall movement along the coordinate axes. By using these two sets of buttons, the user can arbitrarily adjust the position of the standard VTA 3D model within the display space. "Clockwise Rotation" and "Counterclockwise Rotation" refer to rotating the standard VTA 3D model clockwise or counterclockwise on the current display plane within the display space. Through these buttons, the user can arbitrarily adjust the size, position, and orientation (angle) of the standard VTA 3D model.

[0037] The model display area 21 is used to display the electrode model 211, the standard VTA 3D model, and the actual VTA 3D model. Adjusting the size, position, and orientation of the standard VTA 3D model in the display space is actually to adjust its positional relationship with the various electrode contacts on the electrode model 211.

[0038] Figure 3 The example shows a user setting up a standard VTA 3D model and adjusting it to the desired position and size; the result of the adjustment is referred to as the actual VTA 3D model 212. Figure 3 The actual VTA three-dimensional model 212 shown is located at the electrode contact R2 of the electrode model 211.

[0039] like Figure 4As shown, this solution allows users to set multiple standard VTA 3D models. In this embodiment, the user sets two models, located at electrode contact R1 and electrode contact R4 respectively. The user can set these two models in sequence according to the above setting process. The combination of the two models after setting is called the actual VTA 3D model 212.

[0040] After determining the actual VTA 3D model, the model needs to be digitized, which is performed by the processing unit. Specifically, the user clicks the "Parameter Calculation" button in the model settings area 22, and the processing unit calculates the contact information and operating parameters corresponding to this model. The operating parameters include the amplitude, pulse width, and frequency of the stimulation signal, such as... Figure 3 and Figure 4 The interface also includes a parameter display area, which displays information about the identified stimulation points and their operating parameters. For example... Figure 3 The calculation results shown in the parameter display area 23 indicate that when the amplitude of the stimulation signal of electrode contact R2 is 1.5V, the pulse width is 60μs, and the frequency is 150Hz, it means that the nerve stimulation device can generate the actual VTA set by the user when the stimulation signal is output according to this configuration. Figure 4 The calculation results shown in the parameter display area 23 are for electrode contacts R1 and R4, with an amplitude of 1.5V, a pulse width of 60μs, and a frequency of 150Hz, which can generate the actual VTA set by the user.

[0041] If the user determines that the calculated operating parameters are to be used to control the operation of the stimulation device in the patient's body, the information of the determined stimulation contact points and their operating parameters are sent to the implantable neurostimulation device through the communication unit, so that the corresponding electrode contacts send stimulation signals to the stimulation object and generate the corresponding VTA.

[0042] The following describes a method for setting neural stimulation parameters. This method can be executed by the aforementioned programmable device, or by electronic devices such as computers, tablets, or servers, and includes the following steps:

[0043] S1, Obtain at least one standard VTA 3D model selected by the user from a set of preset standard VTA 3D models.

[0044] S2, based on the user's settings for the position and shape of the selected standard VTA 3D model, determine the actual VTA 3D model. Steps S1-S2 can be specifically referred to the operation of the programmable control device in the above embodiments. If using a computer or other electronic devices, the user can adjust the size, position, and orientation of each standard VTA 3D model using input devices such as a mouse and keyboard.

[0045] S3. Based on the shape of the actual VTA three-dimensional model and its positional relationship with the electrode model, determine the electrode contacts and calculate the working parameters of the electrode contacts. The determined electrode contacts and their working parameters can generate a VTA that matches the actual VTA three-dimensional model.

[0046] There are various specific calculation methods. In one embodiment, each standard VTA three-dimensional model corresponds to at least one set of standard stimulation parameters for each stimulation type. The stimulation type refers to the stimulation signal output by the electrode contacts under different polarity settings. For example, for unipolar and bipolar stimulation, each standard VTA three-dimensional model corresponds to two sets of operating parameters at its initial size. As a specific example, for a spherical standard VTA three-dimensional model, the operating parameters for bipolar stimulation are amplitude a1, pulse width p1, and frequency f1; the operating parameters for unipolar stimulation are amplitude a2, pulse width p2, and frequency f2.

[0047] When a user selects a standard VTA 3D model, they also need to select a specific stimulus type. Then, the specific set of operating parameters corresponding to that stimulus type can be obtained. For example, if a user selects a bipolar stimulus and chooses a spherical standard VTA 3D model, and then adjusts it to an actual VTA 3D model, the operating parameters of this actual VTA 3D model are calculated based on amplitude a1, pulse width p1, and frequency f1.

[0048] A simple calculation method is to first calculate the volume change factor of the actual VTA 3D model compared to the standard VTA 3D model, and then calculate the corresponding operating parameters based on this factor; next, identify the electrode contact closest to the center of the actual VTA 3D model in the display space, thereby determining the contact number information. For example... Figure 3 As shown, in this embodiment, electrode model 211 has directional electrode contacts and ring electrode contacts. The three directional electrode contacts form a ring electrode contact R2. Since the actual VTA three-dimensional model 212 set by the user covers the entire ring electrode contact R2, the determined contact information is R2 (which is also equivalent to contacts 2, 3, and 4).

[0049] Figure 5 Another scenario is shown where, since the actual VTA 3D model 212 set by the user only covers one directional electrode contact 3 of the annular electrode contact R2, the determined contact information is "3".

[0050] Figures 3-5The results shown are relatively simple and are only provided as an example to clearly illustrate the purpose of this solution. In practical applications, users can set more complex model combinations, and the corresponding calculation methods are also more complex. For example, an actual model may cover multiple adjacent electrode contacts, so the model also has multiple contacts. For example, the contact information corresponding to an actual VTA 3D model may be R2, R3, and R4.

[0051] As an optional calculation method, all possible model combinations are enumerated in advance using simulation tools, and the corresponding contact information and operating parameters are recorded as reference data. This reference data can be stored locally or on a server. When the user sets the model combination, the matching or closest model combination and its contact information and operating parameters can be queried from these reference data.

[0052] As an alternative computational method, a neural network algorithm can be used to determine the contact point information and operating parameters. Specifically, training data is constructed in advance through simulation experiments or by collecting actual user data. Each sample data includes the shape category of the VTA model, the model's volume information, the distance information between the model and each contact point, the stimulus type, and the sample label as the contact point number of the actual output stimulus signal and the contact point's operating parameters. After training the neural network with a large amount of sample data and labels, it will have the corresponding computational capabilities. When in use, the actual VTA 3D model is converted into a digital representation (VTA model shape category, model volume information, distance information between the model and each contact point) and the stimulus type as input data for the neural network. The neural network will output the optimal contact point number and operating parameters.

[0053] In some cases, the actual VTA 3D model set by the user may cover multiple contacts in the electrode model or be near them, or there may be other complex situations, such as covering two adjacent contacts above or below, or between them. In similar cases, the combination of contact configuration and operating parameters that can actually satisfy this VTA is not unique. For example, using a large stimulation amplitude on only one contact can produce a basically satisfactory VTA, and using small stimulation amplitudes on two contacts simultaneously can also produce a basically satisfactory VTA. Therefore, in step S3, all basically satisfactory contact configurations and operating parameters can be calculated, and then the VTA they produce can be calculated separately, i.e., simulated VTA results. These results are then compared with the user-set VTA 3D model to obtain the corresponding similarity information. Finally, the contact configuration and operating parameters corresponding to the simulated VTA result with the highest similarity and above the similarity threshold are selected as the final calculation result. If there are more than one calculation result above the similarity threshold, their simulated VTA results can also be presented separately for the user to make a final selection; if there is no simulated VTA result above the similarity threshold, the user can be prompted that there is no contact configuration and operating parameters that match their set VTA 3D model.

[0054] On the other hand, in this context, similarity information can be introduced to present the therapeutic effects and risks of the calculated touchpoint configuration and operating parameters. Specifically, after calculating the touchpoint configuration (touchpoint combination) and operating parameters that conform to the user-defined actual VTA 3D model, a corresponding simulated VTA result can be generated based on the calculation results. This simulated result is compared with the user-defined actual VTA 3D model to obtain similarity information. The higher the similarity, the more the touchpoint configuration (touchpoint combination) and operating parameters meet the user's needs; conversely, the lower the similarity, the less it meets the user's needs, and it indicates potential risks, such as possible side effects. Furthermore, the simulated VTA and the user-defined actual VTA 3D model can be simultaneously displayed in the model display area 21 to show the differences between the VTA ranges. Combined with the displayed stimulus object model (such as a human brain model), the differences in the activated areas can be intuitively displayed, thereby facilitating the analysis of the effects and risks of the stimulation parameters for target stimulation.

[0055] Those skilled in the art will understand that embodiments of the present invention can be provided as methods, systems, or computer program products. Therefore, the present invention can take the form of a completely hardware embodiment, a completely software embodiment, or an embodiment combining software and hardware aspects. Furthermore, the present invention can take the form of a computer program product embodied on one or more computer-usable storage media (including, but not limited to, disk storage, CD-ROM, optical storage, etc.) containing computer-usable program code.

[0056] This invention is described with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, special-purpose computer, embedded processor, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, generate instructions for implementing the flowchart illustrations and / or block diagrams. Figure 1 One or more processes and / or boxes Figure 1 A device that provides the functions specified in one or more boxes.

[0057] These computer program instructions may also be stored in a computer-readable storage medium that can direct a computer or other programmable data processing device to function in a particular manner, such that the instructions stored in the computer-readable storage medium produce an article of manufacture including instruction means, which are implemented in a process Figure 1 One or more processes and / or boxes Figure 1 The function specified in one or more boxes.

[0058] These computer program instructions may also be loaded onto a computer or other programmable data processing equipment to cause a series of operational steps to be performed on the computer or other programmable equipment to produce a computer-implemented process, thereby providing instructions that execute on the computer or other programmable equipment for implementing the process. Figure 1 One or more processes and / or boxes Figure 1 The steps of the function specified in one or more boxes.

[0059] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A method for setting neural stimulation parameters, characterized in that, include: Obtain at least one standard VTA 3D model selected by the user from a set of preset standard VTA 3D models; The actual VTA 3D model is determined based on the user's settings for the position and shape of the selected standard VTA 3D model. Based on the shape of the actual VTA 3D model and its positional relationship with the electrode model, candidate contact configurations and operating parameters are determined. The VTA generated by the candidate contact configurations and operating parameters is calculated respectively, and the simulated VTA results corresponding to each candidate contact configuration are obtained. The simulated VTA results are compared with the actual VTA 3D model set by the user to obtain the corresponding similarity information. Based on the similarity information, the corresponding simulated VTA results are presented for the user to make a selection.

2. The method according to claim 1, characterized in that, The preset standard VTA 3D models include at least two different types of VTA 3D models.

3. The method according to claim 1, characterized in that, Users can customize the morphology of the selected standard VTA 3D model by enlarging or reducing its overall volume.

4. The method according to claim 1, characterized in that, The user's position settings for the selected standard VTA 3D model include adjusting the angle and position of the standard VTA 3D model relative to the electrode model.

5. The method according to claim 1, characterized in that, The multiple standard VTA three-dimensional models each correspond to standard stimulus parameters under at least one stimulus type; In the step of calculating working parameters, the stimulus type selected by the user is obtained, and the actual stimulus parameters are calculated based on the stimulus parameters corresponding to the standard VTA three-dimensional model contained in the actual VTA three-dimensional model under the stimulus type selected by the user.

6. The method according to any one of claims 1-5, characterized in that, The operating parameters include the amplitude, pulse width, and frequency of the stimulation signal.

7. A programmable control device, characterized in that, include: Interaction unit, communication unit, and processing unit; The processing unit is used to perform the method of any one of claims 1-6 to determine the electrode contacts and their operating parameters; The interactive unit is used to present an interactive interface and receive user operations. The interactive interface includes a model display area and a model setting area. The model setting area is used to receive user selection and setting operations for the standard VTA model. The model display area is used to display the electrode model, the standard VTA three-dimensional model, and the actual VTA three-dimensional model. The communication unit is used to send information about the determined stimulation contact points and their operating parameters to the implantable neurostimulation device, so that the electrodes send stimulation signals to the stimulation object and generate corresponding VTA.

8. The programmable control device according to claim 7, characterized in that, The model settings area includes a standard VTA selection area, which displays graphic examples of selectable standard VTA 3D models. The graphic examples are configured as operable objects, and when the graphic example is selected by the user, the corresponding standard VTA 3D model is displayed at a set position in the model display area.

9. The programmable control device according to claim 7, characterized in that, The model settings area includes operation buttons for adjusting the shape, position, and angle of the standard VTA 3D model displayed in the model display area.

10. The programmable control device according to any one of claims 7-9, characterized in that, The interactive interface also includes a parameter display area, which displays information about the determined stimulation points and their operating parameters.

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