Neural stimulation range display method, apparatus, and system

Abstract

The application provides a nerve stimulation range display method, device and system, the method is executed by an external programming device of an implantable nerve stimulation device, the programming device pre-stores electrode model data and standard electric field data of various electrode contacts under various polarity settings, and the method comprises the following steps: the programming device acquires contact configuration information; standard electric field data corresponding to the contact configuration is read according to the contact configuration information; actual electric field data corresponding to the contact configuration is calculated according to the standard electric field data corresponding to the contact configuration and working parameters of the electrode contacts; the nerve stimulation range threshold and its equivalent surface are calculated according to the working parameters of the electrode contacts and parameters of a stimulation object, and then a three-dimensional model of the nerve stimulation range is generated and displayed.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more specifically to a method, apparatus, and system for displaying the range of nerve stimulation. 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 device implantation, doctors need to program the device. Currently, in clinical practice, doctors generally select a contact point based on their experience, set stimulation parameters, and inquire about and observe the patient's reaction. If the stimulation is ineffective or causes serious side effects, the selected contact point is changed. If there is some therapeutic effect, the stimulation parameters are fine-tuned, allowing the patient to experience the effect. Throughout the programming process, adjustments are mainly made based on the doctor's experience and the patient's subjective feelings, often requiring multiple adjustments to achieve a relatively good state. This process has several problems: the programming time and effect depend on the doctor's experience, which introduces subjectivity; the degree of personalization is low, and even if the patient has postoperative imaging data, it is difficult to fully utilize the image data during the programming process due to limited outpatient time; the programming software lacks effect indication feedback, making it difficult to have a direct impression of the effect of the programming parameters. Therefore, a system that can intuitively reflect the patient's condition and display the effect of stimulation parameters is needed during the programming process.

[0005] VTA (Volume of Tissue Activation) refers to the range of neural tissue that electrical stimulation can affect under set parameters. This range is influenced by electrode polarity configuration and stimulation parameters. To visualize the VTA under different contact configurations and stimulation parameters, modeling, simulation, and calculation can be used to represent the electrodes and VTA. However, modeling and simulation place high demands on equipment performance, and the portability requirements of the programming devices used by physicians limit equipment performance, making it difficult for programming devices to achieve the aforementioned goals. Summary of the Invention

[0006] In view of this, this application provides a method for displaying the range of action of nerve stimulation. The method is executed by an external programming device of an implantable nerve stimulation device. The programming device pre-stores electrode model data and standard electric field data of various electrode contacts under various polarity settings. The method includes: the programming device acquiring contact configuration information; reading standard electric field data corresponding to the contact configuration based on the contact configuration information; calculating actual electric field data corresponding to the contact configuration based on the standard electric field data corresponding to the contact configuration and the working parameters of the electrode contacts; calculating the threshold of the range of action of nerve stimulation and its isosurface based on the working parameters of the electrode contacts and the parameters of the stimulation object, thereby generating and displaying a three-dimensional model of the range of action of nerve stimulation.

[0007] Optionally, based on the standard electric field data configured for the contact point and the operating parameters of the electrode contacts, the actual electric field data corresponding to the contact point configuration is calculated, including:

[0008] The programmable device communicates with external equipment to obtain impedance information of the stimulated object;

[0009] The actual electric field data is calculated based on the impedance information, the corresponding standard electric field data of the contact configuration, and the working parameters of the electrode contacts.

[0010] Optionally, the programmable device communicates with external devices to obtain impedance information of the stimulus object, including:

[0011] The programmable device controls the implantable neurostimulation device to output stimulation signals to perform impedance testing and determine the impedance information.

[0012] Send a request to the server to use impedance information;

[0013] Once the server approves the usage request, the programmable device obtains the impedance information.

[0014] Optionally, the programmable device pre-stores a stimulation object model, and the three-dimensional model that generates and displays the range of neural stimulation includes:

[0015] The programmable device acquires the electrode implantation angle and position configured by the user;

[0016] Based on the implantation angle and location, the electrode model, the three-dimensional model of the nerve stimulation range, and the stimulation object model are displayed.

[0017] Optionally, the standard electric field data pre-stored in the programmable device includes standard electric field data corresponding to various human tissues; the contact configuration information also includes stimulation object information or electrode contact implantation location information; the standard electric field data programmable device corresponding to the contact configuration refers to standard electric field data corresponding to the contact configuration and the stimulation object.

[0018] Optionally, the standard electric field data is three-dimensional point cloud data, wherein each point includes location information and standard electric field strength information; the point located at the center of the three-dimensional point cloud data corresponds to the location of the electrode contact.

[0019] Optionally, the points in the three-dimensional point cloud data are non-uniformly distributed, wherein the distance between multiple points closer to the center is smaller than the distance between multiple points farther from the center.

[0020] Optionally, the electrode contacts include annular electrode contacts and directional electrode contacts; the operating parameters include the amplitude and pulse width of the stimulation signal; and the parameters of the stimulation object include the axon diameter.

[0021] The present invention also provides a programmable device, comprising: at least one processing unit, and a storage unit, an interaction unit, and a communication unit communicatively connected to the at least one processing unit; wherein, the storage unit stores instructions executable by the processing unit, the instructions being executed by the at least one processing unit to cause the at least one processing unit to perform the above-described method for displaying the range of action of nerve stimulation, the communication unit being used to interact with an implantable nerve stimulation device, and the interaction unit being used to acquire user touch point configuration operations and display a three-dimensional model of the range of action of nerve stimulation.

[0022] This invention also includes a system for displaying the range of nerve stimulation, comprising:

[0023] The aforementioned programmable device; and the implantable neurostimulation device, patient terminal, and server, wherein the programmable device is used to control the implantable neurostimulation device to perform impedance testing to obtain impedance information, the patient terminal is used to upload the impedance information and the authorization license for using the impedance information to the server, and the server, upon finding the authorization license, allows the programmable device to use the impedance information to calculate the actual electric field data.

[0024] The present invention provides a method for displaying the range of action (VTA) of nerve stimulation. The programmable device is equipped with electrode model data and standard electric field data. This data can be pre-modeled and simulated by a computer and then imported into the programmable device. When VTA display is required, the programmable device only needs to acquire the contact configuration information, thereby reading the standard electric field data corresponding to the contact configuration information, and then calculating the actual electric field data based on the stimulation parameters. This generates and displays a three-dimensional model of the nerve stimulation range and the electrode model. The VTA is calculated according to the patient's actual condition, making the display results personalized. The programmable device in this solution does not need to perform time-consuming and computationally intensive modeling and simulation operations; it only requires simple real-time calculations and can adjust the VTA display results in real time according to the parameters, achieving a balance between device portability and performance, and enabling real-time changes.

[0025] The programmable device in this invention can also acquire the patient's impedance information, and combine it with the patient's electrode impedance results measured during the actual programmable process to calculate VTA, making the calculation results more accurate.

[0026] The standard electric field data in this invention includes a series of standard electric field data generated for different human tissues. The programmable device can read the corresponding pre-modeled and simulated data according to the electrode implantation position to distinguish the target position.

[0027] The standard electric field data used in this invention can be non-uniformly distributed three-dimensional point cloud data. The point distribution is denser in the region near the electrode contact and sparser in the region far from the electrode contact. When calculating the actual electric field under commonly used operating parameters, the high grid density can ensure the calculation accuracy. Under uncommon operating parameters, the low grid density reduces the amount of data and shortens the calculation time.

[0028] According to the nerve stimulation range display system provided by the present invention, when a doctor needs to use a programmable device to download impedance information from a server, the server, upon finding the patient's uploaded authorization for the use of the impedance information, allows the programmable device to download and use the impedance information, thereby protecting the patient's personal information security. Furthermore, the patient can upload the authorization for the use of the impedance information to the server in advance using the patient terminal, without needing to authorize it on-site during programmable operation, thus improving convenience. Attached Figure Description

[0029] 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.

[0030] Figure 1 This is a schematic diagram of the programmable control device and the computer in an embodiment of the present invention;

[0031] Figure 2 This is a schematic diagram of the electrode model in an embodiment of the present invention;

[0032] Figure 3 This is a schematic diagram of the VTA model generated in an embodiment of the present invention;

[0033] Figure 4 This is a schematic diagram of a nerve stimulation range display system according to an embodiment of the present invention;

[0034] Figure 5 This is a schematic diagram of the electrode model structure in an embodiment of the present invention;

[0035] Figure 6 This is a schematic diagram of standard electric field data in an embodiment of the present invention;

[0036] Figure 7 This is a schematic diagram of another standard electric field data in an embodiment of the present invention;

[0037] Figure 8 This is a flowchart of a method for displaying the range of nerve stimulation effect executed by a programmable device in an embodiment of the present invention. Detailed Implementation

[0038] 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.

[0039] 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.

[0040] This application provides a method for displaying the range of action of nerve stimulation. The method is executed by an external control device of an implantable nerve stimulation device. The external control device can be operated by a doctor and can be a programmable device for various nerve stimulators such as vagus nerve stimulator, deep brain stimulator, spinal cord nerve stimulator, and sacral nerve stimulator.

[0041] like Figure 1 As shown, the programmable device 2 includes an interactive unit, such as a display screen, input keys, or a touch screen; a communication unit, such as a wired communication device and a wireless communication device such as a local area network, Bluetooth, or near-field communication; a storage unit and a processing unit, which store and execute application programs to control the implantable neurostimulation device and, in this embodiment, perform related operations to display the range of neurostimulation.

[0042] To display the range of nerve stimulation, the programmable device 2 executing this method stores electrode model data and standard electric field data for various electrode contacts under different polarity settings. The electrode model data includes model data for at least one type of electrode used in vagus nerve stimulation systems, deep brain stimulation systems, spinal cord stimulation systems, and sacral nerve stimulation systems. The stored electrode model data and standard electric field data can be generated by computer 1 and imported into the programmable device 2 before leaving the factory. The electrode model data is used to generate electrode models in the programmable device 2.

[0043] Common electrodes used in nerve stimulation systems include cylindrical electrodes and paddle electrodes. For example, Figure 2 Two types of cylindrical electrodes are shown, each with multiple contacts. The programmable device 2 can control all or part of these contacts to output stimulation signals. The types of electrode contacts include ring electrode contacts and directional electrode contacts. Figure 2 In the diagram, the electrodes on the right side are all ring-shaped electrode contacts 22; the electrodes on the left side have ring-shaped electrode contacts 22 at both the top and bottom, and the two sets of contacts in the middle are directional electrode contacts 21. Of course, besides the differences in electrode shape and electrode contacts, variations can be made in the number of contacts, their arrangement, and the spacing between them, resulting in various types of electrodes suitable for different stimulation systems and targets. Therefore, the electrode models and electrode model data of this application also have correspondingly multiple types.

[0044] The standard electric field described in this application refers to the electric field generated by the electrode contacts in the surrounding medium under preset operating parameters, such as the electric field generated when the stimulation voltage is 1V. Specifically, finite element method (FEM) software can be used to model and simulate the electric field using electrode and tissue models. Since the electric field generated by the electrode contacts differs under different polarity settings, it is also necessary to simulate the standard electric field of the electrode contacts under different polarity settings.

[0045] It is also important to note that the characteristics of the surrounding tissues differ depending on the electrode implantation location, leading to variations in the standard electric field. Therefore, in a preferred embodiment, different stimulation object models are generated based on the different tissue characteristics to obtain the standard electric field corresponding to each stimulation object. In deep brain stimulation applications, the tissues surrounding the contact point in the brain include gray matter, white matter, cerebrospinal fluid, etc.; in spinal cord stimulation applications, the tissues surrounding the contact point in the spinal cord may include gray matter, white matter, dorsal root nerves, spinal cord dorsal meninges, cerebrospinal fluid, etc. These tissues have different characteristics, especially different electrical conductivities, which affect the potential distribution after voltage application. To make the standard electric field value more accurate, it is necessary to simulate and generate the standard electric field of the electrode contact point in these different tissues and their combinations. Each contact on the same electrode can be configured as either positive or negative. Combinations of polarity configurations will create various stimulation modes such as unipolar, bipolar, and multipolar stimulation. The standard electric field of the same contact differs in different polarity combinations (stimulation modes). Furthermore, the standard electric field of two different types of contacts—ring electrode contacts and directional electrode contacts—also differs within the same stimulation mode. Therefore, it is necessary to generate corresponding standard electric field data for each possible combination. Additionally, since the contacts may act on different tissues, it is also necessary to generate standard electric field data separately for each tissue or combination of tissues. The more types and numbers of contacts on the electrode, the more standard electric field data needs to be generated. Therefore, it is necessary to use computer 1 to generate a large amount of standard electric field data, i.e., to exhaustively enumerate the standard electric field data of various electrode contacts under all implantation sites, all media types (human tissue), and all polarity settings.

[0046] In this application, the programmable device 2 is communicatively connected to the computer 1, receiving electrode model data generated by the computer 1, and then establishing the electrode model during use, configuring the positional relationship between the electrode model and the stimulation object. The stimulation object may be, for example, the patient's brain, vagus nerve, sacral nerve, or spinal cord nerve. Specifically, the user (doctor) can control the programmable device 2 to set the angle and position of the electrode model according to the actual electrode implantation, and can further select pre-stored standard models of the stimulation object, such as pre-stored models of the brain, vagus nerve, sacral nerve, and spinal cord nerve, or import an actual model generated based on local medical images of the patient, thereby determining the positional relationship between the electrode model and the stimulation object model.

[0047] like Figure 8 As shown, the method for displaying the range of neural stimulation performed by the programmable device 2 includes the following steps:

[0048] S1, Obtain contact configuration information. The user provides contact configuration information according to the treatment plan, such as which contacts to select (the number of the enabled contacts), the polarity of the contacts, and stimulation parameters (frequency, amplitude, pulse width).

[0049] S2, based on the contact configuration information, reads the standard electric field data corresponding to the contact configuration from the pre-stored standard electric field data. In a preferred embodiment, the contact configuration information also includes stimulation object information or electrode contact implantation location information. The programmable device 2 can read the standard electric field data corresponding to the contact configuration and the stimulation object from a large amount of pre-stored standard electric field data based on the contact configuration information.

[0050] S3 calculates the actual electric field data corresponding to the contact configuration based on the standard electric field data and the working parameters of the electrode contacts.

[0051] There are several specific methods for calculating the actual electric field based on the contact point configuration and stimulation amplitude. For example, standard electric field data of the corresponding contact points can be read and superimposed according to the contact point configuration. The actual electric field data corresponding to this stimulation amplitude can be calculated using a pre-stored fitting formula between stimulation amplitude and electric field. The pre-stored fitting formula is obtained by pre-simulating the electric field under different stimulation amplitudes and fitting the stimulation amplitude-electric field using the simulation results. This simulation calculation process can be executed by computer 1, with the fitting formula configured in the programmable control device 2. The actual electric field can then be calculated by substituting the formula into the programmable control device 2.

[0052] In optional embodiments, a neural network algorithm can also be used to calculate the actual electric field. The electric field under different stimulus amplitudes is simulated in advance to obtain a large amount of sample data. Each sample includes a standard electric field, a stimulus amplitude, and is labeled as the actual electric field. After training the neural network with a large amount of sample and labeled data, it can be used to predict the actual electric field. The trained neural network is configured in the programmable control device 2. The programmable control device 2 uses the standard electric field data and stimulus amplitude corresponding to the contact configuration as input data for the neural network, and outputs the corresponding actual electric field data after calculation.

[0053] S4: Based on the operating parameters of the electrode contacts and the parameters of the stimulated object, calculate the threshold and isosurface of the nerve stimulation range, and then generate and display a three-dimensional model of the nerve stimulation range. In this step, first calculate the VTA threshold based on the stimulation pulse width and nerve axon diameter. Then, based on the actual electric field and this threshold, use algorithms for extracting isosurfaces in three dimensions (such as Marching Cubes algorithm, Dual Contouring algorithm, Dividing Cubes algorithm, Marchingtetrahedra algorithm, etc.) to obtain the isosurface result of the threshold, which is the interface between the active and inactive regions. The area inside the isosurface is the VTA, and thus the active region is taken as the nerve stimulation range.

[0054] There are several specific methods for calculating the VTA threshold based on the stimulation pulse width and axon diameter. For example, a neuron model can be pre-built, using the same voltage but different pulse widths or axon diameters to simulate the neuron's activation under different conditions. The pulse width / axon diameter can then be fitted to the activation electric field value (the VTA threshold), and the resulting fitting formula is stored in the programmable control device 2. During calculation, the stimulation pulse width and axon diameter are substituted into the fitting formula to obtain the VTA threshold. Similarly, a neural network algorithm can be used. The neural network is pre-trained and configured in the programmable control device 2. The programmable control device 2 uses the stimulation pulse width and axon diameter as input data to the neural network and calculates and outputs the corresponding VTA threshold.

[0055] After calculating the VTA, the programmable device 2 can use an open graphics library to draw the electrodes and VTA, and set appropriate colors and materials for the electrodes and VTA, and determine the lighting mode. Users can then perform interactive operations such as translation, rotation, and scaling. In a preferred embodiment, the programmable device 2 can also provide a stimulus object model, such as a brain model.

[0056] In step S4, the programmable device 2 obtains the electrode implantation angle and position configured by the user, and displays the electrode model, the three-dimensional model of the nerve stimulation range and the stimulation object model according to the electrode implantation angle and position configured by the user, thereby indicating the current display side and the position of the electrode relative to the stimulation object.

[0057] Figure 3 A three-dimensional model of the four neural stimulation areas is shown, with the two on the left including directional electrode contacts and ring electrode contacts, and the two on the right consisting entirely of ring electrode contacts. The figure shows the VTA model generated based on the contact configuration.

[0058] To more accurately calculate the actual electric field data, the programmable device 2 can also acquire the user's actual impedance information. The programmable device 2 communicates with external devices to obtain the impedance information of the stimulated object, which is used to calculate the actual electric field data. These external devices can be servers or patient terminals.

[0059] Because impedance information is patient data, it requires patient authorization to be accessed for security and patient privacy reasons. In a preferred embodiment, based on, as... Figure 4 The system shown includes a programmable controller 2, a server 3, a patient terminal 4, and an implantable neurostimulation device 5. The patient terminal 4 can be a programmable controller held by the patient or an ordinary electronic device, such as a mobile phone or a tablet computer.

[0060] The programmable device 2 controls the implantable neurostimulation device 5 to output stimulation signals for impedance testing. After obtaining the impedance information, the patient terminal 4 can upload it to the server 3, or send it directly to the programmable device 2 if authorized. The patient terminal 4 can upload the patient's authorization to the server 3 in real time or in advance. When the server 3 finds that authorization exists, it allows the programmable device 2 to obtain the impedance information from the server 3 or the patient terminal 4 for calculating the actual electric field data.

[0061] This application takes into account the security of patients' personal information. Authorization can be obtained in advance through the patient's terminal. When the programmable device 2 uses the patient's data, it only needs to confirm the existence of authorization from the server 3. There is no need to authorize on-site, which improves convenience.

[0062] Furthermore, according to this system, the programmable device service provider can update standard electric field data, electrode model data, actual electric field calculation model (including fitting formula and trained neural network), VTA threshold calculation model (including fitting formula and trained neural network), etc., and upload the updated data or calculation model to server 3 through computer 1. The doctor's programmable device 2 can then download the latest basic data at any time. Even when implantable neurostimulation devices are updated, the doctor's programmable device 2 can update the basic data in a timely manner to optimize the local electrode model, standard electric field, actual electric field, and VTA display. Server 3 can send the patient's impedance information and authorization to computer 1, so that the programmable device service provider can continuously optimize the standard electric field data, electrode model data, actual electric field calculation model, VTA threshold calculation model, etc., using real patient data to make them more accurate, thereby improving the accuracy of the neurostimulation range generated by the programmable device 2.

[0063] In a preferred embodiment, an optional electrode model data structure and a VTA isosurface data structure are provided, which can be used to draw and display a three-dimensional model of the electrode model and the range of nerve stimulation in the programmable device 2. Taking the electrode model data structure as an example, such as... Figure 5 As shown in the figure, this is a bottom view of a cylindrical electrode. The electrode model data generated by computer 1 includes multiple planar graphic data. In this embodiment, the plane is triangular; in other embodiments, it could also be a polygonal plane.

[0064] The planar graphic data includes vertex number information and vertex position information, where the vertex position information is three-dimensional coordinates. The electrode model data also includes the arrangement relationship information of the vertex number information in each planar graphic data. When the programmable control device 2 receives this data structure, it can draw each planar graphic according to the vertex number information and vertex position information, and then combine the planar graphics into an electrode model according to the arrangement relationship information, thereby drawing a three-dimensional electrode model, such as... Figure 5The electrode model shown is a three-dimensional model composed of several triangular planes.

[0065] Similar to the electrode model data, the VTA isosurface, which is the boundary of the VTA, is also a three-dimensional shape. This three-dimensional shape can be assembled using a similar data structure. The isosurface includes multiple planar graphic data, each containing vertex numbering and position information. The isosurface also includes the arrangement relationship information of the vertex numbers within each planar graphic data. The programmable control device 2 draws each planar graphic based on the vertex numbering and position information, and combines these planar graphics into a three-dimensional model of the neural stimulation range based on the arrangement relationship information.

[0066] This application takes into account the computational efficiency and data volume of standard electric field data, and the following is combined with... Figure 6 and Figure 7 Two optional standard electric field data sets are introduced. Standard electric field data can be represented as a three-dimensional network, but for clarity, the image used only shows one two-dimensional facet of the three-dimensional network; the other faces are similar. For ease of explanation, [the following will be used]. Figure 6 The content shown is called uniform standard electric field data; Figure 7 The content shown is called non-uniform standard electric field data.

[0067] Standard electric field data is three-dimensional point cloud data, where each point includes its location information and the standard electric field strength (electric field value) at that location. The point at the center of the three-dimensional point cloud data corresponds to the location of the electrode contact (center). For example... Figure 6 The uniform standard electric field data shown refers to the fact that all adjacent points in the network are equidistant, or that adjacent points in the same plane are equidistant. The denser the points in the network, the larger the amount of standard electric field data, and the more accurate the VTA calculation will be.

[0068] like Figure 7 The non-uniform standard electric field data shown refers to the non-uniform distribution of points in a three-dimensional point cloud. The spacing between points closer to the center is smaller than the spacing between points farther from the center. For example, the spacing between points 0-a1 is smaller than the spacing between points a1-a2. In other words, the point cloud is denser closer to the electrode contact (center) and relatively sparser further away. This optimized data structure ensures the accuracy of the electric field values ​​under commonly used parameters, reduces data volume, and improves computation speed, achieving a balance between computational accuracy and computation time / storage requirements.

[0069] Specifically, the aforementioned commonly used parameters refer to the commonly used values ​​for stimulation amplitude. For example, for general nerve stimulation devices, the stimulation amplitude in voltage mode generally does not exceed 6V. Therefore, ensuring that the calculated actual electric field within a voltage of 6V is sufficiently accurate is sufficient to meet routine usage requirements. Thus, when providing a standard electric field, it is necessary to determine the distance at which the conventional parameters can generate the electric field. Figure 7 For example, the ranges from -a1 to a1 and from -b1 to b1 represent the range within which a conventional parameter (6V) can generate an electric field. Therefore, points within this range are configured more densely to represent the electric field values ​​at various points within this range in detail, while points further away are configured more sparsely to reduce the amount of data. This achieves a balance between computational accuracy and computation time and storage requirements with a limited number of points.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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 displaying the range of action of nerve stimulation, characterized in that, The method is executed by an external programming device of an implantable neurostimulation device. The programming device pre-stores electrode model data and standard electric field data for various electrode contacts under various polarity settings. The method includes: The programmable control device acquires contact configuration information; Read the standard electric field data corresponding to the contact configuration based on the contact configuration information; Based on the standard electric field data corresponding to the contact configuration, the working parameters of the electrode contacts are calculated, and the actual electric field data corresponding to the contact configuration is obtained. The threshold of the nerve stimulation range and its isosurface are calculated based on the working parameters of the electrode contacts and the parameters of the stimulation object, thereby generating and displaying a three-dimensional model of the nerve stimulation range; the working parameters include the amplitude and pulse width of the stimulation signal; the parameters of the stimulation object include the axon diameter; The calculation of the actual electric field data corresponding to the contact configuration based on the standard electric field data and the working parameters of the electrode contacts includes: The programmable device communicates with external equipment to obtain impedance information of the stimulated object; The actual electric field data is calculated based on the impedance information, the corresponding standard electric field data of the contact configuration, and the working parameters of the electrode contacts.

2. The method according to claim 1, characterized in that, The programmed control device communicates with external devices to obtain impedance information of the stimulated object, including: The programmable device controls the implantable neurostimulation device to output stimulation signals to perform impedance testing and determine the impedance information. Send a request to the server to use impedance information; Once the server approves the usage request, the programmable device obtains the impedance information.

3. The method according to claim 1, characterized in that, The programmable device has a pre-stored model of the stimulation object, and the three-dimensional model that generates and displays the range of nerve stimulation includes: The programmable device acquires the electrode implantation angle and position configured by the user; Based on the implantation angle and location, the electrode model, the three-dimensional model of the nerve stimulation range, and the stimulation object model are displayed.

4. The method according to claim 1, characterized in that, The pre-stored standard electric field data in the programmable device includes standard electric field data corresponding to various human tissues; the contact configuration information also includes information on the stimulation object or the implantation location information of the electrode contact; the standard electric field data corresponding to the contact configuration refers to the standard electric field data that is corresponding to both the contact configuration and the stimulation object.

5. The method according to claim 1, characterized in that, The standard electric field data is three-dimensional point cloud data, where each point includes location information and standard electric field strength information; the point located at the center of the three-dimensional point cloud data corresponds to the location of the electrode contact.

6. The method according to claim 5, characterized in that, The points in the three-dimensional point cloud data are non-uniformly distributed, wherein the distance between multiple points closer to the center is smaller than the distance between multiple points farther from the center.

7. The method according to claim 1, characterized in that, The electrode contacts include annular electrode contacts and directional electrode contacts.

8. A programmable control device, characterized in that, include: At least one processing unit, and a storage unit, an interaction unit, and a communication unit communicatively connected to the at least one processing unit; wherein the storage unit stores instructions executable by the at least one processing unit, the instructions being executed by the at least one processing unit to cause the at least one processing unit to perform the neurostimulation range display method as described in any one of claims 1-7, the communication unit is used to interact with an implantable neurostimulation device, and the interaction unit is used to acquire user touch point configuration operations and display a three-dimensional model of the neurostimulation range.

9. A system for displaying the range of nerve stimulation, characterized in that, include: The programmable control device as described in claim 8; as well as An implantable neurostimulation device, a patient terminal, and a server are provided, wherein the programming device is used to control the implantable neurostimulation device to perform impedance testing to obtain impedance information, the patient terminal is used to upload the impedance information and a license to use the impedance information to the server, and the server, upon finding the license, allows the programming device to use the impedance information to calculate the actual electric field data.

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