CN115105746A - Nerve stimulation action range display method, device and system - Google Patents

Nerve stimulation action range display method, device and system Download PDF

Info

Publication number
CN115105746A
CN115105746A CN202210784520.0A CN202210784520A CN115105746A CN 115105746 A CN115105746 A CN 115105746A CN 202210784520 A CN202210784520 A CN 202210784520A CN 115105746 A CN115105746 A CN 115105746A
Authority
CN
China
Prior art keywords
electric field
stimulation
field data
electrode
standard electric
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202210784520.0A
Other languages
Chinese (zh)
Inventor
郑翊宸
陈浩
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Beijing Pins Medical Co Ltd
Original Assignee
Beijing Pins Medical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Beijing Pins Medical Co Ltd filed Critical Beijing Pins Medical Co Ltd
Priority to CN202210784520.0A priority Critical patent/CN115105746A/en
Publication of CN115105746A publication Critical patent/CN115105746A/en
Pending legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128Control systems
    • A61N1/36135Control systems using physiological parameters
    • A61N1/36139Control systems using physiological parameters with automatic adjustment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36053Implantable neurostimulators for stimulating central or peripheral nerve system adapted for vagal stimulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36062Spinal stimulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36067Movement disorders, e.g. tremor or Parkinson disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36082Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128Control systems
    • A61N1/36135Control systems using physiological parameters
    • A61N1/3614Control systems using physiological parameters based on impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128Control systems
    • A61N1/36146Control systems specified by the stimulation parameters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37235Aspects of the external programmer
    • A61N1/37247User interfaces, e.g. input or presentation means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37252Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Neurology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Neurosurgery (AREA)
  • Hospice & Palliative Care (AREA)
  • Biophysics (AREA)
  • Physiology (AREA)
  • Human Computer Interaction (AREA)
  • Child & Adolescent Psychology (AREA)
  • Developmental Disabilities (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Psychiatry (AREA)
  • Psychology (AREA)
  • Electrotherapy Devices (AREA)

Abstract

The invention provides a method, a device and a system for displaying a neural stimulation action range, wherein the method is executed by an in-vitro program control device of implantable neural stimulation equipment, electrode model data and standard electric field data of various electrode contacts under various polarity settings are prestored in the program control device, and the method comprises the following steps: the program control device acquires contact configuration information; reading standard electric field data corresponding to the contact configuration according to the contact configuration information; calculating actual electric field data corresponding to the contact configuration according to the standard electric field data corresponding to the contact configuration and working parameters of the electrode contact; and calculating the neural stimulation action range threshold value and the isosurface thereof according to the working parameters of the electrode contact and the parameters of the stimulation object, and further generating and displaying a three-dimensional model of the neural stimulation action range.

Description

Nerve stimulation action range display method, device and system
Technical Field
The invention relates to the field of medical equipment, in particular to a method, a device and a system for displaying a nerve stimulation action range.
Background
Neurostimulation therapy can be used for treating various diseases, for example, deep brain electrical stimulation therapy is an effective means for treating diseases such as Parkinson's disease, essential tremor, dystonia, obsessive-compulsive disorder and the like; vagus nerve stimulation therapy can be used for treating epilepsy and inhibiting epileptic seizure; similarly, there are spinal nerve stimulation therapies, sacral nerve stimulation therapies, and the like.
Neurostimulation therapy requires implanting a pulse generator, extension leads and electrodes into the body, controlling through extracorporeal devices, and transmitting electrical pulses to specific areas to control disease symptoms. When stimulation is applied, stimulation parameters need to be adjusted through the extracorporeal device, so that different stimulation effects are realized. For example, the stimulation position is changed by adjusting the polarity of the contact points, and the stimulation influence range is changed by modifying the amplitude, the pulse width and the frequency.
After implantation of the device, a physician is required to perform the programming. Currently, in clinic, doctors generally select a contact point according to the prior experience, set stimulation parameters, inquire and observe the reaction of patients. If the stimulation is ineffective or has serious side effects, the selected contact is replaced. If the patient has a certain curative effect, the stimulation parameters are finely adjusted to allow the patient to feel. In the whole program control process, adjustment is mainly carried out according to the experience of doctors and the subjective feeling of patients, and multiple times of adjustment are often needed to achieve a relatively good state. This procedure has several problems: the program control time and effect depend on the experience of doctors, and the subjectivity exists; the individuation degree is low, even if the patient has postoperative image data, the image data are difficult to be fully utilized in the program control process due to the limited clinic time; the lack of effect indication feedback in the program control software makes it difficult to have a visual impression on the effect of the program control parameters. Therefore, a system capable of intuitively reflecting the condition of the patient and displaying the effect of the stimulation parameters is needed in the program control process.
Vta (volume of Tissue activation) refers to the range of neural Tissue that can be affected by electrical stimulation under set parameters, which range is affected by the electrode polarity configuration and stimulation parameters. To realize that the corresponding VTA is displayed under the condition of different contact configurations and stimulation parameters, the electrodes and the VTA can be visually displayed in modes of modeling, simulation, calculation and the like. The modeling and simulation have high requirements on the performance of the equipment, and the program control device used by a doctor for program control has the requirement of portability, so that the performance of the equipment is limited, and the purpose is difficult to realize by the program control device.
Disclosure of Invention
In view of the above, the present application provides a method for displaying a neurostimulation action range, which is performed by an external programmable device of an implantable neurostimulation apparatus, wherein the programmable device is pre-stored with electrode model data and standard electric field data of various electrode contacts under various polarity settings, and the method comprises: the program control device acquires contact configuration information; reading standard electric field data corresponding to the contact configuration according to the contact configuration information; calculating actual electric field data corresponding to the contact configuration according to the standard electric field data corresponding to the contact configuration and working parameters of the electrode contact; and calculating the neural stimulation action range threshold value and the isosurface thereof according to the working parameters of the electrode contact and the parameters of the stimulation object, and further generating and displaying a three-dimensional model of the neural stimulation action range.
Optionally, calculating actual electric field data corresponding to the contact configuration according to the standard electric field data corresponding to the contact configuration and the working parameters of the electrode contact, including:
the program control device communicates with an external device to acquire impedance information of a stimulation object;
and calculating the actual electric field data according to the impedance information, the standard electric field data corresponding to the contact configuration and the working parameters of the electrode contact.
Optionally, the program control device communicates with an external device to obtain impedance information of the stimulation subject, including:
the program control device controls the implantable nerve stimulation equipment to output stimulation signals to carry out impedance test, and the impedance information is determined;
sending a request for use of impedance information to a server;
the programming device obtains the impedance information after the server grants the request for use.
Optionally, the programming device prestores a stimulation object model, and the generating and displaying a three-dimensional model of the neural stimulation effect range includes:
the program control device acquires an electrode implantation angle and position configured by a user;
and displaying the electrode model, the three-dimensional model of the nerve stimulation action range and the stimulation object model according to the implantation angle and the implantation position.
Optionally, the standard electric field data pre-stored in the program control device includes standard electric field data corresponding to various human tissues; the contact configuration information further includes stimulation object information or implantation position information of the electrode contacts; the standard electric field data program control device corresponding to the contact configuration refers to standard electric field data corresponding to the contact configuration and corresponding to a stimulation object.
Optionally, the standard electric field data is three-dimensional point cloud data, wherein each point includes position information and standard electric field strength information; and the point positioned at the center in the three-dimensional point cloud data corresponds to the position of the electrode contact.
Optionally, the points in the three-dimensional point cloud data are non-uniformly distributed, wherein a spacing of a plurality of points near the center is smaller than a spacing of a plurality of points far away from the center.
Optionally, the electrode contacts comprise a ring electrode contact and a direction electrode contact; the working parameters comprise the amplitude and pulse width of the stimulation signal; the parameter of the stimulating subject comprises axon diameter.
The invention also provides a program control device, comprising: the system comprises at least one processing unit, and a storage unit, an interaction unit and a communication unit which are in communication connection with the at least one processing unit; the storage unit stores instructions executable by the processing unit, the instructions are executed by the at least one processing unit to enable the at least one processing unit to execute the neural stimulation effect range display method, the communication unit is used for interacting data with the implantable neural stimulation device, and the interaction unit is used for acquiring a contact configuration operation of a user and displaying a three-dimensional model of a neural stimulation effect range.
The invention also provides a system for displaying the nerve stimulation effect range, which comprises:
the program control device; the system comprises a programmable device, an implantable nerve stimulation device, a patient terminal and a server, wherein the programmable device is used for controlling the implantable nerve stimulation device to perform impedance test to obtain impedance information, the patient terminal is used for uploading the impedance information to the server and authorizing permission for using the impedance information, and the server allows the programmable device to use the impedance information when inquiring the authorizing permission for calculating the actual electric field data.
According to the nerve stimulation action range display method provided by the invention, the program control device is configured with the electrode model data and the standard electric field data, the data can be obtained by modeling and simulation calculation in advance through a computer, then the data are imported into the program control device, when VTA display is needed, the program control device only needs to acquire the contact configuration information, so that the standard electric field data corresponding to the contact configuration information is read, the actual electric field data is calculated according to stimulation parameters, then the three-dimensional model and the electrode model of the nerve stimulation action range are generated and displayed, and the VTA is calculated according to the actual condition of a patient, so that the display result is personalized. The program control device in the scheme does not need to execute modeling simulation operation which is long in time consumption and large in calculation amount, only needs simple real-time calculation, can adjust the display result of the VTA in real time according to the parameters, achieves balance between equipment portability and performance, and achieves real-time change.
The program control device can also acquire the impedance information of the patient, and the VTA is calculated by combining the electrode impedance result of the patient measured in the actual program control process, so that the calculation result is more accurate.
The standard electric field data in the invention comprises a series of standard electric field data generated aiming at different human tissues, and the program control device can read corresponding data which are modeled and simulated in advance according to the electrode implantation position, thereby realizing the distinguishing of target positions.
The standard electric field data used in the invention can be three-dimensional point cloud data which are non-uniformly distributed, the points in the area close to the electrode contact are more densely distributed, the points in the area far away from the electrode contact are sparser distributed, and when the actual electric field is calculated under the common working parameters, the calculation precision can be ensured due to high grid density; under the condition of using working parameters very much, the used grid density is low, the data volume is reduced, and the calculation time is shortened.
According to the nerve stimulation action range display system provided by the invention, when a doctor needs to use the program control device to download the impedance information from the server, the server allows the program control device to download and use the impedance information under the condition that the server inquires about the use authorization permission of the impedance information uploaded by a patient, so that the personal information safety of the patient is protected, and the patient can upload the use authorization permission of the impedance information to the server by using the patient terminal in advance without authorization on the site of program control operation, so that the convenience is improved.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.
FIG. 1 is a schematic diagram of a programming device and a computer in an embodiment of the invention;
FIG. 2 is a schematic view of an electrode model in an embodiment of the invention;
FIG. 3 is a schematic diagram of a VTA model generated in an embodiment of the present invention;
FIG. 4 is a schematic diagram of a system for displaying the range of action of neurostimulation in accordance with an embodiment of the present invention;
FIG. 5 is a schematic diagram of an electrode model according to an embodiment of the present invention;
FIG. 6 is a diagram illustrating standard electric field data in an embodiment of the present invention;
FIG. 7 is a diagram illustrating another standard electric field data in an embodiment of the present invention;
fig. 8 is a flowchart of a method for displaying the range of action of neurostimulation performed by the programming device in an embodiment of the present invention.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
In addition, the technical features involved in the different embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.
The application provides a nerve stimulation action range display method, which is executed by external control equipment of implanted nerve stimulation equipment, wherein the external control equipment can be controlled by a doctor, and specifically can be program control devices of various nerve stimulators such as a vagus nerve stimulator, a deep brain electrical stimulator, a spinal nerve stimulator, a sacral nerve stimulator and the like.
As shown in fig. 1, the programming device 2 is provided with an interaction unit, such as a display screen, an input key, 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, and near field communication; and the storage unit and the processing unit are used for storing and executing the application program, so that the control of the implantable nerve stimulation device is realized, and the related operation of displaying the action range of the nerve stimulation is executed in the embodiment.
In order to display the nerve stimulation action range, electrode model data and standard electric field data of various electrode contacts under various polarity settings are prestored in the program control device 2 executing the method. The electrode model data comprises model data of at least one specification type of electrode used by a vagus nerve stimulation system, a deep brain electrical stimulation system, a spinal nerve stimulation system and a sacral nerve stimulation system. The pre-stored electrode model data and standard electric field data may be generated by the computer 1 and imported into the programming device 2 before shipment. Wherein the electrode model data is used to generate an electrode model in the programming device 2.
Common electrodes for neurostimulation systems include cylindrical electrodes, paddle electrodes, and the like. By way of example, fig. 2 shows two kinds of cylindrical electrodes, on which a plurality of contacts are provided, and the programming device 2 can control all or part of the contacts to output stimulation signals, and the kinds of the electrode contacts include a ring electrode contact and a direction electrode contact. In fig. 2, all of the right-hand electrodes are ring electrode contacts 22; the contacts at the upper and lower ends of the electrode on the left side are ring electrode contacts 22, and the two groups of contacts in the middle are direction electrode contacts 21. Of course, except for the difference of the electrode shape and the electrode contacts, the differential design can be carried out on the number of the contacts, the arrangement and combination among the contacts and the intervals among the contacts, so that various types of electrodes are formed to be suitable for different stimulation systems and action targets. Accordingly, the electrode model and the electrode model data of the present application also have a corresponding plurality of types.
The standard electric field in the present application refers to an electric field generated by the electrode contact in the surrounding medium under preset operating parameters, for example, an electric field generated when the stimulation voltage is 1V. Specifically, finite element software can be used for modeling and simulating the electric field by using an electrode model and a tissue model. The electric fields generated by the electrode contacts under different polarity settings are different, so that the standard electric fields of the electrode contacts under different polarity settings need to be simulated.
It is also noted that the location of the electrode implantation is different and there are differences in the characteristics of the surrounding tissue, which also results in different standard electric fields. Therefore, in a preferred embodiment, different stimulation object models are generated according to different tissue characteristics, and standard electric fields corresponding to different stimulation objects are obtained. In the application scenario of deep brain electrical stimulation, the tissues around the contacts in the brain include gray matter, white matter, cerebrospinal fluid, etc.; in the context of spinal cord electrical stimulation applications, the tissue surrounding the contacts in the spinal cord may have gray matter, white matter, dorsal root nerves, spinal cord dorsal membrane, cerebrospinal fluid, and the like. These tissues have different properties, in particular different conductivities, which influence the potential distribution after application of a voltage. In order to make the value of the standard electric field more accurate, it is necessary to simulate the standard electric field that generates the electrode contacts in these different tissues and combinations thereof. Each contact on the same electrode can be respectively configured to be a positive electrode or a negative electrode, the combination of polarity configuration forms a plurality of stimulation modes such as unipolar stimulation, bipolar stimulation and multipolar stimulation, the standard electric fields of the same contact in different polarity combinations (stimulation modes) are different, and the standard electric fields of two different types of contacts, namely a ring electrode contact and a directional electrode contact, in the same stimulation mode are different, so that corresponding standard electric field data need to be respectively generated aiming at various possible combination situations; in addition, since the contact points may act on different tissues, it is also necessary to generate standard electric field data separately for each tissue or for a combination of tissues. The more the types and the number of the contacts on the electrode are, the more the standard electric field data need to be generated, so that the computer 1 needs to be used for generating a large amount of standard electric field data, namely, the standard electric field data of all the electrode contacts under all implantation positions, all medium types (human tissues) and all polarity settings are exhausted.
In the present application, the program control device 2 is connected to the computer 1 in a communication manner, receives electrode model data generated by the computer 1, and further establishes an electrode model when in use, and configures a positional relationship between the electrode model and a stimulation object. The stimulation target is, for example, a brain, a vagus nerve, a sacral nerve, a spinal nerve, or the like of the patient. Specifically, the user (doctor) may manipulate the program control device 2 to set the angle and position of the electrode model according to the actual implantation condition of the electrode, and may further select a pre-stored standard model of the stimulation object, such as a pre-stored model of the brain, the vagus nerve, the sacral nerve, and the spinal nerve, or introduce an actual model generated according to the local medical image of the patient, thereby determining the positional relationship between the electrode model and the stimulation object model.
As shown in fig. 8, the method for displaying the neural stimulation action range executed by the programmed device 2 includes the following steps:
s1, contact configuration information is acquired. The user provides contact configuration information according to the treatment protocol, including, for example, which contacts to select (number of contacts to be activated), polarity of the contacts, stimulation parameters (frequency, amplitude, pulse width).
And S2, reading standard electric field data corresponding to the contact configuration from the pre-stored standard electric field data according to the contact configuration information. In a preferred embodiment, the contact configuration information further comprises stimulation object information or implantation position information of the electrode contacts. The program control device 2 can read standard electric field data corresponding to the contact configuration and corresponding to the stimulation object from a large number of pre-stored standard electric field data according to the contact configuration information.
And S3, calculating actual electric field data corresponding to the contact configuration according to the standard electric field data corresponding to the contact configuration and the working parameters of the electrode contact.
There are various specific calculation methods for calculating the actual electric field according to the contact configuration condition and the stimulation amplitude, for example, standard electric field data of corresponding contacts can be read according to the contact configuration for superposition, and the actual electric field data corresponding to the stimulation amplitude can be calculated by using a fitting formula of the pre-stored stimulation amplitude and the electric field. The pre-stored fitting formula is to simulate the electric field under different stimulation amplitudes in advance, and the simulation result is used for fitting the stimulation amplitudes to the electric field to obtain the fitting formula, wherein the simulation calculation process can be executed by the computer 1, the fitting formula is configured in the program control device 2, and the actual electric field can be calculated by substituting the formula into the program control device 2.
In an optional embodiment, a neural network algorithm may also be used to calculate the actual electric field, the electric fields under different stimulation amplitudes are simulated in advance to obtain a large number of sample data, each sample includes a standard electric field and a stimulation amplitude, the label is the actual electric field, and the actual electric field can be predicted after the neural network is trained through the large number of samples and the label data. The trained neural network is configured in the program control device 2, the program control device 2 takes the standard electric field data and the stimulation amplitude corresponding to the contact configuration as input data of the neural network, and corresponding actual electric field data are output through calculation.
And S4, calculating the neural stimulation action range threshold value and the isosurface thereof according to the working parameters of the electrode contact and the parameters of the stimulation object, and further generating and displaying a three-dimensional model of the neural stimulation action range. In the step, a threshold of the VTA is calculated according to the stimulation pulse width and the nerve axon diameter, then an isosurface result of the threshold is obtained by utilizing an algorithm (such as Marching cups algorithm, Dual bounding algorithm, Dividing cups algorithm, Marching tetrahedra algorithm and the like) for three-dimensionally extracting an isosurface based on the actual electric field and the threshold, namely the isosurface result is an interface between an activation region and a non-activation region, the inside of the isosurface is the VTA, and the activation region is used as a nerve stimulation action range. .
There are various specific calculation methods for calculating the threshold of VTA according to the stimulation pulse width and the axon diameter, for example, a neuron model may be constructed in advance, the activation conditions of the neuron under different conditions are obtained by simulation using the same voltage, different pulse widths or axon diameters, and the fitting between the pulse width/axon diameter and the activation electric field value (threshold of VTA) is performed, so as to obtain a fitting formula, which is stored in the program control device 2. And substituting the stimulation pulse width and the axon diameter into a fitting formula during calculation to obtain the threshold value of the VTA. Similarly, a neural network algorithm may also be used to train the neural network in advance, configure the trained neural network in the programming device 2, and the programming device 2 uses the stimulation pulse width and the axon diameter as input data of the neural network, and outputs the corresponding threshold value of the VTA through calculation.
After the VTA is calculated, the program control device 2 may use the open graphic library to draw the electrodes and the VTA, set appropriate colors and materials for the electrodes and the VTA, determine an illumination mode, and enable a user to perform interactive operations such as translation, rotation, and scaling. In a preferred embodiment, the programming means 2 may also provide a model of the stimulating object, such as a brain model.
In step S4, the programming device 2 obtains the user-configured electrode implantation angle and position, and displays the electrode model, the three-dimensional model of the neurostimulation action range, and the stimulation object model according to the user-configured electrode implantation angle and position, so as to indicate the current display side and the position of the electrode relative to the stimulation object.
Fig. 3 shows a three-dimensional model of the range of action of 4 neurostimulation, in which the two left-hand sides include the direction electrode contacts and the ring electrode contacts, and the two right-hand sides are all ring electrode contacts. The figure shows a VTA model generated from the contact configuration.
The programming device 2 may also obtain actual impedance information of the user in order to more accurately calculate the actual electric field data. The programming device 2 communicates with an external device, such as a server or a patient terminal, to obtain impedance information of the stimulating subject for calculating the actual electric field data.
Since impedance information pertains to patient data, patient authorization needs to be obtained to be accessible for security and patient privacy. In a preferred embodiment, based on the system shown in fig. 4, the system includes a programming apparatus 2, a server 3, a patient terminal 4 and an implantable neurostimulation device 5, wherein the patient terminal 4 can be a programming apparatus held by a patient, and can also be a common electronic device, such as a mobile phone, a tablet computer, etc.
The program control device 2 controls the implantable nerve stimulation device 5 to output stimulation signals to perform impedance test, and the patient terminal 4 can upload impedance information to the server 3 or directly send the impedance information to the program control device 2 under the authorized condition. The patient terminal 4 may upload the patient's authorization permission to the server 3 in real time or in advance, allowing the programming device 2 to obtain impedance information from the server 3 or the patient terminal 4 for use in calculating actual electric field data when the server 3 queries that authorization permission exists.
According to the method and the device, personal information safety of the patient is considered, authorization can be obtained in advance through the patient side, the program control device 2 only needs to determine authorization from the server 3 when using patient data, authorization on site is not needed, and convenience is improved.
In addition, according to the system, a program control equipment service provider can update standard electric field data, electrode model data, an actual electric field calculation model (comprising a fitting formula and a trained neural network), a VTA threshold calculation model (comprising a fitting formula and a trained neural network) and the like, the updated data or calculation model is uploaded to the server 3 through the computer 1, the program control device 2 of a doctor can download latest basic data at any time, and even under the condition that the implantable nerve stimulation equipment is updated, the program control device 2 of the doctor can update the basic data timely to optimize local electrode models, standard electric fields, actual electric fields and VTA display; the server 3 can send the impedance information and the authorization permission of the patient to the computer 1, so that a program control equipment service provider can continuously optimize standard electric field data, electrode model data, an actual electric field calculation model, a VTA threshold calculation model and the like by using the data of the real patient, the standard electric field data, the electrode model data, the actual electric field calculation model, the VTA threshold calculation model and the like are more accurate, and the accuracy of the nerve stimulation action range generated by the program control device 2 is further improved.
In a preferred embodiment, an alternative electrode model data structure and VTA isosurface data structure is provided for rendering a three-dimensional model representation of the electrode model, the neurostimulation coverage, in the programming device 2. Taking the electrode model data structure as an example, as shown in fig. 5, which shows a bottom view of a cylindrical electrode, the electrode model data generated by the computer 1 includes a plurality of plane graph data. The present embodiment is a triangular plane, and may be a polygonal plane in other embodiments.
The planar graphics data includes vertex number information and vertex position information, wherein the vertex position information is three-dimensional coordinates. The electrode model data further includes arrangement relation information of vertex number information in each of the plane figure data. When receiving the data structure, the program control device 2 may draw each plane figure according to the vertex number information and the vertex position information, and further combine each plane figure into an electrode model according to the arrangement relationship information, thereby drawing a three-dimensional electrode model, where the electrode model shown in fig. 5 is a three-dimensional model composed of a plurality of triangular planes.
Similar to the electrode model data, the VTA isosurface, i.e., the boundary of the VTA, is also a three-dimensional shape as a whole, which can be assembled using similar data structures. The isosurface comprises a plurality of plane graph data, the plane graph data comprises vertex number information and vertex position information, and the isosurface also comprises arrangement relation information of the vertex number information in each plane graph data; and the program control device 2 draws each plane graph according to the vertex number information and the vertex position information, and combines each plane graph into a three-dimensional model of the nerve stimulation action range according to the arrangement relation information.
In view of the computational efficiency and data size of the standard electric field data, two alternative standard electric field data are described below in conjunction with fig. 6 and 7. The standard electric field data may be expressed as a three-dimensional network, but for clarity of presentation, the picture used shows only one two-dimensional face of the three-dimensional network, the other faces being similar to this face. For convenience of explanation, the contents shown in fig. 6 are referred to as uniform standard electric field data; the contents shown in fig. 7 are referred to as non-uniform standard electric field data.
The standard electric field data is three-dimensional point cloud data in which each point includes position information and standard electric field strength information (electric field value) of the position. The point at the center in the three-dimensional point cloud data corresponds to the position where the electrode contact (center) is located. The uniform standard electric field data shown in fig. 6 means that the distances between all adjacent points in the network are all the same, or the distances between adjacent points in the same plane are all the same, and the denser the points in the network are, the larger the standard electric field data amount is, and the more accurate the VTA is finally calculated.
The non-uniform standard electric field data shown in fig. 7 refers to the point in the three-dimensional point cloud data being non-uniformly distributed, wherein the distance between a plurality of points close to the center is smaller than the distance between a plurality of points far away from the center, such as the distance between points 0-a1, which is smaller than the distance between points a1-a2, i.e., the closer the point cloud is to the position where the electrode contact (center) is located, the denser the point cloud is, and the farther the point cloud is relatively sparse. The optimized data structure can ensure the accuracy of the electric field value under the condition of common parameters, reduce the data volume, improve the calculation speed and achieve the balance of calculation precision, calculation time and storage.
Specifically, the common parameter refers to a common value of the stimulation amplitude, for example, for a general nerve stimulation device, the stimulation amplitude does not exceed 6V in a voltage mode, so that it is ensured that an actual electric field calculated within 6V of voltage is accurate enough to meet a conventional use requirement. Therefore, when providing the standard electric field, the distance that the electric field can be generated by the conventional parameters needs to be determined, taking fig. 7 as an example, the range of-a 1-a 1, -b 1-b 1 is the range that the electric field can be generated by the conventional parameters (6V). Therefore, the points within the range are arranged more densely, so that the electric field values at various positions within the range are expressed in detail, the points farther away are arranged sparsely, so that the data volume is reduced, and under the condition of a limited number of points, the balance of calculation accuracy, calculation time and storage volume is achieved.
As will be appreciated by one skilled in the art, embodiments of the present invention may be provided as a method, system, or computer program product. Accordingly, the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment or an embodiment combining software and hardware aspects. Furthermore, the present invention may 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, and the like) having computer-usable program code embodied therein.
The present 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 flow and/or block of the flow diagrams and/or block diagrams, and combinations of flows and/or blocks in the flow diagrams and/or block diagrams, can be implemented by computer program instructions. These computer program instructions may 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, create means for implementing the functions specified in the flowchart flow or flows and/or block diagram block or blocks.
These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including instruction means which implement the function specified in the flowchart flow or flows and/or block diagram block or blocks.
These computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified in the flowchart flow or flows and/or block diagram block or blocks.
It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims (10)

1. A method for displaying a neurostimulation action range, which is performed by an external programmable device of an implantable neurostimulation apparatus, wherein the programmable device is pre-stored with electrode model data and standard electric field data of various electrode contacts under various polarity settings, the method comprising:
the program control device acquires contact configuration information;
reading standard electric field data corresponding to the contact configuration according to the contact configuration information;
calculating actual electric field data corresponding to the contact configuration according to the standard electric field data corresponding to the contact configuration and working parameters of the electrode contact;
and calculating the neural stimulation action range threshold value and the isosurface thereof according to the working parameters of the electrode contact and the parameters of the stimulation object, and further generating and displaying a three-dimensional model of the neural stimulation action range.
2. The method of claim 1, wherein calculating actual electric field data corresponding to the contact configuration based on the standard electric field data corresponding to the contact configuration and the operating parameters of the electrode contact comprises:
the program control device communicates with an external device to acquire impedance information of a stimulation object;
and calculating the actual electric field data according to the impedance information, the standard electric field data corresponding to the contact configuration and the working parameters of the electrode contact.
3. The method of claim 2, wherein the programming device communicates with an external device to obtain impedance information of a stimulating subject, comprising:
the program control device controls the implantable nerve stimulation equipment to output stimulation signals to carry out impedance test, and the impedance information is determined;
sending a request for use of impedance information to a server;
the programming device obtains the impedance information after the server grants the request for use.
4. The method of claim 1 or 2, wherein the programming device is pre-stored with a model of a stimulation subject, and the generating and displaying a three-dimensional model of the neurostimulation coverage comprises:
the program control device acquires an electrode implantation angle and position configured by a user;
and displaying the electrode model, the three-dimensional model of the nerve stimulation action range and the stimulation object model according to the implantation angle and the implantation position.
5. The method according to claim 1 or 2, characterized in that the standard electric field data pre-stored in the program control device comprises standard electric field data corresponding to various human tissues; the contact configuration information further includes stimulation object information or implantation position information of the electrode contact; the standard electric field data corresponding to the contact configuration refers to standard electric field data corresponding to the contact configuration and corresponding to a stimulation object.
6. The method according to claim 1 or 2, wherein the standard electric field data is three-dimensional point cloud data, wherein each point comprises position information and standard electric field strength information; and the point positioned at the center in the three-dimensional point cloud data corresponds to the position of the electrode contact.
7. The method of claim 6, wherein the points in the three-dimensional point cloud data are non-uniformly distributed, wherein a spacing of a plurality of points near the center is less than a spacing of a plurality of points away from the center.
8. The method of claim 1, wherein the electrode contacts comprise a ring electrode contact and a direction electrode contact; the working parameters comprise the amplitude and pulse width of the stimulation signal; the parameter of the stimulating subject includes an axon diameter.
9. A programmable device, comprising: the system comprises at least one processing unit, and a storage unit, an interaction unit and a communication unit which are in communication connection with 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 execute the neurostimulation range of action displaying method according to any of claims 1-8, the communication unit is used for interacting data with the implantable neurostimulation device, and the interaction unit is used for acquiring a contact configuration operation of a user and displaying a three-dimensional model of the neurostimulation range of action.
10. A neurostimulation range of action display system, comprising:
the programming device of claim 9; and
the system comprises an implantable nerve stimulation device, a patient terminal and a server, wherein the programmable device is used for controlling the implantable nerve stimulation device to conduct impedance test to obtain impedance information, the patient terminal is used for uploading the impedance information to the server and authorizing permission of use of the impedance information, and the server allows the programmable device to use the impedance information when inquiring the authorization permission for calculating the actual electric field data.
CN202210784520.0A 2022-06-28 2022-06-28 Nerve stimulation action range display method, device and system Pending CN115105746A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202210784520.0A CN115105746A (en) 2022-06-28 2022-06-28 Nerve stimulation action range display method, device and system

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202210784520.0A CN115105746A (en) 2022-06-28 2022-06-28 Nerve stimulation action range display method, device and system

Publications (1)

Publication Number Publication Date
CN115105746A true CN115105746A (en) 2022-09-27

Family

ID=83332739

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202210784520.0A Pending CN115105746A (en) 2022-06-28 2022-06-28 Nerve stimulation action range display method, device and system

Country Status (1)

Country Link
CN (1) CN115105746A (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117936024A (en) * 2024-03-20 2024-04-26 景昱医疗科技(苏州)股份有限公司 Program control parameter configuration method and related device

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117936024A (en) * 2024-03-20 2024-04-26 景昱医疗科技(苏州)股份有限公司 Program control parameter configuration method and related device

Similar Documents

Publication Publication Date Title
CN108712921B (en) System for constructing neural stimulation patterns using neural network models
JP6452836B2 (en) Method and apparatus for programming complex neural stimulation patterns
Duffley et al. Evaluation of methodologies for computing the deep brain stimulation volume of tissue activated
EP3503967B1 (en) Customized targeted fields for electrotherapy applications
EP3648832B1 (en) System for selecting stimulation configuration and target for neuromodulation
US8849411B2 (en) User-defined graphical shapes used as a visualization aid for stimulator programming
US9358398B2 (en) Collection of clinical data for graphical representation and analysis
US20160279429A1 (en) Method and apparatus for controlling temporal patterns of neurostimulation
US20140067020A1 (en) Method and System of Graphical Representation of Lead Connector Block and Implantable Pulse Generators on a Clinician Programmer
US20140067016A1 (en) Method and System of Bracketing Stimulation Parameters on Clinician Programmers
US20170239486A1 (en) Clinical guidance user interfaces for neurostimulator programming
US20140067354A1 (en) Method and System of Suggesting Spinal Cord Stimulation Region Based on Pain and Stimulation Maps with a Clinician Programmer
AU2012255746A1 (en) User-defined graphical shapes used as a visualization aid for stimulator programming
AU2019274427B2 (en) Adaptive chronic pain relief via implanted electrical neurostimulation
WO2023124390A1 (en) Program-controlled device and implantable neurostimulation system
CN115105746A (en) Nerve stimulation action range display method, device and system
CN115120880A (en) Method, device and system for implanting nerve stimulation electrode and displaying nerve nucleus
CN115050455A (en) Electric field data generation method and equipment of nerve stimulation electrode and program control device
EP4084860B1 (en) Graphical display of volume of activation
US12002151B2 (en) Graphical display of volume of activation
EP2488253B1 (en) System for modeling electrode morphologies and estimating volume of activation in tissue
CN115116596A (en) Neural stimulation parameter setting method and program control device

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination