Method and device for determining pulse modulation parameters, equipment and medium

Abstract

The embodiment of the invention discloses a pulse modulation parameter determination method and device, equipment and a medium. The method comprises the following steps: determining an electric field region generated on a preset target spot by a first pulse modulated according to a preset pulse parameter based on an implantation position of an electrode lead in the implantable medical system on the preset target spot; determining a target nerve fiber activated by the electric field area; based on a preset activation condition corresponding to the target nerve fiber, performing modulation processing on the preset pulse parameter to obtain a target pulse parameter; wherein the electric field area generated by the target pulse parameter does not activate at least one target nerve fiber, and the preset activation condition is a parameter condition required to be met by the pulse for activating the target nerve fiber. According to the technical scheme provided by the embodiment of the invention, the condition of abnormal nerve impulse after the pulse corresponding to the target pulse parameter stimulates the nerve fiber is avoided, and the working accuracy and safety of the implantable medical system are improved.

Description

Technical Field

[0001] The embodiments of the present invention relate to the field of implantable medical technology, and in particular to a method, apparatus, device, and medium for determining pulse modulation parameters. Background Art

[0002] With the development of science and technology and the advancement of equipment, the application prospects of implantable medical systems are becoming increasingly broad. In existing technologies, implantable medical systems generate stimulation pulses according to preset pulse parameters each time, and the stimulation pulses generate an electric field area at the target site, thereby affecting the target site.

[0003] However, in the process of implementing the present invention, it was found that the existing technology has at least the following technical problems: the stimulation pulse is modulated by preset pulse parameters, and the electric field generated by the stimulation pulse is used to stimulate the target point for treatment, but it may also bring other unnecessary side effects, thereby affecting the effect of the entire neural stimulation treatment, making the working accuracy and safety of the implantable medical system poor. Summary of the Invention

[0004] Embodiments of the present invention provide a method, apparatus, device, and medium for determining pulse modulation parameters to avoid abnormal nerve impulses caused by stimulation of nerve fibers by pulses corresponding to target pulse parameters, thereby improving the accuracy and safety of implantable medical systems.

[0005] According to one aspect of the present invention, a method for determining pulse parameters is provided, comprising:

[0006] Determining, based on the implantation position of the electrode lead in the implantable medical system at the preset target point, an electric field region generated at the preset target point by a first pulse modulated according to preset pulse parameters;

[0007] determining target neural fibers activated by the electric field region;

[0008] Based on the preset activation conditions corresponding to the target nerve fibers, the preset pulse parameters are modulated to obtain target pulse parameters; wherein, the electric field region generated by the target pulse parameters does not activate at least one of the target nerve fibers, and the preset activation conditions are parameter conditions that need to be met by the pulse to activate the target nerve fibers.

[0009] According to another aspect of the present invention, there is provided a pulse parameter determination device, the device comprising:

[0010] An electric field region determination module, configured to determine, based on the implantation position of the electrode lead in the implantable medical system on the preset target point, the electric field region generated by the first pulse modulated according to the preset pulse parameters on the preset target point;

[0011] a nerve fiber determination module, configured to determine target nerve fibers activated by the electric field region;

[0012] A modulation parameter determination module is used to modulate the preset pulse parameters based on the preset activation conditions corresponding to the target nerve fibers to obtain target pulse parameters; wherein the electric field area generated by the target pulse parameters does not activate at least one of the target nerve fibers, and the preset activation conditions are parameter conditions that need to be met by the pulse to activate the target nerve fibers.

[0013] According to another aspect of the present invention, there is provided a program-controlled device, comprising:

[0014] at least one processor; and

[0015] a memory communicatively connected to the at least one processor; wherein,

[0016] The memory stores a computer program executable by the at least one processor, and the computer program is executed by the at least one processor so that the at least one processor can perform the pulse parameter determination method according to any embodiment of the present invention.

[0017] According to another aspect of the present invention, there is provided an implantable medical system, comprising:

[0018] An implantable medical device, comprising at least a stimulator and an electrode lead implanted in a target object, wherein the implanted end of the electrode lead is provided with a plurality of electrode contacts, and the stimulator is connected to the electrode lead;

[0019] The program-controlled device is configured to store preset activation conditions and execute the pulse parameter determination method described in any embodiment of the present invention to determine target pulse parameters.

[0020] According to another aspect of the present invention, a computer-readable storage medium is provided, wherein the computer-readable storage medium stores computer instructions, and the computer instructions are used to enable a processor to implement the pulse parameter determination method according to any embodiment of the present invention when executed.

[0021] The technical solution of the embodiment of the present invention determines the electric field area generated by the first pulse modulated according to the preset pulse parameters at the preset target point through the implantation position of the electrode wire in the implantable medical system at the preset target point; further, determines the target nerve fibers activated by the electric field area; thus, taking into account the influence of the electric field area on the nerve fibers, the preset pulse parameters are modulated by combining the preset activation conditions corresponding to the target nerve fibers to obtain the target pulse parameters; wherein, the electric field area generated by the target pulse parameters does not activate at least one target nerve fiber, and the preset activation conditions are the parameter conditions that the pulse needs to meet to activate the target nerve fibers. The technical solution of this embodiment takes into account the influence of the electric field area on the nerve fibers, and determines the target pulse parameters in combination with the preset activation conditions of the nerve fibers, thereby avoiding the occurrence of abnormal nerve impulses after the pulse corresponding to the target pulse parameters stimulates the nerve fibers, thereby improving the working accuracy and safety of the implantable medical system.

[0022] It should be understood that the content described in this section is not intended to identify the key or important features of the embodiments of the present invention, nor is it intended to limit the scope of the present invention. Other features of the present invention will become readily understood through the following description. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0024] Figure 1 is a schematic diagram of an impact range of electrical stimulation provided according to an embodiment of the present invention;

[0025] Figure 2 is a flow chart of a method for determining pulse parameters according to an embodiment of the present invention;

[0026] Figure 3 is a pulse comparison schematic diagram provided according to an embodiment of the present invention;

[0027] Figure 4 2 is a schematic structural diagram of a pulse parameter determination device provided by an embodiment of the present invention;

[0028] Figure 5 It is a structural diagram of a program-controlled device for implementing the pulse parameter determination method according to an embodiment of the present invention. DETAILED DESCRIPTION

[0029] In order to enable those skilled in the art to better understand the solutions of the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts should fall within the scope of protection of the present invention.

[0030] It should be noted that the terms "first", "second", etc. in the description and claims of the present invention and the above-mentioned drawings are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that the numbers used in this way can be interchanged where appropriate so that the embodiments of the present invention described herein can be implemented in an order other than those illustrated or described herein. In addition, the terms "including" and "etc." and any variations thereof are intended to cover non-exclusive inclusions. For example, a process, method, system, product or device that includes a series of steps or units is not necessarily limited to those steps or units clearly listed, but may include other steps or units that are not clearly listed or inherent to these processes, methods, products or devices.

[0031] It should be noted that the collection, collection, updating, analysis, processing, use, transmission, and storage of user personal information involved in the technical solutions disclosed herein comply with relevant laws and regulations, are used for legitimate purposes, and do not violate public order and good morals. Necessary measures are taken with respect to user personal information to prevent unauthorized access to user personal information data and maintain the security of user personal information and network security.

[0032] The following is a brief description of the technical field and related terms of the embodiments of the present disclosure.

[0033] Implantable medical systems consist of implantable devices and programmable devices. Implantable medical systems include implantable neural stimulation systems, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDDS), and lead switching systems. Examples of implantable neural stimulation systems include deep brain stimulation (DBS), cortical nerve stimulation (CNS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), and vagus nerve stimulation (VNS).

[0034] The implantable neural electrical stimulation system includes a stimulator implanted in the patient's body (i.e., an implantable neural stimulator) and a programmable device disposed outside the patient's body. In other words, the stimulator is a medical device, or in other words, the medical device includes a stimulator. The relevant neuromodulation technology mainly involves implanting electrodes (electrodes, for example, in the form of electrode wires) in specific locations (i.e., target points) of the tissues of an organism through stereotactic surgery, sending discharge pulses to the target points through the electrodes, and regulating the electrical activity and function of the corresponding neural structures and networks, thereby improving symptoms and alleviating pain.

[0035] As an example, DBS includes an IPG (Implantable Pulse Generator), an extension lead, and an electrode lead. The IPG is connected to the electrode lead via the extension lead. The IPG is implanted in the patient's body, for example, in the patient's chest or other body parts.

[0036] As another example, DBS includes an IPG and an electrode lead, with the IPG directly connected to the electrode lead. The IPG is implanted in the patient's head, for example, by making a groove in the patient's skull and then installing the IPG in the groove. In this case, the IPG may not protrude from the outer surface of the skull, or it may partially protrude from the outer surface of the skull.

[0037] The IPG responds to programmed instructions from a programmable device, relying on sealed batteries and circuits to provide controlled electrical stimulation therapy (or electrical stimulation energy) to tissues within the body. The IPG delivers one or more specific, controllable electrical stimulation pathways to specific areas of tissue within the body via electrode leads.

[0038] In some embodiments, the extension lead is used in conjunction with the IPG as a transmission medium for electrical stimulation, transmitting the electrical stimulation generated by the IPG to the electrode lead.

[0039] In some embodiments, electrical stimulation can be delivered in the form of a pulsed signal or a non-pulsed signal. For example, electrical stimulation can be delivered as a signal having a variety of waveform shapes, frequencies, and amplitudes. Thus, electrical stimulation in the form of a non-pulsed signal can be a continuous signal, which can have a sinusoidal waveform or other continuous waveform.

[0040] After receiving the electrical stimulation transmitted by the IPG or the extension wire, the electrode wire delivers the electrical stimulation to a specific area of ​​the tissue in the body through a plurality of electrode contacts. The stimulator is provided with, for example, one or more electrode wires on one side or both sides, and a plurality of electrode contacts are provided on the electrode wire, and the electrode contacts can be arranged uniformly or non-uniformly in the circumferential direction of the electrode wire. As an example, the electrode contacts can be arranged in an array of 4 rows and 3 columns (a total of 12 electrode contacts) in the circumferential direction of the electrode wire. The electrode contacts may include stimulation electrode contacts and / or collection electrode contacts. The electrode contacts may, for example, be in the shape of sheets, rings, dots, etc.

[0041] In some embodiments, the stimulated tissue in the body can be the patient's brain tissue, and the stimulated site can be a specific site in the brain tissue. Depending on the patient's disease type, the stimulated site generally varies, as does the number of stimulation contacts (single source or multiple sources), the use of one or more specific electrical stimulation channels (single channel or multiple channels), and the stimulation parameters (values).

[0042] The embodiments of the present disclosure do not limit the types of diseases that can be treated, and can be diseases that can be treated with deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral nerve stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation. The types of diseases that DBS can be used to treat or manage include, but are not limited to, spastic disorders (e.g., epilepsy), pain, migraine, mental illness (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety, post-traumatic stress disorder, minor depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, movement disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric diseases and injuries.

[0043] In the embodiment of the present disclosure, when the programmable device and the stimulator establish a programmable connection, the programmable device can be used to adjust one or more stimulation parameters of the stimulator (or one or more stimulation parameters of the pulse generator, different stimulation parameters correspond to different electrical stimulations), or the stimulator can be used to sense the patient's electrophysiological activities to collect electrophysiological signals, and the collected electrophysiological signals can be used to continue to adjust the stimulation parameters of the stimulator to achieve closed-loop control (or adaptive adjustment) of the stimulation parameters.

[0044] Stimulation parameters may include at least one of the following: electrode contact identification for delivering electrical stimulation (for example, electrode contact #2 and electrode contact #3), frequency (for example, the number of electrical stimulation sub-pulse signals within a unit time of 1s, in Hz), pulse width (duration of each pulse, in μs), amplitude (generally expressed in voltage, that is, the intensity of each pulse, in V), timing (for example, it can be continuous or burst, and burst refers to a discontinuous timing behavior composed of multiple processes), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode and cyclic stimulation mode), upper and lower limits controlled by the doctor (the range that the doctor can adjust) and upper and lower limits controlled by the patient (the range that the patient can adjust independently).

[0045] In some embodiments, various stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

[0046] Programmable devices may include doctor-controlled devices (i.e., programmable devices used by doctors) and / or patient-controlled devices (i.e., programmable devices used by patients). Doctor-controlled devices are, for example, tablet computers, laptop computers, desktop computers, mobile phones, and other intelligent terminal devices equipped with programmable software. Patient-controlled devices are, for example, tablet computers, laptop computers, desktop computers, mobile phones, and other intelligent terminal devices equipped with programmable software. Patient-controlled devices may also be other programmable devices with programmable functions (e.g., chargers with programmable functions, electrophysiological data acquisition devices, etc.).

[0047] Before introducing the technical solution, an example of the application scenario can be first described. This technical solution can be applied to the scenario of determining the pulse parameters of the electric pulses generated in the implantable medical system. The pulse parameters include but are not limited to waveform, pulse width, frequency, intensity, phase, period, intermittent time, on-off ratio, current direction, etc. The implantable medical system provided in this embodiment includes: an implantable medical device, the implantable medical device at least includes a stimulator and an electrode wire implanted in the target object, the implanted end of the electrode wire is provided with a plurality of electrode contacts, and the stimulator is connected to the electrode wire; a programmable device, configured to store preset activation conditions and execute the above-mentioned pulse parameter determination method to determine the target pulse parameters. The electrode wire is provided with a plurality of electrode contacts, which are implanted into the preset target point of the target object, and an electric field area is formed on the preset target point by modulating the stimulation pulse. The preset target point contains nerve fibers, and the nerve fibers covered by the electric field area transmit electrical signals to the preset target point to affect the operation of the preset target point and assist the preset target point in completing the corresponding biological activity.

[0048] Figure 1 Schematic diagram of the influence range of an electrical stimulation provided according to an embodiment of the present invention; Figure 1 As shown, the electrode wire is implanted into the preset target. The preset target may include a nucleus. Four electrode sheets are deployed on the electrode wire as electrode contacts. The preset target includes five nerve fibers, namely nerve fiber 1, nerve fiber 2, nerve fiber 3, nerve fiber 4 and nerve fiber 5. When the stimulation pulse is modulated according to the preset pulse parameters, when the modulated stimulation pulse is transmitted to the preset target through the electrode wire, the electric field area generated on the preset target is as shown in FIG. Figure 1 As shown in the dotted elliptical area. The electric field area covers nerve fiber 1, nerve fiber 2, nerve fiber 3 and nerve fiber 4, but does not cover nerve fiber 5, which means that the generated electric field area affects nerve fiber 1, nerve fiber 2, nerve fiber 3 and nerve fiber 4, but does not affect nerve fiber 5. When the electric potential in the electric field area is greater than the preset potential, nerve fiber 1, nerve fiber 2, nerve fiber 3 and nerve fiber 4 will be activated. Since different nerve fibers can pass through different nuclei, that is, nerve fiber 1, nerve fiber 2, nerve fiber 3 and nerve fiber 4 will transmit electrical signals to other nuclei, the nuclei that do not need to receive the electrical signals transmitted by the nerve fibers are also affected by the electrical signals, resulting in abnormal operation. In order to avoid abnormal operation of non-preset targets, the pulse modulation parameters are determined by the present technical solution so that the stimulation pulse obtained by modulation does not affect non-preset targets.

[0049] Through this technical solution, the target pulse parameters can be determined based on the conditions of the nerve fibers at the preset target point, avoiding abnormal nerve impulses after stimulation of the nerve fibers, and improving the working accuracy and safety of the implantable medical system.

[0050] Figure 2 The flowchart of a pulse parameter determination method provided according to an embodiment of the present invention is applicable to determining pulse parameters for controlling the operation of an electrode lead in an implantable medical system before the electrode lead is implanted into a target subject. The method can be performed by a pulse parameter determination device, which can be implemented in hardware and / or software.

[0051] like Figure 2 As shown, the method of this embodiment may specifically include:

[0052] S110. Based on the implantation position of the electrode wire in the implantable medical system on the preset target point, determine the electric field area generated by the first pulse modulated according to the preset pulse parameters on the preset target point.

[0053] Among them, the preset target can be set according to the actual needs of the user, for example, the preset target is a nucleus. The implantation position is the position of the electrode wire when it is implanted on the target object. The preset pulse parameters can be pulse modulation parameters pre-set by the staff (generally a clinician); or, they are historical modulation parameters used when the preset target is electrically stimulated by the implantable medical system within a historical time period. The electric field area generated by the first pulse generated according to the preset pulse parameters, wherein the coverage area of ​​the electric field area on the preset target is greater than the preset coverage area. For example, the electric field area exceeds a specified proportion of the target area (such as 60%, 70%, 80%, etc.), which can ensure that the target is electrically stimulated more, thereby achieving a certain therapeutic effect.

[0054] The preset pulse parameters include at least one of a first pulse width, a first amplitude, and a first trigger frequency. The pulse modulated by the preset pulse parameters is a first pulse, which can be delivered to the target through the electrode wire. Exemplarily, the preset pulse parameters include a first pulse width and / or a first amplitude of the pulse; the first pulse width is greater than the preset pulse width, and the first amplitude is greater than the preset amplitude. The preset pulse width and / or preset amplitude can be set according to the actual situation of the target, such as determining the intensity of electrical stimulation required based on the type or location of the target, which intensity can ensure an effective therapeutic effect on the target, and then determining the parameters of the electrical stimulation to be output (i.e., the preset pulse parameters) based on the intensity.

[0055] Of course, the electrode contact combination and preset pulse parameters corresponding to the stimulation electric field that can cover at least a preset volume ratio of the target can also be determined based on the area where the target is located and the positional relationship of the electrode contacts in the electrode wire.

[0056] In a specific implementation, the implantation location (i.e., the positional relationship between the electrode contact and the target) and the preset pulse parameters for a preset target can be predetermined. Specifically, the implantation location can be determined by, in response to an input trigger operation for the implantation location, reading the implantation location of the electrode lead at the preset target. The preset pulse parameters can be determined by, from pre-stored historical modulation parameters, identifying historical modulation parameters that match the preset target and using them as the preset pulse parameters; or, in response to an input operation for the preset pulse parameters, reading the preset pulse parameters.

[0057] In order to better combine the individual differences of the target object and accurately determine the electric field area of ​​the first pulse, the electric field area generated by the first pulse modulated according to the preset pulse parameters on the preset target point based on the implantation position of the electrode wire in the implantable medical system on the preset target point can be determined. The implementation method can also be: based on the acquired medical imaging data of the target object, the electrical characteristic distribution information of the target object is determined; based on the implantation position of the electrode wire in the implantable medical system on the preset target point, the preset pulse parameters and the electrical characteristic distribution information, the electric field area generated by the first pulse on the preset target point is determined.

[0058] Specifically, the medical imaging data may be magnetic resonance imaging data or computed tomography data of a preset target point of the target object, etc. Alternatively, the medical imaging data may be imaging data collected before the electrode lead is implanted into the preset target point of the target object.

[0059] Furthermore, based on the medical imaging data, a 3D model corresponding to a preset target point in the target object can be generated. Based on the 3D model, the preset target point can be classified into tissue categories. Based on the tissue classification results, attribute information corresponding to each data point in the 3D model is determined. Attribute information is a parameter that characterizes the property characteristics of the data point. This attribute information may include tissue electrical characteristic parameters, such as conductivity and relative dielectric constant.

[0060] Specifically, the tissue classification result is the tissue category label value for each 3D coordinate point in the 3D model. The 3D coordinate points can be used as data points, the corresponding brain tissue category label value as attribute information, and the data point collection consisting of these discrete data points can be used as the target point cloud. The electrical characteristic distribution information corresponding to the preset target can be determined by using each data point in the target point cloud and the tissue electrical characteristic parameters corresponding to that data point. The electrical characteristic distribution information is used to characterize the distribution of electrical characteristic parameters corresponding to different locations of the preset target.

[0061] Furthermore, the electric field distribution information of the first pulse can be determined based on the implantation location of the electrode lead, preset pulse parameters, and electrical characteristic distribution information corresponding to the preset target point. The electric field distribution information is the three-dimensional coordinates and corresponding electrical characteristic values ​​corresponding to the stimulated locations in the electrical characteristic distribution information. The electrical characteristic values ​​can be, for example, current values, voltage values, etc. The range corresponding to each stimulated location on the preset target point is the electric field area.

[0062] In this embodiment, the electric field area generated by the first pulse on the preset target point is determined in combination with the medical imaging data of the target object, so that the electric field area corresponding to the preset pulse parameters can be accurately determined taking into account the differences between different target objects.

[0063] S120. Determine target nerve fibers activated by the electric field area.

[0064] In this embodiment, medical imaging data of a target object is collected using medical equipment. Based on this data, a 3D model of the target object is generated. The 3D model is used to determine the location of nerve fibers within the target object. Based on this location information and the activation conditions for different nerve fibers, nerve fibers that pass through the electric field region and are capable of being activated are designated as target nerve fibers.

[0065] Specifically, first, the set of nerve fibers covered by the electric field area is determined. The activation conditions corresponding to different nerve fibers in the set may be different, and the positions of different nerve fibers in the electric field area are also different. Then, through the above-determined electric field area, the electric field strength (such as stimulation intensity or duration) at different positions in the electric field area can be determined. In this way, the electric field strength at the electric field position where different nerve fibers are located can be determined, and then the preset activation conditions for different nerve fibers are collected to determine which nerve fibers can be activated, so that the target nerve fibers can be determined.

[0066] S130. Based on the preset activation conditions corresponding to the target nerve fibers, the preset pulse parameters are modulated to obtain target pulse parameters; wherein the electric field region generated by the target pulse parameters does not activate at least one target nerve fiber, and the preset activation conditions are parameter conditions that must be met by the pulse to activate the target nerve fibers.

[0067] It should be noted that, under normal circumstances, nerve fibers operate according to certain rules and regularity, transmitting EEG signals to the corresponding areas, thereby maintaining the normal functioning of the brain or human body. Activation of target nerve fibers refers to the generation of abnormal signals, i.e., abnormal signals, by the target nerve fibers due to external electrical stimulation, causing them to operate abnormally and transmit these signals to the tissues to which they are connected (such as the nucleus), which may lead to certain side effects. Different modulation parameters of the pulses generated on the electrode wires will result in different signal intensities of the electrical signals generated on the target nerve fibers, and thus different degrees of activation of the target nerve fibers.

[0068] In order to ensure that the pulses modulated by the target pulse parameters only affect the preset target points without affecting the normal activities of other tissues, the target pulse parameters can be determined in combination with the preset activation conditions corresponding to the target nerve fibers. In a specific implementation, each target nerve fiber corresponds to a preset activation condition, and the modulation parameters that do not meet each preset activation condition can be determined as the target pulse parameters.

[0069] It should be noted that the preset pulse parameters can be the initial stimulation parameters determined by the doctor based on the electrode implantation position and the actual situation of the patient. The initial stimulation parameters will not be delivered to the patient's target target. The target pulse parameters obtained by modulation are the stimulation parameters that ultimately need to be delivered to the patient's target target. Therefore, in order to ensure that the modulated parameters have a certain therapeutic effect, that is, to avoid the invalidity of the modulated stimulation parameters, it is also necessary that the electric field area generated by the pulse corresponding to the target pulse parameters obtained after modulation has a coverage area on the preset target that is greater than the preset coverage area, so that stimulation parameters that can achieve a certain therapeutic effect and reduce certain side effects can be obtained. The preset coverage area can be a preset proportion of the preset target area, such as 60%-100%, or can be 60%, 70%, 80%, etc. The specific proportion is not limited in the embodiments of this specification.

[0070] In practical applications, the number of nerve fibers that can be covered by the electric field area is large. It is difficult and time-consuming to determine the modulation parameters considering the preset activation conditions of each nerve fiber. In order to reduce the difficulty of determining the modulation parameters without affecting other tissues, the preset activation conditions of some target nerve fibers can be considered to determine the target pulse parameters.

[0071] Specifically, based on the preset activation conditions corresponding to the target nerve fibers, the preset pulse parameters are modulated to obtain the target pulse parameters. The implementation method can be as follows: when the number of target nerve fibers is greater than the preset number threshold, the target nerve fibers that meet the preset screening conditions are used as reference nerve fibers; based on the preset activation conditions corresponding to the reference nerve fibers, the preset pulse parameters are modulated to obtain the target pulse parameters.

[0072] In this embodiment, those skilled in the art may set a preset number threshold according to actual application conditions. For example, the preset number threshold is greater than or equal to 1. When the number of target nerve fibers is less than or equal to the preset number threshold, the target pulse parameters may be determined in combination with the preset activation conditions of each target nerve fiber. When the number of target nerve fibers is greater than the preset number threshold, reference nerve fibers that meet the preset screening conditions may be screened out from multiple target nerve fibers to ensure that the reference nerve fibers are not activated; and target nerve fibers that do not meet the preset screening conditions may be disregarded, thereby ensuring that the efficiency of determining the target pulse parameters is improved without affecting the activities of other tissues.

[0073] Optionally, the preset screening conditions include at least one of the following: the priority of the target nerve fiber is greater than a preset level; the target nerve fiber is in a preset set of inactive objects. The priority of the target nerve fiber can be set according to the functional importance of the nerve fiber. For example, the priority of nerve fibers related to life-sustaining functions is higher than the priority of nerve fibers that control muscle movement; the priority of nerve fibers that control muscle movement is higher than the priority of nerve fibers that control sensory conduction. The priority can be divided into three levels, and the preset level can be the second level. By considering the preset activation conditions of target nerve fibers with a priority greater than the preset level, the determined target pulse parameters do not affect the important functions of the target object.

[0074] Furthermore, a set of inactive objects can be pre-set, and the inactive object set can include nerve fibers with a sensitivity greater than a preset sensitivity threshold. For example, nerve fiber 1 is a nerve fiber with a sensitivity greater than the preset sensitivity threshold, and nerve fiber 2 is a nerve fiber with a sensitivity less than the preset sensitivity threshold. When the same electrical stimulation is provided to these two nerve fibers, the reaction degree produced by nerve fiber 1 is greater than the reaction degree of nerve fiber 2, that is, the side effects caused by nerve fiber 1 are greater. To reduce side effects, nerve fibers with a sensitivity greater than the preset sensitivity threshold can be added to the inactive object set. Those skilled in the art can set the specific value of the preset sensitivity threshold according to actual application conditions, and this embodiment does not limit this.

[0075] In this embodiment, target nerve fibers that meet preset screening conditions can be determined as reference nerve fibers, and modulation parameters that meet preset activation conditions corresponding to each reference nerve fiber can be determined as target pulse parameters.

[0076] In this embodiment, reference nerve fibers are screened out through preset screening conditions, and target pulse parameters are determined based on the preset activation conditions of the reference nerve fibers, thereby ensuring that no abnormal effects are caused to other tissues while reducing the difficulty of determining modulation parameters and improving efficiency.

[0077] The technical solution of the embodiment of the present invention determines the electric field area generated by the first pulse modulated according to the preset pulse parameters at the preset target point through the implantation position of the electrode wire in the implantable medical system at the preset target point; further, determines the target nerve fibers activated by the electric field area; thus, taking into account the influence of the electric field area on the nerve fibers, the preset pulse parameters are modulated by combining the preset activation conditions corresponding to the target nerve fibers to obtain the target pulse parameters; wherein, the electric field area generated by the target pulse parameters does not activate at least one target nerve fiber, and the preset activation conditions are the parameter conditions that the pulse needs to meet to activate the target nerve fibers. The technical solution of this embodiment takes into account the influence of the electric field area on the nerve fibers, and determines the target pulse parameters in combination with the preset activation conditions of the nerve fibers, thereby avoiding the occurrence of abnormal nerve impulses after the pulse corresponding to the target pulse parameters stimulates the nerve fibers, thereby improving the working accuracy and safety of the implantable medical system.

[0078] In this embodiment, based on the above embodiment, optionally, the preset pulse parameters include a first pulse width and / or a first amplitude; the preset activation conditions include: the pulse width of the corresponding pulse of the electric field received by the nerve fiber is greater than the preset pulse width, and / or the amplitude of the pulse is greater than the preset amplitude threshold.

[0079] The first pulse width is the pulse width of the first pulse, and the first amplitude is the amplitude of the first pulse width. The preset activation condition provided in this embodiment limits both pulse width and amplitude, thereby accurately and comprehensively screening pulses that activate nerve fibers.

[0080] In this embodiment, when there are multiple target nerve fibers, it can be determined whether the first pulse meets each preset activation condition. When the first pulse does not meet each preset activation condition, it means that the first pulse will not affect the activity of other tissues, and the preset pulse parameters corresponding to the first pulse can be directly determined as the target pulse parameters.

[0081] If at least one of the preset activation conditions is met, the first pulse activates the target nerve fiber and may affect the activity of other tissues. To avoid affecting other tissues, target pulse parameters can be determined based on the preset pulse parameters, such that the target pulse parameters do not meet the preset activation conditions for at least one of the target nerve fibers, and the pulse modulated based on the target pulse parameters does not produce side effects.

[0082] In this embodiment, the target pulse parameters can be divided into two cases. The first case is that the target pulse parameters are used to reflect the pulse parameters of a pulse, that is, a complete pulse can be modulated by the target pulse; the second case is that the target pulse parameters are the pulse parameters of a burst pulse. Based on the target pulse parameters, a burst pulse composed of multiple stimulation sub-pulses can be modulated.

[0083] In the case where the target pulse parameters are the pulse parameters corresponding to the burst pulses, the preset pulse parameters are modulated to obtain the target pulse parameters, including: when the first pulse width is greater than the preset duration, the first pulse width is used as the total duration of the burst pulse; wherein the burst pulse is composed of at least two stimulation sub-pulses; based on the total duration and the preset activation conditions corresponding to each target nerve fiber, the pulse modulation parameters of the stimulation sub-pulses contained in the burst pulse are determined; the pulse modulation parameters obtained by modulating all the preset pulse parameters are determined as the target pulse parameters; wherein the pulse modulation parameters include the pulse width and / or pulse amplitude of each stimulation sub-pulse in the burst pulse, and the pulse width is less than the preset duration.

[0084] It should be noted that when the first pulse width is greater than the preset duration, the first pulse does not match the neuronal discharge pattern. The release of excitatory and inhibitory neurotransmitters in neurons has specific timing characteristics. Stimulation with a pulse width greater than the preset duration may lead to asynchronous activation, thereby interfering with normal neural signal transmission. It should be noted that the preset duration can have different values ​​depending on the abnormal function of the target subject. For example, if the abnormal function is a movement disorder, the preset duration can be 60μs; if the abnormal function is a mental function, the preset duration can be 200μs.

[0085] In order to avoid interfering with normal neural signal transmission, when the first pulse meets the preset activation conditions and the first pulse width is greater than the preset duration, a burst pulse consisting of at least two stimulation sub-pulses is generated based on the first pulse, and the first pulse width is used as the total duration of the burst pulse. According to the total duration, the preset target is effectively controlled while complying with the discharge pattern of the neuron, thereby ensuring the normal transmission of neural signals. Figure 3 As shown, the pulse corresponding to mark 1 is the first pulse modulated according to the preset pulse parameters; the pulse corresponding to mark 2 is a burst pulse formed by taking the first pulse width as the total duration.

[0086] Specifically, the number of stimulation sub-pulses can be predetermined. Exemplarily, the number of stimulation sub-pulses is 3 or 4. Based on the number of stimulation sub-pulses, pulse modulation parameters are determined that meet preset conditions. The preset conditions are: the sum of the pulse widths of each stimulation sub-pulse modulated according to the pulse modulation parameters is less than the total duration, and each pulse width is less than or equal to a preset duration.

[0087] Furthermore, the first amplitude of the first pulse can be determined as the pulse amplitude, thereby obtaining the pulse modulation parameters. It can be determined whether the pulse modulation parameters meet the preset activation conditions of each target nerve fiber. If so, the pulse modulation parameters can be used as the target pulse parameters. If not, the preset amplitude threshold can be updated to the pulse amplitude, thereby ensuring that the pulse modulation parameters do not meet the preset activation conditions before the pulse modulation parameters are used as the target pulse parameters. Since different nerve fibers correspond to a preset activation condition, that is, each nerve fiber corresponds to a preset amplitude threshold. The preset amplitude threshold of some nerve fibers is relatively small. If each stimulation sub-pulse in the burst pulse is less than the preset amplitude threshold, the stimulation effect on the preset target point will be affected. Therefore, for target nerve fibers whose preset amplitude threshold is less than the minimum value of the preset threshold, the pulse modulation parameters of each stimulation sub-pulse in the burst pulse can be determined by using the method of satisfying the preset activation condition at intervals. For example, the pulse amplitudes of two adjacent stimulation sub-pulses in a burst pulse can be one smaller than a preset amplitude threshold and the other larger than the preset amplitude threshold, that is, one pulse is separated and the preset activation condition is satisfied once, thereby avoiding continuous activation of target nerve fibers whose preset amplitude threshold is smaller than the minimum value of the preset threshold, reducing certain side effects while ensuring the stimulation effect of the preset target.

[0088] In the case where the first pulse meets the preset activation conditions and the first pulse width is less than or equal to the preset duration, it means that the first pulse conforms to the discharge pattern of the neuron. Based on the first amplitude and / or first pulse width of the first pulse, the target pulse parameters that do not meet the preset activation conditions can be determined.

[0089] This embodiment determines the target pulse parameters by determining the pulse modulation parameters that meet the preset conditions, so that the second pulse width in the target pulse parameters is less than the preset duration, thereby matching the discharge pattern of the neuron and ensuring the normal transmission of the neural signal.

[0090] In addition, in some other embodiments, in order to enable the pulse obtained by modulating the target pulse parameters to produce effective stimulation on the preset target point, the coverage area of ​​the electric field area corresponding to the target pulse parameters on the preset target point and the difference between the coverage area of ​​the electric field area corresponding to the preset pulse parameters on the preset target point are first calculated. When the difference is not less than zero, it indicates that the modulated target pulse parameters can still have a good therapeutic effect and the target pulse parameters can be delivered to the electrode. When the difference is less than zero, it indicates that the treatment area of ​​the modulated target pulse parameters is reduced. Therefore, it is necessary to evaluate whether the treatment is effective. Therefore, it can be determined whether the absolute value of the difference is less than the preset difference. The preset difference can be the area difference that maintains a similar therapeutic effect as the preset pulse parameters. If so, it indicates that the two areas are close, and the target pulse parameters can also have an effective therapeutic effect. If not, it indicates that the coverage area of ​​the electric field area corresponding to the modulated pulse parameters on the preset target point is reduced too much, and it is difficult to have a therapeutic effect. Therefore, re-modulation is required to ensure the therapeutic effect.

[0091] For the case where the target pulse parameter is one pulse (i.e., a first pulse is modulated into one pulse, rather than a burst of pulses), the preset pulse parameter is modulated to obtain the target pulse parameter, including: determining a first difference obtained by subtracting a preset pulse width offset value from a first pulse width; when the first difference is less than the preset pulse width, the preset pulse width is the activation condition for at least one of the target nerve fibers, the first difference and the preset pulse width are used as boundary values ​​to form a pulse width range to be selected, i.e., the first difference and the preset pulse width are used as the two endpoints of the pulse width range to be selected, and based on the pulse width range to be selected, a second pulse width is determined, and the second pulse width is used as the target pulse parameter. For example, a pulse width can be randomly selected as the second pulse width based on the pulse width range to be selected.

[0092] Determine a second difference obtained by subtracting a preset amplitude offset value from the first amplitude; when the second difference is less than the preset amplitude threshold, use the second difference and the preset amplitude threshold as boundary values ​​to form a selected amplitude range, determine the second amplitude based on the selected amplitude range, and use the second amplitude as the target pulse parameter.

[0093] Among them, the preset pulse width offset value refers to the maximum offset value of the pulse width of the pulse after modulation relative to the first pulse width, that is, while ensuring the therapeutic effect (i.e. achieving the target therapeutic effect), the preset pulse width offset value is the maximum value to which the current pulse width can be reduced; the preset amplitude offset value is known to be the maximum offset value of the amplitude of the pulse after modulation relative to the first amplitude. Accordingly, the preset amplitude offset value is also the maximum value of the amplitude adjustment that can ensure the therapeutic effect.

[0094] It should be noted that in order to avoid the situation where the degree of effect of the modulated pulse on the preset target is significantly different from that of the first pulse on the preset target, thereby affecting the effect on the preset target, the target pulse parameters can be determined based on the preset pulse width offset value and / or the preset amplitude offset value.

[0095] In a specific implementation, the preset activation condition for any target nerve fiber can be: the pulse width of the corresponding pulse of the electric field received by the target nerve fiber is greater than the preset pulse width b. A first difference a can be determined by subtracting the preset pulse width offset from the first pulse width. If a is less than b, it indicates that any pulse width in [a, b] does not meet the preset activation condition for the target nerve fiber. In this case, a range of candidate pulse widths can be set to [a, b]. Within this range, any value can be determined as the second pulse width.

[0096] For example, the preset activation condition of one target nerve fiber is that the stimulation pulse width is greater than 70μs, the first pulse width in the initial preset pulse parameters is 90μs, and the maximum value of the stimulation pulse width adjustment effective for the current preset target is 30μs. In this way, the minimum pulse width to ensure the effective treatment effect is 60μs, and the modulated pulse width selection range is 60μs-70μs. In this way, a value can be selected from 60μs-70μs according to a rule (such as random) as the modulated pulse width value, which can not only ensure the treatment effect but also avoid activating the target nerve fiber.

[0097] When there are multiple target nerve fibers, the candidate pulse width range of each target nerve fiber can be determined based on the same process, and then the candidate pulse width ranges of all target nerve fibers are intersection-processed to obtain the final target candidate pulse width range. The pulse width determined from the target candidate pulse width range can not only ensure the treatment effect, but also avoid the activation of all target nerve fibers, greatly reducing side effects and improving the patient's treatment experience.

[0098] Of course, if the intersection is zero, it is also possible to determine some target nerve fibers with greater side effects from all target nerve fibers, and then perform intersection processing on some nerve fibers to suppress the target nerve fibers that produce greater side effects, that is, not activate them.

[0099] In this embodiment, the preset activation condition for any target nerve fiber may also be: the amplitude of the corresponding pulse of the electric field received by the nerve fiber is greater than a preset amplitude threshold. Therefore, a second difference c between the first amplitude and the preset amplitude offset value may also be determined. If c is less than the preset amplitude threshold d, it indicates that any amplitude value in [c, d] does not meet the preset activation condition for at least one of the target nerve fibers, and the candidate amplitude range may be set to [c, d]. Within the candidate amplitude range, any value is determined as the second amplitude.

[0100] For example, the preset activation condition of one target nerve fiber is that the stimulation pulse amplitude is greater than 2.5V, the first amplitude in the initial preset pulse parameters is 3V, and the maximum value of the stimulation amplitude adjustment effective for the current preset target is 1V. In this way, the minimum amplitude to ensure the effective treatment effect is 2V, and the amplitude selection range after modulation is 2V-2.5V. In this way, a value can be selected from 2V-2.5V as the amplitude after modulation according to a rule (such as random), which can not only ensure the treatment effect but also avoid activating the target nerve fiber.

[0101] When there are multiple target nerve fibers, the candidate amplitude range of each target nerve fiber can be determined based on the same process, and then the candidate amplitude ranges of all target nerve fibers can be intersection-processed to obtain the final target candidate amplitude range. The amplitude determined from the target candidate amplitude range can not only ensure the treatment effect, but also avoid the activation of all target nerve fibers, greatly reducing side effects and improving the patient's treatment experience.

[0102] Of course, if the intersection is zero, it is also possible to determine some target nerve fibers with greater side effects from all target nerve fibers, and then perform intersection processing on some nerve fibers to suppress the target nerve fibers that produce greater side effects, that is, not activate them.

[0103] In the embodiment, by presetting the pulse width offset value and the preset amplitude offset value, it is ensured that the deviation between the obtained target pulse parameters and the preset pulse parameters is within a certain range, which is conducive to the pulse obtained by modulating the target pulse parameters to produce effective stimulation on the preset target point.

[0104] In another embodiment, for burst pulses, that is, a single preset pulse is modulated into multiple sub-pulses, in order to ensure that the modulated burst pulse can have an effective effect on the preset target, the sum of the pulse widths of each stimulation sub-pulse in the burst pulse is not less than the first difference obtained by subtracting the preset pulse width offset value from the first pulse width; that is to say, for the modulation of a single pulse, the sum of the pulse widths of multiple stimulation sub-pulses based on the timing output can also ensure the stimulation effect, thereby ensuring the patient's treatment experience.

[0105] The amplitude of each stimulation sub-pulse in a burst pulse shall not be lower than the second difference obtained by subtracting the preset amplitude offset value from the first amplitude. That is to say, for the modulation of a single pulse, multiple stimulation sub-pulses based on timing output are obtained, and the amplitude of each stimulation sub-pulse also needs to ensure a certain therapeutic effect.

[0106] In this embodiment, it also includes: when the first trigger frequency of the first pulse is greater than or equal to the preset frequency, using the first trigger frequency as the second trigger frequency of the cluster pulse; when the first trigger frequency of the first pulse is less than the preset frequency, using the preset frequency as the second trigger frequency of the cluster pulse.

[0107] To ensure suppression of abnormal population neuronal activity, a high-frequency stimulation mode can be used to generate pulses. A high-frequency stimulation mode refers to a mode in which the triggering frequency of the pulses is greater than or equal to a preset frequency. The preset frequency reflects the triggering frequency of the pulses. For example, the preset frequency may be the minimum triggering frequency required to activate abnormal population neuronal activity.

[0108] In this embodiment, if the first trigger frequency of the first pulse is greater than or equal to the preset frequency, the first trigger frequency may be used as the second trigger frequency of the pulse burst to ensure that the modulated pulse burst can maintain the stimulation effect of the first pulse on the preset target. If the first trigger frequency of the first pulse is less than the preset frequency, the preset frequency may be used as the second trigger frequency of the pulse burst to ensure stable stimulation of the preset target.

[0109] This embodiment provides high-frequency stimulation to a preset target by ensuring that the trigger frequency of the burst pulses is greater than or equal to a preset frequency, thereby being able to suppress abnormal group neuronal activity and reduce side effects by more accurately matching single neuronal activity.

[0110] Figure 4 : This is a schematic diagram of the structure of a pulse parameter determination device provided in accordance with an embodiment of the present invention. The device is used to execute the pulse parameter determination method provided in any of the above embodiments. The device and the pulse parameter determination method of the above embodiments belong to the same inventive concept. For details not fully described in the embodiments of the pulse parameter determination device, reference can be made to the embodiments of the above pulse parameter determination method. Figure 4 As shown, the device includes:

[0111] The electric field region determination module 10 is configured to determine, based on the implantation position of the electrode lead in the implantable medical system at the preset target point, the electric field region generated by the first pulse modulated according to the preset pulse parameters at the preset target point;

[0112] a nerve fiber determination module 11, configured to determine target nerve fibers activated by the electric field region;

[0113] a modulation parameter determination module 12 for modulating preset pulse parameters based on preset activation conditions corresponding to target nerve fibers to obtain target pulse parameters; wherein the target pulse parameters generate an electric field region that does not activate at least one target nerve fiber, and the preset activation conditions are parameter conditions that must be met by the pulse to activate the target nerve fiber;

[0114] Based on any optional technical solution in the embodiments of the present invention, optionally, the preset pulse parameters include a first pulse width and / or a first amplitude; the preset activation conditions include: the pulse width of the corresponding pulse of the electric field received by the nerve fiber is greater than the preset pulse width, and / or the amplitude of the pulse is greater than the preset amplitude threshold.

[0115] Based on any optional technical solution in the embodiments of the present invention, optionally, the parameter determination unit includes:

[0116] a duration determination subunit, configured to use the first pulse width as the total duration of the burst pulse when the first pulse width is greater than a preset duration; wherein the burst pulse is composed of at least two stimulation sub-pulses;

[0117] A parameter determination subunit is used to determine the pulse modulation parameters of the stimulation sub-pulses contained in the burst pulse based on the total duration and the preset activation conditions corresponding to each target nerve fiber; the pulse modulation parameters obtained by modulating all the preset pulse parameters are determined as the target pulse parameters; wherein the pulse modulation parameters include the pulse width and / or pulse amplitude of each stimulation sub-pulse in the burst pulse, and the pulse width is less than the preset duration.

[0118] Based on any optional technical solution in the embodiments of the present invention, optionally, the parameter determination unit includes:

[0119] a pulse width determination subunit, configured to determine a first difference value obtained by subtracting a preset pulse width offset value from a first pulse width; if the first difference value is less than the preset pulse width, using the first difference value and the preset pulse width as boundary values ​​to form a pulse width range to be selected, determining a second pulse width based on the pulse width range to be selected, and using the second pulse width as a target pulse parameter; and / or,

[0120] The amplitude determination subunit is used to determine the second difference obtained by subtracting the preset amplitude offset value from the first amplitude; when the second difference is less than the preset amplitude threshold, the second difference and the preset amplitude threshold are used as boundary values ​​to form a selected amplitude range, and based on the selected amplitude range, the second amplitude is determined and the second amplitude is used as the target pulse parameter.

[0121] Based on any optional technical solution in the embodiments of the present invention, optionally, the sum of the pulse widths of each stimulation sub-pulse in a burst pulse is not less than a first difference value obtained by subtracting a preset pulse width offset value from the first pulse width; the amplitude of each stimulation sub-pulse in a burst pulse is not less than a second difference value obtained by subtracting a preset amplitude offset value from the first amplitude.

[0122] Based on any optional technical solution in the embodiments of the present invention, optionally, the method further includes:

[0123] A first frequency determination subunit is configured to use the first trigger frequency as the second trigger frequency of the burst pulse when the first trigger frequency of the first pulse is greater than or equal to a preset frequency; wherein the preset frequency is used to reflect the trigger frequency of the pulse;

[0124] The second frequency determining subunit is configured to use the preset frequency as the second triggering frequency of the burst pulses when the first triggering frequency of the first pulses is lower than the preset frequency.

[0125] Based on any optional technical solution in the embodiment of the present invention, optionally, the modulation parameter determination module 12 includes:

[0126] a second parameter determination unit configured to, when the number of target nerve fibers is greater than a preset number threshold, use target nerve fibers that meet a preset screening condition as reference nerve fibers; and modulate the preset pulse parameters based on preset activation conditions corresponding to the reference nerve fibers to obtain target pulse parameters;

[0127] The preset screening conditions include at least one of the following:

[0128] The priority of the target nerve fiber is greater than the preset level;

[0129] The target nerve fibers are in a pre-defined set of inactive objects.

[0130] Based on any optional technical solution in the embodiments of the present invention, optionally, the electric field region determining module 10 includes:

[0131] an information determining unit, configured to determine electrical characteristic distribution information of the target object based on the acquired medical imaging data of the target object;

[0132] The electric field area determination unit is used to determine the electric field area generated by the first pulse on the preset target point based on the implantation position of the electrode wire in the implantable medical system on the preset target point, the preset pulse parameters and the electrical characteristic distribution information.

[0133] Based on any optional technical solution in the embodiment of the present invention, optionally, the nerve fiber determination module 11 includes:

[0134] an association relationship determining unit, configured to determine an association relationship between the nuclei and the nerve fibers based on the acquired medical imaging data of the target object;

[0135] The nerve fiber determination unit is used to determine the first nerve fiber associated with the preset target based on the association relationship when the preset target is a nucleus, and determine the first nerve fiber passing through the electric field area as the target nerve fiber stimulated by the electric field area.

[0136] The technical solution of the embodiment of the present invention determines the electric field area generated by the first pulse modulated according to the preset pulse parameters at the preset target point through the implantation position of the electrode wire in the implantable medical system at the preset target point; further, determines the target nerve fibers activated by the electric field area; thus, taking into account the influence of the electric field area on the nerve fibers, the preset pulse parameters are modulated by combining the preset activation conditions corresponding to the target nerve fibers to obtain the target pulse parameters; wherein, the electric field area generated by the target pulse parameters does not activate at least one target nerve fiber, and the preset activation conditions are the parameter conditions that the pulse needs to meet to activate the target nerve fibers. The technical solution of this embodiment takes into account the influence of the electric field area on the nerve fibers, and determines the target pulse parameters in combination with the preset activation conditions of the nerve fibers, thereby avoiding the occurrence of abnormal nerve impulses after the pulse corresponding to the target pulse parameters stimulates the nerve fibers, thereby improving the working accuracy and safety of the implantable medical system.

[0137] It is worth noting that in the embodiment of the above-mentioned pulse parameter determination device, the various units and modules included are only divided according to functional logic, but are not limited to the above-mentioned division, as long as the corresponding functions can be achieved; in addition, the specific names of the functional units are only for the convenience of distinguishing each other, and are not used to limit the scope of protection of the present invention.

[0138] Figure 5 is a schematic diagram of the structure of a program-controlled device for implementing the pulse parameter determination method of an embodiment of the present invention. The program-controlled device is intended to represent various forms of digital computers, such as laptop computers, desktop computers, workstations, personal digital assistants, servers, blade servers, mainframe computers, and other suitable computers. The program-controlled device can also represent various forms of mobile devices, such as personal digital assistants, cellular phones, smart phones, wearable devices (such as helmets, glasses, watches, etc.) and other similar computing devices. The components shown herein, their connections and relationships, and their functions are merely examples and are not intended to limit the implementation of the present invention described and / or claimed herein.

[0139] like Figure 5As shown, the program-controlled device 20 includes at least one processor 21 and a memory, such as a read-only memory (ROM) 22 and a random access memory (RAM) 23, that is communicatively connected to the at least one processor 21. The memory stores a computer program that can be executed by the at least one processor, and the processor 21 can perform various appropriate actions and processes according to the computer program stored in the read-only memory (ROM) 22 or the computer program loaded from the storage unit 28 into the random access memory (RAM) 23. Various programs and data required for the operation of the program-controlled device 20 can also be stored in the RAM 23. The processor 21, ROM 22, and RAM 23 are interconnected via a bus 24. An input / output (I / O) interface 25 is also connected to the bus 24.

[0140] Several components in the program-controlled device 20 are connected to the I / O interface 25, including an input unit 26, such as a keyboard and mouse; an output unit 27, such as various types of displays and speakers; a storage unit 28, such as a magnetic disk and optical disk; and a communication unit 29, such as a network card, a modem, a wireless communication transceiver, etc. The communication unit 29 allows the program-controlled device 20 to exchange information / data with other devices via a computer network such as the Internet and / or various telecommunication networks.

[0141] The processor 21 may be any general-purpose and / or specialized processing component with processing and computing capabilities. Examples of the processor 21 include, but are not limited to, a central processing unit (CPU), a graphics processing unit (GPU), various specialized artificial intelligence (AI) computing chips, various processors running machine learning model algorithms, a digital signal processor (DSP), and any other suitable processor, controller, microcontroller, etc. The processor 21 executes the various methods and processes described above, such as the method for determining pulse modulation parameters.

[0142] In some embodiments, the method for determining pulse modulation parameters can be implemented as a computer program tangibly embodied in a computer-readable storage medium, such as storage unit 28. In some embodiments, part or all of the computer program can be loaded and / or installed on program-controlled device 20 via ROM 22 and / or communication unit 29. When the computer program is loaded into RAM 23 and executed by processor 21, one or more steps of the method for determining pulse modulation parameters described above can be performed. Alternatively, in other embodiments, processor 21 can be configured to perform the method for determining pulse modulation parameters in any other appropriate manner (e.g., via firmware).

[0143] Various embodiments of the systems and techniques described herein can be implemented in digital electronic circuit systems, integrated circuit systems, field programmable gate arrays (FPGAs), application specific integrated circuits (ASICs), application specific standard products (ASSPs), system-on-chip systems (SOCs), programmable logic devices (CPLDs), computer hardware, firmware, software, and / or combinations thereof. These various embodiments can include being implemented in one or more computer programs that are executable and / or interpreted on a programmable system that includes at least one programmable processor, which can be a special purpose or general purpose programmable processor that can receive data and instructions from a storage system, at least one input device, and at least one output device, and transmit data and instructions to the storage system, the at least one input device, and the at least one output device.

[0144] Computer programs for implementing the methods of the present invention may be written in any combination of one or more programming languages. These computer programs may be provided to a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing device, such that when the computer program is executed by the processor, the functions / operations specified in the flowcharts and / or block diagrams are implemented. The computer program may be executed entirely on the machine, partially on the machine, as a stand-alone software package, partially on the machine and partially on a remote machine, or entirely on a remote machine or server.

[0145] In this embodiment, the implantable medical system includes: an implantable medical device, the implantable medical device at least including a stimulator and an electrode wire implanted in a target object, the implanted end of the electrode wire is provided with a plurality of electrode contacts, and the stimulator is connected to the electrode wire; a programmable device, configured to store preset activation conditions and execute the above-mentioned pulse parameter determination method of the claim to determine the target pulse parameters.

[0146] In the context of the present invention, computer-readable storage media can be tangible media that can contain or store a computer program for use with an instruction execution system, device or equipment or used in combination with an instruction execution system, device or equipment. Computer-readable storage media can include but are not limited to electronic, magnetic, optical, electromagnetic, infrared or semiconductor systems, devices or equipment, or any suitable combination of the foregoing. Alternatively, computer-readable storage media can be machine-readable signal media. More specific examples of machine-readable storage media can include electrical connections based on one or more lines, portable computer disks, hard disks, random access memories (RAM), read-only memories (ROM), erasable programmable read-only memories (EPROM or flash memory), optical fibers, portable compact disk read-only memories (CD-ROM), optical storage devices, magnetic storage devices, or any suitable combination of the foregoing.

[0147] To provide interaction with a user, the systems and techniques described herein can be implemented on a programmable device having: a display device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor) for displaying information to the user; and a keyboard and pointing device (e.g., a mouse or trackball) through which the user can provide input to the programmable device. Other types of devices can also be used to provide interaction with the user; for example, the feedback provided to the user can be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user can be received in any form (including acoustic input, voice input, or tactile input).

[0148] The systems and techniques described herein can be implemented in a computing system that includes back-end components (e.g., as a data server), or a computing system that includes middleware components (e.g., an application server), or a computing system that includes front-end components (e.g., a user computer with a graphical user interface or web browser through which a user can interact with implementations of the systems and techniques described herein), or a computing system that includes any combination of such back-end components, middleware components, or front-end components. The components of the system can be interconnected by any form or medium of digital data communication (e.g., a communication network). Examples of communication networks include: a local area network (LAN), a wide area network (WAN), a blockchain network, and the Internet.

[0149] A computing system may include clients and servers. The clients and servers are typically remote from each other and typically interact via a communication network. This client-server relationship arises through computer programs running on the respective computers, creating a client-server relationship. The server may be a cloud server, also known as a cloud computing server or cloud host. This server is a hosting product within the cloud computing service ecosystem that addresses the management difficulties and limited scalability of traditional physical hosting and VPS services.

[0150] In particular, according to an embodiment of the present invention, the process described above with reference to the flowchart can be implemented as a computer software program. For example, an embodiment of the present invention includes a computer program product that includes a computer program carried on a non-transitory computer-readable medium, the computer program containing program code for executing the method shown in the flowchart. In such an embodiment, the computer program can be downloaded and installed from the network via the communication unit 29, or installed from the storage unit 28, or installed from the ROM 22. When the computer program is executed by the processor 21, the above-mentioned functions defined in the method of the embodiment of the present invention are performed.

[0151] The computer program product may be implemented by writing computer program code for performing the operations of the present invention in one or more programming languages, or a combination thereof, including object-oriented programming languages ​​such as Java, Smalltalk, C++, and conventional procedural programming languages ​​such as "C" or similar programming languages. The program code may be executed entirely on the user's computer, partially on the user's computer, as a stand-alone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In cases involving a remote computer, the remote computer may be connected to the user's computer via any type of network, including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computer (e.g., via the Internet using an Internet service provider).

[0152] It should be understood that the various forms of the processes shown above can be used to reorder, add, or delete steps. For example, the steps described in the present invention can be performed in parallel, sequentially, or in a different order, as long as the desired results of the technical solution of the present invention can be achieved. This is not limited herein.

[0153] The above specific embodiments do not limit the scope of protection of the present invention. Those skilled in the art will appreciate that various modifications, combinations, sub-combinations, and substitutions may be made based on design requirements and other factors. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention are intended to be included within the scope of protection of the present invention.

Claims

1. A method for determining pulse parameters, characterized in that: include: Determining, based on the implantation position of the electrode lead in the implantable medical system at the preset target point, an electric field region generated at the preset target point by a first pulse modulated according to preset pulse parameters; determining target neural fibers activated by the electric field region; Based on the preset activation conditions corresponding to the target nerve fibers, the preset pulse parameters are modulated to obtain target pulse parameters; wherein, the electric field region generated by the target pulse parameters does not activate at least one of the target nerve fibers, and the preset activation conditions are parameter conditions that need to be met by the pulse to activate the target nerve fibers.

2. The method according to claim 1, characterized in that The preset pulse parameters include a first pulse width and / or a first amplitude; The preset activation conditions include: the pulse width of the corresponding pulse of the electric field received by the nerve fiber is greater than the preset pulse width, and / or the amplitude of the pulse is greater than the preset amplitude threshold.

3. The method according to claim 2, characterized in that The modulating the preset pulse parameters to obtain target pulse parameters includes: When the first pulse width is greater than a preset duration, the first pulse width is used as the total duration of the burst pulse; wherein the burst pulse is composed of at least two stimulation sub-pulses; determining pulse modulation parameters of the stimulation sub-pulses included in the burst pulse based on the total duration and the preset activation condition corresponding to each of the target nerve fibers; The pulse modulation parameters obtained by modulating all preset pulse parameters are determined as the target pulse parameters; wherein the pulse modulation parameters include the pulse width and / or pulse amplitude of each stimulation sub-pulse in the burst pulse, and the pulse width is less than the preset duration.

4. The method according to claim 1, wherein The coverage area of ​​the electric field region generated by the pulse corresponding to the target pulse parameter on the preset target point is larger than the preset coverage area.

5. The method according to claim 2, characterized in that The modulating the preset pulse parameters to obtain target pulse parameters includes: Determining a first difference value obtained by subtracting a preset pulse width offset value from the first pulse width, wherein the preset pulse width offset value is a maximum value of pulse width adjustment for achieving a target therapeutic effect; When the first difference is smaller than the preset pulse width, the first difference and the preset pulse width are respectively used as boundary values ​​to form a pulse width range to be selected, and a second pulse width is determined based on the pulse width range to be selected, and the second pulse width is used as the target pulse parameter; and / or determining a second difference obtained by subtracting a preset amplitude offset value from the first amplitude, where the preset amplitude offset value is a maximum amplitude adjustment value for achieving a target therapeutic effect; When the second difference is smaller than the preset amplitude threshold, the second difference and the preset amplitude threshold are respectively used as boundary values ​​to form a selected amplitude range. Based on the selected amplitude range, the second amplitude is determined and used as the target pulse parameter.

6. The method according to claim 4, characterized in that The sum of the pulse widths of the stimulation sub-pulses in the burst pulse is not less than a first difference obtained by subtracting a preset pulse width offset value from the first pulse width; The amplitude of each stimulation sub-pulse in the burst pulse is not less than a second difference obtained by subtracting a preset amplitude offset value from the first amplitude.

7. The method according to claim 4, characterized in that Also includes: When a first trigger frequency of the first pulse is greater than or equal to a preset frequency, using the first trigger frequency as a second trigger frequency of the burst pulse; In a case where the first trigger frequency of the first pulse is lower than a preset frequency, the preset frequency is used as the second trigger frequency of the burst pulse.

8. The method according to claim 1, characterized in that The step of modulating the preset pulse parameters based on the preset activation conditions corresponding to the target nerve fibers to obtain target pulse parameters includes: When the number of the target nerve fibers is greater than a preset number threshold, the target nerve fibers that meet the preset screening conditions are used as reference nerve fibers; Based on the preset activation condition corresponding to the reference nerve fiber, modulating the preset pulse parameter to obtain the target pulse parameter; The preset screening condition includes at least one of the following: The priority of the target nerve fiber is greater than a preset level; The target nerve fibers are in a preset set of inactive objects.

9. The method according to claim 1, characterized in that The method of determining, based on the implantation position of the electrode wire in the implantable medical system on the preset target point, an electric field region generated by a first pulse modulated according to preset pulse parameters on the preset target point includes: Determining electrical characteristic distribution information of the target object based on the acquired medical image data of the target object; Based on the implantation position of the electrode wire in the implantable medical system on the preset target point, the preset pulse parameters and the electrical characteristic distribution information, the electric field area generated by the first pulse on the preset target point is determined.

10. A pulse parameter determination device, characterized in that: The device comprises: An electric field region determination module, configured to determine, based on the implantation position of the electrode lead in the implantable medical system on the preset target point, the electric field region generated by the first pulse modulated according to the preset pulse parameters on the preset target point; a nerve fiber determination module, configured to determine target nerve fibers activated by the electric field region; A modulation parameter determination module is used to modulate the preset pulse parameters based on the preset activation conditions corresponding to the target nerve fibers to obtain target pulse parameters; wherein the electric field area generated by the target pulse parameters does not activate at least one of the target nerve fibers, and the preset activation conditions are parameter conditions that need to be met by the pulse to activate the target nerve fibers.

11. A program-controlled device, characterized in that: The program-controlled device comprises: at least one processor; and a memory communicatively connected to the at least one processor; wherein, The memory stores a computer program executable by the at least one processor. The computer program is executed by the at least one processor to enable the at least one processor to perform the pulse parameter determination method according to any one of claims 1 to 8.

12. An implantable medical system, characterized in that: The implantable medical system comprises: An implantable medical device, comprising at least a stimulator and an electrode lead implanted in a target object, wherein the implanted end of the electrode lead is provided with a plurality of electrode contacts, and the stimulator is connected to the electrode lead; The program-controlled device is configured to store preset activation conditions and execute the pulse parameter determination method according to any one of claims 1 to 7 to determine target pulse parameters.

13. A computer-readable storage medium, characterized in that The computer-readable storage medium stores computer instructions, and the computer instructions are used to enable a processor to implement the pulse parameter determination method according to any one of claims 1 to 8 when executed.

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