CN118217535A - Implantable electrical stimulation systems, methods, devices, and storage media - Google Patents

Implantable electrical stimulation systems, methods, devices, and storage media Download PDF

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Publication number
CN118217535A
CN118217535A CN202410649484.6A CN202410649484A CN118217535A CN 118217535 A CN118217535 A CN 118217535A CN 202410649484 A CN202410649484 A CN 202410649484A CN 118217535 A CN118217535 A CN 118217535A
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China
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parameter value
stimulation parameter
ecap
stimulation
pulse
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何罗建
赵云
赵春
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Beijing New Cloud Medical Technology Co ltd
Suzhou Xinyun Medical Equipment Co ltd
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Beijing New Cloud Medical Technology Co ltd
Suzhou Xinyun Medical Equipment Co ltd
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Priority to CN202410649484.6A priority Critical patent/CN118217535A/en
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Abstract

The present disclosure provides an implantable electrical stimulation system, method, apparatus, and storage medium, the implantable electrical stimulation system comprising: an electrode lead for delivering therapeutic pulses and evoked pulses to the body; the sensor is used for acquiring the attitude information of the machine body; and a controller coupled to the electrode leads and the sensor, the controller configured to: transmitting therapeutic pulses to the body based on the first stimulation parameter values through the electrode leads and transmitting induced pulses to the body; judging whether the current gesture of the machine body is matched with a preset gesture according to the gesture information; if yes, therapeutic pulses are sent to the body based on second stimulation parameter values corresponding to the preset postures; if not, a therapeutic pulse is issued to the body based on a third stimulation parameter value resulting from adjusting the first stimulation parameter value in accordance with the ECAP signal. Thereby, stability of the therapeutic effect is improved.

Description

Implantable electrical stimulation systems, methods, devices, and storage media
Technical Field
The present disclosure relates to the technical field of medical devices, and in particular, to an implantable electrical stimulation system, method, device, and storage medium.
Background
The implanted nerve stimulator has remarkable treatment effect as a medical means capable of directly acting on the organism, and is gradually and widely applied to the treatment processes of pain relief, tissue injury repair and the like.
However, in the related art, there is a problem in that the therapeutic effect of the implantable neurostimulator is unstable after implantation in a patient.
Disclosure of Invention
The present disclosure provides implantable electrical stimulation systems, methods, devices, and storage media for improving stability of electrical stimulation therapy effects.
A first aspect of the present disclosure provides an implantable electrical stimulation system comprising: an electrode lead for delivering therapeutic pulses and evoked pulses to the body; the sensor is used for acquiring the attitude information of the machine body; and a controller connected to the electrode leads and the sensor, wherein the controller is configured to: transmitting a therapeutic pulse to the body based on the first stimulation parameter value through the electrode lead and transmitting an evoked pulse to the body, wherein the evoked pulse is used for causing the body to be evoked an Evoked Compound Action Potential (ECAP) signal corresponding to the first stimulation parameter value; judging whether the current gesture of the machine body is matched with a preset gesture according to the gesture information; if yes, sending a treatment pulse to the body based on a second stimulation parameter value through the electrode lead, wherein the second stimulation parameter value is a stimulation parameter value corresponding to a preset posture; if not, a therapeutic pulse is sent to the body through the electrode lead based on a third stimulation parameter value, wherein the third stimulation parameter value is obtained by the controller adjusting the first stimulation parameter value according to the ECAP signal.
According to the implantable electrical stimulation system provided by the disclosure, the current posture of the body can be confirmed through the sensor, and the current suitable stimulation parameter value of the body can be confirmed in different modes by judging whether the posture is a pre-calibrated preset posture or not: directly adopting a corresponding second stimulation parameter value under a preset gesture; and in other postures, a third stimulation parameter value calculated according to ECAP signals fed back by the organism is adopted. Therefore, the implantable electrical stimulation system provided by the disclosure can adaptively adjust the stimulation parameter value when the body is in posture change, so that the problem that the body feels uncomfortable is effectively avoided; furthermore, the implantable electrical stimulation system can realize reduction of battery consumption based on a flexible parameter adjustment mode, so that the problems of inconvenience and battery life caused by frequent charging are avoided.
In an embodiment of the present disclosure, the controller adjusts the first stimulation parameter value to obtain a third stimulation parameter value according to the ECAP signal, comprising: the first stimulation parameter value is adjusted based on the deviation between the ECAP signal and the target ECAP to obtain a third stimulation parameter value.
In the process of changing the body posture, the distance and the relative position between the electrode leads and the nerve fibers may be changed, so that the degree of the electric stimulation pulse actually acting on the nerve fibers of the body is also changed, at this time, the symptom of the body may not be effectively relieved due to insufficient stimulation, or the body is damaged due to excessive electric stimulation. The ECAP signal sent by the nerve fiber of the organism can reflect the actual acting degree of the electric stimulation pulse on the nerve fiber, the target ECAP can be a preset target value of the ECAP signal, the stimulation parameter value of the electric stimulation pulse is regulated according to the difference between the actually collected ECAP signal and the target ECAP, and the ECAP signal fed back by the organism when the regulated electric stimulation pulse is received can be as close to the target ECAP as possible. Therefore, the implantable electrical stimulation system provided by the disclosure can utilize ECAP to adjust the parameter value of the stimulation pulse when the posture of the body changes, so that the body is prevented from being subjected to unsuitable electrical stimulation, and the treatment effect is improved.
In an embodiment of the present disclosure, the controller is further configured to: when the current posture of the machine body is judged to be matched with the preset posture, comparing the second stimulation parameter value with the third stimulation parameter value, and judging whether the difference value between the second stimulation parameter value and the third stimulation parameter value meets the preset difference range or not; if not, the target ECAP is modified according to the second stimulation parameter value.
In general, the second stimulation parameter value directly determined by the preset gesture has a higher accuracy than the third stimulation parameter value calculated from the ECAP signal. Based on this, in the implantable electrical stimulation system provided in the present disclosure, when a large difference exists between the second stimulation parameter value and the third stimulation parameter value, the target ECAP used for calculating the third stimulation parameter value may be corrected based on the second stimulation parameter value, so as to timely eliminate an error introduced in the calculation process of the third stimulation parameter value, improve the calculation accuracy of the third stimulation parameter value, avoid using an inappropriate third stimulation parameter value to perform stimulation treatment on the body, and improve the treatment effect.
In one embodiment of the present disclosure, the first stimulus parameter value is set to x1, the third stimulus parameter value is set to x2, the deviation is set to y, the second stimulus parameter value is set to x0, and the actual deviation between the ECAP signal and the modified target ECAP is set to y'. Wherein the controller adjusts the first stimulation parameter value according to a deviation between the ECAP signal and the target ECAP to obtain a third stimulation parameter value, comprising: the third stimulation parameter value is calculated from x2=x1-f (y), where f is a predetermined one, multiple or multiple function. The controller corrects the target ECAP based on the second stimulation parameter value, comprising: and calculating to obtain an actual deviation according to f -1 (x 1-x 0) =y', and calculating to obtain a corrected target ECAP according to the ECAP signal and the actual deviation.
In the implantable electrical stimulation system provided by the disclosure, when the stimulation parameter value of the electrical stimulation pulse is adjusted according to the difference between the actually acquired ECAP signal and the target ECAP, a relationship between the deviation (between the ECAP characteristic value difference and the target value) and the amount to be adjusted of the stimulation parameter value can be set by adopting a primary function, a multiple function or a multiple-segment function, so that adjustment calculation of the stimulation parameter value is realized. On the basis, when the target ECAP is corrected according to the second stimulation parameter value, the second stimulation parameter value can be set as a target result of ECAP adjustment, and a new target ECAP is obtained through inverse function back-calculation, namely the target ECAP which is more suitable for the organism in the current state. That is, the present disclosure can easily and accurately implement the stimulation parameter adjustment process based on the ECAP signal and the correction process of the target ECAP by providing an implementation of ECAP adjustment calculation and an implementation of correction of ECAP.
In an embodiment of the present disclosure, the controller is further configured to pre-determine the target ECAP, the process comprising: repeatedly adjusting the test stimulation parameter value, and sending treatment pulses to the organism based on the test stimulation parameter value after each change to obtain a test ECAP signal corresponding to each treatment pulse; according to the feedback of the organism, confirming a plurality of treatment pulses which make the organism feel comfortable; determining a numerical range formed by the characteristic value difference values of the test ECAP signals corresponding to the multiple treatment pulses as a target ECAP range; the middle value of the target ECAP range is set as the target ECAP.
There is a very significant difference between the different organisms, so for each organism, after implantation of the electrode leads, the target ECAP can be predetermined by actual testing and calculation, so that the adjustment of the electrical stimulation parameters can be performed during the subsequent treatment using the target ECAP appropriate for that organism, to improve the pertinence and effectiveness of the treatment.
In an embodiment of the present disclosure, the controller is further configured to pre-determine a second stimulation parameter value, the process comprising: when the body is in a preset posture, repeatedly adjusting the test stimulation parameter value, and sending a treatment pulse to the body based on the test stimulation parameter value after each change; according to the feedback of the organism, confirming a plurality of treatment pulses which make the organism feel comfortable; and determining a second stimulation parameter value according to the test stimulation parameter values corresponding to the multiple treatment pulses.
Similarly, for each body, after implantation of the electrode leads and sensors, stimulation parameter values that the body feels comfortable in each posture may be determined by actual testing and stored in association with each posture, so that corresponding second stimulation parameter values are determined from each posture during subsequent treatment.
In one embodiment of the present disclosure, the electrode lead is adapted to be placed within a spinal canal of a body to contact spinal nerves of the body, the electrode lead also being used to collect ECAP signals; the sensor is adapted to be fixedly arranged under the skin of the body.
In the implantable electrical stimulation system provided by the disclosure, the electrode lead can be an electrode lead for spinal cord electrical stimulation, and the length direction of the electrode lead can be basically parallel to the spine and is close to spinal nerves as much as possible through implantation in the vertebral canal of the body, so that the stimulation effect is improved. The sensor can be sutured under the skin of the machine body, so that a better fixing effect is realized, the relative position change with the machine body can hardly occur, and the gesture change information with higher accuracy can be stably provided.
In an embodiment of the present disclosure, the electrode lead includes a plurality of contacts, and the controller is configured to deliver the therapeutic pulse to the body through at least two first contacts of the plurality of contacts and to deliver the evoked pulse to the body through at least two second contacts of the plurality of contacts. Based on this, the plurality of contacts on the electrode lead can deliver stimulation pulses to the body in different positions and directions, and by assigning different functions to different contacts of the plurality of contacts, a more diversified treatment regimen can be achieved.
In an embodiment of the present disclosure, a particular contact of the plurality of contacts is defined as a first contact during a first time period and the particular contact is defined as a second contact during a second time period, wherein the first time period and the second time period do not overlap.
After the electrode lead is implanted into the body, the target of the body may be changed, in which case the position of the first contact for delivering the therapeutic pulse may be adjusted according to the position of the new target, so that the new target is effectively stimulated. For example, if a site that receives therapy within a first time period no longer needs to be stimulated for a second time period, delivery of therapeutic pulses to the body through the electrode contact corresponding to the site may be stopped, at which point the electrode contact may become the second contact for delivering evoked pulses to the body. According to the implantable electrical stimulation system provided by the disclosure, the positions of the first contact and/or the second contact can be flexibly adjusted, so that stable electrical stimulation output is provided under different requirements (for example, the original first contact does not need to deliver therapeutic pulses any more, or the original second contact needs to deliver therapeutic pulses, etc.), and the therapeutic effect is ensured.
In an embodiment of the present disclosure, the controller is further configured to collect ECAP signals through a third contact of the plurality of contacts, and a distance between the first contact and/or the second contact and the third contact is 30% -80% of a distance between two farthest contacts of the plurality of contacts in a length direction of the electrode lead.
In the implantable electrical stimulation system provided by the disclosure, the electrode lead further comprises a third contact, and the third contact is used for sensing ECAP signals sent by nerve fibers of the body after the second contact sends out the induction pulse and transmitting the ECAP signals to the controller. The ECAP signal is acquired at a distance between the first contact and/or the second contact and the third contact, i.e. at a distance from the position at which the therapeutic pulse and/or the induction pulse is emitted. Based on the design, the degree of influence of the wake of the stimulation pulse on the ECAP signal and the distortion degree of the ECAP signal in long-distance transmission can be well balanced, so that more effective ECAP signals are collected, and the accuracy of electric stimulation adjustment is improved.
A second aspect of the present disclosure provides an implantable electrical stimulation method comprising: delivering a therapeutic pulse to the body based on the first stimulation parameter value and delivering an evoked pulse to the body, wherein the evoked pulse is used to cause the body to be evoked an Evoked Compound Action Potential (ECAP) signal corresponding to the first stimulation parameter value; judging whether the current posture of the machine body is matched with a preset posture according to the posture information of the machine body; if yes, a treatment pulse is sent to the organism based on a second stimulation parameter value, wherein the second stimulation parameter value is a stimulation parameter value corresponding to a preset posture; if not, the first stimulation parameter value is adjusted according to the ECAP signal to obtain a third stimulation parameter value, and a treatment pulse is sent to the body based on the third stimulation parameter value.
According to the implantable electrical stimulation method provided by the disclosure, the current posture of the body can be confirmed, and the current suitable stimulation parameter value of the body can be determined in different modes by judging whether the posture is a preset posture calibrated in advance or not: directly adopting a corresponding second stimulation parameter value under a preset gesture; and in other postures, a third stimulation parameter value calculated according to ECAP signals fed back by the organism is adopted. Therefore, the implantable electrical stimulation method provided by the disclosure can adaptively adjust the stimulation parameter value when the organism changes the posture, so that the organism feel uncomfortable; furthermore, the implantable electrical stimulation system can realize reduction of battery consumption based on a flexible parameter adjustment mode, so that the problems of inconvenience and battery life caused by frequent charging are avoided.
A third aspect of the present disclosure provides an implantable electrical stimulation device comprising: the implantable electrical stimulation device comprises a controller and a storage medium, wherein the storage medium stores a program which, when executed by the controller, causes the controller to execute the implantable electrical stimulation method provided in the second aspect.
A fourth aspect of the present disclosure provides a storage medium having stored therein a program which, when executed by a processor, causes the processor to perform the implantable electrical stimulation method provided in the second aspect described above.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings required for the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present disclosure, and other drawings may be obtained according to these drawings without inventive effort to those of ordinary skill in the art.
Fig. 1 is a schematic diagram of an implantable electrical stimulation system according to an embodiment of the present disclosure.
Fig. 2 is a schematic flow chart of a controller in an implantable electrical stimulation system according to an embodiment of the present disclosure for performing closed-loop adjustment according to ECAP signals.
Fig. 3 is a schematic waveform diagram of ECAP signals according to an embodiment of the disclosure.
Fig. 4 is a schematic view of a partial structure of an electrode lead in an implantable electrical stimulation system according to an embodiment of the present disclosure.
Fig. 5 is a schematic view of a partial structure of an electrode lead in an implantable electrical stimulation system according to another embodiment of the present disclosure.
Fig. 6 is a flow chart illustrating an implantable electrical stimulation method according to an embodiment of the disclosure.
Fig. 7 is a flow chart illustrating an implantable electrical stimulation method according to another embodiment of the present disclosure.
Fig. 8 is a schematic structural diagram of an implantable electrical stimulation device according to an embodiment of the present disclosure.
Detailed Description
The technical solutions in the embodiments of the present disclosure will be clearly and completely described below with reference to the drawings in the embodiments of the present disclosure, and it is apparent that the described embodiments are only some embodiments of the present disclosure, but not all embodiments. All other embodiments derived from the embodiments in the disclosure by a person of ordinary skill in the art are within the scope of the protection of the present disclosure.
Fig. 1 is a schematic diagram of an implantable electrical stimulation system 100 according to an embodiment of the present disclosure. In fig. 1, reference numeral SC indicates the spinal cord of the patient, and reference numeral SK indicates the skin of the patient. In addition, the implantable electrical stimulation system provided by the present disclosure may also be used for electrical stimulation treatment of other parts than the spinal cord, such as brain, waist, leg, etc., and the present embodiment is merely described by taking the electrical stimulation system for the spinal cord as an example, and does not represent that the implantable electrical stimulation system provided by the present disclosure is limited to be used for the spinal cord.
In the related art, an implanted electric stimulator generally adopts an open-loop stimulation manner, that is, after setting a stimulation parameter value is completed in an initial stage, a stimulation treatment is performed in a body by using the stimulation parameter value all the time, and the stimulation parameter value cannot be adaptively adjusted. However, when the posture of the body is changed (e.g., from standing to sitting, sitting to lying, or bending down, squatting, even coughing, sneezing, etc.), the distance and relative position between the electrode leads and the nerve fibers of the body may change. At this time, the degree to which the electrical stimulation pulse actually acts on the nerve fibers of the body is also changed, if the stimulation mode with the constant stimulation parameter value is adopted, insufficient stimulation may occur when the distance between the electrode lead and the nerve fibers is increased, so that the symptoms of the body cannot be effectively relieved, and excessive stimulation may occur when the distance between the electrode lead and the nerve fibers is reduced, so that the body is damaged due to excessive electrical stimulation.
To solve this problem, a closed-loop stimulation method may be used. The evoked compound action potential (ECAP, evoked compound action potential) signal from the nerve fibers of the body reflects the actual degree of electrical stimulation applied to the nerve fibers, and thus the current degree of stimulation experienced by the body can be observed using the ECAP signal. In the closed-loop stimulation mode, by collecting ECAP signals fed back by a body and adaptively adjusting stimulation parameter values according to changes of the ECAP signals, the stimulation effect can be maintained to be basically unchanged when the distance between an electrode lead and nerve fibers is changed due to changes of the body posture, and discomfort of a patient is avoided.
In order to achieve ECAP-based closed-loop adaptive regulation in real time, the corresponding operations need to be performed continuously, resulting in faster battery drain of the implantable electrostimulator, which the user needs to charge more frequently. This not only brings inconvenience to the user, but also is detrimental to maintenance of battery life. In addition, since an operation may be required when the implanted electric stimulator is to replace the battery, it also places a burden on the patient's body.
In view of this, as shown in fig. 1, an embodiment of the present disclosure provides an implantable electrical stimulation system 100. Implantable electrical stimulation system 100 includes electrode lead 10, sensor 20, and controller 30. The electrode lead 10 is configured to be implanted within the body of a subject to deliver electrical stimulation pulses (including therapeutic pulses and evoked pulses) to the subject. The sensor 20 is configured to be implanted in the body of the subject for sensing motion of the subject to obtain pose information of the subject. The sensor 20 may be, for example, a sensor such as a gyroscope, an accelerometer, a magnetic sensor, or the like. The controller 30 may be configured to be implanted within the body of the subject or may be configured to be located outside of the subject. The controller 30 is connected to the electrode lead 10 and the sensor 20 by a wired or wireless manner so as to be able to deliver a stimulation pulse to the body through the electrode lead 10 and acquire posture information of the body detected by the sensor 20.
Further, in the implantable electrical stimulation system 100 provided by the embodiments of the present disclosure, the controller 30 is configured to: delivering a therapeutic pulse to the body via the electrode lead 10 based on the first stimulation parameter value and delivering an induction pulse to the body, wherein the induction pulse is for causing the body to be induced with an ECAP signal corresponding to the first stimulation parameter value; judging whether the current gesture of the machine body is matched with a preset gesture according to the gesture information; if yes, a treatment pulse is sent to the body through the electrode lead 10 based on a second stimulation parameter value, wherein the second stimulation parameter value is a stimulation parameter value corresponding to a preset posture; if not, a therapeutic pulse is delivered to the body via the electrode lead 10 based on a third stimulation parameter value, wherein the third stimulation parameter value is derived by the controller adjusting the first stimulation parameter value in accordance with the ECAP signal.
In the present disclosure, electrical stimulation pulses (including therapeutic pulses and/or evoked pulses) may refer to current pulses or voltage pulses. The stimulation parameters of the electrical stimulation pulses may comprise the amplitude of the pulses and/or the pulse width of the pulses, and the stimulation parameter values may accordingly comprise specific values of the amplitude of the pulses and/or the pulse width of the pulses.
The therapeutic pulse is used to treat a symptom of the body, for example, to relieve pain of the body, and thus its stimulation parameter value (including other parameters than the amplitude of the pulse and the pulse width of the pulse, for example, frequency) needs to satisfy the symptom that the therapeutic pulse effectively acts on the body to achieve a therapeutic effect. The evoked pulses are used for exciting ECAP signals, so that the stimulation parameter values of the evoked pulses only need to meet the requirement that nerve fibers of the organism emit ECAP signals, and the evoked pulses do not participate in the treatment effect. In some cases, the therapeutic pulse and the evoked pulse may have the same stimulation parameter values, where the therapeutic pulse and the evoked pulse may be considered the same pulse.
According to the implantable electrical stimulation system provided by the embodiment of the disclosure, the current posture of the body can be confirmed through the sensor, and the current suitable stimulation parameter value of the body can be determined in different modes by judging whether the posture is a preset posture calibrated in advance or not: directly adopting a corresponding second stimulation parameter value under a preset gesture; and in other postures, a third stimulation parameter value calculated according to ECAP signals fed back by the organism is adopted. Therefore, the implantable electrical stimulation system can adaptively adjust the stimulation parameter value when the body is changed in posture, so that the problem that the body feels uncomfortable is effectively avoided; furthermore, the implantable electro-excitation system can realize the reduction of battery consumption based on a flexible parameter adjustment mode, thereby avoiding the problems of inconvenience and battery life caused by frequent charging.
Illustratively, as shown in fig. 1, an embodiment of the present disclosure provides an implantable electrical stimulation system 100 that may be used for electrical stimulation therapy of the spinal cord, wherein an electrode lead 10 is adapted to be placed within a spinal canal of a body to contact spinal nerves of the body; the sensor 20 is adapted to be fixedly arranged under the skin of the body.
By implanting the electrode lead 10 into the spinal canal of the body, the longitudinal direction of the electrode lead 10 can be made substantially parallel to the spinal cord SC, and as close to spinal nerves as possible, thereby improving the stimulation effect. The sensor 20 can be sutured under the skin of the body, so that a better fixing effect is achieved, the relative position change with the body hardly occurs, and the posture change information with higher accuracy can be stably provided.
In one embodiment, the controller 30 adjusts the first stimulation parameter value to obtain a third stimulation parameter value based on the ECAP signal, including: the first stimulation parameter value is adjusted based on the deviation between the ECAP signal and the target ECAP to obtain a third stimulation parameter value.
As described above, during the change of the body posture, the distance and the relative position between the electrode lead and the nerve fiber may be changed, resulting in a change in the degree to which the electrical stimulation pulse actually acts on the nerve fiber of the body. The ECAP signal sent by the nerve fiber of the organism can reflect the actual acting degree of the electric stimulation pulse on the nerve fiber, based on the ECAP signal, the stimulation parameter value of the electric stimulation pulse is adjusted according to the difference between the actually collected ECAP signal and the preset target ECAP, so that the ECAP signal fed back by the organism when the regulated electric stimulation pulse is received is as close to the target ECAP as possible, namely, the organism receives proper electric stimulation intensity, and the treatment effect is improved.
For example, as shown in fig. 2, the process of performing closed loop adjustment by the controller 30 according to the ECAP signal may include the following steps S210 to S270.
S210: ECAP signals emitted by the nerve fibers are acquired after the therapeutic pulses are emitted and the evoked pulses are emitted based on the first stimulation parameter values.
S220: and filtering the acquired signals to remove interference caused by other signals except the ECAP signals.
S230: it is determined whether the waveform of the ECAP signal is a valid waveform.
If no obvious peak value and no obvious valley value exist in the waveform, the waveform of the ECAP signal can be identified as an invalid waveform, and the current adjusting process is abandoned.
S240: the characteristic value P2 and the characteristic value N1 in the waveform are extracted, and the difference between the characteristic value P and the characteristic value N1 is calculated as a characteristic value difference value.
As shown in the schematic diagram of the ECAP signal in fig. 3, the characteristic values of the waveform of the ECAP signal generally include a peak value P1, a peak value P2, and a valley value N1, and the value of (P2-N1) may be regarded as a characteristic value difference, which can represent the ECAP signal to some extent.
S250: comparing the characteristic value difference value of the ECAP signal with the characteristic value difference value of the target ECAP, and calculating to obtain the deviation value of the current ECAP signal.
S260: and (5) bringing the deviation value into a preset function, and calculating to obtain the adjustment quantity of the stimulation parameter value.
S270: and calculating a third stimulation parameter value according to the first stimulation parameter value and the adjustment quantity.
Therefore, the implantable electrical stimulation system provided by the disclosure can utilize ECAP signals and target ECAP to adaptively adjust the parameter values of the stimulation pulses when the posture of the body changes, so that the body is prevented from being subjected to unsuitable electrical stimulation, and the treatment effect is improved.
In an embodiment of the present disclosure, the controller 30 is further configured to: when the current posture of the machine body is judged to be matched with the preset posture, comparing the second stimulation parameter value with the third stimulation parameter value, and judging whether the difference value between the second stimulation parameter value and the third stimulation parameter value meets the preset difference range or not; if not, the target ECAP is modified according to the second stimulation parameter value.
It can be appreciated that the ECAP closed-loop adjustment process is not limited by a preset posture, and can adjust the stimulation parameter value in any posture in real time, but problems such as signal acquisition failure, characteristic value extraction failure or errors introduced in calculation may occur in the adjustment process, and some unstable factors exist in accuracy and reliability. Compared with the prior art, the stimulation parameter value corresponding to the preset gesture is determined in advance, and only the direct switching is needed, a complex calculation process is not needed, and the accuracy is high. Therefore, when the body is in the preset posture, the second stimulation parameter value may be considered to be more accurate relative to the third stimulation parameter value. Based on this, in the implantable electrical stimulation system 100 provided in the embodiment of the present disclosure, when a large difference exists between the second stimulation parameter value and the third stimulation parameter value, the calculation process of the third stimulation parameter value may be modified based on the second stimulation parameter value.
Specifically, the calculation process of the third stimulation parameter value can be adjusted by correcting the target ECAP, so that errors introduced in the calculation process of the third stimulation parameter value are eliminated in time, the calculation accuracy of the third stimulation parameter value is improved, the stimulation treatment of the organism by adopting an unsuitable third stimulation parameter value is avoided, and the treatment effect is improved.
In one embodiment, the first stimulus parameter value may be set to x1, the third stimulus parameter value may be set to x2, the deviation between the ECAP signal and the target ECAP may be set to y, the second stimulus parameter value may be set to x0, and the actual deviation between the ECAP signal and the modified target ECAP may be set to y'.
Wherein the controller adjusts the first stimulation parameter value according to a deviation between the ECAP signal and the target ECAP to obtain a third stimulation parameter value, comprising: the third stimulation parameter value is calculated from x2=x1-f (y). Here, f may be a preset function in the embodiment shown in fig. 2, and f may be a predetermined primary function, a plurality of functions, or a multi-segment function.
It can be understood that the function f is used to characterize the relationship between the deviation (i.e. the deviation between the ECAP characteristic value difference and the target value) and the amount to be adjusted of the stimulation parameter value, and because different organisms have large differences in the pain feeling degree and the pain relieving degree under the same stimulation degree, the relationship (i.e. the function f) also varies among different organisms, and when the function f is specifically implemented, a person skilled in the art can perform multiple experiments on a specific organism and perform trial and error according to the acquired data, so as to determine that the function f is more suitable for adjusting the stimulation parameter value. For example, the function f may be a linear function, i.e., f (y) =a×y+b, where a and b are constants determined by a plurality of experiments and trial-and-error. The function f may also be a quadratic function or other multiple functions, or may be a multi-segment function consisting of a linear function and/or multiple functions, so as to more accurately fit the relationship between the deviation for a specific body and the amount to be adjusted of the stimulation parameter value, which is not specifically limited in the present disclosure.
Illustratively, the process of determining the function f for a particular organism may include: repeatedly adjusting the stimulation parameter value and sending stimulation pulse to the organism, confirming ECAP when the organism feels comfortable under each gesture, and taking the middle value of the range formed by the ECAP as the target ECAP of the organism; after the posture of the body is changed, a stimulus pulse is sent to the body based on the initial stimulus parameter value, and an ECAP signal fed back by the body in response to the stimulus pulse is collected in real time; determining a deviation value y between the ECAP signal and the target ECAP, wherein when the deviation value y is larger (at the moment, the body cannot feel comfortable under the current stimulation parameter value, and therefore, the initial stimulation parameter value needs to be adjusted; Wherein the deviation threshold value for determining whether the deviation value y is large may be determined according to the bearing degree of the machine body, substituting the deviation value y into the relation x2=x1-f 0 (y), wherein x1 is an initial stimulation parameter value, the initial function f 0 may be, for example, a primary function f 0(y)=a0*y+b0, wherein a 0=1,b0 =0, calculating x2 as the adjusted stimulation parameter value; sending out a stimulation pulse to the organism again based on the regulated stimulation parameter value, collecting corresponding ECAP signals, determining the deviation value y again, and judging whether the deviation value y is larger or not; If the deviation value is still large, updating the initial function f 0, for example, to f 1(y)=a1*y+b1, wherein a 1=2,b1 =1, and recalculating a new stimulation parameter value (where x1 is the adjusted stimulation parameter value) by using the relation x2=x1-f 1 (y); Sending out stimulation pulse to the organism again based on the new stimulation parameter value, collecting ECAP signal again, repeating the process of 'determining deviation value-judging whether the deviation value is larger-adjusting again to obtain a function f n when the deviation value is larger-bringing the deviation value into the relation formed by f n, calculating to obtain the new stimulation parameter value' until the deviation value reaches a proper range, determining the function f m(y)=am*y+bm at that time as the function f finally adopted, for enabling the adjustment of the stimulation parameter values based on the ECAP signal during subsequent use. it should be appreciated that the above process of determining the function f is merely exemplary, and that one skilled in the art may determine the appropriate function f using other trial and error approaches, which are not limited by the present disclosure.
Accordingly, in this embodiment, the process of the controller correcting the target ECAP according to the second stimulation parameter value may include: and calculating to obtain an actual deviation according to f -1 (x 1-x 0) =y', and calculating to obtain a corrected target ECAP according to the ECAP signal and the actual deviation.
When the target ECAP is corrected according to the second stimulation parameter value, the second stimulation parameter value may be set as the target result of ECAP adjustment, i.e. the second stimulation parameter value is set as the adjusted third stimulation parameter value. Based on the above, the inverse function is used to perform inverse calculation, and according to the difference between the second stimulation parameter value and the first stimulation parameter value, a new target ECAP is calculated, that is, the target ECAP which is more suitable for the organism in the current state.
In the implantable electrical stimulation system provided by the disclosure, by providing an implementation manner of ECAP adjustment calculation and an implementation manner of correcting ECAP, a stimulation parameter adjustment process based on ECAP signals and a correction process of a target ECAP can be easily and accurately realized.
Alternatively, in some embodiments, the controller 30 may send an alarm message to an external device (e.g., a user terminal held by a doctor or patient) when the third stimulation parameter value is found to be too far from the second stimulation parameter value. After receiving the alarm information, the relevant personnel or programs can timely confirm whether the electrode lead 10 is in an abnormal state, such as serious displacement, breakage or failure of the electrode lead. It can be appreciated that the above-described abnormality of the electrode lead 10 may occur when an unexpected situation such as a high drop of the body, a traffic accident, or the like occurs.
It should be appreciated that there is a significant variability between different organisms, and if the same stimulation parameters are used to treat different organisms, the same or similar therapeutic effect cannot be achieved even for the same condition, the same pain level, or the same focal site. Thus, for each body, after implantation of the electrode leads, the target ECAP can be predetermined by actual testing and calculation, so that adjustment of the electrical stimulation parameters can be performed during subsequent treatment using the target ECAP appropriate for that body to improve the pertinence and effectiveness of the treatment.
In an embodiment of the present disclosure, the controller 30 is further configured to pre-determine the target ECAP, the process comprising: repeatedly adjusting the test stimulation parameter value, and sending treatment pulses to the organism based on the test stimulation parameter value after each change to obtain a test ECAP signal corresponding to each treatment pulse; according to the feedback of the organism, confirming a plurality of treatment pulses which make the organism feel comfortable; determining a numerical range formed by the characteristic value difference values of the test ECAP signals corresponding to the multiple treatment pulses as a target ECAP range; the middle value of the target ECAP range is set as the target ECAP.
Specifically, in the testing process, different stimulation parameter values can be set for multiple times and therapeutic pulses can be sent to the body, and after the body receives the different therapeutic pulses, the pain can be perceived to be relieved, and corresponding feedback is provided. According to the feedback of the organism, the upper limit and the lower limit of the stimulation parameter value and the corresponding ECAP waveform can be obtained, further, the characteristic value difference of the ECAP waveform corresponding to the upper limit and the characteristic value difference of the ECAP waveform corresponding to the lower limit can be obtained through calculation, and then the target range of the ECAP characteristic value difference between the upper limit and the lower limit can be obtained.
Similarly, for each body, after implantation of electrode lead 10 and sensor 20, stimulation parameter values that the body feels comfortable in each posture may be determined by actual testing and stored in association with each posture, so that corresponding second stimulation parameter values are determined from each posture during subsequent treatment.
In an embodiment of the present disclosure, the controller 30 is further configured to pre-determine a second stimulation parameter value, the process comprising: when the body is in a preset posture, repeatedly adjusting the test stimulation parameter value, and sending a treatment pulse to the body based on the test stimulation parameter value after each change; according to the feedback of the organism, confirming a plurality of treatment pulses which make the organism feel comfortable; and determining a second stimulation parameter value according to the test stimulation parameter values corresponding to the multiple treatment pulses.
Specifically, during testing, the origin of coordinates of the sensor 20 may be set while the machine body is in a first pose (e.g., standing pose); when the machine body is in the second posture, the sensor 20 senses the position change of the machine body, and the controller 30 can acquire the current coordinate value of the sensor 20 from the sensor. The controller 30 may also send therapeutic pulses to the body through different stimulation parameter values at each posture while acquiring the coordinate value corresponding to each posture, and determine the stimulation parameter value that makes the body feel comfortable, so that the correspondence between the coordinate value of each posture and the stimulation parameter value that is suitable for the body at the posture may be obtained and stored.
In one embodiment of the present disclosure, as shown in fig. 1, the electrode lead 10 may include a plurality of contacts 11, and the controller 30 is configured to emit therapeutic pulses to the body through at least two first contacts of the plurality of contacts 11 and to emit induction pulses to the body through at least two second contacts of the plurality of contacts 11.
Preferably, the at least two first contacts are at least two adjacent contacts of the plurality of contacts 11, including at least one contact for emitting positive phase pulses and at least one contact for emitting negative phase pulses. Similarly, the at least two second contacts are adjacent at least two contacts of the plurality of contacts 11, including at least one contact for emitting positive phase pulses and at least one contact for emitting negative phase pulses.
Based on this, the plurality of contacts on the electrode lead can deliver stimulation pulses to the body in different positions and directions, and by assigning different functions to different contacts of the plurality of contacts, a more diversified treatment regimen can be achieved.
In some embodiments, the controller 30 may be configured to define a particular contact of the plurality of contacts 11 as a first contact during a first time period and define the particular contact as a second contact during a second time period. Wherein the first time period and the second time period do not overlap.
Specifically, in some embodiments, the therapeutic pulses and the evoked pulses may be emitted alternately by the same contact, i.e., the same contact sends the evoked pulses within the gaps of adjacent therapeutic pulses. For example, a contact may send an evoked pulse after a therapeutic pulse is sent, then a therapeutic pulse is sent, and so on; or a contact may send an evoked pulse after a number of therapeutic pulses are sent, then a number of therapeutic pulses are sent, and so on. That is, one contact may be repeatedly switched between the first contact and the second contact in time series.
Furthermore, in some embodiments, the therapeutic pulse and the evoked pulse may be delivered by different contacts. For example, in the electrode lead 10 shown in fig. 4, the therapeutic pulse may be continuously delivered to the body by the contact 11a and the contact 11b as the first contact and the evoked pulse may be continuously delivered to the body by the contact 11c and the contact 11d as the second contact during the first period; during the second period of time, therapeutic pulses may be continuously delivered to the body by contact 11c and contact 11d as first contacts and evoked pulses may be continuously delivered to the body by contact 11a and contact 11b as second contacts.
It will be appreciated that the target site of the body (i.e., the site where stimulation is desired) may be altered after the electrode lead is implanted in the body. According to the implantable electrical stimulation system provided by the present disclosure, in this case, the position of the first contact for delivering the therapeutic pulse may be adjusted according to the change of the target point, so that the new target point is effectively stimulated.
If a treatment site that received treatment during a first period of time no longer needs to be stimulated during a second period of time, delivery of treatment pulses to the body through the corresponding electrode contacts of the treatment site may be stopped. The electrode contact may, for example, not deliver any type of stimulation pulse during the second period of time, or the electrode contact may become the second contact for delivering the evoked pulse to the body during the second period of time. In some embodiments, the electrode lead 10 may further include a third contact for collecting ECAP signals, where the electrode contact may also become the third contact during the second period of time, for collecting ECAP signals sent by the body.
According to the implantable electrical stimulation system provided by the disclosure, the positions of the first contact and/or the second contact can be flexibly adjusted, so that stable electrical stimulation output is provided under different requirements (for example, the original first contact does not need to deliver therapeutic pulses any more, or the original second contact needs to deliver therapeutic pulses, etc.), and the therapeutic effect is ensured.
The switching of the function of the electrode contacts (i.e. the switching between the first contact, the second contact or the third contact) can be realized by means of a switching circuit, for example. Specifically, the switching circuit may connect the electrode contact to a different circuit according to an instruction of the controller to perform a switching action. It should be understood that embodiments of the present disclosure are not limited in terms of implementation of functional switching of electrode contacts.
In an embodiment of the present disclosure, the controller 30 is further configured to collect ECAP signals through a third contact of the plurality of contacts, the third contact being configured to sense ECAP signals emitted by nerve fibers of the body after the second contact emits the evoked pulse, and to communicate the same to the controller 30. In the length direction of the electrode lead 10, the distance between the first contact and/or the second contact and the third contact is 30% -80% of the distance between the two farthest contacts in the plurality of contacts. Here, the distance between the contacts may be defined as the distance between the midpoints of the contacts in the length direction of the electrode lead.
Preferably, the third contact is not located between the plurality of first contacts, the third contact is not located between the plurality of second contacts, and the third contact is not located between the first contact and the second contact. This can avoid the excessive influence of the stimulation pulses on the signal acquisition.
The electrical stimulation pulse may have a stimulation trail (also known as an artifact) after the pulse is emitted, and if a third contact is provided near the first contact and/or the second contact, the third contact will receive the ECAP signal shortly after the pulse is emitted. At this point, the stimulus wake has not disappeared, and the ECAP signal is likely to be affected by the stimulus wake, and is collected by the third contact together with the more serious noise, so that the controller cannot accurately determine the waveform of the ECAP signal from the waveforms obtained by the third contact. In this regard, the ECAP signal may be captured by the third contact after a certain time of transmission in the nerve fiber by keeping the third contact as far away from the first contact and/or the second contact as possible, thereby avoiding the effects of the stimulation trail. However, since the speed of transmitting the ECAP signal by the nerve fiber does not have good consistency, the ECAP signal acquired by the third contact may be distorted after a long time of transmission, and thus an accurate calculation basis may not be provided.
In view of the above, the inventor finds through experiments and researches that the distance between the first contact and/or the second contact and the third contact is 30% -80% of the distance between the two farthest contacts in the plurality of contacts, so that the degree of influence of the stimulation trail on the ECAP signal and the distortion degree of the ECAP signal in transmission can be balanced well, more effective ECAP signals are collected, and the accuracy of electric stimulation adjustment is improved.
For example, in the embodiment shown in fig. 4, the plurality of contacts 11 of the electrode lead 10 may specifically include 8 contacts 11a to 11h of the same size, which are equally spaced apart. The controller 30 may have the contacts 11a and 11b as first contacts and the contact 11f as a third contact. As shown, the distance between the two contacts (11 a and 11 h) farthest apart from each other among the plurality of contacts is D, and the distance between the first contact 11b and the third contact 11f is D, where D/d=4/7 (about 57.14%).
For another example, in the embodiment shown in fig. 5, the plurality of contacts 11 of the electrode lead 10 may specifically include 8 contact groups equally spaced in the length direction of the electrode lead 10, each contact group including 3 contacts spaced in the circumferential direction of the electrode lead 10, and thus the plurality of contacts 11 include 11a1、11a2、11a3、11b1、11b2、11b3、11c1、11c2、11c3、11c1、11c2、11c3、11d1、11d2、11d3、11e1、11e2、11e3、11f1、11f2、11f3、11g1、11g2、11g3、11h1、11h2 and 11h3, 24 contacts in total. At this time, the controller 30 may use the contacts 11a1 and 11a2 as the first contacts, the contacts 11b1 and 11b2 as the second contacts, and the contact 11f3 as the third contact. As shown in the drawing, the distance between the two farthest contacts (11 a1 and 11h 1) among the plurality of contacts in the length direction of the electrode lead 10 is D, the distance between the first contact 11a1 or 11a2 and the third contact 11f3 is D1, where D1/d=5/7 (about 71.43%), and the distance between the second contact 11b1 or 11b2 and the third contact 11f3 is D2, where D2/d=4/7 (about 57.14%).
In this embodiment, it is ensured that the first contact and/or the second contact is/are spaced apart from the third contact, i.e. the ECAP signal is acquired at a position remote from the position at which the therapeutic pulse and/or the evoked pulse is/are emitted. Based on the design, the degree of influence of the wake of the stimulation pulse on the ECAP signal and the distortion degree of the ECAP signal in long-distance transmission can be well balanced, so that more effective ECAP signals are collected, and the accuracy of electric stimulation adjustment is improved.
Fig. 6 is a flow chart illustrating an implantable electrical stimulation method according to an embodiment of the disclosure. As shown in FIG. 6, the implantable electrical stimulation method comprises the following steps S610 to S640.
S610: a therapeutic pulse is emitted to the body based on the first stimulation parameter value and an induction pulse is emitted to the body, wherein the induction pulse is used to cause the body to be induced with an ECAP signal corresponding to the first stimulation parameter value.
S620: and judging whether the current posture of the machine body is matched with the preset posture according to the posture information of the machine body.
If yes, then execute S630; if not, S640 is performed.
S630: and sending out treatment pulses to the body based on the second stimulation parameter value, wherein the second stimulation parameter value is a stimulation parameter value corresponding to the preset posture.
S640: the first stimulation parameter value is adjusted according to the ECAP signal to obtain a third stimulation parameter value, and a therapeutic pulse is emitted to the body based on the third stimulation parameter value.
According to the implantable electrical stimulation method provided by the disclosure, the current posture of the body can be confirmed, and the current suitable stimulation parameter value of the body can be determined in different modes by judging whether the posture is a preset posture calibrated in advance or not: directly adopting a corresponding second stimulation parameter value under a preset gesture; and in other postures, a third stimulation parameter value calculated according to ECAP signals fed back by the organism is adopted. Therefore, the implantable electrical stimulation method provided by the disclosure can adaptively adjust the stimulation parameter value when the organism changes the posture, so that the organism feel uncomfortable; furthermore, the implantable electrical stimulation system can realize reduction of battery consumption based on a flexible parameter adjustment mode, so that the problems of inconvenience and battery life caused by frequent charging are avoided.
Fig. 7 is a flow chart illustrating an implantable electrical stimulation method according to another embodiment of the present disclosure. As shown in fig. 7, in this embodiment, the step S640 may include, based on the embodiment shown in fig. 6:
s645: the first stimulation parameter value is adjusted according to the deviation between the ECAP signal and the target ECAP to obtain a third stimulation parameter value, and therapeutic pulses are sent to the body based on the third stimulation parameter value.
Further, as shown in fig. 7, in an embodiment, the implantable electrical stimulation method may further include:
s650: when the current posture of the machine body is judged to be matched with the preset posture, comparing the second stimulation parameter value with the third stimulation parameter value, and judging whether the difference value between the second stimulation parameter value and the third stimulation parameter value meets the preset difference range or not;
If not, step S660 is performed.
S660: and correcting the target ECAP according to the second stimulation parameter value.
In one embodiment, the first stimulus parameter value is x1, the third stimulus parameter value is x2, the deviation is y, the second stimulus parameter value is x0, and the actual deviation between the ECAP signal and the modified target ECAP is y'.
At this time, as a specific implementation manner, the step S645 may include: calculating a third stimulation parameter value according to x2=x1-f (y), wherein f is a predetermined primary function, a plurality of functions or a multi-section function; the S660 may include: and calculating to obtain an actual deviation according to f -1 (x 1-x 0) =y', and calculating to obtain a corrected target ECAP according to the ECAP signal and the actual deviation.
In an embodiment, before the step S610, the implantable electrical stimulation method may further include:
Repeatedly adjusting the test stimulation parameter value, and sending treatment pulses to the organism based on the test stimulation parameter value after each change to obtain a test ECAP signal corresponding to each treatment pulse;
according to the feedback of the organism, confirming a plurality of treatment pulses which make the organism feel comfortable;
Determining a numerical range formed by the characteristic value difference values of the test ECAP signals corresponding to the multiple treatment pulses as a target ECAP range;
The middle value of the target ECAP range is set as the target ECAP.
In an embodiment, before the step S610, the implantable electrical stimulation method may further include:
When the body is in a preset posture, repeatedly adjusting the test stimulation parameter value, and sending a treatment pulse to the body based on the test stimulation parameter value after each change;
according to the feedback of the organism, confirming a plurality of treatment pulses which make the organism feel comfortable;
And determining a second stimulation parameter value according to the test stimulation parameter values corresponding to the multiple treatment pulses.
In one embodiment, the therapeutic pulses and the evoked pulses are delivered to the body by an electrode lead implanted in the body, such as electrode lead 10 shown in fig. 1. The electrode lead 10 may include a plurality of contacts 11, at least two first contacts of the plurality of contacts 11 for delivering therapeutic pulses to the body, and at least two second contacts of the plurality of contacts 11 for delivering evoked pulses to the body.
Here, the electrode leads may be the electrode leads 10 shown in fig. 1, 6 or 5, and other types of electrode leads may be used, which are not limited by the embodiments of the present disclosure.
In an embodiment, the implantable electrical stimulation method provided by the present disclosure may further include:
a particular contact of the plurality of contacts is defined as a first contact during a first time period and a particular contact is defined as a second contact during a second time period, wherein the first time period does not overlap the second time period.
It should be understood that the implantable electrical stimulation method provided in the above embodiment of the present disclosure may be performed by the controller 30 in the implantable electrical stimulation system shown in fig. 1 of the present disclosure, or may be performed by a module having a processing function in another type of implantable electrical stimulation system, which is not limited in this disclosure.
The definition, action, function, technical effect that can be achieved, and technical problems that can be solved, etc. of each element involved in the implantable electrical stimulation method provided in the foregoing embodiments of the present disclosure may refer to the corresponding content described in the foregoing embodiments of the implantable electrical stimulation system of the present disclosure, and in order to avoid repetition, the description is omitted herein.
Fig. 8 is an implantable electro-stimulation device 800 provided in an embodiment of the present disclosure, comprising: a controller 810, and a storage medium 820, wherein the storage medium 820 stores therein a program which, when executed by the controller 810, causes the controller 810 to perform the implantable electrical stimulation method provided by the above-described embodiments.
Embodiments of the present disclosure also provide a storage medium in which a program is stored, which when executed by a processor causes the processor to perform the implantable electrical stimulation method provided by the above embodiments.
It should be understood that the term "include" and variations thereof as used in this disclosure are intended to be open-ended, i.e., including, but not limited to. The term "one embodiment" means "at least one embodiment," and the term "another embodiment" means "at least one other embodiment.
The specific features (elements) described in the foregoing embodiments may be combined in any suitable manner, and in order to avoid unnecessary repetition, the disclosure does not further describe various possible combinations.
Those of ordinary skill in the art will appreciate that the elements or modules of the examples described in connection with the embodiments disclosed herein may be implemented as electronic hardware, or as a combination of computer software and electronic hardware. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the solution. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present disclosure.
In the several embodiments provided in the present disclosure, it should be understood that the disclosed systems and apparatuses may be implemented in other ways. For example, the apparatus embodiments described above are merely illustrative, and the division of the units or modules is merely a logical function division, and there may be additional divisions when actually implemented, for example, multiple units or modules may be combined or integrated into another system, or some features may be omitted or not performed. Alternatively, the coupling or direct coupling or communication connection shown or discussed with each other may be through some interfaces, units or modules, or may be in electrical or other forms.
In addition, each functional unit or module in the embodiments of the present disclosure may be integrated in one processing unit or module, or each unit or module may exist alone physically, or two or more units or modules may be integrated in one unit or module.
The foregoing is merely a specific embodiment of the disclosure, but the protection scope of the disclosure is not limited thereto, and any person skilled in the art will recognize that changes and substitutions are within the technical scope of the disclosure. Therefore, the protection scope of the present disclosure shall be subject to the protection scope of the claims.

Claims (20)

1. An implantable electrical stimulation system, comprising:
an electrode lead for delivering therapeutic pulses and evoked pulses to the body;
The sensor is used for acquiring the posture information of the machine body; and
A controller connected to the electrode leads and the sensor,
Wherein the controller is configured to:
issuing the therapeutic pulse to the body based on a first stimulation parameter value through the electrode lead and the evoked pulse to the body, wherein the evoked pulse is used to cause the body to be evoked an Evoked Compound Action Potential (ECAP) signal corresponding to the first stimulation parameter value;
Judging whether the current gesture of the machine body is matched with a preset gesture according to the gesture information;
If yes, sending the treatment pulse to the organism based on a second stimulation parameter value through the electrode lead, wherein the second stimulation parameter value is a stimulation parameter value corresponding to the preset gesture;
if not, the therapeutic pulse is sent to the organism through the electrode lead based on a third stimulation parameter value, wherein the third stimulation parameter value is obtained by the controller according to the ECAP signal to adjust the first stimulation parameter value.
2. The implantable electrical stimulation system of claim 1, wherein the controller adjusts the first stimulation parameter value to obtain the third stimulation parameter value in accordance with the ECAP signal, comprising:
And adjusting the first stimulation parameter value according to the deviation between the ECAP signal and the target ECAP so as to obtain the third stimulation parameter value.
3. The implantable electrical stimulation system of claim 2, wherein the controller is further configured to:
when the current posture of the machine body is judged to be matched with the preset posture, comparing the second stimulation parameter value with the third stimulation parameter value, and judging whether the difference value between the second stimulation parameter value and the third stimulation parameter value meets a preset difference range or not;
and if not, correcting the target ECAP according to the second stimulation parameter value.
4. The implantable electrical stimulation system of claim 3, wherein the first stimulation parameter value is x1, the third stimulation parameter value is x2, the deviation is y, the second stimulation parameter value is x0, the actual deviation between the ECAP signal and the modified target ECAP is y', wherein,
The controller adjusts the first stimulation parameter value according to a deviation between the ECAP signal and a target ECAP to obtain the third stimulation parameter value, comprising: calculating the third stimulation parameter value according to x2=x1-f (y), wherein f is a predetermined one-time function, a plurality of functions or a multi-segment function,
The controller corrects the target ECAP according to the second stimulation parameter value, including: and calculating to obtain the actual deviation according to f -1 (x 1-x 0) =y', and calculating to obtain the corrected target ECAP according to the ECAP signal and the actual deviation.
5. The implantable electrical stimulation system of claim 2, wherein the controller is further configured to pre-determine the target ECAP, the process comprising:
Repeatedly adjusting the test stimulation parameter value, and sending treatment pulses to the organism based on the test stimulation parameter value after each change to obtain a test ECAP signal corresponding to each treatment pulse;
confirming a plurality of therapeutic pulses that make the body feel comfortable based on the feedback of the body;
Determining a numerical range formed by the characteristic value differences of the test ECAP signals corresponding to the multiple treatment pulses as a target ECAP range;
and setting the intermediate value of the target ECAP range as the target ECAP.
6. The implantable electrical stimulation system of claim 1, wherein the controller is further configured to predetermine the second stimulation parameter value, the process comprising:
Repeatedly adjusting the test stimulation parameter value when the machine body is in the preset posture, and sending a treatment pulse to the machine body based on the test stimulation parameter value after each change;
confirming a plurality of therapeutic pulses that make the body feel comfortable based on the feedback of the body;
And determining the second stimulation parameter value according to the test stimulation parameter value corresponding to the multiple treatment pulses.
7. The implantable electrical stimulation system of claim 1, wherein the implantable electrical stimulation device comprises,
The electrode lead is adapted to be placed within a spinal canal of the body to contact spinal nerves of the body, the electrode lead further adapted to collect the ECAP signal;
The sensor is adapted to be fixedly arranged under the skin of the body.
8. The implantable electrical stimulation system of claim 1, wherein:
The electrode lead includes a plurality of contacts,
The controller is configured to send the therapeutic pulse to the body through at least two first contacts of the plurality of contacts and to send the evoked pulse to the body through at least two second contacts of the plurality of contacts.
9. The implantable electrical stimulation system of claim 8, wherein the controller is further configured to:
Defining a specific contact of the plurality of contacts as the first contact during a first time period and defining the specific contact as the second contact during a second time period, wherein the first time period and the second time period do not overlap.
10. The implantable electrical stimulation system of claim 8, wherein:
The controller is further configured to collect the ECAP signal through a third contact of the plurality of contacts,
And in the length direction of the electrode lead, the distance between the first contact and/or the second contact and the third contact is 30% -80% of the distance between two farthest contacts in the plurality of contacts.
11. An implantable electrical stimulation method, comprising:
Delivering a therapeutic pulse to a body based on a first stimulation parameter value and delivering an evoked pulse to the body, wherein the evoked pulse is used to cause the body to be evoked an Evoked Compound Action Potential (ECAP) signal corresponding to the first stimulation parameter value;
Judging whether the current posture of the machine body is matched with a preset posture according to the posture information of the machine body;
If yes, sending the treatment pulse to the organism based on a second stimulation parameter value, wherein the second stimulation parameter value is a stimulation parameter value corresponding to the preset gesture;
If not, the first stimulation parameter value is adjusted according to the ECAP signal to obtain a third stimulation parameter value, and the treatment pulse is sent to the organism based on the third stimulation parameter value.
12. The method of implantable electrical stimulation according to claim 11, wherein said adjusting the first stimulation parameter value according to the ECAP signal to obtain a third stimulation parameter value comprises:
And adjusting the first stimulation parameter value according to the deviation between the ECAP signal and the target ECAP so as to obtain the third stimulation parameter value.
13. The implantable electrical stimulation method of claim 12, further comprising:
when the current posture of the machine body is judged to be matched with the preset posture, comparing the second stimulation parameter value with the third stimulation parameter value, and judging whether the difference value between the second stimulation parameter value and the third stimulation parameter value meets a preset difference range or not;
and if not, correcting the target ECAP according to the second stimulation parameter value.
14. The implantable electrical stimulation method of claim 13 wherein the first stimulation parameter value is x1, the third stimulation parameter value is x2, the deviation is y, the second stimulation parameter value is x0, the actual deviation between the ECAP signal and the modified target ECAP is y', wherein,
The adjusting the first stimulation parameter value according to the deviation between the ECAP signal and the target ECAP to obtain the third stimulation parameter value comprises: calculating the third stimulation parameter value according to x2=x1-f (y), wherein f is a predetermined one-time function, a plurality of functions or a multi-segment function,
Said modifying said target ECAP according to said second stimulation parameter value, comprising: and calculating to obtain the actual deviation according to f -1 (x 1-x 0) =y', and calculating to obtain the corrected target ECAP according to the ECAP signal and the actual deviation.
15. The method of implantable electrical stimulation according to claim 12, wherein prior to the delivering therapeutic pulses to the body based on the first stimulation parameter values, further comprising:
Repeatedly adjusting the test stimulation parameter value, and sending treatment pulses to the organism based on the test stimulation parameter value after each change to obtain a test ECAP signal corresponding to each treatment pulse;
confirming a plurality of therapeutic pulses that make the body feel comfortable based on the feedback of the body;
Determining a numerical range formed by the characteristic value differences of the test ECAP signals corresponding to the multiple treatment pulses as a target ECAP range;
and setting the intermediate value of the target ECAP range as the target ECAP.
16. The method of implantable electrical stimulation according to claim 11, wherein prior to the delivering therapeutic pulses to the body based on the first stimulation parameter values, further comprising:
Repeatedly adjusting the test stimulation parameter value when the machine body is in the preset posture, and sending a treatment pulse to the machine body based on the test stimulation parameter value after each change;
confirming a plurality of therapeutic pulses that make the body feel comfortable based on the feedback of the body;
And determining the second stimulation parameter value according to the test stimulation parameter value corresponding to the multiple treatment pulses.
17. The implantable electrical stimulation method of claim 11, wherein the therapeutic pulse and the evoked pulse are delivered to the body by an electrode lead implanted within the body, the electrode lead including a plurality of contacts, at least two first contacts of the plurality of contacts being used to deliver the therapeutic pulse to the body, at least two second contacts of the plurality of contacts being used to deliver the evoked pulse to the body.
18. The implantable electrical stimulation method of claim 17, further comprising:
Defining a specific contact of the plurality of contacts as the first contact during a first time period and defining the specific contact as the second contact during a second time period, wherein the first time period and the second time period do not overlap.
19. An implantable electrical stimulation device, comprising:
A controller, and
A storage medium, wherein the storage medium has a program stored therein, which when executed by the controller causes the controller to perform the implantable electrical stimulation method of any one of claims 11-18.
20. A storage medium having a program stored therein, which when executed by a processor causes the processor to perform the implantable electrical stimulation method of any one of claims 11-18.
CN202410649484.6A 2024-05-24 2024-05-24 Implantable electrical stimulation systems, methods, devices, and storage media Pending CN118217535A (en)

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