Spinal cord stimulation pulse generator and spinal cord stimulation system

Abstract

This invention discloses a spinal cord stimulation pulse generator and a spinal cord stimulation system. The spinal cord stimulation pulse generator receives user information sent by a programmable device to obtain the target user's ECAP guidance range and target ECAP amplitude E. T The system acquires ECAP signals via stimulation electrodes. Based on whether the ECAP amplitude of the current cycle or the weighted ECAP amplitude of multiple adjacent cycles exceeds the range, a control algorithm is executed to determine the stimulation parameters for the next cycle, ultimately stabilizing the ECAP amplitude at the target ECAP amplitude within the ECAP guidance range. T This allows for dynamic and precise stimulation adjustment, enhancing the stability of spinal cord electrical stimulation.

Description

Technical Field

[0001] This invention relates to the field of implantable active medical devices, and more particularly to a spinal cord stimulation pulse generator and a spinal cord stimulation system. Background Technology

[0002] Spinal cord stimulation (SCS) is an important clinical approach for treating chronic pain. It relieves pain by transmitting electrical impulses to the spinal cord to interfere with the transmission of pain signals. This technique has significant value in the management of treatment-resistant neuropathic pain.

[0003] Most existing technologies employ open-loop stimulation, which involves pre-setting fixed stimulation parameters and continuously outputting them. However, open-loop systems struggle to adapt to changes in the distance between the electrodes and the spinal cord caused by changes in patient position. This can easily lead to insufficient or excessive stimulation, thereby affecting the stability of therapeutic effects and making it difficult to achieve dynamic and precise stimulation adjustment. Summary of the Invention

[0004] In view of this, the purpose of this invention is to provide a spinal cord stimulation pulse generator and a spinal cord stimulation system that can achieve dynamic and precise stimulation adjustment and improve the stability of spinal cord electrical stimulation.

[0005] In a first aspect, embodiments of the present invention provide a spinal cord stimulation pulse generator, the pulse generator comprising: a communication unit, an output unit, a data acquisition unit, and a control unit; The pulse generator is electrically connected to the stimulation electrode and communicatively connected to the programmable control equipment. The communication unit is used to receive user information sent by the programmable device; The output unit is used to output stimulation pulses based on the stimulation parameters of the current period; The acquisition unit is used to acquire ECAP signals through stimulation electrodes; The control unit is used to determine the stimulation parameters for the next cycle based on the ECAP amplitude of the current cycle or the weighted ECAP amplitude of multiple adjacent cycles and user information.

[0006] In some embodiments, the weighted ECAP amplitude of the plurality of neighboring periods is a weighted average of the ECAP amplitudes of the plurality of neighboring periods, the plurality of neighboring periods including the current period and the previous 1-5 periods.

[0007] In some embodiments, the user information includes the target user's ECAP pilot range and the target ECAP amplitude E. T .

[0008] In some embodiments, the target ECAP amplitude ,in, This is the upper threshold of the ECAP guidance range. P is the lower limit threshold of the ECAP guidance range, and P is the target ECAP amplitude. Quantiles in the ECAP guiding interval.

[0009] In some embodiments, the control unit determines the stimulation parameters for the next cycle based on the ECAP amplitude of the current cycle or the weighted ECAP amplitude of multiple adjacent cycles and user information, including the following steps: Step S141: Receive the ECAP signal acquired by the acquisition unit and obtain the ECAP amplitude E of the current period. N Or further calculate the weighted ECAP amplitude E of multiple adjacent periods. N '; Step S142: Determine the ECAP amplitude E of the current period. N Or the weighted ECAP amplitude E of the multiple adjacent periods N 'Whether it is within the ECAP guidance range. If the determination is true, then execute step S143; otherwise, execute step S144.' Step S143: Determine that the stimulation parameters for the next cycle remain unchanged; Step S144: Based on the target ECAP amplitude E T The stimulation parameters are adjusted using a PID control algorithm until the ECAP amplitude matches the target ECAP amplitude E. T The difference is less than the error threshold.

[0010] In some embodiments, the target ECAP amplitude E T The stimulation parameters are adjusted using a PID control algorithm until the ECAP amplitude matches the target ECAP amplitude. T If the absolute value of the difference is less than the error threshold, the following steps are included: Step S1441: Based on the ECAP amplitude E of the current period N Or the weighted ECAP amplitude of multiple adjacent periods E N 'With the target ECAP amplitude E T Calculate the current error e(t); Step S1442: Determine whether the absolute value of the current error e(t) is less than the error threshold. If the determination is true, proceed to step S1443; otherwise, proceed to step S1444. Step S1443: Keep the current stimulation parameters and return to step S141; Step S1444: Based on the current error e(t), execute the PID control algorithm to calculate the amplitude of the stimulation current in the next cycle; Step S1445: When the timing reaches the next cycle, receive the ECAP signal acquired by the acquisition unit and obtain the ECAP amplitude E of the current cycle. N Or further calculate the weighted ECAP amplitude E of multiple adjacent periods. N ', return to step S1441.

[0011] In some embodiments, the proportional coefficient of the PID control algorithm Determined based on user sensitivity D, =1 / D×A+B, where A is a preset coefficient, representing the appropriate proportion coefficient for standard users with a sensitivity of 1, and B is a preset constant.

[0012] In some embodiments, the pulse generator incorporates a pose sensor for recognizing user posture.

[0013] In some embodiments, the control unit can select the user sensitivity D corresponding to the user's posture.

[0014] In a second aspect, embodiments of the present invention provide a spinal cord stimulation system, the system comprising: stimulation electrodes, a programmable device, and a pulse generator as described in the first aspect.

[0015] The spinal cord stimulation pulse generator of this invention obtains the target user's ECAP guidance interval and target ECAP amplitude E by receiving user information sent by a programmable device. T The system acquires ECAP signals via stimulation electrodes. Based on whether the ECAP amplitude of the current cycle or the weighted ECAP amplitude of multiple adjacent cycles exceeds the range, a PID control algorithm is executed to determine the stimulation parameters for the next cycle, ultimately stabilizing the ECAP amplitude within the target ECAP amplitude E within the ECAP guide range. T This allows for dynamic and precise stimulation adjustment, enhancing the stability of spinal cord electrical stimulation. Attached Figure Description

[0016] The above and other objects, features and advantages of the present invention will become clearer from the following description of embodiments of the invention with reference to the accompanying drawings, in which: Figure 1 This is a schematic diagram of the spinal cord stimulation system according to an embodiment of the present invention; Figure 2 This is a schematic diagram of a spinal cord stimulation pulse generator according to an embodiment of the present invention; Figure 3 This is a flowchart illustrating the adjustment of stimulation parameters by the control unit in an embodiment of the present invention; Figure 4 This is a flowchart illustrating how the control unit in an embodiment of the present invention adjusts stimulation parameters using a PID control algorithm. Detailed Implementation

[0017] The present application will be described below based on embodiments, but the present application is not limited to these embodiments. In the detailed description of the present application below, certain specific details are described in detail. Those skilled in the art will fully understand the present application even without these detailed descriptions. To avoid obscuring the essence of the present application, well-known methods, processes, flows, elements, and circuits are not described in detail.

[0018] Furthermore, those skilled in the art should understand that the accompanying drawings provided herein are for illustrative purposes only and are not necessarily drawn to scale.

[0019] At the same time, it should be understood that in the following description, unless the context explicitly requires it, words such as "including" or "contains" throughout the application should be interpreted as including rather than exclusive or exhaustive; that is, meaning "including but not limited to".

[0020] In the description of this application, it should be understood that the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance. Furthermore, in the description of this application, unless otherwise stated, "a plurality of" means two or more.

[0021] The solutions described in this specification and embodiments, if involving the processing of personal information, will be processed only on the premise of having a legal basis (such as obtaining the consent of the personal information subject, or being necessary for the performance of a contract), and will only be processed within the scope stipulated or agreed upon. A user's refusal to process personal information beyond what is necessary for basic functions will not affect the user's use of basic functions.

[0022] Spinal cord stimulation (SCS), as a non-pharmacological and reversible neuromodulation therapy, has been widely used to treat various refractory chronic pain syndromes. SCS involves implanting electrodes to apply weak electrical pulses to the spinal cord nerves, blocking the transmission of pain signals to the brain or remodeling neural conduction circuits to restore function. For example, electrodes implanted in the epidural space of the spinal cord can inhibit pain signals or promote nerve regeneration by modulating neuronal activity. Currently, most clinically used SCS systems still employ open-loop stimulation, meaning that fixed stimulation parameters (such as amplitude, pulse width, and frequency) are pre-set and remain unchanged long-term after implantation unless manually adjusted by the patient using an external programming device.

[0023] The pain suppression effect in patients is closely related to the intensity of SCS stimulation, which is affected by the stimulation amplitude and the relative position of the electrode and the spinal cord. The relative position of the electrode and the spinal cord is further constrained by the patient's current posture. In traditional open-loop stimulation, with the stimulation amplitude remaining constant, the patient's pain suppression effect is unstable due to changes in the relative position of the electrode and spinal cord caused by the patient's daily activities. This can lead to overstimulation or understimulation during postural adjustments or short-term strenuous exercise (coughing, sneezing, etc.).

[0024] Therefore, embodiments of the present invention provide a spinal cord stimulation pulse generator and a spinal cord stimulation system to achieve dynamic and precise stimulation regulation and improve the stability of spinal cord electrical stimulation.

[0025] Specifically, Figure 1 This is a schematic diagram of the spinal cord stimulation system according to an embodiment of the present invention. Figure 1 As shown, the spinal cord stimulation system of this embodiment includes a pulse generator 1 and a stimulation electrode 2.

[0026] In some embodiments, the pulse generator 1 can be implanted in a suitable location on the target user's body. The pulse generator 1 is used to output stimulation pulses. The stimulation electrode 2 is implanted into the spinal cord segment corresponding to the target user's pain signal and is electrically connected to the pulse generator 1 to receive the output of the pulse generator 1 and then release electrical pulses to stimulate specific spinal cord nerve fibers.

[0027] Furthermore, the electrical pulses released by stimulating electrode 2 activate nerve fiber clusters near the electrode, causing them to generate action potentials. Simultaneously, after releasing the electrical pulses, stimulating electrode 2 switches to detection mode, recording the minute electrical signals generated after the nerve fiber clusters are activated, thus obtaining the ECAP (Evolved Compound Action Potential) signal. The recorded ECAP signal is immediately sent back to pulse generator 1 for analysis.

[0028] In some embodiments, the spinal cord stimulation system further includes a programming device 3, which is wirelessly connected to the pulse generator 1. The programming device 3 can be a general electronic device such as a laptop, desktop computer, tablet computer, or mobile phone, or a dedicated electronic device such as a patient programmer or a clinician programmer.

[0029] The wireless connection between the pulse generator 1 and the programmable device 3 can be achieved based on various wireless communication methods, such as RFID (Radio Frequency Identification), NFC (Near Field Communication), Bluetooth, Wi-Fi, Zigbee, etc.

[0030] The programmer (patient, doctor, or other person) can send control commands to the pulse generator 1 through the programming device 3, such as commands to adjust stimulation parameters and on / off signals. At the same time, the pulse generator 1 can also report relevant information to the programming device 3, such as device information and collected physiological signals.

[0031] In traditional spinal cord stimulation, after the stimulation parameters are set by the programmable device 3, the pulse generator 1 outputs stimulation with fixed parameters, regardless of changes in the patient's physical condition. However, the pain suppression effect on the patient varies with changes in the electrode-spinal cord position relationship caused by the patient's daily activities, and is not stable. It may lead to overstimulation or understimulation during posture adjustments or short-term strenuous exercise (coughing, sneezing, etc.).

[0032] Therefore, this invention proposes to use closed-loop control technology to ensure the accuracy and personalization of the stimulation effect by adjusting the stimulation intensity in real time.

[0033] Specifically, Figure 2 This is a schematic diagram of a spinal cord stimulation pulse generator according to an embodiment of the present invention. Figure 2 As shown, the pulse generator 1 of this embodiment includes: a communication unit 11, an output unit 12, a data acquisition unit 13, and a control unit 14.

[0034] Among them, the communication unit 11 is used to receive user information sent by the program-controlled device 3; Output unit 12 is used to output stimulation pulses based on the stimulation parameters of the current period; Acquisition unit 13 is used to acquire ECAP signals through stimulation electrode 2; The control unit 14 is used to determine the stimulation parameters for the next cycle based on the ECAP amplitude of the current cycle or the weighted ECAP amplitude of multiple adjacent cycles and user information.

[0035] In this embodiment, the target user is a patient, and the user information includes the target user's ECAP guidance range and target ECAP amplitude E. T The ECAP guidance range is the ECAP amplitude range that the target user feels comfortable with.

[0036] Specifically, since different users perceive stimuli to varying degrees, it is necessary to determine the ECAP guidance range for the target user. The ECAP guidance range can be obtained through testing.

[0037] The testing process can be performed using an implanted pulse generator 1 or an external test pulse generator connected to an implanted stimulation electrode 2; the control process is identical in both cases. The following section uses the former as an example to illustrate the specific testing process for the ECAP guided region: First, the initial amplitude, frequency, and pulse width of the test stimulation pulse are sent to the pulse generator 1 via the programmable control device 3. The initial amplitude of the test stimulation pulse can be determined empirically and set within the range of 0.1~1.0mA. Based on the amplitude, frequency, and pulse width of the test stimulation pulse, the pulse generator 1 continuously releases electrical pulses through the stimulation electrode 2 to stimulate specific nerve fibers.

[0038] Simultaneously, pulse generator 1 controls stimulation electrode 2 to detect the ECAP signal and sends it to programmable device 3. Programmable device 3 displays the ECAP amplitude and ECAP waveform based on the ECAP signal returned by pulse generator 1. The ECAP waveform is a curve showing how ECAP changes over time. The ECAP amplitude is a quantitative indicator measured from the processed ECAP waveform, specifically the amplitude difference between the first trough and the second peak of the ECAP waveform.

[0039] Then, during the test, the stimulation system changes the amplitude of the stimulation pulse and records the ECAP amplitude under different user sensation states. Furthermore, the ECAP amplitude is correlated with the stimulation pulse amplitude. When changing the stimulation pulse amplitude, the system can manually modify the amplitude via the programmable control device 3, or it can automatically traverse the amplitude in a step-by-step manner by controlling the pulse generator 1. The different user sensation states include: initially feeling comfortable, good inhibition effect, and initially feeling excessive inhibition effect. Further, different user states may also include: perceiving stimulation, perceiving pain inhibition effect, perceiving uncomfortable stimulation intensity, and perceiving unbearable stimulation intensity.

[0040] Finally, based on the obtained state test records, the user's ECAP bootstrapping interval is calculated. In one embodiment, the lower limit threshold E of the ECAP bootstrapping interval is... L It is the ECAP amplitude at which the user "begins to feel comfortable" in the state test record, and the upper threshold E of the ECAP guidance range. H This is the ECAP amplitude at which the user "begins to feel excessive inhibition." This range makes the ECAP guidance range more focused on a more comfortable range for the user. In other embodiments, the lower limit threshold E of the ECAP guidance range can also be set. L Set to 2 / 3 of the ECAP amplitude corresponding to the initial "perceived stimulus intensity as unbearable", and set the upper threshold E of the ECAP guide zone. HSet to the ECAP amplitude corresponding to the initial perception of "uncomfortable stimulus intensity". This range makes the ECAP guidance range larger, focusing on the range acceptable to the user, and because the intensity perception is stronger, it is easier to provide accurate feedback in the test.

[0041] It should be noted that during the above testing phase, the pulse generator 1 does not use the closed-loop control method of the present invention embodiment, but adopts an open-loop method to control spinal cord electrical stimulation according to the test stimulation parameters at the current moment.

[0042] For the target ECAP amplitude E T The target ECAP amplitude can be set within the ECAP guidance range via programmable device 3. It can be a specific amplitude or indirectly represented by the quantile P. The quantile P ranges from 30% to 70%. For example, in the user information, the target ECAP amplitude E... T When the quantile P is set to 30%, it indicates that the target ECAP amplitude E T At the 30% mark of the ECAP guidance zone. Numerically, this is specifically reflected as:

[0043] Subsequently, pulse generator 1 obtains the lower limit threshold E of the ECAP guidance interval by receiving user information sent by programmable device 3. L and upper limit threshold E H and the target ECAP amplitude E T .

[0044] In this embodiment, the control unit 14 of the pulse generator adjusts the stimulation parameters according to a set cycle. In each cycle, the output unit 12 outputs stimulation pulses based on the stimulation parameters of the current cycle.

[0045] Furthermore, in response to the current cycle being the first cycle, the control unit 14 controls the output unit 12 to output stimulation pulses based on the initial stimulation parameters. The initial stimulation parameters can be a pre-set default value or an initial value received from the programmable control device 3. In response to the current cycle not being the first cycle, the control unit 14 controls the output unit 12 to output stimulation pulses based on the stimulation parameters calculated in the previous cycle.

[0046] In this embodiment, the pulse generator 1 controls the stimulation electrode 2 to release electrical pulses by periodically adjusting the stimulation parameters. Within each cycle, the control unit 14 determines the stimulation parameters for the next cycle based on the ECAP amplitude of the current cycle and user information. In other embodiments, the stimulation parameters for the next cycle can also be determined based on the weighted ECAP amplitudes of multiple adjacent cycles and user information. These multiple adjacent cycles include the current cycle and the previous 1-5 cycles. The weighted ECAP amplitude of the multiple adjacent cycles is obtained by calculating a weighted average of the multiple ECAP amplitudes of the multiple adjacent cycles.

[0047] In this embodiment, the control period can be preset according to the actual scenario, for example, set in the range of 10ms to 25ms. Only one stimulus is performed in one period, and one stimulus induces one ECAP waveform.

[0048] Specifically, Figure 3 This is a flowchart illustrating the adjustment of stimulation parameters by the control unit 14 in an embodiment of the present invention. Figure 3 As shown, the control unit 14 determines the stimulation parameters for the next cycle based on the ECAP amplitude of the current cycle or the weighted ECAP amplitude of multiple adjacent cycles and user information, including the following steps: Step S141: Receive the ECAP signal acquired by the acquisition unit 13 and obtain the ECAP amplitude E of the current period. N Alternatively, to eliminate acquisition noise, the weighted ECAP amplitude E of multiple adjacent periods can be further calculated. N '.

[0049] Step S142: Determine the ECAP amplitude E of the current period. N Or the weighted ECAP amplitude of multiple adjacent periods E N 'Whether it is within the ECAP guidance range.'

[0050] In this embodiment, the control unit 14 determines the ECAP amplitude E of the current period. N Whether it is within the ECAP guidance range, that is, detection ≤E N ≤ Whether it is valid or not.

[0051] if ≤E N ≤ Once established, proceed to step S143.

[0052] if ≤E N ≤ If not, proceed to step S144.

[0053] Alternatively, control unit 14 determines the weighted ECAP amplitude E of multiple adjacent periods. N 'Whether it is within the ECAP guidance range, that is, detection ≤E N '≤ Whether it is valid or not.

[0054] if ≤E N '≤ Once established, proceed to step S143.

[0055] if ≤E N '≤ If not, proceed to step S144.

[0056] Step S143: Determine that the stimulation parameters for the next cycle remain unchanged.

[0057] In this embodiment, if ≤E N ≤ or ≤E N '≤ This is true, meaning it responds to the ECAP amplitude E in the current period. N Or the weighted ECAP amplitude of multiple adjacent periods E N Within the ECAP guidance range, the stimulation parameters do not need to be changed.

[0058] Step S144: Based on the target ECAP amplitude E T The stimulation parameters are adjusted using a PID control algorithm until the ECAP amplitude matches the target ECAP amplitude. T The difference is less than the error threshold.

[0059] In this embodiment, if ≤E N ≤ or ≤E N '≤ This is not valid; that is, if the ECAP amplitude of the current period or the weighted ECAP amplitude of multiple adjacent periods is not within the ECAP guidance range, then the target ECAP amplitude E is used. T To achieve the target value, a PID closed-loop algorithm is used to adjust the stimulus parameters until the ECAP amplitude (which can be the ECAP amplitude of the current period or the weighted ECAP amplitude of multiple neighboring periods) approaches the target ECAP amplitude E. T The error threshold should not exceed 10μV, and can be set to 2μV, 5μV, or 10μV.

[0060] Specifically, Figure 4 This is a flowchart illustrating how the control unit 14 in this embodiment of the invention adjusts the stimulation parameters using a PID control algorithm. Figure 4 As shown, based on the target ECAP amplitude E T The stimulation parameters are adjusted using a PID control algorithm until the ECAP amplitude matches the target ECAP amplitude. T If the absolute value of the difference is less than the error threshold, the following steps are included: Step S1441: Based on the ECAP amplitude E of the current period N Or the weighted ECAP amplitude of multiple adjacent periods E N 'With the target ECAP amplitude E T Calculate the current error e(t).

[0061] Step S1442: Determine whether the absolute value of the current error e(t) is less than the error threshold. If the absolute value of the difference e(t) is less than the error threshold, then execute step S1443: Keep the current stimulus parameters and return to step S141; otherwise, execute step S1444.

[0062] Step S1444: Based on the current error e(t), execute the PID control algorithm to calculate the amplitude of the stimulation current in the next cycle.

[0063] In this embodiment, the specific formula of the PID control algorithm is as follows:

[0064] Wherein, the error e(t) includes the positive error. and negative error . For E N or E N 'with E T The difference, i.e. =E N -E T ,or, = E N '-E T ; For E T With E N or E N The difference between ', i.e. =E T -E N ,or, = E T -E N '. The preset first proportional coefficient, The first integral coefficient is preset. The first differential coefficient is preset; This is the preset second proportional coefficient. The second integral coefficient is preset. This is the preset second differential coefficient. That is, for E... N or E N When the range of ECAP amplitude is different, the proportional, integral and derivative control parameters can be set separately. If the change in current amplitude is the value of the stimulation current in the next cycle, then the stimulation current amplitude will be... It can be specifically expressed as = +△I(t), where, This represents the amplitude of the stimulation current in the current cycle.

[0065] Step S1445: When the timing reaches the next cycle, receive the ECAP signal collected by the acquisition unit 13 and obtain the ECAP amplitude E of the current cycle. N Return to step S1441. Alternatively, to eliminate acquisition noise, the weighted ECAP amplitude E of multiple adjacent periods can be further calculated. N Then return to step S1441.

[0066] Furthermore, in other embodiments of this application, the first scaling factor Second proportional coefficient It can be determined based on user sensitivity D, for example, =1 / D×A+B. Where A is a preset coefficient and B is a preset constant. This application uses the rate of change of the ECAP amplitude with the stimulus current amplitude as the user's sensitivity D in a certain posture. A higher sensitivity value indicates that the target user is more sensitive to the stimulus, and a lower sensitivity value indicates that the target user is less sensitive to the stimulus. Furthermore, the preset coefficient A specifically represents a suitable proportional coefficient for a standard user with a sensitivity of 1, preferably within the range of 30%–70%, and should not exceed 100%, otherwise, overshooting of the proportional control may occur, causing the perceived stimulus intensity to repeatedly jump between discomfort and excess.

[0067] In this embodiment, the sensitivity D can be sent to the pulse generator 1 by the programmable device 3 as one of the user information. Specifically, in the ECAP guidance interval test mentioned above, in addition to obtaining the ECAP guidance interval, the sensitivity D of the target user to spinal cord electrical stimulation can also be obtained.

[0068] Specifically, during the test, the user maintains a fixed posture (e.g., supine, sitting, standing), and the amplitude of the stimulation current is adjusted. The change in the ECAP amplitude during the change of the stimulation current amplitude is calculated, and the rate of change of the ECAP amplitude with the stimulation current amplitude is taken as the user's sensitivity in that posture. Furthermore, the average of the sensitivities across multiple postures can be used as the overall sensitivity of the target user to spinal cord stimulation.

[0069] In this embodiment, the pulse generator 1 has a built-in pose sensor that can identify the user's posture. Therefore, before step S1444, the process includes determining the current sensitivity. Specifically, the user's posture is identified based on the pose information from the pose sensor, and the control unit 14 selects the sensitivity corresponding to the user's posture. The postures include supine posture, sitting posture, and standing posture.

[0070] In other embodiments of this application, the pulse generator 1 does not have a built-in pose sensor and can use overall sensitivity.

[0071] Furthermore, the target ECAP amplitude E T When setting the quantile P within the ECAP guidance range, the range of values ​​for quantile P can be adjusted according to the sensitivity D. For users with higher sensitivity D, the range of values ​​for quantile P is relatively lower, for example, 30%-60%; for users with lower sensitivity D, the range of values ​​for quantile P is relatively higher, for example, 40%-70%.

[0072] Furthermore, in other embodiments of this application, after calculating the stimulation current amplitude for the next cycle in step S1444, the method further includes determining whether the calculated stimulation current amplitude is within a preset safe output range. If it is within the safe output range, the stimulation current amplitude is output in the next cycle. Otherwise, the stimulation current amplitude remains within the safe output range boundary. The safe output range boundary for the stimulation current amplitude is preset, or it can be determined based on the aforementioned ECAP guidance range test. For example, during the specific testing process of the aforementioned ECAP guidance range, if the ECAP amplitude is correlated and recorded with the stimulation pulse amplitude, then the stimulation current amplitude corresponding to the ECAP amplitude at the boundary of the ECAP guidance range during the test can be used as the safe output range.

[0073] This invention acquires the target user's ECAP guidance range, determines whether to execute PID control based on whether the ECAP signal exceeds the range, and stabilizes the ECAP signal within the target value of the ECAP guidance range through PID control. This enables dynamic and precise stimulation adjustment, improving the stability of spinal cord electrical stimulation.

[0074] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A spinal cord stimulation pulse generator, characterized in that, The pulse generator includes: a communication unit, an output unit, a data acquisition unit, and a control unit; The pulse generator is electrically connected to the stimulation electrode and communicatively connected to the programmable control equipment. The communication unit is used to receive user information sent by the programmable device; The output unit is used to output stimulation pulses based on the stimulation parameters of the current period; The acquisition unit is used to acquire ECAP signals through stimulation electrodes; The control unit is used to determine the stimulation parameters for the next cycle based on the ECAP amplitude of the current cycle or the weighted ECAP amplitude of multiple adjacent cycles and user information.

2. The pulse generator according to claim 1, characterized in that, The weighted ECAP amplitude of the multiple neighboring periods is the weighted average of the multiple ECAP amplitudes of the multiple neighboring periods, which includes the current period and the previous 1-5 periods.

3. The pulse generator according to claim 1, characterized in that, The user information includes the target user's ECAP guidance range and the target ECAP amplitude E. T .

4. The pulse generator according to claim 3, characterized in that, The target ECAP amplitude ,in, This is the upper threshold of the ECAP guidance range. P is the lower limit threshold of the ECAP guidance range, and P is the target ECAP amplitude. Quantiles in the ECAP guiding interval.

5. The pulse generator according to claim 3, characterized in that, The control unit determines the stimulation parameters for the next cycle based on the ECAP amplitude of the current cycle or the weighted ECAP amplitude of multiple adjacent cycles and user information, including the following steps: Step S141: Receive the ECAP signal acquired by the acquisition unit and obtain the ECAP amplitude E of the current period. N Or further calculate the weighted ECAP amplitude E of multiple adjacent periods. N '; Step S142: Determine the ECAP amplitude E of the current period. N Or the weighted ECAP amplitude E of the multiple adjacent periods N 'Whether it is within the ECAP guidance range. If the determination is true, then execute step S143; otherwise, execute step S144.' Step S143: Determine that the stimulation parameters for the next cycle remain unchanged; Step S144: Based on the target ECAP amplitude E T The stimulation parameters are adjusted using a PID control algorithm until the ECAP amplitude matches the target ECAP amplitude E. T The difference is less than the error threshold.

6. The pulse generator according to claim 5, characterized in that, The target ECAP amplitude E T The stimulation parameters are adjusted using a PID control algorithm until the ECAP amplitude matches the target ECAP amplitude. T If the absolute value of the difference is less than the error threshold, the following steps are included: Step S1441: Based on the ECAP amplitude E of the current period N Or the weighted ECAP amplitude of multiple adjacent periods E N 'With the target ECAP amplitude E T Calculate the current error e(t); Step S1442: Determine whether the absolute value of the current error e(t) is less than the error threshold. If the determination is true, proceed to step S1443; otherwise, proceed to step S1444. Step S1443: Keep the current stimulation parameters and return to step S141; Step S1444: Based on the current error e(t), execute the PID control algorithm to calculate the amplitude of the stimulation current in the next cycle; Step S1445: When the timing reaches the next cycle, receive the ECAP signal acquired by the acquisition unit and obtain the ECAP amplitude E of the current cycle. N Or further calculate the weighted ECAP amplitude E of multiple adjacent periods. N ', return to step S1441.

7. The pulse generator according to claim 6, characterized in that, The proportional coefficient of the PID control algorithm Determined based on user sensitivity D, =1 / D×A+B, where A is a preset coefficient, representing the appropriate proportion coefficient for standard users with a sensitivity of 1, and B is a preset constant.

8. The pulse generator according to claim 1 or 7, characterized in that, The pulse generator has a built-in pose sensor, which is used to identify the user's posture.

9. The pulse generator according to claim 8, characterized in that, The control unit can select the user sensitivity D corresponding to the user's posture based on the user's posture.

10. A spinal cord stimulation system, characterized in that, The system includes: a stimulation electrode, a programmable device, and a pulse generator according to any one of claims 1-9, wherein the stimulation electrode is electrically connected to the pulse generator, and the programmable device is communicatively connected to the pulse generator.

Images