Control system and method for electrical stimulation pulse of implantable pulse generator

Abstract

The invention belongs to the technical field of medical instruments, and discloses an electrical stimulation pulse control system and method of an implantable pulse generator, the system is composed of a control module, a pulse distribution module, a sensing module, a pulse analysis module and a man-machine interaction module, and the method is composed of two parts of comfort evaluation and electrical stimulation pulse adaptive adjustment. The stimulation pulse energy can be smoothly output in a gradually increasing mode according to the preset parameters, so that smooth distribution of the stimulation pulse is realized, the problem of discomfort of human tissues caused by sudden energy change in the stimulation pulse switching process is effectively solved, and meanwhile, the stimulation pulse energy can be smoothly output. According to the method, the actual operation condition of the current electrical stimulation pulse in the human tissue can be presented to a doctor in a graphic visualization mode through wireless transmission, more accurate data is provided for clinic, and the system can bring more comfortable experience to a patient while the cost is reduced.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a control system and method for electrical stimulation pulses of an implantable pulse generator. Background Art

[0002] The implantable neurostimulation system is a medical device, which consists of an implantable electrode wire and a pulse generator. The implantable electrode wire is provided with electrode contacts. When the electrode wire is connected to the pulse generator, the pulse generator can generate electric pulses between the electrode contacts. After the implantable electrode wire is implanted in the human body, the electrode contacts will come into contact with the biological tissue of the human body. At this time, the pulse generator will generate electric pulses through the electrode contacts, and the electric pulses can affect the nerve tissue around the electrode contacts. In the application of clinical pain medicine, this electric pulse can inhibit the conduction of nerve pain to the central nervous system, thereby playing a role in inhibiting pain.

[0003] In the clinical application of implantable neurostimulators, electrical pulses are required to stimulate nerve tissue at designated locations. The key question is how much energy of electrical pulse stimulation is most suitable for the patient. Due to differences in the human body, the effective treatment energy that each patient can accept is different. If the energy is too low, the treatment effect will be greatly reduced; if the energy is too high, it will not only cause discomfort to the patient, but may even cause harm to the patient. Therefore, the right energy selection is crucial for patients.

[0004] At present, in terms of improving patient comfort and determining the stimulation pulse energy that best suits the patient, the main existing method is to manually adjust the initial electrical stimulation pulse parameters, and then use some algorithms to automatically adjust the electrical stimulation pulses during the process of issuing electrical stimulation pulses, so as to achieve the purpose of improving patient comfort. For example, a method for controlling electrical stimulation pulses proposed in patent CN115350397A first converts the electrical stimulation pulse data into an analog signal, and then outputs it after timing control and amplitude amplification processing. At the same time, the output analog signal is collected and analyzed, and then the electrical stimulation pulse parameters are adjusted in real time based on the analysis. For example, the neural stimulation system proposed in patent CN116271527A: collects human body parameters through sensing components, analyzes the collected information, and then automatically optimizes and issues stimulation pulses based on the analyzed data.

[0005] However, there are certain defects in this method, which converts the electrical stimulation pulse data into analog signals, collects and analyzes them after processing and output, and adjusts the generated electrical stimulation pulses in real time. On the one hand, the pulse energy acts on the human body first, and then adjusts in real time. In this process, the pulse energy will continue to affect the human tissue. Due to the lack of energy transition stage, it is likely to cause discomfort symptoms to the patient. On the other hand, the energy of automatic adjustment is uncontrollable. When abnormal analysis occurs and there is no energy comfort zone protection mechanism, the abnormal electrical stimulation pulse may cause harm to the patient. The method of further optimizing the electrical stimulation pulse parameters and issuing stimulation in real time by collecting and analyzing human body parameters also has this defect. When determining the most suitable electrical stimulation pulse parameters for the patient, the doctor needs to repeatedly adjust the pulse parameters. From the perspective of patient comfort, each new electrical stimulation pulse directly acts on the human tissue and lacks an energy transition process, which reduces the patient's comfort to a certain extent. In terms of work efficiency and patient experience, repeatedly adjusting parameters will lead to reduced work efficiency and poor patient experience. Therefore, a control system and control method that can achieve smooth issuance of stimulation pulses are needed to solve this problem. Summary of the invention

[0006] The object of the present invention is to provide a control system and method for electrical stimulation pulses of an implantable pulse generator to solve the problems raised in the above-mentioned background technology.

[0007] In order to achieve the above-mentioned object, the present invention provides the following technical solutions: a control system and method for electrical stimulation pulses of an implantable pulse generator, the system comprising a control module, a pulse issuing module, a sensing module, a pulse analyzing module and a human-computer interaction module;

[0008] The control module is implemented using a single-chip microcomputer chip U1, and the U1 can realize all the functions of the control module, including communication with the human-computer interaction module, data processing of the pulse analysis module, data collection of the sensing module and pulse timing control of the pulse emission module; the pulse emission module is used to discharge the energy output by the energy source to the load in the form of current pulses; the sensing module collects the impedance value between human tissues in real time according to the instructions issued by the control module, and transmits the data to the pulse analysis module; the pulse analysis module analyzes the actual situation of the current electrical stimulation pulse acting on the human tissue through the pulse voltage estimation method; the human-computer interaction module is a tablet computer with visual operation, which processes the real-time operation status of the acquired electrical stimulation pulse and displays it to the doctor in a graphical visualization manner.

[0009] Preferably, the control module is the main control unit and is connected to the pulse issuing module, the sensing module, the pulse analyzing module and the human-computer interaction module;

[0010] The control module can control the pulse emission module to send electric pulse stimulation with specified parameters, the control module can control the sensing module to collect the impedance value of the current pulse acting on the human tissue part, the control module can obtain the actual situation of the current electric stimulation pulse acting on the human body from the pulse analysis module, the control module can obtain pulse control parameter information from the human-computer interaction module, and pass the data obtained from the pulse analysis module to the human-computer interaction module.

[0011] Preferably, the pulse emission module is composed of a DAC chip U2, a switch Key1, a resistor R1, a resistor R2, a resistor R3, a resistor R4, a resistor R5, an adjustable potentiometer RP and an operational amplifier;

[0012] The DAC chip U2 is mainly used to convert digital signals into analog signals of specified size, and serves as an energy source to provide energy for stimulation pulses. The constant current source circuit module composed of the resistor R1, the resistor R2, the resistor R3, the resistor R4, the adjustable potentiometer RP and the operational amplifier ensures that the energy output from the DAC chip U2 is output to human tissue in a constant current manner.

[0013] Preferably, the sensing module is composed of a switch Key2, a resistor R6, a diode and an operational amplifier;

[0014] The switch Key2 is used to control the sensing module to perform data collection. The resistor R6 and the operational amplifier form a voltage follower to ensure that the collected data is accurately transmitted to the pulse analysis module. The diode, using its unidirectional conductivity, clamps the voltage transmitted to the pulse analysis module so that it does not exceed the maximum input voltage of the analog-to-digital conversion chip inside the module, further ensuring the normal operation of the pulse analysis module.

[0015] Preferably, the pulse analysis module is composed of a resistor R7, a capacitor C1 and an ADC chip U3;

[0016] The resistor R7 and the capacitor C1 form a filter circuit for filtering the data transmitted by the sensing module to further improve the validity of the data. The ADC chip U3 is responsible for converting the filtered data into digital signals for subsequent software algorithm processing.

[0017] Preferably, the method consists of two parts: comfort evaluation and adaptive adjustment of electrical stimulation pulses, and the specific steps are:

[0018] Step 1: The doctor sets the comfort assessment parameters with the help of the human-computer interaction module, and lets the control module start the comfort assessment;

[0019] Step 2: Based on the patient's feedback, the doctor can use the human-computer interaction module to determine the comfort zone in the subsequent adaptive adjustment process of the electrical stimulation pulse. If the comfort zone is not calibrated, the doctor needs to reset the comfort assessment parameters and repeat the above process.

[0020] Step 3: After the comfort assessment is completed, the doctor can set the comfortable start and stop time through the human-computer interaction module. At the same time, the control module will display the comfort zone to the human-computer interaction module for the doctor to confirm;

[0021] Step 4: After the information is confirmed to be correct, the doctor can use the human-computer interaction module to start the electrical stimulation pulse;

[0022] Step 5: During the delivery of the electrical stimulation pulse, the control module combines the data transmitted by each module and automatically adjusts the electrical stimulation pulse in real time according to the principle of energy smooth transition to ensure that the electrical stimulation pulse is always within the comfortable range;

[0023] Step 6: When the pulse end time is finally reached, the stimulator automatically turns off the electrical stimulation pulse.

[0024] Preferably, during the control process of the method, as long as the electrical stimulation pulse is issued, the control module will control the sensing module to collect the impedance value of the tissue at the stimulation position of the patient, and pass the collected data to the pulse analysis module. After receiving the data, the pulse analysis module uses the pulse voltage estimation method to analyze the actual operation of the electrical stimulation pulse on the human tissue, and transmits the situation to the human-computer interaction module through the control module in real time for fitting, and further presents it to the doctor.

[0025] Preferably, the specific process of the comfort assessment is:

[0026] A1. The doctor uses the human-computer interaction module to set the comfort assessment parameters and transmits these data to the control module through wireless communication technology;

[0027] A2. After receiving the data, the control module processes the smooth transition time and target pulse parameters using a linear increasing algorithm, further determines the smooth delivery mode of the electrical stimulation pulse, and controls the pulse delivery module to deliver the electrical stimulation pulse;

[0028] A3. During the process of electrical stimulation pulse delivery, doctors can mark the minimum parameter point of the comfort zone based on the actual effect of the electrical stimulation pulse in human tissue displayed by the human-computer interaction module and the patient's response;

[0029] A4. After the minimum parameter point of the comfort zone is confirmed, the control module uses a linear increasing algorithm to process the second smooth transition time, the current operating pulse parameters and the target pulse parameters, parses out the smooth delivery method of the second electrical stimulation pulse, and controls the pulse delivery module to output the electrical stimulation pulse according to the new delivery method;

[0030] A5. Before the electrical stimulation pulse reaches the target pulse parameters, the doctor can mark the optimal stimulation parameters and comfort zone. After the comfort assessment is completed, the control module automatically stores the comfort zone.

[0031] Preferably, the specific process of the adaptive adjustment of the electrical stimulation pulse is:

[0032] B1. After completing the comfort assessment, the doctor sets the comfort start and stop time through the human-computer interaction module, and verifies and confirms the comfort interval and optimal stimulation parameter information. After confirmation, the doctor sends an instruction to start the electrical stimulation pulse to the control module;

[0033] B2. After receiving the instruction, the control module processes the comfortable start-stop time and target parameters using a linear increasing algorithm to confirm the next electrical stimulation pulse delivery method. At the same time, the control module controls the sensing module to collect the impedance value of the patient's stimulation site and starts the delivery of electrical stimulation pulses.

[0034] B3. During the process of electrical stimulation pulse delivery, the pulse analysis module uses the pulse voltage estimation method to analyze the actual effect of the current electrical stimulation pulse in the patient's body based on the impedance data transmitted in real time by the sensing module and the current delivery of the electrical stimulation pulse, and transmits it to the control module;

[0035] B4. After receiving the data, the control module determines whether the current electrical stimulation pulse is within the comfort zone. If it exceeds the comfort zone, the control module controls the pulse issuing module to smoothly adjust the electrical stimulation pulse in real time to keep it within the comfort zone at all times.

[0036] B5. If it is within the appropriate interval, keep the current pulse until the pulse time ends.

[0037] The beneficial effects of the present invention are as follows:

[0038] The present invention can smoothly output the stimulation pulse energy in a gradually increasing (decreasing) manner according to preset parameters, thereby achieving smooth delivery of stimulation pulses, effectively solving the problem of discomfort caused to human tissues due to sudden energy changes of stimulation pulses during switching. At the same time, the method can present the actual operation of the current electrical stimulation pulses in human tissues to doctors in a graphically visualized manner through wireless transmission, providing more accurate data for clinical use. The overall design concept is relatively simple, reducing the use of high-precision signal control electronic components, while reducing costs and providing patients with a more comfortable experience. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 The overall circuit diagram of the control system of the present invention;

[0040] Figure 2 This is a circuit diagram of the control module of the present invention;

[0041] Figure 3 This is a circuit diagram of a pulse emission module of the present invention;

[0042] Figure 4 This is a circuit diagram of the sensing module of the present invention;

[0043] Figure 5 This is a circuit diagram of a pulse analysis module of the present invention;

[0044] Figure 6 A flow chart of a control method for adjusting electrical stimulation pulses in real time using a smoothing method according to the present invention;

[0045] Figure 7 This is a flow chart of the comfort evaluation method of the present invention;

[0046] Figure 8 This is a schematic diagram of the operation of electrical stimulation pulses in the comfort evaluation process of the present invention;

[0047] Fig. 9 This is a flow chart of the method for adaptively adjusting the electrical stimulation pulse of the present invention;

[0048] Fig.10 It is a schematic diagram of a specific implementation process of the electric stimulation pulse adaptive adjustment when the electric stimulation pulse parameter exceeds the maximum value of the comfort zone of the present invention;

[0049] Fig.11 It is a schematic diagram of a specific implementation process of adaptively adjusting the electrical stimulation pulse when the electrical stimulation pulse parameter exceeds the minimum value of the comfort range according to the present invention. DETAILED DESCRIPTION

[0050] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0051] like Figures 1 to 11 As shown, an embodiment of the present invention provides a control system and method for electrical stimulation pulses of an implantable pulse generator, the system comprising a control module, a pulse issuing module, a sensing module, a pulse analyzing module and a human-computer interaction module;

[0052] The control module is implemented using a single-chip microcomputer chip U1, and the U1 can realize all the functions of the control module, including communication with the human-computer interaction module, data processing of the pulse analysis module, data collection of the sensing module and pulse timing control of the pulse emission module; the pulse emission module is used to discharge the energy output by the energy source to the load in the form of current pulses; the sensing module collects the impedance value between human tissues in real time according to the instructions issued by the control module, and transmits the data to the pulse analysis module; the pulse analysis module analyzes the actual situation of the current electrical stimulation pulse acting on the human tissue through the pulse voltage estimation method; the human-computer interaction module is a tablet computer with visual operation, which is responsible for transmitting information such as pulse parameters and smooth transition time, and processes the real-time operation status of the acquired electrical stimulation pulses and displays them to the doctor in a graphically visualized manner.

[0053] The control module adjusts the pulse energy through a linear increase / decrease algorithm, and realizes smooth output and adaptive adjustment of the electrical stimulation pulse based on the impedance data collected by the sensing module and the voltage estimation result of the pulse analysis module.

[0054] The control module is the main control unit and is connected to the pulse emission module, the sensing module, the pulse analysis module and the human-computer interaction module;

[0055] The control module can control the pulse emission module to send electric pulse stimulation with specified parameters, the control module can control the sensing module to collect the impedance value of the current pulse acting on the human tissue part, the control module can obtain the actual situation of the current electric stimulation pulse acting on the human body from the pulse analysis module, the control module can obtain information such as pulse control parameters from the human-computer interaction module, and pass the data obtained from the pulse analysis module to the human-computer interaction module.

[0056] Among them Figure 2 As shown, the control module adopts a single-chip microcomputer chip U1, which integrates the main computer components such as the central processing unit (CPU), random access memory (RAM), read-only memory (ROM), input / output interface (I / O interface) and timer / counter.

[0057] The pulse emission module is composed of a DAC chip U2, a switch Key1, a resistor R1, a resistor R2, a resistor R3, a resistor R4, a resistor R5, an adjustable potentiometer RP and an operational amplifier;

[0058] The DAC chip U2 is mainly used to convert digital signals into analog signals of specified size, and serves as an energy source to provide energy for stimulation pulses. The constant current source circuit module composed of the resistor R1, the resistor R2, the resistor R3, the resistor R4, the adjustable potentiometer RP and the operational amplifier ensures that the energy output from the DAC chip U2 is output to human tissue in a constant current manner.

[0059] Among them Figure 3 As shown, the pulse issuing module can select the electrode contact position of the electrical stimulation pulse and determine the electrode contact polarity, and the electrode contact polarity can be set to positive, negative and invalid. When the pulse is issued, the control module controls the pulse issuing module to issue an electrical stimulation pulse with a certain frequency and pulse to the load between the specified positive contact and the negative contact;

[0060] It should be noted that due to the limited output capacity of the DAC chip U2, when large current energy output is required, the output current value is further changed by changing the resistance of the adjustable potentiometer RP in the constant current source circuit module to complete the output of large current energy; and when the system detects an abnormality (such as a sudden decrease in impedance, possible electrode detachment), the input of the energy source can be interrupted at any time through the switch Key1; the resistor R5 represents the tissue at the human body stimulation position, and at the same time, before the current pulse energy acts on the human body load R5, the interface of the impedance value at the human body stimulation position is collected through the sensing module.

[0061] Wherein, the sensing module is composed of a switch Key2, a resistor R6, a diode and an operational amplifier;

[0062] The switch Key2 is used to control the sensing module to perform data collection. The resistor R6 and the operational amplifier form a voltage follower to ensure that the collected data is accurately transmitted to the pulse analysis module. The diode, using its unidirectional conductivity, clamps the voltage transmitted to the pulse analysis module so that it does not exceed the maximum input voltage of the analog-to-digital conversion chip inside the module, further ensuring the normal operation of the pulse analysis module.

[0063] Wherein, the pulse analysis module is composed of a resistor R7, a capacitor C1 and an ADC chip U3;

[0064] The resistor R7 and the capacitor C1 form a filter circuit for filtering the data transmitted by the sensing module to further improve the validity of the data. The ADC chip U3 is responsible for converting the filtered data into digital signals for subsequent software algorithm processing.

[0065] Among them Figure 5As shown, the pulse analysis module combines the data collected by the sensing module with the parameters of the electrical stimulation pulse currently being issued through the pulse voltage estimation method, analyzes the actual situation of the current electrical stimulation pulse acting on human tissue, and transmits the analyzed data to the human-computer interaction module through the control module for curve fitting.

[0066] The pulse emission module in the present application may be composed of components mainly based on analog switches that cooperate with each other, or may be composed of a dedicated pulse output chip.

[0067] The pulse analysis module in the present application may be composed of components mainly based on an analog-to-digital conversion chip in conjunction with a software algorithm, or may be composed of a dedicated voltage acquisition chip.

[0068] The method consists of two parts: comfort assessment and adaptive adjustment of electrical stimulation pulses, and the specific steps are as follows:

[0069] Step 1: The doctor sets the comfort assessment parameters with the help of the human-computer interaction module, and lets the control module start the comfort assessment;

[0070] Step 2: Based on the patient's feedback, the doctor can use the human-computer interaction module to determine the comfort zone in the subsequent adaptive adjustment process of the electrical stimulation pulse. If the comfort zone is not calibrated, the doctor needs to reset the comfort assessment parameters and repeat the above process.

[0071] This method of determining the comfort zone not only avoids the doctor's repeated parameter adjustments, but also improves the patient's comfort and experience.

[0072] Step 3: After the comfort assessment is completed, the doctor can set the comfortable start and stop time (used when the stimulation pulse changes the output energy during the adaptive adjustment process) through the human-computer interaction module. At the same time, the control module will display the comfort zone (where the optimal treatment parameter point is the initial target pulse parameter of the adaptively adjusted electrical stimulation pulse) to the human-computer interaction module for the doctor's confirmation;

[0073] Step 4: After the information is confirmed to be correct, the doctor can use the human-computer interaction module to start the electrical stimulation pulse;

[0074] Step 5: During the delivery of the electrical stimulation pulse, the control module combines the data transmitted by each module and automatically adjusts the electrical stimulation pulse in real time according to the principle of energy smooth transition to ensure that the electrical stimulation pulse is always within the comfortable range;

[0075] Step 6: When the pulse end time is finally reached, the stimulator automatically turns off the electrical stimulation pulse.

[0076] In the first part of the comfort assessment, this method uses relevant assessment techniques and analysis methods to comprehensively consider various influencing factors, and then accurately determine the stimulation parameter range that can achieve both therapeutic effects and patient comfort, providing a basic basis for the subsequent adaptive adjustment of electrical stimulation pulses. The second part is the adaptive adjustment part during the stimulation pulse release process. The control module strictly follows the principle of smooth transition of pulse energy according to the actual operation of the current electrical stimulation pulse analyzed by the pulse analysis module, and adaptively adjusts the electrical stimulation pulse to ensure that it is always within the comfort range. The purpose of this is to prevent potential harm to patients caused by abnormal energy and energy mutations, and to ensure the safety and comfort of patients when receiving electrical stimulation treatment.

[0077] Among them, during the control process of this method, as long as the electrical stimulation pulse is issued, the control module will control the sensing module to collect the impedance value of the tissue at the patient's stimulation position, and pass the collected data to the pulse analysis module. After receiving the data, the pulse analysis module uses the pulse voltage estimation method to analyze the actual operation of the electrical stimulation pulse on the human tissue, and transmits the situation to the human-computer interaction module through the control module in real time for fitting, and further presents it to the doctor.

[0078] The specific process of analysis using the pulse voltage estimation method is as follows: the pulse analysis module combines the received impedance data and the current pulse energy amplitude actually output by the current stimulator to calculate the voltage value generated by the current stimulation site. Since the impedance value of human tissue will change with changes in environmental factors and the current pulse output by the stimulator is fixed, the energy actually acting on the human body creates an uncontrollable risk. Using the voltage pulse estimation method, the voltage value of the stimulated tissue position can be analyzed to effectively illustrate the actual operation of the electrical stimulation pulse between human tissues.

[0079] The specific process of the comfort assessment is as follows:

[0080] A1. The doctor uses the human-computer interaction module to set comfort evaluation parameters such as target pulse parameters (maximum effective treatment pulse parameters commonly used by doctors in clinical experiments), energy smooth transition time 1 (determine the lowest point in the comfort zone) and energy smooth transition time 2 (determine the best stimulation parameter point and the highest point in the comfort zone), and transmits these data to the control module through wireless communication technology;

[0081] A2. After receiving the data, the control module processes the smooth transition time and target pulse parameters using a linear increasing algorithm, further determines the smooth delivery mode of the electrical stimulation pulse, and controls the pulse delivery module to deliver the electrical stimulation pulse;

[0082] The process of processing data using the linear increasing (decreasing) algorithm in this step is: calculating the difference between the energy currently released by the electrical stimulation pulse and the target energy, and determining whether the pulse energy output trend is increasing or decreasing. Then, the energy difference is evenly divided according to the smooth transition time to determine the pulse energy increasing (decreasing) value. Finally, the energy source is controlled to gradually increase (decrease) the pulse energy output at the specified time node to achieve the effect of smooth release of electrical stimulation pulses.

[0083] A3. During the process of electrical stimulation pulse delivery, the doctor can mark the minimum parameter point of the comfort zone (the stimulation parameter when the patient reacts) by combining the actual effect of the electrical stimulation pulse in human tissue displayed by the human-computer interaction module with the patient's reaction;

[0084] A4. After the minimum parameter point of the comfort zone is confirmed, the control module uses a linear increasing algorithm to process the second smooth transition time, the current operating pulse parameters and the target pulse parameters, parses out the smooth delivery method of the second electrical stimulation pulse, and controls the pulse delivery module to output the electrical stimulation pulse according to the new delivery method;

[0085] In order to determine more accurate optimal treatment stimulation parameters, the second smooth transition time is much longer than the smooth transition time, so that patients can feel the effects of the stimulation pulse more accurately and give doctors more effective feedback.

[0086] A5. Before the electrical stimulation pulse reaches the target pulse parameters, the doctor can mark the optimal stimulation parameters and the comfort zone. During the comfort assessment process, whether the comfort zone has been marked or the comfort zone has not been marked but the electrical stimulation pulse has reached the target parameters, the electrical stimulation pulse will stop being issued in both cases. After the comfort assessment is completed, the control module automatically stores the comfort zone to facilitate adaptive adjustment when the subsequent electrical stimulation pulses are issued.

[0087] like Figure 8As shown, at time t0, the comfort assessment is started, and the control module 100 processes the smooth transition time 1 and the target pulse parameters (effective treatment pulse parameters commonly used by doctors in clinical experiments) through a linear increasing algorithm, calculates the electrical stimulation pulse delivery mode, and controls the pulse delivery module 200 to start the electrical stimulation pulse. At time t1, the minimum parameter point of the comfort interval is marked in the pulse delivery schematic diagram. At this time, the control module 100 processes the smooth transition time 2, the current operating pulse parameters and the target pulse parameters through a linear increasing algorithm, and switches the electrical stimulation pulse delivery mode according to the calculation results. At time t2, the optimal stimulation parameter point is marked in the pulse delivery schematic diagram. At time t3, the maximum parameter point of the comfort interval is marked in the pulse schematic diagram. At this point, the comfort assessment is completed, the electrical stimulation pulse automatically stops being delivered, and the comfort interval and the optimal stimulation parameters are stored in the control module 100, so that the electrical stimulation pulses delivered subsequently can be adaptively adjusted.

[0088] The three points marked in the above process are marked in the order of minimum parameter point, optimal stimulation pulse parameter point and maximum parameter point. If the minimum parameter point of the comfort zone is not marked, the electrical stimulation pulse will continue to stimulate at time t1 in the same manner as the electrical stimulation pulse in the time period from t0 to t1, until time t4, when the target amplitude of the pulse energy is reached, and then the electrical stimulation pulse is terminated. If the optimal comfort point or maximum parameter point is not marked, the electrical stimulation pulse will continue to stimulate in the same manner as the electrical stimulation pulse in the time period from t1 to t2, until time t4, when the target amplitude of the pulse energy is reached, and then the electrical stimulation pulse is terminated.

[0089] The specific process of the adaptive adjustment of the electrical stimulation pulse is as follows:

[0090] B1. After completing the comfort assessment, the doctor sets the comfort start and stop time through the human-computer interaction module, and verifies and confirms the comfort interval and optimal stimulation parameters. After confirmation, the doctor sends a command to start the electrical stimulation pulse to the control module;

[0091] B2. After receiving the instruction, the control module processes the comfortable start-stop time and target parameters using a linear increasing algorithm to confirm the next electrical stimulation pulse delivery method. At the same time, the control module controls the sensing module to collect the impedance value of the patient's stimulation site and starts the delivery of electrical stimulation pulses.

[0092] B3. During the process of electrical stimulation pulse delivery, the pulse analysis module uses the pulse voltage estimation method to analyze the actual effect of the current electrical stimulation pulse in the patient's body based on the impedance data transmitted in real time by the sensing module and the current delivery of the electrical stimulation pulse, and transmits it to the control module;

[0093] B4. After receiving the data, the control module determines whether the current electrical stimulation pulse is within the comfort zone. If it exceeds the comfort zone, the control module controls the pulse issuing module to smoothly adjust the electrical stimulation pulse in real time to keep it within the comfort zone at all times.

[0094] B5. If it is within the appropriate interval, keep the current pulse until the pulse time ends.

[0095] Fig.10 The specific implementation process of the adaptive adjustment of the electric stimulation pulse when the stimulation pulse parameters exceed the maximum value of the comfort interval is presented. At t0, the electric stimulation pulse is started and the pulse emission module starts working. In the time period from t0 to t1, the pulse emission module emits the electric stimulation pulse according to the results of the analysis of the comfortable start-stop time and the optimal stimulation pulse parameters based on the linear increasing algorithm. At t1, the electric stimulation pulse reaches the optimal stimulation parameter, at which time the stimulation pulse energy stops increasing, and the electric stimulation pulse is emitted stably. In the time period from t1 to t2, the energy of the electric stimulation pulse changes with the change of the stimulation position impedance, but always maintains in the comfort interval. At t2, due to the sudden change of the stimulation position impedance, the voltage of the electric stimulation pulse acting on the tissue exceeds the maximum value of the comfort interval. At this time, the control module analyzes the data transmitted by the pulse analysis module through the linear decreasing algorithm, and then controls the pulse emission module to gradually reduce the output stimulation energy. In the time period from t3 to t4, the stimulation pulse energy gradually decreases. Until t4, the electric stimulation pulse reaches the optimal stimulation parameter, the stimulation pulse energy stops decreasing, and the electric stimulation pulse is emitted stably.

[0096] Fig.11 The specific implementation process of the adaptive adjustment of electrical stimulation pulses is presented. When the stimulation pulse parameters are lower than the minimum value of the comfort zone, the adaptive adjustment of electrical stimulation pulses is realized. Figure 3 The difference is that during the electrical stimulation pulse delivery process, the electrical stimulation pulse parameter is lower than the minimum parameter of the comfort zone due to the abnormal decrease of tissue impedance at the stimulation position. In this case, the pulse delivery module 200 will gradually increase the stimulation energy output until the optimal stimulation parameter is reached.

[0097] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device.

[0098] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A control system for electrical stimulation pulses of an implantable pulse generator, characterized in that: The system consists of a control module, a pulse emission module, a sensing module, a pulse analysis module and a human-computer interaction module; The control module is implemented using a single-chip microcomputer chip U1, and the U1 can realize all the functions of the control module, including communication with the human-computer interaction module, data processing of the pulse analysis module, data collection of the sensing module and pulse timing control of the pulse emission module; the pulse emission module is used to discharge the energy output by the energy source to the load in the form of current pulses; the sensing module collects the impedance value between human tissues in real time according to the instructions issued by the control module, and transmits the data to the pulse analysis module; the pulse analysis module analyzes the actual situation of the current electrical stimulation pulse acting on the human tissue through the pulse voltage estimation method; the human-computer interaction module is a tablet computer with visual operation, which processes the real-time operation status of the acquired electrical stimulation pulse and displays it to the doctor in a graphical visualization manner.

2. The control system of the electrical stimulation pulse of the implantable pulse generator according to claim 1, characterized in that: The control module is the main control unit and is connected to the pulse emission module, the sensing module, the pulse analysis module and the human-computer interaction module; The control module can control the pulse emission module to send electric pulse stimulation with specified parameters, the control module can control the sensing module to collect the impedance value of the current pulse acting on the human tissue part, the control module can obtain the actual situation of the current electric stimulation pulse acting on the human body from the pulse analysis module, the control module can obtain pulse control parameter information from the human-computer interaction module, and pass the data obtained from the pulse analysis module to the human-computer interaction module.

3. The control system of the electrical stimulation pulse of the implantable pulse generator according to claim 1, characterized in that: The pulse emission module is composed of a DAC chip U2, a switch Key1, a resistor R1, a resistor R2, a resistor R3, a resistor R4, a resistor R5, an adjustable potentiometer RP and an operational amplifier; The DAC chip U2 is mainly used to convert digital signals into analog signals of specified size, and serves as an energy source to provide energy for stimulation pulses. The constant current source circuit module composed of the resistor R1, the resistor R2, the resistor R3, the resistor R4, the adjustable potentiometer RP and the operational amplifier ensures that the energy output from the DAC chip U2 is output to human tissue in a constant current manner.

4. The control system of the electrical stimulation pulse of the implantable pulse generator according to claim 1, characterized in that: The sensing module is composed of a switch Key2, a resistor R6, a diode and an operational amplifier; The switch Key2 is used to control the sensing module to perform data collection. The resistor R6 and the operational amplifier form a voltage follower to ensure that the collected data is accurately transmitted to the pulse analysis module. The diode, using its unidirectional conductivity, clamps the voltage transmitted to the pulse analysis module so that it does not exceed the maximum input voltage of the analog-to-digital conversion chip inside the module, further ensuring the normal operation of the pulse analysis module.

5. The control system of the electrical stimulation pulse of the implantable pulse generator according to claim 1, characterized in that: The pulse analysis module is composed of a resistor R7, a capacitor C1 and an ADC chip U3; The resistor R7 and the capacitor C1 form a filter circuit for filtering the data transmitted by the sensing module to further improve the validity of the data. The ADC chip U3 is responsible for converting the filtered data into digital signals for subsequent software algorithm processing.

6. The method for controlling electrical stimulation pulses of an implantable pulse generator according to claim 1, characterized in that: The method consists of two parts: comfort assessment and adaptive adjustment of electrical stimulation pulses. The specific steps are as follows: Step 1: The doctor sets the comfort assessment parameters with the help of the human-computer interaction module, and lets the control module start the comfort assessment; Step 2: Based on the patient's feedback, the doctor can use the human-computer interaction module to determine the comfort zone in the subsequent adaptive adjustment process of the electrical stimulation pulse. If the comfort zone is not calibrated, the doctor needs to reset the comfort assessment parameters and repeat the above process. Step 3: After the comfort assessment is completed, the doctor can set the comfortable start and stop time through the human-computer interaction module. At the same time, the control module will display the comfort zone to the human-computer interaction module for the doctor to confirm; Step 4: After the information is confirmed to be correct, the doctor can use the human-computer interaction module to start the electrical stimulation pulse; Step 5: During the delivery of the electrical stimulation pulse, the control module combines the data transmitted by each module and automatically adjusts the electrical stimulation pulse in real time according to the principle of energy smooth transition to ensure that the electrical stimulation pulse is always within the comfortable range; Step 6: When the pulse end time is finally reached, the stimulator automatically turns off the electrical stimulation pulse.

7. The method for controlling electrical stimulation pulses of an implantable pulse generator according to claim 6, characterized in that: During the control process of this method, as long as the electrical stimulation pulse is issued, the control module will control the sensing module to collect the impedance value of the tissue at the patient's stimulation position, and pass the collected data to the pulse analysis module. After receiving the data, the pulse analysis module uses the pulse voltage estimation method to analyze the actual operation of the electrical stimulation pulse on the human tissue, and transmits the situation to the human-computer interaction module through the control module in real time for fitting, and further presents it to the doctor.

8. The method for controlling electrical stimulation pulses of an implantable pulse generator according to claim 6, characterized in that: The specific process of the comfort assessment is as follows: A1. The doctor uses the human-computer interaction module to set the comfort assessment parameters and transmits these data to the control module through wireless communication technology; A2. After receiving the data, the control module processes the smooth transition time and target pulse parameters using a linear increasing algorithm, further determines the smooth delivery mode of the electrical stimulation pulse, and controls the pulse delivery module to deliver the electrical stimulation pulse; A3. During the process of electrical stimulation pulse delivery, the doctor can mark the minimum parameter point of the comfort zone by combining the actual effect of the electrical stimulation pulse in human tissue displayed by the human-computer interaction module and the patient's response; A4. After the minimum parameter point of the comfort zone is confirmed, the control module uses a linear increasing algorithm to process the second smooth transition time, the current operating pulse parameters and the target pulse parameters, parses out the smooth delivery method of the second electrical stimulation pulse, and controls the pulse delivery module to output the electrical stimulation pulse according to the new delivery method; A5. Before the electrical stimulation pulse reaches the target pulse parameters, the doctor can mark the optimal stimulation parameters and comfort zone. After the comfort assessment is completed, the control module automatically stores the comfort zone.

9. The method for controlling electrical stimulation pulses of an implantable pulse generator according to claim 6, characterized in that: The specific process of the adaptive adjustment of the electrical stimulation pulse is as follows: B1. After completing the comfort assessment, the doctor sets the comfort start and stop time through the human-computer interaction module, and verifies and confirms the comfort interval and optimal stimulation parameter information. After confirmation, the doctor sends an instruction to start the electrical stimulation pulse to the control module; B2. After receiving the instruction, the control module processes the comfortable start-stop time and target parameters using a linear increasing algorithm to confirm the next electrical stimulation pulse delivery method. At the same time, the control module controls the sensing module to collect the impedance value of the patient's stimulation site and starts the delivery of electrical stimulation pulses. B3. During the process of electrical stimulation pulse delivery, the pulse analysis module uses the pulse voltage estimation method to analyze the actual effect of the current electrical stimulation pulse in the patient's body based on the impedance data transmitted in real time by the sensing module and the current delivery of the electrical stimulation pulse, and transmits it to the control module; B4. After receiving the data, the control module determines whether the current electrical stimulation pulse is within the comfort zone. If it exceeds the comfort zone, the control module controls the pulse issuing module to smoothly adjust the electrical stimulation pulse in real time to keep it within the comfort zone at all times. B5. If it is within the appropriate interval, keep the current pulse until the pulse time ends.

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