Bipolar pulse generating active implantable pulse generator system and control method

Abstract

The application relates to the technical field of implantable medical devices, in particular to an active implantable pulse generator system generating bidirectional pulses and a control method. The system comprises a microcontroller, a bidirectional pulse generation circuit, a charge pump unit, a DA unit, an electrode lead and a sensing filter amplification unit. The bidirectional pulse generation circuit comprises two charging capacitor units and a plurality of discharge circuits. Under the control of the microcontroller, the two charging capacitor units are first charged by the charge pump unit, then the bidirectional pulse generation circuit can discharge a preset group number of bidirectional pulses to human tissues according to a preset voltage value and a preset pulse discharge time, so as to achieve the treatment purpose, and finally the charge in the human tissues is balanced by short-circuiting the discharge electrode, the charge accumulation effect caused by the unidirectional stimulation pulse is eliminated, and the problem that the charge accumulation effect causes damage to the human tissues is avoided.

Description

Technical Field

[0001] This application relates to the field of implantable medical device technology, and in particular to an active implantable pulse generator system and control method for generating bidirectional pulses. Background Technology

[0002] Implantable pulse generators are active medical devices that are implanted in the human body for extended periods. These include pacemakers, various nerve stimulators, and muscle stimulators. An implantable pulse generator typically consists of a circuit board, a titanium casing, a battery, and epoxy resin. It delivers pulse stimulation signals to the target treatment site via implanted electrodes to achieve therapeutic effects. Implantable pulse generators usually have accompanying programmable control equipment, and the two exchange information via two-way wireless communication.

[0003] In existing technologies, implantable pulse generators generally emit unidirectional stimulation pulses with relatively low energy. Although unidirectional stimulation pulses have a good effect on inducing movement, multiple studies have confirmed that the charge accumulation effect of unidirectional stimulation pulses can cause damage to the stimulated nerves and human tissues. Summary of the Invention

[0004] This application provides an active implantable pulse generator system and control method for generating bidirectional pulses, in order to solve the problem of damage to stimulated nerves and human tissues caused by the charge accumulation effect generated by traditional implantable pulse generators.

[0005] The technical solution adopted in this application to solve the above-mentioned technical problems is as follows:

[0006] In a first aspect, an active implantable pulse generator system for generating bidirectional pulses is characterized by comprising:

[0007] A microcontroller is used to control the operation of an active implantable pulse generator;

[0008] A bidirectional pulse generation circuit, connected to the microcontroller, is used to deliver bidirectional pulses to human tissue via electrode wires;

[0009] A charge pump unit, connected to the microcontroller and the bidirectional pulse generation circuit, is used to double the power supply voltage of the active implantable pulse generator and then supply power to the bidirectional pulse generation circuit.

[0010] The DA unit, connected to the microcontroller, the bidirectional pulse generation circuit, and the charge pump unit, is used to convert the digital signal generated by the microcontroller for controlling the target amplitude of the bidirectional pulse into an analog signal and transmit it to the bidirectional pulse generation circuit and the charge pump unit, so that the bidirectional pulse generation circuit generates a bidirectional pulse with a preset amplitude.

[0011] The electrode wire is connected to the bidirectional pulse generation circuit and is used to apply the bidirectional pulse generated by the bidirectional pulse generation circuit to human tissue.

[0012] The sensing, filtering, and amplifying unit is connected to the microcontroller and the electrode wires. It is used to detect weak signals from human tissue sensed by the electrode wires, filter and amplify the signals, and convert them into analog signals for transmission to the microcontroller.

[0013] Furthermore, the charge pump unit includes: a first charge pump and a second charge pump;

[0014] The electrode wire includes a positive electrode, a negative electrode, and a common terminal for the positive electrode.

[0015] Furthermore, the bidirectional pulse generation circuit includes: a first charging capacitor unit, a second charging capacitor unit, a nineteenth on / off switch, and several discharge circuits;

[0016] The first charging capacitor unit is connected to the first charge pump via the eleventh on / off switch, and the second charging capacitor unit is connected to the second charge pump via the twelfth on / off switch;

[0017] One end of the discharge circuit is connected to the moving end of the first selector switch, and the other end is connected to the moving end of the second selector switch.

[0018] One contact of the first selector switch is connected between the first charging capacitor unit and the eleventh on / off switch, and the other contact of the first selector switch is connected to system ground;

[0019] One contact of the second selector switch is connected between the second charging capacitor unit and the twelfth on / off switch, and the other contact of the second selector switch is connected to system ground;

[0020] The nineteenth on / off switch is connected in parallel across the two ends of the discharge circuit.

[0021] Furthermore, the discharge circuit includes: a first discharge on / off switch, a second discharge on / off switch, a third discharge on / off switch, and a fourth discharge on / off switch;

[0022] One end of the first discharge switch is connected to the moving end of the first selector switch, and the other end of the first discharge switch is connected to one end of the second discharge switch and one end of the third discharge switch, respectively.

[0023] The other end of the second discharge switch is connected to one end of the positive electrode, and the other end of the third discharge switch is connected to one end of the common terminal of the positive electrode.

[0024] The other end of the positive electrode and the other end of the common positive electrode are both used to connect to human tissue.

[0025] One end of the fourth discharge on / off switch is connected to the moving end of the second selector switch, and the other end of the fourth discharge on / off switch is connected to one end of the negative electrode.

[0026] The other end of the negative electrode is used to connect to the human tissue.

[0027] Furthermore, the first charging capacitor unit includes: a first group of charging capacitors and a first group of charging and discharging on / off switches corresponding to the first group of charging capacitors;

[0028] One end of the first group of charging capacitors is grounded, and the other end is connected to one end of the eleventh on / off switch and one contact of the first connecting switch through the first group of charging and discharging on / off switches.

[0029] The second charging capacitor unit includes: a second set of charging capacitors and a second set of charge / discharge on / off switches corresponding to the second set of charging capacitors;

[0030] One end of the second set of charging capacitors is grounded, and the other end is connected to one end of the twelfth on / off switch and one contact of the second connecting switch through the second set of charging / discharging on / off switches.

[0031] Furthermore, the first group of charging capacitors includes a first charging capacitor, a second charging capacitor, and a third charging capacitor, and the first group of charging and discharging on / off switches includes a thirteenth on / off switch, a fourteenth on / off switch, and a fifteenth on / off switch.

[0032] One end of the first charging capacitor, one end of the second charging capacitor, and one end of the third charging capacitor are all grounded. The other end of the first charging capacitor is connected to one end of the thirteenth on / off switch, the other end of the second charging capacitor is connected to one end of the fourteenth on / off switch, and the other end of the third charging capacitor is connected to one end of the fifteenth on / off switch. The other ends of the thirteenth, fourteenth, and fifteenth on / off switches are all connected to one end of the eleventh on / off switch and one contact of the first selector switch.

[0033] The second group of charging capacitors includes a fourth charging capacitor, a fifth charging capacitor, and a sixth charging capacitor; the second group of charging and discharging on / off switches includes a sixteenth on / off switch, a seventeenth on / off switch, and an eighteenth on / off switch.

[0034] One end of the fourth charging capacitor, one end of the fifth charging capacitor, and one end of the sixth charging capacitor are all grounded. The other end of the fourth charging capacitor is connected to one end of the thirteenth on / off switch. The other end of the fifth charging capacitor is connected to one end of the seventeenth on / off switch. The other end of the sixth charging capacitor is connected to one end of the eighteenth on / off switch. The other ends of the sixteenth, seventeenth, and eighteenth on / off switches are all connected to one end of the twelfth on / off switch and one contact of the second selector switch.

[0035] Secondly, a control method for an active implantable pulse generator system that generates bidirectional pulses, the method comprising:

[0036] The microcontroller controls the charge pump unit to charge the bidirectional pulse generation circuit.

[0037] The microcontroller controls the bidirectional pulse generation circuit to generate and emit several sets of bidirectional pulses;

[0038] Short-circuit the discharge electrodes to achieve charge balance.

[0039] Furthermore, the microcontroller controlling the charge pump unit to charge the bidirectional pulse generation circuit includes:

[0040] Charging the first charging capacitor unit includes: the microcontroller sending a charging switch closing command to close the eleventh on / off switch, thereby closing the thirteenth, fourteenth, and fifteenth on / off switches respectively;

[0041] The first charge pump detects the voltage values ​​of the first charging capacitor, the second charging capacitor, and the third charging capacitor, respectively. If the first charge pump detects that the voltage values ​​of the first charging capacitor, the second charging capacitor, and the third charging capacitor are consistent with the preset voltage value indicated by the DA unit output, then the microcontroller sends a charging switch disconnect command to disconnect the eleventh on / off switch, the thirteenth on / off switch, the fourteenth on / off switch, and the fifteenth on / off switch.

[0042] Charging the second charging capacitor unit includes: the microcontroller sending a charging switch closing command to close the twelfth open switch, thereby closing the sixteenth, seventeenth, and eighteenth open switches respectively;

[0043] The second charge pump detects the voltage values ​​of the fourth, fifth, and sixth charging capacitors respectively. If the voltage values ​​of the fourth, fifth, and sixth charging capacitors detected by the second charge pump are consistent with the preset voltage value indicated by the DA unit output, the microcontroller sends a charging switch disconnect command to disconnect the twelfth, sixteenth, seventeenth, and eighteenth on / off switches.

[0044] Furthermore, the microcontroller controls the bidirectional pulse generation circuit to generate and emit several sets of bidirectional pulses, including:

[0045] The microcontroller controls the bidirectional pulse generation circuit to generate and discharge a positive pulse discharge, including:

[0046] The microcontroller sends a positive pulse discharge switch closing command:

[0047] To open and close the thirteenth and / or fourteenth and / or fifteenth on / off switches;

[0048] The first discharge circuit is turned off and closed, the second or third discharge circuit is turned off and closed, and the fourth discharge circuit is turned off and closed.

[0049] Connect the second selector switch to its system ground contact;

[0050] After a preset pulse discharge time, the microcontroller sends a positive pulse discharge switch disconnect command:

[0051] Disconnect the thirteenth on / off switch and / or the fourteenth on / off switch and / or the fifteenth on / off switch;

[0052] The first discharge switch is disconnected, the second discharge switch or the third discharge switch is disconnected, and the fourth discharge switch is disconnected.

[0053] This causes the second selector switch to connect its other contact;

[0054] The microcontroller controls the bidirectional pulse generation circuit to generate and emit a single negative pulse discharge, including:

[0055] The microcontroller sends a negative pulse discharge switch closing command:

[0056] To open and close the sixteenth and / or seventeenth and / or eighteenth disconnect switches;

[0057] The fourth discharge circuit is closed when the circuit is turned off; the second or third discharge circuit is closed when the circuit is turned off when the circuit is turned off when the circuit is turned off when the circuit is turned off when the circuit is turned off when the circuit is turned off;

[0058] Connect the first selector switch to its system ground contact;

[0059] After the preset pulse discharge time, the microcontroller sends a negative pulse discharge switch disconnect command:

[0060] Disconnect the sixteenth on / off switch and / or the seventeenth on / off switch and / or the eighteenth on / off switch;

[0061] The fourth discharge switch is disconnected, the second discharge switch or the third discharge switch is disconnected, and the first discharge switch is disconnected.

[0062] This causes the first selector switch to connect its other contact;

[0063] One set of bidirectional pulses includes a positive pulse discharge and a negative pulse discharge.

[0064] Furthermore, the step of short-circuiting the discharge electrodes to perform charge balance includes:

[0065] The microcontroller sends a charge balance switch closing command, causing the first, second, third, and fourth discharge on / off switches in each discharge circuit to close, and causing the nineteenth on / off switch to close.

[0066] After a preset charge balance time, the microcontroller sends a charge balance switch disconnect command, causing the first discharge switch, the second discharge switch, the third discharge switch, and the fourth discharge switch in each discharge circuit to disconnect.

[0067] The technical solution provided in this application includes the following beneficial technical effects:

[0068] This application provides an active implantable pulse generator system and control method for generating bidirectional pulses. The system includes a microcontroller, a bidirectional pulse generation circuit, a charge pump unit, a DA unit, electrode leads, and a sensing, filtering, and amplification unit. The bidirectional pulse generation circuit includes two charging capacitor units and several discharge circuits. Under the control of the microcontroller, the system first charges the two charging capacitor units through the charge pump unit. Then, the bidirectional pulse generation circuit can deliver a preset number of bidirectional pulses to the human tissue according to a preset voltage value and a preset pulse discharge time to achieve the therapeutic purpose. Finally, by short-circuiting the discharge electrodes, the charge in the human tissue is balanced, eliminating the charge accumulation effect caused by unidirectional stimulation pulses, thereby avoiding the problem of charge accumulation effect causing damage to human tissue. Attached Figure Description

[0069] Figure 1 A schematic diagram of an active implantable pulse generator system for generating bidirectional pulses provided in an embodiment of this application;

[0070] Figure 2 The bidirectional pulse generation circuit provided in the embodiments of this application;

[0071] Figure 3 This is a schematic diagram of a bidirectional pulse sequence waveform provided in an embodiment of this application.

[0072] Figure reference numerals: 100-Microcontroller, 200-Bidirectional pulse generation circuit, 300-Charge pump unit, 301-First charge pump, 302-Second charge pump, 400-DA unit, 500-Electrode wire, 600-Sensing filter amplification unit, 700-Human tissue, E1-First charging capacitor, E2-Second charging capacitor, E3-Third charging capacitor, E4-Fourth charging capacitor, E5-Fifth charging capacitor, E6-Sixth charging capacitor, K1-First selector switch, K2-Second selector switch, K3-Third on / off switch, K4-Fourth on / off switch, K5-Fifth on / off switch, K6-Sixth on / off switch, K7-Seventh on / off switch, K8-Eighth on / off switch Switches: K9 - Ninth switch, K10 - Tenth switch, K11 - Eleventh switch, K12 - Twelfth switch, K13 - Thirteenth switch, K14 - Fourteenth switch, K15 - Fifteenth switch, K16 - Sixteenth switch, K17 - Seventeenth switch, K18 - Eighteenth switch, K19 - Nineteenth switch; R1 - First human tissue equivalent resistance; R2 - Second human tissue equivalent resistance; 501 - First electrode positive terminal; 502 - First electrode negative terminal; 503 - First electrode positive terminal common terminal; 504 - Second electrode positive terminal; 505 - Second electrode negative terminal; 506 - Second electrode positive terminal common terminal. Detailed Implementation

[0073] To facilitate the description and understanding of the technical solution of this application, the technical solution of this application will be further explained below in conjunction with the accompanying drawings and embodiments. First, some concepts involved in this application will be explained.

[0074] In existing technologies, implantable pulse generators typically emit unidirectional stimulation pulses with relatively low energy. Although unidirectional stimulation pulses are effective in inducing movement, studies have shown that the charge accumulation effect of unidirectional stimulation pulses can damage the stimulated nerves and human tissues. Bidirectional pulses, on the other hand, can achieve charge balance, reducing the damage to nerves and human tissues caused by pulse stimulation.

[0075] See Figure 1 This is a schematic diagram of the structure of an active implantable pulse generator system for generating bidirectional pulses provided in an embodiment of this application. Figure 1 As shown, the system includes a microcontroller unit 100, a bidirectional pulse generation circuit 200, a charge pump unit 300, a DA unit 400, electrode wires 500, and a sensing, filtering, and amplifying unit 600. The microcontroller unit 100 controls the charging and discharging switch logic of the bidirectional pulse generation circuit 200, the voltage multiplier selection of the charge pump unit 300, and the acquisition of the analog signal output by the sensing, filtering, and amplifying unit 600. The charge pump unit 300 supplies power to the bidirectional pulse generation circuit 300 after voltage multiplication of the power supply voltage of the active implantable pulse generator, and also controls the target capacitor voltage during the charging phase to not exceed the pulse amplitude setting value indicated by the output of the DA unit 400. The DA unit 400 converts the digital signal generated by the microcontroller for controlling the target amplitude of the bidirectional pulse into an analog signal and transmits it to the bidirectional pulse generation circuit and the charge pump unit, so that the bidirectional pulse generation circuit generates bidirectional pulses of a preset amplitude. The bidirectional pulse generation circuit 200 is the core circuit for generating bidirectional therapeutic pulses. It charges the target capacitor to a specified amplitude according to the instructions of the microcontroller 100 and delivers bidirectional pulses to the human tissue 700 through the electrode wire 500 according to the timing requirements. The sensing, filtering, and amplifying unit 600 detects the weak signal from the human tissue 700 sensed by the electrode wire 500, filters and amplifies the detected weak signal, and converts it into an analog quantity for transmission to the microcontroller 100.

[0076] The active implantable pulse generator system for generating bidirectional pulses provided in this application, under the control of a microcontroller, first charges two charging capacitor units through a charge pump unit. Then, the bidirectional pulse generation circuit can deliver a preset number of bidirectional pulses to the human tissue according to a preset voltage value and a preset pulse discharge time to achieve the therapeutic purpose. Finally, by short-circuiting the discharge electrodes, the charge in the human tissue is balanced, thereby avoiding the problem of charge accumulation effect causing damage to the human tissue. The specific implementation circuit and method of this function are described below.

[0077] See Figure 2 This is a bidirectional pulse generation circuit provided in the embodiments of this application. The following description uses two discharge circuits as an example to illustrate the bidirectional pulse generation circuit 200 provided in the embodiments of this application. Depending on actual needs, several sets of discharge circuits can be provided in this bidirectional pulse generation circuit 200.

[0078] The bidirectional pulse generation circuit 200 includes: a first charging capacitor unit, a second charging capacitor unit, a nineteenth on / off switch K19, and two sets of discharge circuits. The first charging capacitor unit includes a first set of charging capacitors and a first set of charge / discharge on / off switches corresponding to the first set of charging capacitors. The first charging capacitor unit is connected to the first charge pump 301 via the eleventh on / off switch K11. The second charging capacitor unit includes a second set of charging capacitors and a second set of charge / discharge on / off switches corresponding to the second set of charging capacitors. The second charging capacitor unit is connected to the second charge pump 302 via the twelfth on / off switch K12. Further, one end of the first set of charging capacitors is grounded, and the other end is connected to one end of the eleventh on / off switch K11 and a contact of the first connecting switch K1 via the first set of charge / discharge on / off switches. One end of the second set of charging capacitors is grounded, and the other end is connected to one end of the twelfth on / off switch K12 and a contact of the second connecting switch K2 via the second set of charge / discharge on / off switches.

[0079] Each discharge circuit includes a first discharge on / off switch, a second discharge on / off switch, a third discharge on / off switch, and a fourth discharge on / off switch. One end of each discharge circuit is connected to the moving end of the first selector switch K1, and the other end is connected to the moving end of the second selector switch K2. One contact of the first selector switch K1 is connected between the first charging capacitor unit and the eleventh on / off switch K11, and the other contact of the first selector switch K1 is connected to system ground. One contact of the second selector switch K2 is connected between the second charging capacitor unit and the twelfth on / off switch K12, and the other contact of the second selector switch K2 is connected to system ground. The nineteenth on / off switch K19 is connected in parallel across the two ends of the discharge circuit. Specifically, one end of the first discharge switch is connected to the moving end of the first selector switch K1, and its other end is connected to one end of the second discharge switch and one end of the third discharge switch, respectively; the other end of the second discharge switch is connected to one end of the positive electrode; the other end of the third discharge switch is connected to one end of the common terminal of the positive electrode; both the other end of the positive electrode and the other end of the common terminal of the positive electrode are used to connect with human tissue; one end of the fourth discharge switch is connected to the moving end of the second selector switch K2, and its other end is connected to one end of the negative electrode; the other end of the negative electrode is used to connect with human tissue.

[0080] Specifically, such as Figure 2As shown, the first group of charging capacitors includes a first charging capacitor E1, a second charging capacitor E2, and a third charging capacitor E3. The first group of charging and discharging on / off switches includes a thirteenth on / off switch K13, a fourteenth on / off switch K14, and a fifteenth on / off switch K15. One end of the first charging capacitor E1, one end of the second charging capacitor E2, and one end of the third charging capacitor E3 are all grounded. The other end of the first charging capacitor E1 is connected to one end of the thirteenth on / off switch K13, the other end of the second charging capacitor E2 is connected to one end of the fourteenth on / off switch K14, and the other end of the third charging capacitor E3 is connected to one end of the fifteenth on / off switch K15. The other ends of the thirteenth on / off switch K13, the fourteenth on / off switch K14, and the fifteenth on / off switch K15 are all connected to one end of the eleventh on / off switch K11 and one contact of the first selector switch K1.

[0081] The second set of charging capacitors includes the fourth charging capacitor E4, the fifth charging capacitor E5, and the sixth charging capacitor E6. The second set of charging and discharging on / off switches includes the sixteenth on / off switch K16, the seventeenth on / off switch K17, and the eighteenth on / off switch K18. One end of the fourth charging capacitor E4, one end of the fifth charging capacitor E5, and one end of the sixth charging capacitor E6 are all grounded. The other end of the fourth charging capacitor E4 is connected to one end of the thirteenth on / off switch K13. The other end of the fifth charging capacitor E5 is connected to one end of the seventeenth on / off switch K17. The other end of the sixth charging capacitor E6 is connected to one end of the eighteenth on / off switch K18. The other ends of the sixteenth on / off switch K16, the seventeenth on / off switch K17, and the eighteenth on / off switch K18 are all connected to one end of the twelfth on / off switch K12 and one contact of the second selector switch K2.

[0082] The first discharge circuit includes a third on / off switch K3, a seventh on / off switch K7, an eighth on / off switch K8, and a fifth on / off switch K5. One end of the third on / off switch K3 is connected to the moving end of the first selector switch K1, and its other end is connected to one end of the seventh on / off switch K7 and one end of the eighth on / off switch K8. The other end of the seventh on / off switch K7 is connected to one end of the positive electrode 501 of the first electrode. The other end of the eighth on / off switch K8 is connected to one end of the common terminal 503 of the positive electrode of the first electrode. Both the other end of the positive electrode 501 and one end of the common terminal 503 of the first electrode are used to connect to the first human tissue, as exemplarily shown below. Figure 2 As shown, one end of the positive electrode 501 and one end of the common terminal 503 of the positive electrode are both connected to one end of the equivalent resistance R1 of the first human tissue; one end of the fifth on / off switch K5 is connected to the moving end of the second selector switch K2, and its other end is connected to one end of the negative electrode 502 of the first electrode; the other end of the negative electrode 502 is used to connect to the first human tissue, i.e., as exemplarily shown... Figure 2As shown, the other end of the first electrode negative 502 is connected to the other end of the first human tissue equivalent resistance R1.

[0083] The second discharge circuit includes a fourth on / off switch K4, a ninth on / off switch K9, a tenth on / off switch K10, and a sixth on / off switch K6. One end of the fourth on / off switch K4 is connected to the moving end of the first selector switch K1, and its other end is connected to one end of both the ninth and tenth on / off switches K9 and K10, respectively. The other end of the ninth on / off switch K9 is connected to one end of the positive electrode 504 of the second electrode. The other end of the tenth on / off switch K10 is connected to one end of the common terminal 506 of the positive electrode 504 of the second electrode. Both the other end of the positive electrode 504 and one end of the common terminal 506 of the positive electrode 506 are used to connect to the second human tissue, as exemplarily shown below. Figure 2 As shown, one end of the positive terminal 504 of the second electrode and one end of the common terminal 506 of the positive terminal 506 of the second electrode are both connected to one end of the equivalent resistance R2 of the second human tissue; one end of the sixth on / off switch K6 is connected to the moving end of the second selector switch K2, and its other end is connected to one end of the negative terminal 505 of the second electrode; the other end of the negative terminal 505 of the second electrode is used to connect to the second human tissue, i.e., as exemplarily shown... Figure 2 As shown, the other end of the negative electrode 505 of the second electrode is connected to the other end of the equivalent resistance R2 of the second human tissue. One end of the nineteenth on / off switch K19 is connected to the moving end of the first selector switch K1, and the other end is connected to the moving end of the second selector switch K2. That is, the nineteenth on / off switch K19 is connected in parallel across the two ends of the discharge circuit.

[0084] The exemplary bidirectional pulse generation circuit 200 described above includes six charging capacitors: a first charging capacitor E1, a second charging capacitor E2, a third charging capacitor E3, a fourth charging capacitor E4, a fifth charging capacitor E5, and a sixth charging capacitor E6. These two sets of charging capacitors allow therapeutic pulses to be emitted from both directions of the electrodes, stimulating human tissue to achieve a therapeutic effect. A first selection switch K1 connects the positive electrode to the pulse generator system or to the first set of charging capacitors (first charging capacitor E1 and / or second charging capacitor E2 and / or third charging capacitor E3). A second selection switch K2 connects the negative electrode to the pulse generator system or to the second set of charging capacitors (fourth charging capacitor E4 and / or fifth charging capacitor E5 and / or sixth charging capacitor E6). A third on / off switch K3 connects the polarity-selected positive terminal 501 of the first electrode or the common terminal 503 of the first electrode to the first set of discharge circuits of the therapeutic pulse. The fourth on / off switch K4 is used to connect the polarity-selected positive terminal 504 of the second electrode or the common terminal 506 of the second electrode positive terminal to the second group of discharge circuits of the treatment pulse. The fifth on / off switch K5 is used to connect the negative terminal 502 of the first electrode to the first group of discharge circuits of the treatment pulse. The sixth on / off switch K6 is used to connect the negative terminal 505 of the second electrode to the second group of discharge circuits of the treatment pulse. The seventh on / off switch K7 is used to connect the positive terminal 501 of the first electrode to the first group of discharge circuits of the treatment pulse. The eighth on / off switch K8 is used to connect the common terminal 503 of the first electrode positive terminal to the first group of discharge circuits of the treatment pulse. The ninth on / off switch K9 is used to connect the positive terminal 504 of the second electrode to the second group of discharge circuits of the treatment pulse. The tenth on / off switch K10 is used to connect the common terminal 506 of the second electrode positive terminal to the second group of discharge circuits of the treatment pulse. The eleventh on / off switch K11 is used to connect the first charge pump 301 to the first charging circuit of the treatment pulse. The twelfth on / off switch K12 is used to connect the second charge pump 302 to the second charging circuit of the treatment pulse. The thirteenth on / off switch K13 is used to connect the first charging capacitor E1 to the treatment pulse charging / discharging circuit. The fourteenth on / off switch K14 is used to connect the second charging capacitor E2 to the treatment pulse charging / discharging circuit. The fifteenth on / off switch K15 is used to connect the third charging capacitor E3 to the treatment pulse charging / discharging circuit. The sixteenth on / off switch K16 is used to connect the fourth charging capacitor E4 to the treatment pulse charging / discharging circuit. The seventeenth on / off switch K17 is used to connect the fifth charging capacitor E5 to the treatment pulse charging / discharging circuit. The eighteenth on / off switch K18 is used to connect the sixth charging capacitor E6 to the treatment pulse charging / discharging circuit. The nineteenth on / off switch K19 is used to short-circuit the discharge electrode.

[0085] By default, all on / off switches are in the off state, and both selector switches are connected to a contact that is not in the system ground.

[0086] The microcontroller 100 in the active implantable pulse generator system for generating bidirectional pulses provided in the above embodiment controls the charge pump unit 300 to charge the bidirectional pulse generation circuit 200 using the following method:

[0087] Charging the first charging capacitor unit includes:

[0088] The microcontroller 100 sends a charging switch closing command, which closes the eleventh on / off switch K11, and closes the thirteenth on / off switch 13, the fourteenth on / off switch K14 and the fifteenth on / off switch K15 respectively, while the remaining switches remain in their default state.

[0089] The first charge pump 301 detects the voltage values ​​of the first charging capacitor E1, the second charging capacitor E2, and the third charging capacitor E3, respectively. If the voltage values ​​of the first charging capacitor E1, the second charging capacitor E2, and the third charging capacitor E3 detected by the first charge pump 301 are consistent with the preset voltage values ​​indicated by the output of the DA unit 400, that is, the charging capacitors of the first charging capacitor unit are fully charged, then the microcontroller 100 sends a charging switch disconnect command to disconnect the eleventh on / off switch K11, the thirteenth on / off switch K13, the fourteenth on / off switch K14, and the fifteenth on / off switch K15, thereby stopping charging.

[0090] Charging the second charging capacitor unit includes:

[0091] The microcontroller 100 sends a charging switch closing command, which closes the twelfth on / off switch K12, and closes the sixteenth on / off switch K16, the seventeenth on / off switch K17 and the eighteenth on / off switch K18 respectively, while the remaining switches remain in their default state;

[0092] The second charge pump 302 detects the voltage values ​​of the fourth charging capacitor E4, the fifth charging capacitor E5, and the sixth charging capacitor E6, respectively. If the voltage values ​​of the fourth charging capacitor E4, the fifth charging capacitor E5, and the sixth charging capacitor E6 detected by the second charge pump 302 are consistent with the preset voltage values ​​indicated by the output of the DA unit 400, that is, the charging capacitors of the second charging capacitor unit are fully charged, then the microcontroller 100 sends a charging switch disconnect command to disconnect the twelfth on / off switch K12, the sixteenth on / off switch K16, the seventeenth on / off switch K17, and the eighteenth on / off switch K18, thereby stopping charging.

[0093] Bidirectional pulses achieve therapeutic effects by releasing electrical energy from a charging capacitor into human tissue. A set of bidirectional pulses consists of one positive pulse and one negative pulse. When observing the bidirectional pulse pattern on an oscilloscope, a positive pulse is defined as one where the pulse leading edge is a rising edge and the entire pulse is above the oscilloscope baseline; conversely, a negative pulse is defined as one where the pulse leading edge is a falling edge and the entire pulse is below the oscilloscope baseline. Specifically, the oscilloscope probe for observing the waveform is connected to the negative terminal of the pulse-generating electrode, and the oscilloscope ground is connected to the positive terminal. The pulse can be emitted from either of the two electrodes or simultaneously from both electrodes. The pulse can be emitted in a bipolar circuit or a unipolar circuit. Typically, bidirectional pulses consist of a sequence of pulses. The specific process of generating and emitting a set of bidirectional pulses is as follows:

[0094] The microcontroller 100 controls the bidirectional pulse generation circuit to generate and discharge a single positive pulse discharge, including:

[0095] Microcontroller 100 sends a positive pulse discharge switch closing command:

[0096] The thirteenth on / off switch K13 and / or the fourteenth on / off switch K14 and / or the fifteenth on / off switch K15 are closed, that is, the positive pulse discharge is achieved by the first charging capacitor E1, the second charging capacitor E2 and the third charging capacitor E3 discharging separately or by the three charging capacitors discharging together. By closing one of the thirteenth on / off switches K13, the fourteenth on / off switch K14 and the fifteenth on / off switch K15, that is, closing the thirteenth on / off switch K13 to discharge the first charging capacitor E1, closing the fourteenth on / off switch K14 to discharge the second charging capacitor E2, and closing the fifteenth on / off switch K15 to discharge the third charging capacitor E3, or closing the thirteenth on / off switch K13, the fourteenth on / off switch K14 and the fifteenth on / off switch K15 simultaneously, the first charging capacitor E1, the second charging capacitor E2 and the third charging capacitor E3 are discharged simultaneously, so as to increase the energy released by a single positive pulse.

[0097] The first discharge switch is closed, the second or third discharge switch is closed, and the fourth discharge switch is closed, even if the third and / or fourth, seventh, eighth, ninth, or tenth switches, and fifth and / or sixth switches are all closed. The operation of the third and / or fourth switches is synchronized with that of the fifth and / or sixth switches. That is, when the first electrode and the second electrode are discharged simultaneously, the third switch K3 and the fourth switch K4 are both closed, and the fifth switch K5 and the sixth switch K6 are both closed; when the first electrode is discharged, the third switch K3 and the fifth switch K5 are both closed, and the fourth switch K4 and the sixth switch K6 remain open; when the second electrode is discharged, the fourth switch K4 and the sixth switch K6 are both closed, and the third switch K3 and the fifth switch K5 remain open.

[0098] Connect the second selector switch K2 to its system ground contact;

[0099] After a preset pulse discharge time, the microcontroller sends a positive pulse discharge switch disconnect command. The preset pulse discharge time determines the positive pulse width.

[0100] Disconnect the thirteenth on / off switch K13 and / or the fourteenth on / off switch K14 and / or the fifteenth on / off switch K15;

[0101] The first discharge switch is turned off, the second or third discharge switch is turned off, the fourth discharge switch is turned off, and the second selector switch K2 is turned on at its other contact, thus controlling the switches in both discharge circuits to return to their default state and end the positive pulse discharge.

[0102] The microcontroller 100 controls the bidirectional pulse generation circuit to generate and discharge a single negative pulse discharge, including:

[0103] Microcontroller 100 sends a negative pulse discharge switch closing command:

[0104] The sixteenth on / off switch K16 and / or the seventeenth on / off switch K17 and / or the eighteenth on / off switch K18 are closed, meaning that the negative pulse discharge is achieved by the fourth charging capacitor E4, the fifth charging capacitor E5, and the sixth charging capacitor E6 discharging separately or by the three charging capacitors discharging together. By closing one of the sixteenth on / off switches K16, K17, and K18, i.e., closing the sixteenth on / off switch K16 to discharge the fourth charging capacitor E4, closing the seventeenth on / off switch K17 to discharge the fifth charging capacitor E5, and closing the eighteenth on / off switch K18 to discharge the sixth charging capacitor E6, or simultaneously closing the sixteenth on / off switch K16, K17, and K18, the fourth charging capacitor E4, the fifth charging capacitor E5, and the sixth charging capacitor E6 are simultaneously discharged, thereby increasing the energy released by a single positive pulse.

[0105] The fourth discharge switch is closed, the second or third discharge switch is closed, and the first discharge switch is closed, even if the fifth switch K5 and / or the sixth switch K6, the seventh switch K7 or the eighth switch K8, the ninth switch K9 or the tenth switch K10, the third switch K3 and / or the fourth switch K4 are all closed. The operation of the fifth switch K5 and / or the sixth switch K6 is synchronized with that of the third switch K3 and / or the fourth switch K4. That is, when the first electrode and the second electrode are discharged simultaneously, the fifth on / off switch K5 and the sixth on / off switch K6 are both closed, and the third on / off switch K3 and the fourth on / off switch K4 are both closed; when the first electrode is discharged, the third on / off switch K3 and the fifth on / off switch K5 are both closed, and the fourth on / off switch K4 and the sixth on / off switch K6 remain open; when the second electrode is discharged, the fourth on / off switch K4 and the sixth on / off switch K6 are both closed, and the third on / off switch K3 and the fifth on / off switch K5 remain open.

[0106] Connect the first selector switch K1 to its system ground contact;

[0107] After the preset pulse discharge time, the microcontroller sends a negative pulse discharge switch disconnect command, wherein the preset pulse discharge time determines the negative pulse width:

[0108] Disconnect the sixteenth on / off switch K16 and / or the seventeenth on / off switch K17 and / or the eighteenth on / off switch K18;

[0109] The fourth discharge switch is turned off, the second or third discharge switch is turned off, the first discharge switch is turned off, and the first selector switch K1 is turned on at its other contact, thus controlling the switches in both discharge circuits to return to their default state and end the negative pulse discharge.

[0110] After the negative pulse discharge ends, a set of pulses has been delivered.

[0111] A set of pulses can be sent by first sending a positive pulse and then a negative pulse, as described above, or by first sending a negative pulse and then a positive pulse.

[0112] The pulse sequence used for treatment consists of multiple sets of pulses, which can be 1 to 5 sets.

[0113] The pulse charging and discharging sequence can be as follows: the charging capacitors are charged uniformly after the pulse sequence ends. Alternatively, the non-discharging charging capacitors can be charged during pulse transmission; that is, when a positive pulse is transmitted, the fourth charging capacitor E4, the fifth charging capacitor E5, and the sixth charging capacitor E6 can be charged; when a negative pulse is transmitted, the first charging capacitor E1, the second charging capacitor E2, and the third charging capacitor E3 can be charged.

[0114] Based on the characteristics of the implantable pulse generator, the treatment pulse amplitude can be selected from 0.1V to 7.5V, with a step size of 0.1V; the treatment pulse width can be selected from 0.1ms to 10ms, with a step size of 0.1ms.

[0115] In actual circuits, the pulse charge-discharge switching circuit generates parasitic capacitance during operation. Over time, this can cause charge accumulation on certain electrodes, resulting in substandard electrical neutrality and potentially damaging human tissue. The active implantable pulse generator system for generating bidirectional pulses provided in this application enters a charge balance phase after each pulse sequence is completed, ensuring that all electrodes achieve electrical neutrality.

[0116] The specific control method is as follows: the microcontroller 100 sends a charge balance switch closing command, so that the first discharge switch, the second discharge switch, the third discharge switch and the fourth discharge switch in each discharge circuit are all closed, so that the nineteenth switch K19 is closed, so that the third switch K3, the fourth switch K4, the fifth switch K5, the sixth switch K6, the seventh switch K7, the eighth switch K8, the ninth switch K9 and the tenth switch K10 are all closed, so that the nineteenth switch K19 is closed.

[0117] After a preset charge balance time, i.e., after maintaining the preset charge balance time, the microcontroller 100 sends a charge balance switch disconnect command, causing the first, second, third, and fourth discharge on / off switches in each discharge circuit to disconnect, and the third, fourth, fifth, sixth, sixth, seventh, seventh, eighth, ninth, tenth, and nineteenth on / off switches K3, K4, K5, K6, K7, K8, K9, K10, and K19 to disconnect, thus completing the electrode charging process. During this process, the remaining switches remain in their default states. The preset charge balance time can be selected from 10ms to 100ms, with a step size of 1ms.

[0118] See Figure 3 This is a schematic diagram of a bidirectional pulse sequence waveform provided in an embodiment of this application. The output pulse sequence shape of the active implantable pulse generator system for generating bidirectional pulses provided in the above embodiment is as follows: Figure 3 As shown, this schematic diagram can represent the waveform between the first positive electrode 501 and the first negative electrode 502, or it can represent the waveform between the second positive electrode 504 and the second negative electrode 505. Figure 3 The pulse sequence shown is a typical waveform of the output pulse of the bidirectional pulse generation circuit 200. The pulse sequence consists of 3 groups of pulses, with the positive pulse first and the negative pulse second in each group, and the amplitudes of the positive and negative pulses in each group are the same.

[0119] The active implantable pulse generator system and control method for generating bidirectional pulses provided in this application can deliver a preset number of bidirectional pulses to human tissue. Finally, by short-circuiting the discharge electrodes, the charge in the human tissue is balanced, thereby avoiding the problem of charge accumulation effect causing damage to human tissue.

Claims

1. An active implantable pulse generator system for generating bidirectional pulses, characterized in that, include: A microcontroller is used to control the operation of an active implantable pulse generator; A bidirectional pulse generation circuit, connected to the microcontroller, is used to deliver bidirectional pulses to human tissue via electrode wires; A charge pump unit, connected to the microcontroller and the bidirectional pulse generation circuit, is used to double the power supply voltage of the active implantable pulse generator and then supply power to the bidirectional pulse generation circuit. The DA unit, connected to the microcontroller, the bidirectional pulse generation circuit, and the charge pump unit, is used to convert the digital signal generated by the microcontroller for controlling the target amplitude of the bidirectional pulse into an analog signal and transmit it to the bidirectional pulse generation circuit and the charge pump unit, so that the bidirectional pulse generation circuit generates a bidirectional pulse with a preset amplitude. The electrode wire is connected to the bidirectional pulse generation circuit and is used to apply the bidirectional pulse generated by the bidirectional pulse generation circuit to human tissue. The sensing, filtering, and amplifying unit is connected to the microcontroller and the electrode wires. It is used to detect the weak signals of human tissue sensed by the electrode wires, filter and amplify the signals, and convert them into analog signals for transmission to the microcontroller. The charge pump unit includes: a first charge pump and a second charge pump; The electrode wire includes a positive electrode, a negative electrode, and a common terminal of the positive electrode. The bidirectional pulse generation circuit includes: a first charging capacitor unit, a second charging capacitor unit, a nineteenth on / off switch, and several discharge circuits. The first charging capacitor unit is connected to the first charge pump via the eleventh on / off switch, and the second charging capacitor unit is connected to the second charge pump via the twelfth on / off switch; One end of the discharge circuit is connected to the stationary end of the first selector switch, and the other end is connected to the stationary end of the second selector switch. One contact of the first selector switch is connected between the first charging capacitor unit and the eleventh on / off switch, and the other contact of the first selector switch is connected to system ground; One contact of the second selector switch is connected between the second charging capacitor unit and the twelfth on / off switch, and the other contact of the second selector switch is connected to system ground; The nineteenth on / off switch is connected in parallel across the two ends of the discharge circuit.

2. The active implantable pulse generator system for generating bidirectional pulses according to claim 1, characterized in that, The discharge circuit includes: a first discharge on / off switch, a second discharge on / off switch, a third discharge on / off switch, and a fourth discharge on / off switch; One end of the first discharge switch is connected to the stationary end of the first selector switch, and the other end of the first discharge switch is connected to one end of the second discharge switch and one end of the third discharge switch, respectively. The other end of the second discharge switch is connected to one end of the positive electrode, and the other end of the third discharge switch is connected to one end of the common terminal of the positive electrode. The other end of the positive electrode and the other end of the common positive electrode are both used to connect to human tissue. One end of the fourth discharge on / off switch is connected to the stationary end of the second selector switch, and the other end of the fourth discharge on / off switch is connected to one end of the negative electrode. The other end of the negative electrode is used to connect to the human tissue.

3. The active implantable pulse generator system for generating bidirectional pulses according to claim 1 or 2, characterized in that, The first charging capacitor unit includes: a first group of charging capacitors and a first group of charge / discharge on / off switches corresponding to the first group of charging capacitors; One end of the first group of charging capacitors is grounded, and the other end is connected to one end of the eleventh on / off switch and one contact of the first selector switch through the first group of charging and discharging on / off switches. The second charging capacitor unit includes: a second set of charging capacitors and a second set of charge / discharge on / off switches corresponding to the second set of charging capacitors; One end of the second set of charging capacitors is grounded, and the other end is connected to one end of the twelfth on / off switch and one contact of the second selector switch through the second set of charging / discharging on / off switches.

4. The active implantable pulse generator system for generating bidirectional pulses according to claim 3, characterized in that, The first group of charging capacitors includes a first charging capacitor, a second charging capacitor, and a third charging capacitor, and the first group of charging and discharging on / off switches includes a thirteenth on / off switch, a fourteenth on / off switch, and a fifteenth on / off switch; One end of the first charging capacitor, one end of the second charging capacitor, and one end of the third charging capacitor are all grounded. The other end of the first charging capacitor is connected to one end of the thirteenth on / off switch, the other end of the second charging capacitor is connected to one end of the fourteenth on / off switch, and the other end of the third charging capacitor is connected to one end of the fifteenth on / off switch. The other ends of the thirteenth, fourteenth, and fifteenth on / off switches are all connected to one end of the eleventh on / off switch and one contact of the first selector switch. The second group of charging capacitors includes a fourth charging capacitor, a fifth charging capacitor, and a sixth charging capacitor; the second group of charging and discharging on / off switches includes a sixteenth on / off switch, a seventeenth on / off switch, and an eighteenth on / off switch. One end of the fourth charging capacitor, one end of the fifth charging capacitor, and one end of the sixth charging capacitor are all grounded. The other end of the fourth charging capacitor is connected to one end of the sixteenth on / off switch. The other end of the fifth charging capacitor is connected to one end of the seventeenth on / off switch. The other end of the sixteenth on / off switch, the other end of the seventeenth on / off switch, and the other end of the eighteenth on / off switch are all connected to one end of the twelfth on / off switch and one contact of the second selector switch.

5. A control method for an active implantable pulse generator system that generates bidirectional pulses, characterized in that, The method uses the active implantable pulse generator system for generating bidirectional pulses as described in claim 1, and the method includes: The microcontroller controls the charge pump unit to charge the bidirectional pulse generation circuit. The microcontroller controls the bidirectional pulse generation circuit to generate and emit several sets of bidirectional pulses; Short-circuit the discharge electrodes to achieve charge balance.

6. The control method for the active implantable pulse generator system for generating bidirectional pulses according to claim 5, characterized in that, The microcontroller controls the charge pump unit to charge the bidirectional pulse generation circuit, including: Charging the first charging capacitor unit includes: the microcontroller sending a charging switch closing command to close the eleventh on / off switch, thereby closing the thirteenth, fourteenth, and fifteenth on / off switches respectively; The first charge pump detects the voltage values ​​of the first charging capacitor, the second charging capacitor, and the third charging capacitor, respectively. If the first charge pump detects that the voltage values ​​of the first charging capacitor, the second charging capacitor, and the third charging capacitor are consistent with the preset voltage value indicated by the DA unit output, then the microcontroller sends a charging switch disconnect command to disconnect the eleventh on / off switch, the thirteenth on / off switch, the fourteenth on / off switch, and the fifteenth on / off switch. Charging the second charging capacitor unit includes: the microcontroller sending a charging switch closing command to close the twelfth open switch, thereby closing the sixteenth, seventeenth, and eighteenth open switches respectively; The second charge pump detects the voltage values ​​of the fourth, fifth, and sixth charging capacitors respectively. If the voltage values ​​of the fourth, fifth, and sixth charging capacitors detected by the second charge pump are consistent with the preset voltage value indicated by the DA unit output, the microcontroller sends a charging switch disconnect command to disconnect the twelfth, sixteenth, seventeenth, and eighteenth on / off switches.

7. The control method for the active implantable pulse generator system for generating bidirectional pulses according to claim 5, characterized in that, The microcontroller controls the bidirectional pulse generation circuit to generate and emit several sets of bidirectional pulses, including: The microcontroller controls the bidirectional pulse generation circuit to generate and discharge a positive pulse discharge, including: The microcontroller sends a positive pulse discharge switch closing command: To open and close the thirteenth and / or fourteenth and / or fifteenth on / off switches; The first discharge circuit is turned off and closed, the second or third discharge circuit is turned off and closed, and the fourth discharge circuit is turned off and closed. Connect the second selector switch to its system ground contact; After a preset pulse discharge time, the microcontroller sends a positive pulse discharge switch disconnect command: Disconnect the thirteenth on / off switch and / or the fourteenth on / off switch and / or the fifteenth on / off switch; The first discharge switch is disconnected, the second discharge switch or the third discharge switch is disconnected, and the fourth discharge switch is disconnected. This causes the second selector switch to connect its other contact; The microcontroller controls the bidirectional pulse generation circuit to generate and emit a single negative pulse discharge, including: The microcontroller sends a negative pulse discharge switch closing command: To open and close the sixteenth and / or seventeenth and / or eighteenth disconnect switches; The fourth discharge circuit is closed when the circuit is turned off; the second or third discharge circuit is closed when the circuit is turned off when the circuit is turned off when the circuit is turned off when the circuit is turned off when the circuit is turned off when the circuit is turned off; Connect the first selector switch to its system ground contact; After the preset pulse discharge time, the microcontroller sends a negative pulse discharge switch disconnect command: Disconnect the sixteenth on / off switch and / or the seventeenth on / off switch and / or the eighteenth on / off switch; The fourth discharge switch is disconnected, the second discharge switch or the third discharge switch is disconnected, and the first discharge switch is disconnected. This causes the first selector switch to connect its other contact; One set of bidirectional pulses includes a positive pulse discharge and a negative pulse discharge.

8. The control method for the active implantable pulse generator system for generating bidirectional pulses according to claim 5, characterized in that, The step of short-circuiting the discharge electrodes to achieve charge balance includes: The microcontroller sends a charge balance switch closing command, causing the first, second, third, and fourth discharge on / off switches in each discharge circuit to close, and causing the nineteenth on / off switch to close. After a preset charge balance time, the microcontroller sends a charge balance switch disconnect command, causing the first discharge switch, the second discharge switch, the third discharge switch, and the fourth discharge switch in each discharge circuit to disconnect.

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