Detailed Description
Reference will now be made in detail to exemplary embodiments, examples of which are illustrated in the accompanying drawings. When the following description refers to the accompanying drawings, the same numbers in different drawings refer to the same or similar elements, unless otherwise indicated. The implementations described in the following exemplary examples do not represent all implementations consistent with the application. Rather, they are merely examples of apparatus and methods consistent with aspects of the application as detailed in the accompanying claims.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used in this specification and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should also be understood that the term "and/or" as used herein refers to and encompasses any or all possible combinations of one or more of the associated listed items.
It should be understood that although the terms first, second, third, etc. may be used herein to describe various information, these information should not be limited by these terms. These terms are only used to distinguish one type of information from another. For example, first information may also be referred to as second information, and similarly, second information may also be referred to as first information, without departing from the scope of the application. The term "if" as used herein may be interpreted as "at..once" or "when..once" or "in response to a determination", depending on the context.
Currently, the frequency of an electric pulse signal stimulated by electric pulses is generally hundreds of hertz, and the power supply voltage of the implanted electric pulse stimulator is kept unchanged in all phases of the electric pulse stimulation.
Referring to fig. 1, fig. 1 is a schematic diagram showing a stimulus waveform of an electrical pulse signal. The waveforms shown in fig. 1 are stimulus waveforms of the electric pulse signals output by the electric pulse stimulus, and the stimulus periods of the stimulus waveforms include a p+ period, a P-period and an Idle period.
Wherein, the P+ period is a positive pulse width period, the P-period is a negative pulse width period, and the Idle period is an Idle period. In Idle period, since the stimulus waveform does not need to be output, the power supply voltage which is kept unchanged is invalid output, which not only causes waste of power consumption, but also causes unavoidable standby power consumption of the stimulus circuit which is continuously powered.
In order to solve the above-mentioned problems, the present application provides an implantable electric pulse stimulator, which further comprises the following embodiments:
Referring to fig. 2, fig. 2 is a schematic diagram illustrating an implantable electrical pulse stimulator according to an exemplary embodiment of the present application. The implanted electric pulse stimulator may be an implanted medical device such as a spinal cord nerve stimulator, a digestive system nerve stimulator, etc. for outputting electric pulse signals for electric pulse stimulation to target tissues such as nerves, muscles, etc.
As shown in fig. 2, the implantable electrical pulse stimulator may include a power supply battery 20, a main control unit 21, a voltage converter 22, and a stimulation circuit 23.
Wherein the implantable electrical pulse stimulator is an internally powered electrical pulse stimulator. The power supply battery 20 in the implanted electric pulse stimulator is connected with the main control unit 21 and the voltage converter 22 respectively and is used for supplying power to the main control unit 21 and the voltage converter 22.
The stimulating circuit 23 is connected to the main control unit 21 and the voltage converter 22, respectively, and is used for measuring the human body impedance formed by the electrode contacts after the electrode contacts are contacted with human body tissues, and providing the measured human body impedance to the main control unit 21. The stimulation circuitry 23 is also configured to output electrical pulse stimulation energy to the treatment site that is consistent with the particular stimulation current, frequency, pulse width, etc.
The main control unit 21 is connected with the voltage converter 22 and is used for calculating the voltage value of the electric pulse stimulation based on the stimulation current and the human body impedance measured by the stimulation circuit 23 and determining the stimulation period of the electric pulse stimulation according to the pulse width and the frequency of the electric pulse stimulation. And also for switching on the voltage converter 22 during a stimulation period of the stimulation cycle.
The main control unit 21 generally carries with it radio frequency communication (such as bluetooth, wifi, nfc, etc.), and can exchange data with external program control devices. The main control unit 21 can also be connected with each module in the implantable electric pulse stimulator for coordinating the operation of each module.
The voltage converter 22 is configured to output a power supply voltage to the stimulation circuit 23 according to the voltage value calculated by the main control unit 21, so that the stimulation circuit 23 outputs the electrical pulse stimulation energy.
The voltage converter 22 may be a dc-dc converter (DCDC), a Charge Pump (Charge Pump), or a low dropout linear regulator (Low Dropout Regulator, LDO).
The stimulation current is the current transmitted to the target tissue through the electrode, and can be set and adjusted according to the actual application scene of the electric pulse stimulation. The voltage value of the electric pulse stimulation is the voltage magnitude transmitted to the target tissue through the electrode, and is used for designating the power supply voltage required to be output by the voltage converter 22 by the main control unit 21.
Pulse width refers to the length of time that a pulse current or voltage lasts after reaching its maximum value, and frequency refers to the number of repetitions of the pulse current or voltage per unit time. The pulse width and the frequency can also be set and adjusted according to the actual application scene of the electric pulse stimulation.
The stimulation period of an electrical pulse stimulation refers to the time interval from the start of one electrical pulse stimulation to the start of the next identical electrical pulse stimulation.
The stimulation period may include a stimulation period and an idle period. The stimulation period refers to the period of time during which the pulsed current or voltage is actually applied to the target tissue. The idle period refers to a period from the end of the pulse stimulation to the beginning of the next pulse stimulation, i.e., a portion of the stimulation period is removed.
Taking the stimulus waveform shown in fig. 1 as an example, the p+ period, the P-period, and the Idle period may constitute one stimulus period, the p+ period and the P-period constitute a stimulus period in the stimulus period, and the Idle period is an Idle period in the stimulus period.
It will be understood that the connection relation of each unit in the implantable electric pulse stimulator shown in fig. 2 is just an example, and may be selected differently from the example of the present application, so long as the implantable electric pulse stimulator can implement the voltage control method described in the embodiment of the present application, which is not limited thereto.
Referring to fig. 3, fig. 3 is a flowchart illustrating a voltage control method of electric pulse stimulation according to an exemplary embodiment of the present application. The voltage control method for the electric pulse stimulation can be applied to an implantable electric pulse stimulator, and the implantable electric pulse stimulator comprises a power supply battery, a main control unit, a voltage converter and a stimulation circuit.
Taking the implantable electric pulse stimulator as shown in fig. 2 as an example, the voltage control method may include the following steps:
step 302, the main control unit calculates the voltage value of the electric pulse stimulation based on the stimulation current and the human body impedance.
In this step, the stimulation circuit 23 measures the human body impedance formed after the electrode contact is in contact with the human body tissue, and supplies the measured human body impedance to the main control unit 21. The main control unit 21 calculates a voltage value of the electric pulse stimulation based on the stimulation current and the human body impedance.
For example, the main control unit 21 may calculate the voltage value of the electrical pulse stimulation according to the following formula 1:
(1)
Wherein, The voltage value representing the stimulation of the electrical pulse,Indicating the stimulus current is represented by the current,Representing the impedance of the human body.
Step 304, the main control unit determines the stimulation period of the electric pulse stimulation according to the pulse width and the frequency of the electric pulse stimulation.
In this step, the main control unit 21 determines the stimulation period of the electric pulse stimulation according to the pulse width and frequency of the electric pulse stimulation. Each stimulation period of the electrical pulse stimulation is determined based on the frequency of the electrical pulse stimulation, and the stimulation period and the idle period in each stimulation period are determined based on the pulse width of the electrical pulse stimulation. The stimulation period is the period of time represented by the pulse width, while the idle period is the stimulation period minus the pulse width.
Step 306, the main control unit starts the voltage converter in the stimulation period.
In this step, the main control unit 21 turns on the voltage converter 22 during the stimulation period in each stimulation period.
Step 308, the voltage converter outputs a power supply voltage to the stimulation circuit according to the voltage value.
In this step, in the stimulation period of each stimulation period, the voltage converter 22 outputs the power supply voltage corresponding to the voltage value to the stimulation circuit 23 according to the voltage value calculated by the main control unit 21, and the stimulation circuit 23 outputs the electric pulse stimulation energy according with the stimulation current, frequency and pulse width to the treatment site.
According to the voltage control method for electric pulse stimulation, the main control unit calculates the voltage value of electric pulse stimulation based on the stimulation current and the human body impedance measured by the stimulation circuit, the stimulation period of the electric pulse stimulation is determined according to the pulse width and the frequency of the electric pulse stimulation, and the voltage converter outputs the power supply voltage to the stimulation circuit according to the calculated voltage value in the stimulation period, so that the voltage converter outputs the power supply voltage as required, the ineffective power consumption waste in the idle period in the stimulation period is reduced, the standby power consumption generated by the stimulation circuit is reduced, the standby time of the power supply battery is prolonged, the service life of the power supply battery is prolonged greatly, the charging frequency of a user is also reduced, and better use experience is brought to the user.
In the foregoing embodiments, the periodic turning on of the voltage converter during the stimulation period is described, the voltage converter outputting the supply voltage to the stimulation circuit, reducing the waste of power consumption that is ineffective during the idle period in the stimulation period. In the following embodiments, the structure of the implantable electric pulse stimulator will be described in more detail, and may be applied to any of the above embodiments.
In one embodiment, the stimulation periods may include a positive going pulse width period and a negative going pulse width period. The positive pulse width period may be simply referred to as a positive pulse width, and refers to a time interval between a certain specific point of a rising edge and the same specific point of an adjacent falling edge of an electrical pulse signal. A negative pulse width period, which may be referred to simply as a negative pulse width, refers to the time interval between an electrical pulse signal from a certain point of a falling edge to the same certain point of an adjacent rising edge.
The main control unit can start the voltage converter before the positive pulse width period starts to output, the voltage converter outputs the power supply voltage to the stimulation circuit, and the voltage converter provides stable power supply voltage in the positive pulse width period and the negative pulse width period of the stimulation output. And when the main control unit outputs the negative pulse width period, the voltage converter is turned off, and the voltage converter stops outputting the power supply voltage to the stimulation circuit.
As described above, the voltage converter in the implantable electric pulse stimulator is enabled to start outputting the supply voltage before outputting the positive pulse width period, and the voltage converter is turned off to stop outputting the supply voltage when outputting the negative pulse width period, so that the supply voltage in the idle period is disabled while ensuring normal output of the stimulation waveforms in the positive pulse width period and the negative pulse width period, thereby reducing the power consumption of the voltage converter.
In one embodiment, a capacitor may be included in the voltage converter. The main control unit can also consider the charging time required by capacitor charging when controlling the voltage converter to be turned on and off.
The main control unit calculates the charging time required for charging the capacitor, the voltage converter is started in the charging time and the stimulating time, and the voltage converter is started in advance in the charging time before the electric pulse signal in the stimulating time is output, so that the capacitor just completes charging when the stimulating time begins to be output.
The capacitor can be positioned at the output part of the voltage converter and used for charging and storing energy, so that the stability of the output power supply voltage can be kept, the drop of the power supply voltage can be reduced, and the stability of the implanted electric pulse stimulator can be improved.
The capacitor can also have a filtering function and is used for removing alternating current components in the output power supply voltage, so that the power supply voltage is more stable.
The charging period is the period of time during which the supply voltage charges the capacitor prior to the stimulation period. The voltage converter outputs a supply voltage vout=capacitor charge Q/capacitance C, and the capacitor charge q=output current I of the voltage converter is equal to the capacitor charge duration T.
The main control unit can calculate the charging time of the capacitor according to the following formula 2:
(2)
Wherein, Indicating the length of time the capacitor is charged,Representing the supply voltage output by the voltage converter,Representing the capacitance value of the capacitor,Representing the output current of the voltage converter.
Referring to fig. 4, fig. 4 shows a schematic diagram of a supply voltage and a stimulus waveform. Where VOUT represents the supply voltage output by the voltage converter, EN represents the Enable Signal (Enable Signal) of the voltage converter, and CLK represents the Clock Signal (Clock Signal) of the voltage converter.
For example, the T period (green frame) is the charging time required for charging the capacitor, and the main control unit turns on the voltage converter in the T period, and the voltage converter outputs the supply voltage to charge the capacitor.
After the T period is finished, the voltage converter is still in an on state, the power supply voltage is output to the stimulation circuit, and the stimulation circuit outputs electric pulse signals in the P+ period and the P-period. After the stimulation period is over, the main control unit turns off the voltage converter.
It will be appreciated that the stimulus waveform of the electrical pulse signal shown in fig. 4 is only an example, and may be applied to other stimulus waveforms, as long as the voltage converter is periodically turned on during the charging period and the stimulus period, which is not limited in the embodiment of the present application.
As described above, by calculating the charging time period required for charging the capacitor in the voltage converter, the voltage converter is turned on during the charging time period before the stimulation period and during the stimulation period, so that the capacitor is ensured to just complete charging when the stimulation period of each stimulation period starts to be output, and the voltage converter outputs the power supply voltage for the electric pulse signal of the stimulation period, the distortion of the output stimulation waveform caused by the charging of the capacitor by using the power supply voltage during the stimulation period is avoided, and meanwhile, the power consumption waste caused by the early output of the power supply voltage is avoided.
In one embodiment, during idle periods in the stimulation cycle, the charge of the capacitor in the voltage converter slowly bleeds off, eventually approaching the battery voltage of the power supply battery. The power supply battery may also be used to output the current battery voltage of the power supply battery to the main control unit.
The main control unit takes the difference between the power supply voltage and the battery voltage of the power supply battery as the voltage difference of capacitor charging. Based on the voltage difference of capacitor charging, the charging time of the capacitor is calculated.
The main control unit can calculate the charging time of the capacitor according to the following formula 3:
(3)
Wherein, Indicating the length of time the capacitor is charged,Representing the supply voltage output by the voltage converter,Representing the battery voltage of the power supply battery,Representing the capacitance value of the capacitor,Representing the output current of the voltage converter.
As described above, by taking the difference between the supply voltage and the battery voltage of the supply battery as the voltage difference of capacitor charging, calculating the charging duration of the capacitor based on the voltage difference of capacitor charging, the voltage in the idle period is close to the battery voltage due to slow leakage of the charge of the capacitor, and calculating the charging duration by using the voltage difference between the supply voltage and the battery voltage, the charging duration can be made more accurate.
In an embodiment, the main control unit may further consider a static power consumption current of the stimulus circuit when calculating the charging time of the capacitor. The main control unit acquires the static power consumption current of the stimulation circuit.
And subtracting the static power consumption current part when calculating the charging current of the capacitor, and taking the current difference between the output current of the voltage converter and the static power consumption current as the charging current of the capacitor. Based on the voltage difference and the charging current, a charging time period of the capacitor is calculated.
The main control unit can calculate the charging time of the capacitor according to the following formula 4:
(4)
Wherein, Indicating the length of time the capacitor is charged,Representing the supply voltage output by the voltage converter,Representing the battery voltage of the power supply battery,Representing the capacitance value of the capacitor,Representing the output current of the voltage converter,Representing the quiescent power consumption current of the stimulus circuit.
As described above, by acquiring the static power consumption current of the stimulus circuit, taking the current difference between the output current of the voltage converter and the static power consumption current as the charging current of the capacitor charging, calculating the charging time based on the voltage difference and the charging current, and since the charging current deducts the influence of the static power consumption current, the calculated charging time can be more accurate.
In an embodiment, the master control unit may obtain the voltage switching power consumption of the voltage converter and the voltage power consumption of the idle period in the stimulation period.
And under the condition that the voltage switching power consumption is lower than the voltage power consumption in the idle period, starting the voltage converter in the stimulation period, and realizing an on-demand output mode of the power supply voltage.
When the voltage switching power consumption is higher than or equal to the voltage power consumption in the idle period, for example, when the charging period of the capacitor is close to or longer than the idle period in the stimulation period, or the idle period is far shorter than the stimulation period, the voltage converter is switched to the power supply voltage continuous output mode, and the voltage converter is continuously started in the stimulation period.
The voltage switching power consumption is power consumption generated by switching the power supply voltage between the start output and the stop output.
As described above, by acquiring the voltage switching power consumption of the voltage converter and the voltage power consumption of the idle period in the stimulation period, when the voltage switching power consumption is lower than the voltage power consumption of the idle period, the voltage converter is turned on in the stimulation period, so that the output state of the power supply voltage is prevented from being switched when the voltage switching power consumption is higher than the voltage power consumption of the idle period, and further, the power consumption waste is reduced by outputting the power supply voltage in the stimulation period.
In an embodiment, since the constant current control circuit in the stimulation circuit may consume a part of the power supply voltage, the main control unit may add a compensation value to the voltage value when calculating the voltage value of the electric pulse stimulation, so as to obtain the compensated voltage value. The voltage converter can output the compensated power supply voltage to the stimulation circuit according to the voltage value compensated by the main control unit.
The compensation value is used for compensating the loss voltage in the stimulation circuit, and can be set and adjusted according to the actual condition of the stimulation circuit. The depletion voltage is a voltage generated by a constant current control circuit for ensuring the stability of the current in the stimulus circuit.
The voltage value calculated by the main control unit according to the stimulation current and the human body impedance is 3V, and the voltage value can be increased by a compensation value of 2V, so that a compensated voltage value of 5V is obtained. The voltage converter can output 5V power supply voltage to the stimulation circuit according to the voltage value compensated by the main control unit.
As described above, the voltage value is compensated by adding the compensation value to the voltage value by the main control unit, and the voltage converter outputs the compensated power supply voltage to the stimulation circuit according to the compensated voltage value, so that the loss voltage of the constant current control circuit in the stimulation circuit can be compensated, and the output electric pulse signal is more accurate.
For further description of the voltage control method of the electric pulse stimulation, referring to fig. 5, fig. 5 shows a flowchart of another voltage control method of the electric pulse stimulation, the voltage control method of the electric pulse stimulation may be applied to an implantable electric pulse stimulator, and the voltage control method may include the following steps:
step 502, the stimulation circuit provides the measured human body impedance to the main control unit.
In this step, the stimulating circuit measures the human body impedance formed after the electrode contact contacts with human body tissue, and supplies the measured human body impedance to the main control unit.
Step 504, the main control unit calculates the voltage value of the electric pulse stimulation based on the stimulation current and the human body impedance.
In the step, the main control unit calculates the voltage value of the electric pulse stimulation based on the set stimulation current and the human body impedance measured by the stimulation circuit.
Step 506, the main control unit increases the voltage value by a compensation value and provides the compensated voltage value for the voltage converter.
In this step, the main control unit adds a compensation value to the voltage value, and provides the compensated voltage value to the voltage converter, so that the turned-on voltage converter outputs the compensated power supply voltage according to the compensated voltage value.
Step 508, the master control unit determines whether the voltage switching power consumption is lower than the voltage power consumption in the idle period.
In the step, the main control unit acquires the voltage switching power consumption of the voltage converter and the voltage power consumption of the idle period in the stimulation period, and judges whether the voltage switching power consumption is lower than the voltage power consumption of the idle period.
If the voltage switching power consumption is lower than the voltage power consumption in the idle period, continuing to execute step 510;
If the voltage switching power consumption is greater than or equal to the voltage power consumption of the idle period, step 520 is performed.
Step 510, the main control unit uses the difference between the power supply voltage and the battery voltage as the voltage difference of capacitor charging.
In this step, the main control unit uses the difference between the compensated power supply voltage and the battery voltage as the voltage difference of capacitor charging when the voltage switching power consumption is lower than the voltage power consumption in the idle period.
Step 512, the main control unit uses the current difference between the output current of the voltage converter and the static power consumption current as the charging current of the capacitor.
In the step, the main control unit obtains the static power consumption current of the stimulation circuit, and takes the current difference between the output current of the voltage converter and the static power consumption current as the charging current of the capacitor.
Step 514, the main control unit calculates the charging time of the capacitor based on the voltage difference and the charging current.
Step 516, the main control unit starts the voltage converter in the charging period and the stimulating period.
In the step, the main control unit starts the voltage converter in the charging time period and the stimulating time period. The main control unit starts the voltage converter in advance in the charging time before the electric pulse signals of each stimulation period are output, the voltage converter outputs the power supply voltage, and the capacitor starts to charge.
And when the charging period is over, the capacitor is charged, the voltage converter outputs the power supply voltage to the stimulation circuit, and the stimulation circuit outputs the electric pulse signal in the stimulation period. And at the end of the stimulation period, the main control unit turns off the voltage converter, and the voltage converter stops outputting the power supply voltage.
The main control unit waits for the stimulating period in the next stimulating period, and starts the voltage converter again in advance in the charging period before the electric pulse signal in the next stimulating period is output, so that the voltage converter starts to output the power supply voltage, the capacitor can be charged again, and the stimulating circuit outputs the electric pulse signal in the next stimulating period until the electric pulse signals in all stimulating periods are output.
Step 518, the voltage converter outputs the power supply voltage to the stimulation circuit according to the voltage value compensated by the main control unit.
In the step, the voltage converter outputs the compensated power supply voltage to the stimulation circuit according to the voltage value compensated by the main control unit during the starting period, and the stimulation circuit outputs an accurate electric pulse signal.
Step 520, the main control unit continuously turns on the voltage converter in the stimulation period.
In this step, under the condition that the voltage switching power consumption is higher than or equal to the voltage power consumption in the idle period, the main control unit continuously turns on the voltage converter in the stimulation period, and the voltage converter does not need to be switched on and off according to the stimulation period.
The foregoing describes certain embodiments of the present application. Other embodiments are within the scope of the following claims. In some cases, the actions or steps recited in the claims can be performed in a different order than in the embodiments and still achieve desirable results. In addition, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results. In some embodiments, multitasking and parallel processing are also possible or may be advantageous.
Other embodiments of the application will be apparent to those skilled in the art from consideration of the specification and practice of the application disclosed herein. The application is not limited to the precise construction which has been described above and shown in the drawings, and various modifications and changes may be made without departing from the scope thereof. The scope of the application is limited only by the appended claims.
The foregoing description of the preferred embodiments of the application is not intended to be limiting, but rather to enable any modification, equivalent replacement, improvement or the like to be made within the spirit and principles of the application.