An individualized dose dynamic regulation method of an intelligent drug delivery pump for urology

Abstract

The application relates to the technical field of medical instrument electric control, and discloses an individualized dose dynamic regulation method of an intelligent drug pump for urology surgery. The method is executed by a controller of the intelligent drug pump, in which, in the same control cycle, intravesical pressure data, urine flow data, urine pH value data, pipeline pressure data and output flow detection data are acquired, urinary feedback states and pump body output states are respectively generated, and a preset state combination table is called to determine a normal output regulation mode, a pressure limiting and flow reducing mode or a blockage removal mode. Under different target control modes, the controller generates corresponding motor steering signals, motor drive frequency signals, drive pulse number signals and infusion valve opening degree signals according to individualized dose constraint data, calibration data and a preset mapping table, and controls pumping execution mechanisms and infusion valves through a drive circuit to regulate the liquid output amount or the liquid withdrawal amount of an output pipeline.

Description

Technical Field

[0001] This invention relates to the field of electrical control technology for medical devices, and in particular to a method for individualized dynamic dose control of an intelligent drug delivery pump for urology. Background Technology

[0002] In the field of medical device electrical control technology, urological fluid delivery equipment typically includes a reservoir assembly, tubing assembly, pump actuator, valve assembly, and corresponding control unit. During use, the control unit generally controls the pump actuator and valve assembly based on preset flow rate, preset output volume, or preset time parameters, thereby allowing fluid to be output through the outlet tubing in a predetermined manner. For fluid delivery scenarios that require correlation with bladder status, existing technologies also include solutions that use pressure sensors to collect bladder pressure and control the opening and closing of the infusion or voiding assembly based on bladder pressure thresholds.

[0003] For example, patent application CN102715898A discloses a bladder function recovery device. This device includes an irrigation device, a urination device, a bladder pressure acquisition unit, and a central processing unit. The irrigation device infuses a liquid medium into the bladder, the urination device empties the liquid medium from the bladder, the bladder pressure acquisition unit acquires bladder pressure in real time, and the central processing unit compares the bladder pressure with a maximum preset pressure and a minimum preset pressure, controlling the opening or closing of corresponding control components based on the comparison results. This type of solution allows the urinary system's fluid input or output process to not rely entirely on manual timed operation, but instead introduces bladder pressure as a control basis.

[0004] However, the aforementioned existing technologies primarily rely on threshold comparisons based on a single bladder pressure parameter to control the opening and closing of the infusion or urination pathways. For urological drug delivery pumps, the control involves not only the starting and stopping of the pump actuator and infusion valve, but also the flow rate of the drug solution in the output tubing, the output volume per cycle, and the pump's operating status. If the controller relies solely on a single pressure threshold or manually preset parameters, it is difficult to reflect changes in patient-side urinary system parameters such as urine flow rate and urine pH, and also difficult to reflect changes in pump-side output status such as tubing pressure and flow rate deviation.

[0005] Meanwhile, conventional drug delivery pumps typically execute constant speed or constant volume output according to preset parameters, and their control logic usually remains at the level of setting and executing target flow rate or target volume. When there is abnormal pressure in the output pipeline, the output flow rate deviates from the target value, or the bladder pressure is restricted, the controller has difficulty in timely associating and judging the parameters of the patient's urinary system with the output status of the pump, and it is also difficult to adjust the electrical control signals such as motor drive frequency, drive pulse number, and infusion valve opening according to different operating states.

[0006] Therefore, the actual technical problem to be solved by this application is: how to use the patient's urinary system parameters and the pump's output status together for the actuator and infusion valve's electrical control, so as to improve the output control accuracy and operational control safety of the drug delivery pump under different pipeline conditions and urinary feedback conditions. Summary of the Invention

[0007] To overcome the aforementioned technical deficiencies, the present invention aims to provide a method for individualized dynamic dose control of an intelligent drug delivery pump for urology. This invention employs a technical solution that involves collecting patient-side urinary system parameters and pump-side output status within the same control cycle, generating urinary feedback status and pump output status respectively, and selecting a normal output adjustment mode, pressure-limiting and flow-reducing mode, or blockage-relief mode through a preset status combination table. This generates corresponding electrical control signals for the pumping actuator and infusion valve, thus solving the problem in the prior art where drug delivery pumps struggle to utilize both patient-side parameters and pump-side status for actuator-level electrical control.

[0008] This invention discloses a method for individualized dynamic dose control of an intelligent drug delivery pump for urology. The method is executed by a controller of the intelligent drug delivery pump. The intelligent drug delivery pump includes a controller, a reservoir assembly, a pumping actuator, an output pipeline, an infusion valve, a patient parameter acquisition interface, a pump body detection interface, and a drive circuit. The pumping actuator includes a motor. The method includes:

[0009] Pre-acquire and store individualized dose constraint data, forward output calibration data, reverse pullback calibration data, preset state combination table, preset tubing residual volume mapping table, preset tubing blockage conditions, preset insufficient output conditions, preset output recovery conditions, preset bladder pressure limiting conditions, preset normal output conditions, and recovery step sequence.

[0010] Within the same control cycle, bladder pressure data, urine flow rate data, and urine pH value data are acquired through the patient parameter acquisition interface, and pipeline pressure data and output flow rate detection data of the output pipeline are acquired through the pump detection interface.

[0011] A urinary feedback status is generated based on bladder pressure data, urine flow data, and urine pH data. The urinary feedback status includes bladder pressure range markers, urine flow range markers, and urine pH range markers.

[0012] The pump output status is generated based on pipeline pressure data and output flow detection data. The pump output status includes pipeline pressure range identifier and output flow deviation identifier.

[0013] Call the preset state combination table, and determine the target control mode from normal output adjustment mode, pressure limiting and flow reduction mode and blockage release mode based on the urinary feedback state and pump output state;

[0014] In normal output regulation mode, the target drug output flow rate and target single-cycle output volume are determined based on individualized dose constraint data, urine pH range marking and forward output calibration data, and a first electrical control signal is generated. The first electrical control signal includes a forward motor direction signal, a motor drive frequency signal, a drive pulse count signal and an infusion valve opening signal.

[0015] In the pressure limiting and flow reduction mode, a second electrical control signal is generated based on the bladder pressure zone identifier. The second electrical control signal includes a motor drive frequency signal and an infusion valve opening signal.

[0016] In the blockage release mode, the reverse retraction volume is determined based on the pipeline pressure range identifier, output flow deviation identifier, and preset pipeline residual volume mapping table. The third electrical control signal is generated in the order of stopping drive, closing infusion valve, reverse retraction, retraction verification, and recovery sequence output. The third electrical control signal includes reverse motor direction signal, drive pulse count signal, infusion valve control signal, recovery motor drive frequency signal, and recovery infusion valve opening signal. The first, second, or third electrical control signal is sent to the pumping actuator and infusion valve via the drive circuit to control the output volume of the medicine in the output pipeline or the amount of medicine retraction in the output pipeline.

[0017] Within the same control cycle, the controller configures control cycle identifiers and channel identifiers for bladder pressure data, urine flow rate data, urine pH value data, pipeline pressure data, and output flow detection data, respectively. When any data lacks a corresponding control cycle identifier or channel identifier, the controller prohibits the target control mode from being set as the normal output regulation mode.

[0018] The bladder pressure zone identifier is obtained by matching the intrabladder pressure data with the preset intrabladder pressure zone; the urine flow rate zone identifier is obtained by matching the urine flow rate data with the preset urine flow rate zone; and the urine pH zone identifier is obtained by matching the urine pH value data with the preset pH zone.

[0019] The pipeline pressure range identifier is obtained by matching the pipeline pressure data with the preset pipeline pressure range, and the output flow deviation identifier is obtained by matching the target liquid output flow rate of the previous control cycle with the output flow detection data of the current control cycle.

[0020] The preset state combination table records the correspondence between bladder pressure range identifier, urine flow range identifier, urine pH range identifier, pipeline pressure range identifier, output flow deviation identifier and target control mode; when the pipeline pressure range identifier meets the preset pipeline blockage condition and the output flow deviation identifier meets the preset output deficiency condition, the target control mode is determined to be the blockage release mode.

[0021] When the bladder pressure zone indicator meets the preset bladder pressure limit condition and the tubing pressure zone indicator does not meet the preset tubing blockage condition, the target control mode is determined to be the pressure limiting and flow reducing mode; when the combination relationship of the bladder pressure zone indicator, urine flow rate zone indicator, urine pH zone indicator, tubing pressure zone indicator and output flow deviation indicator meets the preset normal output condition, the target control mode is determined to be the normal output regulation mode.

[0022] In normal output regulation mode, the controller reads the baseline output flow rate, single-cycle output volume limit, unit time output volume limit, and urine pH range adjustment table from the individualized dose constraint data. Based on the baseline output flow rate, urine pH range identifier, urine pH range adjustment table, and positive output calibration data, the controller determines the target drug output flow rate. Based on the target drug output flow rate and the cycle duration of the current control cycle, the controller determines the target single-cycle output volume and limits the target single-cycle output volume according to the single-cycle output volume limit and the unit time output volume limit.

[0023] When the urine pH range indicator changes relative to the previous control period, and the bladder pressure range indicator does not meet the preset bladder pressure limit, the controller limits the change in the target drug output flow rate relative to the previous control period based on the preset upper limit of flow rate change. When the urine pH range indicator changes and the bladder pressure range indicator meets the preset bladder pressure limit, the controller determines the target control mode as pressure limiting and flow reduction mode.

[0024] In the pressure limiting and flow reduction mode, the controller reads the corresponding flow reduction coefficient according to the bladder pressure range identifier, determines the target drug output flow rate of the current control cycle based on the target drug output flow rate and flow reduction coefficient of the previous control cycle, and synchronously reduces the motor drive frequency signal and infusion valve opening signal in the second electrical control signal to the value corresponding to the target drug output flow rate of the current control cycle.

[0025] After the pressure-limiting and flow-reducing mode has been maintained for a preset number of cycles, if the bladder pressure range indicator still meets the preset bladder pressure limit condition, the controller will set the target drug output flow rate of the current control cycle to zero, send a stop drive signal to the pump actuator, and send a close signal to the infusion valve.

[0026] Individualized dose constraint data includes the upper limit of single-cycle pullback volume; in the blockage release mode, the controller reads the candidate pullback volume in the preset pipeline residual volume mapping table according to the pipeline pressure range identifier and the output flow deviation identifier, and limits the candidate pullback volume according to the upper limit of single-cycle pullback volume to obtain the reverse pullback volume.

[0027] The controller converts the reverse pullback volume into the number of reverse drive pulses based on the reverse pullback calibration data, and generates the number of drive pulses in the third electrical control signal based on the number of reverse drive pulses; wherein, the reverse pullback calibration data is different from the forward output calibration data.

[0028] The post-reverse retraction verification includes: after completing the reverse retraction, the controller reacquires pipeline pressure data and output flow detection data; when the reacquired pipeline pressure data does not meet the preset pipeline blockage condition, and the reacquired output flow detection data meets the preset output recovery condition, the controller exits the blockage release mode.

[0029] Preferably, the recovery sequence output includes: within multiple consecutive control cycles after exiting the blockage release mode, the controller sequentially generates the recovery motor drive frequency signal and the recovery infusion valve opening signal in the third electrical control signal according to the recovery step sequence; the recovery motor drive frequency and recovery infusion valve opening corresponding to each control cycle in the recovery step sequence are not greater than the motor drive frequency and infusion valve opening corresponding to the normal output adjustment mode.

[0030] Preferably, the controller performs mode locking processing when switching between normal output regulation mode, voltage limiting and current reducing mode and blocking release mode; the mode locking processing includes setting a minimum number of maintenance control cycles for the current target control mode, and prohibiting switching to a control mode with a lower priority than the current target control mode within the minimum number of maintenance control cycles; wherein, the blocking release mode has a higher priority than the voltage limiting and current reducing mode, and the voltage limiting and current reducing mode has a higher priority than the normal output regulation mode.

[0031] Compared with existing technologies, the above technical solution has the following advantages:

[0032] 1. This invention collects bladder pressure data, urine flow rate data, urine pH value data, tubing pressure data, and output flow rate detection data within the same control cycle, and generates urinary feedback status and pump output status respectively. This allows the patient's urinary system parameters and the pump's output status to jointly participate in the execution-level electrical control of the drug delivery pump, thereby avoiding reliance on a single pressure threshold or manually preset parameters for constant speed output and improving the adaptability of the intelligent drug delivery pump to different urinary feedback status and tubing status.

[0033] 2. This invention maps the urinary feedback state and the pump output state to a normal output adjustment mode, a pressure limiting and flow reducing mode, or a blockage release mode through a preset state combination table. This enables the controller to generate corresponding first, second, or third electrical control signals for different operating states, thereby realizing the sub-mode control of the pumping actuator and the infusion valve, and improving the stability of the control logic during the operation of the drug delivery pump.

[0034] 3. In the normal output regulation mode, this invention determines the target drug output flow rate and target single-cycle output volume based on individualized dose constraint data, urine pH range markings, and positive output calibration data, and converts them into motor drive frequency signals, drive pulse count signals, and infusion valve opening signals, so that the target output parameters can be implemented in the underlying electrical control of the motor and infusion valve, thereby improving the control accuracy of drug output flow rate and single-cycle output volume.

[0035] 4. In the pressure limiting and flow reducing mode, the present invention synchronously reduces the motor drive frequency signal and the infusion valve opening signal according to the bladder pressure range indicator, and after the pressure limiting and flow reducing mode is maintained for a preset number of maintenance cycles, it executes the control to stop the drive and close the infusion valve, which helps to reduce the risk of continuous output under bladder pressure limitation and improves the operational control safety of the intelligent drug delivery pump under abnormal pressure conditions.

[0036] 5. In the blockage relief mode, the present invention determines the reverse pullback volume based on the pipeline pressure range identifier, the output flow deviation identifier, and the preset pipeline residual volume mapping table, and sequentially executes the stop drive, close the infusion valve, reverse pullback, pullback post-verification, and recovery sequence output. This allows the pipeline blockage state to be processed in a closed loop through the reverse drive pulse number and the recovery motor drive frequency signal, reducing pipeline pressure peaks and output fluctuations during the recovery phase, and improving the output recovery stability after blockage relief. Attached Figure Description

[0037] Figure 1 This is a schematic diagram of the hardware system architecture of the intelligent drug delivery pump provided in an embodiment of the present invention;

[0038] Figure 2 This is a schematic diagram of the main process of the individualized dose dynamic control method of the intelligent drug delivery pump for urology provided in an embodiment of the present invention.

[0039] Figure 3 This is a schematic diagram illustrating the mode switching logic between the urinary feedback state, the pump output state, and the target control mode provided in an embodiment of the present invention.

[0040] Figure 4 A timing diagram of the underlying electrical control signals under the blocking release mode provided in an embodiment of the present invention;

[0041] Figure 5 This is a schematic diagram of the recovery sequence output steps after exiting the blockage release mode, as provided in an embodiment of the present invention.

[0042] Figure 6 This is a schematic diagram of the multi-parameter linkage control effect curve provided in an embodiment of the present invention. Detailed Implementation

[0043] The following detailed description of this embodiment is provided in conjunction with the accompanying drawings. It should be understood that the following embodiments are used to illustrate specific implementations of the technical solution and are not intended to limit the scope of protection of this application. Where there is no conflict, the technical features of the following embodiments can be combined with each other.

[0044] like Figure 1 As shown, this embodiment provides a method for individualized dynamic dose control of a smart drug delivery pump 100 for urological use, the method being executed by a controller of the smart drug delivery pump 100. The smart drug delivery pump 100 includes a controller, a reservoir assembly, a pumping actuator, an output line, an infusion valve, a patient parameter acquisition interface, a pump body detection interface, and a drive circuit. The pumping actuator includes a motor and a rotor or push rod driven by the motor. The reservoir assembly is connected to the output line through the pumping actuator, and the infusion valve is located on the output line. The controller is electrically connected to the pumping actuator and the infusion valve through the drive circuit. The controller is also connected to the patient parameter acquisition interface and the pump body detection interface. The patient parameter acquisition interface is used to receive bladder pressure data, urine flow rate data, and urine pH data. The pump body detection interface is used to receive line pressure data and output flow rate detection data from the output line.

[0045] In this embodiment, the controller employs a microcontroller with timer output, analog signal acquisition, and non-volatile memory functions, such as the STM32 series microcontroller. The patient parameter acquisition interface includes input channels for a bladder pressure sensor, a urine flow sensor, and a urine pH sensor. The pump detection interface includes input channels for a tubing pressure sensor and an output flow detector. The bladder pressure sensor input channel is used to acquire bladder pressure data, the urine flow sensor input channel is used to acquire urine flow data, the urine pH sensor input channel is used to acquire urine pH data, the tubing pressure sensor input channel is used to acquire tubing pressure data from the output tubing, and the output flow detector input channel is used to acquire output flow detection data.

[0046] In this embodiment, the controller's control cycle is 100 ms. Within each control cycle, the controller reads bladder pressure data, urine flow rate data, urine pH data, tubing pressure data, and output flow detection data, and assigns a control cycle identifier and a channel identifier to each data item. The control cycle identifier indicates the control cycle to which the data belongs, and the channel identifier indicates the corresponding acquisition channel. If any data lacks a corresponding control cycle identifier or channel identifier, the controller will prevent the target control mode from being determined as the normal output adjustment mode.

[0047] Before the device operates, the controller pre-acquires and stores individualized dose constraint data, forward output calibration data, reverse pullback calibration data, a preset state combination table, a preset tubing residual volume mapping table, preset tubing blockage conditions, preset output insufficiency conditions, preset output recovery conditions, preset bladder pressure limiting conditions, preset normal output conditions, preset flow rate variation upper limit, preset maintenance cycle number, and recovery step sequence. The controller also pre-acquires and stores preset intravesical pressure ranges, preset urine flow ranges, preset pH ranges, preset tubing pressure ranges, urine pH range adjustment tables, and flow reduction coefficient tables. This data can be stored as static arrays, configuration files, or calibration parameters in the controller's Flash memory, EEPROM memory, or external non-volatile memory.

[0048] Individualized dose constraint data can be written to the controller via the device operation parameter configuration interface, medical information system interface, or local maintenance configuration interface. This individualized dose constraint data is used as the device operation constraint data for the intelligent drug delivery pump 100, and includes the basic output flow rate, maximum output volume per cycle, maximum output volume per unit time, and maximum pullback volume per cycle. Forward output calibration data and reverse pullback calibration data can be written to the controller during factory calibration, maintenance calibration, or pre-use calibration. A preset state combination table is used to establish the correspondence between urinary feedback state, pump output state, and target control mode; a preset tubing residual volume mapping table is used to determine the reverse pullback volume in the blockage release mode; and a recovery step sequence is used to progressively generate the recovery motor drive frequency signal and the recovery infusion valve opening signal after exiting the blockage release mode.

[0049] In this embodiment, the pumping actuator is a peristaltic pump driven by a stepper motor. The motor's step angle is 1.8°, and the driver's microstepping is 16, resulting in 3200 drive pulses per motor revolution. Factory calibration specifies a forward output volume of 0.5 mL per motor revolution. Therefore, forward output calibration data can include the forward output volume per pulse, and reverse pullback calibration data can include the reverse pullback volume per pulse. In this embodiment, the forward output volume per pulse is 0.00015625 mL, and the reverse pullback volume per pulse is 0.00015000 mL. Because the peristaltic pump tubing exhibits different elastic recovery states during forward compression and reverse pullback, the forward output calibration data and reverse pullback calibration data are stored and used separately.

[0050] like Figure 2 As shown, within one control cycle, the controller first acquires bladder pressure data, urine flow rate data, urine pH value data, pipeline pressure data, and output flow detection data. It then generates urinary feedback status and pump output status respectively. Subsequently, it calls a preset status combination table to determine the target control mode. Finally, it generates the corresponding electrical control signal based on the target control mode and sends it to the drive circuit. The target control modes include normal output adjustment mode, pressure limiting and current reducing mode, and blockage release mode.

[0051] In this embodiment, bladder pressure data is matched with a preset bladder pressure range to obtain a bladder pressure range identifier; urine flow rate data is matched with a preset urine flow rate range to obtain a urine flow rate range identifier; and urine pH value data is matched with a preset pH range to obtain a urine pH range identifier. The bladder pressure range identifier, urine flow rate range identifier, and urine pH range identifier together constitute the urinary feedback status. Specifically, the bladder pressure range identifier may include a low-pressure range, a normal range, and a restricted range; the urine flow rate range identifier may include a low-flow range, a normal-flow range, and a high-flow range; and the urine pH range identifier may include a slightly acidic range, a normal pH range, and a slightly alkaline range.

[0052] In this embodiment, the pipeline pressure data is matched with a preset pipeline pressure range to obtain a pipeline pressure range identifier, and the target liquid output flow rate from the previous control cycle is matched with the output flow rate detection data of the current control cycle to obtain an output flow rate deviation identifier. The pipeline pressure range identifier and the output flow rate deviation identifier together constitute the pump output status. In the first control cycle, the target liquid output flow rate from the previous control cycle is replaced by the baseline output flow rate. The output flow rate deviation can be calculated using the following formula:

[0053]

[0054] In the formula, For output flow rate deviation; The target output flow rate of the drug solution in the previous control cycle is expressed in mL / h and is replaced by the base output flow rate in the first control cycle. This is the output flow rate detection data for the current control cycle, in mL / h. When... When the deviation is less than 5%, the output flow rate deviation is marked as normal; when When the output flow deviation is greater than or equal to 5% but less than 15%, it is identified as an increased deviation; when When the deviation is greater than or equal to 15%, the output flow deviation indicator meets the preset insufficient output condition.

[0055] like Figure 3 As shown in this embodiment, the preset state combination table is used to record the correspondence between bladder pressure range identifiers, urine flow range identifiers, urine pH range identifiers, pipeline pressure range identifiers, output flow deviation identifiers, and target control modes. An example of the preset state combination table is shown in Table 1. In Table 1, "any range" indicates that the corresponding identifier can take any of the aforementioned defined ranges.

[0056] Table 1. Examples of Preset State Combinations

[0057]

[0058] In this embodiment, the preset bladder pressure limiting condition can be that the bladder pressure range indicator is in the restricted range; the preset tubing blockage condition can be that the tubing pressure range indicator is in the blocked range; the preset normal output condition can be that the combination of the bladder pressure range indicator, urine flow rate range indicator, urine pH range indicator, tubing pressure range indicator, and output flow deviation indicator belongs to the normal output adjustment mode combination item in the preset state combination table. The preset output recovery condition can be that the output flow rate detection data reaches more than 90% of the target drug output flow rate.

[0059] In normal output regulation mode, the controller reads the baseline output flow rate, single-cycle output volume limit, unit-time output volume limit, and urine pH range adjustment table from the individualized dose constraint data. Based on the baseline output flow rate, urine pH range identifier, urine pH range adjustment table, and positive output calibration data, it determines the target drug output flow rate. Then, based on the target drug output flow rate and the duration of the current control cycle, it determines the target single-cycle output volume. The target drug output flow rate can be calculated using the following formula:

[0060]

[0061] In the formula, The target drug solution output flow rate is expressed in mL / h. The base output flow rate is expressed in mL / h. This is the urine pH range adjustment coefficient; This represents the positive output calibration coefficient. The symbols mentioned above correspond to different technical names, and different technical features are not represented by the same symbol.

[0062] An example of a urine pH range adjustment table is shown in Table 2.

[0063] Table 2. Examples of urine pH range adjustment

[0064]

[0065] For example, within a certain control period, if the baseline output flow rate is 50 mL / h, the urine pH value is 5.8, the corresponding urine pH range adjustment coefficient is 1.20, and the positive output calibration coefficient is 0.95, then the target drug solution output flow rate is:

[0066]

[0067] If the current control cycle duration is 100 ms, the target single-cycle output volume can be calculated using the following formula:

[0068]

[0069] In the formula, The target single-cycle output volume is expressed in mL. The target drug solution output flow rate is expressed in mL / h. This represents the duration of the current control cycle, measured in seconds (s). 57 mL / h and When the time is 0.1 s, the target single-cycle output volume is:

[0070]

[0071] The controller also limits the target single-cycle output volume based on the upper limit of the single-cycle output volume and the upper limit of the output volume per unit time. For example, if the upper limit of the single-cycle output volume is 0.003 mL and the upper limit of the output volume per unit time is 60 mL / h, the corresponding cycle output limit value is 0.001667 mL. Therefore, the above-mentioned target single-cycle output volume of 0.001583 mL does not exceed the limit and can be used as the output control quantity for the current control cycle.

[0072] In normal output regulation mode, the controller generates a first electrical control signal. This first electrical control signal includes a forward motor direction signal, a motor drive frequency signal, a drive pulse count signal, and an infusion valve opening signal. The controller controls the motor rotation by outputting pulse signals through a timer, controls the motor speed through the pulse frequency, and controls the output volume through the number of pulses. The number of forward drive pulses can be calculated using the following formula:

[0073]

[0074] In the formula, This represents the number of positive drive pulses. The target single-cycle output volume is expressed in mL. This represents the positive output volume per pulse, in mL. For example, when It is 0.001583 mL. When the volume is 0.00015625 mL, the number of positive drive pulses is approximately 10.

[0075] Furthermore, the controller generates a corresponding motor drive frequency signal based on the duration of the current control cycle and the number of positive drive pulses. The motor drive frequency can be calculated using the following formula:

[0076]

[0077] In the formula, This is the motor drive frequency, measured in Hz. This represents the number of positive drive pulses. This represents the duration of the current control cycle, measured in seconds (s). For example, when the number of forward drive pulses is 10 and the duration of the current control cycle is 0.1 s, the motor drive frequency is 100 Hz. The controller outputs 10 pulses at a frequency of 100 Hz within the current control cycle to drive the motor to perform a forward output action.

[0078] The infusion valve opening signal is implemented using a PWM duty cycle signal. The controller outputs a PWM waveform through a timer. When the PWM duty cycle is 0%, the infusion valve is fully closed; when the PWM duty cycle is 100%, the infusion valve is fully open. In this embodiment, the infusion valve opening corresponds one-to-one with the PWM duty cycle. When the infusion valve opening is 60%, the PWM duty cycle output by the controller is 60%. The infusion valve opening can be determined according to the following formula:

[0079]

[0080] In the formula, This refers to the opening degree of the infusion valve; Minimum allowable opening; This is the maximum permissible opening. The target drug solution output flow rate; This represents the maximum allowable output flow rate corresponding to the upper limit of the output volume per unit time. In this embodiment, It is 20%. 90%, At 60 mL / h, when When the infusion rate is 57 mL / h, the valve opening is:

[0081]

[0082] When the urine pH range indicator changes relative to the previous control cycle, and the bladder pressure range indicator does not meet the preset bladder pressure limit, the controller limits the change in the target drug output flow rate relative to the previous control cycle based on a preset upper limit for flow rate change. This preset upper limit for flow rate change can be set to 15% of the base output flow rate, and not exceeding 8 mL / h. For example, if the base output flow rate is 50 mL / h, 15% of the base output flow rate is 7.5 mL / h, which is less than 8 mL / h; therefore, the preset upper limit for flow rate change in the current control cycle is 7.5 mL / h. If the target drug output flow rate in the previous control cycle was 50 mL / h, and the target drug output flow rate calculated using the urine pH range adjustment table is 62 mL / h, then the target drug output flow rate in the current control cycle is limited to 57.5 mL / h. When the urine pH range indicator changes and the bladder pressure range indicator meets the preset bladder pressure limit, the controller determines the target control mode to pressure-limiting and flow-reducing mode.

[0083] In pressure-limiting and flow-reducing mode, the controller reads the corresponding flow-reducing coefficient based on the bladder pressure range identifier, determines the target drug output flow rate for the current control cycle based on the target drug output flow rate and the flow-reducing coefficient from the previous control cycle, and synchronously reduces the motor drive frequency signal and the infusion valve opening signal in the second electrical control signal to the value corresponding to the target drug output flow rate for the current control cycle. An example of a flow-reducing coefficient table is shown in Table 3.

[0084] Table 3. Examples of Downflow Coefficients

[0085]

[0086] For example, if the target drug output flow rate in the previous control cycle was 50 mL / h, the current bladder pressure is 27 kPa, the bladder pressure range is marked as moderately restricted, and the flow reduction coefficient is 0.60, then the target drug output flow rate in the current control cycle is 30 mL / h. The controller synchronously reduces the motor drive frequency signal and the infusion valve opening signal, so that the pump actuator and the infusion valve operate in a consistent pressure-limiting and flow-reducing mode.

[0087] After the pressure-limiting and flow-reducing mode has been maintained for a preset number of maintenance cycles, if the bladder pressure zone indicator still meets the preset bladder pressure limit, the controller sets the target drug output flow rate for the current control cycle to zero, sends a stop drive signal to the pump actuator, and sends a close signal to the infusion valve. For example, if the preset number of maintenance cycles is 5 and the control cycle is 100 ms, and the bladder pressure zone indicator is still within the restricted range after the pressure-limiting and flow-reducing mode has been maintained for 500 ms, the controller stops the motor drive and closes the infusion valve.

[0088] In the blockage release mode, the controller determines the reverse pullback volume based on the pipeline pressure range identifier, the output flow deviation identifier, and a preset pipeline residual volume mapping table. An example of the preset pipeline residual volume mapping table is shown in Table 4.

[0089] Table 4. Example of Preset Piping Residual Volume Mapping

[0090]

[0091] In the blockage release mode, if the pipeline pressure data is 45 kPa and the output flow deviation is 30%, the controller reads a candidate pullback volume of 3.0 mL from the preset pipeline residual volume mapping table. If the upper limit of the single-cycle pullback volume in the individualized dose constraint data is 2.5 mL, then the reverse pullback volume is limited to 2.5 mL. The number of reverse drive pulses can be calculated according to the following formula:

[0092]

[0093] In the formula, This represents the number of reverse drive pulses. The reverse pullback volume is expressed in mL. This represents the reverse pullback volume per pulse, in mL. When It is 2.5 mL. When the volume is 0.00015000 mL, the number of reverse drive pulses is approximately 16667.

[0094] like Figure 4As shown, in the blockage release mode, the controller generates the third electrical control signal in the following sequence: stop drive, close infusion valve, reverse retraction, retraction verification, and recovery sequence output. The third electrical control signal includes a reverse motor direction signal, a drive pulse count signal, an infusion valve control signal, a recovery motor drive frequency signal, and a recovery infusion valve opening signal. The controller first sets the motor drive frequency signal to zero, stopping the pumping actuator; then it sends a close signal to the infusion valve; next, it outputs the reverse motor direction signal and drive pulse count signal, causing the motor to rotate in reverse and perform reverse retraction; after completing the reverse retraction, it re-acquires pipeline pressure data and output flow detection data for retraction verification.

[0095] In this embodiment, the post-reversal verification includes: after completing the reverse reversal, the controller reacquires pipeline pressure data and output flow detection data; when the reacquired pipeline pressure data does not meet the preset pipeline blockage condition, and the reacquired output flow detection data meets the preset output recovery condition, the controller exits the blockage release mode. For example, the preset pipeline blockage condition is that the pipeline pressure data is greater than or equal to 40 kPa and the output flow deviation is greater than or equal to 15%, and the preset output recovery condition is that the output flow detection data reaches more than 90% of the target liquid output flow rate. After completing the reverse reversal, if the pipeline pressure data decreases to 18 kPa and the output flow detection data reaches 92% of the target liquid output flow rate, the controller exits the blockage release mode.

[0096] like Figure 5 As shown, the recovery sequence output includes: within multiple consecutive control cycles after exiting the blockage release mode, the controller sequentially generates the recovery motor drive frequency signal and the recovery infusion valve opening signal in the third electrical control signal according to the recovery step sequence. The recovery motor drive frequency and recovery infusion valve opening corresponding to each control cycle in the recovery step sequence are no greater than the corresponding motor drive frequency and infusion valve opening under normal output regulation mode. An example of the recovery step sequence is shown in Table 5.

[0097] Table 5. Example of Recovery Step Sequence

[0098]

[0099] Because of the pressure transmission delay within the output pipeline and the acquisition delay of the urinary feedback status, if the motor drive frequency and infusion valve opening are immediately restored to the normal output regulation mode after the blockage is removed, it can easily cause fluctuations in the output flow rate. By restoring the step sequence, the motor drive frequency and infusion valve opening are restored step by step over multiple consecutive control cycles, ensuring the continuous operation of the pump actuator and infusion valve.

[0100] In this embodiment, the controller performs mode locking processing when switching between normal output regulation mode, voltage limiting and current reducing mode, and slack removal mode. Mode locking processing includes setting a minimum number of maintenance control cycles for the current target control mode, and prohibiting switching to a control mode with lower priority than the current target control mode within this minimum number of maintenance control cycles. Specifically, the slack removal mode has a higher priority than the voltage limiting and current reducing mode, and the voltage limiting and current reducing mode has a higher priority than the normal output regulation mode. For example, if the minimum number of maintenance control cycles is 5, when the controller enters the voltage limiting and current reducing mode, switching to the normal output regulation mode is prohibited for 5 consecutive control cycles; when the controller enters the slack removal mode, switching to the voltage limiting and current reducing mode or the normal output regulation mode is prohibited until the reverse rollback and post-rollback verification are completed. This mode locking processing can reduce repeated mode switching caused by fluid pressure fluctuations and acquisition noise, and reduce the impact of frequent motor acceleration and deceleration on the drive circuit and mechanical structure.

[0101] like Figure 6 As shown, this embodiment also underwent bench simulation verification. The comparative example uses a single bladder pressure threshold opening and closing control method, where the controller controls the opening or closing of the liquid output pathway solely based on the comparison between the bladder pressure data and the pressure threshold. The embodiment employs the aforementioned individualized dose dynamic control method. The test platform includes a peristaltic pump of the same specification, an output tubing of the same length and inner diameter, an adjustable damping valve, a pressure simulation chamber, and a flow detector. The test conditions are: a base output flow rate of 50 mL / h, a control cycle of 100 ms, a preset tubing blockage condition of tubing pressure data greater than or equal to 40 kPa and an output flow deviation greater than or equal to 15%, and a preset output recovery condition of the output flow detection data reaching more than 90% of the target drug output flow rate. The tubing blockage state is simulated by adjusting the damping valve, and bladder pressure changes are output through the pressure simulation chamber. The test results are shown in Table 6.

[0102] Table 6 Comparative Experiment or Simulation Data Table

[0103]

[0104] As shown in Table 6, under the same test conditions, this embodiment, through the combined judgment of bladder pressure data, urine flow rate data, urine pH value data, pipeline pressure data, and output flow detection data, enables the controller to switch between normal output regulation mode, pressure limiting and flow reduction mode, and blockage release mode. The switching results are reflected in motor direction, motor drive frequency, drive pulse count, infusion valve opening degree, and infusion valve control signal. Compared to a single bladder pressure threshold opening and closing control method, this embodiment can reduce pipeline pressure peaks, decrease output flow deviation, shorten blockage release time, and reduce output fluctuations during the recovery phase.

[0105] In summary, this embodiment collects bladder pressure data, urine flow rate data, urine pH value data, tubing pressure data, and output flow detection data within the same control cycle to generate urinary feedback status and pump output status, respectively. A preset status combination table is then used to determine the target control mode, allowing the patient's urinary system parameters and pump output status to jointly participate in the execution-level electrical control of the pump actuator and infusion valve. In normal output adjustment mode, the controller determines the target drug output flow rate and target single-cycle output volume based on individualized dose constraint data, urine pH range identifiers, and forward output calibration data. In pressure-limiting and flow-reducing mode, the controller synchronously reduces the motor drive frequency and infusion valve opening based on bladder pressure range identifiers. In blockage relief mode, the controller determines the reverse pullback volume based on tubing pressure range identifiers, output flow deviation identifiers, and a preset tubing residual volume mapping table, and performs reverse pullback, pullback verification, and recovery sequence output. All of the above processes generate corresponding electrical control signals from the controller, which are then applied to the pump actuator and infusion valve through the drive circuit. Therefore, this method belongs to the category of drug delivery pump electrical control methods in medical device electrical control technology.

[0106] It should be noted that the embodiments of the present invention have better implementability and are not intended to limit the present invention in any way. Any person skilled in the art may use the above-disclosed technical content to change or modify it into equivalent effective embodiments. However, any modifications or equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention shall still fall within the scope of the technical solution of the present invention.

Claims

1. A method for individualized dynamic dose control of a smart drug delivery pump for urology, characterized in that, The method is executed by the controller of the intelligent drug delivery pump, which includes a controller, a liquid storage assembly, a pumping actuator, an output pipeline, an infusion valve, a patient parameter acquisition interface, a pump body detection interface, and a drive circuit. The pumping actuator includes a motor. The method includes: Pre-acquire and store individualized dose constraint data, forward output calibration data, reverse pullback calibration data, preset state combination table, preset tubing residual volume mapping table, preset tubing blockage conditions, preset insufficient output conditions, preset output recovery conditions, preset bladder pressure limiting conditions, preset normal output conditions, and recovery step sequence. Within the same control cycle, bladder pressure data, urine flow rate data, and urine pH value data are acquired through the patient parameter acquisition interface, and pipeline pressure data and output flow rate detection data of the output pipeline are acquired through the pump detection interface. A urinary feedback status is generated based on the bladder pressure data, the urine flow rate data, and the urine pH value data. The urinary feedback status includes bladder pressure range identifiers, urine flow rate range identifiers, and urine pH range identifiers. The pump output status is generated based on the pipeline pressure data and the output flow detection data. The pump output status includes a pipeline pressure range identifier and an output flow deviation identifier. The preset state combination table is invoked, and the target control mode is determined from the normal output adjustment mode, pressure limiting and flow reducing mode, and blockage release mode based on the urinary feedback state and the pump output state. In the normal output adjustment mode, the target drug output flow rate and target single-cycle output volume are determined based on the individualized dose constraint data, the urine pH range identifier and the forward output calibration data, and a first electrical control signal is generated. The first electrical control signal includes a forward motor direction signal, a motor drive frequency signal, a drive pulse count signal and an infusion valve opening signal. In the pressure limiting and flow reducing mode, a second electrical control signal is generated based on the bladder pressure range identifier. The second electrical control signal includes a motor drive frequency signal and an infusion valve opening signal. In the blockage release mode, the reverse retraction volume is determined according to the pipeline pressure range identifier, the output flow deviation identifier, and the preset pipeline residual volume mapping table. A third electrical control signal is generated in the order of stopping drive, closing the infusion valve, reverse retraction, retraction verification, and recovery sequence output. The third electrical control signal includes a reverse motor direction signal, a drive pulse count signal, an infusion valve control signal, a recovery motor drive frequency signal, and a recovery infusion valve opening signal. The first electrical control signal, the second electrical control signal, or the third electrical control signal is sent to the pumping actuator and the infusion valve via the drive circuit to control the output volume of the output pipeline or the retraction volume of the output pipeline.

2. The method for individualized dynamic dose control of the intelligent drug delivery pump for urology according to claim 1, characterized in that, Within the same control cycle, the controller configures a control cycle identifier and a channel identifier for the bladder pressure data, urine flow rate data, urine pH value data, pipeline pressure data, and output flow detection data, respectively. When any data lacks a corresponding control cycle identifier or channel identifier, the controller prohibits the target control mode from being determined as the normal output adjustment mode.

3. The method for individualized dynamic dose control of the intelligent drug delivery pump for urology according to claim 1, characterized in that, The bladder pressure range identifier is obtained by matching the intrabladder pressure data with a preset intrabladder pressure range, the urine flow rate range identifier is obtained by matching the urine flow rate data with a preset urine flow rate range, and the urine pH range identifier is obtained by matching the urine pH value data with a preset pH range.

4. The method for individualized dynamic dose control of the intelligent drug delivery pump for urology according to claim 1, characterized in that, The pipeline pressure range identifier is obtained by matching the pipeline pressure data with the preset pipeline pressure range, and the output flow deviation identifier is obtained by matching the target liquid output flow rate of the previous control cycle with the output flow detection data of the current control cycle.

5. The method for individualized dynamic dose control of the intelligent drug delivery pump for urology according to claim 1, characterized in that, The preset state combination table records the correspondence between the bladder pressure range identifier, the urine flow range identifier, the urine pH range identifier, the pipeline pressure range identifier, the output flow deviation identifier, and the target control mode; when the pipeline pressure range identifier meets the preset pipeline blockage condition and the output flow deviation identifier meets the preset output deficiency condition, the target control mode is determined as the blockage relief mode.

6. The method for individualized dynamic dose control of the intelligent drug delivery pump for urology according to claim 5, characterized in that, When the bladder pressure zone indicator meets the preset bladder pressure limit condition and the tubing pressure zone indicator does not meet the preset tubing blockage condition, the target control mode is determined to be the pressure limiting and flow reducing mode; when the combination relationship of the bladder pressure zone indicator, the urine flow rate zone indicator, the urine pH zone indicator, the tubing pressure zone indicator, and the output flow deviation indicator meets the preset normal output condition, the target control mode is determined to be the normal output regulation mode.

7. The method for individualized dynamic dose control of the intelligent drug delivery pump for urology according to claim 1, characterized in that, In the normal output regulation mode, the controller reads the baseline output flow rate, the upper limit of the single-cycle output volume, the upper limit of the output volume per unit time, and the urine pH range adjustment table from the individualized dose constraint data. Based on the baseline output flow rate, the urine pH range identifier, the urine pH range adjustment table, and the positive output calibration data, the controller determines the target drug output flow rate. Based on the target drug output flow rate and the cycle duration of the current control cycle, the controller determines the target single-cycle output volume. The controller then limits the target single-cycle output volume based on the upper limit of the single-cycle output volume and the upper limit of the output volume per unit time.

8. The method for individualized dynamic dose control of the intelligent drug delivery pump for urology according to claim 1, characterized in that, When the urine pH range identifier of the current control cycle changes relative to the urine pH range identifier of the previous control cycle, and the bladder pressure range identifier does not meet the preset bladder pressure limit condition, the controller limits the change in the target drug output flow rate relative to the target drug output flow rate of the previous control cycle according to the preset upper limit of flow rate change obtained in advance; when the urine pH range identifier changes and the bladder pressure range identifier meets the preset bladder pressure limit condition, the controller determines the target control mode as the pressure limiting and flow reducing mode.

9. The method for individualized dynamic dose control of the intelligent drug delivery pump for urology according to claim 1, characterized in that, In the pressure limiting and flow reduction mode, the controller reads the corresponding flow reduction coefficient according to the bladder pressure range identifier, determines the target drug output flow rate of the current control cycle according to the target drug output flow rate of the previous control cycle and the flow reduction coefficient, and synchronously reduces the motor drive frequency signal and the infusion valve opening signal in the second electrical control signal to the value corresponding to the target drug output flow rate of the current control cycle.

10. The method for individualized dynamic dose control of a smart drug delivery pump for urology according to claim 1 or 9, characterized in that, The controller performs mode locking processing when switching between the normal output adjustment mode, the voltage limiting and current reducing mode, and the blocking release mode. The mode locking processing includes setting a minimum number of maintenance control cycles for the current target control mode, and prohibiting switching to a control mode with a lower priority than the current target control mode within the minimum number of maintenance control cycles. The blocking release mode has a higher priority than the voltage limiting and current reducing mode, and the voltage limiting and current reducing mode has a higher priority than the normal output adjustment mode.

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