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WO2015158230A1 - 一种使用磁电阻传感器的微型导螺杆泵及其制造方法 - Google Patents

一种使用磁电阻传感器的微型导螺杆泵及其制造方法 Download PDF

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Publication number
WO2015158230A1
WO2015158230A1 PCT/CN2015/076428 CN2015076428W WO2015158230A1 WO 2015158230 A1 WO2015158230 A1 WO 2015158230A1 CN 2015076428 W CN2015076428 W CN 2015076428W WO 2015158230 A1 WO2015158230 A1 WO 2015158230A1
Authority
WO
WIPO (PCT)
Prior art keywords
lead screw
screw pump
rotation angle
micro
motor
Prior art date
Application number
PCT/CN2015/076428
Other languages
English (en)
French (fr)
Inventor
迪克·詹姆斯·G
金玉琴
Original Assignee
江苏多维科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201410146550.4A external-priority patent/CN103920207B/zh
Application filed by 江苏多维科技有限公司 filed Critical 江苏多维科技有限公司
Priority to US15/304,251 priority Critical patent/US10232109B2/en
Priority to EP15780592.0A priority patent/EP3132820A4/en
Priority to JP2016562589A priority patent/JP6976683B2/ja
Publication of WO2015158230A1 publication Critical patent/WO2015158230A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/1684—Monitoring, detecting, signalling or eliminating infusion flow anomalies by detecting the amount of infusate remaining, e.g. signalling end of infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01R—MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES
    • G01R33/00—Arrangements or instruments for measuring magnetic variables
    • G01R33/02—Measuring direction or magnitude of magnetic fields or magnetic flux
    • G01R33/06—Measuring direction or magnitude of magnetic fields or magnetic flux using galvano-magnetic devices
    • G01R33/09—Magnetoresistive devices
    • G01R33/093—Magnetoresistive devices using multilayer structures, e.g. giant magnetoresistance sensors
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01R—MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES
    • G01R33/00—Arrangements or instruments for measuring magnetic variables
    • G01R33/02—Measuring direction or magnitude of magnetic fields or magnetic flux
    • G01R33/06—Measuring direction or magnitude of magnetic fields or magnetic flux using galvano-magnetic devices
    • G01R33/09—Magnetoresistive devices
    • G01R33/098—Magnetoresistive devices comprising tunnel junctions, e.g. tunnel magnetoresistance sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type

Definitions

  • the present invention relates to a medical device, and more particularly to a miniature lead screw pump that drives an insulin pump.
  • the insulin pump needs to continuously inject a basic dose of insulin or a large dose of insulin according to the needs of the diabetic to correct the hyperglycemia after meals. Since the insulin pump can inject insulin according to the basic dose distribution map of the diabetic, the blood glucose concentration in the patient's blood can be kept at the same level, and the patient's organs are under less stress. Also for the foregoing reasons, the insulin pump must be capable of continuously injecting small doses of insulin (approximately 0.1-1.0 cm 3 /day), and the rate of injection (ie, the basic dose rate and the high dose rate) can be adjusted over a wide range. ) to suit the different needs of the patient.
  • the rate of injection ie, the basic dose rate and the high dose rate
  • the micro-screw pump drives the sleeve to move within the reservoir, and the insulin in the reservoir is introduced into the patient.
  • the motor that rotates the lead screw is a stepping motor that can precisely control the rotational speed.
  • the cost of using a stepper motor on the one hand is the high price of an insulin pump, and the price of an insulin pump can be as high as $10,000, which greatly limits the use of the patient.
  • the accuracy of the control of the infusion speed of the stepper motor depends on the number of phases and the number of beats.
  • the present invention uses a magnetoresistive rotation angle sensor together with a DC motor to replace the stepping motor, reduces the cost of the insulin pump, and improves the performance of the insulin pump.
  • the present invention relates to a micro-guide screw pump for driving an insulin pump, which uses a magnetoresistance rotation angle sensor and Continuous Glucose monitor (CGM, continuous blood glucose monitor), with Micro Control Unit (MCU, microcontroller) feedback control of the infusion speed, replacing the way to control the infusion speed with a stepper motor.
  • CGM continuous blood glucose monitor
  • MCU Micro Control Unit
  • the present invention can use other motors instead of stepper motors, and can also be used with stepper motors to improve the accuracy and reliability of infusion speed of insulin or other liquids.
  • a miniature lead screw pump is installed in a pump box, the micro lead screw pump includes a motor, the motor drives a lead screw and a driving head connected to the lead screw, and the lead screw has a thread with a lead screw Rotating in a reverse threaded nut to drive the drive head to push the sleeve to move within the reservoir, the micro lead screw pump further comprising
  • At least one permanent magnet rotating coaxially with the lead screw
  • a magnetoresistive rotation angle sensor capable of sensing a magnetic field generated by the at least one permanent magnet, and the magnetoresistive rotation angle sensor is in a region where the magnetic field generated by the at least one permanent magnet is unidirectional and saturated;
  • the magnetoresistance rotation angle sensor is one of a two-axis rotary magnetic sensor, two orthogonal single-axis rotation sensors, and a single-axis or dual-axis magnetic sensor.
  • the magnetoresistive rotation angle sensor is an AMR, GMR or TMR sensor.
  • a central axis of the permanent magnet and a central axis of the lead screw pass through a center of the magnetoresistive rotation angle sensor.
  • the at least one permanent magnet is an integral permanent magnet or a split permanent magnet, which is disc-shaped, annular or square.
  • the at least one permanent magnet is two permanent magnets, each of the permanent magnets has a plurality of different magnetic poles, and the two permanent magnets are respectively located at two ends of the lead screw or placed in a string in the The same end of the lead screw .
  • the MCU controls the steering and the rotational speed of the motor through a motor controller.
  • the MCU includes a magnetoresistive sensor information management unit including a motor rotation angle counting unit that monitors a rotation angle of the motor, a lead screw position unit that calculates a linear movement position of the lead screw, and/or a calculation sleeve at a sleeve position unit at a position in the accumulator, a solution volume unit for calculating a volume of the solution in the accumulator, and a flow rate unit for converting the rotational speed of the lead screw into an infusion rate of the accumulator .
  • a magnetoresistive sensor information management unit including a motor rotation angle counting unit that monitors a rotation angle of the motor, a lead screw position unit that calculates a linear movement position of the lead screw, and/or a calculation sleeve at a sleeve position unit at a position in the accumulator, a solution volume unit for calculating a volume of the solution in the accumulator, and a flow rate unit for converting the rotational speed of the lead screw into an infusion
  • the MCU has wired and/or wireless data communication interconnect functionality.
  • the MCU receives a signal sent by a CGM connected thereto, and calculates an actually required infusion speed according to a CGM lookup table preset in the MCU.
  • the micro lead screw pump A comparison unit for comparing an infusion rate of the micro-screw pump with the actual required infusion rate, the MCU adjusting a rotational speed of the lead screw according to a comparison data feedback of the comparison unit.
  • the motor is a DC motor or a stepper motor.
  • a transmission connecting the motor and the lead screw is included.
  • a slide or guide rod is included, the slide or guide rod being parallel to the lead screw, the drive head sliding within the slide or sliding along the guide rod.
  • a backflushing device is included that is located on the lead screw.
  • the micro lead screw pump includes a lead screw and a driving head connected to the lead screw, and the lead screw rotates clockwise or counterclockwise, thereby driving the driving head to push the sleeve to move in the accumulator, the method include:
  • At least one permanent magnet on the lead screw so as to be rotatable coaxially with the lead screw, and mounting a position of the magnetoresistance rotation angle sensor in a unidirectional and saturated region of a magnetic field generated by the at least one permanent magnet;
  • An MCU that controls the steering and speed of the lead screw according to the signal feedback of the magnetoresistive rotation angle sensor is installed.
  • the magnetoresistive rotation angle sensor is an AMR, GMR or TMR sensor.
  • the conventional stepper motor can be used without using an expensive stepping motor according to the present invention, the cost of the insulin pump is reduced.
  • the application of a low-power magnetoresistance rotation angle sensor also reduces the power consumption of the insulin pump and reduces the frequency of charging, which is an important improvement for the battery-powered insulin pump and is convenient to use.
  • the insulin pump of the present invention has the characteristics of high sensitivity, high reliability, low power consumption, low cost and convenient use.
  • Figure 1 is a top plan view of an insulin pump
  • FIG. 2 is a schematic view of a permanent magnet and its magnetization direction
  • FIG. 3 is a schematic diagram of the MCU control
  • Figure 4 is a schematic diagram of a magnetoresistive sensor information management unit
  • Figure 5 is a conversion curve.
  • FIG. 1 is a top plan view of a micro lead screw pump or insulin pump 2. It includes a motor 52, a lead screw 22 driven by a motor 52, and a drive head 18 that is mounted within the pump casing 15.
  • the pump box 15 has a lid 35.
  • the reservoir 4 has a sleeve 8 that is movable therein.
  • a locking interface 3 (Luer lock) connects the reservoir 4 to the interface 5 of the infusion tube, and the interface 5 of the infusion tube is connected to a hose for delivering insulin to the patient.
  • One end of the lead screw 22 connected to the motor 52 is rotatably fixed to the front base 16A, and the other end is rotatably fixed to the rear base 16B.
  • the lead screw 22 is coupled to the drive head 18 via the linkage rod 61 to convert its rotation into translation of the drive head 18, and can have internal threads that match the external threads of the lead screw 22.
  • the nut 7 rotates.
  • the nut 7 is fixed to the pump casing 15.
  • the motor 52 drives the lead screw 22 to rotate in the nut 7 clockwise or counterclockwise by a mechanical transmission that can change the rotational speed, including one or more reduction gears 13 and gears 31, so that the lead screw 22 drives the drive head 18
  • the motion is repeated in a straight line in a direction parallel to the slide 17.
  • the slide 17 is a groove that allows the drive head 18 to slide therein, which is parallel to the lead screw 22.
  • a pulley and a transmission belt may be used instead of the gear 31 and the reduction gear 13.
  • the backflushing device 19 is mounted on the lead screw 22 to prevent backlash from moving.
  • the stabilizing guide bar may be one or plural.
  • the motor 52 can be a DC motor, an AC motor, a stepper motor, or a servo motor.
  • the miniature lead screw pump further includes a magnetoresistive rotation angle sensor 28 and at least one permanent magnet 30 that rotates coaxially with the lead screw 22, and the magnetoresistive rotation angle sensor 28 is stationary and capable of sensing a magnetic field generated by the permanent magnet 30.
  • the drive head 18 has a pair of reservoir clamps 14 for fixing different diameters of the reservoir 4 on the same or different central axis of the syringe for holding the sleeve 8, so that when the lead screw 22 is rotated in the nut 7 At the same time, the drive head 18 moves linearly in the direction of the slide 17, thereby urging the sleeve 8 to move in the reservoir 4.
  • a pair of syringe clamps 12 are mounted on the pump casing 15 to hold the reservoirs 4 of different diameters on the same or different center axis of the injector.
  • FIG. 2A is a schematic cross-sectional view showing the positional relationship between the magnetoresistance rotation angle sensor 28 and the permanent magnet 30, and FIG. 2B-D is a schematic view showing the magnetization direction of the permanent magnet 30.
  • the lead screw 22 has a long axis 100 oriented in the Z-axis direction, perpendicular to the XY plane, passing through the center of the permanent magnet 30, and being coaxial with the permanent magnet 30.
  • the central axis of the permanent magnet 30 and the central axis of the lead screw 22 pass through the center of the magnetoresistance rotation angle sensor 28.
  • the magnetoresistance rotation angle sensor 28 is a two-axis rotary magnetic sensor or two orthogonal single-axis rotation sensors, and may be a linear sensor or a dual-axis linear sensor.
  • the magnetoresistance rotation angle sensor 28 is an AMR, GMR, or TMR sensor.
  • Figures 2B, 2C and 2D show partially permanent magnets suitable for use in the present invention.
  • the shape of the permanent magnet 30 is a disc shape, a ring shape or a square shape, which is an integral permanent magnet or a split permanent magnet; the permanent magnet 30 may also be two pieces, each of which has a plurality of different magnetic poles.
  • the surface area of the magnetoresistive rotation angle sensor 28 in the XY plane is smaller than the area covered by the permanent magnet 30 in the XY plane.
  • the permanent magnet 30 is magnetized in the diameter or diagonal direction, and its magnetization direction is perpendicular to the Z-axis direction or the long-axis direction of the lead screw 22.
  • Disc-shaped, ring-shaped permanent magnets are magnetized in the diameter direction, and square permanent magnets are magnetized in the diagonal direction.
  • the permanent magnet 30 may be located on the lead screw 22 away from the end of the motor 52 or at the same end as the motor 52. If the permanent magnets 30 are two pieces, the two permanent magnets are respectively located at both ends of the lead screw 22 or placed in a string at the same end of the lead screw 22.
  • the permanent magnet 30 may be located near the magnetoresistance rotation angle sensor 28 or may be remote. If two permanent magnets are placed in series at the same end of the lead screw 22, the magnetoresistive rotation angle sensor 28 can be located near or away from the lead screw.
  • the magnetoresistive rotation angle sensor 28 is located in a unidirectional and saturated region of the magnetic field of the permanent magnet 30.
  • FIG. 3 is a control schematic diagram of the MCU 50.
  • the insulin pump 2 includes an MCU 50 that receives signals from a magnetoresistive rotation angle sensor 28 and controls the steering and speed of the motor 52 via a motor controller/motor control unit 48 coupled thereto.
  • the MCU 50 is also coupled to an operating keypad 56, a display 60 and a battery 64. Display 60 and keyboard 56 are located on cover 35.
  • the motor controller 48 is also used to monitor the output signal of the magnetoresistive rotation angle sensor 28, and if a predetermined sleeve position and infusion speed is found, the motor controller 48 activates the alarm 54 connected thereto.
  • the MCU 50 displays information that is known to the user of the insulin pump 2 on the display screen 60.
  • the user can also communicate with the insulin pump 2 via a keyboard 56 connected to the MCU 50.
  • the MCU 50 is coupled to the force sensor 51, which can detect the force applied to the reservoir 4, and when the force exceeds the set value, the force sensor 51 activates the alarm 54 via the motor controller 48.
  • a typical design of the force sensor 51 is a bridge structure that uses analog signal-to-digital signal conversion (ADCs) with differentially programmable gain amplification inputs or ADCs and external differential instrumentation for signal conditioning.
  • ADCs analog signal-to-digital signal conversion
  • Battery 64 provides the electrical power required by the electrical components and motor 52.
  • the battery display depends on a simple battery voltage or temperature sensor 27.
  • the voltage or temperature reading is digitized at ADC 23.
  • the MCU 50 will receive the digitized data, process the data and use the pre-stored lookup table to determine the remaining charge.
  • the battery level is displayed on the display 60; when the battery is too low, the alarm 54 will sound an alarm.
  • the power management unit 66 connected to the battery 64 converts the power supply to the low power consumption state when the power supply is turned off or when the insulin pump 2 is not in use.
  • the simplest way to generate a power-on reset signal is to monitor the logic supply.
  • the logic voltage rises above its threshold, and the multi-voltage monitor resets the watchdog 59 connected to the power management unit 66 to begin the reset phase, ensuring that the MCU 50 is turned on in sequence.
  • the multi-voltage monitoring reset watchdog 59 continues to detect any possible short-term power supply problems or power outages.
  • the existing multi-voltage monitoring reset watchdog 59 on the market can monitor two, three or even four supply voltages.
  • Display 60 When the user enters information, there should be a visual or audible signal.
  • Display 60 provides insulin dose and infusion speed, remaining charge, time and date, prompts and system alarms (ie, blockage or low amount of residual insulin).
  • Display 60 also provides self-test information upon power up.
  • the sounder 33 must have a self-test function that can accept sound by indirectly monitoring the impedance of the miniature horn or by placing a loudspeaker next to the miniature horn to confirm that the sound is at an appropriate level.
  • An automatic amplifier 35 connected to the sounder 33 is used to adjust the volume.
  • the display screen 60 can be a touch screen; if the display screen 60 is a touch screen, it is preferably placed on the inside of the lid 35.
  • Insulin pump 2 requires visual and audible alerts when an error is detected, a specified time has elapsed, or any event requiring an alarm has occurred.
  • the alarm 54 will alarm when the following events occur: low battery, low battery, low insulin, no insulin in the insulin bottle, excess of insulin, pump pause, pump not working (can have many different conditions), blockage Wait.
  • a single LED can also be used to indicate the operating state of insulin pump 2, red is not normal, green is normal.
  • the electrostatic protection 37 is achieved by an electronic device with built-in protection or electrostatic discharge (ESD) line protection.
  • ESD electrostatic discharge
  • Data port 39 allows for data transfer and download of upgrade software, which also allows historical files to be entered into the application software for the physician to assist with the treatment.
  • a wired and/or wireless data communication interconnect module can also be set up in the MCU 50.
  • the clock source 53 and the radio frequency link 55 receive data on the glucose concentration in the patient from the CGM 45. If CGM45 is used, the signal can be accepted using the Bluetooth ISM-band.
  • CGM 45 provides glucose concentration in the patient.
  • the MCU 50 presets a CGM lookup table that provides an indication of the glucose concentration and insulin input rate in the patient.
  • the MCU 50 receives the signal from the CGM 45 connected thereto and calculates the actually required infusion rate based on the CGM lookup table preset in the MCU 50.
  • the MCU 50 has a comparison unit 47.
  • the MCU 50 converts the rotational speed of the lead screw 22 into an insulin infusion rate, and the comparing unit 47 compares the islet infusion rate with the actual required infusion rate according to the glucose concentration in the patient's body on the CGM lookup table, and the MCU 50 adjusts the said according to the result of the comparison.
  • the rotational speed of the lead screw 22 converts the rotational speed of the lead screw 22 into an insulin infusion rate, and the comparing unit 47 compares the islet infusion rate with the actual required infusion rate according to the glucose concentration in the patient's body on the CGM lookup table, and the MCU 50 adjusts the said according to the result of the comparison.
  • the rotational speed of the lead screw 22 converts the rotational speed of the lead screw 22 into an insulin infusion rate
  • a multiplexer or mux 25 is used to select the signal input to the ADC 23.
  • the real-time clock (RTC) 68 is used for real-time recording and program changes, as well as for timekeeping and recording time.
  • VREF21 provides a fixed voltage regardless of the system installed equipment, fluctuations in power supply, temperature changes, and time lapse.
  • a current limiter 33 connected to the MCU 50 limits the upper limit of the current used to prevent a short circuit or the like from occurring.
  • MCU A 50-connected level shifter 29 provides a switching interface for components that use different voltages.
  • the memory card 46 is a data storage device for the electronic flash memory used by the current limiter 33 and the level shifter 29.
  • the MCU 50 can further adjust the speed of the motor 52 according to the signal feedback of the magnetoresistance rotation angle sensor 28 through the motor controller 48, thereby enabling the infusion. The speed is more precise.
  • FIG. 4 shows the MCU The principle of the magnetoresistance rotation angle sensor information management unit 49 in 50.
  • the magnetoresistance rotation angle sensor information management unit 49 includes a motor rotation number counting unit 66, a lead screw position unit 70, a sleeve position unit 74, a solution volume unit 68, and a flow rate unit 72, and the preset reservoir 4
  • the conversion table of the infusion volume and the position of the sleeve 8 in the accumulator 4 the conversion table of the position of the sleeve 8 of the accumulator 4 in the accumulator 4 and the position of the lead screw 22, the number of revolutions of the lead screw 22 and The calculation procedure for the position of the lead screw 22.
  • MCU 50 can be used to calibrate the insulin pump 2 and calculate the volume and speed of the infusion.
  • the lead screw 22 rotates, and the sleeve 8 moves accordingly.
  • the motor rotation number counting unit 66 records the number of turns and time of the lead screw 22 rotation. The calculation of the number of turns of the lead screw 22 and the number of revolutions of the lead screw 22 and the position of the lead screw 22 preset in the MCU 50,
  • the lead screw position unit 70 can calculate the position of the lead screw 22 or its linear distance moving in the Z-axis direction; at the same time, the conversion table of the position of the lead screw 22 and the position of the sleeve 8 in the accumulator 4, the sleeve
  • the position unit 74 can know the position of the sleeve 8 in the reservoir 4; further, the solution volume unit 68 can be informed of the infusion by the conversion table of the diameter of the reservoir 4 and the position of its sleeve 8 in the reservoir 4.
  • the volume or remaining liquid volume; the flow rate unit 72 can calculate the speed of the infusion according to the volume and time of the infusion described above.
  • the flow rate unit 72 can record the number of turns and the time of rotation of the lead screw 22 according to the conversion table and the motor rotation number counting unit 66. , calculate the speed of the infusion faster.
  • the MCU 50 instructs the motor controller 48 to adjust the steering and speed of the motor 52.
  • the MCU 50 will instruct motor controller 48 to adjust the steering and speed of motor 52.
  • the magnetoresistive rotation angle sensor information management unit 49 records the position of the magnetoresistive sensor 28 detecting the sleeve 8 in the accumulator 4, and then Add a known volume of liquid to the reservoir 4 and enter the volume value into the MCU In 50, the magnetoresistive rotation angle sensor information management unit 49 can obtain the relationship between the liquid volume and the positional relationship of the sleeve 8 in the accumulator 4 and the position of the lead screw 22, and calculate the calibration parameters.
  • FIG. 5 is a conversion curve of the magnetoresistance rotation angle sensor 28.
  • the magnetoresistance rotation angle sensor 28 converts the amplitude of the magnetic field generated by the permanent magnet 30 into an analog voltage signal, and the obtained analog voltage signal can be directly outputted, or can be outputted by converting it into a digital signal by using an analog-to-digital conversion circuit (ADC).
  • ADC analog-to-digital conversion circuit
  • At least one permanent magnet 30 is mounted on the lead screw 22 so as to be rotatable coaxially with the lead screw 22, and the magnetic field generated in at least one permanent magnet 30 is single.
  • a magnetoresistive rotation angle sensor 28 is mounted to a position within the saturation region; and an MCU 50 that controls the rotation and speed of the motor 52 to rotate the lead screw 22 according to the signal feedback of the magnetoresistive rotation angle sensor 28 is mounted.

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  • Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Condensed Matter Physics & Semiconductors (AREA)
  • General Physics & Mathematics (AREA)
  • Diabetes (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Reciprocating Pumps (AREA)

Abstract

一种微型导螺杆泵（2），其使用磁电阻传感器（28）和MCU（50）监测导螺杆（22）的转动，并通过电机控制器（48）控制反馈控制导螺杆（22）的转向和速度，从而控制向病人的输液速度。此外该微型导螺杆泵（2）可以根据CGM（45）监测的病人的血糖的浓度控制胰岛素的输液速度。该微型导螺杆泵（2）具有高灵敏度，高可靠性，低功耗，低成本和方便使用的特点。

Description

一种使用磁电阻传感器的微型导螺杆泵及其制造方法 技术领域
本发明涉及一种医疗器械，具体地说，涉及一种驱动胰岛素泵的微型导螺杆泵。
背景技术
随着全球范围内糖尿病人的数量增加，胰岛素泵的需求也在增长。胰岛素泵需根据糖尿病人的需要持续地注射基本剂量胰岛素或注射大剂量的胰岛素以纠正饭后血糖过高的情况。由于胰岛素泵可以根据糖尿病人的基本剂量分布图注射胰岛素，所以病人血液内的血糖浓度更能保持相同水平，病人的器官承受较小的压力。也因前述的原因，胰岛素泵必须能够连续地注射小剂量的胰岛素（大约0.1-1.0cm3/天），而且，能在较宽的范围内调整注射的速度（即基本剂量速度和大剂量速度），以适于病人的不同需要。正因如此，市场上很多的胰岛素泵是使用微型导螺杆泵驱动；由微型导螺杆泵驱动套筒在储液器内移动，将储液器内的胰岛素输入病人体内。其中，转动导螺杆的电机是可以精确控制转速的步进电机。一方面使用步进电机的代价是胰岛素泵的高价，一台胰岛素泵的价格可高达5000美元，其极大地限制了病人的使用。另一方面，步进电机的控制输液速度的精度取决于的相数和拍数，相数和拍数越多，其精度越高；步进电机在低速时易出现低频振动现象；启动频率过高或负载过大则易丢步或出现堵转的现象，停止时转速过高易出现过冲现象。为了降低胰岛素泵的价格，本发明将磁电阻旋转角度传感器和DC电机一起使用从而取代步进电机，降低了的胰岛素泵的成本，改善了胰岛素泵的性能。
发明内容
本发明是关于驱动胰岛素泵的微型导螺杆泵，其使用了磁电阻旋转角度传感器和Continuous glucose monitor（CGM，连续血糖监测仪），配合Micro Control Unit（MCU，微控制器）反馈控制输液速度，取代了用步进式电机控制输液速度的方式。本发明可以使用其它电机取代步进式电机，也可以与步进式电机一起使用，提高了胰岛素或其它液体的输液速度的精度和可靠性。
一种微型导螺杆泵，安装于泵盒内，所述微型导螺杆泵包括电机，所述电机驱动导螺杆和与所述导螺杆相连的驱动头，所述导螺杆在有与导螺杆的螺纹反向的螺纹的螺母中转动，从而带动所述驱动头推动套筒在储液器内移动，所述微型导螺杆泵还包括
与所述导螺杆同轴转动的至少一块永磁体；
能够感应所述至少一块永磁体产生的磁场的磁电阻旋转角度传感器，并且所述磁电阻旋转角度传感器在所述至少一块永磁体产生的磁场单向并饱和的区域内；
接收所述磁电阻旋转角度传感器的信号并根据所述磁电阻旋转角度传感器的信号反馈控制所述导螺杆的转向和速度的MCU 。
优选地， 所述磁电阻旋转角度传感器为双轴旋转磁传感器、两个正交的单轴旋转传感器、单轴或双轴线性磁传感器中的一种 。
优选地， 所述磁电阻旋转角度传感器是AMR，GMR或TMR传感器 。
优选地， 所述永磁体的中心轴线和所述导螺杆的中心轴线穿过所述磁电阻旋转角度传感器的中心 。
优选地，所述至少一块永磁体为一块一体式永磁体或分体式永磁体，呈圆盘形、环形或方形。
优选地，所述至少一块永磁体为两块永磁体，每块所述永磁体有不同的多个磁极，所述两块永磁体分别位于所述导螺杆的两端或成串放置于所述导螺杆的同一端 。
优选地， 所述MCU通过电机控制器控制所述电机的转向和转速 。
优选地， 所述MCU包括磁电阻传感器信息管理单元，所述磁电阻传感器信息管理单元包括监控电机旋转角度的电机旋转角度计数单元，计算导螺杆的直线移动位置的导螺杆位置单元和/或计算套筒在储液器中的位置的套筒位置单元，计算储液器中溶液的体积的溶液体积单元，将所述导螺杆的转动速度转换成所述储液器的输液速度的流速单元 。
优选地，所述MCU具有有线和/或无线数据通信互联功能。
优选地，所述MCU接收与其相连接的CGM发出的信号，并根据预置于所述MCU中的CGM查询表计算实际所需的输液速度。
优选地， 所述微型导螺杆泵 包括比较所述微型导螺杆泵的输液速度与所述实际所需的输液速度的比较单元，所述MCU根据所述比较单元的比较的数据反馈调整所述导螺杆的转动速度。
优选地，所述电机是DC电机或步进电机。
优选地，包括连接所述电机和所述导螺杆的传动装置。
优选地，包括滑道或导向杆，所述滑道或导向杆平行于所述的导螺杆，所述驱动头在所述滑道内滑动或沿所述导向杆滑动。
优选地，包括反后冲装置，其位于所述导螺杆上。
一个制造上述微型导螺杆泵的方法， 所述微型导螺杆泵包括导螺杆和与所述导螺杆相连的驱动头，所述导螺杆正时针或逆时针转动，从而带动所述驱动头推动套筒在储液器内移动，所述方法包括：
将至少一块永磁体安装在所述导螺杆上使其可与导螺杆同轴转动，并且安装磁电阻旋转角度传感器在所述至少一块永磁体产生的磁场的单向并饱和的区域内的位置；
安装根据所述磁电阻旋转角度传感器的信号反馈控制所述导螺杆的转向和速度的MCU 。
优选地，所述磁电阻旋转角度传感器是AMR，GMR或TMR传感器。
由于根据本发明，可以不使用昂贵的步进式电机，而使用普通DC电机，因此降低了胰岛素泵的成本。此外，低功耗的磁电阻旋转角度传感器的应用也会降低胰岛素泵的功耗，减少充电的频率，这对通常是由电池供电的胰岛素泵来说是一个重要的改进，方便了使用。综上，本发明的胰岛素泵具有高灵敏度，高可靠性，低功耗，低成本和方便使用的特点。
附图说明
图1为胰岛素泵的俯视示意图；
图2为永磁体及其磁化方向示意图；
图3为MCU控制原理图；
图4为磁电阻传感器信息管理单元原理图；
图5为转化曲线。
具体实施方式
上述说明仅是本发明技术方案的概述。为了能够更清楚地说明本发明的技术手段，并可依照说明书的内容实施本发明，以下结合实施例并配合附图对本发明进行了详细地说明。本发明的具体实施方式由以下实施例详细地给出。
图1是微型导螺杆泵或胰岛素泵2的俯视示意图。其包括电机52，由电机52驱动的导螺杆22和驱动头18，其安装于泵盒15内。泵盒15有盒盖35。储液器4有一能够在其中移动的套筒8。锁紧接口3（Luer lock）连接储液器4和输液管的接口5，输液管的接口5连接到向病人体内输胰岛素的软管。
导螺杆22连接电机52的一端可转动地固定在前基座16A上，另一端可转动地固定在后基座16B上。为了能够带动驱动头18，导螺杆22通过连动杆61连接在驱动头18上从而将其转动转换为驱动头18的平动，并可在具有与导螺杆22的外螺纹相匹配的内螺纹的螺母7中旋转。螺母7固定于泵盒15上。电机52通过可以改变旋转速度的机械传动装置，包括一个或多个减速齿轮13以及齿轮31，来带动导螺杆22正时针或反时针地在螺母7中转动，从而，导螺杆22带动驱动头18沿与滑道17平行的方向呈直线反复运动。滑道17是允许驱动头18在其中滑动的槽，其平行于导螺杆22。在电机52，减速齿轮13，齿轮31之间，为了降低成本，也可以使用滑轮和传动带取代齿轮31和减速齿轮13。反后冲装置19安装在导螺杆22上防止齿隙游动。
也可以不使用滑道17，而采用导向杆起稳定和导向作用，该导向杆平行于导螺杆22。起稳定作用的导向杆可以是一个，也可以是多个。
电机52可以是直流电机，交流电机，步进电机，或伺服电机等。
微型导螺杆泵还包括磁电阻旋转角度传感器28和与导螺杆22同轴旋转的至少一个永磁体30，磁电阻旋转角度传感器28静止不动并能够感应永磁体30产生的磁场。
驱动头18上有一对可固定不同直径的储液器4位于同一或不同一注射器中心轴线上的储液器夹子14，用以把住套筒8，所以，当导螺杆22在螺母7中转动时，驱动头18沿滑道17的方向呈直线运动，从而推动套筒8在储液器4中移动。泵盒15上安装有一对针筒夹子12可固定不同直径的储液器4位于同一或不同一注射器中心轴线上。
图2A为磁电阻旋转角度传感器28与永磁体30的位置关系剖面示意图和图2B-D为永磁体30的磁化方向示意图。导螺杆22有一长轴100，其方向为Z轴方向，垂直于XY平面，穿过永磁体30的中心，并与永磁体30共轴。永磁体30的中心轴线和导螺杆22的中心轴线穿过磁电阻旋转角度传感器28的中心。磁电阻旋转角度传感器28是双轴旋转磁传感器或者两个正交的单轴旋转传感器，也可以是一个线性传感器或双轴线性传感器。磁电阻旋转角度传感器28是AMR，GMR，或TMR传感器。图2B，2C和2D显示了部分适用于本发明的永磁体。永磁体30的形状为圆盘形、环形或方形，其为一块一体式永磁体或分体永磁体；永磁体30也可以是两块，每块永磁体有不同个数的多个磁极。磁电阻旋转角度传感器28在XY平面的表面面积小于所述永磁体30在XY平面覆盖的面积。永磁体30被沿直径或对角线方向磁化，并且其磁化方向垂直于Z轴方向或导螺杆22的长轴方向。圆盘形、环形永磁体被沿直径方向磁化，而方形永磁体被沿对角线方向磁化。永磁体30可以位于导螺杆22上远离电机52一端，也可以与电机52在同一端。如果永磁体30是两块，则两块永磁体分别位于导螺杆22的两端或成串放置于导螺杆22的同一端。永磁铁30可以位于磁电阻旋转角度传感器28附近，也可以远离。如果两块永磁体成串放置于导螺杆22的同一端，磁电阻旋转角度传感器28可以位于导螺杆附近也可以远离。磁电阻旋转角度传感器28位于永磁体30的磁场单向并饱和区域内。
图3是MCU 50的控制原理图。胰岛素泵2包括MCU 50，它从磁电阻旋转角度传感器28接收信号，并通过与其相连的电机控制器/电机控制单元48控制电机52的转向和速度。此外，MCU 50还与操作键盘56，显示器60和电池64相连。显示屏60和键盘56位于盒盖35上。
电机控制器48还用于监控磁电阻旋转角度传感器28的输出信号，如果发现预先设定的套筒位置和输液速度，电机控制器48就会激发与其相连接的警报器54。
MCU 50 将需要胰岛素泵2使用者知道的信息显示在显示屏60上。使用者也能通过与MCU50相连的键盘56与胰岛素泵2交流。MCU50与力传感器相连51，力传感器51可以检测施加于储液器4上的力，当该力超过设定值时，力传感器51就会通过电机控制器48激发警报器54。力传感器51的典型设计是桥式结构，使用模拟信号-数字信号转换（ADCs）与差分可编程的增益放大输入或ADCs与用于信号调节的外置的差分仪器放大。
电池64提供电器元件和电机52所需的电力。电量显示依赖于简单的电池电压或温度传感器27。电压或温度的读数在ADC 23数字化。MCU 50将会接收数字化后的数据后处理这些数据并使用预存的查询表决定剩余的电量。电量显示在显示屏60上；当电量过低时，警报器54就会发出警报。
与电池64相连的电力管理单元66在关掉电力供应或当胰岛素泵2不使用时，将其转换成低功耗的状态。
在多电压的体系中，最简单地产生上电复位信号的方法是监视逻辑电源。在上电时，逻辑电压升至高于它的门槛值，与电力管理单元66相连的多电压监控复位看门狗59开始复位阶段，确保按顺序开启MCU50。只要主机的电源的电压在规定的规格内，多电压监控复位看门狗59继续检测任何可能短时间的电力供应问题或停电。市场上现有的多电压监控复位看门狗59能监测两个，三个，甚至四个供电电压。
当使用者输入信息时，应有视觉或听觉信号。显示屏60提供胰岛素的剂量和输液速度，剩余的电量，时间和日期，提示和系统的警报（即堵塞或剩余胰岛素量低）。显示屏60也会在上电时提供自测的信息。声播器33必须有自测功能，这种自测功能可以通过间接地监视微型喇叭的阻抗或在微型喇叭旁放一个扩音器，接受声音，以确认声音是在合适的水平。与声播器33连接的自动放大器35用于调整音量。显示屏60可以是触摸屏；如果显示屏60是触摸屏，其最好置于盒盖35的内侧。
胰岛素泵2要求，当发现错误，规定的时间到了或任何需警报的事件发生时，提供视觉和听觉警报。警报器54在如下事件发生时会报警：电量低，电池不工作，胰岛素量低，胰岛素瓶内无胰岛素，超过了胰岛素的量，泵暂停，泵不工作（可以有很多不同的情况），堵塞等。单个LED也可以用来显示胰岛素泵2的运行状态，红色是不正常，绿色是正常。
静电保护37是通过有内置保护的电子装置或静电放电（ESD）线保护实现的。
数据端口39允许数据转移和下载升级软件，它也允许历史文件输入到应用软件，以便医生帮助治疗。
MCU 50 中还可以设置有线和/或无线数据通信互联模块。时钟脉冲源53和射频链接55从CGM 45接受病人体内葡萄糖浓度的数据。如果使用了CGM45，可以使用蓝牙ISM-band接受信号。CGM 45提供病人体内葡萄糖浓度。MCU 50预置了CGM查询表，提供病人体内葡萄糖浓度和胰岛素输入速度的查询。MCU50接收与其相连接的CGM45发出的信号，并根据预置于MCU50中的CGM查询表计算实际所需的输液速度。MCU 50有比较单元47。MCU50将导螺杆22的转动速度转换成胰岛素输液速度，比较单元47则比较胰岛输液速度与CGM查询表上根据病人体内的葡萄糖浓度规定的实际所需输液速度，MCU 50根据比较的结果调整所述导螺杆22的转动速度。
多路复用器（multiplexer or mux）25用于选择输入到ADC 23的信号。
实时时钟（real-time clock，RTC）68用于实时记录和程序的变化，也用于报时和记录时间。
无论系统安装的装置，电力供应的波动，温度变化，时间流逝如何，VREF21提供固定的电压。
与MCU 50相连的限流器33限制使用电流的上限，以防止短路或者类似的问题发生。与MCU 50相连的电平转换器29为使用不同电压的元件提供转换界面。记忆卡46是供限流器33和电平转换器29使用的电子闪存的数据存储装置。
在使用步进电机时，除了电机52自身有调节电机转速的功能以外，MCU50还可以进一步通过电机控制器48，根据磁电阻旋转角度传感器28的信号反馈调控电机52的速度，由此可使输液的速度更精确。
图4显示了MCU 50中的磁电阻旋转角度传感器信息管理单元49的原理。磁电阻旋转角度传感器信息管理单元49包括的电机旋转圈数计数单元66，导螺杆位置单元70，套筒位置单元74，溶液体积单元68和流速单元72，并预置了的储液器4的输液体积和套筒8在储液器4内的位置的转换表、储液器4的套筒8在储液器4中的位置与导螺杆22位置的转换表、导螺杆22旋转圈数与导螺杆22位置的计算程序。
在使用胰岛素泵2时，有必要对其进行校准。MCU 50能够用于校准胰岛素泵2，并可计算输液的体积和速度。导螺杆22转动，套筒8随之移动，根据磁电阻旋转角度传感器28的信号，电机旋转圈数计数单元66记录导螺杆22转动的圈数和时间。由导螺杆22旋转的圈数和预置在MCU50里的导螺杆22旋转圈数与导螺杆22位置的计算程序（algorithm），
导螺杆直线移动的距离=（旋转角度）*（纵向丝杠螺距）
导螺杆位置单元70就可以计算导螺杆22的位置或其在Z轴方向移动的直线距离；同时，由导螺杆22的位置和套筒8在储液器4中的位置的转换表，套筒位置单元74可以知道套筒8在储液器4中的位置；进一步，溶液体积单元68，可以由储液器4的直径和其套筒8在储液器4内的位置的转换表知道输液的体积或剩余的液体体积；流速单元72根据前述的输液的体积和时间，即可计算输液的速度。如果预置了导螺杆22旋转圈数和的储液器4的输液体积的转换表，流速单元72就可以根据此转换表和电机旋转圈数计数单元66记录导螺杆22转动的圈数和时间，更快地计算输液的速度。当输液速度过高或过低地偏离设定值时，MCU50会指示电机控制器48调整电机52的转向和速度。根据套筒位置单元74提供的套筒8在储液器4中的位置，或根据溶液体积单元68的输液体积的数据，MCU 50会指示电机控制器48调整电机52的转向和速度。
胰岛素泵2的校准过程：将空的储液器4置于注射器泵2上，由磁电阻旋转角度传感器信息管理单元49记录磁电阻传感器28检测套筒8在储液器4中的位置，然后，在储液器4中加入已知体积的液体，并将该体积数值输入到MCU 50中，磁电阻旋转角度传感器信息管理单元49就可以得到液体体积和套筒8在储液器4中的位置关系及与导螺杆22位置的关系，计算校准参数。
图5为磁电阻旋转角度传感器28的转换曲线。当永磁体30随着导螺杆22沿旋转方向101旋转时，磁电阻旋转角度传感器28所检测到的X轴和Y轴磁场分量随旋转角度的变化曲线分别如图4中的曲线41和42所示。磁电阻旋转角度传感器28将永磁体30所产生的磁场幅度转化为模拟电压信号，所得到的模拟电压信号可以直接输出，也可以通过用模拟数字转换电路（ADC）转换成数字信号后输出。根据输出的信号便可以得知永磁体30的旋转角度，也即导螺杆22的旋转角度。
上述微型导螺杆泵/胰岛素泵2的制造方法概述为：将至少一块永磁体30安装在导螺杆22上使其可与导螺杆22同轴转动，并且在至少一块永磁体30产生的磁场的单向和饱和区域内的位置安装磁电阻旋转角度传感器28；再安装根据磁电阻旋转角度传感器28的信号反馈控制电机52旋转导螺杆22的转向和速度的MCU50。
以上所述仅为本发明的优选实施例而已，并不用于限制本发明，对于本领域的技术人员来说，本发明可以有各种更改和变化，本发明中的实施也可以进行不同组合变化，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (17)

  1. 一种微型导螺杆泵，安装于泵盒内，所述微型导螺杆泵包括电机，所述电机驱动导螺杆和与所述导螺杆相连的驱动头，所述导螺杆在有与导螺杆的螺纹反向的螺纹的螺母中转动，从而带动所述驱动头推动套筒在储液器内移动，其特征在于，所述微型导螺杆泵还包括
    与所述导螺杆同轴转动的至少一块永磁体；
    能够感应所述至少一块永磁体产生的磁场的磁电阻旋转角度传感器， 并且所述磁电阻旋转角度传感器在所述至少一块永磁体产生的磁场单向并饱和的区域内；
    接收所述磁电阻旋转角度传感器的信号并根据所述磁电阻旋转角度传感器的信号反馈控制所述导螺杆的转向和速度的 MCU 。
  2. 根据权利要求 1 所述的微型导螺杆泵，其特征在于，所述磁电阻旋转角度传感器为双轴旋转磁传感器、两个正交的单轴旋转传感器、单轴或双轴线性磁传感器中的一种。
  3. 根据权利要求 1 所述的微型导螺杆泵，其特征在于，所述磁电阻旋转角度传感器是 AMR ， GMR 或 TMR 传感器。
  4. 根据权利要求 1 所述的微型导螺杆泵，其特征在于，所述永磁体的中心轴线和所述导螺杆的中心轴线穿过所述磁电阻旋转角度传感器的中心。
  5. 根据权利要求 1 至 4 的任一项所述的微型导螺杆泵，其特征在于，所述至少一块永磁体为一块一体式永磁体或分体式永磁体，呈圆盘形、环形或方形。
  6. 根据权利要求 1 至 4 任一项所述的微型导螺杆泵，其特征在于，所述至少一块永磁体为两块永磁体，每块所述永磁体有不同的多个磁极，所述两块永磁体分别位于所述导螺杆的两端或成串放置于所述导螺杆的同一端。
  7. 根据权利要求 1 所述的微型导螺杆泵，其特征在于，所述 MCU 通过电机控制器控制所述电机的转向和转速。
  8. 根据权利要求 7 所述的微型导螺杆泵，其特征在于，所述 MCU 包括磁电阻传感器信息管理单元，所述磁电阻传感器信息管理单元包括监控电机旋转角度的电机旋转角度计数单元，计算导螺杆的直线移动位置的导螺杆位置单元和 / 或计算套筒在储液器中的位置的套筒位置单元，计算储液器中溶液的体积的溶液体积单元，将所述导螺杆的转动速度转换成所述储液器的输液速度的流速单元。
  9. 根据权利要求 1 或 7 所述的微型导螺杆泵，其特征在于，所述 MCU 具有有线和 / 或无线数据通信互联功能。
  10. 根据权利要求 1 ， 7 或 8 任一项所述的微型导螺杆泵，其特征在于，所述 MCU 接收与其相连接的 CGM 发出的信号，并根据预置于所述 MCU 中的 CGM 查询表计算实际所需的输液速度。
  11. 根据权利要求 10 所述的微型导螺杆泵，其特征在于，所述微型导螺杆泵包括比较所述微型导螺杆泵的输液速度与所述实际所需的输液速度的比较单元，所述 MCU 根据所述比较单元的比较的数据反馈调整所述导螺杆的速度。
  12. 根据权利要求 1 所述的微型导螺杆泵，其特征在于，所述电机是 DC 电机或步进电机。
  13. 根据权利要求 1 所述的微型导螺杆泵，其特征在于，所述微型导螺杆泵包括连接所述电机和所述导螺杆的传动装置。
  14. 根据权利要求 1 所述的微型导螺杆泵，其特征在于，所述微型导螺杆泵包括滑道或导向杆，所述滑道或导向杆平行于所述的导螺杆，所述驱动头在所述滑道内滑动或沿所述导向杆滑动。
  15. 根据权利要求 1 所述的微型导螺杆泵，其特征在于，包括反后冲装置，其位于所述导螺杆上。
  16. 一个制造如权利要求 1 所述的微型导螺杆泵的方法，所述微型导螺杆泵包括导螺杆和与所述导螺杆相连的驱动头，所述导螺杆正时针或逆时针转动，从而带动所述驱动头推动套筒在储液器内移动，其特征在于，所述方法包括：
    将至少一块永磁体安装在所述导螺杆上使其可与导螺杆同轴转动，并且安装磁电阻旋转角度传感器在所述至少一块永磁体产生的磁场的单向并饱和的区域内的位置；
    安装根据所述磁电阻旋转角度传感器的信号反馈控制所述导螺杆的转向和速度的 MCU 。
  17. 根据权利要求 16 所述的制造微型导螺杆泵的方法，其特征在于，所述磁电阻旋转角度传感器是 AMR ， GMR 或 TMR 传感器。
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US10232109B2 (en) 2019-03-19
EP3132820A4 (en) 2017-12-13
JP2017519532A (ja) 2017-07-20
JP6976683B2 (ja) 2021-12-08
EP3132820A1 (en) 2017-02-22
CN103920207A (zh) 2014-07-16

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