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WO2024066185A1 - 一种导管流体动力学参数检测设备 - Google Patents

一种导管流体动力学参数检测设备 Download PDF

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Publication number
WO2024066185A1
WO2024066185A1 PCT/CN2023/078035 CN2023078035W WO2024066185A1 WO 2024066185 A1 WO2024066185 A1 WO 2024066185A1 CN 2023078035 W CN2023078035 W CN 2023078035W WO 2024066185 A1 WO2024066185 A1 WO 2024066185A1
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WO
WIPO (PCT)
Prior art keywords
catheter
bracket
pressure
flow rate
infusion
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/CN2023/078035
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English (en)
French (fr)
Inventor
张海军
支树迪
袁坤山
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shandong Branden Medical Devices Co Ltd
Original Assignee
Shandong Branden Medical Devices Co Ltd
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
Application filed by Shandong Branden Medical Devices Co Ltd filed Critical Shandong Branden Medical Devices Co Ltd
Priority to US18/277,777 priority Critical patent/US20250010020A1/en
Publication of WO2024066185A1 publication Critical patent/WO2024066185A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • 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
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/02028—Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A61B5/02152—Measuring pressure in heart or blood vessels by means inserted into the body specially adapted for venous pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • 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
    • 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
    • A61M5/44—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 having means for cooling or heating the devices or media
    • 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
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1588—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
    • 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
    • A61M2205/10—General characteristics of the apparatus with powered movement mechanisms
    • A61M2205/103—General characteristics of the apparatus with powered movement mechanisms rotating
    • 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
    • A61M2205/3327—Measuring
    • 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
    • A61M2205/3331—Pressure; Flow
    • 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
    • A61M2205/3368—Temperature
    • 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
    • A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates
    • 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
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • 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
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/02—Equipment for testing the apparatus

Definitions

  • the invention relates to the technical field of medical catheter detection equipment, and mainly to a catheter fluid dynamics parameter detection device.
  • Central venous catheters, peripherally inserted central venous catheters, and midline catheters are intravascular catheters that can be placed in large veins for a period of time to provide patients with infusion access.
  • long-term catheterization exposes the catheter to some common long-term complications, such as thrombosis, venous stenosis, and insufficient flow.
  • these complications are usually discovered by medical staff only when the symptoms have obviously affected the normal use of the catheter.
  • the catheter is likely to be removed, which not only increases the patient's pain and treatment costs, but also may affect the patient's later treatment (for patients with poor venous conditions) in severe cases, causing the patient to permanently lose the infusion access.
  • Patent CN 104950130A discloses a medical catheter flow rate meter, which obtains the catheter flow rate by weighing the mass of the liquid flowing out of the tail end of the catheter at a certain height, and is used to evaluate the catheter flow rate performance index in the laboratory.
  • the liquid of the device will directly contact the water tank, heating device and delivery pipeline, and the mass of the liquid flowing out of the end of the catheter needs to be collected. Therefore, it cannot be used clinically to detect the fluid dynamic parameters of the vascular access of patients with tubes.
  • the device has only simple calculation functions and cannot record and process the test data, so it is impossible to achieve measurement and evaluation during the entire catheter indwelling time.
  • the present invention provides a catheter fluid dynamics parameter detection device with a simple structure and easy operation.
  • the detection device can be used in clinical practice to detect the fluid dynamics parameters of a catheter located in a blood vessel, perform data processing and analysis, and perform a dual assessment of the catheter status based on personal standards and similar standards, providing a reference for medical staff.
  • the catheter fluid dynamics parameter detection equipment has the following functions:
  • a catheter fluid dynamics parameter detection device comprises a power system, a lifting system, a measuring system, a control and processing system, a constant temperature storage system and an adjustment chair.
  • the power system includes a workbench, a motor and a transmission device; wherein the workbench is located at the bottom of the catheter fluid dynamics parameter detection device, and the motor and the transmission device are fixed inside the workbench.
  • the lifting system includes a bracket, a guide rod, a rolling screw, a movable cross arm and a displacement encoder; wherein the bracket is installed above the workbench, the guide rod and the rolling screw are located inside the bracket, the movable cross arm is connected to the bracket through the guide rod, and the displacement encoder is installed on the top of the bracket.
  • the measurement system includes a mass sensor and a fixing device, the mass sensor is hinged to the movable cross arm, the fixing device is connected below the mass sensor, and the two are suspended in series below the movable cross arm, wherein the mass sensor includes four strain gauges and a DC voltage source.
  • control and processing system includes a computer, a digital collector, a digital controller and a signal line; the computer and the digital collector, and the computer and the digital controller are connected via signal lines; the digital collector includes a multimeter and a digital filter.
  • the computer reduces the drift of the mass sensor by using a principal component analysis (PCA) algorithm; the computer acquires data during use in real time, and performs a dual evaluation of the catheter status according to personal standards and similar standards; the data during the infusion process acquired by the computer in real time include: catheter model, catheter use time, liquid type, infusion pressure, flow rate at the infusion pressure, and complications;
  • /F S *100% and the same type deviation ⁇ AS
  • the third step is to use the least squares method for the series of data groups under the same catheter, the same liquid type and the same flow rate to obtain a set of pressure change curves and functional relationships with product usage time.
  • the constant temperature storage system includes a partition and a constant temperature heating device, wherein the partition is an elastic partition or a bucket-shaped partition; the constant temperature heating device is installed in the workbench and is located directly below the fixing device.
  • the adjustable chair comprises an electric lifting system, a rotating shaft and a handle; the handle is connected to the rotating shaft to control the bending angle of the adjustable chair.
  • the electric lifting system is installed at the bottom of the adjustable chair.
  • the transmission device includes a transmission gear and a transmission sleeve.
  • the transmission sleeve is fixed in the workbench.
  • the transmission gear and the transmission sleeve are integrally formed.
  • the transmission gear is located between the motor and the transmission sleeve.
  • the transmission gear is rollingly connected to the motor and the transmission sleeve respectively.
  • the motor is a servo motor.
  • the power system, displacement encoder and movable cross arm are connected together through a rolling screw, which is installed in a groove of the bracket and passes through a transmission sleeve and is threadedly connected to the transmission sleeve; the end of the rolling screw is threadedly connected to the displacement encoder.
  • the bracket is a " ⁇ " type bracket or a single-arm bracket.
  • the bracket is equipped with an upper limit buckle and a lower limit buckle; the side of the bracket is equipped with position control buttons, including " ⁇ ", " ⁇ ”and They represent up, down, start and pause respectively; a deceleration device is installed on the side where the bracket is connected to the movable cross arm, which is a kind of speed reduction belt or speed reducer.
  • the fixing device is one of a hook or a universal clamp.
  • the computer includes: an operating system, a temperature controller, a position controller and a data processing system; the temperature controller can control the temperature at 36.5 ⁇ 1°C; the input end of the position controller is connected to the digital controller, and the output end is connected to the motor.
  • the digital controller and the displacement encoder are connected via a signal line.
  • the partition is one of an elastic partition and a bucket-shaped partition; the elastic partition is symmetrically installed on both sides of the " ⁇ "-shaped bracket through movable buckles; the bucket-shaped partition is used in conjunction with the single-arm bracket, and the small mouth of the bucket-shaped partition faces downward and is installed on the storage slot.
  • the constant temperature heating device includes a storage groove, a heating device, a temperature sensor and a thermal conductive filler;
  • the storage groove has a depth of not less than 20 cm, a square cross-section, and a side length of not less than 10 cm;
  • the temperature sensor is connected to the input end of the temperature controller, and the heating device is connected to the output end of the temperature controller.
  • the electric lifting system of the adjustable chair can adopt the electric lifting system disclosed in the prior art, and can directly adopt commercially available products.
  • the electric lifting system is composed of a top plate, a sliding rod, a support rod, a movable nail, a conveyor belt buckle, a bidirectional motor, a power transmission belt, a transmission pulley, a bottom rod and a bottom plate; wherein the bidirectional motor is fixed on the bottom plate; a plurality of bottom rods are evenly distributed and fixed on the bottom plate; and the sliding rods are evenly distributed on the top plate, slidably connected to the top plate, and correspond to the bottom rods in the vertical direction.
  • the upper and lower ends of the support rod are rotatably connected to the two sides of the slide rod and the bottom rod through movable nails, one end of the power transmission belt is connected to the upper 1/3 of the support rod through the power transmission belt buckle, and the other end bypasses the transmission pulley and is connected to the bidirectional motor;
  • the height of the chair can be adjusted by driving the support rod to rotate in the same direction through the clockwise or counterclockwise rotation of the bidirectional motor.
  • the catheter is an intracorporeal catheter or an extracorporeal catheter, wherein the intracorporeal catheter is one of a midline catheter, a peripherally inserted central venous catheter, a central venous catheter, and an infusion port, and the extracorporeal catheter is one of an indwelling needle and an infusion set.
  • the detection equipment does not come into contact with liquid and does not affect normal clinical treatment
  • the detection equipment is controlled by computer, with high degree of automation. It adopts principal component analysis algorithm to reduce the drift of mass sensor and increase the detection accuracy.
  • the workbench of the testing equipment is equipped with a constant temperature device, which can maintain the temperature of the infusion liquid at 36.5 ⁇ 1°C, reduce stimulation to the human body, and stabilize the test conditions;
  • This testing equipment provides equipment support for the detection of catheter fluid dynamics parameters and evaluates medical catheters, and can be used as a reference for clinical vascular access status scoring.
  • FIG. 1 is a schematic structural diagram of the front side of the “ ⁇ ” type catheter fluid dynamics parameter detection device.
  • FIG. 2 is a schematic structural diagram of a liftable chair.
  • FIG. 3 is a schematic structural diagram of the side surface of the constant temperature heating device.
  • FIG. 4 is a schematic structural diagram of the side surface of the main body of the single-arm catheter fluid dynamics parameter detection device.
  • FIG5 is a cross-sectional view of the side of the workbench and bracket of the single-arm catheter fluid dynamics parameter detection equipment.
  • FIG. 6 is a schematic structural diagram of the front side of the electric lifting system.
  • FIG. 7 is a schematic structural diagram of the electric lifting system from the side.
  • FIG8 is a flow chart of the catheter fluid dynamics parameter detection equipment control and processing system.
  • Figure 9 shows the PCA data processing process.
  • 6 is an adjustable chair; 6.1 is a rotating shaft; 6.2 is a handle; 6.3 is an electric lifting system;
  • Examples 1-4 respectively describe a non-first test of a catheter that is not the first test of a device, a first test of a catheter that is not the first test of a device, a first test of a catheter that is the first test of a device, and a non-first test of a catheter that is the first test of a device.
  • the present embodiment relates to a catheter fluid dynamics parameter detection device, including a power system, a lifting system, a measurement system, a control and processing system, a constant temperature storage system and an adjustment chair.
  • the power system includes a workbench, a motor and a transmission device; wherein the workbench is located at the bottom of the catheter fluid dynamics parameter detection device, and the motor and the transmission device are fixed inside the workbench.
  • the lifting system includes a bracket, a guide rod, a rolling screw, a movable cross arm and a displacement encoder; wherein the bracket is installed above the workbench, the guide rod and the rolling screw are located inside the bracket, the movable cross arm is connected to the bracket through the guide rod, and the displacement encoder is installed on the top of the bracket.
  • the measurement system includes a mass sensor and a fixing device, the mass sensor is hinged to the movable cross arm, the fixing device is connected to the bottom of the mass sensor, and the two are suspended in series below the movable cross arm, wherein the mass sensor includes four strain gauges and a DC voltage source.
  • control and processing system includes a computer, a digital collector, a digital controller and a signal line; the computer and the digital collector, as well as the computer and the digital controller, are connected via signal lines; the digital collector includes a multimeter and a digital filter.
  • the computer reduces the drift of the mass sensor through the principal component analysis algorithm (PCA); the computer acquires data during use in real time, and performs a dual evaluation of the catheter status according to personal standards and similar standards;
  • the data acquired by the computer in real time during the infusion process include: catheter model, catheter usage time, liquid type, infusion pressure and flow rate under the infusion pressure, and complications;
  • the similar standard It is a series of arrays of catheters of the same model without complications under the same catheter use time, each array includes liquid type, infusion pressure, and flow rate under the infusion pressure; for the same liquid, each flow rate corresponds to a group of pressures, and the group of pressures is averaged to obtain the average pressure FA
  • / FS *100% and the same type deviation ⁇ AS
  • the constant temperature storage system includes a partition and a constant temperature heating device, wherein the partition is an elastic partition or a bucket-shaped partition; the constant temperature heating device is installed in the workbench and is located directly below the fixing device.
  • the adjustable chair comprises an electric lifting system, a rotating shaft and a handle; the handle is connected to the rotating shaft to control the bending angle of the adjustable chair.
  • the electric lifting system is installed at the bottom of the adjustable chair.
  • the transmission device includes a transmission gear and a transmission sleeve.
  • the transmission sleeve is fixed in the workbench.
  • the transmission gear and the transmission sleeve are integrally formed.
  • the transmission gear is located between the motor and the transmission sleeve.
  • the transmission gear is rollingly connected to the motor and the transmission sleeve respectively.
  • the motor is a servo motor.
  • the power system, displacement encoder and movable cross arm are connected together through a rolling screw, which is installed in a groove of the bracket and passes through a transmission sleeve and is threadedly connected to the transmission sleeve; the end of the rolling screw is threadedly connected to the displacement encoder.
  • the bracket is a " ⁇ " type bracket or a single-arm bracket.
  • the bracket is equipped with an upper limit buckle and a lower limit buckle; the side of the bracket is equipped with position control buttons, including " ⁇ ", " ⁇ ”and They represent up, down, start and pause respectively; a deceleration device is installed on the side where the bracket is connected to the movable cross arm, which is a kind of speed reduction belt or speed reducer.
  • the fixing device is one of a hook or a universal clamp.
  • the computer includes: an operating system, a temperature controller, a position controller and a data processing system; the temperature controller can control the temperature at 36.5 ⁇ 1°C; the input end of the position controller is connected to the digital controller, and the output end is connected to the motor.
  • the digital controller and the displacement encoder are connected via a signal line.
  • the partition is an elastic partition or a bucket-shaped partition; the elastic partition is symmetrically installed on both sides of the " ⁇ "-shaped bracket through movable buckles; the bucket-shaped partition is used in conjunction with the single-arm bracket, and the small mouth of the bucket-shaped partition faces downward and is installed on the storage slot.
  • the constant temperature heating device includes a storage groove, a heating device, a temperature sensor and a thermal conductive filler;
  • the storage groove has a depth of not less than 20 cm, a square cross-section, and a side length of not less than 10 cm;
  • the temperature sensor is connected to the input end of the temperature controller, and the heating device is connected to the output end of the temperature controller.
  • the electric lifting system of the adjustable chair is composed of a top plate, a sliding rod, a support rod, a movable nail, a conveyor belt buckle, a bidirectional motor, a power transmission belt, a transmission pulley, a bottom rod and a bottom plate; wherein the bidirectional motor is fixed on the bottom plate; a plurality of bottom rods are evenly distributed and fixed on the bottom plate; the sliding rods are evenly distributed on the top plate, slidably connected to the top plate, and correspond to the bottom rods in the vertical direction.
  • the upper and lower ends of the support rod are rotatably connected to the two sides of the sliding rod and the bottom rod through movable nails, one end of the power transmission belt is connected to the upper 1/3 of the support rod through the power transmission belt buckle, and the other end bypasses the transmission pulley and is connected to the bidirectional motor; the power transmission belt drives the support rod to rotate in the same direction through the clockwise or counterclockwise rotation of the bidirectional motor to adjust the height of the chair.
  • the catheter is an intracorporeal catheter and an extracorporeal catheter, wherein the intracorporeal catheter is one of a midline catheter, a peripherally inserted central venous catheter, a central venous catheter, and an infusion port, and the extracorporeal catheter is one of an indwelling needle and an infusion set.
  • Preliminary preparation adjust the height and angle of the adjustable chair so that the tip of the inserted catheter is at the same height as the workbench, and fix the glass infusion bottle with a universal clamp.
  • the extracorporeal medical catheter is connected to the infusion liquid, and then passes through the baffle and storage slot. After exhausting the air, it is connected to the internal medical catheter, and the flow rate regulator in the infusion set is closed to stop the flow of liquid;
  • Venous pressure test Select the venous pressure test in the computer operating system, fully open the flow regulator, and increase the height of the movable cross arm through the position control button next to the bracket until there is no blood return. Then click the start button, and the mass of the test solution does not decrease over time. Click the OK button, and the software automatically records the position height H 0 at this time, which is the venous pressure F 0 ;
  • Fluid dynamics parameter test Select the dynamics parameter test in the computer operating system, set the pre-test position H1 , and the position controller controls the motor to turn, and through the transmission device, drives the rolling screw and the movable cross arm to move to the set position; click Click the "Start" button, the mass sensor transmits the real-time mass of the test liquid to the data processing system.
  • the software normalizes the data and calculates the SPE value of the statistic based on the established PCA model. It is compared with the control limit calculated in the previous stage, and the valid data is screened for mean processing.
  • the software converts the reduction in the mass of the test liquid per unit time into the liquid volume according to the density of the measured liquid, and calculates the liquid flow rate in mL/min.
  • the first test of the first test catheter of the device is basically the same as that of Example 2, except that:
  • M [m 1 , m 2 , m 3 , m 4 ] is the mean of the variable x; diag is the logarithmic matrix; ⁇ 2 is the variance;
  • ti is the component vector of the i-th principal element, and vi is the i-th load vector;
  • the four eigenvalues of X S are calculated and sorted from large to small, namely ⁇ 1 , ⁇ 2 , ⁇ 3 and ⁇ 4 :
  • the number of principal components is determined by the cumulative and percentage method of principal component contribution rate
  • ⁇ i is the eigenvalue of X S , which replaces the variance of the i-th principal element in the calculation
  • Fluid dynamics parameter test only data storage is performed, and the specific implementation method is: the computer records the infusion pressure F 1 and the corresponding flow rate V 1 ;
  • Database update The medical staff will determine whether complications are found during this use, and then make a choice to import this group of data into the database.
  • ⁇ s1 ⁇ 5 the catheter is in good condition; when 5 ⁇ ⁇ s1 ⁇ 10 , it indicates risk; when 10 ⁇ ⁇ s1 ⁇ 20 , it indicates that processing is required; when ⁇ s1 >20, the system alarms. Click "Retest", the result will not be saved, and the test will be restarted.

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Abstract

一种导管流体动力学参数检测设备，涉及医用导管检测设备技术领域，通过控制液面高度调控导管中压力；通过监控液体质量变化得到流速，利用最小二乘法对使用中获取的数据进行处理，得到压力-流速关系函数，建立个人标准及同类标准对导管进行评估，为医用导管流体动力学指标提供了检测设备，为导管性能及导管通路评分提供了数据支持。设备不接触输注液体，不引入污染，可以在临床中使用。

Description

一种导管流体动力学参数检测设备 技术领域
本发明涉及医用导管检测设备技术领域，主要涉及一种导管流体动力学参数检测设备。
背景技术
中心静脉导管、经外周中心静脉导管和中线导管属于血管内导管，可放置于大静脉中一段时间，为患者提供输液通路。但是长时间的置管使导管面临一些常见的远期并发症，如血栓形成、静脉狭窄、流量不足等。目前，这些并发症通常是在症状已经明显影响导管正常使用时才能通过医护人员发现，此时处理无效后极大可能予以拔管处理，不仅增加病人的痛苦及治疗费用，严重时可能影响病人后期治疗(对于静脉情况不佳患者来说)，使患者永久失去输液通路。通过每次输液检测导管流体动力学参数，可提前发现流量不足，静脉压升高等情况。进行小角度旋转或调整导管深度，消除由于导管尖端与血管壁相贴造成的“贴壁”；通过溶栓处理解决早期血栓，延长导管使用寿命，减轻患者负担。同时，临床上广泛收集导管流体动力学参数，可对不同导管进行综合评价，为以后导管选择提供参考。但目前临床上缺少直接检测导管流体动力学参数的测试方法及设备，因此急需一种技术方案填补空缺。
专利CN 104950130A公布了一种医用导管流速测定仪，通过称取一定高度下导管尾端流出的液体质量获得导管流速，用于在实验室中评定导管流速性能指标。但该设备一方面在检测过程中液体会直接与水箱、加热装置及输送管道接触，一方面需要收集导管末端流出液体质量，因此不能用于临床上检测带管患者的血管通路的流体动力学参数。另一方面该设备仅有简单的计算功能，不能对检测数据进行记录处理，因此无法实现整个导管留置时间内测量及评估。
发明内容
针对现有技术的不足之处，本发明提供了一种结构简单、操作便利的导管流体动力学参数检测设备，该检测设备可在临床中使用，检测位于血管内导管的流体动力学参数，并进行数据处理分析，对导管状态进行个人标准和同类标准双重评估，为医护人员提供参考。
该导管流体动力学参数检测设备具备以下功能：
(1)检测体内导管末端静脉压；
(2)测定临床中导管流体动力学参数；
(3)收集临床数据，对导管状态进行评估，为后期建立血管通路体内动力学参数参考值范围提供数据基础。
为实现以上功能，本发明采用的技术方案如下：
一种导管流体动力学参数检测设备，包括动力系统、升降系统、测量系统、控制及处理系统、恒温收纳系统和调节椅。
进一步的，所述动力系统包括工作台、电动机及传动装置；其中工作台位于导管流体动力学参数检测设备底部，电动机及传动装置固定在工作台内部。
进一步的，所述升降系统包括支架、导杆、滚动丝杠、活动横臂和位移编码器；其中支架安装于工作台上方，导杆和滚动丝杠位于支架内部，活动横臂与支架通过导杆相连，位移编码器安装于支架顶端。
进一步的，所述测量系统包括质量传感器和固定装置，质量传感器与活动横臂铰链连接，固定装置连接于质量传感器下方，二者串联悬挂于活动横臂下方，其中，质量传感器包括四个应变片和直流电压源。
进一步的，所述控制及处理系统包括计算机、数字采集器、数字控制器和信号线；计算机和数字采集器之间、计算机和数字控制器之间均通过信号线连接；数字采集器包括万用表和数字滤波器。所述计算机通过主成分分析算法(Principal Component Analysis，PCA)降低质量传感器漂移；计算机实时获取使用过程中的数据，对导管状态进行个人标准和同类标准双重评估；计算机实时获取的输液过程中的数据包括：导管型号、导管使用时间、液体种类、输注压力和该输注压力下流速以及并发症情况；所述个人标准为该导管输注液体首次测试结果，是一系列数组，每一数组包括液体种类、输注压力、该输注压力下流速及并发症情况，通过最小二乘法获得不同液体种类下压力-流速关系曲线及函数关系式Fs＝f(v)；所述同类标准为相同型号导管在相同导管使用时间情况下无并发症的一系列数组，每一数组包括液体种类、输注压力、该输注压力下流速；同种液体，每一流速对应一组压力，对该组压力进行均值处理，得到该流速下均值压力FA，将流速与均值压力进行最小二乘法处理，得到该使用时间下同类标准曲线及函数关系式FA＝f(v)。
进一步的，数据处理通过以下四步实现：第一步，同一导管以相同产品使用时间、相同液体种类下获取的数据为一组，该组数据中流速vi代入个人标准曲线对应函数关系式中，获取个人标准压力FS，带入同类标准曲线对应函数关系式中，获得同类标准压力FAS，并依次与实际测量压力Fi进行对比，获得个人偏差αs＝|FS-Fi|/FS*100％和同类偏差αAS＝|FAS-Fi|/FAS*100％，根据双偏差进行导管状态评估；第二步，本组数据录入完成，计算获得本次压力-流速关系曲线及函数关系式Fi＝f(vi)；第三步，对同一导管、相同液体种类、相同流速下的系列数据组采用最小二乘法，获得一组压力随产品使用时间变化曲线及函数关系式 F＝f(t)，同时输入并保存并发症情况；第四步，将无并发症数据录入同类标准数据库。
进一步的，所述恒温收纳系统包括隔挡和恒温加热装置，所述隔挡为弹性隔挡或斗状隔挡中的一种；恒温加热装置安装在工作台内，位于固定装置正下方。
进一步的，所述调节椅包括电动升降系统、转轴和把手；把手与转轴相连，控制调节椅弯折角度。所述电动升降系统安装在调节椅底部。
进一步的，所述传动装置包括传动齿轮和传动套筒，传动套筒固定在工作台内，传动齿轮与传动套筒一体成型，传动齿轮位于电动机和传动套筒之间，传动齿轮分别与电动机、传动套筒滚动连接，电动机为伺服电动机。
进一步的，所述动力系统、位移编码器及活动横臂通过滚动丝杠连接在一起，滚动丝杠安装在支架的凹槽内，穿过传动套筒与传动套筒螺纹连接；滚动丝杠末端与位移编码器螺纹连接。
进一步的，所述支架为“冂”型支架或单臂支架中的一种。支架上安装有上限位扣、下限位扣；支架侧面安装有位置控制按钮，包括“▲”、“‖”和依次代表上、下、开始、暂停；支架与活动横臂相连侧安装有减速装置，为减速带或减速机中的一种。
进一步的，所述固定装置为吊钩或万能夹中的一种。
进一步的，所述计算机包括：操作系统、温度控制器、位置控制器及数据处理系统；温度控制器可将温度控制在36.5±1℃；位置控制器输入端与数字控制器相连，输出端与电动机相连。
进一步的，所述数字控制器与位移编码器之间通过信号线连接。
进一步的，所述隔挡为弹性隔挡或斗状隔挡中的一种；弹性隔挡通过活动卡扣对称安装在“冂”型支架两侧；斗状隔挡配合单臂支架使用，斗状隔挡小口端朝下，安装在收纳槽上。
进一步的，所述恒温加热装置包含收纳槽、加热装置、温度传感器和导热填料；收纳槽深度不低于20cm，横截面为正方形，边长不低于10cm；温度传感器与温度控制器的输入端相连，加热装置与温度控制器的输出端相连。
进一步的，调节椅处的电动升降系统可以采用现有技术中公开的电动升降系统，可以直接采用市购产品。例如，电动升降系统由顶板、滑杆、支撑杆、活动钉、传送带卡扣、双向电机、传力带、传送滑轮、底杆和底板构成；其中双向电机固定在底板上；多个底杆均匀分布固定在底板上；滑杆均匀分布在顶板上，与顶板滑动连接，与底杆垂直方向上对应。
进一步的，所述的支撑杆上下两端通过活动钉转动连接在滑杆和底杆两侧，传力带一端通过传力带卡扣与支撑杆的上1/3处连接，另一端绕过传送滑轮连接在双向电机上；传力带 通过双向电机的顺时针或逆时针转动带动支撑杆同向转动，对椅子高度进行调节。
进一步的，所述调节椅中间存在一个多角度旋转轴，右下方设有角度开启把手，可通过上拉把手，调节椅背角度。
进一步的，所述导管为体内导管或体外导管，其中体内导管为中线导管、经外周中心静脉导管、中心静脉导管、输液港中的一种，体外导管为留置针、输液器中的一种。
本发明具有以下有益效果：
1、该检测设备不接触液体、不影响正常临床治疗；
2、该检测设备通过计算机控制，自动化程度高，采用主成分分析算法，降低了质量传感器漂移，增加了检测精度；
3、该检测设备工作台设有恒温装置，可维持输注液体温度为36.5±1℃，减少对人体的刺激，同时稳定测试条件；
4、该检测设备为导管流体动力学参数检测提供了设备支持，并对医用导管进行评估，可作为临床上血管通路状态评分参考依据。
附图说明
图1为“冂”型导管流体动力学参数检测设备正面的结构示意图。
图2为可升降椅的结构示意图。
图3为恒温加热装置侧面的结构示意图。
图4为单臂导管流体动力学参数检测设备主体侧面的结构示意图。
图5为单臂导管流体动力学参数检测设备工作台及支架侧面的剖面图。
图6为电动升降系统正面的结构示意图。
图7为电动升降系统侧面的结构示意图。
图8为导管流体动力学参数检测设备控制及处理系统流程图。
图9为PCA数据处理过程。
图1中，1.1数字控制器；1.2计算机；2.1下限位扣；2.2支架；2.3活动横臂；2.4上限位扣；2.5位移编码器；3.1质量传感器；3.2吊钩；4恒温收纳系统；4.1弹性隔挡；4.2恒温加热装置；5动力系统；5.1工作台；
图2中，6调节椅；6.1旋转轴；6.2把手；6.3电动升降系统；
图3中，4.2.1收纳槽；4.2.2加热装置；4.2.3导热填料；4.2.4温度传感器；
图4中，3.3万能夹；2.9位置控制按钮；4.3斗状隔挡；
图5中，5.2传动套筒；5.3传动齿轮；5.4电动机；2.6导杆；2.7滚动丝杠；2.8减速 装置；
图6中，6.3.1顶板；6.3.2滑杆；6.3.3支撑杆；6.3.4.2传送滑轮；6.3.4.3传力带；6.3.4.4双向电机；6.3.5底杆6.3.6底板；
图7中，6.3.3.1活动钉；6.3.4.1传力带卡扣。
具体实施方式
为了更清晰地表述本发明的目的、技术方法及优点，以下结合附图1-7及实施例，对本发明进行详细说明。需要说明的是，“冂”型支架和单臂支架仅外观不同，其功能无差别。吊钩和万能夹针对不同输液瓶和输液袋，带孔的使用吊钩固定，无孔的使用万能夹固定，其功能无差别。下述实施例中所述产品和体内导管均为血管内导管。不同实施例中设备启动、软件准备、静脉压测试、第N组数据测试、数据保存和输出以及活动横臂归位步骤是完全一致的。应当理解，此处所描述的具体实施例仅用于解释本发明，并不限定本发明。
实施例1-4分别描述了非设备首条测试导管的非首次测试、非设备首条测试导管的首次测试、设备首条测试导管的首次测试和设备首条测试导管的非首次测试。
实施例1
参照图1-7，本实施例涉及一种导管流体动力学参数检测设备，包括动力系统、升降系统、测量系统、控制及处理系统、恒温收纳系统和调节椅。
所述动力系统包括工作台、电动机及传动装置；其中工作台位于导管流体动力学参数检测设备底部，电动机及传动装置固定在工作台内部。所述升降系统包括支架、导杆、滚动丝杠、活动横臂和位移编码器；其中支架安装于工作台上方，导杆和滚动丝杠位于支架内部，活动横臂与支架通过导杆相连，位移编码器安装于支架顶端。所述测量系统包括质量传感器和固定装置，质量传感器与活动横臂铰链连接，固定装置连接于质量传感器下方，二者串联悬挂于活动横臂下方，其中，质量传感器包括四个应变片和直流电压源。
进一步的，所述控制及处理系统包括计算机、数字采集器、数字控制器和信号线；计算机和数字采集器之间、计算机和数字控制器之间均通过信号线连接；数字采集器包括万用表和数字滤波器。所述计算机通过主成分分析算法(Principal Component Analysis，PCA)降低质量传感器漂移；计算机实时获取使用过程中的数据，对导管状态进行个人标准和同类标准双重评估；计算机实时获取的输液过程中的数据包括：导管型号、导管使用时间、液体种类、输注压力和该输注压力下流速以及并发症情况；所述个人标准为该导管输注液体首次测试结果，是一系列数组，每一数组包括液体种类、输注压力、该输注压力下流速及并发症情况，通过最小二乘法获得不同液体种类下压力-流速关系曲线及函数关系式Fs＝f(v)；所述同类标准 为相同型号导管在相同导管使用时间情况下无并发症的一系列数组，每一数组包括液体种类、输注压力、该输注压力下流速；同种液体，每一流速对应一组压力，对该组压力进行均值处理，得到该流速下均值压力FA，将流速与均值压力进行最小二乘法处理，得到该使用时间下同类标准曲线及函数关系式FA＝f(v)。
进一步的，数据处理通过以下四步实现：第一步，同一导管以相同产品使用时间、相同液体种类下获取的数据为一组，该组数据中流速vi代入个人标准曲线对应函数关系式中，获取个人标准压力FS，带入同类标准曲线对应函数关系式中，获得同类标准压力FAS，并依次与实际测量压力Fi进行对比，获得个人偏差αs＝|FS-Fi|/FS*100％和同类偏差αAS＝|FAS-Fi|/FAS*100％，根据双偏差进行导管状态评估；第二步，本组数据录入完成，计算获得本次压力-流速关系曲线及函数关系式Fi＝f(vi)；第三步，对同一导管、相同液体种类、相同流速下的系列数据组采用最小二乘法，获得一组压力随产品使用时间变化曲线及函数关系式F＝f(t)，同时输入并保存并发症情况；第四步，将无并发症数据录入同类标准数据库。
进一步的，所述恒温收纳系统包括隔挡和恒温加热装置，所述隔挡为弹性隔挡或斗状隔挡中的一种；恒温加热装置安装在工作台内，位于固定装置正下方。
进一步的，所述调节椅包括电动升降系统、转轴和把手；把手与转轴相连，控制调节椅弯折角度。所述电动升降系统安装在调节椅底部。
进一步的，所述传动装置包括传动齿轮和传动套筒，传动套筒固定在工作台内，传动齿轮与传动套筒一体成型，传动齿轮位于电动机和传动套筒之间，传动齿轮分别与电动机、传动套筒滚动连接，电动机为伺服电动机。
进一步的，所述动力系统、位移编码器及活动横臂通过滚动丝杠连接在一起，滚动丝杠安装在支架的凹槽内，穿过传动套筒与传动套筒螺纹连接；滚动丝杠末端与位移编码器螺纹连接。
进一步的，所述支架为“冂”型支架或单臂支架中的一种。支架上安装有上限位扣、下限位扣；支架侧面安装有位置控制按钮，包括“▲”、“‖”和依次代表上、下、开始、暂停；支架与活动横臂相连侧安装有减速装置，为减速带或减速机中的一种。
进一步的，所述固定装置为吊钩或万能夹中的一种。
进一步的，所述计算机包括：操作系统、温度控制器、位置控制器及数据处理系统；温度控制器可将温度控制在36.5±1℃；位置控制器输入端与数字控制器相连，输出端与电动机相连。
进一步的，所述数字控制器与位移编码器之间通过信号线连接。
进一步的，所述隔挡为弹性隔挡或斗状隔挡中的一种；弹性隔挡通过活动卡扣对称安装在“冂”型支架两侧；斗状隔挡配合单臂支架使用，斗状隔挡小口端朝下，安装在收纳槽上。
进一步的，所述恒温加热装置包含收纳槽、加热装置、温度传感器和导热填料；收纳槽深度不低于20cm，横截面为正方形，边长不低于10cm；温度传感器与温度控制器的输入端相连，加热装置与温度控制器的输出端相连。
进一步的，调节椅处的电动升降系统由顶板、滑杆、支撑杆、活动钉、传送带卡扣、双向电机、传力带、传送滑轮、底杆和底板构成；其中双向电机固定在底板上；多个底杆均匀分布固定在底板上；滑杆均匀分布在顶板上，与顶板滑动连接，与底杆垂直方向上对应。支撑杆上下两端通过活动钉转动连接在滑杆和底杆两侧，传力带一端通过传力带卡扣与支撑杆的上1/3处连接，另一端绕过传送滑轮连接在双向电机上；传力带通过双向电机的顺时针或逆时针转动带动支撑杆同向转动，对椅子高度进行调节。
进一步的，调节椅中间存在一个多角度旋转轴，右下方设有角度开启把手，可通过上拉把手，调节椅背角度。
进一步的，所述导管为体内导管和体外导管，其中体内导管为中线导管、经外周中心静脉导管、中心静脉导管、输液港种的一种，体外导管为留置针、输液器中的一种。
实施例2
作为非设备首条测试导管的非首次测试，包含以下过程：
1.前期准备：调整调节椅高度、角度使置入的导管尖端与工作台同等高度，将玻璃输液瓶用万能夹固定。体外医用导管与输注液体相连，然后穿过隔挡、收纳槽，排尽空气后，与体内医用导管相连，关闭输液器中的流速调节器，阻止液体流动；
2.设备启动：打开计算机、电动机及数字控制器电源及信号联通开关；通过温度传感器的反馈，温度控制器控制加热装置，使恒温加热装置的温度保持36.5±1℃；
3.软件准备：于计算机操作系统中选择液体种类，系统自动得到液体密度；手动或计算机调节活动横臂至下限位扣。下限位扣位置处，输注液体液面与工作台齐平，将位置数据清零；
4.静脉压测试：在计算机操作系统中选择静脉压测试，完全打开流量调节器，通过支架旁位置控制按钮，增加活动横臂高度，至不返血。然后点击开始按钮，测试溶液质量不随时间减少，点击确定按钮，软件自动记录此时位置高度H0，为静脉压F0；
5.流体动力学参数测试：在计算机操作系统中选择动力学参数测试，设定预测试位置H1，位置控制器控制电动机转向，通过传动装置，带动滚动丝杠、活动横臂移动至设定位置；点 击“开始”按钮，质量传感器将测试液体的实时质量传递给数据处理系统，数据处理系统根据四个应变片输出数据得到一组向量x＝[x1，x2，x3，x4]，软件对数据进行归一化处理，并基于已建立的PCA模型，计算统计量的SPE值，并与前期计算的控制限做比较，筛选有效数据，进行均值处理；软件将单位时间内测试液体质量的减少量，根据测量液体的密度换成液体体积，求出液体流速，以mL/min表示，数值波动范围为±0.01mL/min后，输出该位置高度H1，计算得到输注压力F1＝H1-H0，和测试液体流速V1，于计算机软件页面点击“确定”按钮，计算机记录输注压力F1及对应流速V1，计算机自动将流速V1依次带入个人标准曲线对应关系式Fs＝f(v)和同类标准曲线对应关系式FA＝f(v)，得到标准压力FS1和FAS1，并依次与实际测量压力F1进行对比，获得偏差αs1＝|FS1-F1|/FS1*100％和αAs1＝|FAS1-F1|/FAS1*100％，当α≤5时，导管状态良好；当5＜α≤10时，提示风险；当10＜α≤20时，提示需要进行处理；当α＞20，系统报警。点击“重新检测”，则结果不保存，重新开始测试；
6.第N组数据测试：设定位置HN，位置控制器控制电动机，通过传动装置，带动滚动丝杠，进而移动活动横臂至设定位置；点击开始按钮，重复5过程，得到压力FN＝HN-H0、流速VN及偏差；
7.数据保存及输出：测试完成后，选择本次测试数据，点击“生成图像”计算机采用最小二乘法，获得本次测试曲线、压力-流速函数关系式；选取该产品不同使用时间收集的数据，筛选特定液体种类、流速下压力值，获得一组压力，点击“生成图像”计算机采用最小二乘法获得压力随使用时间变化曲线及函数关系式F＝f(t)。点击“生成报告”，生成实验报告，显示试验结果；
8.活动横臂归位：至液体输注完成后，关闭流量调节器，设定位置为“0”，活动横臂移动至下限位扣处，更换输注液体或断开体外医用导管与体内医用短管连接，对体内医用导管进行常规封管，防止返血；
9.数据库更新：由医护人员判断选择本次使用是否发现并发症，然后进行选择，将本组数据导入数据库，选择筛选依据“产品型号”、“产品使用时间”、“液体种类”和“无并发症发生”，点击“数据筛选”，获得所有该型号产品在同一使用时间下，可正常输注同种液体的压力-流速数据，对相同流速下压力取平均值，有：利用最小二乘法，得到均值压力-流速曲线及关系式FA＝f(v)，点击“保存”，更新同类标准曲线及函数关系式。
实施例3
作为非设备首条测试导管的首次测试，其实施方式与实施例1基本相同，不同点在于：作为某一产品首次使用，在流体动力学参数测试中仅与同类标准进行对比计算偏差；具体实施为：计算机记录输注压力F1及对应流速V1，计算机自动将流速V依次带入同类标准曲线对应关系式FA＝f(v)，得到标准压力FAS1，并与实际测量压力F1进行对比，获得偏差αAs1＝|FAS1-F1|/FAS1*100％，当αAs1≤5时，导管状态良好；当5＜αAs1≤10时，提示风险；当10＜αAs1≤20时，提示需要进行处理；当αAs1＞20，系统报警。
实施例4
作为设备首条测试导管的首次测试，基本与实施例2相同，不同点在于：
1.前期准备工作增加一步，为安装后质量传感器正模型建立：
利用标准砝码(1Kg、500g、250g、1g)，在传感器量程范围内，收集正常情况下输出数据：
对X进行归一化处理，消除不同纲量造成的虚假变异影响：
式中：M＝[m1，m2，m3，m4]为变量x的均值；diag为对数矩阵；σ2为方差；
对XS奇异分解：
式中ti为第i个主元的分向量，vi为第i个负载向量；
计算得到XS的4个特征值，并进行从大到小排序，依次为λ1，λ2，λ3和λ4：
由主元贡献率累计和百分比法确定主元个数；
第i个主元的方差贡献率σi：
式中λi为XS特征值，此处在计算中代替第i个主元的方差
前h个主元的累计方差贡献率S:
当S大于85％，得到主元的个数h并确定平方预报误差(Squared Prediction Error，SPE)的控制限；
2.流体动力学参数测试：仅进行数据存储，具体实施方法为：计算机记录输注压力F1及对应流速V1；
3.数据库更新：由医护人员判断选择本次使用是否发现并发症，然后进行选择，将本组数据导入数据库。
实施例5
作为设备首条测试导管的非首次测试，与实施例1基本相同，其不同点在于：在流体动力学参数测试中，计算机自动将流速V1仅带入个人标准曲线对应关系式Fs＝f(v)，得到标准压力FS1，并与实际测量压力F1进行对比，获得偏差αs1＝|FS1-F1|/FS1*100％，当αs1≤5时，导管状态良好；当5＜αs1≤10时，提示风险；当10＜αs1≤20时，提示需要进行处理；当αs1＞20，系统报警。点击“重新检测”，则结果不保存，重新开始测试。

Claims (10)

  1. 一种导管流体动力学参数检测设备，包括动力系统、升降系统、测量系统、控制及处理系统、恒温收纳系统和调节椅，其特征在于：
    所述动力系统包括工作台、电动机及传动装置；其中工作台位于检测设备底部，电动机及传动装置固定在工作台内部；
    所述升降系统包括支架、导杆、滚动丝杠、活动横臂和位移编码器；其中支架安装于工作台上方，导杆和滚动丝杠位于支架内部，活动横臂与支架通过导杆相连，位移编码器安装于支架顶端；
    所述测量系统包括质量传感器和固定装置，质量传感器与活动横臂铰链连接，固定装置连接于质量传感器下方，二者串联悬挂于活动横臂下方，其中，质量传感器包括四个应变片和直流电压源；
    所述控制及处理系统包括计算机、数字采集器、数字控制器和信号线；计算机和数字采集器之间、计算机和数字控制器之间均通过信号线连接；数字采集器包括万用表和数字滤波器；
    所述计算机通过主成分分析算法降低质量传感器漂移；计算机实时获取输液过程中的数据，对导管状态进行个人标准和同类标准双重评估；计算机实时获取的输液过程中的数据包括：导管型号、导管使用时间、液体种类、输注压力和该输注压力下流速以及并发症情况；所述个人标准为该导管输注液体首次测试结果，是一系列数组，每一数组包括液体种类、输注压力、该输注压力下流速及并发症情况，通过最小二乘法获得不同液体种类下压力-流速关系曲线及函数关系式Fs＝f(v)；所述同类标准为相同型号导管在相同导管使用时间情况下无并发症的一系列数组，每一数组包括液体种类、输注压力、该输注压力下流速；同种液体，每一流速对应一组压力，对该组压力进行均值处理，得到该流速下均值压力FA，将流速与均值压力进行最小二乘法处理，得到该使用时间下同类标准曲线及函数关系式FA＝f(v)；
    数据处理通过以下四步实现：
    第一步，同一导管以相同导管使用时间、相同液体种类下获取的数据为一组，该组数据中流速vi代入个人标准曲线对应函数关系式中，获取个人标准压力FS，带入同类标准曲线对应函数关系式中，获得同类标准压力FAS，并依次与实际测量压力Fi进行对比，获得个人偏差αs＝|FS-Fi|/FS*100％和同类偏差α AS＝|FAS-Fi|/FAS*100％，根据双偏差进行导管状态评估；
    第二步，本组数据录入完成，计算获得本次压力-流速关系曲线及函数关系式Fi＝f(vi)；
    第三步，对同一导管、相同液体种类、相同流速下的系列数据组采用最小二乘法，获得一组压力随导管使用时间变化曲线及函数关系式F＝f(t)，同时输入并保存并发症情况；
    第四步，将无并发症数据录入同类标准数据库；
    所述恒温收纳系统包括隔挡和恒温加热装置，所述隔挡为弹性隔挡或斗状隔挡中的一种；恒温加热装置安装在工作台内，位于固定装置正下方；
    所述调节椅包括电动升降系统、转轴和把手；把手与转轴相连，控制调节椅弯折角度。
  2. 根据权利要求1所述的导管流体动力学参数检测设备，其特征在于：所述传动装置包括传动齿轮和传动套筒，传动套筒固定在工作台内，传动齿轮位于电动机和传动套筒之间，与二者滚动连接。
  3. 根据权利要求2所述的导管流体动力学参数检测设备，其特征在于：所述动力系统、位移编码器及活动横臂通过滚动丝杠连接在一起，滚动丝杠与传动套筒及位移编码器螺纹连接。
  4. 根据权利要求1所述的导管流体动力学参数检测设备，其特征在于：所述支架为“冂”型支架或单臂支架中的一种，所述“冂”型支架上安装有上限位扣、下限位扣和活动卡扣，而单臂支架仅安装有上限位扣、下限位扣；所述“冂”型支架或单臂支架侧面均安装有位置控制按钮，包括“▲”、“▼”、“‖”和依次代表上、下、开始、暂停。
  5. 根据权利要求4所述的导管流体动力学参数检测设备，其特征在于：所述弹性隔挡通过活动卡扣对称安装在“冂”型支架两侧，斗状隔挡配合单臂支架使用。
  6. 根据权利要求1所述的导管流体动力学参数检测设备，其特征在于：所述支架与活动横臂相连侧安装有减速装置。
  7. 根据权利要求1所述的导管流体动力学参数检测设备，其特征在于：所述固定装置为吊钩或万能夹中的一种。
  8. 根据权利要求1所述的导管流体动力学参数检测设备，其特征在于：所述计 算机包括：操作系统、温度控制器、位置控制器及数据处理系统；数字控制器与位移编码器之间通过信号线连接；温度控制器将温度控制在设定范围；位置控制器输入端与数字控制器相连，输出端与电动机相连。
  9. 根据权利要求1所述的导管流体动力学参数检测设备，其特征在于：所述恒温加热装置包含收纳槽、加热装置、温度传感器和导热填料；温度传感器与温度控制器的输入端相连，加热装置与温度控制器的输出端相连；斗状隔挡小口端朝下，安装在收纳槽上。
  10. 根据权利要求1所述的导管流体动力学参数检测设备，其特征在于：所述导管为中线导管、经外周中心静脉导管、中心静脉导管、输液港、留置针、输液器中的一种。
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