Pulse type urine drainage system

Abstract

A pulse type urine drainage system comprises a pulse type urodynamic control device (10) and a drainage assembly matched with the pulse type urodynamic control device (10). The pulse type urine drainage system provides two working modes of pulse type negative pressure drainage and pressure control drainage according to characteristics of a patient and clinical requirements, and allows medical staff to autonomously set drainage control parameters including drainage interval time, a drainage negative pressure value or a pressure control threshold value. The pulse type urine drainage system can empty the urine left in the bladder or the drainage tube (23) and calculate the real urine volume generated by the patient in the time period.

Description

Pulse urine drainage system TECHNICAL FIELD

[0001] The present application relates to a pulse urine drainage system for monitoring patients with indwelling catheter, belonging to the field of medical devices or nursing supplies. BACKGROUND

[0002] Oliguria (referring to the urine volume per hour less than 17ml) is an independent predictor of acute kidney injury (AKI), and a large number of medical researches have confirmed that persistent oliguria in ICU inpatients is related to higher mortality. Therefore, oliguria has been included in the early sensitive indicators of acute kidney injury, and should be strictly monitored dynamically. The existing indwelling catheter nursing technical specification is to place the catheter in the patient's bladder, use the drainage tube to connect the catheter and the urine collector, suspend the urine collector at a lower position outside the bed than the wound surface, and use the siphon effect caused by the difference between the bladder and the urine collector to drain the urine in the bladder into the urine collector. When the patient's urine volume needs to be calculated, the urine volume collected in the urine collector is measured and recorded manually using a measuring cup. In recent years, with the continuous deepening of the application of electronic technology in medicine, electronic urine volume meters (collectively referred to as similar products with this function) for dynamically monitoring the urine volume of patients have successively entered clinical use. The basic principle of this type of product is to install the electronic urine volume meter at the periphery of the patient's bed, suspend the urine collector on the gravity sensor provided on the electronic urine volume meter, and dynamically weigh the urine in the urine collector by the gravity sensor to convert it into a urine volume display reading.

[0003] The existing urine volume measurement method has great defects, mainly manifested in that: in clinical practice, due to the long distance from the patient's bladder to the urine collector, and the need to meet the patient's position changes such as turning over to the left and right, therefore, the drainage tube from the catheter interface to the urine collector is generally designed to be 120cm-150cm in length. According to the measurement in the real clinical scene, taking the drainage tube with a length of 120cm and an inner diameter of 5mm as an example, the urine volume retained in the drainage tube laid on the bed upstream of the catheter interface to the urine collector is between 45ml-50ml. As can be seen, whether manual measurement or electronic urine volume meter measurement can only measure the urine volume collected in the urine collector, and cannot measure the urine volume retained in the drainage tube or the bladder, so the obtained urine volume value deviates greatly from the actual urine volume produced by the patient per unit time. Especially for oliguria patients with urine volume less than 17ml per hour, the urine in the first 1-3 hours may be completely retained in the bladder or the drainage tube laid on the bed, and as the urine volume discharged from the bladder continues to increase, the retained urine in the drainage tube slowly peristalsis to the urine bag, and finally all the urine is simultaneously discharged into the urine collector under the siphon effect, such as in the 4th hour, and is incorrectly calculated into the urine volume of this period. Therefore, the existing drainage state and measurement method cannot accurately reflect the actual urine volume secreted by the patient per unit time, affecting the early diagnosis of acute kidney injury (AKI).

[0004] On the other hand, urine is retained in the drainage tube, and sugar, protein and inorganic salts such as calcium and sodium in the urine are easily deposited, leading to salt crystallization at the head of the urinary catheter or blockage of the drainage tube, causing urine to be unable to be normally discharged. Moreover, for patients with indwelling urinary catheters, the urinary catheter, drainage tube and urine collector establish a drainage channel, and urine is retained in the drainage tube, which is easy to cause bacterial breeding, and the bacteria in the urine collector retrograde and move upward to the bladder, increasing the risk of urinary tract infection. Therefore, the present inventors propose a pulse type urine drainage system and a drainage control method to fill the gap in the existing urine volume monitoring and drainage technology. Technical solution

[0005] The present application relates to a pulse type urine drainage system, mainly comprising a pulse type urodynamic control device and a drainage assembly matched with the device, wherein:

[0006] The pulse type urodynamic control device comprises a control mainboard, a cutoff device, a negative pressure device, a pressure sensor, a urine metering device and a human-computer interaction interface.

[0007] The control mainboard is an integrated circuit constructed by core processors, memories, signal processors, communication modules and other components. The core processor adopts a single-chip microcomputer (MCU), and the communication module adopts any one of WiFi, Bluetooth or ZigBee.

[0008] The control mainboard is provided with embedded software, which is a software program with hardware driving, function setting, data analysis and negative pressure drainage control, and is burned in the memory of the control mainboard.

[0009] The cutoff device is an electronic control device for controlling the closed or open state of the drainage tube passage, and the drive circuit of the cutoff device is connected with the control mainboard and controlled by the core processor.

[0010] The cutoff device mainly comprises a DC motor, a transmission member and a clamp, the drive part of the DC motor is combined with the transmission member, the transmission member is combined with the clamp, and the clamp is arranged on the outer periphery of the drainage tube to form a set of linkage mechanism. The working mode of the cutoff device is that the rotary motion of the DC motor is converted into the linear or arc motion of the clamp through the transmission member, so as to drive the clamp to clamp or release the drainage tube. When the clamp clamps the drainage tube, the drainage tube passage is closed; when the clamp releases the drainage tube, the drainage tube passage is open.

[0011] The DC motor includes but is not limited to a micro hollow cup motor, a reduction motor or a stepping motor.

[0012] The transmission member includes but is not limited to any one or combination of gears, racks, pulleys, crankshafts, connecting rods, belts, chains, axles, shafts and the like.

[0013] The clamp includes, but is not limited to, a parallel clamp, a cam clamp, a V-shaped clamp, a spherical clamp, or a tongue clamp, preferably to freely control the open or closed state of the drainage tube passage.

[0014] The negative pressure device is used to provide a negative pressure environment for the inner cavity of the drainage assembly, and the negative pressure device is in communication with the control mainboard and is controlled by the core processor. The working pressure range of the negative pressure device is not less than -10 cmH20~0. Commonly used is that the negative pressure device adopts a micro vacuum pump.

[0015] The pressure sensor is used to dynamically monitor the pressure value of the inner cavity of the drainage assembly, and the pressure sensor is in communication with the control mainboard and sends the pressure data obtained by dynamic monitoring to the core processor. The range of the pressure sensor is not less than -10 cmH20~0, and the measurement accuracy is not less than 1 cmH20.

[0016] The urine metering device is used to dynamically monitor the urine volume discharged by the patient, and the range of the urine metering device is not less than 0~1000 ml, and the measurement accuracy is not less than 1 ml. The urine metering device is in communication with the control mainboard and sends the urine volume data obtained by dynamic monitoring to the core processor.

[0017] According to different urine volume monitoring technologies, the urine metering device that can be selected includes, but is not limited to, an ultrasonic liquid flow meter, an optical response drop speed sensor, a turbine liquid flow meter, a gravity sensor, and a tension sensor.

[0018] For example, the ultrasonic liquid flow meter is arranged on the outer periphery of the drainage tube to dynamically measure the urine volume flowing in the pipeline per unit time.

[0019] Alternatively, the gravity sensor is arranged below the urine collector, the weight of the urine in the urine collector per unit time is dynamically measured by the gravity sensor, and then the urine weight is converted into the urine volume according to the urine density of the patient.

[0020] In one embodiment, the optical response drop speed sensor is used to dynamically monitor the urine volume. Specifically, a drip cup is arranged between the drainage tube and the urine collector, and the infrared drop speed sensor is arranged on the outer periphery of the drip cup. When there is no urine drop passing through the drip cup, the receiving tube of the infrared drop speed sensor is light-conducting, and the output signal is marked as 0 drops. When there is a urine drop passing through the drip cup, the liquid drop refracts light, and the light flux of the receiving tube is insufficient, and the output signal is marked as 1 drop. In this way, the number of urine drops per unit time is calculated. Since the volume of each drop of urine is basically constant, the volume of each drop of urine is multiplied by the number of urine drops to calculate the urine volume drained per unit time.

[0021] Preferably, a combination of light sensing drop rate sensor and gravity sensor is adopted. Specifically, a drip cup is arranged between the drainage tube and the urine collector, and the infrared drop rate sensor is arranged on the outer periphery of the drip cup. At the same time, a gravity sensor is arranged, and the urine collector is hung below the gravity sensor. The advantage of this technical solution is that the light sensing drop rate sensor and the gravity sensor are synchronized to measure, the light sensing drop rate sensor calculates the urine volume in a unit time, the gravity sensor calculates the weight of the urine in the unit time, and the density or specific gravity of the urine is dynamically calculated. The calculation formula of the density of the urine is: density of the urine = weight of the urine ÷ volume. According to the corresponding relationship among the weight, the density and the volume, the volume of the urine in the unit time is calculated.

[0022] The man-machine interaction interface is used for setting and information prompting of the negative pressure drainage parameter, and the man-machine interaction interface includes a display screen, a data interface and an operation function key.

[0023] The drainage assembly matched with the device is a special machine and special consumable used in combination with the pulse type urodynamic control device. The drainage assembly includes a urinary catheter, a conversion joint, a drainage tube, a pressure measuring tube, a negative pressure tube and a urine collector. Among them:

[0024] The urinary catheter is a catheter left in the patient's body, and the head of the urinary catheter is provided with a balloon for anchoring the urinary catheter in the bladder. According to the number of lumens of the urinary catheter, the urinary catheter includes a double-lumen urinary catheter, a triple-lumen urinary catheter or a four-lumen urinary catheter. According to the functions of the urinary catheter, the urinary catheter further includes a super-smooth urinary catheter, a temperature measuring urinary catheter, a pressure measuring urinary catheter or a temperature and pressure measuring urinary catheter. The urinary catheter with different functions is matched with the pulse type urodynamic control device to obtain more physiological parameters of the patient, such as:

[0025] When the temperature measuring urinary catheter is used in combination, the pulse type urodynamic control device can collect and display the body temperature data collected from the patient's bladder.

[0026] When the pressure measuring urinary catheter is used in combination, the pulse type urodynamic control device can measure the pressure of the patient's bladder to obtain and display the bladder pressure or intra-abdominal pressure data of the patient.

[0027] When the temperature and pressure measuring urinary catheter is used in combination, the pulse type urodynamic control device can collect and display the body temperature, bladder pressure or intra-abdominal pressure data of the patient.

[0028] The drainage tube is a flexible pipeline connecting the urinary catheter and the urine collector to drain the urine in the bladder to the urine collector. The front end of the drainage tube is connected with the urinary catheter through the conversion joint, and the tail end of the drainage tube is connected with the urine collector.

[0029] The pressure measuring tube is a flexible tube for dynamically monitoring the negative pressure value in the lumen of the drainage assembly. One end of the pressure measuring tube is in communication with the pressure measuring port of the pressure sensor, and the other end of the pressure measuring tube is in communication with the lumen of the drainage tube or the lumen of the urine collector.

[0030] The negative pressure tube is a flexible tube for providing negative pressure to the lumen of the drainage assembly. One end of the negative pressure tube is connected to the negative pressure port of the negative pressure device, and the other end of the negative pressure tube is in communication with the lumen of the drainage tube or the lumen of the urine collector.

[0031] The urine collector is a container for collecting urine discharged from the drainage tube. The shape or structure of the urine collector is not limited, including a urine collection bag, a drainage bottle, or a combination structure of a urine collection bag and a drainage bottle.

[0032] For example, the urine collector uses a urine collection bag. The upstream of the urine collection bag is provided with a negative pressure suction chamber. The negative pressure suction chamber is a hollow chamber provided between the drainage tube and the urine collector and has a tube interface, and can withstand a negative pressure of-10 cmH2O or more. The negative pressure suction chamber is provided with three tube interfaces, one of which is in communication with the drainage tube upstream of the urine collector, one is in communication with the liquid inlet of the downstream urine collector, and the other is connected to the negative pressure tube.

[0033] Alternatively, a drainage bottle is used. The drainage bottle can withstand a negative pressure of-10 cmH2O or more. The drainage bottle is provided with two tube interfaces, one of which is in communication with the upstream drainage tube, and the other is connected to the negative pressure tube.

[0034] In order to prevent the urine in the urine collector from flowing back to the drainage tube, a check valve is further provided between the drainage tube and the urine collector. The shape and structure of the check valve are not limited, including but not limited to a thin film check valve and a silica gel duckbill valve.

[0035] A pulse urine drainage system, a cutoff device, a negative pressure device, a pressure sensor, a core processor and a drainage assembly are organically combined to form a closed-loop controlled urine drainage system. According to different clinical application scenarios, two working modes of pulse negative pressure drainage and pressure-controlled drainage can be selected.

[0036] The working principle of the pulse negative pressure drainage mode includes: the core processor instructs the cutoff device to clamp the drainage tube, so that the internal passage of the drainage tube is in a normally closed state, and the negative pressure device is in a standby working state. The drainage interval time and the drainage negative pressure value are set on the man-machine interaction interface. When the set first drainage time is reached, the core processor instructs the cutoff device to open the drainage tube, and the negative pressure device is started to work synchronously. The negative pressure device loads negative pressure into the drainage tube or the inner cavity of the urine collector through the negative pressure tube. Under the continuous action of the negative pressure device, the urine stored in the bladder or the drainage tube is sucked into the urine collector. During this period, the pressure sensor dynamically monitors the negative pressure value of the drainage tube or the inner cavity of the urine collector and dynamically feeds back to the core processor. The core processor instructs the negative pressure device to dynamically adjust the working pressure, so that the working load of the negative pressure device is limited within the set drainage negative pressure value range, so as to avoid overloading negative pressure from damaging the inner wall of the bladder or urethra. The urine metering device dynamically senses and calculates the urine increment. When the urine increment stops, the negative pressure device automatically stops working. The cutoff device clamps the drainage tube again, and the internal passage of the drainage tube is in a closed state. The first negative pressure drainage ends. After the negative pressure device stops working, the core processor starts to re-timing. When the set drainage interval time is reached, the core processor instructs the cutoff device to open the drainage tube again, and the negative pressure device is started to work synchronously. According to the control program of the first negative pressure drainage, the second negative pressure drainage, the third negative pressure drainage, and the Nth negative pressure drainage are started. In this way, the pulse negative pressure drainage control is automatically realized in the unattended state, the urine retained in the bladder or the drainage tube is automatically emptied at regular intervals, and the new urine volume, the hourly urine volume and the daily cumulative urine volume of this drainage are calculated.

[0037] The pulse negative pressure drainage mode also includes pipeline abnormal state recognition. The recognition method includes: during the first, second, or Nth negative pressure drainage, the pressure sensor dynamically monitors the negative pressure value of the drainage tube or the inner cavity of the urine collector. When the negative pressure value of the drainage tube or the inner cavity of the urine collector exceeds or stably remains at the set drainage negative pressure value, and the urine metering device senses no urine increment, the core processor prompts the pipeline abnormality on the man-machine interface. The pipeline abnormality prompt information includes poor drainage caused by catheter blockage, drainage pipeline blockage or drainage pipeline folding pressure, prompting medical staff to intervene.

[0038] According to the foregoing working principle, the control mode of the pulse negative pressure drainage mode includes:

[0039] S1: After starting, the core processor instructs the cutoff device to clamp the drainage tube, and the internal passage of the drainage tube is in a normally closed state, and the negative pressure device is in a standby working state.

[0040] For example: after starting, press the "clamping and closing" function key on the man-machine interaction interface, and the core processor instructs the cutoff device to clamp the drainage tube in advance, and the drainage tube is in a normally closed state.

[0041] S2: According to the clinical needs, the working mode is selected, and the pulse negative pressure drainage mode is selected.

[0042] S3: The drainage interval time is set by medical staff on the man-machine interaction interface, and the set range of the drainage interval time is between 5 min and 60 min. After the setting is completed, the core processor starts the countdown. Preferably, the drainage interval time is set between 15 min and 30 min.

[0043] For example, for patients who need to strictly monitor the time-sharing urine volume, the drainage interval time is set to 15 min.

[0044] S4: The drainage negative pressure value is set by medical staff on the man-machine interaction interface, and the set range of the drainage negative pressure value is between -40 cmH20 and 0 cmH20.

[0045] For example, the drainage negative pressure value is set between -20 cmH20 and -10 cmH20.

[0046] In one embodiment, after setting the drainage interval time and the drainage negative pressure value, the core processor presses the "clamping" function key on the man-machine interaction interface, and the core processor instructs the cutoff device to clamp the drainage tube in advance. After starting, the operation sequence of the cutoff device clamping the drainage tube and the parameter setting (i.e., the sequence of S1 and S2, S3, and S4) does not affect the expected effect of the pulse negative pressure drainage, and does not constitute a limitation on the present application.

[0047] S5: When the set drainage time is reached, the core processor instructs the cutoff device to open the drainage tube, and the negative pressure device starts to work synchronously. The negative pressure device applies negative pressure to the drainage tube or the inner cavity of the urine collector through the negative pressure tube, and absorbs the urine stored in the bladder or the drainage tube into the urine collector.

[0048] For example, the negative pressure device automatically starts to work after 15 minutes, and the set working negative pressure value -10 cmH20 is the upper limit. Under the continuous action of the negative pressure device, the urine stored in the bladder or the drainage tube is absorbed into the urine collector.

[0049] S6: During this period, the pressure sensor dynamically collects and monitors the negative pressure value of the drainage tube or the inner cavity of the urine collector through the pressure measuring tube, and dynamically feeds back to the core processor.

[0050] S7: During this period, if the negative pressure value of the drainage tube or the inner cavity of the urine collector exceeds or stably remains at the set negative pressure value, and the urine metering device senses no urine volume increment, the core processor prompts the pipeline to be abnormal on the man-machine interface, and prompts medical staff to intervene.

[0051] For example, the set negative pressure value of the drainage is-10 cmH20, and the pressure sensor dynamically monitors the negative pressure value of the drainage tube or the inner cavity of the urine collector. In the normal drainage state, the negative pressure value of the drainage tube or the inner cavity of the urine collector is kept at a low level (generally between-5 cmH20 and-3 cmH20). When the catheter or drainage tube is blocked by a large foreign matter that cannot be sucked by negative pressure, or the tube is folded and pressed, etc., causing the tube cavity to be blocked, the negative pressure value of the drainage tube or the inner cavity of the urine collector gradually rises and exceeds or remains at the set negative pressure value. After the catheter or drainage tube is blocked, the urine cannot be normally drained. Therefore, when the urine metering device senses that there is no urine increment at this time, the core processor prompts the tube to be abnormal on the human-machine interface.

[0052] S8: During the period, the urine metering device dynamically senses and calculates the urine increment, and when the urine increment stops, the negative pressure device automatically stops working, the cutoff device clamps the drainage tube again, and the internal passage of the drainage tube is in a closed state, the first negative pressure drainage is ended, and the negative pressure device enters the standby working state again, and the core processor starts the countdown again.

[0053] S9: When the set drainage time is reached again, the system works again according to the steps of S5-S8, and the process is repeated.

[0054] The working method of the foregoing pulse negative pressure drainage mode S1-S8 is programmed by software and written into the embedded software of the system, and the embedded software is burned into the memory of the control mainboard.

[0055] For patients with long-term indwelling catheter, the bladder is in a long-term empty or disuse state because it does not need to contract to empty urine. After the tube is removed, the patient may not be able to normally perceive the degree of bladder filling or normal urination. Therefore, before removing the catheter, the patient with long-term indwelling catheter needs to be clinically trained for bladder function recovery, to help the bladder and urethra to re-exercise and recover normal urine storage and urination function. A pulse urine drainage system also provides a pressure-controlled drainage working mode for bladder function recovery training.

[0056] The working principle of the pressure control drainage mode includes: the core processor instructs the cutoff device to clamp the drainage tube, so that the internal passage of the drainage tube is in a normally closed state, and the pressure control threshold at which the drainage tube is opened is set on the man-machine interaction interface. During this period, the pressure sensor dynamically monitors the pressure value in the drainage tube or the inner cavity of the urine collector and dynamically feeds back to the core processor. When the set pressure control threshold is reached, the core processor instructs the cutoff device to open the drainage tube, and under the action of gravity and siphon of urine, the urine stored in the bladder or the drainage tube is guided to the urine collector. The urine metering device dynamically senses and calculates the urine increment, and when the urine increment stops, the cutoff device clamps the drainage tube again, and the internal passage of the drainage tube is in a closed state again, and the first pressure control drainage ends. The core processor starts to retime, and when the set pressure control threshold is reached again, the core processor instructs the cutoff device to open the drainage tube again, and the second pressure control drainage is started according to the control program of the first pressure control drainage, the third...... the Nth pressure control drainage, and the cycle is repeated periodically. In the unattended state, the bladder functions like the normal person's urine storage function, and helps the patient to restore the bladder function, and calculates the new urine volume and the daily cumulative urine volume.

[0057] The control mode of the pressure control drainage includes:

[0058] S1: After starting, the core processor instructs the cutoff device to clamp the drainage tube, and the internal passage between the drainage tube and the urine collector is in a normally closed state.

[0059] S2: Select the working mode, select the pressure control drainage mode according to the clinical needs;

[0060] S3: Set the pressure control threshold, which is set between 30cmH20 and 40cmH20.

[0061] S4: During this period, the pressure sensor dynamically collects and monitors the pressure value in the inner cavity of the drainage tube through the pressure measuring pipe, and dynamically feeds back to the core processor.

[0062] S5: In the pressure control drainage mode, when the pressure value in the inner cavity of the drainage tube reaches the pressure control threshold set in S2, the core processor instructs the cutoff device to open the drainage tube, and the urine flows into the urine collector.

[0063] For example, the pressure control threshold set in S2 is 35cmH20, and when the pressure sensor monitors that the pressure value in the inner cavity of the drainage tube reaches 35cmH20, the core processor instructs the cutoff device to open the drainage tube, and the urine flows into the urine collector.

[0064] S6: After the cutoff device opens the drainage tube, the urine metering device dynamically senses and calculates the urine increment, and when the urine increment stops, the cutoff device clamps the drainage tube again, and the internal passage of the drainage tube is in a closed state again, and the first pressure control drainage ends.

[0065] S7: The pressure sensor dynamically monitors the pressure value in the drainage tube lumen, and implements feedback to the core processor. When the pressure threshold set in S2 is reached again, the system works again according to steps S3-S6, and so on.

[0066] The working method of the foregoing S1-S7 pressure-controlled drainage is programmed by software and written into the embedded software of the system, and the embedded software is burned into the memory of the control mainboard.

[0067] When entering the pressure-controlled drainage working mode, in order to strengthen the self-urination awareness of the patient and improve the effect of bladder function recovery training, the negative pressure device does not actively intervene in the working mode in the normal state. However, if the pressure threshold set in S2 is reached during the pressure-controlled drainage, the core processor instructs the cutoff device to open the drainage tube, and the urine metering device dynamically senses that there is no new urine volume (i.e., no urine flow) or abnormal urine volume (i.e., oliguria). At this time, the human-computer interaction interface prompts that the drainage state is abnormal, and the inducing factors of the abnormal drainage state include blockage of large foreign matters or pipe folding. Therefore, when entering the pressure-controlled drainage working mode, the negative pressure device can be manually started to perform negative pressure suction to remove the foreign matters in the pipe. Advantages

[0068] The advantages of the present application are as follows:

[0069] According to the characteristics of the patient and the clinical needs, two working modes including the pulse negative pressure drainage mode and the pressure-controlled drainage mode are provided, the drainage control parameters including the drainage interval time, the drainage negative pressure value or the pressure threshold value are autonomously set, the urine retained in the bladder or the drainage tube is periodically emptied, and the real urine volume generated by the patient in the period is calculated.

[0070] In the pulse negative pressure drainage working mode, the drainage pipe is opened at a fixed time, and the pulse negative pressure drainage is performed by loading the negative pressure. In the pressure-controlled drainage working mode, the negative pressure device can be manually started to perform negative pressure suction, which is beneficial to the cleaning of the residual foreign matters in the urinary catheter or the drainage tube and reduces the risk of pipe blockage.

[0071] (3) The cutoff device adopts the pulse control mode of "clamping-closing drainage, opening drainage again, clamping again-opening drainage again" according to the control program, automatically controls the internal pipe state, greatly shortens the opening time of the drainage path established by the bladder, the drainage tube and the urine collector, effectively blocks the reverse upward of the bacteria in the drainage tube or the urine collector to the bladder or the urethra, and reduces the risk of urinary tract infection. At the same time, the periodic bladder function recovery training can also be automatically realized when the pressure-controlled drainage mode is adopted. BRIEF DESCRIPTION OF DRAWINGS

[0072] Fig. 1 is a schematic block diagram of a system of the present application

[0073] Figure 2 is a schematic diagram of the structure of a pulse-type urodynamic control device according to the present invention.

[0074] Figure 3 is a schematic diagram of one embodiment of the drainage component used in conjunction with the device.

[0075] Figure 4 is a schematic diagram of the combination of the pulse-type urodynamic control device and the supporting drainage component of the present invention.

[0076] As shown in the figure:

[0077] 10. Pulse-type urodynamic control device; 11. Human-machine interface; 12. Cut-off device; 13. Negative pressure device interface; 14. Pressure sensor interface; 15. Urine metering device; 16. Limiting groove; 21. Urinary catheter; 22. Adapter connector; 23. Drainage tube; 24. Pressure measuring tee interface; 25. Negative pressure tube; 26. Pressure measuring tube; 27. Urine collector. The best embodiment of the present invention

[0078] The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0079] Example 1: A method for preparing the pulse-type urodynamic control device 10 of the present invention

[0080] 1. As shown in Figure 1, the schematic diagram of the design of the pulse-type urodynamic control device 10 is shown.

[0081] 2. The list of main components used is as follows:

[0082] The core processor (MCU) uses the STC89C52 microcontroller (STC Corporation).

[0083] The pressure sensor used is a GZP6847 micro pressure sensor with a range of -30 kPa to 50 kPa.

[0084] The negative pressure device uses a miniature vacuum pump, model EDZP1, with a working voltage of 3V, a flow rate of ≥1L / min, a maximum working pressure of 60cmH2O, and a noise level of <50dB.

[0085] The shut-off device 12 consists of a DC motor, a transmission component, and a clamp. The DC motor has a rated power of 0.3W.

[0086] The voltage is 3.7V, the speed is 3rpm~76rpm, and the torque is 0.3NM. The transmission components consist of stainless steel gears, screws, and nuts. The clamp is made of nylon tongues, and the tongues and nuts are combined. The clockwise or counterclockwise rotation of the DC motor drives the tongues to move linearly on the screw through the transmission components, so that the tongues clamp or release the drainage tube 23, controlling the closed or open state of the inner cavity of the drainage tube 23.

[0087] The urine metering device 15 adopts a gravity sensor of model SBT620, with a maximum error of ±0.2% and a range of 0-2000g;

[0088] The communication module adopts a WiFi module of model QCA9377 (Qualcomm Inc.);

[0089] The storage module adopts a Samsung HY27US08561A chip with a storage capacity of 32M.

[0090] The function keys of the human-computer interaction interface 11 adopt Omron B3F light touch switch buttons with a size of 12*12*7.3. The display screen adopts a 2.9-inch LCD liquid crystal with a working voltage of DC 3.0V. The sound prompter adopts a conventional buzzer.

[0091] 3. The power supply adopts an internal power source, and a 10000mA, 3.7V rechargeable lithium battery is selected.

[0092] The PCB of the control mainboard is designed according to the conventional integrated circuit technology, and the control mainboard is prepared by adopting electronic patching or welding process, with a length of 60mm, a width of 40mm, and a thickness of 0.8mm.

[0093] The pressure sensor is packaged on the PCB of the control mainboard, and the pressure measuring port of the pressure sensor is in communication with the pressure sensor interface 14 on the top of the protective shell through an extension pipe.

[0094] 4. The lead wire is adopted to connect the negative pressure device, the cutoff device 12, and the urine metering device 15 with the control mainboard, and they are controlled by the core processor.

[0095] 5. As shown in FIG. 2, a protective shell mold matching the size of the control mainboard is designed, and the left side of the protective shell is provided with a negative pressure device interface 13 connected with the internal vacuum pump. The right side is provided with a USB line interface and a DC charging interface. The front of the protective shell is provided with an observation window matching the liquid crystal screen, and the function keys are arranged below the observation window, including the power on / off key, the negative pressure value setting key, the drainage interval time setting key, etc. The bottom of the protective shell is provided with a urine metering device 15 mounting position, and the suspension fixing device of the urine collector 27 is arranged below the urine metering device.

[0096] 6. The components are installed and fixed in the protective shell, and the machine is tested. If it is qualified, it can be used.

[0097] Example 2 Preparation of the drainage assembly matched with the pulse type urodynamic control device 10

[0098] 1. As shown in Figure 3, an extrusion mold is used to manufacture the urinary catheter 21, drainage tube 23, negative pressure tube 25, and pressure measuring tube 26. The urinary catheter 21 is made of silicone rubber using an extrusion process; the drainage tube 23, negative pressure tube 25, and pressure measuring tube 26 are made of medical-grade soft polyvinyl chloride using an extrusion process. Wherein:

[0099] The urinary catheter 21 is 18Fr in size and 400mm in length.

[0100] The drainage tube 23 has an inner diameter of 6mm and an outer diameter of 8mm, and is cut into two specifications: section A is 130cm long and section B is 30cm long.

[0101] The negative pressure tube 25 has an inner diameter of 3mm and an outer diameter of 5.5mm, and is cut into 30cm segments.

[0102] The pressure measuring tube 26 has an inner diameter of 2mm and an outer diameter of 3.5mm, and is cut into 20cm segments.

[0103] 2. Injection molds for the branch connectors of catheter 21 are manufactured using silicone rubber injection molding; injection molds for the adapters of conversion connector 22, negative pressure tube 25, and pressure measuring tube 26 are manufactured using medical-grade polyvinyl chloride injection molding. The dimensions of each connector are matched to the interfaces of the corresponding tubing.

[0104] 3. Manufacture a blow molding mold for the pressure testing tee interface 24 using PET material blow molding process.

[0105] 4. Manufacture the blow molding mold for urine collection device 27, using PET material blow molding process, with a capacity of 2000ml.

[0106] 5. Use medical adhesive (silicone rubber, cyclohexanone, etc.) to connect each connector to its corresponding catheter, for example:

[0107] The catheter body 21 is bonded to the branch interface.

[0108] The head of the A-line of the drainage tube 23 is bonded to the conversion connector 22, and the tail of the A-line is connected to the drainage port at the top of the pressure testing tee interface 24.

[0109] One end of the pressure testing tube 26 is connected to the top pressure testing port of the pressure testing tee interface 24, and the other end is glued to the adapter of the pressure testing tube 26.

[0110] The head of the B-tube of the drainage tube 23 is bonded to the bottom drainage hole of the pressure measuring tee interface 24, and the tail of the B-tube can be connected to the interface of the inlet of the urine collector 27.

[0111] One end of the negative pressure tube 25 is connected to the urine collector 27, and the other end is glued to the adapter of the negative pressure tube 25.

[0112] 6. Check the firmness and tightness of each fixed connection part, the tensile strength is not less than 10N, no leakage, after packing, sterilization.

[0113] Example 3 An application example of pulse urodynamic control device 10 matched with drainage assembly

[0114] 1. As shown in Figure 4, fix the pressure measuring tee joint interface 24 in the limiting groove 16 on the left side of the pulse urodynamic control device 10, and make the negative pressure pipe 25 communicate with the negative pressure device interface 13 on the right side of the pulse urodynamic control device 10.

[0115] 2. Hang the urine collector 27 vertically on the urine metering device 15 below the pulse urodynamic control device 10.

[0116] 3. Connect the conversion joint 22 of the drainage tube 23 with the interface of the indwelling catheter 21 in the patient's body.

[0117] 4. Start the pulse urodynamic control device 10, select the pulse negative pressure drainage mode on the human-computer interaction interface 11; the core processor instructs the cutoff device 12 to clamp the B section of the drainage tube 23, and make the internal passage between the drainage tube 23 and the urine collector 27 in a normally closed state.

[0118] 5. Set the drainage interval time as 20 min and the maximum drainage negative pressure value as -15 cmH2O on the human-computer interaction interface 11. The core processor starts the countdown, and the negative pressure pump is in standby state.

[0119] 6. After reaching 20 min, the core processor instructs the cutoff device 12 to release the B section of the drainage tube 23, and the negative pressure device starts working synchronously. The pressure sensor dynamically monitors the pressure in the pressure measuring tee joint interface 24, and the urine metering device 15 dynamically meters the urine volume in the urine collector 27, and displays and reads out the urine volume and metering time on the human-computer interaction interface 11. If abnormal conditions such as oliguria or polyuria occur, prompt information is given.

[0120] 7. During the drainage, if the negative pressure value reaches or exceeds -15 cmH2O, the human-computer interaction interface 11 prompts that the pipeline is abnormal, and it is possible that there is foreign matter blocking or pipeline folding in the catheter 21 or the drainage tube 23.

[0121] 8. After the urine metering device 15 senses that there is no new urine volume, the core processor instructs the negative pressure device to stop working, and instructs the cutoff device 12 to clamp the B section of the drainage tube 23, and make the internal passage between the drainage tube 23 and the urine collector 27 in a normally closed state again, and the drainage ends this time.

[0122] 9. The core processor starts the countdown, and the negative pressure pump is in standby state. After reaching the set interval time (20 min), the negative pressure drainage is started again, and the process is repeated.

[0123] Example 4 Application example of pulse urodynamic control device 10 combined with drainage assembly for bladder function recovery training

[0124] 1. When bladder function recovery training is needed, follow the steps 1-3 of example 3.

[0125] 2. Turn on the pulse urodynamic control device 10, select the pressure control drainage mode on the human-computer interaction interface 11; the core processor instructs the cutoff device 12 to clamp the B section of the drainage tube 23, and makes the internal passage between the drainage tube 23 and the urine collector 27 in a normally closed state.

[0126] 3. Set the pressure control threshold to 35 cmH20 on the human-computer interaction interface 11.

[0127] 4. The pressure sensor dynamically collects and monitors the pressure value in the lumen of the drainage tube 23 through the pressure measuring tube 26, and dynamically feeds back to the core processor.

[0128] 5. When the pressure value in the lumen of the drainage tube 23 reaches the pressure control threshold of 35 cmH20, the core processor instructs the cutoff device 12 to open the B section of the drainage tube 23, and the urine flows into the urine collector 27.

[0129] 6. After the cutoff device 12 opens the drainage tube 23, the urine metering device 15 dynamically calculates the urine volume increment, and when the urine volume stops increasing, the cutoff device 12 clamps the B section of the drainage tube 23 again, and the internal passage of the drainage tube 23 is closed again, and the pressure control drainage ends.

[0130] 7. The pressure sensor dynamically monitors the pressure value in the lumen of the drainage tube 23, and feeds back to the core processor, and when the set pressure control threshold of 35 cmH20 is reached again, the core processor instructs the cutoff device 12 to open the B section of the drainage tube 23, and so on.

[0131] The above drawings and examples are only used to illustrate the technical solutions of the present application and are not limited. Although the present application has been described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that the technical solutions of the present application can be modified or replaced equivalently without departing from the purpose and scope of the present application, and they should be covered in the scope of the claims of the present application. The protection scope of the present application does not constitute any limitation.

Claims

1. A pulsatile urinary drainage system comprising mainly a pulsatile urodynamic control device (10) and a drainage assembly associated with the device, wherein: The pulse type urodynamic control device (10) comprises a control mainboard, a cutoff device (12), a negative pressure device, a pressure sensor, a urine metering device (15) and a man-machine interface (11), the drainage assembly matched with the device is a special machine special consumable used in combination with the pulse type urodynamic control device (10), and the drainage assembly comprises a catheter (21), a conversion joint (22), a drainage tube (23), a pressure measuring tube (26), a negative pressure tube (25) and a urine collector (27); characterized in that the cutoff device (12), the negative pressure device, the pressure sensor and the core processor are organically combined to form a closed-loop control urine drainage system; according to the patient characteristics and clinical needs, two working modes including a pulse type negative pressure drainage mode and a pressure control drainage mode are provided, the drainage control parameters including a drainage interval time, a drainage negative pressure value or a pressure control threshold value are autonomously set, the urine retained in the bladder or the drainage tube (23) is periodically emptied, and the real urine volume generated by the patient in the period is calculated.

2. A pulsatile urinary drainage system according to claim 1, wherein, The working principle of the pulse type negative pressure drainage mode comprises that the core processor instructs the cutoff device (12) to clamp the drainage tube (23), so that the internal passage of the drainage tube (23) is in a normally closed state, and the negative pressure device is in a standby working state; the drainage interval time and the drainage negative pressure value are autonomously set on the man-machine interface (11), when the set first drainage time is reached, the core processor instructs the cutoff device (12) to open the drainage tube (23), and the negative pressure device is synchronously started to work, the negative pressure device loads negative pressure into the internal cavity of the drainage tube (23) or the urine collector (27) through the negative pressure tube (25), and under the continuous action of the negative pressure device, the urine retained in the bladder or the drainage tube (23) is sucked into the urine collector (27); during the period, the pressure sensor dynamically monitors the negative pressure value of the internal cavity of the drainage tube (23) or the urine collector (27) and dynamically feeds back to the core processor, the core processor instructs the negative pressure device to dynamically adjust the working pressure, so that the working load of the negative pressure device is limited in the set drainage negative pressure value range, and the bladder or the inner wall of the urethra is prevented from being damaged by overload negative pressure; the urine metering device (15) dynamically senses and calculates the urine volume increment, when the urine volume stops increasing, the negative pressure device is automatically stopped, the cutoff device (12) clamps the drainage tube (23) again, and the internal passage of the drainage tube (23) is in a closed state, and the first negative pressure drainage is ended; after the negative pressure device is stopped, the core processor starts to retime, when the set drainage interval time is reached, the core processor instructs the cutoff device (12) to open the drainage tube (23) again, the negative pressure device is synchronously started to work, the second negative pressure drainage, the third negative pressure drainage and the Nth negative pressure drainage are started according to the control program of the first negative pressure drainage, and the cycle is repeated periodically, so that the pulse type negative pressure drainage control is automatically realized in the unattended state, the urine retained in the bladder or the drainage tube (23) is periodically emptied, and the new urine volume, the hourly urine volume and the daily cumulative urine volume of this drainage are calculated.

3. A pulsatile urinary drainage system according to claim 1, wherein, The pulse negative pressure drainage mode further comprises pipeline abnormal state identification. The identification method comprises: during the negative pressure drainage, the pressure sensor dynamically monitors the negative pressure value of the drainage tube (23) or the inner cavity of the urine collector (27), when the negative pressure value of the drainage tube (23) or the inner cavity of the urine collector (27) exceeds or stably remains at the set drainage negative pressure value, and the urine metering device (15) senses no urine volume increment, the core processor prompts pipeline abnormality on the human-computer interface; the pipeline abnormality prompt information comprises poor drainage caused by catheter (21) blockage, drainage tube (23) blockage or drainage tube (23) folding and pressing, and prompts medical staff to intervene.

4. The pulsatile urinary drainage system of claim 1, wherein, Further provided is a pressure-controlled drainage working mode for bladder function recovery training; the working principle of the pressure-controlled drainage mode comprises: the core processor instructs the cutoff device (12) to clamp the drainage tube (23), so that the internal passage of the drainage tube (23) is in a normally closed state, and the pressure-controlled threshold value of the drainage tube (23) is set on the human-computer interaction interface (11) autonomously; during this period, the pressure sensor dynamically monitors the pressure value of the drainage tube (23) or the inner cavity of the urine collector (27) and dynamically feeds back to the core processor. When the set pressure-controlled threshold value is reached, the core processor instructs the cutoff device (12) to open the drainage tube (23), and under the action of the gravity and siphon effect of urine, the urine stored in the bladder or the drainage tube (23) is guided to the urine collector (27); the urine metering device (15) dynamically senses and calculates the urine volume increment, and after the urine volume stops increasing, the cutoff device (12) clamps the drainage tube (23) again, and the internal passage of the drainage tube (23) is in a closed state, and the first pressure-controlled drainage ends; the core processor starts to retime, and when the set pressure-controlled threshold value is reached again, the core processor instructs the cutoff device (12) to open the drainage tube (23) again, and the second pressure-controlled drainage, the third pressure-controlled drainage, and the Nth pressure-controlled drainage are started according to the control program of the first pressure-controlled drainage, and the cycle is repeated periodically; in the unattended state, the bladder is relaxed like the normal urine storage function, helping the patient to recover the bladder function, and the new urine volume of this drainage and the daily cumulative urine volume are calculated.

5. The pulsatile urinary drainage system of claim 1, wherein, The cutoff device (12) adopts the pulse control mode of “clamping and closing-open drainage, clamping again-open drainage” according to the control program, automatically controls the internal pipeline state, greatly shortens the opening time of the drainage passage established by the bladder, the drainage tube (23) and the urine collector (27), effectively blocks the reverse upward of bacteria in the drainage tube (23) or the urine collector (27) to the bladder or the urethra, and reduces the risk of urinary tract infection.

6. The pulsatile urinary drainage system of claim 1, wherein, The control mode of the pulse negative pressure drainage mode comprises: S1: after starting, the core processor instructs the cutoff device (12) to clamp the drainage tube (23), and the internal passage of the drainage tube (23) is in a normally closed state, and the negative pressure device is in a standby working state; S2: according to the clinical requirement, the working mode is selected, and the pulse negative pressure drainage mode is selected; S3: The drainage interval time is set by medical staff on the man-machine interaction interface (11), and the setting range of the drainage interval time is between 5 min and 60 min. After the setting is completed, the core processor starts the countdown; S4: The drainage negative pressure value is set by medical staff on the man-machine interaction interface (11), and the setting range of the drainage negative pressure value is between -40 cmH20 and 0 cmH20; S5: When the set drainage time is reached, the core processor instructs the cutoff device (12) to open the drainage tube (23), and the negative pressure device is started to work synchronously. The negative pressure device applies negative pressure to the inner cavity of the drainage tube (23) or the urine collector (27) through the negative pressure tube (25), so that the urine stored in the bladder or the drainage tube (23) is sucked into the urine collector (27); S6: During this period, the pressure sensor dynamically collects and monitors the negative pressure value in the inner cavity of the drainage tube (23) or the urine collector (27) through the pressure measuring tube (26), and dynamically feeds back to the core processor; S7: During this period, if the negative pressure value in the inner cavity of the drainage tube (23) or the urine collector (27) exceeds or stably remains at the set negative pressure value, and the urine metering device (15) senses no urine volume increment, the core processor prompts the pipeline to be abnormal on the man-machine interface, prompting medical staff to intervene; S8: During this period, the urine metering device (15) dynamically senses and calculates the urine volume increment. When the urine volume stops increasing, the negative pressure device is automatically stopped, the cutoff device (12) clamps the drainage tube (23) again, and the internal passage of the drainage tube (23) is in a closed state. The first negative pressure drainage is completed, and the negative pressure device enters the standby working state again. The core processor starts the countdown again; S9: When the set drainage time is reached again, the system works again according to steps S5-S8, and the process is repeated; The working method of the foregoing S1-S8 pulse negative pressure drainage mode is programmed by software and written into the embedded software of the system, and the embedded software is burned into the memory of the control mainboard.

7. The pulsatile urinary drainage system of claim 1, wherein, The control mode of pressure-controlled drainage includes: S1: After starting, the core processor instructs the cutoff device (12) to clamp the drainage tube (23), and the internal passage between the drainage tube (23) and the urine collector (27) is in a normally closed state; S2: Select the working mode according to the clinical needs, and select the pressure-controlled drainage mode; S3: Set the pressure control threshold, and the pressure control threshold is set between 30 cmH20 and 40 cmH20; S4: During this period, the pressure sensor dynamically collects and monitors the pressure value in the inner cavity of the drainage tube (23) through the pressure measuring tube (26), and dynamically feeds back to the core processor; S5: In the pressure-controlled drainage mode, when the pressure value in the inner cavity of the drainage tube (23) reaches the pressure control threshold set in S2, the core processor instructs the cutoff device (12) to open the drainage tube (23), and the urine flows into the urine collector (27); S6: After the cutoff device (12) opens the drainage tube (23), the urine metering device (15) dynamically senses and calculates the urine volume increment. When the urine volume stops increasing, the cutoff device (12) clamps the drainage tube (23) again, and the internal passage of the drainage tube (23) is in a closed state again. The first pressure-controlled drainage is completed; S7: The pressure sensor dynamically monitors the pressure value in the inner cavity of the drainage tube (23), and implements feedback to the core processor. When the pressure threshold set in S2 is reached again, the system works according to steps S4-S6 again, and so on. The working method of the pressure-controlled drainage described in the foregoing S1-S7 is written into the embedded software of the system after software programming, and the embedded software is burned into the memory of the control mainboard.

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