Negative pressure control urine drainage system

Abstract

A negative pressure control urine drainage system comprises a monitoring host and a matched drainage tube. The device has the beneficial effects that urine detained in a bladder or a drainage tube can be emptied regularly, and the real urine volume generated by a patient in the time period can be calculated, so that the accuracy of urine volume metering in unit time is greatly improved, and credible monitoring data, early discovery and early intervention are provided for AKI. Moreover, urine in the bladder or the drainage tube is emptied at regular time, the risks of tube blockage and urinary tract infection can be reduced, the blank in the technical field is filled, and good clinical value is achieved.

Description

Technical Field

[0001] The invention relates to a negative pressure controlled urine drainage system, which is used for dynamic monitoring of patients with indwelling urinary catheters and belongs to the field of medical devices or nursing supplies. Background Art

[0002] Oliguria (defined as urine output less than 17 ml per hour) is an independent predictor of acute kidney injury (AKI). Numerous medical studies have confirmed that persistent oliguria in ICU patients is associated with higher mortality. Therefore, oliguria has been recognized as an early, sensitive indicator of acute kidney injury and requires rigorous, dynamic monitoring. The current standard for indwelling catheterization care involves placing a urinary catheter in the patient's bladder. A drainage tube connects the catheter to a urine collector, which is suspended from the bedside below the wound surface. The siphon effect created by the height difference between the bladder and the collector drains urine from the bladder into the collector. When urine output needs to be calculated, the amount collected in the collector is measured and recorded using a measuring cup. In recent years, with the increasing application of electronic technology in medicine, electronic urine meters (a general term for products with similar functions) for dynamic urine monitoring have gradually entered clinical use. The basic principle of this type of product is to install the electronic urine meter outside the patient's bed, and suspend the urine collector on the gravity sensor provided on the electronic urine meter. The gravity sensor dynamically weighs the urine in the urine collector and converts it into a urine volume display.

[0003] Existing urine volume measurement methods have major drawbacks, mainly in that: in clinical practice, due to the long distance between the patient's bladder and the urine collector, and the need to accommodate changes in patient posture such as turning over, the length of the drainage tube from the catheter interface to the urine collector is generally between 120cm and 150cm. According to measurements in real clinical scenarios, taking a drainage tube with an inner diameter of 5mm as an example, the amount of urine retained in the drainage tube laid flat on the bed from the catheter interface to the upstream of the urine collector is between 45ml and 50ml. Therefore, whether manual measurement or electronic urine meter measurement is used, only the urine volume value in the urine collector can be measured, but the urine volume retained in the drainage tube or bladder cannot be measured. The obtained urine volume value deviates greatly from the actual urine volume produced by the patient per unit time. In particular, for oliguric patients with an hourly urine output of less than 17 ml, all urine from the first 1-3 hours may be retained in the bladder or in the drainage tube lying flat on the bed. As the amount of urine discharged from the bladder continues to increase, the retained urine in the drainage tube slowly peristalsis into the urine bag. Finally, under the siphon effect, for example, in the fourth hour, all the urine is discharged simultaneously into the urine collector and incorrectly counted as urine output for that period. Therefore, this existing drainage status and measurement method cannot accurately reflect the actual urine volume secreted by the patient per unit time, affecting the reliability and validity of early diagnosis of acute kidney injury (AKI).

[0004] On the other hand, urine retention in the drainage tube can easily lead to the deposition of sugar, protein, and inorganic salts such as calcium and sodium in the urine, resulting in salt crystallization at the catheter tip or blockage of the drainage tube. Furthermore, urine retention in the drainage tube can easily lead to bacterial growth and retrograde upward movement into the bladder, increasing the risk of urinary tract infection. Therefore, the inventors have proposed a negative pressure-controlled urine drainage system to address the shortcomings of existing urine volume monitoring and drainage technologies. Summary of the Invention

[0005] The present invention relates to a negative pressure controlled urine drainage system, which mainly comprises:

[0006] A system comprising a monitoring device and supporting drainage materials, wherein:

[0007] The monitoring device includes a control mainboard, a negative pressure generator, a pressure sensor, a urine metering device and a human-computer interaction interface.

[0008] The control motherboard is an integrated circuit composed of components such as a core processor, memory, signal processor, and communication module. The core processor uses a single-chip microcomputer (MCU), and the communication module uses any of WiFi, Bluetooth, or ZigBee.

[0009] The control mainboard is also provided with embedded software, which is a software program used for hardware driving, function setting, data analysis and negative pressure drainage control. The embedded software is burned into the memory of the control mainboard.

[0010] The negative pressure generator is a device that provides a vacuum environment within the drainage material. For example, a small vacuum pump is used. The negative pressure generator is connected to and controlled by the control board. The operating pressure adjustment range of the negative pressure generator is not less than -10cmH20 to 0.

[0011] The pressure sensor dynamically monitors the pressure value within the supporting drainage material. The pressure sensor has a range of no less than -10 cmH20 to 0, and a measurement accuracy of no less than 1 cmH20. The pressure sensor is connected to the control motherboard and sends the pressure data obtained by dynamic monitoring to the core processor.

[0012] The urine metering device dynamically monitors the patient's urine output. The range of the urine metering device is no less than 0-1000ml, and the measurement accuracy is no less than 1ml. The urine metering device is connected to the control motherboard and transmits the urine volume data obtained through dynamic monitoring to the core processor.

[0013] Depending on the urine volume monitoring technology, the optional urine metering devices include but are not limited to ultrasonic liquid flow meters, light-sensitive drip rate sensors, turbine liquid flow meters, gravity sensors, and tension sensors.

[0014] For example, an ultrasonic liquid flow meter is used and placed on the periphery of the drainage tube to dynamically measure the amount of urine flowing through the tube.

[0015] Alternatively, a gravity sensor is used, a urine collector is suspended below the gravity sensor, the weight of the urine in the urine collector is measured, and then the urine weight is converted into urine volume according to the urine density of the patient.

[0016] In one embodiment, a light-sensitive drip rate sensor is used to dynamically monitor urine volume. Specifically, a drip bucket is set between the drainage tube and the urine collector, and an infrared drip rate sensor is set on the periphery of the drip bucket. When no urine drops pass through the drip bucket, the receiving tube of the infrared drip rate sensor is turned on by light, and the output signal is marked as 0 drops. When urine drops pass through the drip bucket, the droplets refract the light, the light flux of the receiving tube is insufficient, and the output signal is marked as 1 drop. This is accumulated to calculate the number of urine drops per unit time. Since the volume of each drop of urine is basically constant, the volume of each drop is multiplied by the number of urine drops to calculate the amount of urine drained per unit time.

[0017] Preferably, a combination of a light-sensitive drip rate sensor and a gravity sensor is used. Specifically, a drip bucket is set between the drainage tube and the urine collector, and an infrared drip rate sensor is set on the outer periphery of the drip bucket. At the same time, a gravity sensor is provided, and the urine collector is suspended below the gravity sensor. The advantage of this technical method is that the light-sensitive drip rate sensor and the gravity sensor are measured synchronously. The light-sensitive drip rate sensor calculates the amount of urine per unit time, and the gravity sensor calculates the weight of the urine per unit time, and dynamically calculates the urine density. The calculation formula for urine density is: urine density = urine weight ÷ volume. According to the corresponding relationship between weight, density and volume, the volume of urine per unit time is calculated.

[0018] The human-computer interaction interface includes a display screen, a data interface and operation function keys.

[0019] The drainage materials mentioned above are special consumables used with monitoring equipment. The drainage materials include a conversion joint, a drainage tube, a negative pressure suction chamber, a negative pressure suction tube and a urine collector. Among them:

[0020] The conversion joint is used to connect the drainage device to the urinary catheter placed in the patient's bladder.

[0021] The drainage tube is a flexible pipe that connects the urinary catheter to the urine collector, draining urine from the bladder into the urine collector. The front end of the drainage tube is connected to the urinary catheter using a conversion connector, and the tail end of the drainage tube is connected to the urine collector.

[0022] The negative pressure suction chamber is a hollow cavity located between the drainage tube and the urine collector and has a pipe connection. The negative pressure suction chamber has three pipe connections: one connects to the drainage tube upstream of the urine collector, one connects to the urine collector's liquid inlet downstream, and the third connects to the negative pressure suction tube.

[0023] The negative pressure suction tube is a flexible pipe connecting the negative pressure suction chamber and the suction port of the negative pressure generator.

[0024] A urine collector is a container that collects urine discharged from a drainage tube, including a urine collection bag or drainage bottle.

[0025] Furthermore, to prevent urine in the urine collector from flowing back into the drainage tube, a check valve is provided between the negative pressure suction chamber and the urine collector. The shape and structure of the check valve are not limited, including a film check valve and a silicone duckbill valve.

[0026] In order to improve the integration level of consumables and reduce the time for medical staff to prepare multiple consumables, the catheter can also be combined with the supporting drainage materials to form a drainage consumables combination package dedicated to monitoring equipment.

[0027] The catheters mentioned above include conventional two-lumen or three-lumen catheters, as well as functional catheters such as temperature-measuring catheters, pressure-measuring catheters, and temperature-measuring pressure-measuring catheters. Catheters with different functions can be used with monitoring equipment to obtain more physiological parameters of patients, such as:

[0028] When used in combination with a temperature-measuring catheter, the monitoring device can collect body temperature data from the patient's bladder and display it.

[0029] When used in combination with a manometry catheter, the monitoring device can measure the patient's bladder pressure, obtain the patient's bladder pressure or intra-abdominal pressure data and display the readout.

[0030] When the temperature and pressure measuring catheter is used in combination, the monitoring equipment can collect and obtain the patient's body temperature, bladder pressure or intra-abdominal pressure data and display the readout.

[0031] A method for negative pressure controlled urine drainage system, mainly comprising:

[0032] (1) According to the drainage interval time and drainage negative pressure value set by medical staff in the human-computer interaction interface, the system automatically starts the negative pressure generator for suction, so that negative pressure is generated in the negative pressure suction chamber;

[0033] (2) During this period, the pressure sensor dynamically monitors the negative pressure value in the negative pressure suction chamber and feeds it back to the core processor. The core processor instructs the negative pressure generator to dynamically correct the working pressure and keep the negative pressure value in the negative pressure suction chamber stable within the set drainage negative pressure value range;

[0034] (3) Under the continuous action of the negative pressure generator, the urine retained in the bladder or drainage tube is sucked into the negative pressure suction chamber, and the urine flows into the urine collector under the action of gravity;

[0035] (4) During negative pressure drainage, the urine metering device dynamically senses the increase in urine volume. When the urine volume stops increasing, the negative pressure generator stops working. Alternatively, the human-computer interaction interface can also independently set the negative pressure holding time. When the negative pressure holding time set by the system is reached, the negative pressure generator stops working.

[0036] (5) The urine metering device dynamically monitors the amount of urine added during this period and displays the reading on the human-computer interaction interface. When oliguria or polyuria occurs, a dynamic prompt is given. At this point, a urine negative pressure drainage and metering cycle ends;

[0037] (6) The system periodically repeats the above steps (1) to (5), regularly clears the urine retained in the bladder or drainage tube, and calculates the urine volume.

[0038] (7) The drainage interval time in the system is set between 1 minute and 60 minutes. Preferably, the drainage interval time is set between 5 minutes and 10 minutes.

[0039] (8) The drainage negative pressure value in the system is set between -40 cmH20 and -1 cmH20. Preferably, the drainage negative pressure value is set between -10 cmH20 and -6 cmH20.

[0040] (9) The system can set the negative pressure holding time between 1 minute and 5 minutes. Preferably, the negative pressure holding time is set to 2 minutes.

[0041] The aforementioned negative pressure controlled urine drainage working methods (1) to (9) are written into the embedded software of the system through software programming.

[0042] The beneficial effect of the present invention is that it can independently set the drainage interval time, drainage negative pressure value or negative pressure holding time according to the patient's characteristics and clinical needs, regularly empty the urine retained in the bladder or drainage tube, and calculate the actual urine volume produced by the patient during this period. Not only does it greatly improve the accuracy of urine volume measurement per unit time, it also provides reliable monitoring data for AKI early warning, early detection and early intervention. Moreover, regularly emptying the urine in the bladder or drainage tube can also reduce the risk of tube blockage and urinary tract infection, filling a gap in this technical field and having great clinical value. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 This is a schematic diagram of a system of the present invention.

[0044] Figure 2 This is a schematic diagram of the monitoring device structure of a system of the present invention

[0045] Figure 3 This is a schematic diagram of the combination of the monitoring device and the supporting drainage material of the present invention.

[0046] Figure 4 This is a schematic diagram of the structure of the negative pressure suction chamber and urine collector combined into one in the embodiment of the present invention.

[0047] Figure 1 shows: monitoring device 10, human-machine interface 11, negative pressure generator interface 20, urine metering device 30, conversion joint 40, drainage tube 50, negative pressure suction chamber 60, negative pressure suction tube 70, suction tube joint 71, check valve 72, urine collector 80, urine collector fixing device 90 DETAILED DESCRIPTION

[0048] The present invention will be described in detail below with reference to the accompanying drawings and embodiments.

[0049] Example 1: A preparation method of the monitoring device 10 of the present invention

[0050] 1. If Figure 1 As shown, a schematic diagram of the monitoring device 10 is designed.

[0051] 2. The main components used are as follows:

[0052] The core processor (MCU) uses the STC89C52 microcontroller (STC company);

[0053] The pressure sensor is model GZP6847 micro (Wuxi), with a range of -30KPa to 0KPa;

[0054] The urine metering device 30 uses a gravity sensor model SBT620 (Guangzhou), with a maximum error of ±0.2% and a measuring range of 0 to 2 kg;

[0055] The communication module uses a WiFi module, model QCA9377 (Qualcomm);

[0056] The storage module uses Samsung HY27US08561A chip with a storage capacity of 32M.

[0057] The function keys of the human-machine interface 11 are Omron B3F touch switches, measuring 12*12*7.3. The display screens (1-3) use 2.9-inch LCDs with a DC3.0V operating voltage; the sound indicator uses a conventional buzzer.

[0058] The power supply uses an internal power supply, and a 10000mA, 3.7V rechargeable lithium battery (Evee Company) is selected.

[0059] 3. Design the PCB according to conventional integrated circuit technology, and use electronic patch or welding technology to prepare the control main board. The control main board is 60 mm long and 40 mm wide.

[0060] 4. Design a protective housing mold that matches the size of the control motherboard. The left side of the protective housing is required to be provided with a negative pressure generator interface 20, which is connected to the internal negative pressure generator; the right side is provided with a USB cable interface and a DC charging interface; the front of the protective housing is provided with an observation window that matches the LCD screen, and function keys are set below the observation window. The function keys include a power button, a negative pressure value setting button, a drainage interval time setting button, etc.; the bottom of the protective housing is provided with a mounting position for a urine metering device 30, and a urine collector fixing device 90 is provided below the sensing port of the urine metering device 30.

[0061] 5. If Figure 2 As shown, install and fix each component in the protective shell, start the machine for testing, and ensure it passes the test.

[0062] Example 2 Preparation of a negative pressure controlled urine drainage device matched with the monitoring device 10

[0063] 1. If Figure 3 As shown, the extrusion die for the drainage tube 50 and the negative pressure suction tube 70 is made of medical soft polyvinyl chloride. The drainage tube 50 has an inner diameter of 6 mm and an outer diameter of 8 mm. It is produced using an extrusion process and cut into two sizes: 130 cm per section for tube A and 30 cm per section for tube B. The negative pressure suction tube 70 has an inner diameter of 2 mm and an outer diameter of 3.5 mm. It is also produced using an extrusion process and cut into 30 cm sections.

[0064] 2. Prepare the injection mold for the conversion joint 40, the negative pressure suction chamber 60 and the suction tube joint 71, using medical polyvinyl chloride as the applicable material.

[0065] The conversion joint 40 is a tapered joint, the head end size matches the catheter interface, and the tail end size matches the drainage tube 50 (8.1 mm).

[0066] The suction chamber 60 is a separate structure consisting of an upper cover and a main chamber. The upper cover is equipped with an interface that mates with the drainage tube 50 and the suction tube 70. The bottom of the main chamber is provided with a drainage hole that mates with the drainage tube 50. After injection molding, the upper cover and the main chamber are sealed together using medical glue.

[0067] 3. Urine collector 80 is made of PP film with high frequency heat sealing and has a capacity of 2000ml.

[0068] 4. Use medical glue (such as cyclohexanone) to tightly bond the head of pipe A of the drainage tube 50 to the conversion joint 40 , and tightly connect the tail of pipe A to the interface of the upper cover of the negative pressure suction chamber 60 .

[0069] Medical glue is used to bond the drainage hole at the bottom of the main cavity of the negative pressure suction cavity 60 to the head of the B line of the drainage tube 50 , and the tail of the B line is tightly connected to the interface of the urine collector 80 .

[0070] 5. Use medical glue to tightly bond the head of the negative pressure suction tube 70 to the suction tube joint 71 , and tightly bond the tail of the negative pressure suction tube 70 to the interface of the upper cover of the negative pressure suction chamber 60 .

[0071] 6. Check all fixed connection parts to ensure there is no leakage and the tensile strength is not less than 10N. Pack after passing the inspection.

[0072] Example 3 Application of a negative pressure controlled urine drainage system in combination with a drainage device

[0073] 1. If Figure 3 As shown, the negative pressure suction chamber 60 is fixed on the left side of the monitoring device 10 , and the suction tube joint 71 is connected to the negative pressure generator interface 20 on the left side of the monitoring device 10 .

[0074] 2. Hang the urine collector 80 vertically on the urine collector fixing device 90 below the monitoring device 10.

[0075] 3. Connect the urinary catheter interface indwelling in the patient's body to the conversion connector 40.

[0076] 4. Turn on the monitoring device 10, set the drainage interval time to 10 minutes, set the drainage negative pressure value to -10 cmH2O, and set the negative pressure holding time to 2 minutes to achieve dynamic monitoring of the drainage status and urine volume.

[0077] 5. After 10 minutes, the negative pressure generator starts working, and the pressure sensor dynamically monitors the pressure in the negative pressure suction chamber 60 and keeps it stable at -10 cmH2O. After the negative pressure drainage is maintained for 2 minutes, the negative pressure generator stops working.

[0078] 6. During this period, the urine metering device 30 dynamically measures the amount of urine discharged from the bladder or drainage tube 50, and displays the urine volume and metering time on the human-computer interaction interface. If abnormal conditions such as oliguria or polyuria occur, a prompt message is given.

[0079] Example 4: Drainage material combining negative pressure suction chamber and urine collector

[0080] 1. Using the injection molding process, the negative pressure suction chamber 60 is prepared as a hollow cylinder with an outer diameter of 30 mm and a height of 50 mm, and the urine collector 80 is a thin film urine collection bag with a volume of 2000 ml.

[0081] 2. Two catheter ports are located at the top of the suction chamber 60: one port connects to the drainage tube 50, and the other connects to the suction tube 70. To prevent urine from entering the suction tube 70 under negative pressure, the urination port of the port connecting to the drainage tube 50 should be 2 to 5 cm lower than the port connecting to the suction tube 70.

[0082] 3. A check valve 72 is installed at the bottom of the top of the suction chamber 60. This check valve 72 is a duckbill-shaped device made of silicone film. During negative pressure adsorption, the silicone film fits tightly to prevent urine from the urine collector 80 from flowing back into the suction chamber 60 or the suction tube 70. When urine is present in the suction chamber 60, the silicone film naturally opens under the weight of the urine, allowing the urine to flow into the urine collector 80.

[0083] 4. Use high-frequency heat sealing equipment to seal the upper end of the urine collector 80 with the lower end of the negative pressure suction chamber 60.

[0084] 5. Check that there is no leakage at the fixed connection.

[0085] The above drawings and embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the scope of the present invention. Although the present invention 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 invention may be modified or replaced by equivalents without departing from the purpose and scope of the technical solutions of the present invention, which should all be included in the scope of the claims of the present invention and do not constitute any limitation on the scope of protection of the present invention.

Claims

1. A negative pressure controlled urine drainage system, comprising a monitoring device (10) and supporting drainage materials, wherein: The monitoring device (10) includes a control mainboard, a negative pressure generator, a pressure sensor, a urine metering device (30) and a human-machine interface (11), and the supporting drainage materials include a conversion joint (40), a drainage tube (50), a negative pressure suction chamber (60), a negative pressure suction tube (70) and a urine collector (80); the characteristics are: the negative pressure generator of the monitoring device (10) is a negative pressure device that provides a vacuum environment for the inside of the supporting drainage material, the pressure sensor dynamically matches the pressure value in the drainage material, and the urine metering device ( 30) dynamically monitors the amount of urine discharged by the patient; the supporting drainage material is a special consumable material used in conjunction with the monitoring device (10); the negative pressure suction chamber (60) is a hollow cavity provided between the drainage tube (50) and the urine collector (80) and having a pipeline interface; the negative pressure suction chamber (60) is provided with three pipeline interfaces, wherein one pipeline interface is connected to the drainage tube (50) upstream of the urine collector (80), one interface is connected to the liquid inlet of the urine collector (80) downstream, and the other interface is connected to the negative pressure suction tube (70).

2. A negative pressure controlled urine drainage system according to claim 1, characterized in that: The urine metering device (30) includes but is not limited to an ultrasonic liquid flow meter, a light-sensitive drip rate sensor, a turbine liquid flow meter, a gravity sensor, and a tension sensor.

3. The negative pressure controlled urine drainage system according to claim 1, characterized in that: A combination of a light-sensitive drip rate sensor and a gravity sensor is used. Specifically, a drip bucket is provided between the drainage tube (50) and the urine collector (80), and the infrared drip rate sensor is provided on the periphery of the drip bucket. At the same time, a gravity sensor is provided, and the urine collector (80) is suspended below the gravity sensor.

4. The negative pressure controlled urine drainage system according to claim 1, characterized in that: A check valve is also provided between the negative pressure suction chamber (60) and the urine collector (80).

5. The negative pressure controlled urine drainage system according to claim 1, characterized in that: The negative pressure generator is connected to the control main board and is controlled by the control main board. The working pressure adjustment range of the negative pressure generator is not less than -10cmH20~0.

6. The negative pressure controlled urine drainage system according to claim 1, characterized in that: The measuring range of the pressure sensor shall not be less than -10cmH20~0, and the measuring accuracy shall not be less than 1cmH20.

7. The negative pressure controlled urine drainage system according to claim 1, characterized in that: The measuring range of the urine measuring device (30) is not less than 0-1000 ml, and the measuring accuracy is not less than 1 ml.

8. The negative pressure controlled urine drainage system according to claim 1, characterized in that: The drainage interval time in the system is set between 1min and 60min.

9. The negative pressure controlled urine drainage system according to claim 1, characterized in that: The drainage negative pressure value in the system is set between -40cmH20 and -1cmH20.

10. The negative pressure controlled urine drainage system according to claim 1, characterized in that: The system can set the negative pressure holding time between 1min and 5min.

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