Urethral catheter with real-time monitoring and alarming functions and catheter system

Abstract

The invention discloses a catheter with real-time monitoring and alarming functions and a catheter system, and relates to the technical field of medical instruments, the catheter comprises a catheter main tube, a balloon, an interface, a pressure sensor and a flow sensor; the drainage tube, the flushing tube and the balloon tube penetrate through the inner space of the catheter handle; the drainage cavity electromagnetic valve is matched with the drainage tube penetrating through the catheter handle and is arranged on the catheter handle; the flushing cavity electromagnetic valve is matched with the flushing pipe penetrating through the catheter handle and is arranged on the catheter handle; the control module is used for judging the current normal urination or abnormal urination of the catheter according to the internal pressure of the bladder and / or the urine flow rate, and if the urination is judged to be normal, the drainage cavity electromagnetic valve is controlled to keep the drainage channel communicated; if it is judged that urination is abnormal, the abnormal type is determined by analyzing the internal pressure of the bladder and / or the urine flow rate, and processing including alarming is carried out according to the abnormal type.

Description

[0001] This invention relates to the field of medical device technology, specifically to a urinary catheter and urinary catheter system with real-time monitoring and alarm functions.

[0002] As a commonly used medical device in clinical practice, urinary catheters are widely used in postoperative urination management, bladder irrigation, treatment of urinary retention, urodynamic testing, and nursing care for long-term bedridden patients such as those in the ICU or elderly patients.

[0003] Traditional urinary catheters only have drainage function and cannot monitor bladder pressure (or intravesical pressure) or urine flow status in real time, which may lead to the following problems: (1) Lack of pressure monitoring: If the intravesical pressure is abnormal (e.g., >40cmH2O), it is easy to cause irreversible complications such as bladder overdistension and reflux kidney injury. (2) Lack of early blockage warning mechanism: Blood clots, mucus or crystal deposits can cause catheter blockage. If not treated in time, the catheter needs to be changed frequently, increasing patient pain and infection risk. (3) Infection risk: Frequent manual inspection or catheter replacement may damage the closed drainage system, significantly increasing the risk of catheter-associated urinary tract infection (CAUTI). (4) The judgment of catheter blockage depends on manual observation. Medical staff need to check the drainage of the urine bag regularly, which is inefficient and may delay treatment.

[0004] Some improved urinary catheters have built-in pressure and flow sensors, enabling them to monitor bladder pressure and urine flow, determine normal or abnormal conditions, and provide alarm functions for abnormalities. However, they still have the following problems: (1) They lack the ability to determine the type of abnormality, which cannot meet the clinical needs for differentiated treatment of different types of abnormalities. (2) After an abnormal alarm is triggered, medical staff need to manually observe, judge, and treat the abnormality, which is inefficient and can easily delay the treatment time. Summary of the Invention

[0005] This invention proposes a urinary catheter and urinary catheter system with real-time monitoring and alarm functions, overcoming the above-mentioned defects by improving and upgrading existing urinary catheter technology.

[0006] The present invention provides a urinary catheter with real-time monitoring and alarm functions, comprising:

[0007] The main tube of the urinary catheter has a drainage cavity, an irrigation cavity, and a balloon cavity that extend in parallel along the axis of the main tube.

[0008] A balloon, which is attached to the outer side of the front end of the main catheter and communicates with the balloon cavity, is used to inflate after inflation / inflation to secure the catheter.

[0009] The interface includes a drainage interface, an irrigation interface, and a balloon interface, wherein the drainage cavity, irrigation cavity, and balloon cavity branch at the tail end of the main catheter to form a drainage tube for connecting the drainage cavity and the drainage interface, an irrigation tube for connecting the irrigation cavity and the irrigation interface, and a balloon tube for connecting the balloon cavity and the balloon interface.

[0010] A pressure sensor, embedded in the front end of the drainage cavity, is used to collect intravesical pressure in real time after the main catheter is inserted into the bladder via the urinary tract.

[0011] A flow sensor, embedded in the drainage cavity, is used to collect the urine flow rate drained through the drainage cavity in real time after the main catheter is inserted into the bladder via the urinary tract.

[0012] The catheter handle has its internal space pierced by a drainage tube, an irrigation tube, and a balloon tube.

[0013] A drainage chamber solenoid valve is adapted to a drainage tube that passes through the catheter handle and is located on the catheter handle.

[0014] The flushing chamber solenoid valve is adapted to the flushing tube that passes through the catheter handle and is located on the catheter handle.

[0015] The control module is used to determine whether the current urination of the catheter is normal or abnormal based on the intravesical pressure and / or urine flow rate. If the urination is normal, the control module controls the solenoid valve of the drainage cavity to keep the drainage path open. If the urination is abnormal, the control module analyzes the intravesical pressure and / or urine flow rate to determine the type of abnormality and performs processing including alarm based on the type of abnormality.

[0016] Preferably, the control module determines whether the catheter is currently urinating normally or abnormally based on bladder pressure and / or urine flow, including:

[0017] The control module determines whether the catheter is currently urinating normally or abnormally based on intrabladder pressure and / or urine flow rate, including:

[0018] The control module determines whether the intrabladder pressure is normal by judging whether the intrabladder pressure is within the normal range, and / or determines whether the urine flow is continuous by judging whether multiple consecutive urine flow rates are greater than a preset effective urine flow rate threshold;

[0019] If the intrabladder pressure is normal and / or the urine flow is continuous, the control module determines that the current urination is normal; otherwise, it determines that the current urination is abnormal.

[0020] Preferably, the control module determines the abnormality type by analyzing intravesical pressure and / or urinary flow rate, including:

[0021] If the intravesical pressure is within the preset early obstruction threshold range, the abnormality type is identified as high pressure caused by bladder spasm or early obstruction of the drainage cavity;

[0022] If the rate of change of intravesical pressure is greater than the preset first pressure change threshold and the urine flow rate is less than the preset first urine flow rate change threshold within the preset first time period, then the abnormality type is determined to be progressive obstruction of the drainage tube.

[0023] If the intrabladder pressure is greater than the higher value of the preset early obstruction threshold range, the abnormal type is identified as dangerous high pressure;

[0024] If the intravesical pressure is greater than the lower value of the preset early obstruction threshold range and continues to rise, and the urine flow rate determined based on the urine flow rate is zero within the preset first time period, then the abnormality type is determined to be complete obstruction of the drainage cavity.

[0025] If the intravesical pressure is less than the preset low pressure threshold, or the urine flow is zero within the preset second time period, the abnormality type is determined to be low pressure caused by catheter dislodgement or bladder emptiness.

[0026] Preferably, the control module performs alarm processing based on the anomaly type, including:

[0027] When the abnormality type is high pressure, the control module will issue an alarm. If no alarm cancellation is received within the preset medical treatment time, the control module will connect the flushing chamber solenoid valve to the flushing passage to flush using physiological saline introduced from the flushing passage.

[0028] When the abnormality type is progressive blockage of the drainage cavity, the control module controls the flushing cavity solenoid valve to repeatedly open and close the flushing passage at a set frequency in order to prevent the blockage from worsening by increasing the flushing frequency.

[0029] When the abnormality type is dangerous high pressure or complete blockage of the drainage cavity, the control module will issue a local alarm and generate an emergency alarm message containing patient information, abnormality type, intravesical pressure and urine flow rate, which will be transmitted to the medical staff terminal so that the medical staff can arrive at the scene to handle the situation.

[0030] Preferably, the control module, based on the type of abnormality, further includes alarm processing as follows:

[0031] When the abnormality is caused by catheter dislodgement or low pressure due to bladder emptiness, the control module will issue an alarm. If no alarm is cleared within the preset medical care treatment time, the control module will shut off the drainage path by controlling the drainage chamber solenoid valve to simulate physiological urine storage. After the preset shutdown time, the control module will reconnect the drainage path by controlling the drainage chamber solenoid valve to simulate physiological urination.

[0032] If the intravesical pressure is less than the preset low-pressure threshold or the urine flow is still zero after simulated physiological urination, the control module controls the drainage chamber solenoid valve to close the drainage path and controls the flushing chamber solenoid valve to connect the flushing path to inject physiological saline through the flushing path. When the intravesical pressure is within the preset normal range, the control module controls the flushing chamber solenoid valve to close the flushing path and controls the drainage chamber solenoid valve to connect the drainage path to open the drainage. The control module repeats the above steps until the patient spontaneously feels the urge to urinate and completes urination.

[0033] Preferably, the urinary catheter further includes:

[0034] A drug delivery interface that is independent of the drainage interface, flushing interface and balloon interface, used to inject drugs or contrast agents through the drug delivery interface;

[0035] A drug delivery tube is used to connect the drug delivery interface to the flushing tube that passes through the handle of the urinary catheter to form a drug delivery pathway;

[0036] A solenoid valve for drug delivery chamber, which is adapted to the drug delivery tube and is located on the handle of the urinary catheter;

[0037] The control module controls the drainage chamber solenoid valve to close the drainage path and controls the drug delivery chamber solenoid valve to connect the drug delivery path, so that the drug or contrast agent is injected into the bladder through the drug delivery path and the flushing path and left in place for a preset retention time parameter. After the preset retention time is reached, the control module controls the drainage chamber solenoid valve to open the drainage path and controls the drug delivery chamber solenoid valve to close the drug delivery path, so that the drug or contrast agent is discharged through the drainage path.

[0038] Preferably, the main tube of the urinary catheter also has a sensing cavity that is independent of the drainage cavity, the irrigation cavity, and the balloon cavity and extends along the axis of the main tube. The sensing cavity is provided with signal lines that are connected to the pressure sensor and the flow sensor, respectively, so as to transmit the intravesical pressure collected by the pressure sensor and the urine flow rate collected by the flow sensor to the control module through the signal lines.

[0039] The present invention also provides a urinary catheter with real-time monitoring and alarm functions, comprising:

[0040] The main tube of the urinary catheter has a drainage cavity and a balloon cavity that extend in parallel along the axis of the main tube.

[0041] A balloon, which is attached to the outer side of the front end of the main catheter and communicates with the balloon cavity, is used to inflate after inflation / inflation to secure the catheter.

[0042] The interface includes a drainage interface and a balloon interface, wherein the drainage cavity and the balloon cavity branch at the tail end of the main catheter to form a drainage tube for connecting the drainage cavity and the drainage interface and a balloon tube for connecting the balloon cavity and the balloon interface.

[0043] A pressure sensor, embedded in the front end of the drainage cavity, is used to collect intravesical pressure in real time after the main catheter is inserted into the bladder via the urinary tract.

[0044] A flow sensor, embedded in the drainage cavity, is used to collect the urine flow rate drained through the drainage cavity in real time after the main catheter is inserted into the bladder via the urinary tract.

[0045] The catheter handle has its internal space pierced by a drainage tube and a balloon tube.

[0046] A drainage chamber solenoid valve is adapted to a drainage tube that passes through the catheter handle and is located on the catheter handle.

[0047] The control module is used to determine whether the current urination of the catheter is normal or abnormal based on the intravesical pressure and / or urine flow rate. If the urination is normal, the module controls the drainage chamber solenoid valve to keep the drainage path open. If the urination is abnormal, an alarm is triggered. The alarm is triggered when the abnormality is determined to be catheter dislodgement or low pressure caused by bladder emptiness based on the intravesical pressure and / or urine flow rate. If no alarm is cleared within a preset medical care treatment time, the module controls the drainage chamber solenoid valve to close the drainage path to simulate physiological urine storage. After a preset closure time, the module controls the drainage chamber solenoid valve to open the drainage path to simulate physiological urination.

[0048] The present invention also provides a urinary catheter system with real-time monitoring and alarm functions, comprising:

[0049] The aforementioned urinary catheter with real-time monitoring and alarm functions;

[0050] The flushing pump, under the control of the control module, pumps physiological saline from the reservoir into the bladder through the flushing passage.

[0051] Preferably, the urinary catheter system further includes:

[0052] A drug delivery pump, under the control of a control module, is used to pump drugs or contrast agents from a storage container into the bladder via a drug delivery pathway and an injection pathway.

[0053] The present invention has the following beneficial effects:

[0054] 1. This invention analyzes real-time monitored intravesical pressure and / or urine flow to determine the type of abnormality and perform differentiated automated treatment. For example, for a double-lumen catheter, the control module controls the opening and closing of the drainage path by controlling the solenoid valve of the drainage chamber to simulate physiological urine storage and emptying when the bladder is determined to be empty. For a triple-lumen catheter, the control module controls the solenoid valve of the flushing chamber to open the flushing path for flushing when early obstruction is determined, and controls the solenoid valve of the flushing chamber to repeatedly open and close the flushing path at a set frequency for multiple flushing when progressive obstruction is determined. This can avoid frequent catheter replacement, reduce the risk of infection, and basically meet the clinical needs for differentiated treatment of different types of abnormalities.

[0055] 2. This invention improves the efficiency of abnormality handling and reduces reliance on medical staff by identifying abnormality types and implementing differentiated automatic treatments. Attached Figure Description

[0056] Figure 1 This is a schematic diagram of the double-lumen urinary catheter structure provided in Embodiment 1 of the present invention;

[0057] Figure 2 yes Figure 1 Axial cross-sectional view of the rear end of the central urinary catheter main tube 1 to the interface;

[0058] Figure 3 yes Figure 1 A schematic diagram of the first control structure of the double-lumen urinary catheter shown.

[0059] Figure 4 yes Figure 1 A schematic diagram of the second control structure of the double-lumen urinary catheter shown;

[0060] Figure 5 This is a schematic diagram of the three-lumen urinary catheter structure provided in Embodiment 2 of the present invention;

[0061] Figure 6 yes Figure 5 Axial cross-sectional view of the rear end of the central urinary catheter main tube 1 to the interface;

[0062] Figure 7 yes Figure 5 The diagram shows the control structure of the three-lumen urinary catheter.

[0063] Figure 8 This is a schematic diagram of the four-lumen urinary catheter structure provided in Embodiment 3 of the present invention;

[0064] Figure 9 yes Figure 8 Axial cross-sectional view of the rear end of the central urinary catheter main tube 1 to the interface;

[0065] Figure 10 yes Figure 8 A schematic diagram of the control structure of the four-lumen urinary catheter is shown.

[0066] Explanation of reference numerals in the attached diagram: 1-Main catheter tube; 2-Balloon; 31-Drainage interface; 32-Flushing interface; 33-Balloon interface; 34-Drug administration interface; 4-Pressure sensor; 6-Catheter handle; 71-Drainage chamber solenoid valve; 72-Flushing chamber solenoid valve; 73-Balloon chamber solenoid valve; 74-Drug administration chamber solenoid valve; 81-Drainage tube; 82-Flushing tube; 83-Balloon tube; 84-Drug administration tube. Detailed Implementation

[0067] The embodiments of the present invention will be described in detail below with reference to the accompanying drawings. It should be understood that the embodiments described below are only for illustration and explanation of the present invention and are not intended to limit the present invention.

[0068] Example 1

[0069] See Figures 1 to 4 The present invention provides a urinary catheter with real-time monitoring and alarm functions, comprising: a urinary catheter main tube 1, a balloon 2, an interface, a pressure sensor 4, a flow sensor (not shown in the figure), a urinary catheter handle 6, a drainage tube 81 and a balloon tube 83, a drainage cavity solenoid valve 71, a balloon cavity solenoid valve 73, a control module and other electronic control modules (not shown in the figure).

[0070] 1. Main catheter 1, drainage tube 81 and balloon tube 83

[0071] The main catheter 1, drainage tube 81, and balloon tube 83 are made of medical-grade silicone or polyurethane material, which has good biocompatibility and flexibility. The surface is coated with a silver ion antibacterial coating to reduce the risk of infection.

[0072] The main catheter 1 has a dual-lumen structure, namely, a drainage lumen and a balloon lumen that extend in parallel along the axis of the main catheter. The drainage lumen and the balloon lumen branch at the tail end of the main catheter 1 to form a drainage tube 81 and a balloon tube 83.

[0073] The drainage cavity is the channel for urine drainage, and the balloon cavity is the channel for inflating / inflating the balloon 2.

[0074] 2. Balloon 2

[0075] The balloon 2 is attached to the outer side of the front end of the main catheter 1 and communicates with the balloon cavity. It is used to inflate after inflation / injection of water to fix the catheter and to retract after the gas / liquid is drained by a syringe or air / liquid pump so that the main catheter 1 can be removed.

[0076] 3. Interface

[0077] The interface uses a standard Luer connector, including a drainage interface 31 and a balloon interface 33.

[0078] The drainage port 31 is connected to the drainage cavity of the main catheter 1 through the drainage tube 81, forming a drainage path.

[0079] The balloon interface 33 is connected to the balloon cavity of the urinary catheter main tube 1 through the balloon tube 83 to form a balloon passage.

[0080] 4. Sensors

[0081] Pressure sensor 4 is embedded in the front end (or proximal end) of the catheter body 1 or the side wall of the drainage cavity, for example... Figure 1 The catheter tip shown, such as the anterior sidewall (to reduce blockage), is used to directly contact urine after the main catheter is inserted into the bladder via the urinary tract to measure intrabladder pressure in real time. This data can be transmitted to the control module, displayed by the display module, stored by the data storage module, or wirelessly transmitted by the control module to external terminals such as monitors and medical mobile devices. This pressure sensor can be a miniature MEMS sensor, such as a MEMS piezoresistive sensor, with a surface covered by a biocompatible membrane such as PDMS to avoid irritating the urinary tract mucosa.

[0082] A flow sensor is embedded in the drainage cavity to collect the urine flow rate in real time after the main catheter 1 is inserted into the bladder via the urinary tract. This flow sensor can be a thermal flow sensor, which monitors the urine flow rate through the thermal sensing principle and can also help determine the urine flow status, such as whether the urine flow is continuous, slow, or interrupted.

[0083] Combining urine flow information with intrabladder pressure can improve the accuracy of judgment and provide a basis for early warning of blockage.

[0084] The pressure sensor 4 and flow sensor of this invention can be sensors that transmit signals via signal lines. In this case, the main catheter 1 also has a sensing cavity that is independent of the drainage cavity, irrigation cavity, and balloon cavity and extends along the axial direction of the main catheter. Signal lines connected to the pressure sensor 4 and flow sensor are arranged in this sensing cavity so that the intravesical pressure collected by the pressure sensor 4 and the urine flow rate collected by the flow sensor can be transmitted to the control module via the signal lines. The pressure sensor 4 and flow sensor can also be BLE wireless sensors, so that the sensor monitoring results can be transmitted to the control module wirelessly, reducing the need for modifications to the catheter structure.

[0085] 5. Catheter handle 6

[0086] The internal space of the catheter handle 6 is penetrated by the drainage tube and the balloon tube. Figure 1 and Figure 2 The handle 6 of the central catheter is a cuboid, but in practice it can be any shape that is aesthetically pleasing and easy to use.

[0087] In addition, the purpose of setting the catheter handle 6 is also to install it. Figure 3or Figure 4 Apart from sensors, the installation positions of the electrical modules can be set or adjusted according to actual needs such as waterproofing and layout.

[0088] 6. Solenoid valve

[0089] The solenoid valve includes a drainage chamber solenoid valve 71, which is adapted to the drainage tube 81 that passes through the catheter handle 6 and is located on the catheter handle 6. It can connect or disconnect the drainage path under the control of the control module.

[0090] The solenoid valve may also include a balloon cavity solenoid valve 73, which is adapted to the balloon tube 83 that passes through the handle of the catheter 6 and is located on the catheter handle 6. It can connect or disconnect the balloon passage under the control of the control module, and is suitable for scenarios where the balloon 2 is automatically inflated / deflated using an air pump / liquid pump.

[0091] 7. Electrical modules

[0092] The electrical module, encapsulated at point 6 of the catheter handle, is a core component of the catheter and includes:

[0093] The power supply module uses a button cell battery or a rechargeable lithium battery, with a battery life of 7 days or more.

[0094] The wireless transmission module, using BLE or RFID, enables wireless data transmission and remote communication. For example, it can wirelessly send alarm information to the nurse station monitoring screen or mobile APP to achieve remote alarm.

[0095] The data storage module can locally store the bladder pressure curve and / or urinary flow rate data and alarm records for the most recent 24 hours, for medical staff to review and analyze. It can also be synchronized to the hospital information system (HIS) via the wireless transmission module to provide objective data support for clinical diagnosis and treatment.

[0096] The display module can display bladder pressure and / or urine flow rate in real time, as well as the bladder pressure curve for the most recent 24 hours.

[0097] A local alarm module, including LED indicators (red / yellow / green) and / or a buzzer, is used to implement local alarms.

[0098] The control module can determine whether the current urination of the catheter is normal or abnormal based on the intravesical pressure and / or urine flow rate. If urination is normal, it controls the solenoid valve of the drainage cavity to keep the drainage path open. If urination is abnormal, an alarm is triggered. Furthermore, if the abnormality is determined to be catheter dislodgement or low pressure caused by bladder emptiness based on the intravesical pressure and / or urine flow rate, and no alarm cancellation is received within a preset medical intervention time (e.g., 2 minutes), the solenoid valve of the drainage cavity is controlled to shut off the drainage path to simulate physiological urine storage. After a preset shutdown time, the solenoid valve of the drainage cavity is controlled to reconnect the drainage path to simulate physiological urination.

[0099] The control module determines whether the intrabladder pressure is normal by judging whether the intrabladder pressure fluctuates periodically within the normal range (e.g., 10~20 cmH2O), and / or determines whether the urine flow is continuous by judging whether multiple consecutive urine flow rates are greater than or equal to a preset effective urine flow rate threshold (e.g., ≥1 mL / min). If the intrabladder pressure is normal and / or the urine flow is continuous, the control module judges that the current urination is normal; otherwise, it judges that the current urination is abnormal.

[0100] If abnormal urination is detected, such as blockage or bladder emptiness, an alarm can be triggered. This can be done locally, remotely, or by combining both methods.

[0101] If the intravesical pressure is less than a preset low-pressure threshold (e.g., <5 cmH2O), or the urine flow is zero within a preset second time period (e.g., 30 minutes), the abnormality is determined to be low pressure caused by catheter dislodgement or bladder emptiness. If no alarm is deactivated within the preset medical intervention time, the system will treat it as bladder emptiness, automatically deactivate the alarm, and control the drainage chamber solenoid valve to shut off the drainage path to simulate physiological urine storage. After a preset shutdown time, the drainage chamber solenoid valve will reconnect the drainage path to simulate physiological voiding. Furthermore, if the intravesical pressure remains less than the preset low-pressure threshold (e.g., <5 cmH2O) after simulated physiological voiding, or the urine flow remains zero within the preset second time period (e.g., 30 minutes), an alarm will be triggered again, awaiting medical personnel to arrive and provide assistance.

[0102] In this invention, the comparison between the intravesical pressure and a preset low-pressure threshold (e.g., <5 cmH2O), or the determination of whether the urine flow rate is zero within a preset second time period (e.g., 30 min), can be directly processed by the control module. See [link to relevant documentation]. Figure 3 It can also be implemented through hardware. For example, regarding pressure comparison, see [link to relevant documentation]. Figure 4The bladder pressure collected by the pressure sensor enters the first comparator and the second comparator. The first comparator compares the bladder pressure with a preset low-pressure threshold (i.e., ...). Figure 4 The second comparator compares the intravesical pressure with a preset high-pressure threshold (i.e., the low threshold). Figure 4 The high threshold (e.g., 25 cmH2O) is used to send the comparison results to the control module via two comparators.

[0103] This invention achieves integrated coordination of drainage, pressure and / or flow monitoring, abnormal alarm, and automatic handling of bladder emptiness, which can improve the efficiency of abnormal handling and reduce reliance on medical staff.

[0104] Example 2

[0105] See Figures 5-7 The present invention provides a urinary catheter with real-time monitoring and alarm functions, comprising: a main urinary catheter 1, a balloon 2, an interface, a pressure sensor 4, a flow sensor (not shown in the figure), a urinary catheter handle 6, a drainage tube 81, an irrigation tube 82 and a balloon tube 83, a drainage chamber solenoid valve 71, an irrigation chamber solenoid valve 72 and a balloon chamber solenoid valve 73, a control module and other electronic control modules (not shown in the figure).

[0106] 1. Main catheter 1, drainage tube 81, flushing tube 82, and balloon tube 83

[0107] The main catheter 1, drainage tube 81, flushing tube 82, and balloon tube 83 are made of medical-grade silicone or polyurethane material, which has good biocompatibility and flexibility. The surface is coated with a silver ion antibacterial coating to reduce the risk of infection.

[0108] The main catheter 1 has a three-lumen structure, namely, a drainage lumen, an irrigation lumen, and a balloon lumen that extend in parallel along the axis of the main catheter. The drainage lumen, irrigation lumen, and balloon lumen branch at the tail end of the main catheter 1 to form a drainage tube 81, an irrigation tube 82, and a balloon tube 83.

[0109] The drainage cavity is the channel for urine drainage, the balloon cavity is the channel for inflating / inflating the balloon 2, and the flushing cavity is the channel for injecting water and / or administering medication into the bladder.

[0110] 2. Balloon 2

[0111] The balloon 2 is attached to the outer side of the front end of the main catheter 1 and communicates with the balloon cavity. It is used to inflate after inflation / injection of water to fix the catheter and to retract after the gas / liquid is drained by a syringe or aspiration pump / liquid pump so that the main catheter 1 can be removed.

[0112] 3. Interface

[0113] The interface uses a standard Luer connector, including a drainage interface 31, a flushing interface 32, and a balloon interface 33.

[0114] The drainage port 31 is connected to the drainage cavity of the main catheter 1 through the drainage tube 81, forming a drainage path.

[0115] The flushing port 32 is connected to the flushing chamber of the catheter main tube 1 through the flushing tube 82, forming a flushing passage.

[0116] The balloon interface 33 is connected to the balloon cavity of the urinary catheter main tube 1 through the balloon tube 83 to form a balloon passage.

[0117] 4. Sensors

[0118] Pressure sensor 4 is embedded in the front end (or proximal end) of the catheter body 1 or the side wall of the drainage cavity, for example... Figure 1 The catheter tip shown, such as the anterior sidewall (to reduce blockage), is used to directly contact urine after the main catheter is inserted into the bladder via the urinary tract to measure intrabladder pressure in real time. This data can be transmitted to the control module, displayed by the display module, stored by the data storage module, or wirelessly transmitted by the control module to external terminals such as monitors and medical mobile devices. This pressure sensor can be a miniature MEMS sensor, such as a MEMS piezoresistive sensor, with a surface covered by a biocompatible membrane such as PDMS to avoid irritating the urinary tract mucosa.

[0119] A flow sensor is embedded in the drainage cavity to collect the urine flow rate in real time after the main catheter 1 is inserted into the bladder via the urinary tract. This flow sensor can be a thermal flow sensor, which monitors the urine flow rate through the thermal sensing principle and can also help determine the urine flow status, such as whether the urine flow is continuous, slow, or interrupted.

[0120] Combining urine flow information with intrabladder pressure can improve the accuracy of judgment and provide a basis for early warning of blockage.

[0121] The pressure sensor 4 and flow sensor of this invention can be sensors that transmit signals via signal lines. In this case, the main catheter 1 also has a sensing cavity that is independent of the drainage cavity, irrigation cavity, and balloon cavity and extends along the axial direction of the main catheter. Signal lines connected to the pressure sensor 4 and flow sensor are arranged in this sensing cavity so that the intravesical pressure collected by the pressure sensor 4 and the urine flow rate collected by the flow sensor can be transmitted to the control module via the signal lines. The pressure sensor 4 and flow sensor can also be BLE wireless sensors, so that the sensor monitoring results can be transmitted to the control module wirelessly, reducing the need for modifications to the catheter structure.

[0122] 5. Catheter handle 6

[0123] The internal space of the catheter handle 6 is penetrated by the drainage tube 81, the flushing tube 82, and the balloon tube 83. Figure 1 and Figure 2The handle 6 of the central catheter is a cuboid, but it can be other shapes that are aesthetically pleasing and easy to use in practice.

[0124] In addition, the purpose of setting the catheter handle 6 is also to install it. Figure 3 or Figure 4 Apart from sensors, the installation positions of the electrical modules can be set or adjusted according to actual needs such as waterproofing and layout.

[0125] 6. Solenoid valve

[0126] The solenoid valves include a drainage chamber solenoid valve 71 and a flushing chamber solenoid valve 72. The drainage chamber solenoid valve 71 is adapted to the drainage tube 81 that passes through the catheter handle 6 and is located on the catheter handle 6. It can connect or disconnect the drainage path under the control of the control module. The flushing chamber solenoid valve 73 is adapted to the flushing tube 82 that passes through the catheter handle 6 and is located on the catheter handle 6. It can connect or disconnect the flushing path under the control of the control module.

[0127] The solenoid valve may also include a balloon cavity solenoid valve 73, which is adapted to the balloon tube 83 that passes through the handle of the catheter 6 and is located on the catheter handle 6. It can connect or disconnect the balloon passage under the control of the control module, and is suitable for scenarios where the balloon 2 is automatically inflated / deflated using an air pump / liquid pump.

[0128] 7. Electrical modules

[0129] The electrical module, encapsulated at point 6 of the catheter handle, is a core component of the catheter and includes:

[0130] The power supply module uses a button cell battery or a rechargeable lithium battery, with a battery life of 7 days or more.

[0131] The wireless transmission module, using BLE or RFID, enables wireless data transmission and remote communication. For example, it can wirelessly send alarm information to the nurse station monitoring screen or mobile APP to achieve remote alarm.

[0132] The data storage module can locally store the bladder pressure curve and / or urinary flow rate data and alarm records for the most recent 24 hours, for medical staff to review and analyze. It can also be synchronized to the hospital information system (HIS) via the wireless transmission module to provide objective data support for clinical diagnosis and treatment.

[0133] The display module can display bladder pressure and / or urine flow rate in real time, as well as the bladder pressure curve for the most recent 24 hours.

[0134] The local alarm module includes LED indicators (red / yellow / green) and a buzzer for implementing local alarms.

[0135] The control module determines whether the catheter's current urination is normal or abnormal based on intravesical pressure and / or urine flow rate. If urination is normal, it controls the drainage chamber solenoid valve to maintain drainage path continuity. If urination is abnormal, it analyzes intravesical pressure and / or urine flow rate to determine the type of abnormality and performs appropriate actions, including alarms. For example, if the pressure continues to rise and the blockage / high pressure judgment algorithm determines it as early blockage, an alarm prompts medical staff to manually flush or connect the automatic flushing pump to the flushing path for automatic flushing.

[0136] The control module determines whether the intrabladder pressure is normal by judging whether the intrabladder pressure fluctuates periodically within the normal range (e.g., 10~20 cmH2O), and / or determines whether the urine flow is continuous by judging whether multiple consecutive urine flow rates are greater than or equal to a preset effective urine flow threshold (e.g., ≥1 mL / min). If the intrabladder pressure is normal and / or the urine flow is continuous, the control module judges that the current urination is normal; otherwise, it judges that the current urination is abnormal.

[0137] If the intravesical pressure is within the preset early obstruction threshold range (e.g., 25-40 cmH2O), the abnormality type is determined to be high pressure caused by bladder spasm or early obstruction of the drainage cavity. In this case, the control module will issue a local alarm and / or a remote alarm. If no alarm cancellation is received within the preset medical treatment time, the system will handle the early obstruction of the drainage cavity by controlling the flushing chamber solenoid valve to connect the flushing passage and flush with saline solution introduced from the flushing passage. If the rate of change of intravesical pressure is greater than the preset first pressure change threshold (e.g., >5 cmH2O / min) and the urine flow rate is less than the preset first urine flow rate change threshold (e.g., <1 mL / min) within the preset first time period (e.g., 10 min), the abnormality type is determined to be progressive obstruction of the drainage tube. In this case, the control module will control the flushing chamber solenoid valve to repeatedly open and close the flushing passage at a set frequency to prevent the obstruction from worsening by increasing the flushing frequency. If the intravesical pressure is greater than the high value of the preset early obstruction threshold range (e.g., >40cmH2O), the abnormality type is determined to be dangerous high pressure. Alternatively, if the intravesical pressure is greater than the low value of the preset early obstruction threshold range and continues to rise, and the urine flow rate determined based on the urine flow rate is zero within the preset first time period, the abnormality type is determined to be complete obstruction of the drainage cavity. When the abnormality type is dangerous high pressure or complete obstruction of the drainage cavity, the control module will issue a local alarm and generate emergency alarm information containing patient information, abnormality type, intravesical pressure and urine flow rate, which will be transmitted to the medical staff terminal to realize remote alarm so that medical staff can come to the scene for treatment. If the intravesical pressure is less than the preset low-pressure threshold (e.g., <5 cmH2O), or if the urine flow is zero within the preset second time period (e.g., 30 min), the abnormality is determined to be low pressure caused by catheter dislodgement or bladder emptiness. In this case, the control module will issue an alarm. If no alarm is deactivated within the preset medical care treatment time, the control module will shut off the drainage path using the drainage chamber solenoid valve to simulate physiological urine storage. After the preset shutdown time, the control module will reconnect the drainage path using the drainage chamber solenoid valve to simulate physiological voiding. If the intravesical pressure remains low after simulating physiological voiding... If the urine flow remains zero within a preset low-pressure threshold (e.g., <5cmH2O) or within a preset second time period (e.g., 30min), the control module controls the drainage chamber solenoid valve to close the drainage path and controls the flushing chamber solenoid valve to connect the flushing path, so as to inject physiological saline through the flushing path. When the intravesical pressure is within a preset normal range, the control module controls the flushing chamber solenoid valve to close the flushing path and controls the drainage chamber solenoid valve to connect the drainage path, so as to open the drainage. The control module repeats the above steps until the patient spontaneously feels the urge to urinate and completes urination.

[0138] In this invention, the comparison of intravesical pressure and / or urine flow rate or urine volume can be directly processed by the control module, see [link to relevant documentation]. Figure 7 .

[0139] Figures 5 to 7 The working process of the catheter shown includes:

[0140] 1. Data Acquisition (Pressure and / or Urine Flow Monitoring):

[0141] Sensor activation: After the catheter is inserted into the bladder, the pressure sensor (MEMS) begins to monitor the intrabladder pressure in real time, with a sampling frequency of 1 to 5 times / second.

[0142] Urine flow detection: A flow sensor is used to help determine the state of urine flow, such as whether there is urine flow and the urine flow rate.

[0143] 2. Signal processing (denoising and normalization)

[0144] Filtering: The raw signal acquired by the sensor is low-pass filtered using a low-pass filter circuit, or the raw signal acquired by the sensor is low-pass filtered using a control module to eliminate short-term interference such as breathing and coughing.

[0145] Pressure calibration: Automatically adjusts the zero-point reference value (e.g., based on atmospheric pressure) according to the patient's position (supine / lateral).

[0146] 3. State Judgment (Intelligent Algorithm Analysis)

[0147] Normal urination: Pressure fluctuates periodically (10~20 cmH2O), urine flow is continuous, at this time the green light on catheter handle 6 is always on, and there is no alarm in the data recording.

[0148] Abnormal status determination:

[0149] High pressure warning: When the intrabladder pressure is in the range of 25~40 cmH2O, such as when it is consistently >30 cmH2O, it is considered bladder high pressure (abbreviated as high pressure), which may be caused by bladder spasm or early obstruction.

[0150] Progressive obstruction: Based on the sliding time window algorithm (window length 10 minutes), progressive obstruction is determined when ΔP / Δt > 5 cmH2O / min and urine flow < 1 mL / min. That is, progressive obstruction is determined by the trend of flow or pressure changes.

[0151] Dangerous hypertension: Intrabladder pressure > 40 cmH2O is considered dangerous hypertension.

[0152] Complete blockage: If the pressure suddenly increases and there is no urine flow for more than 10 minutes, it is considered a complete blockage.

[0153] Low pressure alarm: When the pressure inside the bladder is <5 cmH2O, it is determined to be low bladder pressure (referred to as low pressure), indicating catheter dislodgement or bladder emptiness.

[0154] 4. Abnormal Handling

[0155] (1) High bladder pressure

[0156] Local alarm: The yellow light on catheter handle 6 is flashing.

[0157] Remote alarm (optional): Wirelessly transmits data to the central monitoring screen at the nurse station, displaying patient identification (e.g., patient bed number), alarm type, and real-time data (e.g., "Bed 03: bladder high pressure 30cmH2O"). As a supplement, by setting permissions, it can also be synchronously pushed to the mobile APP of medical staff.

[0158] Optionally, a linkage flushing function can be implemented. For example, if the alarm is not handled within 2 minutes (e.g., the alarm is not cleared or the problem is not manually handled), the external flushing pump will be automatically started to inject saline solution to unclog the pipeline.

[0159] The data storage module inside the catheter handle 6 locally records alarm-related information.

[0160] (2) Progressive blockage

[0161] Local alarm: The yellow light on catheter handle 6 flashes and the buzzer sounds intermittently (volume adjustable).

[0162] Remote alarm (optional): Wirelessly transmits data to the central monitoring screen at the nurse station, displaying patient identification (e.g., patient bed number), alarm type, and real-time data (e.g., "Bed 04: Progressive obstruction ΔP / Δt=6cmH2O / min and urine flow 0.8mL / min"). As a supplement, by setting permissions, it can also be synchronously pushed to the mobile APP of medical staff.

[0163] Optionally, a linkage flushing function can be implemented. For example, if the alarm is not handled within 2 minutes (e.g., the alarm is not cleared or the problem is not manually handled), the control module controls the solenoid valve of the flushing chamber to repeatedly open and close the flushing passage at a set frequency, so as to prevent the blockage from worsening by increasing the flushing frequency.

[0164] The data storage module inside the catheter handle 6 locally records alarm-related information.

[0165] (3) Dangerous high pressure or complete blockage

[0166] Local alarm: The red light on catheter handle 6 is constantly on, and the buzzer sounds intermittently.

[0167] Remote alarm: Wirelessly transmits data to the central monitoring screen at the nurse station, displaying patient identification (e.g., patient bed number), alarm type, and real-time data (e.g., "Bed 05: Dangerous high pressure 41cmH2O"). As a supplement, by setting permissions, it can also be synchronously pushed to the mobile APP of medical staff.

[0168] Optionally, in the case of dangerous high pressure, if the alarm is not handled within 2 minutes (e.g., the alarm is not cleared or it is not manually handled), the control module controls the solenoid valve of the flushing chamber to open and close the flushing passage, automatically triggering the flushing pump to flush and restore drainage through flushing.

[0169] The data storage module inside the catheter handle 6 locally records alarm-related information.

[0170] (4) Low bladder pressure

[0171] Local alarm: The blue light on catheter handle 6 is flashing.

[0172] Remote alarm (optional): Wirelessly transmits data to the central monitoring screen at the nurse station, displaying patient identification (e.g., patient bed number), alarm type, and real-time data (e.g., "Bed 05: Low bladder pressure 4cmH2O"). As a supplement, by setting permissions, it can also be synchronously pushed to the mobile APP of medical staff.

[0173] Optionally, the system simulates physiological urine storage and voiding. For example, if an alarm remains unresolved for 2 minutes (e.g., the alarm is not cleared or the patient is not manually addressed), the control module controls the drainage chamber solenoid valve to close the drainage path to simulate physiological urine storage. After a preset shutdown duration, the control module controls the drainage chamber solenoid valve to reconnect the drainage path to simulate physiological voiding. If this method is ineffective, the control module controls the drainage chamber solenoid valve to close the drainage path and controls the flushing chamber solenoid valve to reconnect the flushing passage to inject physiological saline through the flushing passage. When the intrabladder pressure is within a preset normal range, the control module controls the flushing chamber solenoid valve to close the flushing passage and controls the drainage chamber solenoid valve to reconnect the drainage path to open the drainage. The above steps are repeated until the patient spontaneously experiences the urge to urinate and completes voiding.

[0174] The data storage module inside the catheter handle 6 locally records alarm-related information.

[0175] 5. Data recording and backtracking

[0176] Local storage: In addition to recording alarm-related information, the data storage module also records the pressure curve for the most recent 24 hours, and can be expanded to record the pressure curve for the most recent 72 hours.

[0177] Cloud synchronization: The pressure curve can wirelessly transmit data to the hospital information system (HIS) to generate a bladder pressure trend report.

[0178] This invention enables real-time monitoring of drainage, intravesical pressure and / or urine flow rate, graded alarm for abnormal conditions, and automatic control of the urinary catheter for drainage and flushing. It reduces the risk of catheter-related urinary tract infections and kidney damage, optimizes nursing procedures, and solves the technical defects of traditional urinary catheters, such as lack of pressure monitoring, delayed blockage warning, susceptibility to infection, and low nursing efficiency. It is suitable for scenarios such as ICU, post-urological surgery, and elderly care.

[0179] Example 3

[0180] The present invention also provides a urinary catheter system with real-time monitoring and alarm functions, comprising: the urinary catheter with real-time monitoring and alarm functions of Embodiment 2 and an irrigation pump, wherein the irrigation pump is used to pump sterile saline in the storage container into the bladder through the irrigation passage under the control of the control module.

[0181] The inlet of the flushing pump is connected to the outlet of the storage container, and the outlet is sealed to the flushing interface 32. The control module controls an electronic switch connected to the power supply circuit of the flushing pump. When the flushing mode needs to be entered, the control module controls the solenoid valve of the flushing chamber to connect the flushing passage and triggers the electronic switch to conduct the power supply circuit of the flushing pump. The flushing pump works, and sterile saline in the automatic storage container is pumped into the bladder through the flushing passage. The liquid pressure loosens and flushes the drainage holes and blockages (blood clots, crystals, etc.) in the drainage cavity. After flushing, the drainage mode is automatically restored, and waste liquid and blockages are discharged, realizing the automated treatment of blockages.

[0182] Example 4

[0183] See Figures 8-10 The main difference between this embodiment and the catheter in Example 2 is that the catheter with real-time monitoring and alarm functions further includes...

[0184] A drug delivery interface 34, which is independent of the drainage interface 31, the flushing interface 32 and the balloon interface 33, is used to inject drugs or contrast agents through the drug delivery interface 34.

[0185] The administration tube 84 is used to connect the administration interface 34 and the flushing tube 82 that passes through the catheter handle 6 to form an administration pathway;

[0186] A solenoid valve 74 for administration chamber is adapted to administration tube 84 and is located on catheter handle 6;

[0187] The control module controls the drainage chamber solenoid valve 71 to close the drainage path and controls the drug delivery chamber solenoid valve 74 to connect the drug delivery path according to the received drug delivery path and flushing path, so that the drug or contrast agent is injected into the bladder and left for a preset retention time parameter. The control module controls the drug delivery chamber solenoid valve 74 to close the drug delivery path. After the preset retention time is reached, the control module controls the drainage chamber solenoid valve 71 to open the drainage path so that the drug or contrast agent is discharged through the drainage path.

[0188] As a supplement, a mixer can be added at the connection between the administration tube 84 and the flushing tube 82. The mixer has a mixing chamber inside, so that the drug or contrast agent flowing in from the administration tube 84 is more thoroughly mixed with the saline solution flowing in from the flushing tube 82 before entering the bladder through the flushing passage.

[0189] This embodiment achieves seamless switching between drainage, flushing, and drug administration by automatically controlling each solenoid valve, and the control is simple.

[0190] This embodiment enables real-time monitoring of drainage, intravesical pressure and / or urine flow rate, graded alarm for abnormal conditions, automatic control and switching of urinary catheters for drainage, flushing and drug administration, reducing the risk of catheter-related urinary tract infections and kidney injury, optimizing nursing operation procedures, and solving the technical defects of traditional urinary catheters such as lack of pressure monitoring, delayed blockage warning, easy infection and low nursing efficiency. It is suitable for scenarios such as ICU, postoperative urology surgery and elderly care.

[0191] Example 5

[0192] The present invention also provides a urinary catheter system with real-time monitoring and alarm functions, comprising: the urinary catheter of Embodiment 4, as well as an irrigation pump and a drug delivery pump. The irrigation pump is used to pump sterile saline in the reservoir into the bladder through the irrigation passage under the control of the control module. The drug delivery pump is used to pump drugs or contrast agents in the reservoir into the bladder through the drug delivery passage and the injection passage under the control of the control module.

[0193] The inlet of the flushing pump is connected to the outlet of the storage container, and the outlet is sealed to the flushing interface 32. The control module controls an electronic switch connected to the power supply circuit of the flushing pump. When the flushing mode needs to be entered, the control module controls the solenoid valve of the flushing chamber to connect the flushing passage and triggers the electronic switch to conduct the power supply circuit of the flushing pump. The flushing pump works, and sterile saline in the automatic storage container is pumped into the bladder through the flushing passage. The liquid pressure loosens and flushes the drainage holes and blockages (blood clots, crystals, etc.) in the drainage cavity. After flushing, the drainage mode is automatically restored, and waste liquid and blockages are discharged, realizing the automated treatment of blockages.

[0194] The inlet of the drug delivery pump is connected to the outlet of the drug storage container, and the outlet is sealed to the drug delivery interface 32. The control module controls an electronic switch connected to the power supply circuit of the drug delivery pump. When the drug delivery mode needs to be entered, the control module controls the solenoid valve of the drug delivery chamber to connect the drug delivery path and triggers the electronic switch to conduct the power supply circuit of the drug delivery pump. The drug delivery pump works, and the drug or contrast agent in the automatic drug storage container is pumped into the bladder through the drug delivery path and the injection path for automated drug treatment or cystography.

[0195] The present invention has the following technical effects:

[0196] 1. Real-time pressure and / or urine flow monitoring and alarms can provide early warning of bladder high pressure and catheter blockage, reducing the incidence of catheter-related urinary tract infections (CAUTI).

[0197] 2. Automatic alarms reduce more than 80% of ineffective patrols, allowing nursing resources to be focused on higher priority tasks. In addition, kidney injury and CAUTI can prolong hospital stay by 2-5 days. Early intervention can reduce complications, accelerate patient recovery, and reduce hospitalization costs.

[0198] 3. Automatic flushing is achieved through the control module and solenoid valve, which can reduce manual intervention for blockages, improve the efficiency of abnormal handling, and reduce reliance on medical staff.

[0199] 4. By providing continuous and objective bladder pressure and / or urinary flow rate data, it provides data support for postoperative bladder recovery monitoring and personalized treatment plan development, especially suitable for patients with spinal cord injury, post-prostate surgery, etc. For example, it can adjust the frequency of intermittent catheterization for patients with spinal cord injury based on the pressure curve or optimize the dosage of anticholinergic drugs for patients with neurogenic bladder.

[0200] The above embodiments are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Any modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A urinary catheter with real-time monitoring and alarm functions, comprising: The main tube of the urinary catheter has a drainage cavity, an irrigation cavity, and a balloon cavity that extend in parallel along the axis of the main tube. A balloon, which is attached to the outer side of the front end of the main catheter and communicates with the balloon cavity, is used to inflate after inflation / inflation to secure the catheter. The interface includes a drainage interface, an irrigation interface, and a balloon interface, wherein the drainage cavity, irrigation cavity, and balloon cavity branch at the tail end of the main catheter to form a drainage tube for connecting the drainage cavity and the drainage interface, an irrigation tube for connecting the irrigation cavity and the irrigation interface, and a balloon tube for connecting the balloon cavity and the balloon interface. A pressure sensor, embedded in the front end of the drainage cavity, is used to collect intravesical pressure in real time after the main catheter is inserted into the bladder via the urinary tract. A flow sensor, embedded in the drainage cavity, is used to collect the urine flow rate drained through the drainage cavity in real time after the main catheter is inserted into the bladder via the urinary tract. The catheter is characterized in that it further includes: The catheter handle has its internal space pierced by a drainage tube, an irrigation tube, and a balloon tube. A drainage chamber solenoid valve is adapted to a drainage tube that passes through the catheter handle and is located on the catheter handle. The flushing chamber solenoid valve is adapted to the flushing tube that passes through the catheter handle and is located on the catheter handle. The control module is used to determine whether the current urination of the catheter is normal or abnormal based on the intravesical pressure and / or urine flow rate. If the urination is normal, the control module controls the solenoid valve of the drainage cavity to keep the drainage path open. If the urination is abnormal, the control module analyzes the intravesical pressure and / or urine flow rate to determine the type of abnormality and performs processing including alarm based on the type of abnormality.

2. The urinary catheter according to claim 1, characterized in that, The control module determines whether the catheter is currently urinating normally or abnormally based on intrabladder pressure and / or urine flow rate, including: The control module determines whether the intrabladder pressure is normal by judging whether the intrabladder pressure is within the normal range, and / or determines whether the urine flow is continuous by judging whether multiple consecutive urine flow rates are greater than a preset effective urine flow rate threshold; If the intrabladder pressure is normal and / or the urine flow is continuous, the control module determines that the current urination is normal; otherwise, it determines that the current urination is abnormal.

3. The urinary catheter according to claim 1, characterized in that, The control module determines the types of abnormalities by analyzing intravesical pressure and / or urine flow rate, including: If the intravesical pressure is within the preset early obstruction threshold range, the abnormality type is identified as high pressure caused by bladder spasm or early obstruction of the drainage cavity; If the rate of change of intravesical pressure is greater than the preset first pressure change threshold and the urine flow rate is less than the preset first urine flow rate change threshold within the preset first time period, then the abnormality type is determined to be progressive obstruction of the drainage tube. If the intrabladder pressure is greater than the higher value of the preset early obstruction threshold range, the abnormal type is identified as dangerous high pressure; If the intravesical pressure is greater than the lower value of the preset early obstruction threshold range and continues to rise, and the urine flow rate determined based on the urine flow rate is zero within the preset first time period, then the abnormality type is determined to be complete obstruction of the drainage cavity. If the intravesical pressure is less than the preset low pressure threshold, or the urine flow is zero within the preset second time period, the abnormality type is determined to be low pressure caused by catheter dislodgement or bladder emptiness.

4. The urinary catheter according to claim 3, characterized in that, The control module performs alarm processing based on the anomaly type, including: When the abnormality type is high pressure, the control module will issue an alarm. If no alarm cancellation is received within the preset medical treatment time, the control module will connect the flushing chamber solenoid valve to the flushing passage to flush using physiological saline introduced from the flushing passage. When the abnormality type is progressive blockage of the drainage cavity, the control module controls the flushing cavity solenoid valve to repeatedly open and close the flushing passage at a set frequency in order to prevent the blockage from worsening by increasing the flushing frequency. When the abnormality type is dangerous high pressure or complete blockage of the drainage cavity, the control module will issue a local alarm and generate an emergency alarm message containing patient information, abnormality type, intravesical pressure and urine flow rate, which will be transmitted to the medical staff terminal so that the medical staff can arrive at the scene to handle the situation.

5. The urinary catheter according to claim 4, characterized in that, The control module, based on the type of abnormality, performs processing including alarms and also includes: When the abnormality is caused by catheter dislodgement or low pressure due to bladder emptiness, the control module will issue an alarm. If no alarm is cleared within the preset medical care treatment time, the control module will shut off the drainage path by controlling the drainage chamber solenoid valve to simulate physiological urine storage. After the preset shutdown time, the control module will reconnect the drainage path by controlling the drainage chamber solenoid valve to simulate physiological urination. If the intravesical pressure is less than the preset low-pressure threshold or the urine flow is still zero after simulated physiological urination, the control module controls the drainage chamber solenoid valve to close the drainage path and controls the flushing chamber solenoid valve to connect the flushing path to inject physiological saline through the flushing path. When the intravesical pressure is within the preset normal range, the control module controls the flushing chamber solenoid valve to close the flushing path and controls the drainage chamber solenoid valve to connect the drainage path to open the drainage. The control module repeats the above steps until the patient spontaneously feels the urge to urinate and completes urination.

6. The urinary catheter according to claim 1, characterized in that, The urinary catheter also includes: A drug delivery interface that is independent of the drainage interface, flushing interface and balloon interface, used to inject drugs or contrast agents through the drug delivery interface; A drug delivery tube is used to connect the drug delivery interface to the flushing tube that passes through the handle of the urinary catheter to form a drug delivery pathway; A solenoid valve for drug delivery chamber, which is adapted to the drug delivery tube and is located on the handle of the urinary catheter; The control module controls the drainage chamber solenoid valve to close the drainage path and controls the drug delivery chamber solenoid valve to connect the drug delivery path, so that the drug or contrast agent is injected into the bladder through the drug delivery path and the flushing path and left in place for a preset retention time parameter. After the preset retention time is reached, the control module controls the drainage chamber solenoid valve to open the drainage path and controls the drug delivery chamber solenoid valve to close the drug delivery path, so that the drug or contrast agent is discharged through the drainage path.

7. The urinary catheter according to any one of claims 1-6, wherein the main tube of the urinary catheter further comprises a sensing cavity that is independent of the drainage cavity, the irrigation cavity, and the balloon cavity and extends along the axis of the main tube, and the sensing cavity is provided with signal lines connected to the pressure sensor and the flow sensor respectively, so as to transmit the intravesical pressure collected by the pressure sensor and the urine flow rate collected by the flow sensor to the control module through the signal lines.

8. A urinary catheter with real-time monitoring and alarm functions, characterized in that, include: The main tube of the urinary catheter has a drainage cavity and a balloon cavity that extend in parallel along the axis of the main tube. A balloon, which is attached to the outer side of the front end of the main catheter and communicates with the balloon cavity, is used to inflate after inflation / inflation to secure the catheter. The interface includes a drainage interface and a balloon interface, wherein the drainage cavity and the balloon cavity branch at the tail end of the main catheter to form a drainage tube for connecting the drainage cavity and the drainage interface and a balloon tube for connecting the balloon cavity and the balloon interface. A pressure sensor, embedded in the front end of the drainage cavity, is used to collect intravesical pressure in real time after the main catheter is inserted into the bladder via the urinary tract. A flow sensor, embedded in the drainage cavity, is used to collect the urine flow rate drained through the drainage cavity in real time after the main catheter is inserted into the bladder via the urinary tract. The catheter is characterized in that it further includes: The catheter handle has its internal space pierced by a drainage tube and a balloon tube. A drainage chamber solenoid valve is adapted to a drainage tube that passes through the catheter handle and is located on the catheter handle. The control module is used to determine whether the current urination of the catheter is normal or abnormal based on the intravesical pressure and / or urine flow rate. If the urination is normal, the module controls the drainage chamber solenoid valve to keep the drainage path open. If the urination is abnormal, an alarm is triggered. If the abnormality is determined to be catheter dislodgement or low pressure caused by bladder emptiness based on the intravesical pressure and / or urine flow rate, and no alarm cancellation is received within a preset medical care treatment time, the module controls the drainage chamber solenoid valve to shut off the drainage path to simulate physiological urine storage. After a preset shutdown time, the module controls the drainage chamber solenoid valve to reconnect the drainage path to simulate physiological urination.

9. A urinary catheter system with real-time monitoring and alarm functions, characterized in that, include: The urinary catheter with real-time monitoring and alarm functions as described in any one of claims 1-8; The flushing pump, under the control of the control module, pumps physiological saline from the reservoir into the bladder through the flushing passage.

10. The urinary catheter system according to claim 9, characterized in that, Also includes: A drug delivery pump, under the control of a control module, is used to pump drugs or contrast agents from a storage container into the bladder via a drug delivery pathway and an injection pathway.

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