CN106361358B

CN106361358B - Intelligent bladder rehabilitation instrument

Info

Publication number: CN106361358B
Application number: CN201610901594.2A
Authority: CN
Inventors: 王明
Original assignee: Yangzhou Aotai Photoelectric Biological Technology Co ltd
Current assignee: Yangzhou Aotai Photoelectric Biological Technology Co ltd
Priority date: 2016-10-16
Filing date: 2016-10-16
Publication date: 2021-10-26
Anticipated expiration: 2036-10-16
Also published as: CN106361358A

Abstract

The invention discloses an intelligent bladder rehabilitation instrument which comprises a balloon, a catheter body, a pressure transmission pipeline, a three-way interface, a vent valve structure, a pressure data acquisition unit and a control system. The balloon is connected with a first interface of the three-way interface through a pressure transmission pipeline, the other two interfaces of the three-way interface are respectively connected with a first pipeline and a second pipeline, wherein the other end of the first pipeline is connected with an external inflation or water injection device, the other end of the second pipeline is connected with the input end of the vent valve structure, and the output end of the vent valve structure is connected with a pressure sensor through a pressure sensor catheter; the pressure sensor is connected with the control system and transmits the acquired signal to the control system; one end of the catheter body is positioned in the bladder and is used for catheterization. The intelligent bladder rehabilitation instrument is simple to operate, convenient to use, high in data accuracy, stable and reliable.

Description

Intelligent bladder rehabilitation instrument

Technical Field

The invention belongs to the field of medical appliances, and particularly relates to an intelligent bladder rehabilitation instrument.

Background

Neurogenic bladder dysfunction refers to bladder dysfunction due to central, spinal or other neurological problems. This is a common disease, especially in adults with a high incidence of disease, with millions of cases per year in the united states. Neurogenic bladder dysfunction is clinically manifested by dysuria and uncontrolled urination, which further aggravates bladder dysfunction and causes more bladder and urinary system lesions, wherein renal insufficiency caused by hydronephrosis is a main reason for late death of patients with spinal injuries.

For treating autonomic dysfunction of neurogenic bladder, Intermittent urination (Intermittent Catheterization) is a common clinical method. Intermittent urination can be performed by manually controlling the catheter on time, and can also be performed by controlling the catheter by using an instrument. The basic principle of the instruments is that the accumulated urine volume in the bladder is estimated by monitoring the pressure in the bladder, and the on-off time of the urethral catheterization pipeline is controlled according to the estimated urine volume, so that the aim of intermittent urination is fulfilled. These instruments may also weigh the amount of urine collected and calculate the urine flow or urine specific gravity based on the amount and weight of urine collected over a specified period of time.

In the existing clinical instruments for urinary catheterization control, the method for detecting bladder pressure is that urine is led out of a body, and the intravesical pressure is estimated according to the urine pressure generated by the volume of the urine led out of the body. In practice, urine passes through a length of catheter tube to the urine collection container. Because patients have different sitting and lying postures and different sickbeds, the section of the urethral catheterization pipeline contains urine and possibly gas, which brings errors of intravesical pressure detection, and the errors cause that the urethral catheterization control cannot be accurately carried out.

The device is used for deriving the urine volume in vitro, and cannot derive too much urine volume or not too much urine volume under the influence of the clinical state of the bladder of a patient, the clinical use condition of the device, the actual conditions of factors such as the pressure change of the bladder and the like. Thus, the amount of urine excreted outside the body for testing is limited. The method applied to testing the pressure generated by the urine volume in the market is a urine lateral pressure testing method, and the testing error generated by the method under the conditions is extremely large, so that the method cannot actually play a role in accurately controlling intermittent urination.

In addition, these instruments are used for a method for detecting a urine flow rate or a urine specific gravity, and also cannot provide accurate data and effects for clinical evaluation diagnosis or treatment because measurement errors of a urine collection container volume scale and a weighing sensor bring errors to estimated urine flow rate or urine specific gravity data.

In practice, intermittent catheterization is performed to first solve a basic problem: what moment the catheter is started to urinate? In principle, it should be determined according to the amount of urine stored in the bladder and the urine capacity of the patient's bladder, but precisely because it is the patient, the amount of urine stored in the bladder and the urine capacity and hence the desire of the patient are unknown and uncontrollable.

Manual intermittent catheterization presents two significant problems or difficulties in its implementation. Firstly, the application is troublesome, and repeated users suffer pain, are easy to infect, and are accompanied by the risks of edema and hemorrhage; especially, it is inconvenient for patients in operation, coma or inconvenient for other reasons. Secondly, it is impossible to provide real-time specific urodynamic data for clinical and pathological diagnosis and the evaluation of therapeutic effects.

In order to reduce the inconvenience and pain associated with the above problems, there is a need for an apparatus that can perform both automatic intermittent catheterization and conventional catheterization.

The specific numerical values of the relationship between the bladder pressure and the urine retention in the bladder and the central nervous sensory desire vary from person to person. Clinically, the sense of urination will be felt through peripheral nerves and central nerves, and the degree of consciousness that the patient does not urinate autonomously can be physiologically tolerated, and the degree of physiological sensation that the patient cannot tolerate is divided into four grades, namely initial sense of urination, conventional sense of urination, strong sense of urination, and maximum sense of urination. In general, the urine sensation felt by an adult when the adult accumulates urine at 150-. Between the initial and maximum voluntary volumes, the human nerve will inform in time of urination. While the urinary sensation felt with less than 100mL of urine retention or with more than 400mL of urine retention can be classified as abnormal neuronal bladder function.

There are many methods and instruments for detecting the pressure in the bladder, but each has the problem of inconvenient clinical intermittent catheterization, such as high price, and can not be used with rehabilitation therapy; such as problems with long-term retention of the test device within the bladder, resulting in physical discomfort and even bladder perforation, as well as aspiration into the body, loss, or entry into the abdominal cavity.

In addition, some products introduce urine into the body to detect the pressure and the urine volume in the bladder, and the conduction of the urine is obviously influenced due to inherent defects of the detection method and the device thereof, such as the shape of a ureter and the placement mode of the ureter; the air in the urine tube affects the actual pressure of the urine; the in vitro urine is not enough to meet the detection sensitivity and accuracy and the like, and the aim of controlling intermittent urination by an instrument cannot be achieved.

Disclosure of Invention

The invention aims to provide the bladder rehabilitation instrument which is simple in structure, accurate in detection and good in function expansibility.

The technical solution for realizing the purpose of the invention is as follows: an intelligent bladder rehabilitation instrument comprises a balloon, a urethral catheter body, a pressure transmission pipeline, a three-way interface, a vent valve structure, a pressure data acquisition unit and a control system. The balloon is positioned in the bladder and is connected with a first interface of a three-way interface through a pressure transmission pipeline, the other two interfaces of the three-way interface are respectively connected with a first pipeline and a second pipeline, the other end of the first pipeline is connected with an external inflation or water injection device, the other end of the second pipeline is connected with the input end of a vent valve structure, the output end of the vent valve structure is connected with a pressure sensor through a pressure sensor catheter, the pressure sensor is connected with a control system, and the acquired signals are transmitted to the control system; one end of the catheter body is positioned in the bladder and is used for catheterization.

Compared with the prior art, the invention has the following remarkable advantages: 1) the bladder rehabilitation instrument can automatically detect and monitor real-time urodynamics data in the conventional urethral catheterization process of a patient, does not need to use expensive urodynamics detection instruments or other instruments additionally, and does not need other medicines; the device of the invention combines the catheterization, the bladder rehabilitation and the function test together and simultaneously carries out the operation, thereby saving the time and the cost of patients, relieving the pain and accelerating the rehabilitation; 2) the bladder rehabilitation instrument can detect the intravesical pressure in real time, is not influenced by the body position of a patient, does not need to lead urine in advance, is not influenced by bubbles in a urine pipeline, does not limit the horizontal position for placing the instrument, and has the advantages of simple operation, convenient use, high data accuracy, stability and reliability; 3) the intelligent bladder rehabilitation instrument acquires the bladder pressure in the bladder in real time, calculates the filling state of bladder urine according to dynamic data, and controls the urination of a patient according to the filling amount of the urine, so that the patient can perform dynamic evaluation and intelligent bionic training on the bladder function under the normal bladder urine accumulation and urination mechanism, and the improvement and recovery of the bladder function are promoted; 4) the traditional saccule is used for fixing the catheter to the bladder and preventing urine from leaking, the invention improves on the basis of the traditional saccule, and the saccule not only can be used for fixing the catheter to the bladder, but also can be used for collecting the pressure in the bladder, so that the collected pressure data is more accurate; 5) the balloon 310 is left at the bladder mouth after being inflated or injected with water, so that not only the function of fixing the catheter is maintained, but also the actual pressure in the bladder is acquired in real time, an inflation or injection pipeline is used as a part of the pressure transmission pipeline 312, and the balloon 310 and the pressure transmission pipeline 312 are not communicated with the catheter body 410; 6) the bladder rehabilitation instrument has a simple structure, is convenient to implement and can be popularized in a large scale.

The present invention is described in further detail below with reference to the attached drawing figures.

Drawings

Fig. 1 is a structural view of an intelligent bladder rehabilitation instrument system of the present invention.

FIG. 2 is a schematic view of a conventional urinary catheter indwelling in the bladder, wherein FIG. 2(A) is a schematic view of anuria in the bladder; FIG. 2(B) is a schematic view of the storage of urine in the bladder.

Fig. 3 is a block diagram of an electronic system of the intelligent bladder rehabilitation instrument.

Fig. 4 is a comparison graph of the corresponding relationship between the bladder urine storage amount and the bladder pressure, wherein fig. 4(a) is a model graph of the bladder stress, fig. 4(B) is a graph of the corresponding relationship between the bladder pressure and the bladder urine storage amount, and fig. 4(C) is a graph of the corresponding relationship between the balloon pressure and the simulated bladder urine storage amount.

Fig. 5 is a comparison graph of the bladder pressure and the bladder urine storage amount, wherein fig. 5(a) is a graph of the bladder urine storage amount and the bladder pressure, and fig. 5(B) is a graph of the simulated bladder urine storage amount and the balloon pressure.

Detailed Description

The invention discloses an intelligent bladder rehabilitation instrument, which belongs to medical instruments and has the functions of real-time monitoring, detection and rehabilitation treatment. The instrument detects and monitors urodynamics data in real time, provides a physical method and an instrument for patients with bladder diseases caused by neurogenic and other causes through the detected and monitored urodynamics data indexes and intelligent control, and performs rehabilitation training on bladder nerves under the condition of not adding any extra burden to the patients, thereby achieving the purpose of improving and recovering the bladder function. The invention mainly comprises a real-time detection pipeline and a sensor for urodynamics data and a real-time data processing system. The urine dynamic data mentioned in the invention mainly comprises bladder pressure, urine flow rate, urine flow and urine specific gravity.

The invention discloses an intelligent bladder rehabilitation instrument, which comprises a balloon 310, a catheter body 410, a pressure transmission pipeline 312, a three-way interface 320, a vent valve structure 340, a pressure data acquisition unit 510 and a control system 500, wherein the balloon 310 is positioned in a bladder and is connected with a first interface of the three-way interface 320 through the pressure transmission pipeline 312; the other two connectors of the three-way connector 320 are respectively connected with a first pipeline 332 and a second pipeline 321, wherein the other end of the first pipeline 332 is connected with an external inflation or water injection device, and the other end of the second pipeline 321 is connected with the input end of the vent valve structure 340; the output of the vent valve structure 340 is connected to a pressure sensor via a pressure sensor conduit 350; the pressure sensor is connected with the control system 500 and transmits the acquired signal to the control system 500; one end of the catheter body 410 is positioned in the bladder for catheterization.

The catheter body 410 is provided with a urine flow control unit comprising a controllable shut-off valve 420, which is connected to the control system 500.

The catheter body 410 is further provided with a urine flow rate detection unit 430, which is connected to the control system 500.

The output end of the catheter body 410 is provided with a urine specific gravity detection unit 440, and the unit is connected with the control system 500.

The stop valve 420 is a mechanical stop valve or an electronic control stop valve, and the electronic control stop valve is connected with the control system 500.

The control system 500 comprises a central processing unit 520, and a data storage unit 521, a medical record management unit 522, an alarm unit 504, a display control unit 503, a key switch control unit 502, a wireless receiver 501, a pressure data acquisition unit 510, a urination control unit 530, a urine flow data acquisition unit 540, a urine collection data acquisition unit 550, a urodynamics data processing unit 560, a power management unit 570 and a communication interface control unit 580 which are connected with the central processing unit;

the pressure data acquisition unit 510 is connected with the pressure sensor and used for acquiring pressure data;

the urination control unit 530 is connected with the controllable stop valve 420 and is used for controlling urination;

the urine flow data collecting unit 540 is connected to the urine flow detecting unit 430, and is configured to collect urine flow data;

the urine collection data collection unit 550 is configured to collect an initial time, a number of times of urination and a urine volume discharged each time;

the urodynamic data processing unit 560 is configured to process urodynamic data.

The power management unit 570 is connected with the battery power display and safety monitoring unit 574 and the battery charging and management unit 572 to manage and control the same; the communication interface control unit 580 is connected to the communication interface 581, and controls it; the central processor 520 is also connected to the display and control screen 505.

The first pipe 332 is provided with a one-way valve 331, the first pipe 332 and the three-way port 320 are sealed by a first sealing device 330, the second pipe 321 and the vent valve structure 340 are sealed by a second sealing device 322, the vent valve structure 340 and the pressure sensor pipe 350 are sealed by a third sealing device 351, and the pressure sensor pipe 350 and the pressure sensor are sealed by a fourth sealing device 352.

Also included is a manual interface module 582 coupled to the central processor 520, the manual interface module 582 being coupled to a wired remote control.

The vent valve structure 340 further includes a first vent 341 and a second vent 342.

The catheter body 410 penetrates the balloon 310, a section of the pressure transmission pipeline 312 is positioned in the catheter body 410, and the balloon 310 and the pressure transmission pipeline 312 are not communicated with the catheter body 410.

The intelligent bladder rehabilitation instrument has the functions of controlling urination and monitoring urodynamics physiological index data at the same time, and performs intermittent urination according to the monitored urodynamics data. The bladder rehabilitation instrument utilizes the saccule of the conventional catheter to transmit the pressure in the bladder to the pressure sensor configured outside the body, accurately monitors the pressure in the bladder in real time, calculates the urine accumulation amount in the bladder through a corresponding biological algorithm, and controls the urination of the catheter according to the urine accumulation amount or informs patients or nursing staff of artificial urination to realize the controllable intermittent catheterization.

The intravesical pressure testing method of the invention utilizes the standard balloon of the conventional catheter, does not leave any other device in the bladder, does not increase or decrease any burden on a patient, does not generate any side effect, can monitor and monitor the intravesical pressure in real time for a long time so as to detect and monitor the urine volume in the bladder in real time, automatically carries out intermittent catheterization by the device of the invention, and can also inform patients or nursing staff of manual urination according to monitoring data.

The bladder rehabilitation instrument can simultaneously detect and monitor urodynamics data in the conventional catheterization process, automatically or manually control urination according to the real-time detected data or personal feelings of patients or the on-site judgment of medical personnel, perform intelligent bionic improvement treatment on neurogenic bladder urination dysfunction, and further recover the bladder autonomous urination function.

The present invention will be described in further detail with reference to examples.

Example 1

The invention provides a bladder rehabilitation instrument with simple structure, accurate detection and good function expansibility. The bladder rehabilitation instrument is conveniently and accurately used for clinical routine continuous catheterization and intermittent catheterization, promotes patients to improve and recover the autonomous catheterization function of the bladder, can simultaneously detect and monitor the main data of urodynamics in real time, namely the intravesical pressure, the urine flow rate, the urine flow and the urine specific gravity, and quickly provides accurate data for clinical treatment and pathological diagnosis.

Fig. 2-a is a schematic view of a conventional catheter being left in the bladder, and fig. 2-B is a schematic view of a conventional catheter in the urinary bladder with the balloon under pressure in the surface of the bladder, the arrows indicating the direction of force.

The basic principle of the method is that the bladder pressure is received by the balloon, the pressure is transmitted to the pressure sensor through the balloon pipeline pressure transmission mechanism, the urine storage quantity in the bladder is calculated through the control system and an intelligent algorithm software program preset in the control system, and the urine flow control mechanism is started between the initial urine content and the maximum urine content according to a set threshold value to automatically and controllably urinate.

FIG. 4 shows a graphical representation of the statistics of the amount of urine stored in the bladder versus the pressure in the bladder. When the urine storage capacity of the bladder is within 400mL, the relationship between the bladder pressure and the urine volume is approximately that the pressure of about 50 pascals of water is increased by 0.5 cm per 100 milliliters; at a urine storage volume of 400-600mL, the bladder pressure is approximately 500 pascal increase per 100mL of urine, the urine storage volume exceeds 600mL, i.e., the strong urinary tract region, and the bladder pressure is approximately 1500 pascal increase per 100mL of urine.

The above data show that the clinically required catheterization can be controlled within the normal urodynamic range as long as the detection sensitivity of the pressure sensor reaches 10 pascals, that is, the pressure detection sensitivity of 10 pascals can correspond to the urine storage amount per 10 milliliters at the initial stage of urine storage, which is accurate enough for normal urination and urodynamic feeling. In fact, the pressure detection sensitivity of the bladder function rehabilitation instrument is far higher than 10 pascals.

As shown in figure 1, the intelligent bladder function rehabilitation instrument with the functions of conventional catheterization, precise control and real-time urodynamics index function comprises an intelligent electronic and mechanical control system, a catheter balloon pipeline pressure transmission structure, a urine flow control structure, a urine flow speed and flow real-time detection structure, a urine volume real-time detection structure, an alarm and emergency situation processing structure and a manual operation structure for patients or nursing staff. The structure of the intelligent electronic control system corresponding to that shown in fig. 1 is shown in fig. 3.

The catheter sacculus pipeline pressure transmission structure comprises a conventional catheter sacculus, a pressure transmission pipeline, a three-way connector, a pressure sensor exhaust structure and a pressure sensor. The three-way connector is communicated with the balloon pipeline, the pressure sensor pipeline and the inflation or water injection pipeline, and is provided with a pipe valve for inflation and deflation and a water injection and drainage structure. The urine flow control structure comprises an electromagnetic or mechanical valve, a control circuit of the electromagnetic or mechanical valve and an embedded code. The electromagnetic or mechanical valve may be, but is not limited to, a solenoid valve, a magnetically controlled valve, a peristaltic valve, a gas valve, a motor gear arrangement, an electric or pneumatic or other powered push or slide rod arrangement, and any other manner of linear actuator arrangement.

The balloon conduit pressure transfer structure may also include a deflation tube valve structure, depending on clinical needs. After the saccule enters the bladder along with the front section of the catheter, the saccule can be inflated or injected with water to be reserved at the inner opening of the bladder by using a method used by a conventional catheter, is used for fixing the position of the catheter, simultaneously has the function of the cystometrography sensing device and transmits the sensed cystometrography to a pressure sensor outside the body through a pressure transmission pipeline. The balloon interior has a balloon lumen 311.

The balloon is inflated or filled with water by using a three-way interface 320 instead of using a one-way pipe valve used by a conventional catheter, wherein the three-way interface is respectively connected with a balloon catheter 312, an inflation or water filling pipe appliance 332 and a pressure sensor catheter 350, and one end connected with inflation or water filling has the function of a one-way pipe valve 331. The three-way interface can be preassembled in the intelligent bladder rehabilitation instrument, so that the balloon catheter has the advantages of simpler structure, convenience in manufacturing and lower cost. In addition, considering that the conventional catheter is a disposable device, the catheter matched with the intelligent bladder rehabilitation instrument provided by the invention reduces the used materials because the one-way pipe valve is not used, and has the advantages of energy conservation and emission reduction.

The pressure sensor unit consists 510 of a pressure sensor and an additional electrical signal processor. The pressure sensor may be a gas pressure sensor or a liquid pressure sensor, respectively, depending on the clinical requirements for balloon inflation or insufflation. The pressure sensor converts the intravesical pressure sensed by the balloon into an electric signal in real time. The electrical signal processor includes the functions required for signal processing, such as filtering, amplification, digital signal processing, and the like.

A deflation tube valve structure is interposed between the aforementioned balloon and balloon pressure transfer conduit and interface to transmit intravesical pressure to the aforementioned pressure sensor. When the clinical requirement sacculus water injection, the possible gas that mixes in the sacculus pressure transmission pipeline can be discharged through this bleeder valve structure to reduce and eliminate the influence of mixing in the gas to pressure detection precision. When the balloon is clinically required to be inflated for use, the gas filled in the balloon can be discharged through the deflation pipe valve when the conventional catheterization process is finished, and manual deflation of the balloon required in the conventional catheterization process is not needed, so that the complicated procedures are reduced, the catheter is conveniently and safely taken out, and negative pressure is not caused to the pressure sensor.

The urine flow control unit comprises a stop valve 420 which can be controlled automatically by electronic control or manually by a person to control the stopping and opening of the urine flow. The shut-off valve may be, but is not limited to, a magnetically controlled valve, a peristaltic valve, or other fluid control valve structure. The device is also characterized in that the stop valve can stop and open the urine flow and can be automatically controlled by the system according to the bladder pressure detected by the balloon conduit pressure transmission structure or according to a preset program of the system; the control can also be manually carried out by the patient or the medical staff according to the urination feeling or the use time of the patient or the on-site judgment of the medical staff.

The urine flow rate detection unit can be arranged in a conventional urethral catheterization pipeline and also can be arranged at the inlet end of the urine collection container. The urine flow rate detection unit can adopt a real-time flow rate detection technology to really realize real-time dynamic detection of the urine flow rate. The detected real-time urine flow rate data will also be used for urine specific gravity calculation.

The specific gravity of urine is accurately calculated from the relation between the collected urine amount and time, and the number of times of urination and the amount of urine discharged each time in combination with the urine flow rate detected at the same time. This feature is different from the conventional urine specific gravity calculation method, and there is no problem of poor accuracy of urine specific gravity due to errors in detected volume and weight. The urine eventually flows into the urine receptacle 450.

The real-time data detected by the urine flow rate detection unit can be used for accurately calculating the urine specific gravity. The algorithm can be programmed into a computer or a processor program and is preset in the intelligent bladder rehabilitation instrument, and the algorithm program can be respectively embedded into the urine flow rate and urine specific gravity detection units according to the application requirements.

The urine flow control structure is controlled by a central processing unit embedded with a program 3. The preset embedded program comprises a biological pathological algorithm based on clinical and pathological data, and can give a control instruction according to the pressure in the bladder detected or monitored by the pressure sensing unit of the invention to automatically control the urine flow, and patients or nursing staff can also manually control the urine flow according to the urine intention and clinical actual conditions of the patients. The pressure in the bladder changes with the increase of the amount of urine and the sensing of the bladder nerves. The urine sensation evaluation method and the system have the advantages that 400mL is usually adopted as the evaluation index of the feeling of urination clinically, the bladder pressure corresponding to 400mL is used as an initial value to be preset and the system is used for analyzing according to data collected in the actual use process, and the optimal threshold value which is different from person to person is provided for medical staff and patients.

The above-mentioned control of urine flow mainly refers to complete cut-off and complete discharge of urine flow. The urine flow discharge mentioned in the present invention refers to the discharge of urine in the bladder from the bladder through a catheter, and the amount of discharged urine can be automatically adjusted by the device of the present invention, and can also be manually adjusted by patients or nursing staff through the device of the present invention.

The real-time urine flow velocity and flow detection structure comprises a turbine structure and a rotating speed detector thereof, and the turbine structure, the rotating speed detector and an embedded control unit form a novel real-time urine flow velocity and flow detection structure. This novel urine velocity of flow real-time detection structure passes through turbine structure real-time detection and monitoring fluid velocity of flow and flow, for general contactless, pollution-free, small, measure accurate fluid velocity of flow detector. In the structure and the actually realized device of the invention, the signal of the rotating speed detector is collected and processed by a data acquisition system of an electronic control system, and the flow speed and the flow of urine are calculated according to the signal.

The real-time urine volume detection structure comprises a real-time weight sensor, and signals of the weight sensor are collected by a data acquisition unit of the electronic control system and are subjected to signal processing. The urine volume real-time detection structure also has an anti-shaking function, and can filter out the influence brought by environmental vibration, operation shaking and urine collection container structure and manufacturing errors.

The intelligent electronic and mechanical control system comprises one or more central processing units and corresponding peripheral equipment, wherein the central processing units and the corresponding peripheral equipment comprise a program and data storage unit, a pressure, rotating speed, weight, time and other data acquisition and processing unit, a data transmission unit, a communication interface, an operation and display screen, a power supply management unit and an alarm and special condition processing and reporting unit.

The manual operation structure for patients or nursing staff comprises keys and a touch screen which are arranged on the device, a remote controller connected with the device through wires, and an infrared remote controller in wireless connection. The remote controller can also be a radio frequency remote controller, or a remote control device such as a mobile phone tablet personal computer and the like which can communicate by Bluetooth or WiFi.

The present invention was prototyped and tested in prototype according to the protocol described in the previous section, fig. 1 and 3. In the test process, a closed container and a semi-closed container are adopted to simulate the bladder, the simulated bladder is filled with water to simulate the accumulation of urine, a conventional catheter and a balloon thereof are used for collecting the pressure of accumulated water in the simulated bladder, and 10mL of water is filled into the balloon according to the clinical standard.

Data modeling the pressure versus water fill in the bladder are presented in FIGS. 4 and 5, compared to statistical physical models [ http:// aibolita.com/men-diseases/46575-storage-phase. html ] and actual case measurements [ M.Malbrain and D.Deeren, "" Effect of space on measured intrinsic pressure: A.professional co-host "", Critical Care 2006,10: R98 ].

FIG. 4 shows the correlation between the urine storage capacity of the bladder and the pressure in the bladder. Figure 4-a is a cited physical model of the bladder [ http:// aibolita. com/men-diseases/46575-storage-phase. html ], which is equivalent to a thin-walled sphere, with a change in sphere radius with increasing pressure, the wall tension becoming greater, but the ratio of sphere tension to radius remaining nearly constant, so that the bladder pressure does not change much before it is filled with urine. FIG. 4-B is a graph of the change in internal pressure during bladder storage and the radius of the bladder model sphere and the wall tension, with the pressure within the dashed oval showing the area where the bladder will feel strong urine when full. Fig. 4-C is a test result of an implementation scheme of the present invention, the bladder pressure is acquired by 10mL of water injected into the balloon of the conventional urinary catheter, the water conduit and the pressure sensor, and is sent to the central processing unit for processing, and the data trend in the dashed oval circle and the clinical statistical data have a relevant corresponding relationship. Through the automatic control program, the urination of a patient is controlled, and the bladder is treated intermittently, so that the intelligent bladder training nerve is trained, and the control of the bladder by the nerve is improved and recovered.

FIG. 5 is a comparison of bladder pressure versus bladder urine storage. FIG. 5-A is a graph showing the correlation between bladder pressure and bladder filling amount [ M.Malbrain and D.Deeren, "Effect of bladder volume on measured intrinsic expression: A Positive co-hot study", Critical Care 2006,10: R98 ], in which the left-most side shows the trend of bladder pressure change when a case is filled with water,. DELTA.V shows the change in the filling amount, and. DELTA.P 2 shows the corresponding change in bladder pressure in the case. Fig. 5-B is simulated test data for an implementation of the present invention. The test prototypes and conditions were the same as described in FIG. 4, and the data trends and literature [ M.Malbrain and D.Deeren, "Effect of blank volume on measured intrinsic expression: A productive co-hot study", Critical Care 2006,10: R98 ] showed clear correlation.

The invention also records and analyzes data in real time for different patients and clinical conditions, provides the most suitable urination threshold value, provides the optimal catheterization function service and bladder function training for the patients, and improves and recovers the function of bladder nerve control urination while achieving the catheterization.

Example 2

An intelligent bladder rehabilitation instrument comprises a balloon 310, a catheter body 410, a pressure transmission pipeline 312, a three-way interface 320, a vent valve structure 340, a pressure data acquisition unit 510 and a control system 500, wherein the balloon 310 is connected with a first interface of the three-way interface 320 through the pressure transmission pipeline 312; the other two connectors of the three-way connector 320 are respectively connected with a first pipeline 332 and a second pipeline 321, wherein the other end of the first pipeline 332 is connected with an external inflation or water injection device, and the other end of the second pipeline 321 is connected with the input end of the vent valve structure 340; the output of the vent valve structure 340 is connected to a pressure sensor via a pressure sensor conduit 350; the pressure sensor is connected with the control system 500 and transmits the acquired signal to the control system 500; one end of the catheter body 410 is positioned in the bladder for catheterization.

The catheter body 410 is provided with a urine flow control unit comprising a controllable shut-off valve 420, which is connected to the control system 500. The catheter body 410 is further provided with a urine flow rate detection unit 430, which is connected to the control system 500. The output end of the catheter body 410 is provided with a urine specific gravity detection unit 440, which is connected to the control system 500. The stop valve 420 is a mechanical stop valve or an electronic control stop valve, and the electronic control stop valve is connected with the control system 500.

The control system 500 comprises a central processing unit 520, and a data storage unit 521, a medical record management unit 522, an alarm unit 504, a display control unit 503, a key switch control unit 502, a wireless receiver 501, a pressure data acquisition unit 510, a urination control unit 530, a urine flow data acquisition unit 540, a urine collection data acquisition unit 550, a urodynamics data processing unit 560, a power management unit 570 and a communication interface control unit 580 which are connected with the central processing unit; the pressure data acquisition unit 510 is connected with the pressure sensor and used for acquiring pressure data; the urination control unit 530 is connected with the controllable stop valve 420 and is used for controlling urination; the urine flow data collecting unit 540 is connected to the urine flow detecting unit 430, and is configured to collect urine flow data; the urine collection data collection unit 550 is configured to collect an initial time, a number of times of urination and a urine volume discharged each time; the urodynamic data processing unit 560 is configured to process urodynamic data.

The device also includes a manual interface module 582 coupled to the central processor 520, the manual interface module 582 being coupled to a wired remote control.

The traditional saccule is used for fixing the catheter to the bladder and preventing urine from leaking, the invention improves on the basis of the traditional saccule, and the saccule not only can be used for fixing the catheter to the bladder, but also can be used for collecting the pressure in the bladder, so that the collected pressure data is more accurate; the balloon 310 is left at the bladder opening after inflation or water injection, not only to maintain the function of fixing the catheter, but also to collect the actual pressure inside the bladder in real time.

Example 3

With reference to fig. 1, an intelligent bladder rehabilitation apparatus includes a balloon 310, a catheter body 410, a pressure transmission pipeline 312, a three-way interface 320, a vent valve structure 340, a pressure data acquisition unit 510 and a control system 500, wherein the balloon 310 is connected to a first interface of the three-way interface 320 through the pressure transmission pipeline 312; the other two connectors of the three-way connector 320 are respectively connected with a first pipeline 332 and a second pipeline 321, wherein the other end of the first pipeline 332 is connected with an external inflation or water injection device, and the other end of the second pipeline 321 is connected with the input end of the vent valve structure 340; the output of the vent valve structure 340 is connected to a pressure sensor via a pressure sensor conduit 350; the pressure sensor is connected with the control system 500 and transmits the acquired signal to the control system 500; one end of the catheter body 410 is positioned in the bladder for catheterization. The vent valve structure 340 further includes a first vent 341 and a second vent 342. The catheter body 410 penetrates the balloon 310, a section of the pressure transmission pipeline 312 is positioned in the catheter body 410, and the balloon 310 and the pressure transmission pipeline 312 are not communicated with the catheter body 410.

The invention is improved on the basis of the traditional saccule, and the saccule not only can be used for fixing the catheter on the bladder, but also can be used for collecting the pressure in the bladder, so that the collected pressure data is more accurate.

Claims

1. The intelligent bladder rehabilitation instrument is characterized by comprising a balloon (310), a catheter body (410), a pressure transmission pipeline (312), a three-way interface (320), a vent valve structure (340), a pressure data acquisition unit (510) and a control system (500), wherein the balloon (310) is connected with a first interface of the three-way interface (320) through the pressure transmission pipeline (312); the other two interfaces of the three-way interface (320) are respectively connected with a first pipeline (332) and a second pipeline (321), wherein the other end of the first pipeline (332) is connected with an external inflation or water injection device, and the other end of the second pipeline (321) is connected with the input end of the vent valve structure (340); the output end of the vent valve structure (340) is connected with the pressure sensor through a pressure sensor conduit (350); the pressure sensor is connected with the control system (500) and transmits the acquired signal to the control system (500); one end of the catheter body (410) is positioned in the bladder and is used for catheterization; the catheter body (410) penetrates through the balloon (310), one section of the catheter body of the pressure transmission pipeline (312) is positioned in the catheter body (410), and the balloon (310) and the pressure transmission pipeline (312) are not communicated with the catheter body (410).

2. The intelligent bladder rehabilitation apparatus according to claim 1, wherein a urine flow control unit is provided on the catheter body (410), the urine flow control unit comprising a controllable stop valve (420), the urine flow control unit being connected to the control system (500).

3. The intelligent bladder rehabilitation apparatus according to claim 2, wherein a urine flow rate detection unit (430) is further disposed on the catheter body (410), and the urine flow rate detection unit (430) is connected to the control system (500).

4. The intelligent bladder rehabilitation apparatus according to claim 1, wherein the output end of the catheter body (410) is provided with a urine specific gravity detection unit (440), and the urine specific gravity detection unit (440) is connected with the control system (500).

5. The intelligent bladder rehabilitation apparatus according to claim 2, wherein the controllable stop valve (420) is a mechanical stop valve or an electrically controlled stop valve, and the electrically controlled stop valve is connected to the control system (500).

6. The intelligent bladder rehabilitation apparatus according to claim 3, wherein the control system (500) comprises a central processing unit (520) and a data storage unit (521), a medical record management unit (522), an alarm unit (504), a display control unit (503), a key switch control unit (502), a wireless receiver (501), a pressure data acquisition unit (510), a urination control unit (530), a urine tachyuria flow data acquisition unit (540), a urine collection data acquisition unit (550), a urodynamics data processing unit (560), a power management unit (570) and a communication interface control unit (580) connected with the central processing unit;

the pressure data acquisition unit (510) is connected with the pressure sensor and is used for acquiring pressure data;

the urination control unit (530) is connected with the controllable stop valve (420) and is used for controlling urination;

the urine flow rate data acquisition unit (540) is connected with the urine flow rate detection unit (430) and is used for acquiring urine flow rate data;

the urine collection data acquisition unit (550) is used for acquiring the initial time, the times and the urine volume each time of urination;

the urodynamic data processing unit (560) is configured to process urodynamic data.

7. The intelligent bladder rehabilitation instrument according to claim 6, wherein the power management unit (570) is connected with the battery level display and safety monitoring unit (574) and the battery charging and management unit (572) to manage and control the battery level display and safety monitoring unit (574) and the battery charging and management unit (572); the communication interface control unit (580) is connected with the communication interface (581) and controls the communication interface (581); the central processor (520) is also connected to a display and control screen (505).

8. The intelligent bladder rehabilitation instrument according to claim 1, wherein a one-way valve (331) is arranged on the first pipeline (332), the first pipeline (332) is sealed with the three-way interface (320) through a first sealing device (330), the second pipeline (321) is sealed with the vent valve structure (340) through a second sealing device (322), the vent valve structure (340) is sealed with the pressure sensor catheter (350) through a third sealing device (351), and the pressure sensor catheter (350) is sealed with the pressure sensor through a fourth sealing device (352).

9. The intelligent bladder rehabilitation apparatus according to claim 6, further comprising a manual interface module (582) connected to the central processor (520), the manual interface module (582) being connected to a wired remote control.

10. The intelligent bladder rehabilitation apparatus according to claim 1, wherein the vent valve structure (340) further comprises a first vent port (341) and a second vent port (342).