WO2013097791A1 - 尿液引流装置、引流控制装置、引流控制系统及排尿方法 - Google Patents

尿液引流装置、引流控制装置、引流控制系统及排尿方法 Download PDF

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Publication number
WO2013097791A1
WO2013097791A1 PCT/CN2012/087979 CN2012087979W WO2013097791A1 WO 2013097791 A1 WO2013097791 A1 WO 2013097791A1 CN 2012087979 W CN2012087979 W CN 2012087979W WO 2013097791 A1 WO2013097791 A1 WO 2013097791A1
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WO
WIPO (PCT)
Prior art keywords
pressure
urine
urination
pressure transmitting
preset
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Application number
PCT/CN2012/087979
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English (en)
French (fr)
Inventor
董东生
Original Assignee
北京东方潮汐科技发展有限公司
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Filing date
Publication date
Application filed by 北京东方潮汐科技发展有限公司 filed Critical 北京东方潮汐科技发展有限公司
Priority to EP12861691.9A priority Critical patent/EP2799096A4/en
Priority to JP2014549347A priority patent/JP5865513B2/ja
Priority to US14/369,349 priority patent/US20140378918A1/en
Publication of WO2013097791A1 publication Critical patent/WO2013097791A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/70—Gravity drainage systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/207—Sensing devices adapted to collect urine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/451—Genital or anal receptacles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/69—Drainage containers not being adapted for subjection to vacuum, e.g. bags
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/74—Suction control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0496—Urine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/07—General characteristics of the apparatus having air pumping means

Definitions

  • the invention relates to the technical field of medical instruments, in particular to a urine drainage device, a drainage control device, a drainage control system and a urination method.
  • the catheterization device used in conventional indwelling catheterization consists of a catheter inserted into the urethra and a urine bag connected to the lower end of the catheter.
  • the urinary catheter continuously leads the urine in the bladder, resulting in the formation of normal intravesical pressure in the bladder.
  • the patient's detrusor and intravesical sphincters are in a state of disuse for a long time, unable to use low-pressure urine storage and low-pressure urination.
  • the principle of urinary control protects the entire urinary tract system. Long-term use of this type of catheter has the following risks:
  • the pressure sensor By setting a preset pressure, the pressure sensor is used to collect the bladder pressure, and when the bladder pressure continues to reach or exceed the preset pressure. The distance of the pressure is determined to be equal to or greater than the preset time. If the duration is equal to or greater than the preset time, the control component alarms to urinate or automatically open the urination, and automatically closes the catheter after the urine is discharged. This process simulates people The normal physiological urination of the body avoids the loss of bladder function caused by the continuous catheterization of the catheter in the traditional catheterization mode.
  • the purpose of the above preset time setting is to prevent the patient from artificially raising the bladder pressure due to changes in body position, coughing, sneezing, bladder spasm, etc., and automatically opening the urine to empty the bladder when the actual pressure of the bladder does not reach the preset pressure. Therefore, it is impossible to simulate the physiological urination of the human body.
  • the above device does not correctly handle the special situation in which the patient's bladder pressure is pseudo-instantly increased. Because the transient false high pressure generated by the bladder has a short duration, it is not enough to reach the preset time, and the control component does not alarm to prompt urination or automatic.
  • the catheter Open urination, the catheter is still closed, the bladder pressure will push the urine to the direction of the kidney, causing the urine to flow backwards, even into the renal pelvis, causing bacterial infections such as the ureter and renal pelvis; in addition, the bladder pressure can also make the urine It overflows into the gap between the catheter and the urethra, forming an overflow of urine.
  • the urine between the catheter and the urethra becomes a medium for bacteria and viruses. The bacteria and viruses will reverse into the bladder and cause greater damage. Risk of infection.
  • urodynamic examination is also a commonly used examination item in clinical practice. Patients with indwelling catheterization undergoing urodynamic testing are required to go to a special urinalysis test room for examination. First, the catheter indwelling in the urethra is pulled out and inserted into the pressure measurement. Tube, artificially fill the bladder, check it, and after the test is completed, insert the catheter again. This causes great pain to the patient, increases the patient's medical burden, and increases the risk of infection.
  • the existing urodynamic examination can not monitor the parameters related to urodynamics in real time, nor can it reflect the physiological state of bladder filling, and it is impossible to realize personalized biomimetic urine drainage, especially for indwelling catheterization patients who are in bed for a long time.
  • An object of the present invention is to provide a urine drainage device comprising a urine inlet connectable to a catheter inserted into a human body and a urine outlet connectable to a urine storage bag for storing urine, the urine drainage device further Including a bladder biomimetic unit, the bladder biomimetic unit includes a urine storage unit capable of forming a body member of the reservoir cavity, the reservoir cavity being in communication with the urine inlet and the urine outlet through a connecting conduit, the body member including deformation capable of deforming with a change in urine pressure in the reservoir cavity
  • the first pressure transmitting surface and the second pressure transmitting surface, the connecting pipeline connecting the liquid storage cavity and the urine outlet is a connecting lower pipeline, and the connecting lower pipeline is provided with a first active region which can be externally applied a second active region, the first active region and the second active region are oppositely disposed; when the first active region and the second active region are simultaneously subjected to an external force, the communication between the liquid storage cavity and the urine outlet is blocked; According to the deformation of the first pressure
  • the main body member is formed with a liquid storage cavity for storing urine, and the liquid storage cavity is connected to the human bladder through a urinary catheter.
  • the urine pressure and the liquid in the human bladder The urine pressure in the cavity is the same.
  • the urine pressure in the human bladder and the urine pressure in the liquid storage cavity can be converted according to the height difference, so the sputum collection liquid is empty.
  • the change in urine pressure in the lumen directly leads to changes in urine pressure in the human bladder.
  • the urine pressure change in the urine cavity of the urine flow device can be deformed by the pressure transmitting surface, and then the urinary flow is determined according to the shape variable of the pressure transmitting surface, thereby achieving the function of assisting the patient to urinate.
  • the patient In the manual mode control, the patient can be urinated manually according to the size of the pressure transfer surface and the patient's urine.
  • the mechanical control and electronic control can be understood by referring to the following examples.
  • the urine drainage device of the structure has a simple structure and is suitable for large-scale production.
  • the first active area is opposite to the second active area, and when the two are engaged, the connecting lower pipeline is formed, and the external force acting on any active area can eliminate the formation of the liquid storage cavity and the urine outlet.
  • the cross-sectional area required for communication of course, when the external forces acting on the first active area and the second active area are all eliminated, the communication between the liquid storage cavity and the urine outlet is smoother.
  • the body member comprises two diaphragms, and a first pressure transmission is formed on the diaphragm a second pressure transmitting surface and a second active area are formed on the other surface of the first surface, the film is buckled and sealed, and the first pressure transmitting surface and the second An internal cavity formed by the opposing pressure transmitting faces is the reservoir cavity.
  • the first pressure transmitting surface and the second pressure transmitting surface are made of an elastic material, and the first active region and the second active region are made of a flexible material.
  • the first pressure transmitting surface, the first The two pressure transmitting faces, the first acting region, and the second acting region may be made of a flexible material having elasticity.
  • the bladder bionic unit further comprises a rigid covering shell, and the covering shell can be wrapped to cover the first pressure transmitting surface, the first acting region and the second pressure on the main body member a portion other than the second active area, the covering shell can protect the first pressure transmitting surface, the first acting region, the second pressure transmitting surface, and the second acting region from external force, and can also make the entire bladder
  • the bionic unit is fixed in position.
  • the urine inlet and the urine outlet are respectively connected with a urinary catheter and a urinary catheter, and a urinary catheter joint for connecting the urinary catheter is provided on the urinary catheter.
  • the urinary catheter connector and/or the urinary catheter is provided with a self-sealing region for temperature enthalpy collection and/or urine sputum, and the self-sealing region for temperature enthalpy collection can be sharply entangled.
  • the device is penetrated, the device is automatically sealed after being removed, and the urine is not leaked to pollute the medical staff; the self-sealing region for the urine sample also has the self-sealing function described above.
  • the present invention also provides a urine drainage control device comprising a urine drainage portion, a control portion, and a housing for accommodating a urine drainage portion and a control portion, wherein the urine drainage portion is the above-described urine drainage device;
  • the portion includes a pressure transmitting member and a closing member, the pressure transmitting member being capable of contacting the deformed first pressure transmitting surface and/or the second pressure transmitting surface and being deformed by the first pressure transmitting surface and/or the second pressure transmitting surface Positional movement occurs by the force generated;
  • the closure member is movable with movement of the position of the pressure transmitting member, and the position of the closure member can be applied or eliminated to act on the first active region and/or the second active region The external force thereby blocks or unblocks the communication between the reservoir cavity and the urine outlet.
  • a gap is left between the pressure transmitting member and its corresponding pressure transmitting surface, and the pressure transmitting surface can be tapered until it is deformed as the pressure in the liquid reservoir cavity increases.
  • the purpose of leaving a gap is to ensure that the reservoir cavity has a certain volume, and the pressure transmission surface can Deformation occurs in a reasonable space, and also to prevent adhesion between the diaphragms.
  • the pressure transmitting surface corresponding to the pressure transmitting member refers to a pressure transmitting surface that can be in mechanical relationship with the pressure transmitting member, and may be a first pressure transmitting surface or a second pressure transmitting surface.
  • the corresponding active area can also be the first active area or the second active area.
  • control portion further includes a resistance member that applies a predetermined resistance to the pressure transmitting member and/or the closing member to prevent the corresponding pressure transmitting surface from deforming, and when the corresponding pressure transmitting surface acts on the pressure transmission
  • a resistance member that applies a predetermined resistance to the pressure transmitting member and/or the closing member to prevent the corresponding pressure transmitting surface from deforming, and when the corresponding pressure transmitting surface acts on the pressure transmission
  • the resistance of the resistance member is generated by a spring having one end connected to the housing and the other end connected to the pressure transmitting member or the closing member.
  • the resistance member further includes an adjustment portion that adjusts the resistance member, and the adjustment portion may compress or release the spring of the resistance member to adjust a predetermined resistance applied by the spring to the pressure transmitting member or the closure member.
  • the pressure transmitting member and the closing member are of a unitary structure
  • the control portion further includes a rotating shaft, and the pressure transmitting member moves with a corresponding pressure transmitting surface to change position, the pressure transmitting member and the The closure members are collectively rotated about the axis of rotation such that the closure member applies or eliminates an external force to the respective active region, thereby blocking or unblocking communication between the reservoir cavity and the urine outlet.
  • the pressure transmitting member and the closing member are of a unitary structure
  • the pressure transmitting member is provided with a guiding rod
  • the housing is provided with a socket
  • the guiding rod can be inserted in the direction of the spring expansion and contraction Moving within the hole, the pressure transmitting member and the closing member moving together in the socket when the pressure transmitting member is deformed in position with the corresponding pressure transmitting surface, so that the closing member is applied or eliminated
  • the external force of the active area thereby blocks or unblocks the communication between the reservoir cavity and the urine outlet.
  • the pressure transmitting member and the closing member are in a split design
  • the pressure transmitting member includes a first gear
  • the closing member includes a closing head and a second gear meshing with the first gear
  • the first gear and the second gear are both fixed relative to the housing;
  • the spring is coupled to the pressure transmitting member via a movable shaft, and the pressure transmitting member moves in position as the corresponding pressure transmitting surface deforms.
  • the first gear drives the second gear to rotate,
  • the closing head is used to apply or eliminate an external force to the corresponding action area, thereby blocking or unblocking the communication between the reservoir cavity and the urine outlet.
  • the pressure transmitting member is hinged with the closing member, and when the pressure transmitting member is deformed to move with a corresponding pressure transmitting surface, the closing member is rotated to apply or eliminate an external force to the corresponding acting region. Thereby the communication between the reservoir cavity and the urine outlet is blocked or unblocked.
  • the control portion includes a manual control valve for manually applying or eliminating an external force to the corresponding action region according to parameters such as the magnitude of the pressure transfer surface variable, thereby blocking or unblocking the reservoir cavity and the chamber The connection between the urine outlets is described.
  • the urine drainage control device transmits a force generated by deformation of the pressure transmitting surface to the pressure transmitting member by using a mechanical principle, and causes the pressure transmitting member to drive the closing member to apply or eliminate an external force to the corresponding action region, thereby Blocking or unblocking the communication between the reservoir cavity and the urine outlet.
  • the sealing member acts on a certain external force in the corresponding action area, and blocks the communication between the liquid storage cavity and the urine outlet.
  • the bladder pressure reaches the pressure relief threshold, the force generated by the pressure transmission surface deformation can be triggered.
  • the position of the pressure transmitting member and the closing member is moved, thereby eliminating the external force acting on the active region, the communication between the liquid storage cavity and the urine outlet, and the urine entering the urine storage bag through the urine outlet to complete the pressure relief urination process.
  • the beneficial effect of the device is that when the patient's bladder pressure caused by coughing, turning over, etc. is pseudo-instantly increased, it can act as an instantaneous pressure relief, preventing urine reflux, overflowing urine, etc. caused by an instantaneous increase in intravesical pressure. risk.
  • the urine drainage control device can also simulate the normal physiological urination of the human body under the cooperation of the manual control valve. When the patient feels that there is a urine or a pressure transfer surface variable, the manual control valve can be manually opened for urination, which helps the patient to be trained. The function of the bladder.
  • the invention also provides a urine drainage control system, comprising a urine drainage control part and an electronic control part, wherein the urine drainage control part and the electronic control part are housed in the housing, and the urine drainage control part is the above-mentioned urine drainage control
  • the electronic control part comprises a central controller, an executing component and a pressure sensor for collecting bladder pressure, and the central controller receives the pressure signal output by the pressure sensor, when the pressure is equal to or greater than a urination threshold, and the duration is equal to or greater than a preset
  • the central controller outputs an instruction to communicate the fluid chamber and the urine outlet to the actuator.
  • the urine drainage control system fully considers the special situation of the patient's bladder pressure pseudo-instantaneous rise due to changes in body position, cough, sneezing, bladder spasm, etc., and considers the normal physiological urination of the human body under the effective pressure of the bladder.
  • the situation, the "double insurance" on the urination process not only achieves the function of the patient's bladder training, but also avoids the risks brought by urine reflux, overflow of urine.
  • the electronic control portion controls the reservoir cavity to communicate with the urine outlet, the process simulating the normal physiological urination process of the human body.
  • the mechanical part opens the pressure-relief urination function to avoid the risk of overflowing urine and urine reflux.
  • the purpose of the above setting is to avoid the defect that the general electronic control device cannot solve the risk caused by the instantaneous false increase of the bladder pressure of the patient, and on the other hand, the normal physiological urination of the human body is more accurately simulated.
  • the general electronic control device encounters a false increase in the bladder pressure of the patient, if the urination is turned on, it is equivalent to emptying the urine in the bladder of the patient when the actual pressure of the bladder does not reach the pressure required to urinate, and the human body cannot be simulated realistically.
  • the risk of overflowing urine and urine reflux caused by the sudden increase of pressure cannot be solved.
  • the mechanical device After the mechanical device is added, the instantaneously elevated pressure can drive the pressure due to the mechanical structure.
  • the transmitting part and the closing part are displaced and communicate with the liquid storage cavity and the urine outlet.
  • the pressure sensor collects bladder pressure transmitted by the corresponding pressure transmitting surface, and the actuator applies or eliminates an external force to the corresponding action region, thereby blocking or unblocking the reservoir cavity and The connection between the urine outlets.
  • the pressure transmitting surface corresponding to the pressure sensor refers to a pressure transmitting surface capable of transmitting bladder pressure to the pressure sensor, and may be a first pressure transmitting surface or a second pressure transmitting surface.
  • the corresponding active area can also be the first active area or the second active area.
  • the driving mechanism of the actuator is a motor, a solenoid valve, a gas pump or the like.
  • the executing component further includes a gas cylinder, and the central controller controls the air pump to inflate to the air pressure according to the pressure signal of the pressure sensor, so that the air force exerts an external force on the corresponding action area, Or controlling the gas venting to eliminate external force on the corresponding action area Actuating, thereby blocking or unblocking the communication between the reservoir cavity and the urine outlet.
  • the drainage control device is provided with a positioning card slot
  • the housing covering the urine drainage control system is provided with a positioning boss that cooperates with the positioning card slot, which is more convenient and quick to use.
  • the urine drainage control system further includes a weight sensor for monitoring the weight of urine in the urine storage bag in real time and outputting a signal to the central controller.
  • the urine drainage control system further comprises a display component, an input component, and a data storage component;
  • the display component is connected to the central controller for displaying monitored data and manually set data and a central controller a result of the operation;
  • the input component is coupled to the central controller for setting parameters and/or querying a storage record of the data storage component and an operation result of the central controller;
  • the data storage component for data Output and data input, the data storage component can store the parameters set by the input component, and the urine flow rate curve generated by the central controller according to parameters such as pressure, weight, time, urine density, urine output curve, bladder pressure curve, abdominal cavity Pressure curve, etc., and can transfer the above curve to an external device, and also transmit parameters input on the external device to the central controller;
  • the pressure sensor of the urine drainage control system monitors the bladder pressure in real time and transmits the pressure signal to the central controller. After processing by the central controller, a series of curves and parameters reflecting the bladder function can be obtained, including monitoring the residual urine volume in the bladder. , bladder capacity, bladder capacity during urinary tract, and contractile force of detrusor during urination.
  • the weight sensor can monitor the change of urine weight in the urine storage bag in real time. The weight signal is transmitted to the central controller and processed to obtain the change of urine volume with time, so as to obtain the urine flow rate curve and the urinary curve.
  • the weight sensor and the central controller can also accurately measure the 24-hour urine volume, the urine volume per hour, etc., and display whether the human body is polyuria, oliguria, no urine, according to a preset urine volume analysis value.
  • this urine drainage control system can be used for urodynamic testing of patients, especially for indwelling catheterization patients who are in bed for a long period of time, able to perform bedside urinary power monitoring for patients 24 hours a day, Accurate and dynamic access to the patient's urinary dynamic parameters; no need to insert and remove the catheter multiple times, naturally filling the bladder, reducing patient suffering, reducing the risk of infection, can truly reflect the natural filling physiological state of the bladder.
  • the device is further provided with a moving display component and an external abdominal pressure collecting component, wherein the external abdominal pressure collecting component can collect the abdominal pressure of the human body and transmit the signal of the collecting
  • the central controller is provided with an external connection An interface for connecting the abdominal pressure collecting component
  • the mobile display component is wirelessly connected to the central controller, and configured to display the content displayed by the external abdominal pressure collecting component.
  • the urination pressure relief is started within the pressure relief start time, and the pressure relief time is a preset pressure relief duration.
  • the method further comprises: presetting a urinary threshold and determining time, urinating duration, the urinating threshold is less than the pressure relief threshold; collecting pressure in the bladder; determining whether the pressure is equal to or greater than a preset pressure relief threshold If the result of the judgment is that the pressure is equal to or greater than the preset pressure relief threshold, the urination pressure is started during the pressure relief start time, and the pressure relief time is the preset pressure relief duration; if the judgment result is that the pressure is less than the preset The pressure relief threshold continues to determine whether the pressure is equal to or greater than the urination threshold.
  • the pressure duration is equal to or greater than the determination time, and if the determination result is When the pressure duration is equal to or greater than the determination time, urination is performed, and the urination time is a preset urination duration.
  • the pressure is equal to or greater than a preset urination threshold; if the judgment result is that the pressure is equal to or greater than a preset urination threshold, further determining whether the pressure is equal to or greater than a preset pressure relief threshold, if If the pressure is equal to or greater than the preset pressure relief threshold, the urination pressure is started during the pressure relief start time, and the pressure relief time is a preset pressure relief duration; if the judgment result is that the pressure is equal to or greater than the preset pressure When the urination threshold is less than the pressure relief threshold, it is further determined whether the pressure duration is equal to or greater than the determination time.
  • the judgment result is that the pressure duration is equal to or greater than the determination time, urinating is performed, and the urination time is a preset urination duration. If the result of the judgment is that the pressure is less than the preset urination threshold, continue to collect the pressure in the bladder to judge.
  • the pressure relief duration is less than the duration of urination.
  • the pressure relief start time is a shorter time, and the pressure relief start time is less than the determination time, and in some cases is close to zero, that is, Immediately urinate and release pressure.
  • the above process is cyclical, and when all the judgments are no, the pressure judgment is continued.
  • It is still another object of the present invention to provide a urine drainage control system including a urine inlet connectable to a catheter inserted into a human body, a urine outlet connectable to a urine storage bag, and a urine inlet At least one pressure transmitting surface on at least one region between the urine outlets, the pressure transmitting surface capable of transmitting pressure in the bladder, the urine drainage control system further comprising: a pressure sensor, the pressure sensor is collected by the pressure transmitting surface The pressure in the bladder is generated and a pressure signal is generated for transmission, and the pressure transmitting surface does not necessarily deform, as long as the pressure can be collected by the pressure sensor;
  • the central controller receives the pressure signal outputted by the pressure sensor and determines whether the pressure is equal to or greater than the pressure relief threshold. If the judgment result is yes, the urination pressure is started during the pressure relief start time, and the pressure relief time is If the judgment result is no, continue to determine whether the pressure is equal to or greater than the urination threshold. If the judgment result is yes, further determine whether the pressure duration is equal to or greater than the determination time, and if the judgment result is yes , outputting an instruction to open the urine outlet for urination, and the urination time is a preset urination duration;
  • the central controller receives the pressure signal output by the pressure sensor, and determines whether the pressure is equal to or greater than a preset urination threshold. If the determination result is yes, further determining whether the pressure is equal to or greater than a preset pressure relief threshold, if If the result is yes, the urination pressure is started during the pressure relief start time, and the pressure relief time is the preset pressure relief duration; if the judgment result is no, then it is determined whether the pressure duration is equal to or greater than the determination time, if judging The result is yes, the command to open the urine outlet is output for urination, and the urination time is the preset duration of urination;
  • the executing unit receives an instruction from the central controller to control whether urine flows out of the urine outlet.
  • the above urination method is intended to combine the instantaneous false increase of the patient's bladder pressure with the normal physiological urination of the simulated human body, and all of them are controlled by pressure control and connection control by electronic control, which is more accurate and smaller in product volume than the mechanical structure. The operation is more convenient and so on.
  • the driving mechanism of the actuator is a motor, a solenoid valve, a gas pump or the like.
  • the executing component further includes a gas cylinder, wherein the middle
  • the central controller controls the air pump to inflate to the air vent according to the pressure signal of the pressure sensor, so that an external force is applied to the urine outlet to close the urine outlet; or the bleed air is controlled to eliminate the external force pair.
  • the function of the urine outlet opens the urine outlet.
  • the urine drainage control system further includes a weight sensor for monitoring the weight of urine in the urine storage bag in real time and outputting a weight signal to the central controller.
  • the urine drainage control system further comprises a display component, an input component, and a data storage component; the display component is connected to the central controller for displaying monitored data and manually set data and a central controller a result of the operation; the input component is coupled to the central controller for setting parameters and/or querying a storage record of the data storage component and an operation result of the central controller; the data storage component for data Output and data input, the data storage component can store the parameters set by the input component, and the urine flow rate curve generated by the central controller analysis, the urine output curve, the bladder pressure curve, the abdominal pressure curve, and can transmit the above curve to External device and capable of transmitting parameters entered on the external device to the central controller; to more accurately reflect bladder pressure and perform urodynamic testing, the system further includes a mobile display member and an external abdominal pressure collecting member, the external abdominal pressure The collection component can collect the abdominal pressure of the human body and The signal is input to the central controller, and the central controller is provided with an interface connected to the external abdominal pressure collecting component; the mobile display component is wirelessly connected with
  • the pressure transmitting surface is made of an elastic material that is deformable as a function of pressure within the bladder.
  • the urine drainage control system further includes a control portion including a pressure transmitting member and a closing member, the pressure transmitting member being capable of contacting the pressure transmitting surface and being moved by the force generated by the deformation of the pressure transmitting surface;
  • the closure member is movable with movement of the position of the pressure transmitting member, and when the position of the closure member is moved, it is possible to control whether urine is discharged from the urine.
  • FIG. 1 is a schematic partial half cross-sectional view showing a bladder bionic unit of the urine drainage device of the present invention
  • Figure 2 is a partial enlarged half-sectional view of A in Figure 1;
  • Figure 3 is a schematic exploded view of the bladder bionic unit of the urine drainage device of the present invention
  • Figure 4 is a schematic exploded view of the bladder bionic unit of the urine drainage device of the present invention
  • Figure 5 is a perspective view of the bladder bionic unit of the urine drainage device of the present invention
  • Figure 6 is a perspective view of the bladder bionic unit of the urine drainage device of the present invention 2;
  • Figure 7 is a schematic structural view showing the connection of the urine drainage device and the urine storage bag of the present invention.
  • Figure 8 is a partial enlarged view of B in Figure 7;
  • Figure 9 is a half cross-sectional view showing the whole of the urine drainage control device of the present invention.
  • Figure 10 is a perspective exploded view of the urine drainage control device
  • Figure 11 is a perspective exploded view of the resistance component of the urine drainage control device
  • Figure 12 is a half cross-sectional view showing the state in which the manual control valve of the urine drainage control device is opened;
  • Figure 13 is a half cross-sectional view showing the closed state of the manual control valve of the urine drainage control device
  • Figure 14 is a schematic view showing the structure of the urine drainage control device of the present invention in a closed state 1-1;
  • Figure 15 is a schematic structural view of the urine drainage control device of the present invention in an open state 1-2;
  • Figure 16 is a structural schematic view of the closed state of the urine drainage control device of the present invention 2-1;
  • Figure 17 is a schematic structural view of the urine drainage control device of the present invention in an open state 2-2;
  • Figure 18 is a schematic view showing the structure of the closed state of the urine drainage control device of the present invention 3-1;
  • Figure 19 is a schematic structural view showing the open state of the urine drainage control device of the present invention 3-3;
  • Figure 20 is a structural schematic view of the closed state of the urine drainage control device of the present invention 4-1;
  • Figure 21 is a schematic structural view of the urine drainage control device of the present invention in an open state 4-2;
  • Figure 22 is a schematic structural view of a urine drainage control system of the present invention.
  • Figure 23 is a flow chart showing the urine discharging method of the urine 1-flow control system of the present invention.
  • Figure 24 is a flow chart 1 of the method for urinating bladder function of the present invention.
  • Figure 25 is a flow chart 2 of the method for urinating bladder function according to the present invention.
  • Figure 26 is a schematic view showing the structure of a urine drainage control system for carrying out the urination method shown in Figures 24 and 25; 11 pressure transmitting member, 111 first gear, 12 closing member, 121 closing head, 122 second gear, 13 resistance member, 131 Spring, 132 adjustment part, 132a handle, 132b indexing plate,
  • a urine drainage device includes a urine inlet 31 connectable to a catheter inserted into a human body, and a urine outlet 32.
  • the urine outlet 32 can be connected to a urine storage bag 43 for storing urine. It is also possible to connect other components capable of carrying urine, that is, the urine drainage device has a function of being able to discharge urine in the bladder of the human body.
  • the urine drainage device further includes a bladder bionic unit 2, and the bladder bionic unit 2 includes a body member 21 capable of forming a reservoir cavity 215 for storing urine, and the reservoir cavity 215 is connected through the communication line 216.
  • the urine inlet 31 and the urine outlet 32 block the communication between the reservoir cavity 215 and the urine outlet 32, the urine inlet 31 and the urine outlet 32 are disconnected, and urine cannot be discharged.
  • There are many ways to block such as setting the manual control valve 7.
  • the body member 21 includes a first pressure transmitting surface 211 and a second pressure transmitting surface 213 that are deformable in response to changes in urine pressure in the reservoir cavity 215, the first pressure transmitting surface 211 and the second pressure transmitting
  • the face 213 may be injection molded of an elastic material of polyvinyl chloride, integrally formed with the body member 21, or may be formed by sealingly bonding the body member 21 with a medical adhesive.
  • the connecting line 216a of the connecting liquid chamber 215 and the urine outlet 32 is provided with a first active area 212 and a second active area 214 which can be blocked by an external force.
  • An active region 212 and a second active region 214 may be injection molded from a flexible material polyvinyl chloride, integrally formed with the body member 21, or It is made by sealing the body member 21 with a medical adhesive.
  • the first active region 212 and the second active region 214 are oppositely disposed.
  • the communication between the liquid storage cavity 215 and the urine outlet 32 is Blocked; according to the deformation of the first pressure transmitting surface 211 and/or the second pressure transmitting surface 213, the external force applied to the first active region 212 and/or the second active region 214 can be eliminated, When any external force on the first active region 212 and the second active region 214 is eliminated, the blockage between the reservoir cavity 215 and the urine outlet 32 can be released, and the reservoir cavity 215 is The connection of the urine outlet 32 can be restored.
  • the urine drainage device is provided with the first pressure transmitting surface 211 and the second pressure transmitting surface 213, whether it is manual, electronically controlled or mechanically controlled, the first pressure transmitting surface 211 and/or the The deformation of the second pressure transmitting surface 213 determines whether or not to urinate, thereby achieving the function of assisting the patient to urinate.
  • the artificial control it is possible to judge whether the patient needs to urinate according to the magnitude of the deformation of the pressure transmitting surface, and thus the flexibility is stronger.
  • the urine drainage device of the structure has the advantages of simple structure and suitable for industrial production.
  • the main body member 21 includes two diaphragms, that is, the first diaphragm 21a and the second diaphragm 21b shown in Fig. 4.
  • a first pressure transmitting surface 211 and a first active region 212 are formed on the first diaphragm 21a, and a second pressure transmitting surface 213 and a second acting region 214 are formed on the second diaphragm 21b.
  • the first active region 212 and the second active region 214 are opposite to each other to form a connecting lower pipe 216a.
  • the first pressure transmitting surface 211 and the second pressure transmitting surface 213 are opposed to each other to form the above-mentioned liquid storage cavity 215.
  • the sealing of the two membranes can be achieved by ultrasonic welding or a heat sealing process.
  • the bladder bionic unit 2 further includes a covering shell 22 made of a hard material. As shown in FIGS. 3 and 4, the covering shell 22 is divided into a covering right casing 222 and a bag. Covering the two parts of the left casing 221, the two parts are conformed to the main body part 21, and the main body part 21 is sandwiched therebetween, and the two covering cases can be wrapped to cover the first pressure transmitting surface of the main body part 21 211. A portion other than the first active region 212, the second pressure transmitting surface 213, and the second active region 214.
  • the covering shell 22 is provided with a dew hole 223 for exposing the first pressure transmitting surface 211, the first acting region 212, the second pressure transmitting surface 213, and the second acting region 214 to avoid deformation of the interference pressure transmitting surface and The closure of the active area.
  • the covering casing 22 can better support, position and protect the main body member 21, so that the urine drainage device has a resistance. The ability to destroy a certain external force.
  • the cladding housing 22 can be specifically injection molded from an acrylonitrile-butadiene-styrene material.
  • the connecting lower tube 216a connecting the liquid storage cavity 215 and the urine outlet 32 has an elongated tubular shape
  • the liquid storage cavity 215 has an elliptical shape
  • the first pressure transmitting surface 211 and the second pressure transmitting surface 213 are also Elliptical, the shape design of the pressure transmitting surface can more clearly protrude the deformation of the pressure transmitting surface, and the elongated design of the connecting lower pipe 216a is convenient for being blocked by an external force.
  • the urine inlet 31 and the urine outlet 32 may be connected to the urine line 41 and the urine outlet line 42, respectively, into the catheter.
  • the road 41 is in communication with the catheter
  • the urine line 42 is in communication with the urine bag 43.
  • a manual control valve 7 can be provided on both the urinary line 41 and the urinary line 42 so that the line can be blocked as needed to be blocked.
  • the urinary catheter line 41 is provided with a urinary catheter connector 44 for connecting a urinary catheter, and the urinary catheter connector 44 or the urinary catheter line 41 is provided for temperature collection 45 and/or urine.
  • the self-sealing region of the liquid sample 46 can be penetrated by a sharp temperature collecting needle for the temperature measuring point to contact the urine for temperature collection, and the temperature is ⁇ When the needle set is removed, the insertion position is automatically restored due to the flexible self-sealing area, which has an automatic sealing function to maintain a good seal and prevent urine leakage.
  • the self-sealing region of the urine sample 46 has the technical effect as described above.
  • the present invention also provides a urine drainage control device comprising the above-described urine drainage device, further comprising a control portion.
  • the control portion includes a pressure transmitting member 11 and a closing member 12, both of which may be integrally provided or separately provided.
  • the pressure transmitting member 11 is capable of contacting the deformed first pressure transmitting surface 211 and/or the second pressure transmitting surface 213 and is deformed by the first pressure transmitting surface 211 and/or the second pressure transmitting surface 213 Positional movement occurs; the closure member 12 is movable with the movement of the position of the pressure transmitting member 11, and the position of the closure member 12 can be applied or eliminated to act on the first active region 212 and/or the second active region.
  • the external force on 214 thereby blocks or unblocks the communication between the reservoir cavity 215 and the urine outlet 32.
  • the closure member 12 blocks the communication between the reservoir cavity 215 and the urine outlet 32.
  • the pressure in the bladder rises instantaneously.
  • the pressure transmitting member 11 drives the closing member 12 to move, the closing member 12 eliminates the external force applied to the active region, the liquid storage cavity 215 communicates with the urine outlet 32, and the urine discharges the pressure.
  • the pressure transfer surface shape variable is reduced, the pressure transmitting member 11, the closing member 12 Also correspondingly reset, the closure member 12 continues to apply an external force to the active area to block communication between the reservoir cavity 215 and the urine outlet 32.
  • the selection of the pressure transmitting surface may be the first pressure transmitting surface 211 or the second pressure transmitting surface 213.
  • Another state when the device is initially used, the sealing member 12 applies an external force to the active area to block the communication between the reservoir cavity 215 and the urine outlet 32.
  • the first pressure transmitting surface 211 and/or the second pressure transmitting surface 213 are gradually deformed, and it is determined whether the manual control valve 7 is operated to open the liquid storage cavity 215 and the urine outlet 32 according to the degree of deformation of the pressure transmitting surface. Interconnection.
  • This kind of setting makes it possible to urinate when the urine pressure in the bladder reaches a certain value, thereby training the bladder to sense the filling of the urine in the bladder and complete the urinary reflex, thereby achieving the effect of managing bladder urination activity, and finally achieving spontaneous bladder urination.
  • the manual control valve 7 is located on the urine drainage control device, and includes a rotary handle 71, a valve body 72, a reset member 73, a valve core 74, and a valve housing 75.
  • the working principle is as follows: 71 driving the valve body 72 can push or release the push valve core 74, and then use the valve core 74 to block or unblock the first active region 212 or the second active region 214, blocking the first active region 212 or the second active region
  • the handle 71 rotates the valve body 72 to cause the spool 74 to protrude outside the valve housing 75, as shown in FIG. 13; when the first active region 212 or the second active region 214 is unblocked, the handle 71 rotates the valve body 72.
  • the spool 74 is retracted inside the valve housing 75, and the reset member 73 can help the spool 74 to retract inside the valve housing 75, as shown in FIG.
  • the urine drainage control device uses a mechanical principle to control the pressure relief urination, protects the bladder from damage to achieve the technical effect of preventing backflow and preventing urine overflow, and realizes the function of normal physiological urination according to the pressure in the bladder. It is easy to operate and easy for the patient and the medical staff to operate.
  • a gap is left between the pressure transmitting member 11 and the pressure transmitting surface.
  • the pressure transmitting surface is deformed as the pressure in the liquid reservoir cavity 215 is increased, the gap can be tapered until it is eliminated, that is, the urine in the liquid storage cavity 215.
  • the deformation of the first pressure transmitting surface 211 or the second pressure transmitting surface 213 can satisfy the contact with the pressure transmitting member 11, thereby driving the pressure transmitting member. 11 moves.
  • the control portion of the urine drainage control device further includes a resistance member 13, as shown in Fig. 11, the resistance member 13 is applied to the pressure transmitting member 11 and/or the closing member 12 - predetermined resistance to prevent the corresponding pressure transmitting surface from being deformed,
  • the preset resistance can be set to a human bladder safety pressure value of 40 cmH 2 O, or it can be personalized according to the patient's bladder function.
  • the pressure transmitting member 11 causes the closing member 12 to move in position to release the liquid reservoir 215 and the urine outlet 32.
  • the pressure is released and urination is performed.
  • the resistance of the resistance member 13 is generated by a spring 131, one end of the spring 131 may be connected to the housing 6, and the other end is connected to the pressure transmitting member 11 or the closing member 12, and the spring 131 may be in a pre-compressed state.
  • the deformation of the pressure transmitting surface to the pressure transmitting member 11 can overcome the spring force to drive the pressure transmitting member 11 to move, thereby realizing the opening of the urine drainage device for pressure relief and urination;
  • the resistance member 13 further includes an adjusting portion 132,
  • the adjusting portion 132 includes a handle 132a, an indexing plate 132b, a threaded right housing 132c, and a threaded left housing 132d.
  • the handle 132a drives the threaded right housing 132c to rotate inside the threaded left housing 132d to compress or release the spring 131.
  • the length is adjusted, thereby adjusting the predetermined resistance applied to the pressure transmitting member 11 and/or the closing member 12, and the indexing plate 132b can display the adjusted value of the predetermined resistance.
  • the pressure transmitting member 11 and the closing member 12 are integrally formed and integrally molded; the control portion further includes a rotating shaft 15, and the pressure transmitting member 11 moves when the first pressure transmitting surface 211 is deformed.
  • the pressure transmitting member 11 and the closing member 12 are rotatable together about the rotating shaft 15.
  • the pressure transmitting member 11 since the urine in the bladder is not much, and the resistance value of the resistance member 13 is not reached, the pressure transmitting member 11 does not move in position, and the closing member 12 continues to apply an external force to the first action region 212, and the urine cannot be removed from the urine.
  • the reservoir cavity 215 flows out through the urine outlet 32. As shown in Fig.
  • the pressure transmitting member 11 and the closing member 12 may also be of a split structure, and the two may be relatively fixed.
  • the pressure transmitting member 11 may further be provided with a limiting member 14, which may be a part of the pressure transmitting member 11, for restricting the displacement of the pressure transmitting member 11 within a certain range or positioning after the displacement of the pressure transmitting member 11 The position causes the closure member 12 to release the closure of the first active region 212 for a period of time.
  • a limiting member 14 which may be a part of the pressure transmitting member 11, for restricting the displacement of the pressure transmitting member 11 within a certain range or positioning after the displacement of the pressure transmitting member 11 The position causes the closure member 12 to release the closure of the first active region 212 for a period of time.
  • the pressure transmitting member 11 and the closing member 12 are of a unitary structure; the pressure transmitting member 11 is provided with a guiding rod, and the housing 6 is provided with a socket, and the guiding rod can extend along the direction of the spring 131 Move inside the jack.
  • the guide rods and the insertion holes are mainly used to define the moving directions of the pressure transmitting member 11 and the closing member 12 so that they can only move in the telescopic direction of the spring 131. As shown in Fig.
  • a guide rod is respectively disposed at both ends of the pressure transmitting member 11, in fact, one or more guide rods are possible; the spring 131 is disposed in parallel with the guide rod, and the guide rod can only follow the spring 131 Move in the telescopic direction.
  • the guide rod is substantially perpendicular to the pressure transmitting member 11, and when the spring 131 is extended, the pressure transmitting member 11 is pressed against the first pressure transmitting surface 211. At this time, the closing member 12 is pressed against the first acting region 212, and the liquid is stored. The communication between the cavity 215 and the urine outlet 32 is blocked.
  • the closing member 12 gradually moves away from the first acting region 212, thereby releasing the blockage and achieving pressure relief and urination.
  • the spring 131 is reset and returns to the blocked state.
  • the pressure transmitting member 11 includes a first gear 111
  • the closing member 12 includes a closing head 121 and a second gear 122 that meshes with the first gear 111.
  • the first gear 111 and the second gear 122 are both opposite to the housing.
  • the spring 131 and the pressure transmitting member 11 are connected by a movable shaft, and the pressure transmitting member 11 includes a contact plate that can be in contact with the first pressure transmitting surface 211, and the contact plate is fixed to the first gear 111, and when the contact disk moves, the first A gear 111 rotates, the first gear 111 drives the second gear 122 to rotate, and when the second gear 122 rotates, the closing head 121 can be moved to release the communication between the liquid storage cavity 215 and the urine outlet 32, thereby achieving pressure relief and urination. . As shown in Fig. 19, after the pressure is released, the spring 131 is reset and returned to the blocked state.
  • the pressure transmitting member 11 is hinged to the closing member 12, and when the pressure transmitting member 11 is deformed to move in position as the first pressure transmitting surface 211 is deformed, the closing member 12 is rotated to block or unblock the reservoir cavity 215.
  • the communication with the urine outlet 32, that is, the pressure transmitting member 11 and the closing member 12 form a link mechanism, thereby achieving linkage.
  • the pressure transmitting member 11 is bent
  • the lever includes a linkage section and a contact section for contacting the first pressure transmitting surface 211; the closure member 12 is also a bent lever including a linkage section and a closed section for applying an external force to the first active area 212.
  • the interlocking sections of the pressure transmitting member 11 and the closing member 12 are in contact with each other and lifted up; when the contact section of the pressure transmitting member 11 is moved and lifted, the closed section of the closing member 12 is also lifted, thereby unblocking the liquid storage.
  • the cavity 215 is in communication with the urine outlet 32. As shown in Fig. 21, after the pressure is released and the urine is urination, the spring 131 is reset and returns to the blocked state.
  • a positioning boss can be disposed on the casing 6 of the urine drainage control device, and a positioning card groove matching the positioning boss is disposed on the covering casing 22 of the urine drainage device. This type of arrangement simply makes the urine drainage device easier to install, quicker, and easier to disassemble.
  • the present invention also provides a urine drainage control system, as shown in FIG. 22, comprising: a urine drainage control portion and an electronic control portion, wherein the urine drainage control portion is the urine drainage control device of the above embodiment, the pressure transmission member 11 and the closing member 12 respectively act on the first pressure transmitting surface 211 and the first acting region 212.
  • the electronic control portion includes a central controller 52, an operating component 53 and a pressure sensor 51 that monitors the bladder pressure.
  • the central controller 52 receives the pressure signal output by the pressure sensor 51 when the bladder pressure is equal to or greater than the urination threshold and the duration is equal to or When the determination time is greater than the determination time, the central controller 52 outputs an instruction to communicate the reservoir cavity 215 and the urine outlet 32 to the actuator 53; the pressure sensor 51 and the actuator 53 act on the second pressure transmitting surface 213 and the second active region 214, respectively. on.
  • the urine drainage control system further includes a weight sensor 54, a display member 55, an input member 56, a data storage member 57, a moving display member 58, and an external abdominal pressure collecting member 59.
  • the weight sensor 54 is used to monitor the weight of urine in the urine storage bag 43 in real time and to transmit a weight signal to the central controller 52.
  • the weight sensor 54 is connected to the hook 431 of the urine bag 43.
  • the central controller 52 can issue a warning signal to replace the urine bag 43, and the central controller 52 can according to the weight signal and the urination time.
  • the urine specific gravity and other parameters are used to draw a series of curves reflecting the bladder function, such as the urine flow rate curve, the urine output curve, and the weight change curve.
  • the display unit 55 is coupled to the central controller 52 for displaying monitored data and manually set data and operational results of the central controller 52; the input unit 56 is coupled to the central controller 52 for setting parameters and/or Or querying the storage record of the data storage unit 57 and the operation result of the central controller 52; the data storage unit 57 for outputting data and inputting data, the data storage unit 57 being capable of storing parameters set by the input unit 56, and Central control
  • the controller 52 analyzes the generated urine flow rate curve, the urine output curve, the bladder pressure curve, the abdominal pressure curve, and transmits the above curve to the external device, and can also transmit the parameters entered on the external device to the central controller 52; the external device
  • the abdominal pressure collecting member 59 can collect the abdominal pressure of the human body and send the collecting signal to the central controller 52.
  • the central controller 52 is provided with an interface connected with the external abdominal pressure collecting member 59.
  • the moving display member The wireless controller is connected to the central controller 52 for displaying the content displayed by the external abdominal pressure collecting unit 59.
  • the system can be powered by a battery or a fixed power source.
  • the workflow of the above urine drainage control system is as shown in FIG. 23.
  • the pressure sensor 51 monitors that the bladder pressure transmitted by the second pressure transmitting surface 213 is equal to or greater than the urination threshold, and the duration is equal to or greater than the determination time
  • the central controller 52 An instruction is issued to the actuator member 53, the actuator 53 eliminates the external force acting on the second action region 214, and the reservoir cavity 215 communicates with the urine outlet 32.
  • the bionic person normally urinates normally, and the urination time is a preset duration of urination.
  • the urination threshold can be set to a normal human bladder urination threshold of about 20 cm 3 ⁇ 4 O, and the threshold value can also be set according to the bladder function state of the patient; the determination time is a time set according to the bladder function state of the patient, and can generally be set to 10 seconds.
  • the preset urination duration is also set according to the patient's bladder function status, and can generally be set to any value between 10 seconds and 300 seconds, or personalized according to the patient's needs.
  • the first pressure transmitting surface 211 of the urine drainage control portion of the urine drainage control system is deformed, causing the pressure transmitting member 11 to drive the closing member 12 to eliminate application to the first active region 212.
  • the external force connects the liquid storage cavity 215 and the urine outlet 32, and the urine enters the urine storage bag 43 through the urine outlet 32, which acts as an instantaneous pressure relief. After the pressure is lowered, the liquid storage cavity 215 and The urine outlet 32 is reconnected and blocked.
  • the urine drainage control system is equivalent to the combination of electrical control and mechanical control.
  • the electronic control part can use normal urination which simulates the physiological function of the human body, and on the other hand, the mechanical part is used to prevent the pseudo-initial rise of the pressure inside the bladder. The risk of urinary reflux and overflow of urine.
  • the above-mentioned actuator member 53 includes an air pump and a gas cylinder, and the air cylinder can apply an external force to the second action region 214 to block the communication between the liquid reservoir cavity 215 and the urine outlet 32, and can also perform a control signal venting from the central controller 52.
  • the air pump inflates the air sputum, restoring the communication between the sump cavity 215 and the urine outlet 32.
  • a urination method for protecting bladder function as shown in Figs. 24 and 25: preset pressure relief threshold, urinary threshold and pressure relief duration, urination duration, determination time, pressure relief start time, the pressure relief threshold can be set
  • the safe pressure value for the bladder is 40cmH 2 O, or it is set to any value between the safe pressure value of the bladder and the urinary threshold.
  • the pressure relief threshold can effectively protect the bladder from damage, it is also based on the individual bladder function.
  • the pressure relief threshold may be set to a value higher than the bladder safety pressure value of 40 cm 3 ⁇ 4 O; the pressure relief duration is a time set according to the patient's bladder function condition, such as may be set to about 3 seconds; the urination threshold is based on
  • the threshold value of the patient's bladder function status setting can be generally set to about 20 cmH 2 O; the determination time is also set according to the time of the patient's bladder function status, for example, it can be set to about 10 seconds; the preset urination duration is The time set according to the patient's bladder function can be set to any value between 10 seconds and 300 seconds, or personalized according to the patient's needs. .
  • the urinary threshold is less than the pressure relief threshold, and the pressure relief duration is less than the urination duration; the specific method is: first collecting the pressure in the bladder to determine whether the pressure is equal to or greater than a preset pressure relief threshold;
  • the urination pressure relief is started during the pressure relief start time, and the pressure relief time is a preset pressure relief duration;
  • Figure 26 is a urine drainage control system for carrying out the urination method shown in Figures 24 and 25, the urine drainage control system comprising: a urine inlet 31 connectable to a catheter inserted into the human body and capable of storing urine
  • the urine outlet port 32 is connected to the urine outlet 32, and a pressure transmitting surface is provided on an area between the urine inlet 31 and the urine outlet 32.
  • the pressure transmitting surface can transmit the pressure in the bladder.
  • the urine drainage control system further includes:
  • the pressure sensor 51 collects the bladder pressure through the pressure transmitting surface, and generates a pressure signal for transmission;
  • the central controller 52 receives the pressure signal outputted by the pressure sensor 51 and determines whether the pressure is equal to or greater than the pressure relief threshold. If the determination result is yes, the urination pressure relief is started during the pressure relief start time, and the pressure is released. The time is the preset pressure relief duration. If the judgment result is no, continue to determine whether the pressure is equal to or greater than the urination threshold.
  • the determination result is yes, further determine whether the pressure duration is equal to or greater than the determination time, if it is determined As a result, the command to open the urine outlet 32 is performed to perform urination, and the urination time is a preset urination duration; or the central controller 52 receives the pressure signal output from the pressure sensor 51, and determines whether the pressure is equal to or greater than The preset urination threshold, if the judgment result is yes, further determine whether the pressure is equal to or greater than a preset pressure relief threshold.
  • the urination pressure relief is started during the pressure relief start time, and the pressure relief time is The preset pressure relief duration; if the judgment result is no, continue to judge the pressure duration Whether it is equal to or greater than the determination time, if the judgment result is yes, the instruction to open the urine outlet 32 is output for urination, and the urination time is the preset urination duration; the executing unit 53 receives the instruction output by the central controller 52, and controls the urine. Whether the liquid is taken out from the urine outlet 32.
  • the driving mechanism of the executing component 53 is an air pump, and the executing component 53 further includes a gas cylinder, and the central controller 52 controls the air pump to inflate to the gas according to the pressure signal of the pressure sensor 51. ⁇ , so that an external force is applied to the urine outlet 32 to close the urine outlet 32; or the gas venting is controlled to eliminate the external force acting on the urine outlet 32, and the urine outlet 32 is opened. .
  • the urine drainage control system further includes a weight sensor 54, a display member 55, an input member 56, a data storage member 57, a moving display member 58, and an external abdominal pressure collecting member 59.
  • the weight sensor 54 is used to monitor the weight of the urine in the urine storage bag 43 in real time and to transmit the weight signal to the central controller 52.
  • the central controller 52 can issue a warning signal to replace the urine storage bag 43, and the central controller 52 can draw a urine flow rate curve and a urine output according to parameters such as weight signal, urination time, and urine specific gravity. Curves, weight change curves, etc. reflect a series of curves of bladder function.
  • the display unit 55 is coupled to the central controller 52 for displaying monitored data and manually set data and operational results of the central controller 52; the input unit 56 is coupled to the central controller 52 for setting parameters and/or Or querying the storage record of the data storage unit 57 and the operation result of the central controller 52; the data storage unit 57 for outputting data and inputting data, the data storage unit 57 being capable of storing parameters set by the input unit 56, and
  • the central controller 52 analyzes the generated urine flow rate curve, the urine output curve, the bladder pressure curve, the abdominal pressure curve, and can transmit the above curve to an external device, and can also transmit the parameters entered on the external device to the central controller 52;
  • the external abdominal pressure collecting component 59 can collect the abdominal pressure of the human body and input the signal to the central controller 52.
  • the mobile display component 58 is wirelessly connected to the central controller 52 for displaying the external abdominal cavity. The contents displayed by the pressure collecting unit 59.
  • the system can be powered by a battery or a fixed power source.
  • the pressure-transfer surface of the urinary bow] flow control system is made of an elastic material that deforms as the pressure within the bladder changes.
  • the urine drainage control system further includes a control portion including a pressure transmitting member 11 and a closing member 12, the pressure transmitting member 11 being capable of coming into contact with the pressure transmitting surface and being caused by a force generated by deformation of the pressure transmitting surface Positional movement;
  • the closure member 12 is movable with the movement of the position of the pressure transmitting member 11, and when the position of the closure member 12 is moved, it is possible to control whether urine flows out of the urine outlet 32.
  • the urine drainage device, the urine drainage control device, the urination method for protecting the bladder function, and the urine flow 1 flow control system provided by the present invention are all described in detail above.
  • the principle and embodiment of the present invention are described in the following by using specific examples, and the description of the above embodiments It is only used to help understand the method of the present invention and its core ideas. It should be noted that those skilled in the art can make various modifications and changes to the present invention without departing from the spirit and scope of the invention.

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Abstract

一种尿液引流装置、引流控制装置、引流控制系统及排尿方法。其中，尿液引流装置包括尿液入口（31）、尿液出口（32）和膀胱仿生单元（2），膀胱仿生单元（2）包括形成贮液空腔（215）的主体部件（21），贮液空腔（215）通过连接管路（216）与尿液入口（31）、尿液出口（32）连通，还包括随贮液空腔（215）内尿液压力变化发生形变的第一压力传递面（211）和第二压力传递面（213），连接下管路（216a）上设有可被外力作用的第一作用区域（212）和第二作用区域（214）；两个作用区域（212，214）同时受外力作用时，贮液空腔（215）与尿液出口（32）被阻断；当作用区域上任意一个（212，214）外力被消除时，贮液空腔（215）与尿液出口（32）连通。该尿液引流装置贮液空腔（215）内尿液压力变化可通过压力传递面（211，213）的形变体现，进而根据压力传递面（211，213）的形变量决定是否导通排尿，从而实现辅助患者排尿的功能，且结构简单，适合规模化生产。

Description

尿液引流装置、 引流控制装置、 引流控制系统及排尿方法
本申请要求于 2011 年 12 月 31 日提交中国专利局、 申请号为 201110457491.9、发明名称为"一种尿液引流及其控制装置"，以及同日申请 的申请号为 201120571031.4、 发明名称为 "一种尿液引流及其控制装置" 的中国专利申请的优先权， 其全部内容通过引用结合在本申请中。 技术领域
本发明涉及医疗器械技术领域， 特别涉及一种尿液引流装置、 引流控 制装置、 引流控制系统及排尿方法。
背景技术
临床上有许多因脑血管、 脊髓血管疾病引发的截瘫、 偏瘫患者， 以及 膀胱造瘘的患者、 昏迷患者、 高位截瘫患者等， 他们大部分伴有排尿方面 的障碍， 而留置导尿成为解决上述患者排尿障碍的常用手段。
传统留置导尿使用的导尿装置由插入尿道的导尿管和导尿管下端连接 的尿袋组成。 导尿管持续不断的将膀胱内的尿液导出， 导致膀胱内无法形 成正常的膀胱内压， 患者的逼尿肌和膀胱内括约肌长时间处于废用状态， 无法利用低压储尿和低压排尿的控尿原理保护整个尿路系统， 长期使用这 种结构的导尿管会产生以下几个风险：
1.导尿管持续引流使患者膀胱长时间缺乏充盈状态， 容易导致膀胱壁 粘连；
2.导尿管持续引流使膀胱与外界压力梯度减小， 为了保证引流通畅常 常需增大管壁外径、 硬度等， 导致患者尿道粘膜受压并发生缺血性损伤；
3.导尿管持续引流使膀胱的神经感受器产生适应性改变， 不能感知膀 胱内尿液充盈并完成排尿反射， 发生尿潴留。
由于传统导尿装置存在的上述风险， 医疗器械研发人员开发了多种导 尿类医疗器械， 通过设定预设压力， 利用压力传感器釆集膀胱压力， 当膀 胱压力持续达到或超过预设压力时， 再次判断该压力的持续时间是否等于 或大于预设时间， 若持续时间等于或大于预设时间时， 控制部件报警提示 排尿或自动开启排尿， 尿液排放完毕后自动关闭导尿管路。 此过程模拟人 体正常生理排尿， 避免传统导尿方式留置导尿管持续排尿引起的膀胱功能 丧失， 在一定程度上实现了模拟人体生理周期性排尿的目的。 上述预设时 间设置的目的在于防止患者由于体位变化、 咳嗽、 打喷嚏、 膀胱痉挛等因 素引发膀胱压力假性瞬间升高， 而膀胱实际压力未达到预设压力时自动开 启排尿将膀胱排空，从而无法实现模拟人体生理周期性排尿的目的。 然而， 上述装置并未对患者膀胱压力假性瞬间升高的特殊情况作出正确的处理， 由于膀胱产生的瞬间假性高压持续时间短， 不足以达到预设时间， 控制部 件不报警提示排尿或自动开启排尿， 导尿管路仍旧处于关闭状态， 膀胱高 压会将尿液推向肾脏方向， 使尿液逆向流动， 甚至进入肾盂， 引发输尿管、 肾盂等细菌感染； 另外， 膀胱高压还能使尿液溢出到导尿管和尿道之间的 间隙内， 形成溢尿， 导尿管与尿道之间的尿液会成为细菌、 病毒的培养基， 细菌、 病毒更会逆向进入膀胱内部， 造成更大的感染风险。
综上， 对于膀胱压力假性瞬间升高导致的尿液返流和溢尿的风险及膀 胱压力假性瞬间升高与模拟人体生理排尿的矛盾， 现有产品均没有公开任 何技术方案加以解决， 在实际临床治疗中也一直存在返流和溢尿的现象， 当前产品已经不能满足患者安全导尿的需求， 医疗器械研发人员需要寻求 一种能够安全保护尿路系统，并实现模拟人体生理排尿的导尿类医疗器械。
另外， 尿动力学检查也是临床常用的检查项目， 进行尿动力学测试的 留置导尿患者需到专门的尿动力测试室进行检查， 首先将留置在尿道内的 导尿管拔出、 插入测压管、 人工充盈膀胱， 进行检查， 检查完成后， 再次 插入导尿管。 这给患者带来了极大的痛苦， 加重了患者医疗负担， 并增加 了感染风险。并且现有尿动力学检查无法对尿动力相关参数进行实时监测， 也无法反映膀胱自然充盈的生理状态， 更无法实现个性化的仿生学尿液引 流， 尤其对于长期卧床的留置导尿患者极为不便， 目前尚未发现能够对留 置导尿患者进行实时尿动力检查的装置的报道。
发明内容
本发明的目的在于提供一种尿液引流装置， 包括能够与插入人体的导 尿管连接的尿液入口和能够与贮存尿液的贮尿袋连接的尿液出口， 所述尿 液引流装置还包括膀胱仿生单元， 膀胱仿生单元包括能够形成贮存尿液的 贮液空腔的主体部件， 所述贮液空腔通过连接管路与所述尿液入口和所述 尿液出口连通， 主体部件包括能够随所述贮液空腔内尿液压力变化发生形 变的第一压力传递面和第二压力传递面， 连通贮液空腔与尿液出口的连接 管路为连接下管路,所述连接下管路上设有可被外力作用第一作用区域和 第二作用区域， 第一作用区域和第二作用区域相对设置； 当第一作用区域 和第二作用区域同时受外力作用时， 所述贮液空腔与尿液出口之间的连通 被阻断； 根据所述第一压力传递面和 /或第二压力传递面的形变， 可消除施 加在所述第一作用区域和 /或第二作用区域的外力， 当作用于第一作用区域 和第二作用区域上的任意一个外力被消除时， 所述贮液空腔与尿液出口之 间的阻断可被解除， 所述贮液空腔与所述尿液出口的连通即可恢复。 当第 一压力传递面与第二压力传递面功能相同时， 可根据实际需要选择使用第 一或第二压力传递面； 同样， 当第一作用区域与第二作用区域功能作用相 同时， 也可根据实际需要选择使用第一或第二作用区域。 所述主体部件上 形成有贮存尿液的贮液空腔， 该贮液空腔通过导尿管与人体膀胱相连通， 当二者处于同一水平位置时， 人体膀胱内的尿液压力与贮液空腔内的尿液 压力一致， 当二者处于不同的水平位置时， 人体膀胱内的尿液压力与贮液 空腔内的尿液压力可根据高度差换算得出， 因此釆集贮液空腔内的尿液压 力变化可直接得出人体膀胱内的尿液压力变化。
该尿液 ^ 1流装置贮液空腔内尿液压力变化可通过压力传递面的形变体 现， 进而根据压力传递面的形变量决定是否导通排尿， 从而实现辅助患者 排尿的功能。 人工方式控制时， 可以根据压力传递面的形变量大小和患者 是否有尿意， 手动为患者进行排尿， 具有较高的灵活性； 机械控制和电控 可以参考下述实施例得以理解。 另外， 该结构的尿液引流装置结构简单， 适合规模化生产。
优选地， 第一作用区域与第二作用区域相对设置， 且二者相扣合时形 成连接下管路， 消除作用在任一作用区域上的外力都可以形成所述贮液空 腔与尿液出口连通所需要的截面积， 当然， 作用在第一作用区域与第二作 用区域上的外力全部被消除时， 贮液空腔与尿液出口的连通更为通畅。
优选地， 所述主体部件包括两膜片， 一所述膜片上形成有第一压力传 递面、 第一作用区域， 另一所述膜片上形成有第二压力传递面、 第二作用 区域， 两所述膜片扣合并封固， 所述第一压力传递面和所述第二压力传递 面相对设置形成的内部空腔为所述贮液空腔。
优选地， 所述第一压力传递面、 第二压力传递面由弹性材料制成， 所 述第一作用区域、 第二作用区域由柔性材料制成， 当然， 所述第一压力传 递面、 第二压力传递面、 第一作用区域、 第二作用区域可由一种具有弹性 的柔性材料制成。
优选地， 所述膀胱仿生单元还包括硬质的包覆壳体， 所述包覆壳体扣 合后能够包覆所述主体部件上除第一压力传递面、 第一作用区域、 第二压 力传递面、 第二作用区域以外的部分， 该包覆壳体可以保护上述第一压力 传递面、 第一作用区域、 第二压力传递面、 第二作用区域不受外力破坏， 还可以使整个膀胱仿生单元位置固定。
优选地， 所述尿液入口和所述尿液出口分别连接有入尿管路和出尿管 路，入尿管路上设有用于连接导尿管的导尿管接头。 所述导尿管接头和 /或 入尿管路上设有用于温度釆集和 /或尿液釆样的可自密封区域， 所述用于温 度釆集的可自密封区域可以被尖锐的温度釆集装置穿透， 釆集装置拔除后 可自动密封， 尿液不泄露污染医护人员； 所述用于尿液釆样的可自密封区 域同样具有上述自密封功能。
本发明还提供一种尿液引流控制装置， 包括尿液引流部分， 控制部分 以及容纳尿液引流部分和控制部分的壳体， 所述尿液引流部分为上述的尿 液引流装置； 所述控制部分包括压力传递部件和封闭部件， 所述压力传递 部件能够与发生形变的第一压力传递面和 /或第二压力传递面相接触， 并受 第一压力传递面和 /或第二压力传递面形变产生的力的作用而发生位置移 动； 所述封闭部件能够随压力传递部件位置的移动而移动， 封闭部件位置 移动时能够施加或消除作用于所述第一作用区域和 /或第二作用区域上的 外力， 由此阻断或解除阻断所述贮液空腔与尿液出口之间的连通。
优选地， 所述压力传递部件与其相对应的压力传递面之间留有间隙， 所述压力传递面随贮液空腔内压力增大而形变时， 该间隙能够渐缩直至消 除。 留有间隙的目的在于保证贮液空腔有一定的体积， 压力传递面能够在 合理的空间内发生形变， 同时也为了防止膜片之间的粘连。 与压力传递部 件相对应的压力传递面是指能够与压力传递部件相互发生力学关系的压力 传递面， 可以是第一压力传递面， 也可以是第二压力传递面。 当然， 相应 的作用区域也可以是第一作用区域或第二作用区域。
优选地， 所述控制部分还包括阻力部件， 所述阻力部件施加于压力传 递部件和 /或封闭部件一预定阻力以阻止相对应的压力传递面形变， 当相对 应的压力传递面作用于压力传递部件或封闭部件上的力大于该预定阻力 时， 压力传递部件带动封闭部件发生位置移动。 所述阻力部件的阻力由弹 簧产生， 所述弹簧的一端连接所述壳体， 另一端连接所述压力传递部件或 所述封闭部件。
优选地， 阻力部件还包括调节阻力部件的调节部分， 该调节部分可以 对上述阻力部件的弹簧压缩或放开， 从而调节弹簧对所述压力传递部件或 所述封闭部件施加的预定阻力。
优选地， 所述压力传递部件和所述封闭部件为一体式结构， 控制部分 还包括旋转轴， 所述压力传递部件随相对应的压力传递面形变而位置移动 时， 所述压力传递部件和所述封闭部件共同绕所述旋转轴转动， 以使所述 封闭部件施加或消除对相应作用区域的外力， 由此阻断或解除阻断所述贮 液空腔与尿液出口之间的连通。
优选地， 所述压力传递部件和所述封闭部件为一体式结构， 所述压力 传递部件上设有导杆， 所述壳体上设有插孔， 所述导杆能够沿弹簧伸缩方 向在插孔内移动， 所述压力传递部件随相对应的压力传递面形变而位置移 动时， 所述压力传递部件和所述封闭部件共同在插孔内移动， 以使所述封 闭部件施加或消除对相应作用区域的外力， 由此阻断或解除阻断所述贮液 空腔与尿液出口之间的连通。
优选地， 所述压力传递部件和所述封闭部件为分体式设计， 所述压力 传递部件包括第一齿轮， 所述封闭部件包括封闭头以及与所述第一齿轮啮 合的第二齿轮， 所述第一齿轮和所述第二齿轮均相对于所述壳体固定； 所 述弹簧与所述压力传递部件通过活动轴连接， 所述压力传递部件随相对应 的压力传递面形变而位置移动时， 所述第一齿轮驱动所述第二齿轮转动， 以带动所述封闭头施加或消除对相应作用区域的外力， 由此阻断或解除阻 断所述贮液空腔与尿液出口之间的连通。
优选地， 所述压力传递部件与所述封闭部件铰接， 所述压力传递部件 随相对应的压力传递面形变而位置移动时， 带动所述封闭部件转动， 施加 或消除对相应作用区域的外力， 由此阻断或解除阻断所述贮液空腔与尿液 出口之间的连通。 优选地， 所述控制部分包括手动控制阀， 以便根据压力传递面形变量 大小等参数， 手动施加或消除对相应作用区域的外力， 由此阻断或解除阻 断所述贮液空腔和所述尿液出口之间的连通。
该尿液引流控制装置釆用机械原理， 将压力传递面形变产生的力传递 至压力传递部件， 并使所述压力传递部件带动所述封闭部件， 施加或消除 对相应作用区域的外力， 由此阻断或解除阻断所述贮液空腔与尿液出口之 间的连通。 该装置初始使用时， 封闭部件作用在相应作用区域一定外力， 并阻断贮液空腔和尿液出口之间的连通， 当膀胱压力达到泄压阈值时， 压 力传递面形变产生的力能够引发压力传递部件和封闭部件的位置移动， 由 此消除作用在作用区域的外力， 贮液空腔和尿液出口之间连通， 尿液通过 尿液出口进入贮尿袋， 完成泄压排尿过程。 此装置有益效果在于， 当患者 咳嗽、翻身等引起的膀胱压力假性瞬间升高时， 能够起到瞬间泄压的作用， 防止膀胱内压力瞬间升高而导致的尿液返流、 溢尿等风险。 该尿液引流控 制装置在手动控制阀的配合下还可以模拟人体正常生理排尿， 当患者感觉 有尿意或压力传递面形变量较大时， 可手动开启手动控制阀进行排尿， 有 助于训练患者的膀胱功能。
本发明还提供一种尿液引流控制系统， 包括尿液引流控制部分和电控 部分， 尿液引流控制部分和电控部分容纳于壳体内， 所述尿液引流控制部 分为上述尿液引流控制装置， 所述电控部分包括中央控制器、 执行部件以 及釆集膀胱压力的压力传感器， 中央控制器接收压力传感器输出的压力信 号， 当压力等于或大于排尿阈值， 且持续时间等于或大于预设的判定时间 时， 所述中央控制器输出连通所述贮液空腔和所述尿液出口的指令至所述 执行部件。 该尿液引流控制系统充分考虑了患者由于体位变化、 咳嗽、 打喷嚏、 膀胱痉挛等因素引发的患者膀胱压力假性瞬间升高的特殊情况， 同时考虑 了患者膀胱达到有效压力下人体正常生理排尿的情况，对排尿过程上了"双 保险"， 不仅实现了患者膀胱训练的功能， 也避免了尿液返流、 溢尿等带来 的风险。 当患者膀胱压力等于或大于预设的排尿阈值， 并且持续时间等于 或大于判定时间时， 电控部分控制所述贮液空腔和所述尿液出口连通， 此 过程模拟了人体正常生理排尿过程， 有利于患者膀胱功能的恢复； 当遇到 患者膀胱压力假性瞬间升高的特殊情况时，由机械部分开启泄压排尿功能， 避免患者出现溢尿和尿液返流的风险。 上述设置的目的一方面避免一般电 控装置无法解决患者膀胱压力瞬间假性升高导致风险的缺陷， 另一方面更 加精确的模拟了人体正常生理排尿。 由于一般电控装置当遇到患者膀胱压 力瞬间假性升高时， 若开启排尿， 相当于在膀胱实际压力未达到需要排尿 的压力时即排空患者膀胱内的尿液， 不能真实的模拟人体正常生理排尿过 程， 若不开启排尿， 就无法解决压力瞬间升高带来的溢尿和尿液返流的风 险； 增加了机械装置后， 由于机械结构的特点， 瞬间升高的压力能够驱使 压力传递部件和封闭部件发生位移并将贮液空腔和尿液出口连通， 随着压 力快速下降， 压力传递面形变量减小， 压力传递部件和封闭部件位移量也 随之减小， 封闭部件重新对相应作用区域施加外力， 将贮液空腔和尿液出 口之间的连通阻断， 有效的避免了溢尿和尿液返流的风险。
优选地，所述压力传感器釆集所述相对应压力传递面传递的膀胱压力， 所述执行部件施加或消除对相应作用区域的外力， 由此阻断或解除阻断所 述贮液空腔和尿液出口之间的连通。 与压力传感器相对应的压力传递面是 指能够给压力传感器传递膀胱压力的压力传递面，可以是第一压力传递面， 也可以是第二压力传递面。 当然， 相应的作用区域也可以是第一作用区域 或第二作用区域。
优选地， 所述执行部件的驱动机构为电机、 电磁阀、 气泵等。 在利用 气泵作为执行部件的驱动机构时， 所述执行部件还包括气嚢， 中央控制器 根据所述压力传感器的压力信号控制气泵充气至气嚢， 以使气嚢施加外力 作用于相应作用区域， 或控制所述气嚢放气以消除外力对相应作用区域的 作用， 由此阻断或解除阻断所述贮液空腔和尿液出口之间的连通。
优选地， 所述引流控制装置上设有定位卡槽， 包覆所述尿液引流控制 系统的壳体设有与所述定位卡槽配合的定位凸台， 使用时更加方便快捷。
优选地， 所述尿液引流控制系统还包括重量传感器， 该重量传感器用 于实时监测贮尿袋内尿液的重量并输出信号至所述中央控制器。
优选地， 所述尿液引流控制系统还包括显示部件、 输入部件、 数据存 储部件； 所述显示部件与所述中央控制器连接， 用于显示监测的数据和人 工设定的数据以及中央控制器的运算结果； 所述输入部件与所述中央控制 器连接，用于设置参数和 /或查询所述数据存储部件的储存记录以及中央控 制器的运算结果； 所述数据存储部件， 用于数据的输出和数据的输入， 该 数据存储部件能够存储输入部件设置的参数， 以及中央控制器根据压力、 重量、 时间、 尿密度等参数分析生成的尿流率曲线、 排尿量曲线、 膀胱压 力曲线、 腹腔压力曲线等， 并可将上述曲线移动传输至外部设备， 同时还 能够传输外部设备上录入的参数至中央控制器；
尿液引流控制系统的压力传感器可以实时监测膀胱压力， 并将压力信 号传输至中央控制器， 经中央控制器处理后能够得到反映膀胱功能的一系 列曲线和参数， 包括监测膀胱内的残余尿量、 膀胱容量、 初尿感时膀胱容 量、 排尿期逼尿肌的收缩力等。 重量传感器可以实时监测贮尿袋内尿液重 量的变化， 重量信号传输至中央控制器并经处理后能够得到尿量随时间的 变化， 从而得出尿流率曲线和排尿曲线。 所述重量传感器和中央控制器还 可以精确计量 24小时尿量、每小时尿量等， 并根据预设的尿量分析值， 在 显示部件上显示人体是否为多尿、 少尿、 无尿、 1 小时少尿等异常情况， 此尿液引流控制系统可以为患者进行尿动力学测试， 尤其适用于长期卧床 的留置导尿患者， 能够对患者进行 24小时实施床边尿动力监控， 可及时、 准确、 动态的获得患者的尿动力参数； 无需多次插拔导尿管， 自然充盈膀 胱， 减少患者痛苦， 降低感染风险， 可真实反映膀胱自然充盈生理状态。
为更加准确反应膀胱压力和进行尿动力学检测， 本装置还设有移动显 示部件和外接腹腔压力釆集部件， 所述外接腹腔压力釆集部件可以釆集人 体腹压， 并将釆集信号输送至所述中央控制器， 中央控制器上设有与外接 腹腔压力釆集部件相连接的接口， 移动显示部件与所述中央控制器无线连 接， 用于显示所述外接腹腔压力釆集部件所显示的内容。
本发明的目的还在于提供一种保护膀胱功能的排尿方法，该方法包括： 预设泄压阈值以及泄压开始时间、 泄压持续时间；
釆集膀胱内的压力；
判断该压力是否等于或大于预设的泄压阈值；
若判断结果为该压力等于或大于预设的泄压阈值， 则在泄压开始时间 内启动排尿泄压， 泄压时间为预设的泄压持续时间。
优选地， 该方法还包括： 预设排尿阈值以及判定时间、排尿持续时间， 所述排尿阈值小于上述泄压阈值； 釆集膀胱内的压力； 判断该压力是否等 于或大于预设的泄压阈值； 若判断结果为该压力等于或大于预设的泄压阈 值， 则在泄压开始时间内启动排尿泄压， 泄压时间为预设的泄压持续时间； 若判断结果为该压力小于预设的泄压阈值， 则继续判断该压力是否等于或 大于排尿阈值， 若判断结果为该压力等于或大于预设的排尿阈值， 则进一 步判断该压力持续时间是否等于或大于判定时间， 若判断结果为该压力持 续时间等于或大于判定时间， 则进行排尿， 排尿时间为预设的排尿持续时 间。
当然， 也可以判断该压力是否等于或大于预设的排尿阈值； 若判断结 果为该压力等于或大于预设的排尿阈值， 则进一步判断该压力是否等于或 大于预设的泄压阈值， 若判断结果为该压力等于或大于预设的泄压阈值， 则在泄压开始时间内启动排尿泄压， 泄压时间为预设的泄压持续时间； 若 判断结果为该压力等于或大于预设的排尿阈值且小于泄压阈值时， 则继续 判断该压力持续时间是否等于或大于判定时间， 若判断结果为该压力持续 时间等于或大于判定时间， 则进行排尿，排尿时间为预设的排尿持续时间； 若判断结果为该压力小于预设的排尿阈值， 则继续釆集膀胱内的压力进行 判断。
优选地， 所述泄压持续时间小于排尿持续时间。 所述泄压开始时间为 较短的时间， 泄压开始时间小于判定时间， 在某种情况下可接近于零， 即 立即进行排尿泄压。 当然， 上述过程是循环往复的， 当所有判断为否时， 即继续进行压力判断。
本发明的目的还在于提供一种尿液引流控制系统， 包括能够与插入人 体的导尿管连接的尿液入口、 能够与贮存尿液的贮尿袋连接的尿液出口、 以及位于尿液入口、尿液出口之间至少一个区域上的至少一个压力传递面， 该压力传递面能够传递膀胱内的压力， 所述尿液引流控制系统还包括： 压力传感器， 压力传感器通过上述压力传递面釆集膀胱内的压力， 并 生成压力信号进行传送， 所述压力传递面不一定发生形变， 只要能够被压 力传感器釆集到压力即可；
中央控制器， 中央控制器接收压力传感器输出的压力信号， 并判断该 压力是否等于或大于泄压阈值， 若判断结果为是， 则在泄压开始时间内启 动排尿泄压， 泄压时间为预设的泄压持续时间， 若判断结果为否， 则继续 判断该压力是否等于或大于排尿阈值， 若判断结果为是， 则进一步判断该 压力持续时间是否等于或大于判定时间， 若判断结果为是， 则输出打开尿 液出口的指令进行排尿， 排尿时间为预设的排尿持续时间；
或中央控制器接收压力传感器输出的压力信号， 并判断该压力是否等 于或大于预设的排尿阈值， 若判断结果为是， 则进一步判断该压力是否等 于或大于预设的泄压阈值， 若判断结果为是， 则在泄压开始时间内启动排 尿泄压， 泄压时间为预设的泄压持续时间； 若判断结果为否， 则继续判断 该压力持续时间是否等于或大于判定时间， 若判断结果为是， 则输出打开 尿液出口的指令进行排尿， 排尿时间为预设的排尿持续时间；
执行部件， 接收中央控制器输出的指令， 控制尿液是否从所述尿液出 口流出。
上述排尿方法意在将患者膀胱压力瞬间假性升高与模拟人体正常生理 排尿结合， 并全部利用电控方式进行压力釆集和连通控制， 与机械结构相 比， 具有更加精确、 产品体积更小、 操作更加方便等优点。
优选地， 所述执行部件的驱动机构为电机、 电磁阀、 气泵等。 当选用 气泵作为所述执行部件的驱动机构时， 所述执行部件还包括气嚢， 所述中 央控制器根据所述压力传感器的压力信号控制气泵充气至气嚢， 以使气嚢 施加外力作用于所述尿液出口上， 关闭尿液出口； 或控制所述气嚢放气以 消除外力对所述尿液出口的作用， 打开尿液出口。
优选地， 所述尿液引流控制系统还包括重量传感器， 该重量传感器用 于实时监测贮尿袋内尿液的重量， 并将重量信号输出至所述中央控制器。
优选地， 所述尿液引流控制系统还包括显示部件、 输入部件、 数据存 储部件； 所述显示部件与所述中央控制器连接， 用于显示监测的数据和人 工设定的数据以及中央控制器的运算结果； 所述输入部件与所述中央控制 器连接，用于设置参数和 /或查询所述数据存储部件的储存记录以及中央控 制器的运算结果； 所述数据存储部件， 用于数据的输出和数据的输入， 该 数据存储部件能够存储输入部件设置的参数 , 以及中央控制器分析生成的 尿流率曲线、 排尿量曲线、 膀胱压力曲线、 腹腔压力曲线， 并可将上述曲 线移动传输至外部设备，且能够传输外部设备上录入的参数至中央控制器； 为更加准确反应膀胱压力和进行尿动力学检测， 上述系统还包括移动 显示部件和外接腹腔压力釆集部件， 所述外接腹腔压力釆集部件可以釆集 人体腹压， 并将釆集信号输入至所述中央控制器， 中央控制器上设有与外 接腹腔压力釆集部件相连接的接口； 移动显示部件， 与所述中央控制器无 线连接， 用于显示所述外接腹腔压力釆集部件所显示的内容。
优选地， 所述压力传递面由弹性材料制成， 能够随膀胱内压力变化发 生形变。 所述尿液引流控制系统还包括控制部分， 控制部分包括压力传递 部件和封闭部件， 所述压力传递部件能够与压力传递面相接触， 并受压力 传递面形变产生的力的作用而发生位置移动； 所述封闭部件能够随压力传 递部件位置的移动而移动， 封闭部件位置移动时能够控制尿液是否从尿液 出口 出。
附图说明
图 1为本发明尿液引流装置的膀胱仿生单元的整体半剖示意图；
图 2为图 1中 A局部放大半剖示意图；
图 3为本发明尿液引流装置的膀胱仿生单元的分解示意图 1 ; 图 4为本发明尿液引流装置的膀胱仿生单元的分解示意图 2; 图 5为本发明尿液引流装置的膀胱仿生单元的立体示意图 1 ;
图 6为本发明尿液引流装置的膀胱仿生单元的立体示意图 2;
图 7为本发明尿液引流装置与贮尿袋连接的结构示意图；
图 8为图 7中 B局部放大示意图；
图 9为本发明尿液引流控制装置整体半剖示意图；
图 10为尿液引流控制装置的立体分解示意图；
图 11为尿液引流控制装置阻力部件的立体分解示意图；
图 12为尿液引流控制装置手动控制阀开启状态的半剖示意图；
图 13为尿液引流控制装置手动控制阀关闭状态的半剖示意图；
图 14为本发明尿液引流控制装置封闭状态的结构示意图 1-1 ;
图 15为本发明尿液引流控制装置开启状态的结构示意图 1-2;
图 16为本发明尿液引流控制装置封闭状态的结构示意图 2-1 ;
图 17为本发明尿液引流控制装置开启状态的结构示意图 2-2;
图 18为本发明尿液引流控制装置封闭状态结构示意图 3-1 ;
图 19为本发明尿液引流控制装置开启状态的结构示意图 3-3;
图 20为本发明尿液引流控制装置封闭状态的结构示意图 4-1 ;
图 21为本发明尿液引流控制装置开启状态的结构示意图 4-2;
图 22为本发明尿液引流控制系统结构示意图；
图 23为本发明尿液 1流控制系统排尿方法的流程图；
图 24为本发明保护膀胱功能的排尿方法的流程图 1 ;
图 25为本发明保护膀胱功能的排尿方法的流程图 2;
图 26为实施图 24、 图 25所示排尿方法的尿液引流控制系统结构示意图； 11压力传递部件、 111第一齿轮、 12封闭部件、 121封闭头、 122第 二齿轮、 13阻力部件、 131弹簧、 132调节部分、 132a手柄、 132b分度盘、
132c螺纹右壳体、 132d螺纹左壳体、 14限位部件、 15旋转轴、 2膀胱仿 生单元、 21主体部件、 21a第一膜片、 21b第二膜片、 211第一压力传递面、 212第一作用区域、 213第二压力传递面、 214第二作用区域、 215贮液空 腔、 216连接管路、 216a连接下管路、 22包覆壳体、 222包覆右壳体、 221 包覆左壳体、 223棵露孔、 31尿液入口、 32尿液出口、 41入尿管路、 42 出尿管路、 43贮尿袋、 431挂钩、 44导尿管接头、 45温度测量、 46尿液 釆样、 51压力传感器、 52中央控制器、 53执行部件、 54重量传感器、 55 显示部件、 56输入部件、 57数据存储部件、 58移动显示部件、 59外接腹 腔压力釆集部件、 6壳体、 7手动控制阀、 71旋转手柄、 72阀主体、 73复 位件、 74阀芯、 75阀壳。
具体实施方式
为使本发明的目的、 技术方案和有益效果更加清楚明白， 以下结合附 图对本发明的具体实施方式进一步详细说明。 在此， 本发明示意性的实施 方式及其说明用于解释本发明， 但并不作为对本发明的限定。
如图 7所示，一种尿液引流装置， 包括能够与插入人体的导尿管连接的 尿液入口 31 , 以及尿液出口 32, 尿液出口 32可以与贮存尿液的贮尿袋 43 连接， 也可以连接其它能够承载尿液的部件， 即该尿液引流装置具有能够 将人体膀胱内尿液导出的功能。
如图 1所示， 尿液引流装置具体还包括膀胱仿生单元 2, 膀胱仿生单 元 2包括能够形成贮存尿液的贮液空腔 215的主体部件 21 , 贮液空腔 215 通过连通管路 216连通尿液入口 31和尿液出口 32, 阻断贮液空腔 215与 尿液出口 32的连通时， 尿液入口 31与尿液出口 32断开， 尿液无法排出。 阻断的方式可以有多种， 比如设置手动控制阀 7等。所述主体部件 21包括 能够随所述贮液空腔 215 内尿液压力变化发生形变的第一压力传递面 211 和第二压力传递面 213 , 所述第一压力传递面 211和第二压力传递面 213 可以由弹性材料聚氯乙烯注塑制成， 与主体部件 21整体制成，也可与主体 部件 21釆用医用粘合剂密封式粘接制成。 如图 2所示， 连通贮液空腔 215 与尿液出口 32的连接下管路 216a上设有可被外力作用而发生阻断的第一 作用区域 212和第二作用区域 214, 所述第一作用区域 212和第二作用区 域 214可以由柔性材料聚氯乙烯注塑制成， 与主体部件 21整体制成，也可 与主体部件 21 釆用医用粘合剂密封式粘接制成。 所述第一作用区域 212 和第二作用区域 214相对设置， 当第一作用区域 212和第二作用区域 214 同时受外力作用时， 所述贮液空腔 215与尿液出口 32之间的连通被阻断； 根据所述第一压力传递面 211和 /或第二压力传递面 213的形变， 可消除施 加在所述第一作用区域 212和 /或第二作用区域 214的外力， 当作用于第一 作用区域 212和第二作用区域 214上的任意一个外力被消除时， 所述贮液 空腔 215与尿液出口 32之间的阻断可被解除，所述贮液空腔 215与所述尿 液出口 32 的连通即可恢复。 由于该尿液引流装置设置了第一压力传递面 211和第二压力传递面 213 ,无论是釆取人工、电控，还是机械控制的方式， 均可以根据第一压力传递面 211和 /或第二压力传递面 213的形变决定是否 导通排尿， 从而实现辅助患者排尿的功能。 当釆用人工方式控制时， 可以 根据压力传递面的形变量大小，判断患者是否需要排尿，从而灵活性更强。 同时， 该结构的尿液引流装置具有结构简单， 适合工业化生产等优势。
具体地， 主体部件 21包括两膜片， 即图 4中所示的第一膜片 21a和第 二膜片 21b。 第一膜片 21a上形成有第一压力传递面 211、 第一作用区域 212, 第二膜片 21b上形成有第二压力传递面 213、 第二作用区域 214, 两 膜片扣合并封固时， 第一作用区域 212和第二作用区域 214相对， 形成连 接下管路 216a; 第一压力传递面 211和第二压力传递面 213相对， 形成上 述的贮液空腔 215。 两膜片的封固具体可以通过超声波焊接或热合工艺等 方式实现。
为了保护膜片不被外力破坏， 膀胱仿生单元 2还包括硬质材料制成的 包覆壳体 22, 如图 3、 4所示， 包覆壳体 22分为包覆右壳体 222和包覆左 壳体 221两部分， 两部分相适形包覆在主体部件 21上， 把主体部件 21夹 在中间 ,两包覆壳体扣合后能够包覆主体部件 21上除第一压力传递面 211、 第一作用区域 212、 第二压力传递面 213、 第二作用区域 214以外的部分。 所述包覆壳体 22设有棵露第一压力传递面 211、 第一作用区域 212、 第二 压力传递面 213、第二作用区域 214的棵露孔 223 , 以免干涉压力传递面的 形变以及对作用区域的封闭。 如图 5、 6所示， 包覆壳体 22对主体部件 21 可以起到较好的支撑、 位置固定和保护作用， 从而使尿液引流装置具有抵 御一定外力破坏的能力。 包覆壳体 22具体可以由丙烯腈 -丁二烯-苯乙烯材 料注塑制成。
具体地， 连接贮液空腔 215和尿液出口 32的连接下管路 216a呈细长 管状，贮液空腔 215呈椭圓状，第一压力传递面 211和第二压力传递面 213 也呈椭圓状， 上述压力传递面的形状设计可更加明显的突出压力传递面发 生的形变， 连接下管路 216a的细长设计便于其被外力阻断。
针对上述各实施例，为了便于膀胱仿生单元 2和贮尿袋 43以及导尿管 连通， 尿液入口 31和尿液出口 32可以分别连接入尿管路 41和出尿管路 42, 入尿管路 41与导尿管连通， 出尿管路 42与贮尿袋 43连通。 入尿管路 41和出尿管路 42上均可以设置手动控制阀 7,从而能够根据需要夹闭管路 使其被阻断。如图 8所示，入尿管路 41设有用于连接导尿管的导尿管接头 44, 所述导尿管接头 44或入尿管路 41上设有用于温度釆集 45和 /或尿液 釆样 46的可自密封区域， 所述用于温度釆集 45的可自密封区域能够被尖 锐的温度釆集针头穿入， 以便温度测量点接触尿液进行温度釆集， 另外， 温度釆集针头釆集完成拔出时， 由于是柔性自密封区域， 插入位置会自动 恢复， 即具有自动密封功能， 从而保持良好的密封性， 防止尿液泄漏。 所 述尿液釆样 46的可自密封区域具有同上所述的技术效果。
如图 9-13所示， 本发明还提供一种尿液引流控制装置， 包括上述的尿 液引流装置，还包括控制部分。 所述控制部分包括压力传递部件 11和封闭 部件 12, 两者可以一体设置或分体设置。 所述压力传递部件 11 能够与发 生形变的第一压力传递面 211和 /或第二压力传递面 213相接触， 并受第一 压力传递面 211和 /或第二压力传递面 213形变产生的力的作用而发生位置 移动； 所述封闭部件 12能够随压力传递部件 11位置的移动而移动， 封闭 部件 12位置移动时能够施加或消除作用于所述第一作用区域 212和 /或第 二作用区域 214上的外力， 由此阻断或解除阻断所述贮液空腔 215与尿液 出口 32之间的连通。
一种状态： 装置初始使用时，封闭部件 12阻断贮液空腔 215和尿液出 口 32之间的连通， 当患者出现体位变化、 咳嗽、 膀胱痉挛等情况时， 膀胱 内的压力瞬间升高， 超过膀胱所能承受的安全值时， 压力传递面形变产生 的力能够带动压力传递部件 11移动， 压力传递部件 11再带动封闭部件 12 移动，封闭部件 12消除对作用区域施加的外力， 贮液空腔 215和尿液出口 32连通， 尿液排出泄压， 从而保护膀胱不受损伤， 并防止尿液返流、 溢尿 等危险情况的发生； 当膀胱内的压力下降到膀胱安全值以内， 压力传递面 形变量减小， 压力传递部件 11、 封闭部件 12也相应地复位， 封闭部件 12 继续对作用区域施加外力 , 阻断贮液空腔 215和尿液出口 32之间的连通。 上述压力传递面的选择可以是第一压力传递面 211或第二压力传递面 213。
另一种状态： 装置初始使用时， 封闭部件 12对作用区域施加外力， 阻 断贮液空腔 215和尿液出口 32之间的连通，随着贮液空腔 215内的尿液的 增多， 第一压力传递面 211和 /或第二压力传递面 213逐渐发生形变， 根据 人肉目艮观察压力传递面的形变程度确定是否操控手动控制阀 7以开启贮液 空腔 215和尿液出口 32之间的连通。该种设置使得膀胱内尿液压力达到一 定值时才能排尿， 从而训练膀胱感知膀胱内尿液充盈并完成排尿反射， 达 到管理膀胱排尿活动的效果， 并最终实现膀胱自主排尿。
如图 12、 13所示， 该手动控制阀 7位于尿液引流控制装置上， 包括旋 转手柄 71、 阀主体 72、 复位件 73、 阀芯 74、 阀壳 75 , 其工作原理是： 利 用旋转手柄 71带动阀主体 72可以推动或解除推动阀芯 74,再利用阀芯 74 阻断或解除阻断第一作用区域 212或第二作用区域 214, 在阻断第一作用 区域 212或第二作用区域 214时，手柄 71旋转阀主体 72使阀芯 74凸出阀 壳 75外部， 如图 13所示； 在解除阻断第一作用区域 212或第二作用区域 214时， 手柄 71旋转阀主体 72使阀芯 74退回阀壳 75内部， 复位件 73可 以帮助阀芯 74退回阀壳 75内部， 如图 12所示。
该尿液引流控制装置釆用了机械原理控制泄压排尿， 保护膀胱不受损 伤以达到防返流、 防溢尿的技术效果， 并实现了根据膀胱内的压力仿人体 正常生理排尿的功能， 且操控简单， 易于患者本人及医护人员操作。
压力传递部件 11与压力传递面之间留有间隙，当压力传递面随贮液空 腔 215 内压力增大而形变时， 该间隙能够渐缩直至消除， 即贮液空腔 215 内的尿液压力达到一定程度时，第一压力传递面 211或第二压力传递面 213 的形变量才能够满足与压力传递部件 11实现接触，进而带动压力传递部件 11移动。
尿液引流控制装置的控制部分还包括阻力部件 13 , 如图 11所示， 所 述阻力部件 13施加于压力传递部件 11和 /或封闭部件 12—预定阻力以阻 止相对应的压力传递面形变， 预设阻力可以设置为人体膀胱安全压力值 40cmH2O, 也可以根据患者膀胱功能的情况进行个性化设置。 当相对应的 压力传递面作用于压力传递部件 11或封闭部件 12上的力大于该预定阻力 时，压力传递部件 11带动封闭部件 12发生位置移动，解除对贮液空腔 215 和尿液出口 32之间连通的阻断， 则进行泄压排尿。 所述阻力部件 13的阻 力由弹簧 131产生， 所述弹簧 131的一端可以连接所述壳体 6, 另一端连 接所述压力传递部件 11或所述封闭部件 12, 弹簧 131可以处于预压缩状 态，压力传递面的形变对压力传递部件 11的作用力只有克服该弹簧力， 才 能带动压力传递部件 11移动，从而实现尿液引流装置泄压排尿的开启； 所 述阻力部件 13还包括调节部分 132, 该调节部分 132包括手柄 132a、分度 盘 132b、 螺纹右壳体 132c、 螺纹左壳体 132d, 利用手柄 132a带动螺纹右 壳体 132c在螺纹左壳体 132d内部转动， 压缩或放开弹簧 131 , 调节其长 度， 由此调节施加于压力传递部件 11和 /或封闭部件 12上的预定阻力， 分 度盘 132b可以显示该预定阻力的调节值。
如图 14所示， 所述压力传递部件 11和封闭部件 12为一体式结构， 整 体注塑制成； 控制部分还包括旋转轴 15 , 压力传递部件 11 随第一压力传 递面 211形变而位置移动时， 压力传递部件 11和封闭部件 12能够共同绕 旋转轴 15转动。 图 14 中， 由于膀胱内积尿不多， 没有达到阻力部件 13 预设的阻力值， 则压力传递部件 11没有发生位置移动， 封闭部件 12继续 施加对第一作用区域 212外力， 尿液无法从贮液空腔 215经尿液出口 32 流出。 如图 15 所示， 由于膀胱内的压力突然升高， 第一压力传递面 211 克服阻力部件 13的阻力， 推动压力传递部件 11逆时针转动， 封闭部件 12 也相应地作逆时针转动， 封闭部件 12不再阻断贮液空腔 215和尿液出口 32的连通； 膀胱内的压力降低至一定值时， 弹簧 131复位而推动压力传递 部件 11顺时针转动， 封闭部件 12相应地顺势针转动， 从而重新阻断贮液 空腔 215和尿液出口 32的连通。 此处的压力传递部件 11和封闭部件 12也可以为分体式结构， 二者保 持相对固定即可。 另外， 压力传递部件 11上还可以设置限位部件 14, 其 可以是压力传递部件 11上的一部分， 用于限制压力传递部件 11在一定范 围内位移或当压力传递部件 11位移后定位于某一位置， 使封闭部件 12在 一段时间内解除对第一作用区域 212的封闭。
如图 16、 17所示，所述压力传递部件 11和封闭部件 12为一体式结构； 压力传递部件 11 上设有导杆， 壳体 6上设有插孔， 导杆能够沿弹簧 131 伸缩方向在插孔内移动。导杆和插孔主要是用于限定压力传递部件 11和封 闭部件 12的移动方向， 使得二者仅能沿弹簧 131伸缩方向移动。 如图 16 所示， 压力传递部件 11的两端分别设置了一个导杆， 实际上， 一个或一个 以上的导杆都是可以的；弹簧 131与导杆平行设置，则导杆仅能沿弹簧 131 伸缩方向移动。 导杆大致与压力传递部件 11垂直， 弹簧 131伸出时， 将压 力传递部件 11压紧于第一压力传递面 211上， 此时， 封闭部件 12压紧于 第一作用区域 212, 对贮液空腔 215和尿液出口 32的连通实施阻断； 第一 压力传递面 211推动压力传递部件 11移动后， 封闭部件 12逐渐远离第一 作用区域 212, 进而解除阻断， 实现泄压排尿。如图 17所示， 泄压排尿后， 弹簧 131复位， 又恢复为阻断状态。
如图 18所示， 压力传递部件 11包括第一齿轮 111 , 封闭部件 12包括 封闭头 121 以及与第一齿轮 111啮合的第二齿轮 122, 第一齿轮 111和第 二齿轮 122均相对于壳体 6固定；弹簧 131与压力传递部件 11通过活动轴 连接，压力传递部件 11包括能够与第一压力传递面 211接触的接触盘，接 触盘与第一齿轮 111 固定， 当接触盘移动时， 带动第一齿轮 111转动， 第 一齿轮 111驱动第二齿轮 122转动， 第二齿轮 122转动时能够带动封闭头 121移动， 从而解除阻断贮液空腔 215和尿液出口 32的连通， 实现泄压排 尿。 如图 19所示， 泄压排尿后， 弹簧 131复位， 又恢复为阻断状态。
如图 20所示， 压力传递部件 11与封闭部件 12铰接， 压力传递部件 11随第一压力传递面 211形变而位置移动时， 带动封闭部件 12转动以阻 断或解除阻断贮液空腔 215和尿液出口 32的连通， 即压力传递部件 11和 封闭部件 12形成了连杆机构， 从而实现联动。 压力传递部件 11呈弯折状 的杠杆， 包括联动段和用于接触第一压力传递面 211的接触段； 封闭部件 12也呈弯折状的杠杆， 包括联动段和用于施加外力于第一作用区域 212的 封闭段。 阻断时， 压力传递部件 11和封闭部件 12的联动段相接并翘起； 压力传递部件 11的接触段移动而翘起时， 封闭部件 12的封闭段也翘起， 从而解除阻断贮液空腔 215和尿液出口 32的连通。 如图 21所示， 泄压排 尿后， 弹簧 131复位， 又恢复为阻断状态。
尿液引流控制装置的壳体 6上可以设置定位凸台， 尿液引流装置的包 覆壳体 22上设置与定位凸台配合的定位卡槽。该种设置方式简单地使尿液 引流装置安装时更加方便、 快速， 且便于拆卸。
本发明还提供一种尿液引流控制系统， 如图 22所示： 包括尿液引流控 制部分和电控部分， 所述尿液引流控制部分为上述实施例的尿液引流控制 装置， 压力传递部件 11与封闭部件 12分别作用在第一压力传递面 211和 第一作用区域 212上。 所述电控部分包括中央控制器 52、 执行部件 53以 及监测膀胱压力的压力传感器 51 , 中央控制器 52接收压力传感器 51输出 的压力信号， 当膀胱压力等于或大于排尿阈值， 且持续时间等于或大于判 定时间时， 中央控制器 52输出连通贮液空腔 215和尿液出口 32的指令至 执行部件 53;压力传感器 51和执行部件 53分别作用在第二压力传递面 213 和第二作用区域 214上。 尿液引流控制系统还包括重量传感器 54、 显示部 件 55、 输入部件 56、 数据存储部件 57、 移动显示部件 58、 外接腹腔压力 釆集部件 59。 该重量传感器 54用于实时监测贮尿袋 43内尿液的重量并将 重量信号输送至中央控制器 52。 该重量传感器 54与贮尿袋 43的挂钩 431 连接， 当尿液重量超过预设值时， 中央控制器 52可以发出警示信号以更换 贮尿袋 43 , 中央控制器 52能够根据重量信号、 排尿时间、 尿比重等参数 绘制出尿流率曲线、 排尿量曲线、 重量变化曲线等反应膀胱功能的一系列 曲线。 该显示部件 55与中央控制器 52连接， 用于显示监测的数据和人工 设定的数据以及中央控制器 52的运算结果； 输入部件 56与所述中央控制 器 52连接，用于设置参数和 /或查询所述数据存储部件 57的储存记录以及 中央控制器 52的运算结果； 数据存储部件 57, 用于数据的输出和数据的 输入， 该数据存储部件 57能够存储输入部件 56设置的参数， 以及中央控 制器 52分析生成的尿流率曲线、排尿量曲线、膀胱压力曲线、 腹腔压力曲 线， 并可将上述曲线传输至外部设备， 还能够传输外部设备上录入的参数 至中央控制器 52; 该外接腹腔压力釆集部件 59可以釆集人体腹压， 并将 釆集信号输送至所述中央控制器 52, 中央控制器 52上设有与外接腹腔压 力釆集部件 59相连接的接口； 移动显示部件 58, 与所述中央控制器 52无 线连接，用于显示所述外接腹腔压力釆集部件 59所显示的内容。该系统可 由电池供电或固定电源供电。
上述尿液引流控制系统的工作流程如图 23所示， 当压力传感器 51监 测第二压力传递面 213传递的膀胱压力等于或大于排尿阈值， 且持续时间 等于或大于判定时间时， 中央控制器 52向执行部件 53发出指令， 执行部 件 53消除作用在第二作用区域 214的外力， 贮液空腔 215与尿液出口 32 连通， 仿生人体正常生理性排尿， 排尿时间为预设的排尿持续时间。 所述 排尿阈值可设为正常人膀胱排尿阈值 20cm¾O左右，也可以根据患者的膀 胱功能状况设定阈值； 所述判定时间是根据患者的膀胱功能状况设定的时 间，一般可设为 10秒钟左右；预设的排尿持续时间也是根据患者的膀胱功 能状况设定的时间，一般可设定为 10秒钟到 300秒钟之间的任意数值，或 根据患者需要个性化设置。排尿过程结束后，执行部件 53继续施加作用在 第二作用区域 214上的外力， 阻断贮液空腔 215和尿液出口 32的连通。 当 患者发生膀胱内的压力瞬间升高时， 尿液引流控制系统的尿液引流控制部 分的第一压力传递面 211发生形变， 使压力传递部件 11带动封闭部件 12 消除对第一作用区域 212施加的外力，使贮液空腔 215和尿液出口 32之间 连通， 尿液经尿液出口 32进入贮尿袋 43 , 即起到瞬间泄压的作用， 压力 降低后， 贮液空腔 215与尿液出口 32连通重新被阻断。该尿液引流控制系 统相当于电气控制和机械控制相结合， 一方面能够利用电控部分进行仿人 体生理功能的正常排尿， 另一方面利用机械部分防止膀胱内压力假性瞬间 升高而导致的尿液返流和溢尿的风险。
上述执行部件 53 包括气泵和气嚢,气嚢能够向第二作用区域 214施加 外力， 阻断贮液空腔 215与尿液出口 32的连通， 也可以执行中央控制器 52发出的控制信号放气， 以消除施加在第二作用区域 214上的外力， 使贮 液空腔 215与尿液出口 32连通， 进行正常排尿。排尿过程结束后， 气泵为 气嚢充气， 恢复阻断贮液空腔 215与尿液出口 32的连通。
一种保护膀胱功能的排尿方法， 如图 24、 25所示： 预设泄压阈值、 排 尿阈值以及泄压持续时间、 排尿持续时间、 判定时间、 泄压开始时间， 所 述泄压阈值可设为膀胱的安全压力值 40cmH2O, 或设为膀胱的安全压力值 与排尿阈值之间的任意数值， 另外， 由于泄压阈值的设置可以有效保护膀 胱不受损伤， 所以根据个人膀胱功能状况也可将泄压阈值设为高于膀胱安 全压力值 40cm¾O的数值；所述泄压持续时间是根据患者的膀胱功能状况 设定的时间， 如可设为 3秒钟左右； 所述排尿阈值是根据患者膀胱功能状 况设定的阈值， 一般可设为 20cmH2O左右 ； 所述判定时间同样根据患者 的膀胱功能状况设定的时间，如可设为 10秒钟左右；预设的排尿持续时间 是根据患者的膀胱功能状况设定的时间，一般可设为 10秒钟到 300秒钟之 间的任意数值，或根据患者需要个性化设置。上述排尿阈值小于泄压阈值， 泄压持续时间小于排尿持续时间； 具体方法为： 首先釆集膀胱内的压力， 判断该压力是否等于或大于预设的泄压阈值；
( 1 )若判断结果为该压力等于或大于预设的泄压阈值， 则在泄压开始 时间内启动排尿泄压， 泄压时间为预设的泄压持续时间；
( 2 )若判断结果为该压力 d、于预设的泄压阈值，则继续判断该压力是 否等于或大于排尿阈值，若判断结果为该压力等于或大于预设的排尿阈值， 则进一步判断该压力持续时间是否等于或大于判定时间， 若判断结果为该 压力持续时间等于或大于判定时间， 则进行排尿， 排尿时间为预设的排尿 持续时间。
当然， 也可以首先判断该压力是否等于或大于预设的排尿阈值； ( 1 )若判断结果为该压力等于或大于预设的排尿阈值， 则进一步判断 该压力是否等于或大于预设的泄压阈值， 若判断结果为该压力等于或大于 预设的泄压阈值， 则在泄压开始时间内启动排尿泄压， 泄压时间为预设的 泄压持续时间；
( 2 )若判断结果为该压力等于或大于预设的排尿阈值， 则进一步判断 该压力是否等于或大于预设的泄压阈值， 若判断结果为该压力小于预设的 泄压阈值， 则继续判断该压力持续时间是否等于或大于判定时间， 若判断 结果为该压力持续时间等于或大于判定时间， 则进行排尿， 排尿时间为预 设的排尿持续时间；
( 3 )若判断结果为该压力小于预设的排尿阈值， 则继续釆集膀胱内的 压力进行判断。
图 26为实施图 24、 图 25所示排尿方法的一种尿液引流控制系统， 该 尿液引流控制系统包括：能够与插入人体的导尿管连接的尿液入口 31和能 够与贮存尿液的贮尿袋 43连接的尿液出口 32、 以及位于尿液入口 31、 尿 液出口 32之间一个区域上设有的一个压力传递面，该压力传递面可以传递 膀胱内的压力。 该尿液引流控制系统还包括：
压力传感器 51 , 压力传感器 51通过上述压力传递面釆集膀胱压力， 并生成压力信号进行传送；
中央控制器 52 , 中央控制器 52接收压力传感器 51输出的压力信号， 并判断该压力是否等于或大于泄压阈值， 若判断结果为是， 则在泄压开始 时间内启动排尿泄压， 泄压时间为预设的泄压持续时间，若判断结果为否， 则继续判断该压力是否等于或大于排尿阈值， 若判断结果为是， 则进一步 判断该压力持续时间是否等于或大于判定时间， 若判断结果为是， 则输出 打开所述尿液出口 32的指令进行排尿， 排尿时间为预设的排尿持续时间； 或中央控制器 52接收压力传感器 51输出的压力信号， 并判断该压力 是否等于或大于预设的排尿阈值， 若判断结果为是， 则进一步判断该压力 是否等于或大于预设的泄压阈值， 若判断结果为是， 则在泄压开始时间内 启动排尿泄压， 泄压时间为预设的泄压持续时间； 若判断结果为否， 则继 续判断该压力持续时间是否等于或大于判定时间， 若判断结果为是， 则输 出打开尿液出口 32的指令进行排尿， 排尿时间为预设的排尿持续时间； 执行部件 53 , 接收中央控制器 52输出的指令， 控制尿液是否从尿液 出口 32 υ出。
所述执行部件 53的驱动机构为气泵， 所述执行部件 53还包括气嚢， 所述中央控制器 52才艮据所述压力传感器 51的压力信号控制气泵充气至气 嚢， 以使气嚢施加外力作用于所述尿液出口 32上， 关闭尿液出口 32; 或 控制所述气嚢放气以消除外力对所述尿液出口 32 的作用， 打开尿液出口 32。
尿液引流控制系统还包括重量传感器 54、 显示部件 55、 输入部件 56、 数据存储部件 57、 移动显示部件 58、 外接腹腔压力釆集部件 59。 该重量 传感器 54用于实时监测贮尿袋 43内尿液的重量并将重量信号输送至中央 控制器 52。 当尿液重量超过预设值时， 中央控制器 52可以发出警示信号 以更换贮尿袋 43 , 中央控制器 52能够根据重量信号、 排尿时间、 尿比重 等参数绘制出尿流率曲线、 排尿量曲线、 重量变化曲线等反应膀胱功能的 一系列曲线。 该显示部件 55与中央控制器 52连接， 用于显示监测的数据 和人工设定的数据以及中央控制器 52的运算结果； 输入部件 56与所述中 央控制器 52连接，用于设置参数和 /或查询所述数据存储部件 57的储存记 录以及中央控制器 52的运算结果； 数据存储部件 57 , 用于数据的输出和 数据的输入， 该数据存储部件 57能够存储输入部件 56设置的参数， 以及 中央控制器 52分析生成的尿流率曲线、排尿量曲线、膀胱压力曲线、 腹腔 压力曲线， 并可将上述曲线传输至外部设备， 还能够传输外部设备上录入 的参数至中央控制器 52; 该外接腹腔压力釆集部件 59可以釆集人体腹压， 并将釆集信号输入至所述中央控制器 52; 移动显示部件 58 , 与所述中央控 制器 52无线连接，用于显示所述外接腹腔压力釆集部件 59所显示的内容。 该系统可由电池供电或固定电源供电。
尿液弓 ]流控制系统的压力传递面由弹性材料制成， 能够随膀胱内压力 变化发生形变。 所述尿液引流控制系统还包括控制部分， 控制部分包括压 力传递部件 11和封闭部件 12, 所述压力传递部件 11能够与压力传递面相 接触， 并受压力传递面形变产生的力的作用而发生位置移动； 所述封闭部 件 12能够随压力传递部件 11位置的移动而移动，封闭部件 12位置移动时 能够控制尿液是否从尿液出口 32流出。
以上对本发明所提供的一种尿液引流装置、 尿液引流控制装置、 保护 膀胱功能的排尿方法以及尿液弓 1流控制系统均进行了详细介绍。 本文中应 用了具体个例对本发明的原理及实施方式进行了阐述， 以上实施例的说明 只是用于帮助理解本发明的方法及其核心思想。 应当指出， 对于本技术领 域的普通技术人员来说， 在不脱离本发明原理的前提下， 还可以对本发明 进行若干改进和修饰， 这些改进和修饰也落入本发明权利要求的保护范围 内。

Claims

权 利 要 求
1、一种尿液引流装置， 包括能够与插入人体的导尿管连接的尿液入口 (31 )和能够与贮存尿液的贮尿袋（43)连接的尿液出口 （32), 其特征在 于，
所述尿液引流装置还包括膀胱仿生单元 ( 2 ), 膀胱仿生单元 ( 2 )包括 能够形成贮存尿液的贮液空腔（215)的主体部件（21 ),所述贮液空腔（215) 通过连接管路 (216)与所述尿液入口 （31 )和所述尿液出口 （32)连通， 主体部件（21 )包括能够随所述贮液空腔（215)内尿液压力变化发生形变 的第一压力传递面（211 )和第二压力传递面（213), 连通贮液空腔（215) 与尿液出口 （32)的连接管路 (216)为连接下管路（216a)，所述连接下管路 ( 216a )设有可被外力作用的第一作用区域（ 212 )和第二作用区域（ 214 ), 第一作用区域（212)和第二作用区域（214)相对设置；
当第一作用区域（212)和第二作用区域（214) 同时受外力作用时， 所述贮液空腔（215)与尿液出口 （32)之间的连通被阻断； 根据所述第一 压力传递面 （211 )和 /或第二压力传递面 （213) 的形变， 可消除施加在所 述第一作用区域（212)和 /或第二作用区域（214)的外力， 当作用于第一 作用区域（212)和第二作用区域（214)上的任意一个外力被消除时， 所 述贮液空腔（215)与尿液出口 （32)之间的阻断可被解除， 所述贮液空腔 (215) 与所述尿液出口 （32) 的连通即可恢复。
2、根据权利要求 1所述的尿液引流装置， 其特征在于， 所述主体部件
(21 ) 包括两膜片， 一所述膜片上形成有第一压力传递面 （211)、 第一作 用区域（212), 另一所述膜片上形成有第二压力传递面 （213)、 第二作用 区域（214), 两所述膜片扣合并封固， 所述第一压力传递面（211 )和所述 第二压力传递面 （213)相对设置形成的内部空腔为所述贮液空腔（215)。
3、根据权利要求 1所述的尿液引流装置， 其特征在于， 所述膀胱仿生 单元（2)还包括硬质的包覆壳体（22), 所述包覆壳体（22)扣合后能够 包覆所述主体部件 ( 21 )上除第一压力传递面（ 211 )、第一作用区域 ( 212 )、 第二压力传递面 （213)、 第二作用区域（214) 以外的部分。
4、根据权利要求 1所述的尿液引流装置， 其特征在于， 所述尿液入口 ( 31 )和所述尿液出口（ 32 )分别连接有入尿管路（ 41 )和出尿管路（ 42 ) , 入尿管路（41 )上设有用于连接导尿管的导尿管接头 （44)。
5、根据权利要求 4所述的尿液引流装置， 其特征在于， 所述导尿管接 头（ 44 )和 /或入尿管路（ 41 )上设有用于温度釆集（ 45 )和 /或尿液釆样 ( 46 ) 的可自密封区域。
6、 一种尿液引流控制装置， 包括尿液引流部分、控制部分以及容纳尿 液引流部分和控制部分的壳体（6), 其特征在于， 所述尿液引流部分为权 利要求 1-5任一项所述的尿液引流装置； 所述控制部分包括压力传递部件 ( 11 )和封闭部件（ 12), 所述压力传递部件（ 11 )能够与发生形变的第一 压力传递面 （211 )和 /或第二压力传递面 （213)相接触， 并受第一压力传 递面（211 )和 /或第二压力传递面 （213)形变产生的力的作用而发生位置 移动； 所述封闭部件（ 12)能够随压力传递部件（ 11 )位置的移动而移动， 封闭部件（ 12 )位置移动时能够施加或消除作用于所述第一作用区域（ 212 ) 和 /或第二作用区域（214)上的外力， 由此阻断或解除阻断所述贮液空腔 (215) 与尿液出口 （32)之间的连通。
7、根据权利要求 6所述的尿液引流控制装置， 其特征在于， 所述压力 传递部件 （11 ) 与其相对应的压力传递面之间留有间隙， 所述压力传递面 随所述贮液空腔（215) 内压力增大而发生形变时， 该间隙渐缩直至消除。
8、根据权利要求 6所述的尿液引流控制装置， 其特征在于， 所述控制 部分还包括阻力部件（ 13 ), 所述阻力部件（ 13 )施加于压力传递部件（ 11 ) 和 /或封闭部件（12)—预定阻力以阻止相对应的压力传递面形变， 当相对 应的压力传递面作用于压力传递部件（11 )或封闭部件 （12)上的力大于 该预定阻力时， 压力传递部件（11 ) 带动封闭部件（12)发生位置移动。
9、根据权利要求 8所述的尿液引流控制装置， 其特征在于， 所述阻力 部件（13) 的阻力由弹簧（131 )产生， 所述弹簧（131 ) 的一端连接所述 壳体（6), 另一端连接所述压力传递部件（11 )或所述封闭部件（12)。
10、 根据权利要求 9所述的尿液引流控制装置， 其特征在于， 所述压 力传递部件（11 )和所述封闭部件（12)为一体式结构； 控制部分还包括 旋转轴 ( 15 ), 所述压力传递部件 ( 11 )随相对应的压力传递面形变而位置 移动时， 所述压力传递部件 （11 )和所述封闭部件 （12)共同绕所述旋转 轴 （ 15 )转动， 以使所述封闭部件（ 12 )施加或消除对相应作用区域的外 力， 由此阻断或解除阻断所述贮液空腔（215)与尿液出口 （32)之间的连 通。
11、 根据权利要求 9所述的尿液引流控制装置， 其特征在于， 所述压 力传递部件（ 11 )和所述封闭部件（ 12)为一体式结构； 所述压力传递部 件（ 11 )上设有导杆，所述壳体（6)上设有插孔，所述导杆能够沿弹簧（ 131 ) 伸缩方向在插孔内移动， 所述压力传递部件 （ 11 ) 随相对应的压力传递面 形变而位置移动时， 所述压力传递部件 （11 )和所述封闭部件 （12)共同 随所述导杆沿插孔方向移动， 以使所述封闭部件（12)施加或消除对相应 作用区域的外力，由此阻断或解除阻断所述贮液空腔（ 215 )与尿液出口（ 32 ) 之间的连通。
12、 根据权利要求 9所述的尿液引流控制装置， 其特征在于， 所述压 力传递部件（ 11 ) 包括第一齿轮（ 111 ), 所述封闭部件（ 12) 包括封闭头 ( 121 ) 以及与所述第一齿轮（ 111 )啮合的第二齿轮（ 122), 所述第一齿 轮（ 111 )和所述第二齿轮（ 122)均相对于所述壳体（6) 固定； 所述弹簧 ( 131 )与所述压力传递部件（ 11 )通过活动轴连接，所述压力传递部件（ 11 ) 随相对应的压力传递面形变而位置移动时， 所述第一齿轮 ( 111 )驱动所述 第二齿轮（ 122)转动， 以带动所述封闭头 （ 121 )施加或消除对相应作用 区域的外力， 由此阻断或解除阻断所述贮液空腔（215)与尿液出口 （32) 之间的连通。
13、 根据权利要求 9所述的尿液引流控制装置， 其特征在于， 所述压 力传递部件 （ 11 ) 与所述封闭部件 （ 12)铰接， 所述压力传递部件（ 11 ) 随相对应的压力传递面形变而位置移动时， 带动所述封闭部件 ( 12)转动， 施加或消除对相应作用区域的外力， 由此阻断或解除阻断所述贮液空腔 (215) 与尿液出口 （32)之间的连通。
14、根据权利要求 6-13任一项所述的尿液引流控制装置，其特征在于， 所述控制部分还包括手动控制阀 （7 ), 以手动施加或消除对相应的所述作 用区域的外力， 由此阻断或解除阻断所述贮液空腔（215 )和所述尿液出口 ( 32 )之间的连通。
15、 一种尿液引流控制系统， 包括尿液引流控制部分和电控部分， 尿 液引流控制部分和电控部分容纳于壳体（6 )内， 其特征在于， 所述尿液引 流控制部分为权利要求 6-13任一项所述的尿液引流控制装置；
所述电控部分包括中央控制器（ 52 )、 执行部件（ 53 ) 以及釆集膀胱压 力的压力传感器（51 ), 中央控制器（52 )接收压力传感器（51 )输出的压 力信号， 当压力超过排尿阈值，且持续时间等于或大于预设的判定时间时， 所述中央控制器（52 )输出连通所述贮液空腔（215 )和所述尿液出口（32 ) 的指令至所述执行部件（ 53 )。
16、根据权利要求 15所述的尿液引流控制系统， 其特征在于， 所述压 力传感器（ 51 )釆集所述相对应压力传递面传递的压力，所述执行部件（ 53 ) 施加或消除对相应的所述作用区域的外力， 由此阻断或解除阻断所述贮液 空腔（215 )和所述尿液出口 （32 )之间的连通。
17、根据权利要求 15所述的尿液引流控制系统， 其特征在于， 所述执 行部件（53 ) 的驱动机构包括电机、 电磁阀， 以及气泵。
18、根据权利要求 17所述的尿液引流控制系统， 其特征在于， 所述执 行部件 ( 53 )还包括气嚢，所述中央控制器（ 52 )根据所述压力传感器（ 51 ) 的压力信号控制气泵充气至气嚢以使气嚢施加外力作用于相应的所述作用 区域， 或控制所述气嚢放气以消除外力对相应的所述作用区域的作用。
19、根据权利要求 15所述的尿液引流控制系统， 其特征在于， 还包括 重量传感器（54 ), 该重量传感器（54 )用于实时监测尿液引流部分的贮尿 袋（43 ) 内尿液的重量， 并将重量信号输出至所述中央控制器（52 )。
20、根据权利要求 15所述的尿液引流控制系统， 其特征在于， 还包括 显示部件 ( 55 )、 输入部件 ( 56 )、 数据存储部件 ( 57 );
显示部件（55 )与所述中央控制器（52 )连接， 用于显示监测的数据 和人工设定的数据以及中央控制器（52 ) 的运算结果； 输入部件（56 )与所述中央控制器（52 )连接， 用于设置参数和 /或查 询所述数据存储部件（57 )的储存记录以及中央控制器（52 )的运算结果； 数据存储部件（57 ), 用于数据的输出和数据的输入， 该数据存储部件 ( 57 ) 能够存储输入部件（56 )设置的参数， 以及中央控制器（52 )分析 生成的尿流率曲线、 排尿量曲线、 膀胱压力曲线、 腹腔压力曲线， 并可将 上述曲线移动传输至外部设备， 且能够传输外部设备上录入的参数至中央 控制器（52 )。
21、 一种保护膀胱功能的排尿方法， 其特征在于， 该方法包括： 预设泄压阈值以及泄压开始时间、 泄压持续时间；
釆集膀胱内的压力；
判断该压力是否等于或大于预设的泄压阈值；
若判断结果为该压力等于或大于预设的泄压阈值， 则在泄压开始时间 内启动排尿泄压， 泄压时间为预设的泄压持续时间。
22、 根据权利要求 21所述的排尿方法， 其特征在于， 该方法还包括： 预设排尿阈值以及判定时间、 排尿持续时间， 所述排尿阈值小于上述 泄压阈值；
釆集膀胱内的压力；
判断该压力是否等于或大于预设的泄压阈值；
( 1 )若判断结果为该压力等于或大于预设的泄压阈值， 则在泄压开始 时间内启动排尿泄压， 泄压时间为预设的泄压持续时间；
( 2 )若判断结果为该压力 d、于预设的泄压阈值，则继续判断该压力是 否等于或大于排尿阈值，若判断结果为该压力等于或大于预设的排尿阈值， 则进一步判断该压力持续时间是否等于或大于判定时间， 若判断结果为该 压力持续时间等于或大于判定时间， 则进行排尿， 排尿时间为预设的排尿 持续时间；
或判断该压力是否等于或大于预设的排尿阈值；
( 1 )若判断结果为该压力等于或大于预设的排尿阈值， 则进一步判断 该压力是否等于或大于预设的泄压阈值， 若判断结果为该压力等于或大于 预设的泄压阈值， 则在泄压开始时间内启动排尿泄压， 泄压时间为预设的 泄压持续时间；
( 2 )若判断结果为该压力等于或大于排尿阈值且小于泄压阈值， 则继 续判断该压力持续时间是否等于或大于判定时间， 若判断结果为该压力持 续时间等于或大于判定时间， 则进行排尿， 排尿时间为预设的排尿持续时 间；
( 3 )若判断结果为该压力小于预设的排尿阈值， 则继续釆集膀胱内的 压力进行判断。
23、根据权利要求 22所述的排尿方法， 其特征在于， 所述泄压开始时 间小于判定时间。
24、根据权利要求 22所述的排尿方法， 其特征在于， 所述泄压持续时 间小于排尿持续时间。
25、 一种尿液引流控制系统， 包括能够与插入人体的导尿管连接的尿 液入口 （31 )和能够与贮存尿液的贮尿袋（43 )连接的尿液出口 （32 )、 以 及位于尿液入口 （31 )、 尿液出口 （32 )之间至少一个区域上的至少一个压 力传递面， 该压力传递面能够传递膀胱内的压力， 其特征在于， 该尿液引 流控制系统还包括：
压力传感器 ( 51 ), 压力传感器 ( 51 )通过压力传递面釆集的膀胱内的 压力， 生成压力信号进行传送；
中央控制器 ( 52 ), 中央控制器 ( 52 )接收压力传感器 ( 51 )输出的压 力信号， 并判断该压力是否等于或大于泄压阈值， 若判断结果为是， 则在 泄压开始时间内启动排尿泄压， 泄压时间为预设的泄压持续时间， 若判断 结果为否， 则继续判断该压力是否等于或大于排尿阈值，若判断结果为是， 则进一步判断该压力持续时间是否等于或大于判定时间，若判断结果为是， 则输出打开尿液出口 （32 ) 的指令进行排尿， 排尿时间为预设的排尿持续 时间；
或中央控制器（52 )接收压力传感器（51 )输出的压力信号， 并判断 该压力是否等于或大于预设的排尿阈值， 若判断结果为是， 则进一步判断 该压力是否等于或大于预设的泄压阈值， 若判断结果为是， 则在泄压开始 时间内启动排尿泄压， 泄压时间为预设的泄压持续时间； 若判断结果为否， 则继续判断该压力持续时间是否等于或大于判定时间， 若判断结果为是， 则输出打开尿液出口 （32) 的指令进行排尿， 排尿时间为预设的排尿持续 时间；
执行部件（53), 接收中央控制器（52)输出的指令， 控制尿液是否从 所述尿液出口 （32) 流出。
26、根据权利要求 25所述的尿液引流控制系统， 其特征在于， 所述执 行部件（53) 的驱动机构包括电机、 电磁阀， 以及气泵。
27、根据权利要求 26所述的尿液引流控制系统， 其特征在于， 所述执 行部件 ( 53 )还包括气嚢，所述中央控制器（ 52 )根据所述压力传感器（ 51 ) 的压力信号控制气泵充气至气嚢， 以使气嚢施加外力作用于所述尿液出口 (32)上， 关闭尿液出口 （32); 或控制所述气嚢放气以消除外力对所述尿 液出口 （32) 的作用， 打开尿液出口 （32)。
28、根据权利要求 25所述的尿液引流控制系统， 其特征在于， 还包括 重量传感器（54), 该重量传感器（54)用于实时监测贮尿袋（43) 内尿液 的重量， 并将重量信号输出至所述中央控制器（52)。
29、根据权利要求 25所述的尿液引流控制系统， 其特征在于， 还包括 显示部件 ( 55 )、 输入部件 ( 56 )、 数据存储部件 ( 57 );
显示部件（55)与所述中央控制器（52)连接， 用于显示监测的数据 和人工设定的数据以及中央控制器（52) 的运算结果；
输入部件（ 56 )与所述中央控制器（ 52 )连接， 用于设置参数和 /或查 询所述数据存储部件（57)的储存记录以及中央控制器（52)的运算结果； 数据存储部件（57), 用于数据的输出和数据的输入， 该数据存储部件 (57) 能够存储输入部件（56)设置的参数， 以及中央控制器（52)分析 生成的尿流率曲线、 排尿量曲线、 膀胱压力曲线、 腹腔压力曲线， 并可将 上述曲线移动传输至外部设备， 且能够传输外部设备上录入的参数至中央 控制器（52)。
30、根据权利要求 25所述的尿液引流控制系统， 其特征在于， 所述压 力传递面由弹性材料制成， 能够随所述膀胱内压力变化发生形变。
31、根据权利要求 30所述的尿液引流控制系统， 其特征在于， 所述尿 液引流控制系统还包括控制部分， 控制部分包括压力传递部件 （11 )和封 闭部件 ( 12 ), 所述压力传递部件 ( 11 )能够与压力传递面相接触， 并受压 力传递面形变产生的力的作用而发生位置移动； 所述封闭部件（12 ) 能够 随压力传递部件（ 11 )位置的移动而移动， 封闭部件（ 12 )位置移动时能 够控制尿液是否从尿液出口 （ 32 ) 流出。
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