Patent Application
20140378918
This application claims the priority of China Patent Application No. 201110457491.9, filed with the Patent Office of China on Dec. 31, 2011, titled “A URINE DRAINAGE AND CONTROL DEVICE THEREOF”, and the priority of China Patent Application No. 201120571031.4, filed with the Patent Office of China on the same day, titled “A URINE DRAINAGE AND CONTROL DEVICE THEREOF”, the contents of which are incorporated herein by reference in their entirety.
The present invention relates to the technical field of medical device, particularly to a urine drainage device, drainage control device, drainage control system and micturition method.
Clinically, there are many patients of paraplegia and hemiplegia caused by cerebrovascular diseases and spinal vascular diseases, and patients with bladder fistula, coma patients, patients with high paraplegia, etc. Most of them are accompanied by disorders of micturition, and indwelling catheterization has become a common means to solve the patient's micturition dysfunction.
The urinary catheterization device used in traditional indwelling urinary catheterization consists of a urinary catheter inserted into the urethra and a urine bag connected to the lower end of the urinary catheter. The urinary catheter continuously outputs the urine in the bladder, which results in that no normal internal pressure of the bladder can be formed, so that the detrusor and internal bladder sphincter of the patient are in a long period of disuse state. Consequently, the entire urinary tract system can not be protected by using the urinary continence principle of storing urine at low pressure and micturating at low pressure. Long-term use of urinary catheters in such a structure will produce the following risks.
1. The continuous drainage by the urinary catheter makes the bladder of a patient lack filling state for a long time, easily leads to adhesions of bladder wall.
2. The continuous drainage by the urinary catheter decreases the pressure gradient between the bladder and the outside, so that, in order to ensure a smooth drainage, it is often required to increase the outer diameter, hardness, etc. of the catheter wall, which results in the oppression of the urethral mucosa of the patient and the occurrence of ischemic injury.
3. The continuous drainage by the urinary catheter makes the nerve receptors in the bladder produce adaptive changes, so that they can no longer perceive the filling of urine within the blader or complete the micturition reflex, leading to urinary retention.
Due to the above risks of a traditional urinary catheterization device, researchers of medical devices have developed a variety of medical devices for urinary catheterization, in which, by setting a preset pressure, the pressure in the bladder is collected by a pressure sensor, and when the pressure in the bladder continuously reaches or exceeds the preset pressure, it is further determined whether the duration of the pressure is equal to or greater than the preset time. If the duration of the pressure is equal to or greater than the preset time, the control component alarms to prompt micturition, or automatically starts the micturition, and automatically closes the urinary catheterization route after the completion of the urine discharge. This process simulates the normal physiological micturition of the human body, avoids the loss of bladder fuction caused by the continuous micturition in the traditional urinary catheterization manner of indwelling urinary catheterization, and achieves, to some extent, the purpose of simulating the physiological periodic micturition in human body. The purpose of the avove-mentioned setting of the preset time is to prevent automatically starting the micturition to void the bladder because of the pseudo transiently increased bladder pressure in the patient caused by postural changes, coughing, sneezing, bladder spasms and other factors, but the actual pressure has not reached the preset pressure, so that the purpose of simulating the physiological periodic micturition in human body cannot be achieved. However, the above-mentioned devices have not made the correct handling for special conditions of the pseudo transiently increased bladder pressure in the patient. Because the duration of the pseudo transiently increased bladder pressure is short and is insufficient to reach the preset time, the control component will not alarm to prompt micturition or automatically start the micturition and the urinary catheterization route is still in a closed state, so that the high pressure in the bladder will push the urine to the direction of kidney and will make the urine flow in the opposite direction, even enter into the renal pelvis, leading to bacterial infections in ureter, renal pelvis, etc. Furthermore, the high pressure in the bladder can also make the urine escape into the gap between urinary catheter and the urethra, forming overflow of urine. The urine between the urinary catherter and the urethra will become the culture medium for bacteria and viruses, and the bactera and viruses will also go backward into the bladder, leading to greater risks of infection.
In summary, for the risks of urinary reflux and overflow of urine caused by pseudo transiently increased bladder pressure as well as the contradiction between the pseudo transiently increased bladder pressure and the simulation of physiological micturition in human body, all the prior products have not disclosed any technical solutions to solve them. In practical clinical treatment, the phenomena of urinary reflux and overflow of urine always exist. The current products can no longer meet the requirements of a patient for a safe urinary catheterization. Researches of medical devices need to find a medical device capable of safely proctecting the urinary route system and achieve the simulation of the physiological micturition in human body.
Furthermore, urodynamic examination is also an item commonly used in clinical examinations. The patients underwent indwelling urinary catheterization for performing urodynamic tests need to conduct examination in s specialized testing room for urodynamic tests, wherein, firstly extracting the indwelling urinary catheter in the urethra, inserting a piezometer tube, artificially filling the bladder, conducting examination, and inserting the urinary catheter again after completing the examination. This has brought great suffering to the patient, has increased the medical burden on the patient, and has increased the risks of infection. Moreover, the existing urodynamic examinations cannot performing real-time monitoring on the urodynamic parameters, and cannot reflect the physiological state of the naturally filled bladder, and also cannot achieve individualized bionic urinary drainage, and they are especially inconvenient for those bedridden patients with indwelling urinary catheterization. Currently, no such device has been reported which is capable of performing real-time urodynamic examination on patients underwent indwelling urinary catheterization.
The purpose of the present invention is to provide a urine drainage device comprising a urine inlet capable of connecting to the urinary catheter which is inserted into the human body and a urine outlet capable of connecting to the urine storage bag which stores urine, the urine drainge device further comprises a bionic bladder unit, the bionic bladder unit comprises a main body component capable of forming a urine storage cavity which strores urine, the urine storage cavity is connected to the urine inlet and the urine outlet via a connecting tube, the main body component comprises a first pressure transmission surface and a second pressure transmission surface capable of deforming with the change of the urine presure in the urine storage cavity, the connecting tube connecting the urine storage cavity and the urine outlet is a lower connecting tube, the lower connecting tube is provided with a first action area and a second action area on which external forces can be applied, the first action area and the second action area are oppositely disposed; when the external force is applied on both the first action area and the second action area simultaneously, the communication between the urine storage cavity and the urine outlet is blocked; the external force applied on the first action area and/or the second action area can be removed according to the deformation of the first pressure transmission surface and/or the second pressure transmission surface, and when any one external force applied on the first action area and the second action area is removed, the blockage between the urine storage cavity and the urine outlet can be removed, the communication between the urine storage cavity and the urine outlet can be restored. When the first pressure transmission surface and the second pressure transmission surface have the same function, the first pressure transmission surface or the second pressure transmission surface can be selected and used according to the actual need; similarly, when the first action area and the second action area have the same function and effect, the first action area or the second action area can be selected and used according to actual need. The urine storage cavity for storing urine is formed on the main body component, the urine storage cavity is communicated with the bladder in human body via a urinary catheter, and when the two are in different horizontal positions, the urine pressure in the bladder in human body and the urine pressure in the urine storage cavity can be mutually calculated according to the height difference, and therefore, collecting the changes of the urine pressure in the urine storage cavity can directly obtain the changes of urine pressure in the bladder in human body.
The change of the urine pressure in the urine storage cavity of the urine drainage device can be reflected by the deformation of the pressure transmission surfaces, and in turn it is further determined whether to conduct micturition according to the deformation level of the pressure transmission surfaces, thereby assisting the function of a patient to micturate. When controlled in an artificial manner, micturition can be conducted manually for the patient according to the deformation level and the micturition desire of the patient, which is high in flexibility; when mechanically controlled and electrically controlled, the examples described below can be referred for understanding. Furthermore, the urine drainage device in such a structure is of a simple structure and is suitable for large sclae production.
Preferably, the first action area and the second action area are oppositely disposed, and form a lower connecting tube when they are fastened. Removal of the external force acted on any one of the action areas can form the sectional area required for the communication between the urine storage cavity and the urine outlet. Of course, when all the external forces acted on both the first action area and the second action area are removed, the communication between the urine storage cavity and the urine outlet will become smoother.
Preferably, the main body component comprises two diaphragms, one diaphragm forms the first pressure transmission surface and the first action area, and the other diaphragm forms the second pressure transmission surface and the second action area. The two diaphragms are fastened and sealed, and the internal cavity formed by the oppositely disposed first pressure transmission surface and second pressure transmission surface is the urine storage cavity.
Preferably, the first pressure transmission surface and the second transmitting surface are made of an elastic material, and the first action area and the second action area are made of a flexible material. Of couse, the first pressure transmission surface, the second transmitting surface, the first action area and the second action area can be made of one flexible material having elasticity.
Preferably, the bionic bladder unit further comprises a hard cover housing. After fastening, the cover housing is capable of covering the portions on the main body component except the first pressure transmission surface, the second transmitting surface, the first action area and the second action area. The cover housing can protect the above-mensioned first pressure transmission surface, first action area, second transmitting surface and second action area against damage from exteral forces, and can fix the position of the entire bionic bladder unit.
Preferably, the urine inlet and the urine outlet are connected to a urine inlet tube and a urine outlet tube respectively, and the urine inlet tube is provided with a urinary catheter connector for connecting to the urinary catheter. The urinary catheter connector and/or the urine inlet tube are provided with a self-sealable region for temperature collecting and/or urine sampling. The self-sealable region for collecting temperature can be penetrated by a sharp temperature-collecting device, and can self-seal after extracting the collecting device, so that the urine does not leak out and contaminate the medical staff. The self-sealable region for urine sampling also has the above-mentioned self-sealable function.
The present invention further privides a urine drainage control device, comprising a urine drainage portion, a control portion and a housing containing the urine drainage portion and the control portion, the urine drainage portion is the above-mentioned urine drainage device; the control portion comprises a pressure transmission component and a closure component, the pressure transmission component is capable of contacting with the deformed first pressure transmission surface and/or second pressure transmission surface, and shifts in position by the action of force produced by the deformation of the first pressure transmission surface and/or the second pressue transmitting surface; the closure component is capable of shifting along with the shift in position of the pressure transmission component, and when shifting in position, the closure component is capable of applying or removing the external force acted on the first action area and/or the second action area, thereby blocking or unblocking the communication between the urine storage cavity and the urine outlet.
Preferably, there is a gap between the pressure transmission component and the corresponding pressure transmission surface thereof, and when the pressure transmission surface deforms along with the increasing pressure in the urine storage cavity, the gap can be tapered until eliminated. The purpose to leave the gap is to ensure that the urine storage cavity has a certain volume, so that the pressure transmission surface is capable of deforming within a resonable space, and simultaneously prevents the adhesion between the diaphragms. The pressure transmission surface corresponding to the pressure transmission component refers to a pressure transmission surface capable of having mechanical relationship with the pressure transmission component, and can be the first pressure transmission surface, or can also be the second pressure transmission surface. Of course, the corresponding action area can also be the first action aera or the second action area.
Preferably, the control portion further comprises a resistance component, the resistance component applies a predetermined resistance to the pressure transmission component and/or the closure component to block the deformation of the corresponding pressure transmission surface, and when the force of the corresponding pressure transmission surface acted on the pressure transmission component and/or the closure component is greater than the predetermined resistance, the pressure transmission component drives the closure component to shift in position. The resistance of the resistance component is produced by a spring, one end of the spring connects to the housing, and the other end connects to the pressure transmission component or the closure component.
Preferably, the resistance component further comprises an adjustment portion which adjusts the resistance component, the adjustment portion can compress or release the spring of the above-mentioned resistance component, so as to adjust the predetermined resistance applied by the spring to the pressure transmission component or the closure component.
Preferably, the pressure transmission component and the closure component are a unitary structure, the control portion further comprises a rotation axis, and when the pressure transmission component shifts in position along with the deformation of the corresponding pressure transmission surface, the pressure transmission component and the closure component rotate together around the rotation axis, so that the closure component applies or removes the external force acted on the corresponding action area, thereby blocking or unblocking the communication between the urine storage cavity and the urine outlet.
Preferably, the pressure transmission component and the closure component are a unitary structure, the pressure transmission component is provided with a guide rod, the housing is provided with a socket, the guide rod is capable of shift in the socket in the stretching direction of the spring, and when the pressure transmission component shifts in position along with the deformation of the corresponding pressure transmission surface, the pressure transmission component and the closure component shift together in the socket, so that the closure component applies or removes the external force acted on the corresponding action area, thereby blocking or unblocking the communication between the urine storage cavity and the urine outlet.
Preferably, the pressure transmission component and the closure component are a split design, the pressure transmission component comprises a first gear, the closure component comprises a closure head and a second gear engaged with the first gear, both the first gear and the second gear are fixed with respect to the housing; the spring and the pressure transmission component are connected by a movable axis, and when the pressure transmission component shifts in position along with the deformation of the corresponding pressure transmission surface, the first gear drives the rotation of the second gear so as to drive the closure head to apply or remove the external force acted on the corresponding action area, thereby blocking or unblocking the communication between the urine storage cavity and the urine outlet.
Preferably, the pressure transmission component and the closure component are hinged, and when the pressure transmission component shifts in position along with the deformation of the corresponding pressure transmission surface, it drives the rotation of the closure component, applies or removes the external force acted on the corresponding action area, thereby blocking or unblocking the communication between the urine storage cavity and the urine outlet.
Preferably, the control portion comprises a manually controlled valve, so as to manually apply or remove the external force acted on the corresponding action area according to the parameters such as the deformation level, thereby blocking or unblocking the communication between the urine storage cavity and the urine outlet.
The urine drainage control device employs mechanical principles, transfers the pressure produced by the deformation of the pressure transmission surface to the pressure transmission component, and thus the pressure transmission component drives the closure component to apply or remove the external force on the corresponding action area, thereby blocks or unblocks the communication between the urine storage cavity and the urine outlet. When the device is initially used, the closure component applies a certain external force acted on the corresponding action area, and blocks the communication between the urine storage cavity and the urine outlet, and when the pressure in the bladder reach the threshold, the force produced by the deformation of the pressure transmission surface is capable of triggering the shift in position of the pressure transmission component and the closure component, thereby removes the external force acted on the action area, the urine storage cavity and the urine outlet communicate, the urine enters into a urine storage bag, so as to complete the process of releasing pressure and micturition. The advantageous effect of the device is that, when the patient coughs, turns over or the like so as to cause a pseudo instant increase of the bladder pressure, the device is capable of instantly releasing the pressure, so as to prevent the risks of urine reflux, overflow of urine, etc. caused by the instantly increase of the pressure in the bladder. The urine drainage device can also simulate the normal physiological micturition of the human body in coorperation with the manually controlled valve. When the patient feels a micturition desire or the deformation level of the pressure transmission surface is relatively greater, the patient can manually start the manually controlled valve to perform micturition. This helps to train the bladder function of the patient.
The present invention further provides a urine drainage control system, comprising a urine drainage control portion and an electric control portion, the urine drainage control portion and the electric control portion are contained in the housing, the urine drainage control portion is the above-mensioned urine drainage control device, the electric control portion comprises a central controller, an execution component, and a pressure sensor that collects the pressure in the bladder, the central controller receives the pressure signal outputted by the pressure sensor, and when the pressure is equal to or greater than the micturition threshold, and the duration is equal to or greater than the preset judgement time, the central controller outputs an instruction of communicating the urine storage cavity and the urine outlet to the execution componet.
The urine drainage control system sufficiently contemplates the special conditions of a pseudo transiently increased bladder pressure in the patient caused by postural changes, coughing, sneezing, bladder spasms and other factors, and at the same time contemplates the condition of normal physiological micturition when the bladder of the patient reach an effective pressure, which provides a “double insurance” for the process of micturition, not only achieves the function of training the bladder of the patient, but also avoids the the risks of urine reflx, overflow of urine, etc. When the bladder pressure of the patient is equal to or greater than the preset micturition threshold, and the duration is equal to or greater than the judgement time, the electric control portion controls the communication between the urine storage cavity and the urine outlet, and this process simulates the process of normal physiological micturition of the human body, and helps to restore the bladder function of the patient; when the special conditions of a pseudo transiently increased bladder pressure in the patient occur, the risks of urinary reflux and overflow of urine in the patient are avoided because the function of releasing pressure and micturition are started by the mechanical portion. One aspect of the purpose of the above setting avoids the defects that a general electric control device cannot solve the risk caused by pseudo transiently increased bladder pressure in the patient, and the other aspect simulates the normal physiological micturition more precisely. For a common electric control device, when the pseudo transiently increased bladder pressure in the patient occurs, if the micturition is started, this is equivalent to empty the urine in the bladder of the patient before the actual pressure arrives the required micturition pressure, and thus cannot truly simulate the process of normal physiological micturition, if the micturition is not started, the risks of overflow of urine and urine reflux brought by the transiently increased pressure cannot be solved; after adding the mechanical device, due to the chararistics of a mechanical structure, the transiently increased pressure can drive the pressure transmission component and the closure component to shift in position and thus communicate the urine storage cavity and the urine outlet, and with the rapid decrease of pressure, the deformation level of the pressure transmission surface decrease, and the amount of shift of the pressure transmission component and the closure component also decrease, the closure component again applies external force on the corresponding action area and blocks the communication between the urine storage cavity and the urine outlet, so as to effectively avoid the risks of overflow of urine and urine reflux.
Preferably, the pressure sensor collects the blader pressue transmitted by the corresponding pressure transmission surface, and the execution component applies or removes the external force on the corresponding action aera, thereby blocking or unblocking the communication between the urine storage cavity and urine outlet. The pressure transmission surface corresponding to the pressure sensor refers to a pressue transmitting surface capable of transmitting the bladder pressure to the pressure sensor, and can be the first pressure transmission surface, or can be the second pressure transmission surface. Of course, the corresponding action area can also be the first action area or the second action area.
Preferably, the driving mechanism of the execution component is an electric motor, a solenoid valve, an air pump, etc. When utilizing an air pump as the execution component, the execution component further comprises an air sac, the central controller controls the air pump to inflate the air sac according to the pressure signal from the pressure ssensor in order that the air sac applies external force acted on the corresponding action area, or controls the air sac to deflate in order to remove the external force acted on the corresponding action area, thereby blocking or unblocking the communication between the urine storage cavity and the urine outlet.
Preferably, the drainage control device is provided with a positioning slot, a housing covering the urine drainage control system is provided with a positioning projection fitted to the positioning slot, so that it is more convenient and efficient when using the device.
Preferably, the urine drainage control system further comprises a weight sensor, which is used for real-time monitoring the weight of urine in the urine storage bag, and outputs the signal to the central controller.
Preferably, the urine drainage control system further comprises a display component, an input component, a data storage component; the display component connects to the central controllor, for displaying the monitored data and the artificially set data as well as the calculated result by the central controller; the input component connects to the central controller, for setting parameters and/or querying the storage record of the data storage component and the calculated result of the central controller; the data strorage component which is used for the output of data and the input of data, the data storage component is capable of storing the parameter set by the input component, as well as the urine flow rate curve, the urinary output curve, the bladder pressure curve, the abdominal pressure curve, etc. that are anlyzed and generated by the central controller according to the parameters of pressure, weight, time, urine density, etc., and transports the above-mentioned curves to an external device, and is capable of further tranporting the parameter recorded on the external devices to the central controller;
the pressure sensor of the urine drainage system can real-time monitor the bladder pressure, and transport the pressure signal to the central controller, a series of curves and parameters reflecting the bladder function can be obtained after processing by the central controller, including monitoring the residual urine volume in the bladder, bladder volume, bladder volume when initially feeling the sense of urine, the contraction force of detrusor during micturition, etc. The weight sensor can real-time monitor the change of urine weight in the urine storage bage, the change of urine amount over time can be obtained after the weight signal is transported to the central controller and processed, so as to obtain the flow rate curves and the micturition curves. The weight sensor and the central controller may further precisely meter the urine amount over 24 h, the urine amount per hour, etc., and display whether the human body is in an abnormal condition of polyuria, oliguria, anuria, oliguria over 1 h, etc. on the display component, according to the preset analytical value of urine amount. The urine drainage control system can perform urodynamic tests, which is especially suitable for the long-term bedridden patients patients with indwelling urinary catheterization, and can perform 24 h real-time urodynamic monitoring on a patient in bed, and can timely, accurately, dynamically obtain the urodynamic parameters; there is no need to repeatedly insert and extract the urinary catheter, the bladder is naturally filled, the agony of the patient is reduced, the risk for infection is decreased, and the naturally filled physiological state of bladder can be truly reflected.
In order to more accurately reflect the bladder pressure and perform urodynamic test, the present device is further provided with a mobile display component and an external abdominal pressure acquisition component, the external abdominal pressure acquisition component can collect the abdominal pressure of human body, and transport the collected signal to the central controller, the central controller is provided with a connector which connect to the external abdominal pressure acquisition component, the mobile display component is wirelessly connected to the central controllor, for displaying the contents displayed by the external abdominal pressure acquisition component.
The purpose of the present invention is to further provide a micturition method which protects the bladder function, the method comprises:
presetting a threshold of releasing pressure as well as a time to start releasing pressure and a duration of releasing pressure;
collecting the pressure in the bladder;
judging whether the pressure is equal to or greater than the preset threshold of releasing pressure;
if the judgement result is that the pressure is equal to or greater than the preset threshold of releasing pressure, then starting micturition to release pressure within the time to start releasing pressure, and the time for releasing pressure is the preset duration of releasing pressure.
Preferably, the method further comprises: presetting a micturition threshold, a judgement time and a micturition duration, the micturition threshold is smaller than the above-mentioned threshold of releasing pressure; collecting the pressure in the bladder; judging whether the pressure is equal to or greater than the preset threshold of releasing pressure; if the judgement result is that the pressure is equal to or greater than the preset threshold of releasing pressure, then stating micturition to release pressure within the time to start releasing pressure, the time for releasing pressure is the preset duration of releasing pressure; if the judgement result is that the pressure is smaller than the preset threshold of releasing pressure, then continuing to judge whether the pressure is equal to or greater than the micturition threshold, if the judgement result is that the pressure is equal to or greater than the preset micturition threshold, then further judging whether the duration of the pressure is equal to or greater than the judgement time, if the judgement result is that the duration of the pressure is equal to or greater than the judgement time, then performing micturition, and the time for micturition is the preset micturition duration.
Of course, it can also be judged whether the pressure is equal to or greater than the preset micturition threshold; if the judgement result is that the pressure is equal to or greater than the preset micturition threshold, then further judging whether the pressure is equal to or greater than the preset threshold of releasing pressure, if the judgement result is that the pressrue is equal to or greater than the threshold of releasing pressure, then starting the micturition to release pressure within the time to start releasing pressure, the time for releasing pressure is the preset duration of releasing pressure; if the judgement result is that the pressure is equal to or greater than the preset micturition threshold and smaller than the micturition threshold, then continuing to judge whether the duration of the pressure is equal to or greater than the judgement time, if the judgement result is that the duration of the pressure is equal to or greater than the judgement time, then performing micturition, and the time for micturition is the preset micturition duration; if the judgement result is that the pressure is smaller than the preset micturition threshold, then continuing to collect the pressure in the bladder for performing judgement.
Preferably, the duration of releasing pressure is smaller than the micturition duration. The time to start releasing pressure is a shorter time, the time to start releasing pressure is smaller than the judgement time, and may be close to zero in some conditions, that is to immediately perform micturition to release pressure. Of course, the above-mentioned process is repeated, and when all the judgement is negative, the judgement for pressure is continued to perform.
The purpose of the present invention is to further proved a urine drainage control system, comprising a urine inlet capable of connecting to a urinary catheter which is inserted into the human body, a urine outlet capable of connecting to a urine storage bag which stores the urine, and at least a pressure transmission surface on at least one area between the urine inlet and the urine outlet, the pressure transmission surface is capable of transmitting the pressure in the bladder, the urine drainage control system further comprises:
a pressure sensor, which collects the pressure in the bladder through the above-mentioned pressure transmission surface, and generates and transports pressure signal, the pressure transmission surface is not necessarily deformed, as long as the pressure can be collected by the pressure sensor;
a central contoller, which receives the pressure signal outputted by the pressure sensor, and judges whether the pressure is equal to or greater than the threshold of releasing pressure, if the judgement result is yes, then starting the micturition to release pressure within the time to start releasing pressure, the time for releasing pressure is the preset duration of releasing pressure, if the judgement result is no, then continuing to judge whether the pressure is equal to or greater than the micturition threshold, if the judgement result is yes, then further judging whether the duration of the pressure is equal to or greater than the judgement time, if the judgement result is yes, then outputing an instruction of openning the urine outlet to perform micturition, and the time for micturition is the preset micturition duration;
or central controller recives the pressure signal outputted by the pressure sensor, and judges whether the pressure is equal to or greater than the preset micturition threshold, if the judgement result is yes, then further judging whether the pressure is equal to or greater than the preset threshold of releasing pressure, if the judgement result is yes, then starting the micturition to release pressrue within the time to start releasing pressure; if the judgement result is no, then continuing judging whether the duration of the pressure is equal to or greater than the judgement time, if the judgement result is yes, then outputing an instruction of opening the urine outlet to perform micturition, and the time for micturition is the preset micturition duration;
an execution component, which receives the instruction from the central controller, and controls whether the urine flows out from the urine outlet.
The above-mentioned micturition method is intended to combine the pseudo transiently increased bladder pressure of the patient with simulating the normal physiological micturition in human body, and conducting pressure collecting and communication control all by utilizing electronically controlled manner, which has the following advantages as compared to a mechanical structure: more precise, the product is smaller in volume, and the operation is more convenient, etc.
Preferably, the driving mechanism of the execution component is an electric motor, a solenoid valve, an air pump, etc. When selecting an air pump as the execution component, the execution component further comprises an air sac, the central controller controls the air pump to inflate the air sac according to the pressure signal from the pressure ssensor in order that the air sac applies external force acted on the corresponding action area, thereby closing the urine outlet; or controls the air sac to deflate in order to remove the external force acted on the corresponding action area, thereby opening the urine outlet.
Preferably, the urine drainage control system further comprises a weight sensor, the weight sensor is used for real-time monitoring the weight of urine in the urine storage bag, and transports the weight signal to the central controller.
Preferably, the urine drainage control system further comprise a display component, an input component, a data storage component; the display component connects to the central controllor, for displaying the monitored data and the artificially set data and the calculated result by the central controller; the input component connects to the central controller, for setting parameters and/or querying the storage record of the data storage component and the calculated result by the central controller; the data strorage component which is used for the output of data and the input of data is capable of storing the parameters set by the input component, as well as the urine flow rate curve, the urinary output curve, the bladder pressure curve and the abdominal pressure curve that are anlyzed and generated by the central controller, and is capable of transporting the above-mentioned curves to an external device, and is capable of further tranporting the parameter recorded on the external devices to the central controller;
In order to more accurately reflect the bladder pressure and perform urodynamic test, the above-mentioned system further comprises a mobile display component and an external abdominal pressure acquisition component, the external abdominal pressure acquisition component can collect the abdominal pressure of human body, and transports the collected signals to the central controller, the central controller is provided with a connector which connects to the external abdominal pressure acquisition component; the mobile display component is wirelessly connected to the central controllor, for displaying the contents displayed by the external abdominal pressure acquisition component.
Preferably, the pressure transmission surface is made of an elastic material, and can deform along with the change of pressure in the bladder. The urine drainage control system further comprises a control portion, the control portion comrpises a pressure transmission component and a closure component, the pressure transmission component is capable of contacting with the pressure transmission surface, and shifts in position by the action of force produced by the deformation of the pressure transmission surface; the closure component can shift along with the shift in position of the pressure transmission component, and when shifting in position, the closure component is capable of controling whether the urine flows out from the urine outlet.
pressure transmission component 11, first gear 111, closure component 12, closure head 121, second gear 122, resistance component 13, spring 131, adjustment portion 132, handle 132a, index plate 132b, right threaded housing 132c, left threaded housing 132d, limit component 14, rotation axis 15, bionic bladder unit 2, main body component 21, first diaphragm 21a, second diaphragm 21b, first pressure transmission surface 211, first action area 212, second pressure transmission surface 213, second action area 214, urine storage cavity 215, connecting tube 21.6, lower connecting tube 216a, cover housing 22, right cover housing 222, left cover housing 221, bare hole 223, urine inlet 31, urine outlet 32, urinary inlet tube 41, urinary outlet tube 42, urine storage bag 43, hook 431, urinary catheter connector 44, temperature measuring 45, urine sampling 46, pressure sensor 51, central controller 52, execution component 53, weight sensor 54, display component 55, input component 56, data storage component 57, mobile display component 58, external abdominal pressure acquisition component 59, housing 6, manually controlled valve 7, rotation handle 71, valve main body 72, reset component 73, valve spool 74, valve housing 75.
In order to make the purpose, the technical solution and the benificial effect of the present invention more clearly under understood, the specific embodiments of the present invention are further illustrated in detail below in conjuction with accompanied drawings. The illustrative embodiments and the description thereof of the present invention herein are used for explanation of the present invention, without limiting the present invention.
As is shown in
As is shown in
Specifically, the main body component 21 comprises two diaphragms, i.e. the first diaphragm 21a and the second diaphragm 21b as shown in
In order to protect the diaphragms from being damaged by external force, the bionic bladder unit 2 further comprises a cover housing 22 made of hard material, as is shown in
Specifically, the lower connecting tube 216a connecting the urine storage cavity 215 and the urine outle 32 is in an elongated tubular shape, the urine storage cavity 215 is in an oval shape, the first pressure transmission surface 211 and the second pressure transmission surface 213 are also in an oval shape. The shape of the above-mentioned pressure transmission surface is designed to more significantly highlight the deformation of the pressure transmission surface, and the elongated design of the lower connecting tube 216a is convinient for its blockage by external force.
With respect to each exapmple mentioned above, to facilitate the communication of the bionic bladder unit 2 and the urine storage bag 43 as well as the urinary catheter, the urine inlet 31 and urine outlet 32 can connect to the urinary inlet tube 41 and urinary outlet tube 42 respectively, wherein the urinary inlet tube 41 is communicated with the urinary catheter, and the urinary outlet tube 42 is communicated with the urine storage bag 43. Both the urinary inlet tube 41 and the urinary outlet tube 42 can be provided with a manually controlled valve 7, so that they can be blocked by clamping the tube if required. As is shown in
As is shown in
In one status: when the device is initially used, the closure component 12 blocks the communication bewteen the urine storage cavity 215 and the urine outlet 32, and when postural changes, coughing, bladder spasms and other factors occur in a patient, the pressure in the bladder transiently increases and exceeds the safe value that can be afforded by the bladder, the force produced by the deformation of the pressure transmission surface is capable of driving the pressure transmission component 11 to shift, the pressure transmission component 11 further drives the closure component 12 to shift, the closure component 12 removes the external force applied on the the action area, the urine storage cavity 215 and the urine outlet 32 communicate, and the urine are micturated to release pressure, thereby protecting the bladder from damage, and preventing the occurrence of dangerous conditions such as urine reflux and overflow of urine; when the pressure in the bladder reduces below the safe value of the bladder, the deformation level of the pressure transmission surface reduces, the pressure transmission component 11 and the closure component 12 also recover correspondingly, the closure component 12 continues to apply external force on the action area, so as to block the communication between the urine storage cavity 215 and the urine outlet 32. The pressure transmission surface mentioned above can be selected to be the first pressure transmission surface 211 or the second pressure transmission surface 213.
In another status: when the device is initially used, the closure component 12 applies external forces to the action area so as to block the communication between the urine storage cavity 215 and the urine outlet 32, and with the increasing of urine in the urine storage cavity 215, the first pressure transmission surface 211 and/or the second pressure transmission surface 213 gradually deform, and whether to operate the manually controlled valve 7 to open the comunication between the urine storage cavity 215 and the urine outlet 32 is determined according to the deformation level of the pressure transmission surface observed by the naked eyes of human. This type of setting makes it possible to micturate when the urine pressure in the bladder achieves a certain value, thereby training the the effects of the bladder to perceive the filling of urine in the bladder and to achieve the urinary reflex, so as to ahieve tha effect of managing the micturition activity of the bladder, and finally achieving the vuluntary micturition of the bladder
As is shown in
The urine drainage control device employs a mechanical principle to control the releasing of pressure and the micturition, protects the bladder form damage, to achieve the technical effects of preventing reflux and preventing overflow of urine, and achieves the function of simulating the normal physiological micturition in human body according to the pressure in the bladder, and the operation is simple, and easy for the patients themselves and medical staff to operate.
There is a gap between the pressure transmission component 11 and the pressure transmission surface, and when the pressure transmission surface deforms along with the increasing pressure in the urine storage cavity 215, the gap can be tapered until eliminated, i.e. when the urine pressure in the urine storage cavity 215 reaches a certain level, the deformation level of the first pressure transmission surface 211 or the second pressure transmission surface 213 can satisfy to achieve contacting with the pressure transmission component 11, thereby driving the pressure transmission component 11 to shift.
The control portion of the urine drainage control device further comprises a resistance component 13, as is shown in
As is shown in
The pressure transmission component 11 and the closure component 12 herein can also be a split structure, as long as both of them remain relatively fixed. In addition, the pressure transmission component 11 can also be provided with a limit component 14, which can be a portion on the pressure transmission component 11, for limiting the pressure transmission component 11 to shift within a certain rainge or to locate at a certain position after the shifting of the pressure transmission component 11, so that the closure component 12 remove the closure to the first action area 212 within a period of time.
As is shown in
As is shown in
As is shown in
The housing 6 on the urine drainage control device can be provided with a positioning projection, the cover housing 22 of the urine drainage device is provided with a positioning slot fitted to the positioning projection. This type of setting manner simply makes the installation of the urine drainage device be more convenient, rapid, and easy to dissambly.
The present invention further provides a urine drainage control system, as is shown in
The working flow chart of the above-mensioned urine drainage control system is as shown in
The above-mentioned execution component 53 comprises an air pump and an air sac, the air sac is capable of applying an external force to the second action area 214, blocks the communication between the urine storage cavity 215 and the urine outlet 32, and can also execute the control signal of releasing air sent by the central controller 52, to remove the external force applied on the second action area 214, and comunicates the urine storage cavity 215 with the urine outlet 32, to perform normal micturition. After the completing of the micturition process, the air pump inflates the air sac, to restore blocking the communication between the urine storage cavity 215 and the urine outlet 32.
A micturition method that protects the bladder function, as is shown in
(1) if the judgement result is that the pressure is equal to or greater than the preset threshold of releasing pressure, then starting micturition to release pressure within the time to start releasing pressure, and the time for releasing pressure is the preset duration of releasing pressure;
(2) if the judgement result is that the pressure is smaller than the preset threshold of releasing pressure, then continuing to judge whether the pressure is equal to or greater than the micturition threshold, if the judgement result is that the pressure is equal to or greater than the preset micturition threshold, then further judging whether the duration of the pressure is equal to or greater than the judgement time, if the judgement result is that the duration of the pressure is equal to or greater than the judgement time, then performing micturition, and the time for micturition is the preset micturition duration.
Of course, it can also initially juge whether the pressure is equal to or greater than the preset micturition threshold;
(1) if the judgement result is that the pressure is equal to or greater to the preset micturition threshold, then further judging whether the pressure is equal to or greater than the preset threshold of releasing pressure, if the judgement result is that the pressure is equal to or greater than the preset threshold of releasing pressure, then starting micturition to release pressure within the time to start releasing pressure, and the time for releasing pressure is the preset duration of releasing pressure;
(2) if the judgement result is that the pressure is equal to or greater than the preset micturition threshold, then further judging whether the pressure is equal to or greater than the preset threshold of releasing pressure, if the judgement result is that the pressure is smaller than the preset threshold of releasing pressure, then continuing to judge whether the duration of the pressrue is equal to or greater than the judgement time, if the judgement result is that the duration of the pressure is equal to or greater than the judgement time, then performing micturition, and the time for micturition is the preset micturition duration;
(3) if the judgement result is that the pressure is smaller than the preset micturition threshold, then continuing to collect the pressure in the bladder for judgement.
a pressure sensor 51, which collects the bladder pressure via the above-mentioned pressure transmission surface, and generates and transmits a pressure signal;
a central controller 52, which receives the pressure signal outputted by the pressure sensor 51, and judges whether the pressure is equal to or greater than the threshold of releasing pressure, if the judgement result is yes, then starting micturition to release pressure within the time to start releasing pressure, and the time for releasing pressure is the preset duration of releasing pressure, if the judgement result is no, then continuing to judge whether the pressure is equal to or greater than the micturition threshold, if the judgement result is yes, then outputing an instruction of opening the urine outlet 32 to perform micturition, and the time for micturition is the preset micturition duration;
or the central controller 52 receives the pressure signals outputted by the pressure sensor 51, and judges whether the pressure is equal to or greater than the preset micturition threshold, if the judgement result is yes, then further judging whether the pressure is equal to or greater than the preset threshold of releasing pressure, if the judgement result is yes, then starting micturition to release pressure within the time to start releasing pressure, and the time for releasing pressure is the preset duration of releasing pressure; if the result for judging is no, then continuing to judge whether the duration of the pressure is equal to or greater than the judgement time, if the judgement result is yes, then outputing an instruction of opening the urine outlet 32 to perform micturition, the time for micturition is the preset micturition duration;
an execution component 53, which receives the instruction outputted by the central controller 52, and controls whether the urine flows out from the urine outlet 32.
The driving mechanism of the execution component 53 is an air pump, the execution component 53 further comprises an air sac, the central controller 52 controls the air pump to inflate the air sac according to the pressure signal from the pressure sensor 51, so that the air sac applies an external force acted on the urine outlet 32 to close the urine outlet 32; or controls to deflate the air sac, so as to remove the external force acted on the urine outlet 32 to open the urine outlet 32.
The urine drainage control system further comprises a weight sensor 54, a display component 55, an input component 56, a data storage component 57, a mobile display component 58 and an external abdominal pressure acquisition component 59. The weight sensor 54 is used for real-time monitoring the weight of urine in the urine storage 43, and transports the weight signal to the central controller 52. When the urine weight exceeds the preset value, the central controller 52 can send out a warning signal to change the urine storage bag 43, and the central controller 52 is capable of plotting a series of curves reflecting the bladder functions, such as urine flow rate curve, urinary output and weight change curve, according to the parameters such as weight signal, micturition time and urine density. The display component 55 is connected to the central controller 52, for displaying the monitored data and the artificially set data as well as the calculated results of the central controller 52; the input component 56 is connected to the central controller 52, for setting parameter and/or querying the stored record of the data storage component 57 and the calculated result of the central controller 52; the data stroage component 57 is used for the output of data and the input of data, the data storage component 57 is capable of storing the parameter set by the input component 56, as well as the urine flow rate curve, the urinary output curve, the bladder pressure curve and the abdominal pressure curve that are anlyzed and generated by the central controller, and is capable of transporting the above-mentioned curves to an external device, and is capable of further tranporting the parameter recorded on the external devices to the central controller; the external abdominal pressure acquisition component 59 can collect the abdominal pressure in the human body, and transports the collected signal to the central controller 52; the mobile display component 58 is wirelessly connected to the central controllor, for displaying the contents displayed by the external abdominal pressure acquisition component 59. This system can be powered by a battery or powered by a fixed power source.
The pressure transmission surface of the urine drainage control system is made of an elastic material, and is capable of deforming along with the change of pressure in the bladder. The urine drainage control system further comprises a control portion, the control portion comrpises a pressure transmission component 11 and a closure component 12, the pressure transmission component 11 is capable of contacting with the pressure transmission surface, and shifts in position by the action of force produced by the deformation of the pressure transmission surface; the closure component 12 is capable of shifting along with the shift in position of the pressure transmission component 11, when shifting in position, the closure component 12 is capable of controling whether the urine flows out from the urine outlet 32.
The urine drainge device, the urine drainage control device, the micturition method which protects the bladder function and the urine drainage control system provided by the present invention are all described above in detail. Particular examples are utilized herein to illustrate the principles and embodiments of the present invention, however, the examples described above are used for helping understanding the method of the present invention and the core idea thereof. It should be pointed out that an ordinary person skilled in the art can further performing various improvements and modifications to the present invention without departing from the principles of the present invention, and these improvements and modifications also fall within the protection scope of the claims of the present invention.
| Number | Date | Country | Kind |
|---|---|---|---|
| 201110457491.9 | Dec 2011 | CN | national |
| 201120571031.4 | Dec 2011 | CN | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/CN2012/087979 | 12/31/2012 | WO | 00 | 6/27/2014 |
