WO2023243745A1

WO2023243745A1 - Urodynamic study apparatus for controlling sensor location

Info

Publication number: WO2023243745A1
Application number: PCT/KR2022/008513
Authority: WO
Inventors: 오승준
Original assignee: 사피엔메드 주식회사
Priority date: 2022-06-16
Filing date: 2022-06-16
Publication date: 2023-12-21

Abstract

The present invention provides a urodynamic study apparatus comprising: a urethral catheter that is inserted into the bladder of a patient; a first sensor distanced from the patient and connected to the urethral catheter to measure internal pressure of the bladder; a rectal catheter that is inserted into the rectum of the patient; a second sensor distanced from the patient and positioned adjacent to the first sensor and connected to the rectal catheter to measure the abdominal pressure; and a first location control unit that controls the height of the first and second sensors in accordance with the posture of the patient.

Description

Urodynamic testing device for sensor position control

The present invention relates to a device that can adjust the positions of the bladder pressure sensor and abdominal pressure sensor of a urodynamic examination device.

Proper storage and excretion of urine is achieved through the integration of the functions of the bladder and urethral sphincter and the nervous system that controls these organs. A urodynamic study is a detailed test that diagnoses dysfunction of the bladder and urethral sphincter. Urodynamic tests include uroflowmetry, filling cystometry, pressure-flow study, urethral pressure profile, and urethral sphincter electromyography. ) is a general name for tests consisting of several detailed items such as: In patients with urinary disorders and urinary incontinence, detailed tests are selectively performed.

Through urodynamic testing, medical staff can obtain detailed information necessary to accurately identify the characteristics of lower urinary tract dysfunction. Based on the results of urodynamic testing, medical staff can clearly distinguish between various types of bladder and urethral dysfunction that can be expressed clinically even in a single disease entity.

The most important role of urodynamic testing is to provide the medical staff with the detailed information necessary to determine the prognosis and establish a treatment plan for patients with specific urinary tract dysfunction. Based on this, we can provide the best treatment method applicable to the patient.

Urodynamic testing is the single most important test in determining the prognosis and treatment of lower urinary tract dysfunction. Therefore, it is essential for medical staff to accurately interpret the patient's urodynamic test results.

Figure 1a shows intravesical pressure (Pves), abdominal pressure (Pabd), detrusor pressure (Pdet), and urethral pressure measured during filling cystometry with the patient in the supine position. This is a graph of sphincter electromyography (EMG) activity.

Referring to Figure 1A, urodynamic testing includes several detailed measurements that identify various indicators related to the storage and emptying function of urine. The urodynamic test uses the patient's intravesical pressure (11, Pves), abdominal pressure (12, Pabd), detrusor pressure (13, Pdet), and urethral sphincter activity (14, urinary sphincter activity) information measured through the urodynamic test device. By having medical staff interpret the results, it is possible to diagnose the patient's lower urinary tract dysfunction.

Here, since the detrusor pressure (13) cannot be directly measured by a urodynamic test device, it is displayed as a virtual value obtained by subtracting the abdominal pressure (12) from the intravesical pressure (11) in real time through computer calculation.

Before performing a correct urodynamic test, basic preparation processes such as calibration and zeroing are necessary. Urodynamic test indicators currently used, such as pressure or urinary flow, are values measured as electrical signals and then reinterpreted in real time as actual values. Therefore, there is no need to perform it for every test, but it is necessary to periodically calibrate the actual values and electrical signal measurements.

Meanwhile, the zero point adjustment process is not only necessary for each patient's examination, but is also required for each detailed examination even for one patient's examination. In the case of urodynamic testing, since the pressure transducer is not the same as intravesical pressure or abdominal pressure, the electrical signal values of each pressure transducer have different conversion standards.

In particular, in urodynamic tests, detrusor pressure is calculated and observed in real time by calculating the difference between intravesical pressure and abdominal pressure. If the standards for these two values are different, the measured values may show completely different values. Therefore, it is difficult to make the standard heights the same and adjust the zero point. very important. Therefore, just before performing the urodynamic test for each patient, the patient is placed in the supine position and the reference heights of these transducers are adjusted to zero before the test is started. After performing filling cystometry in the supine position, the patient is usually placed in a standing or sitting position for a pressure-flow study. do. Therefore, if the patient's posture changes during each detailed examination, the zero point must be adjusted again.

The method of zero-adjusting the pressure is to first set the pressure transducer position to the standard height at atmospheric pressure, zero-adjust it to zero, and then measure the pressure. In the International Continence Society (ICS), this reference height is set at the upper edge of the symphysis pubis and is called the ICS reference level.

When performing detailed tests of urodynamic testing, the test may be performed by changing the patient's test position to a standing position, sitting position, or semi-Fowler's position. Each time this position is changed, the position of the suprapubic border changes, and each time, the reference height of the pressure transducer must be manually adjusted to the position of the patient's suprapubic border. Meanwhile, during a urodynamic test, the patient can assume positions such as supine position, sitting position, or standing position. During this process, the pressure transducer and the patient's bladder or rectum are connected to the patient's bladder or rectum. A height difference occurs at the end of the catheter, which affects the intravesical pressure (11, Pves) and abdominal pressure (12, Pabd) measurements.

However, the conventional urodynamic testing device has a problem in that the change in height of the catheter end that occurs due to a change in the patient's posture is directly reflected in the measurement value.

Figure 1b is a graph of intravesical pressure, abdominal pressure, detrusor pressure, and urethral sphincter activity measured when the patient changes from the supine position to the standing position during filling.

Referring further to Figure 1b, at the time (t1) when the patient changes posture from the supine position to the standing position, the intravesical pressure (11, Pves) and abdominal pressure (12, Pabd) rapidly increase. You can check that it does.

That is, in conventional urodynamic testing devices, there is a problem in that the intravesical pressure (Pves) and abdominal pressure (Pabd) measurements are affected by changes in the position of the end of the catheter, and this problem may cause medical staff to misdiagnose. .

The present invention was created to solve the above-mentioned problems and provides a urodynamic examination device for sensor position control that can precisely adjust the positions of the sensor and the end of the catheter according to the patient's posture.

A urodynamic testing device according to an embodiment of the present invention includes a urethral catheter inserted into the bladder through the patient's urethra to measure intravesical pressure (Pves); A first sensor arranged to be spaced apart from the patient and connected to the urethral catheter to measure intravesical pressure; A rectal catheter inserted into the rectum to measure the patient's abdominal pressure (Pabd); a second sensor spaced from the patient, disposed adjacent to the first sensor, and connected to the rectal catheter to measure abdominal pressure; and a first position control unit that adjusts the height of the first sensor and the second sensor according to the patient's posture.

The first position adjusting unit is coupled to a transfer rail to enable transfer in the vertical direction on the transfer rail, and includes a mounting frame on which the first sensor and the second sensor are installed, and, depending on the patient's posture, the mounting frame and The mounting frame may be transferred in the vertical direction on the transport rail so that the distance between the signal transmitting and receiving unit that measures the distance between the patient's pubic bone and the mounting frame and the patient's pubic bone is the shortest distance.

The urodynamic testing device may further include a second position adjusting unit that adjusts the heights of the first sensor and the second sensor, respectively, depending on the positions of the tip of the urethral catheter tip and the rectal catheter.

The second position adjusting unit includes a first height adjusting unit installed on the mounting frame to adjust the height of the first sensor, and installed on the mounting frame adjacent to the first height adjusting unit to control the second sensor. It may include a second height adjustment unit that adjusts the height.

The urodynamic testing device further includes a posture detection unit that detects the patient's posture, and the first position control unit adjusts the heights of the first sensor and the second sensor according to the patient's posture detected by the posture detection unit. It can be characterized by adjustment.

The urodynamic testing device for sensor position adjustment of the present invention can provide medical staff with data on intravesical pressure, abdominal pressure, and detrusor pressure that are not affected by changes in the patient's posture, allowing medical staff to make errors in testing related to zero point adjustment. Without it, the patient's test results can be interpreted more accurately.

Figure 1a is a graph of intravesical pressure, abdominal pressure, detrusor pressure, and urethral sphincter activity measured when the patient is filling in the supine position;

Figure 1b is a graph of intravesical pressure, abdominal pressure, detrusor pressure, and urethral sphincter activity measured when the patient changes from the supine position to the standing position during filling;

Figure 2 is a diagram for explaining a part of a urodynamic testing device for sensor position control according to an embodiment of the present invention;

Figure 3 is a conceptual diagram of a urodynamic testing device for sensor position control according to an embodiment of the present invention mounted on a patient in a supine position;

Figure 4 is a conceptual diagram of a urodynamic testing device for sensor position control according to an embodiment of the present invention mounted on a patient in a standing position;

Figure 5 is a diagram for explaining the first position adjusting unit of the urodynamic examination device of Figure 3;

Figure 6 is a diagram showing the ends of the urethral catheter and rectal catheter of the urodynamic examination device of Figure 3 inserted into the bladder and rectum, respectively, when the patient is lying down;

Figure 7 is a diagram showing the ends of the urethral catheter and rectal catheter of the urodynamic examination device of Figure 4 inserted into the bladder and rectum, respectively, when the patient is standing;

Figure 8 is a block diagram of the urodynamic testing device of Figure 3;

FIG. 9 is a diagram for explaining the second position control unit of the urodynamic examination device of FIG. 3.

Hereinafter, some embodiments of the present invention will be described in detail through illustrative drawings. When adding reference numerals to components in each drawing, it should be noted that identical components are given the same reference numerals as much as possible even if they are shown in different drawings.

Also, when describing embodiments of the present invention, if it is determined that detailed descriptions of related known configurations or functions interfere with understanding of the embodiments of the present invention, the detailed descriptions will be omitted.

Additionally, when describing the components of an embodiment of the present invention, terms such as first, second, A, B, (a), and (b) may be used. These terms are only used to distinguish the component from other components, and the nature, sequence, or order of the component is not limited by the term.

Hereinafter, with reference to the drawings, a urodynamic inspection device for sensor position adjustment according to an embodiment of the present invention will be described in detail.

FIG. 2 is a diagram illustrating a part of a urodynamic testing device for sensor position control according to an embodiment of the present invention, and FIG. 3 is a diagram showing the position of a sensor according to an embodiment of the present invention mounted on a patient in a supine position. This is a conceptual diagram of a urodynamic testing device for adjustment, and Figure 4 is a conceptual diagram of a urodynamic testing device for adjusting the sensor position according to an embodiment of the present invention mounted on a patient in a standing position.

Referring to FIGS. 2 to 4, the urodynamic testing device 100 (hereinafter referred to as “urodynamic testing device”) for sensor position control according to an embodiment of the present invention is inserted into the patient’s bladder 11. A urethral catheter (110, urethral catheter), a rectal catheter (130, rectal catheter) inserted into the patient's rectum, and a first device that is connected to the urethral catheter (110) to measure the internal pressure of the patient's bladder (11). A pressure transducer (120, hereinafter referred to as “first sensor”) and a second pressure transducer (140, hereinafter referred to as “second sensor”) connected to the rectal catheter (130, rectal catheter) to measure the patient’s abdominal pressure. And, the first sensor 120 and the second sensor 140 are each connected to the first sensor 120, the second sensor 140, the urethral catheter 110, and the rectal catheter 130. ) It includes a first bag 101 that supplies a fluid such as physiological saline solution to the urethral catheter 110, and a second bag 102 that is connected to the urethral catheter 110 and supplies a fluid such as physiological saline solution to the urethral catheter 110.

The urethral catheter 110 may include a first passage 111 connected to the first sensor 120 and a second passage 112 connected to the second pocket. The urethral catheter 110 may have the first flow path 111 and the second flow path 112 formed independently inside the tube.

A pump 103 is provided between the second bag 102 and the second flow path 112, and the pump 103 pumps the fluid in the second bag 102 through the second flow path 112. It can be introduced into the patient's bladder (11).

FIG. 5 is a diagram for explaining the first position adjusting unit of the urodynamic examination device of FIG. 3.

Referring further to FIG. 5, the urodynamic testing device 100 further includes a first position adjusting unit 150 and a control unit 160.

The urethral catheter 110 is inserted into the bladder 11 through the patient's urethra so that the tip portion is located in the patient's bladder 11.

When the fluid in the first bag 101 is injected into the first sensor 120 and the first flow passage 111, the fluid is discharged to the patient's bladder 11 at the end of the first flow passage 111. , At this time, the first sensor 120 can measure the internal pressure of the patient's bladder 11 by measuring the hydraulic pressure of the first flow passage 111.

The first sensor 120 has a filling phase for supplying fluid, such as physiological saline solution, to the patient's bladder 11 through the second flow path 112, and a physiological saline solution filled in the patient's bladder 11. During the voiding phase, when fluid such as fluid is discharged through the urethra, the internal pressure of the patient's bladder 11 can be measured.

The rectal catheter 130 is inserted into the rectum 12 through the anus of the patient so that the tip portion is located in the rectum 12 of the patient.

A rectal balloon 131 is provided at the tip of the rectal catheter 130, and the rectal balloon 131 may be filled with a fluid such as physiological saline.

When the fluid in the first bag 101 is injected into the second sensor 140 and the rectal catheter 130, the fluid flows into the rectal balloon 131 located at the tip of the rectal catheter 130.

At this time, the second sensor 140 can measure the patient's abdominal pressure by measuring the hydraulic pressure of the rectal catheter 130.

The urodynamic testing device 100 may further include electromyography electrodes 165.

The EMG electrode 165 is attached adjacent to the patient's anus and measures the activity of the urethral sphincter. The measured EMG activity indicates that detrusor contraction is synergistic with urethral sphincter activity. Alternatively, it can be used to determine whether a person is dyssynergic.

The control unit 160 is connected to the first sensor 120, the second sensor 140, and the EMG electrode 165 to control the first sensor 120, the second sensor 140, and the EMG electrode. Based on the signal received from (165), intravesical pressure (11, Pves), abdominal pressure (12, Pabd), detrusor pressure (13, Pdet), and urethral sphincter activity (14) can be displayed on the display.

The first sensor 120 and the second sensor 140 are mounted on the first position adjusting unit 150.

The first position adjusting unit 150 can adjust the height of the first sensor 120 and the second sensor 140 according to the height of the superior pubic bone (ICS reference level), which is a reference height.

That is, the first position adjusting unit 150 can change the height of the first sensor 120 and the second sensor 140 by following the height of the upper edge of the patient's pubis, which changes depending on the patient's posture.

For this purpose, the first position adjusting unit 150 includes a signal transmitting and receiving unit 151, a mounting frame 152, and a transfer rail 153.

The transport rail 153 is arranged perpendicular to the ground, the first sensor 120 and the second sensor 140 are installed on the mounting frame 152, and the mounting frame 152 is configured to transport the transport rail 153. It can move in the vertical direction on the rail 153.

Specifically, the mounting frame 152 can move in the vertical direction on the transfer rail 153 by the driving force of an actuator such as a motor.

The signal transceiver 151 can measure the distance between the upper edge of the patient's pubis 14 and the mounting frame 152.

The signal transceiving unit 151 includes a receiving unit 1511 and a transmitting unit 1512.

One of the receiving unit 1511 and the transmitting unit 1512 is installed on the upper edge of the patient's pubis 14, and the other is installed on the mounting frame 152, and is installed on the upper edge 14 of the patient's pubic bone. The distance between the mounting frames 152 can be measured.

For example, the receiver 1511 is installed on the upper edge of the patient's pubis 14, and the transmitter 1512 is installed on the mounting frame 152, and the upper edge 14 of the patient's pubis 14 and the mounting frame ( 152) The distance between them can be measured.

The distance between the transmitter 1512 and the receiver 1511 can be measured by the time when the signal transmitted from the transmitter 1512 is received by the receiver 1511.

The signal transmitted and received between the transmitter 1512 and the receiver 1511 can be any signal that can measure distance, such as ultrasonic waves, vision, infrared light, or visible light.

The control unit 160 is based on the distance between the transmitting unit 1512 and the receiving unit 1511 measured by the signal transmitting and receiving unit 151, between the upper edge of the patient's pubis 14 and the mounting frame 152. The position of the mounting frame 152 on the transfer rail 153 can be adjusted in the vertical direction so that the distance is maintained as the shortest.

For example, when the height of the first sensor 120 and the second sensor 140 is higher than the upper edge of the patient's pubis 14, the transmitter 1512 and the receiver 1511 have a height difference. This occurs, and the distance (L2) between the transmitting unit 1512 and the receiving unit 1511 becomes farther than the reference distance (L1). In this case, the control unit 160 moves the transfer rail 153 downward from the mounting frame 152 so that the distance between the transmitter 1512 and the receiver 1511 is the reference distance L1. You can.

And even when the height of the first sensor 120 and the second sensor 140 is lower than the upper edge of the patient's pubic bone 14, a height difference occurs between the transmitter 1512 and the receiver 1511. As a result, the distance L3 between the transmitter 1512 and the receiver 1511 becomes farther than the reference distance L1. In this case, the control unit 160 moves the transfer rail 153 upward from the mounting frame 152 so that the distance between the transmitter 1512 and the receiver 1511 is the reference distance L1. You can.

Here, the reference distance (L1) is when the height of the upper edge of the patient's pubis 14 from the horizontal ground and the height of the first sensor 120 and the second sensor 140 from the horizontal ground are the same, the transmitter ( 1512) and the receiver 1511, and the control unit 160 transfers the transfer rail 153 in the mounting frame 152 in the vertical direction to connect the transmitter 1512 and the receiver (1512) to the receiver 1511. 1511), the reference distance (L1) can be determined by finding the point that is the shortest distance.

Therefore, the present invention tracks the height of the upper edge of the patient's pubic bone (14) according to the patient's posture so that the height of the first sensor 120 and the second sensor 140 is higher than the upper edge of the patient's pubic bone (14). It can be controlled to match the height.

Specifically, when the patient changes posture such as supine position, sitting position, standing position, etc., the receiver 1511 installed on the upper edge of the patient's pubic bone 14 The position is changed, and at this time, the transmitter 1512 moves in the vertical direction by the mounting frame 152, finds the shortest distance between the transmitter 1512 and the receiver 1511, and moves the upper edge of the patient's pubis 14. By tracking the height, the height of the first sensor 120 and the second sensor 140 can follow the height of the upper edge of the patient's pubic bone 14.

Figure 6 is a view showing the ends of the urethral catheter and rectal catheter of the urodynamic test device of Figure 3 inserted into the bladder and rectum, respectively, when the patient is lying down, and Figure 7 is a view of the urodynamic test device of Figure 4 when the patient is standing. It is a drawing of the ends of the urethral catheter and the rectal catheter inserted into the bladder and rectum, respectively. Figure 8 is a block diagram of the urodynamic test device of Figure 3, and Figure 9 is a second position adjustment of the urodynamic test device of Figure 3. This is a drawing to explain wealth.

Referring further to FIGS. 6 to 9, the urodynamic testing device 100 may further include a second position adjusting unit 170.

The second position control unit 170 adjusts the heights of the first sensor 120 and the second sensor 140 according to the positions of the tip of the urethral catheter 110 and the tip of the rectal catheter 130. It can be adjusted.

The second position adjusting unit 170 may be installed on the mounting frame 152.

The second position adjusting unit 170 may include a first height adjusting unit 171 and a second height adjusting unit 172.

The first height adjustment unit 171 and the second height adjustment unit 172 each have an actuator such as a motor, and can slide in the up and down direction on the mounting frame.

The first sensor 120 is installed in the first height adjustment unit 171, and the first sensor 120 is moved in the vertical direction in the mounting frame 152 by the first height adjustment unit 171. can be transported.

The second sensor 140 is installed in the second height adjustment unit 172.

The second height adjustment unit 172 is adjacent to the first height adjustment unit 171 and can move in the vertical direction on the mounting frame 152. The second sensor 140 can be moved in the vertical direction on the mounting frame 152 by the second height adjustment unit 172.

That is, the second position adjusting unit 170 can individually transfer the height of the first sensor 120 and the height of the second sensor 140.

The second position adjusting unit 170 may be characterized in that it adjusts the heights of the first sensor 120 and the second sensor 140, respectively, according to the patient's posture.

To this end, the urodynamic testing device 100 may further include a posture detection unit 180.

The posture detection unit 180 detects the patient's posture, such as supine position, sitting position, and standing position.

The posture detection unit 180 may be composed of an acceleration sensor and a gyro sensor.

The control unit 160 controls the second position control unit 170 based on the information detected by the posture detection unit 180 to adjust the heights of the first sensor 120 and the second sensor 140, respectively. It can be adjusted.

Specifically, depending on the patient's posture, the control unit ( 160) can control the second position adjusting unit 170 to adjust the heights of the first sensor 120 and the second sensor 140, respectively.

In the above, just because all the components constituting the embodiment of the present invention have been described as being combined or operated in combination, the present invention is not necessarily limited to this embodiment. That is, as long as it is within the scope of the purpose of the present invention, all of the components may be operated by selectively combining one or more of them.

In addition, all terms, including technical or scientific terms, described above, unless otherwise defined, have the same meaning as generally understood by those skilled in the art to which the present invention pertains. Commonly used terms, such as terms defined in a dictionary, should be interpreted as consistent with the contextual meaning of the related technology, and should not be interpreted in an idealized or overly formal sense unless explicitly defined in the present invention.

The above description is merely an illustrative explanation of the technical idea of the present invention, and various modifications and variations will be possible to those skilled in the art without departing from the essential characteristics of the present invention. Accordingly, the embodiments disclosed in the present invention are not intended to limit the technical idea of the present invention, but rather to explain it, and the scope of the technical idea of the present invention is not limited by these embodiments. The scope of protection of the present invention should be interpreted in accordance with the claims below, and all technical ideas within the equivalent scope should be construed as being included in the scope of rights of the present invention.

Claims

A urethral catheter inserted inside the patient's bladder;

A first sensor arranged to be spaced apart from the patient and connected to the urethral catheter to measure intravesical pressure;

A rectal catheter inserted inside the patient's rectum;

a second sensor spaced from the patient, disposed adjacent to the first sensor, and connected to the rectal catheter to measure abdominal pressure; and

A urodynamic examination device comprising a first position control unit that adjusts the height of the first sensor and the second sensor according to the patient's posture.
In claim 1,

The first position control unit,

transfer rail,

A mounting frame coupled to the transport rail in a vertical direction and on which the first sensor and the second sensor are installed,

A signal transmitting and receiving unit that measures the distance between the mounting frame and the upper edge of the patient's pubis according to the patient's posture,

A urodynamic examination device in which the mounting frame is transported in the vertical direction on the transport rail so that the distance between the mounting frame and the upper edge of the patient's pubis is the shortest distance.
In claim 2,

Urodynamic examination device further comprising a second position control unit that adjusts the heights of the first sensor and the second sensor, respectively, according to the positions of the tip of the urethral catheter tip and the rectal catheter.
In claim 3,

The second position control unit,

A first height adjuster installed on the mounting frame to adjust the height of the first sensor,

A urodynamic testing device comprising a second height adjustment unit installed on the mounting frame adjacent to the first height adjustment unit and adjusting the height of the second sensor.
In claim 3,

Further comprising a posture detection unit that detects the patient's posture,

The first position adjusting unit adjusts the height of the first sensor and the second sensor according to the patient's posture detected by the posture detecting unit.