KR20230064071A - System for reducing insertion pressure of the ureteral access sheath for retrograde intrarenal surgery by artificially inducing hydronephrosis and measuring the induced degree of hydronephrosis with flow and hydraulic pressure - Google Patents

Abstract

The present invention relates to a system for determining the location of a ureteral access sheath (UAS) in the ureter based on measurements of the pressure associated with the insertion of the UAS for retrograde intrarenal surgery (RIRS), artificially inducing hydronephrosis by injecting fluid into the ureter when the UAS reaches the appropriate location within the ureter, reducing the pressure of UAS ureteral insertion, and minimizing the occurrence of wounds within the ureter due to UAS ureteral insertion.

Description

A system for reducing the insertion pressure of the ureteral entry house by artificially inducing hydronephrosis in the ureter in subsequent ureteral and kidney stone removal surgery and measuring the degree of hydronephrosis with flow rate and hydraulic pressure {SYSTEM FOR REDUCING INSERTION PRESSURE OF THE URETERAL ACCESS SHEATH FOR RETROGRADE INTRARENAL SURGERY BY ARTIFICIALLY INDUCING HYDRONEPHROSIS AND MEASURING THE INDUCED DEGREE OF HYDRONEPHROSIS WITH FLOW AND HYDRAULIC PRESSURE}

The present invention identifies the location of the UAS in the ureter based on the measurement of the pressure associated with the insertion of the ureteral access sheath (UAS) in retrograde intrarenal surgery (RIRS), and When the proper position is reached in the ureter, liquid is injected into the ureter to artificially induce hydronephrosis, and by measuring the degree of hydronephrosis with flow rate and hydraulic pressure, the pressure of UAS ureter insertion is reduced and the effect of UAS ureter insertion is reduced. It relates to a system for minimizing the occurrence of wounds in the ureter.

Retrograde intrarenal surgery (RIRS) is a procedure in which a ureteroscope is inserted through the urethra to check for stones, and then the stones are destroyed using a laser crusher. Existing rigid ureteroscopes were often difficult to access depending on the location of urinary stones, so the scope of application was limited. If it is difficult to apply rigid ureteroscopy for urinary stone removal, convert to invasive methods such as percutaneous nephrolithotomy (PNL) or laparoscopic surgery, or use extracorporeal shockwave lithotripsy (ESWL) There was a problem that had to be repeated in turn. In order to compensate for this problem, a flexible ureteroscope was first developed in 1994 and applied to urinary stone removal, but it was not universalized due to technical limitations in the early days. However, with the recent breakthrough in technology, flexible ureteroscopy has become popular worldwide, and RIRS has become the standard treatment method for urinary stone removal.

The advantages of RIRS using a flexible ureteroscope are: 1) no skin incision, very little postoperative pain and hematuria, and 2) stones in the upper ureter and kidneys (renal pelvis, renal bladder) that cannot be accessed with conventional rigid ureteroscopy 3) a significant number of stones that could only be treated with laparoscopic surgery or PNL can be removed, avoiding various complications, and 4) multiple, large, or lower kidney stones with a low success rate of removal after ESWL. There are certain points that can effectively remove stones. Thanks to these advantages, the recent international treatment guidelines for urolithiasis recommend the expansion of RIRS using a flexible ureteroscope, and a new paradigm for urolithiasis has been formed.

The reason for the expansion of RIRS is the proven usefulness and popularization of the ureteral access sheath (UAS). When UAS is used, 1) the flexible ureteroscope can be easily entered into the renal pelvis, 2) crushed stones can be easily removed through re-entry of the flexible ureteroscope several times, and 3) intrarenal pressure is minimized during surgery. and 4) reduce the bulking pressure of the ureter.

However, there are not only advantages to the use of UAS. If excessive pressure is applied to insert the UAS in a thin ureter, shear injury may occur in the ureter, which has been reported to occur in up to 50% of cases. In addition, when the ureter is pressed against the UAS, there is a risk of secondary ureteral stenosis occurring later due to local ischemia. In the implementation of RIRS, the insertion of UAS into the ureter is an essential procedure, but 16% of cases in which the insertion of the UAS into the ureter fails due to excessive resistance or the operation cannot proceed further due to damage to the ureter.

Various methods and devices have been proposed for the insertion of UAS into the ureter with low pressure and frictional force. 1) UAS coated with a hydrophilic outer film has been released to reduce the frictional force when UAS is inserted into the ureter. However, for patients with an inherently thin ureteral diameter, this approach is less effective. 2) A method of passively dilating the ureter using ureteral stent indwelling 1 to 2 weeks before RIRS surgery has been proposed. In clinical studies, it has been reported that ureteral damage caused by UAS insertion is significantly less when a ureteral stent is inserted before RIRS. However, in order to insert the ureteral stent before RIRS, a complicated procedure is required, and there is a problem in that patients experience discomfort such as hematuria, difficulty in urination, and flank pain due to the ureteral stent. 3) A ureteral balloon dilation has been suggested. This is a method of inserting UAS by actively dilating the narrow ureter using a balloon. However, this is not recommended because it can lead to secondary ureteral stricture in the long term.

Therefore, there is a need for a system for effectively and safely inserting the UAS into the ureter by reducing the pressure for inserting the UAS into the ureter and minimizing the occurrence of wounds in the ureter due to the insertion of the UAS into the ureter.

Korean Patent Publication No. 10-2017-0118821 (2017.10.25.) (Access system, access system and related method)

Based on the foregoing discussion, the present invention provides a system for effectively and safely inserting a ureteral access sheath (UAS) into the ureter.

In addition, the present invention determines the location of the UAS in the ureter based on the measurement of the pressure associated with the insertion of the UAS in retrograde intrarenal surgery (RIRS), and when the UAS reaches the appropriate position in the ureter In this case, by injecting liquid into the ureter to artificially induce hydronephrosis, and measuring the degree of hydronephrosis with the flow rate and hydraulic pressure, to reduce the ureteral insertion pressure of the UAS and to minimize the occurrence of wounds in the ureter due to the ureteral insertion of the UAS. provide a system for

According to various embodiments of the present invention, in the system, a Y-shaped medical connector; and an electronic device coupled to the medical connector, wherein the medical connector includes: a first cylinder including a first opening and a second opening; And a second cylinder connected to the first cylinder at an inclined angle and including a third opening so that the fluid can be introduced into the third opening and the fluid is discharged into the first opening, and the first opening includes a ureter entry house ( ureteral access sheath (UAS), the first cylinder is configured to pass a guide wire through the first opening and the second opening, the guide wire passes through the UAS, and the electronic device includes: a memory; processor; a wired or wireless transmission/reception unit, or an output unit configured to output an audio or visual display; A force measurement gauge configured to measure UAS insertion force (UASIF) upon insertion of the UAS into the bladder and ureter; a flow measurement sensor configured to measure a flow rate of the fluid flowing out through the first opening; and a hydraulic pressure measuring sensor configured to measure a hydraulic pressure of the first opening due to outflow of the fluid, wherein the processor determines the location of the UAS in the bladder and the ureter based on the measured UASIF, and determines the UAS according to the peak value of the measured UASIF. Information indicating that the UAS has reached UVJ by determining the location in the bladder and ureter as the urethra, ureterovesical junction (UVJ), and proximal ureter, respectively, and controlling the transceiver or output unit is transmitted or output to another device connected by wire or wirelessly, and by controlling the transmission/reception unit or the output unit, after the UAS reaches the UVJ, the flow rate information of the fluid flowing out through the first opening and the hydraulic pressure information due to the outflow of the fluid are displayed. A system configured to transmit or output to another device is provided.

According to various embodiments of the present disclosure, in a method for operating an electronic device in a system according to various embodiments of the present disclosure, a processor determines the location of the UAS in the bladder and ureter based on UASIF measured by a force measuring gauge doing; determining, by a processor, locations of the UAS in the bladder and ureter, respectively, as the urethra, the ureterovesical junction (UVJ), and the proximal ureter according to the peak value of the measured UASIF; transmitting or outputting information notifying that the UAS has reached the UVJ to another device connected by wire or wirelessly by controlling the transmission/reception unit or the output unit; After the UAS reaches the UVJ, by controlling the transmission/reception unit or the output unit, a method comprising transmitting or outputting flow rate information of the fluid flowing out through the first opening and hydraulic pressure information due to the outflow of the fluid to another device is provided. do.

According to various embodiments of the present disclosure, a computer program, when executed by a processor, is configured to cause the processor to perform a method of operating an electronic device according to various embodiments of the present disclosure, and is recorded in a computer readable storage medium. A computer program is provided.

The present invention provides a system for effectively and safely inserting a ureteral access sheath (UAS) into the ureter.

In addition, the present invention determines the location of the UAS in the ureter based on the measurement of the pressure associated with the insertion of the UAS in retrograde intrarenal surgery (RIRS), and when the UAS reaches the appropriate position in the ureter In this case, by injecting liquid into the ureter to artificially induce hydronephrosis, and measuring the degree of hydronephrosis with the flow rate and hydraulic pressure, to reduce the ureteral insertion pressure of the UAS and to minimize the occurrence of wounds in the ureter due to the ureteral insertion of the UAS. provide a system for

The effects obtainable in the present invention are not limited to the effects mentioned above, and other effects not mentioned can be clearly understood by those skilled in the art from the description below. will be.

1 shows an example of ureteroscope entry through the ureteral access sheath (UAS) for the bladder, ureters and kidneys.
Figure 2 shows an example of UAS entry into the ureter.
3 shows the configuration of a system according to various embodiments of the present invention.
Figure 4 shows a graph of pressure for each location in the ureter of UAS.
5 illustrates a configuration of a device among configurations of a system according to various embodiments of the present disclosure.
6 illustrates an example actually implemented for a force measuring gauge among configurations of a system according to various embodiments of the present disclosure.
7 illustrates an example actually implemented for a hydraulic pressure measuring sensor among configurations of a system according to various embodiments of the present disclosure.
8 illustrates an example actually implemented for a flow rate measurement sensor and a fluid input pump among configurations of a system according to various embodiments of the present disclosure.
9 illustrates an example actually implemented for a computer program according to various embodiments of the present disclosure.
10 illustrates an example of actually implementing a system according to various embodiments of the present disclosure.
FIG. 11 illustrates an example of actually implementing an output of a measured value and an output of whether or not the measured value exceeds a set threshold according to the operation of a computer program according to various embodiments of the present disclosure.
FIG. 12 illustrates an example of actually implementing the output of a measured number and the output of whether or not the measured number exceeds a set threshold according to the operation of a computer program according to various embodiments of the present disclosure.
13 shows an example of UAS entry into the ureter.
14 illustrates an example of actually implementing a process of determining a location of a UAS in a bladder using a system according to various embodiments of the present disclosure.
15 illustrates an example of actually implementing a process of determining a location of a UAS in a bladder using a system according to various embodiments of the present disclosure.

Terms used in the present invention are only used to describe a specific embodiment, and may not be intended to limit the scope of other embodiments. Singular expressions may include plural expressions unless the context clearly dictates otherwise. Terms used herein, including technical or scientific terms, may have the same meaning as commonly understood by a person of ordinary skill in the art described in the present invention. Among the terms used in the present invention, terms defined in a general dictionary may be interpreted as having the same or similar meaning as the meaning in the context of the related art, and unless explicitly defined in the present invention, an ideal or excessively formal meaning not be interpreted as In some cases, even terms defined in the present invention cannot be interpreted to exclude embodiments of the present invention.

1 shows an example of ureteroscope entry through the ureteral access sheath (UAS) for the bladder, ureters and kidneys.

Referring to Figure 1, the kidney 101 is connected to the bladder 102 via the ureter. When urine produced in the kidneys 101 passes through the renal pelvis, it is a thin and long tube that delivers the urine to the bladder. The portion proximal to the kidney of the ureter is the proximal ureter (103). At the end of the proximal ureter 103 is the renal pelvis. The portion of the ureter close to the bladder is the distal ureter. At the end of the distal ureter is the bladder 102.

The ureter is upwardly connected to the kidney 101 based on the border between the proximal ureter 103 and the renal pelvis, and downwardly connected to the bladder 102 while forming a long tunnel in the bladder wall to prevent bladder ureteral reflux.

A ureterovesical junction (UVJ) 104 is located where the ureter meets the bladder 102 . UVJ has ureterobladder valves to prevent backflow of urine. If UVJ is disrupted, vesicoureteral reflux may occur.

Since the proximal ureter 103, the border of the renal pelvis, and the UVJ 104 are narrow, ureteral stones tend to occur.

The urethra 105 is a membranous tube that carries urine from the bladder 102 out of the body. The urethra 105 starts at the lower opening of the bladder 102 and leads out of the body. The urethra 105 may be narrowed due to scar tissue or the like in the urethra 105, which may cause urethral stricture. Urethral stricture can lead to complications such as the formation of stones in the bladder.

The guide wire first enters the bladder, ureter and kidney, and then the UAS 107 through the guide wire enters the bladder, ureter and kidney. After the UAS 107 enters the bladder, ureter, and kidney, the ureteroscope 106 may enter the bladder, ureter, and kidney through the UAS 107.

Figure 2 shows an example of UAS entry into the ureter.

Referring to FIG. 2 , after the guide wire 203 enters the kidney 201 via the bladder and ureter, the UAS 206 enters the bladder, ureter and kidney 201 along the guide wire 203 .

The UAS 206 is composed of an inner sheath 204 and an outer sheath 205. The inner house 204 is placed inside than the outer house 205. When the UAS 206 enters the bladder, ureter, and kidney 201 along the guide wire 203, the inner sheath 204 and the outer sheath 205 enter in a combined form. After the UAS 206 has reached the appropriate location, the inner house 204 can be removed. After the inner sheath 204 is separated, the ureteroscope can enter the space where the inner sheath 204 was located in the outer sheath 205 . The ureteroscope can be entered through the outer sheath 205 without causing friction damage to the bladder, ureters and kidneys 201 .

UAS 206 may cause frictional damage when the passage narrows while entering the bladder, ureter and kidney 201 . Representative places where the passage narrows are the urethra, the ureterovesical junction (UVJ), and the proximal ureter (202).

2 shows a condition in which the UAS 206 can cause friction in the proximal ureter 202 . At the proximal ureter 202, the passage of the UAS 206 bends toward the renal pelvis. At this time, when the passage of the UAS 206 is narrow in the proximal ureter 202, the front portion of the UAS 206 may cause frictional damage to the proximal ureter 202.

3 shows the configuration of a system according to various embodiments of the present invention.

A system according to various embodiments of the present disclosure includes a Y-shaped medical connector 301 and an electronic device 307 coupled to the medical connector 301 .

The medical connector 301 injects fluid into a first cylinder 304 including a first opening 302 and a second opening 303 and a third opening 305 so that the fluid flows out through the first opening 302. The second cylinder 306 is connected to the first cylinder 304 at an inclined angle and includes a third opening 305.

The first opening 302 is configured to connect to a ureteral access sheath (UAS) 309 . UAS 309 is configured to enter the bladder, ureters and kidneys.

The first cylinder 304 is configured such that the guide wire 311 passes through the first opening 302 and the second opening 303 . Guide wire 311 passes through UAS 309 .

The device 307 includes a force measurement gauge configured to measure a UAS insertion force (UASIF) upon insertion of the UAS 309 into the bladder and ureter.

According to various embodiments of the present disclosure, the third opening 305 may be connected to a device for injecting fluid such as the syringe 310 . According to various embodiments of the present disclosure, a fluid may be injected through the third opening 305 using a fluid injection pump instead of the syringe 310 . In this case, the flow rate of the fluid flowing out from the third opening through the first opening may be measured using a flow rate measuring sensor included in the fluid injecting pump while adjusting the amount of fluid injected from the fluid injecting pump.

According to various embodiments of the present disclosure, the electronic device 307 includes a memory and a processor, and the processor may be configured to determine the location of the UAS 309 in the bladder and ureter based on the measured UASIF.

According to various embodiments of the present invention, the processor determines the location of the UAS 309 in the bladder and the ureter according to the measured peak value of the UASIF in the urethra, the ureterovesical junction (UVJ), and the proximal ureter ( proximal ureter).

According to various embodiments of the present invention, the processor determines the location of the UAS in the bladder and the ureter according to the order of the peak value of the measured UASIF in the urethra, the ureterovesical junction (UVJ), and the proximal ureter, respectively. (proximal ureter), and the order of peak values of the measured UASIF may mean the order in which peak values exceeding a predetermined error range or more than the previous peak value of the measured UASIF occurred.

According to various embodiments of the present invention, the memory stores the cut-off value of the peak value of the UASIF for each location in the bladder and ureter of the UAS 309, and the processor compares the measured peak value of the UASIF with the cut-off value. It may be further configured to determine the location of the UAS 309 in the bladder and ureter as the urethra, the ureterovesical junction (UVJ), and the proximal ureter, respectively.

According to various embodiments of the present disclosure, the electronic device 307 may further include at least one of a wired or wireless transmission/reception unit or an output unit configured to output a voice or visual display, and the transmission/reception unit may wired or wirelessly It may be configured to transmit information of the measured UASIF to another connected device 308, or the output unit may be configured to output the measured UASIF as an audio or visual display.

According to various embodiments of the present disclosure, the electronic device 307 may further include at least one of a wired or wireless transmission/reception unit or an output unit configured to output a voice or visual display, and the transmission/reception unit may wired or wirelessly It may be configured to transmit information indicating that the UAS 309 has reached the UVJ to another connected device 308, or the output unit outputs information indicating that the UAS 309 has reached the UVJ as a voice or visual display. can be configured to

According to various embodiments of the present disclosure, the electronic device 307 may further include a flow measurement sensor configured to measure the flow rate of the fluid flowing out through the first opening 302, and the transceiver may be wired or wirelessly connected. The device 308 may be further configured to transmit flow rate information of the fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ, or the output unit may be configured to transmit the UAS 309 to the UVJ. After that, it may be further configured to output flow rate information of the fluid flowing out through the first opening 302 as a voice or visual display.

According to various embodiments of the present disclosure, the device 307 may further include a hydraulic pressure measurement sensor configured to measure the hydraulic pressure of the first opening due to the outflow of the fluid. The processor of the device 307 controls the transmission/reception unit or the output unit so that after the UAS 309 reaches the UVJ, flow rate information of the fluid flowing out through the first opening 302 and/or hydraulic information due to the outflow of the fluid It may be configured to transmit to another device 308 or output through an output unit.

According to various embodiments of the present invention, the memory may store a cut-off value of the flow rate of the fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ, and the transceiver is wired or wirelessly connected. Further configured to transmit information to the other device 308 indicating that the flow rate of the fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ has reached a cut-off value of the flow rate, or The output unit may be further configured to output information indicating that the flow rate of the fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ has reached a cut-off value of the flow rate, as an audio or visual display. .

According to various embodiments of the present invention, the cut-off value of the flow rate is determined to cause hydronephrosis in the proximal ureter after the fluid flowing out through the first opening 302 flows toward the proximal ureter through the UAS 309 reaching the UVJ. It may be a value of flow rate that can be.

According to various embodiments of the present disclosure, the memory stores a first cut-off value of the flow rate of the fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ and a second cut-off value of the hydraulic pressure. can be configured to store The processor of the device 307 controls the transmission/reception unit or the output unit so that the flow rate and hydraulic pressure of the fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ are the first cut-off value and the second cut-off value. It may be configured to transmit information indicating that the OFF value has been reached to another device 308 or to output it through an output unit. According to various embodiments of the present invention, the first cut-off value of the flow rate is the hydronephrosis in the proximal ureter after the fluid flowing out through the first opening 302 flows out toward the proximal ureter through the UAS 309 reaching the UVJ. Is the value of the flow rate that can cause , and the second cut-off value of the hydraulic pressure is the hydronephrosis in the proximal ureter after the fluid flowing out through the first opening 302 flows out toward the proximal ureter through the UAS 309 reaching the UVJ. It may be the value of hydraulic pressure that can cause

Figure 4 shows a graph of pressure for each location in the ureter of UAS.

In order to obtain the graph of FIG. 4, the following first study was performed.

patient

A total of 156 patients from a single institution who underwent RIRS for stones in the ureteropelvic junction or renal pelvis were preliminarily enrolled in this study from December 2015 to January 2017. Patients were identified on the basis of clinic visits. UASIF was measured and recorded for patients. This study was approved by the Institutional Ethics Committee (3-2016-0117).

UAS development

A UASIF measurement gauge was designed and manufactured to measure real-time UASIF during ureteral insertion of UAS. The UASIF measurement gauge is a V-block jig that holds the UAS hub, a linear jig that counteracts potential torque on the V-block jig during UAS insertion, and a range of 1.0 to 5,000 at millisecond frequencies. It consists of four components, including a ZTA-50N digital force gauge (IMADA Instruments, Toyohashi City, Japan) capable of measuring UASIF in units of 1 G over a range of G, and an aluminum linear lift installed for all jigs. .

surgery

All patients were placed in the standard lithotomy position under general anesthesia, and UASIF was recorded by a single surgeon (KCK). The surgery began with placement of a guide wire (Amplatz super stiff Urowire XF (Boston Sceintific Microinvasive, Miami, FL, USA)). Retrograde ureteropyelography was performed to exclude pre-existing pathological lesions. After placing the guide wire, the UAS with the UASIF measuring gauge was inserted. A UAS of 12/14 Fr diameter (male 46 cm, female 35 cm) was used.

The UAS with the UASIF measuring gauge was inserted into the patient, and the location of the distal tip of the UAS was identified by real-time X-ray imaging. The peak UASIF was recorded and considered the maximum UASIF. Maximum UASIF was measured as the UAS passed through the urethra, UVJ and proximal ureter.

Referring to FIG. 4, with respect to the peak value of UASIF, according to the order in which new peak values that exceed the previous peak value by a predetermined error range, for example, 50 g or more, are generated, the distal tip of the UAS is respectively urethra ( urethra), the ureterovesical junction (UVJ), and the proximal ureter. Thus, based on the measurement of UASIF and analysis of peak values, the location of UAS in the bladder and ureter can be determined.

In addition, as another method, a cut-off value may be applied to the peak value of UASIF to determine the location of UAS in the bladder and ureter. For example, if the peak value of UASIF exceeds 300 g for the first time, the UAS is located in the urethra; if the peak value of UASIF exceeds 500 g for the first time, the UAS is located in the ureterovesical junction (UVJ); If the peak value of exceeds 600 g for the first time, it can be seen that the UAS is located in the proximal ureter. This cut-off value is exemplary and may be changed according to user settings.

In the present invention, based on the data of FIG. 4, after determining the location of the UAS in the bladder and ureter, by inducing artificial hydronephrosis for the proximal ureter, which is a location where friction damage is likely to occur when the UAS is inserted, the proximal while the UAS passes A system for artificially widening the passage of the ureter is provided.

When the tip of the UAS is positioned in the UVJ, hydronephrosis may be induced to the extent that the UAS passes through the proximal ureter easily by spraying a predetermined amount of fluid, for example, water, toward the proximal ureter.

In order to verify the effect of the present invention, the following second study was conducted.

Development of an artificial hydronephrosis inducer

A pulse-type metering motor capable of injecting fluid causing artificial hydronephrosis at a constant flow rate was fabricated, and an algorithm capable of adjusting the flow rate and cycle was developed. The pressure range of the injected fluid was selected through previous studies, and the collection range (mmHg) of the liquid pressure sensor was selected accordingly. A flow path was designed to measure the pressure in the sprayed fluid, and a pressure sensor was installed at a location that would not interfere with the procedure. An amplifier circuit to amplify the measured pressure signal and a single board microcontroller circuit to collect information were constructed. In order to communicate with a personal portable terminal, a Bluetooth circuit module was installed in the circuit, and an algorithm was developed to receive pressure information from the wireless communication module using the App Inventor platform and to display it on the screen of the terminal and store it inside the terminal.

Verification of artificial hydronephrosis inducer

The 3D modeling was designed by simulating the stenotic shape of the ureter, and the ureter, which requires artificial hydronephrosis induction, was simulated and fabricated using liquid curing type silicone. Using the developed integrated pressure device, the axial force generated by the UAS in the simulated ureter and the pressure of the injected liquid were simultaneously collected and wirelessly communicated with the terminal. When the UAS passed through the stenotic ureter, the collected axial force and the pressure of the ejected liquid were observed to quantitatively confirm whether artificial hydronephrosis induces relief of the UAS insertion pressure.

RIRS surgical procedure animal testing

All RIRS were performed under general anesthesia in the lithotomy position. Prior to UAS insertion, retrograde ureteropyelography was performed to evaluate the organic ureteral opening location, ureteral stricture, and stone location. If ureteral strictures were observed, they were removed from the study pool. For the artificial paranephrosis group, the artificial paranephrosis inducing motion was performed through the artificial paranephrosis inducer. After confirming that there is no ureteral stricture, a guide wire (Amplatz super stiff Urowire XF (Boston Sceintific Microinvasive, Miami, FL, USA)) was placed into the renal pelvis, and a UAS was inserted along the guide wire while performing real-time X-ray imaging. For accurate measurement of UAS insertion pressure, 1) no safety guidewire was used, 2) UAS with a diameter of 12/14 Fr (male 46 cm, female 35 cm) was used in all cases, and 3) between observers. To minimize measurement deviation, all manipulations and measurements were performed by a single researcher.

UASIF Measurement Animal Test for UAS Entry Pressure Measurement

The UAS was inserted while relying on the UASIF measuring gauge, that is, the UAS insertion pressure measuring gauge, in a direction parallel to the guide wire (Super stiff guidewire). Using an X-ray fluoroscopy device, the UASIF, that is, the urethral resistance pressure for the UAS was measured until the distal tip of the UAS reached the front of the ureteral opening. Thereafter, the maximum pressure was measured when entering the ureteral orifice of the UAS, the UVJ, and the proximal ureter, respectively, and the limit value for the urethral resistance pressure was recorded.

Evaluation of ureteral damage after surgery in animal experiments

After completing the animal experiment operation, the UAS was removed, and the presence or absence of ureteral damage and the damage grade were evaluated and recorded. The grade of ureteral damage was established using the following standard table [Table 1]. As a result of the evaluation of ureteral damage, it was confirmed that the average grade of ureteral damage caused by UAS insertion in the artificial hydronephrosis group was significantly lower than the average grade of ureteral damage caused by UAS insertion in the group without artificial hydronephrosis induction.

[Table 1] Grade of ureteral injury by UAS insertion

Expected effect and contribution

Recently, flexible ureteroscopes have become popular worldwide, and RIRS has become the standard treatment for urolithiasis. However, UAS used during the surgical procedure can cause damage to the ureter due to excessive insertion pressure, so it is not recognized as a standard despite its many advantages.

Improvement of RIRS surgery success rate and prevention of complications

The ultimate expected effect of the present invention and research is to increase the success rate of UAS insertion with minimal risk and to have a positive effect on patients by shortening the surgical time required to insert UAS.

5 illustrates a configuration of a device among configurations of a system according to various embodiments of the present disclosure.

Specifically, the electronic device 500 of FIG. 5 shows an example of a detailed configuration of the electronic device 307 among the system configurations of FIG. 3 .

Referring to FIG. 5 , the electronic device 500 includes a force measurement gauge 501 configured to measure a UAS insertion force (UASIF) according to insertion of the UAS into the bladder and ureter. The force measuring gauge 501 may be composed of a force measuring gauge such as the ZTA-50N digital force gauge (IMADA Instruments, Toyohashi City, Japan) used in the experiment of the present invention.

According to various embodiments of the present disclosure, the electronic device 500 includes a processor 502 and a memory 503, and the processor 502 determines the location of the UAS 309 in the bladder and ureter based on the measured UASIF. It can be configured to determine.

The processor 502 controls overall operations of the electronic device 500 . For example, the processor 502 controls the transceiver 506 to transmit or receive information or the like. The processor 502 controls the output unit 505 to output information and the like. Also, the processor 502 writes data to and reads data from the memory 503 . Processor 502 may include at least one processor.

The memory 503 is connected to the processor 502 and stores data such as a basic program for operation of the processor 502, an application program, and setting information. The memory 503 includes information on cut-off values of peak values of UASIF for each location in the bladder and ureter of the pre-measured UAS, information on cut-off values of the fluid flow rate for inducing artificial hydronephrosis, and UAS measured upon insertion of the UAS. UASIF information, etc. can be stored. The memory 503 may be composed of volatile memory, non-volatile memory, or a combination of volatile and non-volatile memory. And, the memory 503 provides stored data according to the request of the processor 502 .

According to various embodiments of the present invention, the processor 502 determines the location of the UAS 309 in the bladder and the ureter according to the measured peak value of the UASIF, respectively, in the urethra, the ureterovesical junction (UVJ), It can be further configured to determine with the proximal ureter.

According to various embodiments of the present invention, the processor 502 determines the location of the UAS in the bladder and the ureter according to the order of peak values of the measured UASIF, respectively, in the urethra and the ureterovesical junction (UVJ). , It may be further configured to determine the proximal ureter, and the order of the peak values of the measured UASIF may mean the order in which the peak values exceeding the previous peak value of the measured UASIF by more than a predetermined error range occurred. there is.

According to various embodiments of the present disclosure, the memory 503 stores a cut-off value of the UASIF peak value for each location in the bladder and ureter of the UAS 309, and the processor 502 stores the measured peak value of the UASIF and the cut-off value. Based on the comparison of the off values, it may be further configured to determine the location of the UAS 309 within the bladder and ureter as the urethra, ureterovesical junction (UVJ), and proximal ureter, respectively.

According to various embodiments of the present disclosure, the electronic device 500 may further include at least one of a wired or wireless transceiver 506 or an output unit 505 configured to output a voice or visual display, The transceiver 506 may be configured to transmit information of the measured UASIF to another device 308 connected by wire or wirelessly, or the output unit 505 may output the measured UASIF as a voice or visual display. can be configured.

The output unit 505 is connected to the processor 502 and includes the measured UASIF, information indicating that the UAS 309 has reached the UVJ, and the first opening 302 after the UAS 309 has reached the UVJ. The flow rate information of the outgoing fluid, the information indicating that the flow rate of the fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ reaches the cut-off value of the flow rate, etc. in the form of voice or visual display can be output as The output unit 505 may include at least one of a speaker and a display.

The transceiver 506 is connected to the processor 502 and can transmit and/or receive information to another device 308 connected by wire and/or wirelessly. All or part of the transceiver 506 may be referred to as a transmitter, a receiver, or a transceiver. The transceiver 506 is a wired access system and/or wireless access system, such as an institute of electrical and electronics engineers (IEEE) 802.xx system, an IEEE Wi-Fi system, a 3rd generation partnership project (3GPP) system, and a 3GPP long term LTE (LTE) system. evolution) system, 3GPP 5G new radio (NR) system, 3GPP2 system, and Bluetooth. At least one of various wireless communication standards may be supported.

The other device 308 is a device capable of transmitting and/or receiving and outputting information with the electronic device 500 wired and/or wirelessly, such as a smart phone, a tablet computer, and a personal computer.

According to various embodiments of the present disclosure, the electronic device 500 may further include at least one of a wired or wireless transceiver 506 or an output unit 505 configured to output a voice or visual display, The transceiver 506 may be configured to transmit information notifying that the UAS 309 has reached the UVJ to another device 308 connected by wire or wirelessly, or the output unit 505 may be configured to transmit information indicating that the UAS 309 has reached the UVJ. It may be configured to output information informing that UVJ has been reached as a voice or visual display.

According to various embodiments of the present disclosure, the electronic device 500 may further include a flow measurement sensor 504 configured to measure the flow rate of the fluid flowing out through the first opening 302, and the transceiver 506 may be further configured to transmit flow rate information of the fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ to another device 308 connected by wire or wirelessly, or an output unit ( 505 may be further configured to output flow rate information of the fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ as an audio or visual display. According to various embodiments of the present disclosure, the flow rate sensor 504 may be coupled to the first cylinder 304 to measure the flow rate of the fluid flowing out through the first opening 302 .

According to various embodiments of the present disclosure, the electronic device 500 may further include a hydraulic pressure measurement sensor configured to measure the hydraulic pressure of the first opening 302 due to the outflow of the fluid through the first opening 302 . The transceiver 506 may be further configured to transmit hydraulic information due to fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ to another device 308 connected by wire or wirelessly. . Alternatively, the output unit 505 may be further configured to output hydraulic information of the fluid flowing out through the first opening 302 as a voice or visual display after the UAS 309 reaches the UVJ. According to various embodiments of the present disclosure, the oil pressure measurement sensor may be combined with the first cylinder 304 to measure the oil pressure of the fluid flowing out through the first opening 302 .

According to various embodiments of the present disclosure, the memory 503 may store a cut-off value of the flow rate of the fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ, and the transceiver 506 ) transmits information indicating that the flow rate of the fluid flowing out through the first opening 302 reaches the cut-off value of the flow rate after the UAS 309 reaches the UVJ to another device 308 connected by wire or wirelessly. Alternatively, the output unit 505 transmits information indicating that the flow rate of the fluid flowing out through the first opening 302 reaches the cut-off value of the flow rate after the UAS 309 reaches the UVJ. Alternatively, it may be further configured to output as a visual display.

According to various embodiments of the present invention, the cut-off value of the flow rate is determined to cause hydronephrosis in the proximal ureter after the fluid flowing out through the first opening 302 flows toward the proximal ureter through the UAS 309 reaching the UVJ. It may be a value of flow rate that can be.

According to various embodiments of the present disclosure, the memory 503 stores a first cut-off value of the flow rate of the fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ, and a second cut-off value of the hydraulic pressure. Can be configured to store an off value. The processor 502 of the electronic device 500 controls the transmission/reception unit 506 or the output unit 505 so that the UAS 309 reaches the UVJ and the flow rate of the fluid flowing out through the first opening 302 and It may be configured to transmit information indicating that the hydraulic pressure has reached the first cut-off value and the second cut-off value to the other device 308 or output through an output unit. According to various embodiments of the present invention, the first cut-off value of the flow rate is the hydronephrosis in the proximal ureter after the fluid flowing out through the first opening 302 flows out toward the proximal ureter through the UAS 309 reaching the UVJ. Is the value of the flow rate that can cause , and the second cut-off value of the hydraulic pressure is the hydronephrosis in the proximal ureter after the fluid flowing out through the first opening 302 flows out toward the proximal ureter through the UAS 309 reaching the UVJ. It may be the value of hydraulic pressure that can cause

According to various embodiments of the present disclosure, an operating method of the electronic device 307 of the system configuration of FIG. 3, that is, the electronic device 500 of FIG. 5 is provided.

According to various embodiments of the present disclosure, the operating method of the electronic device 500 of FIG. 5 includes determining the location of the UAS in the bladder and ureter based on the UASIF measured by the force measuring gauge 501; Determining, by the processor 502, the location of the UAS in the bladder and ureter according to the peak value of the measured UASIF as the urethra, ureterovesical junction (UVJ), and proximal ureter, respectively; controlling the transmission/reception unit 506 or the output unit 505 to transmit or output information indicating that the UAS has reached the UVJ to another device connected by wire or wirelessly; By controlling the transmission/reception unit 506 or the output unit 505, after the UAS reaches the UVJ, the flow rate information of the fluid flowing out through the first opening and the hydraulic pressure information due to the outflow of the fluid are transmitted to or output to other devices. steps may be included.

According to various embodiments of the present disclosure, the memory 503 stores a first cut-off value of the flow rate of the fluid flowing out through the first opening after the UAS reaches the UVJ, and a second cut-off value of the hydraulic pressure, The operating method of the electronic device 500 of FIG. 5 controls the transmission/reception unit 506 or the output unit 505 so that after the UAS reaches the UVJ, the flow rate and hydraulic pressure of the fluid flowing out through the first opening are set to the first The method may further include transmitting or outputting information indicating that the cut-off value and the second cut-off value have been reached to another device.

According to various embodiments of the present invention, the first cut-off value of the flow rate is the flow rate at which the fluid flowing out through the first opening can cause hydronephrosis in the proximal ureter after the fluid flowing out toward the proximal ureter through the UAS reaching the UVJ. value, and the second cut-off value of the hydraulic pressure may be a hydraulic pressure value capable of causing hydronephrosis in the proximal ureter after the fluid flowing out through the first opening reaches the UVJ and flows toward the proximal ureter.

According to various embodiments of the present disclosure, in a computer program, when executed by the processor 502, the processor 502 performs a method of operating the electronic device 500 of FIG. 5 according to various embodiments of the present disclosure. A computer program configured to perform and recorded on a computer readable storage medium may be provided.

6 illustrates an example actually implemented for a force measuring gauge among configurations of a system according to various embodiments of the present disclosure.

Referring to FIG. 6, an example of a force measuring gauge actually implemented is a force sensor, a charging terminal, a power source, a record switch, a printed circuit board (PCB), a load cell arm, tongs, nitrile gloves, a battery, and an alarm LED (light emitting diode). ).

The force measuring gauge according to the example of FIG. 6 may be configured to measure UAS insertion force (UASIF) according to insertion of the UAS into the bladder and ureter in the system according to various embodiments of the present disclosure.

The UASIF information measured by the force measuring gauge according to the example of FIG. 6 may be output through an output unit or transmitted to another device connected wirelessly or wired through a transceiver unit.

7 illustrates an example actually implemented for a hydraulic pressure measuring sensor among configurations of a system according to various embodiments of the present disclosure.

Referring to FIG. 7 , an example of a hydraulic pressure measurement sensor actually implemented includes a sensor hall, a pressure sensor, a power source, a record switch, a charging terminal, a battery, a PCB, and an alarm LED.

The hydraulic pressure measurement sensor according to the example of FIG. 7 may be configured to measure the hydraulic pressure of the first opening due to the outflow of the fluid injected into the third opening through the first opening in the system according to various embodiments of the present disclosure.

The oil pressure information measured by the oil pressure measurement sensor according to the example of FIG. 7 may be output through an output unit or transmitted to another device connected wirelessly or wired through a transceiver unit.

8 illustrates an example actually implemented for a flow rate measurement sensor and a fluid input pump among configurations of a system according to various embodiments of the present disclosure.

Referring to FIG. 8 , the actually implemented flow measurement sensor and fluid injection pump include a battery, a power source, a peristaltic pump, and an alarm LED.

The flow rate measuring sensor and the fluid injection pump according to the example of FIG. 8 may be configured to inject the fluid into the third opening by adjusting the flow rate, and may be configured to measure the flow rate of the fluid flowing out from the third opening through the first opening. can

Information on the flow rate measured by the flow rate sensor and the fluid injection pump according to the example of FIG. 8 may be output through an output unit or transmitted to another device connected wirelessly or wired through a transceiver unit.

9 illustrates an example actually implemented for a computer program according to various embodiments of the present disclosure.

Referring to FIG. 9, the computer program actually implemented using a tablet computer using the Android operating system includes a BLE (Bluetooth low energy) connection button icon, a graph screen of numerical values and thresholds measured by sensors, and graph scale adjustment. and threshold value setting bar, real-time sensor value and time display, data reset button icon, status bar, save button icon for saving data spreadsheet in tablet computer device, e.g. as an excel file, measured value It may be configured to display a threshold notification icon indicating whether a threshold has been exceeded.

A tablet computer in which the computer program of FIG. 9 is implemented may correspond to a device in a system according to various embodiments of the present disclosure, or may correspond to another device connected to the device in a wired or wireless manner.

10 illustrates an example of actually implementing a system according to various embodiments of the present disclosure.

10, UASIF information measured from the force measurement gauge is transmitted to the tablet computer by executing an application program in the tablet computer connected to the force measurement gauge connected to the UAS by wire or wirelessly, and based on the information received by the tablet computer It can be seen that the location of the UAS can be analyzed.

The example of FIG. 10 is illustrative, and the flow rate measurement sensor and the oil pressure measurement sensor can also be connected to the UAS, and the flow rate information and hydraulic pressure information measured by the flow rate measurement sensor and the oil pressure measurement sensor can also be transmitted to the tablet computer. In addition, by comprehensively analyzing UASIF information, flow rate information, and hydraulic pressure information on a tablet computer, the location of the UAS, whether hydronephrosis has occurred, whether the UAS can be injected toward the proximal ureter, and whether the UAS can be injured in the ureter can be analyzed and output. can

FIG. 11 illustrates an example of actually implementing an output of a measured value and an output of whether or not the measured value exceeds a set threshold according to the operation of a computer program according to various embodiments of the present disclosure.

Referring to FIG. 11 , it can be confirmed that the UASIF measured by the force measuring gauge is before the set threshold value is exceeded.

FIG. 12 illustrates an example of actually implementing the output of a measured number and the output of whether or not the measured number exceeds a set threshold according to the operation of a computer program according to various embodiments of the present disclosure.

Referring to FIG. 12 , it can be confirmed that the UASIF measured by the force measuring gauge has exceeded a set threshold.

13 shows an example of UAS entry into the ureter.

UAS 206 may cause frictional damage when the passage narrows while entering the bladder, ureter and kidney 201 . Typically, there are three places where the passage is narrowed: the urethra, the ureterovesical junction (UVJ), and the proximal ureter, that is, the ureteropelvic junction (UPJ).

Because the urethra, UVJ, and UPJ are places where the passage of the UAS is narrowed, friction damage can be caused by the anterior part of the UAS.

14 illustrates an example of actually implementing a process of determining a location of a UAS in a bladder using a system according to various embodiments of the present disclosure.

Specifically, FIG. 14 shows an example of measuring the UASIF and determining the location of the UAS in the ureter based on the device of FIG. 10 actually implemented for a man whose stent was applied to the ureter.

Referring to FIG. 14, it can be confirmed that the UAS has reached the urethra, UVJ, and proximal ureter, respectively, through a section in which the UASIF specifically overshoots.

15 illustrates an example of actually implementing a process of determining a location of a UAS in a bladder using a system according to various embodiments of the present disclosure.

Specifically, FIG. 15 shows an example of measuring the UASIF and determining the location of the UAS in the ureter based on the device of FIG. 10 actually implemented for a woman.

Referring to FIG. 15, it can be confirmed that the UAS has reached the urethra, UVJ, and proximal ureter, respectively, through a section in which the UASIF specifically overshoots.

In the specific embodiments of the present invention described above, components included in the invention are expressed in singular or plural numbers according to the specific embodiments presented. However, the singular or plural expressions are selected appropriately for the presented situation for convenience of description, and the present invention is not limited to singular or plural components, and even if the components expressed in plural are composed of a singular number or singular Even the expressed components may be composed of a plurality.

Meanwhile, in the detailed description of the present invention, specific embodiments have been described, but various modifications are possible without departing from the scope of the present invention. Therefore, the scope of the present invention should not be limited to the described embodiments and should not be defined, but should be defined by not only the scope of the claims to be described later, but also those equivalent to the scope of these claims.

101 kidney 102 bladder
103 proximal ureter 104 ureter-bladder junction
105 urethra 106 ureteroscope
107 ureter entry sheath 201 kidney
202 proximal ureter 203 guide wire
204: inner house 205: outer house
206: ureteral entry house 301: medical connector
302: first opening 303: second opening
304: first cylinder 305: third opening
306: second cylinder 307: device
308 other device 309 ureteral entry house
310: syringe 311: guide wire
500: device 501: force measuring gauge
502: processor 503: memory
504: flow measurement sensor 505: output unit
506: transceiver

Claims (10)

in the system,
Y-shaped medical connector; and
Including an electronic device coupled to the medical connector,
The medical connector,
a first cylinder including a first opening and a second opening; and
A second cylinder connected to the first cylinder at an inclined angle and including the third opening so that the fluid can flow out through the first opening by injecting the fluid into the third opening,
The first opening is configured to connect to a ureteral access sheath (UAS),
The first cylinder is configured to pass a guide wire through the first opening and the second opening, the guide wire penetrates the UAS,
The electronic device,
Memory;
processor;
a wired or wireless transmission/reception unit, or an output unit configured to output an audio or visual display;
a force measurement gauge configured to measure UAS insertion force (UASIF) according to insertion of the UAS into the bladder and ureter;
a flow measurement sensor configured to measure a flow rate of the fluid flowing out through the first opening;
And a hydraulic pressure measurement sensor configured to measure the hydraulic pressure of the first opening due to the outflow of the fluid,
the processor,
determining the location of the UAS in the bladder and the ureter based on the measured UASIF;
According to the peak value of the measured UASIF, the location of the UAS in the bladder and the ureter is determined as the urethra, ureterovesical junction (UVJ), and proximal ureter, respectively,
Controlling the transmission/reception unit or the output unit to transmit or output information indicating that the UAS has reached the UVJ to another device connected by wire or wirelessly;
By controlling the transmission/reception unit or the output unit, after the UAS reaches the UVJ, the flow rate information of the fluid flowing out through the first opening and the hydraulic pressure information due to the outflow of the fluid are transmitted to or output from the other device. configured to
system.
According to claim 1,
the processor,
It is further configured to determine the location of the UAS in the bladder and the ureter as the urethra, the ureterovesical junction (UVJ), and the proximal ureter, respectively, according to the order of the peak values of the measured UASIF. ,
The order of the peak values of the measured UASIF means the order in which peak values exceeding the previous peak value of the measured UASIF by a predetermined error range occurred,
system.
According to claim 1,
The memory stores a cut-off value of a peak value of UASIF for each location of the UAS in the bladder and the ureter;
the processor,
Based on the comparison between the measured peak value of UASIF and the cutoff value, the location of the UAS in the bladder and the ureter is determined as the urethra, the ureterovesical junction (UVJ), and the proximal ureter, respectively. further configured to determine
system.
According to claim 1,
the processor,
Further configured to transmit or output the measured UASIF to the other device by controlling the transceiver or the output unit,
system.
According to claim 1,
The memory stores a first cut-off value of the flow rate of the fluid discharged through the first opening after the UAS reaches the UVJ, and a second cut-off value of hydraulic pressure;
the processor,
By controlling the transmission/reception unit or the output unit, after the UAS reaches the UVJ, the flow rate and the hydraulic pressure of the fluid flowing out through the first opening correspond to the first cut-off value and the second cut-off value. Further configured to transmit or output information indicating arrival to the other device,
system.
According to claim 5,
The first cut-off value of the flow rate is a value of a flow rate at which hydronephrosis can be caused in the proximal ureter after the fluid flowing out through the first opening has flowed out toward the proximal ureter through the UAS reaching the UVJ. ego,
The second cut-off value of the hydraulic pressure is a value of hydraulic pressure capable of causing hydronephrosis in the proximal ureter after the fluid flowing out through the first opening reaches the UVJ and flows toward the proximal ureter through the UAS. ,
system.
In the operating method of the electronic device in the system of claim 1,
determining, by a processor, a position of the UAS in the bladder and the ureter based on the UASIF measured by the force measuring gauge;
Determining, by a processor, locations of the UAS in the bladder and the ureter as the urethra, the ureterovesical junction (UVJ), and the proximal ureter, respectively, according to the measured peak value of the UASIF;
transmitting or outputting information indicating that the UAS has reached the UVJ to another device connected by wire or wirelessly by controlling the transmission/reception unit or the output unit;
By controlling the transmission/reception unit or the output unit, after the UAS reaches the UVJ, the flow rate information of the fluid flowing out through the first opening and the hydraulic pressure information due to the outflow of the fluid are transmitted to or output from the other device. Including the steps of
method.
According to claim 7,
The memory stores a first cut-off value of the flow rate of the fluid discharged through the first opening after the UAS reaches the UVJ, and a second cut-off value of hydraulic pressure;
By controlling the transmission/reception unit or the output unit, after the UAS reaches the UVJ, the flow rate and the hydraulic pressure of the fluid flowing out through the first opening correspond to the first cut-off value and the second cut-off value. Further comprising transmitting or outputting information indicating arrival to the other device,
method.
According to claim 8,
The first cut-off value of the flow rate is a value of a flow rate at which hydronephrosis can be caused in the proximal ureter after the fluid flowing out through the first opening has flowed out toward the proximal ureter through the UAS reaching the UVJ. ego,
The second cut-off value of the hydraulic pressure is a value of hydraulic pressure capable of causing hydronephrosis in the proximal ureter after the fluid flowing out through the first opening reaches the UVJ and flows toward the proximal ureter through the UAS. ,
method.
In a computer program,
When executed by a processor, it is configured to cause the processor to perform the method according to any one of claims 7 to 9;
recorded on a computer readable storage medium,
computer program.

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