KR102651140B1 - 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 determines 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) for retrograde intrarenal surgery (RIRS), and determines the location of the UAS in the ureter. About a system for reducing the pressure of UAS ureteral insertion and minimizing the occurrence of wounds within the ureter due to UAS ureteral insertion by artificially causing hydronephrosis by injecting fluid into the ureter when it reaches the appropriate position in the ureter. will be.

Description

A system for reducing the insertion pressure of the ureteral entry sheath by artificially inducing hydronephrosis in the ureter and measuring the degree of induction of hydronephrosis using flow rate and hydraulic pressure in retrograde ureteral and kidney stone removal surgery {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 determines 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 determines the location of the UAS in the ureter. When the appropriate position within the ureter is reached, hydronephrosis is artificially induced by injecting fluid into the ureter. By measuring the degree of hydronephrosis induced by flow rate and hydraulic pressure, the pressure of UAS ureteral insertion is reduced and the ureteral insertion pressure of the UAS is reduced. This relates to a system for minimizing the occurrence of wounds within the ureter.

Retrograde intrarenal surgery (RIRS) is a surgery in which stones are identified by entering a ureteroscope through the urethra and the stones are crushed using a laser lithotripter. Existing rigid ureteroscopes were often difficult to access depending on the location of urinary stones, so their scope of application was limited. When it is difficult to use a rigid ureteroscope to remove urinary stones, switch to invasive methods such as percutaneous nephrolithotomy (PNL) or laparoscopic surgery, or use extracorporeal shockwave lithotripsy (ESWL) in several ways. There was a problem that it had to be repeated one after another. To compensate for these problems, a flexible ureteroscope was first developed in 1994 and attempted to be applied to remove urinary tract stones, but it was initially not universalized due to technical limitations. However, recently, with groundbreaking technological advancements, flexible ureteroscopes have become widespread worldwide, and RIRS has established itself as a standard treatment method for removing urinary stones.

The advantages of RIRS using a flexible ureteroscope include 1) no skin incision, very little post-operative pain and hematuria, and 2) stones in the upper ureter and inside the kidney (pyelin, renal abdomen) that cannot be accessed with a conventional rigid ureteroscope. 3) It is possible to remove a significant number of stones that could only be treated by laparoscopic surgery or PNL, thereby avoiding various complications, and 4) It is possible to avoid multiple, large, or lower renal abdomen stones for which the success rate of removal after ESWL is low. There are points that can effectively remove stones. Thanks to these advantages, RIRS using a flexible ureteroscope was recently recommended to be expanded in international treatment guidelines for urinary stones, creating a new paradigm for urinary stone removal.

The reason for the expansion of RIRS was the validation and generalization of the ureteral access sheath (UAS). When using UAS, 1) the flexible ureteroscope can easily enter the renal pelvis, 2) crushed stones can be easily removed through multiple re-entry of the flexible ureteroscope, and 3) the pressure within the kidney during surgery is minimized. 4) It can reduce the bulking pressure of the ureters.

However, the use of UAS does not only have advantages. When excessive pressure is applied to insert a UAS in a thin-diameter ureter, shear injury may occur in the ureter, and this is reported to occur in up to 50% of cases. Additionally, if the ureter is pressed against the UAS and pressure is applied, there is a risk of secondary ureteral stenosis occurring later due to local ischemia. In the implementation of RIRS, insertion of a UAS into the ureter is an essential procedure, but in 16% of cases, the insertion of a UAS into the ureter fails due to excessive resistance or the surgery cannot proceed further due to damage to the ureter.

Several methods and devices have been proposed for inserting UAS into the ureter with low pressure and friction. 1) To reduce friction when inserting UAS into the ureter, a UAS coated with a hydrophilic outer membrane has been released. However, in patients with inherently thin ureteral diameters, these measures are 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 a clinical study, it was reported that ureteral damage due to UAS insertion was significantly less when a ureteral stent was inserted before RIRS. However, a complicated procedure is required to insert a ureteral stent before RIRS, and there is a problem in that the patient experiences discomfort such as hematuria, difficulty urinating, and flank pain due to the ureteral stent. 3) Ureteral balloon dilation has been proposed. This is a method of actively expanding a narrow ureter using a balloon and inserting a UAS. However, this is not recommended because secondary ureteral strictures may occur in the long term.

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

Republic of Korea Patent Publication No. 10-2017-0118821 (2017.10.25.) (Access system, access system and related methods)

Based on the above 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 determines whether the UAS has reached the appropriate position in the ureter. In this case, by injecting fluid into the ureter to artificially induce hydronephrosis and measuring the degree of hydronephrosis induced by flow rate and hydraulic pressure, the pressure of UAS ureteral insertion is reduced and the occurrence of wounds within the ureter due to UAS ureteral insertion is minimized. Provides a system for

According to various embodiments of the present invention, the system includes: 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 to allow fluid to be injected into the third opening and fluid to flow out of the first opening, and including a third opening, the first opening being a ureteral entry house ( It is configured to be connected to a ureteral access sheath (UAS), the first cylinder is configured to allow a guide wire to pass 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 transmitting and receiving unit, or an output unit configured to output an audio or visual display; A force measurement gauge configured to measure the UAS insertion force (UASIF) due to insertion of the UAS into the bladder and ureter; a flow measurement sensor configured to measure the flow rate of 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 outflow of fluid, wherein the processor determines a position of the UAS within the bladder and ureter based on the measured UASIF, and determines the UAS according to the peak value of the measured UASIF. The location of the bladder and ureters is determined as the urethra, ureterovesical junction (UVJ), and proximal ureter, respectively, and the transmitter/receiver or output unit is controlled to inform that the UAS has reached the UVJ. transmits or outputs to another device connected wired or wirelessly, and controls the transmitting/receiving unit or output unit, so that 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 A system configured to transmit or output to another device is provided.

According to various embodiments of the present invention, in a method of operating an electronic device in a system according to various embodiments of the present invention, the position of the UAS in the bladder and ureter is determined by the processor based on the UASIF measured by the force measurement gauge. steps; Determining by the processor the location of the UAS in the bladder and ureter as the urethra, ureterovesical junction (UVJ), and proximal ureter, respectively, according to the measured peak value of UASIF; Controlling the transceiver or output unit to transmit or output information indicating that the UAS has reached UVJ to another device connected wired or wirelessly; A method is provided including the step of controlling the transceiver or output unit to transmit or output 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 to another device after the UAS reaches the UVJ. do.

According to various embodiments of the present invention, 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 invention, and is recorded on 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 determines whether the UAS has reached the appropriate position in the ureter. In this case, by injecting fluid into the ureter to artificially induce hydronephrosis and measuring the degree of hydronephrosis induced by flow rate and hydraulic pressure, the pressure of UAS ureteral insertion is reduced and the occurrence of wounds within the ureter due to UAS ureteral insertion is minimized. Provides a system for

The effects that can be obtained from 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.

Figure 1 shows an example of ureteroscope entry through a ureteral access sheath (UAS) to the bladder, ureters and kidneys.
Figure 2 shows an example of entry of a UAS into the ureter.
Figure 3 shows the configuration of a system according to various embodiments of the present invention.
Figure 4 shows a graph of pressure by location within the ureter of the UAS.
Figure 5 shows the configuration of a device among the configurations of a system according to various embodiments of the present invention.
Figure 6 shows an example of an actual implementation of a force measurement gauge among the configurations of a system according to various embodiments of the present invention.
Figure 7 shows an example of an actual implementation of a hydraulic pressure measurement sensor among the configurations of a system according to various embodiments of the present invention.
Figure 8 shows an example of the flow measurement sensor and fluid injection pump actually implemented in the configuration of the system according to various embodiments of the present invention.
Figure 9 shows an example of an actual implementation of a computer program according to various embodiments of the present invention.
Figure 10 shows an example of actually implementing a system according to various embodiments of the present invention.
Figure 11 shows an example of actually implementing the output of a measured value and an output of whether the measured value exceeds a set threshold according to the operation of a computer program according to various embodiments of the present invention.
Figure 12 shows an example of actually implementing the output of a measured value and an output of whether the measured value exceeds a set threshold according to the operation of a computer program according to various embodiments of the present invention.
Figure 13 shows an example of UAS entry into the ureter.
Figure 14 shows an example of actually implementing a process for determining the location of a UAS in the bladder using a system according to various embodiments of the present invention.
Figure 15 shows an example of actually implementing a process for determining the location of a UAS in the bladder using a system according to various embodiments of the present invention.

Terms used in the present invention are merely used to describe specific embodiments and may not be intended to limit the scope of other embodiments. Singular expressions may include plural expressions, unless the context clearly indicates otherwise. Terms used herein, including technical or scientific terms, may have the same meaning as generally understood by a person of ordinary skill in the technical field described in the present invention. Among the terms used in the present invention, terms defined in general dictionaries may be interpreted to have the same or similar meaning as the meaning they have in the context of related technology, and unless clearly defined in the present invention, have an ideal or excessively formal meaning. It is not interpreted as In some cases, even terms defined in the present invention cannot be interpreted to exclude embodiments of the present invention.

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

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

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

The ureterovesical junction (UVJ) 104 is located where the ureter meets the bladder 102. UVJ has a ureterovesical valve that prevents reflux of urine. If UVJ is disturbed, vesicoureteral reflux may occur.

The border of the proximal ureter (103) and renal pelvis and the UVJ (104) are narrow, so ureteral stones are easily formed.

The urethra (105) is a membranous tube that transports urine from the bladder (102) to the outside of the body. The urethra 105 begins at the lower opening of the bladder 102 and extends outside the body. The urethra 105 may become narrow due to scar tissue within the urethra 105, which may cause urethral stricture. Urethral strictures can cause complications such as stones in the bladder.

After the guide wire first enters the bladder, ureters, and kidneys, the UAS 107 that communicates using the guide wire enters the bladder, ureters, and kidneys. After the UAS 107 enters the bladder, ureters, and kidneys, the ureteroscope 106 may enter the bladder, ureters, and kidneys through the UAS 107.

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

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

The UAS 206 consists of an inner sheath 204 and an outer sheath 205. The inner house 204 is placed inside the outer house 205. When the UAS 206 enters the bladder, ureter, and kidney 201 along the guide wire 203, it enters in a form in which the inner sheath 204 and the outer sheath 205 are combined. After the UAS 206 reaches the appropriate location, the interior house 204 can be separated. After the inner sheath 204 is separated, the ureteroscope can be brought into the space where the inner sheath 204 was located within the outer sheath 205. The ureteroscope can be entered through the external sheath 205 without causing frictional damage to the bladder, ureters and kidneys 201.

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

Figure 2 illustrates a condition in which the UAS 206 may cause friction in the proximal ureter 202. In the proximal ureter 202, the passage of UAS 206 bends toward the renal pelvis. At this time, if the passage of the UAS (206) in the proximal ureter (202) is narrow, the front part of the UAS (206) may cause frictional damage to the proximal ureter (202).

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

A system according to various embodiments of the present invention 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 the first cylinder 304 and the third opening 305, which include the first opening 302 and the second opening 303, and the fluid flows out of the first opening 302. It includes a second cylinder 306 that 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 to allow the guide wire 311 to pass through the first opening 302 and the second opening 303. Guide wire 311 penetrates UAS 309.

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

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

According to various embodiments of the present invention, 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 at the urethra, ureterovesical junction (UVJ), and proximal ureter, respectively, according to the measured peak value of UASIF. It can be further configured to determine the proximal ureter.

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

According to various embodiments of the present invention, the memory stores the cutoff value of the peak value of the UASIF for each position in the bladder and ureter of the UAS 309, and the processor bases the comparison between the measured peak value of the UASIF and the cutoff value. Thus, the UAS 309 may be further configured to determine the location of the bladder and ureter as the urethra, ureterovesical junction (UVJ), and proximal ureter, respectively.

According to various embodiments of the present invention, the electronic device 307 may further include at least one of a wired or wireless transceiver, or an output unit configured to output a voice or visual display, and the transceiver may be wired or wireless. It may be configured to transmit information on 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 invention, the electronic device 307 may further include at least one of a wired or wireless transceiver, or an output unit configured to output a voice or visual display, and the transceiver may be wired or wireless. It may be configured to transmit information indicating that the UAS 309 has reached UVJ to another connected device 308, or the output unit outputs information indicating that the UAS 309 has reached UVJ by voice or visual display. It can be configured to do so.

According to various embodiments of the present invention, the electronic device 307 may further include a flow measurement sensor configured to measure the flow rate of fluid flowing out through the first opening 302, and the transceiver may be connected to another wired or wirelessly connected device. The device 308 may be further configured to transmit flow rate information of fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ, or the output may be configured to transmit to the device 308 the flow rate information of the fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ. 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 invention, 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 fluid. The processor of the device 307 controls the transceiver or output unit to provide flow rate information of the fluid flowing out through the first opening 302 and/or hydraulic pressure information due to the fluid flowing out after the UAS 309 reaches the UVJ. It may be configured to transmit to another device 308 or output it through an output unit.

According to various embodiments of the present invention, the memory may store the cutoff value of the flow rate of the fluid flowing out through the first opening 302 after the UAS 309 reaches UVJ, and the transmitter and receiver may be connected by wire or wirelessly. further configured to transmit to another device 308 information indicating that the flow rate of 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 by voice or visual indication indicating that the flow rate of 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. .

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 the value of the flow rate.

According to various embodiments of the present invention, the memory stores a first cut-off value of the flow rate of 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. It can be configured to save. The processor of the device 307 controls the transceiver or output unit to adjust the flow rate and hydraulic pressure of the fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ to the first cut-off value and the second cut-off value. Information indicating that the off value has been reached may be transmitted to another 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 such that the fluid outflowing through the first opening 302 reaches the UVJ and flows toward the proximal ureter through the UAS 309, after which the fluid flows into the proximal ureter. is the value of the flow rate that can cause 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 a value of hydraulic pressure that can cause .

Figure 4 shows a graph of pressure by location within the ureter of the UAS.

To obtain the graph in Figure 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 prospectively enrolled in this study from December 2015 to January 2017. Patients were identified based on clinic visits. UASIF was measured and recorded for patients. This study was approved by the institutional ethics committee (3-2016-0117).

UAS development

We designed and manufactured a UASIF measurement gauge to measure real-time UASIF during ureteral insertion of UAS. UASIF measurement gauges include a V-block jig that holds the UAS hub, a linear jig that offsets the potential torque applied to the V-block jig during UAS insertion, and a 1.0 to 5,000 at millisecond frequency. It consisted of four components, including a ZTA-50N digital force gauge (IMADA Instruments, Toyohashi City, Japan) capable of measuring UASIF in 1 G increments over a range of G, and an aluminum linear lift mounted on 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 preexisting pathological lesions. After placing the guide wire, a UAS with a UASIF measurement gauge attached was inserted. A UAS with a diameter of 12/14Fr (46 cm for men and 35 cm for women) was used.

A UAS equipped with a UASIF measurement gauge was inserted into the patient, and the location of the distal tip of the UAS was identified through real-time X-ray imaging. The peak UASIF was recorded and considered as the maximum UASIF. The maximum UASIF was measured with UAS passing through the urethra, UVJ, and proximal ureter.

Referring to FIG. 4, with respect to the peak value of UASIF, the distal tip of UAS is positioned in the urethra ( It can be seen that it is located in the urethra, ureterovesical junction (UVJ), and proximal ureter. Therefore, based on measurement and peak value analysis of UASIF, the location of UAS in the bladder and ureters can be determined.

Additionally, as another method, a cut-off value can be applied to the peak value of UASIF to determine the location of UAS in the bladder and ureter. For example, when the peak value of UASIF first exceeds 300 g, the UAS is located in the urethra, and when the peak value of UASIF first exceeds 500 g, the UAS is located at the ureterovesical junction (UVJ), and UASIF When the peak value of exceeds 600g for the first time, it can be seen that the UAS is located in the proximal ureter. These cut-off values are illustrative and may change depending on the user's settings.

In the present invention, based on the data in FIG. 4, the location of the UAS in the bladder and ureter is identified, and then artificial hydronephrosis is induced in the proximal ureter, which is a location where friction damage is likely to occur during insertion of the UAS, thereby causing proximal hydronephrosis while the UAS passes. A system for artificially widening the passage of the ureter is provided.

When the tip of the UAS is located in the UVJ, a predetermined amount of fluid, for example, water, can be sprayed toward the proximal ureter to induce hydronephrosis to the extent that the UAS can easily pass through the proximal ureter.

The following second study was conducted to verify the effectiveness of the present invention.

Development of artificial hydronephrosis inducer

We manufactured a pulse-type quantitative motor that can spray fluid that causes artificial hydronephrosis at a constant flow rate, and developed an algorithm that can control the flow rate and cycle. Through previous research, the pressure range of the injected fluid was selected, and the collection range (mmHg) of the liquid pressure sensor was selected accordingly. A flow path was designed to measure the pressure in the injected fluid, and a pressure measurement sensor was installed in a location that would not interfere with the procedure. An amplification circuit to amplify the measured pressure signal and a single-board microcontroller circuit to collect information were constructed. For communication 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, diagram it on the terminal screen, and save it inside the terminal.

Verification of artificial hydronephrosis inducer

A 3D modeling was designed by simulating the shape of the ureter's stricture, and a ureter requiring artificial hydronephrosis was created using liquid-curable silicone. Using the developed integrated pressure device, the axial force experienced by the UAS within the simulated ureter and the pressure of the sprayed liquid were simultaneously collected and communicated wirelessly with the terminal. When the UAS passed through the stenotic ureter, we observed the collected axial force and the pressure of the sprayed liquid to quantitatively confirm whether artificial hydronephrosis relief relieved the UAS insertion pressure.

RIRS surgical procedure animal experiments

All RIRS were performed under general anesthesia in the lithotomy position. Before inserting the UAS, retrograde ureteropyelography was performed to evaluate the location of the organic ureteral opening, presence of ureteral stricture, and stone location. If ureteral strictures were observed, subjects were excluded from the subject pool of this study. In the artificial hydronephrosis inducing group, artificial hydronephrosis inducing movements were performed using an artificial hydronephrosis inducing device. After confirming that there was no ureteral stricture, a guide wire (Amplatz super stiff Urowire For accurate measurement of UAS insertion pressure, 1) no safety guidewire was used, 2) a UAS with a 12/14 Fr diameter (46 cm for men, 35 cm for women) was used in all cases, and 3) interobserver measurement was used. To minimize measurement deviation, all manipulations and measurements were performed by one researcher.

UASIF measurement animal experiment to measure UAS entry pressure

The UAS was inserted while relying on the UASIF measurement gauge, that is, the UAS insertion pressure measurement gauge, in a direction parallel to the guide wire (super stiff guidewire). Using an Afterwards, the maximum pressure upon entry into the ureteral orifice, UVJ, and proximal ureter of the UAS was measured, and the limiting value for urethral resistance pressure was recorded.

Evaluation of ureteral damage after animal experimental surgery

After completing the animal experiment surgery, the UAS was removed, and the presence or absence of ureteral damage and damage grade were evaluated and recorded. The following established standard table [Table 1] was used to grade ureteral damage. As a result of the ureteral damage evaluation, it was confirmed that the average ureteral damage grade due to UAS insertion in the group that performed artificial hydronephrosis induction was significantly lower than the average ureteral damage grade due to UAS insertion in the group that did not perform artificial hydronephrosis induction.

[Table 1] Grades of ureteral damage caused by UAS insertion

Expected effects and contribution

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

Improving RIRS surgery success rate and preventing complications

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

Figure 5 shows the configuration of a device among the configurations of a system according to various embodiments of the present invention.

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

Referring to FIG. 5 , the electronic device 500 includes a force measurement gauge 501 configured to measure UAS insertion force (UASIF) due to insertion of the UAS into the bladder and ureter. The force measurement gauge 501 may be composed of a force measurement 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 invention, 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, etc. The processor 502 controls the output unit 505 to output information, etc. Additionally, the processor 502 writes and reads data into 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 basic programs, application programs, and setting information for operation of the processor 502. The memory 503 includes information on the cut-off value of the peak value of the UASIF for each position in the bladder and ureter of the UAS measured in advance, information on the cut-off value of the fluid flow rate for causing artificial hydronephrosis measured in advance, and information on the cut-off value of the fluid flow rate for inducing artificial hydronephrosis measured in advance. UASIF information, etc. can be stored. The memory 503 may be comprised of volatile memory, non-volatile memory, or a combination of volatile memory 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 into the urethra, ureterovesical junction (UVJ), and ureterovesical junction (UVJ), respectively, according to the measured peak value of UASIF. It may be further configured to determine the proximal ureter.

According to various embodiments of the present invention, the processor 502 determines the positions of the UAS within the bladder and the ureter into the urethra and the ureterovesical junction (UVJ), respectively, according to the order of the peak values of the measured UASIF. , 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 value exceeding the previous peak value of the measured UASIF by more than a predetermined error range occurs. there is.

According to various embodiments of the present invention, the memory 503 stores the cutoff value of the peak value of the UASIF for each position in the bladder and ureter of the UAS 309, and the processor 502 stores the measured peak value of the UASIF and the cutoff value. Based on the comparison of the OFF values, the position of the UAS 309 in the bladder and ureter may be further configured to determine the urethra, ureterovesical junction (UVJ), and proximal ureter, respectively.

According to various embodiments of the present invention, 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 an audio or visual display, The transceiver 506 may be configured to transmit information on the measured UASIF to another device 308 connected wired or wirelessly, or the output unit 505 may be configured to output the measured UASIF as a voice or visual display. It can be configured.

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

The transceiver unit 506 is connected to the processor 502 and can transmit and/or receive information to another device 308 that is connected wired and/or wirelessly. All or part of the transceiver 506 may be referred to as a transmitter, receiver, or transceiver. The transmitting and receiving unit 506 uses a wired access system and/or a wireless access system such as the Institute of Electrical and Electronics Engineers (IEEE) 802.xx system, IEEE Wi-Fi system, 3rd generation partnership project (3GPP) system, and 3GPP LTE (long term) system. evolution) system, 3GPP 5G NR (new radio) system, 3GPP2 system, and Bluetooth can support at least one of various wireless communication standards.

The other device 308 is a device that can transmit and/or receive and output information with the electronic device 500 wired and/or wirelessly, such as a smartphone, tablet computer, personal computer, etc.

According to various embodiments of the present invention, 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 an audio or visual display, The transceiver 506 may be configured to transmit information indicating that the UAS 309 has reached UVJ to another device 308 connected wired or wirelessly, or the output unit 505 may be configured to transmit information indicating that the UAS 309 has arrived at UVJ. It may be configured to output information indicating that UVJ has been reached in a voice or visual display.

According to various embodiments of the present invention, the electronic device 500 may further include a flow measurement sensor 504 configured to measure the flow rate of 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 wired 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 as an audio or visual display after the UAS 309 reaches the UVJ. According to various embodiments of the present invention, the flow measurement sensor 504 may be combined with the first cylinder 304 to measure the flow rate of fluid flowing out through the first opening 302.

According to various embodiments of the present invention, 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 fluid through the first opening 302. The transceiver 506 may be further configured to transmit hydraulic information due to the fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ to another device 308 connected wired 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 an audio or visual display after the UAS 309 reaches the UVJ. According to various embodiments of the present invention, the hydraulic pressure measurement sensor may be combined with the first cylinder 304 to measure the hydraulic pressure of the fluid flowing out through the first opening 302.

According to various embodiments of the present invention, 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 UVJ, and the transceiver 506 ) transmits information indicating that the flow rate of fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ has reached the cut-off value of the flow rate to another device 308 connected wired or wirelessly. Alternatively, the output unit 505 may output information indicating that the flow rate of fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ has reached the cut-off value of the flow rate. Or 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 the value of the flow rate.

According to various embodiments of the present invention, the memory 503 stores a first cut-off value of the flow rate of 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 transceiver 506 or output unit 505 to determine the flow rate and flow rate of the fluid flowing out through the first opening 302 after the UAS 309 reaches the UVJ. Information indicating that the hydraulic pressure has reached the first cut-off value and the second cut-off value may be transmitted to another 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 such that the fluid outflowing through the first opening 302 reaches the UVJ and flows toward the proximal ureter through the UAS 309, after which the fluid flows into the proximal ureter. is the value of the flow rate that can cause 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 a value of hydraulic pressure that can cause .

According to various embodiments of the present invention, a method of operating 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 invention, the method of operating the electronic device 500 of FIG. 5 includes determining the position of the UAS within the bladder and ureter based on the UASIF measured by the force measurement gauge 501; Determining by the processor 502 the positions of the UAS in the bladder and ureter as the urethra, ureterovesical junction (UVJ), and proximal ureter, respectively, according to the measured peak value of UASIF; Controlling the transceiver 506 or output unit 505 to transmit or output information indicating that the UAS has reached UVJ to another device connected wired or wirelessly; By controlling the transmitting and receiving 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 or output to another device. May include steps.

According to various embodiments of the present invention, the memory 503 stores a first cut-off value of the flow rate of fluid flowing out through the first opening after the UAS reaches the UVJ, and a second cut-off value of the hydraulic pressure, The method of operating the electronic device 500 in FIG. 5 controls the transmitter/receiver 506 or the output unit 505 so that the flow rate and hydraulic pressure of the fluid flowing out through the first opening after the UAS reaches the UVJ are adjusted to the first It 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 that can cause hydronephrosis in the proximal ureter after the fluid outflowing through the first opening flows out toward the proximal ureter through the UAS reaching the UVJ. value, and the second cut-off value of hydraulic pressure may be a value of hydraulic pressure that can cause hydronephrosis in the proximal ureter after the fluid flowing out through the first opening flows out toward the proximal ureter through the UAS reaching the UVJ.

According to various embodiments of the present invention, in the 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 invention. A computer program configured to execute and recorded on a computer-readable storage medium may be provided.

Figure 6 shows an example of an actual implementation of a force measurement gauge among the configurations of a system according to various embodiments of the present invention.

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

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

The UASIF information measured by the force measurement 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.

Figure 7 shows an example of an actual implementation of a hydraulic pressure measurement sensor among the configurations of a system according to various embodiments of the present invention.

Referring to FIG. 7, an example of an actually implemented hydraulic pressure measurement sensor 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 fluid introduced into the third opening through the first opening in the system according to various embodiments of the present invention.

Information on the hydraulic pressure measured by the hydraulic 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.

Figure 8 shows an example of the flow measurement sensor and fluid injection pump actually implemented in the configuration of the system according to various embodiments of the present invention.

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

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

Information on the flow rate measured by the flow measurement 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 transmitter and receiver.

Figure 9 shows an example of an actual implementation of a computer program according to various embodiments of the present invention.

Referring to Figure 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 values and thresholds measured by the sensor, and graph scale adjustment. and threshold setting bar, display of real-time sensor values and time, data reset button icon, status bar, data spreadsheet within the tablet computer device, e.g. save button icon for saving to an Excel file, the measured values It may be configured to display a threshold notification icon indicating whether the threshold has been exceeded.

The tablet computer on which the computer program of FIG. 9 is implemented may correspond to a device in the system according to various embodiments of the present invention, or may correspond to another device connected to the device in the system by wire or wirelessly.

Figure 10 shows an example of actually implementing a system according to various embodiments of the present invention.

Referring to FIG. 10, by running an application program in a tablet computer connected wired or wirelessly to a force measurement gauge connected to the UAS, UASIF information measured from the force measurement gauge is transmitted to the tablet computer, 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 measurement sensor and the oil pressure measurement sensor can also be connected to the UAS, and the information on the flow rate and oil pressure measured by the flow measurement sensor and the oil pressure measurement sensor can also be transmitted to the tablet computer. In addition, by comprehensively analyzing UASIF information, flow information, and hydraulic information on a tablet computer, the location of the UAS, whether hydronephrosis occurs, whether the UAS can be injected into the proximal ureter, and whether the UAS can cause injury within the ureter can be analyzed and printed. You can.

Figure 11 shows an example of actually implementing the output of a measured value and an output of whether the measured value exceeds a set threshold according to the operation of a computer program according to various embodiments of the present invention.

Referring to Figure 11, it can be confirmed that the UASIF measured by the force measurement gauge exceeds the set threshold value.

Figure 12 shows an example of actually implementing the output of a measured value and an output of whether the measured value exceeds a set threshold according to the operation of a computer program according to various embodiments of the present invention.

Referring to FIG. 12, it can be confirmed that the UASIF measured by the force measurement gauge exceeds the set threshold value.

Figure 13 shows an example of UAS entry into the ureter.

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

Since the urethra, UVJ, and UPJ are places where the UAS passageway becomes narrow, friction damage can be caused by the front part of the UAS.

Figure 14 shows an example of actually implementing a process for determining the location of a UAS in the bladder using a system according to various embodiments of the present invention.

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

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

Figure 15 shows an example of actually implementing a process for determining the location of a UAS in the bladder using a system according to various embodiments of the present invention.

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

Referring to Figure 15, it can be confirmed that the UAS reached the urethra, UVJ, and proximal ureter, respectively, through a section where 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 depending on the specific embodiment presented. However, the singular or plural expressions are selected to suit the presented situation for convenience of explanation, and the present invention is not limited to singular or plural components, and even components expressed in plural may be composed of singular or singular. Even expressed components may be composed of plural elements.

Meanwhile, in the detailed description of the present invention, specific embodiments have been described, but of course, 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, but should be determined not only by the scope of the patent claims described later, but also by the scope of this patent claim and equivalents.

101: Kidney 102: Bladder
103: proximal ureter 104: ureterovesical junction
105: urethra 106: ureteroscope
107: ureter entry house 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 devices 309: Ureteral entry house
310: syringe 311: guide wire
500: device 501: force measurement gauge
502: Processor 503: Memory
504: flow measurement sensor 505: output unit
506: Transmitter and receiver

Claims (10)

In medical devices,
The medical device includes a Y-shaped medical connector; and an electronic device coupled to the medical connector,
The medical connector is,
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 fluid can be injected into the third opening and flow out of the first opening,
The first opening is configured to be connected to a ureteral access sheath (UAS),
The first cylinder is configured to allow a guide wire to pass through the first opening and the second opening, and the guide wire passes through the UAS,
The electronic device is,
Memory;
processor;
A wired or wireless transmitting and receiving unit, or an output unit configured to output an audio or visual display;
A force measurement gauge configured to measure a force (UAS insertion force, UASIF) resulting from insertion of the UAS into the bladder and ureter;
a flow measurement sensor configured to measure the flow rate of fluid flowing out through the first opening;
A hydraulic pressure measurement sensor configured to measure the hydraulic pressure of the first opening due to the outflow of the fluid,
The processor,
Determine the location of the UAS within the bladder and the ureter based on the measured UASIF,
According to the measured peak value of 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 transceiver or the output unit to transmit or output information indicating that the UAS has reached the UVJ to another device connected wired or wirelessly,
By controlling the transceiver or the output unit, after the UAS reaches the UVJ, flow rate information of the fluid flowing out through the first opening and hydraulic pressure information due to the outflow of the fluid are transmitted or output to the other device. configured to,
Medical devices.
According to claim 1,
The processor,
It is further configured to determine the positions of the UAS in the bladder and the ureter as the urethra, ureterovesical junction (UVJ), and proximal ureter, respectively, according to the order of the measured peak values of the UASIF. ,
The order of the peak values of the measured UASIF means the order in which peak values that exceed the previous peak value of the measured UASIF by more than a predetermined error range occur,
Medical devices.
According to claim 1,
The memory stores a cutoff value of the peak value of UASIF for each location of the UAS in the bladder and the ureter,
The processor,
Based on the comparison of the measured peak value of UASIF and the cut-off value, the location of the UAS in the bladder and the ureter is determined as the urethra, ureterovesical junction (UVJ), and proximal ureter, respectively. further configured to determine,
Medical devices.
According to claim 1,
The processor,
Further configured to control the transceiver or the output unit to transmit or output the measured UASIF to the other device,
Medical devices.
According to claim 1,
the memory stores a first cut-off value of the flow rate of fluid flowing out through the first opening after the UAS reaches the UVJ, and a second cut-off value of hydraulic pressure;
The processor,
By controlling the transceiver or the output unit, the flow rate and the hydraulic pressure of the fluid flowing out through the first opening after the UAS reaches the UVJ are adjusted 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,
Medical devices.
According to clause 5,
The first cut-off value of the flow rate is a value of the flow rate that can cause hydronephrosis in the proximal ureter after the fluid flowing out through the first opening flows toward the proximal ureter through the UAS reaching the UVJ. ego,
The second cut-off value of the hydraulic pressure is a value of the hydraulic pressure that can cause hydronephrosis in the proximal ureter after the fluid flowing out through the first opening flows toward the proximal ureter through the UAS reaching the UVJ. ,
Medical devices.
In the method of operating the electronic device in the medical device of claim 1,
determining, by a processor, a position of the UAS within the bladder and the ureter based on the measured UASIF by the force measurement gauge;
Determining by the processor the positions of the UAS within the bladder and the ureter as the urethra, ureterovesical junction (UVJ), and proximal ureter, respectively, according to the measured peak value of the UASIF;
Controlling the transceiver or the output unit to transmit or output information indicating that the UAS has reached the UVJ to another device connected wired or wirelessly;
By controlling the transceiver or the output unit, after the UAS reaches the UVJ, flow rate information of the fluid flowing out through the first opening and hydraulic pressure information due to the outflow of the fluid are transmitted or output to the other device. Including the steps of:
method.
According to clause 7,
the memory stores a first cut-off value of the flow rate of fluid flowing out through the first opening after the UAS reaches the UVJ, and a second cut-off value of hydraulic pressure;
By controlling the transceiver or the output unit, the flow rate and the hydraulic pressure of the fluid flowing out through the first opening after the UAS reaches the UVJ are adjusted 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 clause 8,
The first cut-off value of the flow rate is a value of the flow rate that can cause hydronephrosis in the proximal ureter after the fluid flowing out through the first opening flows toward the proximal ureter through the UAS reaching the UVJ. ego,
The second cut-off value of the hydraulic pressure is a value of the hydraulic pressure that can cause hydronephrosis in the proximal ureter after the fluid flowing out through the first opening flows toward the proximal ureter through the UAS reaching the UVJ. ,
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.

Images