System and method for removing kidney stone fragments

Abstract

A system for guiding and removing particulate matter from a subject's body, particularly small stone fragments from the subject's kidneys, is presented. The system comprises a ureterorenary access sheath, a renal irrigation catheter, an image generator, and a dual-action pumping device. The ureterorenary access sheath has a fluid discharge port connected to the dual-action pumping device. The renal irrigation catheter has a fluid inlet port connected to the dual-action pumping device. A method for removing particulate matter from a subject's kidneys using the above system is also disclosed.

Description

Technical Field

[0001] The present invention relates to a system and method for guiding and removing particulate solids, and more particularly to a system and method for removing kidney stones from a subject's body.

Background Art

[0002] Urolithiasis is a disorder that can occur to anyone, related to the formation and growth of insoluble deposits in the kidneys of a subject. These deposits, commonly called kidney stones, are derived from chemicals contained in urine and are basically classified into four types: calcium oxalate stones, uric acid stones, struvite stones, and cystine stones based on their components. When the symptoms that can occur to anyone, that is, urolithiasis, occur, severe pain is felt in the back, urine emits a bad smell or becomes cloudy, and in severe cases, blood mixes in the urine, and discomfort, nausea, fever, or chills may also be felt.

[0003] Such disorders affect approximately 10% of the population in developed countries, mainly due to modern lifestyles such as excessive salt or sugar intake, obesity, lack of exercise, and little water intake.

[0004] Once formed, the stones may remain in the kidneys without causing pain and may not be detected if they do not cause any disorders. However, the stones can also reach from the ureter into the urethra and further descend. Small stones discharged outside the body together with urine usually do not cause much pain. On the other hand, relatively large stones may become clogged during movement in the kidneys, ureters, bladder, or urethra, causing backflow. In such cases, the subject may feel intense pain.

[0005] Today, as various treatment methods for urolithiasis, treatment methods related to direct physical removal of stones and / or reducing the size of stones in advance (such as intrauterine endoscopic treatment, percutaneous nephrolithotomy, percutaneous nephrolithotripsy, and extracorporeal lithotripsy) can be used.

[0006] In practice, various methods are used, either alone or in combination, depending on the shape and size of the one or more stones to be removed. Percutaneous nephrolithotomy is mainly performed on patients with large or irregularly shaped kidney stones or those suffering from infections. This method requires accessing the kidney through a small incision in the back, and the procedure usually requires anesthesia and a hospital stay of about two to three days.

[0007] Among the various lithotripsy methods, shock wave lithotripsy is a widely used procedure that attempts to break kidney stones into smaller pieces using shock waves from outside the body. This procedure typically involves positioning the body so that a water-filled cushion is in contact with the patient's torso or placed behind the kidney to allow for precise targeting of the stones. Depending on the degree of fragmentation, the results of this method are pieces so small that they can be described as "stone fragments" or even "stone dust," and are considered small enough to pass through the urethra with the urine. The main advantage of this type of procedure is that, because it can be performed on the patient by external means, it generally reduces the complexities, length of hospital stay, costs, and recovery period associated with surgical intervention.

[0008] Recently, laser lithotripsy has been attracting attention. Laser lithotripsy does not use sound waves as an energy source from outside the body, but rather uses energy pulses of a laser beam that are directly irradiated onto stones inside the body, such as in the urethra. Thus, this technology involves, for example, using an endoscope to directly irradiate the stone with a laser device before it is calcined.

[0009] Lithotripsy is widely accepted among internists due to its ease of handling and short hospital stay. However, after "fragmentation" or "dust formation," the small pieces of material are not completely flushed out by normal urination and remain in the renal cavity or poles of the kidney, which are biologically designed to collect urine before urination. In particular, due to the effects of gravity, they mainly remain in the renal calyces at the lower poles, eventually forming new seed crystals that grow into larger stones. In fact, recent reports show that as many as 60% of patients experience a recurrence of discomfort after the procedure.

[0010] U.S. Patent Application Publication No. 2017 / 319776(A1) discloses a system and method for guiding and removing an object from a subject. The method includes guiding a flexible tube having a first passage and a second passage into a subject's tubing; positioning the distal end of the first passage near the object; allowing a liquid to seep into the second passage; and removing the object, along with at least a portion of the liquid, through the first passage when no suction is being performed.

[0011] U.S. Patent Application Publication No. 2021 / 204968(A1) discloses a system, apparatus and method for removing objects from the body. The apparatus may be a urethral catheter configured to aspirate kidney stones from the urethra (urinary tract) via one or more suction portions located on the distal surface of the catheter or along its transverse side. The catheter may have one or more irrigation (washing) portions located on the distal surface of the catheter or along its lateral side for removing kidney stones.

[0012] U.S. Patent Application Publication No. 2021 / 022757(A1) discloses a method for removing a stone from a patient, comprising the steps of: providing a suction retraction assembly including a sheath and one or more side arms; inserting and positioning the distal end of the sheath into the cavity or lumen of a patient having a stone; connecting a tube to one of the side arms and a collection bottle; connecting the other tubes to the collection bottle and a negative pressure system; activating the negative pressure system to remove the stone from the cavity if the diameter of the stone is smaller than the diameter of the sheath and side arms; crushing the stone into fragments having a diameter small enough to pass through the assembly; and collecting the stone in a collection bottle.

[0013] Other challenges when attempting to flush small objects out of the body include preventing an increase in internal pressure in the kidneys and maintaining a nearly constant internal pressure in the body or organ being treated, but conventional techniques do not adequately address these issues.

[0014] European Patent No. 3960098 discloses a device for urethral surgery comprising a sheath structure capable of enclosing a surgical tool. The disclosed sheath structure is designed to provide an irrigation channel through which fluid can be introduced into the patient's urinary system, while the introduced fluid is extracted by the surgical tool. The disclosed reflux technique has the advantage of bringing the kidney stone close to the extraction channel while keeping the debris away from the camera at the tip of the sheath, thus creating a device suitable for urethral surgery. [Overview of the Initiative] [Problems that the invention aims to solve]

[0015] The aforementioned reflux technique still has problems, such as the difficulty in reaching and dislodgeing kidney stones located in the small renal calyces of the kidney. This is because the inflow of irrigation (washing) fluid occurs at the exit of the sheath, which is positioned to access the patient's urethra. Another disadvantage of this reflux technique is that debris, or diffused material, can clog the lumen of the surgical tool, interfering with the surgery.

[0016] The object of the present invention is to overcome the shortcomings of the prior art in providing a system and method for removing almost all particulate kidney stone material from a subject's kidney to reduce the recurrence of urinary tract stones. At the same time, it is desirable that the pressure within the kidney to be treated does not substantially exceed the treatment-acceptable limit. At the same time, it is desirable that the system can easily resolve various problems of the suction channel caused by material clogging inside the suction channel. [Means for solving the problem]

[0017] The present invention solves the above problems by providing a system and method for removing small fragments from a subject's kidney. The system comprises a ureterorenary access sheath, a renal irrigation catheter, an image generating device, and a dual-action pumping device. The ureterorenary access sheath has a fluid discharge port connected to the dual-action pumping device. The renal irrigation catheter has a fluid inlet port connected to the dual-action pumping device.

[0018] The ureteral-renal access sheath is designed and configured to receive a renal irrigation catheter inside it and to have a shape and dimensions that allow fluid and small pieces to pass between the inner wall of the ureteral access sheath and the wall of the renal irrigation catheter. The renal irrigation catheter can move axially within the renal access sheath, and its tip can protrude sufficiently from the distal end of the sheath to advance into the renal calyces of the kidney. Furthermore, at the tip of the renal irrigation catheter, at least the tip portion is adapted to bend or rotate 360 ​​degrees relative to the axis of the catheter within the sheath in order to direct the flow of fluid supplied from the tip into all cavities of the subject's kidney (directed fluid can remove small stone material, i.e., debris, from the renal cavities). The image generating device provides images of the kidney and / or the poles and calyces of the kidney, particularly images of the anterior and periphery of the irrigation catheter, and contributes to guiding the catheter during operation. The image generating device may be a camera with a light source located at the tip of the irrigation catheter. Alternatively, an ultrasound device may function as such an image generator. In some cases, the image generator may be connected to a display device to make the kidney region easier to visualize.

[0019] The system further includes a dual-action pumping device capable of performing pumping and releasing actions almost simultaneously. One side of the dual-action pumping device is connected to the fluid outlet port of the ureterorenary access sheath to provide a suction function, while the other side of the dual-action pumping device is connected to the fluid inlet of the renal irrigation catheter to provide a pressure increase function.

[0020] The present invention further presents a method for removing small kidney stones, fragments and / or stone dust from a subject's kidney (e.g., which can be obtained after lithotripsy treatment using the above system on the surface or inside of an individual to be treated). This method includes the steps of preparing the system of the present invention, inserting a ureteral renal access sheath containing a renal perfusion catheter inside into the subject's kidney, and while flowing fluid into the kidney and / or its poles and renal calyces through the renal perfusion catheter using a dual-action pumping device, discharging the fluid in the kidney and / or its poles and renal calyces containing the expelled substances through the lumen of the renal access sheath using the dual-action pumping device, thereby swirling small pieces, stone fragments and / or stone dust present in the kidney and / or its poles, and repeating the above operation one or more times while rotating or displacing the position of the tip of the perfusion catheter from its previous position.

Brief Description of the Drawings

[0021] [Figure 1] A diagram schematically showing a preferred embodiment of the system of the present invention for removing kidney stones. [Figure 2A] A diagram showing an artificial kidney model filled with physiological saline and kidney stones. [Figure 2b] A diagram showing the artificial kidney model after treatment using the system of the present invention. [Figure 3] A diagram showing a kidney model presenting the anatomical shape, dimensions and flexibility of a living body's kidney.

Modes for Carrying Out the Invention

[0022] The present invention will be described with reference to FIG. Ⅰ showing a preferred embodiment of the system of the present invention.

[0023] The system of the present invention includes a ureteral renal access sheath 1, a renal perfusion catheter 2, an image generating device 3, and a dual-action pumping device 5.

[0024] The ureteral renal access sheath 1 is a flexible hollow tube, which has been conventionally used in the art for accessing the kidney. It is made of materials permitted for human application. The ureteral renal access sheath 1 used in the present invention has a shape and volume that can be passed through the bladder and into the ureter up to the kidney, and is further designed to receive the kidney perfusion catheter 2 via the access port 11. When receiving, by leaving a sufficient volume of space between the inner wall of the ureteral access sheath 1 and the outer wall of the kidney perfusion catheter 2, fluid and minute individual particles entrained by the fluid flow are carried through that space. This is achieved when the diameter of the lumen of the ureteral renal access sheath is larger than the diameter up to the outer peripheral edge of the kidney perfusion catheter to be used. In this case, the kidney perfusion catheter does not occupy all the space within the ureteral renal access sheath, and the fluid can flow along the side of the catheter within the sheath. That is, the lumen of the sheath forms a suction channel.

[0025] An essential advantage of this design is that, during an operation such as retreating the tip of the catheter from one cavity of the kidney and advancing it into another cavity, by simply moving the catheter back and forth within the sheath, or by intentionally advancing and retreating the catheter (2) within the sheath while keeping the fluid flow rate constant, the kidney stones or their fragments that are in contact and engaged with the perfusion catheter (2) at a position where the ureteral renal access sheath (1) can be occluded are substantially or intentionally released, the engagement is released by rolling the substance, and the substance can be washed away again with fluid.

[0026] In one embodiment, the ureterorenary access sheath 1 has a plurality of spacers arranged along its longitudinal direction on its inner circumferential wall, and these spacers are positioned to maintain the renal irrigation catheter 2, which is placed inside the ureterorenary access sheath 1, in a position approximately midway through the lumen of the ureterorenary access sheath 1. These spacers may extend along the longitudinal direction of the ureterorenary access sheath 1, or they may be positioned only at substantially one end or both ends 12, 13 of the ureterorenary access sheath. In a preferred embodiment, one or more spacers are provided at the end 13 of the ureterorenary access sheath 1 to maintain the renal irrigation catheter 2 in a central position, thereby improving the sealing (occlusion) function.

[0027] The ureterorenary access sheath 1 has a distal end 12 to be inserted into the lumen of the kidney and a proximal end 13, the proximal end 13 of which is provided with an outlet port 14 from which fluid is released and an access port 11 for inserting the renal irrigation catheter 2.

[0028] In one embodiment, the proximal end 13 of the ureterorenary access sheath 1 has a larger dimension or diameter, i.e., a larger volume, than the rest of the ureterorenary access sheath 1. That is, the proximal end 13 is formed to facilitate the discharge of the fluid to be released and to facilitate access for the renal irrigation catheter 2. In such a case, the ureterorenary access sheath 1 may have a larger volume as a part of it, or it may be connected to the ureterorenary access sheath 1 as an additional discharge chamber. The additional chamber comprises a connecting passage that fluidly communicates with the ureterorenary access sheath 1, in the form of a tubular section configured to engage occlusively (watertightly) with the wall of the ureterorenary access sheath 1 (preferably resulting in the form of a seamless tubular connection). On the chamber side opposite this tubular section, a connecting passage for introducing the irrigation catheter 21 into the chamber is provided, aligned with the tubular section. This passage is formed using a penetrating occlusion means and defines the central position of the instrument penetration hole. The renal irrigation catheter 2 can be inserted occlusively (watertightly) along the instrument penetration hole.

[0029] Furthermore, the ureterorenary access sheath 1 or at least its proximal end 13, particularly the deposit chamber 15, is made of a transparent material that allows external visibility to determine, for example, whether some particulate matter 15 has still accumulated after some or several procedures, thereby assisting physicians in determining in-situ whether particulate matter remains in the kidney, as it may be released even if it is not visible using an imaging device 3.

[0030] In principle, the image generation device should be a variety of devices or apparatus capable of providing the operator with images of the spatial environment (the renal irrigation catheter 2 moving in and around the air environment), for example, by displaying them on a monitor. Examples of such image generation devices include a camera positioned at the tip of the renal irrigation catheter 2 and a supersonic device or a fluorescence fluoroscopy device (these may be positioned outside the subject or at the tip of the renal irrigation catheter 2). It may be an automatically recording, insertable microbore endoscope camera. In a preferred embodiment, the image generation device is a fluorescence fluoroscopy device that captures real-time video of the inside of the subject's body during examination and the forward supply and position of the irrigation catheter inside the kidney. In this case, BaSO4 (barium sulfate) may be added to the flexible portion of the irrigation catheter 2 to improve radiopaqueness and visibility.

[0031] When a camera, particularly a microcamera, is positioned at the tip of the renal irrigation catheter 2, a light source 4 may also be provided to visualize the environment in front of and / or around the renal irrigation catheter 2. The image generating device positioned at the tip of the renal irrigation catheter 2 may be connected to a controller and / or display by wire or wireless connection, and the wired connection is dimensioned to fit and be positioned within the ureterorenary access sheath 1 or at a predetermined position on the renal irrigation catheter 2 so as not to obstruct the outflow fluid containing particulate matter to be released.

[0032] The image generation device assists the operator in guiding the renal irrigation catheter 2 to the treatment area (e.g., a specific pole of the kidney) and / or visualizing the presence or absence of contents in that area (i.e., whether or not some residual particulate matter is detected).

[0033] The fluid outlet port 14 is connected in a closed (watertight) manner to a tube or pipe 9, which is connected to a dual-action pumping device 5, and is finally adapted to be connected to a container (not shown) for collecting the discharged fluid.

[0034] During the operation, the fluid outlet port 14 of the ureterorenary access sheath 1 may be positioned lower than the height of the inlet, or opening 11, for the renal irrigation catheter 2. This positioning helps to remove fluid containing fragments (residues) of kidney stones. Additionally, the ureterorenary access sheath 1 may exert a siphon effect when the height of the outlet of the tube 9 is lower than the height of the individual's kidney. To ensure a siphon effect during the operation, the operator may move the tube 9 somewhat during the operation, and the ureterorenary access sheath 1 may have an elongated outlet tube 14' manufactured integrally with the renal access sheath 1, or an elongated outlet tube 14' may be attached to the fluid outlet port 14. It is preferable that the outlet tube be made of a rigid material so that it can be kept facing downwards during the operation. When tube 14' is used, tube 9 is connected to the outlet of tube 14', which in turn is connected to the dual-action pumping device 5.

[0035] The access port 11 within the ureterorenary access sheath 1 for inserting the renal irrigation catheter 2 can be sealed by conventional means (for example, an O-ring made from a material commonly used in surgery, designed to watertightly seal the renal irrigation catheter 2 when acting as an occlusion plug for the entrance port of the renal irrigation catheter 2). In a preferred embodiment, the sealing means are thin films of silicon, each cut into a snowflake or star shape. Such sealing means are made from thin, flexible silicon so that they may have pressure-safe properties. The thickness and elasticity of the above sealing means are selected based on physiological conditions, namely, to allow fluid to flow out of the sheath 1 under excessive pressure conditions, while allowing air to flow into the sheath 1 under low pressure conditions, thereby substantially reducing the siphon activity of the flow and avoiding abrupt pressure changes in the renal pressure, thus regulating the intrarenal pressure to remain within the range of physiological pressure.

[0036] Preferably, a pipe or conduit 9 made of a flexible and transparent material is connected to a dual-action pumping device 5 in fluidic communication, and the dual-action pumping device 5 provides suction and discharge (i.e., fluid flow from the outlet port 14 only) at the connection point with the pipe 9. This can be achieved by various means known in the art configured to direct the fluid flow from the outlet port in the ureterorenary access sheath 1 only to the pumping device (for example, by providing a vacuum pump and / or by placing a one-way valve 53 between the pipe 9 and the outlet port of the ureterorenary access sheath 1). In a preferred embodiment, a second one-way valve 54 is provided in the pipe 9 downstream of the dual-action pumping device 5 to prevent fluid that has flowed downstream from being drawn into the dual-action pumping device 5.

[0037] The system of the present invention further comprises a renal irrigation catheter 2 adapted for insertion into a ureteral renal access sheath 1 via an access port 11. The renal irrigation catheter 2 is, in principle, a flexible pipe having a distal end 21 and a proximal end 22, and having a lumen suitable for carrying fluid. The renal irrigation catheter 2 further comprises means 23 used in the art for guiding the distal end of the catheter to a desired position (for example, by bending, rotating, or advancing it to the position of the lumen / pole of the kidney to be rinsed / washed). It may also further comprise means for connecting to a camera 3 and a light source 4 (such as a wired connection or a Bluetooth® device).

[0038] The proximal end 22 of the renal irrigation catheter 2 is equipped with a fluid inlet port 24, and at the connection point where the fluid inlet port 24 is fluidically connected to a dual-action pumping device via a pipe or conduit 91, the fluid can be pumped at a predetermined pressure suitable for biological conditions. The fluid inlet port 24 is preferably positioned and attached to the catheter 2 in such a manner that it does not hinder the 360-degree rotation of the renal irrigation catheter 2 while maintaining a certain degree of occlusion (seal). The dual-action pumping device 5 and / or the connection at this point are designed to allow only pumping action achieved by known techniques (e.g., by providing a pressure pump and / or by means of a one-way valve 52 positioned between the dual-action pumping device and the fluid inlet port in the renal irrigation catheter 2). The pipe 91 is made of a flexible transparent material and preferably has a more flexible section upstream of the fluid inlet port 24 than other sections of the pipe 91, thereby suppressing or mitigating the effects of various pressures from the dual-action pumping device 5. The dual-action pumping device 5 is preferably connected to the fluid container 8 via a one-way valve 51 adapted to apply various pressures only in the direction of the renal irrigation catheter 2.

[0039] The treatment fluid contained in the fluid container 8 is a variety of fluids commonly used in chemicals for rinsing organs (for example, physiologically permissible pharmaceutical-grade saline solution).

[0040] During the operation, the ureterorenary access sheath 1 is introduced into the subject via the subject's urethra and bladder, and then passed through the urethra to its position within the subject's kidney. Subsequently, the renal irrigation catheter 2 is inserted into the ureterorenary access sheath 1. Once the ureterorenary access sheath 1 is introduced to the renal pelvis, sufficient space is provided for the renal irrigation catheter 2 to protrude from the distal end 12 of the ureterorenary access sheath 1 and be guided to the various poles of the kidney to be irrigated.

[0041] As the renal irrigation catheter 2 protrudes from the ureterorenary access sheath 1, the operator can use means 23 to conveniently change the orientation of the ureterorenary access sheath 1 (e.g., bend, rotate, reverse direction, and / or position it within various renal poles and renal calyces). The distal end 12 of the ureterorenary access sheath 1 may be positioned in the renal pelvis, or similarly, it may be advanced further into the lumen of the kidney to get closer to each pole of the kidney being treated.

[0042] The amount of fluid to be pumped into the kidney is adjusted by those skilled in the art based on parameters such as the subject's age, as well as according to the position of the ureterorenkinal access sheath 1 when flushing the renal pole. Specifically, when the ureterorenkinal access sheath 1 is positioned closer to the renal pole to be flushed compared to when it is positioned in the renal pelvis, a smaller amount of fluid is selected to maintain equilibrium pressure within the subject's kidney. Similarly, it is preferable to position the pump in such a close proximity and to select a location where the release action is performed simultaneously.

[0043] As a general rule, approximately 0.5 to 2.5 ml, preferably approximately 0.75 ml to approximately 2 ml, and more preferably approximately 1 ml to 1.5 ml is used as the amount for flushing (extraction of fluid). By following up on the flushing and release actions, which occur almost simultaneously, the pressure generated in the kidney can be maintained at a value lower than the clinically acceptable limit of approximately 40 mmHg. According to the present invention, the pressure level is maintained at a value lower than approximately 35 mmHg, preferably lower than approximately 30 mmHg, more preferably lower than approximately 25 mmHg, and even more preferably lower than approximately 20 mmHg during the operation.

[0044] To thoroughly flush and drain the renal calyces within all poles of the kidney, the renal irrigation catheter 2 is bent or rotated by, for example, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 160, 180, or 240 degrees for each flush, while the pumping / releasing action is repeated several times within the renal pole, so that the renal irrigation catheter 2 is rotated at least 360 degrees within the renal pole, reaching all parts of the renal pole and expelling all particulate matter remaining in the renal pole. To limit its ability, it can also be rotated only to the right, only to the left, or by different angles to the right and left (for example, 30 degrees to the right followed by 60 degrees to the left, or vice versa).

[0045] In alternative embodiments, the system or the renal irrigation catheter 2 and / or ureterorenary access sheath 1 may further include a pressure sensor designed to detect pressure within the kidney. This pressure sensor assists the operator in regulating the flow rate and / or velocity and / or pressure of the inflow and outflow fluids so as not to exceed the physiological pressure limits normally present within the kidney.

[0046] The system preferably further comprises a processing unit 6 adapted to calculate, display, and / or store images transmitted from a camera, and a monitor 7. The light source 4 may also be operated by the processing unit 6 or independently.

[0047] After the initial lithotripsy and an assessment of the patient's condition (e.g., a thorough examination of their medical history and / or history of preliminary treatments), the operator places the ureterorenary access sheath 1 and renal irrigation catheter 2 into the patient's body as detailed, and activates a dual-action pumping device 5, which is adapted to provide fluid into the kidney and fluid out of the kidney almost simultaneously. The pressure at this time is kept from being excessive, so as to be the pressure the kidney is subjected to under normal physiological conditions.

[0048] In principle, the dual-action pumping device 5 is embodied by a separate pressure pump and a vacuum pump, which deliver and operate the inflow fluid through the renal irrigation catheter 2 and the outflow fluid through the ureterorenary access sheath 1, respectively. Both pumps are connected and adapted to satisfy the requirements of equilibrium pressure conditions within the kidney, i.e., both actions are performed almost simultaneously, with the pressure pump supplying a certain amount of fluid while the vacuum pump releases the same amount. In one embodiment, the release action may be performed with a certain delay so that the fluid containing as much of the expelled material as possible is released.

[0049] Alternatively, as shown in Figure 1, the dual-acting pump device 5 may be embodied from the components of a one-stroke dual-acting piston pump having a pump piston in a cylinder, where when one compression stroke of the piston is performed, a pumping pressure for fluid inflow and a suction force for fluid suction are simultaneously obtained on opposite sides of the piston.

[0050] The dual-action pumping device 5 may be an equal-volume pumping / suction device adapted to manual or foot operation.

[0051] The dual-action compression device 5 pumps fluid into the renal cavity via the renal irrigation catheter 2, with a flow rate and velocity sufficient to expel particulate matter from the fluid. Almost simultaneously with the commencement of the release action of the dual-action pumping device 5, the excess fluid pumped into the kidney, containing the expelled particulate matter, is actively released (aspirated) through the ureterorenary access sheath 1.

[0052] In a preferred embodiment, the amount of fluid pumped into the kidney is approximately the same as the amount of fluid drawn out of the kidney. It is preferable that the amount of fluid pumped into the kidney and the amount of fluid drawn out of the kidney per unit time are the same, so that the amount of fluid in the kidney remains approximately constant.

[0053] In one embodiment, a small amount of fluid is pumped into the kidney in a pulsed manner, while the release action by pump 5 is initiated simultaneously or delayed, for example, after two, three, or four pulses of fluid have been pumped, so that the total amount discharged is the same as the amount pumped into the kidney.

[0054] The pumping / releasing action may be automatically controlled, for example, by running software on a computer, or it may be linked to a manually activated pumping action. This procedure is performed so as to drain approximately the same amount of fluid as is pumped into the kidney (and vice versa), while always taking into account the pressure limits within the kidney.

[0055] The procedure, initiated by changing the directional angle of the tip of catheter 22 or by advancing or retracting its position, is repeatedly performed within each renal pole until, eventually, no particulate matter is observed by the camera or within the sediment chamber. Subsequently, the next pole of the kidney is processed.

[0056] Alternatively, when flushing (extraction) by the siphon principle is also continuously performed, the hydrostatic pressure of the continuously flowing fluid is regulated by changing the height of bag 8, while the outflow fluid is regulated by adjusting the height of pipe 9. In contrast to the volume from the hydrostatic irrigation flow, the pumped flow rate (temporary volume per second) is within a range of up to 2.5 ml. Together, these irrigation volumes and the volume aspirated from the kidney are equal, forming an isococcal irrigation-aspiration system.

[0057] In summary, the present invention provides fluid flow into the kidney via the distal end 21 of the renal irrigation catheter 2, while simultaneously providing fluid discharge from the outlet port 14 in the proximal end 13 of the ureterorenary access sheath 1. In this way, the intrarenal pressure is maintained at a nearly constant level. The ureterorenary access sheath is guided in various directions within the lumen of the kidney to allow fluid to flow out from the renal pelvis, which is to be flushed, in order to completely remove particulate matter such as fragments of kidney stones.

[0058] The present invention also presents a method for removing particulate matter (i.e., kidney stones or fragments, stone powder, obtained, for example, after a lithotomy procedure) from a subject's kidney using the system of the present invention described above. The method of the present invention includes the steps of preparing the system of the present invention, inserting a ureterorenary access sheath 1 containing a renal irrigation catheter 2 into the lumen of the subject's kidney, guiding the renal irrigation catheter 2 to the pole of the kidney and the individual renal calyces, respectively, and introducing a certain amount of fluid from a container 8 through a dual-action pumping device 5 and a pipe 91 into the renal irrigation catheter 2 and the pole of the kidney, thereby swirling the particulate matter contained in the pole and its renal calyces. This flushing action causes the fluid containing the particulate matter expelled from either the pole of the kidney or the lumen to be discharged, and the flushing / discharge action is repeated simultaneously with or immediately after the operation. The new flushing / discharge action is preferably performed after displacing the distal end 21 of the renal irrigation catheter 2 (for example, after rotating the distal end 21 by a predetermined angle).

[0059] To maintain the normal pressure limits of the kidney, the operator first checks the amount present in the kidney to be treated and selectively fills the kidney before starting the treatment. In alternative embodiments, after the full volume is determined (for example, by setting the internal pressure of the kidney near the upper pressure limit), a certain amount of fluid may be discharged through the ureterorenary access sheath 1 before the pumping / releasing action is initiated, so that small pressure fluctuations due to pumping / releasing remain within physiological levels.

[0060] While specific embodiments have been described above with reference to the drawings, please note that the features described for a particular embodiment may be combined with other embodiments and their features, provided there are no technical impediments.

[0061] The following description is for illustrative purposes only and is not intended to limit the present invention.

[0062] Example 1: Decrease in solid particles The effectiveness of this system's operation was verified using an artificial kidney model that reflected the characteristics of a human kidney in terms of the shape of the cavity / pole / calyces within the kidney. This effective kidney model (https: / / link.springer.com / article / 10.1007 / s10439-016-1757-5) was procured from the Max Planck Institute for Intelligent Systems and the Institute of Physical Chemistry at the University of Stuttgart in Germany. Made of silicon with an elastic modulus similar to that of a human kidney, it is transparent to allow external visualization of the model's interior. The model has two openings at opposite ends along its longitudinal axis; the relatively lower opening is designed to reflect the dimensions and diameter of the renal pelvis, while the relatively higher opening has a diameter capable of receiving a pressure sensor. The model further includes pockets with shapes and forms similar to the poles / calyces of the kidney. For pressure measurement, a fabric-type optical pressure sensor FOP-M200, provided by FISO Technology Inc. in Quebec, Canada, was used.

[0063] Pressure sensors inserted into each opening of the model were occluded using Tuohy-Borst occlusion connectors procured from Qosina Corporation, USA. Then, a 0.33g human kidney stone, acquired during a patient's hysteroscopy, fragmented, and sieved to form a stone / fragment with an average diameter of approximately 1mm, was inserted into the model through the lower opening.

[0064] In the next step, a ureteral access sheath (UAS), procured from Wismed PL SP.Z.O.O. in Wroclaw, Poland, was inserted into the model through a low-positioned opening. The space between the UAS and the inner wall of the low-positioned opening of the model was closed by means of pressurizing the artificial ureter.

[0065] The model was completely filled with 8 ml of physiological saline (0.9% NaCl) through the inner tube of the UAS at a temperature of approximately 37.5°C, close to body temperature.

[0066] The suction arm of a dual-action pump, sourced from Wismed PL SP.Z.O.O. in Wroclaw, Poland, was connected to the proximal end of the UAS via a flexible, transparent pipe, while the pumping arm of the dual-action pump was connected to the irrigation source and flexible catheter. As shown in Figure 1, the dual-action pump is equipped with four one-way valves.

[0067] A catheter, procured from Wismed PL SP.Z.O.O. in Wroclaw, Poland, was inserted into the UAS so that it protruded visibly into the model via a pipe connected to a dual-action pump. The model was then briefly shaken to distribute the stones into different pockets (renal calyces) within it, and then placed on an aluminum container, allowing multiple stones to settle into each pocket.

[0068] The storage bag containing the saline solution was positioned approximately 110 cm higher than the kidney model, while the outlet for pipe 9, which releases the saline solution (0.9% sodium chloride), was positioned 30 cm lower than the kidney model.

[0069] The storage bag was open to supply saline solution (0.9% sodium chloride) via a pipe connected to the model. The basic pressure inside the model was measured for over 10 × 5 mins, with an average of 9.97 mmHg.

[0070] Subsequently, the catheter advanced into the pocket, and when the dual-action pump was manually started, a flush (extraction) with a total volume of approximately 2.5 ml / second was supplied and injected into the pocket after one stroke. After several strokes, the tip of the catheter was bent within the same pocket, and the stroke / flush was repeated. In this example, each pocket of the model was treated with five flushes, and the entire inside of the kidney was flushed. After each flush, a clear rotation of the stone within the pocket was observed, which was clearly discernible even after changing the orientation of the tip. After six strokes / flushes in the first pocket, the stone was observed to have largely diffused into the overall fluid lumen of the model, which was observed more clearly after further strokes but became less observable after 10 strokes / flushes. This is due to the displacement of the stone toward the tip of the ureterorenary access sheath, which led to its arrival at the withdrawn position of the UAS.

[0071] After the aforementioned stroke / flush (water expulsion) was repeated in other pockets of the model, a final series of four stroke / flushes was performed in the lumen of the model, resulting in the expulsion of almost all of the stone. As a result of the entire procedure, which took about 5 minutes, approximately 92% of the initial stone fragments (this figure was calculated by subtracting the remaining amount from the initial amount in dry weight) were removed. This result is shown in Figure 2.

[0072] Repeating the treatment after the initial procedure increased the removal efficiency to approximately 96%.

[0073] The pressure measured during the procedure remained below 30 mmHg, which is below the 40 mmHg threshold level considered safe.

[0074] Example 2: Maintaining pressure To demonstrate the system's ability to establish and maintain pressure within an acceptable and safe range, the kidney model from Example 1, which reflects the spatial and mechophysiological features of the kidney, was used.

[0075] In this experiment, the same settings, UAS, and dual-action pump used for the catheter in Example 1 were employed, and a pressure sensor (see Fiso above) was inserted into the lumen of the model via the UAS. In addition, a catheter equipped with a camera at its tip was used to ensure proper placement of the catheter within the pocket.

[0076] The storage bag and outlet were positioned at approximately the same height as the kidney model. The saline storage bag was left open to allow a constant flow of saline into the kidney model. The initial pressure was set to an average of 7.84 mmHg, within the range of standard intrarenal pressure of 0–10 mmHg.

[0077] The dual-action pump was activated by repeatedly injecting approximately 2.5 ml of flush (fluid) into each pocket. Within each pocket, the tip of the catheter was bent before moving to the next pocket.

[0078] The average pressure fluctuation between pumping and discharge operations can be set within a range of approximately 20-30 mmHg, which is considerably lower than a pressure of 40 mmHg.

Claims

1. In a system for removing particulate matter from a subject's kidney, Ureteral renal access sheath (1), A renal irrigation catheter (2) configured to be inserted into a ureterorenary access sheath (1), wherein the renal irrigation catheter (2) is fitted to provide a lumen between the inner wall of the ureterorenary access sheath (1) and the outer wall of the renal irrigation catheter (2) that is large enough to allow a fluid containing particulate matter to flow, An image generating device (3) configured to provide an image of the treatment area, A dual-action pumping device (5) that causes fluid to flow into the renal irrigation catheter (2) and, almost simultaneously, causes approximately the same amount of fluid to flow out into the ureterorenary access sheath (1), Equipped with, The system is characterized in that the renal irrigation catheter (2) is connected to a dual-action pumping device (5) that provides fluid flow into the kidney and is moved forward and backward within the ureterorenary access sheath (1).

2. The system further comprises a sedimentation chamber (15) for collecting the removed particulate matter. The system according to claim 1, characterized in that the sedimentation chamber (15) is in fluid communication with the ureterorenary access sheath (1) and the dual-action pumping device (5).

3. The system according to claim 2, characterized in that the settling chamber (15) is configured so that the collected particulate matter can be visually observed from the outside.

4. The system according to claim 1, characterized in that the renal irrigation catheter (2) has an image generating device at its tip.

5. The system according to any one of claims 1 to 4, characterized in that the image generation device (3) is a camera, an ultrasonic device, or a fluorescence fluoroscopy device.

6. The dual-action pumping device (5) is a dual-action piston pump, characterized in that a single pumping stroke of the piston of the dual-action piston pump (5) simultaneously provides a pumping pressure for introducing fluid and a suction force for releasing fluid. This is the system according to any one of claims 1 to 5.

7. The system according to any one of claims 1 to 6, characterized in that the dual-action pumping device (5) is an equivolute pumping / suction device.

8. The system according to any one of claims 1 to 7, characterized in that the dual-action pumping device (5) is manually operated or foot-operated.

9. The system is A first one-way valve (51) is positioned at a location that provides fluidic communication between the dual-action pumping device (5) and the fluid supply source (8), and allows fluid to flow only in the direction from the fluid supply source (8) to the dual-action pumping device (5). A second one-way valve (52) is positioned between the pumping device (5) and the internal channel (22) of the flexible renal irrigation catheter (2), and allows fluid to flow only in the direction from the pumping device (5) to the internal channel (22), A third one-way valve (53) is positioned at a location that provides a fluidic connection between the outlet port (14) and the dual-action pumping device (5), and allows fluid to flow only in the direction from the outlet port (14) to the dual-action pumping device (5), A fourth one-way valve (54) is positioned at a location that provides a fluidic connection between the dual-action pumping device (5) and the waste liquid outlet (9) of the system, and allows fluid to flow only in the direction from the dual-action pumping device (5) to the waste liquid outlet (9), The system according to any one of claims 1 to 8, further comprising:

10. The system further comprises a processing unit (6), The system according to any one of claims 1 to 9, characterized in that the image generating device (3) is connected to a processing device (6), and the processing device (6) is connected to a monitor (7), so that an operator can observe and save the visual data obtained by the image generating device (3).

11. A method for removing particulate matter from a subject's kidney, Prepare the system according to any one of claims 1 to 10, The pumping / discharge operation is performed repeatedly. Collecting particulate matter from the kidneys of subjects, A method that includes this.

12. The method according to claim 9 or the system according to any one of claims 1 to 8, characterized in that the intrarenal pressure is not raised above 40 mmHg during the operation of the above system.

13. The method according to claim 9, characterized in that the method is performed after the subject has undergone lithotomy.

14. The method according to any one of claims 9 to 12 or the system according to any one of claims 1 to 8, characterized in that the shape of the particulate matter is substantially irregular, the longest length of the smallest particulate matter is in the range of 200 to 2500 μm, and preferably the diameter of the particulate matter does not exceed 1 mm or the particulate matter has an average diameter of about 1 mm.

15. The system according to any one of claims 1 to 14, characterized in that the above fragments are produced by crushing or pulverization.

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