High-performance irrigation and aspiration systems and methods

Abstract

1. An irrigation and aspiration system comprising: a catheter shaft having a distal end in fluid communication with an interior of a kidney; an irrigation channel and an aspiration channel extending through the shaft; a bypass channel fluidly coupled to the irrigation channel and the aspiration channel; a bypass valve configured to control a level of fluid communication between the irrigation channel and the aspiration channel via the bypass channel; an aspiration pump; at least one valve disposed on the aspiration channel and configured to provide a pulsating flow of fluid in the aspiration channel; a pressure sensor in fluid communication with the interior of the kidney; and a controller configured to receive at least one pressure measurement, compare the measured pressure value to a threshold value, and send control commands to at least one of the bypass valve, the aspiration pump, and the at least one valve based on the comparison.

Description

[Technical Field]

[0001] Priority This application claims priority under Section 119 of the United States Patent Act to U.S. Provisional Patent Application No. 63 / 183,675, filed on 4 May 2021, entitled “High-Performance Irrigation and Suction System and Method,” which is incorporated herein by reference in its entirety for all purposes.

[0002] This field of technology generally relates to laser lithotripsy, and more specifically to the laser-assisted removal of kidney stones using a ureteroscope with an emphasis on pressure control within the kidney. [Background technology]

[0003] Kidney stones are a highly prevalent disease, estimated to affect 12% of the world's population. While most patients can pass stones spontaneously, symptoms can become severe enough to require medical intervention. Extreme pain, nausea, vomiting, infection, obstruction of the urinary flow, and loss of kidney function may follow. Laser lithotripsy is a method of treating kidney stones. Light energy guided by an optical fiber is used to break the stones into smaller pieces, allowing them to be passed spontaneously. Conventional approaches to treating kidney stones using flexible ureteroscopes include devices that utilize forced fluid irrigation and natural aspiration through the space between the ureteroscope shaft and the access sheath or natural urinary tract. More recent approaches include devices configured to also include a suction channel within the ureteroscope to aspirate stone fragments and debris resulting from stone ablation (see, for example, Patent Document 1). [Prior art documents] [Patent Documents]

[0004] [Patent Document 1] U.S. Patent Application Publication No. 2017 / 0215965 [Overview of the project] [Problems that the invention aims to solve]

[0005] One of the problems with laser lithotripsy is stone targeting. If the optical fiber is not in contact with the stone, the ablation rate will be slower and the procedure will take longer. Furthermore, the laser pulse may be accidentally directed at an unintended target, causing collateral damage. Another problem is maintaining the balance of pressure and fluids within the kidney and ureteroscope during the procedure. Applying vacuum to remove stone fragments alters the fluid content and pressure within the kidney, which, if not properly managed, can cause unintended damage to the patient or ureteroscope. In addition, a vacuum is created within the suction channel of the ureteroscope during the laser lithotripsy procedure. The distal end of this channel can often become clogged with stones and their fragments. Severe clogging may require repeated removal, irrigation, and reinsertion of the ureteroscope during the procedure. [Means for solving the problem]

[0006] The embodiments and aspects relate to methods and systems for controlling fluid flow in irrigation and suction systems.

[0007] According to an exemplary embodiment, an irrigation and suction system is provided, comprising: a catheter shaft having a proximal and distal end, the distal end of which is in fluid communication with the interior of a kidney; an irrigation channel extending through the shaft from the proximal end to the distal end; a suction channel extending through the shaft from the proximal end to the distal end; a bypass channel fluidly coupled to the irrigation channel and the suction channel; a bypass valve configured to control the level of fluid communication between the irrigation channel and the suction channel via the bypass channel; a suction pump fluidly communicating with the suction channel and configured to pump fluid from the distal end to the proximal end of the suction channel; at least one valve positioned on the suction channel and configured to provide a pulsed flow of fluid into the suction channel; a pressure sensor fluidly communicating with the interior of a kidney; and a controller communicating with the pressure sensor, the bypass valve, the at least one valve, and the suction pump, the controller being configured to receive at least one pressure measurement from the pressure sensor, compare the measured pressure value with a predetermined pressure threshold, and based on the comparison, transmit a control command to at least one of the bypass valve, the at least one valve, and the suction pump.

[0008] In one embodiment, the controller is configured to calculate a measured pressure value per unit time, determine whether the measured pressure value per unit time meets or exceeds a predetermined first threshold, and accordingly send a control command to the suction pump to increase the flow rate of fluid in the suction channel. In one embodiment, the measured pressure value used as the basis for the predetermined first threshold is 50 cmH2O.

[0009] In one embodiment, the controller is configured to determine whether the measured pressure value per unit time meets or exceeds a predetermined second threshold, and accordingly transmit a control command to the bypass valve so that the bypass channel is opened, the irrigation channel is fluid-coupled to the suction channel, and the irrigation fluid is directed to the distal end of the suction channel. In one embodiment, the measured pressure value used as the basis for the predetermined second threshold is 60 cmH2O.

[0010] In one embodiment, the controller is configured to achieve pulsed fluid flow by sending control commands to close at least one valve for a predetermined duration τ1 and at least one valve for a predetermined duration τ2 in a repeating cycle, where τ1 and τ2 are separated by a predetermined period t, and each cycle belongs to period T. In one embodiment, at least one valve is located on a suction channel between a bypass channel and a suction pump.

[0011] In one embodiment, at least one valve comprises a first valve and a second valve, the second valve being located on the suction channel between the bypass channel and the distal end of the suction channel. In a further embodiment, the controller is configured to realize pulsed fluid flow by sending control commands to close the first valve for a predetermined duration τ1 and the second valve for a predetermined duration τ2 in an iterative cycle, wherein τ1 and τ2 are separated by a predetermined period t, and each cycle belongs to period T.

[0012] In one embodiment, the bypass valve is configured as a three-way solenoid pinch valve, and at least one valve is configured as a two-way solenoid pinch valve.

[0013] In one embodiment, the pressure sensor is located close to the outer surface of the catheter shaft.

[0014] In one embodiment, the system further comprises a laser source configured to emit laser radiation, and an optical fiber coupled to the laser source and configured to transmit laser radiation in close proximity to the distal end of the aspiration channel, the optical fiber extending from the proximal end to the distal end of the catheter shaft.

[0015] According to another exemplary embodiment, a method of operating a suction and perfusion system is provided, the method comprising providing a pulsatile fluid flow from the distal end to the proximal end of a suction channel, wherein the distal end of the suction channel is in fluid communication with the interior of the kidney; measuring a pressure value inside the kidney; determining whether the measured pressure value is less than a first pressure threshold; and increasing the velocity of the pulsatile fluid flow if the measured pressure value meets or exceeds the first pressure threshold.

[0016] In one embodiment, the method further comprises providing a fluid flow from the proximal end to the distal end of a perfusion channel, wherein the distal end of the perfusion channel is in fluid communication with the interior of the kidney; determining whether the measured pressure value is less than a second pressure threshold; and directing a fluid flow from the perfusion channel into the suction channel if the measured pressure value meets or exceeds the second pressure threshold. In one embodiment, the fluid flow from the perfusion channel to the suction channel is directed through a bypass channel. In another embodiment, the method further comprises closing a valve disposed on the suction channel between the proximal end of the suction channel and the bypass channel.

[0017] In one embodiment, the pulsatile fluid flow is realized by at least one valve disposed in the suction channel. In one embodiment, the pulsatile fluid flow is realized by closing at least one valve for a predetermined duration τ1 and then closing at least one valve for a predetermined duration τ2 in an iterative cycle, where τ1 and τ2 are separated by a predetermined period t and each cycle belongs to a period T. In another embodiment, the at least one valve includes a first valve and a second valve, and the pulsatile fluid flow is realized by closing the first valve for a predetermined duration τ1 and then closing the second valve for a predetermined duration τ2 in an iterative cycle, where τ1 and τ2 are separated by a predetermined period t and each cycle belongs to a period T. In one embodiment, τ1 and τ2 are in the range of 20 ms to 500 ms, and the period T is in the range of 0.5 s to 3.0 s.

[0018] These and still other aspects, embodiments, and advantages of these exemplary aspects and embodiments are described in detail below. Further, both the foregoing information and the following detailed description are merely illustrative examples of various aspects and embodiments, and are intended to provide an overview or framework for understanding the nature and characteristics of the claimed aspects and embodiments. It should be understood that the embodiments disclosed herein can be combined with other embodiments, and references to "one embodiment", "one example", "some embodiments", "some examples", "alternative embodiments", "various embodiments", "one embodiment", "at least one embodiment", "this embodiment and other embodiments", "specific embodiments", etc. are not necessarily mutually exclusive, and are intended to indicate that the specific features, structures, or characteristics described may be included in at least one embodiment. The appearance of such terms herein does not necessarily refer to all the same embodiments.

[0019] Various aspects of at least one embodiment are described below with reference to the accompanying drawings, which are not intended to be drawn to scale. The drawings are included to provide illustration and further understanding of the various aspects and embodiments, are incorporated herein, and form a part of this specification, but are not intended as a definition of the limits of a particular embodiment. The drawings, together with the remainder of the specification, serve to explain the principles and operation of the described and claimed aspects and embodiments. In the drawings, each identical or nearly identical component shown in the various figures is represented by like reference numerals. For clarity, not all components are labeled in every figure.

Brief Description of the Drawings

[0020] [Figure 1A] FIG. 1A is a schematic diagram of an example of a perfusion and aspiration system according to an aspect of the present invention. [Figure 1B] FIG. 1B is a schematic diagram of another example of a perfusion and aspiration system according to an aspect of the present invention. [Figure 2] FIG. 1C is a block diagram of the perfusion and aspiration system of FIG. 1B. [Figure 3] This is a perspective view of the distal end of one embodiment of a ureteroscope according to an aspect of the present invention. [Figure 4A] This is a schematic diagram of one embodiment of a pulsed flow according to an aspect of the present invention. [Figure 4B] This is a schematic diagram of another embodiment of a pulsed flow according to an aspect of the present invention. [Figure 5] Figure 1B is a time graph showing the functional aspects of the system. [Figure 6] This is a schematic diagram of yet another embodiment of the irrigation and suction system according to an aspect of the present invention. [Figure 7] This graph shows the results of an experiment according to an aspect of the present invention. [Modes for carrying out the invention]

[0021] As described above, problems associated with laser lithotripsy include targeting stones, maintaining pressure and fluid balance within the kidney, and blockage by stone fragments. The solutions disclosed herein aim to overcome these problems and ensure safe and effective outcomes of the clinical procedure by implementing systems and methods that synchronize the functions of the laser and fluid pump systems through monitoring and real-time control of the operating parameters of irrigation, aspiration, and laser radiation.

[0022] In various embodiments, high-performance irrigation and / or suction flows are achieved to enhance suction efficiency and prevent clogging. As used herein, the term “high-performance (smart)” with respect to irrigation and / or suction flows refers to the ability to maintain bidirectional communication (i.e., sending or receiving signals) with the controller. During laser treatment, the negative pressure in the suction channel, combined with the flow of irrigation fluid from the outlet of the irrigation channel, generates a flow of small stones and dust particles in the suction channel, which are the result of the ablation process. It is important to balance these inflows and outflows in order to keep the pressure in the kidney within a safe range. According to embodiments described herein, several functions can be implemented to ensure that the suction channel does not become clogged with ablation particles and remains open for fluid flow. • Hydraulic pressure monitoring in the therapeutic area (kidney) • Continuous pulsation of suction flow • Changes in negative pressure within the suction channel resulting from pressure monitoring • Switching the irrigation flow to the suction channel to remove blockages.

[0023] Blockage detection and kidney pressure control According to various embodiments, the disclosed irrigation and suction system comprises one or more sensors, such as a flow sensor (also called a fluid rate or flow rate sensor) and a pressure sensor, at least one valve, a fluid pump, and a processing computer that functions as a controller or as part of a control system.

[0024] A non-limiting embodiment of an irrigation and aspiration system according to one embodiment is shown overall in 100a of Figure 1A. System 100a comprises a catheter shaft 112 (see Figures 2 and 3) having a proximal end 113 and a distal end 114, the distal end 114 being in fluid communication with the inside of the kidney; an irrigation channel 102; an aspiration channel 104; a bypass channel 108; a bypass valve 132; at least one valve positioned on the aspiration channel (e.g., valve 138); an aspiration pump 115; one or more pressure sensors 156, 158; and a controller 190.

[0025] The irrigation channel 102 and the suction channel 104 extend through the shaft 112 from the proximal end 113 to the distal end 114. The distal ends of both the irrigation channel 102 and the suction channel 104 are in fluid communication with the interior of the kidney. The suction / irrigation system 100a is used within a ureteroscope 105, also known as a "3-channel" ureteroscope (for fiber, suction, and irrigation). Fluid is delivered through the irrigation channel 102 (e.g., to the kidney) and discharged from the kidney through the suction channel 104. The term "proximal end," when used in relation to a channel, refers to the end attached to the corresponding pump, while the term "distal end" refers to the end exposed within the ureteroscope so that it is within the internal volume of the kidney when the distal end is positioned for lithotomy procedures (e.g., the distal end is shown in Figure 3).

[0026] As will be described in more detail below, the bypass channel 108 is fluid-coupled to the irrigation channel 102 and the suction channel 104, and the bypass valve 132 is configured to control the level of fluid communication between the irrigation channel 102 and the suction channel 104 via the bypass channel 108. The suction pump 115 is fluid-coupled to the suction channel 104 and is configured to pump fluid from the distal end to the proximal end of the suction channel 104. In this embodiment, at least one valve located on the suction channel 104 includes a valve 138 located between the bypass channel 108 and the suction pump 115.

[0027] Pressure sensors 156 and 158 are in fluid communication with the inside of the kidney and are configured to measure pressure, respectively. In some embodiments, the catheter 112 is configured to include the pressure sensor 158. Figure 3 shows two possible positions for the pressure sensor 158, each position located at or near the distal end 114 of the catheter shaft 112. In some embodiments, as shown in Figure 3, the pressure sensor 158 may be located close to the outer surface of the catheter shaft 112. For example, in the embodiment shown in Figure 3, the outer surface of the catheter shaft 112 has a small recess for housing the pressure sensor 158. According to another embodiment, as shown in Figure 3, the pressure sensor 158 is located close to the camera 165 of the ureteroscope 105, for example, on the upper surface of the camera 165.

[0028] In some embodiments, the pressure sensor 156 is positioned within the kidney via a separate insertion device. In this example, the pressure sensor 156 is positioned outside the catheter shaft 112 (not attached to or integrated with the catheter shaft 112) and is referred to herein as an “external” pressure sensor. For example, a small pressure sensor can be inserted into the kidney via a needle and / or catheter, or any other access sheath, and is therefore outside the ureteroscope (i.e., outside the catheter shaft, suction channel, and irrigation channel). According to some embodiments, the pressure sensor 156 has at least one dimension (e.g., diameter or length) less than 19 millimeters (mm), in a further embodiment it has at least one dimension less than 15 mm, and in yet another embodiment it has at least one dimension less than 11 mm. According to certain embodiments, the pressure sensor 156 has a diameter less than 0.5 mm, and in one embodiment it has a diameter less than 0.3 mm. In certain embodiments, the pressure sensor 156 has a length less than 6 mm, and in one embodiment it has a length less than 5 mm. The pressure sensor 156 can be positioned close to the distal end of the catheter shaft 112 and placed inside the kidney to provide in vivo monitoring of pressure within the kidney.

[0029] According to one or more embodiments, at least one valve located on the suction channel 104 is configured to provide a pulsed flow of fluid within the suction channel 104. In system 100a of Figure 1, valve 138 is configured to provide a pulsed flow of fluid within the suction channel 104. Valve 138 is configured as a pinch valve, such as a two-way solenoid pinch valve. When these types of valves are not energized, the plunger opens, allowing fluid to flow through the valve via the inlet and outlet ports. When the plunger is energized, it closes, compressing the suction tube and completely blocking the fluid flow. Simultaneously, as a result of the compression of the suction tube, a small amount of liquid is pushed back along the suction line. In some embodiments, a controller 190 is configured to achieve a pulsed flow of fluid within the suction channel by sending one or more control commands to at least one of the suction pump 115 and valve 138. The controller 190 is configured to send control commands to valve 138 to open and close. The suction pump 115 is also controlled by the controller 190 to pump fluid from the distal end to the proximal end of the suction channel 104, thereby "drawing" the fluid through the valve 138. The valve 138 interrupts the flow of the suction fluid by sending short pulses of back pressure along the liquid in the suction channel, thereby promoting particle mixing and reducing the risk of clogging. Furthermore, the suction channel is constructed from a material that provides minimal stretching properties, i.e., high elastic memory. According to one embodiment, the suction channel is constructed from a thermoplastic elastomer such as PEBAX®.

[0030] A schematic diagram of a non-limiting embodiment of pulsed fluid flow is shown in Figure 4A. Controller 190 sends control commands to close valve 138 for a predetermined duration τ1 and then for a predetermined duration τ2, where τ1 and τ2 are separated by a predetermined period t in an iterative cycle, and each cycle belongs to period T. Period T is the duration from the beginning of τ1 to the beginning of the following consecutive τ1. The resulting pulsed flow in the fluid is also shown in Figure 4A. In this example shown in Figure 4A, τ1 and τ2 are equal to each other, but it should be understood that in some embodiments, τ1 and τ2 are different from each other.

[0031] Another non-limiting embodiment of the irrigation and suction system according to a different embodiment is shown overall in Figure 1B, 100b. System 100b is substantially identical to system 100a in Figure 1A, except that in this example, the pulsed fluid flow in the suction channel 104 is realized using two valves. Thus, at least one valve of the suction channel 104 includes a first valve 138 and a second valve 136, the second valve 136 being located on the suction channel 104 between the bypass channel 108 and the distal end of the suction channel 104. A schematic diagram of one non-limiting embodiment of the pulsed fluid flow is shown in Figure 4A, and another embodiment is shown in Figure 4B. Referring to Figures 4A and 4B, in this configuration, the controller 190 sends control commands to close the first valve 138 for a predetermined duration τ1 and to close the second valve 136 for a predetermined duration τ2, where τ1 and τ2 are separated by a predetermined period t in an iterative cycle, and each cycle belongs to period T. As mentioned above, period T is the duration from the beginning of τ1 to the beginning of the following consecutive τ1. In Figure 4A, τ1 is equal to (i.e., the same as) τ2, which is also the configuration shown in Example D of Figure 4B. Furthermore, the interval between τ1 and τ2 (i.e., a predetermined period t) is the duration between the end of τ1 and the beginning of τ2, but in other embodiments, the predetermined period t may be defined as the duration between the beginning of τ1 and the beginning of τ2, as described below with reference to Examples A to C of Figure 4B.

[0032] According to other embodiments, τ1 and τ2 are not equal to each other, as shown in Figures 4BA, B, and C. As described above, in these embodiments, a predetermined period t, which means the interval between τ1 and τ2, is defined as the duration between the beginning of τ1 and the beginning of τ2. The combined effect of pulses in a fluid (water) is shown in all embodiments of Figures 4A and 4B.

[0033] In some embodiments, τ1 and τ2 are durations in the range of 20 milliseconds to 500 milliseconds (ms). According to some embodiments, τ1 and τ2 may have different durations from one cycle or period to the next. In certain embodiments, a given period t is in the range of 1 ms to 500 ms. In some embodiments, a given period t is in the range of 1 ms to 200 ms. According to some embodiments, a period T is in the range of 0.5 seconds to 3.0 seconds (s).

[0034] The pulsed flow, achieved using at least one valve within the suction channel 104, offers several advantages. Firstly, the pulsed flow can prevent clogging of the suction channel 104. Furthermore, pulsing the flow of the suction fluid can further improve or increase the laser ablation rate. For example, if the pressure within the suction channel 104 is maintained at a constant or near-constant value, a situation may arise where the laser ablation crater grows, but the ablation efficiency decreases as the distance from the tip of the optical fiber to the surface of the stone (i.e., the bottom of the crater) continues to increase. Ultimately, this can lead to a stalemate where the laser continues to emit, but no further stone fracture occurs. The pulsed suction fluid flow allows the stone to change position slightly away from the suction channel 104, thereby allowing the laser to be emitted at different locations on the stone (laser emission can be performed by a series of laser pulses). Additionally, the stone is pulled towards the opening of the suction channel 104 by the pressure pulses generated by this pulsed fluid flow.

[0035] As shown in Figures 1A and 1B, systems 100a and 100b may also include a flow sensor 140 configured to measure the flow rate in the irrigation channel 102, a pressure sensor 150 configured to measure the pressure in the irrigation channel 102, and an irrigation pump 110 in fluid communication with an irrigation fluid source 160. Systems 100a and 100b also include a laser source 107 that supplies laser energy to an optical fiber 106. The laser energy emitted from the distal end of the optical fiber 106 functions to excise kidney stone material.

[0036] According to at least one embodiment, the flow of irrigation fluid is initiated within the system 100 by a controller 190 transmitting a control signal or control command to an irrigation pump 110, which is configured to pump the irrigation fluid from an irrigation source 160 to the distal end of an irrigation channel 102. The fluid flow rate of the irrigation fluid in the irrigation channel 102 can be measured by a flow sensor 140, and the flow rate of the irrigation fluid can be adjusted by the irrigation pump 110, which is configured as a variable-speed pump. In some embodiments, the fluid flow rate of the irrigation fluid is in the range of 60 mL / min to 120 mL / min. In one embodiment, the fluid flow rate of the irrigation fluid is 80 mL / min.

[0037] A pressure measurement obtained by at least one of the pressure sensors 156 and 158 in the kidney is used as at least one of the feedbacks to the controller 190 when controlling systems 100a and 100b. According to at least one embodiment, the controller 190 is configured to receive at least one pressure measurement from pressure sensors 156 and / or 158, compare the measured pressure value with a predetermined pressure threshold, and based on the comparison, send a control command or control at least one of the bypass valve 132, at least one valve (136 and / or 138), and suction pump 115. As will be further described below, the controller 190 is also capable of receiving input from other sensors in system 100 (e.g., pressure sensor 150 in irrigation channel 102, flow sensor 140 in irrigation channel 102, flow sensor 144 in suction channel 104) and controlling other components of system 100 (e.g., irrigation pump 140, laser 107).

[0038] During the procedure, an initial target pressure value within the kidney (e.g., 40 cmH2O, which is one embodiment of a predetermined pressure threshold) is used as a reference by the controller 190 (also called the control system) to control the suction pump 115 and the fluid flow in the suction channel 104 in the initial operating mode. The suction pump 115 is also configured as a variable-speed pump and can be adjusted so that the pressure within the kidney reaches the initial target pressure value. For example, if the initial pressure within the kidney is too low, the controller 190 can decelerate the suction pump 115 so that less fluid is removed from the kidney, and if the initial pressure within the kidney is too high, the controller 190 can accelerate the suction pump 115 to remove more fluid from the kidney. According to some embodiments, the fluid flow rate in the suction channel 104 is in the range of 60 mL / min to 150 mL / min. The intrarenal pressure changes as the procedure progresses, and this intrarenal pressure, measured by sensors 156 and / or 158, is used by the controller 190 when controlling other components in the system 100.

[0039] Figure 2 is a block diagram of the irrigation and suction system in Figure 1B, and Figure 5 is a time graph showing the functional aspects of the system in Figure 1B. However, please understand that the functions shown in Figure 5 also apply to system 100a in Figure 1A.

[0040] During normal operation, channel "A" of the bypass valve 132 is open and channel "B" of the bypass valve 132 (i.e., bypass channel 108) is closed, as shown on the left side of the graph in Figure 5. According to one embodiment, the bypass valve 132 is configured as a three-way solenoid pinch valve. The irrigation fluid is pumped by the irrigation pump 110 through channel A of the bypass valve 132 to the irrigation channel 102 and along the irrigation channel until it exits the distal end of the irrigation channel 102 and enters the kidney. As previously mentioned, the suction channel 104 is configured to provide a pulsed fluid flow through at least one valve 136 and / or 138, and in Figure 5 both valves 136 and 138 are included, but it should be understood that the pulsed fluid flow may be realized with a single valve, as shown in Figure 1a. The lower left side of Figure 5 shows the cumulative effect of a pulsed suction flow similar to a "cough" regime, generating short pulses of back pressure along the fluid in the suction channel 104. When the laser is emitted to excise the kidney stone material, ablation product particles are generated near the distal end of the suction channel 104. As described above, the pulsed flow within the suction channel 104 promotes the mixing of these particles, reducing the risk of blockage within the suction channel 104.

[0041] The controller 190 can be used to monitor and control the fluid pressure within the kidney. The controller 190 receives pressure measurements from pressure sensors 156 and / or 158 and analyzes this data. In some embodiments, the controller 190 compares the measured pressure value to a predetermined pressure threshold and, based on the comparison, sends a control command to at least one of the bypass valve 132, at least one valve 136, 138, and suction pump 115.

[0042] According to at least one embodiment, the controller 190 is configured to calculate a measured pressure value per unit time and to determine whether the measured pressure value per unit time meets or exceeds one or more thresholds. Accordingly, the controller 190 transmits control commands to one or more components in the system 100, such as the bypass valve 132, at least one valve 136, 138, and / or the suction pump 115. According to an additional embodiment, the controller 190 can also receive inputs from other sensors, such as the pressure sensor 150 in the irrigation channel and / or the fluid flow sensor 140 in the irrigation channel, and / or the fluid flow sensor 144 in the suction channel, and transmit control commands to components in the system 100, such as the laser source 107.

[0043] According to a particular embodiment, the initial or primary blockage detection operation mode of the system 100 can be performed by the controller 190. Blockage of the suction channel 104 will cause an increase in pressure within the kidney because fluid has not been effectively removed from the kidney and irrigation fluid from the irrigation channel 102 is still entering the kidney. According to one embodiment, the initial or primary blockage detection operation mode can be initiated when the controller 190 calculates a measured pressure value per unit time and determines that the measured pressure value per unit time meets or exceeds a predetermined first threshold. Accordingly, the controller 190 sends a control command to the suction pump 115 to increase the flow rate of fluid in the suction channel 104. According to one method, the controller 190 determines whether the measured pressure value is less than the first pressure threshold, and if the measured pressure value meets or exceeds the first pressure threshold, increases the velocity of the pulsed fluid flow. For example, if the measured pressure values ​​from pressure sensors 156 and / or 158 exceed a target value (e.g., 40 cmH2O) by a predetermined percentage or range (e.g., 25%) over a predetermined period (e.g., 2 seconds), the fluid flow rate in the suction channel 104 can be increased by the suction pump 115 via the controller 190. For example, the measured pressure value may be within a range of 5% to 100% above the target value over a period of 0.2 s to 10 s for the primary blockage detection operation mode being performed. In another example, the measured pressure value may be within a range of 20% to 30% above the target value over a period of 1 to 5 s for the primary blockage detection operation mode being performed. According to some embodiments, pressure monitoring is performed continuously. In some embodiments, the flow rate of the suction fluid can be increased from 100 mL / min up to a maximum of 150 mL / min. According to certain embodiments, the flow rate of the suction fluid is increased so that the negative pressure in the suction channel increases by 50%. In some embodiments, the flow rate of the suction fluid is increased so that the negative pressure in the suction channel increases within a range of 5% to 100%. In certain embodiments, the flow rate of the suction fluid is increased so that the negative pressure in the suction channel increases within a range of 25% to 75%.According to one embodiment, the measured pressure value used as a reference for a predetermined first threshold or first pressure threshold is 50 cmH2O (25% above the target of 40 cmH2O). In this specification, a target pressure value of 40 cmH2O is used as one example, but it should be understood that other target pressure values ​​are also within the scope of this disclosure.

[0044] An embodiment of the primary blockage detection mode is shown in the intermediate region of Figure 5, which is similar to a “deep breath” regime, in which the negative pressure in the suction channel 104 increases over a period of time, for example, the period between the two arrows in Figure 5. This additional “sucking” action of the suction channel 104 is similar to a person taking a deep breath.

[0045] According to certain embodiments, a secondary blockage detection operation mode of the system 100 can also be performed by the controller 190. In this case, the controller 190 is configured to determine whether the measured pressure value per unit time meets or exceeds a predetermined second threshold. This mode may be triggered when the response during the primary blockage detection operation mode (i.e., the increase in fluid flow rate in the suction channel) fails to reduce the kidney pressure to an acceptable level. In at least one embodiment, if the pressure in the kidney has decreased to an acceptable level (e.g., 40 cmH2O) within a predetermined period (e.g., 5 seconds), the controller 190 can decelerate the speed of the suction pump 115 back to the initial level. According to some embodiments, this predetermined period is in the range of 2 to 30 seconds. However, if the pressure does not decrease within the predetermined period, the controller 190 can perform a secondary blockage detection operation mode as described below.

[0046] According to one embodiment, when the controller 190 determines that the measured pressure value per unit time meets or exceeds a predetermined second threshold, the controller 190 sends a control command to the bypass valve 132, thereby opening the bypass channel 108, fluid-couples the irrigation channel 102 to the suction channel 104, and directs the irrigation fluid to the distal end of the suction channel 104. According to one method, the controller 190 determines whether the measured pressure value is less than the second pressure threshold, and if the measured pressure value meets or exceeds the second pressure threshold, directs the fluid flow from the irrigation channel 102 into the suction channel 104. Furthermore, the controller 190 can send a control command to the valve 138 to close the valve 138 and stop the fluid flow from the distal end to the proximal end of the suction channel 104. This allows the irrigation fluid to flow to the distal end of the suction channel 104 via the suction pump 115 without a reaction force that would push the irrigation fluid in another direction. In some embodiments, the controller 190 can send a control command to the suction pump 115 to stop pumping (e.g., power off). According to one embodiment, if the measured pressure value exceeds a target value (e.g., 40 cmH2O) by a predetermined percentage or range (e.g., 50%) over a predetermined period (e.g., 2 seconds), the fluid flow from the irrigation channel 102 may be directed to the suction channel via the controller 190 (via the bypass valve 132). For example, the measured pressure value may be in the range of 5 to 100% above the target value over a period in the range of 0.2 to 10 s for the secondary blockage detection operation mode being performed. In another embodiment, the measured pressure value may be in the range of 30% to 70% above the target value over a period in the range of 1 to 5 s for the secondary blockage detection operation mode being performed. According to one embodiment, the measured pressure value used as a basis for a predetermined second threshold is 60 cmH2O (50% above the target of 40 cmH2O).

[0047] The secondary blockage detection operation mode is shown on the right side of the graph in Figure 5. During this secondary blockage detection operation mode, valve 138 may be closed, and when the irrigation fluid is bypassed into the suction channel 108, the pulsed flow of fluid in the suction channel 104 is interrupted. Furthermore, during this mode, the controller 190 closes channel A of the bypass valve 132 (i.e., the flow of irrigation fluid is interrupted or terminated) to prevent the irrigation fluid from being directed to the distal end of the irrigation channel 102, thereby further increasing the pressure within the kidney. Channels A of valve 138 and bypass valve 132 remain closed for a predetermined period τ s It is closed for a period of time (also referred to herein as the switching period or bypass duration). Furthermore, the bypass channel 108 (channel B of the bypass valve 132) is closed for a predetermined period τ s It is opened during the following period. In some embodiments, for a predetermined period τ s This is within the range of 0.5s to 3.0s. In other embodiments, a predetermined period τ s τ is 1 second. In some embodiments, τ s This is based on a predetermined fluid volume, such as 2 milliliters (ml). According to certain embodiments, the predetermined fluid volume may be in the range of 0.5 ml to 10 ml. According to other embodiments, back pressure pulses may be performed in the suction channel 104 (via valves 136 and 138) based on a measured pressure value. For example, depending on the measured pressure value or the rate / change of the measured pressure, back pressure pulses may be performed in the suction channel 104 using valves 136 and / or 138. These back pressure pulses can function to clear blockages in the suction channel 104.

[0048] The lower right side of Figure 5 shows the effect of an interrupted and redirected irrigation fluid flow, similar to the “sneeze” regime, where the fluid pressure in the suction channel 104 increases for a longer period than the “cough regime,” just as a human “sneeze” is typically longer (and more forceful) than a human “cough.” sWhen this is complete, channel A of the bypass valve 132 is opened and bypass channel 108 (channel B) of the bypass valve 132 is closed. In some embodiments, valve 138 is also opened. This configuration is shown on the far right of Figure 5 (showing that the irrigation fluid flow is returned to the irrigation channel 102), and if the measured renal pressure is at an acceptable level, a pulsed suction flow may also be returned. As shown in Figure 5, after the secondary blockage detection operation mode is performed, the pressure level in the kidney decreases. However, if the pressure level in the kidney does not decrease to an acceptable level after the secondary blockage detection operation mode is performed, this mode can be repeated multiple times until the renal pressure decreases to an acceptable level. The number of repetitions may be limited so as not to harm the kidney. In some cases, the secondary blockage detection operation mode (i.e., the operation of the bypass channel 108 for a predetermined period of time) can be repeated up to five times consecutively.

[0049] The control scheme illustrated in Figure 5 is characterized by a particular aspect of avoiding or preventing sudden or rapid increases and decreases in renal pressure. The kidney can withstand longer-term increases in pressure up to a predetermined maximum value (e.g., 250 cmH2O), but if this threshold is reached in a shorter or more rapid time (e.g., less than 30 seconds), the kidney may be damaged. The control scheme outlined in Figure 5 is intended to acquire this ability of the kidney by avoiding sudden increases (and decreases) in pressure. According to a particular embodiment, the disclosed control scheme prevents the kidney from reaching 250 cmH2O (from 40 cmH2O) in less than 30 seconds (which would be harmful to the kidney).

[0050] Another non-limiting embodiment of the irrigation and suction system according to one embodiment is shown overall in Figure 6 as 200. System 200 has many of the same components as system 100a in Figure 1A and system 100b in Figure 1B, except that in this configuration valves 136 and 138 are replaced by an ultrasonic transducer 216, and the bypass valve 232 combined with the bypass channel 208 has a slightly different configuration. The bypass channel 208 is still configured to fluidize the irrigation channel 102 to the suction channel 104, but in this example channel "A" of the first valve 232 fluidizes the suction channel 104 instead of the irrigation channel 102. During normal operating modes, channel A is open and channel B is closed so that fluid flows from the distal end to the proximal end of the suction channel 104. The ultrasonic transducer 216 is configured to mechanically vibrate the suction channel 104. The vibration can be configured to generate back pressure within the suction channel (i.e., via the controller 190), similar to the pinch valves 138 and 136 of systems 100a and 100b. As shown in Figure 6, according to one embodiment, the ultrasonic transducer 216 is positioned between the distal end of the suction channel 104 and the bypass channel 208.

[0051] Figure 3 is a perspective view of the distal end of one embodiment of a ureteroscope 105 according to at least one embodiment. A laser source 107 is configured to emit laser radiation, and an optical fiber 106 is coupled to the laser source 107 and configured to transmit laser radiation in close proximity to the distal end of the suction channel 104 shown in Figure 3. The optical fiber 106 extends from the proximal end 113 to the distal end 114 of the catheter shaft 112 (see, for example, Figure 2). In certain embodiments, the system 100 may comprise one or more components of an imaging system. For example, the ureteroscope 105 may comprise a camera 165 located at the distal end of the catheter shaft 112, as shown in Figure 3. Furthermore, at least one outlet 146 is defined at the distal end of the irrigation channel 104. In one embodiment, at least one outlet 146 is configured to guide the irrigation flow at an angle in the range of 0 to 170 degrees with respect to the central axis 111 of the catheter shaft 112 (see, for example, Figure 2). In some embodiments, the flow angle is in the range of 10 to 90 degrees.

[0052] In addition to camera 165, in some embodiments, ultrasound can be used to provide visualization of the treatment area within the kidney. For example, ultrasound can be applied to the patient's skin near the kidney, and the resulting images can be displayed on a screen for use by the physician. In some cases, ultrasound images can be used as a control source. For example, a baseline image can be taken before the procedure and used as a reference source throughout the procedure when controlling the pressure within the kidney.

[0053] According to one or more embodiments, systems 100a and 100b may include one or more temperature sensors. Temperature sensors 170a and 170b are shown in systems 100a and 100b of Figures 1A and 1B, respectively. In some embodiments, at least one of the temperature sensors 170a and 170b, as well as the pressure sensor 156, is positioned inside the kidney, i.e., near the treatment area outside the ureteroscope. In other embodiments, the catheter shaft may be configured to include one or more temperature sensors, for example, at the distal end of the catheter shaft. According to at least one embodiment, temperature measurements are acquired by the temperature sensors and used by the controller 190 to prevent the temperature from becoming too high and harming the kidney. As can be understood, the heat generated by the laser can raise the fluid temperature inside the kidney. In some cases, the controller 190 can control the speed of one or more components of the system 100, such as the suction pump 115 and / or the irrigation pump 110, and / or the laser source 107, to ensure that the temperature inside the kidney is maintained within an acceptable range, for example, between 20°C and 45°C.

[0054] In another embodiment, systems 100a and 100b may also be configured such that one or more components can be operated or controlled manually. For example, as shown in Figure 2, the bypass valve 132 can be operated manually by the system operator (e.g., a physician). A manual pump 134 located in the suction channel 104 (see, for example, Figures 1A and 1B) can be used by the user to pump fluid through the suction channel 104.

[0055] Increased ablation rate According to at least one embodiment, during the lithotomy procedure, the ureteroscope 105 is manipulated to approach the stone target, and the aspiration / irrigation system 100 is configured to detect when the stone is near the laser 106. This capability is based on the premise that when the entrance to the channel is partially blocked by the stone, the pressure and flow rate in the aspiration channel 104 change (increase and decrease, respectively).

[0056] As shown in Figure 3, the optical fiber 106 that carries light energy is positioned within the suction channel 104, next to the suction channel, or in close proximity to the suction channel. Functionally, this means that the distal end 103 of the optical fiber 106 is positioned at the mouth (distal end) of the suction channel 104. In some embodiments, the optical fiber 106 may have its own channel; in other embodiments, the optical fiber 106 may have its own lumen within the suction channel 104; and in yet another embodiment, the optical fiber 106 may be positioned within the suction channel 104 and extend along the length of the suction channel 104. When a stone blocks the suction channel 104 of the ureteroscope 105, the flow through the suction channel 104 decreases, but the vacuum pressure increases. According to one embodiment, the fluid flow rate in the suction channel 104 can be monitored using a fluid flow sensor, such as a fluid flow sensor 144 as shown in Figures 1A, 1B, and 2. In some embodiments, the flow sensor 144 is attached to or positioned at the distal end of the suction channel 104. Stone detection can be determined by a controller 190 that detects a decrease in fluid flow rate and an increase in pressure within the kidney based on the measured fluid flow rate value in the suction channel 104, which can be determined based on the measured pressure value from at least one of the pressure sensors 156 and 158. The controller 190 receives pressure and flow rate measurements from sensor 144 and at least one of sensors 156 and 158, and analyzes this data to determine whether the changes in pressure and flow rate per unit time meet or exceed predetermined limit or target values. For example, according to one embodiment, a 30% decrease (change) in flow rate and a 25% increase (change) in pressure indicate the presence of a stone. According to some embodiments, the duration associated with stone detection is in the range of 1 to 10 seconds.

[0057] The controller 190 can be used to synchronize the laser operation with the detection of the calculus, allowing it to fire when the calculus is close to the optical fiber. This has been shown to substantially increase the ablation rate. Once it is determined that the calculus is close to the laser, the vacuum (i.e., vacuum pressure) generated in the suction channel 104 is used to hold the calculus close to the optical fiber 106 at the distal end of the suction channel 104. In some cases, the presence of the calculus itself generates sufficient vacuum pressure to hold it in place, but according to at least one embodiment, the vacuum pressure in the suction channel 104 may be further increased (e.g., via the suction pump 115) to ensure that the calculus is firmly held in place. This vacuum increases the ablation rate by increasing the contact time between the fiber and the calculus. In addition to increasing the ablation rate, an additional benefit is that the laser discharge occurs only when the calculus is within the target region, thereby limiting the possibility of collateral damage. Thus, the vacuum attachment with laser synchronization increases the ablation rate and minimizes undesirable laser discharge.

[0058] In another embodiment, the laser is configured to emit pulsed laser radiation, which can be synchronized with the pulsation of the fluid flow through the aspiration channel 104. For example, when the stone is in an optimal target position (i.e., the mouth or distal end of the aspiration channel 104), a predetermined laser pulse sequence (e.g., 1 to 1000 laser pulses) is directed at the stone, and subsequently, the pressure within the aspiration channel 104 is pulsed until the stone is again in an optimal target position. This cycle is then repeated. The efficiency of stone ablation is also improved by this technique. In some embodiments, the pulsation of the fluid flow and the laser pulses are not synchronized. According to one non-limiting embodiment of such an embodiment, the frequency of the pressure pulse may be as low as 0.1 Hz, and the repetition rate of the laser pulse may be in the range of about 3 Hz to 3000 Hz.

[0059] According to another aspect, the suction channel 104 can include a temperature sensor (not shown in the drawings) for measuring the temperature of the fluid flowing within the suction channel 104. This feature can help prevent the tissue from overheating. For example, upon detecting an increase in the temperature of the return fluid (above a predetermined target) within the suction channel 104, there may be a need to increase the rate of fluid exchange at the treatment site or decrease the power of the laser radiation emitted by the laser source (implemented by commands from the controller 190). In addition to preventing tissue damage due to overheating, this feedback mechanism also maintains the laser output at a safe level to ensure a high ablation rate.

[0060] Maintenance of Equilibrium - Calculation To more accurately define the parameters of the fluid pump system and maintain the balance of fluid flow and pressure, specific calculations can be performed, and an overview of which is described below.

[0061] First, using some modeling techniques, one or more parameters of the components of the system, such as a pump, can be defined. Using the Hagen - Poiseuille equation, the pressure for an increase in flow rate can be calculated. The Hagen - Poiseuille equation defines the pressure difference δP (Pascals), which is necessary to generate a volume flow rate Q (m 3 / sec) of a fluid with viscosity μ (Pa - sec) within a channel having an inner radius r (m) and length L (m). Pressure difference: δP = 8μLQ / πr 4 μ = kinematic viscosity. For 0.9% saline: μ = 1.02 * 10 -3 Pa - sec L = scope length. L = 0.7m Q = volume flow rate. Q = 70 mL / min = 1.17 mL / sec = 1.17 * 10 -6 m 3 / sec r = radius of the suction channel. r = 0.6 mm = 6 * 10 -4 m

[0062] In this way, the pressure difference for suction can be calculated. According to one embodiment, the average flow rate through the ureter / bladder / urethra and around the outer body of the scope is approximately 30 mL / min, with a maximum value of 100 mL / min. As a result, approximately 70 mL / min passes through the suction channel. Erotica P asp =8*1.02*10 -3 *0.7*1.17*10 -6 / π*1296*10 -16 = = 1.63 * 10 4 Pa = 16300 Pa = 164 cm of water = 2.36 psi

[0063] The result of 2.36 psi is the pressure that needs to be applied to the proximal end of the scope to "aspirate" fluid from the kidney. This is a negative pressure. Assuming the working pressure of the kidney is 40 CM (where CM = centimeters of water column (cmH2O)), the negative pressure at the proximal end of the scope is as follows: Suction pressure Pasp=40 CM-164 CM=-124 CM=-1.8 psi

[0064] This result means that a flow rate of 100 mL / min can be produced by applying -1.8 psi. Furthermore, if positive pressure exists within the kidney, this flow rate will reduce this positive pressure within the kidney.

[0065] Similarly, the irrigation pressure can be calculated. In one embodiment, the irrigation flow rate is 100 mL / min, which is 1.67 * 10 -6 m 3 The time interval is / sec. The scope length is 0.7m, and the radius of the irrigation channel is 0.6mm. Erotica P irr =8*1.02*10 -3 *0.7*1.67*10 -6 / π*1296*10 -16 = =2.32*10 4 Pa=23200 Pa=233 CM=3.36 psi

[0066] The result of 3.36 psi is the pressure difference required to have a flow rate of 100 mL / min through a channel with a diameter of 1.2 mm and a length of 0.7 m. Assuming that a hydrostatic pressure of approximately 40 cm is still required within the kidney, the irrigation pump must transmit a pressure of approximately 273 cm or approximately 4 psi.

[0067] The above analysis indicates that the irrigation pump must be configured to generate a pressure of at least 4 psi and a flow rate of at least 100 mL / min, and the suction pump must be configured to generate a negative pressure of at least 1.8 psi and a flow rate of at least 70 mL / min.

[0068] control The controller 190 can utilize a control program to control the operation of the system 100. Generally speaking, the controller 190 includes a data acquisition component 192 (e.g., the data logger in Figure 2), a storage component (not shown), and a browsing component (not shown).

[0069] The data acquisition component 192 queries and acquires measurement data from one or more sensors, such as pressure and / or flow sensors, and the measurement data is then processed by the controller 190. The controller 190 can also receive user input that can be used by the control program. The information is then processed by the controller 190 and can be used to control the laser source 107, valves 132, 136, 138, irrigation pump 110, and / or suction pump 115. The diagram in Figure 2 shows that the control of these components is via the data acquisition component 192, but it should be understood that the controller 190 can directly control these components. For example, the operation of a valve is controlled by a voltage signal transmitted by the controller 190.

[0070] As described above, the controller 190 can be programmed with a control program that utilizes a preset or predetermined target value (which can be stored) or manually controlled value for one or more of the laser source 107, valves 132, 136, 138, and pumps 110, 115 (and ultrasonic transducer 216), based on measurements received from the data acquisition component 192 and transmitted by one or more sensors of system 100a, 100b (or system 200). It should also be understood that the controller 190 can control the data acquisition component 192 to initiate data acquisition operations, i.e., measurement data or other signal data. According to at least one embodiment, one or more of the pressure sensors and / or flow sensors can acquire measurement data at various time intervals or continuously.

[0071] The control program used by the controller 190 can be configured to perform many different control operations or control states to achieve one or more desired results, such as synchronizing laser emission with stone attachment, ensuring sustained stone / fiber contact, clearing blockages in the suction channel, or maintaining equilibrium within the kidney and system. For example, abnormal pressure and flow can be corrected by opening and closing channel valves and adjusting the speed of the fluid pump.

[0072] As mentioned above, one or more (pressure, fluid flow) sensors can be used to help maintain the target equilibrium pressure in the kidney. Furthermore, sensors within the irrigation channel 102 (e.g., pressure sensor 150 and / or flow sensor 140) can also be used to verify that the irrigation channel 102 is functioning properly and to detect potential damage. For example, if the irrigation pump 110 is pumping (i.e., on), but the sensor cannot detect fluid flow in the irrigation channel 102, this indicates a system error. Furthermore, if the pressure sensor measures a value that is too high or too low, this also indicates a system error.

[0073] Examples The functions and advantages of the embodiments of the systems and technologies disclosed herein can be better understood based on the embodiments described below. The embodiments described below are intended to illustrate various aspects of the disclosed suction and irrigation systems, but are not intended to illustrate their entire scope.

[0074] Example - Experiment on laser power output and suction fluid flow rate Experiments were conducted to test the ability to achieve higher laser power by utilizing the fluid flow within the suction channel of a ureteroscope. Higher laser power can offer several advantages, including an increased ablation rate, potentially reducing procedure time. The fluid flow within the suction channel can be used to control the temperature near the laser, thereby keeping the tissue within a safe temperature range.

[0075] The experiment was conducted using a silicone urinary tract model filled with saline solution, which facilitated the insertion of a ureteroscope shaft fitted with a thulium fiber laser, and irrigation and suction flows were activated using tubing. The laser was operated with a pulse energy of 1 joule (J), a peak output of 500 watts (W), and a variable pulse repetition rate of nine different average outputs (10, 20, 30, 60, 70, 80, 90, 100, 120 W). Suction flow rates were tested at values ​​of 50 ml / min to 90 ml / min (as shown in Figure 7), and the irrigation flow rate was set to approximately 10 ml / min more than the suction flow rate. Two temperature sensors (thermocouple type K) were placed approximately 20 mm to 30 mm above and below the distal end of the shaft, which had an outer diameter of 3 mm.

[0076] Temperature measurements were obtained after reaching saturation and temperature stability levels, which took up to 15 minutes. A maximum temperature rise (delta) of 23°C was selected, with an initial fluid temperature of 20°C and a maximum allowable temperature of 45°C. The results are shown in Figure 7, demonstrating that increasing the aspirated fluid flow rate to 50 ml / min to 90 ml / min allows for the safe use of twice the laser power, i.e., up to 60 W to 120 W. In contrast, with a conventional flow rate of 10 ml / min by natural aspiration through the access sheath, the maximum laser power that can be safely used is typically 20 W to 25 W.

[0077] The embodiments disclosed herein in accordance with the present invention are not limited in their application to the structural and arrangement details of the components described below or shown in the accompanying drawings. These embodiments may envision other embodiments and may be carried out or implemented in various ways. Examples of specific embodiments are provided herein for illustrative purposes only and are not intended to limit them. In particular, the operations, components, elements, and features described in relation to any one or more embodiments are not intended to be excluded from similar roles in any other embodiments.

[0078] Furthermore, the expressions and terms used herein are for illustrative purposes only and should not be considered limiting. Any reference herein to an example, embodiment, component, element, or operation of a system or method referred to in the singular may also include a plural embodiment, and any plural reference herein to an embodiment, component, element, or operation may also include an embodiment that includes only the singular form. References in the singular or plural form are not intended to limit the systems or methods, their components, operations, or elements of the disclosure. The use herein of “including,” “comprising,” “having,” “containing,” “involving,” and variations thereof means that they include the items listed thereafter and their equivalents, as well as additional items. References to “or” may be construed as comprehensive, such that any term written using “or” may refer to one, more than one, or all of the terms written. Furthermore, in the event of any inconsistency in the use of terminology between this document and any document incorporated herein by reference, the use of terminology in the incorporated reference shall supplement the use in this document, and in the event of any irreconcilable discrepancies, the use of terminology in this document shall prevail. Additionally, titles or subtitles may be used herein for the convenience of the reader, and these shall not affect the scope of the invention.

[0079] While several aspects of at least one embodiment have been described in this manner, those skilled in the art will understand that various changes, modifications, and improvements are readily conceivable. For example, the embodiments disclosed herein may be used in other circumstances. Such changes, modifications, and improvements are intended to be part of this disclosure and within the scope of the embodiments described herein. Accordingly, the above description and drawings are merely examples. [Explanation of symbols]

[0080] 100 System, 100a System, 100b System, 102 Irrigation Channel, 103 Distal End, 104 Suction Channel, 105 Ureteroscope, 106 Optical Fiber, 107 Laser Source, 108 Bypass Channel, 110 Irrigation Pump, 111 Central Axis, 112 Catheter Shaft, 113 Proximal End, 114 Distal End, 115 Suction Pump, 132 Bypass Valve, 134 Manual Pump, 136 Valve, 138 Valve, 140 Flow Sensor, 144 Flow Sensor, 146 Outlet, 150 Pressure Sensor, 156 Pressure Sensor, 158 Pressure Sensor, 160 Irrigation Fluid Source, 165 Camera, 170a Temperature Sensor, 170b Temperature Sensor, 190 Controller, 192 Data Acquisition Components, 200 System, 208 Bypass Channel, 216 Ultrasonic transducer, 232 bypass valve

Claims

1. A catheter shaft having a proximal end and a distal end, wherein the distal end is in fluid communication with the inside of the kidney, An irrigation channel extending from the proximal end to the distal end through the catheter shaft, A suction channel extending from the proximal end to the distal end through the catheter shaft, The irrigation channel and the bypass channel fluid-coupled to the suction channel, A bypass valve configured to control the level of fluid communication between the irrigation channel and the suction channel via the bypass channel, A suction pump is configured to communicate with the suction channel and pump the fluid from the distal end to the proximal end of the suction channel, At least one valve disposed on the suction channel and configured to provide a pulsed flow of fluid into the suction channel to prevent clogging of the suction channel, A pressure sensor that is in fluid communication with the inside of the kidney, A controller communicating with the pressure sensor, the bypass valve, at least one of the valves, and the suction pump, Equipped with, The aforementioned controller The pressure sensor receives at least one measured pressure value, The measured pressure value is compared with a predetermined pressure threshold, Based on the above comparison, a control command is transmitted to at least one of the bypass valve, at least one of the valves, and the suction pump. An irrigation and suction system configured as follows.

2. The system according to claim 1, wherein the controller is configured to calculate a measured pressure value per unit time, determine whether the measured pressure value per unit time satisfies or exceeds a predetermined first threshold, and accordingly transmit a control command to the suction pump to increase the flow rate of fluid in the suction channel.

3. The system according to claim 2, wherein the measured pressure value used as a basis for a predetermined first threshold is 50 cmH₂O.

4. The system according to claim 2, wherein the controller is configured to determine, after a predetermined period of time, whether the measured pressure value per unit time satisfies or exceeds a predetermined second threshold, and accordingly transmit a control command to the bypass valve such that the bypass channel is opened, the irrigation channel is fluid-coupled to the suction channel, and the irrigation fluid is directed to the distal end of the suction channel.

5. The system according to claim 4, wherein the measured pressure value used as a basis for a predetermined second threshold is 60 cmH₂O.

6. The controller is configured to realize the pulsed flow of the fluid by transmitting control commands to close at least one of the valves for a predetermined duration τ1 and to close at least one of the valves for a predetermined duration τ2 during a repeating cycle. The system according to claim 1, wherein τ1 and τ2 are separated by a predetermined period t, and each cycle belongs to period T.

7. The system according to claim 1, wherein at least one of the valves is located on the suction channel between the bypass channel and the suction pump.

8. The system according to claim 7, wherein at least one of the valves comprises a first valve and a second valve, the second valve being positioned on the suction channel between the bypass channel and the distal end of the suction channel.

9. The controller is configured to realize the pulsed flow of the fluid by sending control commands in a repeating cycle to close the first valve for a predetermined duration τ1 and to close the second valve for a predetermined duration τ2. τ1 and τ2 are separated by a predetermined period t, and each cycle belongs to period T. The system according to claim 8.

10. The system according to claim 1, wherein the bypass valve is configured as a three-way solenoid pinch valve, and at least one of the valves is configured as a two-way solenoid pinch valve.

11. The system according to claim 1, wherein the pressure sensor is located in close proximity to the outer surface of the catheter shaft.

12. A laser source configured to emit laser radiation, An optical fiber coupled to the laser source and configured to transmit the laser radiation in proximity to the distal end of the aspiration channel, wherein the optical fiber extends from the proximal end to the distal end of the catheter shaft, and The system according to claim 1, further comprising:

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