Intelligent flushing and pumping system

Abstract

A flush and aspiration system includes a catheter shaft having a distal end in fluid communication with an interior of a kidney, a flush channel and an aspiration channel extending through the shaft, a bypass channel fluidly coupled with the flush channel and the aspiration channel, a bypass valve configured to control a level of fluid communication between the flush 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 pulsed 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 to a threshold, and based on the comparison, send a control command to at least one of the bypass valve, the aspiration pump, and the at least one valve.

Description

Technical Field

[0001] This application generally relates to laser lithotripsy, and more specifically to the use of a ureteroscope for laser-assisted removal of kidney stones, focusing on pressure control within the kidney. Background Technology

[0002] Kidney stones are a prevalent condition affecting an estimated 12% of the world's population. While most patients pass the stones naturally, the condition can be so severe that medical intervention is required. This can result in extreme pain, nausea, vomiting, infection, urinary obstruction, and loss of kidney function. Laser lithotripsy is a method used to treat kidney stones. Optical energy guided by fiber optics is used to break the stones into smaller fragments that can be passed naturally. Conventional methods for treating kidney stones using a flexible ureteroscope include a device that provides forced fluid flushing and natural aspiration through the space between the ureteroscope's axis and the access sheath or natural urethra. More recent methods include devices that also incorporate a suction channel within the ureteroscope to vacuum-remove stone fragments and debris generated by stone erosion (see, for example, U.S. Patent Publication No. 2017 / 0215965).

[0003] One of the problems with laser lithotripsy is stone targeting. When the fiber optic cable is not in contact with the stone, the ablation rate is very low, which increases the procedure time. Furthermore, the laser pulse can be misdirected towards the unintended target, causing collateral damage. Another issue is maintaining pressure and fluid balance in the kidney and ureteroscope during the procedure. Applying a vacuum to remove stone fragments alters the fluid content and pressure within the kidney and, if not managed properly, can lead to accidental damage to the patient or the ureteroscope. Additionally, a vacuum is created in the aspiration channel of the ureteroscope during laser lithotripsy. The distal end of this channel often becomes blocked by stones and their fragments. Severe blockage may require repeated removal, cleaning, and reinsertion of the ureteroscope during the procedure. Summary of the Invention

[0004] The aspects and embodiments relate to methods and systems for controlling fluid flow in flushing and suction systems.

[0005] According to an exemplary embodiment, a flushing and aspiration system is provided, comprising: a catheter shaft having a proximal end and a distal end, the distal end being in fluid communication with the interior of a kidney; a flushing channel extending from the proximal end through the catheter shaft to the distal end; an aspiration channel extending from the proximal end through the catheter shaft to the distal end; a bypass channel fluidly connected to the flushing channel and the aspiration channel; a bypass valve configured to control the level of fluid communication between the flushing channel and the aspiration channel via the bypass channel; and a aspiration pump fluidly connected to the aspiration channel and configured to draw water from the distal end of the aspiration channel. The device includes: a pump that delivers fluid proximally to the kidney; at least one valve disposed on the suction channel and configured to provide a pulsed flow of fluid in the suction channel to prevent blockage; a pressure sensor in fluid communication with the internal structure of the kidney; and a controller in communication 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, send a control command to at least one of the bypass valve, the at least one valve, and the suction pump.

[0006] In one example, 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 first predetermined threshold, and, in response, send a control command to the suction pump to increase the flow rate of fluid in the suction channel. In one example, the measured pressure value used as the basis for the first predetermined threshold is 50 cmH2O.

[0007] In one example, the controller is configured to determine whether the measured pressure value per unit time meets or exceeds a second predetermined threshold, and in response, sends a control command to the bypass valve, causing the bypass passage to open and the flushing passage to be fluidly connected to the suction passage, and the flushing fluid to be directed to the distal end of the suction passage. In one example, the measured pressure value used as the basis for the second predetermined threshold is 60 cmH2O.

[0008] In one example, the controller is configured to implement the pulsed flow of the fluid by sending control commands to: repeatedly close the at least one valve for a predetermined duration τ1 and for a predetermined duration τ2, wherein τ1 and τ2 are spaced apart by a predetermined time period t, and each cycle has a time period T. In one example, the at least one valve is arranged on the suction channel between the bypass channel and the suction pump.

[0009] In one example, the at least one valve includes a first valve and a second valve, the second valve being disposed on the suction channel between the bypass channel and the distal end of the suction channel. In another example, the controller is configured to implement the pulsed flow of the fluid by sending control commands to: repeatedly close the first valve for a predetermined duration τ1 and close the second valve for a predetermined duration τ2, wherein τ1 and τ2 are spaced apart by a predetermined time period t, and each cycle has a time period T.

[0010] In one example, the bypass valve is configured as a three-way solenoid pinch valve, and the at least one valve is configured as a two-way solenoid pinch valve.

[0011] In one example, the pressure sensor is located near the outer surface of the conduit shaft.

[0012] In one example, the system further includes: a laser source configured to emit laser radiation; and an optical fiber coupled to the laser source and configured to transmit the laser radiation to a distal end adjacent to the suction channel, the optical fiber extending from the proximal end to the distal end of the conduit axis.

[0013] According to another exemplary embodiment, a method of operating a suction and flushing system is provided, comprising: providing a pulsed fluid flow from a distal end to a proximal end of a suction channel, the distal end of the suction channel being in fluid communication with the interior of a kidney; measuring a pressure value inside the kidney; determining whether the measured pressure value is less than a first pressure threshold; and increasing the flow rate of the pulsed fluid flow when the measured pressure value meets or exceeds the first pressure threshold.

[0014] In one example, the method further includes: providing a fluid flow from a proximal to a distal end of a flushing channel, the distal end of which is in fluid communication with the internal structure of the kidney; determining whether a measured pressure value is less than a second pressure threshold; and when the measured pressure value meets or exceeds the second pressure threshold, directing the fluid flow from the flushing channel into the aspiration channel. In one example, the fluid flow is directed from the flushing channel into the aspiration channel via a bypass channel. In another example, the method further includes closing a valve disposed on the aspiration channel between the proximal end of the aspiration channel and the bypass channel.

[0015] In one example, the pulsed fluid flow is implemented by at least one valve arranged on the suction channel. In another example, the pulsed fluid flow is implemented by repeatedly closing the at least one valve for a predetermined duration τ1 and closing the at least one valve for a predetermined duration τ2, wherein τ1 and τ2 are spaced apart by a predetermined time interval t, and each cycle has a time period T. In another example, the at least one valve includes a first valve and a second valve, and the pulsed fluid flow is implemented by repeatedly closing the first valve for a predetermined duration τ1 and closing the second valve for a predetermined duration τ2, wherein τ1 and τ2 are spaced apart by a predetermined time interval t, and each cycle has a time period T. In one example, τ1 and τ2 are in the range of 20 ms to 500 ms including the endpoints, and the time period T is in the range of 0.5 s to 3.0 s including the endpoints.

[0016] Other aspects, embodiments, and advantages of these exemplary aspects and embodiments are discussed in detail below. Furthermore, it should be understood that 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. The embodiments disclosed herein may be combined with other embodiments, and references to “embodiment,” “example,” “some embodiments,” “some examples,” “alternative embodiments,” “various embodiments,” “one embodiment,” “at least one embodiment,” “this and other embodiments,” “some embodiments,” etc., are not necessarily mutually exclusive and are intended to indicate that a particular feature, structure, or characteristic described may be included in at least one embodiment. The appearance of such terms herein does not necessarily refer to the same embodiment. Attached Figure Description

[0017] At least one embodiment will now be discussed with reference to the accompanying drawings, which are not drawn to scale. The drawings are included to provide illustration and further understanding of the aspects and embodiments, and are incorporated in and constitute a part of this specification, but are not intended to be limiting of any 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 illustrated in the various figures is indicated by similar reference numerals. For clarity, not every component is labeled in every figure; in the drawings:

[0018] Figure 1A This is a schematic representation of an example of a flushing and suction system according to various aspects of the present invention;

[0019] Figure 1BThis is a schematic representation of another example of a flushing and suction system according to various aspects of the present invention;

[0020] Figure 2 yes Figure 1B A block diagram of the flushing and suction system;

[0021] Figure 3 This is a distal perspective view of an example of a ureteroscope according to various aspects of the present invention;

[0022] Figure 4A This is a schematic representation of an example of a pulse flow according to various aspects of the present invention;

[0023] Figure 4B These are schematic representations of other examples of pulse flows according to various aspects of the present invention;

[0024] Figure 5 It is shown Figure 1B A timeline of the system's functional aspects;

[0025] Figure 6 This is a schematic representation of yet another example of a flushing and suction system according to various aspects of the present invention; and

[0026] Figure 7 This is a diagram illustrating experimental results according to various aspects of the present invention. Detailed Implementation

[0027] As discussed above, issues associated with laser lithotripsy include stone targeting, maintaining pressure and fluid balance in the kidneys, and blockage from stone fragments. The solutions disclosed herein aim to overcome these issues and ensure safe and effective clinical outcomes by implementing systems and methods that synchronize the functions of the laser and fluid pump systems through monitoring and real-time control of irrigation, aspiration, and laser radiation operating parameters.

[0028] Depending on the specifics, intelligent flushing and / or aspiration flows are implemented to improve aspiration efficiency and prevent clogging. As used herein, the term "intelligent" regarding flushing and / or aspiration flows refers to the ability to maintain bidirectional communication with the controller (i.e., sending or receiving signals). During laser therapy, the negative pressure in the aspiration channel, combined with the flushing fluid flow from the outlet of the flushing channel, creates a flow of small stone particles and dust within the aspiration channel, a result of the ablative process. Balancing these inflows and outflows is crucial for maintaining renal pressure within safe limits. According to the embodiments described herein, several functions can be implemented to keep the aspiration channel free from clogging by ablative particles and to maintain openness to fluid flow:

[0029] • Fluid pressure monitoring in the treatment area (kidney);

[0030] • Continuous pulses of suction flow;

[0031] • Change the negative pressure in the suction channel as a result of pressure monitoring;

[0032] • Switch the flushing flow to the suction channel to remove blockages.

[0033] Blockage detection and kidney pressure control

[0034] According to various embodiments, the disclosed flushing and suction system includes one or more sensors such as a flow sensor (also known as a fluid velocity 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.

[0035] A non-limiting example of a flushing and suction system according to one embodiment is shown below. Figure 1A The general designation is 100a. System 100a includes: a catheter shaft 112 having a proximal end 113 and a distal end 114 (see...). Figure 2 and Figure 3 The device includes: a distal end 114 in fluid communication with the interior of the kidney; a flushing channel 102; a suction channel 104; a bypass channel 108; a bypass valve 132; at least one valve (e.g., valve 138) disposed on the suction channel; a suction pump 115; one or more pressure sensors 156, 158 and a controller 190.

[0036] A flushing channel 102 and an aspiration channel 104 extend from the proximal end 113 through the shaft 112 to the distal end 114. The distal ends of both the flushing channel 102 and the aspiration channel 104 are in fluid communication with the interior of the kidney. An aspiration / flushing system 100a is used within a ureteroscope 105, also referred to as a "three-channel" ureteroscope (for fiber optic, aspiration, and flushing). Fluid is pumped into (e.g., to the kidney) through the flushing channel 102 and pumped out of the kidney through the aspiration channel 104. When referring to channel usage, the term "proximal" refers to the end attached to the corresponding pump, while the term "distal" refers to the end exposed within the ureteroscope (e.g., in…). Figure 3 The distal end is positioned so that when the distal end is in place for lithotripsy, it is located within the internal volume of the kidney.

[0037] A bypass passage 108 is fluidly connected to both the flushing passage 102 and the suction passage 104, and a bypass valve 32 is configured to control the level of fluid communication between the flushing passage 102 and the suction passage 104 via the bypass passage 108, as discussed in more detail below. A suction pump 115 is in fluid communication with the suction passage 104 and is configured to pump fluid from the distal end of the suction passage 104 toward the proximal end. In this embodiment, at least one valve disposed on the suction passage 104 includes a valve 138 disposed between the bypass passage 108 and the suction pump 115.

[0038] Pressure sensors 156 and 158 are in fluid communication with the interior of the kidney, and each pressure sensor 156 and 158 is configured to measure pressure. In some embodiments, the catheter shaft 112 is configured with pressure sensor 158. Figure 3 Two possible locations for the pressure sensor 158 are shown, each positioned at or near the distal end 114 of the conduit shaft 112. In some embodiments, such as Figure 3 As shown, the pressure sensor 158 can be located near the outer surface of the conduit shaft 112. For example, in Figure 3 In the example shown, the outer surface of the conduit shaft 112 has a small recess to accommodate the pressure sensor 158. According to another example, and as... Figure 3 As shown, the pressure sensor 158 is positioned near the camera 165 of the ureteroscope 105, for example, on a surface above the camera 165.

[0039] In some embodiments, the pressure sensor 156 is positioned into the kidney via a separate insertion device. In this case, the pressure sensor 156 is positioned outside the catheter shaft 112 (and is not attached to or otherwise integrated with the catheter shaft 112), and is also referred to herein as an "external" pressure sensor. For example, a miniature pressure sensor may be inserted into the kidney via a needle and / or catheter or any other access sheath, and is therefore located outside the ureteroscope (i.e., outside the catheter shaft, aspiration 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 mm, in other embodiments, the pressure sensor 156 has at least one dimension less than 15 mm, and in other embodiments, the pressure sensor 156 has at least one dimension less than 11 mm. According to some embodiments, the pressure sensor 156 has a diameter less than 0.5 mm, and in one embodiment, a diameter less than 0.3 mm. In some embodiments, the pressure sensor 156 has a length less than 6 mm, and in one embodiment, a length less than 5 mm. The pressure sensor 156 can be positioned within the kidney, such that the pressure sensor 156 is near the distal end of the catheter axis 112, and provides in vivo monitoring of intrarenal pressure.

[0040] According to one or more embodiments, at least one valve arranged on the suction channel 104 is configured to provide a pulsed flow of fluid in the suction channel 104. In system 100a of FIG. 1, valve 138 is configured to provide a pulsed flow of fluid in 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 is open, allowing fluid to flow through the valve via inlet and outlet ports. When the plunger is energized, the plunger closes, thereby compressing the suction line and completely cutting off the liquid flow. Simultaneously, as a result of the compression of the suction line, a small amount of liquid is pushed back along the suction line. In some embodiments, controller 190 is configured to implement the pulsed flow of fluid in the suction channel by sending one or more control commands to at least one of the suction pump 115 and valve 138. Controller 190 is configured to send control commands to valve 138 to open or close. The suction pump 115 can also be controlled by the controller 190 to pump fluid from the distal end to the proximal end of the suction channel 104, thereby "pulling" the fluid through the valve 138. The valve 138 interrupts the suction fluid flow by sending short pulses of back pressure along the liquid within the suction channel, which promotes particle mixing and reduces the risk of clogging. Furthermore, the suction channel is constructed of a material that provides minimal tensile properties (i.e., high elastic memory). According to one embodiment, the suction channel is constructed of a thermoplastic elastomer, such as PEBAX®.

[0041] exist Figure 4A The diagram illustrates a schematic representation of a non-limiting example of pulsed fluid flow. Controller 190 sends control commands to close valve 138 for a predetermined duration τ1 and τ2, wherein τ1 and τ2 are spaced apart by a predetermined time interval t in a repeating cycle, and wherein each cycle has a time period T. The time period T is the duration between the start of τ1 and the start of the subsequent τ1. Figure 4A The image also illustrates the pulsed flow generated within the fluid. In this example, such as... Figure 4A As shown, 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.

[0042] Another non-limiting example of a flushing and suction system according to another embodiment is... Figure 1B In general, it is indicated by 100b. Without misunderstanding, System 100a and System 100b are also collectively referred to as System 100. System 100b is almost identical to... Figure 1A The system is consistent with system 100a, but in this case, the pulsed fluid flow in the suction channel 104 is implemented using two valves. Therefore, at least one valve in the suction channel 104 includes a first valve 138 and a second valve 136, wherein the second valve 136 is arranged on the suction channel 104 between the bypass channel 108 and the distal end of the suction channel 104. Figure 4A The diagram illustrates a schematic representation of a non-limiting example of pulsed fluid flow, and... Figure 4B Other examples are shown below. References Figure 4A and Figure 4B In this configuration, controller 190 sends control commands to close first valve 138 for a predetermined duration τ1 and close second valve 136 for a predetermined duration τ2, wherein τ1 and τ2 are separated by a predetermined time period t in a repeating cycle, and wherein each cycle has a time period T. As previously mentioned, the time period T is the duration between the start of τ1 and the start of the subsequent τ1. Figure 4A In this case, τ1 equals τ2 (i.e., is the same as τ2), which is also Figure 4B The configuration is shown in Example D. Additionally, the interval between τ1 and τ2 (i.e., the predetermined time period t) is the duration between the end of τ1 and the beginning of τ2; however, in other embodiments, the predetermined time period t may be defined as the duration between the beginning of τ1 and the beginning of τ2, as referenced below. Figure 4B Examples A through C are described.

[0043] According to other embodiments, τ1 and τ2 are not equal to each other, such as Figure 4BAs shown in A, B, and C. As mentioned above, in these examples, the predetermined time interval t representing the interval between τ1 and τ2 is defined as the duration between the start of τ1 and the start of τ2. Figure 4A and Figure 4B All examples illustrate the combined effects of pulses in a fluid (water).

[0044] In some embodiments, τ1 and τ2 each have a duration ranging from 20 milliseconds to 500 milliseconds (ms) including the end value. According to some embodiments, τ1 and τ2 may have different durations from one cycle or time period to the next. In some embodiments, the predetermined time period t ranges from 1 ms to 500 ms including the end value. In some embodiments, the predetermined time period t ranges from 1 ms to 200 ms including the end value. According to some embodiments, the time period T ranges from 0.5 seconds to 3.0 seconds (s) including the end value.

[0045] The pulsed flow implemented using at least one valve in the suction channel 104 offers several advantages. Firstly, the pulsed flow prevents blockage in the suction channel 104. Furthermore, pulsed flow of the suction fluid can further enhance or otherwise increase the laser ablation rate. For example, when the pressure in the suction channel 104 is maintained at or near a constant value, the laser ablation pit may develop and grow, but the ablation efficiency decreases because the distance from the end of the fiber to the surface of the stone (i.e., the bottom of the pit) increases continuously. Ultimately, this can lead to a stalemate, where the laser continues to ablate, but no further stone destruction occurs. Pulsed suction fluid flow allows the stone to move slightly away from the suction channel 104 and change position, enabling the laser to ablate (through a series of laser pulses) different locations on the stone. Additionally, the stone is drawn towards the opening of the suction channel 104 by the pressure pulses formed by the pulsed fluid flow.

[0046] like Figure 1A and Figure 1B As illustrated, systems 100a and 100b may further include: a flow sensor 140 configured to measure flow rate within flushing channel 102; a pressure sensor 150 configured to measure pressure within flushing channel 102; and a flushing pump 110 in fluid communication with flushing fluid source 160. Systems 100a and 100b also include a laser source 107 providing laser energy to optical fiber 106. The laser energy emitted from the distal end of optical fiber 106 is used to ablate kidney stone material.

[0047] According to at least one embodiment, a flushing fluid flow is initiated in system 100 by causing controller 190 to send a control signal or control command to flushing pump 110, which is configured to pump flushing fluid from flushing source 160 to the distal end of flushing channel 102. The flow rate of the flushing fluid in flushing channel 102 can be measured by flow sensor 140, and the flow rate of the flushing fluid can be adjusted by flushing pump 110, which is configured as a variable speed pump. In some embodiments, the flow rate of the flushing fluid is in the range of 60 mL / min to 120 mL / min, including extreme values. In one embodiment, the flow rate of the flushing fluid is 80 mL / min.

[0048] Pressure measurements taken in the kidney by at least one of pressure sensors 156 and 158 are used as feedback for at least one of the controllers 190 in control systems 100a and 100b. According to at least one embodiment, the controller 190 is configured to: receive at least one pressure measurement value 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 otherwise control at least one of bypass valve 132, at least one valve (136 and / or 138), and suction pump 115. As discussed further below, the controller 190 also has the capability to receive input from other sensors in system 100 (e.g., pressure sensor 150 in flushing channel 102, flow sensor 140 in flushing channel 102, flow sensor 144 in suction channel 104) and to control other components of system 100 (e.g., flushing pump 110, laser / source 107).

[0049] During surgery, an initial target pressure value in the kidney (e.g., 40 cmH2O, an example of a predetermined pressure threshold) is used as a basis by controller 190 (also referred to as the control system) to control the fluid flow in the suction pump 115 and 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 in the kidney is at the initial target pressure value. For example, if the initial pressure in the kidney is too low, controller 190 can slow down the suction pump 115 to remove less fluid from the kidney, and if the initial pressure in the kidney is too high, 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, including extreme values. The internal pressure of the kidney will change as the surgery progresses, and this internal kidney pressure, measured by sensors 156 and / or 158, is used by controller 190 to control other components in the system 100.

[0050] Figure 2yes Figure 1B A block diagram of the flushing and suction system, and Figure 5 It is shown Figure 1B The timeline of the functional aspects of System 110b. However, it should be understood that... Figure 5 The functions shown also apply to Figure 1A System 100a.

[0051] During normal operation mode, such as Figure 5 As shown on the left side of the diagram, passage "A" of bypass valve 132 is open and passage "B" (i.e., bypass passage 108) of bypass valve 132 is closed. According to one embodiment, bypass valve 132 is configured as a three-way solenoid pinch valve. Fluid is pumped by flushing pump 110 through flushing passage 102, through passage A of bypass valve 132, and along the flushing passage until the flushing fluid exits the distal end of flushing passage 102 and enters the kidney. As previously described, aspiration passage 104 is configured to provide a pulsed fluid flow via at least one valve 136 and / or 138. Figure 5 In this context, at least one valve 136 and / or 138 includes both valves 136 and 138, but it should be understood that a single valve can be used to achieve pulsed fluid flow, such as... Figure 1A As shown. Figure 5 The bottom left side illustrates the cumulative effect of the pulsed aspiration flow, which resembles a "coughing" state, where short pulses of back pressure are created by the fluid along the aspiration channel 104. As the laser ablates and erodes the kidney stone material, ablation product particles are generated near the distal end of the aspiration channel 104. As previously mentioned, the pulsed flow in the aspiration channel 104 promotes the mixing of these particles and reduces the risk of blockage in the aspiration channel 104.

[0052] The controller 190 can be used to monitor and control fluid pressure in the kidneys. The controller 190 receives pressure measurements from pressure sensors 156 and / or 158 and analyzes the data. In some embodiments, the controller 190 compares the measured pressure value with 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 the suction pump 115.

[0053] According to at least one embodiment, controller 190 is configured to calculate a measured pressure value per unit time and determine whether the measured pressure value per unit time meets or exceeds one or more thresholds. In response, controller 190 sends control commands to one or more components in system 100, such as bypass valve 132, at least one valve 136, 138, and / or suction pump 115. According to an additional aspect, controller 190 may also receive input from other sensors (e.g., pressure sensor 150 in the flushing channel, and / or fluid flow sensor 140 in the flushing channel, and / or fluid flow sensor 144 in the suction channel) and send control commands to components in system 100 (e.g., laser source 107).

[0054] According to some embodiments, an initial or primary blockage detection operating mode of system 100 can be implemented by controller 190. Blockage in suction channel 104 will cause an increase in pressure in the kidney because fluid is not effectively removed from the kidney and flushing fluid from flushing channel 102 still enters the kidney. According to one embodiment, the initial or primary blockage detection operating mode can be initiated when controller 190 calculates a measured pressure value per unit time and determines that the measured pressure value per unit time meets or exceeds a first predetermined threshold. In response, controller 190 sends a control command to suction pump 115 to increase the flow rate of fluid in suction channel 104. According to one method, controller 190 determines whether the measured pressure value is less than a first pressure threshold and increases the rate of pulsed fluid flow when the measured pressure value meets or exceeds the first pressure threshold. For example, when the measured pressure value from pressure sensors 156 and / or 158 exceeds a target value (e.g., 40 cmH2O) by a predetermined percentage or percentage range (e.g., 25%) for a predetermined period of time (e.g., 2 s), the fluid flow rate in the suction channel 104 can be increased by the suction pump 115 via controller 190. For example, the measured pressure value may be in the range of 5% to 100% (inclusive) exceeding the target value for a period of time ranging from 0.2 s to 10 s (inclusive) to implement a primary blockage detection operating mode. In another example, the measured pressure value may be in the range of 20% to 30% (inclusive) exceeding the target value for a period of time ranging from 1 s to 5 s (inclusive) to implement a primary blockage detection operating mode. According to some embodiments, pressure monitoring is performed continuously. In some embodiments, the suction fluid flow rate can be increased from 100 mL / min to a maximum of 150 mL / min. According to some embodiments, the increase in the suction fluid flow rate causes a 50% increase in negative pressure in the suction channel. In some embodiments, the suction fluid flow rate is increased such that the negative pressure in the suction channel increases within a range of 5% to 100% of the endpoint value. In some embodiments, the suction fluid flow rate is increased such that the negative pressure in the suction channel increases within a range of 25% to 75% of the endpoint value. According to one embodiment, the measured pressure value used as the basis for the first predetermined threshold or the first pressure threshold is 50 cmH2O (25% above the target of 40 cmH2O). The target pressure value of 40 cmH2O is used herein as an example; however, it should be understood that other target pressure values ​​are also within the scope of this disclosure.

[0055] exist Figure 5 The middle area illustrates an example of the primary blockage detection pattern, which resembles a "deep breathing" state, where the negative pressure in the suction channel 104 increases over a period of time, for example... Figure 5The time interval between the two arrows in the diagram. This additional "inhalation" action of the suction channel 104 is similar to a human taking a deep breath.

[0056] According to some embodiments, the auxiliary blockage detection operating mode of system 100 can also be implemented by controller 190. In this case, controller 190 is configured to determine whether the measured pressure value per unit time meets or exceeds a second predetermined threshold. This mode can be triggered when the response during the primary blockage detection operating mode (i.e., increasing the fluid flow rate in the aspiration channel) fails to reduce the kidney pressure to an acceptable level. In at least one embodiment, if the pressure in the kidney drops to an acceptable level (e.g., 40 cmH2O) within a predetermined time period (e.g., 5 seconds), controller 190 can reduce the speed of aspiration pump 115 back to its initial level. According to some embodiments, this predetermined time period is in the range of 2 to 30 seconds, including the endpoint. However, if the pressure fails to drop within the predetermined time period, controller 190 can implement a second blockage detection operating mode, as described below.

[0057] According to one embodiment, in response to controller 190 determining that a measured pressure value per unit time meets or exceeds a second predetermined threshold, controller 190 sends a control command to bypass valve 132, causing bypass passage 108 to open and flush passage 102 to fluidly connect to suction passage 104, and flushing fluid is directed toward the distal end of suction passage 104. According to a method, controller 190 determines whether a measured pressure value is less than a second pressure threshold, and when the measured pressure value meets or exceeds the second pressure threshold, directs fluid flow from flush passage 102 into suction passage 104. Alternatively, controller 190 may send a control command to valve 138, causing valve 138 to close to stop fluid flow from the distal end of suction passage 104 toward the proximal end. This allows flushing fluid to flow to the distal end of suction passage 104 without any reaction force pumping the flushing fluid in the opposite direction via suction pump 115. In some embodiments, controller 190 may send a control command to suction pump 115 to stop pumping (e.g., shut down). According to one example, when the measured pressure value exceeds a predetermined percentage or percentage range (e.g., 50%) of a target value (e.g., 40 cmH2O) for a predetermined period of time (e.g., 2 seconds), fluid flow from the flushing channel 102 can be directed into the suction channel via the controller 190 (via the bypass valve 132). For example, the measured pressure value can be in the range of 5% to 100% (inclusive) exceeding the target value for a period of time ranging from 0.2 s to 10 s (inclusive) to implement an auxiliary blockage detection operating mode. In another example, the measured pressure value can be in the range of 30% to 70% (inclusive) exceeding the target value for a period of time ranging from 1 s to 5 s (inclusive) to implement an auxiliary blockage detection operating mode. According to one embodiment, the measured pressure value used as the basis for the second predetermined threshold is 60 cmH2O (50% exceeding the target of 40 cmH2O).

[0058] exist Figure 5 The right side of the diagram shows the auxiliary blockage detection operation mode. During this auxiliary blockage detection operation mode, valve 138 can be closed, and the pulsating flow of fluid in suction channel 104 is interrupted as flushing fluid is bypassed into suction channel 108. Additionally, during this mode, controller 190 closes channel A of bypass valve 132, preventing flushing fluid from being directed to the distal end of flushing channel 102 (i.e., flushing fluid flow is shut off or terminated), which further increases pressure in the kidney. The closure of channel A of valve 138 and bypass valve 132 lasts for a predetermined time period τ. s (This is also referred to as the switching time period or bypass duration). Additionally, bypass channel 108 (channel B of bypass valve 132) is open for a predetermined time period τ. s In some embodiments, the predetermined time period τ sThe time period is within the range of 0.5 seconds to 3.0 seconds, including the endpoint. In other embodiments, the predetermined time period τ s One second. In some embodiments, τ s Based on a predetermined fluid volume, such as 2 ml. According to some embodiments, the predetermined fluid volume can range from 0.5 ml to 10 ml, including extreme values. According to other embodiments, back pressure pulses can be applied in the suction channel 104 (via valves 136 and 138) based on a measured pressure value. For example, back pressure pulses can be applied in the suction channel 104 using valves 136 and / or 138 in response to a measured pressure value or the rate / change of the measured pressure. These back pressure pulses can be used to remove blockages in the suction channel.

[0059] Figure 5 The bottom right side illustrates the effect of interrupted and redirected flushing fluid flow, analogous to a "sneezing" state, where the fluid pressure in suction channel 104 increases for a longer period than in a "coughing" state, roughly in the same way that a human "sneeze" is typically longer (and more forceful) than a human "cough." Once the predetermined time period τ... s If the connection has been terminated, then channel A of bypass valve 132 is open and bypass channel 108 (channel B) of bypass valve 132 is closed. In some embodiments, valve 138 is also open. Figure 5 The rightmost indicator shows this configuration (which indicates that the flushing fluid flow is restored to flushing channel 102), and the pulsed aspiration flow can also be restored if the measured kidney pressure is at an acceptable level. Figure 5 As shown, after the auxiliary obstruction detection operation mode has been implemented, the pressure level in the kidney decreases. However, if the pressure level in the kidney fails to decrease to an acceptable level after implementing the auxiliary obstruction detection operation mode, the mode can be repeated multiple times until the kidney pressure decreases to an acceptable level. The number of repetitions can be limited to avoid causing damage to the kidney. In some cases, the auxiliary obstruction detection operation mode (i.e., implementing bypass channel 108 for a predetermined period of time) can be repeated up to 5 times consecutively.

[0060] Figure 5 The control scheme illustrated is characterized in some respects by avoiding or preventing sudden or abrupt increases and decreases in renal pressure. The kidneys can withstand pressure increases to a predetermined maximum value (e.g., 250 cmH2O) over a relatively long period of time, but if this threshold is reached in a shorter or faster amount of time (e.g., less than 30 s), the kidneys may be damaged. Figure 5 The control scheme outlined herein aims to capture this ability of the kidneys by avoiding sudden increases (and decreases) in pressure. According to some embodiments, the disclosed control scheme prevents the kidneys from reaching 250 cmH2O in less than 30 seconds (from 40 cmH2O) to avoid damaging the kidneys.

[0061] exist Figure 6 The term 200 generally indicates another non-limiting example of a flushing and suction system according to one embodiment. System 200 has a number of... Figure 1A System 100a and Figure 1B The system uses the same components as system 100b, but in this configuration, valves 136 and 138 are replaced by an ultrasonic transducer 216, and the bypass valve 232, combined with bypass channel 208, is configured slightly differently. Bypass channel 208 is still configured to fluidly connect flushing channel 102 to suction channel 104, but in this case, channel "A" of the first valve 232 is in fluid communication with suction channel 104, instead of flushing channel 102. During normal operation, channel A is open and channel B is closed, allowing fluid to flow from the distal end to the proximal end of suction channel 104. The ultrasonic transducer 216 is configured to mechanically vibrate suction channel 104. Vibration can (i.e., via controller 190) be configured to create back pressure in the suction channel in a manner similar to that of pinch valves 138 and 136 in systems 100a and 100b. Figure 6 As indicated, according to one embodiment, the ultrasonic transducer 216 is arranged between the distal end of the suction channel 104 and the bypass channel 208.

[0062] Figure 3 This is a distal perspective view of an example 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 the laser radiation to the vicinity of the distal end immediately adjacent to the suction channel 104. Figure 3 The optical fiber 106 extends from the proximal end 113 of the conduit shaft 112 to the distal end 114 (see, for example, see...). Figure 2 In some embodiments, system 100 may include one or more components of an imaging system. For example, ureteroscope 105 may include camera 165, such as... Figure 3 As shown, the camera 165 is positioned at the distal end of the conduit shaft 112. Additionally, at least one outlet 146 is defined at the distal end of the flushing channel 104. In one embodiment, the at least one outlet 146 is configured relative to the central axis 111 of the conduit shaft 112 (e.g., see...). Figure 2 The flushing flow is guided at an angle, which ranges from 0 to 170 degrees, including the endpoint. In some embodiments, the flow angle ranges from 10 to 90 degrees, including the endpoint.

[0063] 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 a physician. In some cases, ultrasound images can be used as a control source. For example, a baseline image can be taken before surgery and used as a comparative source for controlling pressure within the kidney throughout the procedure.

[0064] According to one or more embodiments, systems 100a and 100b may include one or more temperature sensors. (The remaining text appears to be incomplete and requires further context.) Figure 1A System 100a and Figure 1B Temperature sensors 170a and 170b are shown in system 100b. In some embodiments, at least one of temperature sensors 170a and 170b is located inside the kidney, i.e., near the treatment area, outside the ureteroscope 105, similar to pressure sensor 156. In other embodiments, catheter shaft 112 may be configured with one or more temperature sensors, for example, at the distal end of catheter shaft 112. According to at least one aspect, temperature measurement is performed by the temperature sensors and used by controller 190 to ensure that the temperature does not become too high, which could damage the kidney. As will be understood, heat generated by the laser can increase the temperature of the fluid within the kidney. In some cases, controller 190 may control one or more components of system 100, such as controlling the speed of suction pump 115 and / or flushing pump 110, and / or controlling laser source 107, to ensure that the temperature within the kidney is maintained within an acceptable range, for example, in the range including extreme values ​​of 20°C to 45°C.

[0065] According to another aspect, systems 100a and 100b can also be configured such that one or more components can be manually operated or otherwise controlled. For example, as Figure 2 As shown, the bypass valve 132 can be manually operated by the system operator (e.g., a doctor). A manual pump 134 (e.g., see [reference needed]) is arranged in the suction channel 104. Figure 1A and Figure 1B (This is used by the user to pump fluid through the suction channel 104.)

[0066] Increase erosion rate

[0067] According to at least one aspect, during lithotripsy, the ureteroscope 105 is manipulated to be very close to the target stone, and the aspiration / flushing system 100 is configured to detect whether the stone is near the laser / source 107. This capability is based on the premise that when the entrance to the channel is partially blocked by a stone, the pressure and flow rate in the aspiration channel 104 will change (increase and decrease, respectively).

[0068] like Figure 3 As shown, the optical fiber 106 guiding the light energy is placed within, beside, or otherwise adjacent to the suction channel 104. Functionally, this means that the distal end 103 of the optical fiber 106 is positioned at the opening (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 cavity within the suction channel 104; and in still other embodiments, the optical fiber 106 may be placed within and extend the length of the suction channel 104. When a stone obstructs the suction channel 104 of the ureteroscope 105, the flow through the suction channel 104 decreases, while the vacuum pressure increases. According to one embodiment, a fluid flow sensor, such as... Figure 1A , Figure 1B and Figure 2 The fluid flow sensor 144 shown can be used to monitor the fluid flow rate in the suction channel 104. In some embodiments, the flow sensor 144 is attached to or otherwise arranged at the distal end of the suction channel 104. Stone detection can be determined by the controller 190 based on the fluid flow rate values ​​measured in the suction channel 104 and the increase in pressure in the kidney, the increase in pressure in the kidney being determined based on pressure values ​​measured from at least one of 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 the data to determine whether the changes in pressure and flow rate per unit time meet or exceed predetermined limits or target values. For example, according to one example, a 30% decrease (change) in flow rate and a 25% increase (change) in pressure would indicate the presence of a stone. According to some embodiments, the duration associated with stone detection ranges from 1 second to 10 seconds, including the endpoints.

[0069] Using controller 190, laser operation can be synchronized with stone detection, and ablation occurs once the stone is very close to the optical fiber. This has been shown to significantly improve the ablation rate. Once the stone is determined to be near the laser, a vacuum (i.e., vacuum pressure) generated in suction channel 104 is used to hold the stone close to the optical fiber 106 located at the distal end of suction channel 104. In some cases, the presence of the stone itself generates sufficient vacuum pressure to hold it in place, but according to at least one embodiment, the vacuum pressure in suction channel 104 can be further increased (e.g., by suction pump 115) to ensure the stone is firmly held in place. This vacuum improves the ablation rate by increasing the contact time between the optical fiber and the stone. In addition to the improved ablation rate, an additional benefit is that the laser is emitted only when the stone is within the target area, which limits potential collateral damage. Therefore, vacuum attachment synchronized with laser can improve the ablation rate and minimize unwanted laser emission.

[0070] According to another embodiment, the laser / source is configured to emit pulsed laser radiation that can be synchronized with the pulses of the fluid flow through the suction channel 104. For example, once the stone is in the optimal target position (i.e., the opening or distal end of the suction channel 104), a predetermined sequence of laser pulses (e.g., between 1 and 1000 laser pulses) is aimed at the stone, and then pressure pulses are applied within the suction channel 104 until the stone is again in the optimal target position. This cycle is then repeated. This technique also improves the efficiency of stone ablation. In some embodiments, the pulses of the fluid flow and the laser pulses are not synchronized. According to a non-limiting example of this embodiment, the frequency of the pressure pulses can have a minimum value of 0.1 Hz, and the repetition rate of the laser pulses can be in the range of approximately 3 Hz to 3000 Hz.

[0071] According to another aspect, the aspiration channel 104 may include a temperature sensor (not explicitly shown) to measure the temperature of the fluid flowing within the aspiration channel 104. This feature can help ensure that tissue does not overheat. For example, detecting an increase in the temperature of the returning fluid in the aspiration channel 104 (above a predetermined target) can create a need to increase the fluid exchange rate at the treatment site or reduce the power of the laser radiation emitted by the laser source (implemented via commands from the controller 190). In addition to preventing tissue damage due to overheating, this feedback mechanism can also maintain the laser power at a safe level to ensure a high ablation rate.

[0072] Maintaining balance - calculation

[0073] To more accurately define the parameters of the fluid pump system and maintain the balance between fluid flow rate and pressure, certain calculations can be performed, which are summarized below.

[0074] First, using some modeling techniques, one or more parameters of a system component (e.g., a pump) can be defined. According to the Hagen-Poiseuille equation, the pressure as the flow rate increases can be calculated. The Hagen-Poiseuille equation defines a pressure difference δP (Pascals), which is needed to derive the volumetric flow rate Q (m³) of the fluid. 3 The fluid has a viscosity of µ (Pa·sec) in a channel with an inner radius of r (m) and a length of L (m).

[0075] Pressure difference: δP = 8µLQ / πr 4

[0076] µ = dynamic viscosity. For a 0.9% brine solution: µ = 1.02 * 10⁻⁶ -3 Pa·sec

[0077] L = Length of the observation mirror. L = 0.7m

[0078] Q = volumetric flow rate. Q = 70 mL / min = 1.17 mL / sec = 1.17 * 10⁻⁶ -6 m 3 / sec

[0079] r = radius of the suction channel. R = 0.6 mm = 6 * 10 -4 m

[0080] This allows the pressure differential for aspiration to be calculated. According to one example, the average flow rate through the ureter / bladder / artery and around the external endoscope is approximately 30 mL / min, with a maximum of 100 mL / min. This leaves approximately 70 mL / min available for the aspiration channel.

[0081] δP asp = 8 * 1.02 * 10 -3 *0.7*1.17*10 -6 / π*1296*10 -16 = 1.63 * 10 4 Pa = 16300Pa = 164 CM = 2.36 psi

[0082] The result of 2.36 psi is the pressure required to "suck" fluid out of the kidney by applying pressure to the proximal end of the endoscope. This is negative pressure. Assuming the working pressure in the kidney is 40 cm⁻¹ (where cm = centimeters of water column (cmH₂O)), the negative pressure at the proximal end of the endoscope would be:

[0083] Suction pressure P asp = 40 CM - 164 CM = -124 CM = -1.8 psi

[0084] This result means that a flow rate of 100 mL / min can be achieved by applying -1.8 psi. Furthermore, if positive pressure is present in the kidneys, this flow rate will reduce that positive pressure.

[0085] Similarly, the flushing pressure can be calculated. In one example, the flushing flow rate is 100 mL / min, which is 1.67 * 10⁻⁶. -6 m 3 / sec; the length of the observation mirror is 0.7m, and the radius of the rinsing channel is also 0.6 mm.

[0086] δP irr = 8 * 1.02 * 10 -3 *0.7*1.67*10-6 / π*1296*10 -16 = 2.32 * 10 4 Pa = 23200Pa = 233 CM = 3.36 psi

[0087] The result of 3.36 psi is the pressure differential required through a channel with a diameter of 1.2 mm and a length of 0.7 m at a flow rate of 100 mL / min. Assuming that the kidney still requires a water pressure of approximately 40 cm, the flushing pump must deliver a pressure of approximately 273 cm, or approximately 4 psi.

[0088] The above analysis indicates that the flushing pump should 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 should be configured to generate a negative pressure of at least 1.8 psi and a flow rate of at least 70 mL / min.

[0089] control

[0090] The controller 190 can use a control program to control the operation of the system 100. Generally, the controller 190 includes a data acquisition unit 192 (e.g., Figure 2 The data logger, storage unit (not shown), and viewing unit (not shown).

[0091] Data acquisition unit 192 queries and acquires measurement data from one or more sensors (e.g., pressure and / or flow sensors), which is then processed by controller 190. Controller 190 can also receive input from the user, which is used by the control program. This information can then be processed and used by controller 190 to control laser source 107, valves 132, 136, 138, flushing pump 110, and / or suction pump 115. Figure 2 The diagram illustrates that these components are controlled via data acquisition unit 192, but it should be understood that controller 190 can directly control these components. For example, valve actuation can be controlled via voltage signals sent by controller 190.

[0092] As mentioned above, controller 190 can be programmed with a control program that utilizes preset or predetermined target values ​​(which may be stored) or manually controlled values ​​from one or more of the laser source 107, valves 132, 136, 138, and pumps 110, 115 (and ultrasonic transducer 216), based on measurement results received from data acquisition unit 192 and transmitted by one or more sensors of system 100a, 100b (or system 200). It should be understood that controller 190 can also control data acquisition unit 192 to initiate data acquisition actions, i.e., measurement data or other signal data. According to at least one embodiment, one or more of the pressure and / or flow sensors can acquire measurement data at various time intervals or continuously.

[0093] The control program used by controller 190 can be configured to perform multiple different control actions or control states to achieve one or more desired results, such as synchronizing laser ablation with stone attachment, ensuring persistent stone / fiber contact, clearing blocked aspiration channels, or maintaining balance within the kidneys and system. For example, pressure and flow anomalies can be regulated by opening or closing channel valves and adjusting the fluid pump speed.

[0094] As previously mentioned, one or more (pressure, fluid flow) sensors can be used to help maintain a target balanced pressure in the kidneys. Additionally, sensors in the flushing channel 102 (e.g., pressure sensor 150 and / or flow sensor 140) can also be used to ensure proper functioning of the flushing channel 102 and to detect potential damage. For example, if the flushing pump 110 is pumping (i.e., on), but the sensors fail to detect any fluid flow in the flushing channel 102, this indicates a system malfunction. Furthermore, if the pressure sensor reading is too high or too low, this also indicates a system malfunction.

[0095] Example

[0096] The functionality and advantages of embodiments of the systems and techniques disclosed herein will be more fully understood based on the examples described below. The following examples are intended to illustrate various aspects of the disclosed suction and flushing systems, but are not intended to fully illustrate their entire scope.

[0097] Example – Laser power and pumped fluid flow rate experiment

[0098] Experiments were conducted to test the ability to achieve higher laser power using fluid flow within the aspiration channel of a ureteroscope. Higher laser power can offer several benefits, including increased ablation rates, which could potentially shorten procedure time. The fluid flow within the aspiration channel can also be used to control the temperature near the laser, allowing tissue to be maintained within a safe temperature range.

[0099] Experiments were conducted using a silicone model of the urinary tract filled with saline solution, which was used to insert the shaft of a ureteroscope equipped with a thulium fiber laser, and the tubing was used to actuate flushing and aspiration flow. The laser operated with a variable pulse repetition rate of 1 joule (J), a peak power of 500 watts (W), and nine different average powers (10 W, 20 W, 30 W, 60 W, 70 W, 80 W, 90 W, 100 W, and 120 W). Aspiration flow rates were tested at values ​​ranging from 50 ml / min to 90 ml / min (e.g., ...). Figure 7 As shown in the figure, the flushing flow rate was set to be approximately 10 ml / min higher than the suction flow rate. Two temperature sensors (K-type thermocouples) were placed approximately 20 mm to 30 mm above and below the distal end of the shaft, which has an outer diameter of 3 mm.

[0100] Temperature measurements were obtained after saturation and temperature stability were reached, which took up to 15 minutes. The maximum temperature rise (increment) was chosen to be 23°C, with an initial fluid temperature of 20°C and a maximum permissible temperature of 45°C. Results are as follows... Figure 7 As shown, increasing the aspirated fluid flow rate from 50 ml / min to 90 ml / min allows for the safe use of more than twice the laser power—from 60 W to 120 W. In contrast, at a conventional flow rate of 10 ml / min, the maximum safe laser power for natural aspiration via the access sheath is typically 20 W to 25 W.

[0101] The invention, in its application, is not limited to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. These aspects are capable of other embodiments and can be practiced or implemented in a variety of different ways. The examples of specific embodiments provided herein are for illustrative purposes only and are not intended to be limiting. In particular, the actions, components, elements, and features discussed in connection with any one or more embodiments are not intended to exclude similar effects in any other embodiment.

[0102] Furthermore, the wording and terminology used herein are for descriptive purposes and should not be construed as limiting. Any reference to examples, embodiments, components, elements, or actions of systems and methods mentioned in the singular herein may also cover plural embodiments, and any plural reference to any embodiment, component, element, or action herein may also cover singular embodiments only. References in singular or plural form are not intended to limit the currently disclosed systems or methods, their components, actions, or elements. The terms “comprising,” “including,” “having,” “containing,” “involving,” and variations thereof, as used herein, are intended to cover the items listed thereafter and their equivalents, as well as additional items. References to “or” may be interpreted inclusively, such that any term described using “or” may refer to a single, more than one, or any of all the terms described. Furthermore, in the event of any inconsistency between the use of terminology in this document and in a document incorporated herein by reference, the usage of terminology in the incorporated reference shall be supplementary to this document; in the case of irreconcilable inconsistencies, the usage of terminology in this document shall prevail. Additionally, headings or subheadings may be used in the specification for the convenience of the reader, without affecting the scope of the invention.

[0103] Having described several aspects of at least one example, it should be understood that various changes, modifications, and improvements will readily occur to those skilled in the art. For example, the examples disclosed herein can also be used in other contexts. Such changes, modifications, and improvements are intended to be part of this disclosure and are intended to be within the scope of the examples discussed herein. Therefore, the foregoing description and figures are merely illustrative.

[0104] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 183,675, filed May 4, 2021, entitled “SMARTIRRIGATION AND ASPIRATION SYSTEM”, pursuant to 35 USC § 119. The entire contents of that U.S. Provisional Patent Application are incorporated herein by reference for all purposes.

Claims

1. A flushing and suction system, comprising: A duct axis having a proximal end and a distal end, the distal end being in fluid communication with the interior of the kidney; A flushing channel extending from the proximal end through the conduit axis to the distal end; A suction channel extending from the proximal end through the catheter axis to the distal end; A bypass channel, which is fluidly connected to the flushing channel and the suction channel; A bypass valve configured to control the level of fluid communication between the flushing passage and the suction passage via the bypass channel; A suction pump, which is in fluid communication with the suction channel and is configured to pump fluid from the distal end of the suction channel toward the proximal end. At least one valve is disposed on the suction channel and configured to provide a pulsed flow of fluid in the suction channel to prevent blockage in the suction channel; A pressure sensor, wherein the pressure sensor is in fluid communication with the interior of the kidney; as well as A controller, connected to the pressure sensor, the bypass valve, the at least one valve, and the suction pump, is configured to: Receive at least one pressure measurement value from the pressure sensor. The measured pressure value is compared with a predetermined pressure threshold, and Based on the comparison, a control command is sent to at least one of the bypass valve, the at least one valve, and the suction pump.

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

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

4. The system according to claim 2, wherein, The controller is configured to determine whether the measured pressure value per unit time after a predetermined time period meets or exceeds a second predetermined threshold, and in response, sends a control command to the bypass valve, causing the bypass channel to open and the flushing channel to be fluidly connected to the suction channel, and the flushing fluid to be directed to the distal end of the suction channel.

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

6. The system according to claim 1, wherein, The controller is configured to implement the pulsed flow of the fluid by sending control commands, so that: The at least one valve is closed for a predetermined duration τ1 and τ2 in a repeated cycle, wherein... τ1 and τ2 are separated by a predetermined time interval t, and each cycle has a time period T.

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

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

9. The system according to claim 8, wherein, The controller is configured to implement the pulsed flow of the fluid by sending control commands, so that: The first valve is closed for a predetermined duration τ1, and the second valve is closed for a predetermined duration τ2, in a repeated cycle, wherein... τ1 and τ2 are separated by a predetermined time interval t, and each cycle has a time period T.

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

11. The system according to claim 1, wherein, The pressure sensor is located near the outer surface of the conduit shaft.

12. The system according to claim 1, further comprising: A laser source, the laser source being configured to emit laser radiation; as well as An optical fiber is connected to the laser source and configured to transmit the laser radiation to a distal end adjacent to the suction channel, the optical fiber extending from the proximal end to the distal end of the conduit axis.

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