Endoscopic access system and method

Abstract

A system and method for in-situ unblocking a working channel in a medical device during surgery are disclosed. An exemplary unblocking system includes: a flow sensor that senses the flow rate through the working channel; and a control module that detects a channel state indicating the presence or absence of blockage based on the flow rate. In the event of channel blockage, the control module can control one or more flushing or suction sources to provide flushing fluid or suction pressure, respectively, to unblock the channel. The control module can adjust one or more of the flushing or suction flow rates through the working channel during surgery to maintain a desired pressure at the anatomical site or to maintain a desired flow condition in the working channel.

Description

[0001] Priority requirements

[0002] This application claims the benefit of priority to U.S. Patent Application Serial No. 16 / 803,612, filed February 27, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This article generally relates to endoscopic systems, and more specifically to a patency system for clearing the endoscope during endoscopic surgery while maintaining in-situ pressure of the anatomical environment at the anatomical site under control. Background Technology

[0004] Endoscopes are commonly used to provide access to a patient's internal location, thus providing a visual access channel for physicians. Some endoscopes are used in minimally invasive surgical procedures to remove unwanted tissue or foreign bodies from a patient's body. For example, endoscopic tissue removal devices are instruments used by clinicians to remotely access necrotic, cancerous, damaged, infected, or otherwise unwanted soft tissue, bone, or other anatomical structures at an anatomical site, remove said unwanted material from adjacent anatomical structures, and remove them from the anatomical site. Clinicians use nephroscopy to examine the renal system and perform various procedures under direct visual control. For example, percutaneous nephrolithotomy (PCNL) involves placing a nephroscope through the patient's flank into the renal pelvis. Stones or masses from various areas of the body, including, for example, the urinary system, gallbladder, nasal passages, gastrointestinal tract, stomach, or tonsils, can be visualized and extracted. Larger stones can be ablated into smaller fragments using oscillatory forces such as shock waves, ultrasonic energy (via specialized devices such as ultrasonic lithotripters), or lasers.

[0005] Some endoscopes have a suction channel (also called an aspiration channel) to deliver removed tissue, stones (e.g., stones or stone fragments in various stone-forming areas), masses, and other unwanted materials. A flow of irrigation fluid (e.g., saline solution) can be introduced into the anatomical site through the irrigation channel in the endoscope during the procedure. The irrigation fluid facilitates the removal of tissue fragments, stone fragments, and other unwanted materials through the suction channel. The irrigation fluid also helps the clinician performing the procedure maintain clear visibility of the anatomical environment. Additionally, the irrigation flow has a cooling effect on the endoscopic tissue removal device and can help dissipate heat generated during the ablation of stones (e.g., kidney stones).

[0006] Unwanted substances generated during endoscopic surgery can accumulate and clog the working channels of the endoscope (e.g., aspiration or flushing channels). Monitoring for blockages and clearing them promptly and effectively can shorten procedure time and improve the efficiency, safety, and success rate of endoscopic surgery. Summary of the Invention

[0007] This document describes a system and method for in-situ unblocking of the working channel of an endoscope during endoscopic surgery while maintaining pressure at the anatomical site under control during the procedure. According to one aspect of this document, an unblocking system includes: a flow sensor configured to sense the flow rate through the working channel of the endoscope; and a control module configured to use the sensed flow rate to detect a channel state indicating the presence or absence of blockage in the working channel. In response to the presence of blockage in the working channel, the control module can control one or more flushing or aspiration sources to provide flushing fluid or aspiration pressure, respectively, to the working channel to unblock it. The control module can automatically adjust one or more of the flushing or aspiration flow rates through the working channel during endoscopic surgery to maintain the pressure of the anatomical environment at the anatomical site at a substantially desired pressure level (e.g., a predetermined or user-specified pressure level), or to achieve a desired flow condition corresponding to the desired pressure. Flushing fluid or aspiration pressure can be applied as long as the channel blockage persists.

[0008] Example 1 is a system for clearing at least one working channel of a medical device during a patient's surgery. The system includes: a flow sensor configured to sense the flow rate through at least one working channel of the medical device; and a control module configured to: detect a channel status using the sensed flow rate, the channel status indicating the presence or absence of a blockage in at least one working channel; and, in response to the detected channel status indicating a blockage in at least one working channel, control one or more flushing or suction sources to provide flushing fluid or suction pressure, respectively, to clear at least one working channel.

[0009] In Example 2, the subject of Example 1 may optionally include a control module that can be configured to control one or more flushing or suction sources to provide flushing fluid or suction pressure, respectively, to clear at least one working channel, whenever a detected channel status indicates that there is a blockage in at least one working channel.

[0010] In Example 3, the subject of any one of Examples 1 to 2 may optionally include a control module that can be configured to: detect a blockage in at least one working channel in response to a sensed flow rate decreasing to below a first threshold; and detect the absence of a blockage in at least one working channel in response to a sensed flow rate increasing to above a second threshold.

[0011] In Example 4, any one or more of the subjects in Examples 1 to 3 may optionally include a control module that can be configured to: clear at least one working channel, including alternating between applying flushing fluid to at least one working channel and applying suction pressure.

[0012] In Example 5, any one or more of the subjects in Examples 1 to 4 may optionally include a control module that can be configured to control one or more of the flushing or suction sources to clear at least one working channel by adjusting the flow rate of the flushing fluid or the flow rate of the suction pressure, respectively.

[0013] In Example 6, the subject matter of any one or more of Examples 3 to 5 may optionally include: a user input configured to receive from a user a desired pressure of the anatomical environment to be applied to the anatomical site of the patient; and a pressure sensor configured to sense the pressure of the anatomical environment at the anatomical site; and wherein the control module is configured to adjust one or more of the flushing flow rate or aspiration flow rate through at least one working channel to maintain the sensed pressure at a substantially desired pressure level.

[0014] In Example 7, the subject matter of Example 6 may optionally include: a user input configured to receive a desired flow condition in at least one working channel, the desired flow condition corresponding to a desired pressure to be applied to the anatomical environment; and a control module configured to control one or more of the flushing flow rate or aspiration flow rate through at least one working channel of the medical device to maintain the desired flow condition.

[0015] In Example 8, the subject matter of any one or more of Examples 6 to 7 may optionally include: at least one working channel, which may include a suction channel and a flushing channel; and a control module that can be configured to: fluidly couple a flushing source to one of the flushing channel or the suction channel to provide flushing fluid thereto at an adjustable flushing flow rate; and fluidly couple a suction source to the other of the flushing channel or the suction channel to provide suction pressure thereto at an adjustable suction flow rate.

[0016] In Example 9, the subject of Example 8 may optionally include a control module that can be configured to: control a flushing source to provide flushing fluid to the suction channel in response to the presence of a blockage in the suction channel; control the suction source to apply suction pressure to the flushing channel in response to an increase in the pressure of the anatomical environment at the sensed anatomical site, so as to maintain the sensed pressure at a substantially desired pressure level; and control the suction source to apply suction pressure to the suction channel and control the flushing source to provide flushing fluid to the flushing channel in response to the absence of a blockage in the suction channel.

[0017] In Example 10, the subject of Example 8 may optionally include a control module that can be configured to: control a suction source to apply suction pressure to the flushing channel in response to the presence of a blockage in the flushing channel; control the flushing source to provide flushing fluid to the suction channel in response to a decrease in the pressure of the anatomical environment at the sensed anatomical site, so as to maintain the sensed pressure at a substantially desired pressure level; and control the suction source to apply suction pressure to the suction channel and control the flushing source to provide flushing fluid to the flushing channel in response to the absence of a blockage in the flushing channel.

[0018] In Example 11, the subject of Example 9 may optionally include a desired pressure, which may be substantially net zero pressure, and wherein the control module may be configured to: in response to an increase in sensed pressure, control the suction source to apply suction pressure to the flushing channel at a level substantially neutral to the increase in sensed pressure.

[0019] In Example 12, the subject matter of Example 10 may optionally include a desired pressure, which may be substantially net zero pressure, and wherein the control module may be configured to: in response to a sensed decrease in pressure, control the flushing source to provide flushing fluid to the suction channel at a flushing flow rate that substantially neutralizes the sensed decrease in pressure.

[0020] In Example 13, the subject of Example 9 may optionally include a desired pressure, which may be a positive pressure, and wherein the control module may be configured to: in response to an increase in the sensed pressure, control the suction source to apply suction pressure to the flushing channel at a certain level to maintain the sensed pressure at a substantially desired positive pressure level.

[0021] In Example 14, the subject of Example 10 may optionally include a desired pressure, which may be a positive pressure, and wherein the control module may be configured to: in response to a decrease in the sensed pressure, control the flushing source to supply flushing fluid to the suction channel at a flushing flow rate, such that the sensed pressure is maintained at a substantially desired positive pressure level.

[0022] In Example 15, the subject of Example 9 may optionally include a desired pressure, which may be a negative pressure, and wherein the control module may be configured to: in response to an increase in the sensed pressure, control the suction source to apply suction pressure to the flushing channel at a certain level to maintain the sensed pressure at a substantially desired negative pressure level.

[0023] In Example 16, the subject of Example 10 may optionally include a desired pressure, which may be a negative pressure, and wherein the control module may be configured to: in response to a decrease in the sensed pressure, control the flushing source to supply flushing fluid to the suction channel at a flushing flow rate, such that the sensed pressure is maintained at a substantially desired negative pressure level.

[0024] Example 17 is an endoscopic surgical system comprising: an endoscope including an imaging module, a surgical module, and at least one working channel configured to conduct flushing fluid or aspiration pressure; a user input configured to receive from a user a desired pressure of the anatomical environment to be applied to an anatomical site of a patient; a flow sensor configured to sense the flow rate through the at least one working channel of the endoscope; a pressure sensor configured to sense the pressure of the anatomical environment at the anatomical site; and a control module configured to: detect a channel status using the sensed flow rate, the channel status indicating the presence or absence of a blockage in the at least one working channel; control one or more flushing or aspiration sources to provide flushing fluid or aspiration pressure, respectively, to clear the at least one working channel, in response to the detected channel status indicating a blockage in the at least one working channel and whenever the detected channel status indicates a blockage in the at least one working channel; and adjust one or more of the flushing or aspiration flow rates through the at least one working channel to maintain the sensed pressure at a substantially desired pressure level.

[0025] Example 18 is a method for clearing at least one working channel of a medical device during a patient's surgery. The method includes the steps of: sensing a flow rate through at least one working channel of the medical device via a flow sensor; detecting a channel status via a control module using the sensed flow rate, the channel status indicating whether or not a blockage exists in at least one working channel; and, in response to the detected channel status indicating a blockage in at least one working channel, controlling one or more flushing or suction sources to provide flushing fluid or suction pressure, respectively, to clear at least one working channel.

[0026] In Example 19, the subject matter of Example 18 may optionally include: that flushing fluid or suction pressure may continue to be provided to clear at least one working channel as long as the detected channel status indicates that there is a blockage in at least one working channel.

[0027] In Example 20, the subject matter of any one or more of Examples 18 to 19 may optionally include detecting channel status, which may include the steps of: detecting a blockage in at least one working channel in response to a sensed flow rate decreasing to below a first threshold; and detecting the absence of a blockage in at least one working channel in response to a sensed flow rate increasing to above a second threshold.

[0028] In Example 21, the subject matter of any one or more of Examples 18 to 20 may optionally include unblocking at least one working channel, which may include alternating between applying flushing fluid to at least one working channel and applying suction pressure.

[0029] In Example 22, the subject matter of any one or more of Examples 18 to 21 may optionally include the steps of: receiving, via user input, a desired pressure of the anatomical environment to be applied to the anatomical site of the patient; sensing, via a pressure sensor, the pressure of the anatomical environment at the anatomical site; and adjusting, via at least one working channel, one or more of a flushing flow rate or aspiration flow rate, to maintain the sensed pressure at a substantially desired pressure level.

[0030] In Example 23, the subject matter of Example 22 may optionally include the steps of: receiving a desired flow condition in at least one working channel, the desired flow condition corresponding to a desired pressure to be applied to the anatomical environment; and adjusting one or more of the flushing flow rate or suction flow rate through at least one working channel to maintain the desired flow condition.

[0031] In Example 24, the subject matter of Example 22 optionally includes at least one working channel, which may include an aspiration channel and a flushing channel. The method includes the steps of: controlling a flushing source to provide flushing fluid to the aspiration channel in response to the presence of a blockage in the aspiration channel; controlling the aspiration source to apply aspiration pressure to the flushing channel in response to an increase in pressure of the anatomical environment at a sensed anatomical site, to maintain the sensed pressure at a substantially desired pressure level; and controlling the aspiration source to apply aspiration pressure to the aspiration channel and controlling the flushing source to provide flushing fluid to the flushing channel in response to the absence of a blockage in the aspiration channel.

[0032] In Example 25, the subject matter of Example 22 optionally includes at least one working channel, which may include a suction channel and a flushing channel. The method includes the steps of: controlling a suction source to apply suction pressure to the flushing channel in response to a blockage in the flushing channel; controlling the flushing source to provide flushing fluid to the suction channel in response to a sensed decrease in pressure of the anatomical environment at the anatomical site, to maintain the sensed pressure at a substantially desired pressure level; and controlling the suction source to apply suction pressure to the suction channel and controlling the flushing source to provide flushing fluid to the flushing channel in response to the absence of a blockage in the flushing channel.

[0033] This overview is a summary of some of the teachings of this application and is not intended to be exclusive or exhaustive of the subject matter. Further details regarding the subject matter can be found in the detailed description and the appended claims. Other aspects of this disclosure will become apparent to those skilled in the art after reading and understanding the following detailed description and examining the accompanying drawings, which form a part thereof, and none of them should be construed in a limiting sense. The scope of this disclosure is defined by the appended claims and their legal equivalents. Attached Figure Description

[0034] Various embodiments are illustrated by way of example in the accompanying drawings. Such embodiments are illustrative and are not intended to be exhaustive or exclusive embodiments of the subject matter.

[0035] Figure 1 This is a block diagram illustrating an example of a system for clearing the working channel of an endoscope in situ during minimally invasive surgery and maintaining the pressure of the anatomical environment at the anatomical site at a substantially desired level.

[0036] Figures 2A to 2B It shows that it can be seen in reference, etc. Figure 1 A diagram of the powered tissue removal device 200 used in the described system.

[0037] Figures 3A to 3B This is a diagram illustrating an endoscopic system used to clear obstructed passages and maintain the pressure of the anatomical environment at substantially the desired level during endoscopic surgery.

[0038] Figure 4A An exemplary technique for clearing obstructions in the working channel of an endoscope according to the embodiments discussed herein is shown.

[0039] Figures 4B to 4C It is a graph showing the flow rate changes in the working channel in the presence of congestion and during the dredging process.

[0040] Figure 5 This is a diagram illustrating an exemplary feedback control pressure regulation system that adjusts ambient pressure in the absence of channel blockage.

[0041] Figure 6A This is a diagram illustrating an exemplary feedback control pressure regulation system for adjusting ambient pressure in the event of a blockage in the suction channel.

[0042] Figure 6B This is a timing diagram of flushing / suction in the suction channel during the unblocking of a blocked suction channel.

[0043] Figure 6C This is a timing diagram showing the activation of flushing / suction in the flushing channel during the clearing of a blocked suction channel to maintain the desired pressure at the anatomical site.

[0044] Figure 7A This is a diagram illustrating an exemplary feedback control pressure regulation system that adjusts ambient pressure in the event of a blockage in the flushing channel.

[0045] Figure 7B This is a timing diagram of flushing / vacuuming in the flushing channel during the unblocking of a blocked flushing channel.

[0046] Figure 7C This is a timing diagram showing the activation of flushing / suction in the suction channel during the clearing of a blocked flushing channel to maintain the desired pressure at the anatomical site.

[0047] Figure 8 This is a flowchart illustrating a method for in-situ unblocking of the working channels in a medical device during minimally invasive surgery.

[0048] Figure 9 This is a flowchart illustrating a method for in-situ clearing the working channels of a medical device and maintaining the pressure of the anatomical environment at the anatomical site at a substantially desired level. Detailed Implementation

[0049] An endoscope comprises a tubular portion that can be inserted into the interior of an organ or cavity in the body to aid in diagnosis or treatment. One or more working channels (e.g., aspiration channels and / or flushing channels) may be located inside the tubular portion and extend along its length. To reduce the risk of damaging unwanted tissue, the insertable tubular portion may have a small diameter. Consequently, the working channels also have a small lumen diameter. Because tissue debris and foreign bodies (e.g., stones and their fragments) typically have a length of one to two lumen diameters, some tissue or stone particles can accumulate and block the working channels.

[0050] In this article, “clog” refers to the accumulation of tissue debris, stones (e.g., kidney stones or stone fragments) and other substances that partially or completely obstruct the lumen of the endoscope, and “clogging” refers to a state of partial or complete obstruction of the lumen of the endoscope. Clogging can occur in any working channel of an endoscope. Clogging in the aspiration channel can significantly reduce the efficiency of removing tissue debris and stone fragments through it. Delayed or inefficient removal of unwanted material from the anatomical site can inhibit or prevent further treatment (e.g., debridement or stone ablation), contaminate the anatomical site, and expose the patient to increased risks. On the other hand, clogging in the irrigation channel can reduce the volume and / or flow rate of irrigation fluid flowing through it and supplying the anatomical environment. A slow irrigation flow may be less efficient in flushing away unwanted material from the anatomical site and increases the likelihood of clogging in the aspiration channel. Reduced irrigation volume and flow rate may also affect its cooling effect on surgical components and the anatomical environment and increase the chance of heat buildup at the anatomical site. In addition, any blockage in the working channel can obstruct the endoscope lens, reduce the visibility of the object being examined, and reduce the quality of images taken in an anatomical setting, thereby increasing the difficulty and time of the surgery.

[0051] Suction and flushing can cause negative and positive pressure changes in the anatomical environment at the anatomical site, respectively. If not properly controlled, these changes can be harmful to internal organs exposed to the anatomical site. For example, while the body can regulate some positive pressure changes, many organs are relatively defenseless against negative pressure changes. Blockages in the working channels (e.g., suction or flushing channels) can disrupt the pressure balance between the positive pressure associated with fluid flow and the negative pressure associated with suction, thereby exposing internal organs at the anatomical site to harmfully excessive positive or negative pressure.

[0052] Various methods have been explored to prevent or resolve blockages in the endoscope's access channel. For example, breaking unwanted material (e.g., tissue fragments or stone debris) into finer pieces can reduce the likelihood of blockage. However, this can consume more energy, take longer, and potentially increase patient risk due to increased surgical complexity and time. Fine particles or stone powder can reduce visibility of the surgical area. Routinely, unblocking is usually performed externally, requiring the clinician to retract the endoscope from the body, flush out any blockages to clear them, and reinsert the flushed endoscope into the anatomical location. This approach increases surgical time, adds inconvenience to the clinician, and can potentially increase surgical risk for the patient. In-situ unblocking of the working channel while the endoscope is inserted and held in place often requires high-pressure flushing, which can apply excessive positive pressure to internal organs.

[0053] The inventors have recognized an unmet need for endoscopic systems: the ability to automatically monitor and stabilize desired internal pressure while enabling user-input flow rates (e.g., aspiration and / or flushing flow rates) to protect internal organs from pressure-related hazards.

[0054] For at least the reasons mentioned above, the inventors have recognized an unmet need for systems and methods that can detect blockages in the working channel, clear blocked channels, and increase the efficiency, safety, and success rate of endoscopic surgery while keeping pressure changes in the anatomical environment under control during the duration of the surgery.

[0055] This document discloses a system and method for in-situ unblocking working channels, such as flushing or aspiration channels, within an endoscope during endoscopic surgery. According to one aspect of this document, the unblocking system can use flow information sensed by a flow sensor to detect channel status indicating the presence or absence of blockage in the working channel, and unblock the blocked channel by, for example, applying flushing fluid or aspiration pressure alternately to the working channel. The unblocking system can adjust one or more of the flushing or aspiration flow rates through one or more channels inside the endoscope to maintain the pressure of the anatomical environment under control during the duration of the procedure, for example, maintaining substantially zero net pressure, or a desired positive or negative pressure specified by the user.

[0056] The unblocking systems and methods described in this document offer improved solutions for in-situ unblocking of endoscopes during endoscopic procedures. According to various aspects described herein, these systems and methods provide users with endoscopic examinations without the need for repeated insertion and removal of endoscopic attachments and accessories for external flushing and unblocking. Compared to unblocking via high-pressure flushing that may expose internal organs to a high risk of positive pressure, controlled flushing and aspiration, such as those applied alternately to the same obstructed passage, as discussed in this document, provide environmental stability for the internal organs. Various embodiments of this unblocking system can unblock passages by effectively separating obstructive particles of different sizes that accumulate and block the passage, while avoiding or minimizing dangerous positive or negative pressure changes on the internal organs. Therefore, unwanted material can be removed from the anatomical site safely and more effectively, reducing operative time in minimally invasive procedures and improving patient safety and recovery time.

[0057] Figure 1This is a block diagram illustrating an example of system 100 for in-situ clearing of the working channel of an endoscope during minimally invasive surgery on a patient, while maintaining the pressure of the anatomical environment 101 at the anatomical site at a substantially desired level. System 100 may include a medical device 110 and optional components. Optional components may include any one of a suction source 120, a flushing source 130, a user interface 140, sensor circuitry 150, or a control module 160. In various examples, system 100 may have a modular design that provides enhanced flexibility to allow for easy configuration and replacement of individual components. In the example, user interface 140, sensor circuitry 150, and control module 160 may be included in a suction / flushing control unit. The suction / flushing control unit may be fluidly coupled to one or more of the device 110, suction source 120, or flushing source 130. The suction / flushing control unit may be adapted to different types of medical devices and different types of flushing and suction sources. See below. Figures 3A to 3B An exemplary aspiration / flushing control unit is discussed. The aspiration / flushing control unit can selectively enable or disable flushing and / or aspiration through the working channel 111, and adjust one or more of the flushing flow rate, flushing fluid pressure, aspiration flow rate, or aspiration pressure. By controlling aspiration and / or flushing according to the various embodiments discussed herein, blocked channels can be cleared, and the pressure of the anatomical environment 101 can be maintained at a desired level during the procedure.

[0058] Medical device 110 can be used for diagnostic, analytical, or therapeutic applications, including, for example, minimally invasive surgical procedures such as endoscopic surgery. By way of example and not limitation, medical device 110 can be used for joint surgery, orthopedic surgery, various ENT surgeries including but not limited to sinus surgery and tonsillectomy, or combinations thereof. Medical device 110 can be controlled by a user to perform surgery in organs or remove organ tissue within anatomical environment 101. Controls for medical device 110 may include handheld devices or indirect controls, such as those via a robotic surgical console or user interface.

[0059] Examples of medical device 100 may include a tissue removal device comprising a blade assembly configured to rotate and / or reciprocate to remove unwanted tissue from a target anatomical structure. The blade assembly may be driven by a motor powered by an energy source internal to or alternatively external to the handpiece. The energy source may also perform other functions, such as providing power to the medical device 110 for flushing and suction, as discussed below. Various blade assemblies may be used, including, for example, razors, debridements, blades, or bone drills. Depending on the blade assembly used, the tissue removal device may be used to scrape, cut, abrade, or otherwise remove necrotic, cancerous, damaged, infected, or other unwanted soft tissue, bone, or other anatomical features or objects at or from a target anatomical structure. See below. Figures 2A to 2B Discuss exemplary tissue removal devices.

[0060] Another example of medical device 110 may include an endoscope. Examples of endoscopes may include: a cystoscope for examining the bladder; a nephroscope for examining the kidneys; a bronchoscope for examining the bronchi; an arthroscope for examining joints; a colonoscope for examining the colon; a cholangioscope for examining biliary regions (e.g., bile ducts); a duodenoscope for examining gastrointestinal regions; or a laparoscope for examining the abdomen or pelvis, etc. Endoscopes may include a light source for illuminating the anatomical environment at the anatomical site, and an imaging module for generating images or videos of the anatomical environment during endoscopic procedures. Some endoscopes, such as endoscopic tissue removal devices, may include a tissue resection member configured to scrape, cut, abrade, or otherwise remove unwanted tissue portions from a target anatomical structure. The resected tissue fragments can then be extracted from the anatomical site. Some endoscopes may include an ablation member configured to break up or remove foreign bodies, such as crystalline mineral structures, from the anatomical environment. For example, a nephroscope may be at least partially inserted into the kidney. Ultrasonic energy, electromagnetic shock waves, lasers, and other forms of energy can be delivered to kidney stones to break them down into fragments or "stone powder," which can then be extracted from the anatomical site. (See below for reference.) Figures 3A to 3B Discuss exemplary endoscopes.

[0061] The medical device 110 may include one or more working channels 111 for delivering scraped, cut, excised, abraded, or removed tissue, bone, or other anatomical features or objects, fragments of stones and substances, bodily fluids at anatomical sites, and flushing fluids, collectively referred to herein as “unwanted material.” The working channels 111 may be selectively coupled to one or more of aspiration sources 120 (e.g., via aspiration ports on the medical device 110) or flushing sources 130 (e.g., via flushing ports on the medical device 110).

[0062] The suction source 120 can be used to extract, aspirate, suction, aspirate, or otherwise move or remove unwanted material from an anatomical site. The unwanted material can be moved to a receiver located proximally to the medical device 110, inside the handpiece, or remotely from the medical device 110. In an example, the handpiece may include a container or reservoir for at least temporarily collecting unwanted material before the handpiece is cleaned and the collected material is removed. The suction source 120 can perform the aforementioned functions by generating a vacuum, suction, or negative pressure and applying said vacuum, suction, or negative pressure to the working channel 111 of the medical device 110. In an example, the suction source 120 may be detachable from the medical device 110 and connected to the medical device 110 via one or more tubes, lines, or hoses. In another example, the suction source 120 may be included in or attached to the medical device 110. For example, the suction source 120 may be included within the handpiece of a tissue removal device or endoscope. The suction source can be powered by an energy source that also powers the medical device, or it can be powered by its own energy source.

[0063] The flushing source 130 can be used to supply flushing fluid to the working channel 111 to help remove unwanted material (e.g., tissue fragments or stone debris) through the working channel 111. The flushing fluid can also cool the tissue removal device or resection element during rotational or reciprocating debridement or resection and helps dissipate heat generated during stone fragmentation. The flushing fluid can be gravity-fed or pressurized. In one example, the flushing source may include a bag elevated relative to the working channel 111 and the anatomical site to generate gravity-fed flushing fluid. In another example, a pump may generate a pressurized flushing flow. The flushing fluid can be supplied from the flushing source 130 or the location containing the flushing fluid to and through an external fluid supply line, and is drawn into the working channel 111. Under suction pressure provided by the suction source 120, the flushing fluid, along with unwanted material, can flow proximally through the working channel 111 and be removed from the anatomical site.

[0064] In this example, a single working channel 111 can be used for both flushing and aspiration. The control module 160 can controllably enable flushing and aspiration through the working channel 111 at different times. In another example, the medical device 110 may include two or more separate working channels, such as an aspiration channel 112 and a flushing channel 114, as... Figure 1As shown. Suction channel 112 can be controllably connected to suction source 120 to guide the suction of unwanted material. Rinse channel 114 can be controllably connected to rinse source 130 to guide rinse fluid through it. In the example, suction channel 112 can be controllably connected to rinse source 130. In the example, rinse channel 114 can be controllably connected to suction source 120. Rinsing and suction according to the various examples discussed herein can be used to help remove unwanted material, clear one or more working channels, transfer heat generated in the surgical area of ​​the tissue site, maintain the pressure of the anatomical environment at a desired level, and maintain a desired flow condition in the working channels corresponding to the desired pressure, etc.

[0065] In the example, the suction channel 112 and the flushing channel 114 may be arranged in a parallel orientation along the length of the tubular portion of the handpiece of the medical device 110. In the example, the suction channel 112 and the flushing channel 114 may be arranged coaxially with a common axis, for example, in a nested configuration. In the example, the medical device 110 includes an outer member and an inner member located within the outer member. The suction channel 112 may be located inside the inner member. The flushing channel 114 may be located outside the outer member. In some configurations, flushing fluid may be supplied through a gap (hereinafter referred to as the "flushing gap") defined between the inner and outer members of the medical device 110, in addition to, or instead of, flushing fluid supplied through the flushing channel 114. One of the flushing channel 114 or the flushing gap may be selectively activated to supply flushing fluid to the medical device 110. In some examples, both the flushing channel 114 and the flushing gap may be activated to supply flushing fluid simultaneously. This can advantageously allow clinicians to adjust the amount of flushing fluid used during surgery. For example, when more tissue fragments or stone debris are generated, or in the event of a blockage detected in the channel, both the flushing channel 114 and the flushing gap can be activated to deliver a larger volume of fluid to the medical device 110.

[0066] The control module 160 can be configured to control the operation of the medical device 110, including one or more functions such as tissue resection or stone ablation, illumination, imaging, irrigation, and aspiration during endoscopic surgery. In an example, the control module 160 can be implemented as part of a microprocessor circuit, such as a dedicated processor, application-specific integrated circuit (ASIC), microprocessor, or other type of processor for processing information, generating control signals to enable, disable, or alter the operation of components of system 100. Alternatively, the microprocessor circuit can be a processor capable of receiving and executing instructions for performing the functions, methods, or techniques described herein.

[0067] The control module 160 can at least partially implement in applications such as... Figures 3A to 3BThe control module 160 is shown as a separate unit from the medical device 110. Alternatively, portions of the control module 160 may be integrated into or otherwise attached to the medical device 110. In some examples, the control module 160 may include circuit groups that individually or in combination perform the functions, methods, or techniques described herein. In examples, the hardware of the circuit group may include components that are invariably connected and designed to perform a specific operation (e.g., hardwiring). In examples, the hardware of the circuit group may include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) to encode instructions for a specific operation, the variably connected physical components including physically modified (e.g., invariably assembled particles, magnetically or electrically movable placement, etc.) computer-readable media. When connecting physical components, the fundamental electrical characteristics of the hardware components are altered, for example, from an insulator to a conductor or from a conductor to an insulator. The instructions enable embedded hardware (e.g., an execution unit or loading mechanism) to create members of the circuit group in the hardware via the variably connected components to perform portions of a specific operation during operation. Therefore, when the device is operating, the computer-readable medium is communicatively coupled to other components of the circuit group members. In the example, any component of the physical components can be used in more than one member of more than one circuit group. For example, under operation, an execution unit can be used at one point in time in a first circuit of a first circuit group, and can be reused at different times by a second circuit in the first circuit group or by a third circuit in the second circuit group.

[0068] like Figure 1 As shown, the control module 160 may be coupled to the user interface 140 and receive user commands from the user interface 140 for enabling, disabling, or adjusting one or more functions of the medical device 110. The user interface 140 may be at least partially integrated into or otherwise attached to the medical device 110. Alternatively, the user interface 140 may be separate from the medical device 110, such as... Figures 3A to 3B The exemplary system shown. User interface 140 may be mobile and may be attached to medical device 110 and fluid system (e.g., pump, flushing). In the example, user interface 140 may include one or more user controls that allow a user (e.g., a clinician) to turn aspiration on or off or adjust the aspiration flow rate or aspiration pressure. User controls may be located on a mobile user interface separate from medical device 110. Alternatively, user controls may be located on medical device 110, such as a tissue removal device. Figure 2AThe device or endoscope handheld device shown. In response to user commands, control module 160 can enable or disable the suction flow from suction source 120, or increase or decrease the suction pressure applied to working channel 111 to achieve a desired suction flow rate. Similarly, user interface 140 may include one or more user controls that allow the user to turn flushing on or off, or adjust the flushing flow rate or flushing fluid pressure (e.g., via a pump). In response to user commands, control module 160 can enable or disable the flushing flow from flushing source 130, or increase or decrease the flushing flow rate through working channel 111.

[0069] In some examples, the user controls on user interface 140 may include a pressable flush control button that, when repeatedly pressed, cycles through one or more flush and / or suction levels before shutting off flushing and suction. In some examples, flushing and suction may be controlled together with a single control. Other suitable control elements may also be used, such as a positionable slider, positionable lever, or positionable dial that can specify flush and / or suction levels. In some examples, user interface 140 may allow the user to select from one of a plurality of specified discrete flush or suction levels, or alternatively specify flush or suction levels in a continuous (e.g., non-discrete) manner.

[0070] In addition to, or instead of, independent control of aspiration and rinsing, control module 160 can automatically control either aspiration or rinsing based on the condition of one of them. In an example, control module 160 can automatically activate aspiration when the medical device is powered on or when the rinsing source 130 supplies rinsing fluid to the medical device 110; and control module 160 can automatically deactivate aspiration when the medical device is not powered on or when the rinsing source 130 stops supplying rinsing fluid to the medical device 110. In an example, control module 160 can automatically adjust the rinsing flow rate or fluid volume in response to the aspiration flow rate (e.g., by enabling or disabling flow defined in the rinsing gap between the inner and outer components). For example, under increased aspiration (e.g., due to the removal of a large amount of unwanted material), control module 160 can automatically increase the rinsing flow rate or supply rinsing fluid via both the rinsing channel 114 and the rinsing gap. Conversely, under reduced suction (e.g., due to the removal of a small amount of unwanted material), the control module 160 can automatically reduce the flushing flow rate, or supply flushing fluid only through one of the flushing channels 114 or the flushing gap, instead of both.

[0071] Control module 160 may include a blockage controller 161 configured to detect a channel state indicating the presence or absence of blockage in working channel 111, and to control one or more of suction sources 120 or flushing sources 130 to provide suction pressure or flushing fluid, respectively, to clear the blocked working channel. In this example, blockage controller 161 may monitor channel state and detect channel blockage based on flow information in working channel 111. Sensor circuitry 150 may include circuitry coupled to a flow sensor located within working channel 111 and configured to sense the flow rate or volume of liquid moving therein. Flow sensors, such as microelectromechanical systems (MEMS) sensors, may employ a variety of flow measurement techniques. By way of example and not limitation, flow sensors may include: a thermal anemometer that measures the rate of heat transfer from a heat source; a differential pressure sensor that measures pressure drops at a range of locations; an ultrasonic flow sensor that measures the frequency shift or travel / time-of-flight Doppler effect; an electromagnetic sensor that measures changes in fluid conductivity indicating flow rate, etc.

[0072] The blockage controller 161 can detect channel blockage using flow information sensed by a flow sensor. In one example, the blockage controller 161 can detect channel blockage in response to a sensed flow rate decreasing to, for example, below a first flow rate threshold; and if the sensed flow rate increases and exceeds a second flow rate threshold, the blockage controller 161 can detect that there is no blockage or that the blocked working channel has been successfully cleared. In another example, channel blockage can be detected using the flow rate stability within the channel, for example, when the variability of the flow rate measurement exceeds a threshold. In some examples, the blockage controller 161 can detect channel blockage by comparing the inflow rate of fluid entering the channel with the outflow rate of fluid leaving the channel. A mismatch between the inflow and outflow rates, such as an outflow rate significantly lower than the inflow rate (exceeding a specified tolerance), indicates the presence of channel blockage.

[0073] In the event of a channel blockage, the blockage controller 161 can automatically switch from the standard mode of flushing / suction operation discussed above (e.g., where suction source 120 provides suction pressure to suction channel 112 and flushing source 130 provides a flow of flushing fluid to flushing channel 114) to a clearing mode of flushing / suction operation. To clear a blocked channel, the blockage controller 161 can alternate between applying flushing fluid to the blocked channel and applying suction pressure. Referring now to... Figure 4AFigure 410 illustrates a channel clearing technique according to an embodiment discussed in this document. Figure 410 shows a fluid-filled channel 411 blocked by blockage 412 during a standard flushing mode activated by flushing source 140. Blockage 412 comprises tissue fragments or stone debris of varying sizes. As shown in Figure 410, smaller particles, such as particle 412A, are located proximally, while larger particles, such as particle 412B, are located distally. Figure 420 illustrates switching from the standard mode to the clearing mode, where the blockage controller 161 fluidly couples the suction source 120 to the proximal portion of channel 411, activating the suction source 120 and applying suction pressure to channel 411 for a specified suction duration. The user can adjust the suction pressure and suction duration via user interface 140. Blockage particles of different sizes (and therefore different masses) can respond differently to the applied suction pressure. For example, compared to larger particles 412B, smaller particles 412A can move towards the proximal end of the channel at a faster speed and travel a longer distance during (and after) the application of suction. Therefore, some particles can be removed from the blockage 412 and separated from the larger particles.

[0074] Figure 430 illustrates a fluid-filled channel 411 blocked by blockage 413 during a standard suction mode activated by suction source 120. The particles in blockage 413 accumulate differently from those in blockage 412, with smaller particles such as particle 413A located at the distal end, and larger particles such as particle 413B located at the proximal end. Figure 440 illustrates switching from the standard mode to a clearing mode, where the blockage controller 161 fluidly couples flush source 140 to the proximal portion of channel 411, activating flush source 140 and applying flushing fluid for a specified flushing duration to flush channel 411. The user can adjust the flushing flow rate or the pressure used to pump the flushing fluid, as well as the flushing duration. Blockage particles of different sizes (and therefore different masses) can respond differently to the flushing fluid. For example, smaller particles 413A can move towards the distal end of the channel at a faster rate and travel a longer distance during (and after) flushing compared to larger particles 413B. Therefore, some particles can be removed from blockage 413 and separated from the larger particles.

[0075] Additional flushing and / or suction can be used to extract separated particles along the working channel 411. In this example, one or more of the suction pressure, suction flow rate, flushing flow rate, or pump pressure used to pressurize the flushing fluid can be varied (e.g., via user interface 140) to separate particles by size. For example, a higher flow rate can be applied to remove larger particles, and a lower flow rate can be applied to remove smaller particles through channel 411.

[0076] Figures 4B to 4CIt is a graph showing the flow changes in the working channel in the presence of blockage and during the clearing process. Figure 4B The flow changes in the clogged flushing channel are shown, such as Figure 4A As shown in Figures 410 and 420, flow parameters, such as flow rate, can be measured using a flow sensor positioned within the flushing channel. Flow measurements (on the y-axis) have values ​​between -1 and 1. Positive flow values ​​indicate flow toward the distal end of the suction channel (or toward the anatomical environment 101, see Figure 410). Figure 4A The flow direction (see Figure 410). Negative flow values ​​indicate the opposite direction, i.e., towards the proximal end of the suction channel (or away from the anatomical environment 101, see Figure 410). Figure 4A The flow rate (Figure 420) is shown. The measured flow rate is related to the unobstructed flow through the flushing channel. That is, a flow rate value of "1" indicates the flow rate during flushing in the unobstructed channel, while a flow rate value of "-1" indicates the flow rate during suction in the unobstructed channel.

[0077] During the standard flushing mode of a cleared flushing channel, the flow sensor can detect a positive flow rate F0, approximately "1". As shown, the flow rate F0 includes fluctuations superimposed on a constant flow rate, indicating that small debris is being drawn in. At T1, the flow rate decreases to F1 (less than F0). If the decrease in F0-F1 exceeds the blockage detection threshold, a blockage is detected. In this example, F1 is at a level greater than zero, indicating that the channel is not completely blocked, and flushing continues. Particles continue to accumulate until the flow rate decreases to F2 at T2. F2 is approximately zero, indicating a basic channel blockage (e.g., ...). Figure 4A (As shown in Figure 410). The unblocking mode can be activated at T2 or at a time corresponding to specific (e.g., user-specified) flow conditions. Suction can be applied to the blocked channel, drawing fluid and material towards the proximal end of the suction channel (e.g., ...). Figure 4A (As shown in Figure 420). The flow sensor can sense negative flow F3. (Refer to the above). Figure 4A As discussed in Figure 420, suction breaks down blockages, allowing smaller particles to separate from the rest of the blockage and travel a longer distance toward the proximal end of the channel. Suction can continue as the channel is cleared, allowing the negative flow rate F3 to reach approximately its maximum value ("-1", indicating a substantially unobstructed flow) at T3. Suction can be stopped at T4 after applying suction for the specified duration and removing the dislodged particles from the channel. The negative flow rate can then be reduced to a substantially zero flow rate F4. At T5, a standard flushing pattern is restored by applying flushing fluid to the cleared channel. When the channel is successfully cleared and particles are removed from it, the flow sensor can sense a positive flow rate F5 with a value approximately "1".

[0078] Figure 4CThe flow changes in the blocked suction channel are shown, such as Figure 4A As shown in Figures 430 and 440, flow parameters, such as flow rate, can be measured using a flow sensor positioned within the suction channel. Flow measurements (on the y-axis) have values ​​between -1 and 1. Positive flow values ​​indicate flow towards the proximal end of the suction channel (or away from the anatomical environment 101, see Figure 430 and 440). Figure 4A The flow direction (see Figure 430). Negative flow values ​​indicate the opposite direction, i.e., towards the distal end of the suction channel (or towards the anatomical environment 101, see Figure 430). Figure 4A The flow rate is measured in Table 440. The flow rate measurement value is related to the unobstructed flow through the suction channel. That is, a flow rate value of "1" indicates the flow rate during suction in the unobstructed channel, while a flow rate value of "-1" indicates the flow rate during flushing in the unobstructed channel.

[0079] During standard suction mode applied to a cleared suction channel, the flow sensor can detect a positive flow rate F0, approximately "1". As shown, the flow rate F0 includes fluctuations superimposed on a constant flow rate, indicating that small debris is being suctioned. At T1, the flow rate decreases to F1 (less than F0). If the decrease in F0-F1 exceeds the blockage detection threshold, a blockage is detected. In this example, F1 is at a level greater than zero, indicating that the channel is not completely blocked, and suction continues. Particles continue to accumulate until the flow rate decreases to F2 at T2. F2 is approximately zero, indicating a basic channel blockage (e.g., ...). Figure 4A (As shown in Figure 430). The unblocking mode can be activated at T2 or at a time corresponding to specific (e.g., user-specified) flow conditions. Flushing fluid can be injected into the blocked channel (e.g., towards the distal end of the suction channel and towards the anatomical environment) towards the obstructed channel. Figure 4A (As shown in Figure 440). The flow sensor can sense negative flow F3. (Refer to the above). Figure 4A As discussed in Figure 440, the flushing fluid breaks down the blockage, allowing smaller particles to separate from the rest of the blockage and travel a longer distance toward the far end of the channel. Flushing continues as the channel is cleared, allowing the negative flow rate F3 to reach approximately its maximum value ("-1", indicating a substantially unobstructed flow) at T3. After flushing is applied within the specified flushing period, flushing can be stopped at T4. The negative flow rate can then be reduced to a substantially zero flow rate F4 as the separated particles settle in the channel. At T5, the standard suction mode is resumed by applying additional suction to extract the separated particles from the channel. When the channel is successfully cleared and particles are removed from the channel, the flow sensor can sense a positive flow rate F5 with a value approximately "1".

[0080] In some examples, suction pressure and flushing fluid can be repeatedly applied to channel 411 in an alternating manner. This allows for more efficient separation of blockage particles without prior knowledge or determination of the structure of the blockage 412. Furthermore, continuous suction followed by occasional flushing can help reduce the incidence of blockage formation. Sensor circuitry 150 can monitor the flow rate while alternating suction and flushing are repeatedly applied. Unblocking operations, including applying flushing fluid or suction pressure to the blocked channel, can continue as long as the channel blockage persists. When the monitored flow rate increases and exceeds a threshold, the blocked channel is considered successfully unblocked. Blockage controller 161 can switch from unblocking operation mode back to the standard flushing / suction operation mode.

[0081] Return to reference Figure 1 The control module 160 may include a pressure controller 162 configured to maintain the pressure of the anatomical environment (also referred to as "ambient pressure") under control, for example, maintaining the ambient pressure at a substantially desired pressure level (e.g., a predetermined level, or specified by the user via user interface 140). In an example, the ambient pressure is considered to be maintained at the desired pressure level if the difference between the ambient pressure measurement (e.g., measured by a pressure sensor) and the desired pressure falls within a tolerance range, for example, ±5% to 10% as a non-limiting example. The desired pressure level to be maintained at the anatomical site of the anatomical environment 101 can be received from user interface 140. As previously mentioned, aspiration can cause a negative pressure change at the anatomical site, while flushing can cause a positive pressure change at the anatomical site. Negative and positive pressure changes can have adverse effects on internal organs exposed at the anatomical site. Maintaining the ambient pressure at a controlled pressure level can improve patient safety and effectively reduce surgical time. In some examples, in addition to receiving the desired pressure level, or instead of receiving the desired pressure level, the desired flow condition can be received, for example, from user interface 140. The desired flow condition includes information about the inflow rate (e.g., the rate of flushing fluid applied to the anatomical environment) relative to the outflow rate (e.g., the rate of aspiration applied to the anatomical environment). The desired flow condition corresponds to the desired pressure to be applied to the anatomical environment. For example, a desired flow condition where the inflow and outflow rates are substantially equal corresponds to a substantially net zero ambient pressure, a desired flow condition where the inflow rate is higher than the outflow rate corresponds to a positive ambient pressure, and a desired flow condition where the inflow rate is lower than the outflow rate corresponds to a negative ambient pressure. The pressure controller 162 can control one or more of the flushing or aspiration flow rates through one or more working channels to maintain the desired flow condition during surgery.

[0082] Pressure controller 162 can achieve controlled pressure by automatically enabling, disabling, or adjusting one or more of aspiration or flushing. Sensor circuitry 150 can monitor the pressure of the anatomical environment (“ambient pressure”) during endoscopic surgery. In an example, sensor circuitry 150 can be coupled to a pressure sensor to sense ambient pressure or sense a signal indicating ambient pressure or otherwise related to ambient pressure. Examples of pressure sensors can include resistive pressure sensors, capacitive pressure sensors, piezoelectric pressure sensors, optical pressure sensors, or microelectromechanical systems (MEMS) pressure sensors. In an example, the pressure sensor can be attached to or integrated into a distal portion of the medical device 110, such as the distal end of an insertable tubular portion of an endoscope, such that the pressure sensor is in contact with the anatomical environment 101. In an example, the pressure sensor can be positioned proximally within the tubular portion of the endoscope, away from the anatomical environment 101. Control module 160 can receive the desired ambient pressure to be maintained during surgery from user interface 140. The control module 160 can compare the sensed ambient pressure with the desired ambient pressure and adjust one or more of the flushing flow rate or suction flow rate to drive the ambient pressure toward the desired ambient pressure level.

[0083] When system 100 operates in standard flushing / suction mode (when no blockage is detected in any working channel) and in unblocking flushing / suction mode (when at least one, but not all, working channels are blocked), pressure controller 162 can maintain controlled ambient pressure. See below for further details. Figure 5 (In the absence of channel blockage) and Figures 6 and 7 (in the presence of channel blockage) discuss exemplary systems for regulating ambient pressure via automatic adjustment of suction flow rate and / or flushing flow rate.

[0084] User interface 140 may include an output unit, such as a display, to present information collected during endoscopic surgery, such as: images (including live video) of the surgical area; the operational status of medical device 110, including the status of working channel 111; information about the channel status, such as whether the channel is blocked or successfully cleared; and environmental pressure, such as that sensed by sensor circuitry 150.

[0085] Figure 2AA perspective view of a powered tissue removal device 200, exemplified as a medical device 110, is shown. The powered tissue removal device 200 may include a handheld member 210 and a tubular assembly 222 extending from the handheld member 210. The tubular assembly 222 includes a proximal portion 226 located at the handheld member 210 and an opposing distal portion 228. Although the distal portion 228 is shown as a “straight axis” aligned with the remainder of the tubular assembly 222, in some examples, the distal portion 228 may be bent or angled relative to the remainder of the tubular assembly 222, including the proximal portion 226.

[0086] Figure 2B An exemplary configuration of the distal portion 228 is shown. The tubular assembly 222 includes an outer tubular member 252 and an inner tubular member 254 located within the outer tubular member 252. The outer member 252 includes an outer member window 262. The inner member 254 includes a cut portion 264 and a suction channel 274 defined within the inner member 254. The inner member 254 or the cut portion 264 includes an inner member window 266 communicating with the suction channel 274.

[0087] The powered tissue removal device 200 includes a flushing channel 272 located outside or outside the outer member 252. The flushing channel 272 extends along the length of the outer member 252. The proximal end of the flushing channel 272 includes a proximal flushing port 282 in fluid communication with a flushing source 230, and the distal end of the flushing channel 272 includes a distal flushing port 284 attached to the powered tissue removal device 200 or the outer member 252.

[0088] The powered tissue removal device 200 may be coupled to an energy source 240, a suction source 220, and a flushing source 230. The energy source 240 is configured to supply power to the powered tissue removal device 200, the suction source 220, the flushing source 230, or a combination thereof. The suction source 220, as an embodiment of suction source 120, may be in fluid communication with a suction channel 274 defined within the inner member 254. The suction source 220 is configured to apply suction to the powered tissue removal device 200 or to evacuate the powered tissue removal device 200 via the suction channel 274. The flushing source 230, as an embodiment of flushing source 130, may be in fluid communication with a flushing channel 272 located outside or outside the outer member 252. Alternatively or additionally, the flushing source 230 may be in fluid communication with the gap between the inner member 254 and the outer member 252.

[0089] The powered tissue removal device 200 includes one or more user controls 224 for operating the powered tissue removal device 200, energy source 240, suction source 220, irrigation source 230, or combinations thereof. By way of example and not limitation, the user controls 224, as an implementation of the user interface 140, may be located at the handpiece 210 to allow easy access and manipulation by the user during the procedure. In this example, the user controls 224 may allow the user to manually control debridement, enable, disable, or adjust one or more of the irrigation flow rate or suction flow, and other irrigation or suction parameters.

[0090] The powered tissue removal device 200 includes a control module (not shown) located at least partially within the handheld component 210. The control module, which may be an embodiment of control module 160, can be configured to control the operation of the powered tissue removal device 200 in response to user commands from user control 224, including one or more of the following functions: tissue debridement, irrigation, aspiration, and others. In an example, the control module may detect blockages in the working channel (e.g., an integrated irrigation / aspiration channel, or a separate irrigation channel or a separate aspiration channel) based on flow rate sensed from the working channel, and clear the blockage, for example, by alternating between applying irrigation fluid to the blocked channel and applying aspiration pressure. The control module may enable and adjust one or more irrigation flow parameters or one or more aspiration flow parameters to keep the pressure of the anatomical environment (“ambient pressure”) under control, for example, maintaining the ambient pressure at a substantially user-specified desired pressure during surgery, as referenced above. Figure 1 The subject of discussion.

[0091] Figures 3A to 3B Endoscopic systems 300A and 300B for use in endoscopic surgery are shown as examples. Endoscopic systems 300A and 300B are embodiments of system 100. (Refer to...) Figure 3ASystem 300A includes an endoscope 310A, a suction source 320, a flushing source 330, and a suction / flushing control unit 340. As an example of medical device 110, endoscope 310A may extend into a sheath and include a tube 311 extending from a distal end to a hub 312. Hub 312 terminates at a proximal end. Endoscope 310A may include an optical port 314 and a viewing port 315. Optical port 314 may be used to supply light into the endoscope and exit light from the tube 311 of the endoscope, illuminating features of interest in the anatomical environment (e.g., removed tissue or stones and material). For example, the optical port is advantageous for enhancing visibility when the feature of interest is in low-light conditions. Viewing port 315 may be used to provide an observation window that allows the user to observe the feature of interest. In an example, viewing port 315 may be an optical window at the proximal end that provides visual access to an observation lens at the distal end. In another example, the viewing portion 315 may provide a connection point to a camera to capture images or videos of the features of interest and the anatomical environment. These images or videos can be output and displayed on a monitor.

[0092] Endoscope 310A may include a flushing / suction port 313 for receiving aspiration or flushing fluid. The flushing / suction port 313 may be located external to hub 312 or at other locations on endoscope 310A, such as the proximal end of endoscope 310A. The flushing / suction port 313 opens into a working channel (not shown) inside tube 311. The working channel may be sized, shaped, and configured to deliver flushing fluid and / or for aspiration. In one example, the same working channel may be used for both flushing and aspiration (also referred to as an integrated flushing / suction channel). In another example, the flushing channel and the aspiration channel are separately located within tube 311.

[0093] In this example, endoscope 310A may be a nephroscope. During use, the flexible distal portion of tube 311 can be surgically inserted into the patient's kidney. The proximal portion of tube 311 may remain outside the patient's body. The interior of tube 311 may include an optical fiber extending along the length of endoscope 310A. The optical fiber may be multimode or single-mode. A laser external to the nephroscope can generate a laser beam. The laser beam can be coupled to the proximal end of the optical fiber via a suitable connector. The optical fiber can deliver the laser beam to the kidney stone to ablate it into fragments. In some examples, the laser beam may have a wavelength corresponding to the absorption spectral peaks of human blood and saline, such as 2100 nm, 1942 nm, etc. Generally, delivering a laser beam with significant absorption in blood and saline is beneficial because such a laser beam can be minimally invasive to surrounding tissues, reducing or eliminating damage to tissues at or near the kidney stone. The laser controller may be located on the grippable proximal portion of endoscope 310A. Similar to... Figure 2A The user control 224 shown enables manual control of the cleaning process. The laser controller allows the user to switch the state of the laser beam between an operating state (“on”) and a non-operating state (“off”). In some examples, the user can adjust one or more settings of the laser, such as output power, on the laser housing rather than via the laser controller.

[0094] The suction / irrigation control unit 340 can provide suction and irrigation to the endoscope 310A during endoscopic surgery while maintaining the pressure of the anatomical environment under control, for example, maintaining the pressure at a substantially user-specified pressure level (e.g., a user-specified pressure with a tolerance of, for example, ±5% to ±10%). The suction / irrigation control unit 340 may include a pressure monitor (implemented as sensor circuitry 150), a control module (implemented as control module 160), a pump, and a power supply. The control module can communicate with, for example, a user interface 341 located external to the suction / irrigation control unit 340 (implemented as user interface 140) to control the control module.

[0095] Aspiration source 320 can be connected to aspiration / flushing control unit 340 via an external aspiration line 326. Aspiration / flushing control unit 340 includes a control valve 342 configured to control aspiration between aspiration source 320 and endoscope 310A, such that aspiration can be shut off for all or part of the flushing fluid application cycle. Flushing source 330 can be connected to aspiration / flushing control unit 340 via an external flushing line 336. A pump included in aspiration / flushing control unit 340 can pressurize the flushing fluid before it enters endoscope 310A via flushing line 336. Figure 3A As shown, the external suction line 326 and the external flushing line 336 can be connected together at a common fitting 350, which can be coupled to a common line 356 for supplying fluid or suction to the endoscope 310A via the flushing / suction port 313.

[0096] The control module in the suction / flushing control unit 340 can be configured to control the operation of the endoscope 310A in response to user commands from the user interface 341. In an example, the control module can detect blockages in the working channel (e.g., an integrated flushing / suction channel, a separate flushing channel, or a separate suction channel) based on the flow rate sensed from the working channel, and clear the blocked channel, for example, by alternately applying flushing fluid and suction pressure. The control module can automatically enable and adjust one or more of the flushing flow parameters and one or more of the suction flow parameters to keep the pressure of the anatomical environment (“ambient pressure”) under control, for example, maintaining the ambient pressure at a substantially user-specified pressure level, as referenced above. Figure 1 The subject of discussion.

[0097] like Figure 3B The illustrated system 300B is similar to system 300A and includes an endoscope 310B, a suction source 320, a flushing source 330, and a suction / flushing control unit 340. Similar to endoscope 310A, endoscope 310B may include a tube 311, a hub 312, a light port 314, and a viewing port 315. However, endoscope 310B includes a separate suction port 313A adapted for fluid communication with the suction source 320 and a separate flushing port 313B adapted for fluid communication with the flushing source 330, instead of a single flushing / suction port 313. The suction source 320 is fluidly coupled to the suction port 313A via an external suction line 326. The flushing source 330 is fluidly coupled to the flushing port 313B via an external flushing line 336. The suction port 313A and the flushing port 313B may each open to one or more working channels within the tube 311. In the example, the flushing channel and the suction channel are respectively located inside the tube 311. The suction port 313A can be selectively opened to either the suction channel or the flushing channel. Similarly, the flushing port 313B can be selectively opened to either the suction channel or the flushing channel inside the tube 311.

[0098] Figure 5 This is a diagram illustrating an exemplary feedback control pressure regulation system 500 as an implementation of the environmental pressure control portion of system 100. System 500 can be configured to regulate the environmental pressure at the anatomical site when there is no channel blockage, and when system 500 is operating in a standard flushing / aspiration mode (e.g., controlling the suction source 120 to provide suction pressure to suction channel 112, and controlling the flushing source 130 to provide flushing fluid flow to flushing channel 114). System 500 can regulate the environmental pressure via automatic adjustment of the suction and / or flushing flow rates in the respective suction channel 112 and flushing channel 114. In the example, the longitudinal axes of suction channel 112 and flushing channel 114 can be parallel to each other. In the example, suction channel 112 and flushing channel 114 can be arranged coaxially using a common axis, for example, in a nested configuration. In the example, flushing and aspiration can be applied at different times through the same working channel, such as an integral flushing / aspiration channel. Pressure monitor 550 can monitor the pressure of the anatomical environment 101 via pressure sensor 352. As an example and not a limitation, control module 160 may include a proportional-integral (PI) controller or a proportional-integral-derivative (PID) controller, as well as other feedback controllers. The difference between the sensed pressure (at pressure monitor 550) and the desired pressure—also known as the “error”—can be used to determine the P, I, or D term in the feedback controller.

[0099] Based on the desired pressure (or desired flow rate) provided by the user, system 500 can operate in a stable pressure mode when the desired pressure is substantially zero (corresponding to a desired flow rate where the inflow rate of the flushing fluid applied to the anatomical environment and the outflow rate of the suction fluid applied to the anatomical environment are substantially equal); or when the desired pressure is positive or negative (corresponding to a desired flow rate where there is an imbalance between the inflow and outflow rates), system 500 can operate in a pressure control mode. When operating in stable pressure mode, the flushing or suction flow rate can be manually adjusted by the user, for example, via respective user controls on user interface 140. During endoscopic surgery, an increase in the flushing flow rate can lead to an increase in ambient pressure at the anatomical site, which can be sensed by pressure monitor 550. Control module 160 can responsively enable suction by applying suction pressure to suction channel 112. Suction can generate negative pressure to counteract the increased pressure generated by flushing. The control module 160 can adjust the suction flow rate or suction pressure until the pressure increase (due to increased flushing) is substantially neutralized by the suction flow. The ambient pressure can then be driven towards substantially zero and maintained at substantially zero.

[0100] Similarly, an increase in the aspiration flow rate can lead to a decrease in ambient pressure at the anatomical site. Control module 160 can responsively enable flushing by supplying a flow of flushing fluid to flushing channel 114. Flushing can generate positive pressure to counteract the reduced pressure caused by aspiration. Control module 160 can adjust the flushing flow rate until the pressure drop (due to increased aspiration) is substantially neutralized by the flushing flow. The ambient pressure can then be driven towards substantially zero and maintained at substantially zero.

[0101] In some cases, maintaining either positive or negative environmental pressure at the anatomical site is desirable. Controlled positive pressure within safe limits can help dilate anatomical structures (e.g., ureters, kidneys, uterus, or other organs) during endoscopy, allowing for better visualization via the endoscope without tissue damage due to excessive positive pressure. Positive pressure also prevents tissue debris or stone fragments from becoming trapped in anatomical structures and can assist in their removal. In some cases, maintaining controlled negative pressure within safe limits during endoscopy can also facilitate the extraction of debris from anatomical structures without risking excessive negative pressure on internal organs.

[0102] When a positive desired ambient pressure is provided by the user, for example via user interface 140, system 500 can operate in pressure control mode. Control module 160 can automatically increase the flushing flow rate through flushing channel 114 to increase the positive ambient pressure at the anatomical site. Alternatively, control module 160 can automatically decrease the suction flow rate through suction channel 112 to reduce the negative pressure at the anatomical site. Automatic adjustment of flushing and / or suction can continue until the sensed ambient pressure reaches a level that is substantially the desired positive pressure.

[0103] Similarly, when a negative desired ambient pressure is provided by the user, for example via user interface 140, system 500 can operate in pressure control mode. Control module 160 can automatically increase the suction flow rate through suction channel 112 to increase the negative ambient pressure at the anatomical site. Alternatively, control module 160 can automatically decrease the flushing flow rate through flushing channel 114 to reduce the positive pressure at the anatomical site. Automatic adjustment of flushing and / or suction can continue until the sensed ambient pressure reaches a level that is substantially the desired negative pressure.

[0104] Control module 160 may include safety mechanisms to maintain the pressure of the anatomical environment within a safe range defined by a lower negative pressure limit and an upper positive pressure limit. If the sensed ambient pressure reaches the upper positive pressure limit, control module 160 may automatically shut off, reduce, or maintain the current flushing flow rate to prevent further increase in ambient pressure. Similarly, if the sensed ambient pressure reaches the lower negative pressure limit, control module 160 may automatically shut off, reduce, or maintain the current suction flow rate to prevent further decrease in ambient pressure. When the system operates in pressure control mode, the desired positive and negative pressures received from the user are checked to ensure they fall within safe ranges. In an unrestricted example, the desired positive pressure is 5 pounds per square inch (psi) (or approximately 34.5 kPa), the desired negative pressure is -5 psi (or approximately -34.5 kPa), and the safe range is between the lower limit of -6 psi (or approximately 41.4 kPa) and the upper limit of 6 psi (or approximately 41.4 kPa). In the example, if the expected positive pressure received from the user exceeds the upper limit of positive pressure, or if the expected negative pressure falls below the safe limit of negative pressure, a warning can be issued (e.g., from user interface 140). Using such a safety mechanism, control module 160 can maintain the environmental pressure at the user-specified level while preventing or minimizing excessive positive or negative pressure applied to the anatomical environment during surgery.

[0105] Figure 6AThis is a diagram illustrating an exemplary feedback control pressure regulation system 600 as an implementation of system 100. System 600 can be configured to regulate the pressure (“ambient pressure”) of the anatomical environment 101 in the event of a blockage in the suction channel 112. (Refer to the above...) Figure 4A As discussed, when a blockage is detected in the suction channel 112, the blockage controller 161 of the controller module 160 can switch from the standard mode of applying suction pressure to the suction channel 112 (see [link to standard mode]). Figure 5 Switch to unblocking mode. In unblocking mode, flushing source 130 is fluidly coupled to suction channel 112 to provide flushing flow to suction channel 112.

[0106] The flushing flow applied to the suction channel 112 can cause an increase in anatomical pressure at the anatomical site. The pressure controller 162 of the control module 160 can regulate ambient pressure by automatically adjusting the suction flow rate and / or flushing flow rate through the suction channel 112 and the flushing channel 114. For example, in response to an increase in ambient pressure (e.g., sensed by the pressure monitor 550), the pressure controller 162 can automatically apply suction pressure to the flushing channel 114. If the flushing channel 114 is not blocked, the suction applied in the flushing channel 114 can create a negative pressure on the anatomical environment 101 to counteract the pressure increase caused by flushing through the suction channel 112. In this example, the pressure monitor 550 can monitor ambient pressure continuously or periodically, and the pressure controller 162 can adjust the suction flow rate or suction pressure to drive the ambient pressure towards a desired pressure level.

[0107] In one example, the desired pressure is essentially zero net pressure. Pressure controller 162 can adjust the suction flow rate or suction pressure in flushing channel 114 to essentially neutralize any increase in sensed ambient pressure. This allows the ambient pressure to be driven towards essentially zero and maintained at essentially zero. In another example, the desired pressure is positive. Pressure controller 162 can adjust the suction flow rate or suction pressure in flushing channel 114 to a level that drives the sensed ambient pressure towards a desired positive pressure level. An example of a desired positive pressure is 5 pounds per square inch (psi), or approximately 34.5 kPa. In yet another example, the desired pressure is negative, and pressure controller 162 can adjust the suction flow rate or suction pressure in flushing channel 114 to a level that drives the sensed ambient pressure towards a desired negative pressure level. An example of a desired negative pressure is -5 psi, or equivalently approximately -34.5 kPa.

[0108] As referenced above Figures 3A to 3B The unblocking process discussed may involve alternating between applying suction and flushing to the blocked channel. Figure 6B This is to activate flushing / suction in the suction channel when a blockage occurs in the suction channel 112 (e.g., Figure 7A The timing diagram is shown below. To clear the suction channel, flushing is applied to the suction channel for a duration t1 (“flushing duration”). During the transition period t... d Then, suction pressure is applied to the suction channel for a duration t2 (“suction duration”). Transition period t d This allows clogging particles of different sizes and masses to travel different distances along the suction channel, which helps with particle separation and channel clearing. Flushing can induce positive anatomical pressure (+PA)661 at the anatomical site, while suction can induce negative pressure (-PA)662 at the anatomical site.

[0109] Figure 6C This is a timing diagram showing the activation of flushing / aspiration in the flushing channel during the clearing process to achieve pressure control at the anatomical site, for example, to maintain the desired anatomical pressure. During t1, pressure controller 162 can activate aspiration of the flushing channel 114, which can generate negative anatomical pressure (-PA) 671 to counteract the positive anatomical pressure (+PA) 661 at the anatomical site. During t2, pressure controller 162 can activate flushing of the flushing channel 114, which can generate positive anatomical pressure (+PA) 672 to counteract the negative anatomical pressure (-PA) 662 at the anatomical site. Thus, the pressure of the anatomical environment can be maintained at the desired level while clearing the obstructed aspiration channel.

[0110] When the flow monitor 650 senses an increase in flow rate through the suction channel 112 via the flow sensor 652, it determines that the blocked channel has been successfully cleared. The blockage controller 161 can switch back to the standard mode of flushing / suction operation (e.g., controlling the suction source to apply suction pressure to the suction channel and controlling the flushing source to supply flushing fluid to the flushing channel). The pressure controller 162 can operate suction and flushing to maintain the ambient pressure under control, as described above. Figure 5 The subject of discussion.

[0111] Figure 7A This is a diagram illustrating an exemplary feedback control pressure regulation system 700 as an implementation of system 100. System 700 can be configured to regulate the pressure (“ambient pressure”) applied to the anatomical environment 101 in the event of a blockage in the flushing channel 114. (Refer to the above...) Figure 4A As discussed, when a blockage is detected in the flushing channel 114, the blockage controller 161 of the controller module 160 can switch from a standard mode of supplying flushing fluid to the flushing channel 114 to a clearing mode. In the clearing mode, the suction source 120 can be fluidly coupled to the flushing channel 114 to suction the blocked flushing channel 114 or to evacuate the blocked flushing channel 114.

[0112] The suction pressure applied to the flushing channel 114 can cause a decrease in pressure at the anatomical site of the anatomical environment 101. The pressure controller 162 of the control module 160 can regulate the ambient pressure by automatically adjusting the suction and / or flushing flow rates through the suction channel 112 and the flushing channel 114. For example, in response to a decrease in ambient pressure (which can be sensed by the pressure monitor 550), the pressure controller 162 can automatically enable flushing fluid inflow into the suction channel 112. If the suction channel 112 is not blocked, the flushing fluid applied in the suction channel 112 can generate positive pressure to counteract the pressure drop at the anatomical environment 101 caused by suction through the flushing channel 114. In this example, the pressure monitor 550 can monitor the ambient pressure continuously or periodically, and the pressure controller 162 can adjust the flushing flow rate to drive the ambient pressure towards a desired pressure level.

[0113] In one example, the desired pressure is essentially zero net pressure. Pressure controller 162 can adjust the flushing flow rate through suction channel 112 to a level that substantially neutralizes the reduction in sensed ambient pressure. The ambient pressure, as sensed by pressure sensor 550, can then be driven towards essentially zero, or maintained at essentially zero. In another example, the desired pressure is positive. Pressure controller 162 can adjust the flushing flow rate through suction channel 112 to a level that drives the sensed ambient pressure towards the desired positive pressure level. In yet another example, the desired pressure is negative, and pressure controller 162 can adjust the flushing flow rate through suction channel 112 to a level that drives the sensed ambient pressure towards the desired negative pressure level.

[0114] Figure 7B This is to activate flushing / suction in the flushing channel when a blockage occurs in flushing channel 114 (e.g., Figure 7A The timing diagram is shown below. To clear the flushing channel, suction is applied to the flushing channel for a duration of t3 (“suction duration”). During the transition period t... d Then, flushing pressure is applied to the flushing channel for a duration t4 (“flushing duration”). Transition period t d This allows clogging particles of different sizes and masses to travel different distances along the flushing channel, which helps with particle separation and channel clearing. Suction can induce negative anatomical pressure (-PA)761 at the anatomical site, while flushing can induce positive anatomical pressure (+PA)762 at the anatomical site.

[0115] Figure 7CThis is a timing diagram showing the activation of flushing / aspiration in the suction channel during the clearing process to achieve pressure control at the anatomical site, for example, to maintain the desired anatomical pressure. During t3, pressure controller 162 can activate flushing of the suction channel 112, which can generate positive anatomical pressure (+PA) 771 to counteract negative anatomical pressure (-PA) 761 at the anatomical site. During t4, pressure controller 162 can activate aspiration of the suction channel 112, which can generate negative anatomical pressure (-PA) 772 to counteract positive anatomical pressure (+PA) 762 at the anatomical site. Thus, the pressure of the anatomical environment can be maintained at the desired level while clearing the obstructed flushing channel.

[0116] When the flow monitor 650 senses an increase in flow rate through the suction channel 112 via the flow sensor 652, it determines that the blocked channel has been successfully cleared. The blockage controller 161 can switch back to the standard mode of flushing / suction operation (e.g., controlling the suction source to apply suction pressure to the suction channel and controlling the flushing source to supply flushing fluid to the flushing channel). The pressure controller 162 can operate suction and flushing to maintain the ambient pressure under control, as described above. Figure 5 The subject of discussion.

[0117] Figure 8 This is a flowchart illustrating a method 800 for in-situ clearing of a working channel in a medical device during minimally invasive procedures such as endoscopic surgery. The medical device includes a tubular portion that can be inserted into a hollow organ or body cavity to assist in medical diagnosis or surgical treatment. Examples of medical devices may include, for example... Figures 2A to 2B The tissue removal device shown or such Figures 3A to 3B The endoscope, etc., shown are examples. Medical devices may include one or more working channels configured to provide flushing fluid to the anatomical site and to remove tissue fragments, stones or lumps, bodily fluids, and flushing fluid (collectively referred to herein as unwanted substances) from the anatomical site. The working channels may be located at least partially within the tubular portion of the medical device. In one example, the working channel is an integrated flushing / aspiration channel that is controllably (e.g., at different times) used for flushing and aspiration. In another example, the working channel may include separate flushing and aspiration channels disposed within the tubular portion of the medical device. According to the various embodiments discussed in this document, the flushing and aspiration channels may each receive flushing fluid or aspiration pressure, for example, under automatic control by a controller unit, to perform different tasks or achieve different functions during endoscopic procedures.

[0118] Method 800 includes one or more processes operating a dredging system such as system 100 or its variants (e.g., one of system 200, 300A, or 300B). While the processes of method 800 are drawn in a flowchart, they do not need to be executed in a specific order. In various examples, some of the processes may be executed in a different order than that shown herein.

[0119] At 810, a flow sensor can be used to sense the flow rate through the working channel, which can be located inside the working channel of the medical device. Examples of flow sensors may include a thermal anemometer that measures the rate of heat transfer from a heat source, a differential pressure sensor that measures pressure drop at a series of locations, an ultrasonic flow sensor that measures the Doppler effect or travel / time of flight of a frequency shift, an electromagnetic sensor that measures changes in fluid conductivity indicating the flow rate, etc. At 820, a blockage controller 161 can be used, for example, to detect a channel state indicating the presence or absence of blockage in the working channel based on the sensed flow rate. In an example, a channel blockage can be detected in response to a decrease in flow rate, for example, below a first flow rate threshold. If the sensed flow rate increases and exceeds a second flow rate threshold, it can be detected that the working channel, which is not blocked or is blocked, has been successfully cleared. In an example, both the first and second flow rate thresholds may be relative to a reference flow rate (e.g., a specific percentage thereof), such as a reference flow rate measured in an unblocked channel.

[0120] If the flow rate sensed at 830 indicates a blockage in the working channel, a clearing mode for flushing / aspiration operation is activated at 840 to clear the blocked working channel. When separate flushing and aspiration channels are used in a medical device, the clearing mode includes applying a flow of flushing fluid to the aspiration channel and / or applying aspiration pressure to the flushing channel. This differs from the standard flushing / aspiration operation mode, in which the aspiration source provides aspiration pressure to the aspiration channel and the flushing source provides a flow of flushing fluid to the flushing channel. In this example, at 840, the clearing mode may include alternating between flushing and aspiration of the blocked channel. (Refer to above) Figure 4A As discussed, the blockage controller 161 can controllably enable a suction source (e.g., suction source 120) to provide suction pressure to the blocked working channel for a specified suction duration (e.g., Figure 4A (As shown in block 420). Alternatively or additionally, the blockage controller 161 may enable a flushing source (e.g., flushing source 140) to apply a flow of flushing fluid to the blocked working channel for a specified flushing duration (e.g., as shown in block 420). Figure 4A (As shown in block 440). The suction pressure, suction flow rate, flushing flow rate, or pump pressure used to pressurize the flushing fluid can be adjusted by the user.

[0121] Blocking particles of different sizes (and therefore different masses) may respond differently to suction or flushing fluids. For example... Figure 4A As shown, suction, flushing, or alternation between suction and flushing can help remove smaller particles from the blockage and separate them from the rest of the blockage because smaller particles can move at a faster speed and travel a longer distance along the direction of the suction flow or fluid flow compared to larger particles. By applying additional suction or flushing flow to the working channel, the separated particles can be extracted more easily and effectively along the working channel. In the example, one or more of the suction pressure, suction flow rate, flushing flow rate, or pump pressure can be varied to separate particles by size. For example, a higher flow rate can be applied to remove larger particles, and a lower flow rate can be applied to remove smaller particles through the channel.

[0122] The flow rate at 810 can be monitored continuously or periodically during the clearing process. When the flow rate detected at 830 increases and exceeds a threshold, the blocked channel is considered successfully cleared. The clearing mode can then be switched back to the standard flushing / suction operation mode.

[0123] Figure 9 This is a flowchart illustrating a method 900 for in-situ unblocking the working channel of a medical device while maintaining the pressure of the anatomical environment (“ambient pressure”) under control, such as maintaining the ambient pressure at a substantially user-specified pressure level. The process of controlling the ambient pressure can be implemented in and executed by a pressure controller such as pressure controller 162. The processes of method 900 do not need to be performed in a specific order. For example, some steps may be performed in a different order than that shown herein.

[0124] Method 900 includes steps 910 to 940 for detecting blockages in the working channel and clearing the blocked channel, similar to steps 810 to 840 of method 800. Method 900 also includes steps 950 to 980 for adjusting the environmental pressure during surgery (e.g., endoscopic surgery) with or without channel blockage. As previously mentioned, aspiration may cause negative pressure changes at the anatomical site, while flushing may cause positive pressure changes at the anatomical site. Negative and positive pressure changes can adversely affect internal organs exposed to the anatomical site. Maintaining environmental pressure at a controlled level can increase patient safety and effectively shorten surgical time.

[0125] Ambient pressure can be regulated by automatically adjusting the suction and / or flushing flow rates in one or more working channels. Specifically, at 950, a pressure sensor can be used to sense the ambient pressure. The pressure sensor can be attached to or integrated into a distal portion of the medical device, allowing the sensor to contact the anatomical environment. Examples of pressure sensors can include resistive pressure sensors, capacitive pressure sensors, piezoelectric pressure sensors, optical pressure sensors, or microelectromechanical systems (MEMS) pressure sensors.

[0126] At 960, the sensed tissue pressure can be compared to, for example, the desired pressure provided by the user via user interface 140. The desired pressure represents the pressure to be maintained at the anatomical location during surgery. In one example, the desired pressure is essentially net zero pressure. In another example, the desired pressure is positive pressure. In yet another example, the desired pressure is negative pressure. Maintaining controlled positive pressure within a safe range can help expand anatomical structures (e.g., ureters, kidneys, or other organs) during endoscopic surgery to allow better visualization of the anatomical structures through the endoscope without tissue damage due to excessive positive pressure. Positive pressure also prevents tissue debris or stone fragments from becoming trapped in the anatomical structures and helps remove them. In some cases, maintaining controlled negative pressure within a safe range during endoscopic surgery can also facilitate the extraction of debris from anatomical structures without the risk of placing internal organs under excessive negative pressure.

[0127] If the pressure sensed at 960 does not reach a substantially desired pressure level (i.e., within tolerance, e.g., ±5% to 10% of the desired pressure), then at 970, for example, a pressure controller 162 can be used to adjust one or more of the flushing or aspiration flow rates through one or more working channels to drive the ambient pressure toward the desired pressure level. In some examples, in addition to or instead of the desired pressure level, desired flow conditions can be received, for example, from user interface 140. The desired flow conditions include information about the inflow (e.g., the flow rate of flushing fluid applied to the anatomical environment) relative to the outflow (e.g., the flow rate of aspiration applied to the anatomical environment) and correspond to the desired pressure to be applied to the anatomical environment. One or more of the flushing or aspiration flow rates through one or more working channels can be varied to maintain the desired flow conditions during surgery.

[0128] When no blockage is detected in any working channel, or if a blocked channel has been successfully cleared, the pressure control process at position 970 can be performed using the standard flush / suction operation mode. (Refer to the above.) Figure 5As described, suction applied to the suction channel can generate a negative pressure in the anatomical environment, which can counteract the increase in ambient pressure caused by the increased flushing flow rate. The suction flow rate or suction pressure can be adjusted until the sensed increase in pressure (e.g., caused by increased flushing) is substantially neutralized by the suction flow, thereby generating a desired substantially net zero pressure; or until the sensed ambient pressure reaches a substantially desired positive or negative pressure level. Similarly, the flow of flushing fluid supplied to the flushing channel can generate a positive pressure in the anatomical environment, which can counteract the decrease in ambient pressure caused by suction. The flushing flow rate can be adjusted until the sensed decrease in pressure (e.g., caused by increased suction) is substantially neutralized by the flushing flow, thereby generating a desired substantially net zero pressure; or until the sensed ambient pressure reaches a substantially desired positive or negative pressure level.

[0129] When at least one, but not all, of the working channels is blocked, a pressure control process at 970 points can be performed using the flushing / suction operation in a clearing mode. Figure 6A An example is shown where the suction channel is blocked while the flushing channel is not. As discussed therein, a flow of flushing fluid can be applied to the suction channel to clear the blockage. This can produce an increase in ambient pressure, as can be detected by a pressure sensor. Suction pressure can be applied to the flushing channel, which can create a negative pressure to counteract the pressure increase at the anatomical environment. The suction flow rate or suction pressure in the flushing channel can be adjusted until the sensed pressure increase (caused by increased flushing in the blocked suction channel) is substantially neutralized by the suction flow, thereby producing a desired substantially net zero pressure; or until the sensed ambient pressure reaches a substantially desired positive or negative pressure level.

[0130] In another example, where the flushing channel is blocked but the suction channel is not, suction pressure can be applied to the flushing channel to clear the blockage. This can result in a reduction in ambient pressure. (See above for reference.) Figure 7A The flushing fluid flow discussed can be applied to the suction channel, which can generate positive pressure to counteract the negative increase at the anatomical environment. The flushing flow rate can be adjusted until the sensed pressure reduction (caused by increased suction in the blocked flushing channel) is substantially neutralized by the flushing flow, thereby generating a desired substantially net zero pressure; or until the sensed ambient pressure reaches a level of substantially desired positive or negative pressure.

[0131] At 980, check if the procedure is complete. If the procedure is not complete, the flow rate sensing and drainage process 910 to 940 and the pressure control process 950 to 980 can continue.

[0132] As described in methods 800 and 900, controlled flushing and aspiration—including alternating between applying flushing fluid and applying aspiration pressure to the same blocked channel—can effectively clear the channel by separating debris of different sizes that have accumulated to block it. As described in method 900, pressure control by applying flushing and / or aspiration in one or more working channels can effectively avoid or minimize excessive positive or negative pressure applied to internal organs during endoscopic procedures in the presence or absence of channel obstruction. Therefore, overall operative time can be shortened and patient safety can be improved.

[0133] Additional notes

[0134] The above detailed description includes reference to the accompanying drawings, which form part of the detailed description. The drawings illustrate specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements other than those shown or described. However, the inventors also contemplate examples that provide only those elements shown or described. Furthermore, the inventors contemplate examples using any combination or arrangement of those elements (or one or more aspects thereof) shown or described with respect to a particular example (or one or more aspects thereof) shown or described herein, or with respect to other examples (or one or more aspects thereof).

[0135] In this document, as is common in patent literature, the terms "a" or "an" are used to include one or more, independent of any other instances or uses of "at least one" or "one or more". In this document, unless otherwise indicated, the term "or" is used to refer to a non-exclusive "or", such that "A or B" includes "A but not B", "B but not A", and "A and B". In this document, the terms "including" and "in which" are used as concise Chinese equivalents to the corresponding terms "comprising" and "wherein". Furthermore, in the appended claims, the terms "including" and "comprising" are open-ended, meaning that a system, apparatus, article, composition, formulation, or process that includes elements other than those listed after such terms in the claims is still considered to fall within the scope of the claims. Moreover, in the appended claims, the terms "first", "second", and "third", etc., are used only as designations and are not intended to impose numerical requirements on their objects.

[0136] The above description is intended to be illustrative and not restrictive. For example, the examples described above (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be used by those skilled in the art after reviewing the above description. An abstract is provided to conform to 37C.FR §1.72(b) to allow the reader to quickly determine the nature of the technical disclosure. It should be understood that the submitted abstract will not be used to define or limit the scope or meaning of the claims. Furthermore, in the detailed description above, various features may be combined to organize the disclosure. This should not be construed as meaning that all unclaimed features of the disclosure are necessary for any claim. Rather, the subject matter of the invention may lie in fewer than all features of a particular disclosed embodiment. Therefore, the appended claims are thus incorporated into the detailed description as examples or embodiments, wherein each claim is an independent, separate embodiment, and such embodiments are contemplated to be combined with each other in various combinations or arrangements. The scope of the invention should be determined by reference to the full scope of the appended claims together with the equivalents conferred by such claims.

Claims

1. A system for clearing at least one working channel of a medical device during a patient's surgery, the system comprising: A flow sensor configured to sense the flow rate through at least one working channel of the medical device; as well as The control module is configured to: Based on the sensed flow rate, a channel status indicating whether or not a blockage exists in the at least one working channel is detected; as well as In response to a detected channel status indicating a blockage in at least one working channel, alternating between applying a flushing flow and applying a suction flow to the at least one working channel, including applying one of the flushing flow or the suction flow for a first time period, then interrupting the flushing flow and the suction flow for a specified or adjustable time interval to allow blockage particles of different sizes or masses to be separated by motion, and then applying the other of the flushing flow or the suction flow to the at least one working channel for a second time period.

2. The system of claim 1, wherein, The control module is configured to alternate between applying the flushing flow and applying the suction flow whenever a detected channel status indicates that there is a blockage in at least one working channel.

3. The system of any one of claims 1-2, wherein, The control module is configured to: apply the flushing flow to the at least one working channel using a first adjustable pressure or a first adjustable flow rate, and apply suction to the at least one working channel using a second adjustable pressure or a second adjustable flow rate.

4. The system of any one of claims 1 to 3, wherein, The control module is configured to apply the flushing flow to the at least one working channel for a first specified or adjustable specified duration, and to apply suction to the at least one working channel for a second specified or adjustable specified duration.

5. The system according to any one of claims 1 to 4, wherein, The control module is configured to: In response to a sensed flow rate decreasing below a first threshold, a blockage is detected in at least one operating channel; and The absence of blockage in the at least one working channel is detected in response to a sensed flow rate increase exceeding a second threshold.

6. The system of any of claims 3 to 5, further comprising a pressure sensor configured to sense a pressure of an anatomical environment at the anatomical site of the patient, wherein, The control module is configured to: Receive the desired pressure to be applied to the anatomical environment at the anatomical site in the patient; and Adjust one or more of the flushing flow or the suction flow to maintain the pressure of the sensed anatomical environment at a level substantially the desired pressure.

7. The system according to any one of claims 3 to 5, further comprising a pressure sensor configured to sense the pressure of the anatomical environment at the anatomical site of the patient, wherein, The control module is configured to: Receive the desired flow conditions in the at least one working channel, the desired flow conditions representing the relative situation between the flushing flow and the suction flow and corresponding to the desired pressure to be applied to the anatomical environment; as well as Adjust one or more of the flushing or suction flows to maintain the desired flow conditions in the at least one working channel.

8. The system of any one of claims 6-7, wherein, The at least one working channel includes a suction channel and a flushing channel, and wherein the control module is configured to: The flushing source fluid is fluidly coupled to one of the flushing channels or the suction channels to provide the flushing flow to one of the flushing channels or the suction channels at an adjustable pressure or adjustable flow rate; and The suction source is fluidly coupled to either the flushing channel or the other of the suction channels to provide the suction flow to either the flushing channel or the other of the suction channels at an adjustable pressure or an adjustable flow rate.

9. The system of claim 8, wherein, The control module is configured to: In response to a blockage in the suction channel, the flushing source is controlled to provide a flushing flow to the suction channel; In response to a sensed increase in pressure in the anatomical environment, the suction source is controlled to apply a suction flow to the flushing channel to maintain the sensed pressure at a level substantially the desired pressure. as well as In response to the absence of blockage in the suction channel, the suction source is controlled to apply a suction flow to the suction channel, and the flushing source is controlled to provide a flushing flow to the flushing channel.

10. The system of claim 8, wherein, The control module is configured to: In response to a blockage in the flushing channel, the suction source is controlled to apply a suction flow to the flushing channel; In response to a sensed decrease in the pressure of the anatomical environment at the anatomical site, the flushing source is controlled to provide a flushing flow to the suction channel to maintain the sensed pressure at a level substantially the desired pressure. as well as In response to the absence of blockage in the flushing channel, the suction source is controlled to apply a suction flow to the suction channel, and the flushing source is controlled to provide a flushing flow to the flushing channel.

11. The system of claim 9, wherein, The desired pressure is essentially net zero pressure, and the control module is configured to control the suction source to apply a suction flow to the flushing channel at an adjustable flow rate in response to an increase in the sensed pressure, so as to substantially neutralize the increase in the sensed pressure.

12. The system of claim 10, wherein, The desired pressure is essentially net zero pressure, and the control module is configured to control the flushing source to provide a flushing flow to the suction channel at an adjustable flow rate in response to a sensed decrease in pressure, so as to substantially neutralize the sensed decrease in pressure.

13. The system of claim 9, wherein, The desired pressure is a positive pressure, and the control module is configured to control the suction source to apply a suction flow to the flushing channel at an adjustable flow rate in response to an increase in the sensed pressure, so as to maintain the sensed pressure at a substantially desired positive pressure level.

14. The system of claim 10, wherein, The desired pressure is a positive pressure, and the control module is configured to control the flushing source to provide a flushing flow to the suction channel at an adjustable flow rate in response to a decrease in the sensed pressure, so as to maintain the sensed pressure at a substantially desired positive pressure level.

15. The system of claim 9, wherein, The desired pressure is negative pressure, and the control module is configured to control the suction source to apply a suction flow to the flushing channel at an adjustable flow rate in response to an increase in the sensed pressure, so as to maintain the sensed pressure at a substantially desired negative pressure level.

16. The system according to claim 10, wherein, The desired pressure is negative pressure, and the control module is configured to control the flushing source to provide a flushing flow to the suction channel at an adjustable flow rate in response to a decrease in the sensed pressure, so as to maintain the sensed pressure at a substantially desired negative pressure level.

17. An endoscopic surgical system, comprising: An endoscope, the endoscope including an imaging module, a surgical module and at least one working channel configured to allow a flushing flow or a suction flow to pass through; User input, configured to receive from the user the desired pressure of the anatomical environment to be applied to the patient's anatomical site; A flow sensor configured to sense the flow rate through at least one working channel of the endoscope; A pressure sensor configured to sense the pressure of the anatomical environment at the anatomical site; as well as The control module is configured to: The sensed flow rate is used to detect the channel status, which indicates whether there is a blockage in the at least one working channel; In response to a detected channel status indicating a blockage in at least one working channel, and whenever a detected channel status indicates a blockage in at least one working channel, alternating between applying a flushing flow and applying a suction flow to the at least one working channel, including applying one of the flushing flow or the suction flow for a first time period, then interrupting the flushing flow and the suction flow for a specified or adjustablely specifyable time interval to allow blockage particles of different sizes or masses to be separated by motion, and then applying the other of the flushing flow or the suction flow to the at least one working channel for a second time period; as well as Adjust one or more of the flushing or suction flows through the at least one working channel to maintain the sensed pressure at a level substantially the desired pressure.

18. A method for clearing at least one working channel of a medical device during a patient's surgery, the method comprising: The flow rate through at least one working channel of the medical device is sensed via a flow sensor; The control module uses the sensed flow rate to detect the channel status, which indicates whether there is a blockage in the at least one working channel; as well as In response to a detected channel status indicating a blockage in at least one working channel, alternating between applying a flushing flow and applying a suction flow to the at least one working channel, including applying one of the flushing flow or the suction flow for a first time period, then interrupting the flushing flow and the suction flow for a specified or adjustable time interval to allow blockage particles of different sizes or masses to be separated by motion, and then applying the other of the flushing flow or the suction flow to the at least one working channel for a second time period.

19. The method according to claim 18, wherein, As long as the detected channel status indicates that there is a blockage in at least one working channel, the alternation between the application of the flushing flow and the application of the suction flow continues.

20. The method according to any one of claims 18 to 19, wherein, Detecting the channel status includes: In response to a sensed flow rate decreasing below a first threshold, a blockage is detected in at least one operating channel; and The absence of blockage in the at least one working channel is detected in response to a sensed flow rate increase exceeding a second threshold.

21. The method according to any one of claims 18 to 20, comprising: The desired pressure to be applied to the anatomical environment at the anatomical site in the patient is received via user input; The pressure of the anatomical environment at the anatomical site is sensed via a pressure sensor; as well as Adjust one or more of the flushing flow or the suction flow through the at least one working channel to maintain the sensed pressure at a level substantially the desired pressure.

22. The method of claim 21, comprising: Receive the desired flow conditions in the at least one working channel, the desired flow conditions representing the relative situation between the flushing flow and the suction flow and corresponding to the desired pressure to be applied to the anatomical environment; as well as Adjust one or more of the flushing flow or the suction flow through the at least one working channel to maintain the desired flow conditions in the at least one working channel.

23. The method of any one of claims 21-22, wherein, The at least one working channel includes a suction channel and a flushing channel, and the method includes: In response to a blockage in the suction channel, a flushing source is controlled to provide a flushing flow to the suction channel; In response to a sensed increase in the pressure of the anatomical environment at the anatomical site, the suction source is controlled to apply a suction flow to the flushing channel to maintain the sensed pressure at a level substantially the desired pressure; and In response to the absence of blockage in the suction channel, the suction source is controlled to apply a suction flow to the suction channel, and the flushing source is controlled to provide a flushing flow to the flushing channel.

24. The method of any one of claims 21-23, wherein, The at least one working channel includes a suction channel and a flushing channel, and the method includes: In response to a blockage in the flushing channel, a suction source is controlled to apply a suction flow to the flushing channel; In response to a sensed decrease in the pressure of the anatomical environment at the anatomical site, a flushing source is controlled to provide a flushing flow to the suction channel to maintain the sensed pressure at a level substantially the desired pressure; and In response to the absence of blockage in the flushing channel, the suction source is controlled to apply a suction flow to the suction channel, and the flushing source is controlled to provide a flushing flow to the flushing channel.

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