JP2023515990A - Endoscope jam clearing system and method - Google Patents

Abstract

A system and method are disclosed for in-situ unclogging of working channels in a medical device during a procedure. An exemplary unclogging system includes a flow sensor that senses flow through a working channel and a control module that detects channel conditions indicating the presence or absence of a clog based on the flow. If there is a channel clog, the control module can control one or more of the irrigation or suction sources that provide irrigation fluid or suction pressure, respectively, to unclog the blocked channel. The control module regulates the irrigation flow rate or suction through the working channel to maintain the desired pressure of the anatomical environment at the anatomical site or to maintain the desired flow conditions within the working channel during the procedure. One or more of the flow rates can be adjusted.

Description

PRIORITY CLAIM This application claims the benefit of priority to U.S. patent application Ser. incorporate into the book.

TECHNICAL FIELD This document relates generally to endoscopy systems and, more particularly, to clearing an endoscope during an endoscopic procedure while keeping the in situ pressure of the anatomical environment under control at the anatomical site. It relates to a clearing system for

Endoscopes are commonly used to provide access to internal locations of a patient so that visual access is provided to the physician. Some endoscopes are used in minimally invasive surgery to remove unwanted tissue or foreign bodies from the patient's body. For example, endoscopic tissue removal devices remotely access necrotic, cancerous, injured, infected or other unwanted soft tissue, bone, or other anatomical structures at an anatomical site and remove adjacent anatomy. Instruments used by clinicians to ablate such unwanted material from anatomical structures and to transport these unwanted materials away from the anatomical site. Nephroscopes are used by clinicians to examine the renal system and to perform various procedures under direct visual control. For example, percutaneous nephrolithotomy (PCNL) is a procedure that involves placing a nephroscope through the patient's flank and into the renal pelvis. For example, stones or masses from various regions of the body can be visualized and extracted, including the urinary system, gallbladder, nasal cavity, gastrointestinal tract, stomach, or tonsils. Shock waves, ultrasonic energy (through specialized equipment such as an ultrasonic lithotripter), or vibratory forces such as lasers can be used to dissect larger-sized stones into smaller pieces.

Some endoscopes have a suction channel (also known as a suction channel) that transports excised tissue, stones (e.g., stones or stone fragments in various areas of stone formation) and masses, among other unwanted material. have). A flow of irrigant (eg, saline) can be introduced to the anatomical site through an irrigation channel in the endoscope during the procedure. The irrigation fluid can facilitate removal of tissue debris, calculus fragments, and other unwanted material through the suction channel. The irrigation fluid can also help maintain clear visibility of the anatomical environment for the procedural clinician. Additionally, the irrigation flow has a cooling effect on the endoscopic tissue removal device and can help dissipate heat generated during excision of stones (eg, kidney stones).

Unwanted material produced during an endoscopic procedure can accumulate and clog working channels (eg, aspiration or irrigation channels) of the endoscope. Monitoring channel plugging and timely and efficient unclogging of occluded channels can reduce procedure time and improve the efficiency, safety, and success rate of endoscopic procedures.

This document describes a system and method for in-situ unclogging of a working channel of an endoscope during an endoscopic procedure while keeping pressure at the anatomical site under control during the endoscopic procedure. do. According to one aspect of this document, a clog clearing system includes a flow sensor configured to sense flow through a working channel of an endoscope, and a flow sensor configured to sense flow through a working channel of an endoscope and using the sensed flow to determine the presence or absence of a clog within the working channel. a control module configured to detect the indicated channel conditions. In response to a blockage in the working channel, the control module activates one or more of the irrigation or suction sources that provide irrigation fluid or suction pressure, respectively, to the working channel to unclog the working channel. can be controlled. The control module is configured to maintain the pressure of the anatomical environment at the anatomical site substantially at a desired pressure level (e.g., a predetermined or user-specified pressure level) during an endoscopic procedure, or One or more of the irrigation or aspiration flow rates through the working channel can be automatically adjusted to achieve the desired flow conditions corresponding to the pressure of . Irrigation fluid or suction pressure can be applied as long as channel blockage exists.

Example 1 is a system for unclogging at least one working channel of a medical device during a procedure on a patient. The system includes a flow sensor configured to sense flow through at least one working channel of a medical device; and providing irrigation fluid or suction pressure, respectively, in response to detected channel conditions indicating a blockage within the at least one working channel. to unclog at least one working channel.

In Example 2, the subject of Example 1 is one of the irrigation or aspiration sources providing irrigation fluid or aspiration pressure, respectively, as long as detected channel conditions indicate that there is a blockage in at least one working channel. or more optionally including a control module that can be configured to control the at least one working channel to unclog.

In Example 3, the subject of any one of Examples 1-2 detects a blockage in at least one working channel in response to a decrease in sensed flow rate below a first threshold; optionally including a control module that can be configured to detect the absence of a blockage within the at least one working channel in response to an increase in the sensed flow rate above a threshold of .

In Example 4, the subject matter of any one or more of Examples 1-3 is directed to at least one working channel including alternately applying a irrigation fluid and a suction pressure to the at least one working channel. Optionally includes a control module that can be configured to clear the clog.

In Example 5, the subject matter of any one or more of Examples 1-4 is an irrigation source or irrigation source to unclog at least one working channel by adjusting the flow rate of irrigation fluid or the suction pressure, respectively. A control module is optionally included that can be configured to control one or more of the suction sources.

In Example 6, the subject matter of any one or more of Examples 3-5 was configured to receive from a user a desired pressure to be applied to an anatomical environment at an anatomical site within a patient. Optionally including a user input and a pressure sensor configured to sense pressure of the anatomical environment at the anatomical site, the control module directs the sensed pressure to substantially the desired pressure. is configured to adjust one or more of an irrigation flow rate or an aspiration flow rate through the at least one working channel to maintain a level of

In Example 7, the subject of Example 6 is a user input configured to receive a desired flow condition within at least one working channel corresponding to a desired pressure to be applied to the anatomical environment; a control module configured to control one or more of the irrigation flow rate or the aspiration flow rate through the at least one working channel of the medical device to maintain desired flow conditions.

In Example 8, the subject matter of any one or more of Examples 6-7 includes at least one working channel, which may include an aspiration channel and an irrigation channel, and fluidly couples an irrigation source to one of the irrigation channel or the aspiration channel. to provide irrigation fluid at an adjustable irrigation flow rate to one of the irrigation or aspiration channels, and fluidly couple a suction source to the other of the irrigation or aspiration channels to provide an adjustable aspiration flow rate to the other of the irrigation or aspiration channels. a control module that can be configured to supply suction pressure at .

In Example 9, the subject matter of Example 8 controls the irrigation source to provide irrigation fluid to the aspiration channel in response to a blockage in the aspiration channel and improves the anatomical environment at the anatomical site. controlling the suction source to apply suction pressure to the irrigation channel and maintain the sensed pressure at substantially the desired level of pressure in response to the increase in the sensed pressure, and if there is a clog in the suction channel; Optionally, a control module that can be configured to control the aspiration source to apply aspiration pressure to the aspiration channel and to control the irrigation source to provide irrigation fluid to the irrigation channel in response to the lack of Include in selection.

In Example 10, the subject matter of Example 8 controls the suction source to apply suction pressure to the irrigation channel in response to a blockage in the irrigation channel to improve the anatomical environment at the anatomical site. controlling the irrigation source to provide irrigation fluid to the aspiration channel to maintain the sensed pressure at substantially the desired level of pressure in response to the decrease in the sensed pressure, and if there is a blockage in the irrigation channel; Optionally, a control module that can be configured to control the aspiration source to apply aspiration pressure to the aspiration channel and to control the irrigation source to provide irrigation fluid to the irrigation channel in response to the lack of Include in selection.

In Example 11, the subject matter of Example 9 optionally includes the desired pressure, which can be substantially zero net pressure, and the control module responds to an increase in the sensed pressure by adjusting the sensed pressure The suction source may be configured to control the suction source to apply suction pressure to the irrigation channel at a level that substantially neutralizes an increase in .

In Example 12, the subject matter of Example 10 optionally includes the desired pressure, which can be substantially zero net pressure, wherein the control module reduces the sensed pressure The irrigation source may be configured to control the irrigation source to provide irrigation fluid to the aspiration channel at an irrigation flow rate that substantially counteracts the decrease in .

In Example 13, the subject matter of Example 9 optionally includes a desired pressure, which may be a positive pressure, and the control module, in response to an increase in the sensed pressure, reduces the sensed pressure to substantially the desired pressure. The suction source may be configured to control the suction source to apply suction pressure to the wash channel at a level that maintains a positive pressure level of .

In Example 14, the subject matter of Example 10 optionally includes the desired pressure, which may be a positive pressure, wherein the control module, in response to decreasing the sensed pressure, reduces the sensed pressure to substantially the desired pressure. The irrigation source may be configured to control the irrigation source to provide irrigation fluid to the aspiration channel at an irrigation flow rate such that a positive pressure level of .

In Example 15, the subject matter of Example 9 optionally includes the desired pressure, which may be a negative pressure, and the control module, in response to an increase in the sensed pressure, reduces the sensed pressure to substantially the desired pressure. The suction source may be configured to control the suction source to apply suction pressure to the irrigation channel at a level that maintains the negative pressure level of .

In Example 16, the subject matter of Example 10 optionally includes the desired pressure, which may be a negative pressure, and the control module, in response to decreasing the sensed pressure, reduces the sensed pressure to substantially the desired pressure. The irrigation source may be configured to control the irrigation source to provide irrigation fluid to the aspiration channel at an irrigation flow rate such that a negative pressure level of .

Example 17 is an endoscope including an imaging module, a surgical module, and at least one working channel configured to direct irrigation fluid or suction pressure, and an anatomical environment at an anatomical site within a patient. a user input configured to receive from a user a desired pressure to be applied; a flow sensor configured to sense flow through at least one working channel of the endoscope; and a pressure sensor configured to sense pressure in an anatomical environment of the at least one working channel using the sensed flow rate to detect a channel condition indicative of the presence or absence of a blockage in the detected channel; cleaning fluid or controlling one or more of the irrigation or suction sources, each providing suction pressure, to unclog at least one working channel and to maintain the sensed pressure at substantially the desired level of pressure; and a control module configured to adjust one or more of an irrigation flow rate or an aspiration flow rate through at least one working channel.

Example 18 is a method of unclogging at least one working channel of a medical device during a procedure on a patient. The method comprises the steps of sensing flow through at least one working channel of the medical device via a flow sensor and using the sensed flow to determine a channel condition indicative of a blockage within the at least one working channel. , an irrigation source for providing irrigation fluid or suction pressure, respectively, in response to detecting, via a control module, and detected channel conditions indicating a blockage within the at least one working channel; and controlling one or more of the suction sources to unclog at least one working channel.

In Example 19, the subject matter of Example 18 is directed to clearing at least one working channel, which can continue as long as detected channel conditions indicate that there is a blockage in at least one working channel. Optionally including providing irrigation fluid or suction pressure.

In Example 20, the subject matter of any one or more of Examples 18-19 detects a blockage in at least one working channel in response to a decrease in sensed flow below a first threshold and detecting no blockages in the at least one working channel in response to an increase in sensed flow rate above a second threshold. Include in selection.

In Example 21, the subject matter of any one or more of Examples 18-20 can include alternately applying an irrigation fluid and an aspiration pressure to at least one working channel. Optionally including the step of unclogging the working channel.

In Example 22, the subject matter of any one or more of Examples 18-21 receives, via user input, a desired pressure to be applied to an anatomical environment at an anatomical site within the patient. and sensing the pressure of the anatomical environment at the anatomical site via a pressure sensor; and at least one working channel such that the sensed pressure is maintained substantially at the desired level of pressure. adjusting one or more of the irrigation flow rate or the aspiration flow rate through the .

In Example 23, the subject of Example 22 is the steps of receiving desired flow conditions in at least one working channel corresponding to a desired pressure to be applied to the anatomical environment; and optionally adjusting one or more of the flow rate or the aspiration flow rate to maintain the desired flow conditions.

In Example 24, the subject matter of Example 22 optionally includes at least one working channel that can include an aspiration channel and an irrigation channel. The method comprises controlling an irrigation source to provide irrigation fluid to the aspiration channel in response to a blockage in the aspiration channel; controlling the suction source to apply suction pressure to the irrigation channel to maintain the sensed pressure at substantially the desired level of pressure in response to an increase in the pressure; controlling the aspiration source to apply aspiration pressure to the aspiration channel and controlling the irrigation source to provide irrigation fluid to the irrigation channel in response to .

In Example 25, the subject matter of Example 22 optionally includes at least one working channel that can include an aspiration channel and an irrigation channel. The method comprises controlling a suction source to apply suction pressure to the irrigation channel in response to a blockage in the irrigation channel; controlling the irrigation source to provide irrigation fluid to the aspiration channel to maintain the sensed pressure at substantially the desired level of pressure in response to the decrease in the irrigation channel; controlling the aspiration source to apply aspiration pressure to the aspiration channel and controlling the irrigation source to provide irrigation fluid to the irrigation channel in response to .

This summary is an overview of some of the teachings of the present application and is not intended as an exclusive or exhaustive treatment of the subject matter. Further details about the present subject matter are found in the detailed description and appended claims. Other aspects of the present disclosure will become apparent to those skilled in the art upon reading and understanding the following detailed description and viewing the drawings forming a part thereof. Each of the drawings should not be interpreted in a limiting sense. The scope of the disclosure is defined by the appended claims and their legal equivalents.

Various embodiments are illustrated by way of example in the accompanying drawing figures. Such embodiments are illustrative and not intended to be exhaustive or exclusive embodiments of the present subject matter.

Block showing one example of a system for in situ unclogging a working channel of an endoscope and maintaining pressure of the anatomical environment at a substantially desired level at an anatomical site during a minimally invasive procedure. It is a diagram. 2 illustrates a powered tissue removal device 200 that can be used in a system such as that described with reference to FIG. 1. FIG. 2 illustrates a powered tissue removal device 200 that can be used in a system such as that described with reference to FIG. 1. FIG. 1 illustrates an endoscopic system for unclogging an occluded channel and maintaining pressure in an anatomical environment at substantially a desired level during an endoscopic procedure; FIG. 1 illustrates an endoscopic system for unclogging an occluded channel and maintaining pressure in an anatomical environment at substantially a desired level during an endoscopic procedure; FIG. 3 illustrates an exemplary technique for unclogging a blocked working channel of an endoscope according to one embodiment discussed herein. FIG. 10 illustrates changes in flow in the working channel in the presence of a clog and during the unclogging process. FIG. 10 illustrates changes in flow in the working channel in the presence of a clog and during the unclogging process. FIG. 10 illustrates an exemplary feedback control pressure regulation system for regulating environmental pressure when there is no channel clogging. FIG. 10 illustrates an exemplary feedback control pressure regulation system for regulating environmental pressure when there is a blockage in the suction channel; FIG. 10 is a timing diagram for irrigation/aspiration activation in the aspiration channel during unclogging of a blocked aspiration channel. FIG. 10 is a timing diagram for activating irrigation/aspiration in the irrigation channel to maintain the desired pressure at the anatomical site during unclogging of an occluded aspiration channel. FIG. 10 illustrates an exemplary feedback-controlled pressure regulation system for regulating environmental pressure when there is a blockage in the wash channel; FIG. 10 is a timing diagram for irrigation/aspiration activation in the irrigation channel during unclogging of a blocked irrigation channel. FIG. 10 is a timing diagram for activating irrigation/aspiration in the aspiration channel to maintain the desired pressure at the anatomical site during unclogging of the occluded irrigation channel. FIG. 4 is a flowchart illustrating a method for in situ unclogging a working channel in a medical device during a minimally invasive procedure; FIG. Fig. 10 is a flow chart illustrating a method for in-situ unclogging a working channel of a medical device and maintaining pressure of the anatomical environment at a substantially desired level at an anatomical site;

An endoscope includes a tubular portion that can be inserted into an organ or body cavity to aid in diagnosis or treatment. One or more working channels (eg, aspiration and/or irrigation channels) can be positioned inside the tubular portion and extend along its length. The insertable tubular portion can have a small diameter to reduce the risk of damaging unintended tissue. Therefore, the working channel also has a small lumen diameter. Because tissue debris and foreign bodies (e.g., stones and fragments thereof) typically have dimensions that are one to two lumen diameters in length, some tissue or stone particles can accumulate and clog working channels. There is

As used herein, "clog" refers to tissue debris, stones (e.g., kidney stones or stone fragments) and other material that accumulates to partially or completely block the lumen of a channel and is referred to as "clogging". "Clogging" refers to a condition of partial or complete blockage of the channel lumen. Clogging can occur in any working channel of the endoscope. Clogging in the suction channel can greatly reduce the efficiency of removing tissue debris and calculus debris through the suction channel. Slow or inefficient removal of unwanted material from an anatomical site inhibits or impedes further treatment (e.g., debridement or calculus excision), contaminates the anatomy, and may be at high risk. On the other hand, clogging in the irrigation channel can reduce the volume and/or flow rate of irrigation fluid flowing through the irrigation channel to the anatomical environment. A slow irrigation flow can be less efficient at flushing unwanted material from the anatomy and increases the likelihood of clogging the aspiration channel. Decreased irrigation volumes and flow rates can also affect the surgical element and its cooling effect on the anatomical environment, increasing the potential for heat build-up at the anatomical site. Also, clogging of any working channel blocks the lens of the endoscope, impairs the visibility of the object under examination, and reduces the quality of images taken in the anatomical environment, thereby making the procedure difficult. May increase the degree and time.

Aspiration and irrigation can result in negative and positive pressure changes, respectively, in the anatomical environment at the anatomical site. Negative and positive pressure changes can be harmful to internal organs exposed to anatomical sites if not properly controlled. For example, while the body can accommodate some positive pressure changes, many organs are relatively vulnerable to negative pressure changes. Clogging within a working channel (e.g., aspiration or irrigation channel) disrupts the pressure balance between the positive pressure associated with fluid flow and the negative pressure associated with aspiration, thereby causing internal organs to be harmed at anatomical sites. May expose to excessive positive or negative pressure.

Various approaches have been attempted to prevent or resolve channel clogging in endoscopes. For example, by breaking up unwanted material (eg, tissue debris or calculus fragments) into smaller pieces, the likelihood of clogging the channels can be reduced. However, this consumes more energy, can take longer treatment times, and adds treatment complexity and time, which can increase patient risk. Visibility is reduced visibility of the surgical field due to particulates or stone dust. Conventionally, clearing a blockage is usually done externally, which involves the clinician withdrawing the endoscope from the body, rinsing the blocked endoscope to clear the blockage, inserting the endoscope into the anatomy, and performing the procedure. required to be returned to the target site. This approach increases procedure time, adds inconvenience to the clinician, and can increase surgical risks for the patient. In-situ unclogging of the working channel when the endoscope is inserted and held in place generally requires high pressure washing, which places excessive positive pressure on internal organs. there is a possibility.

The inventors have found that user-input flow rates (e.g., aspiration flow rate and/or irrigation flow rate) can protect internal organs from pressure-related harm while allowing the desired internal pressure to be automatically monitored and stabilized. recognized an unmet need for a capable endoscopy system.

For at least the above reasons, the inventors have determined that clogging conditions within the working channel can be detected and unclogged channels can be unclogged while increasing the efficiency, safety, and success rate of endoscopic procedures. At the same time, they have recognized an unmet need for systems and methods that can keep pressure changes in the anatomical environment under control during a procedure.

Disclosed herein are systems and methods for in-situ unclogging of working channels in an endoscope, such as irrigation or suction channels, during an endoscopic procedure. According to one aspect of this document, a clog clearing system uses flow information sensed by a flow sensor to detect channel conditions indicative of the presence or absence of a clog in a working channel, and alternately adjusts cleaning fluid or suction pressure, for example, to The application can unclog blocked channels. The unclogging system keeps the pressure of the anatomical environment under control, e.g., substantially zero net pressure, or a desired positive or negative pressure as specified by the user, during the procedure. To maintain, one or more of the irrigation or aspiration flow rates through one or more channels inside the endoscope can be adjusted.

The unclogging systems and methods according to various embodiments discussed herein provide an improved solution to in-situ unclogging of an endoscope during an endoscopic procedure. According to various aspects as described herein, the present systems and methods provide an endoscope without repeated insertion and removal of endoscope attachments and accessories for external cleaning and unclogging. Provide the test to the user. Controlled irrigation and suction applied to the same clogged channel, e.g. alternately, as discussed herein, compared to unclogging via high pressure irrigation, which can expose internal organs to the risk of high positive pressure, Provides visceral environmental stabilization. Various embodiments of this unclogging system can unclog channels by effectively separating different sized clogging particles that accumulate and block channels, while allowing dangerous positive or negative pressure changes to internal organs. can be avoided or minimized. As a result, even less invasive procedures can safely and more efficiently remove unwanted material from the anatomy, reducing procedure time, improving patient safety and patient recovery time. can be improved.

FIG. 1 maintains the pressure of the anatomical environment 101 at a substantially desired level at the anatomical site while in situ unclogging the working channel of the endoscope during a minimally invasive procedure on a patient. 1 is a block diagram illustrating an example of a system 100 for System 100 may include medical device 110 and optional components. Optional components may include any of aspiration source 120 , irrigation source 130 , user interface 140 , sensor circuitry 150 , or control module 160 . In various examples, system 100 can have a modular design that increases flexibility and facilitates configuration and replacement of individual components. In one example, user interface 140, sensor circuit 150, and control module 160 may be included in an aspiration/irrigation control unit. The aspiration/irrigation control unit can be fluidly coupled to one or more of instrument 110 , aspiration source 120 , or irrigation source 130 . The aspiration/irrigation control unit can accommodate different types of medical devices and different types of irrigation and aspiration sources. Exemplary aspiration/irrigation control units are discussed below with reference to FIGS. 3A-3B. The aspiration/irrigation control unit can selectively activate or deactivate irrigation and/or aspiration through working channel 111 and adjust one or more of irrigation flow rate, irrigation fluid pressure, aspiration flow rate, or aspiration pressure. . By controlling aspiration and/or irrigation according to the various embodiments discussed herein, blocked channels can be unclogged and pressure in the anatomical environment 101 can be brought to a desired level during the procedure. can be maintained.

Medical device 110 may be used in diagnostic, analytical, or therapeutic applications, including, for example, minimally invasive surgery such as endoscopic procedures. By way of example and not limitation, medical device 110 may be used in a variety of ENT procedures including, but not limited to, joint surgery, plastic surgery, sinus surgery and tonsillectomy, or combinations thereof. . Medical device 110 may be controlled by a user to perform a procedure on an organ or remove organ tissue within anatomical environment 101 . Control of the medical device 110 can include a handpiece or indirect control via, for example, a robotic surgical console or user interface.

An example of medical device 110 may include a tissue removal device that includes a blade assembly configured to rotate and/or reciprocate to remove unwanted tissue from a target anatomy. The blade assembly can be driven by a motor internal to the handpiece or powered by an external energy source. The energy source may also serve other functions, such as providing powered irrigation and suction to the medical device 110, as discussed below. For example, a variety of blade assemblies can be used including shavers, debriders, blades, or bars, among others. Depending on the blade assembly used, the tissue removal device may remove necrotic, cancerous, injured, infected or other unwanted soft tissue, bone, or other anatomical features or objects at the target anatomy. , or can function to scrape, cut, scrape, or otherwise remove from the target anatomy. Exemplary tissue removal devices are discussed below with reference to FIGS. 2A-2B.

Another example of medical device 110 may include an endoscope. Examples of endoscopes are inter alia a cystoscope for examining the bladder, a nephroscope for examining the kidneys, a bronchoscope for examining the bronchi, an arthroscope for examining the joints, and for examining the colon. a colonoscope, a cholangioscope to examine the bile duct region (eg, the bile duct), a duodenoscope to examine the gastrointestinal region, or a laparoscope to examine the abdomen or pelvis. An endoscope can include a light source that illuminates an anatomical environment at an anatomical site and an imaging module that produces an image or video of the anatomical environment during an endoscopic procedure. Some endoscopes, such as endoscopic tissue removal devices, have been configured to scrape, cut, scrape, or otherwise remove portions of unwanted tissue from targeted anatomy. A tissue excision member can be included. The excised tissue residue can then be extracted from the anatomical site. Some endoscopes can include a cutting member configured to break up or remove foreign bodies, such as crystalline mineral structures, from the anatomical environment. For example, a nephroscope can be inserted at least partially into the kidney. Ultrasonic energy, electromagnetic shock waves, or lasers, among other energy modalities, can be delivered to kidney stones to break them into fragments or "stone dust", which are then extracted from the anatomical site. can do. An exemplary endoscope is discussed below with reference to FIGS. 3A-3B.

Medical device 110 includes cut, cut, excised, scraped, or removed tissue, bone, or other anatomical features or objects, stones, and pieces of material, collectively referred to herein as "waste material." , body fluids at the anatomical site, and irrigation fluids. Working channel 111 is selectively coupled to one or more of aspiration source 120 (eg, via an aspiration port on medical device 110) or irrigation source 130 (eg, via an irrigation port on medical device 110). can be done.

Suction source 120 can function to pull, aspirate, draw in, aspirate, or otherwise move or remove unwanted material from an anatomical site. The unwanted material can be moved into a receptacle located at the proximal end of the medical device 110 , inside the handpiece, or away from the medical device 110 . In one example, the handpiece can include a container or reservoir for at least temporarily collecting unwanted material before the handpiece is cleaned and the collected material is removed. Suction source 120 may perform the functions described above by generating and applying a vacuum, suction, or negative pressure to working channel 111 of medical device 110 . In one example, suction source 120 can be separate from medical device 110 and connected to medical device 110 via one or more tubes, wires, or hoses. In another example, suction source 120 can be included in or attached to medical device 110 . For example, the suction source 120 can be included in a tissue removal device or endoscopic handpiece. The suction source can be powered by an energy source that also powers the medical device, or can be powered by its own energy source.

The irrigation source 130 can function to provide irrigation fluid to the working channel 111 to assist in the removal of unwanted material (eg, tissue debris or calculus debris) passing through the working channel 111 . The irrigation fluid may also cool the tissue removal device or ablation element during rotary or reciprocating debridement or ablation and help dissipate heat generated during calculus fragmentation. The cleaning fluid can be gravity fed or pressurized. In one example, the irrigation source can include a bag that is lifted against the medical device 110 and the anatomical site to produce a gravity-fed irrigation fluid. In another example, a pump can generate a pressurized wash flow. Cleaning fluid can be provided to and through the external fluid supply tube and drawn into the working channel 111 from the cleaning source 130 or where the cleaning fluid is contained. Under the suction pressure provided by suction source 120, the irrigation fluid, along with unwanted material, can flow proximally of working channel 111 and be removed from the anatomy.

In one example, a single working channel 111 can be used for both irrigation and aspiration. Control module 160 can controllably activate irrigation and aspiration through working channel 111 at separate times. In another example, medical device 110 can include two or more separate working channels, such as aspiration channel 112 and irrigation channel 114, as shown in FIG. Aspiration channel 112 may be controllably connected to a source of aspiration 120 to direct unwanted material being aspirated through aspiration channel 112 . Wash channel 114 may be controllably connected to wash source 130 to direct wash fluid through wash channel 114 . In one example, suction channel 112 can be controllably connected to irrigation source 130 . In one example, irrigation channel 114 can be controllably connected to suction source 120 . Irrigation and aspiration, according to the various examples discussed herein, are used to remove unwanted material, unclog one or more working channels, generate during a procedure at a tissue site, among other things. It can help transfer the heat produced, maintain pressure in the anatomical environment at a desired level, and maintain desired flow conditions within the working channel corresponding to the desired pressure.

In one example, suction channel 112 and irrigation channel 114 can be arranged in a parallel orientation along the length of the tubular portion of the handpiece of medical device 110 . In one example, aspiration channel 112 and irrigation channel 114 can be arranged coaxially about a common axis, like a nested structure. In one example, medical device 110 includes an outer member and an inner member disposed within the outer member. A suction channel 112 can be disposed inside the inner member. The wash channel 114 can be located outside the outer member. In some configurations, in addition to or instead of supplying cleaning fluid through cleaning channel 114, cleaning fluid is defined between the inner and outer members of medical device 110, hereinafter referred to as the "cleaning gap." It can be fed through the gap. One of the irrigation channels 114 or the irrigation gaps can be selectively activated to supply irrigation fluid to the medical device 110 . In some examples, both the cleaning channel 114 and the cleaning gap can be activated to simultaneously supply cleaning fluid. This advantageously allows the clinician to control how much irrigation fluid is used during the procedure. For example, when more tissue debris or stone debris is being generated, or if a clog is detected within the channel, both the cleaning channel 114 and the cleaning gap may be activated to dispense a greater amount of fluid to the medical device 110 . can be provided to

Control module 160 controls the operation of medical device 110, including one or more of tissue resection or stone removal, lighting, imaging, irrigation, and aspiration, among other functionality during an endoscopic procedure. Can be configured. In one example, the control module 160 is a dedicated processor, application specific integrated circuit (ASIC), microprocessor, or to process information and generate control signals to activate, deactivate, or modify the operation of the components of the system 100. can be implemented as part of a microprocessor circuit, such as other types of processors. Alternatively, microprocessor circuitry may be a processor capable of receiving and executing instructions to perform the functions, methods, or techniques described herein.

Control module 160 can be at least partially implemented in a unit separate from medical device 110, such as those shown in FIGS. 3A-3B. Alternatively, portions of control module 160 may be integrated into or otherwise attached to medical device 110 . In some examples, control module 160 may include a set of circuits that alone or in combination perform the functions, methods, or techniques described herein. In one example, circuit set hardware can include permanently connected components (eg, hardwired) that are designed to perform specific operations. In one example, the circuit set hardware is variable, including computer-readable media physically modified to encode instructions for specific operations (e.g., magnetically, electrically movable arrangements of invariant mass particles, etc.). may include physical components (eg, execution units, transistors, simple circuits, etc.) connected to the . In connecting physical components, the underlying electrical properties of hardware components are changed, for example, from insulator to conductor or vice versa. The instructions allow embedded hardware (eg, an execution unit or loading mechanism) to create members of a set of circuits in hardware via variable connections to perform some particular operation during operation. Accordingly, the computer readable medium is communicatively coupled to other components of the circuit set member when the device is in operation. In one example, any of the physical components can be used in more than one member of more than one circuit set. For example, during operation, an execution unit may be used in a first circuit of a first circuit set at one point in time, by a second circuit in the first circuit set, or at a different time by a second circuit in the second circuit set. 3 circuits can be reused.

As shown in FIG. 1 , control module 160 is coupled to user interface 140 and receives user commands from user interface 140 to activate, deactivate, or adjust one or more functionalities of medical device 110 . can be done. User interface 140 may be at least partially integrated with or otherwise attached to medical device 110 . Alternatively, user interface 140 may be separate from medical device 110, such as in the exemplary system shown in FIGS. 3A-3B. User interface 140 can be movable and can be attached to medical device 110 and fluid systems (eg, pumps, irrigation). In one example, user interface 140 can include one or more user controls that allow a user (eg, a clinician) to turn suction on or off or adjust suction flow rate or suction pressure. . User controls can be located on a mobile user interface separate from medical device 110 . Alternatively, the user controls can be located on the medical device 110, such as the handpiece of an endoscope or tissue removal device, such as the device shown in Figure 2A. Control module 160 can respond to user commands to activate or deactivate aspiration flow from aspiration source 120 or to increase or decrease the aspiration pressure applied to working channel 111 to achieve a desired aspiration flow rate. can. Likewise, user interface 140 includes one or more user controls that allow a user to turn cleaning on or off, or adjust cleaning flow rate or cleaning fluid pressure (eg, via a pump). be able to. The control module 160 can activate or deactivate the wash flow from the wash source 130 or increase or decrease the wash flow through the working channel 111 in response to user commands.

In some examples, a user control on user interface 140 provides a pressable flush that, when pressed repeatedly, cycles through one or more flush and/or suction levels before turning off flush and suction. Control buttons can be included. In some instances, a single control can control irrigation and aspiration together. Other suitable control elements may also be used, such as positionable slides, positionable levers, or positionable dials that can designate irrigation and/or aspiration levels. In some examples, user interface 140 allows a user to select from one of a plurality of designated discrete irrigation or aspiration levels, or alternatively select irrigation levels in a continuous (eg, non-discrete) manner. Alternatively, it becomes possible to specify the suction level.

In addition to or instead of independently controlling aspiration and irrigation, control module 160 can automatically control one of irrigation or aspiration based on the status of the other of irrigation or aspiration. In one example, the control module 160 automatically turns on suction when the medical device is powered or when the irrigation source 130 supplies irrigation fluid to the medical device 110, and turns on suction when the medical device is unpowered or irrigation. Suction can be turned off automatically when the source 130 stops supplying irrigation fluid to the medical device 110 . In one example, the control module 160 automatically adjusts the irrigation flow rate or fluid volume (e.g., by activating or deactivating flow within an irrigation gap defined between the inner and outer members) in response to the aspiration flow rate. can do. For example, when aspiration increases (e.g., due to a large amount of unwanted material to be removed), control module 160 automatically increases the wash flow rate, or directs wash fluid through both wash channel 114 and the wash gap. can supply. Conversely, when aspiration decreases (e.g., due to less unwanted material to be removed), control module 160 automatically decreases the wash flow rate, or the wash channel 114 or wash gap, but not both. The cleaning fluid can be supplied only through the

Control module 160 detects channel conditions indicating the presence or absence of a blockage within working channel 111 and controls one of suction sources 120 or irrigation sources 130 to provide suction pressure or irrigation fluid, respectively, to unclog a blocked working channel. A clog controller 161 configured to control one or more may be included. In one example, clog controller 161 can monitor channel conditions and detect channel clogs based on flow information in working channel 111 . Sensor circuitry 150 may include circuitry coupled to a flow sensor disposed inside working channel 111 and configured to sense the flow or volume of the moving liquid in working channel 111 . Flow sensors, such as microelectromechanical system (MEMS) sensors, can employ various flow measurement techniques. By way of example and not limitation, flow sensors include, among others, thermal anemometers that measure the rate of transfer of heat generated from a heat source, differential pressure sensors that measure pressure drop over a range of locations, frequency shift or travel/time of flight measurements. Ultrasonic flow sensors that measure the Doppler effect, electromagnetic sensors that measure changes in fluid conductance indicative of flow can be included.

The clog controller 161 can detect channel clogs using flow information sensed by flow sensors. In one example, the clog controller 161 can detect a channel clog in response to a decrease in sensed flow below a first flow threshold, and an increase in sensed flow to reach a second flow threshold. , the absence of a clog or successful unclogging of a blocked working channel can be detected. In another example, the stability of the flow rate inside the channel, such as when the variability of the flow rate measurement exceeds a threshold, can be used to detect channel clogging. In some examples, the clog controller 161 can detect channel clogging by comparing the inflow of fluid into the channel with the outflow of fluid out of the channel. A discrepancy between the inflow and outflow such that the outflow is substantially lower than the inflow (exceeds the specified tolerance) indicates the presence of channel blockage.

When there is a channel clog, the clog controller 161 may be configured as discussed above (e.g., suction source 120 provides suction pressure to suction channel 112 and irrigation source 130 provides irrigation fluid flow to irrigation channel 114). ) It can automatically switch from the standard mode of flushing/suction operation to the unclogging mode of flushing/suction operation. To unclog a blocked channel, the clog controller 161 may alternate between applying a cleaning fluid to the blocked channel and applying suction pressure. Referring now to FIG. 4A, a diagram therein illustrates a channel unblocking technique according to one embodiment discussed herein. FIG. 410 shows fluid-filled channel 411 blocked by blockage 412 during the standard mode of irrigation operated by irrigation source 140 . The blockage 412 contains tissue debris or calculus fragments of different sizes. As shown in FIG. 410, smaller particles such as particle 412A are located proximally and larger particles such as particle 412B are located distally. FIG. 420 shows switching from standard mode to unclogging mode, where clog controller 161 fluidly couples suction source 120 to the proximal portion of channel 411, activates suction source 120, and provides a specified suction duration, A suction pressure is applied to channel 411 . A user can adjust suction pressure and suction duration via user interface 140 . Plugging particles of different sizes (and therefore different masses) can respond differently to applied suction pressure. For example, smaller particles 412A can travel longer distances moving towards the proximal end of the channel at a faster velocity than larger particles 412B during (and after) application of suction. As a result, some particles can be removed from the clog 412 and separated from the larger particles.

FIG. 430 shows fluid-filled channel 411 blocked by blockage 413 during the standard mode of suction operated by suction source 120 . The particles in clog 413 accumulate differently than in clog 412, with smaller particles such as particle 413A located distally and larger particles such as particle 413B located proximally. FIG. 440 illustrates switching from standard mode to unclogging mode, where clog controller 161 fluidly couples irrigation source 140 to the proximal portion of channel 411 and activates irrigation source 140 to apply irrigation fluid to the designated irrigation fluid. Wash channel 411 for the specified wash duration. The user can adjust the wash flow rate, or pressure at which the wash fluid is pumped, and the wash duration. Clogging particles of different sizes (and therefore different masses) can react differently to the rinse cleaning fluid. For example, smaller particles 413A can travel longer distances moving towards the distal end of the channel at a faster velocity than larger particles 413B during (and after) a wash application. As a result, some particles can be removed from clog 413 and separated from larger particles.

Separated particles can be extracted down working channel 411 using additional washing and/or suction. In one example, one or more of the suction pressure, suction flow rate, wash flow rate, or pump pressure to pressurize the wash fluid can be varied (eg, via user interface 140) to separate particles by size. For example, a higher flow rate can be applied through channel 411 to remove larger particles and a lower flow rate can be applied to remove smaller particles.

Figures 4B-4C illustrate changes in flow in the working channel in the presence of a clog and during the unclogging process. FIG. 4B shows changes in flow in a clogged wash channel such as shown in diagrams 410 and 420 of FIG. 4A. A flow sensor placed in the wash channel can be used to measure flow parameters such as flow rate. Flow measurements (on the y-axis) have values between -1 and 1. A positive flow value represents a flow direction toward the distal end of the aspiration channel (or toward the anatomical environment 101, see diagram 410 in FIG. 4A). A negative flow value represents flow in the opposite direction, ie, toward the proximal end of the aspiration channel (or away from the anatomical environment 101, see diagram 420 in FIG. 4A). Flow rate measurements are for unobstructed flow through the wash channel. That is, a flow value of "1" represents flow during irrigation of an unoccluded channel, and a flow value of "-1" represents flow during aspiration of an unoccluded channel.

During the standard mode of cleaning of an unplugged cleaning channel, a positive flow F0 of approximately "1" value can be detected by the flow sensor. As shown, flow F0 contains fluctuations superimposed on the constant flow, indicating small debris being aspirated. At T1, the flow rate is reduced to F1 (less than F0). A jam is detected if the decrease in F0-F1 exceeds the jam detection threshold. In this example, F1 is at a level greater than zero, indicating that the channel is not completely blocked and washing continues. Particles continue to accumulate until the flow rate drops to F2 at T2. F2 is nearly zero, indicating substantial channel blockage (as shown in diagram 410 of FIG. 4A). The unclogging mode can be activated at T2 or at times corresponding to particular (eg, user-specified) flow conditions. Suction can be applied to the occluded channel to draw fluid and clots in the occluded channel toward the proximal end of the aspiration channel (as shown in view 420 of FIG. 4A). A negative flow F3 can be sensed by a flow sensor. As discussed above with reference to view 420 of FIG. 4A, aspiration can break up the clog, allowing smaller sized particles to dissociate from the rest of the clog and dissociate toward the proximal end of the channel. Will travel longer distances. Aspiration can continue while the channel is unclogged, allowing negative flow F3 to reach near maximum (“−1”, indicating substantially unobstructed flow) at T3. Become. Suction can be applied for a specified duration of suction time and stopped at T4 after dislodged particles have been extracted from the channel. The negative flow can then be reduced to substantially zero flow F4. At T5, the standard wash mode is resumed by applying wash fluid to the non-clogged channels. When the channel is successfully unclogged and particles are removed from the channel, a positive flow F5 with a value of approximately "1" can be sensed by the flow sensor.

FIG. 4C shows changes in flow in a clogged aspiration channel, such as shown in diagrams 430 and 440 of FIG. 4A. A flow sensor placed in the suction channel can be used to measure flow parameters such as flow rate. Flow measurements (on the y-axis) have values between -1 and 1. A positive flow value represents a flow direction toward the proximal end of the aspiration channel (or away from the anatomical environment 101, see diagram 430 in FIG. 4A). A negative flow value represents flow in the opposite direction, ie, toward the distal end of the aspiration channel (or toward the anatomical environment 101, see view 440 in FIG. 4A). Flow measurement values are for unobstructed flow through the suction channel. That is, a flow value of '1' represents flow during aspiration of an unoccluded channel, and a flow value of '-1' represents flow during irrigation of an unoccluded channel.

During a standard mode of suction applied to a non-clogged suction channel, a positive flow F0 of approximately "1" value can be detected by the flow sensor. As shown, flow F0 contains fluctuations superimposed on the constant flow, indicating small debris being aspirated. At T1, the flow rate is reduced to F1 (less than F0). A jam is detected if the decrease in F0-F1 exceeds the jam detection threshold. In this example, F1 is at a level greater than zero, indicating that the channel is not completely blocked and aspiration continues. Particles continue to accumulate until the flow rate drops to F2 at T2. F2 is nearly zero, indicating substantial channel blockage (as shown in diagram 430 of FIG. 4A). The unclogging mode can be activated at T2 or at times corresponding to particular (eg, user-specified) flow conditions. Irrigation fluid can be injected into the occluded channel toward the distal end of the aspiration channel and toward the anatomical environment (as shown in view 440 of FIG. 4A). A negative flow F3 can be sensed by a flow sensor. As discussed above with reference to view 440 of FIG. 4A, the cleaning fluid can break up the clog, allowing smaller sized particles to dissociate from the rest of the clog and move toward the distal end of the channel. to move longer distances. While the channel is unclogged, washing continues, allowing the negative flow F3 to reach near maximum (“−1”, indicating substantially unobstructed flow) at T3. After applying the wash for a specified period of wash time, the wash can be stopped at T4. As the separated particles settle in the channel, the negative flow rate can then decrease to substantially zero flow F4. At T5, the standard suction mode is resumed by applying additional suction to extract dislodged particles from the channel. A positive flow F5 of approximately "1" value can be sensed by the flow sensor when the channel is successfully unclogged and particles are removed from the channel.

In some examples, aspiration pressure and irrigation fluid can be alternately and repeatedly applied to channel 411 . This allows more efficient separation of the particles of the clog without the need for prior knowledge or determination of the structure of the clog 412 . Also, continuous application of suction followed by occasional rinsing can help reduce the occurrence of clog formation. The sensor circuit 150 can monitor the flow rate during repeated alternating applications of aspiration and irrigation. Unclogging operations, including application of irrigation fluid or suction pressure to the blocked channel, can continue as long as the channel clog exists. Successful unclogging of the blocked channel is considered when the monitored flow increases and exceeds the threshold. The clog controller 161 can switch from the unclog mode of operation back to the standard mode of flush/suction operation.

Returning to FIG. 1, the control module 160 keeps the pressure of the anatomical environment (also referred to as "environmental pressure") under control, e.g. (as specified by a user via user interface 140). In one example, if the difference between the environmental pressure measurement (eg, by a pressure sensor) and the desired pressure is within an acceptable range, such as ±5% to 10% as a non-limiting example, then the environmental pressure is the desired pressure. assumed to be maintained at a pressure level. A desired pressure level to be maintained at an anatomical site of the anatomical environment 101 can be received from the user interface 140 . As mentioned above, aspiration can result in negative pressure changes at the anatomic site, while irrigation can result in positive pressure changes at the anatomic site. Negative and positive pressure changes can adversely affect internal organs exposed to anatomic sites. Maintaining the environmental pressure at a controlled pressure level can increase patient safety and effectively reduce treatment time. In some examples, in addition to or instead of receiving desired pressure levels, desired flow conditions may be received, for example from user interface 140 . Desired flow conditions include information about inflow (eg, flow rate of irrigation fluid applied to the anatomical environment) versus outflow (eg, flow rate of aspiration applied to the anatomical environment). Desired flow conditions correspond to desired pressures to be applied to the anatomical environment. For example, desired flow conditions of substantially equal inflow and outflow correspond to substantially zero net environmental pressure, desired flow conditions of higher inflow than outflow correspond to positive environmental pressure, and outflow Desired flow conditions of lower inflow than volume correspond to negative environmental pressure. Pressure controller 162 can control one or more of irrigation or aspiration flow rates through one or more working channels to maintain desired flow conditions during treatment.

Pressure controller 162 can achieve controlled pressure by automatically activating, deactivating, or adjusting one or more of aspiration or irrigation. Sensor circuitry 150 may monitor the pressure of the anatomical environment (“environmental pressure”) during an endoscopic procedure. In one example, sensor circuitry 150 may be coupled to a pressure sensor to sense environmental pressure, or a signal indicative of, or otherwise correlated to, environmental pressure. Examples of pressure sensors can include resistive, capacitive, piezoelectric, optical, or micro-electromechanical system (MEMS) pressure sensors. In one example, a pressure sensor is attached to or integrated into a distal portion of medical device 110, such as the distal tip of an insertable tubular portion of an endoscope, such that the pressure sensor is in contact with anatomical environment 101. be able to. In one example, the pressure sensor can be placed at a more proximal location inside the tubular portion of the endoscope away from the anatomical environment 101 . Control module 160 may receive from user interface 140 the desired environmental pressure to be maintained during treatment. The control module 160 can compare the sensed environmental pressure to the desired environmental pressure and adjust one or more of the irrigation or suction flow rates to direct the environmental pressure to the desired level of the environmental pressure.

System 100 in wash/aspirate normal mode (when no clog is detected in any working channel) and in wash/aspirate clearing mode (when at least one, but not all, of the working channels is clogged). When actuated, pressure controller 162 can maintain a controlled environmental pressure. An exemplary system for regulating environmental pressure via automatic adjustment of aspiration and/or irrigation flow rates is shown in FIG. 5 (when there is no channel clogging) and FIGS. 6-7 (when there is channel clogging). are discussed below.

User interface 140 provides, for example, images of the surgical field (including live video), operational status of medical device 110 including status of working channel 111, information about channel status such as channel clogging or successful clearing, and An output unit, such as a display, can be included that presents information collected during the endoscopic procedure, including environmental pressure as sensed by sensor circuit 150 .

FIG. 2A shows a perspective view of a powered tissue removal device 200 , which is an example of a medical device 110 . Powered tissue removal device 200 can include handpiece 210 and tubular assembly 222 extending from handpiece 210 . Tubular assembly 222 includes a proximal portion 226 disposed on handpiece 210 and an opposing distal portion 228 . Although distal portion 228 is shown as a "straight shaft" aligned with the rest of tubular assembly 222, in some examples, distal portion 228 includes proximal portion 226 of tubular assembly 222. Can be bent or slanted with respect to the rest.

An exemplary configuration for distal portion 228 is shown in FIG. 2B. Tubular assembly 222 includes an outer tubular member 252 and an inner tubular member 254 disposed inside outer tubular member 252 . Outer member 252 includes an outer member window 262 . The inner member 254 includes a cutting portion 264 and an aspiration channel 274 defined inside the inner member 254 . Inner member 254 or cutting portion 264 includes an inner member window 266 that communicates with aspiration channel 274 .

Powered tissue removal device 200 includes an irrigation channel 272 disposed on the exterior or outside of outer member 252 . Wash channel 272 extends along the length of outer member 252 . The proximal end of irrigation channel 272 includes a proximal irrigation port 282 in fluid communication with irrigation source 230 and the distal end of irrigation channel 272 is a distal irrigation port attached to powered tissue removal device 200 or outer member 252 . Including port 284 .

Powered tissue removal device 200 can be coupled to energy source 240 , suction source 220 , and irrigation source 230 . Energy source 240 is configured to power powered tissue removal device 200, suction source 220, irrigation source 230, or a combination thereof. A suction source 220 , which is one embodiment of suction source 120 , can be in fluid communication with a suction channel 274 defined inside inner member 254 . Suction source 220 is configured to apply suction to or draw vacuum from powered tissue removal device 200 via suction channel 274 . Irrigation source 230 , which is one embodiment of irrigation source 130 , can be in fluid communication with irrigation channel 272 disposed on the exterior or exterior of outer member 252 . The cleaning source 230 may alternatively or additionally be in fluid communication with the gap between the inner member 254 and the outer member 252 .

Powered tissue removal device 200 includes one or more user controls 224 for operating powered tissue removal device 200, energy source 240, suction source 220, irrigation source 230, or combinations thereof. By way of example and not limitation, user controls 224, which are embodiments of user interface 140, may be located on handpiece 210 for easy access and manipulation by a user during a procedure. In one example, user controls 224 allow the user to manually control debridement, activate, deactivate, or adjust one or more of the irrigation or aspiration flow rates, among other irrigation or aspiration parameters. become.

Powered tissue removal device 200 includes a control module (not shown) located at least partially inside handpiece 210 . The control module, which may be an embodiment of the control module 160, is powered in response to user commands from the user controls 224, including one or more of tissue wiping, irrigation, aspiration, among other functionality. It can be configured to control the operation of tissue removal device 200 . In one example, the control module detects clogging in a working channel (e.g., unified irrigation/aspiration channel, or separate irrigation or separate aspiration channels) based on flow sensed from the working channel, e.g. A blocked channel can be unclogged by alternately applying irrigation fluid to the closed channel and applying suction pressure. The control module keeps the pressure of the anatomical environment (“environmental pressure”) under control, e.g. One or more of the irrigation flow parameters or one or more aspiration flow parameters can be actuated and adjusted to maintain the desired pressure.

FIGS. 3A-3B each show, by way of example, endoscopic systems 300A and 300B for use in endoscopic procedures. Endoscopic systems 300 A and 300 B are embodiments of system 100 . Referring to FIG. 3A, system 300A includes endoscope 310A, suction source 320, irrigation source 330, and aspiration/irrigation control unit 340. As shown in FIG. Endoscope 310 A, which is an example of medical device 110 , can extend into a sheath that includes tube 311 extending from a distal end to hub 312 . Hub 312 terminates at the proximal end. Endoscope 310 may include optical port 314 and visual port 315 . Light port 314 provides light into and out of endoscope tube 311 so that features of interest (e.g., resected tissue or stones and material) in the anatomical environment are illuminated. can function. For example, light ports are advantageous for enhancing visibility when features of interest are located in low light conditions. The viewing port 315 can function to provide a viewing window that allows the user to view features of interest. In one example, vision port 315 can be an optical window at the proximal end that provides visual access to a viewing lens at the distal end. In another example, the vision portion 315 can provide a connection point to a camera that captures images or videos of features of interest and the anatomical environment. Images or movies can be output and displayed on a monitor.

Endoscope 310A may include an irrigation/aspiration port 313 for receiving aspiration or irrigation fluids. Irrigation/aspiration port 313 may be located external to hub 312 or elsewhere on endoscope 310A, such as the proximal end of endoscope 310A. Irrigation/aspiration port 313 opens into a working channel (not shown) inside tube 311 . The working channel can be sized, shaped, and configured to transport and/or aspirate wash fluid. In one example, the same working channel can be used for irrigation and aspiration (also referred to as a unified irrigation/aspiration channel). In another example, the irrigation and aspiration channels are positioned separately within tube 311 .

In one example, endoscope 310 can be a nephroscope. In use, the flexible distal portion of tube 311 can be surgically inserted into the patient's kidney. A proximal portion of tube 311 can remain outside the patient. The inside of tube 311 may contain optical fibers that extend along the length of endoscope 310 . The optical fiber can be multimode fiber or single mode fiber. A laser external to the nephroscope can generate the laser beam. A laser beam can be coupled to the proximal end of the optical fiber through a suitable connector. An optical fiber can deliver a laser beam to the kidney stone to cut it into pieces. In some examples, the laser beam can have wavelengths corresponding to spectral peaks of absorption of human blood and saline, such as 2100 nm, 1942 nm, and the like. In general, it may be beneficial to deliver laser beams that are highly absorbed by blood and saline, since such laser beams can be minimally invasive to surrounding tissue, thereby reducing renal failure. This is because it can reduce or eliminate damage to the calculus or nearby tissue. A laser controller can be located on the grippable proximal portion of the endoscope 310 . Similar to user control 224, which allows manual control of debridement as shown in FIG. It may be possible to switch the state of the beam. In some examples, the user can adjust one or more settings of the laser, such as output power, on the housing of the laser rather than through the laser controller.

The aspiration/irrigation control unit 340 provides aspiration and irrigation to the endoscope 310 during an endoscopic procedure while keeping the pressure of the anatomical environment under control, e.g. It can be maintained at a pressure level (eg, a user-specified pressure and a tolerance such as ±5% to 10%). Aspiration/irrigation control unit 340 may include a pressure monitor (which is one embodiment of sensor circuit 150), a control module (which is one embodiment of control module 160), a pump, and a power supply. The control module can communicate with a user interface 341 (which is one embodiment of user interface 140), such as located external to the aspiration/irrigation control unit 340, for controlling the control module.

Aspiration source 320 may be connected to aspiration/irrigation control unit 340 via external aspiration line 326 . The aspiration/irrigation control unit 340 was configured to control the aspiration between the aspiration source 320 and the endoscope 310 such that the aspiration could be turned off during all or part of the irrigation fluid application cycle. A control valve 342 is included. The irrigation source 330 can be connected to the aspiration/irrigation control unit 340 via an external irrigation line 336 . A pump included in aspiration/irrigation control unit 340 can pressurize the irrigation fluid prior to entering endoscope 310 via irrigation line 336 . As shown in FIG. 3A, the external aspiration line 326 and the external irrigation line 336 can be connected together at a common fitting 350 that provides fluid to the endoscope 310 via the irrigation/aspiration port 313 . Or it can be coupled to a common line 356 for supplying suction.

A control module within aspiration/irrigation control unit 340 may be configured to control operation of endoscope 310 in response to user commands from user interface 341 . In one example, the control module detects clogging in a working channel (e.g., unified irrigation/aspiration channel, separate irrigation channel, or separate aspiration channel) based on sensed flow rate from the working channel, e.g. Blocked channels can be unclogged by alternating application of fluid and suction pressure. The control module keeps the pressure of the anatomical environment (“environmental pressure”) under control, for example, substantially reducing the environmental pressure to a user-specified pressure level, as discussed above with reference to FIG. One or more of the irrigation flow parameters or one or more aspiration flow parameters can be automatically activated and adjusted to maintain.

System 300B as shown in FIG. 3B is similar to system 300A and includes endoscope 310B, suction source 320, irrigation source 330, and control aspiration/irrigation control unit 340. As shown in FIG. Similar to endoscope 310A, endoscope 310B can include tube 311 , hub 312 , optical port 314 , and optical port 315 . However, instead of a single irrigation/aspiration port 313, endoscope 310B includes separate aspiration port 313A and irrigation port 313B adapted to be in fluid communication with aspiration source 320 and irrigation source 330, respectively. Aspiration source 320 is fluidly coupled to aspiration port 313A via external aspiration line 326 . Wash source 330 is fluidly coupled to wash port 313B via external wash line 336 . Aspiration port 313 A and wash port 313 B can each open into one or more working channels inside tube 311 . In one example, the irrigation and aspiration channels are positioned separately within tube 311 . Aspiration port 313A can selectively open to either the aspiration channel or the irrigation channel. Similarly, wash port 313B can selectively open into an aspiration channel or a wash channel inside tube 311 .

FIG. 5 is a diagram illustrating an exemplary feedback-controlled pressure regulation system 500 , which is one embodiment of the environmental pressure control portion of system 100 . System 500 operates in a normal mode of irrigation/aspiration (e.g., controls aspiration source 120 to provide aspiration pressure to aspiration channel 112, irrigation channel 114 to The irrigation source 130 can be configured to regulate the environmental pressure at the anatomical site when controlling the irrigation source 130 to provide a flow of irrigation fluid to the anatomical site. System 500 can regulate environmental pressure through automatic adjustment of aspiration and/or irrigation flow rates in aspiration channel 112 and irrigation channel 114, respectively. In one example, the longitudinal axis of suction channel 112 and the longitudinal axis of irrigation channel 114 can be parallel to each other. In one example, aspiration channel 112 and irrigation channel 114 can be arranged coaxially on a common axis, eg, in a nested configuration. In one example, irrigation and aspiration can be applied at different times through the same working channel, such as a unified irrigation/aspiration channel. Pressure monitor 550 can monitor pressure in anatomical environment 101 via pressure sensor 352 . By way of example and not limitation, control module 160 may include a proportional-integral (PI) controller, or a proportional-integral-derivative (PID) controller, among other feedback controllers. The difference between the sensed pressure (at the pressure monitor 550) and the desired pressure, also called "error," can be used to determine the P, I, or D terms in the feedback controller.

Depending on the desired pressure (or desired flow conditions) provided by the user, the system 500 applies (substantially equal inflows of irrigation fluid applied to the anatomical environment and in a steady pressure mode when the desired pressure is substantially net zero (corresponding to the desired flow condition of suction outflow) or to the desired flow condition of imbalance between inflow and outflow. The pressure control mode can be operated when the desired pressure (corresponding) is positive or negative. When operating in steady pressure mode, the irrigation flow rate or aspiration flow rate can be manually adjusted by the user, eg, via respective user controls on user interface 140 . During an endoscopic procedure, an increase in irrigation flow can result in an increase in environmental pressure at the anatomical site, which can be sensed by pressure monitor 550 . Control module 160 can responsively activate aspiration by applying aspiration pressure to aspiration channel 112 . Suction can create a negative pressure to offset the increase in pressure created by irrigation. The control module 160 can adjust the aspiration flow rate or aspiration pressure until the pressure increase (due to increased irrigation) is substantially neutralized by the aspiration flow. The environmental pressure can then be brought to substantially zero and maintained.

Similarly, increased aspiration flow can result in decreased environmental pressure at the anatomical site. The control module 160 can activate cleaning on the fly by providing a flow of cleaning fluid to the cleaning channel 114 . Irrigation can create a positive pressure to offset the reduction in pressure created by aspiration. The control module 160 can adjust the wash flow rate until the pressure drop (due to increased suction) is substantially neutralized by the wash flow. The environmental pressure can then be brought to substantially zero and maintained.

In some situations, it is desirable to maintain positive or negative environmental pressure at an anatomical site. Controlled positive pressure within safe limits may dilate anatomical structures (e.g., ureters, kidneys, uterus, or other organs) during endoscopic procedures, causing tissue damage due to excessive positive pressure. However, it can help to allow better visibility of the anatomy through the endoscope. The positive pressure can prevent tissue debris or calculus debris from lodging the anatomy and assist in removing tissue debris or calculus debris from the anatomy. In some cases, maintaining a controlled negative pressure within a safe range during an endoscopic procedure permits extraction of debris from the anatomy without exposing internal organs to the risk of excessive negative pressure. It can also be made easier.

System 500 can operate in a pressure control mode when a positive desired environmental pressure is provided by a user, for example via user interface 140 . The control module 160 can automatically increase the irrigation flow rate through the irrigation channel 114 to increase the positive environmental pressure at the anatomical site. Additionally or alternatively, control module 160 can automatically decrease the aspiration flow rate through aspiration channel 112 to reduce negative pressure at the anatomical site. Automatic adjustment of irrigation and/or suction can continue until the sensed environmental pressure substantially reaches the desired level of positive pressure.

Similarly, system 500 can operate in a pressure control mode when a negative desired environmental pressure is provided by a user, eg, via user interface 140 . The control module 160 can automatically increase the aspiration flow rate through the aspiration channel 112 to increase the negative environmental pressure at the anatomical site. Additionally or alternatively, the control module 160 can automatically decrease the irrigation flow rate through the irrigation channel 114 to reduce the positive pressure at the anatomical site. Automatic adjustment of irrigation and/or suction can continue until the sensed environmental pressure substantially reaches the desired level of negative pressure.

The control module 160 may include a safety mechanism that keeps 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 environmental pressure reaches the upper positive pressure limit, the control module 160 can automatically stop, reduce, or maintain the wash flow at the current amount to prevent further increases in environmental pressure. Similarly, if the sensed environmental pressure reaches the lower negative pressure limit, the control module 160 may automatically stop, reduce, or maintain the aspiration flow at the current amount to prevent further reduction of the environmental pressure. can be done. When the system operates in pressure control mode, the desired positive pressure and desired negative pressure received from the user are checked to ensure that the desired positive pressure and desired negative pressure are within safe limits. In one non-limiting example, the desired positive pressure is 5 pounds per square inch (psi) (or about 34.5 kilopascals (kPa)) and the desired negative pressure is -5 psi (or about -34.5 kPa). ) and the safe range is between a lower limit of −6 psi (or about 41.4 kPa) and an upper limit of 6 psi (or about 41.4 kPa). In one example, if the desired positive pressure received from the user exceeds the upper positive pressure limit, or if the desired negative pressure is below the safe negative pressure limit, an alert can be issued (eg, from user interface 140). . With such a safety mechanism, control module 160 can maintain environmental pressure at a user-specified level while preventing or minimizing excessive positive or negative pressure on the anatomical environment during a procedure.

FIG. 6A is a diagram illustrating an exemplary feedback-controlled pressure regulation system 600 , which is one embodiment of system 100 . System 600 can be configured to regulate the pressure of anatomical environment 101 (“environmental pressure”) when there is a blockage within suction channel 112 . As discussed above with reference to FIG. 4A, when a clog in suction channel 112 is detected, clog controller 161 of controller module 160 applies suction pressure to suction channel 112 in a standard mode (see FIG. 5). , can be switched to a unclogging mode in which the irrigation source 130 is fluidly coupled to the aspiration channel 112 to provide a irrigation flow to the aspiration channel 112 .

Applying an irrigation flow to the suction channel 112 can result in increased anatomical pressure at the anatomical site. Pressure controller 162 of control module 160 can regulate environmental pressure through automatic adjustment of aspiration and/or irrigation flow rates through aspiration channel 112 and irrigation channel 114 . For example, pressure controller 162 can automatically apply suction pressure to wash channel 114 in response to an increase in environmental pressure (as sensed by pressure monitor 550). If the irrigation channel 114 is not clogged, suction applied to the irrigation channel 114 can create a negative pressure in the anatomical environment 101 to offset the pressure increase created by irrigation through the suction channel 112 . In one example, the pressure monitor 550 can continuously or periodically monitor the environmental pressure, and the pressure controller 162 adjusts the aspiration flow rate, or aspiration pressure, to direct the environmental pressure to the desired pressure level. be able to.

In one example, the desired pressure is substantially zero net pressure. The pressure controller 162 can adjust the aspiration flow rate or aspiration pressure within the irrigation channel 114 to substantially neutralize the sensed increase in environmental pressure. In this way, the environmental pressure can be forced to and maintained at substantially zero. In another example, the desired pressure is positive pressure. The pressure controller 162 can adjust the aspiration flow rate or aspiration pressure within the irrigation channel 114 at a level that directs the sensed environmental pressure toward the desired level of positive pressure. An example of a desired positive pressure is 5 pounds per square inch (psi), or about 34.5 kPa. In yet another example, the desired pressure is negative pressure, and pressure controller 162 adjusts the aspiration flow rate or aspiration pressure within irrigation channel 114 at a level that causes the sensed environmental pressure to steer toward the level of the desired negative pressure. can do. An example of a desired negative pressure is -5 psi, or equivalently about -34.5 kPa.

As discussed above with reference to FIGS. 3A-3B, unclogging can involve alternating applications of suction and irrigation to the occluded channel. FIG. 6B is a timing diagram for activating irrigation/aspiration in the aspiration channel 112 when clogging occurs in the aspiration channel 112 (as shown in FIG. 6A). To unclog the aspiration channel, irrigation is applied to the aspiration channel for a duration t1 (“wash duration”). After the transition period _td , a suction pressure is applied to the suction channel for a duration t2 (“suction duration”). The transition period _td allows clogged particles of different sizes and masses to travel different distances along the suction channel, thereby facilitating particle separation and channel unclogging. Irrigation can cause a positive anatomical pressure (+PA) 661 and suction can cause a negative pressure (-PA) 662 at the anatomical site.

FIG. 6C is a timing diagram of actuating irrigation/suction in the irrigation channel to achieve pressure control at the anatomical site, eg, to maintain a desired anatomical pressure during the unclogging process. During t1, pressure controller 162 can activate suction to irrigation channel 114, thereby generating negative anatomical pressure (−PA) 671 to create positive anatomical pressure (−PA) at the anatomical site ( +PA) 661 can be offset. During t2, pressure controller 162 can activate irrigation to irrigation channel 114, thereby generating positive anatomical pressure (+PA) 672 to create negative anatomical pressure (- PA) 662 can be offset. In this way, pressure in the anatomical environment can be maintained at a desired level while the blocked suction channel is unclogged.

A blocked channel is determined to be successfully unclogged when flow monitor 650 senses an increase in flow through aspiration channel 112 via flow sensor 652 . The clog controller 161 can return to the standard mode of irrigation/aspiration operation (e.g., control the aspiration source to apply aspiration pressure to the aspiration channel and control the irrigation source to provide irrigation fluid to the irrigation channel). ). Pressure controller 162 can operate aspiration and irrigation to keep environmental pressure under control, as discussed above with reference to FIG.

FIG. 7A is a diagram illustrating an exemplary feedback-controlled pressure regulation system 700 , which is one embodiment of system 100 . System 700 can be configured to regulate the pressure on anatomical environment 101 (“environmental pressure”) when irrigation channel 114 is clogged. As discussed above with reference to FIG. 4A, when a clog in wash channel 114 is detected, clog controller 161 of controller module 160 switches from the normal mode of supplying wash fluid to wash channel 114 to the clogged wash channel. A unclogging mode can be switched in which a suction source 120 can be fluidly coupled to the wash channel 114 to aspirate or aspirate the channel 114 .

Application of suction pressure to irrigation channel 114 may result in a pressure reduction at an anatomical site in anatomical environment 101 . Pressure controller 162 of control module 160 can regulate environmental pressure through automatic adjustment of aspiration and/or irrigation flow rates through aspiration channel 112 and irrigation channel 114 . For example, in response to a decrease in environmental pressure (which can be sensed by pressure monitor 550), pressure controller 162 can automatically activate flushing fluid flow into aspiration channel 112. FIG. If the aspiration channel 112 is not clogged, the irrigation fluid applied to the aspiration channel 112 may create a positive pressure to offset the pressure reduction in the anatomical environment 101 created by aspiration through the irrigation channel 114 . can. In one example, the pressure monitor 550 can continuously or periodically monitor the environmental pressure, and the pressure controller 162 can adjust the cleaning flow rate to direct the environmental pressure to the desired pressure level.

In one example, the desired pressure is substantially zero net pressure. Pressure controller 162 may adjust the irrigation flow rate through aspiration channel 112 to a level that substantially neutralizes the sensed decrease in environmental pressure. The environmental pressure, as sensed by pressure monitor 550, can then be forced toward or maintained at substantially zero. In another example, the desired pressure is positive pressure. Pressure controller 162 can regulate the irrigation flow rate through aspiration channel 112 at a level that directs the sensed environmental pressure toward the desired level of positive pressure. In yet another example, the desired pressure is a negative pressure, and pressure controller 162 can adjust the irrigation flow rate through suction channel 112 at a level that causes the sensed environmental pressure to steer toward the level of the desired negative pressure. can.

FIG. 7B is a timing diagram for activating irrigation/suction in the irrigation channel 114 when the irrigation channel 114 becomes clogged (as shown in FIG. 7A). To unclog the wash channel, suction is applied to the wash channel for a duration t3 (“suction duration”). After the transition period _td , a wash pressure is applied to the wash channel for a duration t4 ("wash duration"). The transition period _td allows clogged particles of different sizes and masses to travel different distances along the wash channel, thereby facilitating particle separation and channel unclogging. Suction can cause negative anatomic pressure (−PA) 761 and irrigation can cause positive anatomic pressure (+PA) 762 at the anatomical site.

FIG. 7C is a timing diagram of actuating irrigation/suction in the suction channel to achieve pressure control at the anatomical site, eg, to maintain a desired anatomical pressure during the unclogging process. During t3, pressure controller 162 can activate irrigation to aspiration channel 112, which generates positive anatomic pressure (+PA) 771 to create negative anatomic pressure (- PA) 761 offset. During t4, pressure controller 162 can activate suction to suction channel 112, which generates negative anatomical pressure (−PA) 772 to create positive anatomical pressure (−PA) at the anatomical site ( +PA) to offset 762; In this way, pressure in the anatomical environment can be maintained at a desired level while the blocked irrigation channel is unclogged.

A blocked channel is determined to be successfully unclogged when flow monitor 650 senses an increase in flow through aspiration channel 112 via flow sensor 652 . The clog controller 161 can return to the standard mode of irrigation/aspiration operation (e.g., control the aspiration source to apply aspiration pressure to the aspiration channel and control the irrigation source to provide irrigation fluid to the irrigation channel). ). Pressure controller 162 can operate aspiration and irrigation to keep environmental pressure under control, as discussed above with reference to FIG.

FIG. 8 is a flowchart illustrating a method 800 for in situ unclogging a working channel in a medical device during a minimally invasive procedure, such as an endoscopic procedure. Medical devices include tubular portions insertable into hollow body organs or cavities to aid in medical diagnosis or surgical treatment. Examples of medical devices can include tissue removal devices, such as those shown in FIGS. 2A-2B, or endoscopes, such as those shown in FIGS. 3A-3B, among others. Medical devices are designed to provide cleaning fluid to an anatomical site and to transport tissue debris, stones or clumps, bodily fluids, and cleaning fluid, collectively referred to herein as unwanted material, away from the anatomical site. may include one or more working channels configured to The working channel can be disposed at least partially inside the tubular portion of the medical device. In one example, the working channel is a unified irrigation/aspiration channel that is controllably used (eg, at different times) for irrigation and aspiration. In another example, the working channel can include separate irrigation and aspiration channels disposed within the tubular portion of the medical device. The irrigation and aspiration channels each receive irrigation fluid or aspiration pressure, e.g., under automatic control by a controller unit, and perform different tasks or different pressures during an endoscopic procedure according to various embodiments discussed herein. function.

Method 800 includes one or more processes for operating a clearing system, such as system 100, or variations thereof, such as one of systems 200, 300A, or 300B. Although the processes of method 800 are depicted in one flowchart, they are not required to be performed in any particular order. In various examples, some of the processes can be performed in a different order than shown herein.

At 810, a flow rate through the working channel can be sensed using a flow sensor, which can be located inside the working channel of the medical device. Examples of flow sensors are, among others, thermal anemometers that measure the rate of transfer of heat generated from a heat source, differential pressure sensors that measure pressure drop over a range of locations, frequency shift or the Doppler effect of travel/time of flight. may include ultrasonic flow sensors that measure flow, and electromagnetic sensors that measure changes in fluid conductance that are indicative of flow. At 820, a channel condition indicating the presence or absence of a blockage in the working channel can be detected based on the sensed flow rate, for example using the clog controller 161 . In one example, channel clogging can be detected, eg, in response to a decrease in flow below a first flow threshold. If the sensed flow rate increases and exceeds a second flow rate threshold, then no clogging or successful unclogging of the blocked working channel can be detected. In one example, the first flow threshold or the second flow threshold can each be relative to (eg, a specific percentage of) a reference flow such as that measured in an unplugged channel.

If the sensed flow rate at 830 indicates a clog in the working channel, the unclogging mode of the flush/suction operation is activated at 840 to unclog the blocked working channel. When separate irrigation and aspiration channels are used in the medical device, the unclogging mode includes applying a flow of irrigation fluid to the aspiration channel and/or applying aspiration pressure to the irrigation channel. This unclogging mode differs from the standard mode of irrigation/suction operation in which the aspiration source provides aspiration pressure to the aspiration channel and the irrigation source provides a flow of irrigation fluid to the irrigation channel. In one example, the unclogging mode at 840 can include alternating irrigation and suction to the blocked channel. As discussed above with reference to FIG. 4A, the clog controller 161 provides suction pressure to the blocked working channel (as shown in panel 420 of FIG. 4A) for a specified suction duration. A suction source (eg, suction source 120) can be controllably actuated. The clog controller 161 may alternatively or in addition apply a flow of cleaning fluid to the blocked working channel (as shown in panel 440 of FIG. 4A) for a specified cleaning duration (e.g., a cleaning source). source 140) can be activated. The aspiration pressure, aspiration flow rate, irrigation flow rate, or pump pressure that pressurizes the irrigation fluid can be adjusted by the user.

Clogging particles of different sizes (and therefore different masses) can react differently to suction or to flush cleaning fluid. As shown in FIG. 4A, smaller particles can move faster and travel longer distances along the direction of aspiration flow or the direction of fluid flow, thus aspirating, rinsing, or aspirating and rinsing. Alternating can help dislodge smaller particles from the clog mass and separate them from the rest of the clog. By applying an additional suction or wash flow to the working channel, the separated particles can be more easily and efficiently extracted down the working channel. In one example, one or more of aspiration pressure, aspiration flow rate, wash 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.

During the unclogging process, the flow rate can be monitored continuously or periodically (810). If the monitored flow rate increases and exceeds the threshold at 830, the blocked channel is considered successfully unclogged. The unclogging mode of operation can then be returned to the standard mode of irrigation/suction operation.

FIG. 9 illustrates in situ clogging of a working channel of a medical device while keeping the pressure of the anatomical environment (“environmental pressure”) under control, e.g., maintaining the environmental pressure at substantially a user-specified pressure level. 9 is a flow chart illustrating a method 900 for resolving. The process of controlling environmental pressure can be implemented and executed with a pressure controller, such as pressure controller 162 . The processes of method 900 are not required to be performed in any particular order. For example, some steps may be performed in a different order than shown herein.

Method 900 includes steps 910 through 940 that are similar to steps 810 through 840 of method 800 for detecting a blockage in a working channel and clearing the blocked channel. Method 900 further includes steps 950-980 of adjusting environmental pressure during a procedure (eg, an endoscopic procedure) with or without channel occlusion. As mentioned above, aspiration can result in negative pressure changes at the anatomic site, while irrigation can result in positive pressure changes at the anatomic site. Negative and positive pressure changes can adversely affect internal organs exposed to anatomic sites. Maintaining the environmental pressure at a controlled pressure level can improve patient safety and effectively reduce treatment time.

Regulation of environmental pressure can be achieved through automatic adjustment of aspiration and/or irrigation flow rates in one or more working channels. Specifically, at 950, a pressure sensor can be used to sense environmental pressure. The pressure sensor can be attached to or incorporated into the distal portion of the medical device such that the sensor is in contact with the anatomical environment. Examples of pressure sensors can include resistive, capacitive, piezoelectric, optical, or micro-electromechanical system (MEMS) pressure sensors.

At 960 , the sensed tissue pressure can be compared to the desired pressure as provided by the user via user interface 140 . Desired pressure represents the pressure to be maintained in the anatomical environment during the procedure. In one example, the desired pressure is substantially zero net 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 safe limits dilates anatomical structures (e.g., ureters, kidneys, or other organs) during endoscopic procedures and prevents tissue damage from excessive positive pressure. It can help to allow better visibility of the anatomy through the endoscope without causing complications. Positive pressure can also prevent tissue debris or calculus debris from lodging the anatomy and assist in removing tissue debris or calculus debris from the anatomy. In some cases, maintaining a controlled negative pressure within a safe range during an endoscopic procedure permits extraction of debris from the anatomy without exposing internal organs to the risk of excessive negative pressure. can be made easier.

If the sensed pressure at 960 does not substantially reach the desired pressure level (i.e., within an acceptable range, such as ±5% to 10% of the desired pressure), then at 970 the pressure controller 162 is used, for example. One or more of the irrigation or suction flow rates through one or more of the working channels can be adjusted to direct the environmental pressure to a desired level of pressure. In some examples, desired flow conditions may be received in addition to or instead of desired pressure levels, eg, from user interface 140 . Desired flow conditions include information about inflow (e.g., flow rate of irrigation fluid applied to the anatomical environment) versus outflow (e.g., flow rate of aspiration applied to the anatomical environment) and corresponds to the desired pressure to be applied to . One or more of the irrigation or aspiration flow rates through one or more working channels can be varied to maintain desired flow conditions during treatment.

When no clogs are detected in any of the working channels, or when the clogged channels are successfully unclogged, the pressure control process at 970 can be performed via the standard mode of irrigation/suction operation. As described above with reference to FIG. 5, the suction applied to the suction channel can create a negative pressure in the anatomical environment, which offsets the increased environmental pressure created by the increased irrigation flow rate. can do. until the increase in sensed pressure (as caused by increased irrigation) is substantially neutralized by aspiration flow, thereby resulting in the desired substantially net zero pressure, or the sensed environmental pressure The aspiration flow rate, or aspiration pressure, can be adjusted until the pressure reaches substantially the desired positive or negative pressure level. Similarly, the flow of irrigation fluid supplied to the irrigation channel can create a positive pressure in the anatomical environment, which can offset the reduction in environmental pressure created by aspiration. until the decrease in sensed pressure (as caused by increased suction) is substantially neutralized by the wash flow, thereby resulting in the desired substantially net zero pressure, or the sensed ambient pressure The wash flow rate can be adjusted until the pressure reaches substantially the desired level of positive pressure or negative pressure.

When at least one, but not all, of the working channels are clogged, the pressure control process at 970 can be performed via the unclogging mode of irrigation/suction operation. FIG. 6A shows an example where the aspiration channel is clogged and the irrigation channel is not clogged. As discussed there, a flow of flushing fluid can be applied to the suction channel to unclog a blocked suction channel. This can create an increase in environmental pressure that can be detected by a pressure sensor. A suction pressure can be applied to the irrigation channel, which can create a negative pressure to offset pressure build-up in the anatomical environment. Until the increase in sensed pressure (due to increased irrigation in the occluded aspiration channel) is substantially neutralized by the aspiration flow, thereby resulting in the desired substantially net zero pressure, or The aspiration flow rate, or aspiration pressure, in the irrigation channel can be adjusted until the applied environmental pressure substantially reaches the desired positive or negative pressure level.

In another example where the irrigation channel is clogged and the suction channel is not clogged, suction pressure can be applied to the irrigation channel to unclog the blocked irrigation channel. This can create a reduction in environmental pressure. As discussed above with reference to FIG. 7A, a flow of irrigation fluid can be applied to the suction channel, which can create a positive pressure to offset increased shadowing in the anatomical environment. . Until the decrease in sensed pressure (due to increased suction in the blocked wash channel) is substantially neutralized by wash flow, thereby resulting in the desired substantially net zero pressure, or The wash flow rate can be adjusted until the applied environmental pressure substantially reaches the desired positive or negative pressure level.

At 980, check if the procedure is complete. If the procedure has not been completed, the flow sensing and unclogging processes 910-940 and the pressure control processes 950-980 can continue.

Controlled irrigation and aspiration, which involves alternating application of irrigation fluid and aspiration pressure to the same clogged channel, as described in methods 800 and 900, causes different sizes to accumulate and clog the channel. The channel can be effectively unclogged by separating debris from the Pressure control via the application of irrigation and/or suction within one or more working channels, such as described in method 900, reduces excess stress on internal organs during endoscopic procedures, with and without channel blockages. positive or negative pressure can be effectively avoided or minimized. As a result, overall procedure time can be reduced and patient safety can be improved.

Additional Notes The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as "examples." Such examples can include elements in addition to those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. In addition, the inventors may not be directed to any specific example (or one or more aspects thereof) shown or described with respect to a particular example (or one or more aspects thereof) or with respect to other examples (or one or more aspects thereof) shown or described herein. Examples using any combination or permutation of these elements (or one or more aspects thereof) described above are also contemplated.

As used herein, the term "a" or "an" is used independently of any other instance or usage of "at least one" or "one or more," as is common in patent documents. Used to include one or more than one. As used herein, the term "or" is used, unless otherwise specified, such that "A or B" includes "A but not B," "B but not A," and "A and B." used to refer to non-exclusive or In this document, the terms "including" and "in which" are used as the plain English equivalents of the respective terms "comprising" and "wherein". ing. Also, in the following claims, the terms "including" and "comprising" are open-ended, i.e., any number of terms in addition to those listed after such terms in the claim. Systems, devices, articles, compositions, formulations, or processes that include elements are still considered to fall within the scope of the claims. Also, in the following claims, terms such as "first", "second" and "third" are used merely as references and are not intended to impose numerical requirements on these objects.

The descriptions above are intended to be illustrative, not limiting. For example, the above examples (or one or more aspects thereof) can be used in combination with each other. Other embodiments can be used, eg, by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 CFR §1.72(b) to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description by way of example or embodiment, with each claim standing on its own as a separate embodiment, and combining such embodiments with each other in various combinations or permutations. It is contemplated that they can be combined. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

100 System 101 Anatomical Environment 110 Medical Instrument 111 Working Channel 112 Aspiration Channel 114 Irrigation Channel 120 Suction Source 130 Irrigation Source 140 User Interface 150 Sensor Circuit 160 Control Module 161 Clog Controller 162 Pressure Controller 200 Powered Tissue Removal Device 210 Handpiece 220 Aspiration Source 222 Tubular Assembly 224 User Controls 226 Proximal Portion 228 Distal Portion 230 Irrigation Source 240 Energy Source 252 Outer Tubular Member 254 Inner Tubular Member 262 Outer Member Window 264 Cutting Portion 266 Inner Member Window 272 Irrigation Channel 274 Aspiration Channel 282 Proximal Irrigation Port 284 Distal Irrigation Port 300A Endoscope System 300B Endoscope System 310A Endoscope 310B Endoscope 311 Tube 312 Hub 313 Irrigation/Aspiration Port 313A Aspiration Port 313B Irrigation Port 314 Optical Port 315 Vision Port 320 Suction Source 326 External aspiration line 330 irrigation source 336 external irrigation line 340 aspiration/irrigation control unit 341 user interface 342 control valve 350 fitting 352 pressure sensor 356 common line 411 fluid fill channel 412 clog 413 clog 500 feedback control pressure regulation system 550 pressure monitor 600 feedback control Pressure Regulating System 650 Flow Monitor 652 Flow Sensor 700 Feedback Control Pressure Regulating System

Claims (24)

A system for unclogging at least one working channel of a medical device during a procedure on a patient, comprising:
a flow sensor configured to sense flow through the at least one working channel of the medical device;
detecting a channel condition indicative of a blockage in the at least one working channel based on the sensed flow rate;
alternating application of irrigation flow and application of aspiration flow to said at least one working channel in response to said detected channel condition indicating a blockage within said at least one working channel; separating said application of said wash flow and said application of said suction flow by a specified or adjustably specifiable time interval to allow separation of clogging particles by movement;
a control module configured to
system, including The control module is configured to alternate between the application of the irrigation flow and the application of the aspiration flow as long as the detected channel conditions indicate a blockage within the at least one working channel. 2. The system of claim 1 , configured. The control module is configured to apply the cleaning flow to the at least one working channel using a first adjustable pressure or a first adjustable flow rate and a second adjustable pressure or a first adjustable flow rate. 3. The system of claim 1 or 2, configured to apply suction to the at least one working channel at two adjustable flow rates. The control module is configured to apply the wash stream to the at least one working channel for a first specified or adjustably specifiable duration and a second specified or adjustably specifiable duration. 4. The system of any one of claims 1-3, configured to apply suction to the at least one working channel for a specifiable duration. The control module is
detecting a blockage within the at least one working channel in response to a decrease in the sensed flow rate below a first threshold;
detecting an absence of blockage within the at least one working channel in response to an increase in the sensed flow rate above a second threshold;
5. A system according to any one of claims 1 to 4, configured to: The system further includes a pressure sensor configured to sense an anatomical environment pressure at the patient's anatomy, the control module comprising:
receiving a desired pressure to be applied to an anatomical environment at an anatomical site within the patient;
adjusting one or more of the irrigation flow or the aspiration flow to maintain the sensed pressure of the anatomical environment substantially at the desired level of pressure;
6. A system according to any one of claims 3 to 5, configured to: The system further includes a pressure sensor configured to sense an anatomical environment pressure at the patient's anatomy, the control module comprising:
receiving desired flow conditions in the at least one working channel representing relative conditions between the irrigation flow and the aspiration flow and corresponding to a desired pressure to be applied to the anatomical environment;
adjusting one or more of irrigation or aspiration flows to maintain the desired flow conditions in the at least one working channel;
6. A system according to any one of claims 3 to 5, configured to: the at least one working channel includes an aspiration channel and a wash channel, the control module comprising:
an irrigation source fluidly coupled to one of the irrigation channel or the aspiration channel to provide the irrigation flow at an adjustable pressure or an adjustable flow rate to the one of the irrigation channel or the aspiration channel;
a suction source fluidly coupled to the other of the irrigation channel or the aspiration channel to provide the aspiration flow at an adjustable pressure or an adjustable flow rate to the other of the irrigation channel or the aspiration channel;
8. A system according to claim 6 or 7, configured to: The control module is
controlling the irrigation source to provide a irrigation flow to the aspiration channel in response to a blockage in the aspiration channel;
responsive to an increase in the sensed pressure of the anatomical environment, the suction to apply a suction flow to the irrigation channel to maintain the sensed pressure at substantially the desired level of pressure; control the source,
controlling the suction source to apply a suction flow to the suction channel and controlling the irrigation source to provide a irrigation flow to the irrigation channel in response to the absence of a blockage in the aspiration channel;
9. The system of claim 8, configured to: The control module is
controlling the suction source to apply a suction flow to the wash channel in response to a blockage in the wash channel;
providing an irrigation flow to the aspiration channel to reduce the sensed pressure to substantially the desired pressure level in response to a decrease in the sensed pressure of the anatomical environment at the anatomical site; controlling said cleaning source to maintain at
controlling the suction source to apply a suction flow to the suction channel and controlling the irrigation source to provide a irrigation flow to the irrigation channel in response to the lack of a blockage in the irrigation channel;
9. The system of claim 8, configured to: The desired pressure is substantially a net zero pressure, and the control module is responsive to the increase in the sensed pressure to apply an aspiration flow to the irrigation channel at an adjustable flow rate to the sensed pressure. 10. The system of claim 9, configured to control the suction source to substantially neutralize the increase in applied pressure. The desired pressure is substantially a net zero pressure, and the control module is responsive to the decrease in the sensed pressure to provide an irrigation flow to the aspiration channel at an adjustable flow rate to the sensed pressure. 11. The system of claim 10, configured to control the wash source to substantially neutralize the decrease in applied pressure. The desired pressure is a positive pressure, and the control module is responsive to the increase in the sensed pressure to apply a suction flow to the irrigation channel at an adjustable rate to substantially reduce the sensed pressure. 10. The system of claim 9, wherein the system is configured to control the suction source to maintain the desired level of positive pressure. The desired pressure is a positive pressure, and the control module is responsive to the decrease in the sensed pressure to provide an irrigation flow to the aspiration channel at an adjustable rate to substantially reduce the sensed pressure. 11. The system of claim 10, wherein the system is configured to control the cleaning source to maintain the desired level of positive pressure. The desired pressure is a negative pressure, and the control module is responsive to the increase in the sensed pressure to apply a suction flow to the irrigation channel at an adjustable rate to substantially reduce the sensed pressure. 10. The system of claim 9, wherein the system is configured to control the suction source to maintain the desired level of negative pressure. The desired pressure is a negative pressure, and the control module is responsive to the decrease in the sensed pressure to provide an irrigation flow to the aspiration channel at an adjustable rate to substantially reduce the sensed pressure. 11. The system of claim 10, wherein the system is configured to control the irrigation source to effectively maintain the desired level of negative pressure. an endoscope including an imaging module, a surgical module, and at least one working channel configured to pass an irrigation or aspiration flow;
a user input configured to receive from a user a desired pressure to be applied to the anatomical environment at the patient's anatomy;
a flow sensor configured to sense flow 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;
using the sensed flow rate to detect channel conditions indicative of the presence or absence of blockages in the at least one working channel;
responsive to said detected channel condition indicating a blockage within said at least one working channel, and said detected channel condition indicating a blockage within said at least one working channel; Where indicated, the application of irrigation flow and the application of aspiration flow to said at least one working channel are alternated, said application of said irrigation flow and said aspiration flow being performed by a specified or adjustably specifiable time interval. separating said application of flow to allow separation of clogging particles by motion;
adjusting one or more of the irrigation or suction flow through the at least one working channel to maintain the sensed pressure at substantially the desired level of pressure;
a control module configured to
an endoscopic surgical system including; A method of unclogging at least one working channel of a medical device during a procedure on a patient, comprising:
sensing flow through the at least one working channel of the medical device via a flow sensor;
using the sensed flow rate to detect, via a control module, channel conditions indicative of the presence or absence of blockages in the at least one working channel;
alternating application of irrigation flow and application of aspiration flow to said at least one working channel in response to said detected channel condition indicating a blockage within said at least one working channel; separating said application of said wash flow and said application of said suction flow by a specified or adjustably specifiable time interval to allow separation of clogging particles by motion;
A method, including wherein said alternating between said application of said irrigation flow and said application of said aspiration flow continues as long as said detected channel condition indicates a blockage within said at least one working channel. Item 19. The method of Item 18. The step of detecting channel conditions includes:
detecting a blockage within the at least one working channel in response to a decrease in the sensed flow rate below a first threshold;
detecting an absence of blockage within the at least one working channel in response to an increase in the sensed flow rate above a second threshold;
20. The method of claim 18 or 19, comprising receiving, via user input, a desired pressure to be applied to an anatomical environment at an anatomical site within the patient;
sensing the pressure of the anatomical environment at the anatomical site via a pressure sensor;
adjusting one or more of the irrigation flow or the aspiration flow through the at least one working channel to maintain the sensed pressure at substantially the desired level of pressure;
21. The method of any one of claims 18-20, comprising receiving a desired flow condition in the at least one working channel representing the relative conditions between the irrigation flow and the aspiration flow and corresponding to the desired pressure to be applied to the anatomical environment; a step;
adjusting one or more of the wash flow or the aspiration flow through the at least one working channel to maintain the desired flow conditions within the at least one working channel;
22. The method of claim 21, comprising: the at least one working channel includes an aspiration channel and a wash channel, the method comprising:
controlling an irrigation source to provide a irrigation flow to the aspiration channel in response to a blockage in the aspiration channel;
applying a suction flow to the irrigation channel to reduce the sensed pressure to substantially the desired pressure level in response to the increase in the sensed pressure of the anatomical environment at the anatomical site; controlling the suction source to maintain at
controlling the suction source to apply a suction flow to the suction channel and controlling the irrigation source to provide a irrigation flow to the irrigation channel in response to the absence of a blockage in the aspiration channel; and,
23. The method of claim 21 or 22, comprising the at least one working channel includes an aspiration channel and a wash channel, the method comprising:
controlling a suction source to apply a suction flow to the wash channel in response to a blockage in the wash channel;
providing an irrigation flow to the aspiration channel to reduce the sensed pressure to substantially the desired pressure level in response to a decrease in the sensed pressure of the anatomical environment at the anatomical site; controlling the cleaning source to maintain at
controlling the suction source to apply a suction flow to the suction channel and controlling the irrigation source to provide a irrigation flow to the irrigation channel in response to the absence of a blockage in the irrigation channel; and,
24. The method of any one of claims 21-23, comprising:

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