Aspiration and irrigation control system and method

Abstract

To provide a suction and irrigation system for maintaining an in situ pressure of an anatomical environment at an anatomical site under control during an endoscopic procedure.SOLUTION: Systems and methods for providing in-situ pressure control in an anatomical environment during a procedure are disclosed. The example irrigation and aspiration system includes a user input configured to receive, from a user, a desired pressure to be applied to the anatomical environment or a desired flow condition corresponding to the desired pressure. The system comprises a pressure sensor for sensing a pressure at or near the anatomical environment during the procedure, and a control module for adjusting one or more of an irrigation flow rate or an aspiration flow rate of at least one working channel of the medical device to maintain the pressure in the anatomical environment substantially at a desired pressure level or to maintain desired flow conditions in the working channel.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is related to commonly assigned U.S. patent application Ser. No. 16 / 803,649, entitled "SUCTION AND IRRIGATION CONTROL SYSTEM AND METHOD," filed February 27, 2020 (Attorney Docket No. 5409.175US1), which is incorporated by reference in its entirety.

[0002] This document relates generally to endoscopy systems, and more particularly to aspiration and irrigation systems for maintaining in situ pressure of an anatomical environment at an anatomical site under control during an endoscopic procedure. [Background technology]

[0003] Endoscopes are typically used to provide access to internal locations within a patient, providing visual access to physicians. Some endoscopes are used in minimally invasive surgery to remove unwanted tissue or foreign bodies from a patient's body. For example, an endoscopic tissue removal device is an instrument used by a clinician to remotely access necrotic, cancerous, damaged, infected, or other unwanted soft tissue, bone, or other anatomical structures at an anatomical site, resect the unwanted material from adjacent anatomical structures, and transport it away from the anatomical site. Nephroscopes are used by clinicians to examine the renal system and perform various procedures under direct visual control. For example, percutaneous nephrolithotomy (PCNL) is a procedure that involves placing a nephroscope into the renal pelvis through the patient's flank. For example, stones or masses from various parts of the body, including the urinary system, gallbladder, nasal cavity, gastrointestinal tract, stomach, or tonsils, can be visualized and removed. Larger size stones can be ablated into smaller pieces using vibrational forces such as shock waves, ultrasonic energy (by specialized devices such as ultrasonic lithotriptors), or lasers.

[0004] Some endoscopes have aspiration channels (also known as suction channels) for removing excised tissue, stones (e.g., stones or stone fragments at various stone-forming sites), and clots, among other undesirable materials. A flow of irrigating agent (e.g., saline) can be directed through the irrigation channels in the endoscope to the anatomical site during the procedure. The irrigation fluid can facilitate the removal of tissue debris, stone fragments, and other undesirable material through the aspiration channel. The irrigation fluid can also help maintain a clear view of the anatomical environment for the clinician performing the procedure. Additionally, the irrigation flow can have a cooling effect on the endoscopic tissue removal device, helping to dissipate heat generated during the removal of stones (e.g., kidney stones, etc.). Summary of the Invention [Problem to be solved by the invention]

[0005] The pressure of the anatomical environment at an anatomical site, such as an anatomical structure being manipulated, can change during an endoscopic procedure. For example, the application of flow or irrigation fluid or suction pressure can fluctuate the pressure of the anatomical environment, which can have harmful effects on internal organs. To avoid or reduce pressure-related harm to internal organs, it is desirable to maintain the pressure of the anatomical environment under control during an endoscopic procedure. [Means for solving the problem]

[0006] This document describes systems and methods for maintaining in situ pressure of an anatomical environment at an anatomical site during an endoscopic procedure. According to one aspect of this document, a pressure control system includes a user input configured to receive from a user a desired pressure to be applied to the anatomical environment or a desired flow condition in a working channel of the endoscope corresponding to the desired pressure. The system includes a pressure sensor configured to sense the pressure of the anatomical environment, and a control module configured to adjust one or more of an irrigation flow rate or an aspiration flow force of at least one working channel of the endoscope based on the sensed pressure to maintain the pressure of the anatomical environment substantially at a desired pressure level or to maintain the desired flow condition in the working channel during the endoscopic procedure.

[0007] Example 1 is a system for maintaining a pressure applied to an anatomical environment at an anatomical site of a patient during a procedure with a medical device. The system includes a user input configured to receive from a user a desired pressure to be applied to the anatomical environment at the anatomical site, a pressure sensor configured to sense the pressure of the anatomical environment at the anatomical site, and a control module configured to control one or more of an irrigation flow rate or an aspiration flow rate through at least one working channel of the medical device based on the sensed pressure to maintain the pressure of the anatomical environment substantially at the desired pressure level.

[0008] In Example 2, the subject matter of Example 1 optionally includes a user input that can be configured to receive desired flow conditions in at least one working channel, the desired flow conditions including a user input corresponding to a desired pressure to be applied to an anatomical environment, and the control module is configured to control one or more of an irrigation flow rate or an aspiration flow rate through the at least one working channel of the medical device to maintain the desired flow conditions.

[0009] In Example 3, the subject matter of any one or more of Examples 1-2 optionally includes a control module that may be configured to fluidly couple an irrigation source to the at least one working channel and provide irrigation fluid thereto at an adjustable irrigation flow rate, and to fluidly couple an aspiration source to the at least one working channel and provide aspiration pressure thereto at an adjustable aspiration flow rate.

[0010] In Example 4, the subject matter of Example 3 optionally includes at least one working channel, which may include an irrigation channel and an aspiration channel, and wherein the control module is configured to provide irrigation fluid to the irrigation channel at an adjustable irrigation flow rate and to provide aspiration pressure to the aspiration channel at an adjustable aspiration flow rate.

[0011] In Example 5, the subject matter of any one or more of Examples 1-4 optionally includes a user input that may be configured to receive a user command to increase or decrease one or more of the irrigation flow rate or the aspiration flow rate.

[0012] In Example 6, the subject matter of any one or more of Examples 1-5 optionally includes a desired pressure, which may be substantially net zero pressure in the anatomical environment, and a control module, which may be configured to increase an aspiration flow rate through at least one working channel in response to an increase in the sensed pressure generated by an increase in the irrigation flow rate to substantially counteract the increase in the sensed pressure, and to increase an irrigation flow rate through at least one working channel in response to a decrease in the sensed pressure generated by the increase in the aspiration flow rate to substantially counteract the decrease in the sensed pressure.

[0013] In Example 7, the subject matter of any one or more of Examples 1-5 optionally includes a desired pressure, which may be a positive pressure in the anatomical environment, and a control module, which may be configured to increase the irrigation flow rate or decrease the aspiration flow rate through at least one working channel until the sensed pressure substantially reaches the desired positive pressure level.

[0014] In Example 8, the subject matter of any one or more of Examples 1-5 optionally includes a desired pressure, which may be a negative pressure in the anatomical environment, and a control module that may be configured to decrease the irrigation flow rate or increase the aspiration flow rate through at least one working channel until the sensed pressure substantially reaches the desired negative pressure level.

[0015] In Example 9, the subject matter of any one or more of Examples 1-8 optionally includes a tissue removal device at least partially insertable into the anatomical site, the tissue removal device configured to illuminate at least a portion of the anatomical environment and a surrounding environment, provide an image of the anatomical environment, excise unwanted tissue from the anatomical environment, and remove the excised tissue via at least one working channel, and wherein the control module can be configured to adjust one or more of an irrigation flow rate or an aspiration flow rate to maintain pressure in the anatomical environment substantially at a desired pressure level.

[0016] In Example 10, the subject matter of any one or more of Examples 1-8 optionally includes a nephroscope at least partially insertable into a portion of the patient's urinary tract, the nephroscope configured to illuminate a renal mass and a surrounding environment, provide an image of the illuminated renal mass, break the renal mass into fragments, and remove the fragments of the renal mass via at least one working channel; and a control module that may be configured to adjust one or more of an irrigation flow rate or an aspiration flow rate to maintain pressure in the environment surrounding the renal mass substantially at a desired pressure level.

[0017] Example 11 is an endoscopic surgical system comprising: an endoscope including an imaging module, a surgical module, and at least one working channel configured to transmit irrigation fluid or aspiration pressure; a user input configured to receive from a user a desired pressure to be applied to an anatomical environment at the anatomical site; a pressure sensor configured to sense the pressure of the anatomical environment at the anatomical site; and a control module configured to adjust one or more of the irrigation flow rate or the aspiration flow rate through the at least one working channel based on the sensed pressure to maintain the pressure of the anatomical environment substantially at a desired pressure level.

[0018] In Example 12, the subject matter of Example 11 optionally includes at least one working channel, which may include an irrigation channel and an aspiration channel, and a control module, which may be configured to fluidly couple an irrigation source to the irrigation channel and provide irrigation fluid thereto at an adjustable irrigation flow rate, and to fluidly couple an aspiration source to the aspiration channel and provide aspiration pressure thereto at an adjustable aspiration flow rate.

[0019] In Example 13, the subject matter of any one or more of Examples 11-12 optionally includes a user input that may be configured to receive a user command to increase or decrease one or more of the irrigation flow rate or aspiration flow rate, and the desired pressure may be a substantially net zero pressure, a positive pressure, or a negative pressure in the anatomical environment.

[0020] Example 14 is a method of maintaining pressure applied to an anatomical environment at an anatomical site of a patient during a procedure with a medical device. The method includes receiving a desired pressure to be applied to the anatomical environment at the anatomical site via a user input, sensing the pressure of the anatomical environment at the anatomical site via a pressure sensor, and adjusting, by a control module, one or more of an irrigation flow rate or an aspiration flow rate through at least one working channel based on the sensed pressure to maintain the pressure of the anatomical environment substantially at the desired pressure level.

[0021] In Example 15, the subject matter of Example 14 optionally includes receiving desired flow conditions in at least one working channel, the desired flow conditions corresponding to a desired pressure to be applied to the anatomical environment, and adjusting one or more of an irrigation flow rate or an aspiration flow rate through the at least one working channel to maintain the desired flow conditions.

[0022] In Example 16, the subject matter of any one or more of Examples 14-15 optionally includes at least one working channel, which may include an irrigation channel and an aspiration channel. The method includes controlling an irrigation source to provide irrigation fluid at an adjustable irrigation in the irrigation channel and controlling an aspiration source to provide an aspiration pressure at an adjustable aspiration flow rate through the aspiration channel.

[0023] In Example 17, the subject matter of Example 16 optionally includes receiving a user command from a user input to increase or decrease one or more of the irrigation flow rate or the aspiration flow rate.

[0024] In Example 18, the subject matter of any one or more of Examples 14-17 optionally includes a desired pressure, which may be a substantially net zero pressure in the anatomical environment, and adjusting one or more of the irrigation flow rate or the aspiration flow rate may include: increasing the aspiration flow rate through at least one working channel in response to an increase in the sensed pressure generated by the increase in the irrigation flow rate to substantially counteract the increase in the sensed pressure; and increasing the irrigation flow rate through at least one working channel in response to a decrease in the sensed pressure generated by the increase in the aspiration flow rate to substantially counteract the decrease in the sensed pressure.

[0025] In Example 19, the subject matter of any one or more of Examples 14-17 optionally includes a desired pressure, which may be a positive pressure in the anatomical environment, and adjusting one or more of the irrigation flow rate or aspiration flow rate may include increasing the irrigation flow rate or decreasing the aspiration flow rate through at least one working channel until the sensed pressure substantially reaches the desired positive pressure level.

[0026] In Example 20, the subject matter of any one or more of Examples 14-17 optionally includes a desired pressure, which may be a negative pressure in the anatomical environment, and adjusting one or more of the irrigation flow rate or aspiration flow rate may include decreasing the irrigation flow rate or increasing the aspiration flow rate through at least one working channel until the sensed pressure substantially reaches the desired negative pressure level.

[0027] This Summary provides an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details regarding the present subject matter are found in the detailed description and appended claims. Other aspects of the present disclosure, each of which should not be construed in a limiting sense, will become apparent to those skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof. The scope of the present disclosure is defined by the appended claims and their legal equivalents.

[0028] Various embodiments are illustrated by way of example in the figures of the accompanying drawings. Such embodiments are illustrative and are not intended to be exhaustive or exclusive embodiments of the present subject matter. [Brief explanation of the drawings]

[0029] [Figure 1] FIG. 1 is a block diagram illustrating an example of a system for maintaining in situ pressure of an anatomical environment at an anatomical site at a substantially desired level during a minimally invasive procedure. [Figure 2A]FIG. 2 shows a powered tissue removal device 200 that can be used in the system described with reference to FIG. [Figure 2B] FIG. 2 shows a powered tissue removal device 200 that can be used in the system described with reference to FIG. [Figure 3A] 1 illustrates an endoscopic system capable of maintaining the in situ pressure of an anatomical environment at a substantially desired level during an endoscopic procedure. [Figure 3B] 1 illustrates an endoscopic system capable of maintaining the in situ pressure of an anatomical environment at a substantially desired level during an endoscopic procedure. [Figure 4] FIG. 1 illustrates an exemplary feedback controlled pressure regulation system. [Figure 5] 1 is a flow chart illustrating a method for maintaining an anatomical environment pressure at an anatomical site during a minimally invasive procedure. [Figure 6A] 1 is a flow chart illustrating a method for maintaining balanced environmental pressure in an anatomical environment during an endoscopic procedure. [Figure 6B] 1 is a flow chart illustrating a method for maintaining balanced environmental pressure in an anatomical environment during an endoscopic procedure. [Figure 7A] 1 is a flow chart illustrating a method for maintaining a desired positive pressure in an anatomical environment during an endoscopic procedure. [Figure 7B] 1 is a flow chart illustrating a method for maintaining a desired negative pressure in an anatomical environment during an endoscopic procedure. DETAILED DESCRIPTION OF THE INVENTION

[0030] An endoscope comprises a tubular portion that can be inserted into a body organ or cavity to aid in diagnosis or treatment. One or more working channels (e.g., aspiration and / or irrigation channels) can be disposed inside and extend along the length of the tubular portion to provide flow or irrigation fluid, or suction pressure, during an endoscopic procedure. Irrigation and suction can facilitate the removal of unwanted material generated during an endoscopic procedure, such as tissue debris, stones and clots, or bodily fluids, among other things.

[0031] In an endoscope, suction through the working channel can create negative pressure changes at the anatomical site. In an endoscope, application of irrigation fluid through the working channel can create positive pressure changes at the anatomical site. Negative and positive pressure changes, if not properly controlled, can be harmful to internal organs exposed at the anatomical site. For example, while the body may be able to accommodate some positive pressure changes, many organs are relatively defenseless against negative pressure changes.

[0032] The inventors have recognized an unmet need for an endoscopic system that allows a user to manually control aspiration and / or irrigation flow to monitor the pressure of the anatomical environment at an anatomical site, stabilize the pressure of the anatomical environment during a procedure, and protect internal organs from pressure-related harm.

[0033] Disclosed herein are systems and methods for maintaining in situ pressure of an anatomical environment (e.g., an internal organ or its environment) at an anatomical site during an endoscopic procedure. According to one aspect of this document, an irrigation and aspiration system includes a pressure sensor configured to sense the pressure of the anatomical environment and a control module configured to adjust one or more of an irrigation flow rate or an aspiration flow rate of at least one working channel of the endoscope based on the sensed pressure. The control module can use a feedback control mechanism to keep pressure changes under control, such as to maintain the pressure of the anatomical environment substantially at a desired pressure level or to maintain desired flow conditions in the working channel, during the endoscopic procedure.

[0034] The systems and methods according to various embodiments discussed in this document provide an improved solution to controlling in situ pressure during endoscopic procedures. The proposed solution, including controlled application of irrigation fluid and aspiration pressure, provides environmental stabilization of internal organs. The pressure feedback control discussed herein provides users with an endoscopic procedure without the repeated insertion and removal of endoscopic appendages and accessories, and can effectively reduce procedure time and increase patient safety.

[0035] FIG. 1 is a block diagram illustrating an example of a system 100 for maintaining a substantially desired in-situ pressure of an anatomical environment 101 at an anatomical site during a minimally invasive procedure. The system 100 can include a medical device 110 and optional components. The optional components can include any of a suction source 120, an irrigation source 130, a user interface 140, a sensor circuit 150, or a control module 160. In various examples, the system 100 can have a modular design, providing increased flexibility for easy configuration and replacement of individual components. In examples, the user interface 140, the sensor circuit 150, and the control module 160 can be included in an aspiration / irrigation control unit. The aspiration / irrigation control unit can be fluidly coupled to one or more of the device 110, the aspiration source 120, or the irrigation source 130. The aspiration / irrigation control unit can be adapted to different types of medical devices and to different types of irrigation and aspiration sources. An exemplary aspiration / irrigation control unit is discussed below with reference to FIGS. 3A-3B. The suction / irrigation control unit can selectively activate or deactivate irrigation and / or suction, and adjust one or more of irrigation flow rate, irrigation fluid pressure, aspiration flow rate, or aspiration pressure via the working channel 111. By controlling suction and / or irrigation according to various embodiments discussed herein, the pressure in the anatomical environment 101 can be maintained at a desired level during a procedure.

[0036] The medical device 110 can be used in diagnostic, analytical, or therapeutic applications, including minimally invasive surgery, such as, for example, endoscopic procedures. By way of example and not limitation, the medical device 110 can be used in joint surgery, including, but not limited to, sinus surgery, tonsillectomy, or a combination thereof, plastic surgery, and various ear, nose, and throat procedures. The medical device 110 can be controlled by a user to perform a procedure on an organ or remove organ tissue in the anatomical environment 101. Control of the medical device 110 can include, for example, handpiece or indirect control, such as via a robotic surgical console or user interface.

[0037] An example of the medical device 100 can include a tissue removal device with a blade assembly configured to rotate and / or reciprocate to remove unwanted tissue from a target anatomical structure. The blade assembly can be driven by a motor internal to the handpiece or, alternatively, powered by an external energy source. The energy source can also serve other functions, such as providing powered irrigation and suction to the medical device 110, as discussed below. For example, various blade assemblies can be used, including shavers, debriders, blades, or burrs, among others. Depending on the blade assembly used, the tissue removal device can function to scrape, cut, ablate, or otherwise remove necrotic, cancerous, damaged, infected, or other unwanted soft tissue, bone, or other anatomical features or objects in or from the target anatomical structure. Exemplary tissue removal devices are discussed below with reference to FIGS. 2A-2B.

[0038] Another example of the medical device 110 can include an endoscope. Examples of endoscopes can include, among others, a cystoscope for examining the bladder, a nephroscope for examining the kidneys, a bronchoscope for examining the bronchi, an arthroscope for examining the joints, a colonoscope for examining the colon, a cholangioscope for examining biliary sites (e.g., the bile duct), a duodenoscope for examining gastrointestinal sites, or a laparoscope for examining the abdomen or pelvis. The endoscope can include a light source for illuminating the anatomical environment at the anatomical site and an imaging module for creating images or videos of the anatomical environment during the endoscopic procedure. Some endoscopes, such as endoscopic tissue removal devices, can include a tissue resection element configured to scrape, cut, resect, or otherwise remove portions of unwanted tissue from a targeted anatomical structure. The resected tissue fragments can then be removed from the anatomical site. Some endoscopes can include a resection element configured to destroy or remove foreign bodies, such as crystalline mineral structures, from the anatomical environment. For example, a nephroscope can be inserted at least partially into a kidney. Among other energy modalities, ultrasound energy, electromagnetic shock waves, or lasers can be delivered to kidney stones to break them into fragments, or "stone dust," which can then be removed from the anatomical site. An exemplary endoscope is discussed below with reference to Figures 3A-3B.

[0039] Medical device 110 may include one or more working channels 111 for transporting scraped, cut, resected, abraded, or removed tissue, bone, or other anatomical features or objects, stones and masses, bodily fluids at the anatomical site, and irrigation fluid, collectively referred to herein as "undesirable material." Working channel 111 may be selectively coupled to one or more of suction source 120 (such as via a suction port in medical device 110) or irrigation source 130 (such as via an irrigation port in medical device 110).

[0040] The suction source 120 can act to pull, suck, draw, aspirate, or otherwise move or remove undesirable material from the anatomical site. The undesirable material can be moved to the proximal end of the medical device 110, inside a handpiece, or into a receptacle located remotely from the medical device 110. In an example, the handpiece can include a container or reservoir for at least temporarily collecting the undesirable material before the handpiece is cleaned and the collected material is removed. The suction source 120 can perform the aforementioned functions by generating and applying a vacuum, suction, or negative pressure to the working channel 111 of the medical device 110. In an example, the suction source 120 can be separate from the medical device 110 and connected thereto by one or more tubes, wires, or hoses. In another example, the suction source 120 can be included in or attached to the medical device 110. For example, the suction source 120 can be included within the handpiece of a tissue removal device or endoscope. The suction source may be powered by the energy source that also powers the medical device, or may be powered by its own energy source.

[0041] Irrigation source 130 serves to provide irrigation fluid to working channel 111 to assist in the removal of unwanted material (e.g., tissue debris or stone fragments) through working channel 111. Irrigation fluid can also cool the tissue removal device or ablation element during rotational or reciprocating debridement or ablation, and help dissipate heat generated during stone fragmentation. Irrigation fluid can be gravity-fed or pressurized. In an example, the irrigation source can include a bag that is elevated relative to the medical device 111 and anatomical site to generate gravity-fed irrigation fluid. In another example, a pump can generate the pressurized irrigation flow. Irrigation fluid can be provided from irrigation source 130 or a location where irrigation fluid is contained to and through an external fluid supply tube and drawn into working channel 111. Under the suction pressure provided by suction source 120, the irrigation fluid, along with the undesired material, may flow proximally down working channel 111 and be removed from the anatomical site.

[0042] In an example, a single working channel 111 can be used for both irrigation and aspiration. The control module 160 can controllably activate irrigation and aspiration via the working channel 111 at separate times. In another example, the medical device 110 can include two or more separate working channels, such as aspiration channel 112 and irrigation channel 114, as shown in FIG. 1 . The aspiration channel 112 can be controllably connected to a suction source 120 to deliver undesirable material to be aspirated therethrough. The irrigation channel 114 can be controllably connected to an irrigation source 130 to deliver irrigation fluid therethrough. In an example, the aspiration channel 112 can be controllably connected to the irrigation source 130. In an example, the irrigation channel 114 can be controllably connected to the suction source 120. Irrigation and aspiration according to the various examples discussed herein can be used to assist in removing undesirable material, maintaining the pressure of the anatomical environment at a desired level, and maintaining desired flow conditions within the working channels corresponding to the desired pressure, among other things.

[0043] In examples, the suction channel 112 and the irrigation channel 114 can be arranged in a parallel direction along the length of the tubular portion of the handpiece of the medical device 110. In examples, the suction channel 112 and the irrigation channel 114 can be arranged coaxially on a common axis, such as in a nested configuration. In examples, the medical device 110 includes an outer member and an inner member positioned inside the outer member. The suction channel 112 can be positioned inside the inner member. The irrigation channel 114 can be positioned outside the outer member. In some configurations, in addition to or instead of supplying irrigation fluid through the irrigation channel 114, the irrigation fluid can be supplied through a gap defined between the inner and outer members of the medical device 110, hereinafter referred to as an "irrigation gap." Either the irrigation channel 114 or the irrigation gap can be selectively activated to supply irrigation fluid to the medical device 110. In some examples, both the irrigation channel 114 and the irrigation gap can be activated simultaneously to supply irrigation fluid. This can be advantageous as it allows the clinician to adjust how much irrigation fluid is used during the procedure. For example, when more tissue debris or stone fragments are generated, or when the channels become clogged, the irrigation channel 114 and irrigation gap can both be activated to provide a larger volume of fluid to the medical device 110.

[0044] The control module 160 can be configured to control the operation of the medical device 110 during an endoscopic procedure, including one or more of tissue or stone ablation, illumination, imaging, irrigation, and suction, among other functions. In an example, the control module 160 can be implemented as part of a microprocessor circuit, such as a dedicated processor for processing information, an application specific integrated circuit (ASIC), a microprocessor, or other type of processor, and generates control signals to activate, deactivate, or alter the operation of components of the system 100. Alternatively, the microprocessor circuit can be a processor capable of receiving and executing instructions to implement the functions, methods, or techniques described herein.

[0045] The control module 160 may be at least partially implemented in a unit separate from the medical device 110, such as that shown in FIGS. 3A-3B. Alternatively, some portions of the control module 160 may be integrated into or otherwise attached to the medical device 110. In some examples, the control module 160 may include a circuit set that implements the functions, methods, or techniques described herein, either singly or in combination. In examples, the hardware of the circuit set may include fixedly connected components (e.g., hardwired) designed to perform specific operations. In examples, the hardware of the circuit set may include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) that include computer-readable media that have been physically altered to encode instructions for specific operations (e.g., magnetically, electrically, movable arrangements of invariant mass particles, etc.). In connecting the physical components, the underlying electrical properties of the hardware components may be changed, for example, from insulators to conductors, or vice versa. The instructions enable the embedded hardware (e.g., an execution unit or loading mechanism) to create elements of a circuit set in the hardware via variable connections to perform specific operations when in operation. Thus, the computer-readable medium is communicatively coupled to other components of the circuit set elements when the device is in operation. In examples, any one physical component may be used in multiple elements of multiple circuit sets. For example, under operation, an execution unit may be used in a first circuit of a first circuit set at one time and reused by a second circuit of the first circuit set or a third circuit of the second circuit set at another time.

[0046] As shown in FIG. 1 , the control module 160 is coupled to the user interface 140 and can receive user commands therefrom to activate, deactivate, or adjust one of several functions of the medical device 110. The user interface 140 can be at least partially integrated into or otherwise attached to the medical device 110. Alternatively, the user interface 140 can be separate from the medical device 110, such as in the exemplary system shown in FIGS. 3A-3B . The user interface 140 can be movable and attached to the medical device 110 and fluid system (e.g., pump, irrigation). In an example, the user interface 140 can include one or more user controls that allow a user (e.g., a clinician) to turn suction on / off or adjust suction flow rate or pressure. The user controls can be located on a movable user interface separate from the medical device 110. Alternatively, the user controls can be located on the medical device 110, such as on the handpiece of an endoscope or tissue removal device, such as the device shown in FIG. 2A . In response to user commands, control module 160 can activate or deactivate aspiration flow from suction source 120 or increase or decrease aspiration pressure applied to working channel 111 to achieve a desired aspiration flow rate. Similarly, user interface 140 can include one or more user controls that allow a user to turn irrigation on or off or adjust irrigation flow rate or irrigation fluid pressure (e.g., via a pump). In response to user commands, control module 160 can activate or deactivate irrigation flow from irrigation source 130 or increase or decrease irrigation flow rate through working channel 111.

[0047] In some examples, the user controls on the user interface 140 may include a depressible irrigation control button that, when repeatedly pressed, cycles through one or more irrigation and / or suction levels before turning off irrigation and suction. In some examples, irrigation and suction may be controlled with a single control. Other suitable control elements, such as a positionable slide, a positionable lever, or a positionable dial that can specify an irrigation and / or suction level, may also be used. In some examples, the user interface 140 allows a user to select from one of multiple specified, separate irrigation or suction levels, or alternatively, allows the irrigation or suction level to be specified continuously (e.g., rather than separately).

[0048] In addition to, or instead of, independent control of suction and irrigation, the control module 160 can automatically control either irrigation or suction based on the status of the other of the irrigation or suction. In an example, the control module 160 can automatically turn on suction when the medical device is powered or when the irrigation source 130 supplies irrigation fluid to the medical device 110, and can automatically turn off suction when the medical device is not powered or when the irrigation source 130 stops supplying irrigation fluid to the medical device 110. In an example, the control module 160 can automatically adjust the irrigation flow rate or fluid volume (e.g., by activating or deactivating flow in an irrigation gap defined between the inner and outer members) depending on the aspiration flow rate. For example, at increased suction (e.g., due to a large amount of undesirable material to be removed), the control module 160 can automatically increase the irrigation flow rate or supply irrigation fluid through both the irrigation channel 114 and the irrigation gap. Conversely, at reduced suction (e.g., due to a small amount of undesirable material to be removed), the control module 160 can automatically reduce the irrigation flow rate or supply irrigation fluid through only the irrigation channel 114 or the irrigation gap, rather than both.

[0049] The control module 160 may include a pressure controller 162 configured to maintain the pressure of the anatomical environment (also referred to as "ambient pressure") under control to maintain the ambient pressure substantially at a desired pressure level (e.g., a predetermined level or one specified by a user via the user interface 140). In an example, ambient pressure is considered to be maintained at a desired pressure level when the difference between the ambient pressure measurement (e.g., by a pressure sensor) and the desired pressure is within a tolerance range of, for example, ±5-10%, as a non-limiting example. The desired pressure level to be maintained at an anatomical site in the anatomical environment 101 may be received from the user interface 140. As previously mentioned, suction can create negative pressure changes at an anatomical site, while irrigation can create positive pressure changes at an anatomical site. Negative and positive pressure changes can have deleterious effects on internal organs exposed to the anatomical site. Maintaining ambient pressure at a controlled pressure level can enhance patient safety and effectively reduce procedure time. In some examples, in addition to or instead of receiving a desired pressure level, desired flow conditions can be received, such as from user interface 140. The desired flow conditions include information regarding the inflow rate (e.g., the flow rate of irrigation fluid applied to the anatomical environment) relative to the outflow rate (e.g., the aspiration flow rate applied to the anatomical environment). The desired flow conditions correspond to the desired pressure applied to the anatomical environment. For example, a desired flow condition of substantially equal inflow and outflow rates corresponds to a substantially net-zero environmental pressure, a desired flow condition of an inflow rate higher than the outflow rate corresponds to a positive environmental pressure, and a desired flow condition of an inflow rate lower than the outflow rate corresponds to a negative environmental pressure. Pressure controller 162 can control one or more of the irrigation flow rate or the aspiration flow rate through one or more working channels to maintain the desired flow conditions during a procedure.

[0050] The pressure controller 162 can achieve the controlled pressure by automatically activating, deactivating, or adjusting one or more of the suction or irrigation. The sensor circuit 150 can monitor the pressure of the anatomical environment (“ambient pressure”) during an endoscopic procedure. In an example, the sensor circuit 150 can be coupled to a pressure sensor that senses the ambient pressure or to a signal indicative of or otherwise related to the ambient pressure. Examples of pressure sensors can include resistive, electrostatic, piezoelectric, optical, or microelectromechanical systems (MEMS) pressure sensors. In an example, the pressure sensor can be attached to or integrated into a distal portion of the medical device 110, such as the distal tip of the insertable tubular portion of the endoscope, so that the pressure sensor comes into contact with the anatomical environment 101. In an example, the pressure sensor can be positioned at a more proximal location inside the tubular portion of the endoscope, away from the anatomical environment 101. The control module 160 can receive a desired ambient pressure to be maintained during the procedure from the user interface 140. The control module 160 can compare the sensed environmental pressure to a desired environmental pressure and adjust one or more of the irrigation or aspiration flow rates to drive the environmental pressure toward the desired environmental pressure level. An exemplary system for regulating environmental pressure via automatic adjustment of aspiration and / or irrigation flow rates is discussed below with reference to FIG.

[0051] The user interface 140 may include an output unit such as a display, which may present, for example, information collected during an endoscopic procedure, including, among other things, images of the surgical area (including live video), the operating status of the medical device 110, including the status of the working channel 111, information regarding the channel status, such as a clogged channel or successful removal of a clog, and environmental pressure sensed by the sensor circuit 150.

[0052] 2A shows a perspective view of a powered tissue removal device 200, an example of a medical device 110. The powered tissue removal device 200 can include a handpiece 210 and a tubing assembly 222 extending from the handpiece 210. The tubing assembly 222 includes a proximal portion 226 located at the handpiece 210 and an opposing distal portion 228. Although the distal portion 228 is shown as being a "straight shaft" aligned with the remainder of the tubing assembly 222, in some examples, the distal portion 228 can be bent or angled relative to the remainder of the tubing assembly 222, including the proximal portion 226.

[0053] An exemplary configuration of distal portion 228 is shown in FIG. 2B. Tubular assembly 222 includes an outer tubular member 252 and an inner tubular member 254 positioned inside outer tubular member 252. Outer tubular member 252 includes an outer member window 262. Inner member 254 includes a cutting portion 264 and a suction channel 274 defined therein. Inner member 254 or cutting portion 264 includes an inner member window 266 in communication with suction channel 274.

[0054] Powered tissue removal device 200 includes an irrigation channel 272 located externally to or outside of outer member 252. Irrigation 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 includes a distal irrigation port 284 attached to powered tissue removal device 200 or to outer member 252.

[0055] Powered tissue removal device 200 may be coupled to an energy source 240, a suction source 220, and an irrigation source 230. Energy source 240 is configured to power powered tissue removal device 200, a suction source 220, an irrigation source 230, or a combination thereof. Suction source 220, an embodiment of suction source 120, may be in fluid communication with a suction channel 274 defined within inner member 254. Suction source 220 is configured to apply suction to or draw a vacuum from powered tissue removal device 200 via suction channel 274. Irrigation source 230, an embodiment of irrigation source 130, may be in fluid communication with irrigation channel 272 located external to or outside outer member 252. Irrigation source 230 may alternatively or additionally be in fluid communication with the gap between inner member 254 and outer member 252.

[0056] The powered tissue removal device 200 includes one or more user controls 224 for operating the powered tissue removal device 200, the energy source 214, the suction source 220, the irrigation source 230, or a combination thereof. By way of example and not limitation, the user controls 224, an embodiment of the user interface 140, may be located on the handpiece 210 so as to be easily accessible and operable by a user during a procedure. In an example, the user controls 224 allow a user to manually control the debridement procedure and activate, deactivate, or adjust one or more of the irrigation flow rate or the aspiration flow, among other irrigation or aspiration parameters.

[0057] Powered tissue removal device 200 includes a control module (not shown) located at least partially within handpiece 210. The control module, which may be an embodiment of control module 160, can be configured to control the operation of powered tissue removal device 200, including one or more of tissue debridement, irrigation, and aspiration, among other functions, in response to user commands from user control 224. In an example, the control module can activate and adjust one or more irrigation flow parameters or one or more aspiration flow parameters to keep the pressure of the anatomical environment (“ambient pressure”) under control, such as to maintain the ambient pressure substantially at a user-specified desired pressure during a procedure, as discussed above with reference to FIG.

[0058] 3A-3B illustrate, by way of example, endoscopic systems 300A and 300B, respectively, used in endoscopic procedures. Endoscopic systems 300A and 300B are embodiments of system 100. Referring to FIG. 3A, system 300A includes an endoscope 310A, a suction source 320, an irrigation source 330, and an aspiration / irrigation control unit 340. Endoscope 310A, an example of medical device 110, can extend into a sheath including a tube 311 extending from a distal end to a hub 312. Hub 312 terminates at a proximal end. Endoscope 310 can include a light port 314 and a viewing port 315. Light port 314 can function to transmit light into and out of endoscope tube 311, thereby illuminating a structure of interest in the anatomical environment (e.g., excised tissue, or stones and masses). The light port can be advantageous for improving visibility, for example, when the structure of interest is located in low lighting conditions. The viewing port 315 can function to provide a viewing window that allows a user to observe the structure of interest. In an example, the viewing port 315 can be an optical window at the proximal end that provides visual access for a viewing lens at the distal end. In another example, the viewing port 315 can provide a connection point for a camera to take images or video of the structure of interest and the anatomical environment. The images or video can be output and displayed on a monitor.

[0059] Endoscope 310A can include an irrigation / aspiration port 313 for receiving aspiration or irrigation fluid. Irrigation / aspiration port 313 can be located on the exterior of hub 312 or elsewhere on endoscope 310A, such as at 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 transfer and / or aspirate irrigation fluid. In an example, the same working channel can be used for irrigation and aspiration (also referred to as an integrated irrigation / aspiration channel). In another example, the irrigation channel and aspiration channel are separately located within tube 311.

[0060] In an example, the endoscope 310 may be a nephroscope. During use, a flexible distal portion of the tube 311 may be surgically inserted into a patient's kidney. A proximal portion of the tube 311 may remain outside the patient's body. Inside the tube 311 may include an optical fiber extending along the length of the endoscope 310. The optical fiber may be a multimode fiber or a single-mode fiber. A laser external to the nephroscope may generate a laser beam. The laser beam may be coupled into the proximal end of the optical fiber via an appropriate connector. The optical fiber may deliver the laser beam to the kidney stone to ablate it into fragments. In some examples, the laser beam may have a wavelength corresponding to the spectral peak of absorption in human blood and saline, such as 2100 nm, 1942 nm, and others. Generally, delivering a laser beam with significant absorption in blood and saline is advantageous because such a laser beam may be minimally invasive to surrounding tissue, which may reduce or eliminate damage to tissue at or near the kidney stone. The laser controller can be located on a graspable proximal portion of the endoscope 310. Similar to the user controls 224 that allow for manual control of the debridement procedure shown in FIG. 2A, the laser controller allows the user to switch the state of the laser beam between an operating state (“on”) and a non-operating state (“off”). In some examples, the user can adjust one or more settings of the laser, such as output power, on the laser housing rather than through the laser controller.

[0061] Aspiration / irrigation control unit 340 can provide suction and irrigation to endoscope 310 during an endoscopic procedure while maintaining the pressure of the anatomical environment under control, such as by maintaining the pressure substantially at a user-specified pressure level (e.g., the user-specified pressure with a tolerance of ±5-10%). Aspiration / irrigation control unit 340 can include a pressure monitor (an embodiment of sensor circuit 150), a control module (an embodiment of control module 160), a pump, and a power source. The control module can be in communication with user interface 341 (an embodiment of user interface 140), such as located external to aspiration / irrigation control unit 340, to control the control module.

[0062] The suction source 320 can be connected to the suction / irrigation control unit 340 via an external suction line 326. The suction / irrigation control unit 340 includes a control valve 342 configured to control suction between the suction source 320 and the endoscope 310 so that suction can be stopped during all or part of an irrigation fluid application cycle. The irrigation source 330 can be connected to the suction / irrigation control unit 340 via an external irrigation line 336. A pump included in the suction / irrigation control unit 340 can pressurize the irrigation fluid before it enters the endoscope 310 via the irrigation line 336. As shown in FIG. 3A , the external suction line 326 and the external irrigation line 336 can be connected together in a common fitting 350, which can be coupled to a common line 356 for supplying fluid or suction to the endoscope 310 via the irrigation / suction port 313.

[0063] A control module included in aspiration / irrigation control unit 340 may be configured to control the operation of endoscope 310 in response to user commands from user interface 341. In an example, the control module may automatically activate and adjust one or more irrigation flow parameters or one or more aspiration flow parameters to keep the pressure of the anatomical environment (“ambient pressure”) under control, such as to maintain the ambient pressure substantially at a user-specified pressure level, as discussed above with reference to FIG.

[0064] System 300B shown in FIG. 3B is similar to system 300A and includes an endoscope 310B, a suction source 320, an irrigation source 330, and an aspiration / irrigation control unit 340. Like endoscope 310A, endoscope 310B may include a tube 311, a hub 312, an optical port 314, and a viewing port 315. However, instead of a single irrigation / suction port 313, endoscope 310B includes separate aspiration and irrigation ports 313A and 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 an external aspiration line 326. Irrigation source 330 is fluidly coupled to irrigation port 313B via an external irrigation line 336. Aspiration port 313A and irrigation port 313B may each open into one or more working channels inside tube 311. In the example, the irrigation and suction channels are separately positioned within tube 311. Suction port 313A can selectively open to either the suction or irrigation channel. Similarly, irrigation port 313B can selectively open to either the suction or irrigation channel inside tube 311.

[0065] FIG. 4 illustrates an exemplary feedback-controlled pressure regulation system 400, which is an embodiment of the environmental pressure control portion of system 100. System 400 can be configured to regulate environmental pressure at an anatomical site through automatic adjustment of aspiration and / or irrigation flow rates in each aspiration channel 112 and irrigation channel 114. In an example, the longitudinal axis of aspiration channel 112 and the longitudinal axis of irrigation channel 114 can be parallel to one another. In an example, aspiration channel 112 and irrigation channel 114 can be coaxially arranged with a common axis, such as in a nested configuration. In an example, irrigation and aspiration can be applied at different times through the same working channel, such as an integrated irrigation / aspiration channel. Pressure monitor 450 can monitor the pressure of anatomical environment 101 via pressure sensor 352. By way of example and not limitation, control module 160 can include a proportional-integral (PI) controller or a proportional-integral-derivative (PID) controller, among other feedback controllers. The difference between the sensed pressure (at pressure monitor 450) and the desired pressure, also called the "error," can be used to determine the P, I, or D terms in the feedback controller.

[0066] Depending on the desired pressure (or desired flow condition) provided by the user, the system 500 can operate in a steady pressure mode when the desired pressure is substantially net zero (corresponding to a desired flow condition in which the inflow of irrigation fluid applied to the anatomical environment is substantially equal to the outflow of aspiration fluid applied to the anatomical environment), or in a pressure-controlled mode when the desired pressure is a positive or negative pressure (corresponding to a desired flow condition in which there is an imbalance between the inflow and outflow). When operating in a steady pressure mode, the irrigation flow rate or aspiration flow rate can be manually adjusted by the user, such as through respective user controls on the user interface 140. During an endoscopic procedure, an increase in irrigation flow rate can result in an increase in environmental pressure at the anatomical site, which can be sensed by the pressure monitor 450. The control module 160 can activate aspiration accordingly by applying aspiration pressure to the aspiration channel 112. Aspiration can create a negative pressure that offsets the increased 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 driven towards and maintained at substantially zero.

[0067] Similarly, an increase in aspiration flow rate can result in a decrease in environmental pressure at the anatomical site. Control module 160 can activate irrigation accordingly by sending a flow of irrigation fluid to irrigation channel 114. Irrigation can create a positive pressure to offset the decreased pressure created by aspiration. Control module 160 can adjust the irrigation flow rate until the pressure drop (due to increased aspiration) is substantially neutralized by the irrigation flow. Environmental pressure can then be driven toward and maintained at substantially zero.

[0068] In some situations, it is desirable to maintain a positive or negative environmental pressure at an anatomical site. Positive pressure, controlled within a safe range, can help open anatomical structures (e.g., ureters, kidneys, uterus, or other organs) during endoscopic procedures, allowing for better visualization of the anatomical structure through the scope without causing tissue damage due to excessive positive pressure. Positive pressure can also prevent tissue debris or stone fragments from becoming lodged in the anatomical structure and aid in their removal from the anatomical structure. In some cases, maintaining negative pressure, controlled within a safe range, during endoscopic procedures can also facilitate the removal of debris from the anatomical structure without exposing internal organs to the risk of excessive negative pressure.

[0069] When a desired positive environmental pressure is provided by a user, such as via user interface 140, system 400 can operate in pressure control mode. Control module 160 can automatically increase the irrigation flow rate through 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 decrease the negative pressure at the anatomical site. Automatic adjustment of irrigation and / or aspiration can continue until the sensed environmental pressure substantially reaches the desired positive pressure level.

[0070] Similarly, system 400 can operate in a pressure control mode when a desired negative environmental pressure is provided by a user, such as via user interface 140. Control module 160 can automatically increase the aspiration flow rate through aspiration channel 112 to increase the negative environmental pressure at the anatomical site. Additionally, or alternatively, control module 160 can automatically decrease the irrigation flow rate through irrigation channel 114 to decrease the positive pressure at the anatomical site. Automatic adjustment of irrigation and / or aspiration can continue until the sensed environmental pressure substantially reaches the desired negative pressure level.

[0071] The control module 160 can include a safety mechanism for maintaining 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 current flow rate of the irrigation flow to prevent a further increase in the environmental pressure. Similarly, if the sensed environmental pressure reaches the lower negative pressure limit, the control module 160 can automatically stop, reduce, or maintain the current flow rate of the aspiration flow to prevent a further decrease in the environmental pressure. When the system operates in pressure control mode, the desired positive pressure and desired negative pressure received from the user are checked to ensure they fall within the safe range. In a non-limiting example, the desired positive pressure is 5 pounds per square inch (psi) (or approximately 34.5 kilopascals (kPa)), the desired negative pressure is −5 psi (or approximately −34.5 kPa), and the safety range is between a lower limit of −6 psi (or approximately −41.4 kPa) and an upper limit of 6 psi (or approximately 41.4 kPa). In an example, a warning may be issued (e.g., from the user interface 140) if the desired positive pressure received from the user exceeds the upper positive pressure limit or if the desired negative pressure is lower than the negative pressure safety range. Using such safety mechanisms, the control module 160 can maintain environmental pressure at a user-specified level while preventing or minimizing excessive positive or negative pressure from being applied to the anatomical environment during a procedure.

[0072] FIG. 5 is a flow chart illustrating a method 500 for maintaining the pressure of the anatomical environment ("ambient pressure") of an anatomical site in a patient during a minimally invasive procedure, such as an endoscopic procedure. Examples of medical devices may include a tissue removal device, such as that shown in FIG. 2, or an endoscope, such as that shown in FIGS. 3A-3B, among others. The medical device may include a tubular portion insertable into a hollow organ or cavity of the body to aid in medical diagnosis or surgical treatment. The medical device may include one or more working channels configured to provide irrigation fluid to the anatomical site and to remove tissue debris, stones and clots, bodily fluids, and irrigation fluid, collectively referred to herein as "undesirable material," away from the anatomical site. The working channel may be located at least partially inside the tubular portion of the medical device. In an example, the working channel is an integrated irrigation / aspiration channel controllably used for irrigation and aspiration (e.g., at different times). In another example, the working channel may include separate irrigation and aspiration channels disposed within the tubular portion of the medical device. The irrigation channel and the aspiration channel can each receive irrigation fluid or aspiration pressure, such as under automatic control by a controller unit, to perform different tasks or fulfill different functions during an endoscopic procedure, in accordance with various embodiments discussed herein.

[0073] Method 500 includes one or more processes for operating a clog removal system, such as system 100 or one of its variations, e.g., systems 200, 300A, or 300B. Although the processes of method 500 are depicted in a flow diagram, they need not be performed in any particular order. In various examples, some of the processes may be performed in a different order than depicted here.

[0074] The method 500 can regulate environmental pressure by automatically activating, deactivating, or adjusting one or more of the suction or irrigation flow rates in one or more working channels. As previously mentioned, suction can create negative pressure changes at an anatomical site, while irrigation can create positive pressure changes at an anatomical site. Negative and positive pressure changes can have detrimental effects on internal organs exposed at the anatomical site. Maintaining environmental pressure at a controlled pressure level can increase patient safety and effectively reduce procedure time.

[0075] At 510, a desired environmental pressure may be received from a user, such as via user interface 140. The desired pressure represents the pressure to be maintained in the anatomical environment during the procedure. In various examples, the desired pressure may be one of a substantially net-zero pressure, a desired positive pressure, or a desired negative pressure.

[0076] In some examples, in addition to or instead of receiving a desired pressure, desired flow conditions can be received at 510, such as from user interface 140. The desired flow conditions include information regarding the inflow rate (e.g., the flow rate of irrigation fluid applied to the anatomical environment) relative to the outflow rate (e.g., the flow rate of aspiration applied to the anatomical environment), corresponding to the desired pressure applied to the anatomical environment. One or more of the irrigation flow rates or aspiration flow rates through one or more working channels can be varied during the procedure to maintain the desired flow conditions.

[0077] At 520, the pressure of the anatomical environment (“ambient pressure”) can be sensed, such as with a pressure sensor. The pressure sensor can be attached to or integrated into a distal portion of the medical device, such that the sensor is in contact with the anatomical environment. Examples of pressure sensors include resistive, electrostatic, piezoelectric, optical, or microelectromechanical systems (MEMS) pressure sensors.

[0078] At 530, the sensed pressure can be compared to a desired pressure. If the sensed pressure does not substantially reach the desired pressure level, at 540, one or more of the irrigation flow rate or aspiration flow rate through the working channel can be adjusted, such as with pressure controller 162, to drive the environmental pressure toward the desired pressure level. As discussed above with reference to FIG. 4, suction applied to the aspiration channel can create a negative pressure in the anatomical environment, which can offset an increase in environmental pressure created by the increased irrigation flow rate. Similarly, a flow of irrigation fluid provided to the irrigation channel can create a positive pressure in the anatomical environment, which can offset a decrease in environmental pressure created by the suction. The aspiration flow rate or pressure and the irrigation flow rate or pressure can be adjusted, such as by pressure controller 162, to maintain the environmental pressure substantially at the desired pressure level. Exemplary methods of adjusting aspiration and / or irrigation to maintain a desired environmental pressure, such as net zero pressure, a desired positive pressure, or a desired negative pressure, are discussed below with reference to FIGS. 6A-6B and 7A-7B.

[0079] If the sensed environmental pressure reaches and maintains substantially the desired pressure level at 530 (i.e., within a tolerance such as ±5-10% of the desired pressure), it is determined whether the procedure is complete at 550. If the procedure is not complete, pressure sensing at 520 and adjustment of irrigation / aspiration flow at 540 can continue until the procedure is complete.

[0080] 6A-6B are flow diagrams illustrating methods 600A and 600B, respectively, for maintaining a balanced environmental pressure (e.g., substantially net-zero pressure) in an anatomical environment at an anatomical site during an endoscopic procedure, or for maintaining desired flow conditions in which the inflow of irrigation fluid and the outflow of aspiration applied to the anatomical environment are substantially equal. Equal inflow and outflow correspond to a substantially net-zero pressure in the anatomical environment. Balanced environmental pressure or equal inflow and outflow rates in the working channels may be achieved by automatically activating, deactivating, or adjusting one or more of the aspiration flow rates or irrigation flow rates in one or more working channels. Maintaining a substantially net-zero environmental pressure is also referred to as a stable pressure mode. Methods 600A and 600B may be implemented in and executed by a pressure controller, such as pressure controller 162. The processes of any of these methods need not be performed in a particular order. For example, some steps may be performed in an order different from that shown herein.

[0081] Method 600A includes automatically activating and controlling the application of suction pressure in response to increased irrigation through a working channel during an endoscopic procedure. At 611, a user command to increase the irrigation flow rate can be received from a user interface. The irrigation flow can generate a positive pressure change in the anatomical environment, which can be sensed at 612 using a pressure sensor. In response to the sensed positive pressure change, suction can be activated at 613, such as by fluidly coupling an suction source to the working channel, under the control of pressure controller 162. Pressure controller 162 can include a proportional-integral (PI) controller or a proportional-integral-derivative (PID) controller, among other feedback controllers. The difference between the sensed pressure and the desired pressure, also referred to as the “error” term, can be used to determine the P, I, and D terms in the feedback controller. In some examples, irrigation at 611 and suction at 613 can be applied to separate channels, such as an irrigation channel and an aspiration channel, as shown in FIG. 4. Alternatively, irrigation at 611 and suction at 613 can be applied to the same working channel (an "integrated suction / irrigation channel"), such as at different times.

[0082] Aspiration through the working channel at 613 can generate a negative pressure change that can offset the pressure increase created by the increased flow rate irrigation at 611. To achieve the desired environmental pressure, the aspiration flow rate or aspiration pressure can be adjusted based on the environmental pressure measurement. At 614, the sensed pressure is checked against the desired net zero pressure. If the sensed pressure has not substantially reached the desired pressure level, the aspiration flow rate can be further adjusted at 613 until the increase in sensed pressure (resulting from the increased irrigation) is substantially counteracted by the aspiration flow, thus driving the environmental pressure toward and maintaining it at substantially zero.

[0083] Method 600B includes automatically activating and controlling the application of irrigation fluid flow in response to suction applied to a working channel during an endoscopic procedure. At 621, a user command to apply suction to the working channel can be received from a user interface. Applying suction pressure can generate a negative pressure change in the anatomical environment, which can be sensed by a pressure sensor at 622. In response to the sensed negative pressure change, irrigation can be activated at 623 to provide irrigation flow into the working channel. As shown in FIG. 4, suction at 621 and irrigation at 623 can be applied to separate channels, such as an irrigation channel and a suction channel. Alternatively, irrigation and suction can be applied to an integrated aspiration / irrigation channel, such as at different times.

[0084] Irrigation through the working channel can generate a positive pressure change at 623, which can offset the decrease in pressure created by suction at 611. To achieve the desired environmental pressure, the irrigation flow rate or irrigation pressure (such as controlled by a pump to pressurize the irrigation fluid before directing it to the working channel) can be adjusted based on the environmental pressure measurement. The sensed pressure is compared to the desired net zero pressure at 624. If the sensed pressure does not substantially reach the desired pressure level, irrigation can be further adjusted at 623 until the decrease in sensed pressure (resulting from the applied suction) is substantially negated by the irrigation flow, thus driving the environmental pressure toward and maintaining it at substantially zero.

[0085] 7A-7B are flow diagrams illustrating methods 700A and 700B, respectively, of maintaining a desired positive or negative pressure in an anatomical environment during an endoscopic procedure, or maintaining a flow condition characterized by a desired imbalance between the inflow of irrigation fluid applied to the anatomical environment and the outflow of aspiration applied to the anatomical environment. The desired imbalance corresponds to a desired positive or negative pressure in the anatomical environment. The desired pressure or flow condition can be achieved by automatically activating, deactivating, or adjusting one or more of the aspiration or irrigation flow rates in one or more working channels. Maintaining environmental pressure at a controlled positive or negative level is also referred to as a pressure control mode.

[0086] Methods 700A and 700B may be implemented in and performed by a pressure controller, such as pressure controller 162 of a control module. The processes of any of these methods need not be performed in any particular order. For example, some steps may be performed in a different order than shown herein.

[0087] Referring to FIG. 7A , method 700A includes automatically activating and controlling the application of suction or irrigation to a working channel during an endoscopic procedure to maintain a desired positive anatomical pressure at the anatomical site. Maintaining controlled positive pressure within a safe range can help open anatomical structures (e.g., ureters, kidneys, or other organs) during an endoscopic procedure, allowing for better visualization of the anatomical structure through the scope without causing tissue damage due to excessive positive pressure. Positive pressure can also prevent tissue debris or stone fragments from becoming lodged in the anatomical structure and assist in removing these unwanted materials from the anatomical structure. At 711, the desired positive pressure can be received from a user via a user interface. By way of example and not limitation, the desired positive pressure is 5 psi (approximately 34.5 kPa). At 712, irrigation at an increased flow rate or suction at a decreased flow rate can be applied to the working channel. This can result in a positive change in pressure in the anatomical environment, which can be sensed by a pressure sensor at 713. The sensed pressure can be compared against a desired positive pressure at 714. If the sensed pressure does not reach and maintain the desired positive pressure, adjustments to irrigation and / or aspiration can continue at 712. This can include, for example, further increasing the irrigation flow rate and / or decreasing the aspiration flow rate if the sensed pressure is below the desired positive pressure (e.g., a desired positive pressure of 5 psi and the sensed pressure is 4 psi), or decreasing the irrigation flow rate and / or increasing the aspiration flow rate if the sensed pressure exceeds the desired positive pressure (e.g., a desired positive pressure of 5 psi and the sensed pressure is 6 psi).

[0088] Referring to FIG. 7B , method 700B includes automatically activating and controlling the application of suction or irrigation to a working channel during an endoscopic procedure to maintain a desired negative pressure in the anatomical environment at the anatomical site. Maintaining a controlled negative pressure within a safe range during an endoscopic procedure can also facilitate removal of debris from the anatomical structure without exposing internal organs to the risk of excessive negative pressure. At 721, the desired negative pressure can be received from a user via a user interface. An example of a desired negative pressure is −5 psi (approximately −34.5 kPa). At 722, an increased flow rate of suction or a decreased flow rate of irrigation can be applied to the working channel. Doing so can produce a negative pressure change in the anatomical environment, which can be sensed by a pressure sensor at 723. At 724, the sensed pressure can be compared to the desired negative pressure. If the sensed pressure does not reach and maintain the desired negative pressure, adjustments to irrigation and / or suction can continue at 722. This may include, for example, further increasing the aspiration flow rate and / or decreasing the irrigation flow rate if the sensed pressure exceeds the desired negative pressure (e.g., a sensed pressure of -4 psi for a desired negative pressure of -5 psi), or decreasing the aspiration flow rate and / or increasing the irrigation flow rate if the sensed pressure is equal to or less than the desired negative pressure (e.g., a sensed pressure of -6 psi for a desired negative pressure of -5 psi).

[0089] The above-described methods of controlling the application of irrigation and / or suction through one or more working channels (e.g., methods 500, 600A-600B, and 700A-700B) can effectively avoid or minimize excessive positive or negative pressure imposed on internal organs during endoscopic procedures, thereby reducing overall procedure time and improving patient safety.

[0090] 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 may be practiced. These embodiments are also referred to herein as "examples." Such examples may include elements other than those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. Furthermore, the inventors also contemplate examples using any combination or permutation of the elements shown or described (or one or more aspects thereof) with respect to the particular example (or one or more aspects thereof) shown or described herein, or with respect to other examples (or one or more aspects thereof).

[0091] In this document, the terms "a" or "an" are used, which is common in patent documents, to include one or more, independent of other instances or uses of either "at least one," or "one or more." In this document, the term "or" is used to refer to non-exclusive unless otherwise specified, or "A or B" is used to include "A but not B," "B but not A," and "A and B." In this document, the terms "comprise" and "in which" are used as the plain English equivalents of the respective terms "comprising" and "wherein." Furthermore, in the appended claims, the terms "comprise" and "comprising" are open-ended, i.e., in a claim, a system, device, article, composition, formulation, or process may include elements other than those listed after such term and still be deemed to be within the scope of the claim. Moreover, in the appended claims, the terms "first," "second," and "third," etc., are used merely as labels and are not intended to impose numerical requirements on their objects.

[0092] The above description is intended to be illustrative, not limiting. For example, the foregoing examples (or one or more aspects thereof) can be used in combination with each other. Other embodiments may be utilized by those skilled in the art, such as by reviewing the above description. The Abstract is provided to enable the reader to quickly ascertain the nature of the technical disclosure. It is presented with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Furthermore, in the above Detailed Description, various features may be grouped together to organize the disclosure. This should not be construed as intending that unclaimed disclosed features form the basis for any claim. Rather, inventive subject matter may reside in less than all features of an individual disclosed embodiment. Thus, the appended claims are herein incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalent forms to which such claims are entitled. [Explanation of symbols]

[0093] 100 systems 101 Anatomical environment 110 Medical Devices 111 Working Channel 112 suction channel 114 Irrigation Channel 120 Suction Source 130 Irrigation Sauce 140 User Interface 150 Sensor Circuit 160 Control Module 162 Pressure Controller 200 Powered Tissue Removal Device 210 Handpiece 214 Energy Sources 220 Suction Source 222 Tubular assembly 224 User Control 226 Proximal part 228 Distal part 230 Irrigation Sauce 240 Energy Sources 252 Outer tubular member, outer member 254 Inner tubular member, inner member 262 External member window 264 Cutting part 266 Inner Component Window 272 Irrigation Channel 274 Suction Channel 282 Proximal Irrigation Port 284 Distal Irrigation Port 300A Endoscope System 300B Endoscopy System 310 Endoscope 310A Endoscope 310B Endoscope 311 tube 312 Hub 313 Irrigation / Suction Port 313A Suction Port 313B Irrigation Port 314 optical port 315 Sight Port 320 Suction Source 326 Suction line 330 Irrigation Sauce 336 Irrigation line 340 Suction / Irrigation Control Unit 341 User Interface 342 Control valve 350 Accessories 352 Pressure Sensor 356 Common pipeline 400 Pressure Regulation System 450 Pressure Monitor

Claims

1. 1. A system for regulating pressure at an anatomical site on a patient during a procedure, the system comprising: A medical device comprising: at least one working channel fluidly coupled to a suction source and an irrigation source; a pressure sensor configured to sense pressure at the anatomical site; a medical device comprising: a user interface configured to receive user input to initiate or adjust one or more of irrigation or suction applied to the anatomical site through the at least one working channel; a control circuit, in response to the user input, that initiates or regulates one or more of irrigation or aspiration; comparing the pressure sensed at the anatomical site as a result of the user input to a predetermined pressure level; If the sensed pressure is within a safe pressure range but deviates from the predetermined pressure level by more than a specified margin, generating a control signal to at least one of the irrigation source or the aspiration source to automatically adjust an irrigation flow rate or an aspiration flow rate, respectively, to maintain the pressure within the specified margin of the predetermined pressure level during treatment. a control circuit configured to A system comprising:

2. the predetermined pressure level is zero pressure; the received user input includes a user applying irrigation or increasing an irrigation flow rate; 2. The system of claim 1, wherein the control circuit is configured to generate a control signal to the suction source to automatically initiate suction and adjust the suction flow rate to keep the sensed pressure within the specified margin of zero pressure during treatment.

3. the predetermined pressure level is zero pressure; the received user input comprises a user applying suction or increasing a suction flow rate; 2. The system of claim 1, wherein the control circuit is configured to generate a control signal to the irrigation source to automatically initiate irrigation and adjust the irrigation flow rate to keep the sensed pressure within the specified margin of zero pressure during treatment.

4. the predetermined pressure level is a positive target pressure; the received user input comprises a user increasing an irrigation flow rate or a user decreasing an aspiration flow rate; 2. The system of claim 1, wherein the control circuit is configured to generate control signals to at least one of the irrigation source or the aspiration source to automatically adjust the irrigation flow rate or the aspiration flow rate, respectively, to keep the sensed pressure within the specified margin of the positive target pressure during treatment.

5. the predetermined pressure level is a negative target pressure; the received user input comprises a user increasing an aspiration flow rate or a user decreasing an irrigation flow rate; 2. The system of claim 1, wherein the control circuit is configured to generate control signals to at least one of the irrigation source or the aspiration source to automatically adjust the irrigation flow rate or the aspiration flow rate, respectively, to keep the sensed pressure within a specified margin of the negative target pressure during treatment.

6. The system of claim 1 , wherein the pressure sensor is attached to or integrated into a distal portion of the medical device.

7. the medical device includes an endoscope; The system of claim 6 , wherein the pressure sensor is attached to or integrated into a distal end of an insertable tubular portion of the endoscope.

8. The system of claim 1 , wherein the user interface includes a display configured to display information including the sensed pressure at the anatomical site and the predetermined pressure level.

9. The system of claim 1 , wherein the at least one working channel includes a common pathway for passing irrigation and aspiration flows.

10. 2. The system of claim 1, wherein the at least one working channel includes a first channel coupled to the irrigation source for passing an irrigation flow therethrough, and a second channel separate from the first channel for connecting to the suction source for passing an aspiration flow therethrough.

11. further comprising a surgical device configured to manipulate or surgically remove an object from the anatomical site; 2. The system of claim 1, wherein the control circuit is configured to generate a control signal that adjusts one or more of the irrigation flow rate or the aspiration flow rate to maintain pressure at the anatomical site within the specified margin of the predetermined pressure level during manipulation or surgical removal of the object.

12. 12. The system of claim 11, wherein the surgical device includes a tissue removal device at least partially insertable into the anatomical site, the tissue removal device configured to illuminate at least a portion of the anatomical site and a surrounding environment, provide an image of the anatomical site, resect unwanted tissue from the anatomical site, and remove the resected tissue through the at least one working channel.

13. 12. The system of claim 11, wherein the surgical device includes a nephroscope at least partially insertable into a portion of the patient's urinary tract, the nephroscope configured to illuminate a renal tumor mass and a surrounding environment, provide an image of the illuminated renal tumor mass, fragment the renal tumor mass into fragments, and remove the renal tumor mass fragments through the at least one working channel.

14. 1. A method of regulating pressure at an anatomical site of a patient during a procedure via a medical device, comprising: receiving, via a user interface, user input to initiate or adjust one or more of irrigation or suction applied to the anatomical site through at least one working channel fluidly coupled to an aspiration source and an irrigation source; sensing pressure at the anatomical site via a pressure sensor in response to the user input initiating or adjusting one or more of irrigation or aspiration; comparing the pressure sensed at the anatomical site as a result of the user input to a predetermined pressure level; If the sensed pressure is within a safe pressure range but deviates from the predetermined pressure level by more than a specified margin, automatically adjusting one or more of an irrigation flow rate or an aspiration flow rate via a control circuit to maintain pressure at the anatomical site within the specified margin of the predetermined pressure level during the procedure; A method comprising:

15. the predetermined pressure level is zero pressure; the received user input includes a user applying irrigation or increasing an irrigation flow rate; 15. The method of claim 14, wherein automatic adjustment includes automatically initiating suction and adjusting the aspiration flow rate to keep the pressure sensed during treatment within the specified margin of zero pressure.

16. the predetermined pressure level is zero pressure; the received user input comprises a user applying suction or increasing a suction flow rate; 15. The method of claim 14, wherein automatic adjustment includes automatically initiating irrigation and adjusting the irrigation flow rate to keep the pressure sensed during treatment within the specified margin of zero pressure.

17. the predetermined pressure level is a positive target pressure; the received user input comprises a user increasing an irrigation flow rate or a user decreasing an aspiration flow rate; 15. The method of claim 14, wherein automatically adjusting the irrigation flow rate or the aspiration flow rate comprises maintaining the pressure sensed during treatment within the specified margin of the positive target pressure.

18. the predetermined pressure level is a negative target pressure; the received user input comprises a user increasing an aspiration flow rate or a user decreasing an irrigation flow rate; 15. The method of claim 14, wherein automatically adjusting the irrigation flow rate or the aspiration flow rate comprises maintaining the pressure sensed during the procedure within the specified margin of the negative target pressure.

19. 15. The method of claim 14, further comprising presenting the pressure sensed at the anatomical site and the predetermined pressure level on a display of the user interface.

20. further comprising the step of manipulating or surgically removing an object from the anatomical site via a surgical device; 15. The method of claim 14, wherein automatically adjusting one or more of the irrigation flow rate or the aspiration flow rate comprises maintaining pressure at the anatomical site within the specified margin of the predetermined pressure level during manipulation or surgical removal of the object.

Images