Large diameter suction overtube

Abstract

A large-diameter suction overtube device includes an internal lumen configured to receive an endoscope and to apply suction around the endoscope to remove material from inside the body. In some cases, the endoscope is removed, and in other cases, removal of the endoscope is not required. Methods are also described herein.

Description

[Technical Field]

[0001] Claim of priority

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 500,343, filed on 5 May 2023, entitled “LARGE BORE SUCTION OVERTUBE,” which is incorporated herein by reference in its entirety. [Background technology]

[0002]

[0002] Devices for capturing and retrieving thrombi and debris from the gastrointestinal tract or other body regions include suction catheters and can be used for a variety of procedures that may be performed by less invasive approaches to reach remote locations within the patient's body. These procedures may include access to the digestive system, vascular system, abdominal cavity, lungs, female reproductive tract, or urinary tract.

[0003]

[0003] In some cases, it is beneficial to use a scope (collectively referred to herein as “endoscopy”) to assist in the removal of material containing blood clots. The endoscope may include one or more working channels and / or suction channels and may be used to visualize the blood clot material. In some cases, the endoscope may include mechanical means to assist in the removal and / or destruction (e.g., maceration) of the blood clot. Furthermore, instruments may be utilized through the working channels. However, in part, the effectiveness of the endoscope may be limited by the dimensions of the suction channels, as well as the size and tissue of the material (i.e., if the blood clot is too large and hard relative to the diameter of the working channel). Other examples of problems in the current art include the time or ability required to access the occluded site by the loop of an anatomical endoscope. There is a need for devices and methods that allow for rapid access to material from inside the body (e.g., blood clot material, feces, food, etc.) and optimal suction. The devices and methods described herein can fully address these problems. [Overview of the project] [Means for solving the problem]

[0004]

[0004] Described herein are methods and apparatus (e.g., devices, accessories, systems, etc., including suction overtubes) for removing substances (e.g., feces, blood, blood clots, fragments, lavage fluids, etc.) from the body. These removal apparatus may include a suction overtube adapted for effective and intuitive use with one or more scopes (e.g., endoscopes). These methods and apparatus are called suction overtubes and generally include an elongated body that can be very flexible but reinforced (to withstand the range of applied suction) and a proximal end adapted to receive an endoscope in the lumen of the overtube, allowing suction to be applied at the proximal end and performed at the distal end of the overtube while maintaining sufficient sealing, allowing the endoscope to move longitudinally (proximal / distal) within the lumen. The overtubes described herein may be configured to have the same or different relative stiffness. In some examples, the apparatus may be configured to have varying stiffness along the length of the overtube. For example, the distal end region may be progressively more flexible than the proximal end region.

[0005]

[0005] For example, the suction overtube device may include: an elongated body having an internal lumen extending from a distal end to a proximal end; a proximal end region including an endoscope receiving port configured to receive an endoscope through it into the internal lumen, the endoscope receiving port being in line with the internal lumen of the elongated body; a vacuum port in the proximal end region having fluid communication with the internal lumen; and a control device configured to control the inflow into the vacuum port and to apply suction through the vacuum port when the control device is held in an activated state by the user.

[0006]

[0006] In some examples, the suction overtube device is an elongated body having an internal lumen extending from the distal end to the proximal end, and is capable of withstanding the negative pressure inside the internal lumen (for example, a pressure of at least about 101.33 kPa (760 mmHg), at least about 92.33 kPa (700 mmHg), at least about 79.99 kPa (600 mmHg), at least about 66.66 kPa (500 mmHg), at least about 50.66 kPa (380 mmHg), at least about 39.99 kPa (300 mmHg), etc.) The overtube may include: an elongated body having sufficient circumferential strength; a proximal end region including an endoscope receiving port configured to receive an endoscope through it into an internal lumen, and including one or more seals configured to seal around the endoscope, wherein the endoscope receiving port is aligned with the internal lumen of the elongated body; a vacuum port in the proximal end region that is in fluid communication with the internal lumen; and a control device coupled to the vacuum port and configured to apply suction through the vacuum port when the control device is held in the operating state by the user. Generally, the overtube may be configured to withstand various levels of vacuum, including a variable level of partial vacuum (e.g., 101.33 kPa (760 mmHg) at atmospheric pressure).

[0007]

[0007] As described above, the overtube device may generally include a seal configured to seal around the endoscope, which may be located proximal to the vacuum port. For example, the proximal end region may include one or more sealing gaskets configured to close off around the endoscope. The seal may be configured to allow the endoscope to move (slide) proximal and distally relative to the lumen of the overtube device. In some examples, the seal may be adjustable so that it can be loosened to allow, for example, the scope to move more easily in the proximal and distal directions, and so that it can be activated or tightened, for example, before and / or during the application of suction through the lumen of the overtube. The seal may be annular seals, for example (but not limited to) O-rings or flat, thin elastomer seals. Any of these seals may be lubricated or coated to reduce sliding resistance.

[0008]

[0008] In any of these devices, the endoscope receiving port and the vacuum port may be part of an adapter configured to connect to the proximal end of an elongated body. For example, the adapter may be configured at the proximal end of an overtube device (via friction fitting, screw-in, Luer lock, etc.) and may include a port for applying suction through the overtube lumen (optionally, in some examples, this port may be located on the side of the proximal end region of the overtube or adapter) and a proximal end port for receiving the endoscope. The control device may be connected to the vacuum port and may be part of the adapter. The adapter may be detachably mounted. The adapter may include a seal configured to seal around the endoscope.

[0009]

[0009] Alternatively, the device may not include a detachable adapter, but rather the endoscope receiving port and / or vacuum port may be integrated with the elongated body of the overtube (for example, at the proximal end of the overtube).

[0010]

[0010] Generally, these devices may be configured to withstand a target range of negative pressure (i.e., without leakage or structural collapse). For example, the devices may be configured to withstand negative pressures up to 101.33 kPa (760 mmHg) (e.g., negative pressures of 93.33 kPa (700 mmHg), 79.99 kPa (600 mmHg), 66.66 kPa (500 mmHg), etc.). For example, the elongated body may have circumferential strength sufficient to withstand at least the target pressure range within the internal lumen (for example, the device may be configured to withstand approximately 0.2 atmospheres, 0.4 atmospheres, 0.6 atmospheres, 0.8 atmospheres, or 1 atmosphere or more, such as negative pressures of up to approximately 101.32 kPa (760 mmHg), 93.325 kPa (700 mmHg), 79.99 kPa (600 mmHg), 66.66 kPa (500 mmHg), and 53.3 kPa (400 mmHg)).

[0011]

[0011] In any of these examples, the elongated body may be reinforced. One or more layers of the elongated body forming the lumen may be reinforcing layers, including, but not limited to, braided tubes or coiled reinforcing layers / tubes. For example, an elongated flexible tube may include a coiled reinforcing tube. The coil may be, for example, a helical coil formed from a material exhibiting high compressive and / or tensile strength. This could be a wire, polymer, composite fiber, yarn made from natural or artificial materials (including rigid resin materials, e.g., epoxy-reinforced), metal, metal alloy, composite material, mineral, polymer material, natural fiber, etc. In some cases, it may be a fiber, for example, aramid (Kevlar, Twaron, Technora), Vectran, ultra-high molecular weight polyethylene (UHMWPE) (Dyneema or Spectra), Zylon, nylon, polyester, or carbon fiber. In some cases, it may be formed from a composite of multiple materials. In some examples, the body is made of metal, which may include, for example, nitinol, steel or plated steel, stainless steel alloy, magnesium alloy, tantalum, cobalt-chromium alloy, etc. The coil may be wound in one direction or multiple directions (e.g., clockwise and / or counterclockwise). Thus, the elongated body may include an internal coil winding tube.

[0012]

[0012] As described above, the apparatus may include one or more control devices coupled to the vacuum port to control the application of suction. For example, the control device may be a button, a slider, a knob, a valve, a dial, a lever arm, a switch, a trigger, etc. In some examples, the control device may be a biased valve. Generally, the control device may be biased to maintain the vacuum port in a closed position, and suction will not be applied unless the control device is maintained in an activated state (e.g., maintaining force against bias). In some cases, the valve may be directly actuated, in other cases it may be actuated electronically or remotely and then actuated by an actuator (e.g., a motor, rotary actuator, linear actuator, solenoid, etc.).

[0013]

[0013] The control device may be configured to seal around the endoscope by activating (or increasing) a control seal. For example, the control device may be coupled to a vacuum port and include or incorporate a valve such as, or not limited to, a trumpet valve. The control device may be directly coupled to a vacuum port or coupled by a vacuum (e.g., suction) line coupled to a vacuum port. In some examples, the control device includes a lever or pedal (e.g., a foot pedal, a hand lever, a finger lever, etc.).

[0014]

[0014] Generally, the distal end of the overtube may be tapered. For example, the distal end of the overtube may have a diameter that is a fraction of the inner diameter of the more proximal region of the lumen of the overtube. For example, the diameter of the opening may be between approximately 97% and 50% of the inner diameter of the lumen of the overtube (e.g., less than 90%, less than 85%, less than 80%, less than 75%, less than 70%, less than 65%, less than 60%, etc.). Thus, the distal end opening of the overtube may be narrowed.

[0015]

[0015] The distal end opening of the overtube may have an inner diameter that is approximately the same as or larger than the outer diameter of the distal end of the endoscope. For example, the distal end opening of the overtube may have an opening diameter that is about 5% larger than the outer diameter of the endoscope (e.g., 7.5%, 10%, 12.5%, 15%, 17.5%, 20%, 25%, 30%, 50%, 75%, 100%, 1.5 times, 2 times, 2.5 times, 3 times, 5 times, etc. of the outer diameter of the endoscope). Any of these devices may include an endoscope (for example, as part of a system).

[0016]

[0016] Generally, all of these devices are about 10 mm 2 Larger than (for example, about 12mm) 2 , 15mm 2 , 20mm 2 , 25mm 2 , 30mm 2 , 50mm 2 , 70mm 2It may have an internal lumen with a cross-sectional area (larger than, for example).

[0017]

[0017] The distal end of the overtube (e.g., the tip) includes a distally tapered region surrounding the distal opening to the lumen, but may be transparent and / or translucent. For example, the distal end of the overtube may be configured to allow visualization of the body region outside the distal end region (possibly by the camera of the endoscope as the endoscope is drawn into the lumen). In any of these devices, the distal end region of the overtube (including the tip or proximal to the tip) may include one or more relief holes to prevent complete aspiration, which can help prevent aspiration to the body wall, for example. The device may include one or more (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, etc.) holes or openings to the internal lumen through the device. The aspiration relief holes may be smaller (individually and / or overall) than the distal end opening of the device. The aspiration relief holes may be located proximal to the distal end opening.

[0018]

[0018] In any of the devices described herein, the overtube and / or endoscope may be configured to be rigid. For example, the elongated body of the overtube may be configured to be rigid. The overtube may be configured to be partially or fully rigid, and in some examples, the overtube may be configured to be rigid only in a certain region (e.g., the proximal region). In some examples, the distal end portion (e.g., about 11.43 cm (4.5 inches), 12.70 cm (5 inches), 15.24 cm (6 inches), 17.78 cm (7 inches), etc. from the most distal) may be configured not to be rigid but to maintain flexibility. This may make the device easier to operate on an operable endoscope. In some examples, the elongated body includes a rigid layer having multiple strand lengths intersecting each other, and a compression layer configured to actuate a force on the rigid layer to rigidize the outer sheath from a flexible configuration to a rigid configuration. Examples of rigidizing devices of any function that may be included as part of the overtube and / or endoscope described herein are U.S. Patent No. 11,135,398 (titled “DYNAMICALLY RIGIDIZING COMPOSITE MDEICAL STRUCTURES”), U.S. Patent Application No. 17 / 604,203 (also titled “DYNAMICALLY RIGIDIZING COMPOSITE MDEICAL STRUCTURES”), PCT / US2021 / 024582 (titled “LAYERED WALLS FOR RIGIDIZING DEVICES”), PCT / US2021 / 034292 (titled “RIGIDIZING DEVICES”), and PCT / US2022 / 014497 (titled “DEVICES AND METHODS TO PREVENT INADVERTENT MOTION OF DYNAMICALLY RIGIDIZING DEVICES”). "DEVICES", PCT / US2022 / 019711 (title "CONTROL OF ROBOTIC DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES"), U.S. Provisional Patent Application No. 63 / 265,U.S. Provisional Patent Application No. 934 (titled "METHODS AND APPARATUSES FOR REDUCING CURVATURE OF A COLON"), U.S. Provisional Patent Application No. 63 / 296,478 (titled "RECONFIGURABLE STRUCTURES"), U.S. Provisional Patent Application No. 63 / 308,044 (titled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES"), U.S. Provisional Patent Application No. 63 / 324,011 (titled "METHODS AND APPARATUSES FOR NAVIGATING USING A PAIR OF RIGIDIZING DEVICES"), U.S. Provisional Patent Application No. 63 / 342,618 (titled "EXTERNAL WORKING CHANNELS FOR ENDOSCOPIC DEVICES"), U.S. Provisional Patent Application No. 63 / 335,720 ("HYGIENIC DRAPING FOR ROBOTIC The terms "ENDOSCOPY" are found in U.S. Provisional Patent Application No. 63 / 332,686 (titled "MANAGING AND MANIPULATING A LONG LENGTH ROBOTIC ENDOSCOPE"), and their entire contents are incorporated herein by reference.

[0019]

[0019] Any of these devices may include a negative pressure source (e.g., vacuum), such as a pump. The device may include a control circuit (e.g., a control device including hardware, software and / or firmware for controlling suction, such as a suction manifold having one or more valves). Alternatively or additionally, the device may be configured to operate using wall suction (e.g., suction applied to a center). The devices described herein may include a suction trap (e.g., for capturing liquids and / or solids, including one or more filters for filtering and removing solids from liquids drawn in by an overtube). The device may include piping.

[0020] Any of these devices may be configured to apply a positive pressure. For example, in some instances, any of these devices may be configured to apply a positive pressure to eliminate blockage in the lumen of the overtube. The control circuit may be configured to control the application of positive pressure (e.g., for blockage elimination) in addition to negative pressure.

[0021] Any of these devices may be configured or adapted to apply suction through one or both of the lumen of the overtube and / or the suction lumen of the endoscope. For example, the device may include connection and coupling control to the vacuum port of the overtube and the endoscope suction tube.

[0022] Also described herein is a method of removing a substance from the body using any of the devices described herein. For example, a method of removing a substance from the body includes advancing an overtube and an endoscope distally into the body, where the endoscope is inserted into the lumen of the overtube through the proximal end port of the overtube such that the proximal end of the overtube is sealingly movable around the endoscope, advancing, positioning the distal end of the overtube adjacent to the substance to be removed, and applying suction through the lumen of the overtube from the port at the proximal end of the overtube (e.g., optionally, on the side of the distal region of the overtube or with an adapter on the overtube) while the user activates the control device to draw the substance into the periphery and interior of the overtube and around the endoscope.

[0023]

[0023] For example, a method of removing a substance from the body includes inserting an endoscope through the proximal end port of an overtube into the lumen of the overtube such that the proximal end of the overtube is sealingly and movably disposed around the endoscope, positioning the distal end of the endoscope adjacent to the substance to be removed, positioning the distal end of the overtube adjacent to the distal end of the endoscope, withdrawing the endoscope proximally into the overtube, and applying suction through the port at the proximal end of the overtube through the lumen of the overtube while the user activates a control device to draw the substance into the overtube around and inside the overtube and around the endoscope. The suction can be applied separately or both to the inside of the overtube and the inside of the working channel.

[0024]

[0024] Any of these methods may include coupling a suction source to the port in the proximal end region of the overtube.

[0025]

[0025] In some examples, in the methods described herein, the endoscope may be used at an initial position near (e.g., adjacent to) the substance to be removed. The endoscope may identify the substance to be removed in the body using imaging integrated or coupled with the endoscope, and in some examples, the endoscope may extend distally from the distal end opening of the overtube. The device may be advanced with an endoscope extending distally from the overtube, or the endoscope may be advanced separately distally, and the overtube may be advanced separately when the endoscope is positioned. Any combination of these movements may be performed, advancing the endoscope distally while keeping the overtube more proximal, advancing both the endoscope and the overtube distally together (or withdrawing them proximally together), fixing and holding the endoscope (relative to the patient's body), and advancing (or withdrawing) the overtube relative to the endoscope.

[0026]

[0026] Generally, positioning the distal end of the overtube may include positioning the distal end of the endoscope adjacent to the substance to be removed. Positioning the endoscope adjacent may mean placing the endoscope close enough to the substance to be removed so that it can be drawn into the overtube when suction is applied (for example, within about 5 cm, 4 cm, 3 cm, 2 cm, or 1 cm).

[0027]

[0027] Any of these methods may involve withdrawing the endoscope proximal to the overtube before applying suction through the port. For example, the endoscope may be withdrawn proximal to the overtube lumen so as not to block the opening to the overtube lumen, and in addition, this is advantageous as it allows visualization of the material as it is drawn into the overtube lumen using the camera of the endoscope. For example, the endoscope may be drawn into the overtube lumen so as to extend at least 1 mm (e.g., 2 mm or more, 3 mm or more, 4 mm or more, 5 mm or more, 6 mm or more, 7 mm or more, 8 mm or more, 9 mm or more, 10 mm or more, 15 mm or more, etc.). In any of these methods, the material may include blood clot material. Other materials (e.g., fragments, etc.) can also be removed.

[0028]

[0028] In any of these examples, the substance (e.g., blood clot material or other substance) can be drawn into the lumen of the overtube by suction and pass around the endoscope placed inside the lumen of the overtube.

[0029]

[0029] Furthermore, either of these devices or methods of using the devices may be configured such that suction is applied to the endoscope to draw a substance (e.g., a blood clot) into the overtube, and then the user releases the suction on the endoscope (either before or after initiating suction through the inner lumen of the overtube) so that the blood clot can be aspirated upward by the pathfinder.

[0030]

[0030] In some examples, the device may be configured to maintain a seal around the endoscope as the endoscope is moved proximal or distally within the overtube. For example, the method may include axially moving the endoscope within the lumen of the overtube without breaking the seal while positioning the overtube.

[0031]

[0031] As described above, the methods described herein may include applying suction from a port through the lumen of the overtube in the proximal end region of the overtube. Generally, suction is applied through the overtube (e.g., maintains suction) while the user is operating the control device, for example, while the user is continuously pressing or activating the control device, and stops when the user stops operating the control device. In some examples, the control device may include a trumpet valve, and therefore applying suction from a port through the lumen of the overtube in the proximal end region of the overtube while the user is activating the control device may include applying suction when the user is activating the trumpet valve.

[0032]

[0032] The overtube and / or endoscope may be operable by, for example, mechanical operation (e.g., one or more pull wires, tendons, etc.), pneumatic operation, or electric operation. Generally, any of these methods may involve operating the distal end region of the endoscope independently of the overtube.

[0033]

[0033] Any of these methods may include stiffening either or both of the overtube and the endoscope. For example, any of these methods may include stiffening the overtube. In some examples, advancing the overtube and endoscope may include stiffening the overtube while advancing the endoscope distally from the overtube, destabilizing the overtube, and advancing the overtube distally over the endoscope.

[0034]

[0034] Any of the devices described herein may include or be part of a robotic system. For example, an overtube and / or endoscope (including an overtube and / or an endoscope inserted into or insertable into the overtube, such as an operable and / or rigidifying endoscope) may be controlled by a robotic system.

[0035]

[0035] For example, a method for removing a substance from a patient's body is described herein, which includes positioning the distal end of a rigid overtube adjacent to the substance, wherein the endoscope extends distally from the distal end, and the rigid overtube concentrically surrounds the length of the endoscope such that the overtube and the endoscope form an annular lumen; drawing the proximal end of the endoscope proximal to the distal end region of the rigid overtube; and applying suction through the annular lumen to draw the substance into the annular lumen and around the endoscope.

[0036]

[0036] For example, a method described herein is a method for removing a substance from a patient's body, the method comprising: positioning the distal end of an endoscope adjacent to the substance; positioning the distal end of an overtube extending over the endoscope adjacent to the distal end of the endoscope, the overtube being in a flexible configuration, the endoscope transitioning from an extended configuration extending distally to the overtube to a retracted configuration in which the distal end of the endoscope is housed within the distal end region of the overtube, the overtube concentrically surrounding the endoscope to form an annular lumen; converting the overtube from a flexible configuration to a more rigid configuration; and applying suction through the annular lumen to draw the substance into the annular lumen and around the endoscope.

[0037]

[0037] A method for removing a substance from a patient's body may include: positioning the distal end of an endoscope adjacent to the substance; advancing the distal end of an overtube distally over the endoscope such that the distal end of the overtube is adjacent to the substance while the overtube is in a flexible configuration; positioning the distal end of an endoscope inside the distal end region of the overtube to enable visualization from the distal end of the overtube by the endoscope such that the overtube concentrically surrounds the endoscope and forms an annular lumen; converting the overtube from a flexible configuration to a more rigid configuration; and applying suction to the annular lumen to draw the substance into the annular lumen and around the endoscope.

[0038]

[0038] Any of these methods may involve converting the rigid endoscope from a more flexible configuration when positioning the distal end adjacent to the material to a more rigid configuration before drawing the endoscope proximal into the distal end region of the rigid overtube. The use of a rigid overtube can bring many advantages, including increased stability of the overtube, which can improve both visualization and material removal efficiency. For example, material can be removed by flowing fluid through the endoscope for both overall and concentrated material removal. In a more rigid and less flexible configuration (generally referred to here as a rigid configuration), the applied spray is held stably, allowing for concentrated application of cleaning fluid even at lower fluid pressures, and enabling more effective removal / cleaning of material.

[0039]

[0039] Generally, these methods allow visualization from an endoscope while removing material by suction. Visualization may be performed by one or more optical subsystems / systems in the endoscope and / or overtube. In some examples, the endoscope can be used to visualize the distal end region of the overtube and the internal lumen (viewed through the overtube) while suction is applied and / or fluid (e.g., lavage solution) is supplied.

[0040]

[0040] The methods and apparatus described herein can apply suction through an annular lumen formed between the overtube and the inserted endoscope. When applying suction, the endoscope may be retracted proximal, and the distal end of the endoscope (and thus the camera, working channel, etc.) may be housed and held within the distal end region of the overtube's suction lumen (e.g., within 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, 5 mm distally, more preferably 3 mm to 4 cm distally). This position may be set manually (e.g., by the user moving the overtube relative to the endoscope and / or the endoscope relative to the overtube), or it may be set automatically by including, for example, another engagement part (e.g., a stopper, locking part, etc.) between the overtube and the endoscope. The proximal seal between the endoscope and the overtube can maintain the gap, for example, in the proximal end region, by the seal providing some resistance between the endoscope and the overtube.

[0041]

[0041] Generally, the annular lumens around the endoscope and inside the overtube are particularly, and surprisingly, more effective in removing substances that obstruct the suction lumen of the endoscope and other conventional suction lumens, including feces and blood clots, because they help to shear and fragment the substances. Furthermore, the recessed end of the endoscope inside the suction lumen (especially the inwardly tapered portion of the distal end opening of the overtube) can further help in the fragmentation and removal of substances and in preventing blockages. The recessed position of the distal end of the endoscope not only allows for visualization (e.g., continuous visualization) but also helps in the formation of suction flow, adjustment of suction flow rate, and maceration of substances drawn into the overtube. In some cases, the recessed position of the endoscope (e.g., between 3 mm and 4 cm) can generate turbulence inside the suction opening into the overtube, thereby further aiding in the removal of substances and preventing blockages. For example, any of these methods may be configured to clear the blockage in the annular lumen by repeatedly moving the endoscope distally and proximal within the overtube while applying suction through the annular lumen.

[0042]

[0042] Perfusion may be performed from the overtube or the endoscope, or both, or from a perfusion device extending through the endoscope and / or the overtube. For example, a perfusion fluid may be applied. Perfusion may be performed before or after suction, for example, through an annular lumen. Perfusion may be performed distal to the distal end of the overtube. For example, any of these methods may involve performing perfusion by spraying fluid from the fluid line of the overtube. In some cases, performing perfusion may involve extending a perfusion tube distally from the distal end of the endoscope and perfusing the body from the perfusion tube. The perfusion device may include a radial perfusion device. In some cases, the perfusion device may include a distal perfusion device. Alternatively, in some cases, performing perfusion may involve switching between radial and distal perfusion by extending and retracting a radial perfusion tube relative to the distal end of the endoscope. Alternatively, or additionally, in some cases, performing perfusion may involve performing perfusion through a fluid line integrated with the endoscope.

[0043]

[0043] Any of these methods and apparatus may include moving the endoscope axially inside the overtube while applying suction. Moving the endoscope axially (e.g., distal and proximal) while applying suction may include moving the endoscope axially between approximately 1 mm and 3 cm or more (e.g., between approximately 1 mm and 3 cm, between approximately 1 mm and 2.5 cm, between approximately 1 mm and 2 cm, between approximately 1 mm and 1.5 cm, between approximately 1 mm and 1 cm, between approximately 1 mm and 7 mm, between approximately 1 mm and 5 mm, etc.). The endoscope may be moved back and forth in linear vibration, for example between approximately 1 Hz and 50 Hz (e.g., between approximately 1 Hz and 40 Hz, between approximately 1 Hz and 30 Hz, between approximately 1 Hz and 20 Hz, between approximately 1 Hz and 10 Hz, etc.). Moving the endoscope inside the lumen of the overtube while applying suction may help prevent or remove blockages. Such linear movement of the endoscope relative to the overtube can be particularly effective and safe when the overtube is in a more rigid configuration (e.g., rigid). This provides stability, allowing for more precise movement while protecting the body from hazards.

[0044]

[0044] Generally, the methods and apparatus described herein allow for rotational movement of the endoscope within the lumen of the overtube. In some cases, rotating the endoscope within the overtube (especially if the overtube is a rigid configuration) can increase the maneuverability of the endoscope while minimizing harm to the patient. Generally, these methods may include preventing or removing blood clot formation by rotating the endoscope within the lumen of the overtube (including rotational vibration of the endoscope within the overtube). Linear and / or rotational movement of the endoscope relative to the overtube may be performed manually, semi-automatically, and / or automatically with mechanical assistance, for example.

[0045]

[0045] Any of these methods may include moving the endoscope axially (e.g., in the distal direction / proximal direction) within the overtube while positioning the overtube. For example, when positioning the distal end of the overtube and / or the endoscope, the endoscope or the overtube, or both, may be moved relative to each other. The endoscope may be operated independently of the overtube. For example, the method may include operating the distal end region of the endoscope independently of the overtube.

[0046]

[0046] In some cases, positioning the overtube may include rigidifying the overtube while advancing and operating the endoscope distally from the overtube, deregidifying the overtube, and advancing the overtube distally over the endoscope.

[0047]

[0047] Any of these methods may include sealing the proximal end of the overtube around the endoscope using a seal (e.g., a movably sealed one) that allows the endoscope to advance / retreat distally through the lumen of the overtube while maintaining suction / vacuum inside the lumen of the overtube.

[0048]

[0048] The methods and devices described herein have an annular lumen (suction ring) with a cross-sectional area of about 40 mm 2 to 400 mm 2 (e.g., between about 40 mm 2 and 300 mm 2 , between about 40 mm 2 and 200 mm 2 , between about 40 mm 2 and 150 mm 2 , etc., between about 40 mm 2 and 100 mm 2 etc.) and may be configured as such.

[0049]

[0049] Any of these methods may involve positioning an overtube inside the patient's digestive tract, including the upper gastrointestinal (GI) tract (mouth, esophagus, stomach, pylorus, bile duct, pancreatic duct, etc.), the small intestine (e.g., small intestine, duodenum, jejunum, ileum, etc.), and / or the lower GI tract (rectum, colon region, e.g., sigmoid colon, descending colon, transverse colon, ascending colon, cecum, ileocecal valve, etc.). These methods and apparatus may be configured to remove substances including, but not limited to, feces, blood, washing fluid, food debris, etc.

[0050]

[0050] The methods and apparatus described herein may be configured to help detach the device (e.g., an overtube) from a body wall to which it may be coupled when operating the device. For example, when suction is applied through an annular lumen, the overtube may be attracted to the wall of the body lumen. It may be particularly advantageous to rapidly reduce or eliminate the suction by releasing the negative pressure (suction) inside the annular lumen. For example, any of these methods may include releasing the overtube from the body wall by opening an air relief valve that is in fluid communication with the annular lumen while suction is applied through the annular lumen. The air relief valve is coupled to the internal lumen of the overtube distal to the suction port and is operated in conjunction with the application of suction to adjust or release the suction.

[0051]

[0051] Apparatuses (e.g., systems, devices, etc.) for performing any of these methods are also described herein. For example, a suction overtube apparatus is described herein, comprising an elongated body having an internal lumen extending from a distal end to a proximal end, the elongated body configured to be converted from a flexible configuration to a more rigid configuration by the application or release of pressure within the wall of the elongated body; a rigidification port (e.g., a pressure port) that receives positive and / or negative pressure to convert the elongated body from a flexible configuration to a rigid configuration; and a proximal end region including an endoscope receiving port configured to receive an endoscope into the internal lumen, the proximal end region being in line with the internal lumen of the elongated body, and a vacuum port in the proximal end region that is in fluid communication with the internal lumen.

[0052]

[0052] For example, the suction overtube device described herein includes an elongated body having an internal lumen extending from a distal end to a proximal end, comprising a plurality of layers configured to transition from a flexible configuration to a more rigid configuration by applying pressure to the plurality of layers; a proximal end region including an endoscope receiving port configured to receive an endoscope into the internal lumen, wherein the endoscope receiving port is in line with the internal lumen of the elongated body; a rigidification port (e.g., a pressure port) configured to stiffen the elongated body by receiving positive and / or negative pressure; a vacuum port in the proximal end region that is in fluid communication with the internal lumen; and a control device coupled to the vacuum port and configured to apply suction from the vacuum port through the internal lumen when activated by a user.

[0053]

[0053] The suction overtube device comprises an elongated body having an internal lumen extending from the distal end to the proximal end, comprising a plurality of layers, having circumferential strength sufficient to withstand a vacuum of about 101.33 kPa (760 mmHg) or more, and further configured to transition from a flexible configuration to a more rigid configuration by applying positive and / or negative pressure to the plurality of layers; and a proximal end region comprising an endoscope receiving port configured to receive an endoscope into the internal lumen, and comprising one or more seals configured to seal around the endoscope, wherein the endoscope receiving port is in line with the internal lumen of the elongated body, and may include a rigidification port (e.g., a pressure port) configured to rigidify the elongated body upon receiving positive and / or negative pressure, and a vacuum port in the proximal end region that is in fluid communication with the internal lumen.

[0054]

[0054] The distal end opening of the suction overtube may be tapered.

[0055]

[0055] Generally, the overtube may be made rigid. For example, the elongated body of the overtube includes a rigid layer having multiple strand lengths that intersect each other, and a compression layer configured to compress the rigid layer in a more rigid configuration. Other structures may also be used for rigidification.

[0056]

[0056] Generally, these devices may include seals configured to seal around the endoscope proximal to the vacuum port. For example, the proximal end region of the overtube (or adapter for the overtube) may include one or more sealing gaskets configured to seal around the endoscope.

[0057]

[0057] An overtube can be used if it is appropriately sized. For example, the internal lumen of the overtube is 10 mm 2It may have a larger cross-sectional area. In some cases, the overtube may be between approximately 2.67 mm (8 French) and approximately 10.67 mm (32 French) (or more) (for example, between approximately 3.33 mm (10 French) and approximately 8.00 mm (24 French)).

[0058]

[0058] The apparatus described herein includes an overtube and may be integrated or modular. For example, in some cases, the endoscope receiving port and vacuum port may be part of an adapter configured to be coupled to the proximal end of the elongated body of the overtube. Alternatively, the endoscope receiving port and vacuum port (including seals) may be integrated into the overtube.

[0059]

[0059] Generally, these devices may be configured to withstand the internal (negative) pressure inside the lumen of the overtube without the overtube collapsing or impeding the function of the overtube (including, in some cases, rigidification). The elongated body may have sufficient circumferential strength to withstand negative pressure inside the internal lumen of at least about 92.33 kPa (700 mmHg) (e.g., 99.99 kPa (750 mmHg), 101.33 kPa (760 mmHg), 106.66 kPa (800 mmHg), 119.99 kPa (900 mmHg), 13.33 kPa (100 mmHg), etc.). In some cases, the elongated body further includes an internal coil winding tube. In some cases, the elongated body includes a braided tube.

[0060]

[0060] Any of these devices may include other components of a system that are coupled together, including piping, a suction pump (vacuum), etc. In some cases, the device may include an endoscope. Any of these devices may include a control device for adjusting the application of suction through the overtube. For example, the control device may include a biased valve. The control device may be part of a handle (e.g., a handheld control device), a pedal (e.g., a foot pedal), etc. The control device may be aligned with the vacuum port. In some cases, the control device may be coupled to the vacuum port and / or a fluid line (e.g., piping) coupled to the vacuum port. For example, any of these devices may include a suction pipe configured to connect the vacuum port to a negative pressure source and a control device including a valve configured to control the application of suction through the internal lumen. The control device may include a trumpet valve.

[0061]

[0061] The distal end opening of the overtube may have an inner diameter less than the inner diameter of the inner lumen.

[0062]

[0062] Any of these devices may include one or more perfusion devices configured to pass through the lumen of the endoscope and / or the suction lumen of the overtube. For example, one or more perfusion devices may include radial perfusion devices.

[0063]

[0063] Generally, these devices may include one or more external channels extending along the length of an elongated body. The external work channels are expandable, and an instrument may be inserted into the work channel to expand it.

[0064]

[0064] Also described herein is a method for removing a substance from the body, the method comprising advancing an overtube and an endoscope distally within the body, wherein the endoscope is inserted into the lumen of the overtube through a proximal end port of the overtube, and the proximal end of the overtube is sealed so as to be movable around the endoscope; positioning the distal end of the overtube adjacent to the substance to be removed; and, once the user activates a control device to draw the substance into the overtube and around the endoscope, applying suction from the port through the lumen of the overtube in the proximal end region of the overtube while imaging from the endoscope through the proximal end of the overtube.

[0065]

[0065] Any of these methods may involve spraying fluid from the endoscope or from a fluid line inside the lumen of the overtube. Any of these methods may involve connecting a suction source to a port in the proximal end region of the overtube.

[0066]

[0066] Positioning the distal end of the overtube may include positioning the distal end of the endoscope adjacent to the substance to be removed. These methods may include retracting the endoscope proximal into the overtube before applying suction through the port. The substance may include feces, blood, food fragments, etc.

[0067]

[0067] Any of these methods may include moving the endoscope axially within the lumen of the overtube without breaking the seal while positioning the overtube. For example, this method may include applying suction from a port through the lumen of the overtube in the proximal end region of the overtube, maintaining suction when the user operates the control device, and stopping suction when the user stops operating the control device. Any of these methods may include applying suction from a port through the lumen of the overtube in the proximal end region of the overtube when the user activates the control device, and applying suction when the user activates the trumpet valve. Any of these methods may include operating the distal end region of the endoscope independently of the overtube. As described above, these methods may optionally include stiffening the overtube before applying suction. For example, these methods may include advancing the overtube and endoscope, stiffening the overtube, destiffening the overtube, and advancing the overtube distally over the endoscope while operating the endoscope to advance the overtube distally from the overtube.

[0068]

[0068] A method for removing a substance from the body may include: inserting an endoscope into the lumen of the overtube through the proximal end port of the overtube so that the proximal end of the overtube is sealed so that it can move around the endoscope; positioning the distal end of the endoscope adjacent to the substance to be removed; positioning the distal end of the overtube adjacent to the distal end of the endoscope so that the endoscope images distally from the distal end region of the overtube, and positioning the distal end of the endoscope inside the distal end region of the overtube; and applying suction from the port through the lumen of the overtube in the proximal end region of the overtube to draw the substance into the overtube and around the endoscope.

[0069]

[0069] Also described herein are methods for supplying fluid to the main lumen (e.g., for irrigation). In particular, these methods may include supplying a radial spray (radially around the outer circumference of the perfusion tube) and / or supplying a longitudinal spray or longitudinal flow (e.g. distally from the distal end of the perfusion tube). In some cases, the perfusion tube may be configured to work in conjunction with the endoscope and / or overtube and to convert the spray applied between radial and longitudinal directions using only the perfusion tube configured to perform radial perfusion. For example, a method described herein may include positioning the endoscope inside the body region; extending the perfusion tube distally from the lumen of the endoscope; delivering a radial spray of the perfusion fluid in the perfusion tube; and retracting the perfusion tube proximal to deliver a longitudinal flow of the perfusion fluid.

[0070]

[0070] In some cases, the method may include positioning an endoscope and an overtube concentrically surrounding the endoscope within the region of the digestive (GI) tract, wherein the endoscope is located within the suction lumen of the rigid overtube; extending a perfusion tube distal to the lumen of the endoscope and distal to the overtube while the overtube is held in a rigid configuration; delivering a radial spray of perfusion fluid from the perfusion tube; retracting the perfusion tube proximal to deliver a longitudinal flow of perfusion fluid; and removing the perfusion fluid by applying suction through the suction lumen of the overtube.

[0071]

[0071] All of the methods and apparatus described herein, in any combination, can be used to achieve the advantages described herein as intended.

[0072]

[0072] A better understanding of the features and advantages of the methods and apparatus described herein can be obtained by referring to the following detailed description of exemplary embodiments and the accompanying drawings. [Brief explanation of the drawing]

[0073] [Figure 1A]

[0073] This figure shows an example of the distal end region of an example of the apparatus described herein, including an overtube and an endoscope. [Figure 1B]

[0074] Figure 1A shows an example of the apparatus, illustrating the connection of the proximal end and the negative pressure (e.g., suction) source. [Figure 1C]

[0075] This figure shows another example of the apparatus (e.g., system) described herein. [Figure 1D] Another example of the apparatus (e.g., system) described herein is shown, and is an enlarged view of a portion of Figure 1C. [Figure 2]

[0076] This figure shows an example of an overtube that can be optionally configured as a rigid overtube as described herein. [Figure 3A]

[0077] This is a cross-sectional view of an example of a stiffened overtube that can be made rigid by applying negative pressure. [Figure 3B]

[0078] Figure 3A is an enlarged view showing an example of the layer arrangement inside the elongated, rigid overtube. [Figure 4A]

[0079] This is a cross-sectional view of an elongated, rigid device (e.g., an overtube) that can be made rigid by applying positive pressure. [Figure 4B]

[0080] Figure 4A is another cross-sectional view showing an example of the arrangement of layers inside the elongated, rigidized overtube device. [Figure 5A]

[0081] This figure shows an example of the proximal end (e.g., suction adapter) of the device described herein. [Figure 5B]

[0082] This is an external view of the suction adapter described herein. [Figure 5C]

[0083] Figure 5B is a cross-sectional view of the suction adapter. [Figure 5D]

[0084] Figures 5B and 5C are end views of the suction adapter. [Figure 6A]

[0085] This figure shows an example of a valve (e.g., a trumpet valve) that may be included as part of a control device for applying suction to the apparatus described herein, and is a perspective view of the valve. [Figure 6B] Figure 6A is a cross-sectional view of the valve, showing the valve in a closed (stationary, non-operating) state. [Figure 6C] Figure 6A is a cross-sectional view of the valve, showing the valve in an open (operated) state. [Figure 7A]

[0086] This is a side view showing an example of an adapter configured as a threaded adapter. [Figure 7B] Figure 7A is a cross-sectional view of the adapter. [Figure 8A]

[0087] These are exploded views of a portion (proximal end) of an adapter similar to those shown in Figures 7A and 7B. [Figure 9]

[0088] This figure shows an example of an integrated, rigid overtube including a proximal endoscopy seal and / or suction port. [Figure 10A]

[0089] This figure shows an example of how to operate the apparatus described herein. [Figure 10B] This figure shows an example of how to operate this device. [Figure 10C] This figure shows an example of how to operate this device. [Figure 10D] This figure shows an example of how to operate this device. [Figure 10E] This figure shows an example of how to operate this device. [Figure 11A]

[0090] This figure shows an example of how to use the apparatus described herein. [Figure 11B] This figure shows an example of how to use this device. [Figure 11C] This figure shows an example of how to use this device. [Figure 11D] This figure shows an example of how to use this device. [Figure 11E]This figure shows an example of how to use this device. [Figure 11F] This figure shows an example of how to use this device. [Figure 12A]

[0091] This is a schematic diagram showing an example of the apparatus described herein, including endoscopic perfusion. [Figure 12B]

[0092] This is a schematic diagram illustrating an example of the apparatus described herein, which includes perfusion via a separate perfusion line. [Figure 13A]

[0093] This is a schematic diagram showing another modification of the apparatus described herein, in which the vacuum outlet is integrated into the handle. [Figure 13B] This is a schematic diagram of a modified example of this device. [Figure 14A]

[0094] Another example of a suction adapter for use with (or integrated with) the overtube described herein, and a diagram showing a swivel valve included in the adapter in a certain orientation. [Figure 14B] Figure 14A shows the suction adapter, and the swivel valve is shown in a different orientation. [Figure 14C] Figure 14A shows the suction adapter, and the swivel valve is shown in yet another orientation. [Figure 15A]

[0095] This is a side view showing a first example of a lever valve, which is an example of a control device (e.g., a lever valve) for controlling the application of suction as described herein. [Figure 15B] This is a side perspective view showing a first example of a lever valve. [Figure 15C] This is a cross-sectional view showing another example of a lever valve. [Figure 16A]

[0096] This is a side view showing an example of a control device (configured as a lever valve) for controlling the application of suction as described herein. [Figure 16B] Figure 16A is a cross-sectional view of the lever. [Figure 17A]

[0097] This is a front view showing an example of a control device (configured as a foot pedal) for controlling the application of suction. [Figure 17B] This is a side perspective view. [Figure 17C] This is a top perspective view. [Figure 18A]

[0098] This figure shows an example of the bendability of an overtube, specifically an overtube with low bendability. [Figure 18B] This figure shows another example of an overtube described herein, an overtube having high bending flexibility and high circumferential strength. [Figure 19]

[0099] This figure shows an example of the distal end region of an overtube device having multiple suction relief holes. [Figure 20]

[0100] This figure shows an example of a robotic system including the apparatus described herein. [Figure 21A]

[0101] This figure shows an example of using an air relief valve to release suction against the wall of a body cavity. [Figure 21B] This figure shows an example of using an air relief valve to release suction against the wall of a body cavity. [Figure 21C]

[0102] This figure shows an example of supplying fluid to the suction lumen of an overtube to remove a blockage. [Figure 21D] This figure shows an example of supplying fluid to the suction lumen of an overtube to remove a blockage. [Figure 22A]

[0103] This figure shows an example of an overtube including rinsing channels, where the overtube extends an endoscope and has multiple rinsing channels that are coplanar with the distal end of the overtube. [Figure 22B] This is a side view of an overtube from which an endoscope is extended, and which has multiple angled rinsing channels extending distally at a certain angle to the distal end of the overtube. [Figure 22C] This is a side view of Figure 22B. [Figure 23A]

[0104] This figure shows an example of an irrigation pipe that supplies radial spray. [Figure 23B]

[0105] This figure shows an example of a perfusion tube that supplies longitudinal spray (e.g., a fine stream). [Figure 24A]

[0106] A schematic example of a device including a perfusion tube configured to supply radial spray is shown, and a schematic cross-sectional view of the device showing the deployment of the perfusion tube distally from the lumen of the endoscope of an endoscope housed inside an overtube. [Figure 24B] This diagram shows a irrigation tube that extends distally from the endoscope and overtube, supplying radial spray into the body lumen. [Figure 24C]

[0107] Figures 24A and 24B illustrate the conversion of a spray supplied from a radial perfusion tube into a linear stream. By supplying a spray from a perfusion tube located inside the distal end region of the overtube but outside the endoscope, the radial spray is converted into a distal linear spray. [Figure 24D] This diagram shows how supplying spray from a perfusion tube inside the lumen of an endoscope converts radial spray into distal linear spray. [Figure 25A]

[0108] This figure shows examples of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 25B] This figure shows another example of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 25C] This figure shows another example of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 25D] This figure shows another example of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 25E] This figure shows another example of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 25F]This figure shows another example of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 25G] This figure shows another example of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 25H] This figure shows another example of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 25I] This figure shows another example of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 25J] This figure shows another example of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 26A]

[0109] This figure shows examples of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 26B] This figure shows another example of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 26C] This figure shows another example of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 26D] This figure shows another example of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 26E] This figure shows another example of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 26F] This figure shows another example of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 26G] This figure shows another example of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 26H] This figure shows another example of different nozzle types used at the distal end of a perfusion tube to form different spray / stream patterns. [Figure 27A]

[0110] This figure shows an example of a device (e.g., including an overtube) having one or more external working channels arranged along the external length of the overtube. [Figure 27B] Another figure illustrating the example in Figure 27A. [Figure 27C] Another figure illustrating the example in Figure 27A. [Figure 28A]

[0111] This figure shows examples of suction tubes or inlet tubes that may be used with any of the devices described herein. [Modes for carrying out the invention]

[0074]

[0112] This specification describes methods for removing material from a patient's body, including methods for removing debris (e.g., feces), blood, blood clots, etc., from body lumens such as GI tubes. In some cases, these methods may also be used to remove material from the large intestine or other body lumens. These methods may be used as part of another procedure, for example, as part of a colonoscopy, to assist in imaging and / or surgical procedures to treat the colon.

[0075]

[0113] These devices (e.g., devices, systems, etc.) may include an overtube, which is configured to operate in conjunction with an endoscope and is referred to herein as a suction overtube. The overtube may have an elongated body having an internal lumen extending from a distal end to a proximal end. The overtube may be configured to receive and seal an endoscope within the internal lumen and may have a proximal end region including an endoscope receiving port configured to receive the endoscope into the internal lumen. The endoscope receiving port may be in line with the internal lumen of the elongated body and is configured to seal around the endoscope to allow distal / proximal movement of the endoscope relative to the overtube with virtually no loss of suction within the internal lumen. Generally, the overtube may include a vacuum port in the proximal end region, distal to the seal of the endoscope in the distal end region of the overtube, which is in fluid communication with the internal lumen and to which negative pressure is applied. The overtube may be configured to withstand the application of negative pressure within the internal lumen while allowing movement of the endoscope within the internal lumen.

[0076]

[0114] In any of these devices, the elongated body may be rigidized (e.g., a rigidized overtube). The overtube may be configured to convert between a flexible configuration and a more rigid configuration by the application or release of pressure within the walls of the elongated body. The pressure applied to convert between the rigid and non-rigid configurations (e.g., becoming more rigid upon application of pressure) may be either positive or possibly negative pressure. Therefore, the rigidized overtube may include a rigidizing port (e.g., a pressure port) configured to convert the elongated body from a flexible configuration to a rigid configuration upon receiving positive and / or negative pressure. The rigidizing port may be located in the proximal end region.

[0077]

[0115] In some cases, the overtube may be integrated with the vacuum port and the endoscope receiving port. Alternatively, in some cases, the overtube may be separate from the adapter containing the vacuum port and the endoscope receiving port and coupled to it.

[0078]

[0116] Accordingly, in some cases, the methods and apparatus described herein include an overtube having an internal lumen configured to receive both an endoscope and a suction device for removing material from within the body without the need to remove the endoscope. Generally, the overtube device may include an elongated body having an internal lumen extending from the distal end to the proximal end of the overtube. The device may include a proximal end region configured to receive the endoscope so that the endoscope moves, for example, distally or proximal, within the internal lumen of the endoscope. The receiving port may be located at the proximal end and positioned so that the endoscope is inserted into and through the receiving port into the internal lumen. These devices may include a vacuum port in the proximal end region that is in fluid communication with the internal lumen. Generally, the device may be configured so that a user (e.g., a physician, surgeon, nurse, technician, etc.) can activate and maintain suction through the internal lumen and stop applying suction (e.g., if the control device is no longer activated by the user).

[0079]

[0117] The devices described herein may be configured for use in one or more of the following: neurovascular tissue (e.g., aortic arch, subclavian artery, carotid artery, vertebrae, base, posterior cerebrum, circle of Willis, middle cerebrum, anterior cerebrum, etc.), upper gastrointestinal tract (mouth, esophagus, stomach, pylorus, bile duct, pancreatic duct, etc.), small intestine (e.g., small intestine, duodenum, jejunum, ileum, etc.), lower gastrointestinal tract (rectum, colon region, e.g., sigmoid colon, descending colon, transverse colon, ascending colon, cecum, ileocecal valve, etc.), urinary tract (Urethra, bladder, kidneys, ureters, etc.), peripheral blood vessels (e.g., femoral artery, mesenteric artery, lumbar artery, renal artery, celiac trunk, hepatic artery, chest, etc.), cardiac region (e.g., aorta, right coronary artery, left coronary artery, etc.), left heart (e.g., aorta, aortic valve, left ventricle, etc.), right heart (e.g., vena cava, right atrium, left atrium, mitral valve, coronary sinus, tricuspid valve, right ventricle, pulmonary valve, pulmonary vessels, etc.) and / or right lung region (e.g., mouth, larynx, trachea, bronchi and lung lobes, etc.).

[0080]

[0118] The apparatus described herein may be configured as an integrated overtube including a proximal end region configured to receive an endoscope and / or aspiration port (e.g., a vacuum port) for applying suction through the internal lumen of the overtube, and may be configured to convert an existing overtube (see, for example, U.S. Patent No. 11,135,398, “DYNAMICALLY RIGIDIZING COMPOSITE MDEICAL STRUCTURES,” incorporated herein by reference in its entirety). For example, the adapter described herein is configured to be coupled to the distal end of an existing overtube and to convert the overtube to be operational as described herein. In some cases, the overtube may optionally be a rigid overtube, but these methods and apparatus may be a non-rigid overtube.

[0081]

[0119] Figure 1A shows an example of the distal end region of a flexible overtube 106, from which suction can be applied. In this example, the overtube is a rigid overtube. It is shown that an endoscope 108 extends distally from the overtube. Figure 1B shows an example of a system including an overtube 106, showing the proximal end region of the overtube, which includes an adapter 112 (e.g., a suction adapter) coupled to the proximal end of the overtube. The suction adapter portion of the device includes a proximal end region including an endoscope receiving port 114 configured therefrom to receive the endoscope 108 into the internal lumen. The endoscope receiving port is in line with the internal lumen of the elongated body. The suction adapter portion of the device also includes a vacuum port 116, which is in fluid communication with the internal lumen and is shown connected to a vacuum source 102. Generally, the vacuum port may be connected to a control device (not shown in Figure 1B) for controlling suction through the overtube. In some cases, the control device includes a valve or clamp that is closed when stationary but can be held open by an action performed by the user (such as pushing, squeezing, gripping, or pressing down), keeping the valve open (sometimes fully open, or with selectively adjustable opening). The valve may be operated manually or electronically.

[0082]

[0120] In the examples in Figures 1A and 1B, the overtube is configured as a medium-sized overtube (e.g., having an inner diameter of 14 mm), and the endoscope is shown as a gastroscope (having a tip diameter of approximately 9 mm). Any suitable size overtube and endoscope can be used. The apparatus may include a control device (not shown in Figures 1A-1B) that is coupled to the vacuum port and configured to apply suction through the vacuum port when activated and held by the user.

[0083]

[0121] Figures 1C and 1D show another example of an apparatus (e.g., a system) for use with an endoscope 108, including an overtube 106 similar to that shown in Figures 1A-1B. The endoscope may be included with the apparatus or may be provided separately, for example, as a commercially available endoscope. The apparatus shown in Figure 1C also includes a vacuum source 102 and piping that connects the vacuum to a vacuum port 116 at the proximal end of the overtube. A control device 122 is connected to this piping to switch the suction on and off through the internal lumen of the overtube. In this example, the control device is shown as a foot pedal. The control device may include one or more valves (e.g., pinch valves) to adjust the applied suction. The proximal end of the overtube may also include an endoscope receiving port 114 configured to receive the endoscope 108 into the internal lumen through it. The endoscope receiving port is aligned with the internal lumen of the elongated body. The vacuum port 116 is in fluid communication with the internal lumen and is shown connected to the vacuum source 102 by piping 119. In this example, the overtube also includes a stiffening port, which includes a pressure line 144 configured to receive positive and / or negative pressure to convert the elongated body from a flexible configuration to a rigid configuration. This example also shows another perfusion / wash line 157 that supplies fluid (e.g., water) to the internal lumen. The apparatus may include another pressure source (positive and / or negative pressure) for stiffening the overtube. In some cases, the same vacuum source 102 (or a duplicate source) may be used.

[0084]

[0122] Generally, the overtubes described herein may be configured to withstand the application of suction without collapsing. Therefore, generally, these devices may have circumferential strength capable of withstanding negative pressures of, for example, up to approximately 101.33 kPa (760 mmHg) (1 atmosphere) or more without collapsing. Furthermore, these devices may be configured to maintain very high flexibility (in the case of a flexible configuration). For example, in some modifications, the overtube includes one or more reinforcing layers, including reinforcing coils and / or braided layers (e.g., braided axes). Any of these devices may include a coil-wound reinforcing tube. For example, the reinforced outer layer may be reinforced with multiple filaments wound around (or inside) the layer. The inner tube (e.g., an inner coil-wound tube, ICWT) may include one or more reinforcing wires. The inner coil-wound tube may be adjacent to other layers. In some examples, the use of low-hardness materials can increase overall bending flexibility even when high pressure is required. For example, the overtube body may be formed from a material whose hardness test is less than 90 Shore A, particularly less than 80 Shore A (or less than 75 Shore A, less than 70 Shore A, less than 65 Shore A, less than 60 Shore A, less than 55 Shore A, less than 50 Shore A, etc.). For example, the overtube body may be made of one or more layers of such low-hardness material and may be reinforced with reinforcing layers, such as a helical coil reinforcement layer (as in some examples).

[0085]

[0123] Any of these devices may include a torsional stiffening element (e.g., a torsional stiffening layer). The torsional stiffening layer may be integrated into the inner and / or outer layers, or it may be non-adhesive and not intentionally attached to adjacent layers.

[0086]

[0124] The overtubes described herein may have any suitable length, and are particularly suitable for use with long scopes, even if they are long (e.g., 50 cm or longer, 55 cm or longer, 60 cm or longer, 65 cm or longer, etc.). Furthermore, short or long overtubes may also be included, which are useful for specific anatomical objects.

[0087]

[0125] Furthermore, the overtubes described herein may be configured with a distal tip region adapted for use with an endoscope and for the application of suction. For example, the distal end region of the overtube may include an opening into the lumen of the overtube through which suction is applied and the endoscope is positioned. The distal opening into the overtube may be configured so that the endoscope can be extended from the overtube and retracted into it. In some examples, the distal opening may be narrowed compared to the inner diameter of the lumen of the overtube at a more proximal point. Such narrowing may be helpful for centering, supporting, and / or guiding the endoscope. The narrowing may be, for example, between 98% and 50% of the inner diameter of the inner lumen of the overtube at a more proximal point (e.g., between approximately 98% and 55%, between approximately 98% and 60%, between approximately 98% and 65%, between approximately 98% and 70%, between approximately 98% and 75%, between approximately 98% and 80%, etc.).

[0088]

[0126] The distal tip region of the overtube, including the distal end opening, may be transparent when the overtube is retracted into the lumen, for example, to allow visualization through the distal end by an endoscope. As stated above, any of the devices described herein may include a vacuum relief opening (for example, a hole or opening located at the distal end and / or proximal to the distal end, allowing passive ventilation and preventing suction from adhering to tissue (e.g., the body wall)).

[0089]

[0127] Any of the overtubes described herein may be operable, particularly in the distal end region (e.g., the distal end region of the overtube). The overtube may be operable by mechanical means (e.g., pull wire, tendon, shape memory alloy, etc.), pneumatic means (pressure-driven operation), or electrical / magnetic means.

[0090]

[0128] Optionally, any of the devices described herein may include a stiffening overtube and / or endoscope. For example, an overtube may be controllably convertible between a flexible configuration and a stiffened (less flexible) configuration. These devices can rapidly transition from a flexible configuration (i.e., a loose, flexible, or sagging state) to a stiffened configuration (i.e., a state that is rigid and / or retains its shape when stiffened). A stiffening device (e.g., an overtube) may include multiple layers (e.g., a coiled or reinforcing layer, a slip layer, a stiffening layer, a bladder layer, and / or a sealing sheath) which together form the walls of the stiffening device, and may also be called a “layered stiffening device”. Stiffening devices described herein may be stiffened by packing particles, phase changes, interconnected components (e.g., a cable with a disk or cone), or any other stiffening mechanism. A stiffening device can transition from a flexible configuration to a stiffened configuration by, for example, applying vacuum or pressure to the walls of the stiffening device or inside the walls of the stiffening device. When the vacuum or pressure is removed, the layers are easily shearable or can move relative to one another. When the vacuum or pressure is applied, the layers become rigid by transitioning to a state in which they exhibit virtually strong resistance to shear, motion, bending, torque, and buckling.

[0091]

[0129] Any stiffening device described herein may include a stiffening layer or stiffening region that engages with a compression layer (which may include a bladder), the compression layer applying force to the stiffening layer to stiffen it, or optionally destiffen it (e.g., release it from stiffening). In some examples, these stiffening devices may include a stiffening layer comprising braided, knitted, woven, or cut segments, randomly arranged or randomly oriented filaments or strands, engagement parts, links, scales, plates, segments, particles, granules, intersecting filaments, or other materials forming the stiffening layer. For example, the stiffening layer may include multiple strand lengths or strand segments intersecting each other (e.g., as part of a braid, knit, or woven fabric), and the compression layer may apply force to press the intersecting strand lengths or strand segments against each other. While many of the examples shown herein are braided, these devices may, alternatively or additionally, include a general stiffening layer comprising intersecting strand lengths or strand segments.

[0092]

[0130] Examples of stiffening devices described herein may perform selective and controllable stiffening using pressure (positive pressure) and / or negative pressure. In some examples, the methods described herein can be used with any suitable stiffening device.

[0093]

[0131] Figure 2 shows an exemplary rigid overtube device. The device shown includes a rigid device 300 having walls made up of multiple layers, including a rigid layer, an outer layer (partially cut in this example and configured as a braided layer, showing the underlying rigid layer), and an inner layer. The system further includes a handle 342 having a vacuum inlet or pressure inlet 344 to supply vacuum or pressure to the rigid device 300. An actuation element 346 can be used to turn the vacuum or pressure on and off, thereby transitioning the rigid device 300 between a flexible configuration and a rigid configuration. The distal tip 339 of the rigid device 300 is smooth, flexible and low trauma-resistant, thus facilitating distal movement of the rigid device 300 through the body. As previously mentioned, the tip may be adapted to be tapered or transparent, etc.

[0094]

[0132] In addition to being radially tapered inward so that the internal lumen opening has a narrower opening diameter than the inner diameter of the internal lumen, in all of these examples, the outer diameter of the distal tip is tapered to reduce trauma. For example, the tip 339 is tapered from distal to proximal to further facilitate distal movement of the stiffening device 300 through the body. In this example, the stiffening device is configured as an overtube, but other configurations are also possible.

[0095]

[0133] The rigidifying devices and methods described herein may be part of a medical access system for treating body parts that are difficult to access or operate on internally, particularly during minimally invasive or non-invasive procedures.

[0096]

[0134] The stiffening devices described herein may be configured to stiffen when negative and / or positive pressure is applied. These stiffening devices described herein may be used in conjunction with other stiffening devices that stiffen by other means, including methods that do not depend on the application of positive or negative pressure. For example, a stiffening device may be configured to include multiple layers arranged within an elongated catheter-like body. The proximal end of the device may include a handle or other manipulator and may include a connection to one or more pressure sources. The application of pressure from the pressure source can be controlled by several means, including the operation of a handle or an electronically controlled device. The control may create a pressure difference, causing the device to transition between one or more highly flexible configurations (where the tubular body bends easily when guided by operation or other means, e.g., on a guidewire) and rigid configurations (e.g., a continuum). In some examples, particularly (but not limited to) devices that stiffen based on the application of positive pressure, the stiffness of the elongated body is proportional to the applied pressure difference, so the larger the pressure difference, the stiffer the device may be, at least within a range of pressure difference values.

[0097]

[0135] As described above, these devices may include a stiffening layer and multiple layers (which may be arranged concentrically around an internal lumen) including at least one outer or inner layer. Many of these examples also include a compression layer that can engage with the stiffening layer, and in some examples, the device may include a combined stiffening layer / compression layer. The stiffening layers described herein are particularly well suited for rapid and accurate operation under a variety of pressures, including positive pressures (e.g., high positive pressures, i.e., atmospheric pressures of about 2 or higher, 4 or higher, 6 or higher, 8 or higher, 10 or higher, 15 or higher, 20 or higher, 30 or higher, etc.). Any of these devices may be configured such that at least some of the inner and / or outer layers constituting the stiffening device have different stiffnesses in the internal and external components of either the inner or outer layer. Furthermore, devices and methods including a nested set of the stiffening devices described herein may include any of these stiffening devices. Any of these devices, especially when included as part of a nested pair of rigidizable devices (e.g., as part of an internal or child device), may include one or more torsional reinforcing layers for improving torsional control.

[0098]

[0136] Figure 3A shows an example of a cross-section of an elongated stiffening device, illustrating the arrangement of many possible layers. In this example, the stiffening device 100 is configured to be actuated by the application of negative pressure (e.g., vacuum). The shown device 100 includes an inner layer 115 to be reinforced (e.g., by including one or more reinforcing members such as spirally arranged strips, ribbons, or wires), an optional slip layer 113, a gap 111, a stiffening layer 109 configured as a braided layer in this example, a second gap 107, and an outer layer 101. These layers surround a central lumen 120. In some examples, stiffening may also be achieved by applying a vacuum between the outer and inner layers. For example, a port configured to be coupled to a negative pressure source may be located at the proximal end of the device and be in fluid communication with the gap region 107 between the flexible outer layer 101 and the stiffening layer 109, e.g., the braided layer. Thus, in this example, the outer layer may act as a compression layer. Figure 3B shows a cross-section through one wall region B of the cylindrical body of the device. By applying suction, the outer layer 101 can be pulled onto the stiffening layer, stiffening it and limiting or preventing bending of the device.

[0099]

[0137] Another example of a rigidizable device, e.g., a rigidized overtube 2100 having an internal lumen 2120, is shown in Figures 4A–4B. In this example, the device may be an elongated, catheter or tubular device similar to those in Figures 3A–3B, but may be rigidized by the application of positive pressure. For example, Figure 4A shows a cross-section of an elongated rigidizable device with respect to its long axis. In this example, the layers forming the device are arranged such that the internal reinforcing layer 2115 is the most radially inward layer and may be reinforced with helically wound ribbons, strips, cables, etc. The device may also include an optional slip layer 2113 that can reduce friction between the inner layers and the more radially outward layers. The slip layer may be a powder, a lubricating layer, or a layer of lubricating material. It is shown that the layer of the first gap 2112 separates the inner layer 2115 and / or the slip layer 2113 from the compression layer, which in this example is configured as a bladder layer 2121. A second (or intermediate) gap layer 2111 separates the bladder layer from the stiffening layer 2109, which in this example is shown as a braided layer. A third gap layer 2107 is positioned between the stiffening layer and the outer layer 2101. The outer layer in this example (similar to the inner layer 2115) is reinforced by, for example, a helical filament, wire, fiber, band, etc. Although not shown, when actuated by a positive pressure application between the compression layer (e.g., the bladder layer) and the inner layer, the bladder layer may push the braided layer into the outer layer and stiffen the stiffening layer.

[0100]

[0138] Both examples of devices shown in Figures 3A-3B and 4A-4B may include additional arbitrary layers or components. Furthermore, the composition of the stiffening layers may be modified to improve performance. In particular, the stiffening layers may be modified to include structures that improve or enhance performance (e.g., knitted fabrics, woven fabrics, braids, flakes, plates, filament arrays, granules, or combinations thereof). Stiffening elements may be used alone as a single type or in combination with other stiffening elements. In some examples, the inner and / or outer layers may be modified to improve or enhance performance, including the addition of torsional control components and / or adjustment of the stiffness of the inner and outer regions of these layers.

[0101]

[0139] As mentioned above, in addition to (or instead of) the overtube, the endoscope may be rigid. Generally, the devices described herein are configured to apply suction through the overtube and around the endoscope inside the overtube. In some examples, suction may be applied through the endoscope. The device may be applied to the same suction source or to a different suction source. In some examples, the endoscope may be used by first applying suction to the endoscope to coordinate the movement of the material to be removed, for example, into or near the opening of the overtube, and then applying suction to the overtube to remove the material. Thus, a combination of suction from the endoscope and suction from the overtube may be coordinated to remove the material. In some cases, to prevent clogging of the endoscope, the use of the endoscope may be limited to transporting the material to the opening of the overtube. Any of these methods may, by alternative or additional means, include a dedicated pressure relief line and / or separate pressure relief lines for the overtube and the endoscope.

[0102]

[0140] In some examples, the device may be configured to apply positive pressure through the endoscope, for example, by flowing pressurized fluid through the endoscope's suction lumen or working channel, particularly when the distal tip of the endoscope is inside the lumen of the overtube. This allows the device to clear blockages inside the endoscope lumen without the risk of material release into the body. Any of these devices may further or additionally include one or more fluid lines that can be inserted into the internal lumen of the overtube separately from (or optionally in addition to and / or through) the endoscope. Thus, the fluid lines may supply fluid (e.g., water) into the lumen of the overtube and / or from the distal end of the overtube. The fluid may be supplied as a spray or flow from the distal end region and / or tip nozzles of the device. In some examples, the fluid may be supplied through a perfusion line inside the overtube to clear blockages near the proximal end of the overtube.

[0103]

[0141] In some cases, pressurized fluid is supplied through the suction lumen or working channel of the endoscope, and the flow of high-pressure fluid can be used to break down substances such as blood clots, food, and feces.

[0104]

[0142] The apparatus described herein may generally form a seal around the endoscope, for example, in the area of ​​the overtube (and in some examples, in the area of ​​the suction adapter), and maintain the seal around the endoscope so that suction can be applied through the internal lumen of the overtube with virtually no loss of suction from the proximal end into which the endoscope is inserted.

[0105]

[0143] Figure 5A shows an example of the proximal end of the device, which may be integrated with the overtube or configured as a detachable adapter (also called a suction adapter) for coupling with the overtube (e.g., coupling region 534), and may be mounted via a flexible vacuum line. In Figure 5A, the proximal end region of the device (e.g., suction adapter) includes an endoscope receiving port 514 configured to receive an endoscope. The device also includes a vacuum port 516 configured to be coupled to a vacuum source and to apply suction to the internal lumen of the overtube. A control device 522 may be included in line with the internal lumen of the overtube and the vacuum port 516. Generally, the control device 522 may be configured to be controlled by a user to control the application of suction through the overtube. The control device may be coupled to or integrated with the overtube and / or suction adapter as shown in Figure 5A, may be separate, or may be connected to a suction source (negative pressure) via a control suction port 516' and / or between a negative pressure source and the vacuum port 516 of the adapter region.

[0106]

[0144] Figures 5B–5D show examples of suction adapter portions of a device that may be configured as a separate adapter for use with an overtube, or may be integrated with the overtube. Figures 5B–5C show side views of an adapter region similar to that shown in Figure 5A, but without attached or integrated control devices (including valves) for controlling the application of suction through the device. As shown in the cross-sectional view of Figure 5C, the endoscope receiving port 514 includes a seal 526. In this example, the seal 526 is configured as a material sheet (e.g., elastomer) having a seal opening 524 through which it passes. The seal opening has a diameter smaller than the outer diameter of the endoscope inserted into the overtube lumen 507. The seal may be lubricated, or may be used with a lubricant, to maintain the seal while the endoscope slides inside the seal and prevent vacuum loss when suction is applied. Figure D shows a top view of the suction adapter of Figures 5B–5C, showing the seal opening 524 of the seal 526 as seen through the endoscope receiving port 514. The seals may be coated to enhance lubricity and / or ease of sliding (e.g., by a hydrophilic coating or other lubricating coating).

[0107]

[0145] In Figure 5A, the control device includes a valve biased by a biasing unit (e.g., a spring) configured to hold the valve in the closed position unless a user applies force to displace the spring, as shown in the examples shown in Figures 6A-6C described below. In some configurations, the control device may include a spring-loaded trumpet valve 622, an example shown in Figures 6A-6C. Figure 6A shows an external view, and Figures 6B and 6C show cross-sections through the trumpet valve of Figure 6A in an open configuration (Figure 6B) and a closed configuration (Figure 6C). The valve in this example includes a vacuum port 516 configured to be coupled to a vacuum source and an outlet 536 coupled to the lumen of an overtube. The spring-loaded valve mechanism includes a shaft 628 which may be displaced downward to open the connection between the vacuum port (and thus the connected vacuum source) and the suction lumen outlet 536 when a control input 629 (e.g., a button, knob, etc.) is pressed down, for example by the application of force from a user. For example, the user pushes down on the control device to compress the spring 631 inside the valve, displacing the shaft 628 and forming a connection through which suction can flow from the suction port and from the distal end of the suction lumen of the overtube. In Figure 6B, the control device 622 with the valve is shown in a closed (stationary) configuration, and the shaft 628 includes a pair of seals 633, 635 configured to prevent leakage between the vacuum port 516 and the suction lumen outlet 536. In Figure 6C, the valve of the control device is shown in an open (operated) configuration, for example, when the actuator (control input 629) is held down, it compresses the biasing part (spring 631), displacing the shaft 628 inside the valve and forming a connection between the suction lumen outlet 536 and the vacuum port 516.

[0108]

[0146] Figures 7A–7B show another example of an adapter 722 that attaches to the proximal end of an overtube to convert it into a device for sealing and receiving an endoscope and applying suction through the overtube. In Figure 7A, the example shown is configured to include two parts, a proximal portion 779 and a distal portion 778, which are configured to mate with each other. In this example, the distal portion 778 may be coupled or integrated with the elongated body of the overtube (e.g., via a coupling region 734), but is configured to have a threaded engagement portion 781 that mates with a channel or complementary region on the distal portion. The distal portion includes an endoscope receiving port 714 configured to receive an endoscope, and a vacuum port 716 configured to be coupled with a vacuum source (and / or control device) and to apply suction into the internal lumen of the overtube. Another control device (e.g., a foot pedal, a manual control device, etc.) may be included (not shown) that adjusts the connection (e.g., piping) between the suction port and the suction source with a valve.

[0109]

[0147] Figure 7B shows a cross-section of the assembled adapter 722 of Figure 7A. In this example, it is shown that the internal seal 726 movably seals the endoscope communicating with the internal lumen 707 of the overtube. The seal may include one or more elastomer layers, rings (e.g., O-rings), etc., that prevent or reduce leakage that would prevent the application of suction from the internal lumen of the overtube while allowing insertion and removal of the endoscope. As previously mentioned, the seal may include an opening.

[0110]

[0148] Figure 8A shows an exploded view of the distal region 879 of an adapter similar to that shown in Figures 7A-7B. In this example, the proximal portion 779 includes a suction port 816 and a threaded receiving region 891 inside the proximal region. At the proximal end of this portion of the adapter, the endoscope seal 826 is shown as an elastomer layer having an opening 824 for receiving an endoscope. The seal may be reinforced, for example, radially near the wall. The proximal end may be configured as an endoscope receiving port 814.

[0111]

[0149] As described above, any of these devices may be integrated such that the overtube is integrated to include an endoscope receiving port and a suction port. Figure 9 shows an example of an integrated device configured as an overtube including an endoscope receiving port 914 at the proximal end, including a seal (invisible) as described above. The proximal end also includes a vacuum port 916 configured to fluidly couple with a suction line connected to a suction source (and optionally a control device). The overtube 906 in this example also includes an elongated body 929 which may be configured to stiffen in order to controllably and reversibly transition between a relatively flexible configuration and a more rigid (e.g., less flexible) configuration by the application of pressure (positive and / or negative pressure). In Figure 9, the device includes a stiffening port 944 which may include the length of connector piping for coupling to a negative or positive pressure source. In some cases, the overtube may include an actuator 946 (e.g., a switch, dial, button, etc.) located separately at the proximal end of the overtube itself (e.g., the handle area) or, for example, between a stiffening port and the inner layer of the elongated body of the overtube which may be stiffened. The example shown in Figure 9 also includes a flushing line 957 and an optional pressure relief line 948 (e.g., an air relief line). The distal end 939 of the device shown in Figure 9 is tapered radially inward and may help center the endoscope, extending distally from the overtube to enhance suction into the overtube.

[0112]

[0150] Figures 10A–10E illustrate the preparation of the apparatus, including the overtube, as described herein. Figure 10A shows the overtube 1006 in an elongated, flexible configuration. The suction adapter portion 1040 of the apparatus is shown adjacent to the proximal end of the overtube, but not yet connected. In Figure 10B, the suction adapter portion is coupled to the proximal base of the overtube. The suction adapter 1040 includes a vacuum port 1016 configured to be coupled to a suction source, as shown in Figure 10C, and an endoscope receiving port 1014 for receiving an endoscope 1008. The endoscope may be inserted (along with lubricating material) into the internal lumen of the overtube. The suction adapter may include one or more seals (not shown) to form a seal around the endoscope once inserted into the endoscope receiving port. A suction source, such as a suction pump or wall suction, forms a suction line 1036, which may then be coupled to a suction port (e.g., vacuum port 1016). A control device coupled to the vacuum port may include a biased valve, and while the user activates the control device, a control input unit is driven to the valve to apply suction from the distal end opening of the overtube.

[0113]

[0151] Figures 11A–11F show an example of how the apparatus is operated as described herein. In Figure 11A, the overtube 1106 is advanced so that the endoscope 1108, extending distally from the distal opening 1110 of the overtube, is adjacent to the material to be removed (e.g., blood clot 1110). The endoscope can be visually confirmed using imaging (e.g., one or more cameras) at the distal end of the endoscope to confirm the location and proximity of the blood clot. The overtube 1106 may then be advanced distally toward the blood clot 1110 until the distal end region is adjacent to the blood clot 1110, as shown in Figure 11B. The endoscope may then be retracted proximal into the lumen of the overtube, as shown in Figure 11C, and suction may be applied (Figure 11D), drawing the blood clot into the internal lumen of the overtube, as shown in Figures 11E and 11F. The endoscope can confirm that the blood clot material is drawn in and removed from inside the lumen of the overtube through the internal lumen of the overtube. The material 1110 may be drawn up along the endoscope 1108 contained within the lumen of the overtube, and in some cases, the material may surround the endoscope as it is drawn in proximal. In Figures 11A-11F, the distal portion of the overtube is tapered and includes a distal opening 1110 that is slightly narrower than the inner diameter of the lumen of the overtube.

[0114]

[0152] The above example illustrates a device in which the endoscope is positioned relatively centrally within the overtube (with the vacuum port as a side outlet), but alternative configurations may be used. For example, the endoscope may be positioned off-center from the center of the internal lumen of the overtube. For instance, the device may be configured so that the endoscope is centrally located in the middle and distal overtube lumen, but the endoscope may exit at or near the proximal end through a (sealed) side outlet of the overtube lumen. In this configuration, blood clots may have a direct aspiration path along the center of the overtube lumen.

[0115]

[0153] In some cases, it may be helpful to apply perfusion with a large-diameter suction through an overtube, as shown in Figure 12A. In this example, the device includes an overtube 1206 with an internal suction lumen 1207 and an endoscope 1208, similar to those shown in Figures 11A–11F. The device (as part of the endoscope or as a separate component) may include a perfusion line 1212 (also referred to here as a perfusion tube) that may extend distally from the overtube and / or endoscope, supplying perfusion fluid from one or more perfusion outlets. Perfusion can help remove material that can be removed by applying suction from the overtube (in addition, suction can remove perfusion material). Perfusion may also occur directly from the internal suction lumen / working channel. Any of these devices may also be configured to perform perfusion from the proximal end of the overtube to flush out blockages and, in some cases, clear blockages in the scope.

[0116]

[0154] In some examples, the perfusion tube 1212 is located separately inside the lumen of the overtube and does not need to pass through the endoscope; instead, another perfusion tube 1242 can be used. Generally (and as shown in Figures 25A–25J and 26A–26H), the perfusion tube may include one or more nozzles 1243 or openings to perfusers. For example, as shown in Figure 12B, the perfusion tube 1242 may be inserted along the endoscope 1208 into the internal lumen 1207 of the overtube 1206 and positioned axially independently of the endoscope. Perfusion fluid may be sprayed from the perfusion tube to clear blockages in the endoscope, break up material, and / or clean the endoscope and / or overtube.

[0117]

[0155] As mentioned above, any of these overtubes may be configured as rigid overtubes. Alternatively, none of these devices may be rigid overtubes. For example, Figures 13A-13B show another example of a device including an overtube having one or more reinforcing layers but not configured to be rigid. Figure 13A shows the proximal end region of the device and shows a suction adapter region coupled to the proximal end of the overtube 1306. The suction adapter region includes a suction port 1316 for coupling to a suction source and an endoscope receiving port 1314 for receiving and sealing an endoscope inside the suction lumen of the overtube. The device may also include a flushing line 1344. In the example shown in Figures 13A-13B, the device includes a suction port integrated into the handle region of the overtube device (shown as a Y-shaped port extending from the side of the device). Any of these features may be replaced or added as a rigid overtube (including a built-in Y-shaped port similar to that shown in Figure 13B). The distal end region 1328 may be tapered.

[0118]

[0156] In some examples, a control device for controlling suction inside the overtube may be coupled to the suction adapter portion of the device, as shown in Figure 5A above. For example, the control device may be coupled to the vacuum port 516 of the device and provided in series with the suction source. In some cases, such a connection between the suction line and the device may be a flexible or movable connection, as shown in Figures 14A-14B, which show a swivel connection 1405 between the adapter's suction port 516 and the device. The adapter region may include an endoscope receiving port 514 and a coupling region 524. Similarly, the control device 622 may include a trumpet valve (as shown in Figures 6A-6C in this example) but may also include a control input 629 (e.g., a button, knob, etc.) to open the suction line and apply suction into the lumen of the overtube.

[0119]

[0157] In any of these examples, the control device may instead be applied to a suction (negative pressure) line connecting to the suction port 516 of the overtube (or, in some examples, the suction port of a suction adapter configured to connect to the suction port). The control device may include a valve provided in series or parallel to the suction line connecting a negative pressure (suction) source to the suction port of the device. For example, the control device may include a suction line coupling region 1538 that is coupled to the suction line and configured to close or open (when activated) to apply suction through the internal lumen of the overtube. In the example of the control devices 1522, 1522' shown in Figures 15A–15C, the control device includes a lever valve configured to block the application of suction through the suction line to which it is coupled. In Figure 15A, the actuator (control input 1529) is a lever arm that can be pushed down to allow suction through the suction line to which the control device is attached. Figure 15C schematically shows another example of a control device 1522' having a lever or handle 1529' that can be pushed down (clauched) by a user to allow suction through the lumen of the overtube when activated. When not in operation, the control device may return to a biased and closed position. In some examples, the control device may include a lever valve.

[0120]

[0158] Figures 16A-16B show another example of a control device 1629 including an actuator (control input 1604) with a handle portion 1602, the actuator also shown as a lever that is compressed by the user to allow suction through the internal lumen of the overtube. For example, as shown in Figure 16B, which shows a cross-sectional view of the control device in Figure 16A, the control device may be aligned with the suction line via a suction inlet 1606 and a suction outlet 1608. For example, the device may include a pinch valve 1650 that is biased (by a biasing part such as a spring 1651) and remains closed until actuated by the user.

[0121]

[0159] Figures 17A–17C show another example of a control device 1729 including an actuator (control input 1604) configured to receive a foot 1704 that is compressed by the user to allow suction through the internal lumen of the overtube. For example, as shown in Figures 17A–17C, the control device may be linearly connected to the suction line via a suction inlet 1706 and a suction outlet 1708. The control device may include a pinch valve biased by a biasing mechanism (e.g., a spring) 1751 so that it remains closed until activated by the user.

[0122]

[0160] As mentioned above, any of these devices may be configured as a highly flexible overtube that can withstand and remain flexible even when relatively large negative pressure (suction) is applied through the lumen of the overtube. Figures 18A and 18B illustrate various examples of overtubes with strain gauges attached to show the forces applied to bend the flexible elongated member of the overtube without breaking it.

[0123]

[0161] In Figure 18A, the overtube 1800 includes reinforcing wires but is relatively more rigid than the exemplary overtube 1800' shown in Figure 18B. In this case, the overtube is also very flexible (for example, it has greater bending flexibility compared to the overtube shown in Figure 18A) and has high circumferential strength, capable of withstanding at least 1 atmosphere (approximately 101.33 kPa (760 mmHg)) or more under compression. It is shown that force gauges 1806 are attached to the distal end of each overtube to measure the bending force relative to its length (for example, to determine the bending flexibility). When the same bending force is applied, the exemplary overtube 1800' shown in Figure 18B can be bent relatively easily more than 360 degrees.

[0124]

[0162] As stated above, any of the devices described herein may include one or more (e.g., suction relief or vacuum relief) openings to prevent vacuum locking of the distal end region (including the opening into the internal lumen of the overtube) when the distal end of the overtube is attracted to the wall of the body region. Figure 19 shows an example of a distal end region 1900 including a plurality of suction relief openings 1905, 1905' positioned laterally and proximal to the distal end opening 1930 into the lumen of the overtube. The distal end opening 1930 is tapered and has tapered sides 1928 from the outside and also has an opening diameter narrower than the inner diameter of the lumen region more proximal to the distal end opening. Alternatively or additionally, these devices may include a relief valve, as shown in Figure 21B.

[0125]

[0163] Any overtube device described herein may include one or more external working channels extending downward along the length of the overtube. Examples of external working channels are found, for example, in U.S. Patent Application No. 17 / 940,906, titled "EXTERNAL WORKING CHANNELS," filed September 8, 2022, and U.S. Patent Application No. 18 / 000,062, titled "RIGIDIZING DEVICES," filed May 26, 2021, both of which are incorporated herein by reference in their entirety. This is shown in Figures 27A–27C. Figure 27A shows the distal end region of the overtube 2706 from which the endoscope 2708 extends. The distal end is tapered as described above in this example. The overtube also includes at least one external working channel 2781, which may be configured to lie flat until an accessory device (e.g., a suction tube 2789) is passed through, as shown in Figure 27B. Figure 27C shows an example of an overtube as described herein, which includes multiple (e.g., four) external working channels accessible via the proximal port 2788. The proximal end may include an endoscope-receiving port 2714.

[0126]

[0164] One or more external working channels may be extendable from the outer surface of the overtube and may include a proximal insertion guide region for inserting one or more devices through the external working channels. Robotic device

[0127]

[0165] Any of these devices may be configured as a robotic device or used in conjunction with a robotic device. In some examples, the overtube and endoscope assembly (including the internal endoscope 9310) can be controlled by a robot. Any suitable control subsystem may be used to control movements including manipulation of the distal end, advancement and / or retraction of the overtube and internal endoscope, and rotation of the internal endoscope and / or external overtube. In Figure 20, the exemplary device 9300z, including the overtube 9300 and internal endoscope 9310, can be controlled or operated by a robot (e.g., manipulation, movement, rotation, and in some examples, rigidification). As shown in Figure 20, the external overtube 9300 and internal endoscope 9310 may terminate together in a common structure such as a cassette 9357. The external overtube 9300 is movable relative to the endoscope 9310 by the rotation of a disk 9389 mounted on the cassette 9357. For example, the disk 9389 is a pinion, and the external stiffening device 9300 may have a rack 9382 with several small teeth on its outside. By rotating the disk 9389 relative to the teeth 9382, the overtube 9300 may move forward or backward relative to the endoscope 9310. In some examples, the possible movement or translation of the endoscope and / or overtube is limited by the size or design of the cassette 9357.

[0128]

[0166] Cassette 9357 may further include additional discs 9371a, 9371b, which may be connected to cables 9363a, 9363b, respectively, to operate (e.g., bend or fold) the tip of the endoscope 9310 (and / or external overtube 9300). Other operating mechanisms (e.g., pneumatic, hydraulic, shape memory alloy, electroactive polymers (EAP), motor, etc.) are also possible. In examples with various operating mechanisms, one or more discs in cassette 9357 (e.g., discs 9371a, 9371b) may be used to actuate the operation.

[0129]

[0167] Cassette 9357 may further include bellows 9303a, 9303b that can be connected to the pressure gap of the endoscope 9310 and the overtube 9300, respectively. When the bellows 9303a, 9303b are compressed, fluid is delivered through the pressure line 9305z, increasing the pressure in the pressure gap of the endoscopes 9310, 9300, and stiffening the endoscope 9310 and / or the overtube 9300 (or, in a modified example, either the endoscope and / or overtube configured to stiffen). The bellows 9303a, 9303b may be activated sequentially and / or simultaneously. As shown in the figure, cassette 9357 includes eccentric cams 9374a, 9374b that can control the bellows 9303a, 9303b. Alternatively, one or more linear actuators (e.g., on cassette 9357 or on the drive unit) may be configured to actuate the bellows 9303a, 9303b. Alternatively, devices 9300 and 9310 can be stiffened and destiffened through one or more sumps (as described herein) or pressure sources (e.g., via pressure line 9305z).

[0130]

[0168] Cassette 9357 may include a connector 9315y for connecting to additional lumens and / or wiring in the endoscope 9310 and / or overtube 9300. Connector 9315y may include a connector for delivering both suction and water to the tip of the endoscope 9310. Connector 9315y may include an electrical connector for connecting a camera mounted on the tip of the endoscope 9310 to an external monitor and / or video processing unit. Connector 9315y may include a mechanical connector for connecting to a hollow tube (e.g., a working channel) leading to the tip of the internal rigidification device 9310. By including connector 9315y, all components of system 9300z can be controlled by cassette 9357.

[0131]

[0169] When in use, these devices can remove material from a patient's body very efficiently and safely. For example, Figure 21A shows the operation of an example of the device described herein. In this example, the device includes an overtube 2106 having an elongated body. The overtube can be rigid as described above. The proximal end of the overtube includes a suction port 2116 and an endoscope receiving port 2114 having a seal. The device shown in Figures 21A-21D shows an endoscope 2108 inserted into the internal lumen of the overtube, forming an annular lumen 2121 as shown. The device also includes a port having a three-way valve (e.g., a plug 2138) which has an off position, a first position in which the internal lumen of the overtube is in fluid communication with a rinse line or perfusion line 2136, and a second position in which the internal lumen of the overtube is in fluid communication with an air vent port or opening 2148. Thus, in this example, the device includes a manual three-way plug 2138, which the user can switch between air vent and perfusion. In some cases, perfusion can be used to clear blockages by flowing water into the annular space with a syringe (see Figures 21C-21D). In some cases, the suction relief 2148 includes a seal (e.g., a Tyvek seal) for venting air to the atmosphere, but which can block the associated fluid.

[0132]

[0170] In Figure 21A, the device is shown to apply suction 2151 through the internal lumen of the overtube from a suction port 2116 connected to a source of suction and retrieval (not shown). As described above, during use, the distal end of the rigid overtube 2016 can be positioned adjacent to the material to be removed, and the endoscope 2108 extends distally from the distal end. The rigid overtube 2106 concentrically surrounds the endoscope 2106, and the overtube and endoscope form an annular lumen 2121. The device is steered inside the body by controlling the rigidity of the overtube to assist in the guiding operation. The endoscope is driven distally while the overtube is rigid, then the overtube is made flexible and advanced over the endoscope, and then rigid again to maintain its shape, allowing for additional distal guiding operations relative to the overtube. Once the endoscope is positioned, and after visualizing, for example, the material to be removed or the area to be rinsed and / or treated, the endoscope is slightly retracted proximal to the overtube, and the distal end of the endoscope is placed inside the distal end region of the rigid overtube, as shown in Figure 21A. This can be done with the overtube rigid. Subsequently, suction is applied through the annular lumen to draw the material into the annular lumen and around the endoscope.

[0133]

[0171] In some cases, the overtube may be locked onto the wall 2149 of the lumen, as shown in Figure 21B, in which case the opening in the distal end region may help release the lock from the wall, as described above. Alternatively, in some cases, a relief valve (e.g., an air relief port 2148) may be used. Figure 21B shows a valve 2138', which, with the plug in the second position, allows for rapid release of the vacuum lock on the wall by expelling air from the body.

[0134]

[0172] Figures 21C–21D illustrate an example where the annular lumen 2121 becomes clogged (e.g., with substance 2153), and this clog can be removed by applying a rinsing fluid 2158 (e.g., from a syringe) supplied through a rinsing port 2136 controlled by a three-way valve 2138” (shown in the rinsing position first in Figure 21C). For example, in Figure 21C, the clog 2158 inside the annular lumen of the device 2121 is loosened or removed by applying a rinsing fluid (e.g., saline solution) 2158 when the three-way valve opens the rinsing port (e.g., rinsing port) 2136. In some examples, the rinsing fluid may be supplied by a syringe. The clog can be advanced distally from the device and removed by applying suction 2151 again through the suction port 2116, as shown in Figure 21D. In Figure 21D, the three-way plug 2138 is again in the closed position.

[0135]

[0173] Alternatively, the blockage may be removed by moving the endoscope inside the lumen using any of these methods. For example, the endoscope may be moved axially (proximal / distal). In some cases, the endoscope may be moved axially between approximately 1 mm and 3 cm or more (e.g., between approximately 1 mm and 3 cm, between approximately 1 mm and 2.5 cm, between approximately 1 mm and 2 cm, between approximately 1 mm and 1.5 cm, between approximately 1 mm and 1 cm, between approximately 1 mm and 7 mm, between approximately 1 mm and 5 mm, etc.). The endoscope may be moved back and forth with linear vibrations, for example between approximately 1 Hz and 50 Hz (e.g., between approximately 1 Hz and 40 Hz, between approximately 1 Hz and 30 Hz, between approximately 1 Hz and 20 Hz, between approximately 1 Hz and 10 Hz, etc.). Moving the endoscope inside the lumen of the overtube while applying suction may help prevent or remove the blockage. Alternatively or additionally, the endoscope may be rotated inside the lumen.

[0136]

[0174] In any of these devices, blood clots may be detected if the fluid supplied before and / or during aspiration is not removed. This can be detected or confirmed by observing the recovery device which is in line with the aspiration source.

[0137]

[0175] As described above, during the operation of these devices, fluid may be supplied to loosen and / or remove any packed feces, mucus, or other substances from the body area. The fluid may be supplied through one or more fluid channels, which may be part of the overtube, part of the endoscope, or part of a separate instrument inserted into either the overtube or the endoscope. The fluid may be supplied by a fluid pump at an appropriate flow rate. In some cases, the fluid may be supplied pulsatingly, for example, at a frequency of about 0.1 to 200 Hz (e.g., between 0.5 and 150 Hz). In any of these methods and devices, a gas (e.g., air) may be included in the supplied fluid to break down the substance to be removed.

[0138]

[0176] Figures 22A–22C illustrate an example where fluid is supplied through fluid lines in an overtube. In Figure 22A, the overtube 2206 includes three fluid lines 2246, each containing an outlet that is slightly proximal to the distal end of the overtube. In this example, the fluid outlet is radially positioned on one side of the overtube. In some cases, as shown in Figure 22B, the outlets of the fluid lines (three are shown) 2246' may extend slightly distally from the overtube (but still proximal to the distal end of the overtube) and be angled or positioned at an angle to the long axis of the overtube, as shown in Figures 22B–22C.

[0139]

[0177] Alternatively or additionally, a fluid (e.g., a cleaning fluid or perfusion fluid) may be supplied from the distal end region of a perfusion tube inserted through an endoscope and / or an overtube. The direction of the fluid from any of these fluid lines, including the perfusion device and integrated fluid lines, can be controlled by the nozzle region at the distal end. In some cases, radial spraying may be particularly beneficial, as shown in Figure 23A. Figure 23A shows a perfusion tube 2366 configured as a radial spray perfusion tube, where the distal end region is configured as a nozzle having multiple annular openings to form a radial spray, as shown. In contrast, Figure 23B shows an example of a perfusion tube 2366' in which a linear spray is discharged from a single nozzle opening at the distal end. This allows for the generation of a single jet perfusion spray, as shown.

[0140]

[0178] In some cases, the apparatus may be configured to operate so that a single perfusion tube is used as both a radial sprayer and a longitudinal (e.g., distal) injector by adjusting the relative position of the perfusion tube from the distal end of the endoscope and / or overtube, as shown in Figures 24A–24D. For example, in Figure 24A, the radial spray perfusioner 2466 is advanced distally 2468 through the endoscope 2408, which is slightly retracted proximal within the lumen of the overtube 2406, to form an annular lumen 2463 as described above. The perfusion tube 2466 is coupled to a source of perfusion fluid 2467, which may be a pump or syringe. As the distal end of the perfusion tube 2466 is extended distally from both the endoscope and the overtube 2406, the perfusion fluid may be ejected radially 2469 from the distal end (e.g., a nozzle), as shown in Figure 24B.

[0141]

[0179] The radial spray perfusion tube may also be used to supply longitudinal flow by retracting the radial spray perfusion tube 2466 proximal into the overtube 2406, as shown in Figure 24C, resulting in a flow 2469' that is strongly directed distally, as shown. Alternatively, in some examples, the perfusion tube 2466 may be retracted such that the radial spray nozzle region retracts into the endoscope 2408 at its distal end, resulting in a distal flow 2469”, as shown in Figure 24D.

[0142]

[0180] Figures 25A–25J show examples of various deformations of the distal end of a perfusion tube configured as a nozzle region. Figures 25A–25B show cross-sectional and side perspective views, respectively, of a first distally oriented nozzle. Figures 25C–25D show cross-sectional and side perspective views, respectively, of a spray nozzle oriented distally (e.g., longitudinally). Figures 25E–25F show cross-sectional and side perspective views, respectively, of a combination of radial and distal spray nozzles. Figures 25G–25H show cross-sectional and side perspective views, respectively, of a radial spray nozzle. Figures 25I–25J show cross-sectional and side perspective views, respectively, of an example of a nozzle configured to emit a radial spray (delivered as a fan-shaped spray rather than a discrete flow). These nozzle regions may be formed on the perfusion tube or attached to the distal end of the perfusion tube. In some cases, the nozzle area may be formed by molding, printing (3D printing), laser cutting, or the like.

[0143]

[0181] Figures 26A–26H show side views of various additional examples of nozzle regions in the perfusion tubes described herein. These various perfusion tubes may be used to achieve various variations of spray patterns. Any of these perfusion tubes can be converted into a forward-flowing (e.g., laterally) perfusion tube by being drawn into the overtube and / or into the endoscope, as shown in Figures 24C–24D above.

[0144]

[0182] In addition to the perfusion tubes described herein, other accessories may be included. For example, any of these devices may be used with one or more suction tubes (e.g., in combination) as shown in Figure 28 and described above. For example, the suction tube 2889 may be inserted through an endoscope (e.g., the working channel of the endoscope) and / or an overtube that includes a working channel inside the internal lumen and / or an external working channel. The suction tube 2889 may include one or more openings 2887 into the device, as shown in Figure 28. In this example, the suction tube is a 6 mm disposable suction tube.

[0145]

[0183] All publications and patent applications described herein are incorporated herein in whole by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Furthermore, it should be recognized that all combinations of the concepts described herein and any additional concepts described in more detail below (where the concepts are not inconsistent) may be used to achieve the advantages described herein, with the intent that they may be part of the subject matter of the inventions disclosed herein.

[0146]

[0184] Any method described herein (including user interfaces) may be implemented as software, hardware, or firmware, and may be described as a non-temporary computer-readable storage medium storing a set of instructions that can be executed by a processor (e.g., a computer, tablet, smartphone, etc.), and when the instructions are executed by the processor, the controlling processor performs one of the steps, which include, but are not limited to, display, communication with a user, analysis, modification of parameters (including timing, frequency, intensity, etc.), determination, warning, etc. For example, any method described herein may be at least partially implemented by an apparatus including one or more processors having memory storing a non-temporary computer-readable storage medium storing a set of instructions for the process of the method.

[0147]

[0185] Those skilled in the art will recognize that any process or method disclosed herein can be modified in many ways. The process parameters and the order of steps described and / or illustrated herein are given merely as examples and can be changed as necessary. For example, the steps illustrated and / or described herein are illustrated or described in a particular order, but these steps do not necessarily have to be performed in the order illustrated or described.

[0148]

[0186] The various exemplary methods described and / or illustrated herein may omit one or more of the steps described or illustrated herein, or may include additional steps in addition to those disclosed herein. Furthermore, any step of any method described herein may be combined with one or more steps of any other method described herein.

[0149]

[0187] The processors described herein can be configured to perform one or more steps of any of the methods disclosed herein. Alternatively or in combination, the processors can be configured to combine one or more steps of one or more of the methods described herein.

[0150]

[0188] When a feature or element is referred to in this specification as being "on top of" another feature or element, it may be directly on top of the other feature or element, or there may be intervening features and / or elements. In contrast, when a feature or element is referred to as being "directly on top of" another feature or element, there are no intervening features or elements. Also, when a feature or element is referred to as being "connected," "attached," or "joined" to another feature or element, it will be understood that it may be directly connected to, attached to, or joined to the other feature or element, or that there may be intervening features or elements. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly joined" to another feature or element, there are no intervening features or elements. Features and elements described or illustrated in relation to one embodiment may be applicable to other embodiments. Also, those skilled in the art will understand that a reference to a structure or feature positioned "adjacent" to another feature may have a portion that overlaps or lies above or below that adjacent feature.

[0151]

[0189] The terms used herein are for the sole purpose of describing specific embodiments and are not intended to limit the invention. For example, as used herein, the singular forms “a,” “an,” and “the” are intended to include the plural form unless the context clearly indicates otherwise. The words “equipped with” and / or “equipped with” as used herein indicate the presence of the described feature, step, action, element, and / or component, but it will be further understood that they do not exclude the presence or addition of one or more other features, steps, actions, elements, components, and / or groups thereof. As used herein, the words “and / or” include any combination of one or more of the related enumerated items, but may be omitted as “ / ”.

[0152]

[0190] Spatially relative terms such as “below,” “below,” “lower,” “above,” and “upper” may be used herein for explanatory purposes to describe the relationship between one element or feature shown in a figure and another element or feature. It will be understood that spatially relative terms are intended to include different orientations of a device in use or operation, in addition to the orientation depicted in the figure. For example, if the device in the figure is inverted, an element described as being “below” or “below” another element or feature will be oriented “above” the other element or feature. Thus, the illustrative term “below” may include both up and down orientations. The device may be oriented in other ways (rotated 90 degrees or in other directions), and the spatially relative descriptors used herein will be interpreted accordingly. Similarly, terms such as “upwards,” “downwards,” “vertical,” and “horizontal” are used herein solely for explanatory purposes unless otherwise indicated.

[0153]

[0191] The terms “first” and “second” may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, without departing from the teachings of the invention, the first feature / element described below may also be called the second feature / element, and similarly, the second feature / element described below may also be called the first feature / element.

[0154]

[0192] In general, all apparatuses and methods described herein should be understood as inclusive, although all or a subset of components and / or steps may be exclusive as alternatives, and may be described as "consisting of" or, as an alternative, "essentially consisting of" various components, steps, sub-components or sub-steps.

[0155]

[0193] In this specification and in the claims, including when used in examples, and unless otherwise explicitly specified, all numerical values ​​may be read as if preceded by the word “about” or “approximately,” even if the word does not explicitly appear. The expressions “about” or “approximately” may be used to describe the magnitude and / or location of a stated value and / or location to indicate that it falls within a reasonable expected range of the value and / or location. For example, a numerical value may have a value that is + / -0.1% of the stated value (or range of value), + / -1% of the stated value (or range of value), + / -2% of the stated value (or range of value), + / -5% of the stated value (or range of value), + / -10% of the stated value (or range of value), and so on. Furthermore, any given numerical value in this specification should be understood to include about or approximately that value unless the context makes otherwise. For example, if the value “10” is disclosed, “about 10” is also disclosed. Any numerical range described herein is intended to include all subranges contained therein. Furthermore, when a value is disclosed as "less than or equal to" a certain value, it is understood, in a manner appropriately understood by those skilled in the art, that "greater than or equal to" and possible ranges between values ​​are also disclosed. For example, if the value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" (for example, if X is a number) are also disclosed. Also, throughout this application, it is understood that data is provided in multiple different forms, and that this data represents a range of endpoints and starting points, as well as any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is understood that the ranges greater than 10 and 15, 10 and 15 or greater, less than 10 and 15, 10 and 15 or less, and equal to 10 and 15, as well as the range between 10 and 15, are considered disclosed. It is also understood that each unit between two specific units is disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0156]

[0194] While various exemplary embodiments have been described above, several modifications may be made to various embodiments without departing from the scope of the invention as described in the claims. Optional features of various device and system embodiments may be included in some embodiments but not in others. Therefore, the above description is for illustrative purposes only and should not be construed as limiting the scope of the invention, as the scope is described in the claims.

[0157]

[0195] The examples and illustrations included herein illustrate, not limiting, specific embodiments in which the subject matter is implemented. As stated above, other embodiments may be utilized and derived therefrom, and structural and logical substitutions and modifications may be made without departing from the scope of this disclosure. Such embodiments of the subject matter of the present invention may be referred to herein, individually or collectively, by the term “invention” for mere convenience and without any intention to spontaneously limit the scope of the application to any single invention or inventive concept, if one or more are actually disclosed. Accordingly, while a particular embodiment is illustrated and described herein, any arrangement configuration expected to achieve the same objective may be substituted with respect to the particular embodiment shown. This disclosure is intended to cover all variations and modifications of various embodiments. Combinations of the embodiments described above and other embodiments not specifically described herein will become apparent to those skilled in the art in consideration of the above description.

Claims

1. A method for removing a substance from a patient's body, A step of positioning the distal end of a rigid overtube adjacent to the material, wherein the endoscope extends distally from the distal end, and the rigid overtube concentrically surrounds the elongated portion of the endoscope such that the overtube and the endoscope form an annular lumen. The steps include: retracting the distal end of the endoscope in the proximal direction into the distal end region of the rigidified overtube; A method comprising the step of applying suction through the annular lumen to draw the substance into the annular lumen and around the endoscope.

2. The method according to claim 1, further comprising the step of converting the rigid endoscope from a more flexible configuration when the distal end is positioned adjacent to the material to a more rigid configuration before the endoscope is retracted proximal to the distal end region of the rigid overtube.

3. The method according to claim 1, further comprising the step of visualizing the substance using the endoscope while applying suction.

4. The method according to claim 1, further comprising the step of supplying perfusion distally to the distal end of the overtube.

5. The method according to claim 4, wherein the step of supplying the perfusion includes the step of spraying fluid from the fluid line of the overtube.

6. The method according to claim 4, wherein the step of supplying the perfusion includes extending a perfusion tube distally from the distal end of the endoscope and supplying the perfusion into the body from the perfusion tube.

7. The method according to claim 5, wherein the perfusion apparatus comprises a radial perfusion apparatus.

8. The method according to claim 4, wherein the step of supplying the perfusion includes the step of switching between supplying radial perfusion and distal perfusion by extending or retracting a radial perfusion tube relative to the distal end of the endoscope.

9. The method according to claim 1, further comprising the step of moving the endoscope axially inside the overtube while applying suction.

10. The method according to claim 1, further comprising the step of moving the endoscope axially inside the overtube while positioning the overtube.

11. The method according to claim 1, further comprising the step of operating the distal end region of the endoscope independently of the overtube.

12. The method according to claim 1, wherein the step of positioning the overtube includes the step of advancing the endoscope distally from the overtube, stiffening the overtube, destabilizing the overtube, and advancing the overtube distally over the endoscope.

13. The method according to claim 1, wherein the proximal end of the overtube is movably sealed around the endoscope.

14. The aforementioned annular lumen is 40 mm ２ 200mm ２ The method according to claim 1, having a cross-sectional area between the two.

15. The method according to claim 1, wherein the positioning step includes positioning the overtube inside the patient's digestive tract.

16. The method according to claim 1, wherein the step of removing the substance from the body includes the step of removing one or more of feces, blood, and food debris.

17. The method according to claim 1, further comprising the step of removing the blockage in the annular lumen by repeatedly moving the endoscope distally and proximally inside the overtube while applying suction through the annular lumen.

18. The method according to claim 1, further comprising the step of releasing the overtube from the body wall by opening an air relief valve that is in fluid communication with the annular lumen while applying suction through the annular lumen.

19. A method for removing a substance from a patient's body, The steps include positioning the distal end of the endoscope adjacent to the substance, The endoscope transitions from an extended configuration, where it extends distally to the overtube, to a retracted state, where the distal end of the endoscope is housed within the distal end region of the overtube, and the overtube is in a flexible configuration, with the distal end of the overtube positioned adjacent to the distal end of the endoscope and extending above the endoscope, such that the overtube concentrically surrounds the endoscope to form an annular lumen. The steps include converting the overtube from the aforementioned flexible configuration to a more rigid configuration, A method comprising the step of applying suction through the annular lumen to draw the substance into the annular lumen and around the endoscope.

20. A method for removing a substance from a patient's body, The steps include positioning the distal end of the endoscope adjacent to the substance, Steps include: advancing the distal end of the overtube distally over the endoscope such that the distal end of the overtube is adjacent to the material while the overtube is in a flexible configuration, positioning the distal end of the endoscope within the distal end region of the overtube so that the endoscope can visualize the material from the distal end of the overtube, and the overtube concentrically surrounding the endoscope to form an annular lumen; The steps include converting the overtube from a flexible configuration to a more rigid configuration, A method comprising the step of applying suction through the annular lumen to draw the substance into the annular lumen and around the endoscope.

21. A suction overtube device, An elongated body having an internal lumen extending from the distal end to the proximal end, configured to convert from a flexible configuration to a more rigid configuration by applying or releasing pressure inside the wall of the elongated body, A rigidification port configured to receive positive and / or negative pressure in order to convert the elongated body from a flexible configuration to a rigid configuration, A proximal end region including an endoscope receiving port configured to receive an endoscope into the internal lumen through it, wherein the endoscope receiving port is in a straight line with the internal lumen of the elongated body, A device comprising a vacuum port located in the proximal end region that is in fluid communication with the internal lumen.

22. The apparatus according to claim 21, wherein the distal end opening of the overtube is tapered.

23. The apparatus according to claim 21, wherein the elongated body includes a rigidifying layer comprising a plurality of elongated strands intersecting each other, and a compression layer configured to compress the rigidifying layer to a more rigid configuration.

24. The apparatus according to claim 21, further comprising a seal configured to seal the area around the endoscope located proximal to the vacuum port.

25. The apparatus according to claim 21, wherein the proximal end region further comprises one or more sealing gaskets configured to seal around the endoscope.

26. The internal lumen is 10 mm ２ The apparatus according to claim 21, having a larger cross-sectional area.

27. The apparatus according to claim 21, wherein the endoscope receiving port and the vacuum port are part of an adapter configured to be coupled to the proximal end of the elongated body.

28. The apparatus according to claim 21, wherein the elongated body has sufficient circumferential strength to withstand a negative pressure of at least 101.33 kPa (760 mmHg) inside the internal lumen.

29. The apparatus according to claim 21, wherein the elongated body further includes an internal coil winding tube.

30. The apparatus according to claim 21, wherein the elongated body includes a braided tube.

31. The apparatus according to claim 21, further comprising a control device including a bias valve configured to adjust the application of suction through the internal lumen.

32. The apparatus according to claim 31, wherein the control device is aligned in a straight line with the vacuum port.

33. The apparatus according to claim 31, wherein the control device includes a trumpet valve.

34. The apparatus according to claim 21, wherein the distal end opening of the overtube has an inner diameter less than the inner diameter of the inner lumen.

35. The apparatus according to claim 21, further comprising the aforementioned endoscope.

36. The apparatus according to claim 21, further comprising one or more perfusion devices configured to pass through the lumen of an endoscope.

37. The apparatus according to claim 36, wherein the one or more perfusers include radial perfusers.

38. The apparatus according to claim 21, further comprising a suction pipe configured to connect the vacuum port to a negative pressure source, and a control device including a valve configured to control the application of suction through the internal lumen.

39. The apparatus according to claim 21, further comprising one or more external channels extending along the elongated portion of the elongated body.

40. A suction overtube device, An elongated body having an internal lumen extending from the distal end to the proximal end, comprising multiple layers, configured to transition from a flexible structure to a more rigid structure by applying pressure to the multiple layers, A proximal end region including an endoscope receiving port configured to receive an endoscope through it into the internal lumen, wherein the endoscope receiving port is in a straight line with the internal lumen of the elongated body, A rigidifying port configured to stiffen the elongated body by receiving positive and / or negative pressure, The vacuum port in the proximal end region that is in fluid communication with the internal lumen, A suction overtube device comprising: a control device coupled to the vacuum port, which is configured to apply suction from the vacuum port through the internal lumen when the control device is activated by the user; and a control device coupled to the vacuum port.

41. A suction overtube device, An elongated body having an internal lumen extending from the distal end to the proximal end, comprising multiple layers, having sufficient circumferential strength to withstand a vacuum of 101.33 kPa (760 mmHg) or more, and further configured to transition from a flexible structure to a more rigid structure by applying positive and / or negative pressure to the multiple layers, A proximal end region comprising an endoscope receiving port configured to receive an endoscope through it into the internal lumen, and one or more seals configured to seal around the endoscope, wherein the endoscope receiving port is aligned in a straight line with the internal lumen of the elongated body, A rigidifying port configured to stiffen the elongated body by receiving positive and / or negative pressure, A suction overtube device comprising a vacuum port in the proximal end region that is in fluid communication with the internal lumen.

42. A method of removing substances from inside the body, Steps include advancing the overtube and endoscope distally within the body, wherein the endoscope is inserted into the lumen of the overtube through the proximal end port of the overtube such that the proximal end of the overtube is movably sealed around the endoscope; The steps include positioning the distal end of the overtube adjacent to the substance to be removed, A method comprising the steps of: when the user activates a control device to draw the material into the overtube and around the endoscope, applying suction through the lumen of the overtube from a port in the proximal end region of the overtube while imaging from the distal end of the overtube from the endoscope.

43. The method according to claim 42, further comprising the step of spraying fluid from the endoscope or from a fluid line inside the lumen of the overtube.

44. The method according to claim 42, further comprising the step of connecting a suction source to the port in the proximal end region of the overtube.

45. The method according to claim 42, wherein the step of positioning the distal end of the overtube includes the step of positioning the distal end of the endoscope adjacent to the substance to be removed.

46. The method according to claim 42, further comprising the step of retracting the endoscope proximal into the overtube before applying suction through the port.

47. The method according to claim 42, wherein the substance includes feces, blood, and food fragments.

48. The method according to claim 42, further comprising the step of moving the endoscope axially within the lumen of the overtube without breaking the seal, while positioning the overtube.

49. The method according to claim 42, wherein the step of applying suction from the port through the lumen of the overtube in the proximal end region of the overtube includes the step of maintaining suction when the user operates the control device and stopping the application of suction when the user stops operating the control device.

50. The method according to claim 42, wherein the step of applying suction from the port through the lumen of the overtube at the proximal end region of the overtube when the user activates the control device includes the step of applying suction when the user activates the trumpet valve.

51. The method according to claim 42, further comprising the step of operating the distal end region of the endoscope independently of the overtube.

52. The method according to claim 42, further comprising the step of stiffening the overtube before applying suction.

53. The method according to claim 42, wherein the step of advancing the overtube and the endoscope includes the step of rigidifying the overtube and derigidifying the overtube while operating the endoscope to advance the endoscope distally from the overtube, thereby advancing the overtube distally over the endoscope.

54. A method of removing substances from inside the body, The steps include inserting the endoscope into the lumen of the overtube through the proximal end port of the overtube so that the proximal end of the overtube is movably sealed around the endoscope, The steps include positioning the distal end of the endoscope adjacent to the substance to be removed, The steps include positioning the distal end of the overtube adjacent to the distal end of the endoscope, so that the endoscope images distally from the distal end region of the overtube, and positioning the distal end of the endoscope inside the distal end region of the overtube. A method comprising the step of applying suction from a port through the lumen of the overtube in the proximal end region of the overtube in order to draw the substance into the overtube and around the endoscope.

55. Steps to position the endoscope within the body area, The steps include extending a irrigation tube distally from the lumen of the endoscope, The steps include delivering a radial spray of the perfusion fluid through the perfusion tube, A method comprising the step of drawing the perfusion tube proximal to deliver a longitudinal flow of perfusion fluid.

56. A step of positioning an endoscope and an overtube concentrically surrounding the endoscope within the region of the digestive (GI) tract, wherein the endoscope is located inside the suction lumen of the rigid overtube, The steps include extending the perfusion tube distally from the lumen of the endoscope and distally from the overtube while the overtube is held in a rigid configuration, The steps include delivering a radial spray of the perfusion fluid through the perfusion tube, The steps include: drawing the perfusion tube proximal to deliver a longitudinal flow of perfusion fluid, A method comprising the step of applying suction through the suction lumen of the overtube to remove the perfusion fluid.

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