KR20260018048A - Large diameter suction overtube - Google Patents

Abstract

A large-bore suction overtube device comprising an internal lumen configured to accommodate an endoscope and apply suction around the endoscope to remove material from within 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

Large diameter suction overtube

Claim of priority

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

Devices that capture and retrieve clots and debris from the GI tract or other body areas may include aspiration catheters and can be used for a variety of procedures that require less invasive approaches to reach remote locations within a patient's body. These procedures may involve entry into the patient's gastrointestinal tract, vascular system, abdominal cavity, lungs, female reproductive tract, or urinary tract.

In some cases, it is advantageous to use a scope (hereinafter generally referred to as an "endoscope") to assist in the removal of material, including clots. The endoscope may include one or more working channels and/or aspiration channels and may be used to visualize the clots. In some cases, the endoscope may include mechanical means to assist in the removal and/or destruction (e.g., crushing) of clots. Furthermore, instruments may be utilized through the working channel(s). However, the effectiveness of the endoscope may be limited, in part, by the dimensions of the aspiration channel and the size and structure of the material (i.e., the clot may be too large and hard for the working channel diameter). Another example of a problem with current techniques involves the time required, or even the ability, to access the site of the occlusion due to the endoscope looping within the anatomic structure. There is a need for devices and methods that allow rapid access and optimized aspiration of material (e.g., clots, stool, food, etc.) from within the body. The devices and methods described herein can completely solve these problems.

Methods and devices (e.g., devices, accessories, systems, etc., including a suction overtube) for removing material (e.g., stool, blood, clots, debris, cleaning fluid, etc.) from within the body are described herein. These removal devices may include a suction overtube configured for effective and intuitive use with one or more scopes (e.g., endoscopes). These methods and devices, which may be referred to as a suction overtube, may generally include an elongated body that is highly flexible but reinforced (to withstand the range of applied suction), and a proximal end configured to receive an endoscope within a lumen of the overtube while allowing the endoscope to move longitudinally (proximally/distally) within the lumen while maintaining a sufficient seal to allow suction to be applied at the proximal end to provide suction at the distal end of the overtube. The overtubes described herein may be configured to have the same stiffness or different relative stiffnesses. In some examples, the device may be configured to have varying degrees of stiffness along the length of the overtube. For example, the distal end region may be progressively more flexible than the proximal end region.

For example, a suction overtube device may include: an elongated body having an interior lumen extending from a distal end to a proximal end; a proximal end region including an endoscope receiving port configured to receive an endoscope therethrough into the interior lumen, the endoscope receiving port being in series with the interior lumen of the elongated body; a vacuum port located in the proximal end region and in fluid communication with the interior lumen; and a control configured to control flow into the vacuum port and to apply suction through the vacuum port when the control is operated and maintained by a user.

In some examples, the suction overtube device may include: an elongated body having an interior lumen extending from a distal end to a proximal end, the elongated body having sufficient hoop strength to withstand a negative pressure within the interior lumen (e.g., a pressure of at least about 760 mmHg, a pressure of at least about 700 mmHg, a pressure of at least about 600 mmHg, a pressure of at least about 500 mmHg, a pressure of at least about 380 mmHg, a pressure of at least about 300 mmHg, etc.); a proximal end region including an endoscope receiving port configured to receive an endoscope therethrough within the interior lumen and including one or more seals configured to seal around the endoscope, the endoscope receiving port being in series with the interior lumen of the elongated body; a vacuum port in the proximal end region and in fluid communication with the interior lumen; and a control coupled to the vacuum port and configured to apply suction through the vacuum port when the control is actuated and maintained by a user. In general, the overtube can be configured to withstand various levels of vacuum, including various levels of partial vacuum (e.g., 1 atmosphere of full pressure of 760 mmHg).

As mentioned, the overtube device may generally include a seal configured to seal around the endoscope, which seal may be proximal to the vacuum port. For example, the proximal end region may include one or more sealing gaskets configured to seal around the endoscope. The seal may be configured to allow the endoscope to move proximally and distally (e.g., slide) relative to the lumen of the overtube device. In some instances, the seal may be adjustable, e.g., to allow the scope to move more easily proximally and distally, and may be activated or tightened, e.g., prior to and/or during the application of suction through the lumen of the overtube. The seal may be an annular seal, such as, but not limited to, an O-ring, or a flat, thin elastomeric seal. Any of these seals may be lubricated or coated to reduce sliding drag.

In any of these devices, the endoscope receiving port and the vacuum port may be part of an adapter configured to couple to the proximal end of the elongated body. For example, the adapter may be configured to couple to the proximal end of the overtube device (via a friction fit, threaded connection, Luer lock, etc.) and may include a port for applying suction through the overtube lumen (optionally, in some examples, the port may be located on the side of the proximal end region of the overtube or the adapter) and a proximal end port for receiving the endoscope. The control unit may be associated with the vacuum port and may be part of the adapter. The adapter may be removably attachable. The adapter may include a seal configured to seal around the endoscope.

Alternatively, the device may not include a detachable adapter and may be integrated, such that the endoscope receiving port and/or vacuum port are integrated with the elongated body of the overtube (e.g., at the proximal end of the overtube).

In general, these devices can be configured to withstand (i.e., without leaking or experiencing structural collapse) a target negative pressure range. For example, the device can be configured to withstand a negative pressure of up to 760 mmHg (e.g., up to 700 mmHg, up to 600 mmHg, up to 500 mmHg, etc.). For example, the elongated body can have sufficient hoop strength within its internal lumen to withstand at least the target pressure range (e.g., up to about 760 mmHg, up to 700 mmHg, up to 600 mmHg, up to 500 mmHg, etc.; the device can be configured to withstand about 0.2 atm, 0.4 atm, 0.6 atm, 0.8 atm, or even more than 1 atm).

In any of these examples, the elongated body may be reinforced. One or more layers of the elongated body forming the lumen may be a reinforcement layer, including but not limited to a braided tube or a coiled reinforcement layer/tube. For example, the elongated flexible tube may comprise a coiled-reinforced tube. The coil may be, for example, a helical coil formed of a material exhibiting high compressive and/or tensile strength. This may be a wire, a polymer, a composite fiber, a yarn made of natural or artificial materials (including, for example, those reinforced with a cured resin material such as an epoxy), a metal, a metal alloy, a composite material, a mineral, a polymer material, a natural fiber, or the like. In some cases, this may be a fiber, including, for example, aramid (Kevlar, Twaron, Technora), Vectran, UHMWPE (Dyneema or Spectra), Xylon, nylon, polyester, or carbon fiber. In some cases, this may be formed of a composite of multiple materials. In some cases, it may be formed of a metal, including, for example, nitinol, steel or plated steel, a stainless steel alloy, a magnesium alloy, tantalum, a cobalt-chromium alloy, etc. The coil may be wound in a single direction or in more than one direction (e.g., clockwise and/or counterclockwise). Thus, the elongated body may include an internal coil winding tube.

As mentioned, the device may include one or more controls that can be coupled to the vacuum port to control the application of suction. For example, the controls may be buttons, sliders, knobs, valves, dials, lever arms, switches, triggers, and the like. In some examples, the controls may be biased valves. Typically, the controls may be biased to maintain the vacuum port in a closed position, such that suction will not be applied unless the controls are maintained in an activated state (e.g., by maintaining force against the bias). In some cases, the valve may be directly actuated, while in other cases it may be actuated electronically or remotely, and in turn actuated by an actuator (e.g., a motor, a rotary actuator, a linear actuator, a solenoid, etc.).

The control unit may be configured such that activation of the control unit causes a seal (or increases the seal) around the endoscope. For example, the control unit may be coupled to a vacuum port, and may include or incorporate a valve, such as, but not limited to, a trumpet valve. The control unit may be directly coupled to the vacuum port, or may be coupled by a vacuum (e.g., suction) line coupled to the vacuum port. In some examples, the control unit includes a lever or pedal (e.g., a foot pedal, a hand lever, a finger lever, etc.).

In general, 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 inside diameter of a more proximal region of the lumen of the overtube. For example, the diameter of the opening may be about 97% to about 50% (e.g., less than 90%, less than 85%, less than 80%, less than 75%, less than 70%, less than 65%, less than 60%) of the inside diameter of the lumen of the overtube. Thus, the distal end opening of the overtube may be compressed.

The distal end opening of the overtube can have an inner diameter that is approximately equal to or greater than the outer diameter of the distal end of the endoscope. For example, the distal end opening of the overtube can have an opening diameter that is approximately 5% greater than the outer diameter of the endoscope (e.g., 7.5%, 10%, 12.5%, 15%, 17.5%, 20%, 25%, 30%, 50%, 75%, 100%, 1.5x, 2x, 2.5x, 3x, 5x, etc., of the outer diameter of the endoscope). Any of these devices can include an endoscope (e.g., as part of a system).

In general, any of these devices can have an internal lumen having a cross-sectional area greater than about 10 mm ² (e.g., greater than about 12 mm ² , 15 mm ² , 20 mm ² , 25 mm ² , 30 mm ² , 50 mm ² , 70 mm ^{2 ,} etc.).

The distal end (e.g., tip) of the overtube, including the distal tapered region surrounding the distal opening into the lumen, may be transparent and/or translucent. For example, the distal end of the overtube may be configured to allow visualization of an area of the body outside of the distal end region (in some cases by a camera of the endoscope when the endoscope is retracted into the lumen). In any of these devices, the distal end region of the overtube (including or proximal to the tip) may include one or more vent holes to prevent complete aspiration, which may, for example, help prevent aspiration into a body wall. The device may include one or more holes or openings (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, etc.) into the interior lumen of the device. The vent relief holes may be smaller (individually and/or collectively) than the distal end opening of the device. The suction relief hole may be located proximal to the distal end opening.

In any of the devices described herein, the overtube and/or the 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; in some instances, the overtube is configured such that only a region (e.g., a proximal region) is rigid. In some instances, a distal end portion (e.g., the most distal ~4.5 inches, 5 inches, 6 inches, 7 inches, etc.) may be configured not to be rigid, but may remain flexible. This may allow the device to be more easily steered over a steerable endoscope. In some instances, the elongated body includes a rigidifying layer comprising multiple intersecting strand lengths, and a compression layer configured to apply a force to the rigidifying layer to rigidize the rigidifying outer sheath from a flexible configuration to a rigid configuration. Examples of rigidifying devices that may be included as part of the overtube and/or endoscope described herein include, but are not limited to, those described in U.S. Pat. No. 11,135,398 entitled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES," U.S. Patent Application No. 17/604,203 also entitled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES," PCT/US2021/024582 entitled "LAYERED WALLS FOR RIGIDIZING DEVICES," PCT/US2021/034292 entitled "RIGIDIZING DEVICES," PCT/US2022/014497 (Entitled "DEVICES AND METHODS TO PREVENT INADVERTENT MOTION OF DYNAMICALLY RIGIDIZING DEVICES"), PCT/US2022/019711 (Entitled "CONTROL OF ROBOTIC DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES"), U.S. Provisional Patent Application No. 63/265,934 (Entitled "METHODS AND APPARATUSES FOR REDUCING CURVATURE OF A COLON"), U.S. Provisional Patent Application No. 63/296,478 (Entitled "RECONFIGURABLE STRUCTURES"), U.S. Provisional Patent Application No. No. 63/308,044, entitled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES," U.S. Provisional Patent Application No. 63/324,011, entitled "METHODS AND APPARATUSES FOR NAVIGATING USING A PAIR OF RIGIDIZING DEVICES," U.S. Provisional Patent Application No. 63/342,618, entitled "EXTERNAL WORKING CHANNELS FOR ENDOSCOPIC DEVICES," U.S. Provisional Patent Application No. 63/335,720, entitled "HYGIENIC DRAPING FOR ROBOTIC ENDOSCOPY," and U.S. Provisional Patent Application No. 63/332,686, entitled " The name "MANAGING AND MANIPULATING A LONG LENGTH ROBOTIC ENDOSCOPE" may be found in the appended claims, each of which is incorporated herein by reference in its entirety.

Any of these devices may include a source of negative pressure (e.g., a vacuum), such as a pump. The device may include control circuitry (e.g., a controller comprising 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., centrally applied suction). The device described herein may include a suction trap (e.g., comprising one or more filters for capturing liquid and/or solids, for filtering and removing solids from liquid being drawn in by the overtube). The device may include piping.

Any of these devices may be configured to apply positive pressure. For example, any of these devices may be configured to apply positive pressure to unclog the lumen of the overtube in some instances. The control circuit may be configured to control the application of positive pressure (e.g., for unclogging) in addition to negative pressure.

Any of these devices may be configured or adapted to couple 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 a connection and control for coupling to a vacuum port of the overtube and an endoscopic suction tube.

Methods of removing a substance from within a body using any of the devices described herein are also described herein. For example, the methods of removing a substance from within a body may include: advancing an overtube and an endoscope distally within the body, wherein the endoscope is inserted into a lumen of the overtube through a proximal end port of the overtube such that the proximal end of the overtube is movably sealed around the endoscope; positioning the distal end of the overtube adjacent the substance to be removed; and applying suction through the lumen of the overtube from a port in the proximal end region of the overtube (e.g., optionally on the distal end of the overtube or on the side of an adapter on the overtube) while imaging out of the distal end of the overtube from the endoscope as a user activates a control to draw the substance into the overtube and around the endoscope.

For example, a method of removing a substance from within a body may include: inserting an endoscope into a lumen of the overtube through a proximal end port of the overtube such that the proximal end of the overtube is movably sealed around the endoscope; positioning a distal end of the endoscope adjacent to the substance to be removed; positioning a distal end of the overtube adjacent to a distal end of the distal end of the endoscope; retracting the endoscope proximally into the overtube; and applying suction through the lumen of the overtube from a port at the proximal end of the overtube while the user activates a control to draw the substance into the overtube and around the endoscope. The suction may be applied within the overtube, within the working channel, separately, or both.

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

In some examples, the methods described herein may utilize an endoscope in an initial position proximal to (e.g., adjacent to) the material to be removed. The endoscope may utilize imaging integrated with or associated with the endoscope to identify the material to be removed within the body; in some examples, the endoscope may be extended distally from outside the distal end opening of the overtube. The device may be advanced with the endoscope extending distally outside the overtube, or the endoscope may be advanced distally separately and the overtube advanced separately once the endoscope is positioned. Any combination of these movements: advancing the endoscope distally while the overtube remains more proximally; Advancing both the endoscope and the overtube distally together (or retracting both proximally), holding the endoscope relatively stationary (with respect to the patient's body), and advancing (or retracting) the overtube relative to the endoscope can be performed.

Generally, the step of positioning the distal end of the overtube may include positioning the distal end of the endoscope adjacent to the material to be removed. Positioning the endoscope adjacently may mean positioning the endoscope sufficiently close (e.g., within about 5 cm, about 4 cm, about 3 cm, about 2 cm, about 1 cm, etc.) to the material to be removed such that it can be aspirated into the overtube when suction is applied.

Any of these methods may include a step of retracting the endoscope proximally into the overtube prior to applying suction through the port. For example, the endoscope may be retracted proximally so as not to block the opening into the overtube lumen; further, this may advantageously allow visualization of the material as it is retracted into the lumen of the overtube using a camera of the endoscope. For example, the endoscope may be retracted into the lumen of the overtube such that the tip of the endoscope is retracted 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 clumped material. Other material (e.g., debris, etc.) may also be removed.

Thus, in any of these examples, material (e.g., clots or other material) may be drawn into the lumen of the overtube by suction and may pass around the endoscope, where it remains within the lumen of the overtube.

Additionally, any of these devices and methods of using them may be configured to apply suction on the endoscope to draw a substance (e.g., a clot) into the overtube, after which the user may release suction on the endoscope (either before or after initiating suction through the inner lumen of the overtube) to allow the clot to be adsorbed by the pathfinder.

In some examples, the device may be configured to maintain a seal around the endoscope as the endoscope moves proximally or distally within the overtube. For example, the method may include moving the endoscope axially within the lumen of the overtube without rupturing the seal while positioning the overtube.

As mentioned, the methods described herein may include applying suction through a lumen of the overtube from a port in a proximal end region of the overtube. Typically, suction may be applied through the overtube while a user manipulates the control, e.g., by the user continuously pressing or operating the control, and then discontinuing application of suction (e.g., maintaining suction) when the user stops operating the control. In some examples, the control may include a trumpet valve, and thus, the step of applying suction through the lumen of the overtube from a port in a proximal end region of the overtube while a user activates the control may include applying suction while the user activates the trumpet valve.

The overtube and/or endoscope may be steerable, for example, by mechanical steering (e.g., one or more pull wires, guns, etc.), pneumatic steering, electrical steering, etc. In general, any of these methods may include a step of steering the distal end region of the endoscope independently of the overtube.

Any of these methods may include the step of stiffening one or both of the overtube and the endoscope. For example, any of these methods may include the step of stiffening the overtube. In some examples, the step of advancing the overtube and the endoscope may include the steps of stiffening the overtube while advancing and steering the endoscope distally from the overtube, de-stiffening the overtube, and advancing the overtube distally over the endoscope.

Any of the devices described herein may include or be part of a robotic system. For example, an overtube and/or an endoscope (including an endoscope inserted or insertable through the overtube and/or the overtube, such as a steerable and/or rigid endoscope) may be controlled by the robotic system.

For example, a method of removing a substance from a patient's body is described herein, the method comprising: positioning a distal end of a rigid overtube adjacent the substance with an endoscope extending distally from a distal end thereof, the rigid overtube concentrically surrounding the length of the endoscope such that the overtube and the endoscope form an annular lumen; retracting the distal end of the endoscope proximally into a region of the distal end of the rigid overtube; and applying suction through the annular lumen to aspirate the substance into and around the endoscope.

For example, a method of removing a substance from a patient's body is described herein, comprising: positioning a distal end of an endoscope adjacent to the substance; positioning a distal end of an overtube extending over the endoscope adjacent to a distal end of the distal end of the endoscope with the overtube in a flexible configuration such that the overtube transitions from an extended configuration in which the endoscope extends distally relative to the overtube to a contracted configuration in which the distal end of the endoscope is recessed within a distal end region of the overtube such that the overtube concentrically surrounds the endoscope to form an annular lumen; transitioning the overtube from the flexible configuration to a more rigid configuration; and applying suction through the annular lumen to aspirate the substance into and around the endoscope.

A method of removing a substance from a patient's body may include: positioning a distal end of an endoscope adjacent the substance; advancing the distal end of the overtube distally over the endoscope while the overtube is in a flexible configuration such that the distal end of the overtube is adjacent the substance, positioning the distal end of the endoscope within a region of the distal end of the overtube such that the overtube concentrically surrounds the endoscope to form an annular lumen, thereby allowing visualization of the exterior of the distal end of the overtube by the endoscope; converting the overtube from a flexible configuration to a more rigid configuration; and applying suction through the annular lumen to aspirate the substance into the annular lumen and around the endoscope.

Any of these methods may include a step of converting the rigid endoscope from a more flexible configuration to a more rigid configuration before retracting the endoscope proximally into the distal end region of the rigid overtube when positioning the distal end adjacent to the material. The use of a rigid overtube may provide numerous advantages, including increased stability for the overtube, which may improve both visualization and efficiency of material removal. For example, material may be removed by applying fluid through the endoscope for both general and focused removal of the material. In a more rigid/less flexible configuration (generally referred to herein as a rigid configuration), the applied spray may remain steady, allowing for focused application of the cleaning fluid even at lower fluid pressures, which may result in more effective removal/cleaning of the material.

In general, these methods may allow visualization from the endoscope while suction is applied to remove the material. Visualization may be performed by one or more optical subsystems/systems within the endoscope and/or the overtube. In some instances, the endoscope may be used to visualize the distal end region of the overtube and the body cavity (viewed through the overtube) as suction is applied and/or as fluid (e.g., a irrigating fluid) is applied.

The method and device described herein can apply suction through an annular lumen formed between an overtube and an inserted endoscope. When applying suction, in some cases the endoscope can be retracted proximally such that the distal end of the endoscope (and thus the camera, working channel, etc.) remains recessed within a region of the distal end of the overtube of the overtube 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, etc., more preferably within 3 mm to 4 cm distal). This position can be set manually (e.g., by a user moving the overtube relative to the endoscope and/or the endoscope relative to the overtube), or can be set automatically, for example, by including one or more engagers (e.g., detents, locking devices, etc.) between the overtube and the endoscope. For example, in the proximal end region, the proximal seal between the endoscope and the overtube can maintain the gap because the seal can provide a certain resistance between the endoscope and the overtube.

In general, the annular lumen around the endoscope and within the overtube is surprisingly effective in removing material, including stool, clots, and the like, that may otherwise clog more traditional aspiration lumens, including the suction lumen of the endoscope, because it can help shear and break up the material. Furthermore, the recessed end of the endoscope within the suction lumen (particularly the inwardly tapering distal end opening of the overtube) can also assist in breaking up and removing material and preventing clogging. The recessed position of the distal end of the endoscope allows for visualization (e.g., continuous visualization), helps shape the suction flow, modulates the suction flow rate, and helps break up material drawn into the overtube. In some cases, the recessed position of the endoscope (e.g., 3 mm to 4 cm) can create turbulence within the suction opening into the overtube, which can further assist in removing material and preventing clogging. For example, any of these methods may be configured to include the step of unblocking the annular lumen by repeatedly moving the endoscope distally and proximally within the overtube while applying suction through the annular lumen.

Perfusion can be applied through one or both of the overtube, the endoscope, and/or a perfusion device extending through the endoscope and/or the overtube. For example, a perfusion fluid can be applied. The perfusion can be applied before or after applying suction, for example, through an annular lumen. The perfusion can be applied distally relative to the distal end of the overtube. For example, any of these methods can include applying the perfusion by applying a spray of fluid from a fluid line of the overtube. In some cases, the step of applying the perfusion includes extending a perfusion device tube distally outward from the distal end of the endoscope and applying the perfusion from the perfusion device into the body. The perfusion device can include a radial perfusion device. In some cases, the perfusion device can include a distal perfusion device. Alternatively, in some cases, the step of applying the perfusion includes switching between radial and distal perfusion applications by extending or retracting a radial perfusion tube relative to the distal end of the endoscope. Alternatively or additionally, in some cases, the step of applying the irrigation comprises applying the irrigation through a fluid line integrated within the endoscope.

Any of these methods and devices can include the step of moving the endoscope axially within the overtube while applying suction. Moving the endoscope axially (e.g., distally and proximally) while applying suction can include moving the endoscope axially by +/- about 1 mm to about 3 cm or more, for example, about 1 mm to about 3 cm, about 1 mm to 2.5 cm, about 1 mm to 2 cm, about 1 mm to 1.5 cm, about 1 mm to 1 cm, about 1 mm to 7 mm, about 1 mm to 5 mm, etc. The endoscope can be moved back and forth in a linear oscillation, for example, at about 1 Hz to 50 Hz (e.g., about 1 Hz to 40 Hz, about 1 Hz to 30 Hz, about 1 Hz to 20 Hz, about 1 Hz to 10 Hz, etc.). Moving the endoscope within the lumen of the overtube while applying suction can help prevent or remove blockages. This 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., rigidized). This can provide stability, allowing for more precise movement while protecting the body from injury.

In general, the methods and devices described herein allow rotational movement of an endoscope within the lumen of an overtube. In some cases, rotation of the endoscope within the overtube (particularly when the overtube is of a rigid construction) may improve maneuverability of the endoscope while minimizing injury to the patient. In general, these methods may involve preventing or eliminating clots by rotating the endoscope within the overtube lumen (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, for example, using mechanical assist devices.

Any of these methods may include a step of moving the endoscope axially (e.g., distally/proximally) within the overtube while positioning the overtube. For example, when positioning the overtube and/or the distal end of the endoscope, the endoscope, the overtube, or both may be moved relative to each other. The endoscope may be steered independently of the overtube. For example, the method may include a step of steer- ing the distal end region of the endoscope independently of the overtube.

In some cases, positioning the overtube may include advancing and steering the endoscope distally from the overtube, rigidifying the overtube, de-rigidifying the overtube, and advancing the overtube distally over the endoscope.

Any of these methods may include sealing the proximal end of the overtube around the endoscope using a seal (e.g., a movably sealed seal) that allows the endoscope to be advanced/retracted distally through the overtube lumen while maintaining suction/vacuum within the overtube lumen.

The method and device described herein can be configured such that the cross-sectional area of the annular lumen (suction ring) can be from about 40 mm ² to 400 mm ² (e.g., from about 40 mm ² to 300 mm ² , from about 40 mm ² to 200 mm ² , from about 40 mm ² to 150 mm ² , etc., from about 40 mm ² to 100 mm ^{2 ,} etc.).

Any of these methods may include positioning an overtube within the gastrointestinal tract of a patient, including the upper GI tract (e.g., mouth, esophagus, stomach, pylorus, biliary tract, and pancreatic duct), the small intestine (e.g., small intestine, duodenum, jejunum, ilium, etc.), and/or the lower GI tract (rectum, areas of the colon, e.g., sigmoid colon, descending, transverse, ascending, cecum, ileocecal valve, etc.). These methods and devices may be configured to remove materials such as, but not limited to: stool, blood, irrigation fluid, food debris, etc.

The methods and devices described herein may also be configured to assist in disengaging a device (e.g., an overtube) from a body wall to which it may be engaged during operation of the device. For example, when applying suction through an annular lumen, the overtube may adhere to a body wall. It may be particularly advantageous to rapidly reduce or eliminate suction by releasing negative pressure (suction) within the annular lumen. For example, any of these methods may include disengaging the overtube from the body wall by opening an air relief valve in fluid communication with the annular lumen while applying suction through the annular lumen. The air relief valve may be coupled to the inner lumen of the overtube distal to the suction port and may operate in conjunction with the application of suction to titrate or release the suction.

Apparatus (e.g., systems, devices, etc.) for performing any of these methods are also described herein. For example, a suction overtube device is described herein, which may include an elongated body having an interior lumen extending from a distal end to a proximal end, the elongated body configured to transition between a flexible configuration and a more rigid configuration by application or release of pressure within a wall of the elongated body; a rigidifier port (e.g., a pressure port) configured to receive positive and/or negative pressure to transition the elongated body from the flexible to the rigid configuration; a proximal end region comprising an endoscope receiving port configured to receive an endoscope therethrough into the interior lumen, the endoscope receiving port being in series with the interior lumen of the elongated body; and a vacuum port in the proximal end region and in fluid communication with the interior lumen.

For example, a suction overtube device is described herein, comprising: an elongated body having an interior lumen extending from a distal end to a proximal end, the elongated body comprising a plurality of layers and configured to transition from a flexible configuration to a more rigid configuration upon application of pressure to the plurality of layers; a proximal end region comprising an endoscope receiving port configured to receive an endoscope therethrough within the interior lumen, the endoscope receiving port being in series with the interior lumen of the elongated body; and a rigidifier port (e.g., a pressure port) configured to receive positive and/or negative pressure to rigidify the elongated body; a vacuum port in the proximal end region and in fluid communication with the interior lumen; and a control coupled to the vacuum port, the control being configured to apply suction from the vacuum port through the interior lumen when the control is actuated by a user.

A suction overtube device may include: an elongated body having an interior lumen extending from a distal end to a proximal end, the elongated body comprising a plurality of layers, the elongated body having sufficient hoop strength to withstand a vacuum of at least 760 mmHg, and further configured to transition from a flexible configuration to a more rigid configuration upon application of positive and/or negative pressure to the plurality of layers; a proximal end region comprising an endoscope receiving port configured to receive an endoscope therethrough within the interior lumen and one or more seals configured to seal around the endoscope, the endoscope receiving port being in series with the interior lumen of the elongated body; and a rigidifier port (e.g., a pressure port) configured to receive positive and/or negative pressure to rigidify the elongated body; and a vacuum port in the proximal end region and in fluid communication with the interior lumen.

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

In general, the overtube may be stiffened. For example, the elongated body of the overtube may include a stiffening layer comprising a plurality of intersecting strand lengths, and a compression layer configured to compress the stiffening layer into a more rigid configuration. Other structures for stiffening may be used.

Typically, these devices may include a seal 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.

Any suitable size overtube may be used. For example, the inner lumen of the overtube may have a cross-sectional area greater than 10 mm ² . In some cases, the overtube may be 8 French to 32 French (or more) (e.g., 10 French to 24 French, etc.).

The device described herein, including the overtube, may be integral or modular. For example, in some cases, any of the endoscope receiving ports and the vacuum port may be part of an adapter configured to couple to the proximal end of the elongated body of the overtube. Alternatively, the endoscope receiving port and the vacuum port (including the seal(s)) may be integral to the overtube.

In general, these devices can be configured to withstand inward pressure (negative pressure) within the lumen of the overtube without collapsing the overtube or otherwise interfering with the function (including, in some instances, stiffening) of the overtube. The elongated body can have sufficient hoop strength to withstand a negative pressure of at least 700 mmHg (e.g., 750 mmHg, 760 mmHg, 800 mmHg, 900 mmHg, 100 mmHg, etc.) within the internal lumen. In some cases, the elongated body further comprises an inner coil wound tube. In some cases, the elongated body comprises a braided tube.

Any of these devices may include other components of the system that can be coupled together, including tubing, a suction pump (vacuum), etc. In some cases, the device includes an endoscope. Any of these devices may include a control for regulating the application of suction through the overtube. For example, the control may include a biased valve. The control may be part of a handle (e.g., a handheld control), a pedal (e.g., a foot pedal), etc. The control may be in series with the vacuum port. In some cases, the control is coupled to the vacuum port and/or a fluid line (e.g., tubing) coupled to the vacuum port. For example, any of these devices may include a control including suction tubing configured to connect the vacuum port to a negative pressure source, and a valve configured to control the application of suction through the inner lumen. The control may include a trumpet valve.

The distal end opening of the overtube may have an inside diameter smaller than the inside diameter of the inner lumen.

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

Typically, these devices may include one or more external channels extending along the length of the elongated body. The external working channel may be expandable, such that a tool may be inserted through the working channel to expand the working channel.

A method of removing a substance from within a body, comprising the steps of advancing an overtube and an endoscope distally within the body, wherein the endoscope is inserted into a lumen of the overtube through a proximal end port of the overtube such that the proximal end of the overtube is movably sealed around the endoscope; positioning the distal end of the overtube adjacent the substance to be removed; and applying suction through the lumen of the overtube from a port in the proximal end region of the overtube while imaging out of the distal end of the overtube from the endoscope as a user activates a control to draw the substance into the overtube and around the endoscope.

Any of these methods may include applying a spray of fluid from an endoscope or from a fluid line within the lumen of the overtube. Any of these methods may include coupling an aspiration source to a port in the proximal end region of the overtube.

Positioning the distal end of the overtube may include positioning the distal end of the endoscope adjacent to the material to be removed. These methods may include retracting the endoscope proximally into the overtube prior to applying suction through the port. The material may include stool, blood, and food debris.

Any of these methods may include the step of moving the endoscope axially within the lumen of the overtube without rupturing the seal while positioning the overtube. For example, the method may include the step of applying suction through the lumen of the overtube from a port in the proximal end region of the overtube comprising the step of maintaining the suction while the user manipulates the control and discontinuing the application of the suction when the user ceases to manipulate the control. Any of these methods may include the step of applying suction through the lumen of the overtube from a port in the proximal end region of the overtube while the user activates the control and the step of applying the suction while the user activates the trumpet valve. Any of these methods may include the step of steering the distal end region of the endoscope independently of the overtube. As mentioned, these methods may optionally include the step of stiffening the overtube prior to applying the suction. For example, these methods may include the steps of advancing the overtube and the endoscope: rigidifying the overtube while advancing and steering the endoscope distally from the overtube, de-rigidifying the overtube, and advancing the overtube distally over the endoscope.

A method of removing a substance from within a body may include: inserting an endoscope into a lumen of the overtube through a proximal end port of the overtube such that the proximal end of the overtube is movably sealed around the endoscope; positioning a distal end of the endoscope adjacent to the substance to be removed; positioning the distal end of the overtube adjacent to a distal end of the distal end of the endoscope and positioning the distal end of the endoscope within the distal end region of the overtube such that the endoscope images distally out of the distal end region of the overtube; and applying suction through the lumen of the overtube from a port in the proximal end region of the overtube to draw the substance into the overtube and around the endoscope.

Methods of applying a fluid (e.g., a lavage) to a body cavity are also described herein. In particular, these methods may include applying a radial spray (e.g., radially around the circumference of a perfusion tube) and/or applying a longitudinal spray or stream (e.g., distally from a distal end of the perfusion tube). In some cases, the same perfusion tube may be configured to operate with an endoscope and/or an overtube to convert the applied spray between radial and longitudinal directions using only the perfusion tube configured to apply radial perfusion. For example, a method as described herein may include positioning an endoscope within a body region; extending the perfusion tube distally outside a lumen of the endoscope; delivering a radial spray of perfusion fluid from the perfusion tube; and retracting the perfusion tube proximally to deliver a longitudinal stream of perfusion fluid.

In some cases, the method may include: positioning an endoscope and an overtube concentrically surrounding the endoscope within a region of the gastrointestinal (GI) tract, the endoscope being within an aspiration lumen of the rigid overtube; extending a perfusion tube distally out of the endoscope lumen and distally out of the overtube while the overtube is maintained in a rigid configuration; delivering a radial spray of perfusion fluid from the perfusion tube; retracting the perfusion tube proximally to deliver a longitudinal stream of perfusion fluid; and applying suction through the aspiration lumen of the overtube to remove the perfusion fluid.

All methods and devices described herein are contemplated herein in any combination and may be used to achieve the advantages described herein.

A better understanding of the features and advantages of the methods and devices described herein will be obtained by reference to the following detailed description illustrating illustrative embodiments and the accompanying drawings, in which:
FIG. 1A illustrates an example of a distal end region of an example of a device described herein, including an overtube and an endoscope.
Figure 1b is an example of the device illustrated in Figure 1a, showing the proximal end and the connection to a source of negative pressure (e.g., suction).
Figures 1c and 1d illustrate other examples of a device (e.g., a system) as described herein. Figure 1d illustrates an enlarged view of a portion of Figure 1c.
FIG. 2 illustrates an example of an overtube optionally configured as a stiffening overtube as described herein.
Figure 3a is a cross-sectional view through an example of a rigidifiable overtube that can be rigidified by application of negative pressure.
FIG. 3b is an enlarged view illustrating an example of the arrangement of layers within the elongated rigid overtube of FIG. 3a.
Figure 4a is a cross-sectional view through an elongated rigidifiable device (e.g., an overtube) that can be rigidified by application of positive pressure.
FIG. 4b is an alternative cross-sectional view illustrating an example of the arrangement of layers within the elongated rigid overtube device of FIG. 4a.
FIG. 5A is an example of a proximal end of a device (e.g., a suction adapter) as described herein.
Figure 5b illustrates an external view of a suction adapter as described herein.
Figure 5c illustrates a cross-sectional view through the suction adapter of Figure 5b.
Figure 5d illustrates an end view of the suction adapter of Figures 5b and 5c.
Figures 6a through 6c illustrate an example of a valve (e.g., a trumpet valve) that may be included as part of a control unit for applying suction to a device as described herein. Figure 6a illustrates a perspective view of the valve. Figures 6b and 6c illustrate cross-sectional views of the valve of Figure 6a; Figure 6b illustrates the valve closed (in a resting, non-operating state), and Figure 6c illustrates the valve open (in an operating state).
Figures 7a and 7b illustrate examples of adapters configured as thread forming adapters. Figure 7a is a side view, and Figure 7b illustrates a cross-sectional view through the adapter of Figure 7a.
Figure 8a shows an exploded view of a portion (proximal end) of an adapter similar to that shown in Figures 7a and 7b.
Figure 9 is an example of an integral rigid overtube including a proximal endoscope seal and/or suction port.
FIGS. 10A to 10E illustrate an example of a method of operating a device as described herein.
Figures 11a to 11f illustrate an example of a method of using a device as described herein.
FIG. 12a schematically illustrates an example of a device as described herein, including perfusion through an endoscope.
FIG. 12b schematically illustrates an example of a device as described herein including perfusion through a separate perfusion line.
Figures 13a and 13b schematically illustrate another variation of the device as described herein; in this example, the vacuum outlet is integrated into the handle.
Figures 14a through 14c illustrate other examples of suction adapters for use with (or integrated with) an overtube as described herein. In Figures 14a through 14c, the adapters include swivel valves, which are shown in different orientations.
Figures 15a to 15c illustrate examples of a control unit (e.g., a lever valve) for controlling the application of suction as described herein. Figures 15a and 15b illustrate a first example of a lever valve in a side view and a side perspective view, respectively. Figure 15c illustrates another example of a lever valve in a cross-sectional view.
Figures 16a and 16b illustrate examples of a control unit (configured as a lever valve) for controlling the application of suction as described herein. Figure 16a illustrates a side view, and Figure 16b illustrates a cross-sectional view through the lever of Figure 16a.
Figures 17a to 17c illustrate an example of a control unit (configured as a foot pedal) for controlling the application of suction. Figure 17a illustrates a front view, Figure 17b illustrates a side perspective view, and Figure 17c illustrates a plan perspective view.
Figures 18a and 18b illustrate the flexural flexibility of different examples of overtubes. Figure 18a illustrates an overtube having low flexural flexibility, while Figure 18b illustrates an example of an overtube as described herein having high flexural flexibility and high hoop strength.
Figure 19 illustrates an example of the distal end region of an overtube device having multiple suction relief holes.
FIG. 20 illustrates an example of a robotic system including a device as described herein.
Figures 21a and 21b illustrate examples of releasing suction against the body wall using an air relief valve.
Figures 21c to 21d illustrate examples of applying fluid through the suction lumen of the overtube to remove a blockage.
Figures 22a to 22c illustrate examples of an overtube including a rinsing channel. Figure 22a illustrates an example of an overtube from which an endoscope extends, the overtube having a plurality of rinsing channels flush with the distal end of the overtube. Figures 22b and 22c illustrate side perspective and side views, respectively, of an overtube from which an endoscope extends, the overtube having a plurality of angled rinsing channels extending distally at a predetermined angle relative to the distal end of the overtube.
Figure 23a illustrates an example of a perfusion tube providing a radial spray.
Figure 23b illustrates an example of a perfusion tube providing a longitudinal spray (e.g., a stream).
Figures 24a and 24b schematically illustrate an example of a device comprising a perfusion tube configured to deliver a radial spray. Figure 24a schematically illustrates a cross-sectional view through the device showing the perfusion tube extending distally outside the lumen of an endoscope housed within an overtube. Figure 24b illustrates the perfusion tube extending distally outside the endoscope and outside the overtube to provide a radial spray into the body lumen.
Figures 24c and 24d illustrate the conversion of the applied spray from the radial perfusion tube of Figures 24a and 24b into a linear stream. In Figure 24c, the radial spray is converted into a distal linear spray by applying the spray from the perfusion tube within the distal end region of the overtube but outside the endoscope. In Figure 24d, the radial spray is converted into a distal linear spray by applying the spray from the perfusion tube within the lumen of the endoscope.
Figures 25a through 25j illustrate examples of different nozzle types that may be used at the distal end of the perfusion tube to achieve different spray/stream patterns.
Figures 26a through 26h illustrate examples of different nozzle types that may be used at the distal end of the perfusion tube to achieve different spray/stream patterns.
Figures 27a to 27c illustrate examples of devices (e.g., including an overtube) having one or more external working channels arranged along the outer length of the overtube.
FIG. 28a illustrates an example of a suction or aspiration tube that may be used with any of the devices described herein.

Methods for removing material from a patient's body, including methods for removing debris (e.g., stool), blood, clots, and the like, from a body cavity such as the gastrointestinal tract, are described herein. In some cases, these methods may be used to clear material from the colon or other body cavities. These methods may also be used as part of other procedures, such as, for example, as part of a colonoscopy, or to support imaging and/or surgical procedures to treat the colon.

These devices (e.g., devices, systems, etc.) may include an overtube, which may be configured to operate with an endoscope, and which may be referred to herein as a suction overtube. The overtube may have an elongated body having an interior lumen extending from a distal end to a proximal end. The overtube may be configured to receive and seal an endoscope within the interior lumen, and may have a proximal end region including an endoscope receiving port configured to receive the endoscope therethrough within the interior lumen. The endoscope receiving port may be in series with the interior lumen of the elongated body and configured to seal around the endoscope to allow distal/proximal movement of the endoscope relative to the overtube without substantial loss of suction within the interior lumen. Generally, the overtube may also include a vacuum port, in a proximal end region distal to the seal for the endoscope at the overtube distal end region, in fluid communication with the interior lumen, through which a negative pressure may be applied. The overtube may be configured to withstand the application of negative pressure within the inner lumen while still allowing movement of the endoscope within the inner lumen.

In any of these devices, the elongate body may be rigidified (e.g., a rigidifying overtube). Thus, the overtube may be configured to transition between a flexible configuration and a more rigid configuration by application or release of pressure within the walls of the elongate body. The pressure applied to transition between the rigid configuration and the less rigid configuration (e.g., to become more rigid upon application of pressure) may be positive pressure or, in some cases, negative pressure. Thus, the rigidifying overtube may include a rigidifying port (e.g., a pressure port) configured to receive positive and/or negative pressure to transition the elongate body from a flexible to a rigid configuration. The rigidifying port may be in the proximal end region.

In some cases, the overtube may be integrated with the vacuum port and the endoscope receiving port. Alternatively, in some instances, the overtube may be detachable from and joined to an adapter that includes the vacuum port and the endoscope receiving port.

Accordingly, in some instances, the methods and devices described herein comprise an overtube having an interior lumen configured to receive an endoscope and to receive suction for removing material from within the body without requiring removal of the endoscope. Generally, the overtube device can comprise an elongated body having an interior lumen extending from a distal end of the overtube to a proximal end. The device can also include a proximal end region configured to receive an endoscope such that the endoscope can be moved, for example, distally and proximally, within the interior lumen of the endoscope. A receiving port can be at the proximal end and can be arranged such that the endoscope can be inserted into the receiving port and through the receiving port into the interior lumen. These devices can also include a vacuum port at the proximal end region in fluid communication with the interior lumen. In general, the device may be configured such that a user (e.g., a physician, surgeon, nurse, technician, etc.) can activate and maintain suction through the internal lumen, and can stop suctioning (e.g., when the control is no longer activated by the user).

The devices described herein may be used to: neurovascular (e.g., aortic arch, subclavian, carotid, vertebral, basilar, hindbrain, loop of Willis, midbrain, forebrain, etc.), upper GI tract (e.g., oral esophagus, stomach, pylorus, biliary and pancreatic ducts, etc.), small intestine (e.g., small intestine, duodenum, jejunum, ilium, etc.), lower GI tract (rectum, colon region, e.g., sigmoid, descending, transverse, ascending, cecum, ileocecal valve, etc.), urinary tract (urethra, bladder, kidney, ureter, etc.), peripheral vasculature (e.g., femoral, iliac, mesenteric, lumbar, renal, celiac, liver, thoracic, 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, (e.g., right ventricle, pulmonary valve, pulmonary blood vessels, etc.) and/or one or more of the right lung regions (e.g., mouth, larynx, trachea, bronchial tree, and lobes, etc.).

The devices described herein may be configured as an integral overtube including a proximal end region configured to receive an endoscope and/or a suction port (e.g., a vacuum port) for applying suction through the inner lumen of the overtube, or they may be configured to convert an existing overtube (see, e.g., U.S. Pat. No. 11,135,398, entitled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES," which is incorporated herein by reference in its entirety). For example, described herein is an adapter configured to couple to the distal end of an existing overtube to convert it to allow motion of the overtube as described herein. In some cases, the overtube may optionally be a rigidized overtube; however, these methods and devices may be non-rigidized overtubes.

FIG. 1A illustrates an example of a distal end region of a flexible overtube (106) having a distal end region (110) to which suction can be applied. In this example, the overtube is a rigid overtube. An endoscope (108) is shown extending distally from the overtube. FIG. 1B illustrates an example of a system including an overtube (106) that 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 that includes an endoscope receiving port (114) configured to receive the endoscope (108) therethrough within an inner lumen. The endoscope receiving port is in series with the inner lumen of the elongated body. The suction adapter portion of the device also includes a vacuum port (116) that is shown in fluid communication with the inner lumen and connected to a vacuum source (102). Typically, the vacuum port may be connected to a control (not shown in FIG. 1B) for controlling suction through the overtube. In some instances, the control may include a valve or clamp that may be closed at rest, but can be held open by a user-activated action (e.g., a push, squeeze, grip, push, etc.) to maintain the valve in an open state (fully open or selectively partially open). The valve may be manually operated or may be electronically operated.

In the examples illustrated in FIGS. 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 illustrated as a gastroscope (having a tip diameter of approximately 9 mm). Any suitable sized overtube and endoscope may be used. The device may also include a control unit coupled to the vacuum port and configured to apply suction through the vacuum port when the control unit is operated and maintained by a user (not illustrated in FIGS. 1A and 1B).

FIGS. 1C and 1D illustrate another example of a device (e.g., a system) that includes an overtube (106) similar to that illustrated in FIGS. 1A and 1B for use with an endoscope (108). The endoscope may be provided with the device or may be supplied separately, for example, as a commercial endoscope. The device illustrated in FIG. 1C also includes a vacuum source (102) and tubing connecting the vacuum to a vacuum port (116) on the proximal end of the overtube. A controller (122) is connected to this tubing for turning suction on and off through the overtube inner lumen. The controller is illustrated as a foot pedal in this example. The controller may include one or more valves (e.g., pinch valves) for regulating the applied suction. The proximal end of the overtube also includes an endoscope receiving port (114) configured to receive the endoscope (108) therethrough within the inner lumen. The endoscope receiving port is in series with the inner lumen of the elongate body. A vacuum port (116) is shown in fluid communication with the inner lumen and connected to a vacuum source (102) by a tubing (119). In this example, the overtube may also include a rigidifier port comprising a pressure line (144) configured to receive positive and/or negative pressure to convert the elongate body from a flexible to a rigid configuration. A separate perfusion/flush line (157) is also shown in this example, which may provide fluid (e.g., water) into the inner lumen. The device may also include a separate pressure source (positive and/or negative) for rigidifying the overtube. In some cases, the same vacuum source (102) (or a duplicate source) may be used.

In general, the overtubes described herein can be configured to withstand the application of suction without collapsing. Thus, these devices can generally have a hoop strength capable of withstanding negative pressures of, for example, up to 760 mmHg (1 atmosphere) or more without collapsing. Furthermore, these devices can be configured to maintain a very high degree of flexibility (when in a flexible configuration). For example, in some variations, the overtube comprises one or more reinforcing layers comprising reinforcing coils and/or braided layers (e.g., a braided shaft). Any of these devices can comprise a coil-wound reinforcing tube. For example, the reinforced outer layer can be reinforced with a plurality of filaments wound around (or within) the layer. An inner tube (e.g., an inner coil-wound tube, ICWT) can comprise one or more reinforcing wires. The inner coil-wound tube can be adjacent to another layer. In some instances, by using a lower durometer material, the overall flexural flexibility can be increased even when high pressures are required. For example, the overtube body may be formed of a material having a hardness of 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 body of the overtube may be manufactured from one or more layers of such low-hardness materials, and may be reinforced with a reinforcing layer, such as (in some examples) a helically wound coil reinforcing layer.

Any of these devices may also include a torsional stiffening element (e.g., a torsional stiffening layer). The torsional stiffening layer may be integrated within the inner layer and/or the outer layer. Alternatively, it may be free-floating so as not to be intentionally attached to adjacent layers.

The overtube described herein may be of any suitable length, but may be particularly long and configured for use with long scopes (e.g., greater than 50 cm, greater than 55 cm, greater than 60 cm, greater than 65 cm, etc.). Shorter or longer lengths may also be included, which may be useful for specific anatomical targets.

Additionally, the overtube described herein may comprise a distal tip region configured for use with an endoscope and for applying suction. For example, the distal end region of the overtube may include an opening into the lumen of the overtube through which suction may be applied and through which the endoscope may be positioned. The distal opening of the overtube may be configured to allow the endoscope to extend out of the overtube and retract into the overtube. In some instances, the distal opening may be narrowed compared to a more proximal inner diameter of the lumen of the overtube. This narrowing may assist in centering, supporting, and/or guiding the endoscope. The narrowing may be, for example, from about 98% to about 50% (e.g., about 98% to about 55%, about 98% to about 60%, about 98% to about 65%, about 98% to about 70%, about 98% to about 75%, about 98% to about 80%, etc.) of the inner diameter of a more proximal region of the inner lumen of the overtube.

The distal tip region, including the distal end opening of the overtube, may be transparent to allow visualization through the distal end, for example, by an endoscope, when retracted into the lumen of the overtube. As described above, any of the devices described herein may include a vacuum release opening (e.g., a hole or opening proximal to the distal end and/or distal end to allow manual venting to prevent suction locking on tissue (e.g., a body wall, etc.)).

Any of the overtubes described herein may be steerable, particularly in the distal end region (e.g., the distal end region of the overtube). The overtube may be steerable by mechanical steering (e.g., pull-wire, gun, shape memory alloy, etc.), pneumatic (pressure-actuated steering), electric/magnetic steering, etc.

Optionally, any of the devices described herein may include a rigidifiable overtube and/or endoscope. For example, the overtube may be controllably transitionable between a flexible configuration and a rigid (less flexible) configuration. These devices may be able to rapidly transition from a flexible configuration (i.e., a relaxed, stretched, or sagging configuration) to a rigid configuration (i.e., retaining its shape when stiffened and/or rigidified). The rigidifying device (e.g., the overtube) may include multiple layers (e.g., a coiled or reinforcing layer, a slip layer, a rigidifying layer, a bladder layer, and/or a sealing sheath), which together may form a wall of the rigidifying device, which may be referred to as a "layered rigidifying device." The rigidifying devices described herein may be rigidized by jamming particles, by a phase change, by interlocking components (e.g., cables having discs or cones), or by any other rigidifying mechanism. The rigidifying device can be transitioned from a flexible configuration to a rigid configuration, for example, by applying vacuum or pressure to or within the walls of the rigidifying device. In the absence of vacuum or pressure, the layers can readily shear or move relative to one another. In the presence of vacuum or pressure, the layers can transition to a state in which they exhibit substantially enhanced ability to resist shear, movement, bending, torque, and buckling, thereby providing rigidity.

Any of the stiffening devices described herein can include a stiffening layer or region that engages a compression layer (which may be or include a bladder) that applies a force to the stiffening layer to stiffen the stiffening layer or, in some cases, to de-stiffen (e.g., release from stiffening) the stiffening layer. In some examples, these stiffening devices can include a stiffening layer that may include a braid, a knit, a woven, chopped segments, randomly distributed or randomly oriented filaments or strands, engagers, links, scales, plates, segments, particles, granules, intersecting filaments, or other material that forms the stiffening layer. For example, the stiffening layer can include a plurality of strand lengths or strand segments that intersect one another (e.g., as part of a braid, a knit, a woven, etc.); and the compression layer can apply a force that drives the intersecting strand lengths or strand segments against one another. While many of the examples disclosed herein are braided, any of these devices may instead or additionally include a general stiffening layer comprising intersecting strand lengths or strand segments.

Examples of stiffening devices described herein may utilize pressure (positive pressure) and/or negative pressure for selective and controllable stiffening. In some instances, the methods described herein may be used with any suitable stiffening device.

An exemplary rigidifying overtube device is illustrated in FIG. 2. The device depicted includes a rigidifying device (300) having a wall having multiple layers, including a rigidifying layer, an outer layer (constructed as a braided layer in this example, a portion of which is cut away in this example to reveal the underlying rigidifying layer), and an inner layer. The system further includes a handle (342) having a vacuum or pressure inlet (344) for supplying vacuum or pressure to the rigidifying device (300). An actuating element (346) can be used to turn the vacuum or pressure on and off, thereby transitioning the rigidifying device (300) between a flexible configuration and a rigid configuration. A distal tip (339) of the rigidifying device (300) can be smooth, flexible, and atraumatic to facilitate distal movement of the rigidifying device (300) through the body. As described above, the tip can be configured to be tapered, transparent, or the like.

In addition to the inner lumen opening being tapered radially inwardly to have an opening diameter narrower than the inner diameter of the inner lumen described above, the outer diameter of the distal tip in any of these examples may be tapered to be atraumatic. For example, the tip (339) may be tapered from the distal end to the proximal end to facilitate distal movement of the stiffening device (300) through the body. In this example, the stiffening device is configured as an overtube, although other configurations may be used.

The rigidifying devices and methods described herein may be part of a medical access system for treating areas of the body that are otherwise difficult to access and manipulate, particularly during minimally or non-invasive procedures.

A rigidifying device as described herein may be configured to rigidify when subjected to the application of negative and/or positive pressure. These rigidifying devices as described herein may be used in conjunction with other rigidifying devices that rigidify in other ways, including those that do not rely on the application of positive or negative pressure. For example, the rigidifying device may be configured to include a plurality of 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 sources may be controlled by a number of methods, including manipulation of the handle or an electronic control device. The control may cause a pressure differential that causes the device to transition between one or more (e.g., a continuum) of rigid configurations and a highly flexible configuration that allows the tubular body to readily bend when steered or otherwise guided (e.g., via a guidewire). In some examples, particularly (but not exclusively) referring to devices that are stiffened based on the application of positive pressure, the stiffness of the elongated body is proportional to the applied pressure differential, such that the higher the pressure differential, the stiffer the device will be at least over a range of pressure differential values.

As mentioned, these devices may include a plurality of layers (which may be arranged concentrically around an inner lumen) including a rigidifying layer and at least one of an outer layer or an inner layer. Many of these examples also include a compressive layer that may be interdigitated with the rigidifying layer, and in some examples, the devices may include a combined rigidifying layer/compressive layer. Described herein are rigidifying layers that may be particularly well suited for rapid and precise operation over a range of pressures, including, but not limited to, positive pressures (e.g., high positive pressures, i.e., greater than about 2 atmospheres, greater than 4 atmospheres, greater than 6 atmospheres, greater than 8 atmospheres, greater than 10 atmospheres, greater than 15 atmospheres, greater than 20 atmospheres, greater than 30 atmospheres, etc.). Any of these devices may also be configured such that at least a portion of the inner layer and/or outer layer constituting the rigidifiable device has different hardnesses on the inner and outer portions of the inner layer or outer layer. Also described herein are devices and methods comprising a nested set of rigidifiable devices that can include any of these rigidifiable devices. Any of these devices, particularly when included as part of a nested pair of rigidifiable devices (e.g., as part of an internal or descendant device), can include one or more torsional enhancement layers to improve torsional control.

FIG. 3A illustrates an example of a transverse cross-section through an elongated rigidifying device, illustrating an arrangement of a number of layers that may be included. In this example, the rigidifying device (100) is configured to be actuated by the application of negative pressure (e.g., vacuum). The illustrated device (100) comprises an inner layer (115), which may be reinforced (e.g., by including one or more reinforcing members, such as helically arranged strips, ribbons, or wires), an optional slip layer (113), a gap (111), a rigidifying layer (109), which is configured as a braided layer in this example, a second gap (107), and an outer layer (101). The layers surround a central lumen (120). In some examples, a vacuum may be applied between the outer and inner layers for rigidification. For example, a port configured to be coupled to a source of negative pressure may be located at the proximal end of the device and may be in fluid communication with a gap region (107) between a flexible outer layer (101) and a rigidifying layer (109), for example a braided layer. Thus, in this example, the outer layer may act as a compression layer. FIG. 3B illustrates a cross-section through one wall region (B) of the cylindrical body of the device. Application of suction may cause the outer layer (101) to be drawn onto the rigidifying layer, thereby rigidifying the device and limiting or preventing flexure of the device.

Another example of a rigidifiable device, for example a rigidifying overtube (2100) having an inner lumen (2120), is illustrated in FIGS. 4A and 4B . In this example, the device may also be an elongated device, for example a catheter or tubular device, similar to that of FIGS. 3A and 3B , but capable of being rigidified by the application of positive pressure. For example, FIG. 4A illustrates a cross-sectional view transverse to the major axis of an elongated rigidifiable device. In this example, the layers forming the device are arranged such that the inner reinforced layer (2115) is the most radially inwardly facing layer and may be reinforced, for example, by a helically wound ribbon, strip, cable, or the like. The device may also include an optional slip layer (2113) that may reduce friction between the inner layer and the more radially outwardly facing layer. The slip layer may be a powder, or may be a lubricating layer or a layer of a lubricating material. A first gap layer (2112) is shown separating the inner layer (2115) and/or the slip layer (2113) from the compression layer, which is configured as a bladder layer (2121) in this example. A second (or intermediate) gap layer (2111) separates the bladder layer from the stiffening layer (2109), which is shown as a braided layer in this example. A third gap layer (2107) is positioned between the stiffening layer and the outer layer (2101). In this example, the outer layer (similar to the inner layer (2115)) is reinforced by, for example, helically wound filaments, wires, fibers, bands, or the like. Although not shown, when actuated by application of positive pressure between the compression (e.g., bladder) layer and the inner layer, the bladder layer may push the braided layer into the outer layer, thereby stiffening the stiffening layer.

The devices illustrated in FIGS. 3A, 3B, 4A, and 4B may include additional optional layers or components. Additionally, the composition of the stiffening layer may be modified to improve performance. In particular, the stiffening layer may be modified to include structures (e.g., knitted portions, woven portions, braided portions, scales, plates, arrays of filaments, granules, and combinations thereof) that enhance or improve performance. The stiffening elements may be used alone, as one type, or in combination with other stiffening elements. In some examples, the inner layer and/or the outer layer may be modified to enhance or improve performance, including by adding torsion control components, and/or by adjusting the hardness of the inner and outer regions of these layers.

As described above, the endoscope can be rigidified by adding (or instead of) an overtube. Generally, the device described herein is configured to apply suction through the overtube and around the endoscope within the overtube. In some instances, suction can also be applied through the endoscope. The endoscope can be applied to the same source or suction, or to a different source of suction. In some instances, the device can be used by first applying suction to the endoscope, for example, to move the material to be removed into or near the opening of the overtube, and then to coordinate the application of suction through the overtube to remove the material. Thus, the combination of suction from the endoscope and suction from the overtube can be coordinated to remove the material. In some instances, to prevent clogging of the endoscope, use may be limited to directing the material into the opening of the overtube. Any of these methods may alternatively or additionally include dedicated pressure relief lines and/or pressure relief lines for each of the overtube and the endoscope.

In some instances, the device may be configured to apply positive pressure through the endoscope, for example, by applying pressurized fluid through the suction lumen or working channel of the endoscope, particularly while the distal tip of the endoscope is within the lumen of the overtube. This may allow the device to clear a blockage within the lumen of the endoscope without risk of expulsion of material within the body. Any of these devices may also or additionally include one or more fluid lines, which may be inserted into the inner lumen of the overtube separately from (or in some cases in addition to and/or through) the endoscope. Thus, the fluid lines may apply a fluid (e.g., water) into the lumen of the overtube and/or outward from the distal end of the overtube. The fluid may be applied as a spray or stream from a nozzle onto the distal end region and/or tip of the device. In some instances, the fluid may be applied through a perfusion line within the overtube to clear a blockage near the proximal end of the overtube.

In some instances, a stream of high-pressure fluid may be used to break up material including clots, food, or feces, by means of pressurized fluid that may be applied through the suction lumen or working channel of the endoscope.

The devices described herein generally form a seal around an endoscope, for example in the region of the overtube (and in some examples in the region of the suction adapter), thereby maintaining a seal around the endoscope, such that suction can be applied through the inner lumen of the overtube without substantial loss of suction from the proximal end, wherein the endoscope is inserted within the overtube lumen.

FIG. 5A illustrates an example of a proximal end of a device that may be integrated with an overtube, or may be configured for coupling with the overtube (e.g., at a coupling region (534)), or as a removable adapter (also referred to herein as a suction adapter) attached via a flexible vacuum line. In FIG. 5A , the proximal end region of the device (e.g., the suction adapter) includes an endoscope receiving port (514) configured to receive an endoscope. The device also includes a vacuum port (516) coupled to a vacuum source and configured to apply suction within the inner lumen of the overtube. A control element (522) may be included in series with the overtube inner lumen and the vacuum port (516). Typically, the control element (522) may be configured to be controlled by a user to control the application of suction through the overtube. The control unit may be coupled and/or integrated with the overtube and/or suction adapter, as illustrated in FIG. 5a, or it may be separate and connected to a suction source (negative pressure) via a control suction port (516') and/or between a negative pressure source and a vacuum port (516) in the adapter area.

FIGS. 5B through 5D illustrate examples of a suction adapter portion of a device that may be configured as a separate adapter for use with an overtube or may be integrated with the overtube. FIGS. 5B and 5C illustrate side views of the adapter portion, similar to that illustrated in FIG. 5A, but without an attached or integral control (including a valve) for controlling the application of suction through the device. As illustrated in the cross-sectional view of FIG. 5C, the endoscope receiving port (514) includes a seal (526). In this example, the seal (526) is configured as a sheet of material (e.g., an elastomeric material) having a sealing opening (524) therethrough. The sealing opening has a diameter smaller than the outer diameter of an endoscope to be inserted within the overtube lumen (507). The seal may be lubricated or may be used with a lubricant, such that the endoscope can glide within the seal while still maintaining a seal to prevent loss of vacuum when suction is applied. FIG. 5D illustrates a plan view of the suction adapter of FIGS. 5B and 5C, showing the sealing opening (524) of the seal (526) visible through the endoscope receiving port (514). The seal may be coated to enhance lubricity and/or ease of gliding (e.g., with a hydrophilic coating or other lubricious coating).

In FIG. 5A, the control unit includes a valve biased by a bias (e.g., a spring) configured to maintain the valve in a closed position unless a user applies force to displace the spring, as exemplified in the examples shown in FIGS. 6A-6C described below. In some configurations, the control unit may include a spring-loaded trumpet valve (622), examples of which are illustrated in FIGS. 6A-6C. FIG. 6A illustrates an external view, while FIGS. 6B and 6C illustrate cross-sectional views through the trumpet valve of FIG. 6A in open ( FIG. 6B ) and closed ( FIG. 6C ) configurations. In this example, the valve includes a vacuum port (516) configured to be coupled to a vacuum source and an outlet (536) for coupling to the lumen of the overtube. The spring-loaded valve mechanism includes a shaft (628) that can be displaced downwardly to open a connection between a vacuum port (and thus a connected vacuum source) and an aspiration lumen outlet (536) when a control input (629) (e.g., a button, knob, etc.) is actuated downwardly, for example, by an application of force from a user. For example, the user may push the control downward to compress a spring (631) within the valve to displace the shaft (628), thereby forming a connection that allows suction to flow from the aspiration port out of the distal end of the aspiration lumen of the overtube. In FIG. 6B, the control (622) with the valve is shown in a closed (resting) configuration, and the shaft (628) includes a pair of seals (633, 635) configured to prevent leakage from between the vacuum port (516) and the aspiration lumen outlet (536). In FIG. 6c, the valve of the control unit is shown in an open (operated) configuration, for example, when the actuator (control input (629)) is pressed down, compressing the bias (spring (631)) and displacing the shaft (628) within the valve to form a connection between the suction lumen outlet (536) and the vacuum port (516).

Figures 7a and 7b illustrate another example of an adapter (722) for attaching to the proximal end of an overtube to convert it into a device for sealingly receiving an endoscope and applying suction through the overtube. The example illustrated in Figure 7a is configured to include two portions, a proximal portion (779) and a distal portion (778), which are configured to mate together. In this example, the distal portion (778), which can be joined or integrated with the elongated body of the overtube (e.g., via a joining portion (734)), is configured to have a threaded engagement portion (781) that mates with a channel or complementary portion on the distal portion. The distal portion also includes an endoscope receiving port (714) configured to receive the endoscope and a vacuum port (716) configured to couple with a vacuum source (and/or controller) to apply suction within the interior lumen of the overtube. A separate controller (e.g., foot pedal, hand control, etc.) may be included (not shown in the drawing) that can valve the connection (e.g., piping) between the suction port and the suction source.

Figure 7b illustrates a cross-sectional view through the assembled adapter (722) of Figure 7a. In this example, an internal seal (726) is shown that seals the endoscope in communication with the internal lumen (707) of the overtube. The seal may include one or more elastomeric layers, rings (e.g., O-rings), or the like that may allow insertion and removal of the endoscope while preventing or reducing leakage that would impede the application of suction through the internal lumen of the overtube. As noted, the seal may include an opening.

FIG. 8A illustrates an exploded view of a distal portion (879) of an adapter similar to that illustrated in FIGS. 7A and 7B . In this example, the proximal portion (779) includes a suction port (816) and a threaded-receiving area (891) within the proximal portion. The proximal end of this portion of the adapter has an endoscope seal (826), which is illustrated as an elastomeric layer having an opening (824) for receiving an endoscope. The seal may be reinforced, for example, radially reinforced near the wall. The proximal end may be configured as an endoscope receiving port (814).

As described above, any of these devices may be integrated such that the overtube comprises an endoscope receiving port and a suction port. FIG. 9 illustrates an example of an integrated device configured as an overtube comprising an endoscope receiving port (914) at its proximal end, which comprises a seal (not shown) as described above. The proximal end also comprises a vacuum port (916) configured to fluidly couple with a suction line connected to a suction source (and in some cases, a controller). In this example, the overtube (906) also comprises an elongated body (929) that may be configured to controllably and reversibly transition between a relatively flexible configuration and a more rigid (e.g., less flexible) configuration, for example, by the application of pressure (positive and/or negative pressure). In FIG. 9, the device comprises a rigidification port (944), which may comprise a length of connector tubing for coupling to a source of negative or positive pressure. In some cases, the overtube may include an actuator (946) (e.g., a switch, dial, button, etc.) on the proximal end of the overtube itself (e.g., in the handle area) or separately, for example, between a rigidization port and an inner layer of the elongated body of the overtube that may be rigidized. The example illustrated in FIG. 9 also includes a flush line (957) and an optional pressure relief line (948) (e.g., an air relief line). The distal end (939) of the device illustrated in FIG. 9 is tapered radially inwardly, which may assist in centering an endoscope that may extend distally outside the overtube and may also enhance suction into the overtube.

Figures 10A-10E illustrate the preparation of a device comprising an overtube as described herein. Figure 10A depicts an overtube (1006) of an elongated and flexible configuration. A suction adapter (1040) portion of the device is shown adjacent to, but not yet connected to, the proximal end of the overtube. 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 can be inserted into the inner lumen of the overtube (along with a lubricant). 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, wall suction, etc., forming the suction line (1036) may then be coupled to a suction port (e.g., vacuum port (1016)). A control coupled to the vacuum port may include a biased valve whose control input may be actuated to apply suction from the distal end opening of the overtube while the user activates the control.

Figures 11A through 11F illustrate an example of a method of operating a device as described herein. In Figure 11A, an overtube (1106) is advanced such that an endoscope (1108) extending distally out of a distal opening (1110) of the overtube comes into contact with a material to be removed (e.g., a clot (1110)). The endoscope can use an image (e.g., one or more cameras) on the distal end of the endoscope to visually confirm the location and proximity of the clot. The overtube (1106) can then be advanced distally toward the clot (1110) until the distal end region comes into contact with the clot, as illustrated in Figure 11B. The endoscope can then be retracted proximally into the lumen of the overtube, as illustrated in FIG. 11C , and suction can be applied ( FIG. 11D ) to pull the clot into the inner lumen of the overtube, as illustrated in FIGS. 11E and 11F . The endoscope can then observe the clot being pulled into the inner lumen of the overtube and removed therethrough. The material (1110) can be aspirated next to the endoscope (1108) through the lumen of the overtube; in some cases, the material can surround the endoscope as it is aspirated proximally. In FIGS. 11A through 11F , the distal end of the overtube is tapered and includes a slightly narrower distal opening (1110) compared to the inner diameter of the lumen of the overtube.

While the examples disclosed above illustrate a device in which the endoscope is relatively centered within the overtube (with the vacuum port as a side exit), alternative configurations may be used. For example, the endoscope may be positioned eccentrically relative to the center of the inner lumen of the overtube. For example, the device may be configured such that the endoscope is centered within the overtube lumen for the intermediate and distal sections, but may emerge from a (sealed) side exit of the overtube lumen at or near the proximal end. In this configuration, the clot may have a direct suction path along the center of the lumen of the overtube.

In some instances, as illustrated in FIG. 12A, it may be helpful to apply irrigation through an overtube to a large diameter suction port. In this example, similar to those illustrated in FIGS. 11A-11F, the device comprises an overtube (1206) having an internal suction lumen (1207), and an endoscope (1208). The device (either as part of the endoscope or as a separate component) may include a irrigation line (1212) (also referred to herein as a irrigator tube) that may extend distally outside the overtube and/or the endoscope and may apply irrigation fluid from one or more irrigation outlets. The irrigation may assist in removing material that would otherwise be removed by the application of suction from the overtube (additionally, the suction may remove the irrigation material). The irrigation may also occur directly outside the internal suction lumen/working channel. Any of these devices may also be configured to apply irrigation from the proximal end of the overtube to flush out blockages and potentially clear the scope.

In some examples, the irrigation tube (1212) may be separate within the lumen of the overtube without needing to pass through the endoscope; alternatively, a separate irrigation tube (1242) may be used. Typically (as illustrated in FIGS. 25A-25J and FIGS. 26A-26H ), the irrigation tube may include one or more nozzles (1243) or openings into the irrigator. For example, as illustrated in FIG. 12B , the irrigation tube (1242) may be inserted within the inner lumen (1207) of the overtube (1206) adjacent to the endoscope (1208) and positioned axially independent of the endoscope. Irrigation fluid may be sprayed from the irrigation tube to clean the endoscope, destroy material, and/or flush the endoscope and/or the overtube.

As mentioned, any of these overtubes may be configured as rigid overtubes. Alternatively, any of these devices may not be rigid overtubes. For example, FIGS. 13A and 13B illustrate another example of a device that includes an overtube having one or more reinforcing layers but is not configured to be rigid. FIG. 13A illustrates the proximal end region of the device, which depicts 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 within the suction lumen of the overtube. The device may also include a flush line (1344). In the example illustrated in FIGS. 13A and 13B, the device includes an integrated suction port (illustrated as a Y-port extending from the side of the device) in the handle region of the overtube device. Any of these features may alternatively or additionally be configured as a stiffening overtube (including an integral Y port similar to that illustrated in FIG. 13b). The distal end region (1328) may be tapered.

In some examples, a control for controlling suction within the overtube may be coupled to a suction adapter portion of the device, as illustrated in FIG. 5A . For example, the control may be coupled in series with a suction source to a vacuum port (516) of the device. In some cases, the connection between the suction line and the device may be a flexible or movable connection, as illustrated in FIGS. 14A and 14B , which illustrate a swivel connection (1405) between the suction port (516) of the adapter. The adapter region may include an endoscope receiving port (514) and a coupling region (524). Similarly, a controller (622), which includes a trumpet valve (as illustrated in FIGS. 6A-6C ) (in this example), may also include a control input (629) (e.g., a button, a knob, etc.) for opening the suction line to apply suction into the lumen of the overtube.

In any of these examples, the control element may instead be applied to a suction (negative pressure) line connecting the suction port (516) of the overtube (or, in some examples, the suction port of a suction adapter configured to couple to the suction port). The control element may include a valve in series or parallel with the suction line connecting the negative pressure (suction) source to the suction port of the device. For example, the control element may include a suction line coupling area (1538) coupled to the suction line and configured to close or open (when actuated) to apply suction through the inner lumen of the overtube. In the example of the control element (1522, 1522') illustrated in FIGS. 15A-15C, the control element includes a lever valve configured to block the application of suction through the suction line to which it is coupled. In FIG. 15A, the actuator (control input element (1529)) is a lever arm that can be depressed to allow suction through the suction line to which the control element is attached. FIG. 15C schematically illustrates another example of a controller (1522') having a lever or handle (1529') that can be depressed (or squeezed) by a user to allow suction through the overtube lumen when actuated. The controller may be biased to return to a closed state when not actuated. In some examples, the controller may include a lever valve.

Figures 16A and 16B illustrate another example of a control member (1629) that includes an actuator (control input member (1604)) that also includes a handle portion (1602) that is depicted as a lever that can be compressed by the user to allow suction through the inner lumen of the overtube. For example, as illustrated in Figure 16B, which illustrates a cross-section through the control member of Figure 16A, the control member may be connected in series 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 can be biased (e.g., by a bias such as a spring (1651)) to remain closed until actuated by the user.

Figures 17A through 17C illustrate another example of a controller (1729) that includes an actuator (control input (1604)) configured to receive a foot to be compressed (1704) by a user to allow suction through the inner lumen of the overtube. For example, as illustrated in Figures 17A through 17C, the controller may be connected in series with the suction line via a suction inlet (1706) and a suction outlet (1708). The controller may include a pinch valve that may be biased (1751) (e.g., by a bias such as a spring) to remain closed until actuated by the user.

As described above, any of these devices may be constructed as a highly flexible overtube configured to withstand and remain flexible even under relatively large negative pressures (suction) applied through the lumen of the overtube. Figures 18a and 18b illustrate different examples of overtubes having strain gauges incorporated therein to indicate the force applied to bend the flexible elongated member of the overtube without failure.

In FIG. 18A, the overtube (1800) includes reinforcing wire, but is relatively stiff compared to the exemplary overtube (1800') illustrated in FIG. 18B. In this case, the overtube is extremely flexible (e.g., has greater bending flexibility compared to the overtube illustrated in FIG. 18A) and has a hoop strength under greater compression sufficient to withstand at least 1 atmosphere (760 mmHg). A force gauge (1806) is illustrated attached to the distal end of each overtube to measure the relative force for bending along its length (e.g., to determine bending flexibility). When subjected to equivalent bending forces, the exemplary overtube (1800') illustrated in FIG. 18B is capable of bending more than 360 degrees with relative ease.

As previously described, any of the devices described herein may include one or more openings (e.g., suction releases or vacuum releases) to prevent vacuum locking of the distal end region (including openings into the inner lumen of the overtube) when the distal end of the overtube is adhered to the wall of a body region. FIG. 19 illustrates an example of a distal end region (1900) that includes a plurality of suction release openings (1905, 1905') arranged lateral and proximal to the distal end opening (1930) into the lumen of the overtube. The distal end opening (1930) is tapered (1928) to have an outer tapered profile and has an opening diameter that is narrower than the inner diameter of the region of the lumen that is more proximal to the distal end opening. Alternatively or additionally, these devices may include a relief valve, as illustrated in FIG. 21B.

Any overtube device described herein may include one or more external working channels extending along the length of the overtube. Examples of external working channels can be found, for example, in U.S. Patent Application No. 17/940,906, filed September 8, 2022, entitled "EXTERNAL WORKING CHANNELS," and U.S. Patent Application No. 18/000,062, filed May 26, 2021, entitled "RIGIDIZING DEVICES," each of which is incorporated herein by reference in its entirety. This is illustrated in FIGS. 27A-27C . FIG. 27A depicts a distal end region of the overtube (2706) from which an endoscope (2708) is depicted extending. As described above, the distal end is tapered in this example. The overtube also includes at least one external working channel (2781) that can be configured to lie flat until an accessory device (e.g., a suction tube (2789)) passes through it, as illustrated in FIG. 27b. FIG. 27c illustrates an example of an overtube as described herein that includes a plurality (e.g., four) external working channels that can be accessed via a proximal port (2788). The proximal end can include an endoscope receiving port (2714).

One or more external working channels may be expandable from an 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 devices

Any of these devices may be configured for use as or in conjunction with a robotic device. In some examples, the overtube and endoscope assembly (including the endoscope (9310)) may be robotically controlled. Any suitable control subsystem may be used to control movement, including steering of the distal end, advancement and/or retraction of the overtube and endoscope, and/or rotation of the endoscope and/or the outer overtube. In FIG. 20, an exemplary device (9300z) comprising an overtube (9300) and an endoscope (9310) may be robotically controlled or manipulated (e.g., steering, translation, rotation, etc., including rigidization in some examples). As illustrated in FIG. 20, the outer overtube (9300) and the endoscope (9310) may be terminated together in a common structure, such as a cassette (9357). The outer overtube (9300) may be movable relative to the endoscope (9310) by rotation of a disc (9389) mounted within the cassette (9357). For example, the disc (9389) may be a pinion, and the outer stiffening device (9300) may have a rack (9382) having a plurality of small teeth on its exterior. Rotating the disc (9389) relative to the teeth (9382) may cause the overtube (9300) to advance forward or backward relative to the endoscope (9310). In some instances, the possible movement or translation of the endoscope and/or overtube is limited by the size or design of the cassette (9357).

The cassette (9357) may further include additional disks (9371a, 9371b) that may be connected to cables (9363a, 9363b), respectively, to steer (e.g., bend or deflect) the tip of the endoscope (9310) (and/or the outer overtube (9300)). Other steering mechanisms (e.g., pneumatic, hydraulic, shape memory alloy, electroactive polymer (EAP), or motor) are also possible. Again, in examples having different steering mechanisms, one or more disks (e.g., disks 9371a, 9371b)) in the cassette (9357) may be used to actuate the steering.

The cassette (9357) may further include bellows (9303a, 9303b) that may be connected to the pressure gaps of the endoscope (9310) and the overtube (9300), respectively. The compression bellows (9303a, 9303b) may drive fluid through the pressure line (9305z) to increase the pressure within the pressure gaps of the endoscope (9310, 9300), thereby causing the endoscope (9310) and/or the overtube (9300) (in a variant for an endoscope and/or overtube configured to be rigid) to become rigid. Activation of the bellows (9303a, 9303b) may be applied sequentially and/or simultaneously. As illustrated, the cassette (9357) may include eccentric cams (9374a, 9374b) to control the bellows (9303a, 9303b). Alternatively, one or more linear actuators (e.g., on the cassette (9357) or on the drive unit) may be configured to actuate the bellows (9303a, 9303b). Alternatively, the devices (9300, 9310) may be stiffened and de-stiffened via one or more sumps (as described herein) or pressure sources (e.g., via pressure lines (9305z)).

The cassette (9357) may include a connector (9315y) for connection to additional lumens and/or wiring of the endoscope (9310) and/or the overtube (9300). The connector (9315y) may include connections for both suction and delivery of water to the tip of the endoscope (9310). The 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. The connector (9315y) may include a mechanical connector for connecting to a hollow tube (e.g., a working channel) extending all the way to the tip of the internal stiffening device (9310). By including the connector (9315y), control of all components of the system (9300z) may be performed by the cassette (9357).

In use, these devices can very efficiently and safely remove material from a patient's body. For example, FIG. 21A illustrates the operation of an example of a device as described herein. In this example, the device includes an overtube (2106) having an elongated body. The overtube may be rigidized as described above. The proximal end of the overtube includes a suction port (2116) and an endoscope receiving port (2114) having a seal. The devices illustrated in FIGS. 21A-21D depict an endoscope (2108) inserted into the inner 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 stopcock (2138)) having an off position, a first position in which the inner lumen of the overtube is in fluid communication with a rinse or perfusion line (2136), and a second position in which the inner lumen of the overtube is in fluid communication with an air relief port or opening (2148). Thus, in this example, the device includes a manual three-way stopcock (2138) that allows a user to switch between air relief or perfusion. In some examples, perfusion may allow the use of a syringe to flush out the annular space with water to clear a blockage (see FIGS. 21C-21D ). In some cases, the suction relief (2148) may include a seal (e.g., a Tyvek seal) that allows air to be vented to the atmosphere, but prevents any fluid that would otherwise come with it.

In FIG. 21A, a device is depicted in which suction (2151) is applied through the inner lumen of the overtube from a suction port (2116) connected to a source or suction and collection (not shown). As described above, in use, the distal end of the rigid overtube (2016) can be positioned adjacent to the material to be removed with the endoscope (2108) extending distally from the distal end. The rigid overtube (2106) concentrically surrounds the endoscope (2106), with the overtube and the endoscope forming an annular lumen (2121). The device can be manipulated within the body by controlling the stiffness of the overtube to assist navigation; The endoscope can be steered distally while the overtube is rigid, and the overtube can then become flexible and be driven over the endoscope, and then re-rigidify to maintain its shape, allowing further distal navigation relative to the overtube. Once the endoscope is in position, for example, visualizing the material to be removed or the area to be rinsed and/or processed, the endoscope can be retracted slightly proximally into the overtube, such that the distal end of the endoscope is within the distal end region of the rigid overtube, as illustrated in FIG. 21A. This can be done while the overtube is rigid. Suction can then be applied through the annular lumen to aspirate the material into the annular lumen and around the endoscope.

In some cases, the overtube may be locked onto the wall (2149) of the lumen, as illustrated in FIG. 21B . In this case, as previously described, an opening on the distal end region may aid in releasing the locking device from the wall. Alternatively, in some cases, a relief valve (e.g., an air relief port (2148)) may be used. In FIG. 21B , the valve (2138') is illustrated with the stopcock in a second position, allowing air to be vented from outside the body, which may quickly release the vacuum lock on the wall.

FIGS. 21C-21D illustrate examples in which the annular lumen (2121) becomes clogged (e.g., with a substance (2153)) and the clog can be removed by application of a cleaning fluid (2158) (e.g., from a syringe) through a cleaning port (2136) controlled by a three-way valve (2138") (shown in a first cleaning position in FIG. 21C). For example, in FIG. 21C, a clog (2158) within the annular lumen of the device (2121) is loosened or removed by application of a rinsing fluid (e.g., saline, etc.) (2158) when the three-way valve opens the cleaning port (e.g., rinse port) (2136). The rinsing fluid may be applied by a syringe in some examples. The clog can be driven distally out of the device and, as shown in FIG. 21D, aspirated. It can be removed by applying suction (2151) once more through port (2116). In Fig. 21d, the three-way stopcock (2138) is once more in the closed position.

In any of these methods, the blockage may also or alternatively be cleared by moving the endoscope within the inner lumen. For example, the endoscope may be moved axially (proximally/distally). In some cases, the endoscope may be moved axially by more than about 1 mm to about 3 cm, for example, about 1 mm to about 3 cm, about 1 mm to 2.5 cm, about 1 mm to 2 cm, about 1 mm to 1.5 cm, about 1 mm to 1 cm, about 1 mm to 7 mm, about 1 mm to 5 mm, etc. The endoscope may be moved back and forth in a linear oscillation, for example, at about 1 Hz to 50 Hz (e.g., about 1 Hz to 40 Hz, about 1 Hz to 30 Hz, about 1 Hz to 20 Hz, about 1 Hz to 10 Hz, etc.). Moving the endoscope within the lumen of the overtube while applying suction may help prevent or remove blockages. Alternatively or additionally, the endoscope may be rotated within the lumen.

In any of these devices, clots may be detected when the fluid applied prior to and/or during the application of suction is not removed. This may be detected or confirmed by observing the collector in series with the suction source.

As described above, a fluid may be applied during operation of these devices to loosen and/or remove material, including hardened stool, mucus, and the like, from a body region. The fluid may be applied through one or more fluid channels, which may be part of the overtube, part of the endoscope, or part of a separate instrument inserted within the overtube and/or endoscope. The fluid may be applied by a fluid pump at any suitable flow rate. In some cases, the fluid may be applied in a pulsating manner, for example, at a frequency of about 0.1 to 200 Hz (e.g., about 0.5 to 150 Hz, etc.). In any of these methods and devices, a gas (e.g., air) may be included in the applied fluid to disrupt the material to be removed.

Figures 22a through 22c illustrate examples of fluid application through fluid lines of an overtube. In Figure 22a, the overtube (2206) includes three fluid lines (2246) including an outlet slightly proximal to the distal end of the overtube. In this example, the fluid outlets are positioned radially on one side of the overtube. In some cases, as illustrated in Figure 22b, the outlets of the fluid lines (three of which are illustrated) (2246') may extend slightly distally from the overtube (although still proximal to the distal end of the overtube) and may be angled or otherwise aligned with respect to the major axis of the overtube, as illustrated in Figures 22b and 22c.

Alternatively or additionally, fluid (e.g., irrigation fluid or irrigation fluid) may be applied from the distal end region of a irrigator tube, which may be inserted through the endoscope and/or through an overtube. The direction of fluid from any of these fluid lines, including the irrigator and the integral fluid line, may be controlled by a nozzle region at the distal end. In some cases, it may be particularly advantageous to provide a radial spray, as illustrated in FIG. 23A . FIG. 23A illustrates an irrigator tube (2366) configured as a radial spray irrigator tube, where the distal end region is configured as a nozzle having a plurality of annular openings to form a radial spray, as illustrated. In contrast, FIG. 23B illustrates an example of an irrigator tube (2366') in which a linear spray is emitted out of a single nozzle opening at the distal end. This can produce a single jet irrigation spray, as illustrated.

In some instances, as illustrated in FIGS. 24A-24D , the device may be configured to operate such that a single perfusion tube can be used as both a radial spray and a longitudinal (e.g., distal) jet by adjusting the relative position of the perfusion tube outside the distal end of the endoscope and/or overtube. For example, in FIG. 24A , a radial spray perfusion tube (2466) is advanced distally (2468) through an endoscope (2408) that is slightly proximally constricted within the lumen of the overtube (2406), as described above, forming an annular lumen (2463). The perfusion tube (2466) is coupled to a source (2467) of perfusion fluid, which may be a pump or syringe. Once the distal end of the irrigator tube (2466) is extended distally from both the endoscope and the overtube (2406), irrigation fluid can be sprayed radially from the distal end (e.g., nozzle) (2469), as illustrated in FIG. 24b.

The radial spray irrigator tube may also be used to apply a longitudinal stream by retracting the radial spray irrigator tube (2466) proximally into the overtube (2406), as illustrated in FIG. 24c, thereby generating a large distally directed stream (2469'). Alternatively, in some instances, the irrigator tube (2466) may be retractable such that the radial spray nozzle region at the distal end retracts into the endoscope (2408), as illustrated in FIG. 24d, thereby generating a distal stream (2469").

Figures 25a through 25j illustrate different variations of the distal end of the irrigator tube configured as a nozzle region. Figures 25a and 25b illustrate cross-sectional and side perspective views, respectively, of a first distally oriented nozzle. Figures 25c and 25d illustrate cross-sectional and side perspective views, respectively, of a distally (e.g., longitudinally) oriented spray nozzle. Figures 25e and 25f illustrate cross-sectional and side perspective views, respectively, of a combination radial and distal spray nozzle. Figures 25g and 25h illustrate cross-sectional and side perspective views, respectively, of a radial spray nozzle. Figures 25i and 25j illustrate 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 stream). These nozzle regions may be formed on the perfusion tube, or they may be attached to the distal end of the perfusion tube. In some cases, the nozzle regions may be formed by molding, printing (3D printing), laser cutting, etc.

Figures 26a through 26h illustrate side views of various additional examples of nozzle regions of a perfusion tube as described herein. Different perfusion tubes may be used to achieve a variety of different spray patterns. As described above in Figures 24c and 24d, any of these perfusion tubes may be converted into forward (e.g., lateral) flow perfusion tubes by retracting them into the overtube and/or endoscope.

In addition to the perfusion tubes described herein, these other accessories may likewise be included. For example, any of these devices may be used with (e.g., in conjunction with) one or more suction tubes, as illustrated in FIG. 28 and described above. For example, the suction tube (2889) may be inserted through an endoscope (e.g., a working channel of an endoscope) and/or an overtube, including a working channel within an inner lumen and/or an outer working channel. The suction tube (2889) may include one or more openings (2887) into the device, as illustrated in FIG. 28. In this example, the suction tube is a 6 mm disposable suction tube.

All publications and patent applications mentioned in this specification are incorporated herein 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 understood that any combination of the concepts described above with additional concepts described in more detail below (unless such concepts are mutually inconsistent) is considered part of the inventive subject matter disclosed herein and can be utilized to achieve the advantages described herein.

Any of the methods described herein (including user interfaces) may be implemented as software, hardware, or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions executable by a processor (e.g., a computer, tablet, smartphone, etc.) that, when executed by a processor, cause the processor to perform any of the steps including, but not limited to: displaying, communicating with a user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, etc. For example, any of the methods described herein may be performed, at least in part, by a device that includes one or more processors having a memory storing a non-transitory computer-readable storage medium storing a set of instructions for the process(es) of the method.

Those skilled in the art will recognize that any process or method disclosed herein can be modified in numerous ways. The process parameters and sequences of steps described and/or illustrated herein are provided solely as examples and may be modified as desired. For example, while steps illustrated and/or described herein may be depicted or described in a particular order, these steps do not necessarily need to be performed in the order depicted or illustrated.

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

A processor as described herein may be configured to perform one or more steps of any method disclosed herein. Alternatively, or in combination, the processor may be configured to combine one or more steps of one or more methods disclosed herein.

When a feature or element is referred to as being "on" another feature or element, it will be understood that it may be directly on the other feature or element, or that intervening features and/or elements may also be present. Conversely, when a feature or element is referred to as being "directly on" another feature or element, no intervening features or elements are present. When a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, it will also be understood that the feature or element may be directly connected, attached, or coupled to the other feature or element, or that intervening features or elements may be present. Conversely, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, no intervening features or elements are present. Although described or illustrated with respect to one embodiment, features and elements so described or illustrated may be applicable to other embodiments. It will also be understood by those skilled in the art that a reference to a structure or feature positioned "adjacent" to another feature may have portions that overlap or underlie the adjacent feature.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present invention. For example, when used herein, the singular forms "a," "an," and "the" are intended to include the plural as well, unless the context clearly dictates otherwise. It will also be understood that the terms "comprises" and/or "comprising," when used herein, describe the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The term "and/or," when used herein, includes any and all combinations of one or more of the associated listed items and may be abbreviated as "/."

Spatially relative terms such as "below," "under," "lower," "bottom," "above," and the like may be used herein for ease of description to describe the relationship of one element or feature to other element(s) or feature(s) as depicted in the drawings. It will be understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the drawings. For example, if the device in the drawings were flipped, an element described as being "below" or "beneath" another element or feature would then be oriented "above" the other element or feature. Thus, the exemplary term "below" can encompass both above and below orientations. The device may be oriented in other ways (rotated 90 degrees or in other orientations), and the spatially relative descriptors used herein would be interpreted accordingly. Similarly, the terms "upward," "downward," "vertically," "horizontally," and the like are used herein for descriptive purposes only, unless specifically indicated otherwise.

Although the terms "first" and "second" may be used herein to describe various features/elements (including steps), 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 present invention, a first feature/element described below could be referred to as a second feature/element, and similarly, a second feature/element described below could be referred to as a first feature/element.

In general, any device and method described herein should be understood to be comprehensive, although all or a subset of the components and/or steps may alternatively be exclusive and may be described as “consisting of” or alternatively “consisting essentially of” various components, steps, subcomponents or substeps.

As used herein in this application and claims, including as used in the examples, and unless expressly stated otherwise, all numbers may be read as if they were preceded by the word "about" or "approximately," even if that term does not explicitly appear. The phrases "about" or "approximately" may be used when describing magnitudes and/or positions to indicate that the stated value and/or position is within a reasonably expected range of values and/or positions. For example, a numerical value may have a value of +/- 0.1% of the stated value (or range of values), +/- 1% of the stated value (or range of values), +/- 2% of the stated value (or range of values), +/- 5% of the stated value (or range of values), +/- 10% of the stated value (or range of values), etc. Any numerical value provided herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range recited herein is intended to include all subranges subsumed therein. When a value is disclosed, it is also understood that the value "less than or equal to," "greater than or equal to," and possible ranges between the values are also disclosed, as would be appropriately understood by one of ordinary skill in the art. For example, if the value "X" is disclosed, "less than or equal to" X is also disclosed, as well as "greater than or equal to X" (e.g., where X is a numerical value). It is also understood that throughout this application, data is provided in a number of different formats, and that the data represents endpoints and starting points and ranges for any combination of data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, it is understood that values greater than, greater than, less than, less than, and equal to 10 and 15, as well as values from 10 to 15, are also considered disclosed. It is also understood that each unit between the two particular units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

While various exemplary embodiments have been described above, any number of modifications may be made to the various embodiments without departing from the scope of the present invention as set forth in the claims. Optional features of various device and system embodiments may be included in some embodiments but not in others. Accordingly, the foregoing description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the present invention as set forth in the claims.

The examples and illustrations contained herein are illustrative, not limiting, of specific embodiments in which the subject matter may be practiced. As noted, other embodiments may be utilized and derived therefrom, and structural and logical substitutions and modifications may be made without departing from the scope of the present disclosure. These embodiments of the present subject matter may be referred to herein, individually or collectively, by the term "invention" merely for convenience, and if more than one is actually disclosed, the scope of the present application is not intended to be voluntarily limited to any single invention or inventive concept. Accordingly, while specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. The present disclosure is intended to cover any and all adaptations or variations of the various embodiments. Combinations of the above embodiments and other embodiments not specifically described herein will become apparent to those skilled in the art upon reviewing the above description.

Claims (56)

A method of removing substances from a patient's body,
A step of positioning a distal end of a rigid overtube adjacent to a material with the endoscope extending distally from the distal end, wherein the rigid overtube concentrically surrounds the length of the endoscope so that the overtube and the endoscope form an annular lumen;
A step of retracting the distal end of the endoscope proximally into the distal end region of the rigid overtube;
A method comprising the step of applying suction through the annular lumen to aspirate material into the annular lumen and around the endoscope. A method, in claim 1, further comprising the step of transforming the rigid endoscope from a more flexible configuration to a more rigid configuration before retracting the endoscope proximally into the distal end region of the rigid overtube when positioning the distal end adjacent to the material. A method, further comprising the step of visualizing the substance using an endoscope while applying suction in the first aspect. A method, further comprising the step of applying perfusion to the distal side of the distal end of the overtube in the first paragraph. A method according to claim 4, wherein the step of applying the perfusion comprises the step of applying a spray of fluid from a fluid line of the overtube. In claim 4, the step of applying perfusion comprises extending the perfusion tube distally outside the distal end of the endoscope and applying perfusion from the perfusion tube into the body. In the fifth paragraph, the method comprises a radial perfusion device. In claim 4, the step of applying perfusion comprises switching between radial perfusion and distal perfusion application by extending or retracting a radial perfusion tube relative to the distal end of the endoscope. A method, further comprising the step of moving the endoscope axially within the overtube while applying suction in the first aspect. A method, further comprising the step of moving the endoscope axially within the overtube while positioning the overtube in the first aspect. A method, further comprising the step of steering a distal end region of the endoscope independently of the overtube in the first aspect. A method in claim 1, wherein the step of positioning the overtube comprises the steps of advancing and steering the endoscope distally from the overtube, rigidifying the overtube, de-rigidifying the overtube, and advancing the overtube distally over the endoscope. A method in claim 1, wherein the proximal end of the overtube is sealed so as to be movable around the endoscope. In the first aspect, the method, wherein the annular lumen has a cross-sectional area of 40 mm ² to 200 mm ² . A method according to claim 1, wherein the positioning step comprises positioning the overtube within the patient's gastrointestinal tract. A method according to claim 1, wherein the step of removing a substance from the body comprises the step of removing one or more of feces, blood, and food debris. A method, further comprising the step of unblocking the annular lumen by repeatedly moving the endoscope distally and proximally within the overtube while applying suction through the annular lumen in the first aspect. A method, further comprising the step of releasing the overtube from the body wall by opening an air relief valve in fluid communication with the annular lumen while applying suction through the annular lumen in the first embodiment. A method of removing substances from a patient's body,
A step of positioning the distal end of the endoscope adjacent to the material;
The step of positioning the distal end of the overtube extending over the endoscope adjacent to the distal end of the overtube in a flexible configuration such that the overtube transitions from an extension configuration in which the endoscope extends distally relative to the overtube to a contraction configuration in which the distal end of the endoscope is concave within the distal end region of the overtube such that the overtube concentrically surrounds the endoscope to form an annular lumen;
A step of converting the overtube from a flexible configuration to a more rigid configuration; and
A method comprising the step of applying suction through the annular lumen to aspirate material into the annular lumen and around the endoscope. A method of removing substances from a patient's body,
A step of positioning the distal end of the endoscope adjacent to the material;
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 the flexible configuration, and positioning the distal end of the endoscope within the distal end region of the overtube such that the overtube concentrically surrounds the endoscope to form an annular lumen, thereby allowing visualization of the exterior of the distal end of the overtube by the endoscope;
A step of converting the overtube from a flexible configuration to a more rigid configuration; and
A method comprising the step of applying suction through the annular lumen to aspirate material into the annular lumen and around the endoscope. It is a suction overtube device,
An elongated body having an internal lumen extending from a distal end to a proximal end, wherein the elongated body is configured to transform between a flexible configuration and a more rigid configuration by application or release of pressure within a wall of the elongated body;
A rigidifier port configured to receive positive and/or negative pressure to convert the elongated body from a flexible to a rigid configuration;
A proximal end region comprising an endoscope receiving port configured to receive an endoscope therethrough into the inner lumen, the endoscope receiving port being in series with the inner lumen of the elongated body; and
A device comprising a vacuum port located in the proximal end region and in fluid communication with the internal lumen. In claim 21, the distal end opening of the overtube is tapered. In claim 21, the device comprises a rigidifying layer comprising a plurality of intersecting strand lengths, and a compression layer configured to compress the rigidifying layer into a more rigid configuration. A device further comprising a seal configured to seal around the endoscope at the proximal side with respect to the vacuum port in claim 21. A device in claim 21, wherein the proximal end region further comprises one or more sealing gaskets configured to seal around the endoscope. A device in claim 21, wherein the inner lumen has a cross-sectional area greater than 10 mm ² . In claim 21, the device is a part of an adapter configured to be coupled to the proximal end of the elongated body, 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. A device in claim 21, wherein the elongated body has sufficient hoop strength to withstand a negative pressure of at least 760 mm Hg within the internal lumen. A device in claim 21, wherein the elongated body further includes an internal coil winding tube. In claim 21, the device comprises a long body including a braided tube. A device further comprising a control unit including a biased valve configured to regulate the admission of suction through the internal lumen, in claim 21. In claim 31, the control unit is in series with the vacuum port, the device. In claim 31, the device comprises a control unit including a trumpet valve. In claim 21, the device has a distal end opening of the overtube having an inner diameter smaller than the inner diameter of the inner lumen. A device further comprising an endoscope in claim 21. A device according to claim 21, further comprising one or more irrigators configured to pass through the lumen of the endoscope. In claim 36, the device comprises at least one perfusion device comprising a radial perfusion device. A device further comprising a suction piping configured to connect the vacuum port to a negative pressure source, and a control unit including a valve configured to control the application of suction through the internal lumen. A device according to claim 21, further comprising one or more external channels extending along the length of the elongated body. It is a suction overtube device,
An elongated body having an internal lumen extending from a distal end to a proximal end, wherein the elongated body comprises a plurality of layers and is configured to transition from a flexible configuration to a more rigid configuration upon application of pressure to the plurality of layers;
A proximal end region comprising an endoscope receiving port configured to receive an endoscope therethrough into the inner lumen, the endoscope receiving port being in series with the inner lumen of the elongated body; and
A stiffener port configured to receive positive and/or negative pressure to stiffen the elongated body;
a vacuum port located in the proximal end region and in fluid communication with the internal lumen; and
A device comprising a control unit coupled to a vacuum port configured to apply suction through the internal lumen from the vacuum port when the control unit is actuated by a user. It is a suction overtube device,
An elongated body having an internal lumen extending from a distal end to a proximal end, wherein the elongated body comprises a plurality of layers, the elongated body having sufficient hoop strength to withstand a vacuum of at least 760 mmHg, and wherein the elongated body is configured to transition from a flexible configuration to a more rigid configuration upon application of positive and/or negative pressure to the plurality of layers;
A proximal end region comprising an endoscope receiving port configured to receive an endoscope therethrough within the inner lumen and one or more seals configured to seal around the endoscope, wherein the endoscope receiving port is in series with the inner lumen of the elongated body;
A stiffener port configured to receive positive and/or negative pressure to stiffen the elongated body; and
A device comprising a vacuum port located in the proximal end region and in fluid communication with the internal lumen. It is a method of removing substances from the body.
A step of 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 such that the proximal end of the overtube is sealed so as to be movable around the endoscope;
A step of positioning the distal end of the overtube adjacent to the material to be removed; and
A method comprising applying suction through a lumen of the overtube from a port in a proximal end region of the overtube while imaging outward from the distal end of the overtube from the endoscope as the user activates the control to draw material into the overtube and around the endoscope. A method, further comprising applying a spray of fluid from an endoscope or from a fluid line within the lumen of the overtube, in claim 42. A method, further comprising the step of coupling a suction source to a port in a proximal end region of the overtube, in claim 42. In claim 42, the step of positioning the distal end of the overtube comprises the step of positioning the distal end of the endoscope adjacent to the material to be removed. A method comprising the step of retracting the endoscope proximally into the overtube prior to applying suction through the port in claim 42. A method according to claim 42, wherein the material comprises feces, blood and food debris. A method, further comprising the step of moving the endoscope axially within the lumen of the overtube without breaking the seal while positioning the overtube in claim 42. In claim 42, the step of applying suction through the lumen of the overtube from a port in the proximal end region of the overtube comprises the step of maintaining suction while the user manipulates the control unit and discontinuing application of suction when the user stops manipulating the control unit. In claim 42, the step of applying suction through the lumen of the overtube from a port in the proximal end region of the overtube while the user activates the control unit comprises the step of applying suction while the user activates the trumpet valve. A method, further comprising the step of steering the distal end region of the endoscope independently of the overtube in claim 42. A method according to claim 42, further comprising the step of stiffening the overtube prior to applying suction. A method in claim 42, wherein the step of advancing the overtube and the endoscope comprises the steps of advancing and steering the endoscope distally from the overtube, rigidifying the overtube, de-rigidifying the overtube, and advancing the overtube distally over the endoscope. It is a method of removing substances from the body.
A step of 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 as to be movable around the endoscope;
A step of positioning the distal end of the endoscope adjacent to the material to be removed;
A step of positioning the distal end of the overtube adjacent to the distal end of the endoscope and positioning the distal end of the endoscope within the distal end region of the overtube such that the endoscope images distally outside the distal end region of the overtube; and
A method comprising the step of applying suction through a lumen of the overtube from a port in a proximal end region of the overtube to draw material into the overtube and around the endoscope. It is a method,
The step of positioning the endoscope within the body area;
A step of extending the perfusion tube distally outside the lumen of the endoscope;
A step of delivering a radial spray of a perfusion fluid through a perfusion tube; and
A method comprising the step of retracting the perfusion tube proximally to deliver a longitudinal stream of perfusion fluid. It is a method,
A step of positioning an endoscope and an overtube concentrically surrounding the endoscope within a region of the gastrointestinal (GI) tract, wherein the endoscope is within the suction lumen of the rigid overtube;
A step of extending the perfusion tube distally outside the endoscope lumen and distally outside the overtube while the overtube is maintained in a rigid configuration;
A step of delivering a radial spray of perfusion fluid through a perfusion tube;
A step of retracting the perfusion tube proximally to deliver a longitudinal stream of perfusion fluid; and
A method comprising the step of applying suction through the suction lumen of the overtube to remove the perfusion fluid.