CN121152592A

CN121152592A - Large-aperture suction outer tube

Info

Publication number: CN121152592A
Application number: CN202480030628.8A
Authority: CN
Inventors: 杰西卡·科赫; 范伟利; 凯尔·伊马塔尼; 尼拉杰·A·沙阿; 伊莱亚斯·M·埃莉芙特丽娅德斯
Original assignee: Neptune Medical Inc
Current assignee: Neptune Medical Inc
Priority date: 2023-05-05
Filing date: 2024-05-06
Publication date: 2025-12-16
Also published as: WO2024233497A1; AU2024268679A1

Abstract

A large bore suction overtube device includes an inner lumen configured to receive an endoscope and apply suction therearound to remove material from a body. In some cases, the endoscope is removed, while in other cases, the endoscope need not be removed. Methods are also described herein.

Description

Large aperture suction outer sleeve

Priority claim

This patent application claims priority from U.S. provisional patent application No. 63/500,343 entitled "LARGE BORE SUCTION OVERTUBE (large bore suction outer sleeve)" filed on 5/5 of 2023, which is incorporated herein by reference in its entirety.

Background

Devices for capturing and retrieving thrombus and debris from the gastrointestinal tract or other body area may include aspiration catheters and may be used for a variety of procedures that may be performed in a less invasive manner to reach a remote location within the patient's body. These procedures may include accessing the gastrointestinal system, vascular system, abdominal cavity, lung, female genital tract, or urinary tract of a patient.

In some cases, it may be beneficial to use a mirror (generally referred to herein as an "endoscope") to aid in the removal of materials, including blood clot materials. The endoscope may include one or more working channels and/or aspiration channels, and may be used to visualize clot material. In some cases, the endoscope may include mechanical devices for assisting in removing and/or disrupting (e.g., impregnating) the clot. Further, tools may be used through the working channel(s). However, the effectiveness of the endoscope may be limited, in part, due to the size of the aspiration channel and the size and tissue of the material (i.e., the clot may be too large and too hard relative to the working channel diameter). Other examples of problems with the current technology include the required or even the ability to access the occlusion site due to looping of the endoscope in the anatomy. There is a need for devices and methods that allow for rapid access and optimization of aspiration of materials (e.g., clot material, stool, food, etc.) from within the body. The apparatus and methods described herein fully address these issues.

SUMMARY

Described herein are methods and apparatus (e.g., devices, accessories, systems, etc., including a suction sleeve (overtube)) for removing material (e.g., feces, blood clots, debris, cleaning fluids, etc.) from a body. These removal devices may include an aspiration outer cannula adapted for efficient and intuitive use with one or more mirrors (e.g., endoscopes). These methods and devices may be referred to as suction overtube and may generally include an elongate body that may be highly flexible but reinforced (to withstand a range of applied suction forces) and a proximal end that is adapted to receive an endoscope into the lumen of the overtube while allowing the endoscope to move longitudinally (proximally/distally) within the lumen while maintaining a sufficient seal so that suction may be applied proximally to provide suction at the distal end of the overtube. The outer sleeves described herein may be configured to have the same stiffness or different relative stiffnesses. In some examples, the device may be configured to have various different rigidities along the length of the outer sleeve. For example, the distal region may be progressively more flexible than the proximal region.

For example, the suction cannula device may include an elongate 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 into the interior lumen therethrough, wherein the endoscope receiving port is in series with the interior lumen of the elongate body, a vacuum port in fluid communication with the interior lumen at the proximal end region, and a control member controlling flow into the vacuum port and configured to apply suction through the vacuum port when the control member is held actuated by a user.

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

As described above, the overtube device can generally include a seal configured to seal around the endoscope, which can be proximate to the vacuum port. For example, the proximal 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 (e.g., slide) proximally and distally relative to the lumen of the overtube device. In some examples, the seal may be adjustable such that it may be relaxed, e.g., to allow the mirror to more easily move proximally and distally, and may be activated or tightened, e.g., before and/or during application of suction through the lumen of the outer cannula. The seal may be an annular seal such as, but not limited to, an O-ring or a flat and thin elastomeric seal. Any of these seals may be lubricated or coated to reduce sliding resistance.

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

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

In general, these devices may be configured to withstand (i.e., not leak or have no structural collapse) a target range of negative pressure. For example, the device may be configured to withstand a negative pressure of at most 760mmHg (e.g., a negative pressure of at most 700mmHg, a negative pressure of at most 600mmHg, a negative pressure of at most 500mmHg, etc.). For example, the elongate body may have a hoop strength sufficient to withstand at least a target pressure range within the internal lumen (e.g., a negative pressure of up to about 760mmHg, a negative pressure of 700mmHg, a negative pressure of 600mmHg, a negative pressure of 500mmHg, a negative pressure of 400mmHg, etc., the device may be configured to withstand a hoop strength of about 0.2atm, 0.4atm, 0.6atm, 0.8atm, or full atm or more).

In any of these examples, the elongate body may be reinforced. The one or more layers forming the elongate body of 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 coil reinforcement tube. The coil may be, for example, a helical coil formed from a material exhibiting high compressive and/or tensile strength. This may be threads, polymers, composite fibers, yarns made of natural or man-made materials (including reinforced with rigid resin materials such as epoxy resins), metals, metal alloys, composite materials, minerals, polymeric materials, natural fibers, etc. In some cases, it may be a fiber, including, for example, an aramid (Kevlar, twaron, technora), vectran, UHMWPE (Dyneema or Spectra), zylon, nylon, polyester, or carbon fiber. In some cases, it may be formed from a composite of multiple materials. In some cases, it may be formed of a metal, including, for example, nitinol, steel or plated steel, stainless steel alloys, magnesium alloys, tantalum, cobalt chromium alloys, and the like. The coils may be wound in a single direction or in more than one direction (e.g., clockwise and/or counterclockwise). Thus, the elongate body may comprise an inner coil wound tube.

As described above, the device may include one or more controls that may be coupled to the vacuum port to control the application of suction. For example, the control may be a button, slider, knob, valve, dial, lever arm, switch, trigger, or the like. In some examples, the control may be a biased valve. Typically, the control member may be biased to maintain the vacuum port in the closed position such that suction is not applied unless the control member is maintained in an activated state (e.g., the retention force resists the bias). In some cases, the valve may be directly actuated, while in other cases, the valve may be electronically or remotely actuated and then actuated by an actuator (e.g., motor, rotary actuator, linear actuator, solenoid, etc.).

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

Typically, the distal end of the outer sleeve may be tapered. For example, the distal end of the outer cannula may have a diameter that is a fraction of the inner diameter of the more proximal region of the lumen of the outer cannula. For example, the diameter of the opening may be between about 97% and 50% of the inner diameter of the lumen of the outer cannula (e.g., less than 90%, less than 85%, less than 80%, less than 75%, less than 70%, less than 65%, less than 60%, etc.). Thus, the distal opening of the outer cannula may be constricted.

The distal opening of the overtube can have an outer diameter that is substantially the same as or greater than the outer diameter of the distal end of the endoscope. For example, the distal opening of the outer sleeve can have an opening diameter that is about 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 may include an endoscope (e.g., as part of a system).

Generally, any of these devices can have an internal lumen with a cross-sectional area greater than about 10mm ² (e.g., greater than about 12mm ²、15mm²、20mm²、25mm²、30mm²、50mm²、70mm², etc.).

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

In any of the devices described herein, the outer sleeve and/or endoscope may be configured to be rigidized. For example, the elongate body of the outer sleeve may be configured to be rigidized. The outer cannula may be configured to be partially or fully rigidized, in some examples, the outer cannula is configured such that only one region (e.g., a proximal region) may be rigidized. In some examples, the distal portion (e.g., about 4.5 inches, 5 inches, 6 inches, 7 inches, etc. on the distal-most side) may be configured not to rigidify, but may remain flexible. This may allow the device to be more easily steered over a steerable endoscope. In some examples, the elongate body includes a rigidizer including a plurality of strand segments that intersect one another and a compression layer configured to be actuated to apply a force to the rigidizer to rigidize the rigid outer sheath from the flexible configuration to the rigid configuration. Examples of rigidizer may be found in U.S. patent No. 11,135,398 (titled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES (dynamic rigidized composite medical structure)"), U.S. patent application No. 17/604,203 (also titled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES (dynamic rigidized composite medical structure)"), PCT/US2021/024582 (titled "LAYERED WALLS FOR RIGIDIZING DEVICES (layered wall for rigidizer)"), and the like, PCT/US2021/034292 (referred TO as "RIGIDIZING DEVICES (rigidizer)"), PCT/US2022/014497 (referred TO as "DEVICES AND METHODS TO PREVENT INADVERTENT MOTION OF DYNAMICALLY RIGIDIZING DEVICES (apparatus and method for preventing accidental movement of a dynamic rigidizer)"), PCT/US2022/019711 (referred TO as "CONTROL OF ROBOTIC DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES (control of a robotic dynamic rigidized composite medical structure)"), and METHODS of making and using the same, U.S. provisional patent application No. 63/265,934 (titled "METHODS AND APPARATUSES FOR REDUCING CURVATURE OF A COLON (method and apparatus for reducing colon curvature)"), U.S. provisional patent application No. 63/296,478 (titled "RECONFIGURABLE STRUCTURES (reconfigurable structure)"), U.S. provisional patent application No. 63/308,044 (titled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES (dynamic rigidifying composite medical structure)"), and, U.S. provisional patent application No. 63/324,011 (titled "METHODS AND APPARATUSES FOR NAVIGATING USING A PAIR OF RIGIDIZING DEVICES (method and apparatus for navigating a rigidized device)"), U.S. provisional patent application No. 63/342,618 (titled "EXTERNAL WORKING CHANNELS FOR ENDOSCOPIC DEVICES (external working channel for endoscopic device)"), a method of navigating a rigidized device, and a device for navigating an endoscope, U.S. provisional patent application No. 63/335,720 ("HYGIENIC DRAPING FOR ROBOTIC ENDOSCOPY (sanitary covering for robotic endoscope)") and U.S. provisional patent application No. 63/332,686 (titled "MANAGING AND MANIPULATING A LONG LENGTH ROBOTIC ENDOSCOPE (managing and manipulating long length robotic endoscope)"), the features of either of which may be included as part of the overtube and/or endoscope described herein, each of which is incorporated herein by reference in its entirety.

Any of these devices may include a source of negative pressure (e.g., vacuum), such as a pump or the like. The apparatus may include control circuitry (e.g., a controller including hardware, software, and/or firmware for controlling suction, such as a suction manifold with one or more valves). Alternatively or additionally, the device may be configured to operate using wall suction (e.g., centrally applied suction). The devices described herein may include a suction catcher (e.g., to capture liquid and/or solids, including one or more filters and filter and remove solids from liquid suctioned by the outer cannula). The apparatus may comprise a conduit.

Any of these devices may be configured to apply positive pressure. For example, in some examples, any of these devices may be configured to apply positive pressure to unblock the lumen of the outer cannula. In addition to negative pressure, the control circuitry may be configured to control the application of positive pressure (e.g., for unclogging).

Any of these devices may be configured or adapted to be coupled to apply suction through one or both of the lumen of the outer sleeve and/or the aspiration lumen of the endoscope. For example, the device may include a connector and a control to couple to the vacuum port of the outer sleeve and the endoscope suction tube.

Also described herein are methods of removing material from a body using any of the devices described herein. For example, a method of removing material from a body may include distally advancing an overtube and an endoscope within the body, wherein the endoscope is inserted into a lumen of the overtube through a proximal port of the overtube such that a proximal end of the overtube is movably sealed around the endoscope, positioning a distal end of the overtube adjacent to the material to be removed, and applying suction from a port at the proximal end of the overtube (e.g., optionally on a side of a distal region of the overtube or an adapter on the overtube) through the lumen of the overtube, while a user activates a control to aspirate surrounding material into the overtube and around the endoscope.

For example, a method of removing material from a body may include inserting an endoscope into a lumen of an overtube through a proximal port of the overtube such that a proximal end of the overtube is moveably sealed around the endoscope, positioning a distal end of the endoscope adjacent to the material to be removed, positioning a distal end of the overtube adjacent to a distal end of the endoscope, withdrawing the endoscope proximally into the overtube, and applying suction from a port at the proximal end of the overtube through the lumen of the overtube while a user activates a control to aspirate surrounding material into the overtube and around the endoscope. Suction may be applied within the outer cannula, within the working channel, alone or both.

Any of these methods may include coupling a suction source to a port at a proximal end region of the outer cannula.

In some examples, the methods described herein may use an endoscope at an initial location near (e.g., adjacent to) the material to be removed. The endoscope may use imaging integrated with or associated with the endoscope to identify material to be removed within the body, and in some examples, the endoscope may extend distally from the distal opening of the overtube. The device may be advanced with the endoscope extending distally out of the overtube, or once the endoscope is positioned, the endoscope may be advanced distally alone and the overtube may be advanced alone. Any combination of these movements may be performed by advancing the endoscope distally while the overtube remains more proximal, advancing (or withdrawing) both the endoscope and overtube distally together, holding the endoscope relatively stationary (relative to the patient's body), and advancing (or withdrawing) the overtube relative to the endoscope.

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

Any of these methods may include proximally withdrawing the endoscope into the outer sleeve prior to applying suction through the port. For example, the endoscope may be withdrawn proximally so that it does not block the opening into the lumen of the outer sleeve, and furthermore, this may advantageously allow the material to be visualized using the camera of the endoscope as it is withdrawn into the lumen of the outer sleeve. For example, the endoscope can be withdrawn into the lumen of the outer sleeve such that the tip of the endoscope is withdrawn at least 1mm or more (e.g., 2mm or more, 3mm or more, 4mm or more, 5mm or more, 6mm or more, 7mm or more, 8mm or more, 9mm or more, 10mm or more, 15mm or more, etc.). In any of these methods, the material may comprise a clot material. Other materials (e.g., debris, etc.) may also be removed.

Thus, in any of these examples, a material (e.g., clot material or other material) can be drawn into the lumen of the outer cannula by suction, and the endoscope can be bypassed, with the endoscope remaining within the lumen of the outer cannula.

Further, any of these devices and methods of using them may be configured to apply suction on the endoscope to draw material (e.g., a clot) into the outer cannula, after which the user may release the suction on the endoscope (either before or after beginning suction through the inner lumen of the outer cannula) to allow the clot to be sucked by the probe (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 axially moving the endoscope within the lumen of the outer sleeve without breaking the seal while positioning the outer sleeve.

As described above, the methods described herein may include applying suction from a port at a proximal end region of the outer cannula through a lumen of the outer cannula. Typically, when a user operates a control, such as when the user continuously presses or actuates the control, suction may be applied through the outer sleeve (e.g., suction is maintained), and application of suction is stopped when the user stops operating the control. In some examples, the control may include a horn valve, and thus, when the control is activated by a user, applying suction from the port at the proximal end region of the outer sleeve through the lumen of the outer sleeve may include applying suction when the horn valve is activated by the user.

The outer sleeve and/or endoscope may be steerable, such as by mechanical steering (e.g., one or more wires, tendons, etc.), pneumatic steering, electric steering, etc. Generally, any of these methods can include steering the distal end region of the endoscope independent of the outer sleeve.

Any of these methods may include rigidifying either or both of the outer sleeve and the endoscope. For example, any of these methods may include rigidifying the outer sleeve. In some examples, advancing the overtube and the endoscope can include rigidifying the overtube while distally advancing and steering the endoscope from the overtube, rigidifying the overtube, and distally advancing the overtube over the endoscope.

Any of the devices described herein may include or be part of a robotic system. For example, the outer sleeve and/or endoscope (including steerable and/or rigidized outer sleeve and/or endoscope inserted or insertable through the outer sleeve) may be controlled by a robotic system.

For example, described herein are methods of removing material from a patient's body, the method comprising positioning a distal end of a rigidized overtube adjacent the material, an endoscope extending distally from the distal end, wherein the rigidized overtube concentrically surrounds a 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 distal end region of the rigidized overtube, and applying suction through the annular lumen to aspirate the material into and around the annular lumen.

For example, described herein are methods of removing material from a patient's body, the methods comprising positioning a distal end of an endoscope adjacent to the material, positioning a distal end of an overtube extending over the endoscope adjacent to the distal end of the endoscope, wherein the overtube is in a flexible configuration such that the endoscope transitions from an extended configuration extending distally of the overtube to a retracted configuration, wherein the endoscope distal end is retracted into a distal region of the overtube such that the overtube concentrically surrounds the endoscope, thereby forming an annular lumen, transitioning the overtube from the flexible configuration to a more rigid configuration, and applying suction through the annular lumen to draw material into and around the annular lumen.

A method of removing material from a patient's body may include positioning a distal end of an endoscope adjacent to the material, distally advancing a distal end of an overtube on the endoscope while the overtube is in a flexible configuration such that the distal end of the overtube is adjacent to the material, and positioning the distal end of the endoscope within a distal region of the overtube to allow visualization of the distal end of the overtube through the endoscope such that the overtube concentrically surrounds the endoscope, forming an annular lumen, transitioning the overtube from the flexible configuration to a more rigid configuration, and applying suction through the annular lumen to draw material into the annular lumen and around the endoscope.

Any of these methods may include converting the rigidized endoscope from a more flexible configuration when the distal end is positioned adjacent the material to a more rigid configuration prior to proximally retracting the endoscope into the distal end region of the rigidized overtube. The use of a rigidized outer sleeve may provide a number of benefits, including increased stability of the outer sleeve, which may enhance visualization and efficiency of material removal. For example, material may be removed by applying a fluid through an endoscope for general and local removal of material. In a more rigid/less flexible configuration (generally referred to herein as a rigid configuration), the applied spray may remain stable, allowing concentrated application of the cleaning fluid even at lower fluid pressures, which may more effectively remove/clean the material.

In general, these methods may allow visualization from an endoscope while applying suction to remove material. Visualization may be performed by one or more optical subsystems/systems in the endoscope and/or outer sleeve. In some examples, the endoscope can be used to visualize the distal region of the outer cannula and visualize in the body lumen (as viewed through the outer cannula) when suction is applied and/or when fluid (e.g., a cleaning fluid) is applied.

The methods and devices described herein may apply suction through an annular lumen formed between the outer sleeve and the inserted endoscope. When suction is applied, in some cases, the endoscope may be retracted proximally such that the distal end of the endoscope (and thus the camera, working channel, etc.) remains recessed within the distal end region of the outer cannula (e.g., within 10cm, 9cm, 8cm, 7cm, 6cm, 5cm, 4cm, 3cm, 2cm, 1cm, 5mm, etc., and more preferably within 3mm to 4cm of the distal side of the outer cannula suction lumen). The position may be set manually (e.g., by a user moving the overtube relative to the endoscope and/or the endoscope relative to the overtube), or may be set automatically, e.g., by including one or more adapters (e.g., detents, locks, etc.) between the overtube and the endoscope. The proximal seal between the endoscope and the overtube (e.g., at the proximal region) may remain spaced apart because the seal may provide some resistance between the endoscope and the overtube.

In general, the annular lumen around the endoscope and within the outer sleeve is particularly and surprisingly more efficient at removing material (including fecal matter, clot material, etc.) that might otherwise clog more traditional aspiration lumens (including that of the endoscope) as it may help to shear and break the material. In addition, the recessed end of the endoscope within the aspiration lumen (particularly where the distal opening of the outer sleeve tapers inwardly) can further aid in breaking the removed material and preventing clogging. The retracted position of the distal end of the endoscope allows for both visualization (e.g., continuous visualization) and facilitates the creation of aspiration flow, changing aspiration flow rate, and infusion of material drawn into the outer sleeve. In some cases, the retracted position of the endoscope (e.g., between 3mm and 4 cm) may create turbulence within the suction opening into the outer sleeve, which may further aid in removing material and preventing clogging. For example, any of these methods may be configured to include dredging the annular lumen by repeatedly moving the endoscope distally and proximally within the outer sleeve while applying suction through the annular lumen.

Irrigation may be applied from one or both of an overtube, an endoscope, and/or an irrigator extending through the endoscope and/or overtube. For example, a flushing fluid may be applied. Irrigation may be applied before or after suction is applied, such as through an annular lumen. Irrigation may be applied distally of the distal end of the outer cannula. For example, any of these methods may include applying the flushing by applying a fluid spray from a fluid line of the outer sleeve. In some cases, applying the irrigation includes extending an irrigator tube distally out of the distal end of the endoscope and applying the irrigation from the irrigator tube into the body. The irrigator may comprise a radial irrigator. In some cases, the irrigator may comprise a distal irrigator. Alternatively, in some cases, applying the irrigation includes switching between applying the radial irrigation and the distal irrigation by extending or retracting the radial irrigation tube relative to the distal end of the endoscope. Alternatively or additionally, in some cases, applying the irrigation includes applying the irrigation through a fluid line integrated into the endoscope.

Any of these methods and devices may include axially moving the endoscope within the outer sleeve while applying suction. Axially (e.g., distally and proximally) moving the endoscope while applying suction may include axially moving the endoscope between about 1mm and 3cm or more (e.g., between about 1mm and about 3cm, between about 1mm and 2.5cm, between about 1mm and 2cm, between about 1mm and 1.5cm, between about 1mm and 7mm, between about 1mm and 5mm, etc.). The endoscope may move back and forth in linear oscillation, for example, between about 1Hz and 50Hz (e.g., between about 1Hz and 40Hz, between about 1Hz and 30Hz, between about 1Hz and 20Hz, between about 1Hz and 10Hz, etc.). Moving the endoscope within the lumen of the outer cannula while applying suction can help prevent or remove the blockage. Such linear movement of the endoscope relative to the outer sleeve may be particularly effective and safe when the outer sleeve is in a relatively rigid configuration (e.g., rigidized). This may provide stability, allowing for more accurate movement while protecting the body from injury.

Generally, the methods and devices described herein allow for rotational movement of an endoscope within the lumen of an outer sleeve. In some cases, rotation of the endoscope within the overtube (particularly when the overtube is in a rigid configuration) may enhance the operability of the endoscope while minimizing injury to the patient. Generally, these methods can include preventing or removing a clot by rotating an endoscope within a lumen of an overtube (including rotational oscillations of the endoscope within the overtube). The linear and/or rotational movement of the endoscope relative to the outer sleeve may be performed manually, semi-automatically and/or automatically, for example using mechanical assistance.

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

In some cases, positioning the overtube can include rigidifying the overtube while advancing and steering the endoscope distally from the overtube, rigidifying the overtube, and distally advancing the overtube over the endoscope.

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

The methods and devices described herein may be configured such that the cross-sectional area of the annular lumen (suction ring) may be between about 40mm ² and 400mm ² (e.g., between about 40mm ² and 300mm ², between about 40mm ² and 200mm ², between about 40mm ² and 150mm ², etc., between about 40mm ² and 100mm ², etc.).

Any of these methods can include positioning an overtube within the gastrointestinal tract of a patient, including the upper gastrointestinal tract (oroesophageal, gastric, pylorus, bile duct, pancreatic duct, etc.), the small intestine (e.g., small intestine, duodenum, jejunum, ilium, etc.), and/or the lower gastrointestinal tract (rectum, region of colon, e.g., sigmoid colon, descending colon, transverse colon, ascending colon, cecum, ileocecum, etc.). The methods and devices may be configured to remove materials such as, but not limited to, fecal matter, blood, cleaning fluids, food debris, and the like.

The methods and apparatus described herein may also be configured to help separate an apparatus (e.g., an outer cannula) from a wall of a body, which may become coupled to the wall of the body when the device is operated. For example, when suction is applied through the annular lumen, the outer cannula may be drawn onto the wall of the body lumen. It may be particularly advantageous to rapidly reduce or eliminate the suction by releasing the negative pressure (suction) within the annular lumen. For example, any of these methods may include releasing the outer sleeve from the wall of the body by opening an air relief valve in fluid communication with the annular lumen while applying suction through the annular lumen. An air relief valve may be coupled to the inner lumen of the outer cannula distal to the suction port and may be operated in conjunction with application of suction to regulate or release the suction.

Also described herein are apparatuses (e.g., systems, devices, etc.) for performing any of these methods. For example, described herein are aspiration outer cannula devices that may include an elongate body having an interior lumen extending from a distal end to a proximal end, wherein the elongate body is configured to transition between a flexible configuration to a more rigid configuration by application or release of pressure within a wall of the elongate body, a rigidizing port (e.g., a pressure port) configured to receive positive and/or negative pressure to transition the elongate body from the flexible configuration to the rigid configuration, a proximal end region including an endoscope receiving port configured to receive an endoscope into the interior lumen therethrough, wherein the endoscope receiving port is in series with the interior lumen of the elongate body, and a vacuum port at the proximal end region in fluid communication with the interior lumen.

For example, described herein are suction overtube devices comprising an elongate body having an interior lumen extending from a distal end to a proximal end, wherein the elongate body comprises a plurality of layers and is configured to transition from a flexible configuration to a more rigid configuration by applying pressure to the plurality of layers, a proximal end region comprising an endoscope receiving port configured to receive an endoscope into the interior lumen through the proximal end region, wherein the endoscope receiving port is in series with the interior lumen of the elongate body, a rigidizing port (e.g., a pressure port) configured to receive positive and/or negative pressure to rigidize the elongate body, a vacuum port at the proximal end region in fluid communication with the interior lumen, and a control coupled to the vacuum port, the control configured to apply suction from the vacuum port through the interior lumen when the control is actuated by a user.

An aspiration overtube device may include an elongate body having an interior lumen extending from a distal end to a proximal end, the elongate body including a plurality of layers, wherein the elongate body has a hoop strength sufficient to withstand 760mmHg or more vacuum, further wherein the elongate body is configured to transition from a flexible configuration to a more rigid configuration by applying positive and/or negative pressure to the plurality of layers, a proximal region including an endoscope receiving port configured to receive an endoscope into the interior lumen therethrough, and the endoscope receiving port including one or more seals configured to seal around the endoscope, wherein the endoscope receiving port is in series with the interior lumen of the elongate body, a rigidizing port (e.g., a pressure port) configured to receive positive and/or negative pressure to rigidize the elongate body, and a vacuum port in fluid communication with the interior lumen at the proximal region.

The distal opening of the suction outer sleeve may be tapered.

In general, the outer sleeve may be rigid. For example, the elongate body of the outer sleeve may include a rigidized layer including a plurality of strand segments that intersect one another and a compressed layer configured to compress the rigidized layer in a more rigid configuration. Other structures for rigidizing may be used.

Generally, these devices can 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 of the overtube) can include one or more sealing gaskets configured to seal around the endoscope.

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

The devices described herein (including the outer sleeve) may be integrated or modular. For example, in some cases, the endoscope receiving port and the vacuum port may be part of an adapter configured to couple to the proximal end of the elongate body of the outer sleeve. Alternatively, the endoscope receiving port and the vacuum port (including the seal (s)) may be integrated into the outer sleeve.

In general, these devices may be configured such that the outer cannula may withstand inward (negative) pressure within the lumen of the outer cannula without collapsing or otherwise disrupting the function of the outer cannula (including rigidifying, in some examples). The elongate body can have a hoop strength sufficient to withstand at least 700mmHg (e.g., 750mmHg, 760mmHg, 800mmHg, 900mmHg, 100mmHg, etc.) negative pressure within the internal lumen. In some cases, the elongate body further comprises an inner coil wound tube. In some cases, the elongate body comprises a braided tube.

Any of these devices may include other components of the system that may be coupled together, including tubing, suction pumps (vacuum), and the like. In some cases, the device comprises an endoscope. Any of these devices may include controls to regulate the application of suction through the outer sleeve. For example, the control may include a biased valve. The control may be part of a handle (e.g., a hand-held control), a pedal (e.g., a foot pedal), or the like. The control member may be connected in series with the vacuum port. In some cases, the control is coupled to the vacuum port and/or a fluid line (e.g., a pipe) coupled to the vacuum port. For example, any of these devices may include a suction tube configured to connect a vacuum port to a negative pressure source, and a control member configured to control the application of suction through the internal lumen. The control may comprise a horn valve.

The distal opening of the outer cannula may have an inner diameter that is smaller than the inner 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 aspiration lumen of the outer sleeve. For example, the one or more irrigators may include radial irrigators.

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

Also described herein are methods of removing material from a body, comprising distally advancing an overtube and an endoscope within the body, wherein the endoscope is inserted into a lumen of the overtube through a proximal port of the overtube such that a proximal end of the overtube is movably sealed around the endoscope, positioning a distal end of the overtube adjacent to the material to be removed, and applying suction from a port at a proximal region of the overtube through a lumen of the overtube while capturing the distal end of the overtube from the endoscope to draw the material into the overtube and around the endoscope when a user activates a control.

Any of these methods may include applying a fluid spray from an endoscope or from a fluid line within the lumen of an outer cannula. Any of these methods may include coupling a suction source to a port at a proximal end region of the outer cannula.

Positioning the distal end of the outer sleeve may include positioning the distal end of the endoscope adjacent to the material to be removed. The methods may include proximally withdrawing the endoscope into the outer sleeve prior to applying suction through the port. The material may include fecal material, blood, food debris, and the like.

Any of these methods may include axially moving the endoscope within the lumen of the outer sleeve without breaking the seal while positioning the outer sleeve. For example, the method may include applying suction from a port at a proximal end region of the outer cannula through a lumen of the outer cannula including maintaining suction when a user operates the control and ceasing to apply suction when the user ceases to operate the control. Any of these methods may include applying suction from a port at a proximal end region of the outer cannula through a lumen of the outer cannula while the user activates the control, including applying suction while the user activates the horn valve. Any of these methods may include steering the distal end region of the endoscope independently of the outer sleeve. As described above, these methods may optionally include rigidifying the outer sleeve prior to applying suction. For example, the methods may include advancing the overtube and the endoscope, including rigidifying the overtube while distally advancing and steering the endoscope from the overtube, de-rigidifying the overtube, and distally advancing the overtube over the endoscope.

A method of removing material from a body may include inserting an endoscope into a lumen of an overtube through a proximal port of the overtube such that a proximal end of the overtube is moveably sealed around the endoscope, positioning a distal end of the endoscope adjacent to the material to be removed, positioning a distal end of the overtube adjacent to a distal end of the endoscope and positioning the distal end of the endoscope within a distal region of the overtube such that the endoscope images distally outside of the distal region of the overtube, and applying suction from a port at the proximal region of the overtube through the lumen of the overtube to draw material into the overtube and around the endoscope.

Methods of applying a fluid (e.g., cleansing) to a body cavity are also described herein. In particular, these methods may include applying a radial spray (radially around the circumference of the irrigator tube) and/or applying a longitudinal spray or stream (e.g., distally from the distal end of the irrigator tube). In some cases, the same irrigator tube may be configured to operate in conjunction with an endoscope and/or an outer sleeve to switch the applied spray between radial and longitudinal using only the irrigator tube configured to apply radial irrigation. For example, a method as described herein may include positioning an endoscope within a body region, extending a irrigator tube distally out of a lumen of the endoscope, delivering a radial spray of irrigation fluid of the irrigator tube, and proximally withdrawing the irrigator tube to deliver a longitudinal flow of irrigation fluid.

In some cases, the method may include positioning an endoscope and an overtube concentrically surrounding the endoscope within a region of a Gastrointestinal (GI) tract, wherein the endoscope is within an aspiration lumen of the rigidized overtube, distally extending a irrigator tube out of a lumen of the endoscope and out of the overtube while the overtube remains in a rigid configuration, delivering a radial spray of irrigation fluid of the irrigator tube, proximally withdrawing the irrigator tube to deliver a longitudinal flow of irrigation fluid, and applying suction through the aspiration lumen of the overtube to remove the irrigation fluid.

All methods and apparatus described herein (in any combination) can be contemplated herein and can be used to achieve the benefits as described herein.

Brief Description of Drawings

A better understanding of the features and advantages of the methods and apparatus described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings, in which:

fig. 1A illustrates an example of a distal region of one example of a device as described herein, including an outer cannula and an endoscope.

Fig. 1B is an example of the device shown in fig. 1A, showing the proximal end and connection to a source of negative pressure (e.g., suction).

Fig. 1C and 1D illustrate another example of an apparatus (e.g., system) as described herein. Fig. 1D shows an enlarged view of a portion of fig. 1C.

Fig. 2 illustrates one example of an outer sleeve that may be optionally configured as a rigidized outer sleeve as described herein.

Fig. 3A is a section through an example of a rigidifiable outer sleeve that may be rigidified by the application of negative pressure.

Fig. 3B is an enlarged view showing one example of the arrangement of layers within the elongate rigidifiable outer sleeve of fig. 3A.

Fig. 4A is a section through an elongated rigidifiable device (e.g., an outer sleeve) that may be rigidified by the application of positive pressure.

Fig. 4B is an alternative cross-sectional view showing one example of the arrangement of layers within the elongate rigidized outer sleeve apparatus of fig. 4A.

Fig. 5A is an example of a proximal end of a device (e.g., suction adapter) as described herein.

Fig. 5B shows an external view of a suction adapter as described herein.

Fig. 5C shows a section through the suction adapter of fig. 5B.

Fig. 5D shows an end view of the suction adapter of fig. 5B-5C.

Fig. 6A-6C illustrate one example of a valve (e.g., a trumpet valve) that may be included as part of a control for applying suction to a device as described herein. Fig. 6A shows a perspective view of the valve. Fig. 6B-6C show cross-sectional views of the valve of fig. 6A, fig. 6B shows the valve closed (in a resting, unactuated state), and fig. 6C shows the valve open (in an actuated state).

Fig. 7A-7B illustrate examples of adapters configured as threaded adapters. Fig. 7A is a side view and fig. 7B shows a section through the adapter of fig. 7A.

Fig. 8A shows an exploded view of a portion of an adapter (proximal end) similar to that shown in fig. 7A-7B.

Fig. 9 is an example of an integrated rigidized outer sleeve including a proximal endoscope seal and/or an aspiration port.

Fig. 10A-10E illustrate one example of a method of operating a device as described herein.

Fig. 11A-11F illustrate one example of a method of operating a device as described herein.

Fig. 12A schematically illustrates an example of a device as described herein that includes irrigation through an endoscope.

Fig. 12B schematically illustrates an example of a device as described herein that includes flushing through a separate flush line.

Fig. 13A-13B schematically illustrate another variation of the device as described herein, in this example, the vacuum outlet is integrated into the handle.

Fig. 14A-14C illustrate another example of a suction adapter for use with (or integrated into) an outer sleeve as described herein. In fig. 14A-14C, the adapter includes rotary valves shown in different orientations.

15A-15C illustrate examples of controls (e.g., lever valves) for controlling the application of suction as described herein. Fig. 15A-15B illustrate a first example of a lever valve in side view and side perspective view, respectively. Fig. 15C shows another example of a lever valve in a cross-sectional view.

Fig. 16A and 16B illustrate examples of controls (configured as lever valves) for controlling the application of suction as described herein. Fig. 16A shows a side view and fig. 16B shows a cross-sectional view through the lever of fig. 16A.

Fig. 17A-17C illustrate one example of a control (configured as a foot pedal) for controlling the application of suction. Fig. 17A shows a front view, fig. 17B shows a side perspective view, and fig. 17C shows a top perspective view.

Fig. 18A-18B illustrate different examples of bending flexibility of the outer sleeve. Fig. 18A illustrates an outer sleeve having low bending flexibility, and fig. 18B illustrates an example of an outer sleeve having high bending flexibility and high hoop strength as described herein.

Fig. 19 illustrates an example of a distal end region of an outer cannula device having a plurality of suction relief holes.

Fig. 20 illustrates an example of a robotic system including an apparatus as described herein.

Fig. 21A-21B illustrate examples of releasing suction against a body lumen wall using an air relief valve.

Fig. 21C-21D illustrate examples of applying fluid through the aspiration lumen of the outer cannula to remove an occlusion.

Fig. 22A-22C illustrate examples of outer sleeves that include irrigation channels. Fig. 22A illustrates an example of an outer sleeve from which an endoscope extends, the outer sleeve having a plurality of irrigation channels flush with a distal end of the outer sleeve. Fig. 22B-22C illustrate side perspective and side views, respectively, of an outer sleeve from which an endoscope extends, with a plurality of angled irrigation channels extending distally at an angle relative to a distal end of the outer sleeve.

Fig. 23A shows an example of a flusher tube providing a radial spray.

Fig. 23B shows an example of a flusher tube providing a longitudinal spray (e.g., stream).

Fig. 24A-24B schematically illustrate examples of devices including an irrigator tube configured to apply a radial spray. Fig. 24A schematically illustrates a cross-section through the device showing the irrigator tube deployed distally out of the lumen of an endoscope contained within an outer sleeve. Fig. 24B shows the irrigator tube extending distally out of the endoscope and outer sheath to provide radial injection into the body cavity.

Fig. 24C and 24D illustrate the conversion of an applied spray from the radial irrigator tube of fig. 24A-24B into a linear flow. In fig. 24C, the radial spray is converted to a distally directed linear spray by applying the spray from an irrigator tube within the distal end region of the outer cannula but outside the endoscope. In fig. 24D, the radial spray is converted to a distally directed linear spray by applying the spray from an irrigator tube within the lumen of the endoscope.

Fig. 25A-25J illustrate examples of different nozzle types that may be used at the distal end of the irrigator tube to achieve different spray/flow patterns.

26A-26H illustrate examples of different nozzle types that may be used at the distal end of the irrigator tube to achieve different spray/flow patterns.

Fig. 27A-27C illustrate examples of devices (e.g., including an outer sleeve) having one or more external working channels disposed along an outer length of the outer sleeve.

Fig. 28A illustrates an example of a suction tube or tube that may be used with any of the devices described herein.

Detailed Description

Methods of removing material from a patient's body are described herein, including methods of removing debris (e.g., fecal matter), blood, clot material, etc. from a body cavity (e.g., the gastrointestinal tract). In some cases, these methods may be used to clean material from the colon or other body lumen. These methods may be used as part of another procedure, for example, to assist in imaging and/or surgical procedures to treat the colon, for example, as part of a colonoscopy.

These devices (e.g., devices, systems, etc.) may include an outer cannula, which may be referred to herein as an aspiration outer cannula, which may be configured to operate in conjunction with an endoscope. The outer cannula may have an elongate body with an inner lumen extending from a distal end to a proximal end. The outer sleeve may be configured to receive and seal an endoscope within the inner lumen, and may have a proximal end region including an endoscope receiving port configured to receive an endoscope into the inner lumen therethrough. The endoscope receiving port may be in series with the interior lumen of the elongate body and configured to seal around the endoscope to allow the endoscope to move distally/proximally relative to the overtube without significant loss of suction within the interior lumen. Typically, the outer sleeve may further comprise a vacuum port at the proximal end region distal to the seal for the endoscope at the distal end region of the outer sleeve, the vacuum port being in fluid communication with the interior lumen and through which a negative pressure may be applied. The outer sleeve may be configured to withstand the application of negative pressure within the inner lumen while still allowing the endoscope to move within the inner lumen.

In any of these devices, the elongate body may be rigidized (e.g., a rigidized outer sleeve). Thus, the outer sleeve may be configured to transition between the flexible configuration and the more rigid configuration by applying or releasing pressure within the wall of the elongate body. The pressure applied to switch between the rigid and less rigid configurations (e.g., becoming more rigid as pressure is applied) may be positive or, in some cases, negative. Thus, the rigidized outer sleeve may include a rigidized port (e.g., a pressure port) configured to receive positive and/or negative pressure to transition the elongate body from a flexible configuration to a rigid configuration. The rigidized port may be at a proximal region.

In some cases, the outer sleeve may be integrated with the vacuum port and the endoscope receiving port. Alternatively, in some examples, the outer cannula may be separate from and may be coupled to an adapter that includes a vacuum port and an endoscope receiving port.

Thus, in some cases, the methods and devices described herein include an outer cannula that includes an inner lumen configured to receive an endoscope and to receive suction in order to remove material from the body without removing the endoscope. In general, the outer cannula device may include an elongate body having an inner lumen extending from a distal end to a proximal end of the outer cannula. The device may also include a proximal region configured to receive the endoscope such that the endoscope may be moved within an interior lumen of the endoscope (e.g., distally and proximally). The receiving port may be at the proximal end and arranged such that the endoscope may be inserted into the receiving port and into the internal lumen through the receiving port. The devices may also include a vacuum port at the proximal region in fluid communication with the internal lumen. In general, the device may be configured such that a user (e.g., doctor, surgeon, nurse, technician, etc.) may activate and maintain suction through the internal lumen, and may cease applying suction (e.g., when the user no longer activates the controls).

Any of the devices described herein can be configured for one or more of the neurovasculature (e.g., aortic arch, subclavian, carotid, spinal, basal, hindbrain, wilis's loop, midbrain, forebrain, etc.), upper gastrointestinal tract (oroesophageal, gastric, pylorus, biliary tract, pancreatic duct, etc.), small intestine (e.g., small intestine, duodenum, jejunum, ilium, etc.), lower gastrointestinal tract (rectum, colonic region, e.g., sigmoid colon, descending colon, transverse colon, ascending colon, cecum, ileocecum, etc.), urinary tract (urethra, bladder, kidney, ureter, etc.), peripheral vasculature (e.g., thigh, iliac, mesentery, lumbar vertebra, kidney, celiac trunk, liver, chest, etc.), cardiac region (e.g., aorta, right coronary artery, etc.), left heart (e.g., aortic valve, left ventricle, etc.), right heart (e.g., vena cava, right atrium, left atrium, mitral valve, coronary sinus, tricuspid valve, right ventricle, pulmonary valve, pulmonary vascular system, etc.), and/or right pulmonary region (e.g., mouth, laryngeal system, etc.).

The devices described herein may be configured as an integrated outer sleeve comprising a proximal region configured to receive an endoscope and/or a suction port (e.g., a vacuum port) for applying suction through an internal lumen of the outer sleeve, or the devices described herein may be configured to convert an existing outer sleeve (see, e.g., U.S. patent No. 11,135,398 entitled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES (dynamically rigidized composite medical structure)", which is incorporated herein by reference in its entirety). For example, described herein are adapters configured to couple to the distal end of an existing outer cannula to convert it to allow operation of the outer cannula as described herein. In some cases, the outer sleeve may optionally be a rigidized outer sleeve, however, the methods and apparatus may be non-rigidized outer sleeves.

Fig. 1A illustrates an example of a distal end region of a flexible outer sleeve 106, the flexible outer sleeve 106 having a distal end region 110 from which suction may be applied. In this example, the outer sleeve is a rigidized outer sleeve. Endoscope 108 is shown extending distally from the outer sleeve. Fig. 1B illustrates an example of a system including an outer cannula 106, which shows a proximal end region of the outer cannula including an adapter 112 (e.g., a suction adapter) coupled to a proximal end of the outer cannula. The suction adapter portion of the device includes a proximal end region including an endoscope receiving port 114, the endoscope receiving port 114 configured to receive an endoscope 108 therethrough into an interior lumen. An endoscope receiving port is in series with the interior lumen of the elongate body. The suction adapter portion of the device also includes a vacuum port 116, the vacuum port 116 being in fluid communication with the internal lumen and shown connected to the vacuum source 102. Typically, the vacuum port may be connected to a control (not shown in fig. 1B) for controlling the suction through the outer cannula. In some examples, the control includes a valve or clamp that may close when stationary, but may be held open by a user applying an actuation (e.g., pushing, squeezing, grasping, pressing, etc.) to hold the valve open (fully open or selectively more or less open). The valve may be manually operated or the valve may be electronically operated.

In the example shown in fig. 1A and 1B, the outer sleeve is configured as a medium-sized outer sleeve (e.g., having an inner diameter of 14 mm), and the endoscope is shown as a gastroscope (having a tip diameter of about 9 mm). Any suitable size of overtube and endoscope may be used. The apparatus may further include a control coupled to the vacuum port and configured to apply suction through the vacuum port when the control is held actuated by a user (not shown in fig. 1A-1B).

Fig. 1C and 1D illustrate another example of a device (e.g., system) for use with an endoscope 108 that includes an outer sleeve 106 similar to that shown in fig. 1A-1B. The endoscope may be provided with the device or may be supplied separately, for example as a commercial endoscope. The device shown 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 outer cannula. A control 122 is connected to the tubing to turn on/off aspiration through the inner lumen of the outer cannula. In this example, the control is shown as a foot pedal. The control may include one or more valves (e.g., pinch valves) that regulate the applied suction. The outer cannula proximal end also includes an endoscope receiving port 114, the endoscope receiving port 114 configured to receive an endoscope 108 therethrough into the interior lumen. An endoscope receiving port is in series with the interior lumen of the elongate body. Vacuum port 116 is in fluid communication with the interior lumen and is shown connected to vacuum source 102 by tubing 119. In this example, the outer sleeve further includes a rigidized port including a pressure line 144, the pressure line 144 configured to receive positive and/or negative pressure to transition the elongate body from the flexible configuration to the rigid configuration. Also shown in this example is a separate flush/flush line 157 that may provide fluid (e.g., water) into the internal lumen. The device may further comprise a separate pressure source (positive and/or negative pressure) for rigidifying the outer sleeve. In some cases, the same vacuum source 102 (or a duplicate source) may be used.

In general, the outer sleeves described herein may be configured to withstand the application of suction without collapsing. Thus, in general, these devices may have hoop strength capable of withstanding negative pressures up to, for example, 760mmHg (one atmosphere) or more without collapsing. Furthermore, these devices may be configured to maintain a very high degree of flexibility (when in a flexible configuration). For example, in some variations, the outer sleeve includes one or more reinforcement layers including reinforcement coils and/or a braid (e.g., a braided shaft). Any of these devices may include a coil wound reinforcing tube. For example, the reinforced outer layer may be reinforced with a plurality of wires wrapped around (or within) the layer. The inner tube (e.g., inner coil wound tube ICWT) may include one or more reinforcing wires. The inner coil winding tube may be adjacent to other layers. In some examples, even if it is required to withstand high pressures, the overall bending flexibility may be increased by using a low durometer material. For example, the outer sleeve 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 outer sleeve may be made of one or more layers of such low durometer material, 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 torsion stiffening element (e.g., a torsion stiffening layer). The torsion stiffening layer may be integrated into the inner layer and/or the outer layer. Alternatively, it may be free floating so as not to be intentionally attached to an adjacent layer.

The outer sleeves described herein may be any suitable length, but in particular may be long, and may be suitable for use with long ranges (e.g., 50cm or longer, 55cm or longer, 60cm or longer, 65cm or longer, etc.). Shorter or longer lengths may also be included, which may be useful for certain anatomical targets.

Further, the outer sleeve described herein may be configured to be suitable for use with an endoscope and to apply suction to a distal tip region. For example, the distal region of the outer cannula may include an opening into the lumen of the outer cannula through which suction may be applied and through which the endoscope may be positioned. The distal opening of the access sheath may be configured to allow the endoscope to extend out of the sheath and retract into the sheath. In some examples, the distal opening may be narrowed as compared to a more proximal inner diameter of the lumen of the outer cannula. Such narrowing may help center, support and/or guide the endoscope. The narrowing may be, for example, between 98% and 50% of the inner diameter of the more proximal region of the inner lumen of the outer cannula (e.g., between about 98% and 55%, between about 98% and 60%, between about 98% and 65%, between about 98% and 70%, between about 98% and 75%, between about 98% and 80%, etc.).

The distal tip region of the outer cannula including the distal opening may be transparent to allow visualization through the distal end, e.g., by an endoscope, upon retraction into the lumen of the outer cannula. As described above, any of the devices described herein can include a vacuum release opening (e.g., a hole or opening at and/or near the distal end to allow passive venting to prevent aspiration from locking onto tissue (e.g., body wall, etc.).

Any of the outer sleeves described herein may be steerable, particularly at a distal region (e.g., distal region of the outer sleeve). The outer sleeve may be steered by mechanical steering (e.g., wires, ribs, shape memory alloys, etc.), pneumatic (pressure driven steering), electric/magnetic steering, etc.

Optionally, any of the devices described herein may include a rigidifiable outer sleeve and/or an endoscope. For example, the outer sleeve may be controllably convertible between a flexible configuration and a rigid (less flexible) configuration. These devices can be quickly transformed from a flexible configuration (i.e., a relaxed, soft, or floppy configuration) to a rigid configuration (i.e., a configuration that is rigid and/or retains its shape when rigidized). The rigidizer (e.g., outer sleeve) may include multiple layers (e.g., coiled or reinforced layers, sliding layers, rigidizer layers, balloon layers, and/or sealing jackets) that together may form a wall of the rigidizer, which may be referred to as a "layered rigidizer. The rigidizer described herein may be rigidized by clogging particles, by phase changes, by interlocking components (e.g., cables with disks or cones, etc.), or any other rigidizer mechanism. For example, the rigidizer may be transitioned from the flexible configuration to the rigid configuration by applying a vacuum or pressure to or within a wall of the rigidizer. With the vacuum or pressure removed, the layers can be easily sheared or moved relative to each other. Upon application of vacuum or positive pressure, the layers may transition to a state in which they exhibit significantly enhanced resistance to shear, motion, bending, torque and buckling, thereby providing stiffening.

Any of the rigidifiable devices described herein may include a rigidifying layer or region engaged with a compressive layer (which may be or may include a bladder) that applies a force to the rigidifying layer to rigidify the rigidifying layer or, in some cases, to rigidify (e.g., release from) the rigidifying layer. In some examples, the rigidized devices may include a rigidized layer that may include braids, knits, wovens, chopped segments, randomly distributed or randomly oriented filaments or strands, splices, links, scales, plates, segments, particles, granules, cross-filaments, or other materials forming the rigidized layer. For example, the rigidized layer may include a plurality of strand lengths or strand segments that cross each other (e.g., as part of a braid, knit, weave, etc.), and the compression layer may apply a force to drive the crossing strand lengths or strand segments against each other. Although many of the examples shown herein are braids, any of these devices may alternatively or additionally include a generally rigidized layer including intersecting strand lengths or strand segments.

Examples of rigidizing devices described herein may use pressure (positive pressure) and/or negative pressure to selectively and controllably rigidize. In some examples, the methods described herein may be used with any suitable rigidizing device.

An exemplary rigidized outer sleeve device is shown in fig. 2. The illustrated device includes a rigidizer 300 having a wall with a plurality of layers including a rigidizer, an outer layer (in this example, a portion of the outer layer is cut away to show the rigidizer below the outer layer, which in this example is configured as a woven layer), and an inner layer. The system also includes a handle 342, the handle 342 having a vacuum or pressure inlet 344 to supply vacuum or pressure to the rigidizer 300. The actuation element 346 may be used to turn vacuum or pressure on and off, thereby transitioning the rigidizer 300 between a flexible configuration and a rigid configuration. The distal tip 339 of the rigidizer 300 may be lubricious, flexible, and atraumatic to facilitate distal movement of the rigidizer 300 through the body. As described above, the tip may be adapted to be narrow, transparent, etc.

In addition to narrowing radially inward such that the inner lumen opening has an opening diameter that is narrower than the inner diameter of the inner lumen described above, in any of these examples, the outer diameter of the distal tip may be tapered to be atraumatic. For example, the tip 339 may taper (tip) from distal to proximal to further facilitate distal movement of the rigidizer 300 through the body. In this example, the rigidizer is configured as an outer sleeve, but other configurations may be used.

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

The rigidizing device as described herein may be configured to rigidize upon application of negative and/or positive pressure. These rigidizing devices as described herein may be used in combination with other rigidizing devices that are rigidized by other methods, including those that do not rely on the application of positive or negative pressure. For example, the rigidizer may be configured to include a plurality of layers disposed into an elongate catheter-like body. The proximal end of the device may include a handle or other manipulator and may include a connection to one or more pressure sources. The application of pressure from the pressure source may be controlled by a variety of methods, including operation of a handle or an electronic control device. The control may result in a pressure differential that transitions the device between a highly flexible configuration that allows the tubular body to bend easily when steered or otherwise directed (e.g., over a wire, etc.) and one or more (e.g., continuum) rigid configurations. In some examples, particularly (but not exclusively) with respect to devices rigidifying based on the application of positive pressure, the rigidity of the elongate body is proportional to the applied pressure differential such that the greater the pressure differential, the more rigid the device may become over at least a range of pressure differential values.

As described above, these devices may include multiple layers (which may be arranged concentrically around the inner lumen), including a rigidized 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 joined with the rigidized layer, and in some examples, the apparatus may include a combined rigidized layer/compressive layer. Described herein are rigidifying layers that may be particularly well suited for rapid and precise actuation under a variety of pressures, including in particular positive pressures (e.g., high positive pressures, i.e., standard atmospheric pressures (atm) of about 2 or greater, 4 or greater, 6 or greater, 8 or greater, 10 or greater, 15 or greater, 20 or greater, 30 or greater, etc.). Any of these devices may also be configured such that at least some of the inner and/or outer layers comprising the rigidifiable device have different durometers on the inner and outer portions of the inner or outer layers. Devices and methods including nested rigidifying device sets are also described herein, which may include any of these rigidifying devices. Any of these devices may include one or more torsion enhancement layers for improved torsion control, particularly when included as part of a nested pair of rigidifiable devices (e.g., as part of an internal or sub-device).

Fig. 3A illustrates an example of a cross-section through an elongate rigidizer showing an arrangement of many layers that may be included. In this example, the rigidized device 100 is configured to be actuated by the application of negative pressure (e.g., vacuum). The illustrated device 100 includes an inner layer 115 that may be reinforced (e.g., by including one or more reinforcing members, such as helically arranged strips, ribbons, or wires), an optional sliding layer 113, a gap 111, a rigidizer 109 (configured as a braid, a second gap 107, and an outer layer 101 in this example.) these layers surround a central lumen 120. In some examples, a vacuum may be applied between the outer and inner layers to rigidize. 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 the interstitial region 107 between the flexible outer layer 101 and the rigidized layer 109 (e.g., a braid layer). Fig. 3B shows a cross-section through one wall region B of the cylindrical body of the device, applying suction may allow the outer layer 101 to be pulled onto the rigidized layer, rigidized, limiting or preventing bending of the device.

Another example of a rigidized device, such as a rigidized outer sleeve 2100 with an inner lumen 2120, is shown in fig. 4A-4B. In this example, the device may also be elongate, such as a catheter or tubular device, similar to that of fig. 3A-3B, but may be rigidified by the application of positive pressure. For example, fig. 4A shows a cross-section transverse to the long axis of an elongate rigidized device. In this example, the layers forming the device are arranged such that the inner reinforcement layer 2115 is the most radially inward layer, and may be reinforced, for example, by a helically wound tape, 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 outward layer. The sliding layer may be a powder or it may be a layer of lubricating or lubricating material. The first gap 2112 layer is shown separating the inner layer 2115 and/or the sliding layer 2113 from the compression layer, which in this example is configured as a bladder layer 2121. A second (or intermediate) gap layer 2111 separates the bladder layer from the rigidized layer 2109, the rigidized layer 2109 being shown in this example as a woven layer. A third gap layer 2107 is located between the rigidized layer and the outer layer 2101. The outer layer (similar to inner layer 2115) in this example is reinforced, for example, by helically wound filaments, threads, fibers, ribbons, or the like. Although not shown, when actuated by applying positive pressure between the compressed (e.g., bladder) layer and the inner layer, the bladder layer may push the braid layer into the outer layer to rigidize the rigidizer.

The two examples of the devices shown in fig. 3A-3B and fig. 4A-4B may include additional optional layers or components. Furthermore, the composition of the rigidized layer may be modified in order to improve performance. In particular, the rigidized layer may be modified to include structures (e.g., knits, wovens, knits, scales, plates, filament arrays, particles, combinations thereof, and the like) that may enhance or improve performance. The rigidizing element may be used alone as a type or in combination with other rigidizing elements. In some examples, the inner layer and/or the outer layer may be modified to enhance or improve performance, including adding torsion control features and/or adjusting the stiffness of the inner and outer regions of the layers.

As described above, the endoscope may be rigidized in addition to (or in lieu of) the overtube. Generally, the devices described herein are configured to apply suction through the outer sleeve and around an endoscope within the outer sleeve. In some examples, suction may also be applied through the endoscope. The endoscope may be applied to the same source or suction, or to different suction sources. In some examples, the device may be used by first applying suction to the endoscope, for example, to coordinate moving the material to be removed into or near the mouth of the outer sleeve, and then applying suction through the outer sleeve to remove the material. Thus, the combination of suction from the endoscope and suction from the outer sleeve may be coordinated to remove material. In some cases, use may limit the use of the endoscope to bring material to the opening of the overtube to prevent the endoscope from clogging. Any of these methods may alternatively or additionally include a dedicated pressure relief line and/or a pressure relief line for each of the overtube and the endoscope.

In some examples, the device may be configured to apply positive pressure through the endoscope, for example, by applying pressurized fluid through an aspiration lumen or working channel of the endoscope, particularly when the endoscope distal tip is within the lumen of the overtube. This may allow the device to clear an obstruction within the lumen of the endoscope without risk of release of material within the body. Any of these devices may also or additionally include one or more fluid lines that may be inserted into the interior lumen of the outer sleeve separately from (or in some cases in addition to and/or through) the endoscope. Thus, the fluid line may apply a fluid (e.g., water) into the lumen of the outer cannula and/or out of the distal end of the outer cannula. The fluid may be applied as a spray or stream from a nozzle onto the distal region and/or tip of the device. In some examples, fluid may be applied through an irrigation line within the outer cannula to clear a blockage near the proximal end of the outer cannula.

In some examples, the high pressure fluid stream may be used to separate materials, including clots, food, or stool, by applying pressurized fluid through an aspiration lumen or working channel of an endoscope.

The devices described herein may generally form a seal around the endoscope, such as in the region of the overtube (and in some examples in the region of the suction adapter), to maintain a seal around the endoscope such that suction may be applied through the inner lumen of the overtube without substantial suction loss from the proximal end of the endoscope inserted into the overtube lumen.

Fig. 5A illustrates one example of a proximal end of the device, which may be integrated with the outer cannula, or which may be configured as a removable adapter (also referred to herein as a suction adapter) for coupling with the outer cannula (e.g., at coupling region 534) or attachment via a flexible vacuum tube. In fig. 5A, the proximal region of the device (e.g., suction adapter) includes an endoscope receiving port 514 configured to receive an endoscope. The apparatus further includes a vacuum port 516, the vacuum port 516 configured to couple with a vacuum source and apply suction within the interior lumen of the outer cannula. A control 522 may be included in series with the outer sleeve inner lumen and the vacuum port 516. In general, the control 522 may be configured to be controlled by a user to control the suction applied through the outer cannula. As shown in fig. 5A, the control may be coupled to and/or integrated into the outer cannula and/or suction adapter, or it may be separate and connected to a suction source (negative pressure) via a control suction port 516' and/or between the negative pressure source and a vacuum port 516 of the adapter region.

Fig. 5B-5D illustrate examples of suction adapter portions of the device that may be configured as a separate adapter for use with an outer cannula or may be integrated with the outer cannula. Fig. 5B-5C show side views of the adapter region, similar to the adapter region shown in fig. 5A, but without attached or integrated controls (including valves) for controlling the application of suction through the device. As shown 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., elastomeric material) having a seal opening 524 therethrough. The diameter of the sealing opening is smaller than the outer diameter of the endoscope to be inserted into the outer cannula lumen 507. The seal may be lubricated or may be used with a lubricant so that the endoscope can slide within the seal while still retaining the seal to prevent loss of vacuum when suction is applied. Fig. D illustrates a top view of the suction adapter of fig. 5B-5C showing the seal opening 524 of the seal 526 visible through the endoscope receiving port 514. The seal may be coated to enhance lubricity and/or smoothness of sliding (e.g., by a hydrophilic coating or other lubricious coating).

In fig. 5A, the control member includes a valve biased by a biasing member (e.g., a spring) configured to hold the valve in a closed position unless a user applies a force to displace the spring, as shown in the examples shown in fig. 6A-6C described below. In some configurations, the control may include a spring-loaded horn valve 622, examples of which are shown in fig. 6A-6C. Fig. 6A shows an external illustration, while fig. 6B and 6C show a section through the horn valve of fig. 6A in an open (fig. 6B) and closed (fig. 6C) configuration. The valve in this example includes a vacuum port 516 configured to be coupled to a vacuum source and an outlet 536 coupled to the lumen of the outer cannula. The spring-loaded valve mechanism includes a shaft 628 that can be displaced downwardly to open a connection between the vacuum port (and thus the connected vacuum source) and the aspiration lumen outlet 536 when a control input 629 (e.g., button, knob, etc.) is driven downwardly, such as by application of force from a user. For example, the user may press down on the control to compress the spring 631 within the valve to displace the shaft 628, thereby creating a connection that allows suction from the suction port and out of the distal end of the suction lumen of the outer cannula. In fig. 6B, the control 622 with valve is shown in a closed (stationary) configuration. Shaft 628 includes a pair of seals 633, 635, seals 633, 635 being configured to prevent leakage from between vacuum port 516 and aspiration lumen outlet 536. In fig. 6C, the valve of the control member is shown in an open (actuated) configuration, for example, when the actuator (control input 629) is depressed, compressing the biasing member (spring 631) and displacing the shaft 628 within the valve to form a connection between the aspiration lumen outlet 536 and the vacuum port 516.

Fig. 7A-7B illustrate another example of an adapter 722 for attaching to the proximal end of the outer sleeve to convert it into a means for sealingly receiving an endoscope and applying suction through the outer sleeve. In fig. 7A, the example shown is configured to include two portions, a proximal portion 779 and a distal portion 778, configured to mate together. In this example, a distal portion 778, which may be coupled to or integrated with the elongate body of the outer cannula (e.g., via coupling region 734), is configured with a threaded engagement 781 that mates with a channel or complementary region on the distal portion. The distal portion further includes an endoscope receiving port 714 and a vacuum port 716, the endoscope receiving port 714 configured to receive an endoscope, the vacuum port 716 configured to couple with a vacuum source (and/or controller) and apply suction within the interior lumen of the outer cannula. A separate controller (e.g., foot pedal, manual control, etc.) may be included (not shown) that may valve the connection (e.g., tubing) between the suction port and the suction source.

Fig. 7B shows a section through the assembled adapter 722 of fig. 7A. In this example, the moving inner seal 726 is shown sealing the endoscope in communication with the inner lumen 707 of the outer sleeve. The seal may include one or more elastomeric layers, rings (e.g., O-rings), etc., which may allow insertion and removal of the endoscope while preventing or reducing leakage that could disrupt suction applied through the inner lumen of the outer sleeve. As described above, the seal may include an opening.

Fig. 8A shows an exploded view of a distal region 879 of an adapter similar to that shown in fig. 7A-7B. In this example, the proximal portion 779 includes a suction port 816 and a threaded receiving region 891 located inside the proximal region. Proximal to this portion of the adapter is an endoscope seal 826, which is shown as an elastomeric layer having an opening 824 for receiving an endoscope. The seal may be reinforced, for example, radially adjacent 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 outer sleeve is integrated to include an endoscope receiving port and a suction port. Fig. 9 illustrates one example of an integrated device configured as an overtube that includes an endoscope receiving port 914 at a proximal end, the endoscope receiving port 914 including a seal (not visible) as described above. The proximal end also includes a vacuum port 916, the vacuum port 916 being configured to be fluidly coupled to a suction line connected to a suction source (and in some cases, a controller). In this example, the outer sleeve 906 further includes an elongate body 929, which elongate body 929 can be configured to rigidize by application of pressure (positive and/or negative), for example, to controllably and reversibly transition between a relatively flexible configuration and a more rigid (e.g., less flexible) configuration. In fig. 9, the device includes a rigidized port 944 that may include a length of connector tubing for coupling to a source of negative or positive pressure. In some cases, the outer sleeve may include an actuator 946 (e.g., a switch, dial, button, etc.), the actuator 946 being located on the proximal end of the outer sleeve itself (e.g., a handle region) or separately, such as between a rigidized port and an inner layer of the elongate body of the outer sleeve that may be rigidized. The example shown 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 shown in fig. 9 tapers radially inward, which may help center the endoscope, which may extend distally out of the overtube, and may also enhance suction into the overtube.

Fig. 10A-10E illustrate the preparation of a device comprising an outer sleeve as described herein. Fig. 10A shows the outer sleeve 1006 in an elongated and flexible configuration. The suction adapter 1040 portion of the device is shown adjacent to, but not yet connected to, the proximal end of the outer sleeve. In fig. 10B, the suction adapter portion is coupled to the proximal base of the outer cannula. The suction adapter 1040 includes a vacuum port 1016 and an endoscope receiving port 1014, the vacuum port 1016 being configured to couple to a suction source, and to receive the endoscope 1008 in the endoscope receiving port 1014, as shown in fig. 10C. The endoscope may be inserted (with the lubricating material) into the inner lumen of the outer sleeve. 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 a suction line 1036 may then be coupled to the suction port (e.g., vacuum port 1016). The control member coupled to the vacuum port may include a biasing valve against which the control input member may be driven to apply suction from the distal opening of the outer sleeve upon user activation of the control member.

Fig. 11A-11F illustrate one example of a method of operating a device as described herein. In fig. 11A, the outer cannula 1106 is advanced such that an endoscope 1108 extending distally out of a distal opening 1110 of the outer cannula is adjacent to the material to be removed (e.g., clot material 1110). The endoscope may visually confirm the location and proximity of the clot material using an imaging member (e.g., one or more cameras) on the distal end of the endoscope. The outer cannula 1106 may then be advanced distally toward the clot material 1110, as shown in fig. 11B, until the distal region is adjacent the clot material. The endoscope may then be withdrawn proximally into the lumen of the outer sleeve as shown in fig. 11C, and suction may be applied (fig. 11D), drawing clot material into the inner lumen of the outer sleeve as shown in fig. 11E and 11F. The endoscope can confirm that clot material is aspirated from within the lumen of the outer cannula and removed through the inner lumen of the outer cannula. The material 1110 may be pumped up through the inner lumen of the outer cannula and alongside the indwelling endoscope 1108, and in some cases, when pumped proximally, the material may surround the endoscope. In fig. 11A-11F, the outer cannula distal side is tapered and includes a distal opening 1110 that is slightly narrower than the inner diameter of the lumen of the outer cannula.

Although the examples shown above illustrate a device in which the endoscope is relatively centered in the outer sleeve (with the vacuum port as the side outlet), alternative configurations may be used. For example, the endoscope may be positioned off-center from the inner lumen of the outer sleeve. For example, the device may be configured such that the endoscope is located centrally of the intermediate and distal sections of the outer cannula lumen, but it may exit from the (sealed) side outlet of the outer cannula lumen at or near the proximal end. In this configuration, the clot may have a direct aspiration path along the center of the lumen of the outer cannula.

In some examples, as shown in fig. 12A, it may be helpful to apply irrigation by macroporous suction through the outer sleeve. In this example, the device includes an outer sleeve 1206 having an internal suction lumen 1207 and an endoscope 1208, similar to that shown in fig. 11A-11F. The device (either as part of the endoscope or as a separate component) may include an irrigation line 1212 (also referred to herein as an irrigator tube), which irrigation line 1212 may extend distally out of the outer sleeve and/or the endoscope and may apply irrigation fluid from one or more irrigation outlets. Irrigation may help expel material that may be removed by applying suction from the outer cannula (furthermore, sucking removable irrigation material). Irrigation may also be performed directly from outside the internal aspiration lumen/working channel. Any of these devices may also be configured to apply irrigation from the proximal end of the outer cannula to flush out the blockage and potentially clean the scope.

In some examples, the irrigator tube 1212 may be located solely within the lumen of the outer sleeve without passing through the endoscope, alternatively a separate irrigator tube 1242 may be used. In general (and as shown in fig. 25A-25J and 26A-26H), the irrigator tube may include one or more nozzles 1243 or one or more openings into the irrigator. For example, as shown in fig. 12B, the irrigator tube 1242 can be inserted into the interior lumen 1207 of the outer sleeve 1206, alongside and axially positioned independent of the endoscope 1208. Irrigation fluid may be sprayed from the irrigation tube for cleaning the endoscope, destroying material and/or flushing the endoscope and/or the outer sleeve.

As described above, any of these outer sleeves may be configured as a rigidized outer sleeve. Alternatively, any of these devices may not be a rigidized outer sleeve. For example, fig. 13A-13B illustrate another example of a device that includes an outer sleeve having one or more reinforcing layers, but the outer sleeve is not configured to rigidize. Fig. 13A illustrates a proximal region of the device, showing a suction adapter region coupled to a proximal end of the outer cannula 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 aspiration lumen of the overtube. The apparatus may also include a flush line 1344. In the example shown in fig. 13A-13B, the device includes an integrated suction port (shown as a Y port extending from one side of the device) in the handle region of the outer cannula device. Any of these features may alternatively or additionally be configured to rigidize the outer sleeve (including having a Y-shaped port similar to that shown in fig. 13B). The distal region 1328 may be tapered.

In some examples, a control for controlling suction within the outer cannula may be coupled to the suction adapter portion of the device, as shown in fig. 5A above. For example, the control may be coupled to the vacuum port 516 of the device and in series with the suction source. In some cases, this connection between the suction line and the device may be a flexible or movable connection, as shown in fig. 14A-14B, which illustrates a rotational connection 1405 between the suction ports 516 of the adapter. The adapter region may include an endoscope receiving port 514 and a coupling region 524. Similarly, the controller 622, including (in this example) a horn valve as shown in fig. 6A-6C, may also include a control input 629 (e.g., a push button, knob, etc.) to open the aspiration line to apply suction into the lumen of the outer cannula.

In any of these examples, the control may alternatively be applied to a suction (negative pressure) line that connects the suction port 516 of the outer cannula (or in some examples, the suction port of a suction adapter configured to be coupled to the suction port). The controller may include a valve in series or parallel with a suction line connecting a source of negative pressure (suction) to a suction port of the device. For example, the controller may include a suction line coupling region 1538, the suction line coupling region 1538 configured to couple to a suction line and close or open (when actuated) to apply suction through the inner lumen of the outer sleeve. In the example of the controls 1522, 1522' shown in fig. 15A-15C, the controls include a lever valve configured to shut off the application of suction through the suction line to which it is coupled. In fig. 15A, the actuator (control input 1529) is a lever arm that can be depressed to allow suction through a suction line to which the control is attached. Fig. 15C schematically illustrates another example of a control 1522', the control 1522' having a lever or handle 1529' that can be held down (or squeezed) by a user to allow aspiration through the outer cannula lumen upon actuation. When not actuated, the control member may be biased to return to the closed state. In some examples, the control may include a lever valve.

Fig. 16A-16B illustrate another example of a control 1629 including an actuator (control input 1604) including a handle portion 1602, where the actuator is also shown as a lever that can be pressed by a user to allow aspiration through an interior lumen of an outer cannula. For example, as shown in fig. 16B, which shows a cross-section through the control of fig. 16A, the control may be connected in series with the suction line through suction inlet 1606 and suction outlet 1608. For example, the device may include a pinch valve 1650, and the pinch valve 1650 may be biased (e.g., by a biasing member, such as a spring 1651) to remain closed until actuated by a user.

Fig. 17A-17C illustrate another example of a controller 1729, the controller 1729 including an actuator (control input 1604) configured to receive a foot to be pressurized 1704 by a user to allow aspiration through an interior lumen of an outer cannula. For example, as shown in fig. 17A-17C, the control may be connected in series with the suction line through the suction inlet 1706 and the suction outlet 1708. The controller may include a pinch valve that may be biased 1751 (e.g., by a biasing member such as a spring) to remain closed until actuated by a user.

As described above, any of these devices may be configured as a very flexible outer sleeve configured to withstand and maintain flexibility even in the event of a relatively large negative pressure (suction) being applied through the lumen of the outer sleeve. Fig. 18A and 18B illustrate examples of different examples of outer sleeves to which a strain gauge is coupled in order to demonstrate forces for bending a flexible elongate member of the outer sleeve without breaking.

In fig. 18A, the outer sleeve 1800 includes reinforcing wires, but is relatively stiff compared to the example outer sleeve 1800' shown in fig. 18B. In this case, the outer sleeve is very flexible (e.g., has greater bending flexibility than the outer sleeve shown in fig. 18A) and has sufficient hoop strength under compression to withstand at least one atmosphere (760 mmHg) or more. A load cell 1806 is shown attached to the distal end of each outer sleeve to measure the relative force for bending over length (e.g., to determine bending flexibility). The example outer sleeve 1800' shown in fig. 18B is capable of bending 360 degrees or more relatively easily when an equivalent bending force is applied.

As described above, any of the devices described herein can include one or more openings (e.g., suction release or vacuum release) to prevent vacuum lock of the distal region (including openings into the inner lumen of the outer cannula) when the distal end of the outer cannula is sucked onto the wall of the body region. Fig. 19 illustrates an example of a distal region 1900 that includes a plurality of suction relief openings 1905, 1905' that are laterally disposed proximate a distal opening 1930 in the lumen of the outer cannula. Distal opening 1930 is tapered 1928 to have a tapered profile from the outside and also has an opening diameter that is narrower than the inner diameter of the region of the lumen that is closer to the distal opening. Alternatively or additionally, these means may comprise a pressure relief valve, as shown in fig. 21B.

Any of the outer cannula devices described herein may include one or more external working channels extending along the length of the outer cannula. Examples of external working channels can be found, for example, in U.S. patent application Ser. No. 17/940,906 entitled "EXTERNAL WORKING CHANNELS (external working channel)" filed on 8, 9, 2022 and U.S. patent application Ser. No. 18/000,062 entitled "RIGIDIZING DEVICES (rigidized device)" filed on 26, 5, 2021, each of which is incorporated herein by reference in its entirety. This is shown in fig. 27A-27C. Fig. 27A illustrates a distal end region of the outer sleeve 2706 from which the endoscope 2708 is shown extending. As noted above, in this example, the distal end is tapered. The outer sleeve further includes at least one outer working channel 2781, which outer working channel 2781 can be configured to lie flat until an accessory device (e.g., suction tube 2789) passes through it, as shown in fig. 27B. Fig. 27C illustrates an example of an outer cannula as described herein that includes a plurality (e.g., four) external working channels that can be accessed via proximal port 2788. The proximal end may include an endoscope receiving port 2714

The one or more external working channels may extend from an outer surface of the outer cannula and may include a proximal insertion guide region for inserting one or more devices through the external working channels.

Robot device

Any of these devices may be configured as or used with a robotic device. In some examples, the overtube and endoscope assembly (including the internal endoscope 9310) can be robotically controlled. Any suitable control subsystem may be used to control the movement, including steering, advancing, and/or retracting the distal end, and/or rotating the outer sleeve and inner endoscope. In fig. 20, an exemplary device 9300z including an outer sleeve 9300 and an inner endoscope 9310 can be robotically controlled or manipulated (e.g., steered, moved, rotated, etc., including rigidized in some examples). As shown in fig. 20, the outer sleeve 9300 and the inner endoscope 9310 can be terminated together into a common structure, such as a cassette 9357. The outer sleeve 9300 is movable relative to the endoscope 9310 by rotation of a disk 9389 mounted to a cassette 9357. For example, the disk 9389 may be a pinion gear and the external rigidizing device 9300 may have a rack 9382 comprising a plurality of pinion teeth on its exterior. Rotating the disk 9389 against the teeth 9382 can cause the outer sleeve 9300 to advance forward or backward relative to the endoscope 9310. In some examples, possible movement or translation of the endoscope and/or outer sleeve is limited by the size or design of the cassette 9357.

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

The cassette 9357 may also include bellows 9303a, 9303b, the bellows 9303a, 9303b may be connected to the pressure gap of the endoscope 9310 and the outer cannula 9300, respectively. The compression bellows 9303a, 9303b can drive fluid through the pressure line 9305z, resulting in a pressure rise in the pressure gap of the endoscope 9310, 9300, resulting in the endoscope 9310 and/or the overtube 9300 (in a variation of any of the endoscope and/or overtube that is configured to rigidize) becoming rigid. The activation of the bellows 9303a, 9303b may be applied sequentially and/or simultaneously. As shown, the cassette 9357 may include eccentric cams 9374a, 9374b to control 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. As a further alternative, the devices 9300, 9310 may be rigidized and de-rigidized by one or more of a sump (as described herein) or a pressure source (e.g., via pressure line 9305 z).

The cassette 9357 can include connectors 9315y for connection to additional lumens and/or wiring in the endoscope 9310 and/or the outer cannula 9300. The connector 9315y may include a connection for delivering suction and water to the distal end of the endoscope 9310. The connector 9315y may include an electrical connector for connecting a camera mounted to the distal end of the endoscope 9310 to an external monitor and/or a video processing unit. The connector 9315y may include a mechanical connector that connects to a hollow tube (e.g., working channel) that is routed through the end of the inward stiffening device 9310. Control of all components of the system 9300z can be performed with the cartridge 9357 by including the connector 9315 y.

In use, these devices can remove material from within the patient's body very effectively and safely. For example, fig. 21A illustrates the operation of one example of an apparatus as described herein. In this example, the device includes an outer sleeve 2106 having an elongate body. The outer sleeve may be rigidized as described above. The proximal end of the outer cannula includes an aspiration port 2116 and an endoscope receiving port 2114 with a seal. The device shown in fig. 21A-21D shows an endoscope 2108 inserted into the inner lumen of the outer sleeve, forming an annular lumen 2121 as shown. The device also includes a port having a three-way valve (e.g., stopcock 2138) with a closed position, a first position in which the inner lumen of the outer sleeve is in fluid communication with flush or flush line 2136, and a second position in which the inner lumen of the outer sleeve is in fluid communication with air release port or opening 2148. Thus, in this example, the device includes a manual three-way stopcock 2138 that allows the user to switch between air release or flushing. In some examples, flushing may allow for flushing our annular space with water using a syringe to remove the blockage (see fig. 21C-21D). In some cases, the suction relief 2148 may include a seal (e.g., tyvek seals) to vent air to the atmosphere, but may block fluid that will follow.

In fig. 21A, the apparatus is shown wherein suction 2151 is applied from suction port 2116 through the inner lumen of the outer cannula, the suction port 2116 being connected (not shown) to a suction source and a collection source. As described above, in use, the distal end of the rigidized outer sleeve 2016 may be positioned adjacent to the material to be removed, with the endoscope 2108 extending distally from the distal end. The rigidized outer sleeve 2106 concentrically surrounds the endoscope 2106, the outer sleeve and the endoscope forming an annular lumen 2121. The device can be maneuvered within the body to aid navigation by controlling the stiffness of the overtube, when the overtube is rigid, the endoscope can be steered and driven distally, then the overtube can be made flexible and driven over the endoscope, then again rigid to maintain shape, allowing additional navigation distally of the overtube. Once the endoscope is in place (e.g., visualizing the material to be removed or the area to be irrigated and/or treated), the endoscope may be retracted slightly proximally into the overtube so that the distal end of the endoscope is within the distal region of the rigidized overtube, as shown in fig. 21A. This can be done with rigidification of the outer sleeve. Suction can then be applied through the annular lumen to draw material into the annular lumen and around the endoscope.

In some cases, the outer sleeve may be locked to the wall 2149 of the cavity, as shown in fig. 21B. In this case, as described above, the opening on the distal region may help release the lock from the wall. Alternatively, in some cases, a pressure relief valve (e.g., air relief port 2148) may be used. In fig. 21B, valve 2138' is shown with the stopcock in a second position, allowing air to vent from outside the body, which can quickly release the vacuum lock on the wall.

Fig. 21C-21D illustrate where the annular lumen 2121 becomes occluded (e.g., by material 2153) and the occlusion can be removed by applying a cleaning fluid 2158 (e.g., from a syringe), the cleaning fluid 2158 being applied through a cleaning port 2136, the cleaning port 2136 being controlled by a three-way valve 2138 "(shown in fig. 21C in a first cleaning position). For example, in fig. 21C, when the three-way valve opens a purge port (e.g., flush port) 2136, the plug 2158 within the annular lumen of the device 2121 is loosened or removed by application of a flush fluid (e.g., saline, etc.) 2158. In some examples, the flushing fluid may be applied by a syringe. As shown in fig. 21D, the occlusion may be driven distally out of the device and may be removed by again applying suction 2151 through suction port 2116. In fig. 21D, the three-way stopcock 2138 is again in the closed position.

In any of these methods, the blockage may also or alternatively be removed by moving the endoscope within the interior lumen. For example, the endoscope may be moved axially (proximally/distally). In some cases, the endoscope may be axially movable between about 1mm and 3cm or more (e.g., between about 1mm and about 3cm, between about 1mm and 2.5cm, between about 1mm and 2cm, between about 1mm and 1.5cm, between about 1mm and 1cm, between about 1mm and 7mm, between about 1mm and 5mm, etc.). The endoscope may move back and forth in linear oscillation, for example, between about 1Hz and 50Hz (e.g., between about 1Hz and 40Hz, between about 1Hz and 30Hz, between about 1Hz and 20Hz, between about 1Hz and 10Hz, etc.). Moving the endoscope within the lumen of the outer cannula while applying suction can help prevent or remove the blockage. Alternatively or additionally, the endoscope may rotate within the lumen.

In any of these devices, a clot may be detected when the fluid applied, which may be before and/or during the application of suction, is not removed. This can be detected or seen by looking at a collector in series with the suction source.

As described above, fluids may be applied during operation of these devices to loosen and/or remove material from the body area, including affected fecal matter, mucus, and the like. The fluid may be applied via one or more fluid channels, which may be part of the overtube, part of the endoscope, or part of a separate tool inserted into the overtube and/or the 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 pulsatile manner, e.g., at a frequency between about 0.1Hz and 200Hz (e.g., between about 0.5Hz and 150Hz, etc.). In any of these methods and devices, a gas (e.g., air) may be included in the applied fluid to destroy the material to be removed.

Fig. 22A-22C illustrate examples of applying fluid through a fluid line of an outer sleeve. In fig. 22A, outer sleeve 2206 includes three fluid lines 2246, the three fluid lines 2246 including an outlet slightly proximal to the distal end of the outer sleeve. In this example, the fluid outlet is positioned radially on one side of the outer sleeve. In some cases, as shown in fig. 22B, the outlet of the fluid line (three shown) 2246' may extend slightly distally from the outer cannula (although still near the distal end of the outer cannula) and may be angled or disposed at an angle to the long axis of the outer cannula, as shown in fig. 22B-22C.

Alternatively or additionally, a fluid (e.g., a cleaning fluid or an irrigation fluid) may be applied from a distal region of an irrigator tube, which may be inserted through an endoscope and/or through an outer sleeve. The direction of fluid from any of these fluid lines (including the flusher and the integrated fluid line) may be controlled by the nozzle region at the distal end. In some cases, it may be particularly beneficial to provide a radial spray, as shown in fig. 23A. Fig. 23A shows an irrigator tube 2366 configured as a radial spray irrigator tube, wherein the distal region is configured with a plurality of annular openings to form a radial spray, as shown. In contrast, fig. 23B shows an example of a irrigator tube 2366' where a linear spray is emitted from a single nozzle opening at the distal end. As shown, this may produce a single jet rinse spray.

In some cases, the device may be configured to operate by adjusting the relative position of the irrigator tube away from the distal end of the endoscope and/or outer sleeve so that a single irrigator tube may be used as both a radial spray and a longitudinal (e.g., distal) jet, as shown in fig. 24A-24D. For example, in fig. 24A, radial spray irrigator 2466 is advanced distally 2468 through endoscope 2408, and endoscope 2408 has been retracted slightly proximally within the outer sleeve 2406 lumen, forming annular lumen 2463, as described above. The washer tube 2466 is coupled to a washer fluid source 2467, and the washer fluid source 2467 can be a pump or a syringe. As shown in fig. 24B, once the distal end of the irrigator tube 2466 extends distally out of both the endoscope and the outer sleeve 2406, irrigation fluid may be radially ejected 2469 from the distal end (e.g., nozzle).

As shown in fig. 24C, the radial spray irrigator tube may also be used to apply a longitudinal flow by withdrawing the radial spray irrigator tube 2466 proximally into the outer sleeve 2406, thereby producing a large, distally directed flow 2469', as shown. Alternatively, in some examples, as shown in fig. 24D, the irrigator tube 2466 can be retracted such that the radial nozzle region at the distal end is retracted into the endoscope 2408, thereby creating a distal stream 2469".

Fig. 25A-25J illustrate examples of different variations of the distal end of an irrigator tube configured as a nozzle region. Fig. 25A-25B show a cross-sectional view and a side perspective view, respectively, of a first distally directed nozzle. Fig. 25C-25D illustrate a cross-sectional view and a side perspective view, respectively, of a distally (e.g., longitudinally) oriented nozzle. 25E-25F show a cross-sectional view and a side perspective view, respectively, of a combined radial and distal spray nozzle. Fig. 25G-25H show a cross-sectional view and a side perspective view, respectively, of a radial spray nozzle. Fig. 25I-25J show cross-sectional and side perspective views, respectively, of an example of a nozzle configured to emit a radial spray (delivered as a fan spray rather than as a discrete stream). These nozzle areas may be formed on the irrigator tube, or they may be attached to the distal end of the irrigator tube. In some cases, the nozzle region may be formed by molding, printing (3D printing), laser cutting, or the like.

Fig. 26A-26H illustrate side views of various additional examples of nozzle regions of a flusher tube as described herein. These different flusher tubes can be used to achieve a variety of different spray patterns. Any of these irrigator tubes may be converted to a forward (e.g., lateral) flow irrigator tube by withdrawing it into the overtube and/or endoscope, as described above in fig. 24C-24D.

These other accessories may be included in addition to the irrigator tubes described herein. For example, any of these devices may be used with (e.g., in combination with) one or more suction tubes, such as shown in fig. 28 and described above. For example, the suction tube 2889 can be inserted through an endoscope (e.g., a working channel of an endoscope) and/or an outer sleeve, 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 shown in fig. 28. In this example, the suction tube is a 6mm disposable suction tube.

All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Moreover, it is to be understood that all combinations of the foregoing concepts and additional concepts discussed in more detail below (provided that such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to implement the benefits described herein.

Any of the methods (including user interfaces) described herein 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 capable of being executed by a processor (e.g., a computer, tablet, smartphone, etc.), which when executed by a processor, cause the processor to control the execution of any steps including, but not limited to, displaying, communicating with a user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, prompting, etc. For example, any of the methods described herein may be performed, at least in part, by an apparatus comprising one or more processors having memory storing a non-transitory computer readable storage medium storing a set of instructions for the process of the method.

Those of ordinary skill in the art will recognize that any of the processes or methods disclosed herein may be modified in a variety of ways. The process parameters and sequence of steps described and/or illustrated herein are given by way of example only and may be varied as desired. For example, although the steps illustrated and/or described herein may be illustrated or discussed in a particular order, the steps need not be performed in the order illustrated or discussed.

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

A processor as described herein may be configured to perform one or more steps of any of the methods 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 described herein as being "on" another feature or element, the feature or element can be directly on the other feature or element, or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, it can be directly connected, attached, or coupled to the other feature or element, or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated may be applied to other embodiments. It will also be appreciated by those of skill in the art that reference to a structure or feature that is disposed "adjacent" 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 invention. For example, as used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify 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. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items, and may be abbreviated as "/".

Spatially dependent terms, such as "under", "below", "lower", "above", "upper", and the like, may be used herein for ease of description to describe one element or feature's relationship to another element or feature as illustrated in the figures. 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 figures. For example, if the device in the figures is inverted, elements described as "under" or "under" other elements or features would then be oriented "over" the other elements or features. Thus, the first and second substrates are bonded together, the exemplary term "below" may encompass "within the scope of. Upper" and "in. Below" both orientations. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, unless otherwise specifically indicated, the terms "upward", "downward", "vertical", "horizontal", and the like are used herein for illustrative purposes only.

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 otherwise indicated by the context. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and, similarly, a second feature/element discussed below could be termed a first feature/element, without departing from the teachings of the present invention.

In general, any apparatus and method described herein should be understood to be inclusive, but that all or a subset of the elements and/or steps may, alternatively, be referred to as "consisting of, or alternatively, consisting essentially of, the various elements, steps, sub-elements, or sub-steps.

As used herein in the specification and claims, including in the examples, and unless otherwise expressly stated, all numbers may be understood as if prefaced by the word "about" or "about," even if the term does not expressly appear. The phrase "about" or "approximately" may be used in describing the magnitude and/or position to indicate that the value and/or position being described is within a reasonably expected range of values and/or positions. For example, a 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 values set forth herein should also be understood to include about or approximate such values unless the context dictates otherwise. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed, then "less than or equal to" the value, "greater than or equal to the value," and possible ranges between the values are also disclosed, as would be well understood by one of ordinary skill in the art. For example, if the value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout this application, data is provided in a variety of different formats, and that the data represents endpoints and starting points and ranges for any combination of the data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than or equal to, and equal to 10 and 15, and between 10 and 15, are considered disclosed. It should also be understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

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

The examples and descriptions included herein illustrate by way of illustration, and not by way of limitation, specific embodiments in which the subject matter may be practiced. As noted, other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein, individually or collectively, by the term "application" merely for convenience and without intending to voluntarily limit the scope of this application to any single application or inventive concept if more than one is in fact disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

1. A method for removing material from a patient's body, the method comprising:

The distal end of the rigid outer sleeve is positioned adjacent to the material, wherein the endoscope extends distally from the distal end, and wherein the rigid outer sleeve concentrically surrounds the length of the endoscope such that the outer sleeve and the endoscope form an annular lumen.

The distal end of the endoscope is retracted proximally into the distal region of the rigid outer sleeve;

And by applying suction through the annular lumen to draw the material into the annular lumen and around the endoscope.

2. The method of claim 1, further comprising: converting the rigid endoscope from a more flexible configuration when positioned distally adjacent to the material to a more rigid configuration prior to retracting the endoscope proximally into the distal region of the rigid sheath.

3. The method of claim 1, further comprising using the endoscope to visualize the material while applying suction.

4. The method of claim 1, further comprising applying flushing on the distal side of the distal end of the outer sleeve.

5. The method of claim 4, wherein applying flushing comprises applying a fluid spray from the fluid line of the outer casing.

6. The method of claim 4, wherein applying flushing comprises extending the flushing tube distally out of the distal end of the endoscope and applying flushing from the flushing tube into the body.

7. The method of claim 5, wherein the flusher comprises a radial flusher.

8. The method of claim 4, wherein applying flushing includes switching between applying radial flushing and distal flushing by extending or retracting the radial flushing tube relative to the distal end of the endoscope.

9. The method of claim 1, further comprising axially moving the endoscope within the outer sleeve while applying suction.

10. The method of claim 1, further comprising axially moving the endoscope within the outer sleeve while positioning the outer sleeve.

11. The method of claim 1, further comprising directional control of the distal region of the endoscope independently of the outer sheath.

12. The method of claim 1, wherein positioning the outer sleeve comprises: rigidifying the outer sleeve while advancing the endoscope distally from the outer sleeve and turning the endoscope; derigidifying the outer sleeve; and advancing the outer sleeve distally on the endoscope.

13. The method of claim 1, wherein the proximal end of the outer sleeve is movably sealed around the endoscope.

14. The method of claim 1, wherein the annular cavity has a cross-sectional area between 40 ^mm² and 200 ^mm² .

15. The method of claim 1, wherein positioning includes positioning the outer sheath within the patient's gastrointestinal tract.

16. The method of claim 1, wherein removing the material from the body comprises removing one or more of the following: fecal matter, blood, and food debris.

17. The method of claim 1, further comprising clearing the annular lumen by repeatedly moving the endoscope distally and proximally within the outer sleeve while applying suction through the annular lumen.

18. The method of claim 1, further comprising, while applying suction through the annular cavity, releasing the outer sleeve from the wall of the body by opening an air pressure relief valve in fluid communication with the annular cavity.

19. A method for removing material from a patient's body, the method comprising:

Position the distal end of the endoscope adjacent to the material;

The distal end of the outer sleeve extending on the endoscope is positioned adjacent to the distal end of the endoscope, wherein the outer sleeve is in a flexible configuration such that the endoscope changes from an extended configuration extending to the distal side of the outer sleeve to a retracted configuration, wherein the distal end of the endoscope is retracted into the distal region of the outer sleeve such that the outer sleeve concentrically surrounds the endoscope, thereby forming an annular lumen.

The outer sleeve is converted from the flexible configuration to a more rigid configuration; and

Suction is applied through the annular lumen to draw the material into the annular lumen and around the endoscope.

20. A method for removing material from a patient's body, the method comprising:

Position the distal end of the endoscope adjacent to the material;

When the outer tube is in a flexible configuration, the distal end of the outer tube is advanced distally on the endoscope such that the distal end of the outer tube is adjacent to the material, and the distal end of the endoscope is positioned in the distal region of the outer tube to allow visualization through the endoscope from the distal end of the outer tube, such that the outer tube concentrically surrounds the endoscope to form an annular lumen;

21. A suction outer tube device, the device comprising:

An elongated body having an internal lumen extending from a distal end to a proximal end, wherein the elongated body is configured to switch between a flexible configuration and a more rigid configuration by applying or releasing pressure within the walls of the elongated body;

A rigid port configured to receive positive and/or negative pressure to convert the elongated body from a flexible configuration to a rigid configuration;

A proximal region, the proximal region including an endoscope receiving port configured to receive an endoscope into the internal lumen, wherein the endoscope receiving port is connected in series with the internal lumen of the elongated body; and

A vacuum port is located in the proximal region, and the vacuum port is in fluid communication with the internal lumen.

22. The apparatus of claim 21, wherein the distal opening of the outer sleeve is tapered.

23. The apparatus of claim 21, wherein the elongated body comprises a rigidification layer and a compression layer, the rigidification layer comprising a plurality of intersecting strands, and the compression layer is configured to compress the rigidification layer into the more rigid configuration.

24. The apparatus of claim 21, further comprising a seal configured to seal around the endoscope near the vacuum port.

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

26. The apparatus of claim 21, wherein the internal lumen has a cross-sectional area greater than 10 ^mm² .

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

28. The apparatus of claim 21, wherein the elongated body has circumferential strength sufficient to withstand a negative pressure of at least 760 mmHg within the internal cavity.

29. The apparatus of claim 21, wherein the elongated body further comprises an internal coil winding tube.

30. The apparatus of claim 21, wherein the elongated body comprises a braided tube.

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

32. The apparatus of claim 31, wherein the control element is connected in series with the vacuum port.

33. The apparatus of claim 31, wherein the control element comprises a horn valve.

34. The apparatus of claim 21, wherein the inner diameter of the distal opening of the outer sleeve is smaller than the inner diameter of the inner lumen.

35. The apparatus of claim 21, further comprising the endoscope.

36. The apparatus of claim 21 further includes one or more flushers configured to pass through the lumen of the endoscope.

37. The apparatus of claim 36, wherein the one or more flushers include radial flushers.

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

39. The apparatus of claim 21 further includes one or more external channels extending along the length of the elongated body.

40. A suction outer tube device, the device comprising:

An elongated body having an internal lumen extending from a distal end to a proximal end, wherein the elongated body comprises multiple layers and is configured to change from a flexible configuration to a more rigid configuration by applying pressure to the multiple layers;

The proximal region includes an endoscope receiving port configured to receive an endoscope into the internal lumen, wherein the endoscope receiving port is connected in series with the internal lumen of the elongated body.

A rigid port, configured to receive positive and/or negative pressure to rigidify the elongated body;

A vacuum port at the proximal region, the vacuum port being in fluid communication with the internal lumen; and

A control element, connected to the vacuum port, configured to apply suction from the vacuum port through the internal cavity when the control element is actuated by a user.

41. A suction outer tube device, the device comprising:

An elongated body having an internal lumen extending from a distal end to a proximal end, the elongated body comprising multiple layers, wherein the elongated body has a circumferential strength sufficient to withstand a vacuum of 760 mmHg or greater, and wherein the elongated body is configured to transition from a flexible configuration to a more rigid configuration by applying positive and/or negative pressure to the multiple layers;

The proximal region includes an endoscope receiving port configured to receive an endoscope into the internal lumen, and includes one or more seals configured to seal around the endoscope, wherein the endoscope receiving port is connected in series with the internal lumen of the elongated body.

Rigidification port, the rigidification port being configured to receive positive and/or negative pressure to rigidify the elongated body; and

42. A method for removing material from the body, the method comprising:

The outer cannula and endoscope are advanced distally within the body, wherein the endoscope is inserted into the lumen of the outer cannula through the proximal port of the outer cannula, such that the proximal end of the outer cannula is movably sealed around the endoscope.

Position the distal end of the outer sleeve adjacent to the material to be removed; and

As the user activates the controls, while the endoscope images the distal end of the outer cannula, suction is applied through the lumen of the outer cannula from a port at the proximal region of the outer cannula to draw the material into the outer cannula and around the endoscope.

43. The method of claim 42, further comprising applying a fluid spray from the endoscope or from a fluid line within the lumen of the outer cannula.

44. The method of claim 42, further comprising connecting a suction source to the port at the proximal region of the outer sleeve.

45. The method of claim 42, wherein positioning the distal end of the outer sleeve comprises positioning the distal end of the endoscope adjacent to the material to be removed.

46. The method of claim 42, further comprising retracting the endoscope proximally into the outer cannula before applying suction through the port.

47. The method of claim 42, wherein the material comprises fecal matter, blood, and food debris.

48. The method of claim 42, further comprising axially moving the endoscope within the lumen of the outer sleeve without breaking the seal while positioning the outer sleeve.

49. The method of claim 42, wherein applying suction from the port at the proximal region of the outer tube through the lumen of the outer tube comprises maintaining suction while the user operates the control and stopping applying suction when the user stops operating the control.

50. The method of claim 42, wherein applying suction from the port at the proximal region of the outer tube through the lumen of the outer tube when the user activates the control includes applying suction when the user activates the horn valve.

51. The method of claim 42, further comprising directional control of the distal region of the endoscope independently of the outer sheath.

52. The method of claim 42, further comprising rigidifying the outer tube before applying suction.

53. The method of claim 42, wherein advancing the outer tube and the endoscope comprises: rigidifying the outer tube while advancing the endoscope distally from the outer tube and turning the endoscope; derigidifying the outer tube; and advancing the outer tube distally over the endoscope.

54. A method for removing material from the body, the method comprising:

The endoscope is inserted into the lumen of the outer tube through the proximal port of the outer tube, such that the proximal end of the outer tube is movably sealed around the endoscope.

Position the distal end of the endoscope adjacent to the material to be removed;

Positioning the distal end of the outer sleeve adjacent to the distal end of the endoscope, and positioning the distal end of the endoscope within the distal region of the outer sleeve, such that the endoscope images distally from the distal region of the outer sleeve; and

Suction is applied from the port at the proximal region of the outer sheath through the lumen of the outer sheath to draw the material into the outer sheath and around the endoscope.

55. A method, the method comprising:

Position the endoscope within the body area;

Extend the flushing tube distally out of the lumen of the endoscope;

A radial spray of flushing fluid delivering the flushing fluid from the flushing tube; and

The flushing tube is withdrawn proximally to deliver a longitudinal flow of flushing fluid.

56. A method, the method comprising:

The endoscope and a cannula concentrically surrounding the endoscope are positioned in the region of the gastrointestinal (GI) tract, wherein the endoscope is located within the aspiration lumen of the rigid cannula;

The flushing tube extends distally out of the lumen of the endoscope and the outer sleeve extends distally, while the outer sleeve remains in a rigid configuration;

A radial spray of flushing fluid delivering the flushing fluid from the flusher tube;

The flushing tube is retracted proximally to deliver a longitudinal flow of flushing fluid; and

Suction is applied through the suction lumen of the outer tube to remove the flushing fluid.