Hygienic sheath for endoscope

Abstract

Described are sheaths usable with endoscopes, and particularly robotic and / or telescopic endoscopes, and methods of using these sheaths to prevent cross-contamination between patients and contamination of the endoscope. These sheaths can reduce or eliminate the need for endoscope cleaning and can include both an outer sheath member and one or more inner sheath members that can extend through a lumen of the endoscope.

Description

[Technical field]

[0001] Claiming priority

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 335,720, entitled "HYGIENIC DRAPING FOR ROBOTIC ENDOSCOPY," filed April 27, 2022. The above application is incorporated herein by reference in its entirety. Incorporation by Reference

[0002]

[0002] All publications and patent applications in this specification are 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. [Background technology]

[0003]

[0003] Reusable endoscopes ("scopes"), operated both manually and robotically, perform important diagnostic and therapeutic functions, but present many challenges. Endoscopes can be difficult to clean because they may be long (endoscopes may be over 2 meters long), may have one or more very long and very small lumens, and contain many tiny, delicate parts made of various materials with areas that may harbor bacteria. These areas may include areas where parts meet, in crevices and connections, and areas where there are scratches or localized damage. The use of most endoscopes typically requires that the endoscope be immersed in pathogen-rich contaminants, including blood, faeces, urine, and diseased or infected tissue. Reusable scopes are expected to withstand a very large number of cases, often more than 1000, for extended periods of time, such as years. However, such long life expectations create problems: careful analysis of used scopes reveals that they are often damaged, both internally and externally. Repairing endoscopes is extremely costly, requiring cumbersome transportation, constant quality control and testing, expensive back-up devices, shipping, receiving and proper packaging and transportation. Reusable scopes typically have lifetime costs that exceed the initial purchase cost. Because reusable scopes are expected to last several years, this essentially means that clinicians are performing endoscopy with outdated technology. Cleaning a scope also requires significant capital equipment and the space, training, maintenance and repair required. Good scope cleaning requires successful execution of a highly detailed procedure (often over 100 separate steps), often by undertrained and busy staff with significant turnover, poor communication with end users, and working without all the necessary tools. It is well documented that scope cleaning is not always performed accurately and completely according to a full and complete list of cleaning instructions.The complete set of actions required to clean a scope and return it to a state ready for the next case requires complex, time-consuming, multi-person and costly internal logistical distances as the device moves through various steps in various locations within the hospital, with different tasks being handed off between many different people and departments. Hospital space is very expensive, and the storage, handling and movement of these devices creates very substantial facility costs. The cleaning process also often renders the device out of service for long periods of time, thereby requiring endoscopy facilities to maintain large inventories of rotating devices to perform ongoing procedures. Also, despite the impression that reuse is environmentally good, cleaning scopes creates a significant amount of landfill waste, i.e., gloves, wipes, brushes, personal protective equipment, connectors, tubing, test strips and hazardous chemicals. Chemical cleaners are harsh to the scope, the equipment, the environment and the person doing the cleaning.

[0004] Importantly, although such cleaning processes may clean the scope, the processed scope is not sterile, since many of the scope's materials cannot withstand the rigors of the required chemicals, temperature, or radiation (the goal is High Level Disinfection (HLD)). Sterilization with ethylene oxide requires long exposure and aeration times that are harmful to personnel and patients, and have led to a number of highly publicized and recent hazardous worker health and environmental issues. Sterilization with peroxide is new and promising, but still has most of the above mentioned drawbacks. At worst, peroxide sterilized devices may be sterile, but retain a debris load that can be transferred between cases. Scope contamination spreads, and at worst, infectious disease transmission and deaths have been confirmed.

[0005]

[0005] Currently available disposable scopes are expected to last for multiple cases (eg, 2, 5, 10, 20, etc.) and suffer from many of the same problems as reusable scopes.

[0006]

[0006] Disposable scopes typically arrive sterile and never require cleaning, but they generate a large amount of landfill waste and can be difficult to manufacture with high quality and reasonable cost. They are theoretically recyclable, but actual recycling is very rare and uneconomical. Disposable scopes have been used successfully in certain niches, but have not been widely adopted.

[0007]

[0007] Surgical drapes, sheaths and covers are used to create a sterile field around the surgical site and set up a physical barrier that reduces the risk of device contamination and surgical site infection. Sheaths can be a key element in allowing technicians required to clean waste (e.g., feces) from endoscopes to be freed up to engage in more meaningful and important tasks. Sanitary drapes, including for both manually operated and robotic / telerobotically operated endoscopes, can effectively physically separate devices from the patient during surgical procedures.

[0008]

[0008] Therefore, there is a need for methods, components, systems and apparatus that address these challenges. Summary of the Invention

[0009]

[0009] Described herein are methods and apparatus (e.g., components, accessories, devices and systems, including sheath systems) that can be used with endoscopes and particularly manual or robotic and / or telescopic endoscopes, and methods of using these sheaths to prevent cross-contamination between patients and contamination of the endoscope. In general, these sheaths can reduce or eliminate the need for endoscope cleaning. The sheaths described herein, which may additionally or alternatively be referred to as drapes, are advantageous because they can be quickly and easily loaded onto an endoscope system for a new patient without lengthy reprocessing that would otherwise involve HLD and / or sterilization. These sheaths can protect the exterior of the endoscope and the internal working channels and supply lines of the endoscope, thereby critically preventing contamination of an endoscope having internal working channels and supply lines during a medical procedure. The apparatus (e.g., components, accessories, devices and systems, including sheath devices and sheath systems) and methods described herein can protect patients from cross-contamination, including from other patients, and can be quicker, easier and less costly than reprocessing (cleaning of endoscopes), resulting in less landfill waste and more effective. By reducing or eliminating additional cleaning cycles, endoscopes may experience less wear and collateral damage. By effectively coating the device, critical scope elements may be reused multiple times, thereby reducing the cost per case and reducing landfill waste.

[0010]

[0010] The methods and apparatuses (e.g., systems and devices including sheath systems) described herein can include reusable elements, disposable elements, semi-disposable elements (i.e., disposable elements, elements used a few times), and / or drape elements that can address the above challenges.

[0011]

[0011] The term "endoscope" as used herein is intended to be broadly interpreted. In general, an endoscope may refer to an instrument that can be introduced into the body and can include one or more lumens extending therethrough. Endoscopes may include catheters, trocars, tubes, and the like. Endoscopes may refer to instruments used to examine, access, treat, and / or diagnose the interior of the body, including organs, lumens, cavities, or blood vessels. Any of these endoscopes may include imaging (e.g., typically with CCD, CMOS chips, or fiber optic materials) to provide a view from the distal end or side of the device. Endoscopes described herein may include sensing (e.g., electrical sensing, magnetic sensing, shape sensing, mechanical sensing, etc.). Endoscopes may generally be catheters that include one (or more) internal lumens that extend the length of the endoscope. In some embodiments, endoscopes may include one or more internal lumens (e.g., internal working channels, fluid channels, air insufflation channels, irrigation channels, etc.) that extend the length of the endoscope. For example, any of these endoscopes may include one or more channels for administration or removal of liquids and / or gases (e.g., aspiration / suction, nebulization, irrigation, insufflation). These channels may be coupled with electrical elements, including wiring for illumination, vision, energy delivery, or sensing. These endoscopes may include one or more channels for tools or instruments. The channels may be multipurpose, including for aspiration or irrigation. Any of the endoscopes described herein may include an internal lumen configured as an internal working channel, for example, for passage of one or more accessory devices. Examples of endoscopes include, but are not limited to, a colonoscope, arthroscope, bronchoscope, cystoscope, enteroscope, esophagogastroduodenoscope, hysteroscope, laparoscope, pharyngoscope, mediastinoscope, sigmoidoscope, or thoracoscope, etc.

[0012]

[0012] The methods and devices described herein may be particularly suited for manual endoscopes. Manual endoscopes can be manually steered using controls (e.g., knobs, buttons, levers, dials, etc.) to steer the distal tip region and can be manually advanced or retracted. The sheaths described herein are configurable to act on and work with manual endoscopes such that a distal cap can fit over the distal end of the manual endoscope, an outer sheath (sealed against the cap) can fit over the exterior of the endoscope, and one or more inner sheaths (also sealed against the cap) can fit through and line any internal lumens of the endoscope.

[0013] The methods and devices described herein may be particularly suitable for use with a telescopic system in which an inner endoscope is arranged concentrically with an outer tube. The inner and outer endoscopes may be moved together (e.g., for advancement) and / or separately. All movements of the inner endoscope (also referred to herein as the "child") may be protected by the sheath described herein and may therefore be reusable a certain number of times or may be semi-disposable or disposable (i.e., reusable a certain number of times, e.g., 2-40 times). In some embodiments, the outer endoscope tube (also referred to herein interchangeably as the "mother", outer member or overtube) may be reusable or disposable. The mother may be reusable the same number of times as the child, or may be reusable a different number of times than the child, or one of the elements may be disposable. For example, the outer tube may be completely or partially covered by the outer sheath. In variations in which the outer tube is extensively covered by the outer sheath (e.g., completely or mostly covered, or covered within the sterile field), the outer tube may be reusable after removal of the sheath following a procedure. In variations where the outer sheath is only connected distally (e.g., sealed to the distal end or distal end region of the outer tube), the outer tube may be disposable or require cleaning and / or sterilization before reuse. This may result in further net savings, as the outer tube may be easier, faster and / or less expensive to clean than an endoscope. The outer tube may also be an endoscope.

[0014]

[0014] As mentioned above, the endoscope may equally include (and / or be replaceable with) a catheter. In an embodiment including an inner endoscope and an outer tube, the majority of the length of the inner member (also referred to interchangeably herein as the endoscope, inner endoscope, or "child") may be covered by the outer tube, which may be of a special construction known as a "stiffened" sheath, and the distal portion including the outer sheath may be a thin-film sheath. This may have clinical benefits, for example, when the endoscope is configured for insertion into the rectum, since the portion that slides through the anus for the majority of the procedure may be stiffened, minimizing sheath wear and thus increasing reliability.

[0015] In general, the devices and methods described herein can be used with one or more stiffening members. In embodiments including an endoscope, the endoscope can be the stiffening member, e.g., the selectively stiffening member. In embodiments including an endoscope and an outer tube, both the inner endoscope and the outer tube can be stiffening members, or only the outer or only the endoscope can be stiffened.

[0016]

[0016] For example, described herein is an endoscopic sheath apparatus (e.g., a system, device, etc.) that includes an outer sheath, a cap hermetically sealed to a distal end of the outer sheath, and an inner sheath having one or more lumens and extending within the outer sheath, the inner sheath being hermetically sealed to the cap such that the one or more lumens are open through the cap.

[0017]

[0017] For example, an endoscopic sheath device configured to prevent contamination of an endoscope may include an outer sheath, a cap hermetically sealed to a distal end of the outer sheath, and one or more inner sheaths each extending within the outer sheath, each inner sheath having one or more internal lumens, and each inner sheath further hermetically sealed to the cap such that the one or more internal lumens are open through the cap.

[0018]

[0018] In one embodiment, an endoscopic sheath device configured to prevent contamination of an endoscope may include a soft outer sheath configured to extend over the endoscope to form an impermeable outer barrier, a cap hermetically coupled to a distal end of the outer sheath and configured to mate with the distal end of the endoscope, and one or more inner sheaths, each having one or more internal lumens, each of the one or more inner sheaths extending within the soft outer sheath, each of the one or more inner sheaths configured to pass through a lumen of the endoscope to form an impermeable inner barrier, and each of the one or more inner sheaths hermetically coupled to the cap such that the one or more internal lumens are open through the cap.

[0019]

[0019] Thus, in general, the sheath devices described herein (including the cap, outer and inner sheath devices) can form an impermeable contamination barrier. The impermeable contamination barrier can be impermeable to fluids and / or solids. The barrier can be aseptic or pre-sterilized. Optionally, the barrier need not be sterile, but can be clean and prevent contamination of the endoscope to which it is attached. The endoscope need not be sterile or maintained in a sterile state, but can be kept clean and free of contamination by the sheath devices described herein. In particular, the sheath devices described herein can substantially create a barrier that prevents contamination, so that both the exterior and interior (e.g., channels, lumens, etc.) of the endoscope can be kept clean and free of contamination. Importantly, these sheath devices are configured to be removed without contamination of the endoscope covered by the sheath on the exterior or interior.

[0020]

[0020] An endoscopic sheath device configured to prevent contamination of an endoscope includes a soft outer sheath configured to fit over an endoscope, a cap hermetically sealed to a distal end of the outer sheath, one or more inner sheaths each extending into the outer sheath and configured to fit within a lumen extending through the endoscope, each inner sheath having one or more lumens, each inner sheath further being hermetically sealed to the cap such that one or more internal lumens are open through the cap, and a sealing region at a proximal end of each of the one or more inner sheaths configured to be sealed after use to prevent contamination during removal of the one or more inner sheaths from within the lumen extending through the endoscope.

[0021] For example, in one embodiment, the outer sheath comprises a soft, thin, elastic material. The outer sheath can be made of one or more materials, including plastics, elastomers, plastomers, or composites. Plastomers include polymeric materials that combine the properties of elastomers and plastics, such as rubber-like properties with the processability of plastics. Plastomers can include ethylene alpha olefin copolymers. Suitable materials can include latex, polyvinyl chloride, polyurethane, polyethylene, polypropylene, silicone, or other similar materials. The material can be reinforced with laminates that include fibers or metals. In one embodiment, the distal end of the outer sheath (e.g., distal 10% or more, distal 15% or more, distal 20% or more, distal 25% or more, distal 30% or more, distal 35% or more, etc.) can be a thin-walled sheath, and the remainder of the outer sheath can be toughened. The robust sheath may be thicker (e.g., having a wall thickness of 0.1 mm or more, a wall thickness of 0.2 mm or more, a wall thickness of 0.25 mm or more, a wall thickness of 0.3 mm or more, a wall thickness of 0.35 mm or more, a wall thickness of 0.4 mm or more, a wall thickness of 0.5 mm or more, a wall thickness of 0.55 mm or more, a wall thickness of 0.6 mm or more, a wall thickness of 0.7 mm or more, a wall thickness of 0.8 mm or more, a wall thickness of 0.9 mm or more, a wall thickness of 1 mm or more, etc.). Depending on the material forming the sheath, a thin-walled sheath can have a thickness of, for example, 0.2 mm or less, a thickness of 0.15 mm or less, a thickness of 0.1 mm or less, a thickness of 0.05 mm or less, a thickness of 0.04 mm or less, a thickness of 0.02 mm or less, a thickness between about 0.25 mm and 0.01 mm, a thickness of about 0.2 mm to 0.02 mm, etc. The sheath may be formed from a single material having different regions (e.g., thin-walled regions and thicker-walled or reinforced regions), or the sheath may be formed from different materials that are bonded (fused, sealed, etc.) together.

[0022] In general, the outer sheath may be shorter than the inner sheath, for example, the outer sheath may extend only to the distal end of the elongate outer tube (e.g., the elongate outer tube), or in some embodiments, the outer sheath may extend along the entire length of the elongate outer tube.

[0023]

[0023] The cap can be a polymeric material that can be transparent and / or include a transparent window configured to be aligned with a camera of the endoscope to allow imaging therethrough. The cap can be configured to couple to the distal end of the endoscope. In an embodiment, the cap can be configured to secure to the distal end of the endoscope. For example, there are multiple methods that can be used to attach the cap. Examples can include one or more of a shearing surface configured to secure the cap to the distal end of the endoscope, a snap fit configured to secure the cap to the distal end of the endoscope, a magnet configured to secure the cap to the distal end of the endoscope, a bayonet connector configured to secure the cap to the distal end of the endoscope, or a threaded region configured to secure the cap to the distal end of the endoscope.

[0024] In any of the devices described herein, the outer sheath has a lower buckling resistance than the inner sheath. Thus, the inner sheath can have a higher axial compressive stiffness than the outer sheath, and the outer sheath may be configured to buckle (e.g., wrinkle, pleat, gather, stack on itself, etc.), while the inner sheath is configured to resist buckling. In an embodiment, the inner sheath comprises a multi-lumen catheter. For example, the inner sheath may be formed as an elongated flexible single-lumen or multi-lumen catheter. The inner sheath may be made of a polymeric material such as polyvinyl chloride, polyurethane, polyethylene, polypropylene, etc. The inner sheath may be a composite structure, including wire or fiber reinforcement. The inner sheath may have elements to facilitate sliding (along its inner surface or along its outer surface) during installation, use (including when passing a tool through it), and removal / removal. The components of the inner sheath may vary along its length, including material and / or durometer. Generally, the inner sheath, which may also be referred to as the inner sheath, may be longer than the endoscope into which it is inserted such that the inner sheath extends proximally from the endoscope, in which case the inner sheath may engage a port adapter to provide access into or out of the lumen (or lumens) of the inner sheath.

[0025]

[0025] For example, if the inner sheath has multiple lumens (e.g., configured as a multi-lumen catheter), the proximal end of the inner sheath may include one or more openings into the internal lumen of one or more lumens at the proximal end region of the inner sheath. For example, this may be an end opening and / or a side opening. In one embodiment, the inner sheath includes multiple radially spaced (and optionally laterally or axially spaced) side openings at the proximal end region of the inner sheath, each radially spaced side opening opening into a lumen of the multi-lumen catheter. The port adapter may be coupled to the end of the internal lumen (e.g., multi-lumen catheter) to directly align the opening of the inner sheath with a port or with a source of suction, compressed air ("inflation"), source fluid (e.g., saline), etc. In general, the port adapter may be configured to couple to the multi-lumen catheter to form separate ports in fluid communication with each lumen of the multi-lumen catheter. Thus, the inner sheath is thin, compact, and can be quickly, easily, and accurately attached to and retained (and subsequently removed) from a structure such as a port adapter that can be easily plumbed to multiple inputs, even though the inner sheath is a disposable component that can have multiple lumens. This adaptation by a port adapter can work with both single-lumen and multi-lumen inner sheaths.

[0026] Any of these devices can include multiple inner sheaths. In one embodiment, the device includes a second inner sheath configured as a working channel liner. The working channel liner can have a working channel lumen and can extend into the outer sheath adjacent to the inner sheath, and the working channel liner is sealingly coupled to the cap such that the working channel lumen is open through the cap. The working channel can include a single lumen and can allow one or more tools to enter proximally and then exit distally. The working channel can be used for aspiration or for irrigation.

[0027] Both the outer sheath and the one or more inner sheaths can be hermetically fitted to the cap to provide a barrier to prevent fluids and / or microorganisms from reaching the endoscope. In one embodiment, the outer sheath and / or the inner sheath (including the working channel lumen) can be bonded to the cap by welding, ultrasonic welding and / or adhesive bonding to form a hermetic fit.

[0028] Any of these devices may include a proximal fastener on the outer sheath configured to secure the outer sheath to the exterior surface of the endoscope. The proximal fastener may be a resilient material that allows the outer sheath to be resiliently mounted or secured to the exterior surface of the endoscope. In some embodiments, the proximal fastener may include a sealing fastener (such as, but not limited to, a gasket such as an O-ring, an adhesive, etc.). In general, the proximal fastener for the outer sheath may hold the outer sheath on and / or against the endoscope (in embodiments where the sheath is used with a single endoscope alone) or against the elongated outer tube (in embodiments where the sheath is used with a telescopic assembly including a concentrically arranged elongated outer tube and an inner endoscope).

[0029] After the inner sheath has been used, it must be withdrawn so that it can be disposed of so that the endoscope is ready for an unused or new sheath system. If contaminating fluids have passed through the inner sheath, the inner sheath must be cleanly and effectively terminated so as not to pose a contamination risk. To this end, the inner sheath can be crimped at both ends, including by a metal tube compressed radially. The inner sheath can be sealed by an adhesive that hardens (e.g., by UV curing). The inner sheath can also be heat sealed so that the lumen is effectively sealed and terminated. The diameter of the sealed unit must not be larger than the diameter of the lumen pulled through it, otherwise it cannot be removed. In any of these embodiments, after the inner sheath or sheaths are sealed, the inner sheath can be cut, with a short portion remaining in the port adapter and then a long portion sliding out distally, remaining free of contamination. These methods can seal the inner sheath to prevent contamination when the endoscopic sheath device is removed from the endoscope.

[0030]

[0030] For example, described herein is an endoscopic sheath device that includes a soft outer sheath, a cap sealingly coupled to a distal end of the soft outer sheath and configured to seal against the distal end of an endoscope, one or more inner sheaths having one or more lumens and extending into the soft outer sheath, the inner sheaths sealingly coupled to the cap such that the one or more lumens are open through the cap, and a working channel liner (e.g., a second inner sheath) having a working channel lumen and extending into the soft outer sheath adjacent to the inner sheath, the working channel liner sealingly coupled to the cap such that the working channel lumen is open through the cap.

[0031] Any of the devices described herein may be configured as a sheath assembly including the sheath components described above, such as an outer sheath, an inner sheath, and a cap integrated with an outer tube (e.g., an outer catheter, overtube, or other outer elongated member having an internal lumen within which an endoscope may be placed) in a telescopic configuration. For example, the outer sheath may be fused or otherwise connected (including sealed) to the outer surface of the elongated outer tube to form the sheath assembly. Multiple such sheath assemblies may be used with the same endoscope, as described herein, such that they may be attached and removed without contaminating or compromising the cleanliness of the endoscope.

[0032]

[0032] For example, described herein is a system including a flexible outer tube for use with an inner endoscope in a telescopic configuration, the system including an elongated outer tube including an outer tube lumen, an outer sheath coupled at a first end region to a proximal end region of the elongated outer tube, a cap hermetically coupled to a second end of the outer sheath, and an inner sheath having one or more inner sheath lumens and extending within the outer sheath and into the outer tube lumen, the inner sheath hermetically coupled to the cap such that the one or more inner sheath lumens are open through the cap.

[0033]

[0033] These systems can include any of the features described above. Additionally, the cap can be configured to couple to a distal end of the inner endoscope and the inner sheath can be configured to extend through a lumen of the inner endoscope. As previously mentioned, in general, the sheath devices described herein can be used with non-rigidified or rigidified members (e.g., rigidified endoscopes, catheters and / or overtubes). For example, the elongated outer tube can be configured to be selectively rigidified. The elongated outer tube can be configured to be selectively rigidified by a number of techniques, including application of positive or negative pressure. The device can be robotically or manually operated.

[0034]

[0034] Methods of using any of these devices are also described herein, including methods of mounting and / or removing a sheath from an endoscope or an assembly including an endoscope (e.g., a telescopic assembly), and methods of using a sheath device to keep an endoscope clean. For example, a method of mounting a sanitary sheath on an endoscope may include inserting an inner sheath through a lumen of the endoscope from the distal end to the proximal end such that one or more inner sheath lumens extend through the endoscope from the distal end to the proximal end, positioning an outer sheath over the endoscope such that the outer sheath extends proximally from the distal end, and securing a cap to the distal end of the endoscope, the outer sheath sealingly coupled to the cap such that the inner sheath lumens are open through the cap, and the inner sheath sealingly coupled to the cap.

[0035] Positioning the outer sheath over the endoscope can include positioning the endoscope within the elongated outer tube such that the endoscope can be moved telescopically relative to the elongated outer tube. Inserting the inner sheath through the lumen of the endoscope can include inserting a multi-lumen catheter forming the inner sheath through the lumen of the endoscope.

[0036] Once positioned, in some embodiments, the methods can include coupling the inner sheath to a port adapter at the proximal end region of the inner sheath. Any of the methods can include coupling each of the lumens of the multi-lumen catheter to a port adapter at the proximal end region of the inner sheath to provide separate access to each lumen.

[0037] The proximal end of the flexible outer tube is connectable, including to the base of the endoscope (for manual procedures) or to mating geometry on the main base (for robotic procedures). After the procedure is completed, the mechanism can be removed or disengaged.

[0038]

[0038] In one embodiment, attaching the cap to the distal end of the endoscope includes securing the cap to the distal end of the endoscope using a snap fit, a friction fit, a magnetic coupling, a bayonet connector, or a threaded region.

[0039]

[0039] For example, a method of maintaining cleanliness of an endoscope includes performing a medical procedure with an endoscope, the distal end of which is covered by a cap, an inner sheath hermetically joined to the cap, extending through the lumen of the endoscope from the distal end to the proximal end such that one or more inner sheath lumens extend through the lumen of the endoscope and are open through the cap, and an outer sheath hermetically joined to the cap and extending proximally over the endoscope and connecting to the lumen at the proximal end, removing the cap from the distal end of the endoscope, and withdrawing the endoscope proximally out of the outer sheath such that the inner sheath extends out of the distal end of the lumen of the endoscope, the proximal end region of the inner sheath being hermetically closed.

[0040]

[0040] Performing the medical procedure can include passing material into or out of one or more inner sheaths through the cap and / or imaging through the cap (e.g., through an imaging window and / or through a transparent cap or transparent region of the cap). The outer sheath can be coupled to an outer surface of the outer tube, with the endoscope telescopically positioned within the outer tube. Performing the medical procedure can include moving the endoscope proximally or distally relative to the outer tube. In any of these devices, withdrawing the endoscope proximally from the outer sheath can include withdrawing the endoscope from the outer tube.

[0041] Any of these methods can include sealing the proximal end region of the inner sheath. For example, sealing the proximal end region can include crimping the proximal end region. Sealing the proximal end region can include heat sealing the proximal end region.

[0042] Any of the apparatus (e.g., devices) described herein may include an inner sheath that is a multi-lumen extrusion (e.g., a multi-lumen catheter) having two or more sub-lumens (e.g., three lumens, four lumens, etc.). An inner sheath including a multi-lumen catheter may be used to convert a single lumen of an endoscope into multiple separate lumens. An apparatus, e.g., a device, including a multi-lumen inner sheath may be used to deliver a variety of things, such as suction, insufflation, irrigation fluids, etc. These apparatus may be adapted for use with a port adapter that may provide reliable access to the different lumens of the multi-lumen inner sheath. For example, an endoscope sheath device configured to prevent contamination of an endoscope may include an outer sheath, a cap hermetically coupled to a distal end of the outer sheath, an inner sheath including a multi-lumen catheter extending into the outer sheath, the inner sheath hermetically coupled to the cap such that the lumens of the multi-lumen catheter are open through the cap, and a plurality of radially spaced side openings at a proximal end region of the inner sheath, each side opening opening into an internal lumen of the multi-lumen catheter. A proximal end region of the inner sheath can be configured to mate with a port adapter to form separate ports in fluid communication with each lumen of the multi-lumen catheter.

[0043]

[0043] For example, a method of mounting a sanitary sheath on an endoscope may include inserting an inner sheath through a lumen of the endoscope from the distal end to the proximal end so that one or more inner sheath lumens extend through the endoscope from the distal end to the proximal end, positioning an outer sheath over the endoscope so that the outer sheath extends proximally from the distal end, and mounting a cap on the distal end of the endoscope, wherein the outer sheath is sealingly connected to the cap and the inner sheath is sealingly connected to the cap such that the inner sheath lumens are open through the cap.

[0044]

[0044] The inner sheath may include a multi-lumen catheter, and inserting the inner sheath through a lumen of the endoscope may include inserting the multi-lumen catheter through a lumen of the endoscope. The inner sheath may include a working channel liner, and inserting the inner sheath through a lumen of the endoscope may include inserting the working channel liner through a lumen of the endoscope. Any of these methods may include inserting a second inner sheath through a second lumen of the endoscope from the distal end to the proximal end such that an inner sheath lumen of the second inner sheath extends through the endoscope from the distal end to the proximal end. The inner sheath may include a multi-lumen catheter, and may further include coupling the inner sheath to a port adapter at a distal end region of the inner sheath to form separate ports in fluid communication with each lumen of the multi-lumen catheter.

[0045]

[0045] Mounting the cap on the distal end of the endoscope can include securing the cap to the distal end of the endoscope using one or more of a snap fit, a friction fit, a magnetic coupling, a bayonet connector, or a threaded region. Mounting the cap on the distal end of the endoscope can include manually squeezing (e.g., using two or more fingers to squeeze) a cylindrical mating surface of the cap that is configured to mate with the distal end of the endoscope from an oval resting cross-sectional form to a circular mating cross-sectional form.

[0046]

[0046] Positioning the outer sheath over the endoscope may include positioning the endoscope within the elongated outer tube such that the endoscope can move in a telescopic manner relative to the elongated outer tube.

[0047] For example, a method of maintaining the cleanliness of an endoscope can include performing a medical procedure with the endoscope while the distal end of the endoscope is covered by a cap, with an inner sheath hermetically coupled to the cap, extending through the lumen of the endoscope from the distal end to the proximal end such that one or more inner sheath lumens extend through the lumen of the endoscope and are open through the cap, and an outer sheath hermetically connected to the cap and extending proximally over the endoscope, removing the cap from the distal end of the endoscope, and withdrawing the endoscope proximally out of the outer sheath such that the inner sheath extends out of the distal end of the lumen of the endoscope, the proximal end region of the inner sheath being sealed. Performing the medical procedure can include passing a substance into or out of the one or more inner sheaths through the cap. Performing the medical procedure can include imaging through the cap (e.g., a lens on the cap). The outer sheath can be coupled to an outer surface of an outer tube, with the endoscope telescopically positioned within the outer tube.

[0048]

[0048] Performing the medical procedure can include moving the endoscope proximally or distally relative to the outer tube. Withdrawing the endoscope proximally out of the outer sheath can include withdrawing the endoscope proximally out of the outer tube. As previously mentioned, any of these methods can include sealing the proximal end region of the inner sheath. For example, sealing the proximal end region can include crimping the proximal end region. In one embodiment, sealing the proximal end region includes heat sealing the proximal end region.

[0049] As mentioned above, any of these devices (e.g., sheaths) can be configured to include a crimped region at the proximal end region of the inner sheath configured to be crimped to seal one or more lumens after use to prevent contamination during removal of the inner sheath from within the lumen of the endoscope. The crimped region can include a region formed of a material (e.g., a metallic material such as a cuff or linking region) that can hold the crimp without leakage. In some embodiments, the crimped region can be configured to melt. For example, the crimped region can be configured to be heat sealed and / or pressure sealed. The crimped region can be formed or supplemented with a different material proximal and / or distal to the crimped region. Crimping as used herein can include mechanical crimping (e.g., pinching off a lumen), heat crimping (e.g., heating / melting a lumen so that it closes), or some combination thereof. Crimping can deform the material forming the lumen and / or additional material on or around the lumen.

[0050]

[0050] For example, an endoscopic sheath device configured to prevent contamination of an endoscope may include a flexible outer sheath, a cap hermetically sealed to a distal end of the outer sheath, an inner sheath including a multi-lumen catheter extending within the outer sheath, the inner sheath hermetically sealed to the cap such that the lumens of the multi-lumen catheter are open through the cap, the inner sheath being less flexible than the outer sheath and configured to extend through the lumens of the endoscope, and a plurality of radially and / or axially spaced side openings at a proximal end region of the inner sheath, each side opening opening into an internal lumen of the multi-lumen catheter, the proximal end region of the inner sheath being further configured to mate with a port adapter forming a separated port fluidly connected to each lumen of the multi-lumen catheter.

[0051]

[0051] An endoscopic sheath device configured to prevent contamination of an endoscope includes a soft outer sheath configured to extend over an endoscope, a cap hermetically sealed to a distal end of the outer sheath, an inner sheath including a multi-lumen catheter extending within the outer sheath, the inner sheath hermetically sealed to the cap such that a lumen of the multi-lumen catheter is open through the cap and further configured to extend through a lumen of the endoscope, a plurality of radially and / or axially spaced side openings at a proximal end region of the inner sheath, each side opening opening into an internal lumen of the multi-lumen catheter, and a crimping region at the proximal end region of the inner sheath configured to be crimped to seal one or more lumens after use to prevent contamination during removal of the inner sheath from within the lumen of the endoscope.

[0052] Any of the endoscopic sheath devices (or methods of making and using them and / or systems including them) described herein can be configured to prevent contamination of an endoscope and can include an outer sheath, a cap sealingly coupled to a distal end of the outer sheath, an inner sheath including a multi-lumen catheter extending within the outer sheath, the inner sheath sealingly coupled to the cap such that the lumen of the multi-lumen catheter is open through the cap, and a sealing region at the proximal end region of the inner sheath configured to seal the lumen of the multi-lumen catheter after use to prevent contamination during removal of the inner sheath from within the lumen of the endoscope. As previously mentioned, any of these methods can include a plurality of radially spaced side openings at the proximal end region of the inner sheath, each opening into the internal lumen of the multi-lumen catheter. The proximal end region of the inner sheath can be configured to mate with a port adaptor to form separate ports in fluid communication with each lumen of the multi-lumen catheter. The sealing region can include a crimp region (e.g., a mechanical seal / crimp region) configured to be mechanically crimped. Thus, the sealing area may be configured to be pressure sealed. The sealing area may be configured to be heat sealed.

[0053]

[0053] For example, an endoscopic sheath device configured to prevent contamination of an endoscope may include a soft outer sheath, a cap hermetically sealed to a distal end of the outer sheath, an inner sheath including a multi-lumen catheter extending within the outer sheath, the inner sheath hermetically sealed to the cap such that the lumens of the multi-lumen catheter are open through the cap, and further configured to extend through the lumens of the endoscope, and a crimping region at a proximal end region of the inner sheath configured to be crimped to seal one or more lumens after use to prevent contamination during removal of the inner sheath from within the lumen of the endoscope.

[0054]

[0054] An endoscopic sheath device configured to prevent contamination of an endoscope includes a soft outer sheath configured to extend over an endoscope, a cap hermetically sealed to a distal end of the outer sheath, an inner sheath including a multi-lumen catheter extending within the outer sheath, the inner sheath hermetically sealed to the cap such that a lumen of the multi-lumen catheter is open through the cap and further configured to extend through a lumen of the endoscope, a plurality of radially spaced side openings at a proximal end region of the inner sheath, each side opening opening into an internal lumen of the multi-lumen catheter, and a crimping region at the proximal end region of the inner sheath configured to be crimped to seal one or more lumens after use to prevent contamination during removal of the inner sheath from the lumen of the endoscope.

[0055]

[0055] Also described herein are methods of making any of the endoscopic sheaths described herein. For example, a method of making an endoscopic sheath device configured to prevent contamination of an endoscope can include sealing a distal end region of a tubular inner sheath to an opening through a cap configured to couple to the distal end region of the endoscope, where the tubular inner sheath is configured to be inserted through a lumen of the endoscope, and sealing a distal end region of a tubular outer sheath to the cap, where the tubular outer sheath is configured to fit over an exterior surface of the endoscope. In general, the tubular outer sheath and / or the tubular inner sheath may have any cross-sectional shape and are not limited to circular or oval (e.g., square, rectangular, octagonal, etc.).

[0056]

[0056] Since any of these devices can include an inner sheath having a hydrophilic coating on the inside of the entire length of the inner sheath and / or on the outside of the inner sheath, any of these methods can include coating the inside (and in some embodiments, the outside) of one or more inner sheaths with a hydrophilic coating. In some embodiments, the method can include coating a sheet of inner sheath material with a hydrophilic coating and forming the sheet of inner sheath material in a tube to form a tubular inner sheath such that the hydrophilic coating extends into the lumen of the tubular inner sheath. In some embodiments, the hydrophilic coating is applied as an adhesive to the substrate. The inner sheath having the coating can be a single lumen sheath (e.g., a working channel liner) or a multi-lumen sheath. For example, any of these methods can include sealing a distal end region of a second tubular inner sheath against a second opening through the cap, the second tubular inner sheath comprising a multi-lumen tube. In some embodiments, the tubular inner sheath can comprise a working channel liner having a working channel lumen.

[0057] Any of the devices (e.g., sheaths) described herein may include one or more reinforced inner sheaths, particularly at the distal end region of the inner sheath. This may be particularly useful in variants where the distal end region (e.g., distal tip region) of the catheter is configured to bend, steer, etc. Thus, it may be beneficial to provide a device with a reinforced distal end region (or the entire length of the endoscope, or just the distal 5 cm, distal 4 cm, distal 3 cm, distal 2 cm, distal 1 cm, etc. distal end region). Reinforcing the distal end region of a single lumen inner sheath (e.g., working channel liner) may be particularly useful to prevent pinching closure at the bending distal end region. Thus, any of the methods of forming the devices described herein may also include reinforcing the tubular inner sheath such that the distal end region of the tubular inner sheath is prevented from collapsing upon bending.

[0058] In any of these embodiments, the inner sheath can include a reinforcing structure, such as a reinforcing coil, and thus the method of forming the device can include adding the reinforcing coil. In some embodiments, the method can include adding reinforcement to only the distal end region (e.g., distal 5 cm, distal 4 cm, distal 3 cm, distal 2 cm, distal 1.5 cm, distal 1 cm only, etc.).

[0059]

[0059] In any of these methods, sealing the distal end region of the tubular inner sheath to the cap and sealing the distal end region of the tubular outer sheath may include forming a continuous fluid-impermeable contamination barrier.

[0060] Any of these methods may include packaging the endoscopic sheath device in a rolled configuration, which may make it easier to store and load the sheath device onto an endoscope, including reducing the space it occupies and landfill waste, and reducing any required sterilization costs.

[0061] Any of these methods can include forming a crimped region at a proximal end region of the inner sheath (or each of the sheaths in variations having multiple sheaths) configured to be crimped to seal one or more lumens after use to prevent contamination during removal of the inner sheath from within the lumen of the endoscope. In some embodiments, the crimped region can include a cuff or ring made of a relatively ductile material, such as a metal, that can be pinched closed to seal one or more lumens of the inner sheath. In some embodiments, the inner sheath can include a region formed of a crimpable material as described herein.

[0062]

[0062] The methods of forming the devices described herein can also include stiffening the tubular outer sheath. The tubular outer sheath can be formed shorter than the tubular inner sheath (e.g., the inner sheath can extend beyond the tubular outer sheath). The devices described herein can be formed using any of the caps described herein, including fully or partially transparent caps. The cap can include a cylindrical mating surface having an oval configuration at rest, the cylindrical mating surface configured to be compressed to assume a circular cross-sectional configuration that fits over the distal end of the endoscope. Any of these methods can include mounting a proximal fastener on the tubular outer sheath configured to secure the tubular outer sheath to an exterior surface of the endoscope.

[0063]

[0063] For example, a method of making an endoscopic sheath device configured to prevent contamination of an endoscope may include coating a layer of inner sheath material with a hydrophilic coating; laminating the inner sheath material such that the hydrophilic coating extends into the lumen of a tubular inner sheath; sealing a distal end region of the tubular inner sheath to an opening through a cap configured to be coupled to the distal end region of the endoscope, wherein the tubular inner sheath is configured for insertion through the lumen of the endoscope; and sealing the distal end region of the tubular outer sheath to the cap, wherein the tubular outer sheath is configured to fit over an exterior surface of the endoscope, wherein the tubular outer sheath, cap and tubular inner sheath form a continuous fluid-impermeable contamination barrier.

[0064]

[0064] For example, a method of making an endoscopic sheath device configured to prevent contamination of an endoscope can include reinforcing a tubular inner sheath, including by denser reinforcement at the distal end so that the distal end region of the tubular inner sheath is prevented from collapsing upon bending; sealing the distal end region of the inner sheath against an opening through a cap configured to couple to the distal end region of the endoscope, the inner sheath being configured for insertion through a lumen of the endoscope; and sealing the distal end region of a tubular outer sheath to the cap, the outer sheath being configured to fit over an exterior surface of the endoscope, the outer sheath, cap and inner sheath forming a continuous fluid-impermeable contamination barrier.

[0065]

[0065] As mentioned above, any of these sheath arrangements may include a distal cap configured to couple to an endoscope that includes one or more light sources. These light sources may be light emitting diodes (LEDs), optical fibers, laser light sources, etc. For example, described herein is an endoscopic sheath device configured to prevent contamination of an endoscope, including an outer sheath, a cap that is at least partially transparent and is hermetically coupled to a distal end of the outer sheath and configured to couple to a distal end of the endoscope, (optionally) one or more inner sheaths each extending within the outer sheath, each inner sheath having one or more lumens, and each inner sheath further hermetically coupled to the cap such that the one or more lumens are open through the cap, and one or more light sources on the cap configured to project light distal to the cap.

[0066] In some embodiments, the one or more light sources include light emitting diodes (LEDs). For example, the one or more light sources can include a red light source, a green light source, and a blue light source. The device can be configured to provide white light by illuminating each of the red, green, and blue light sources, and / or by providing a specific wavelength or range of wavelengths (e.g., red or green or blue) to differentially interrogate anatomy using different wavelengths of light. The one or more light sources can include multiple light sources disposed at least partially around the circumference of the cap. The light sources may be disposed around the entire circumference or a portion of the circumference. In some embodiments, the device can include multiple conductive members (e.g., traces, wires, etc.) coupled to the one or more light sources on the cap and extending on or within the outer sheath or on or within the inner sheath. For example, the wires may extend spirally around the outer sheath to couple with a control and / or power source on the proximal end of the device.

[0067] In one embodiment, the device includes one or more electrical contacts on an inner surface of the cap, the one or more electrical contacts being in electrical communication with the one or more light sources. The electrical contacts may be on the inner surface of the cap or may be pads or pins that contact pins or pads on the distal end region of the endoscope.

[0068]

[0068] In general, the cap can include a lens area configured to be positioned over a camera of an endoscope. The lens area can be formed within the cap (of the cap material) and / or can include additional material added to the cap. The lens area can be a lens formed as a concave and / or convex area. The lens area can provide an expanded field of view.

[0069]

[0069] Generally, the cap is configured to be secured to the distal end of the catheter. For example, the cap may include one or more of a friction fit configured to secure the cap to the distal end of the endoscope, a snap fit configured to secure the cap to the distal end of the endoscope, a magnet configured to secure the cap to the distal end of the endoscope, a bayonet connector configured to secure the cap to the distal end of the endoscope, or a threaded region configured to secure the cap to the distal end of the endoscope. In an embodiment, the cap may include a cylindrical engagement region that fits over the endoscope and may include one or more latches.

[0070]

[0070] For example, described herein is an endoscopic sheath device configured to prevent contamination of an endoscope, the device including a flexible, tubular outer sheath, a cap hermetically sealed to a distal end of the outer sheath and at least partially transparent, a tubular, elongated inner sheath extending within the outer sheath and having one or more internal lumens, the inner sheath further being hermetically sealed to the cap such that a distal end region of the tubular, elongated inner sheath is open through the cap with one or more lumens of the tubular, elongated sheath extending therethrough, and one or more light sources on the cap configured to project light distal to the cap.

[0071]

[0071] An endoscopic sheath device configured to prevent contamination of an endoscope includes a flexible, tubular outer sheath, a cap hermetically sealed to a distal end of the outer sheath and at least partially transparent, a tubular, elongated inner sheath extending into the outer sheath and having one or more internal lumens, the inner sheath further being hermetically sealed to the cap such that a distal end region of the tubular, elongated inner sheath is open through the cap, one or more light sources on the cap configured to project light distal to the cap, and one or more electrical contacts on an inner surface of the cap in electrical communication with the one or more light sources.

[0072] Any of the sheath devices described herein can be configured as a rigidifying sheath. For example, rigidifying sheaths are described herein in which an outer sheath is rigidified and can transition from a flexible configuration to a rigid configuration, e.g., by application of pressure, in some embodiments positive pressure can be applied, in some embodiments negative pressure can be applied, and in some embodiments either positive or negative pressure can be applied.

[0073]

[0073] The stiffening sheath devices described herein can transition from a flexible configuration to a rigid configuration. In certain embodiments, the stiffness (e.g., stiffness) can be considered a "variable stiffness" since the stiffness can be selected by a user or a system, for example, based on the applied pressure. For example, the stiffening outer sheath can be stiffened by applying positive or negative pressure to stiffen the stiffening layer within the stiffening outer sheath by driving a compression layer (e.g., a bladder) against the stiffening layer, thereby preventing or limiting movement of the stiffening layer. With the positive or negative pressure removed (or reversed), the layers can easily shear or move relative to each other, and release of the positive or negative pressure can allow the layers to transition to a state that exhibits a substantially reinforced ability to resist shear, movement, bending, torque, and buckling, thereby providing system stiffening. Although the embodiments described herein primarily illustrate stiffening by application of pressure (e.g., positive or negative pressure), the methods and devices described herein can be used with any suitable stiffening sheath and are not limited to positive or negative pressure stiffening devices. For example, the rigidifiable sheath described herein may refer to any suitable rigidifying sheath, including a sheath that can be rigidified by jamming particles, or by a phase change and / or shape memory alloy, or by a linking component (such as a cable with a disk or cone), an EAP (electroactive polymer), or any other rigidifying mechanism.

[0074] Any of the stiffening possible sheaths described herein may include a stiffening layer or region that engages a compression layer (which may be or include a bladder) that applies a force to the stiffening layer to stiffen or, in some cases, to de-stiffen (e.g., release) the stiffening layer. In certain embodiments, these stiffening possible devices may include a stiffening layer that may include braids, knits, weaves, shreds, randomly distributed or randomly oriented fibers or strands, engagers, links, scales, plates, segments, particles, granules, crossing fibers, or other materials that form a stiffening layer. For example, the stiffening layer may include multiple strands or strand segments that cross over one another (e.g., as part of a braid, knit, weave, etc.). The compression layer may apply a force to drive the crossing strands or strand segments against one another. While many of the embodiments shown herein are braids, any of these devices may instead or in addition include a generalized stiffening layer that includes crossing strands or strand segments. The stiffening device embodiments described herein can use pressure (positive pressure) and / or negative pressure to selectively and controllably stiffen, and in some embodiments, the methods described herein can be used with any suitable stiffening device.Examples of stiffening structures that may be included as part of the stiffening sheath include PCT Application No. PCT / US2023 / 064999, filed March 27, 2023, and entitled "METHODS AND APPARATUSES FOR NAVIGATING USING A PAIR OF RIGIDIZING DEVICES," U.S. Patent Application No. 17 / 902,770, filed September 2, 2022, and entitled "NESTED RIGIDIZING DEVICES," U.S. Patent Application No. 18 / 000,062, filed May 26, 2021, and entitled "RIGIDIZING DEVICES," U.S. Patent Application No. 18 / 000,062, filed July 31, 2022, and entitled "DEVICES AND METHODS TO PREVENT INADVERTENT MOTION OF DYNAMICALLY RIGIDIZING No. PCT / US2022 / 014497, entitled "METHOD AND APPARATUSES FOR REDUCING CURVATURE OF A COLON," filed on December 22, 2022, and entitled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES," filed on February 8, 2023, and the like. Each of these applications is incorporated herein by reference in its entirety.

[0075]

[0075] For example, an endoscopic sheath device configured to prevent contamination of an endoscope may include a rigidified outer sheath configured to extend over an endoscope, the rigidified outer sheath including a stiffening layer including a plurality of crossed strands and a compression layer configured to be actuated to apply a force to the stiffening layer to stiffen the rigidified outer sheath from a flexible configuration to a rigid configuration; a cap configured to couple to a distal end of the endoscope and hermetically bonded to a distal end region of the outer sheath; and an inner sheath configured to extend within the rigidified outer sheath and extend through a lumen of the endoscope, the inner sheath having one or more internal lumens and hermetically bonded to the cap such that one or more lumens of the inner sheath are open through the cap.

[0076]

[0076] As mentioned above, in some embodiments, the stiffening layer may include a plurality of crossed strands. The plurality of strands may include one or more of braided, knitted, woven, shredded, randomly dispersed and / or randomly oriented fibers or interlockings. The compression layer may include a bladder. The inner sheath may be less flexible than the soft form of the stiffening outer sheath. Any of these devices may include a pressure port coupled to the stiffening outer sheath and configured to receive pressure to actuate the compression layer. The stiffening outer sheath may be configured to stiffen by application of positive pressure. The stiffening outer sheath may be configured to stiffen by application of negative pressure.

[0077]

[0077] For example, an endoscopic sheath device configured to prevent contamination of an endoscope may include a rigidified outer sheath configured to extend over an endoscope, the rigidified outer sheath including a stiffening layer including a plurality of crossed strands and a compression layer configured to be actuated to apply a force to the stiffening layer to stiffen the rigidified outer sheath from a flexible configuration to a rigid configuration, a cap hermetically coupled to a distal end region of the outer sheath and configured to engage the distal end of the endoscope, and an inner sheath extending within the rigidified outer sheath and configured to extend through a lumen of the endoscope, the inner sheath having one or more internal lumens and hermetically coupled to the cap such that one or more lumens of the inner sheath are open through the cap.

[0078] Any of the devices described herein can be configured to be reinforced, specifically the inner sheath can be reinforced at the distal end to prevent pinching of one or more lumens of the tubular inner sheath. The endoscope can be steerable and therefore bendable at the distal end region. Thus, the sheath devices described herein can be configured to prevent, reduce or minimize the effect of the inner sheath on the overall flexibility of the distal end of the device and therefore steering. In some embodiments, the inner sheath can be configured to be relatively flexible. However, these inner sheaths can also be configured to resist pinching of lumens upon bending or flexing that may otherwise occur with a highly flexible structure. For example, the inner sheaths described herein can be reinforced, such as by reinforcing coils, to prevent collapse while maintaining a high degree of flexibility.

[0079]

[0079] For example, an endoscopic sheath device configured to prevent contamination of an endoscope may include a cap configured to be attached to a distal end of the endoscope, a soft outer sheath configured to extend over the endoscope, the outer sheath having a distal end region hermetically attached to the cap, and a tubular inner sheath configured to be inserted through a lumen of the endoscope, the tubular inner sheath extending proximally from the cap into the outer sheath, the distal end region of the tubular inner sheath being hermetically attached to the cap such that the lumen of the tubular inner sheath is open through the cap, and further, the distal end region of the tubular inner sheath is reinforced to prevent the tubular inner sheath from collapsing when bent.

[0080]

[0080] The distal end region of the tubular inner sheath may include a reinforcing coil. In some embodiments, only the distal end region of the tubular inner sheath may be reinforced, or the majority (or all) of the length of the inner sheath may be reinforced. In some embodiments where multiple inner sheaths are used, only the inner sheath having a single lumen (e.g., a working channel liner) is reinforced as described herein. For example, any of these devices may include a second tubular inner sheath sealingly coupled to the cap and configured to be inserted through a lumen of the endoscope, the second tubular inner sheath extending proximally from the cap into the outer sheath. The second tubular inner sheath may include a multi-lumen catheter. This second tubular inner sheath may be unreinforced.

[0081]

[0081] The tubular inner sheath can include a working channel liner having a working channel lumen. The working channel lumen can include a hydrophilic coating. The soft outer sheath, the cap and the tubular inner sheath can form a fluid-impermeable contamination barrier to prevent contamination of the endoscope.

[0082]

[0082] For example, an endoscopic sheath device configured to prevent contamination of an endoscope can include a cap configured to be coupled to a distal end of the endoscope, a soft outer sheath configured to extend over the endoscope, the soft outer sheath having a distal end region hermetically bonded to the cap, and a tubular inner sheath including a working channel liner configured to be inserted through a lumen of the endoscope, the tubular inner sheath extending proximally from the cap into the outer sheath, the distal end region of the tubular inner sheath being hermetically bonded to the cap such that the lumen of the tubular inner sheath is open through the cap, and further, the distal end region of the tubular inner sheath is reinforced to prevent the tubular inner sheath from collapsing upon bending, wherein the soft outer sheath, cap and tubular inner sheath together form a fluid impermeable contamination barrier to prevent contamination of the endoscope.

[0083]

[0083] For example, an endoscopic sheath device configured to prevent contamination of an endoscope may include a cap configured to be coupled to a distal end of an endoscope, a flexible outer sheath configured to extend over the endoscope, the outer sheath having a distal end region hermetically coupled to the cap, and a first tubular inner sheath including a working channel liner configured to be inserted through a lumen of the endoscope, the tubular inner sheath extending proximally from the cap into the outer sheath, the lumen of the tubular inner sheath being open through the cap. The endoscope may include a first tubular inner sheath, the distal end region of which is hermetically coupled to the cap and further wherein the distal end region of the tubular inner sheath is reinforced to prevent the tubular inner sheath from collapsing upon bending, and a second tubular inner sheath hermetically coupled to the cap and including a multi-lumen catheter configured for insertion through a lumen of the endoscope, the second tubular inner sheath extending proximally from the cap into the outer sheath, the soft outer sheath, the cap and the first and second tubular inner sheaths forming a barrier to prevent contamination of the endoscope during use.

[0084] In any of the methods and devices described herein, the cap configured to couple to the distal end of the device can be a removable cap configured to be squeezed between two fingers to fit over the distal end of the endoscope and configured to be squeezed to remove it from the distal end of the endoscope. For example, an endoscopic sheath device can include a tubular outer sheath configured to extend over the endoscope, a tubular inner sheath configured to extend into the lumen of the endoscope and having one or more lumens, and a cap configured to couple to the distal end of the endoscope, where a distal end region of the tubular outer sheath is sealed against the cap and further, a distal end region of the inner sheath is sealed against the cap such that one or more lumens of the tubular inner sheath are open through the cap, and the cap is configured to be removed by squeezing two sides of the cap. The cap can include a substantially cylindrical mating surface configured to mate with the distal end of the endoscope when compressed from an oval resting cross-sectional configuration to a substantially circular mating cross-sectional configuration. These caps can include stress relief cut out areas configured to reduce the force required to transition a cylindrical mating surface to a circular mating cross section.

[0085]

[0085] As used herein, a substantially cylindrical surface can have approximately parallel sides (e.g., may deviate by about ±10%, 9%, 8%, 7%, 6%, 5%, etc.). A substantially circular cross-sectional configuration can be approximately circular and need not be perfectly circular, e.g., the radius may vary by a percentage around the perimeter of the cross-section (e.g., about ±10% or less, 9% or less, 8% or less, 7% or less, 6% or less, 5% or less, etc.). Thus, when the cap is compressed from an oval rest cross-sectional configuration to a substantially circular mating cross-sectional configuration, the cap can be compressed from the oval rest cross-sectional configuration to a mating cross-sectional configuration that is more circular than the oval rest cross-sectional configuration, but may still be somewhat oval.

[0086]

[0086] In general, the cap may include one or more of a snap fit, a friction fit, a magnetic coupling, a bayonet connector, or a threaded region. Any of these caps may include a latch connector configured to secure the cap to the distal end region of the endoscope. The latch connector may include an opening in the cap configured to engage with a protrusion on the distal end region of the endoscope. Alternatively or additionally, the latch connector may include a protrusion that mates with an opening on the endoscope.

[0087]

[0087] In one embodiment, an endoscopic sheath device configured to prevent contamination of an endoscope includes a cap configured to be coupled to a distal end of an endoscope, an outer sheath hermetically coupled to the distal end of the cap, and one or more inner sheaths extending within the outer sheath, each inner sheath hermetically coupled to a distal end of the cap and opening through the cap.

[0088]

[0088] For example, an endoscopic sheath device can include a tubular outer sheath configured to extend over an endoscope, a tubular inner sheath configured to extend into a lumen of the endoscope and having one or more lumens, a cap configured to couple to a distal end of the endoscope, wherein a distal end region of the tubular outer sheath is sealed against the cap and, further, a distal end region of the inner sheath is sealed against the cap such that one or more lumens of the tubular inner sheath are open through the cap, the cap including a cylindrical mating surface configured to mate with the distal end of the endoscope when the cap is compressed from an oval resting cross-sectional configuration to a circular mating cross-sectional configuration, and a latch connector configured to secure the cap to the distal end region of the endoscope, wherein the soft outer sheath, cap and first and second tubular inner sheaths form a fluid-impermeable contamination barrier to prevent contamination of the endoscope during use.

[0089]

[0089] An endoscopic sheath device may include a tubular outer sheath configured to extend over an endoscope, a first tubular inner sheath configured to extend into a first lumen of the endoscope and having one or more lumens, a second tubular inner sheath configured to extend into a second lumen of the endoscope, a cap configured to couple to a distal end of the endoscope, wherein a distal end region of the tubular outer sheath is sealed against the cap and further, the distal end regions of each of the first inner sheath and second inner sheath are sealed against the cap such that one or more lumens of the tubular inner sheath are open through the cap, the cap including a cylindrical mating surface configured to mate with the distal end of the endoscope when the cap is compressed from an oval resting cross-sectional configuration to a circular mating cross-sectional configuration, and a latch connector configured to secure the cap to the distal end region of the endoscope, wherein the soft outer sheath, cap and first and second tubular inner sheaths form a fluid impermeable contamination barrier to prevent contamination of the endoscope during use.

[0090]

[0090] As mentioned above, also described herein are systems that can include any of the devices described herein. Specifically, described herein are systems that include catheters adapted for use with sheaths as described herein. These catheters can include a handle region configured to pass through the inner sheath. For example, described herein is an endoscopic system including a fluid-impermeable contamination barrier for preventing contamination of an endoscope, the system including an endoscope having a lumen and a handle, and an endoscopic sheath device, the endoscopic sheath device including an outer sheath configured to extend over the endoscope, an inner sheath including one or more lumens and configured to extend through the lumen of the endoscope, and a cap configured to couple to a distal end of the endoscope, a distal end region of the outer sheath sealed against the cap, and a distal end region of the inner sheath sealed against the cap such that the one or more lumens of the inner sheath are open through the cap, the system further including a manifold block removably coupled to the handle of the endoscope, the manifold block including one or more valves in fluid communication with the lumen of the endoscope, the inner sheath configured to engage with the manifold block such that the one or more valves control passage of fluid through the one or more lumens of the inner sheath.

[0091]

[0091] The inner sheath can include a multi-lumen catheter and / or can include a single lumen sheath (eg, a working channel liner).

[0092] Any of these systems may include a port adapter configured to mate with the multi-lumen catheter to form separate ports in fluid communication with each lumen of the multi-lumen catheter. These methods may include a sealing device configured to seal one or more lumens of the inner sheath. The endoscope sheath device may further include a second outer sheath configured to extend through a second lumen of the endoscope, and a distal end region of the second inner sheath is sealed against the cap such that one or more lumens of the second inner sheath are open through the cap. The manifold block may include a lumen connection configured to engage with the second lumen of the inner sheath. In some of these embodiments, the manifold block is disposable. The manifold block may further include an umbilical connecting one or more valves of the manifold block to one or more connectors configured to couple to one or more of a source of irrigation fluid, a source of air, and a source of vacuum.

[0093] Any of the sheath apparatus (devices, systems, etc.) can be used with a robotic endoscope as described, optionally including a nested robotic endoscope. The sheath devices described herein can be fitted over an inner endoscopic member (e.g., an inner rigid endoscope) before being coupled to an outer endoscopic member (e.g., a mother device or overtube) such that the outer sheath covers only the inner member and the outer member can be cleaned or sterilized separately. In some embodiments, the sheath device can be fitted over an inner endoscope after being coupled to an outer endoscopic member such that a soft outer sheath can cover both the inner and outer endoscopes.

[0094] For example, a system including an elongated outer tube for use with an inner endoscope in a telescopic configuration can include an elongated outer tube including an outer tube lumen, an outer sheath coupled at a first end region to a proximal end region of the elongated outer tube, a cap sealingly coupled to a second end of the outer sheath, and an inner sheath having one or more inner sheath lumens and extending within the outer sheath and the outer tube lumen, the inner sheath sealingly coupled to the cap such that the one or more inner sheath lumens are open through the cap. The cap can be configured to couple to a distal end of the inner endoscope, and the inner sheath is configured to extend through a lumen of the inner endoscope. The elongated outer tube can be configured to be selectively stiffened, for example, by application of positive or negative pressure.

[0095]

[0095] Also described herein are methods and devices for inflating or collapsing an outer sheath of an endoscopic sheath device configured to prevent contamination of the endoscope. For example, any of these devices can include a soft tubular outer sheath configured to be collapsed against the endoscope by applying suction (negative pressure) between the soft tubular outer sheath and the outside of the endoscope. The sheath device can be configured to maintain a seal between the soft outer sheath and the endoscope. In an embodiment, the device and / or method can be configured to apply positive pressure between the soft tubular outer sheath and the outside of the endoscope, for example to inflate the soft outer sheath. This can help anchor, navigate and / or secure the endoscope within the body. Both collapsing (e.g., applying negative pressure) and inflating (e.g., applying positive pressure) can help indicate that the sheath device maintains a fluid-impermeable contamination barrier against the body.

[0096]

[0096] For example, an endoscopic sheath device may include a soft tubular outer sheath configured to extend over an endoscope, a cap configured to couple to a distal end of the endoscope, with a distal end region of the soft tubular outer sheath sealed against the cap, and a proximal sealing collar configured to form an airtight seal against the endoscope, such that the proximal end region of the soft tubular outer sheath is sealed against the proximal sealing collar, the proximal sealing collar being configured to form an airtight seal against the endoscope such that the tubular outer sheath can be inflated or deflated by application of fluid pressure (e.g., air pressure, saline pressure, etc.) between the soft tubular outer sheath and the outer surface of the endoscope. Any of these devices may include a pressure port in fluid communication with an inner region of the soft tubular outer sheath and configured to apply positive or negative pressure between the soft tubular outer sheath and the outer surface of the endoscope. For example, a pressure port on the proximal sealing collar may be configured to apply positive or negative pressure between the soft tubular outer sheath and the outer surface of the endoscope. The soft outer sheath may include an elastomeric material. The soft outer sheath may have a non-uniform diameter along its length, hi some embodiments, the soft outer sheath has one or more expansion regions along its length configured to expand to a larger expanded radius when the soft outer sheath is inflated by application of positive pressure.

[0097] The cap can be configured to seal against the distal end of the endoscope. In one embodiment, the cap is configured to be secured to the distal end of the endoscope and includes one or more of a friction fit configured to secure the cap to the distal end of the endoscope, a snap fit configured to secure the cap to the distal end of the endoscope, a magnet configured to secure the cap to the distal end of the endoscope, a bayonet connector configured to secure the cap to the distal end of the endoscope, or a threaded region configured to secure the cap to the distal end of the endoscope.

[0098]

[0098] Any of these devices can include a tubular inner sheath configured to extend into a lumen of the endoscope, the tubular inner sheath having one or more lumens, and a distal end region of the inner sheath sealed against the cap such that the one or more lumens of the tubular inner sheath are open through the cap.

[0099]

[0099] For example, an endoscope sheath device may include a soft tubular outer sheath configured to extend over an endoscope, a tubular inner sheath configured to extend into a lumen of the endoscope and having one or more lumens, a cap configured to couple to a distal end of the endoscope, the distal end region of the soft tubular outer sheath sealed against the cap, and the distal end region of the inner sheath sealed against the cap such that one or more lumens of the tubular inner sheath are open through the cap, and a proximal sealing collar configured to form an airtight seal against the endoscope such that the tubular outer sheath can be inflated or deflated by application of fluid pressure between the soft tubular outer sheath and an outer surface of the endoscope. In one embodiment, the fluid pressure may be applied as air pressure. Alternatively, other gases (e.g., carbon dioxide, etc.) or liquids (e.g., saline) may be used.

[0100]

[0100] Also described herein are methods and devices for verifying that an endoscope is not contaminated after use. In general, these methods can include pressurizing an endoscope sheath to verify that the outer sheath is intact, as may occur if the outer sheath is torn or ruptured. For example, a method can include performing a medical procedure in a body with an endoscope while the endoscope is housed within an endoscopic sheath device, withdrawing the endoscope from the body, applying a positive pressure between the endoscope and the outer sheath of the endoscopic sheath device, and indicating whether the endoscopic sheath device is contaminated or not contaminated based on a decay of pressure from between the outer sheath and the endoscope.

[0101]

[0101] A procedure may be performed using any of the devices described herein. For example, performing may include performing a medical procedure in which an endoscope is sheathed such that an exterior surface of the endoscope is surrounded by an outer sheath of an endoscopic sheath device and an interior lumen of the endoscope is covered by the inner sheath, the outer sheath and the inner sheath forming a continuous fluid-impermeable contamination barrier.

[0102]

[0102] Pressure can be applied from a pressure port on or separate from the endoscope. In some embodiments, the proximal end of the outer sheath can include a port for applying pressure. Any of these methods can include applying positive pressure between the endoscope and the outer sheath of the endoscopic sheath device by at least partially inflating the outer sheath. In any of these methods, the proximal portion of the outer sheath can be sealed against the proximal region of the endoscope. In any of these devices, the distal end of the endoscopic sheath device (e.g., the distal end of the cap and / or the outer sheath) can be configured to seal against the distal end region of the endoscope.

[0103]

[0103] Indicating may include determining whether the outer sheath is leaking based on a decay of pressure from between the outer sheath and the endoscope, where the pressure may be monitored by a pressure port or an applied pressure source, and / or a pressure sensor coupled to the endoscope sheath device. In some embodiments, a pressure indicator (e.g., a gauge, sensor, dial, etc.) may be included. In some cases, the method may include manually observing the inflated outer sheath to detect a loss of pressure (indicative of a leak or possible contamination).

[0104]

[0104] Generally, the indicating can include emitting a signal. Alternatively or additionally, the indicating can include transmitting a signal (e.g., the pressure profile, the pressure signal, and / or a processed signal based on the pressure signal) to a remote processor for storage, further processing, and / or presentation to a user or a third party. In some examples, the indicating includes emitting an alarm, e.g., an audible and / or visual alarm, if the attenuation of pressure from between the outer sheath and the endoscope exceeds a threshold.

[0105]

[0105] For example, a method of verifying that an endoscope is not contaminated may include performing a medical procedure with the endoscope while the distal end of the endoscope is covered by a cap, an inner sheath extending through the lumen of the endoscope from the distal end to the proximal end such that one or more inner sheath lumens extend through the lumen of the endoscope and open through the cap, and an outer sheath sealingly connected to the cap and extending proximally over the endoscope, withdrawing the endoscope from the body, applying a positive pressure between the endoscope and an outer sheath of the endoscopic sheath device, and indicating whether the endoscopic sheath device is contaminated or not based on a decay of pressure from between the outer sheath and the endoscope.

[0106] Any of the devices and methods described herein can include an applicator for loading and / or removing the endoscopic sheath device onto and from a catheter. For example, any of these methods and devices can include a placement handle. The placement handle can include an interior area for holding the outer sheath of the device in a compressed or folded (e.g., pleated, accordion-folded, crinkled, etc.) configuration for deployment. After the procedure is completed, the same placement handle can be used to remove and invert the outer sheath. For example, a system including a mounting handle can be configured as an endoscopic sheath apparatus for preventing contamination of an endoscope, the apparatus including a cap configured to couple to a distal end of an endoscope, an outer sheath sealingly coupled to the cap at a distal end, one or more inner sheaths extending within the outer sheath, each inner sheath sealingly coupled to the cap at a distal end and released through the cap, and a mounting handle, at least a portion of the outer sheath held in a gathered form within a chamber of the mounting handle, and further, the one or more inner sheaths extending distally out from the distal end of the mounting handle through the gathered outer sheath and the chamber.

[0107]

[0107] The cap can be positioned at the distal end of the placement handle. The placement handle can include a coupling portion at the proximal end of the placement handle configured to couple with a corresponding fastener on the endoscope. The outer sheath can be held in a gathered configuration within the chamber such that the outer sheath is compressed. In one embodiment, the outer sheath is held in a gathered configuration within the chamber such that the distal end of the catheter fits within the outer sheath when inserted from the distal end of the placement handle. The placement handle can include an outer gripping surface. In one embodiment, the placement handle includes a cylindrical shape. The outer sheath can be gathered in a bellows (e.g., circular or cylindrical pleated) configuration.

[0108]

[0108] The placement handle can include a distal conical surface on a distal end of the placement handle that can facilitate trapping waste material within the everting outer sheath and guiding the outer sheath to evert back upon itself as the outer sheath is removed from the endoscope.

[0109]

[0109] Also described herein are methods of installing an endoscopic sheath device onto an endoscope, the methods including inserting an inner sheath from a distal end of the endoscope through a lumen of the endoscope, advancing the distal end of the endoscope through an outer sheath held in a gathered form within a installation handle, coupling a cap of the endoscopic sheath apparatus to the distal end region of the endoscope, and pulling the installation handle proximally over the endoscope to position the outer sheath over the endoscope. Any of these methods may include coupling the installation handle to the endoscope and / or removing the endoscopic sheath device from the endoscope by advancing the installation handle distally over the endoscope to invert the outer sheath proximally over itself.

[0110]

[0110] Generally, as discussed above, methods of removing an endoscopic sheath device can include sealing a proximal end region of the inner sheath before withdrawing the inner sheath (or multiple inner sheaths) from the lumen of the endoscope. For example, the inner sheath or sheaths can be sealed at a proximal sealing region configured to be sealed by mechanical sealing (e.g., crimping), heat sealing, etc. Any of these methods can further include removing a cap from the endoscope and withdrawing the sealed inner sheath from the lumen of the endoscope.

[0111]

[0111] All of the methods and apparatus described herein, in any combination, are contemplated and can be used to achieve the advantages as described herein.

[0112]

[0112] The features and advantages of the methods and apparatus described herein will be better understood with reference to the following detailed description setting forth illustrative embodiments and the accompanying drawings. [Brief description of the drawings]

[0113] [Figure 1A]

[0113] FIG. 1 is a schematic diagram illustrating an example of a general purpose endoscope that can be used with the devices and methods described herein. [Figure 1B] FIG. 1 is a schematic diagram illustrating an example of a general purpose endoscope that can be used with the devices and methods described herein. [Figure 1C] FIG. 1 is a schematic diagram illustrating an example of a general purpose endoscope that can be used with the devices and methods described herein. [Figure 2A]

[0114] FIG. 1 illustrates a schematic diagram of an example of a telescopic assembly including an endoscope that can be used with the devices and methods described herein. [Figure 2B] FIG. 1 illustrates a schematic diagram of an example of a telescopic assembly including an endoscope that can be used with the devices and methods described herein. [Figure 2C] FIG. 1 illustrates a schematic diagram of an example of a telescopic assembly including an endoscope that can be used with the devices and methods described herein. [Figure 3A]

[0115] FIG. 2 is a schematic diagram of an embodiment of an endoscopic sheath as is described herein, the embodiment having a relatively short outer sheath that can be secured to a distal end region of an outer tube. [Figure 3B] FIG. 13 illustrates an embodiment including a proximal stop on the outer sheath. [Figure 3C] 13A-13C show an embodiment having a long outer sheath that can extend beyond the length of the outer tube and / or endoscopic member. [Figure 4A]

[0116] FIG. 1A is a schematic diagram of an embodiment of an endoscope sheath shown attached to a telescopic (e.g., mother / child) endoscope assembly. [Figure 4B]FIG. 1A is a schematic diagram of an embodiment of an endoscope sheath shown attached to a telescopic (e.g., mother / child) endoscope assembly. [Figure 4C] FIG. 1A is a schematic diagram of an embodiment of an endoscope sheath shown attached to a telescopic (e.g., mother / child) endoscope assembly. [Figure 5A]

[0117] 1 illustrates an embodiment of an endoscope sheath attached to a telescopic endoscope assembly. [Figure 5B] 1 illustrates an embodiment of an endoscope sheath attached to a telescopic endoscope assembly. [Figure 5C] 1 illustrates an embodiment of an endoscope sheath attached to a telescopic endoscope assembly. [Figure 6A]

[0118] FIG. 1 is a schematic diagram of an embodiment of a telescopic endoscope assembly. [Figure 6B]

[0119] FIG. 1A is a schematic diagram of an embodiment of a telescopic endoscope assembly with a partial sheath. [Figure 7A]

[0120] FIG. 13 is a schematic diagram of an embodiment of a cap for a sheath assembly shown in a front view. [Figure 7B]

[0121] FIG. 2 is a diagram showing an example of a cross section of an embodiment of an endoscope. [Figure 7C]

[0122] FIG. 2 illustrates a cross-section of one embodiment of a sheath assembly. [Figure 7D]

[0123] 7D illustrates a side cross-sectional view of one embodiment of the sheath assembly of FIG. 7C coupled to the endoscope of FIG. 7B. [Figure 7E] 7D illustrates a side cross-sectional view of one embodiment of the sheath assembly of FIG. 7C coupled to the endoscope of FIG. 7B. [Figure 8A]

[0124] 13A-13C illustrate the use of an embodiment of a port adapter to couple to a multi-lumen catheter (inner sheath) as described herein. [Figure 8B]13A-13C illustrate the use of an embodiment of a port adapter to couple to a multi-lumen catheter (inner sheath) as described herein. [Figure 9A]

[0125] FIG. 9 is a schematic cross-sectional view of an embodiment of a port adapter similar to that shown in FIGS. 8A-8B. [Figure 9B]

[0126] FIG. 2 illustrates a cross-section of one embodiment of a port adapter. [Figure 9C]

[0127] FIG. 1 illustrates an example of a port adapter that can be used as described herein. [Figure 9D] FIG. 1 illustrates an example of a port adapter that can be used as described herein. [Figure 9E]

[0128] FIG. 1 illustrates a cross-section of one embodiment of a port adapter including a toy-like connector for securing and sealing a multi-lumen catheter (e.g., an inner sheath configured as a multi-lumen catheter) as described herein. [Figure 10A]

[0129] 13A-13C show an embodiment of sealing the proximal end of the inner sheath. [Figure 10B] 13A-13C show an embodiment of sealing the proximal end of the inner sheath. [Figure 10C] 13A-13C show an embodiment of sealing the proximal end of the inner sheath. [Figure 11]

[0130] FIG. 1 shows a cross-section of one embodiment of a multi-lumen catheter that can be used as an inner sheath as described herein. [Figure 12]

[0131] 1A-1C show an embodiment of a port adapter that couples to a proximal end of a multi-lumen catheter forming an inner sheath. [Figure 13]

[0132] 1A-1C show an embodiment of a port adapter for coupling to a proximal end of a multi-lumen catheter forming an inner sheath. [Figure 14]

[0133] FIG. 13 illustrates the proximal end of the inner sheath including a crimped region for sealing the inner sheath prior to removal of the endoscope from the sheath assembly. [Figure 15A]

[0134] FIG. 1 illustrates an embodiment of a system including an endoscope. [Figure 15B] FIG. 1 illustrates an embodiment of a system including a sheath device. [Figure 15C] FIG. 1 illustrates an embodiment of a system including a sheath device mounted over an endoscope. [Figure 15D] FIG. 1 illustrates an embodiment of a system including an outer endoscope. [Figure 16A]

[0135] FIG. 1 illustrates a system including a sheath device, a separate outer rigid device, and an outer working channel. [Figure 16B] FIG. 13 is a schematic diagram of the system illustrating the use of an outer working channel. [Figure 17A]

[0136] FIG. 1 illustrates an embodiment of a system including an endoscope. [Figure 17B] FIG. 1 illustrates an embodiment of a system including a stiffening sheath device. [Figure 17C] 1 illustrates an embodiment of a system including a stiffening sheath device and an inner endoscope. [Figure 17D] FIG. 1 illustrates an embodiment of a system including an outer endoscope. [Figure 18]

[0137] 1A-1C show an embodiment of a sheath over an endoscope having a steerable distal end region. [Figure 19A]

[0138] 13A-13C show an embodiment of an inner sheath that is reinforced along a portion of its length. [Figure 19B] 13A-13C show an embodiment of an inner sheath that is reinforced along its entire length. [Figure 20A]

[0139] FIG. 1 is a front view of an embodiment of a cap for an endoscopic sheath device. [Figure 20B] 1 is a side perspective view of an embodiment of a cap for an endoscopic sheath device. FIG. [Figure 20C] 1 is a side view of an embodiment of a cap for an endoscopic sheath device. FIG. [Figure 20D] FIG. 13 is a rear view of an embodiment of a cap for an endoscopic sheath device. [Figure 21A]

[0140] FIG. 28 is a distal end view showing a distal end region of an endoscope configured to receive the cap of the sheath device shown in FIGS. 20A-20D. [Figure 21B] FIG. 27 is a perspective view showing a distal end region of an endoscope configured to receive the cap of the sheath device shown in FIGS. 20A-20D. [Figure 21C]

[0141] FIG. 21C is an end view of the endoscope shown in FIGS. 21A-21B with a cap similar to that shown in FIGS. 21A-21B attached to the distal end region of the catheter. [Figure 22A]

[0142] 22A shows an embodiment of an endoscopic sheath device having a cap with multiple LED light sources integrated therein. The endoscopic sheath device is shown attached to an endoscope. In FIG. 22A, the device and endoscope are shown in a front perspective view. [Figure 22B] FIG. 22B is a front (end) view of the embodiment of the endoscopic sheath device of FIG. 22A. [Figure 22C] FIG. 22B is a side view of the endoscopic sheath device of FIG. 22A. [Figure 23A]

[0143] FIG. 1 illustrates an embodiment of a cap for an endoscopic sheath device that is transparent and includes multiple LED lights disposed thereon. [Figure 23B] 1 illustrates an embodiment of a cap for an endoscopic sheath device that is transparent and includes multiple LED lights disposed therein. [Figure 24A]

[0144] FIG. 1 shows an embodiment of a cap that includes a multi-lumen extrusion that carries wires for controlling (eg, powering) built-in LEDs on the cap. [Figure 24B]FIG. 1 shows an embodiment of a cap that includes a multi-lumen extrusion that carries wires for controlling (eg, powering) built-in LEDs on the cap. [Diagram 25]

[0145] FIG. 13 illustrates a schematic diagram of a cap containing multiple LEDs of different wavelengths (eg, colors) that can be controlled to emit different colors or color combinations. [Figure 26A]

[0146] FIG. 1 illustrates the installation of one embodiment of a cap for an endoscope sheath, with the inner and outer sheaths not shown for convenience. [Figure 26B] FIG. 1 illustrates the installation of one embodiment of a cap for an endoscope sheath, with the inner and outer sheaths not shown for convenience. [Figure 27A]

[0147] 13A-13C show an example of a method for removing a cap from an endoscopic sheath device, which may be part of a method for removing an endoscopic sheath device. [Figure 27B] 13A-13C show an example of a method for removing a cap of an endoscopic sheath device, which may be part of a method for removing an endoscopic sheath device. [Figure 27C] 13A-13C show an example of a method for removing a cap from an endoscopic sheath device, which may be part of a method for removing an endoscopic sheath device. [Figure 28A]

[0148] 13A-13C are schematic diagrams illustrating another example of a method for mounting a cap on an endoscopic sheath device, which may be part of a method for mounting an endoscopic sheath device on an endoscope. [Figure 28B] 13A-13C are schematic diagrams illustrating another example of a method for mounting a cap on an endoscopic sheath device, which may be part of a method for mounting an endoscopic sheath device on an endoscope. [Figure 28C] 13A-13C are schematic diagrams illustrating another example of a method for mounting a cap on an endoscopic sheath device, which may be part of a method for mounting an endoscopic sheath device on an endoscope. [Figure 28D]13A-13C are schematic diagrams illustrating another example of a method for mounting a cap on an endoscopic sheath device, which may be part of a method for mounting an endoscopic sheath device on an endoscope. [Figure 29A]

[0149] FIG. 13 is a schematic diagram illustrating a method of mating a cylindrical mating surface of a cap of an endoscopic sheath device to a distal end of an endoscope by compressing the sides of the cylindrical mating surface of the cap to transition the cap from an oval resting cross-sectional configuration to a circular mating cross-sectional configuration. [Figure 29B] FIG. 13 is a schematic diagram illustrating a method of mating a cylindrical mating surface of a cap of an endoscopic sheath device to a distal end of an endoscope by compressing the sides of the cylindrical mating surface of the cap to transition the cap from an oval resting cross-sectional configuration to a circular mating cross-sectional configuration. [Figure 30A]

[0150] 29A-29B show an embodiment of a transparent cap of an endoscopic sheath device similar to that shown in FIGS. 29A-29B. [Figure 30B] 29A-29B show an embodiment of a transparent cap of an endoscopic sheath device similar to that shown in FIGS. 29A-29B. [Figure 31A]

[0151] FIG. 13 is a perspective view illustrating the operation of the multi-lumen inner sheath and cap of the endoscopic sheath device, showing the introduction of air, flushing fluid, and irrigation fluid using the multi-lumen inner sheath while maintaining sterility of an endoscope covered by the endoscopic sheath device. [Figure 31B] FIG. 13 is a front (end) view illustrating the operation of the multi-lumen inner sheath and cap of the endoscopic sheath device, showing the introduction of air, flushing fluid, and irrigation fluid using the multi-lumen inner sheath while maintaining sterility of an endoscope covered by the endoscopic sheath device. [Figure 32A]

[0152] 32A is a side perspective view of the endoscopic sheath device of FIGS. 31A-31B delivering cleaning fluid to clean the optics of the cap. In FIG. 32A, for convenience, the tip cleaning fluid is shown as a cylindrical stream, the actual tip cleaning fluid may take a different shape as it passes over the tip. [Figure 32B]32A-32B is a cross-sectional view of the endoscopic sheath device of FIGs. 31A-31B delivering cleaning fluid to clean the optics of the cap. In FIG. 32B, for convenience, the tip cleaning fluid is shown as a cylindrical stream, the actual tip cleaning fluid may take a different shape as it passes over the tip. [Figure 33A]

[0153] 33A is a side perspective view of the endoscopic sheath device of Figures 31A-31B delivering insufflation from the cap. In Figure 33A, for convenience, the insufflation is shown as a flattened triangle; the actual insufflation (gas such as air) may take a different shape as it passes over the tip. [Figure 33B] 33A-33B is a cross-sectional view of the endoscopic sheath device of Figures 31A-31B delivering insufflation from the cap. In Figure 33B, for convenience, the insufflation is shown as a flattened triangle; the actual insufflation (gas such as air) may take a different shape as it passes over the tip. [Figure 34A]

[0154] 34A is a side perspective view of the endoscopic sheath device of FIGS. 31A-31B delivering irrigation fluid from the cap. In FIG. 34A, for convenience, the irrigation fluid is shown as a cylindrical stream; the actual irrigation fluid may take a different shape as it passes through the tip. [Figure 34B] 34A-34B are cross-sectional views of the endoscopic sheath device of FIGS. 31A-31B delivering irrigation fluid from the cap. In FIG. 34B, for convenience, the irrigation fluid is shown as a cylindrical stream; the actual irrigation fluid may take a different shape as it passes through the tip. [Figure 35A]

[0155] 35A-35C show an embodiment of a port adaptor that can be used with a multi-lumen catheter forming an inner sheath. In Fig. 35A, the port adaptor is partially transparent and is shown engaged with the inner sheath. [Figure 35B]

[0156] FIG. 35B illustrates an example of an end view of the (transparent) port adapter of FIG. 35A, showing separation of the ports for irrigation fluid. [Figure 35C] FIG. 35B illustrates an example of an end view of the (transparent) port adapter of FIG. 35A, showing separation of the ports for cleaning fluids. [Figure 35D]FIG. 35B illustrates an example of an end view of the (transparent) port adapter of FIG. 35A, showing separation of the ports for insufflation. [Figure 36A]

[0157] FIG. 1 is a front (end) view of an embodiment of a cap of an endoscopic sheath device that includes an integrated optical lens as part of the cap. [Figure 36B] 13A-13C are side cross-sectional views of an embodiment of a cap of an endoscopic sheath device that includes an integrated optical lens as part of the cap. [Figure 37A]

[0158] FIG. 1 is a side perspective view showing a removable component (e.g., a scope cap) that can be used with any of the endoscopic sheath devices described herein, with the scope cap removed and the distal end of the endoscopic sheath device placed over an endoscope. [Figure 37B] FIG. 1 is a side perspective view showing a removable component (e.g., a scope cap) that can be used with any of the endoscopic sheath devices described herein, with the scope cap attached and the distal end of the endoscopic sheath device attached over the endoscope. [Figure 37C] A side cross-sectional view of a removable component (e.g., a scope cap) that can be used with any of the endoscopic sheath devices described herein. [Figure 38]

[0159] 1A-1C show an embodiment of an endoscopic sheath device having an integrated (e.g., molded or overmolded) end cap. [Figure 39A]

[0160] FIG. 1 shows an example of an endoscope according to the prior art. [Figure 39B]

[0161] FIG. 1 is a schematic diagram of an example of a manual endoscope adapted for use with the endoscopic sheath described herein. [Figure 40A]

[0162] 1A-1C show an embodiment of an endoscopic sheath device in which the outer sheath can be inflated and / or deflated (contracted), and diagrammatically show an embodiment of a catheter. [Figure 40B]1A-1C show an example of an endoscopic sheath device in which the outer sheath can be inflated and / or deflated (contracted), and are schematic diagrams illustrating an example of an endoscopic sheath configured to form a proximal seal against an endoscope such that the outer sheath can maintain positive or negative pressure. [Figure 40C] 1A-1C show an embodiment of an endoscopic sheath device in which the outer sheath can be inflated and / or deflated (contracted), and are schematic diagrams of the endoscopic sheath device coupled (and sealed) to an endoscope. [Figure 41A]

[0163] 1A-1C are schematic diagrams illustrating an example of an endoscopic sheath device coupled (and sealed) to an endoscope, in which the tubular outer sheath of the endoscopic sheath device has a uniform longitudinal cross-section along the length of the sheath, along with a tube that can be used to aid in placement of the endoscope, thereby allowing for vacuum expansion (outward) of the outer sheath upon placement. [Figure 41B]

[0164] 1A-1C are schematic diagrams illustrating an example of an endoscopic sheath device (having a tapered longitudinal cross-section) coupled to (and sealed to) an endoscope. [Figure 41C]

[0165] 1 is a schematic diagram of an embodiment of an endoscopic sheath device coupled (and sealed) to an endoscope, the tubular outer sheath of which has a stepped down longitudinal cross-section along the length of the sheath. [Diagram 42]

[0166] 1A-1C are schematic diagrams illustrating an example of an endoscopic sheath device coupled (and sealed) to an endoscope after application of negative pressure, showing a tubular outer sheath with a vacuum evacuated against the exterior surface of the endoscope. [Figure 43A]

[0167] 43A-43C are schematic diagrams illustrating an embodiment of an endoscopic sheath device coupled (and sealed) to an endoscope, with positive pressure applied between the outer sheath and the endoscope to inflate the tubular outer sheath. In Fig. 43A, the outer sheath includes a single inflatable (e.g., balloon) region. [Figure 43B]43A-43C are schematic diagrams illustrating an embodiment of an endoscopic sheath device coupled (and sealed) to an endoscope with positive pressure applied between the outer sheath and the endoscope to inflate the tubular outer sheath. In FIG. 43B, the outer sheath includes a pair of inflatable (e.g., balloon) regions. [Diagram 44]

[0168] 1 is a schematic diagram illustrating an example of an endoscopic sheath device configured to evert back on itself for removal from an endoscope after use. [Diagram 45]

[0169] 1 illustrates the problem of endoscope (e.g., catheter) buckling when advanced through tortuous anatomy. [Figure 46A]

[0170] 46A-46C illustrate the use of an endoscopic sheath device for positioning (e.g., advancing) an endoscopic member as described herein. In Fig. 46A, an inner (nested) endoscope is coupled to a sheath at a distal end, and a cover extends over the inner and outer endoscopes. [Figure 46B] 46A-46C illustrate the use of an endoscopic sheath device to position (e.g., advance) an endoscopic member as described herein. As shown in FIG. 46B, application of positive pressure between the outer sheath and the endoscope causes the outer sheath to position distally, thereby driving the inner endoscope distally. [Figure 47]

[0171] 1A-1C show another embodiment of an endoscopic sheath device including an expandable sheath attached to a telescoping endoscope. [Figure 48]

[0172] FIG. 46 is similar to FIG. 45 and illustrates the use of an expandable endoscope sheath device to help guide the positioning of an endoscope within tortuous anatomy. [Figure 49]

[0173] 1A-1C are schematic diagrams illustrating an example of an inflatable endoscope sheath used in an endoscope including a sensor (e.g., an ultrasound sensor). [Figure 50A]

[0174] 50A illustrates an embodiment of an endoscopic sheath apparatus (eg, an endoscopic sheath device) including a placement handle: FIG 50A shows a side view of an embodiment of an endoscopic sheath apparatus including a placement handle in a pre-deployed configuration. [Figure 50B] FIG. 50B is a top front perspective view of the endoscopic sheath apparatus of FIG. 50A. [Figure 50C] FIG. 2 is a rear side perspective view of the same endoscope sheath apparatus. [Figure 51A]

[0175] 1 illustrates one embodiment of a method for mounting an endoscopic sheath apparatus onto an endoscope as described herein using a mounting handle. [Figure 51B] 1 illustrates one embodiment of a method for mounting an endoscopic sheath apparatus onto an endoscope as described herein using a mounting handle. [Figure 51C] 1 illustrates one embodiment of a method for mounting an endoscopic sheath apparatus onto an endoscope as described herein using a mounting handle. [Fig. 51D] 1 illustrates one embodiment of a method for mounting an endoscopic sheath apparatus onto an endoscope as described herein using a mounting handle. [Figure 52A]

[0176] FIG. 2 is a rear (proximal) view of an endoscopic sheath apparatus including a placement handle, illustrating coupling of the placement handle to the proximal end of an endoscope. [Figure 52B] FIG. 2 is a rear (proximal) view of an endoscopic sheath apparatus including a placement handle, illustrating coupling of the placement handle to the proximal end of an endoscope. [Diagram 53]

[0177] 1 illustrates an embodiment of a method for packaging an endoscopic sheath apparatus as described herein, shown in a compact rolled configuration. [Figure 54A]

[0178] 13A-13D illustrate removal of the endoscopic sheath apparatus from the endoscope using the installation handle. [Figure 54B] 13A-13D illustrate removal of the endoscopic sheath apparatus from the endoscope using the installation handle. [Figure 54C]13A-13D illustrate removal of the endoscopic sheath apparatus from the endoscope using the installation handle. [Figure 55]

[0179] 1A-1D are schematic diagrams illustrating one method of making an endoscopic sheath apparatus as described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0114]

[0180] In general, described herein are endoscopic sheath assemblies (e.g., endoscopic sheath devices and systems) that include a cap configured to couple to a distal end of an endoscope, an outer sheath that extends over the endoscope (and optionally seals or covers an elongated outer member concentrically over the endoscope), and one or more inner sheaths that extend into one or more lumens of the endoscope. Both the outer and inner sheaths are configured to seal against the cap. These devices are configurable to prevent contamination of the endoscope without interfering with any of the endoscope's functions, including the ability of the endoscope to pass material into or out of the distal end of the endoscope through an internal lumen or working channel and / or to image from the distal end of the endoscope and / or to move relative to the elongated outer member.

[0115]

[0181] Any of these devices can be used with an endoscope concentrically disposed within a stiffening overtube (elongated outer member). Either or both of the elongated outer member and the endoscope can be configured to be stiffened. Any suitable stiffening can be used, including, but not limited to, stiffening by application of positive and / or negative pressure. In general, the stiffening members described herein can transition from a soft configuration (i.e., a loose, pliable, or floppy configuration) to a rigid configuration (i.e., a configuration that is firm and / or retains its shape when stiffened). The devices and methods described herein are particularly well suited for use with stiffening devices, but can also be used with non-rigidifying devices. In certain examples, the stiffening member (also referred to interchangeably as a stiffening device, selective stiffening device, or selective stiffening member) can include multiple layers (e.g., coil or reinforced layer, slip layer, braided layer, bladder layer, and / or sealing layer) that can combine to form the wall of the stiffening member. The stiffening members can transition from a soft to a rigid configuration, for example, by applying positive or negative pressure to or within the walls of the stiffening device. With the positive or negative pressure removed, the layers can easily shear or move relative to one another. With a vacuum or pressure applied, the layers can transition to a state that exhibits substantially enhanced resistance to shear, movement, bending, torque and buckling, thereby providing stiffening to the system.Examples of stiffening members that can be used with any of the devices and methods described herein include, for example, International Patent Application No. PCT / US2016 / 050290, entitled "DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE," filed on September 2, 2016, and published as WO2017 / 041052; International Patent Application No. PCT / US2018 / 042946, entitled "DYNAMICALLY RIGIDIZING OVERTUBE," filed on July 19, 2018, and published as WO2019 / 018682; International Patent Application No. PCT / US2018 / 042946, entitled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL SYSTEM," filed on July 19, 2019, and published as WO2020 / 018934; No. PCT / US2019 / 042650, entitled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES," filed January 16, 2020, and published as WO2020 / 214221, and PCT / US2021 / 034292, entitled "RIGIDIZING DEVICES," filed May 26, 2021, and published as WO2021 / 242884. Each of these applications is incorporated herein by reference in its entirety.

[0116]

[0182] Any suitable stiffening member may be used, including stiffening members that are not formed of layers and / or that are not actuated by pressure (negative and / or positive pressure). For example, the stiffening members described herein may refer to any suitable stiffening member, including members that can be stiffened by jamming particles, or by phase change and / or shape memory alloys, or by linking components (such as cables with discs or cones), or by EAPs (electroactive polymers), or any other stiffening mechanism.

[0117]

[0183] As mentioned above, the sheath assemblies described herein can be used with one or more robotic systems, including, for example, telescopic rigidifying robotic systems such as those described in U.S. Patent Application No. 17 / 152,706 (entitled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES," now U.S. Patent No. 17 / 493,785 (entitled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES," now U.S. Patent No. 11,478,608), and International Patent Application Nos. PCT / US2021 / 034292 (entitled "RIGIDIZING DEVICES") and PCT / US2021 / 024582 (entitled "LAYERED WALLS FOR RIGIDIZING DEVICES"), each of which is incorporated herein by reference in its entirety.

[0118]

[0184] The endoscopic sheath assemblies described herein can be used with a single endoscope. An endoscope can refer to an elongated instrument that can be introduced into the body, includes one or more lumens extending therethrough, and can be used to examine, treat, and / or diagnose an internal region of the body. Any of these endoscopes can include imaging (e.g., typically with a CCD, CMOS chip, or fiber optic material) to provide a view from the distal end of the device. An endoscope can generally be a catheter that includes one (or more) internal lumens that extend the length of the endoscope. For example, in FIG. 1A, an endoscope 100 includes an elongated flexible (or selectively rigidifiable in some embodiments) body that extends from a distal end 113 to a proximal end 111. The endoscope includes a first lumen 105 (e.g., a working channel), a second lumen 107, and a camera 109. The first lumen can be a working channel through which one or more tools can be inserted and / or manipulated to act on tissue at the distal end of the endoscope within the body. The second lumen can be, for example, a suction, a fluid (air, water, etc.) administration lumen, etc. The lumen (e.g., an internal working channel) can extend the length of the endoscope. The endoscope can be of any suitable length and width and can generally be made of a biocompatible material. Figure IB shows a cross-section of the endoscope of Figure IA, and Figure 1C shows a distal end view of the endoscope of Figure IA.

[0119]

[0185] 2A-2C show an example of an assembly including an inner endoscope 201 concentrically disposed within an outer tube 203. The endoscope 201 may be similar or the same as the endoscope shown in FIGS. 1A-1C, may include one or more internal lumens 105, 107 (e.g., working channel 105), and may be configured to slide axially 220 within the outer tube 203. FIG. 2B shows a cross-section of the assembly of FIG. 2A, and FIG. 2C shows a distal end view of the assembly of FIG. 2A. In an example, the assembly may be a telescopic assembly including an endoscope 201 and an outer tube 203 that is flexible but configured to be selectively rigid. An endoscope or endoscope assembly such as those shown generally in FIGS. 1A-1C and 2A-2C may be used with any of the endoscopic sheaths (sheath devices) described herein.

[0120]

[0186] 3A-3C illustrate an example of an endoscopic sheath as described herein. The sheaths illustrated in FIGS. 3A-3C are shown uncoupled or unconnected to an endoscope or endoscope assembly (e.g., an outer tube and an inner endoscope member). In FIG. 3A, for example, the endoscope assembly 300 includes a cap 327 configured to be secured to and on a distal end region of the endoscope. For example, the cap 327 can be snapped onto the distal end, e.g., the cap can be connected to the distal end of the catheter by deflectable snaps on the cap or the distal end of the endoscope, or both. For example, the cap can include a bendable or flexible member that releasably locks the cap to the distal end of the endoscope (e.g., by a "snap fit"). In some examples, the cap can be secured (releasably secured) to the distal end of the endoscope by a clamping or spring-loaded mechanism. In some examples, the cap can be coupled by engaging a threaded or threaded region. In some examples, the cap 327 can be coupled by a friction fit (e.g., the cap can include one or more shearing surfaces configured to secure the cap to the distal end of the endoscope). In some embodiments, the cap can be magnetically coupled to the distal tip region of the endoscope to secure the cap to the distal tip, hi some embodiments, the cap can be secured to the distal tip of the endoscope by a bayonet connector.

[0121]

[0187] In FIG. 3A, the outer sheath 302 is shown as being sealingly connected (e.g., fused, welded, integrally formed, etc.) to the cap 327. The outer sheath can be flexible, specifically lightweight, and can be thin or thin-walled enough to allow the endoscope to move relative to the outer tube (not shown) as the endoscope moves into and out of the outer tube and / or rotates relative to the outer tube. The embodiment shown in FIG. 3A includes a single inner sheath 315 that extends proximally within the outer sheath and is sealingly connected to the cap 327. The sealing connection between the cap and the inner sheath is such that the inner lumen of the inner sheath is open to the body such that fluids can be administered through the endoscope without compromising the barrier between the patient and the endoscope. In FIGS. 3A-3C, the inner sheath is shown to form only a single lumen in this example, although in other embodiments, multiple lumen structures such as a multi-lumen catheter may be used. Thus, as shown in FIG. 3A, the inner sheath can form an opening 315' through the cap that is continuous with the inner sheath 315 in the figure.

[0122]

[0188] In this embodiment, the outer sheath 302 is shorter than the inner sheath 315, which extends proximally 331 out of the outer sheath 302. In some embodiments, the short outer sheath can be coupled to an outer tube (not shown in FIG. 3A), such as an overtube, and can be sealed to the outside such that the outer tube works with the outer sheath to protect an endoscope extending within the outer tube.

[0123]

[0189] FIG. 3B illustrates another embodiment of an endoscopic sheath device 300′ (e.g., sheath assembly) similar to that shown in FIG. 3A, but with a second inner sheath 317 having a distal opening 317′ through a cap 327 that can pass a substance or tool in and out of the endoscope to treat tissue. In FIG. 3B, the second inner sheath 317 can form a working channel liner that can line the working channel of the endoscope. The inner sheath can be a catheter, including a multi-lumen catheter. The outer sheath 315 in FIG. 3B can be similar to that shown in FIG. 3A and can be relatively short, for example, and can be coupled to an outer tube (not shown). In any of these sheath assemblies described herein, the outer sheath can include a proximal fastener on the outer sheath configured to secure the outer sheath to an outer surface of an outer tube concentrically disposed over the endoscope.

[0124]

[0190] FIG. 3C shows a sheath assembly 300' similar to that shown in FIG. 3B including a first inner sheath 315 that is open 315' through the cap 327, a second inner sheath 317 (e.g., a working channel liner) that is also open 317' through the cap 327, both hermetically attached to the cap, and an outer sheath 302' that is elongated and hermetically joined at its distal end to the cap, and may optionally include a proximal fastener region or fastener 321 for attaching an endoscope or an outer tube configured to fit concentrically over the endoscope.

[0125]

[0191] In any of these embodiments, the cap may be clear (transparent) to allow imaging through the cap or may include a window area configured to align with a camera area of ​​the endoscope, hi some embodiments, the cap has an anti-reflective or anti-glare coating.

[0126]

[0192] 4A-4C show schematic diagrams of an embodiment of a sheath assembly shown coupled to an endoscope and outer tube disposed concentrically over the endoscope to enable telescopic movement between the endoscope and outer tube.

[0127]

[0193] Any of these devices and sheath assemblies may include an outer tube and thus may be disposable components that are connectable to an outer sheath. For example, FIG. 4A shows a cross section of a sheath device configured as a system including a flexible outer tube 403 for use with an inner endoscope 401 in a telescopic configuration. In this embodiment, the elongated outer tube 403 is connected (e.g., sealingly connected 428) to the outer sheath 402 at a distal end region. The outer sheath 402 is further sealingly connected 429 to a cap 427 at the distal end of the outer sheath. The cap 427 is further removably connectable to the endoscope 401 at the distal end of the endoscope. The outer sheath 402 is sealingly connectable around the outer periphery of the cap as shown. A pair of inner sheaths 415, 417 having one or more inner sheath lumens extend within the outer sheath and into the lumen of the endoscope 401. Both inner sheaths are sealingly connected to the cap such that the inner sheath lumens are open through the cap to allow material to pass through the endoscope. For example, one of the inner sheath lumens may connect to a water source, while the other may connect to suction and / or provide a working channel, for example, for tools.

[0128]

[0194] In this embodiment, the outer tube can be connected to the sheath tip with a thin, flexible outer sheath that allows substantial movement of the sheath tip both away from and towards the distal tip of the outer tube, for example, thereby allowing axial (reciprocating) and torsional ("roll axis") motion even in the presence of the outer sheath. The endoscope's internal working channel and supply lines contain a liner (e.g., inner sheath), which is essentially a long tube that runs the length of the endoscope, such that the endoscope lumen is covered by the inner sheath, which functions as a tube for delivering gases and liquids, or as an internal working channel through which surgical instruments or aspiration vacuum can be delivered. The inner and outer sheaths are coupled together at a cap (e.g., sheath tip 427). The cap provides a transparent surface for the endoscope's camera and illumination lights, and can also incorporate a nozzle (e.g., an outlet for tip washing) and a through port for the contents of the inner sheath to be delivered through the cap. As previously mentioned, the cap can be configured to securely fasten to the endoscope tip so that the cap remains well attached during the procedure, but can then be removed to replace the sheath assembly. Thus, the combination of the outer tube sealed to the outer sheath, the outer sheath sealed to the cap, and the cap sealed to the inner sheath completely isolates the endoscope from the patient.

[0129]

[0195] 1 without the endoscope 401, including the attached outer tube 403, cap 427, and pair of inner sheaths 415, 417. The sheath assembly 400 can be removably coupled to an endoscope, for example, by inserting the inner sheaths 415, 417 through a lumen of the endoscope and snap-fitting or otherwise coupling the cap 427 to the distal end of the endoscope.

[0130]

[0196] Figure 4C illustrates another embodiment similar to that shown in Figure 3C in which the outer sheath 402 is not coupled to the outer tube 403, but rather extends proximally along most or all (or more) of the length of the outer tube 403. As shown in this embodiment, the outer sheath 402 extends proximally to the proximal end region of the endoscope and / or outer tube.

[0131]

[0197] 5A-5C show an embodiment of an outer sheath 502 that is attached to an outer tube 503 and includes two inner sheaths 517, 515 (shown in FIG. 5A protruding from the proximal end of the outer tube 503). The outer sheath in the device shown in FIGS. 5A-5C includes a base 522 at the proximal end of the outer sheath that is sealable against the outer endoscope 503 (e.g., an overtube). The outer tube in this embodiment is shown shorter than normal, but is representative of full scale. A cap 527 of the sheath assembly is coupled to the distal end of the outer sheath 502. In FIG. 5A, the sheath assembly is not yet coupled to the endoscope. FIG. 5B shows the endoscope 501 inserted into the outer tube 503 with the endoscope 501 fully extended to the limit of the outer sheath 502. The tip of the outer sheath (cap 527) is secured securely to the distal end region of the endoscope and extends and retracts with the endoscope as described above.

[0132]

[0198] 5C shows endoscope 501 protected within outer sheath 502 and fully retracted into outer tube 503 with outer sheath tip 527 still attached to the endoscope tip. Note that outer sheath 502 stays in place and does not restrict retraction or extension or bending of the endoscope.

[0133]

[0199] In operation, the configuration of the sheath assembly incorporating the outer tube as shown in Figures 5A-5C can be disposable and / or disposable. In this embodiment, the endoscope can be fully inserted through the outer tube into the outer sheath and can be attached to the sheath tip. The outer tube and / or endoscope in this embodiment can be a selectively stiffening device that is actuated by application of positive or negative pressure. In this embodiment, after the endoscope, outer tube and inner sheath are connected to external controls, vacuum and supply lines, the system is ready to be used in a procedure, e.g., inserted into the body. The sheath can protect the endoscope 501 from contact with any material that may contaminate the endoscope. After the procedure, both the inner sheath and the outer tube can be separated from the rest of the system, removed from the endoscope, and then discarded. The endoscope can then receive a new sheath incorporating a new outer tube along with the inner and outer sheaths and is immediately reusable. High level disinfection of the endoscope between procedures is not required, thereby saving time and money. As described herein, the removal process can include sealing the inner sheath to prevent contamination.

[0134]

[0200] In any of these devices and methods, after use of the sheath assembly (e.g., an endoscope sheath device), it can be pressure tested to ensure that it remains leak-free and therefore that the underlying structure (e.g., an endoscope) remains clean. To do this, the outer sheath can be at least partially inflated, for example, by injecting compressed air through a pressure port. The outer sheath can be sealed at one or both ends. The inner sheath can be sealed (e.g., proximally as it exits the liner). The method or device can monitor the pressure, for example, using a pressure sensor configured to detect the pressure within the outer sheath when inflated. The pressure sensor can track a pressure decay curve that can be reported and / or analyzed to determine whether there is a leak that indicates contamination. The pressure data can be reported to an operator and / or the device can automatically or semi-automatically determine whether there is a leak based on the pressure data. For example, the device can include software, hardware and / or firmware configured to receive the pressure data, analyze the pressure data (e.g., the decay curve), and compare the pressure response to a predetermined value to determine whether there is a leak.

[0135]

[0201] In one embodiment, the outer sheath extends the entire length of the outer tube, and the outer tube is not integrated into the outer sheath as shown in Figure 4 C. In this configuration, the outer tube is also completely isolated from contamination and can be reused with a new sheath without the need for sterilization.

[0136]

[0202] Figure 6A shows a schematic embodiment of a telescopic assembly including an outer tube 603 and an endoscope 601, shown without a sheath assembly attached. Unlike the sheath assemblies described above, Figure 6B shows an embodiment of a system that includes only a partial outer sheath portion 672 coupled between the outer tube 603 and the endoscope 601, but does not include a cap or inner sheath. In this embodiment, the space between the endoscope 601 and the outer tube 603 can be kept free of contamination, but both the exterior surface of the outer tube and the internal lumen of the endoscope can become contaminated.

[0137]

[0203] As mentioned above, any suitable cap can be used. For example, FIG. 7A shows one embodiment of a cap 727 shown in an end view. The cap may be made of a transparent material such as a transparent polymeric material (e.g., polycarbonate (PC), polymethyl methacrylate (PMMA), acrylic, polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyethylene (PE), cyclic olefin copolymer (COC), etc.). In one embodiment, as shown in FIG. 7A, a transparent camera window area 736 may be included. The cap may also include a sealing interface 739 to a fixed inner sheath ("fixed sleeve") such as the multi-lumen extruded sheath 717 and / or the working channel sheath 715. The interior of these inner sheaths are open as shown to allow access to the body region at the distal end of the device. For example, the multi-lumen extruded sheath 717 includes three sub-lumens 737, 738, 738', e.g., a water 737, an air 738 and / or a vacuum 738' lumen (or additional air / water channels). In Figure 7A, the working channel sheath also includes an open channel 748 that can be used to pass a tool through the endoscope.

[0138]

[0204] FIG. 7B shows a cross-section of a distal end region of one embodiment of an endoscope 701 that can be used with a sheath assembly as described herein. In FIG. 7B, the endoscope 701 includes an internal lumen 785 that extends the length of the endoscope and is open at the distal end of the endoscope. FIG. 7C shows a cross-sectional view of an embodiment of a sheath assembly 700 that includes a cap 727, an outer sheath 702, and an inner sheath 717 configured as a multi-lumen 738, 737 extruded sheath. The outer sheath 702 may be coupled to an elongated outer tube (not shown in FIG. 7C) or may be a separate elongated outer tube and / or of sufficient length to extend the entire length of the endoscope.

[0139]

[0205] 7D-7E illustrate the fitting of the sheath assembly 700 of FIG. 7C over the endoscope 701 of FIG. 7B. The proximal end of the inner sheath 717 can be inserted first into the inner lumen 785 of the endoscope, and the endoscope can be advanced distally 749 until the cap 727 of the sheath assembly 700 can be mated with the endoscope 701. For example, FIG. 7D illustrates a cross-sectional view of the distal end region of the sheath assembly 700 with the endoscope 701 partially inserted. The outer sheath 702 of the sheath assembly is sealed around the outside of the cap 727, and the inner sheath 717 is also sealed against the interior of the cap 727. As previously mentioned, the inner sheath 717 in this embodiment has two lumens 738, 737 that are open through the cap to allow materials (e.g., air, water saline, etc.) to pass through the endoscope into or out of the sheath lumen without contaminating the lumen of the endoscope 701. Cap 727 in this embodiment is optically transparent at least over camera window area 736 , although in some embodiments the entire cap may be transparent so that imaging camera 786 of endoscope 701 can image through cap 727 .

[0140]

[0206] In FIG. 7D, the sheath assembly is shown with the cap 727 not yet connected to the endoscope 701. The endoscope 701 can be driven distally 749 to engage the cap 727 as shown in FIG. 7E (or the cap can alternatively and / or additionally be driven proximally). In this example, a recessed region 714 at the distal end region of the endoscope can engage with a connector 716 (e.g., a deformable or deflectable connector) on the cap to secure the cap to the distal end of the endoscope as shown in FIG. 7C. The recessed region 714 may be hollow and / or may be a lip, ridge or rim. In an example, the connector may include a shear surface configured to secure the cap to the distal end of the endoscope, a magnet configured to secure the cap to the distal end of the endoscope, a bayonet connector configured to secure the cap to the distal end of the endoscope, a threaded region configured to secure the cap to the distal end of the endoscope, or the like. Because the connection is made within the outer sheath or between the outer and inner sheaths, the connection does not need to form a seal, but does need to be secured so that the cap remains on the distal end of the endoscope as the endoscope is moved axially and / or rotationally.

[0141]

[0207] As mentioned above, in any of these exemplary devices described herein, to prevent contamination of the endoscope and / or outer tube, the inner sheath (e.g., working channel, multi-lumen catheter, etc.) can be sealed before being removed from the endoscope (and possibly the outer tube). This can be done in a number of ways. For example, one or more inner sheaths (which may be configured as catheters) may be plugged, crimped, glued or otherwise plugged, heat sealed, etc. The sealing method used can remain within the outer diameter of the inner sheath so that the inner sheath can be withdrawn through the endoscope. See, e.g., Figures 10A-10C and 14.

[0142]

[0208] The devices described herein can incorporate internal working channels and supply lines within a disposable sheath, which allows those elements of the endoscope to be essentially disposable, thereby protecting the patient and the endoscopic equipment. As previously mentioned, these working channels (working channel liners) can be sealed prior to removal.

[0143]

[0209] Generally, the sheath devices described herein are configured to allow the endoscope and outer tube to roll relative to one another in addition to sliding axially. In certain embodiments, the outer sheath can be purposely torqued to accommodate rotation of one relative to the other. Movement of the inner endoscope and / or outer tube can be accomplished manually or robotically, and the sheath assemblies described herein can advantageously accommodate both a variety of longitudinal / axial and rotational movements between the inner endoscope and outer tube.

[0144]

[0210] Also described herein is a port adapter for easy fluid connectivity to a small diameter multi-lumen catheter (extrusion) that can be used as an inner sheath (working channel liner). For example, Figure 11 shows a cross section of one embodiment of an inner sheath (multi-lumen extrusion, MLE) 1117 that incorporates a working channel 1116 along with three other water / gas channels 1118, 1119, 1120 as a single extrusion. Thus, in some configurations, only one inner sheath may be required.

[0145]

[0211] A multi-lumen inner sheath, such as that shown in FIG. 11, can be used with a port adapter that allows access to all of the internal lumens within the inner sheath. Some of the lumens can be connected in one direction (i.e., side-out) and some can be connected in the other direction (e.g., axially or in-line). In any of these devices and methods, the proximal end of the multi-lumen catheter can be sealed, but one or more openings into the lumens can be located along the side of the distal end region, e.g., for mating with a port adapter, as described herein. In some embodiments, the port adapter can instead be configured to couple to and access the distal end of the multi-lumen catheter that forms the inner sheath (e.g., inner liner), e.g., forming a seal with the individual lumens of the multi-lumen catheter. Any of the port adapters described herein can be configured for use with a single-lumen inner sheath (e.g., single-lumen catheter) by forming a sealing contact with the lumen of the inner sheath through a side opening or distal end (or both).

[0146]

[0212] Turning now to Figures 8A-8B, an inner sheath 817 configured as a multi-lumen extrusion (MLE) is shown along with one embodiment of a port adaptor. In Figure 8A, the inner sheath includes a rigid or semi-rigid connector tip 885 that includes side openings 808 into each of the lumens of the inner sheath 817, shown attached to a proximal end 887 of the inner sheath 817 at an optional joint 886. A joint may or may not be required, i.e., 817 may have an exit hole without the need for a separate connector tip 885. The proximal end may also include an engagement structure (e.g., neck region 889) that is engageable with a port adaptor, as shown in Figure 8B. In Figure 8B, the connector tip 885 of the inner sheath 817 is inserted into a receptacle manifold of a port adaptor 869 that provides a connection for each lumen (or channel) in the inner sheath, as shown in Figures 9A-9B. In this configuration, the system is not radially position dependent, i.e., the system can be inserted to properly connect any radial configuration to the mating lumen. Between each of the radial ports are separation and sealing gaskets (e.g., O-rings). Between each sealing gasket is a spacer ring that allows flow through.

[0147]

[0213] FIG. 9A shows an example of the connection of the inner sheath 817 into a port adapter 869 that provides an individual pass-through connection to each independent lumen in a multi-lumen catheter. In any of these port connectors, the proximal end of the inner sheath can engage with the port connector to secure the proximal end in place and / or to align the opening 808 of the inner sheath with the connector of the port connector. In FIG. 8A, the port connector 869 includes an inner sheath connector receptacle with a releasable locking mechanism 992 that engages with an engagement structure 889 at the proximal end region of the inner sheath. In another embodiment, 885 may not have a special end geometry 889, for example, there may be an angled metal tang that "grabs" the outside of 885, which serves to keep it held. To remove, the tang can be deflected out of the way so that it is no longer in contact with 885.

[0148]

[0214] Figure 9B shows an example cross section of the port adapter of Figure 9A. In this example, the inner sheath's proximal end connector 885 is inserted and latched into the port adapter's receptor manifold as shown in Figure 9A. Flow from each lumen can remain separate and pass through individual ports 971, 972, 973 for connection to supply lines. Although a three channel implementation is shown, this technique can be used to accommodate a greater or lesser number of channels (or lumens).

[0149]

[0215] In FIG. 9B, each individual port includes an annular sealing area 994 (e.g., by use of O-rings 993 forming two or more radial seals). Between the O-rings 993 are rings with spaces, e.g., channels and cross-hole geometries, that direct flow. When the inner sheath 817 is secured within the port connector, the side openings 808 into each lumen are aligned along the length of the proximal end to be positioned by the annular sealing area unique to each lumen. In FIG. 9B, the two annular sealing areas on the right side of the figure are each aligned with an opening 808 in the inner sheath. Thus, fluid can pass into or out of this annular sealing area, which is in fluid communication with ports 972, 973 on the port connector 869. These ports may be standardized to fit any suitable connector.

[0150]

[0216] 9C and 9D show two examples of a port adapter 969, 969' before (FIG. 9C) and after (FIG. 9D) insertion of a multi-lumen catheter forming an inner sheath of an endoscopic sheath device. In FIG. 9C, a first port adapter 969, similar to that shown in FIG. 9A, is configured such that a multi-lumen catheter 917 can be inserted into the inlet 966 and easily slide completely until the distal end of the multi-lumen catheter reaches the back (e.g., stop 988) within the port adapter, as shown by the cross-sectional view in FIG. 9E. In this example, the interior of the port adapter may be divided into regions or compartments corresponding to the number of lumens within the multi-lumen catheter. These regions may be separated by one or more gaskets 983. The multi-lumen catheter can include one or more openings or holes extending through the wall of the multi-lumen catheter into each of the lumens of the multi-lumen catheter disposed along its length such that the openings into a particular lumen of the multi-lumen catheter are within a particular distance from the end of the multi-lumen catheter, such that after insertion into the port adapter, all of the holes corresponding to a particular lumen are within a corresponding region or compartment as depicted in FIG. 9A.

[0151]

[0217] When a multi-lumen catheter (e.g., a multi-lumen channel liner) enters the receptacle manifold 970 of the port adapter, the multi-lumen catheter may encounter high compression loads because the O-ring inner diameter will be smaller than the outer diameter of the multi-lumen catheter to seal. Although such a tight fit may help form a radial seal from the O-ring, it may result in buckling of the multi-lumen catheter. The example port adapter 969 shown in the top of Figures 9C and 9D and in cross section in Figure 9E avoids this problem by increasing the radial clearance of the O-ring and applying a downward pinching force to the O-ring by axially compressing the component stack (e.g., a gasket stack) that results in the necessary radial compression of the seal against the multi-lumen catheter. This motion (e.g., axial advancement by rotation of a thread that results in radial pinching) is similar to that performed by a device on the back of a catheter (e.g., a Towhee Borst adapter) (typically to adjust the back end seal against a guidewire).

[0152]

[0218] In the port adapter 969 shown in Figures 9C-9E, the gasket 983 that forms the seal between each of these separated compartments can be an O-ring with an inner diameter that can be larger than the outer diameter of the multi-lumen catheter. This can be very flexible or allow easy insertion even of the multi-lumen catheter and can help ensure complete insertion of the multi-lumen catheter. As shown in Figure 9E, the port adapter can include a compression mechanism such as a toy connector to secure the multi-lumen catheter within the port adapter. For example, the knob 913 can be twisted clockwise to compress the gasket in the gasket stack (e.g., receptor manifold) against the multi-lumen catheter, and tightening the knob drives the pusher 981 into the receptor manifold (e.g., stack) of the gasket 983, thereby compressing the gasket axially and thus radially compressing the gasket 985, thereby clamping down on the multi-lumen catheter and forming a seal. To remove the multi-lumen catheter, the knob 913 can be untwisted to release the compressive force 985 applied by pushing 986 the pusher 981 into the gasket of the receptor manifold. In any of these devices and methods, the port adapter can be automated. For example, the port adapter can include one or more sensors such that insertion of the multi-lumen catheter can trigger a sensor at the end 988 of the port adapter, thereby automatically turning the knob, or a linear actuator can simply slide the knob axially, thereby compressing the O-ring and forming a seal.

[0153]

[0219] Figures 9C and 9D also show a port adapter 969' similar to port adapter 869 shown in Figures 9A-9B, which may include a catch or lock to secure the multi-lumen catheter within the port adapter. In any of the port adapters described herein, the device may include a spring-loaded pawl or catch-like means to secure the multi-lumen catheter within the port adapter. The port adapters may be one-way or releasable.

[0154]

[0220] FIG. 12 shows another port adapter 1269. In FIG. 12, the port adapter uses a face seal approach. A male connector 1212 is inserted into a female connector 1215. Each lumen in the male connector (three in this figure) is fed by its own separate supply channel. The supply channels are sealed to the end of the male connector by a face seal so that there is no cross-feeding between the channels. FIG. 13 shows another embodiment of this type of port adapter. In this embodiment, the face of the multi-lumen extrusion inner sheath can align each channel with the port, which may require rotational orientation of the input tube. In any of these embodiments, the shaft of the inner sheath 1212 must be aligned to guide the orientation of the inner sheath relative to the port connector.

[0155]

[0221] In Figure 13, the inner sheath 1317 engages the port adaptor 1369 in a manner that is mated so that each internal lumen can engage with a connector in the port connector that can seal an opening at the distal end of the inner sheath to allow access into and out of the lumen in the inner sheath. In the embodiment shown in Figure 13, the upper port connector 1369 is shown engaged to the inner sheath 1317, while the lower port connector 1369' is not engaged to the inner sheath 1317'. Each port connector includes three standard connectors 1368 that can be coupled to tubing for administering / removing substances.

[0156]

[0222] As mentioned above, prior to removal of the sheath assembly, the inner sheath can be shielded to prevent contamination. The inner sheath can be sealed by any suitable manner, including thermal (e.g., melting by force applied by a heated die), mechanical (e.g., crimping, pinching, stapling), etc. FIG. 14 illustrates a crimping method of sealing. The inner sheath, preferably at the proximal end region, can include a crimp 1442, which can be crimped closed after the procedure. To prevent contaminating fluids from leaking out of the sheath, the compressed crimp 1442' seals the sheath, and when compressed, the crimp is smaller in diameter than the outer diameter of the inner sheath 1417 so that the crimp can be pulled out. The inner sheath 1417 can then be wiped clean and removed by pulling it through the endoscope without contaminating the endoscope.

[0157]

[0223] Turning now to Figures 10A-10C, these figures show an alternative form of crimping in which the inner sheath 1015 is sealed by heat sealing after the procedure. The heat seal hygienically seals the inner sheath, safely containing any contamination within the sheath. The internal volume of the tube can be locally reduced to zero, thereby greatly reducing the possibility of contamination. Heat sealing further reduces problems associated with possible residual material. In Figure 10A, the inner sheath 1015 is inserted into a heat sealing device 1042 so that heat (and / or mechanical pressure) can be applied as shown in 10B to melt the material of the inner sheath, resulting in a seal 1016 as shown in Figure 10C. After heat sealing, or as part of the heat sealing operation, the inner sheath can be cut and withdrawn through the endoscope without risk of contamination. Heat sealing of tubes with liquid inside is routinely performed for blood collection and other applications.

[0158]

[0224] The use of an inner sheath for sheath assembly that itself provides a supply conduit and working channel for the endoscope, yet still passes through the interior volume of the endoscope, can be advantageous The outer sheath portion is flexible enough to support extension and retraction of the endoscope relative to the outer tube while still allowing it to flex laterally, and maintaining a physical barrier against contamination.

[0159]

[0225] Any of the endoscopic sheath devices described herein can be used with robotically controlled or manually nested endoscopes. For example, the endoscopic sheath device can be part of a system that includes an elongated outer endoscope and an inner endoscope in a telescopic configuration. The endoscopic sheath device can be configured to fit over both the inner endoscope (which fits within the outer endoscope) and the outer endoscope. Alternatively, as shown in Figures 15A-15D, the endoscopic sheath device can be configured to fit over the inner endoscope and then inserted through the outer endoscope. Figure 15A shows an example of an inner endoscope 1500, which in this example includes a first lumen 1501 and a second lumen 1505. Figure 15B shows an example of an endoscopic sheath device 1535 that can be used with a first (inner) endoscope. The endoscopic sheath device includes a cap 1525 against which an elongated flexible tubular outer sheath 1502 is sealed. A pair of inner sheaths, e.g., a first inner sheath 1515 and a second inner sheath 1517, extend within the length of the outer sheath and are also sealed to the cap at their distal end regions such that the cap is opened to allow passage of the first sheath 1515 and the second sheath 1517 into the lumen.

[0160]

[0226] FIG. 15C shows the endoscopic sheath device 1535 of FIG. 15B mounted over the inner endoscope of FIG. 15A. A cap can be mounted (e.g., latched, friction-fit, snap-fit, etc.) on the distal end region of the endoscope 1500. In FIG. 15C, the endoscope can be inserted into the body without risk of contamination because the endoscopic sheath device forms a complete barrier for both the outer and inner (luminal) surfaces of the endoscope. The endoscopic sheath device does not inhibit or limit (but instead can enhance) the operation of the lumen of the endoscope while maintaining a fluid-impermeable contamination barrier to prevent contamination. Thus, the inner endoscope can be reused after a procedure by removing the endoscopic sheath device as described herein without contaminating the endoscope. For example, the inner sheath can be sealed (by crimping or otherwise) at the proximal end, and the outer sheath can be everted on itself by pulling partially or completely proximally, thereby preventing contamination and trapping contaminants within the everted sleeve of the sheath.

[0161]

[0227] The cap may include one or more transparent portions to allow the use of a camera and lighting built into the endoscope 1500. The two inner sheaths of the endoscopic sheath device may include lumens that can be used to pass material through the endoscope by passing it through the cap and into the lumen of the inner sheath. A multi-lumen catheter may be used for one or both of the inner sheaths, and may include sub-lumens for irrigation, tip washing, and / or air delivery lines that may be directed by the shape of the tip region, which may include, for example, a director, nozzle, etc. For example, the tip may include a tip washing director or nozzle that may direct fluid from a tip washing sub-lumen of a multi-lumen catheter forming one of the inner sheaths to divert the fluid to wash a window for a camera on the tip. As described herein, in some embodiments, the tip may include lighting built into the camera rather than on the endoscope.

[0162]

[0228] FIG. 15D also illustrates the use of an endoscope fitted with an endoscopic sheath device having a second (outer) endoscope. In FIG. 15D, the outer endoscope 1539 includes a lumen through which an inner endoscope covered by the endoscopic sheath device can be inserted. In this example, the outer endoscope 1539 can be configured to function as an overtube and can be single-use or limited-use (e.g., disposable). The endoscope 1500 can be a removable endoscope core that may be reusable. The endoscope 1500 can include one or more cameras, lights, pull cables (e.g., for steering the distal end region), coil pipe assemblies, bends, etc. As previously described, the endoscope can be inserted into an unused endoscopic sheath device and secured in place by coupling a cap to the distal end region of the endoscope and, in some examples, by inserting it into the outer endoscope to perform the procedure.

[0163]

[0229] In general, these methods and apparatus thus allow for replacement of less durable components before each new procedure, including replacing an endoscope sheath device (e.g., configured to be positioned between the outer endoscope / overtube and the inner endoscope) and the associated hydrophilic coating on the outside, while the inner endoscope is reusable multiple times. Thus, the inner endoscope can be hygienically covered by the endoscope sheath device such that it can be reused without the need for high-level disinfection (HLD). The inner endoscope can be completely shielded from any exposure to water and contamination, thereby facilitating a simpler and more cost-effective design and construction. Also, the patient is thus completely shielded from the second endoscope, potentially simplifying the biocompatibility and cleaning requirements of the endoscope. The use of the endoscope sheath device can also extend the life of the endoscope, including some of the most expensive components of the endoscope, such as the camera and flexure components. This configuration also allows for removal and replacement of the inner endoscope during a procedure, while leaving the outer endoscope / overtube in place. These methods can also accommodate the use of the outer surface of the overtube for the addition of accessories, such as an outer working channel, as described with reference to Figures 16A-16B.

[0164]

[0230] In general, any of the devices described herein can include the use of an outer working channel on an endoscopic sheath device and / or on an endoscope used in conjunction with an endoscopic sheath device. Figure 16A illustrates an example in which the device shown in Figure 15D (including an endoscope 1500, an endoscopic sheath device 1535, and an outer overtube 1539) also includes an outer working channel 1545. Examples of outer working channels can be found, for example, in U.S. Patent Application No. 17 / 940,906, entitled "EXTERNAL WORKING CHANNELS," filed September 8, 2022, and U.S. Patent Application No. 18 / 000,062, entitled "RIGIDIZING DEVICES," filed May 26, 2021, each of which is incorporated herein by reference in its entirety.

[0165]

[0231] The one or more outer working channels 1545 may be inflatable from the exterior of the outer endoscope 1539 and may include a proximal insertion guide region 1547 for inserting one or more devices through the outer working channel. FIG. 16B shows an example of a system including an inner endoscope covered by an endoscopic sheath device 1535, such as that described in FIGS. 15A-15D, slidably disposed within the outer endoscope 1539. As previously mentioned, the exterior surface of the endoscopic sheath device may be coated with a hydrophilic coating to aid in axial movement between the outer and inner endoscopes. The system shown in FIG. 16B also includes an outer working channel 1545 configured as a cover over the outer endoscope including a proximal insertion guide 1547. In FIG. 16B, a tool 1549, 1549′ is shown inserted through the insertion guide 1547 and threaded into the working channel of the outer working channel and extending distally from the distal end of the outer endoscope. The proximal end of the inner endoscope 1558 is shown extending from the proximal end of the outer endoscope. In this embodiment, an inner sheath (not shown) can extend proximally and can be coupled to a source of, for example, aspiration, fluid, air insufflation, etc. These working channels can be compatible with a covering system such that the underlying endoscope maintains its cleanliness as tools pass through the working channels and even as tools pass through the outer working channels.

[0166]

[0232] In any of these embodiments, the outer working channel can be mounted onto the overtube, as shown in Figure 16B, using an overtube, such as that depicted in Figure 4A, in which case the working channel, along with the overtube and distal outer sheath, can be disposed of after each procedure.

[0167]

[0233] In some embodiments, the outer working channel can be mounted on an outer sheath of an endoscopic sheath device. For example, one or more outer working channels (including an inflatable working channel) can be incorporated into an outer sheath, such as a full-length outer sheath that fits over the outside of an endoscope or endoscopic assembly (e.g., FIG. 4C). In this configuration, the working channel can be disposed of along with the full-length outer sheath after each procedure, but does not require disposal of the overtube (which is protected under the full length of the outer sheath).

[0168]

[0234] Any of the endoscopic sheath devices described herein can be configured as a stiffened endoscopic sheath. The endoscopic sheath device can be stiffened in any suitable manner, including but not limited to a pressure stiffening device. For example, the endoscopic sheath devices described herein can include a stiffened outer sheath configured to extend over an endoscope and can include a stiffening layer including a plurality of crossed strands and a compression layer configured to apply a force to the stiffening layer when pressure is applied to stiffen the stiffened outer sheath from a flexible configuration to a rigid configuration.

[0169]

[0235] For example, Figures 17A-17D show a system including an endoscope 1700 having one or more lumens (e.g., a first lumen 1701 and a second lumen 1705 in this example) and a rigidified endoscope sheath device 1735. The rigidified endoscope sheath device includes a cap 1727 configured to fit over a distal end region of the endoscope 1700 and includes one or more inner sheaths (a first inner sheath 1715 and a second inner sheath 1717 in this example) configured to fit within the endoscope 1700. The rigidified endoscope sheath device also includes a rigidifiable outer sheath 1702. The rigidifiable outer sheath 1702 is a tubular sheath sealed against the cap 1727. The outer sheath 1702 can have an inner diameter that is slightly larger than the outer diameter of the inner endoscope 1700.

[0170]

[0236] The stiffening outer sheath 1702 can include stiffening layers or regions that engage a compression layer (which may be or include a bladder) that applies a force to the stiffening layer to stiffen or, in some cases, de-stiffen (release) the stiffening layer. In some embodiments, these stiffening outer sheaths 1702 can include stiffening layers that can include braids, knits, wovens, shreds, randomly distributed or randomly oriented fibers or strands, engagers, links, scales, plates, segments, particles, granules, crossed fibers, or other materials that form a stiffening layer. For example, the stiffening layer can include multiple strands or strand segments that cross over one another (e.g., as part of a braid, knit, weave, etc.). The compression layer can apply a force to drive the crossed strands or strand segments against one another. In some embodiments, the stiffening layer can be a braided layer, although any of these devices can alternatively or additionally include a generic stiffening layer that includes crossed strands or strand segments. Examples of stiffening devices described herein can use pressure (positive pressure) and / or negative pressure to selectively and controllably stiffen. In some examples, the methods described herein can be used with any suitable stiffening device.

[0171]

[0237] 17C shows an embodiment of an assembled inner catheter 1700 and rigidified endoscope sheath device 1735. The inner rigidified sheath is inserted into the lumen of the endoscope, a cap is coupled to the distal end of the endoscope, and an outer rigidified endoscope sheath 1702 extends over the exterior surface of the endoscope.

[0172]

[0238] Any of these systems can also optionally include a second, outer endoscope 1739 as shown in Figure 17D. Thus, these devices can be used in a nested configuration. The outer endoscope can also be rigid in some configurations.

[0173]

[0239] As previously mentioned, the outer endoscope 1739 (e.g., overtube) can be disposable and / or reusable (e.g., by cleaning or by sheathing). Similarly, the endoscope sheath device can be disposable or reusable (e.g., by cleaning). The endoscope can be reusable and can include, for example, a camera, lighting, pull cables, coil pipe assemblies, bends, etc. The inner endoscope can be inserted into an unused endoscope sheath device, locked in place for a procedure, and then unlocked and removed after the procedure.

[0174]

[0240] In any of the devices and methods of use and fabrication described herein, the inner sheath can be configured to both prevent contamination and allow the passage of one or more substances or objects. In general, the inner sheath is typically a sealed tubular sheath, such that the distal outer edge is sealed circumferentially within an opening through the cap. The inner sheath is also generally stiffer than the outer sheath, and may be sufficiently stiff to allow passage within the lumen of the catheter. The inner sheath may also be sufficiently stiff to allow unimpeded passage of substances when functioning as an inner working channel (e.g., when the inner sheath is functioning as a working channel liner). In some cases, however, the inner working channel needs to be sufficiently flexible to allow bending of the endoscope, particularly when used with a steerable endoscope such as that shown in FIG. 18.

[0175]

[0241] For example, an endoscope such as that shown in FIG. 18 has different bend radii in different sections. The distal end region ("distal section") 1851 can be made highly flexible as shown, since the distal tip 1543 of the endoscope, to which the cap of the endoscope sheath device can be coupled, can be steered by bending the bending section 1541 of the endoscope. The endoscope can be steered or bent by any suitable technique or structure, including tendons / pull wires, etc. Bending the tip region can be particularly difficult, since bending beyond a certain radius of curvature can result in pinching or collapsing of the lumen of the inner sheath. Thus, these devices may include tube reinforcement, especially in the distal end region corresponding to the distal section 1851. However, it should be understood that other regions can also be reinforced, including the intermediate or central section 1853, which can extend to or nearly to the proximal end of the catheter. The proximal section 1835 can include an extension of the inner sheath 1817 beyond the catheter and / or outer sheath 1828, for example, to a port adapter 1868.

[0176]

[0242] In some embodiments, the entire endoscope may be flexible, with the inner sheath being correspondingly flexible. The inner sheath may be reinforced in any of these devices to provide both flexibility and sufficient stiffness / radial strength to prevent collapse and allow easy insertion of the inner sheath. Any suitable reinforcement and degree of reinforcement may be used. For example, the inner sheath may be reinforced with one or more coils spirally wound around and / or within the inner sheath to prevent local buckling during sharp bends (e.g., bends having a radius of curvature less than 30 mm, less than 20 mm, less than 15 mm, less than 10 mm, less than 7.5 mm, less than 5 mm, less than 4 mm, less than 3 mm, less than 2 mm, etc.).

[0177]

[0243] FIG. 19A shows an embodiment of a first tubular inner sheath. This embodiment is a single lumen inner sheath, sometimes referred to as a tube liner, because it lines the inside of the lumen of the endoscope. In FIG. 19A, the inner sheath 1650 includes a reinforced distal region 1651 and an unreinforced central region 1653. The reinforced distal region 1651 can be reinforced by including an internal coiled tube or by forming a more flexible but crush-resistant or buckling-resistant material (e.g., a polymeric material). In some embodiments, the entire length of the inner sheath 1650 is reinforced by a coil, as shown in FIG. 19B. Other inner sheaths can include multiple lumens and can be reinforced in a similar manner. In some embodiments, a multi-lumen inner sheath may not require reinforcement, as the internal lumen being divided into multiple lumens can provide internal reinforcement.

[0178]

[0244] The inner sheath in some embodiments is formed from a medium durometer elastomer, for example by extrusion. A slip agent can be included to help make the inner sheath slippery, for example within the lumen of the endoscope and relative to the tool passing within its inner diameter. In some embodiments, the inner sheath can be formed as a composite structure. For example, a tube wound with a laminated coil whose coil pitch varies along its length can be used, and the coil can be made of flat wire. The flat wire can be wound more tightly in the distal section to prevent buckling when the bend is forced through a tight radius of curvature. The substrate forming the body of the inner sheath can be a low durometer elastomer (70A urethane) material. The inner surface of the tubular inner sheath can have a hydrophilic coating to allow the tool to slide easily. This can result in much better sliding than is possible with standard PTFE tubing. For example, a reusable scope with standard PTFE tubing allows a tool to be inserted and make two complete turns (e.g., 2×360 degrees). With a hydrophilic coating, this can be increased to 6 turns (e.g., 6 x 360 degrees). Drag in such situations increases exponentially, especially in long bendable / flexible tubes, so this is a significant reduction in drag and is an advantage of the endoscopic sheath device described herein. This resulting lower drag can improve the tactile feel of the instrument. This is another example of how a sheathed system can outperform a reusable system.

[0179]

[0245] Thus, the inner sheath can be reinforced as described herein and / or formed of a material with sufficient properties (e.g., wall thickness, stiffness in bending, buckling in bending, buckling along length, etc.) to prevent pinching or collapsing when manipulating the endoscope. In general, the inner sheath can be made of the same material as the outer sheath or can be made of a different material. Examples of suitable materials for the inner sheath can include, but are not limited to, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxy (PFA), high density polyethylene (HPDP), low density polyethylene (LDPE), polyether block amide (e.g., Pebax™), expanded polytetrafluoroethylene (EPTFE, e.g., Fluroflex™), urethane, etc. These materials can be extruded and combined with other materials, such as, for example, heat set metal coils, coils wound with round wire, flat wire, etc. Examples of materials for the outer sheath can include (but are not limited to) LDPE, polyolefin plastomers, nylon, composites (e.g., urethane laminated thin films containing interdispersed high performance fibers (e.g., Dyneema, Technora, carbon fiber, fiberglass, etc.)), silicones, and urethanes. These can be manufactured by a number of methods including, but not limited to, extrusion, blow molding (including bellows designs), lamination, and heat sealing.

[0180]

[0246] In general, the endoscopic sheath devices described herein can include a tip that allows the endoscopic sheath device to be easily and effectively secured to a distal end region of an endoscope, includes features that allow the outer sheath and inner sheath to form a seal with a cap, and can include built-in features that aid in the function of the endoscope to which the endoscopic sheath device is attached. For example, the endoscopic sheath device can include a tip having any of the features shown in Figures 20A-20D, 21C, 22A-22C, 23A-23B, 24A-24B, 25, 26A-26B, 27A-27C, 28A-28D, 29A-29B, 30A-30B, 31A-31B, 32A-32B, 33A-33B, 34A-34B, 36A-36B, or 38.

[0181]

[0247] For example, Figures 20A-20D show an example of a cap including features that may be included in any of the endoscopic sheath devices described herein. The cap of the figure includes a distal surface that may be fully or partially transparent and may include a transparent camera area 2026 through which a camera on the endoscope may image. As shown in Figures 36A-36B, in an example, the cap may include an integrated lens or camera. In an example, the cap may further include a transparent light passing area 2024 that allows transmission of light from the endoscope through the cap. The cap 2018 may also include one or more optical components (e.g., diffusers, lenses, etc.) that modify the illumination light. In an example, the cap may alternatively or additionally include one or more light sources, e.g., LEDs. The cap may include one or more openings corresponding to inner sheath areas, including openings into the lumen of the first inner sheath 2023 and / or the second inner sheath 2022. Any of these devices can also include one or more flow directors or displacers 2020 that can direct (or redirect) the flow of one or more agents (e.g., irrigation fluid, air, etc.) from the proximal end of the device. For example, the cap can include an irrigation nozzle or irrigation directing outlet 2021 that can be part of the fluid displacer 2020 on the cap.

[0182]

[0248] For example, Fig. 20A shows an end view of the cap in this embodiment. Fig. 20A shows an end view of the cap. Fig. 20B shows a side perspective view including a cylindrical mating region 2033, which may initially be oval, as shown in Fig. 20D. The oval mating region has an oval cross section transverse to the long axis of the device in an unconstrained configuration. The side view of Fig. 20B shows that the cap can include one or more regions for mating with all or a portion of a cylindrical outer sheath, and in Figs. 20B and 20C, the cap includes a concave mating region 2049 into which the outer sheath can be sealed, for example, by an elastic member (elastic retaining ring, not shown) and / or adhesive and / or heat sealing.

[0183]

[0249] As shown in Fig. 20D, the cap 2018 can include a larger rim 2036 that extends around the cylindrical mating surface 2033. Fig. 20D shows the interior of the cap area. It shows the recessed or notched entrances 2022, 2023 for receiving and sealingly mating with the inner sheath. The interior of the cap also includes a recessed area 2039 for receiving the optics (e.g., camera, lens, light guide, etc.) from the endoscope.

[0184]

[0250] The end cap shown in Figures 20B-20D also includes a latch region 2038 extending through the mating surface that is configured to mate with the distal end of an endoscope by compressing the mating surface from an oval resting cross-sectional configuration to a circular mating cross-sectional configuration. The latch 2038, in this embodiment, can be formed as an opening that can be engaged by, for example, a protruding latch member on the distal end region of the endoscope. Alternatively, in some embodiments, a protruding latch member can be on the cap and engage a latch opening on the distal end of the endoscope.

[0185]

[0251] Any of these caps may also include one or more stress relief regions 2039, including stress relief cut out areas, that may make it easier and more reliable to compress the cylindrical mating region 2033 (e.g., a wall).

[0186]

[0252] For example, Figures 21A and 21B show an example of the distal end of an endoscope that includes a camera 2106, a light 2104, a first lumen 2108 through the endoscope, and a second lumen 2109. The endoscope in this example also includes an outer diameter surface 2174 on which the mating latch components (e.g., angled latch protrusions 2112, 2112' in Figure 21B) reside. Figure 21C shows a front view of the endoscopic sheath device of Figures 20A-20D attached to the distal end of the endoscope. The cap 2118 in this example can be attached by first applying pressure (e.g., squeezing the cap) to circularize the oval mating walls, and then sliding it over the distal end to engage the latches 2112 on the upper and lower regions. This is shown in Figures 26A-26B. In this example, the cap 2613 includes a cylindrical mating surface 2033 that is formed into an oval cross-sectional shape (at rest). The transition from an oval cross-sectional shape to a more rounded shape that matches the circumference of the catheter can allow the endoscopic sheath device to be slid onto the more rounded endoscope distal end and mate with the latching component. After pressure is released, the cap can return slightly to the more oval configuration, thereby applying a force to hold the cap onto the distal end region.

[0187]

[0253] As shown in Figure 21C, the cap can include one or more structures, such as a fluid displacer 2120, that can enable the cap to direct the flow of a substance (e.g., irrigation fluid) from the lumen of the inner sheath. In Figure 21C, the inner sheath within this lumen of the catheter is a multi-lumen catheter that is segmented into three regions: insufflation, irrigation, and irrigation.

[0188]

[0254] As mentioned above, any of these caps, and therefore any of the endoscopic sheath devices described herein, can include one or more light sources built into the cap. For example, FIGS. 22A-22C show an example of an endoscopic sheath device including a cap 2218 with a set of built-in LEDs in the lens (rather than or in addition to directing light from the endoscope). In FIG. 22A, the endoscopic sheath device includes an outer sheath 2228 sealed against the outer periphery of the cap 2218 in a channel that secures the outer sheath, for example, by a gasket 2241. A pair of inner sheaths 2210 extend from the cap (e.g., through the cap and sealed around the inner surface of an opening through the cap) and into the lumen of the endoscope 2222. The cap can include other features as well, including a fluid displacer 2220.

[0189]

[0255] The cap 2218 shown in FIGS. 22A-22C also includes a number of LED lights 2243 arranged at least partially around the perimeter of the cap. The LEDs are mounted to a substrate 2244 held or formed within the cap. The LEDs may be powered by including one or more electrical contacts on the interior of the cap that can contact corresponding contacts on the end of the endoscope. For example, FIG. 22C shows an area of ​​a number of electrical contacts 2239 on the endoscope that electrically connect with one or more pads, pins and / or contacts on the cap once the cap is attached. In this example, the oblong mating wall may include one or more of the electrical contacts required to power the LEDs. These contacts may be configured to be on an area of ​​the wall near the minor axis of the cross section of the oblong (e.g., elliptical) mating wall, and this same area may include the latch 2238 (e.g., latch opening and / or latch protrusion).

[0190]

[0256] 23A-23B show another example of a cap portion of an endoscopic sheath device including multiple LEDs 2343 similar to the arrangement of FIGS. 22A-22C. In FIGS. 23A-23B, the cap is configured as a disposable cap with a transparent window. The endoscopic sheath device can be placed over an endoscope during use. However, if the endoscope has a camera and an illumination port, this can cause reflected light from the illumination port to cause reflection artifacts in the camera image. To avoid this issue, in one example, the cap can include an illumination port including LEDs, for example as described above. For example, the LEDs can be placed along the outer edge of the disposable cap. Placing the illumination in the disposable cap also frees up valuable space on the face of the endoscope to support other functions or reduce the diameter of the endoscope. One embodiment may include 1-3 white light LEDs. In the case of multiple LEDs, the different LEDs can be evenly spaced around the circumference of the cap (facing forward), although other patterns are also possible.

[0191]

[0257] Some imaging mechanisms can use illumination other than white light. For example, green, blue and ultraviolet (UV) light can be used to highlight surface features of tissue. Infrared illumination can be used with fluorescence, with or without illumination in other bands. Another illumination scheme can be "steady state" where the vision system is switched to an alternate imaging mode and remains so until the user switches back to white light illumination. Alternatively, the vision system can change the illumination pattern at a frame rate, alternatively using a frame with white light, then a frame with alternate illumination, or other time-varying patterns. Image interpolation can be used by the systems described herein to display an alternate image overlaid with a white light image. An array of LEDs, lasers or other illumination devices on a disposable cap can enable these alternate imaging approaches. For example, a cap with three LEDs each of red, green, blue and UV light can enable the vision system to image in both white light and alternate modes to highlight surface details of tissue. 25, three LEDs 2543 are arranged in clusters spaced 120 degrees apart on the face of the cap 2513, with each cluster containing closely spaced red, green, blue and UV LEDs. Other configurations are possible.

[0192]

[0258] In some embodiments, wires (e.g., wire leads) can be used to power the LEDs. These wires are routed through the endoscope and provide electrical contact between the cap and the endoscope body as described above. Alternatively, the wire leads may be incorporated into an outer sheath that is attached to the cap, e.g., routed spirally around the outer sheath to avoid restricting movement of the endoscope. Alternatively, in some embodiments, the wires may be routed along or through the inner sheath (or multiple inner sheaths). For example, the wires may be thin wires that are coated.

[0193]

[0259] 24A and 24B show an example of a multi-lumen extrusion with embedded wires (in this example, the wires are sealed within 0.013 inch (0.33 mm) twin lumens). In FIG. 24A, the embedded wires 2481 can be coupled to one or more LEDs (not shown), and the frame can be configured to fit over the distal end of a device such as those described above that includes cut-out areas to allow imaging and / or light passage.

[0194]

[0260] As mentioned above, in some embodiments, the cap can be attached and / or removed from the endoscope by applying compression across the major axis of the oval cylindrical mating wall. For example, removal of the cap is shown in Figures 27A-27C (with the outer sheath removed to show the application of a compressive force to remove the device from the tip). As shown, the cap can be removed by squeezing the cap (Figure 27B) to deform the mating wall to allow the latch members to be released so that the cap can be pulled up and separated from the endoscope, leaving the endoscope clean and ready for another use.

[0195]

[0261] This method is illustrated diagrammatically in Figures 28A-28D and 29A-29B. For example, in Figure 28A, an endoscopic sheath device is first set to be fitted onto an endoscope 2800. The inner sheath 2815, 2817 of the endoscopic sheath device can be inserted into the lumen of the endoscope, and the endoscopic sheath device can be slid 2883 proximally until the cap 2813 is located near the distal end region of the endoscope as shown in Figure 28B. Once the cap 2813 is in place, the user can compress the cap with their fingers and deform the shape of the cylindrical mating wall 2884 so that the cap fits over the distal end region of the endoscope as shown in Figure 28C. Pressure applied to the major axis of the cylinder can circularize this normally oval cross-sectional area until it fits over an endoscope having a round cross-sectional area as shown in Figure 28D. The location and extent of stress relief windows 2893 cut into the cylindrical mating passage on opposite sides of the minor axis of the cross section of the cylindrical wall can facilitate changing the cross-sectional shape of the cylindrical mating passage from an oval to a more circular shape. Application of this compressive force 2985 can also facilitate engaging or disengaging the latch 2992. Figures 30A-30B show the application of a compressive force 2985 to elastically deform a cylindrical wall having an oval cross section, as described above.

[0196]

[0262] As mentioned above, any of the caps of the endoscopic sheath device may include one or more features for directing the flow of material into or out of the endoscope. For example, an endoscopic sheath device including a cap such as that shown in Figures 31A and 31B may include built-in or attached features for directing the flow of irrigation fluid, irrigation fluid, and / or insufflation. In this embodiment, the endoscopic sheath device includes a multi-lumen catheter 3115 that forms one of two tubular inner sheaths. A second single-lumen sheath 3117 is also included. The multi-lumen sheath 3115 in this embodiment is divided into three sub-lumens that can be accessed at the proximal end of the device by a port adapter for inputting each of the insufflation fluid 3142, the irrigation fluid 3143, and the irrigation fluid 3144. This is shown in Figures 35A-D, which show the operation of an embodiment of a port adapter 3569. In this embodiment, the multi-lumen inner sheath 3516 is fully inserted into the port adapter until the latches engage the distal end of the port adapter, thereby indicating that the side openings into the different lumens located at different longitudinal positions along the length of the inner sheath are aligned with the appropriate sealing areas of the receptor manifold of the port adapter. For example, in FIG. 35A, irrigation port 3576 to the first lumen is accessed from this position so that irrigation fluid can be input through port adapter input 3571 for irrigation fluid. Irrigation fluid port 3577 to the second lumen is accessed from a central position so that irrigation fluid can be input through port adapter input 3573 for irrigation fluid. Insufflation port 3579 to the third lumen is accessed from a more proximal position so that air can be input through port adapter input 3574 for air insufflation. End views of these different ports are shown in FIGS. 35B-C.

[0197]

[0263] Returning now to Figures 31A-31B, the air insufflation 3142 can be directed out of the multi-lumen catheter forming the inner sheath 3115 by the director 3120 such that the air insufflation 3142, 3242 is directed across the camera area. This is shown in more detail in Figures 33A-33B. The flattened triangular component represents the approximate location of the air insufflation. Similarly, the irrigation fluid 3143, 3243 is directed out of the multi-channel lumen of the inner sheath by the director 3120 on the cap 3113 which can direct the irrigation fluid across the outer surface of the cap 3213 to remove debris that may block the camera. This is shown in more detail in Figures 32A-32B. The bent cylindrical shape shown to represent the irrigation fluid 3243 represents the approximate direction of flow of the irrigation fluid. As illustrated by the representations of irrigation in both Figures 31A-31B and Figures 34A-34B, irrigation fluid 3144, 3442 can be directed out of the multi-lumen catheter forming the inner sheath.

[0198]

[0264] As mentioned above, the cap may also include one or more optical components incorporated (including integrally formed) into the cap. For example, any of these endoscopic sheath devices may include a cap with one or more built-in lenses for an endoscope's camera, as shown in FIGS. 36A-36B. In this example, a dome-shaped lens 3652 is formed as part of the cap 3600, which may include other components such as a fluid displacer 3620. When the cap is attached to the distal end region of the endoscope, as shown in cross section in FIG. 36B, the camera of the endoscope 3688 communicates directly with the lens 3652 formed on the cap. The endoscopic sheath device 3600 of FIGS. 36A-36B also includes a second inner tubular sheath 3617 configured as an inner working channel and lined on the inside by a second inner tubular sheath 3617.

[0199]

[0265] Any of the devices described herein may include one or more accessory elements configured for use with an endoscopic sheath device, such as a scope cap. These accessories may be added or coupled to the endoscope after or before the endoscopic sheath device is attached to the endoscope, or may be incorporated into the endoscopic sheath device, for example, as part of the cap. For example, FIGS. 37A-C show an example of a removable scope cap 3700 that includes a retention mechanism 3708 (configured as a bayonet-type fastener in this example). In FIG. 37A, the removable scope cap 3700 is separate from the endoscopic sheath device (e.g., cap 3713 of the endoscopic sheath device), and in FIG. 37B, the removable scope cap 3700 is coupled to the cap of the endoscopic sheath device. FIG. 37C shows a side cross-sectional view of FIG. 37B.

[0200]

[0266] In general, the methods described herein can include installing, removing, and / or changing among different scope caps as needed by the user. In some embodiments, an endoscopic sheath device can be configured to incorporate one or more of these features, such as a scope cap extending from a distal end. FIG. 38 shows an embodiment of a cap 3813 in which a scope cap portion 3800 is integrally formed with the remainder of the cap.

[0201]

[0267] Also described herein are endoscopes that can be modified to more easily operate with the endoscopic sheath devices described herein. For example, FIG. 39A shows an example of a prior art endoscope that includes an elongated body 3928 having a distal end region 3918 and multiple internal lumens 3957. In this example, the lumens are coupled to suction 3958 and air / water 3959. The device can also include valves, such as a suction valve 3953 and an air / water valve 3951, that can regulate the flow of suction, air, and / or water within the lumens. A handle region 3966 can be coupled to the elongated body 3928 and a cord that can be connected to a source of suction and / or air, for example, via a suction connector 3960 or an air tube 3962.

[0202]

[0268] Any of the devices described herein may include an endoscope adapted for use with an endoscopic sheath device, and these systems may include an endoscopic device in which a valve that controls the flow of a substance (e.g., vacuum, water, air, etc.) within a lumen of the endoscope may be separate from and / or disposable. For example, a catheter adapted for use with an endoscopic sheath device may include a handle region configured to pass through an inner sheath. In an embodiment, the endoscope has an elongated member having a lumen extending from the handle. The system may also include an endoscopic sheath device including an outer sheath, an inner sheath including one or more lumens, and a cap as described above. The system may also include a manifold block removably coupled to the handle of the endoscope, the manifold block including one or more valves in fluid communication with the lumen of the endoscope. The inner sheath may be configured to engage the manifold block such that the one or more valves control the passage of fluid through the one or more lumens of the inner sheath.

[0203]

[0269] For example, FIG. 39B shows a schematic of an endoscope as described herein. In this example, the endoscope includes an elongate shaft (endoscope shaft) having two internal lumens. The first lumen is for receiving a working channel and / or an aspiration channel. The second lumen is for receiving a multi-lumen channel that can be coupled to insufflation, irrigation fluid, and irrigation fluid. In FIG. 39B, the elongate shaft is coupled to a handle region. The handle region can also include a disposable manifold block, which can include multiple valves and / or controls for engaging the internal lumens and / or controlling flow within the lumens. For example, the disposable manifold block can include manual button valves and / or check valves that prevent reverse flow but allow fluid flow from the handle to the distal end of the shaft. The device can also include a sealing / crimping region (e.g., a heat seal access point) that allows the internal shaft to be sealed when use is complete. Finally, the device may also include lumens ("umbilical" lines) and connectors for connecting to sources of irrigation (water), irrigation, insufflation (air / CO2) and / or suction.

[0204]

[0270] In general, the device shown in Figure 39B is configured for use with an endoscopic sheath device such that an outer sheath can cover the outside of the distal tip and shaft (and in some embodiments the handle and optionally the umbilical), and an inner sheath can extend through the lumen and manifold block to mate with the connector. Thus, the manifold block can be adapted to receive the inner sheath, and valves and controls can operate on the inner sheath.

[0205]

[0271] Any of the devices and methods described herein can be configured to apply positive or negative pressure between the outer sheath of the endoscopic sheath device and the exterior surface of the endoscope. Thus, any of these devices can be configured to apply negative pressure (e.g., vacuum) to adhere the outer sheath to the outside of the endoscope, thereby facilitating holding and use (e.g., applying torque). The use of pressure, including negative pressure, can also alert the user to leaks or ruptures in the sheath. Alternatively, any of these methods and devices can use positive pressure to inflate the outer sheath, which can aid in navigation, placement, and / or leak detection.

[0206]

[0272] In any of these apparatus and methods, the endoscopic sheath device can be configured to allow pressurization of the outer sheath by forming a seal at the proximal end region of the outer sheath, e.g., on the endoscopic sheath and / or handle. The distal end region, including the cap, may also form a seal, or may not be sealed in some embodiments, but may be sealed around the more proximal end of the inner sheath.

[0207]

[0273] 40A-40C illustrate a first embodiment of a system including an endoscopic sheath device configured to pressurize an outer sheath of an endoscopic sheath device. FIG. 40A illustrates an embodiment of an endoscope 4000 including an elongate shaft 4001 and a handle region 4003. In this embodiment, the endoscope handle can include a pressure line 4007 (e.g., positive or negative pressure) that can be used to apply pressure between the endoscope and the outer sheath. In one embodiment, the pressure line is coupled to the endoscopic sheath device, for example at the sheath proximal collar. The pressure line may be integrated into the endoscope or endoscopic sheath device, or may be a separate, separately positioned line.

[0208]

[0274] 40B illustrates generally an endoscopic sheath device including a pressurized outer sheath 4002 and a pair of inner sheaths, and a cap 4027 sealed to the outer and inner sheaths. The endoscopic sheath device also includes a proximal collar 4044 configured to maintain a seal between the endoscope and the proximal end of the outer sheath.

[0209]

[0275] FIG 40C shows the endoscope of FIG 40A with the endoscopic sheath device of FIG 40B attached, forming a sealed compartment or region between the outer sheath and the endoscope that can be pressurized by applying a vacuum to collapse the sheath onto the endoscope or applying a positive pressure to expand or inflate the outer sheath. The collar 4044 can be actuated to form an airtight seal 4043. In FIG 40B, the outer sheath of the endoscopic sheath device has a substantially uniform diameter along its length from proximal to distal. In some cases, it may be advantageous to have regions of different radial diameters and / or regions of different elasticity along its length so that different regions can be inflated differently.

[0210]

[0276] For example, Figs. 41A-41C show examples of endoscopic sheath devices with different configurations of the outer sheath. These different configurations can be particularly useful during inflation. The soft outer sheath portion of the endoscopic sheath device may have a constant cross section as shown in Fig. 40B. Alternatively, the cross section may be nominally larger than the shaft so that it can slide easily through a narrow annular gap. Any of these outer sheaths can be relatively resilient so that a vacuum can be drawn to expand it (e.g., by sealing it as a rigid tube at both ends with an annular space between them that is then evacuated). Once in place, e.g., with the sheath fully positioned over the shaft, the vacuum can be released so that the sheath recoils elastically and then snugs against the shaft. This is shown in Fig. 41A, which shows an outer sheath that has a constant diameter but is held within an outer, e.g., rigid tube. A vacuum can then be drawn into this space to expand the outer sheath upon deployment. In Fig. 41A, the outer sheath 4027 has a constant width. Once in place, the vacuum can be released and the outer sheath can resiliently return to its released size to conform snugly to the shaft.

[0211]

[0277] In some embodiments, the outer sheath may be substantially larger than the shaft (e.g., 1.5 times larger diameter, 2 times larger diameter, 2.5 times larger diameter, 3 times larger diameter, 3.5 times larger diameter, 4 times larger diameter, 5 times larger diameter, etc.). This configuration may be advantageous after being inflated by positive pressure as it may help position, stabilize, anchor, and / or guide the device within anatomy, particularly tortuous anatomy.

[0212]

[0278] In some embodiments (see, e.g., FIG. 41B), the outer sheath can have a tapered or stepped cross-section that is larger at the proximal end. This type of cross-section can facilitate removal, i.e., inverting upon itself upon removal, thereby "trapping" biological debris on the outside and making its disposal cleaner and easier. This can also facilitate installation and sanitary removal of a replaceable sheath. In some embodiments, the endoscopic sheath device can be configured to seal at both ends so that a vacuum can then be drawn against the elongate shaft.

[0213]

[0279] In any of these methods and apparatus, the sheath can be placed over the device, either as a manual device (scope or catheter) or as a robotic device (remotely operated device).

[0214]

[0280] In use, the outer sheath may be a snug fit or loose fit over the endoscope shaft. The outer sheath may be a sealed structure after mating with other structures, including the shaft or installation tool. At the proximal end, the outer sheath may have a port that allows access to its (annular) space. Positive or negative pressure may be applied through this space. When negative pressure is applied, the sheath will be sucked down to the underlying structure so that it will vacuum interface with the structure. If the device is to be manually operated, this allows the face to be better gripped by hand and allows the sheath and underlying shaft to move as one. If the sheath is not evacuated, such movement will be difficult as the sheath will move and shear relative to the elongate shaft when movement is attempted.

[0215]

[0281] During installation, the sheath can be mated with an installation tool. Once mated, a vacuum can be drawn in the annular space between them, causing the sheath to elastically expand. This gives the sheath a larger inner diameter so that it can expand more easily onto the shaft. After the sheath is loaded onto the shaft, the vacuum is released and the diameter elastically shrinks to fit snugly onto the shaft.

[0216]

[0282] In any of these methods and devices, the sheath can be inflated with positive pressure. Once inflated, the sheath can contact the biological structure. For example, the sheath can contact the inside of the lung, the inside of the gastrointestinal tract, etc. This can work in other biological structures as well, including but not limited to gynecological, abdominal, orthopedic, vascular, neurovascular, and peripheral vascular. This application of positive pressure and its interaction with the biological structure creates a bond stability. This contact can be localized (i.e., as a single balloon), or in multiple locations (continuous balloon), or over a long length (constant diameter interaction, tapered interaction, etc.).

[0217]

[0283] The endoscopic sheath device can be packaged in multiple configurations, including straight and rolled. These packaging configurations can be configured to reduce installation difficulty and time, and to reduce packaging, shipping and sterilization costs. The endoscopic sheath device can be configured for easy removal. For example, after use, the exterior surface of the device may be contaminated with stool, blood and other bodily fluids. This can be difficult or messy to handle. The device can be configured to evert (i.e., roll back on itself). Doing so shortens the effective sheath length (inverting the wall and folding it in half, thereby shortening the length in half). Inversion also serves to have the exterior (contaminated) side facing inward with the clean side facing outward so that it can be handled removably in a more hygienic manner. For example, FIG. 44 shows an everting sheath 4407 configured for easy removal.

[0218]

[0284] In some embodiments, it may be important to have the sheath electronically registered with the base device. This registration may transmit information including information regarding device type, operation, manufacture, certification, sterility, and legality of embedded use. A reader and / or transmitter (e.g., RFID) may be located, for example, at the base. The sheath proximal collar may register or transmit information because it is in close proximity.

[0219]

[0285] FIG. 42 shows one embodiment of an outer sheath 4227 that has been evacuated to an endoscope 4201. The sheath is sealed onto the endoscope shaft due to a vacuum 4007 applied between the sheath and shaft. Application of negative pressure (vacuum) draws the outer sheath inward, against the endoscope. Application of a vacuum (e.g., between the shaft and sheath) causes the soft sheath to shrink fit onto the soft shaft of the endoscope. For manual endoscopes, this can improve the ability to manually grasp and control the shaft by preventing both longitudinal and torsional slippage between the outer sheath and shaft. The vacuum can be released to remove the sheath. Measurement of the presence or absence of vacuum leaks can also be used to determine if the sheath is leak-free.

[0220]

[0286] 43A-B illustrate the application of positive pressure. FIG. 43A illustrates an embodiment of an endoscopic sheath device having a single distal "balloon" shape when the outer sheath 4227' is inflated. FIG. 43B illustrates an embodiment of an endoscopic sheath device having multiple annular balloon shapes. In these embodiments, the sheath 4227'' can inflate similarly to a balloon when positive pressure is applied. Pressurized gas or fluid can be pumped into the space between the sheath 4227', 4227'' and the endoscope shaft 4201. A variety of inflation balloon profiles can be used, including, but not limited to, a single distal balloon shape, multiple annular ring balloon shapes, helical balloon shapes, constant diameters, etc. The inflation balloons can help stabilize and center the device within the biological lumen.

[0221]

[0287] Also described herein are soft devices (endoscopes, catheters) that can go deep into anatomy (e.g., lung periphery, gastrointestinal tract). However, when they are small enough and flexible enough to do this, kinematic problems become apparent, including looping, prolapse, "tramtracking," and buckling. There are many ways to overcome these problems, including by reducing clinical expectations, changing patient position, pushing against local anatomy, and attempting to solve this problem by using steering, sheaths, and overtubes, but in many cases (e.g., in the lung), the overtube may become too large to advance. This type of buckling is shown in the lung, showing the buckling of the endoscope as it attempts to reach the lung periphery. The use of a sheath, coupled with the use of positive pressure to inflate the sheath, can help eliminate this problem. As shown in FIGS. 45A-46B, the device can have an outer sheath 4607 that passes over the device, and an overtube 4674. The accordion-like zigzag areas on the sheath indicate stretcher material.

[0222]

[0288] At the point where the anatomy is too tight to advance the overtube 4674 any further without pulling back on the scope, the sheath can be pressurized (by applying positive pressure) against the area between the sheath and the endoscope / overtube. Inflating the sheath can have two effects: it stabilizes the outer diameter of the device through localized anatomy contact, and it turns the device into a pneumatic or hydraulic cylinder, thereby facilitating tip advancement through the application of positive pressure. This can minimize the risk of buckling of pushing a very flexible scope forward from its proximal end. This is shown in Figures 46A and 46B.

[0223]

[0289] The overtube 4674 (e.g., the outer endoscope of a nested pair of scopes) can advance the device through tight anatomy without pulling it back by further inflating the sheath, but keep the device stationary. This allows the sheath 4607' to be inflated out like a balloon and used as an anchor against the anatomy, after which the device becomes similar to a more stable guidewire that can guide the overtube forward without being pulled back itself. This is shown in FIG. 47. Once the clinician has reached the anatomical target, the clinician can choose to "lock" the device in place, which can be similar to the technique of inflating a distal balloon. Alternatively, the clinician can choose to inflate the sheath 4807 for an even longer length to gain traction over further anatomy, as shown in FIG. 48. Positive pressure can be applied by gas or by liquid (e.g., saline).

[0224]

[0290] These devices can be used with side-mounted ultrasound as shown in Figure 49. Thus, the outer sheath inflated with saline can act as a saline filled balloon when combined with ultrasound, which can help locate targets that cannot be seen visually. Figure 49 shows a side-mounted ultrasound device that includes an ultrasound transducer 4906 within an inflated outer sheath 4907. Installing the handle

[0225]

[0291] Any of the endoscopic sheath apparatus (e.g., endoscopic sheath devices) described herein can include a mounting handle for mounting and / or removing the apparatus from an endoscope. For example, FIG. 50A shows an endoscopic sheath apparatus including a cap 5027 configured to securely couple to an endoscope, an outer sheath 5002, 5002′, a pair of inner sheaths 5015, 5017, and a mounting handle 5081.

[0226]

[0292] In general, the placement handle is configured to hold or gather the soft / compressible outer sheath in a compact, easy to manipulate form while allowing easy placement of one or more inner sheath members. The placement handle can include a body, which is cylindrical in FIGS. 50A-50C but can use any suitable shape, and an inner chamber into which the outer sheath 5002′ can be gathered. The outer sheath can be gathered by pleating, folding (e.g., accordion folding, bellows folding, etc.), crinkling, etc. The outer sheath can be gathered to leave a passageway through the gathered outer sheath through which the endoscope can be inserted when the inner sheath 5015, 5017 is inserted into the lumen of the endoscope, as shown in FIGS. 51A-51D.

[0227]

[0293] The placement handle 5081 can include an outer gripping area 5087 that can be configured to fit in a user's hand. The placement handle can also include a distal facing cone (or distal funnel) 5088, which can be particularly useful when removing the outer sheath as described in FIGS. 54A-54C. Any of the placement handles described herein can be configured to couple or attach to an endoscope, such as to the proximal end of the endoscope. Thus, in one embodiment, the placement handle can include a coupling at a distal end of the placement handle that is configured to couple with a corresponding fastener on the endoscope. In FIGS. 50A-50C, the coupling 5085 is configured as a BNC type coupling that can engage a pin on the endoscope, although any suitable coupling (and complementary fastener on the endoscope) can be used.

[0228]

[0294] In the illustrated placement handle 5081 embodiment, the placement handle includes an openable window or opening 5083 in an interior chamber that holds a portion of the outer sheath 5002'.

[0229]

[0295] 51A-51D show the attachment of the endoscopic sheath apparatus shown in FIGS. 50A-50C to an endoscope assembly 5100. The endoscope assembly shown in this embodiment includes a pair of nested endoscopes, including an inner endoscope 5103, nested within and slidably connectable to an outer endoscope 5201 (e.g., an overtube). In this embodiment, the inner sheaths 5015, 5017 extending proximally from the endoscopic sheath apparatus are first inserted into a pair of lumens within the endoscope from the distal end of the endoscope as shown in FIG. 51B. The distal end of the endoscope is inserted through the proximal end of the installation handle 5081 and into the lumen of the tubular outer sheath, which is held in a gathered state within the chamber of the installation handle, until the distal end of the endoscope (e.g., inner endoscope 5103) engages with the cap 5027 of the endoscope sheath assembly as shown in FIG. 51C. The user can then pull the placement handle 5081 proximally 5189 such that the outer sheath 5002 is pulled over the endoscope as shown in FIG. 51D. Pulling the placement handle proximally relative to the endoscope advances the outer sheath distally out of the placement handle. In FIG. 51D, the outer sheath is shown to match the outer diameter of the different regions of the inner endoscope 5103 that nest relative to the outer endoscope 5101 (e.g., as when negative pressure is applied between the outer sheath and the endoscope as described above). In any of these devices and methods, the outer sheath can have a uniform diameter that can accommodate the outer diameters of both the inner and outer endoscopes. The same devices and techniques illustrated here can also be used with a single (e.g., non-nested) endoscope.

[0230]

[0296] In Figure 51D, the placement handle 5081 can be coupled to the outer endoscope 5101 by engaging a coupling 5085 with a complementary fastener on the endoscope, as shown in more detail in Figures 52A-52B. As shown in this example, the proximal end of the outer endoscope 5287 includes a fastener 5286 (shown in this example as a pin) that can be engaged with the coupling 5085 (shown in this example as a channel having, for example, a BNC type configuration) of the placement handle. Figure 52B shows the placement handle engaged with the pin of the endoscope. Any suitable coupling can be used (e.g., magnetic, mechanical, etc.).

[0231]

[0297] The endoscopic sheath apparatus described herein can generally be packaged in a ready-to-use state, ready to be mounted on an endoscopy or endoscope assembly. This includes packaging with a mounting handle. The ready-to-use state can include everting and / or compressing the outer sheath (e.g., pleating, folding, crimping, etc.) and / or loading the outer sheath into a mounting handle. For example, FIG. 53 shows an embodiment of an endoscopic sheath apparatus including an everted and compressed outer sheath 5302 (but without a mounting handle in this embodiment), a tip 5327, a proximal base 5335, and a pair of inner sheaths 5315, 5317. The endoscopic sheath apparatus is shown rolled and placed into a packaging material (e.g., box 5366).

[0232]

[0298] As mentioned above, the placement handles described herein may also be useful for removing the endoscopic sheath device from an endoscope. For example, FIGS. 54A-C show removal of the device from the endoscope assembly shown in FIGS. 51A-D. First, the placement handle 5081 may be disengaged from the endoscope proximal end region 5287 and then driven 5490 distally (e.g., by pushing, pulling, etc.) as shown in FIG. 54B. As the placement handle moves distally, the outer sheath is pulled and everted on itself such that contaminants are held between the folded (everted) portions of the outer sheath 5002″ such that only the inner (uncontaminated) portion is exposed proximally. A distal funnel shape 5088 on the placement handle may help collect contaminants and evert the outer sheath 5002.

[0233]

[0299] As mentioned above, the inner sheaths 5015, 5017 can be sealed (e.g., by crimping, heating, etc.) at the proximal end to prevent contamination before the cap is removed and the inner sheath is withdrawn distally, as shown in FIG. 54C. The endoscope sheath assembly can then be discarded. Before removing the endoscope sheath assembly, the assembly can be pressurized to ensure that no leaks have occurred, which could indicate that contamination of the endoscope may have occurred. Production method

[0234]

[0300] Also described herein are methods of making any of these devices. For example, a method of making an endoscopic sheath device configured to prevent contamination of an endoscope is shown generally in FIG. 55. In general, these methods can include sealing a distal end of a tubular inner sheath to an opening through a cap configured to be coupled to a distal end region of an endoscope 5503. Sealing can be done by any suitable technique, including adhesive bonding, laser bonding (welding), and the like. The tubular inner sheath can be inserted into a hole through the cap and sealed by being secured to an outer surface of the inner sheath bonded to the inner diameter of the hole. The tubular inner sheath can be configured to be inserted through a lumen of the endoscope. The distal end region of the tubular outer sheath can then be sealed to the cap 5505, including sealing around the outer circumference of the cap. The tubular outer sheath can be configured to fit over the outer surface of the endoscope. The tubular outer sheath can be sealed to the cap by adhesive bonding and / or welding, and the like. In some embodiments, a gasket or ring (eg, made of an elastomeric material) can be used to seal and secure the tubular outer sheath to the cap.

[0235]

[0301] In some cases, these components may be formed and / or assembled first. For example, as shown in FIG. 55, an optional step may include coating the device, e.g., the inner sheath and / or cap and / or outer sheath, with a material, such as a hydrophilic coating. Specifically, the inner tubular member may be coated with a hydrophilic coating by first coating a flat layer (e.g., a sheet) of material and then forming the tubular inner sheath 5501. In some embodiments, the cap may also be formed. Optionally, in some embodiments, the inner sheath may be reinforced along some (e.g., the distal end) or all of its length to prevent it from collapsing when bent.

[0236]

[0302] Optionally, the assembly including the cap, tubular outer sheath, and tubular inner sheath may be made ready for use or prepared by loading it into a placement handle as described above 5557. For example, the tubular outer sheath may be compressed (e.g., crimped, folded, etc.) into a chamber of the placement handle, with the inner sheath extending proximally from the cap through the placement handle and the outer sheath. The assembly (with or without the placement handle) may be sterilized. Finally, the endoscopic sheath apparatus assembly may be packaged 5559. In one embodiment, the endoscopic sheath apparatus may be packaged in a compact rolled form.

[0237]

[0303] Those skilled in the art will appreciate that any process or method disclosed herein can be modified in many ways. The process parameters and sequence of steps described and / or illustrated herein are provided by way of example only and can be modified as desired. For example, although the steps illustrated and / or described herein may be illustrated or described in a particular order, these steps do not necessarily have to occur in the order illustrated or described.

[0238]

[0304] The various exemplary methods described and / or illustrated herein may omit one or more of the steps described or illustrated herein, or may include additional steps in addition to those disclosed, and the steps of any method disclosed herein may be combined with one or more steps of any other method disclosed herein.

[0239]

[0305] The processors described herein may be configured to perform one or more steps of any of the methods disclosed herein. Alternatively, or in combination, the processors may be configured to combine one or more steps of one or more of the methods disclosed herein.

[0240]

[0306] When a feature or element is referred to herein as being "on" another feature or element, it can be directly on the other feature or element, or there may be intervening features and / or elements. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements. Also, when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, it should be understood that it can be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated are applicable to other embodiments. Those skilled in the art will also recognize that when a structure or feature is referred to as being "adjacent" to another feature, it may have portions that overlap or underlie the adjacent feature.

[0241]

[0307] The terms used herein are for the purpose of describing particular embodiments only and are not intended to limit the invention. For example, as used herein, the singular forms "a," "an," and "the" are intended to include the plural unless the context clearly indicates otherwise. It is further understood that the terms "comprising" and / or "including," as used herein, specify the presence of the described 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 or all combinations of one or more of the associated enumerations and may be abbreviated as " / ."

[0242]

[0308] Spatially relative terms such as "below," "lower," "bottom," "upper," and the like may be used herein to facilitate describing the relationship of one element or feature to another element or feature as depicted in the drawings. It should be understood that these spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the drawings. For example, if the device in the figures were inverted, an element described as being "below" or "below" another element or feature would be oriented "above" that other element or feature. Thus, the illustrative term "below" may encompass both an orientation above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, terms such as "upward," "downward," "vertical," "horizontal," and the like are used herein for descriptive purposes only, unless specifically indicated otherwise.

[0243]

[0309] In this specification, the terms "first" and "second" may be used to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element described below may also be referred to as a second feature / element, and similarly, a second feature / element described below may also be referred to as a first feature / element without departing from the teachings of the present invention.

[0244]

[0310] Throughout this specification and the claims that follow, unless the context requires otherwise, the word "comprise" and variations such as "comprises" and "comprising" mean that various components may be employed together in methods and articles (e.g., devices and compositions and apparatuses that include methods). For example, the term "comprising" should be understood to imply the inclusion of any described elements or steps, but not the exclusion of any other elements or steps.

[0245]

[0311] In general, it will be understood that any of the apparatus and methods described herein are exemplary and that alternatively, all or a subset of the components and / or steps may be excluded and may be expressed as "consisting of" or "consisting essentially of" the various components, steps, subcomponents or substeps thereof.

[0246]

[0312] Unless expressly specified otherwise, including those used in the examples, all numerical values ​​used in the specification and claims may be interpreted as if they were preceded by the term "about" or "approximately" even if the term is not explicitly stated. The phrase "about" or "approximately" may be used when describing a size and / or location to indicate that the stated value and / or location is within a reasonable expected range of values ​​and / or locations. For example, a numerical value may have a value of + / -0.1% of the stated value (or range of values), + / -1% of the stated value (or range of values), + / -2% of the stated value (or range of values), + / -5% of the stated value (or range of values), + / -10% of the stated value (or range of values), etc. Any numerical value provided herein should also be understood to include "about" or "approximately" that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range provided herein is intended to include all subranges contained within that range. Also, when a value is disclosed, it is to be understood that "less than or equal to" that value, "more than or equal to" that value, and possible ranges between the values ​​are also disclosed, as would be understood by one of ordinary skill in the art. For example, if a value "X" is disclosed, "less than or equal to X" and "more than or equal to X" (e.g., where X is a number) are also disclosed. It is also to be understood that data are presented throughout this application in several different formats, and that this data represents endpoints and starting points, and ranges for any combination of the data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is to be understood that greater than, greater than, less than, less than, and equal to 10 and 15 are also considered to be disclosed, as well as between 10 and 15. It is also to be understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0247]

[0313] Although various exemplary embodiments have been described above, any of a number of modifications may be made to the various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which the various method steps described are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be omitted entirely. Optional features of the various device and system embodiments may be included in some embodiments and not included in other embodiments. Thus, the above description has been presented primarily for illustrative purposes and should not be construed as limiting the scope of the invention as described in the claims.

[0248]

[0314] The examples and illustrations contained herein are illustrative and not limiting of specific embodiments in which the subject matter may be practiced. As previously mentioned, other embodiments are available and may be derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Such embodiments of the subject matter of the present invention may be referred to herein, individually or collectively, under the term "invention" for the sole convenience and without any intention of spontaneously limiting the scope of the present application to any single invention or inventive concept when in fact multiple inventions or inventive concepts are disclosed. Thus, although specific embodiments have been shown and described herein, any configuration intended to achieve the same purpose may be substituted for the specific embodiment shown. The present disclosure is intended to cover any modifications or variations of the various embodiments. Combinations of the above embodiments and other embodiments not specifically described herein will be apparent to one of ordinary skill in the art upon reviewing the above description.

Claims

1. 1. An endoscope sheath device configured to prevent contamination of an endoscope, comprising: An outer sheath; a cap sealingly coupled to a distal end of the outer sheath; and one or more inner sheaths each extending within the outer sheath, each inner sheath having one or more internal lumens, each inner sheath further being sealingly coupled to the cap such that the one or more lumens open through the cap.

2. The device of claim 1 , wherein the outer sheath is robustified.

3. The device of claim 1 , wherein the outer sheath has a composite construction.

4. The device of claim 1 , wherein the outer sheath is a dynamically stiffening structure.

5. The device of claim 1 , wherein the outer sheath is shorter than the one or more inner sheaths.

6. The device of claim 1 , wherein the cap is at least partially transparent.

7. The device of claim 1 , wherein the cap includes a transparent region configured to align with a camera of the endoscope.

8. The device of claim 1 , wherein the cap is configured to secure to the distal end of the endoscope.

9. 10. The device of claim 1, wherein the cap is configured to secure to the distal end of the endoscope and includes one or more of a friction fit configured to secure the cap to the distal end of the endoscope, a snap fit configured to secure the cap to the distal end of the endoscope, a magnet configured to secure the cap to the distal end of the endoscope, a bayonet connector configured to secure the cap to the distal end of the endoscope, or a threaded region configured to secure the cap to the distal end of the endoscope.

10. The device of claim 1 , wherein at least one of the one or more inner sheaths comprises a multi-lumen catheter.

11. 11. The device of claim 10, wherein at least one of the one or more inner sheaths is configured to mate with a port adapter to form a separate port in fluid communication with each lumen of the multi-lumen catheter.

12. 2. The device of claim 1, wherein at least one of the one or more inner sheaths includes a multi-lumen catheter having a plurality of side openings at a proximal end region of the inner sheath, each side opening opening into an internal lumen of the multi-lumen catheter.

13. 2. The device of claim 1, wherein at least one of the one or more inner sheaths includes a multi-lumen catheter having a plurality of radially spaced side openings at a proximal end region of the inner sheath, each side opening opening into a lumen of the multi-lumen catheter.

14. The device of claim 1 , wherein at least one of the one or more inner sheaths includes a working channel liner having a working channel lumen.

15. The device of claim 1 , further comprising a proximal fastener on the outer sheath configured to secure the outer sheath to an exterior surface of the endoscope.

16. The device of claim 15 , wherein the proximal fastener comprises an elastic fastener.

17. The device of claim 15 , wherein the proximal fastener comprises a sealing fastener.

18. The device of claim 1 , wherein the outer sheath is flexible and configured to form an outer fluid-impermeable contamination barrier.

19. 10. The device of claim 1, wherein the cap includes a substantially cylindrical mating surface configured to mate with the distal end of the endoscope when compressed from an oval resting cross-sectional configuration to a substantially circular mating cross-sectional configuration.

20. The device of claim 1 , wherein the one or more inner sheaths include a multi-lumen inner sheath and a working channel liner, each configured to form an inner fluid-impermeable contamination barrier.

21. 10. The device of claim 1, further comprising a crimping region at a proximal end region of the inner sheath configured to be crimped to seal the one or more lumens after use to prevent contamination during removal of the one or more inner sheaths from within a lumen of the endoscope.

22. 22. The device of claim 21, wherein the crimped area is configured to be heat sealed and / or pressure sealed.

23. The device of claim 1 , wherein the inner lumen of the one or more inner sheaths comprises a hydrophilic coating.

24. 1. An endoscope sheath device configured to prevent contamination of an endoscope, comprising: a cap configured to couple to a distal end of an endoscope; an outer sheath sealingly coupled to the cap at a distal end; and one or more inner sheaths extending within the outer sheath, each inner sheath being sealingly coupled to the cap at a distal end and opening therethrough.

25. 1. An endoscope sheath device configured to prevent contamination of an endoscope, comprising: a soft outer sheath configured to extend over the endoscope to form a fluid-impermeable outer contamination barrier; a cap sealingly coupled to a distal end of the outer sheath and configured to mate with a distal end of the endoscope; and one or more inner sheaths, each having one or more lumens, each of the one or more inner sheaths extending within the soft outer sheath, each of the one or more inner sheaths configured to pass through a lumen of the endoscope to form a fluid-impermeable inner contamination barrier, each of the one or more inner sheaths sealingly coupled to the cap such that the one or more internal lumens are open through the cap.

26. 1. An endoscope sheath device configured to prevent contamination of an endoscope, comprising: a soft outer sheath configured to fit over the endoscope; a cap sealingly coupled to a distal end of the outer sheath; one or more inner sheaths, each extending within the outer sheath and configured to fit within a lumen extending through the endoscope, each inner sheath having one or more internal lumens, each inner sheath further being sealingly coupled to the cap such that the one or more internal lumens open through the cap; and a sealing region at a proximal end of the one or more inner sheaths configured to be sealed after use to prevent contamination during removal of the one or more inner sheaths from within the lumen extending through the endoscope.

27. 1. An endoscope sheath device configured to prevent contamination of an endoscope, comprising: An outer sheath; a cap sealingly coupled to a distal end of the outer sheath; an inner sheath including a multi-lumen catheter extending within the outer sheath, the inner sheath being sealingly coupled to the cap such that a lumen of the multi-lumen catheter is open through the cap; and a sealing region at a proximal end region of the inner sheath configured to seal the lumen of the multi-lumen catheter after use to prevent contamination during removal of the inner sheath from within the lumen of the endoscope.

28. 28. The endoscopic sheath device of claim 27, further comprising a plurality of radially spaced side openings at a proximal end region of the inner sheath, each side opening into an interior lumen of the multi-lumen catheter.

29. 28. The endoscopic sheath device of claim 27, wherein the proximal end region of the inner sheath is configured to mate with a port adapter to form a separated port in fluid communication with each lumen of the multi-lumen catheter.

30. 28. The device of claim 27, wherein the sealed region comprises a crimped region.

31. 28. The device of claim 27, wherein the sealed area is configured to be heat sealed.

32. 28. The device of claim 27, wherein the enclosed area is configured to be pressure sealed.

33. 30. The device of claim 27, wherein the outer sheath is robustified.

34. 30. The device of claim 27, wherein the outer sheath has a composite construction.

35. 30. The device of claim 27, wherein the outer sheath is a dynamically stiffening structure.

36. 30. The device of claim 27, wherein the outer sheath is shorter than the inner sheath.

37. 28. The device of claim 27, wherein the cap is at least partially transparent.

38. 30. The device of claim 27, wherein the cap includes a transparent region configured to align with a camera of the endoscope.

39. 28. The device of claim 27, wherein the cap is configured to secure to the distal end of the endoscope.

40. 28. The device of claim 27, wherein the cap is configured to secure to the distal end of the endoscope and includes at least one of a friction fit portion configured to secure the cap to the distal end of the endoscope, a snap fit portion configured to secure the cap to the distal end of the endoscope, a magnet configured to secure the cap to the distal end of the endoscope, a bayonet connector configured to secure the cap to the distal end of the endoscope, or a threaded region configured to secure the cap to the distal end of the endoscope.

41. 30. The device of claim 27, further comprising a second inner sheath comprising a working channel liner having a working channel lumen.

42. 30. The device of claim 27, further comprising a proximal fastener on the outer sheath configured to secure the outer sheath onto an exterior surface of the endoscope.

43. 43. The device of claim 42, wherein the proximal fastener comprises an elastic fastener.

44. The device of claim 42 , wherein the proximal fastener comprises a sealing fastener.

45. 28. The device of claim 27, wherein the outer sheath is flexible and configured to form an outer fluid-impermeable contamination barrier.

46. 30. The device of claim 27, wherein the cap includes a cylindrical mating surface configured to mate with a distal end of the endoscope when compressed from an oval resting cross-sectional configuration to a circular mating cross-sectional configuration.

47. 1. An endoscope sheath device configured to prevent contamination of an endoscope, comprising: A flexible outer sheath; a cap sealingly coupled to a distal end of the outer sheath; an inner sheath including a multi-lumen catheter extending within the outer sheath, the inner sheath being sealingly coupled to the cap such that a lumen of the multi-lumen catheter is open through the cap, and further configured to extend through a lumen of the endoscope; and a crimping region at a proximal end region of the inner sheath configured to be crimped to seal the one or more lumens after use to prevent contamination during removal of the inner sheath from within the lumen of the endoscope.

48. 1. An endoscope sheath device configured to prevent contamination of an endoscope, comprising: a soft outer sheath configured to extend over the endoscope; a cap sealingly coupled to a distal end of the outer sheath; an inner sheath including a multi-lumen catheter extending within the outer sheath, the inner sheath being sealingly coupled to the cap such that the lumen of the multi-lumen catheter is open through the cap, and further configured to extend through a lumen of the endoscope; a plurality of radially spaced side openings at a proximal end region of the inner sheath, each side opening into an interior lumen of the multi-lumen catheter; and a crimping region at a proximal end region of the inner sheath configured to be crimped to seal the one or more lumens after use to prevent contamination during removal of the inner sheath from within the lumen of the endoscope.

49. 1. A method of making an endoscopic sheath device configured to prevent contamination of an endoscope, comprising: sealing a distal end region of a tubular inner sheath against an opening through a cap configured to couple to a distal end region of the endoscope, the tubular inner sheath being configured to be inserted through a lumen of the endoscope; and sealing a distal end region of a tubular outer sheath to the cap, the tubular outer sheath being configured to fit over an exterior surface of the endoscope.

50. 50. The method of claim 49, further comprising the steps of coating a sheet of inner sheath material with a hydrophilic coating and forming the sheet of inner sheath material into a tubular shape to form a tubular inner sheath such that the hydrophilic coating extends into a lumen of the tubular inner sheath.

51. 51. The method of claim 50, wherein the hydrophilic coating is applied to a substrate as an additive.

52. 51. The method of claim 50, wherein the hydrophilic coating is applied as a fluid to the interior surface of the tubular inner sheath.

53. 50. The method of claim 49, further comprising the step of sealing a distal end region of a second tubular inner sheath to a second opening extending through the cap, the second tubular inner sheath comprising a multi-lumen tube.

54. 50. The method of claim 49, wherein the tubular inner sheath includes a working channel liner having a working channel lumen.

55. 50. The method of claim 49, further comprising reinforcing the tubular inner sheath such that the distal end region of the tubular inner sheath is prevented from collapsing upon bending.

56. 56. The method of claim 55, wherein the reinforcing step includes adding a reinforcing coil.

57. 56. The method of claim 55, wherein reinforcing comprises adding a reinforcement to the distal end region.

58. 50. The method of claim 49, wherein sealing the distal end region of the tubular inner sheath to the cap and sealing the distal end region of the tubular outer sheath to form a continuous fluid-impermeable contamination barrier.

59. 50. The method of claim 49, further comprising packaging the endoscopic sheath device in a rolled configuration.

60. 50. The method of claim 49, further comprising forming a sealing region at a proximal end region of the inner sheath configured to be sealed to seal the one or more lumens after use to prevent contamination during removal of the inner sheath from within a lumen of the endoscope.

61. 50. The method of claim 49, further comprising the step of stiffening the tubular outer sheath.

62. 50. The method of claim 49, wherein the tubular outer sheath is shorter than the tubular inner sheath.

63. 50. The method of claim 49, wherein the cap is at least partially transparent.

64. 50. The method of claim 49, wherein the cap includes a cylindrical mating surface having an oval configuration at rest, the cylindrical mating surface being configured to be compressed to assume a circular cross-sectional configuration to fit over a distal end of an endoscope.

65. 50. The method of claim 49, further comprising mounting a proximal fastener on the tubular outer sheath configured to secure the tubular outer sheath to an exterior surface of the endoscope.

66. 1. A method of making an endoscopic sheath device configured to prevent contamination of an endoscope, comprising: coating a layer of inner sheath material with a hydrophilic coating and laminating the inner sheath material within the tubular inner sheath such that the hydrophilic coating extends into the lumen of the tubular inner sheath; sealing a distal end region of the tubular inner sheath against an opening through a cap configured to couple to a distal end region of the endoscope, the tubular inner sheath being configured to be inserted through a lumen of the endoscope; sealing a distal end region of a tubular outer sheath to the cap, the tubular outer sheath configured to fit over an exterior surface of the endoscope; The method, wherein the tubular outer sheath, the cap and the tubular inner sheath form a continuous, fluid-impermeable contamination barrier.

67. 1. A method of making an endoscopic sheath device configured to prevent contamination of an endoscope, comprising: reinforcing the tubular inner sheath such that a distal end region of the tubular inner sheath is prevented from collapsing upon bending; sealing a distal end region of the inner sheath against an opening through a cap configured to couple to a distal end region of the endoscope, the inner sheath being configured to be inserted through a lumen of the endoscope; sealing a distal end region of a tubular outer sheath to the cap, the outer sheath configured to fit over an exterior surface of the endoscope; The method, wherein the outer sheath, cap and inner sheath form a continuous, fluid-impermeable contamination barrier.

68. 1. An endoscope sheath device configured to prevent contamination of an endoscope, comprising: An outer sheath; a cap sealingly coupled to a distal end of the outer sheath, the cap being at least partially transparent and configured to couple to a distal end of the endoscope; and one or more light sources on the cap configured to project light distal to the cap.

69. 69. The device of claim 68, further comprising one or more inner sheaths each extending within the outer sheath, each inner sheath having one or more internal lumens, and further wherein each inner sheath is sealingly coupled to the cap such that the one or more internal lumens are open through the cap.

70. 70. The device of claim 68, wherein the one or more light sources comprise light emitting diodes (LEDs).

71. 70. The device of claim 68, wherein the one or more light sources include a red light source, a green light source, and a blue light source.

72. 70. The device of claim 68, wherein the one or more light sources comprise a plurality of light sources disposed at least partially around a periphery of the cap.

73. 70. The device of claim 68, further comprising a plurality of wires coupled to the one or more light sources on the cap and extending over or within the outer sheath.

74. 66. The device of claim 65, further comprising a plurality of wires coupled to the one or more light sources on the cap and extending on or within an inner sheath that extends into the outer sheath, each inner sheath having one or more internal lumens, and each inner sheath is further sealedly coupled to the cap such that the one or more internal lumens are open through the cap.

75. 69. The device of claim 68, further comprising one or more electrical contacts on an inner surface of the cap, the one or more electrical contacts in electrical communication with the one or more light sources.

76. 69. The device of claim 68, wherein the cap includes a lens region configured to be positioned over a camera of the endoscope.

77. 1. An endoscope sheath device configured to prevent contamination of an endoscope, comprising: a flexible, tubular outer sheath; a cap sealingly coupled to a distal end of the outer sheath, the cap being at least partially transparent; a tubular, elongate, inner sheath extending within the outer sheath and having one or more internal lumens, a distal end region of the tubular, elongate, inner sheath being sealingly coupled to the cap such that the one or more internal lumens of the tubular, elongate, sheath are open through the cap; and one or more light sources on the cap configured to project light distal to the cap.

78. 1. An endoscope sheath device configured to prevent contamination of an endoscope, comprising: a flexible, tubular outer sheath; a cap sealingly coupled to a distal end of the outer sheath, the cap being at least partially transparent; a tubular, elongate, inner sheath extending within the outer sheath and having one or more internal lumens, a distal end region of the tubular, elongate, inner sheath being sealingly coupled to the cap such that the one or more internal lumens of the tubular, elongate, inner sheath are open through the cap; one or more light sources on the cap configured to project light distal to the cap; The endoscopic sheath device includes one or more electrical contacts on an inner surface of the cap, the one or more electrical contacts being in electrical communication with the one or more light sources.

79. 1. An inner sheath device configured to prevent contamination of an endoscope, comprising: a rigidified outer sheath configured to extend over the endoscope, the rigidified outer sheath including a stiffening layer including a plurality of crossing strands and a compression layer configured to be actuated to apply a force to the stiffening layer to stiffen the rigidified outer sheath from a flexible configuration to a rigid configuration; a cap configured to couple to a distal end of the endoscope, the cap being sealingly coupled to a distal end region of the outer sheath; an inner sheath extending within the rigidified outer sheath and configured to extend through a lumen of the endoscope, the inner sheath having one or more internal lumens, the inner sheath being sealingly coupled to the cap such that the one or more internal lumens of the inner sheath are open through the cap.

80. 80. The device of claim 79, wherein the stiffening layer comprises a plurality of strands that cross over one another.

81. 81. The device of claim 80, wherein the plurality of strands comprises one or more of a braid, a knit, a woven, a chopped, randomly dispersed and / or randomly oriented fibers, or an interlocking.

82. 80. The device of claim 79, wherein the compressible layer comprises a bladder.

83. 80. The device of claim 79, further comprising a pressure port coupled to the stiffened outer sheath and configured to receive pressure to actuate the compressible layer.

84. 80. The device of claim 79, wherein the rigidifying outer sheath is configured to stiffen by application of positive pressure.

85. 80. The device of claim 79, wherein the stiffening outer sheath is configured to stiffen by application of negative pressure.

86. 80. The device of claim 79, wherein the cap is at least partially transparent.

87. 1. An endoscope sheath device configured to prevent contamination of an endoscope, comprising: a rigidified outer sheath configured to extend over the endoscope, the rigidified outer sheath including a stiffening layer including a plurality of crossing strands and a compression layer configured to be actuated to apply a force to the stiffening layer to stiffen the rigidified outer sheath from a flexible configuration to a rigid configuration; a cap sealingly coupled to a distal end region of the outer sheath and configured to engage a distal end of the endoscope; an inner sheath extending within the rigidified outer sheath and configured to extend through a lumen of the endoscope, the inner sheath sealingly coupled to the cap such that it opens through the cap.

88. 1. An endoscope sheath device configured to prevent contamination of an endoscope, comprising: a cap configured to couple to a distal end of the endoscope; a soft outer sheath configured to extend over the endoscope, a distal end region of the outer sheath being sealingly coupled to the cap; a tubular inner sheath configured to be inserted through a lumen of the endoscope, the tubular inner sheath extending proximally from the cap and into the outer sheath, a distal end region of the tubular inner sheath sealingly joined to the cap such that a lumen of the tubular inner sheath is open through the cap, and further, the distal end region of the tubular inner sheath is reinforced to prevent the tubular inner sheath from collapsing when bent.

89. 90. The device of claim 88, wherein the distal end region of the tubular inner sheath includes a reinforcing coil.

90. 90. The device of claim 88, wherein only the distal end region of the tubular inner sheath is reinforced.

91. 90. The device of claim 88, further comprising a second tubular inner sheath sealingly coupled to the cap and configured to be inserted through a lumen of the endoscope, the second tubular inner sheath extending proximally from the cap and into the outer sheath.

92. 92. The device of claim 91, wherein the second tubular inner sheath comprises a multi-lumen catheter.

93. 92. The device of claim 91, wherein the second tubular inner sheath is unreinforced.

94. 90. The device of claim 88, wherein the tubular inner sheath includes a working channel liner having a working channel lumen.

95. 95. The device of claim 94, wherein the working channel lumen comprises a hydrophilic coating.

96. 95. The device of claim 94, wherein the soft outer sheath, cap and tubular inner sheath form a fluid-impermeable contamination barrier to prevent contamination of the endoscope.

97. 95. The device of claim 94, wherein the cap is at least partially transparent.

98. 1. An endoscope sheath device configured to prevent contamination of an endoscope, comprising: a cap configured to couple to a distal end of the endoscope; a soft outer sheath configured to extend over the endoscope, a distal end region of the outer sheath being sealingly coupled to the cap; a tubular inner sheath including a working channel liner configured to be inserted through a lumen of the endoscope, the tubular inner sheath extending proximally from the cap into the outer sheath, a distal end region of the tubular inner sheath sealingly coupled to the cap such that a lumen of the tubular inner sheath is open through the cap, and further, the distal end region of the tubular inner sheath is reinforced to prevent the tubular inner sheath from collapsing upon bending; An endoscope sheath device, wherein the soft outer sheath, cap and tubular inner sheath form a fluid-impermeable contamination barrier to prevent contamination of the endoscope.

99. 1. An endoscope sheath device configured to prevent contamination of an endoscope, comprising: a cap configured to couple to a distal end of the endoscope; a soft outer sheath configured to extend over the endoscope, a distal end region of the outer sheath being sealingly coupled to the cap; a first tubular inner sheath including a working channel liner configured to be inserted through a lumen of the endoscope, the first tubular inner sheath extending proximally from the cap and into the outer sheath, a distal end region of the tubular inner sheath sealingly coupled to the cap such that a lumen of the tubular inner sheath is open through the cap, and further, the distal end region of the tubular inner sheath is reinforced to prevent the tubular inner sheath from collapsing when bent; a second tubular inner sheath sealingly coupled to the cap and including a multi-lumen catheter configured to be inserted through a lumen of the endoscope, the second tubular inner sheath extending proximally from the cap and into the outer sheath; An endoscope sheath device, wherein the soft outer sheath, the cap and the first and second tubular inner sheaths form a fluid-impermeable contamination barrier to prevent contamination of the endoscope during use.

100. 1. An endoscopic sheath device, comprising: an outer sheath configured to extend over the endoscope; an inner sheath configured to extend within a lumen of the endoscope and having one or more lumens; a cap configured to couple to a distal end of the endoscope, a distal end region of the outer sheath sealed against the cap, and a distal end region of the inner sheath sealed against the cap such that the one or more lumens of the inner sheath are open through the cap; An endoscopic sheath device, wherein the cap is configured to be removed by squeezing two sides of the cap.

101. 101. The device of claim 100, wherein the cap includes a cylindrical mating surface configured to mate with a distal end of the endoscope when compressed from an oval resting cross-sectional configuration to a circular mating cross-sectional configuration.

102. 102. The device of claim 101, further comprising a stress relief cut out area configured to reduce the force required to transition the cylindrical mating surface to the circular mating cross section.

103. 101. The device of claim 100, wherein the cap includes one or more of a snap fit, a friction fit, a magnetic coupling, a bayonet connector, or a threaded region.

104. 101. The device of claim 100, further comprising a latch connector configured to secure the cap to the distal end region of the endoscope.

105. 105. The device of claim 104, wherein the latch connector includes an opening in the cap configured to engage with a protrusion on the distal end region of the endoscope.

106. 101. The device of claim 100, wherein the cap is at least partially transparent.

107. 1. An endoscopic sheath device, comprising: a tubular outer sheath configured to extend over an endoscope; a tubular inner sheath configured to extend within a lumen of the endoscope and having one or more lumens; a cap configured to couple to a distal end of the endoscope, the distal end region of the tubular outer sheath being sealed against the cap and the distal end region of the inner sheath being sealed against the cap such that the one or more lumens of the tubular inner sheath are open through the cap, the cap including a cylindrical mating surface configured to mate with the distal end of the endoscope when the cap is compressed from an oval resting cross-sectional configuration to a circular mating cross-sectional configuration; a latch connector configured to secure the cap to the distal end region of the endoscope; An endoscope sheath device, wherein the soft outer sheath, the cap and the first and second tubular inner sheaths form a fluid-impermeable contamination barrier to prevent contamination of the endoscope during use.

108. 1. An endoscopic sheath device, comprising: a tubular outer sheath configured to extend over an endoscope; a first tubular inner sheath configured to extend within a first lumen of the endoscope, the first tubular inner sheath having one or more lumens; a second tubular inner sheath configured to extend within a second lumen of the endoscope; a cap configured to couple to a distal end of the endoscope, a distal end region of the tubular outer sheath sealed against the cap, and a distal end region of each of the first inner sheath and the second inner sheath sealed against the cap such that the one or more lumens of the tubular inner sheath are open through the cap, the cap including a cylindrical mating surface configured to mate with the distal end of the endoscope when the cap is compressed from an oval resting cross-sectional configuration to a circular mating cross-sectional configuration; a latch connector configured to secure the cap to the distal end region of the endoscope; An endoscope sheath device, wherein the soft outer sheath, the cap and the first and second tubular inner sheaths form a fluid-impermeable contamination barrier to prevent contamination of the endoscope during use.

109. 1. An endoscope system including a fluid-impermeable contamination barrier for preventing contamination of an endoscope, comprising: an endoscope having a lumen and a handle; an endoscope sheath device; The endoscope sheath device comprises: an outer sheath configured to extend over the endoscope; an inner sheath including one or more lumens and configured to extend through the lumens of the endoscope; and a cap configured to couple to a distal end of the endoscope, the distal end region of the outer sheath being sealed against the cap, and the distal end region of the inner sheath being sealed against the cap such that one or more lumens of the endoscope inner sheath are open through the cap; The endoscope system comprises:

1. An endoscopic system comprising: a manifold block removably coupled to the handle of the endoscope, the manifold block including one or more valves in fluid communication with the lumens of the endoscope, the inner sheath configured to engage with the manifold block such that the one or more valves control the passage of fluid through the one or more lumens of the inner sheath.

110. 110. The system of claim 109, wherein the inner sheath comprises a multi-lumen catheter.

111. 111. The system of claim 110, further comprising a port adapter configured to mate with the multi-lumen catheter to form separate ports in fluid communication with each lumen of the multi-lumen catheter.

112. 110. The system of claim 109, further comprising a sealing device configured to seal the one or more lumens of the inner sheath.

113. 110. The system of claim 109, wherein the endoscopic sheath device further includes a second outer sheath configured to extend through a second lumen of the endoscope, and a distal end region of the second inner sheath is sealed against the cap such that one or more lumens of the second inner sheath are open through the cap.

114. 114. The system of claim 113, wherein the manifold block includes a lumen connection configured to engage the second lumen of the inner sheath.

115. 110. The system of claim 109, wherein the manifold block is disposable.

116. The system of claim 109, wherein the manifold block further includes an umbilical connecting the one or more valves of the manifold block to one or more connectors configured to couple to one or more of a source of irrigation fluid, a source of air, and a source of vacuum.

117. 1. A system including an elongated outer tube for use with an inner endoscope in a telescopic configuration, comprising: an elongated outer tube including an outer tube lumen; an outer sheath coupled at a first end region to a proximal end region of the elongate outer tube; a cap sealingly coupled to the second end of the outer sheath; an inner sheath having one or more inner sheath lumens and extending within the outer sheath and into an outer tube lumen, the inner sheath being sealingly coupled to the cap such that the one or more inner sheath lumens of the inner sheath open through the cap.

118. 118. The system of claim 117, wherein the cap is configured to couple to a distal end of the inner endoscope and the inner sheath is configured to extend through a lumen of the inner endoscope.

119. 118. The system of claim 117, wherein the elongate outer tube is configured to be selectively stiffened.

120. 119. The system of claim 118, wherein the elongate outer tube is configured to be selectively stiffened by application of positive or negative pressure.

121. The system of claim 117, further comprising a crimping region at a proximal end region of the inner sheath configured to be crimped to seal the one or more lumens after use to prevent contamination during removal of the inner sheath from within the lumen of the endoscope.

122. 122. The device of claim 121, wherein the crimped area is configured to be heat sealed.

123. 122. The device of claim 121, wherein the crimped area is configured to be pressure sealed.

124. 118. The device of claim 117, wherein the outer sheath is robustified.

125. 118. The device of claim 117, wherein the outer sheath has a composite construction.

126. 118. The device of claim 117, wherein the outer sheath is shorter than the inner sheath.

127. 118. The device of claim 117, wherein the cap is at least partially transparent.

128. 118. The device of claim 117, wherein the cap includes a transparent region configured to align with a camera of the endoscopic sheath device.

129. 118. The device of claim 117, wherein the cap is configured to be secured to the distal end of the endoscope.

130. 118. The device of claim 117, wherein the cap is configured to secure to the distal end of the endoscope and includes one or more of a friction fit portion configured to secure the cap to the distal end of the endoscope, a snap fit portion configured to secure the cap to the distal end of the endoscope, a magnet configured to secure the cap to the distal end of the endoscope, a bayonet connector configured to secure the cap to the distal end of the endoscope, or a threaded region configured to secure the cap to the distal end of the endoscope.

131. 118. The device of claim 117, wherein the inner sheath is less flexible than the outer sheath.

132. 118. The device of claim 117, further comprising a second inner sheath comprising a working channel liner having a working channel lumen.

133. 118. The device of claim 117, further comprising a proximal fastener on the outer sheath configured to secure the outer sheath to an exterior surface of the endoscope.

134. 134. The device of claim 133, wherein the proximal fastener comprises an elastic fastener.

135. 134. The device of claim 133, wherein the proximal fastener comprises a sealing fastener.

136. 118. The device of claim 117, wherein the outer sheath is flexible and configured to form an outer fluid-impermeable contamination barrier.

137. 118. The device of claim 117, wherein the cap includes a cylindrical mating surface configured to mate with the distal end of the endoscope when compressed from an oval resting cross-sectional configuration to a circular mating cross-sectional configuration.

138. 1. A method of installing a sanitary sheath on an endoscope, comprising the steps of: inserting an inner sheath through a lumen of the endoscope from a distal end to a proximal end such that one or more inner sheath lumens extend through the endoscope from the distal end to the proximal end; positioning an outer sheath over the endoscopic sheath device such that the outer sheath extends proximally from the distal end; and attaching a cap to the distal end of the endoscope, the outer sheath being sealingly connected to the cap and the inner sheath being sealingly connected to the cap such that the inner sheath lumen is open through the cap.

139. 139. The method of claim 138, wherein the inner sheath comprises a multi-lumen catheter, and the step of inserting the inner sheath through the lumen of the endoscope comprises the step of inserting the multi-lumen catheter through the lumen of the endoscope.

140. 139. The method of claim 138, wherein the inner sheath includes a working channel liner, and the step of inserting the inner sheath through the lumen of the endoscope includes the step of inserting the working channel liner through the lumen of the endoscope.

141. 139. The method of claim 138, further comprising the step of inserting a second inner sheath through a second lumen of the endoscope from the distal end to the proximal end such that an inner sheath lumen of the second inner sheath extends through the endoscope from the distal end to the proximal end.

142. 139. The method of claim 138, wherein the inner sheath comprises a multi-lumen catheter, further comprising the step of coupling the inner sheath to a port adapter at a distal end region of the inner sheath to form separate ports in fluid communication with each lumen of the multi-lumen catheter.

143. 139. The method of claim 138, wherein mounting the cap to the distal end of the endoscope includes securing the cap to the distal end of the endoscope using one or more of a snap fit, a friction fit, a magnetic coupling, a bayonet connector, or a threaded region.

144. 139. The method of claim 138, wherein the step of mounting the cap on the distal end of the endoscope includes compressing a cylindrical mating surface of the cap configured to mate with the distal end of the endoscope from an oval resting cross-sectional configuration to a circular mating cross-sectional configuration.

145. 139. The method of claim 138, wherein positioning the outer sheath over the endoscope comprises positioning the endoscope within an elongate outer tube such that the endoscope can move in a telescopic manner relative to the elongate outer tube.

146. 1. A method for maintaining the cleanliness of an endoscope, comprising: performing a medical procedure with an endoscope while a distal end of the endoscope is covered by a cap, an inner sheath hermetically connected to the cap extends through a lumen of the endoscope from the distal end to the proximal end, one or more inner sheath lumens extend through the lumen of the endoscope and open through the cap, and an outer sheath hermetically connected to the cap and extends proximally over the endoscope; removing the cap from the distal end of the endoscope; and withdrawing the endoscope proximally out of the outer sheath such that the inner sheath extends out of the distal end of the lumen of the endoscope, a proximal end region of the inner sheath being sealed.

147. 147. The method of claim 146, wherein performing the medical procedure comprises passing a substance through the cap and into or from the one or more internal lumens.

148. 147. The method of claim 146, wherein performing the medical procedure includes imaging through the cap.

149. 147. The method of claim 146, wherein the outer sheath is coupled to an outer surface of an outer tube and the endoscope is telescopically positioned within the outer tube.

150. 150. The method of claim 149, wherein performing the medical procedure includes moving the endoscope proximally or distally relative to the outer tube.

151. 148. The method of claim 147, wherein withdrawing the endoscope proximally from the outer sheath comprises withdrawing the endoscope proximally from the outer tube.

152. 147. The method of claim 146, further comprising the step of sealing the proximal end region of the inner sheath.

153. 153. The method of claim 152, wherein sealing the proximal end region comprises mechanically crimping the proximal end region.

154. 153. The method of claim 152, wherein sealing the proximal end region comprises heat sealing the proximal end region.

155. 1. An endoscopic sheath device, comprising: a flexible tubular outer sheath configured to extend over the endoscope; and a cap configured to couple to a distal end of the endoscope, a distal end region of the soft tubular outer sheath being sealed against the cap; and a proximal sealing collar, a proximal end region of the soft tubular outer sheath sealed against the proximal sealing collar, the proximal sealing collar forming an air-tight seal against the endoscope such that the tubular outer sheath can be inflated or deflated by application of fluid pressure between the soft tubular outer sheath and an exterior surface of the endoscope.

156. 156. The device of claim 155, further comprising a pressure port in fluid communication with an interior region of the soft tubular outer sheath and configured to apply positive or negative pressure between the soft tubular outer sheath and the exterior surface of the endoscope.

157. 156. The device of claim 155, further comprising a pressure port on the proximal sealing collar configured to apply positive or negative pressure between the soft tubular outer sheath and the exterior surface of the endoscope.

158. 156. The device of claim 155, wherein the soft outer sheath comprises an elastomeric material.

159. 156. The device of claim 155, wherein the soft outer sheath has a non-uniform diameter along the length of the soft outer sheath.

160. 156. The device of claim 155, wherein the soft outer sheath has one or more expansion regions along its length configured to expand to a larger expansion radius when the soft outer sheath is inflated by the application of positive pressure.

161. 156. The device of claim 155, wherein the cap is configured to seal against the distal end of the endoscope.

162. 156. The device of claim 155, wherein the cap is configured to secure to the distal end of the endoscope and includes one or more of a friction fit portion configured to secure the cap to the distal end of the endoscope, a snap fit portion configured to secure the cap to the distal end of the endoscope, a magnet configured to secure the cap to the distal end of the endoscope, a bayonet connector configured to secure the cap to the distal end of the endoscope, or a threaded region configured to secure the cap to the distal end of the endoscope.

163. 156. The device of claim 155, further comprising a tubular inner sheath configured to extend within a lumen of the endoscope, the tubular inner sheath having one or more lumens, and a distal end region of the inner sheath sealed against the cap such that the one or more lumens of the tubular inner sheath are open through the cap.

164. 1. An endoscopic sheath device, comprising: a flexible tubular outer sheath configured to extend over the endoscope; and a tubular inner sheath configured to extend within a lumen of the endoscope and having one or more lumens; a cap configured to couple to a distal end of the endoscope, a distal end region of the soft tubular outer sheath sealed against the cap, and a distal end region of the inner sheath sealed against the cap such that the one or more lumens of the tubular inner sheath are open through the cap; and a proximal sealing collar, a proximal end region of the soft tubular outer sheath sealed against the proximal sealing collar, the proximal sealing collar further configured to form an air-tight seal against the endoscope such that the tubular outer sheath can be inflated or deflated by application of fluid pressure between the soft tubular outer sheath and the exterior surface of the endoscope.

165. 1. An endoscope sheath system configured to prevent contamination of an endoscope, the device comprising:

1. An endoscopic sheath device, comprising: An outer sheath; a cap sealingly coupled to a distal end of the outer sheath; an inner sheath including a multi-lumen catheter extending within the outer sheath, the inner sheath being sealingly coupled to the cap such that a lumen of the multi-lumen catheter is open through the cap; and and a port adapter configured to mate with a proximal end region of the multi-lumen catheter to form a plurality of sealed ports in fluid communication with each lumen of the multi-lumen catheter.

166. 164. The system of claim 163, wherein the multi-lumen catheter includes a plurality of radially spaced side openings at a proximal end region of the inner sheath, each side opening opening into an internal lumen of the multi-lumen catheter.

167. 165. The system of claim 164, wherein the port adapter is configured to engage with the plurality of radially spaced side openings in the proximal end region of the inner sheath to form the plurality of sealed ports in fluid communication with each lumen of the multi-lumen catheter.

168. 164. The system of claim 163, wherein the port adapter is configured to engage a distal end of the multi-lumen catheter to form a plurality of sealed ports in fluid communication with each lumen of the multi-lumen catheter.

169. 1. A method for verifying that an endoscope is not contaminated, comprising: performing a medical procedure within a body with the endoscope while the endoscope is sheathed within an endoscopic sheath device; withdrawing the endoscope from the body; applying a positive pressure between the endoscope and the endoscope sheath device; and indicating whether the endoscopic sheath device is contaminated or uncontaminated based on a decay of pressure from between the outer sheath and the endoscope.

170. 170. The method of claim 169, wherein the performing step includes performing the medical procedure in which the endoscope is covered such that an exterior surface of the endoscope is surrounded by the outer sheath of the endoscopic sheath device and an internal lumen of the endoscope is covered by an inner sheath, the outer sheath and the inner sheath forming a continuous fluid-impermeable contamination barrier.

171. 170. The method of claim 169, wherein applying positive pressure between the endoscope and an outer sheath of the endoscopic sheath device comprises at least partially inflating the outer sheath.

172. 170. The method of claim 169, wherein a proximal portion of the outer sheath is sealed to a proximal region of the endoscope.

173. 170. The method of claim 169, wherein the indicating step includes determining whether the outer sheath is leaking based on a decay of pressure from between the outer sheath and the endoscope.

174. 170. The method of claim 169, wherein the indicating step comprises emitting a signal.

175. 170. The method of claim 169, wherein the indicating step includes the step of issuing an alarm if the attenuation of pressure from between the outer sheath and the endoscope exceeds a threshold value.

176. 1. A method for verifying that an endoscope is not contaminated, comprising: performing a medical procedure with the endoscope while a distal end of the endoscope is covered by a cap, an inner sheath hermetically connected to the cap passes through a lumen of the endoscope from the distal end to the proximal end, one or more inner sheath lumens extend through the lumen of the endoscope and extend open through the cap, and an outer sheath hermetically connected to the cap and extends proximally over the endoscope; withdrawing the endoscope from the body; applying a positive pressure between the endoscope and an outer sheath of the endoscopic sheath device; and indicating whether the endoscopic sheath device is contaminated or not based on a decay of pressure from between the outer sheath and the endoscope.

177. 1. An endoscope sheath apparatus configured to prevent contamination of an endoscope, comprising: a cap configured to couple to a distal end of an endoscope; an outer sheath sealingly coupled to the cap at a distal end; one or more inner sheaths extending within the outer sheath, each inner sheath sealingly coupled to the cap at a distal end and opening through the cap; a placement handle, at least a portion of the outer sheath being held in a gathered configuration within a chamber of the placement handle, and the one or more inner sheaths extending distally through the gathered outer sheath and the chamber and out from a distal end of the placement handle.

178. 178. The apparatus of claim 177, wherein the cap is positioned at a proximal end of the installation handle.

179. 178. The apparatus of claim 177, wherein the installation handle includes a coupling at the distal end of the installation handle configured to couple to a corresponding fastener on the endoscope.

180. 178. The apparatus of claim 177, wherein the outer sheath is held in a gathered configuration within the chamber such that the outer sheath is compressed.

181. 178. The device of claim 177, wherein the outer sheath is held in a gathered configuration within the chamber such that the distal end of the catheter resides within the outer sheath when inserted from the distal end of the installation handle.

182. 178. The apparatus of claim 177, wherein the installation handle includes an outer gripping surface.

183. 178. The apparatus of claim 177, wherein the installation handle comprises a cylindrical shape.

184. 178. The apparatus of claim 177, wherein the outer sheath is gathered in a bellows configuration.

185. 178. The apparatus of claim 177, wherein the installation handle includes a distally facing conical surface on a distal end of the installation handle.

186. 1. A method of installing an endoscopic sheath device on an endoscope, comprising: inserting an inner sheath through a lumen of the endoscope from a distal end of the endoscope; advancing the distal end of the endoscope through an outer sheath that is held in a gathered configuration within a placement handle; coupling a cap of the endoscope sheath apparatus to a distal end region of the endoscope; and pulling the placement handle over the endoscope to position the outer sheath over the endoscope.

187. 187. The method of claim 186, further comprising the step of coupling the installation handle to the endoscope.

188. 187. The method of claim 186, further comprising the step of removing the endoscopic sheath device from the endoscope by advancing the installation handle distally over the endoscope to evert the outer sheath proximally on itself.

189. 189. The method of claim 188, further comprising the step of sealing a proximal end region of the inner sheath.

190. 190. The method of claim 189, wherein the sealing step includes a crimping step.

191. 190. The method of claim 189, wherein the sealing step comprises heat sealing.

192. 190. The method of claim 189, further comprising the steps of removing the cap from the endoscope and withdrawing the sealed inner sheath from the lumen of the endoscope.

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