Sanitary sheath for endoscopy

Abstract

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

Description

[0001] Priority claim

[0002] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 335,720, filed on April 27, 2022, entitled “HYGIENIC DRAPING FOR ROBOTIC ENDOSCOPY.” This application is incorporated herein by reference in its entirety.

[0003] Incorporated by Reference

[0004] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0005] background

[0006] Reusable endoscopes ("scopes"), whether manually or robotically operated, perform important diagnostic and therapeutic functions, but present a number of problems. Endoscopes can be difficult to clean because they can be very long (enteroscopes can be over two meters long), can have one or more very long and very small lumens, and they include many small, delicate parts made of a variety of materials that have areas that can harbor microorganisms. These areas can include areas where parts meet, areas of cracks and joints, and areas where scratches and localized damage are present. The use of most endoscopes typically requires immersion in pathogen-rich contaminants, including blood, feces, urine, and diseased and infected tissue. Reusable endoscopes are expected to be used for a very large number of cases (typically more than a thousand) over a long period of time (e.g., several years). However, such a long life expectancy creates problems: careful analysis of used endoscopes shows that they are often damaged both internally and externally. Endoscope maintenance is logistically burdensome, requiring ongoing quality control and inspections, expensive spare units, shipping, receiving, and proper packaging and transportation, and is extremely expensive: the lifetime maintenance cost of a reusable endoscope often exceeds the initial purchase price. Because reusable endoscopes are expected to last for several years, this essentially means clinicians are performing endoscopy with outdated technology. Endoscope cleaning also requires significant capital equipment, as well as the necessary space, training, maintenance, and repair. Successfully cleaning endoscopes requires the successful execution of a highly detailed procedure (often exceeding one hundred individual steps) and is often performed by a highly mobile, poorly trained, rushed staff who lack communication with end users and work without all necessary tools. It has been well documented that accurate and complete cleaning of endoscopes according to a complete and comprehensive list of cleaning instructions is often not possible. The complete set of activities required to clean and return an endoscope ready for the next case requires complex, time-consuming, multi-person, and expensive internal logistics as the unit moves through various steps at different locations within the hospital, with different tasks being transferred between numerous different people and departments. Hospital space is at a premium, and the storage, handling, and movement of these devices incur very real facility costs. Furthermore, the cleaning process often takes the devices out of service for extended periods, requiring facilities performing endoscopy to maintain a large rotation of devices to complete their ongoing procedures. Furthermore, despite the perceived environmental benefits of reuse, endoscope cleaning generates significant waste—gloves, wipes, brushes, PPE, connectors, tubing, test strips, and hazardous chemicals. Chemical cleaning agents are demanding on the endoscopes, the facility, the environment, and the people performing the cleaning.

[0007] Importantly, while such cleaning processes can clean endoscopes, the processed endoscopes are not sterile (the goal of high-level disinfection (HLD)) because the materials of many endoscopes cannot withstand the rigors of the necessary chemicals, temperatures, or radiation. Sterilization by ethylene oxide would require prolonged exposure and ventilation, which is dangerous to workers and patients and has caused many publicized problems with worker health and the environment. Sterilization by peroxide is new and useful, but it still suffers from most of the problems listed above. In the worst case, peroxide-sterilized devices are sterile but will still maintain a debris burden that can be transferred from one case to another. Endoscope contamination is common and, in the worst case, has led to disease transmission and documented deaths.

[0008] Currently available disposable endoscopes are intended to last for multiple cases (eg, 2, 5, 10, 20, etc.) and suffer from many of the same problems as reusable endoscopes.

[0009] Although disposable endoscopes typically arrive sterile and never require cleaning, they contribute significant amounts of landfill waste and can be difficult to manufacture at high quality and reasonable cost. Although they can theoretically be recycled, this practice is rare and uneconomical. Single-use endoscopes are already effectively used in some settings, but they have not been widely adopted.

[0010] Surgical covers, sheaths, and shields are used to create a sterile field around the surgical site and establish a physical barrier, reducing the risk of device contamination and surgical site infection. Sheaths can be a key enabler that allows technicians who need to clean waste (e.g., feces) from endoscopes to perform more meaningful and important work. Hygienic covers, including those used for both manual endoscopy and robotic / telerobotic endoscopy, can effectively physically isolate the device from the patient during surgical procedures.

[0011] Therefore, there is a need for methods, assemblies, systems, and apparatuses that address these problems.

[0012] Overview of the Disclosure

[0013] Described herein are methods and apparatus (e.g., components, accessories, devices, and systems, including sheath systems) that can be used with endoscopes, particularly manual or robotic endoscopes and / or telescopic endoscopes, as well as methods for using these sheaths to prevent cross-contamination between patients and contamination of endoscopes. Generally, these sheaths can reduce or eliminate the need for endoscope cleaning. The sheaths described herein may also or alternatively be referred to as covers and can advantageously be quickly and easily applied to an endoscope system for a new patient, without requiring lengthy reprocessing procedures that would otherwise include HLD and / or sterilization. These covers can protect the exterior of an endoscope as well as any internal working channels and supply lines of the endoscope, which can be crucial in preventing contamination of the endoscope with these internal working channels and supply lines during medical procedures. 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 cross-contamination from other patients, and can be faster, easier, less expensive, result in less landfill, and be more efficient than reprocessing (cleaning of endoscopes). By reducing or eliminating additional cleaning cycles, endoscopes can experience less wear and associated damage. By effectively covering the device, important endoscope components can be reused multiple times, reducing unit costs and reducing landfill waste.

[0014] The methods and devices described herein (e.g., systems and apparatus, including sheath systems) can include reusable elements, disposable elements, semi-disposable elements (i.e., elements that are discarded after a few uses, elements that are reused a small number of times), and / or cover elements that can address the issues raised above.

[0015] As used herein, the term "endoscope" is intended to be broadly understood. In general, an endoscope may refer to an instrument that can be introduced into the body and may include one or more lumens extending therethrough. An endoscope may include a catheter, a trocar, a tube, or the like. An endoscope may refer to an instrument used to inspect, access, treat, and / or diagnose the interior of the body (including organs, cavities, body cavities, or blood vessels). Any of these endoscopes may include imaging (e.g., typically via a CCD, CMOS chip, or fiber optic material) to provide a view from the distal end or side of the device. The endoscopes described herein may include sensing (e.g., electrical sensing, magnetic sensing, shape sensing, mechanical sensing, etc.). An endoscope may generally be a catheter that includes one (or more) lumens extending the length of the endoscope. In some examples, an endoscope may include one or more lumens extending the length of the endoscope (e.g., an internal working channel, a fluid channel, an insufflant channel, a cleaning fluid channel, etc.). For example, any of these endoscopes may include one or more channels for applying or removing liquids and / or gases (e.g., aspirates / aspirates, sprays, cleaning solutions, insufflations). These channels may be connected to electrical components, including wiring for lighting, vision, energy delivery, or sensing. These endoscopes may include one or more channels for tools or instruments. The channels may be used multiple times, including for aspirates or cleaning solutions. Any of the endoscopes described herein may include a lumen configured as an internal working channel, for example, for delivering one or more accessory devices. Examples of endoscopes may include, but are not limited to, colonoscopes, arthroscopes, bronchoscopes, cystoscopes, enteroscopes, esophagogastroduodenoscopes, hysteroscopes, laparoscopes, laryngoscopes, mediastinoscopes, sigmoidoscopes, or thoracoscopes, among others.

[0016] The methods and apparatus described herein may be particularly well-suited for use with manual endoscopes. Manual endoscopes can be manually steered using a controller (e.g., a knob, button, joystick, dial, etc.) to steer the distal tip region and can be manually advanced or retracted. The sheaths described herein can be configured to operate on or with a manual endoscope such that a distal cap can be fitted over the distal end of a manual endoscope, an outer sheath (sealed to the cap) can be fitted over the exterior surface of the endoscope, and one or more inner sheaths (also sealed to the cap) can fit through and line any interior lumen of the endoscope.

[0017] The methods and devices described herein can be particularly well adapted for use with a telescopic system in which an internal endoscope is arranged concentrically with an external tube. The internal endoscope and the other endoscope can move together (e.g., propel) and / or move separately. All operations of the internal endoscope (also referred to herein as a "child") can be protected by the sheath described herein, and therefore can be reusable a certain number of times, or semi-disposable or discarded after several uses (meaning it is reused a certain number of times, e.g., 2 to 40 times). In some examples, the external endoscope tube (which can also be equivalently referred to herein as a "mother," an external member, or an outer sleeve) can be reusable or disposable. The mother can be reusable the same number of times as the child, or the mother can be reusable a different number of times than the child, or one of the elements can be single-use. For example, the external tube can be completely or partially covered by an outer sheath. In variations where the outer tube is extensively covered by the outer sheath (e.g., completely or largely covered, or covered within a sterile field), the outer tube can be reused after the sheath is removed following surgery. In variations where the outer sheath is only attached distally (e.g., sealed to the distal end or distal region of the outer tube), the outer tube can be single-use or may require cleaning and / or sterilization before reuse. This can still be a net savings since the outer tube can be easier, faster, and / or cheaper to clean than an endoscope. The outer tube can also be an endoscope.

[0018] As described above, the endoscope can equivalently include (and / or be replaced by) a catheter. In examples comprising an inner endoscope and an outer tube, the majority of the length of the inner member (equivalently referred to herein as the endoscope, inner endoscope, or "daughter") can be covered by the outer tube, which can have a special configuration such that it is referred to as a "ruggedized" sheath; the distal portion comprising the outer sheath can be a thin film sheath. This can have clinical benefits, for example, when the endoscope is configured for insertion into the rectum, because the portion that slides through the anus during the majority of the procedure can be ruggedized and sheath wear is minimized, thereby increasing reliability.

[0019] In general, the devices and methods described herein can be used with one or more rigidizing members. In examples including an endoscope, the endoscope can be a rigidizing member, such as a selective rigidizing member. In examples including an endoscope and an external tube, both the internal endoscope and the external tube can be rigidizing members, or only the external tube or only the endoscope can be a rigidizing member.

[0020] For example, described herein is an endoscopic sheath apparatus (e.g., system, device, etc.) comprising: an outer sheath; a cap sealingly coupled to a distal end of the outer sheath; and an inner sheath having one or more lumens and extending within the outer sheath, wherein the inner sheath is sealingly coupled to the cap such that the one or more lumens open outwardly through the cap.

[0021] For example, an endoscope sheath device configured to prevent contamination of an endoscope may include: an outer sheath; a cap sealingly coupled to a distal end of the outer sheath; and one or more inner sheaths, each inner sheath extending within the outer sheath, wherein each inner sheath has one or more lumens, and further wherein each inner sheath is sealingly coupled to the cap such that the one or more lumens open outwardly through the cap.

[0022] In some examples, an endoscope sheath device configured to prevent contamination of an endoscope may include: a flexible outer sheath configured to extend over an endoscope to form an impermeable outer barrier; a cap sealingly coupled to a distal end of the outer sheath, wherein the cap is configured to mate with the distal end of the endoscope; and one or more inner sheaths, each inner sheath having one or more lumens, each of the one or more inner sheaths extending within the flexible outer sheath, each of the one or more inner sheaths being configured to pass through a lumen of the endoscope to form an impermeable inner barrier, each of the one or more lumens being sealingly coupled to the cap such that the one or more lumens open through the cap.

[0023] Therefore, generally, the sheath devices described herein (including caps, outer sheath devices and inner sheath devices) can form an impermeable contamination barrier. The impermeable contamination barrier can be impermeable to fluids and / or impermeable to solids. The barrier can be sterile or sterilized. Optionally, the barrier does not have to be sterile, but can be clean and prevent contamination of the endoscope to which the barrier is attached. The endoscope does not need to be sterile or remain sterile, but can be kept clean and free of contaminants by the sheath devices described herein. In particular, both the outside and the inside of the endoscope (e.g., channels, cavities, etc.) can be kept clean and free of contamination because the sheath devices described herein can effectively create a barrier to prevent contamination. Importantly, these sheath devices are configured to be removed from the outside or inside without contaminating the endoscope covered by the sheath.

[0024] An endoscope sheath device configured to prevent contamination of an endoscope may include: a flexible outer sheath configured to fit over an endoscope; a cap sealingly coupled to a distal end of the outer sheath; one or more inner sheaths, each inner sheath extending within the outer sheath and configured to fit within a lumen extending through the endoscope, wherein each inner sheath has one or more lumens, and further wherein each inner sheath is sealingly coupled to the cap such that the one or more lumens open outwardly through the cap; and a sealing area at a proximal end of each of the one or more inner sheaths, the sealing area configured to be sealed after use to prevent contamination during removal of the one or more inner sheaths from the lumen extending through the endoscope.

[0025] For example, in some examples, the outer sheath comprises a flexible, thin, elastic material. The outer sheath can be constructed from one or more materials, including plastics, elastomers, plastomers, or composite materials. Plastomers include polymeric materials that combine the properties of elastomers and plastics, such as rubber-like properties with the processing capabilities of plastics. Plastomers can include ethylene-α-olefin copolymers. Suitable materials include latex, polyvinyl chloride, polyurethane, polyethylene, polypropylene, silicone, or other similar materials. The material can be reinforced by lamination (including with fibers or metal). In some examples, the distal end of the outer sheath (e.g., the distal 10% or more, the distal 15% or more, the distal 20% or more, the distal 25% or more, the distal 30% or more, the distal 35% or more, etc.) can be a thin-walled sheath, while the remainder of the outer sheath can be durable. The durable sheath can be thicker (e.g., having a wall thickness of 0.1 mm or more, 0.2 mm or more, 0.25 mm or more, 0.3 mm or more, 0.35 mm or more, 0.4 mm or more, 0.5 mm or more, 0.55 mm or more, 0.6 mm or more, 0.7 mm or more, 0.8 mm or more, 0.9 mm or more, 1 mm or more, etc.). Depending on the material forming the sheath, the thin-walled sheath can have a thickness of, for example, 0.2 mm or less, 0.15 mm or less, 0.1 mm or less, 0.05 mm or less, 0.04 mm or less, 0.02 mm or less, between about 0.25 mm and 0.01 mm thick, between about 0.2 mm and 0.02 mm thick, etc. The jacket may be formed from a single material having different regions (eg, thin-walled regions and thicker-walled or durable regions), or the jacket may be formed from different materials that are coupled (eg, fused, sealed, etc.) together.

[0026] Typically, the outer sheath can be shorter than the inner sheath. For example, the outer sheath can extend only to the end of an elongated outer tube (e.g., an elongated outer tube); in some examples, the outer sheath can extend along the length of the elongated outer tube.

[0027] The cap can be a polymer material, can be transparent and / or can include a transparent window configured to align 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 some examples, the cap is configured to be secured to the distal end of the endoscope. For example, there are a variety of methods for attaching the cap. Examples may include one or more of: a shear surface configured to secure the cap to the distal end of the endoscope, a snap connection 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.

[0028] In any device described herein, the outer sheath can have a lower resistance to buckling than the inner sheath. Thus, the inner sheath can have a higher axial compressive stiffness than the outer sheath; the outer sheath can be configured to buckle (e.g., curl up, pleat, tighten, stack on itself, etc.), while the inner sheath is configured to resist buckling. In some examples, the inner sheath comprises a multi-lumen catheter. For example, the inner sheath can be formed as a long, flexible single-lumen or multi-lumen catheter. The inner sheath can be formed of a polymeric material such as polyvinyl chloride, polyurethane, polyethylene, polypropylene, etc. The inner sheath can be a composite structure, including wire reinforcement or fiber reinforcement. The inner sheath can have elements that facilitate sliding (along the inner sheath inner surface or along the inner sheath outer surface) during installation, during use (including allowing tools to pass through), and during unloading / removal. The composition of the inner sheath can vary along its length, including material and / or hardness. Often, the inner sheath may also be referred to as an inner sheath and may be longer than the endoscope to be inserted therein, such that the inner sheath extends proximally from the endoscope where it may engage with a port adapter to provide access into or out of the lumen (or lumens) of the inner sheath.

[0029] For example, when 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 that lead to the inner lumens of the one or more lumens at the proximal region of the inner sheath. For example, this can be an end opening and / or a side opening. In some examples, the inner sheath includes a plurality of radially spaced (and optionally laterally or axially spaced) side openings at the proximal region of the inner sheath, wherein each radially spaced side opening leads to a lumen of the multi-lumen catheter. A port adapter can be coupled to the end of the internal cavity (e.g., a multi-lumen catheter) to align the (one or more) openings of the inner sheath with the port or directly with a suction source, a pressurized air source ("insufflator"), a source fluid source (e.g., saline), etc. Typically, a port adapter can be configured to couple to a multi-lumen catheter to produce isolated multiple ports that are fluidically connected to each lumen in the multi-lumen catheter. Thus, although the inner sheath is a disposable component that can be thin and small and have multiple lumens, the inner sheath can be quickly, easily, and accurately attached, retained (and subsequently detached) to a structure such as a port adapter that can easily connect to multiple inputs. This adaptation to the port adapter can work with both single-lumen and multi-lumen inner sheaths.

[0030] Any of these devices can include multiple inner sheaths. In some examples, the device includes a second inner sheath configured as a working channel liner. The working channel liner can have a working channel lumen and extend adjacent to the inner sheath within the outer sheath, wherein the working channel liner is sealingly coupled to the cap so that the working channel lumen is open to the outside 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 to aspirate or flush fluid.

[0031] The outer sheath and the one or more inner sheaths can both be sealingly attached to the cap to provide a barrier to fluids and / or microorganisms, thereby preventing fluids and / or microorganisms from entering the endoscope. In some examples, the outer sheath and / or inner sheath (including the working channel lumen) can be coupled to the cap by welding, ultrasonic welding, and / or adhesive to form a sealing attachment.

[0032] Any of these devices can include a proximal attachment on the outer sheath that is configured to secure the outer sheath to the exterior surface of the endoscope. The proximal attachment can be an elastic material that can elastically attach or secure the outer sheath to the exterior surface of the endoscope. In some examples, the proximal attachment can include a sealing attachment (e.g., a gasket, such as, but not limited to, an O-ring; an adhesive material; etc.). Typically, the proximal attachment for the outer sheath can hold the outer sheath on and / or against the endoscope (in examples where the sheath itself is used alone with a single endoscope) or against the elongated outer tube (in examples where the sheath is used with a telescoping assembly comprising a coaxially arranged elongated outer tube and an inner endoscope).

[0033] After the inner sheath has been used, it must be extracted so that it can be discarded, making the endoscope ready for a fresh and new sheath system. Given that contaminated fluid has passed through the inner sheath, the inner sheath should be cleanly and effectively terminated so that it does not present a risk of contamination. To this end, the inner sheath can be crimped, including crimping with a radially compressed metal tube. The inner sheath can be sealed with a cured adhesive (e.g., UV cured). The inner sheath can be heat sealed so that the cavity is effectively sealed and terminated. The diameter of the sealing unit must not be larger than the diameter of the cavity through which it will be pulled, otherwise it will not be removable. In any of these examples, once one or more inner sheaths are sealed, while still remaining free of contaminants, one or more inner sheaths can be cut, with the short portion remaining in the port adapter and the long portion then sliding out distally. These methods can seal the inner sheath to prevent contamination when the endoscope sheath device is removed from the endoscope.

[0034] For example, the present invention describes an endoscope sheath device comprising: a flexible outer sheath; a cap sealingly coupled to a distal end of the flexible outer sheath, wherein the cap is configured to seal to the distal end of an endoscope; an inner sheath having one or more lumens and extending within the flexible outer sheath, wherein the inner sheath is sealingly coupled to the cap such that the one or more lumens are open outwardly through the cap; and a working channel liner (e.g., a second inner sheath) having a working channel lumen and extending adjacent to the inner sheath within the flexible outer sheath, wherein the working channel liner is sealingly coupled to the cap such that the working channel lumen is open outwardly through the cap.

[0035] Any of the devices described herein can be configured as a sheath assembly comprising the sheath components described above, e.g., an outer sheath, an inner sheath, and a cap integrated with a telescopically arranged outer tube (e.g., an outer catheter, an outer cannula, or other outer elongated member having an interior lumen in which an endoscope can be positioned). For example, the outer sheath can be fused or otherwise connected (including a sealing connection) to the exterior surface of the elongated outer tube to form the sheath assembly. Multiple such sheath assemblies can be used with the same endoscope so that the sheath assemblies can be attached and removed without contaminating or compromising the cleanliness of the endoscope, as described herein.

[0036] For example, the present invention describes a system including a flexible outer tube for use with an internal endoscope in a telescopic arrangement, the system comprising: an elongated outer tube including an outer lumen; an outer sheath coupled to a proximal end region of the elongated outer tube at a first end region; 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 within the outer lumen, wherein the inner sheath is sealingly coupled to the cap such that the one or more inner sheath lumens open outwardly through the cap.

[0037] These systems can include any of the above features. In addition, the cap can be configured to be coupled to the distal end of the internal endoscope, and the inner sheath can be configured to extend through the lumen of the internal endoscope. As described above, generally, the sheath devices described herein can be used with non-rigidized components as well as rigidized components (e.g., rigidized endoscopes, catheters and / or outer cannulas). 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 variety of techniques, including applying positive or negative pressure. The devices can be operated robotically, or they can be manually operated.

[0038] Also described herein are methods of using any of these devices, which can include methods of applying and / or removing a sheath from an endoscope or an assembly (e.g., a telescoping assembly) comprising an endoscope, and methods of using the sheath device to keep an endoscope clean. For example, a method of attaching a sanitary sheath to an endoscope can include: 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 a distal end to a proximal end; positioning an outer sheath on the endoscope such that the outer sheath extends proximally from the distal end; and securing a cap to 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 open outwardly through the cap.

[0039] Positioning the outer sheath on the endoscope may include positioning the endoscope within the elongated outer tube such that the endoscope can move telescopically relative to the elongated outer tube. Inserting the inner sheath through the lumen of the endoscope may include inserting a multi-lumen catheter forming the inner sheath through the lumen of the endoscope.

[0040] Once positioned, in some examples, the methods can include coupling the inner sheath to a port adapter at a proximal region of the inner sheath. Any of these methods can include coupling each of the lumens in the multi-lumen catheter to a port adapter at a proximal region of the inner sheath to provide isolated access to each lumen.

[0041] The proximal end of the flexible outer tube can be connected, including to the base of the endoscope (for manual surgery) or to a mating geometry on the main base (for robotic surgery). Once the surgery is completed, this feature can then be disconnected or disengaged.

[0042] In some examples, attaching 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 fitting, a friction fitting, a magnetic coupling, a bayonet connector, or a threaded region.

[0043] For example, a method of maintaining the cleanliness of an endoscope may include: performing a medical procedure using an endoscope such that the distal end of the endoscope is covered by a cap, wherein an inner sheath sealingly connected to the cap extends 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, further wherein an outer sheath sealingly connected to the cap and extends proximally over the endoscope and connected to the lumen at the proximal end; removing the cap from the distal end of the endoscope; and withdrawing the endoscope proximally from the outer sheath such that the inner sheath extends out of the distal end of the lumen of the endoscope, wherein a proximal region of the inner sheath has been sealed closed.

[0044] Performing a medical procedure can include passing material through the cap into or out of one or more inner sheath lumens and / or imaging through the cap (e.g., through an imaging window and / or through a transparent cap or a transparent region of the cap). The outer sheath can be coupled to an outer surface of the outer tube, and the endoscope can be telescopically disposed within the outer tube. Performing a 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 proximally from the outer tube.

[0045] Any of these methods can include sealing the proximal region of the inner sheath. For example, sealing the proximal region can include pressing the proximal region. Sealing the proximal region can include heat sealing the proximal region.

[0046] Any of the devices (e.g., apparatus) 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 can be used to convert a single lumen of an endoscope into multiple separate lumens. Devices (e.g., apparatus) including multi-lumen inner sheaths can be used to deliver a variety of different things, such as aspirates, insufflants, flushing solutions, etc. These devices can be adapted for use with a port adapter that provides 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 sealingly coupled to a distal end of the outer sheath; and an inner sheath including a multi-lumen catheter extending within the outer sheath, wherein the inner sheath is sealingly coupled to the cap such that the lumens of the multi-lumen catheter open outwardly through the cap; and a plurality of radially spaced side openings at a proximal region of the inner sheath, wherein each side opening opens into one lumen of the multi-lumen catheter. The proximal region of the inner sheath can be configured to mate with a port adapter to create an isolated plurality of ports fluidly connected to each lumen in the multi-lumen catheter.

[0047] For example, a method of attaching a sanitary sheath to 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 on the endoscope such that the outer sheath extends proximally from the distal end; and attaching a cap to 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 open outwardly through the cap.

[0048] The inner sheath may comprise a multi-lumen catheter, and wherein inserting the inner sheath through the lumen of the endoscope comprises inserting the multi-lumen catheter through the lumen of the endoscope. The inner sheath may comprise a working channel liner, and wherein inserting the inner sheath through the lumen of the endoscope comprises inserting the working channel liner through the lumen of the endoscope. Any of these methods may comprise inserting a second inner sheath through the second lumen of the endoscope from the distal end to the proximal end, such that the inner sheath lumen of the second inner sheath extends through the endoscope from the distal end to the proximal end. The inner sheath may comprise a multi-lumen catheter, and further comprising coupling the inner sheath to a port adapter at a distal region of the inner sheath to create a plurality of isolated ports fluidly connected to each lumen in the multi-lumen catheter.

[0049] Attaching the cap to 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 fitting, a friction fitting, a magnetic coupling, a bayonet connector, or a threaded region. Attaching the cap to the distal end of the endoscope can include manually compressing (e.g., using two or more fingers) a cylindrical mating surface of the cap from an oval resting cross-sectional configuration to a circular mating cross-sectional configuration, the cylindrical mating surface of the cap being configured to mate with the distal end of the endoscope.

[0050] Positioning the outer sheath over the endoscope may include positioning the endoscope within the elongate outer tube such that the endoscope is telescopically movable relative to the elongate outer tube.

[0051] For example, a method for maintaining the cleanliness of an endoscope may include: performing a medical procedure using an endoscope while the distal end of the endoscope is covered by a cap, wherein an inner sheath sealingly connected to the cap extends through the lumen of the endoscope from the distal end to the proximal end, and one or more inner sheath lumens extend through the lumen of the endoscope and open outward through the cap, further wherein an outer sheath sealingly connected to the cap extends proximally over the endoscope; removing the cap from the distal end of the endoscope; and withdrawing the endoscope proximally from the outer sheath so that the inner sheath extends out of the distal end of the lumen of the endoscope, wherein the proximal region of the inner sheath has been sealed closed. Performing the medical procedure may include causing material to enter or exit the one or more inner sheath lumens through the cap. Performing the medical procedure may include imaging through the cap (e.g., a lens on the cap). The outer sheath may be coupled to an outer surface of an outer tube, and the endoscope may be telescopically arranged within the outer tube.

[0052] Performing a medical procedure can include moving the endoscope proximally or distally relative to the outer tube. Proximally withdrawing the endoscope from the outer sheath can include proximally withdrawing the endoscope from the outer tube. As described above, any of these methods can include sealing the proximal region of the inner sheath. For example, sealing the proximal region can include pressing the proximal region. In some examples, sealing the proximal region can include heat sealing the proximal region.

[0053] As described above, any of these devices (e.g., sheaths) can be configured to include a crimping region at the proximal region of the inner sheath that is configured to be crimped after use to seal one or more cavities, thereby preventing contamination during removal of the inner sheath from the lumen of the endoscope. The crimping region can include an area formed of a material that can maintain crimping without leaking (e.g., a metal material, such as a cuff or connecting region). In some examples, the crimping region can be configured to melt. For example, the crimping region can be configured to heat seal and / or pressure seal. The crimping region can be formed of a material different from the proximal and / or distal sides of the crimping region or can additionally include a material different from the proximal and / or distal sides of the crimping region. As used herein, crimping can include mechanical crimping (e.g., clamping the cavity) and thermal crimping (e.g., heating / melting the cavity so that the cavity is closed), or some combination of these. The crimping can deform the material forming the cavity and / or additional material on or around the cavity.

[0054] For example, an endoscope sheath device configured to prevent contamination of an endoscope may include: a flexible outer sheath; a cap sealingly connected to the distal end of the outer sheath; and an inner sheath comprising a multi-lumen catheter extending within the outer sheath, wherein the inner sheath is sealingly connected to the cap so that the lumen of the multi-lumen catheter is open to the outside through the cap, further wherein the inner sheath is less flexible than the outer sheath and is configured to extend through the lumen of the endoscope; and a plurality of radially and / or axially spaced side openings at a proximal region of the inner sheath, wherein each side opening leads to an inner lumen of the multi-lumen catheter, further wherein the proximal region of the inner sheath is configured to cooperate with a port adapter to create a plurality of isolated ports that are fluidically connected to each lumen in the multi-lumen catheter.

[0055] An endoscope sheath device configured to prevent contamination of an endoscope may include: a flexible outer sheath configured to extend over an endoscope; a cap sealingly coupled to a distal end of the outer sheath; and an inner sheath comprising a multi-lumen catheter extending within the outer sheath, wherein the inner sheath is sealingly coupled to the cap such that the lumens of the multi-lumen catheter open outwardly through the cap, further wherein the inner sheath is configured to extend through the lumen of the endoscope; a plurality of radially and / or axially spaced side openings at a proximal region of the inner sheath, wherein each side opening leads to an inner lumen of the multi-lumen catheter; and a crimping region at the proximal region of the inner sheath configured to be crimped after use to seal one or more lumens, thereby preventing contamination during removal of the inner sheath from the lumen of the endoscope.

[0056] Any of the endoscope sheath devices herein (or methods of making and using them and / or systems including them) can be configured to prevent contamination of an endoscope and can include: an outer sheath; a cap sealingly coupled to the distal end of the outer sheath; and an inner sheath comprising a multi-lumen catheter extending within the outer sheath, wherein the inner sheath is sealingly coupled to the cap so that the lumens of the multi-lumen catheter are open to the outside through the cap; and a sealing region at the proximal region of the inner sheath, the sealing region being configured to seal the lumens of the multi-lumen catheter after use to prevent contamination during removal of the inner sheath from the lumen of the endoscope. As described above, any of these methods can include a plurality of radially spaced side openings at the proximal region of the inner sheath, wherein each side opening leads to one lumen of the multi-lumen catheter. The proximal region of the inner sheath can be configured to cooperate with a port adapter to create a plurality of isolated ports fluidically connected to each lumen in the multi-lumen catheter. The sealing region can include a crimping region configured to be mechanically crimped (e.g., a mechanical sealing region / mechanical crimping region). Thus, the sealing area may be configured as a pressure seal.The sealing area may be configured as a heat seal.

[0057] For example, an endoscope sheath device configured to prevent contamination of an endoscope may include: a flexible outer sheath; a cap sealingly coupled to a distal end of the outer sheath; and an inner sheath comprising a multi-lumen catheter extending within the outer sheath, wherein the inner sheath is sealingly coupled to the cap such that the lumens of the multi-lumen catheter are open to the outside through the cap, further wherein the inner sheath is configured to extend through the lumen of the endoscope; and a crimping region at a proximal region of the inner sheath, the crimping region being configured to be crimped after use to seal one or more lumens, thereby preventing contamination during removal of the inner sheath from the lumen of the endoscope.

[0058] An endoscope sheath device configured to prevent contamination of an endoscope may include: a flexible outer sheath configured to extend over an endoscope; a cap sealingly coupled to a distal end of the outer sheath; and an inner sheath comprising a multi-lumen catheter extending within the outer sheath, wherein the inner sheath is sealingly coupled to the cap such that the lumens of the multi-lumen catheter open outwardly through the cap, further wherein the inner sheath is configured to extend through the lumen of the endoscope; a plurality of radially spaced side openings at a proximal region of the inner sheath, wherein each side opening leads to an inner lumen of the multi-lumen catheter; and a crimping region at the proximal region of the inner sheath configured to be crimped after use to seal one or more lumens, thereby preventing contamination during removal of the inner sheath from the lumen of the endoscope.

[0059] Also described herein are methods of manufacturing any of the endoscope sheaths described herein. For example, a method of manufacturing an endoscope sheath device configured to prevent contamination of an endoscope may include: sealing a distal region of a tubular inner sheath to a cap having an opening, the cap configured to be coupled to the distal region of an endoscope, wherein the tubular inner sheath is configured to be inserted through a lumen of the endoscope; and sealing a distal region of a tubular outer sheath to the cap, wherein the tubular outer sheath is configured to fit over an exterior surface of the endoscope. Generally, the tubular outer sheath and / or the tubular inner sheath can have any cross-sectional shape, not limited to circular or oval (e.g., square, triangular, octagonal, etc.).

[0060] Any of these methods can include coating the inside (and in some examples, outside) of one or more inner sheaths with a hydrophilic coating, because any of these devices can include an inner sheath with a hydrophilic coating on the inside of the full length of the inner sheath and / or on the outside of the inner sheath. In some examples, the method can include coating an inner sheath material sheet with a hydrophilic coating, and forming the inner sheath material sheet into a tube to form the tubular inner sheath so that the hydrophilic coating extends in the lumen of the tubular inner sheath. In some examples, the hydrophilic coating is applied to the matrix material as an additive. The inner sheath with a 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 the distal end region of the second tubular inner sheath to the second opening through the cap, wherein the second tubular inner sheath comprises a multi-lumen tube. In some examples, the tubular inner sheath can comprise a working channel liner with a working channel cavity.

[0061] Any of the devices described herein (e.g., the sheath) may include a reinforced inner sheath or sheaths, particularly at the distal region of the inner sheath. This may be particularly helpful in variations where the distal region of the catheter (e.g., the distal end region) is configured to bend, turn, etc. Therefore, it may be beneficial to provide a device with a reinforced distal region (or the entire length of the endoscope or only the distal region, e.g., distal 5 cm, distal 4 cm, distal 3 cm, distal 2 cm, distal 1 cm, etc.). Reinforcing the distal region of a single lumen inner sheath (e.g., a working channel liner) may be particularly helpful in preventing pinching closure at a curved distal region. Therefore, any of the methods of forming the devices described herein may also include reinforcing the tubular inner sheath so as to prevent the distal region of the tubular inner sheath from collapsing when bent.

[0062] In any of these examples, the inner sheath can include a reinforcement structure, such as a reinforcement coil; thus, the method of forming the device can include adding the reinforcement coil. In some examples, the method can include adding reinforcement only in the distal region (e.g., only at the distal 5 cm, distal 4 cm, distal 3 cm, distal 2 cm, distal 1.5 cm, distal 1 cm, etc.).

[0063] In any of these methods, sealing the distal region of the tubular inner sheath to the cap and sealing the distal region of the tubular outer sheath can include forming a continuous fluid-impermeable contamination barrier.

[0064] Any of these methods can include packaging the endoscope sheath device in a coiled configuration. Such a configuration can make the sheath device easier to store and apply to the endoscope, including taking up less space and less landfill space, as well as reducing any necessary sterilization costs.

[0065] Any of these methods can include forming a crimp region at a proximal region of the inner sheath (or each sheath in variations having multiple sheaths), the crimp region configured to be crimped after use to seal the one or more lumens, thereby preventing contamination during removal of the inner sheath from the lumen of the endoscope. In some examples, the crimp region can include a band or ring formed of a relatively ductile material (such as metal) that can be squeezed closed to seal the one or more lumens of the inner sheath. In some examples, the inner sheath can include a region formed of a material that can be crimped as described herein.

[0066] The method of forming the device described herein may also include making the tubular outer sheath durable. The tubular outer sheath can be formed to be shorter than the tubular inner sheath (e.g., the inner sheath can extend beyond the tubular outer sheath). The device described herein can be formed using any of the caps described herein, including fully transparent or partially transparent caps. The cap may include a cylindrical mating surface having an oval configuration when at rest, wherein the cylindrical mating surface is configured to be compressed to present a circular cross-sectional configuration to fit over the distal end of the endoscope. Any of these methods may include attaching a proximal attachment to the tubular outer sheath, the proximal attachment being configured to secure the tubular outer sheath to the exterior surface of the endoscope.

[0067] For example, a method of manufacturing an endoscope sheath device configured to prevent contamination of an endoscope may include: coating a layer of an inner sheath material with a hydrophilic coating, and laminating the inner sheath material into a tubular inner sheath such that the hydrophilic coating extends within a lumen of the tubular inner sheath; sealing a distal region of the tubular inner sheath to a cap having an opening, the cap configured to be coupled to a distal region of an endoscope, wherein the tubular inner sheath is configured to be inserted through the lumen of the endoscope; and sealing a distal region of a 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, the cap, and the tubular inner sheath form a continuous fluid-impermeable contamination barrier.

[0068] For example, a method of manufacturing an endoscope sheath device configured to prevent contamination of an endoscope may include: reinforcing a tubular inner sheath, including with a higher density of reinforcement at the distal end, such that a distal region of the tubular inner sheath is prevented from collapsing when bent; sealing the distal region of the inner sheath to a cap having an opening, the cap configured to be coupled to the distal region of an endoscope, wherein the inner sheath is configured to be inserted through a lumen of the endoscope; and sealing the distal region of a tubular outer sheath to the cap, wherein the outer sheath is configured to fit over an exterior surface of the endoscope, wherein the outer sheath, the cap, and the inner sheath form a continuous fluid-impermeable contamination barrier.

[0069] As described above, any of these sheath devices can include a distal cap configured to be coupled to an endoscope that includes one or more light sources. These light sources can be light emitting diodes (LEDs), optical fibers, laser light sources, and the like. For example, an endoscope sheath device configured to prevent contamination of an endoscope is described herein, the endoscope sheath device comprising: an outer sheath; a cap sealingly coupled to the distal end of the outer sheath, wherein the cap is at least partially transparent and configured to be coupled to the distal end of the endoscope; (optionally) one or more inner sheaths, each of which extends within the outer sheath, wherein each inner sheath has one or more lumens, further wherein each inner sheath is sealingly coupled to the cap so that the one or more lumens are open to the outside through the cap; and one or more light sources on the cap, the one or more light sources being configured to project light toward the distal end of the cap.

[0070] In some examples, one or more light sources include light emitting diodes (LEDs). For example, one or more light sources may include a red light source, a green light source, and a blue light source. The device can be configured to apply white light, for example, by illuminating each of the red, green, and blue light sources, and / or applying a specific wavelength or wavelength range (for example, red or green or blue) to use light of different wavelengths to examine anatomical structures differently. One or more light sources may include a plurality of light sources arranged at least partially around the periphery of the cap. The light source may be arranged around the entire periphery or a portion of the periphery. In some examples, the device may include one or more light sources coupled to the cap and a plurality of conductive members (for example, traces, wires, etc.) extending on or in an outer sheath or on or in an inner sheath. For example, a wire may extend spirally around the outer sheath to couple with a controller and / or a power supply on the proximal end of the device.

[0071] In some examples, the device includes one or more electrical contacts on an interior surface of the cap, wherein the one or more electrical contacts are in electrical communication with the one or more light sources. The electrical contacts can be on the interior surface of the cap and can be pads or pins that contact pins or pads on the distal region of the endoscope.

[0072] Typically, the cap can include a lens region configured to be positioned over a camera of an endoscope. The lens region can be formed in the cap (formed from the cap material) and / or the lens region can include additional material added to the cap. The lens region can be a lens formed as a concave and / or convex region. The lens region can expand the field of view.

[0073] Typically, the cap is configured to be secured to the distal end of the catheter. For example, the cap can include one or more of the following: a friction fit configured to secure the cap to the distal end of the endoscope, a snap connection 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 some examples, the cap can include a cylindrical engagement region that fits over the endoscope and can include one or more latches.

[0074] For example, the present invention describes an endoscope sheath device configured to prevent contamination of an endoscope, the device comprising: a flexible tubular outer sheath; a cap sealingly coupled to a distal end of the outer sheath, wherein the cap is at least partially transparent; a tubular elongated inner sheath extending within the outer sheath and having one or more lumens, further wherein a distal region of the tubular elongated inner sheath is sealingly coupled to the cap such that the one or more lumens of the tubular elongated sheath open outwardly through the cap; and one or more light sources on the cap, the one or more light sources being configured to project light toward a distal side of the cap.

[0075] An endoscope sheath device configured to prevent contamination of an endoscope may include: a flexible tubular outer sheath; a cap sealingly coupled to a distal end of the outer sheath, wherein the cap is at least partially transparent; a tubular elongated inner sheath extending within the outer sheath and having one or more lumens, further wherein a distal region of the tubular elongated inner sheath is sealingly coupled to the cap such that the one or more lumens of the tubular elongated sheath open outwardly through the cap; one or more light sources on the cap, the one or more light sources being configured to project light toward a distal side of the cap; and one or more electrical contacts on an interior surface of the cap, wherein the one or more electrical contacts are electrically connected to the one or more light sources.

[0076] Any of the sheath devices described herein can be configured as a rigidified sheath. For example, rigid sheaths are described herein, wherein the outer sheath is rigidified and can be transformed from a flexible configuration to a rigid configuration, for example, by applying pressure; in some examples, positive pressure can be applied, in some examples, negative pressure can be applied, and in some examples, either positive or negative pressure can be applied.

[0077] The rigidizing sheath devices described herein can transition from a flexible configuration to a rigid configuration. In some examples, for example, the stiffness (e.g., hardness) can be considered "variable stiffness" because it can be selected by a user or system, based on the applied pressure. For example, the rigidizing outer sheath can be rigidified by applying positive or negative pressure to rigidify the rigidizing layer within the rigidizing outer sheath by actuating a compression layer (e.g., a bladder) against the rigidizing layer, thereby preventing or limiting movement of the rigidizing layer. When the positive or negative pressure is removed (or reversed), the layers can readily shear or move relative to each other; the release of the positive or negative pressure can allow the layers to transition to a state in which the layers exhibit significantly enhanced resistance to shear, movement, bending, torque, and flexure, thereby providing system rigidification. Although the examples described herein primarily illustrate rigidification by applying pressure (e.g., positive or negative pressure), the methods and devices described herein can be used with any suitable rigidizable sheath, not limited to positive or negative pressure rigidification devices. For example, a rigidifiable sheath as described herein may refer to any suitable rigidified sheath, including a sheath that can be rigidified by blocking particles, by phase change and / or shape memory alloys, by interlocking components (e.g., cables with discs or cones, etc.), EAPs (electroactive polymers), or any other rigidifying mechanism.

[0078] Any of the rigidizable sheaths described herein may include a rigidizing layer or region coupled to a compression layer (which may be a bladder or may include a bladder) that applies a force to the rigidizing layer to rigidify the rigidizing layer or, in some cases, de-rigidize (e.g., release) the rigidizing layer. In some examples, these rigidizable devices may include a rigidizing layer that may include a braid, knit, woven, chopped segments, randomly distributed or randomly oriented wires or strands, adapters, links, scales, plates, segments, particles, granules, crossing wires, or other materials that form a rigidizing layer. For example, the rigidizing layer may include multiple strand lengths or strand segments that cross each other (e.g., as part of a braid, knit, woven, etc.); the compression layer may apply a force to drive the crossing strand lengths or strand segments against each other. Although many of the examples shown herein are braids, any of these devices may alternatively or additionally include a general rigidizing layer that includes crossing strand lengths or strand segments. Examples of rigidification devices described herein can be selectively and controllably rigidified using pressure (positive pressure) and / or negative pressure. In some examples, the methods described herein can be used with any suitable rigidification device.Examples of rigid structures that may be included as part of a rigidified sheath may include those described in PCT patent application No. PCT / US2023 / 064999, entitled “METHODS AND APPARATUSES FOR NAVIGATING USING APAIR OF RIGIDIZING DEVICES,” filed on March 27, 2023, U.S. patent application No. 17 / 902,770, entitled “NESTED RIGIDIZING DEVICES,” filed on September 2, 2022, U.S. patent application No. 18 / 000,062, entitled “RIGIDIZING DEVICES,” filed on May 26, 2021, and U.S. patent application No. 18 / 000,062, entitled “DEVICES AND METHODS TO PREVENTINADVERTENT MOTION OF DYNAMICALLY RIGIDIZING DEVICES,” filed on January 31, 2022. and PCT / US2023 / 062206, entitled “DYNAMICALLYRIGIDIZING COMPOSITE MEDICAL STRUCTURES,” filed on February 8, 2023. Each of these applications is incorporated herein by reference in its entirety.

[0079] For example, an endoscope sheath device configured to prevent contamination of an endoscope may include: a rigidized outer sheath configured to extend over an endoscope, the rigidized outer sheath comprising a rigidizing layer and a compression layer, the rigidizing layer comprising a plurality of strand lengths that cross one another, the compression layer configured to be actuated to apply a force to the rigidizing layer to rigidify the rigid outer sheath from a flexible configuration to a rigid configuration; a cap configured to be coupled to a distal end of the endoscope, wherein the cap is sealingly coupled to a distal region of the outer sheath; and an inner sheath extending within the rigidized outer sheath and configured to extend through a lumen of the endoscope, wherein the inner sheath has one or more lumens and is sealingly coupled to the cap such that the one or more lumens of the inner sheath are open through the cap.

[0080] As described above, in some examples, the rigidizing layer can include multiple lengths of strands that cross one another. The multiple lengths of strands can include one or more of: a braid, a knit, a woven, chopped segments, randomly distributed and / or randomly oriented wires, or a splicer. The compression layer can include a bladder. The flexibility of the inner sheath can be less than the flexible configuration of the rigidizing outer sheath. Any of these devices can include a pressure port coupled to the rigidizing outer sheath and configured to receive pressure to actuate the compression layer. The rigidizing outer sheath can be configured to be rigidified by applying positive pressure. The rigidizing outer sheath can be configured to be rigidified by applying negative pressure.

[0081] For example, an endoscope sheath device configured to prevent contamination of an endoscope may include: a rigidized outer sheath configured to extend over an endoscope, the rigidized outer sheath comprising a rigidizing layer and a compression layer, the rigidizing layer comprising a plurality of strand lengths crossing one another, the compression layer configured to be actuated to apply a force to the rigidizing layer to rigidify the rigid outer sheath from a flexible configuration to a rigid configuration; a cap sealingly coupled to a distal region of the outer sheath and configured to engage the distal end of the endoscope; and an inner sheath extending within the rigidized outer sheath and configured to extend through a lumen of the endoscope, wherein the inner sheath has one or more lumens and is sealingly coupled to the cap such that the one or more lumens of the inner sheath open outwardly through the cap.

[0082] Any of the devices described herein can be configured to be reinforced, and in particular, the inner sheath can be reinforced at the distal end of the inner sheath to prevent clamping of one or more lumens of the tubular inner sheath. The endoscope can be steerable and can therefore be bent in the distal region of the endoscope. Therefore, 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 on steering. In some examples, the inner sheath can be configured to be relatively flexible. However, these inner sheaths can also be configured to resist clamping of the lumen when bent or flexed, which may also occur in the case of highly flexible structures. For example, the inner sheaths described herein can be reinforced, for example, by reinforcing coils, to prevent collapse while maintaining high flexibility.

[0083] For example, an endoscope sheath device configured to prevent contamination of an endoscope may include: a cap configured to be coupled to the distal end of an endoscope; a flexible outer sheath configured to extend over the endoscope, wherein a distal region of the outer sheath is sealingly coupled to the cap; and a tubular inner sheath configured to be inserted through the lumen of the endoscope, the tubular inner sheath extending proximally from the cap within the outer sheath, wherein a distal region of the tubular inner sheath is sealingly coupled to the cap such that the lumen of the tubular inner sheath is open outward through the cap, and further wherein the distal region of the tubular inner sheath is reinforced to prevent the tubular inner sheath from collapsing when bent.

[0084] The distal region of the tubular inner sheath may include a reinforcing coil. In some examples, only the distal region of the tubular inner sheath is reinforced; alternatively, most (or all) of the length of the inner sheath may be reinforced. In some examples, where multiple inner sheaths are used, only those inner sheaths having a single lumen (e.g., a working channel liner) are reinforced as described herein. For example, any of these devices may include a second tubular inner sheath that is sealingly coupled to the cap and configured to be inserted through the lumen of the endoscope, the second tubular inner sheath extending proximally from the cap within the outer sheath. The second tubular inner sheath may include a multi-lumen catheter. The second tubular inner sheath may not be reinforced.

[0085] The tubular inner sheath may include a working channel liner having a working channel lumen. The working channel lumen may include a hydrophilic coating. The flexible outer sheath, cap, and tubular inner sheath may form a fluid-impermeable contamination barrier to prevent contamination of the endoscope.

[0086] For example, an endoscope 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, wherein a distal region of the outer sheath is sealingly coupled to the cap; and a tubular inner sheath comprising a working channel liner configured to be inserted through a lumen of the endoscope, the tubular inner sheath extending proximally from the cap within the outer sheath, wherein a distal region of the tubular inner sheath is sealingly coupled to the cap such that the lumen of the tubular inner sheath is open outwardly through the cap, further wherein the distal region of the tubular inner sheath is reinforced to prevent the tubular inner sheath from collapsing when bent, wherein the flexible outer sheath, the cap, and the tubular inner sheath form a fluid-impermeable contamination barrier to prevent contamination of the endoscope.

[0087] For example, an endoscope 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, wherein a distal region of the outer sheath is sealingly 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 and within the outer sheath, wherein a distal region of the tubular inner sheath is sealingly coupled to the cap. The endoscope is further configured to include a first tubular inner sheath and a second tubular inner sheath connected to a cap such that the lumen of the tubular inner sheath is open outwardly through the cap, further wherein a distal region of the tubular inner sheath is reinforced to prevent the tubular inner sheath from collapsing when bent; and a second tubular inner sheath comprising a multi-lumen conduit sealingly coupled to the cap and configured to be inserted through the lumen of the endoscope, the second tubular inner sheath extending proximally from the cap and within the outer sheath, wherein the flexible outer sheath, the cap, and the first and second tubular inner sheaths form a barrier to prevent contamination of the endoscope during use.

[0088] In any of the methods and devices described herein, the cap configured to be coupled 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 to be squeezed to be removed from the distal end of the endoscope. For example, an endoscope sheath device can include: a tubular outer sheath configured to extend over an endoscope; a tubular inner sheath configured to extend within the lumen of the endoscope, the tubular inner sheath having one or more lumens; and a cap configured to be coupled to the distal end of the endoscope, wherein a distal region of the tubular outer sheath is sealed to the cap, and further wherein a distal region of the inner sheath is sealed to the cap such that the one or more lumens of the tubular inner sheath are open to the outside through the cap, wherein the cap is configured to be removed by squeezing two sides of the cap. The cap may 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. The caps may include a stress relief cutout region configured to reduce the force required to transition the cylindrical mating surface to a circular mating cross-sectional configuration.

[0089] As used herein, a substantially cylindrical surface can have approximately parallel sides (e.g., which may deviate by a certain percentage, such as by + / - 10%, 9%, 8%, 7%, 6%, 5%, etc.). A substantially circular cross-sectional configuration can be approximately circular and need not be completely circular, for example, the radius can vary by a certain percentage around the circumference of the cross section (e.g., by 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 resting cross-sectional configuration to a substantially circular mating cross-sectional configuration, the cap can be compressed from the oval resting cross-sectional configuration to a mating cross-sectional configuration that is more circular than the oval resting configuration, but can still be slightly oval.

[0090] Typically, the cap can 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 can include a latch connector configured to secure the cap to the distal region of the endoscope. The latch connector can include an opening in the cap configured to engage with a protrusion on the distal region of the endoscope. Alternatively or additionally, the latch connector can include a protrusion that mates with an opening on the endoscope.

[0091] In some examples, an endoscope sheath device configured to prevent contamination of an endoscope includes a cap configured to couple to a distal end of an endoscope; an outer sheath sealingly coupled to the cap at the distal end; and one or more inner sheaths extending within the outer sheath, wherein each inner sheath is sealingly coupled to the cap at the distal end and opens outwardly through the cap.

[0092] For example, an endoscope sheath device may include: a tubular outer sheath configured to extend over an endoscope; a tubular inner sheath configured to extend within the lumen of the endoscope, the tubular inner sheath having one or more lumens; and a cap configured to couple to a distal end of the endoscope, wherein a distal region of the tubular outer sheath is sealed to the cap, and further wherein a distal region of the inner sheath is sealed to the cap such that the one or more lumens of the tubular inner sheath open outwardly through the cap, 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; and a latch connector configured to secure the cap to the distal region of the endoscope, wherein the flexible 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.

[0093] An endoscope sheath device may include: 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; and a cap configured to be coupled to a distal end of the endoscope, wherein a distal region of the tubular outer sheath is sealed to the cap, and further wherein the first inner sheath and the second inner sheath are sealed to each other. The distal region of each is sealed to the cap such that one or more lumens of the tubular inner sheath open outwardly through the cap, 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; and a latch connector configured to secure the cap to the distal region of the endoscope, wherein the flexible 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.

[0094] As described above, the present invention also describes a system that can include any of the devices described herein. In particular, the present invention describes a system that includes a catheter suitable for use with the sheaths described herein. These catheters can include a handle area configured to pass through the inner sheath. For example, the present invention describes an endoscope system including a fluid-impermeable contamination barrier to prevent contamination of the endoscope, the system including an endoscope having a lumen and a handle, an endoscope sheath device, and a manifold block, the endoscope sheath device including: an outer sheath configured to extend over the endoscope, an inner sheath including one or more lumens, the inner sheath configured to extend through the lumen of the endoscope, and a cap configured to be coupled to the distal end of the endoscope, wherein the distal region of the outer sheath is sealed to the cap, and further wherein the distal region of the inner sheath is sealed to the cap such that the one or more lumens of the inner sheath are open to the outside through the cap; the manifold block is removably coupled to the handle of the endoscope, wherein the manifold block includes one or more valves in fluid communication with the lumen of the endoscope, wherein the inner sheath is 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.

[0095] The inner sheath may comprise a multi-lumen catheter, and / or may comprise a single lumen sheath (eg, a working channel liner).

[0096] Any of these systems can include a port adapter configured to cooperate with a multi-lumen catheter to create a plurality of isolated ports fluidically connected to each lumen in the multi-lumen catheter. These methods can include a sealing device configured to seal one or more lumens of the inner sheath. The endoscope sheath device can also include a second outer sheath configured to extend through the second lumen of the endoscope, wherein a distal region of the second inner sheath is sealed to a cap such that the one or more lumens of the second inner sheath are open through the cap. The multi-way valve block can include a lumen connector configured to engage with the second lumen of the inner sheath. In some of these examples, the multi-way valve block is disposable. The multi-way valve block can also include an umbilical link connecting one or more valves of the multi-way valve block to one or more connectors configured to couple to one or more of: an irrigation fluid source, an air source, and a vacuum source.

[0097] Any of the sheath devices (devices, systems, etc.) can optionally be used with a robotic endoscope, as described, including a nested robotic endoscope. The sheath devices described herein can be applied to an inner endoscope component (e.g., an inner rigidized endoscope) before it is coupled to an outer endoscope component (e.g., a mother device or outer cannula), such that the outer sheath covers only the inner component, and the outer component can be cleaned or sterilized separately. In some examples, the sheath device can be attached to the inner endoscope component after it is coupled to the outer endoscope component, such that the flexible outer sheath can cover both the inner endoscope and the outer endoscope.

[0098] For example, a system including an elongated outer tube for use with an internal endoscope in a telescoping arrangement may include: an elongated outer tube including an outer lumen; an outer sheath coupled to a proximal end region of the elongated outer tube at a first end region; 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 external lumen, wherein the inner sheath is sealingly coupled to the cap such that the one or more inner sheath lumens open outwardly through the cap. The cap can be configured to couple to a distal end of the internal endoscope, and the inner sheath can be configured to extend through the lumen of the internal endoscope. The elongated outer tube can be configured to be selectively rigidified, for example, by applying positive or negative pressure.

[0099] Also described herein are methods and apparatus for inflating or collapsing an outer sheath of an endoscopic sheath device configured to prevent contamination of an endoscope. For example, any of these devices can include a flexible tubular outer sheath configured to collapse against an endoscope by applying suction (e.g., negative pressure) between the flexible tubular outer sheath and the exterior of the endoscope. The sheath device can be configured to maintain a seal between the flexible outer sheath and the endoscope. In some examples, the apparatus and / or method can be configured to apply positive pressure between the flexible tubular outer sheath and the exterior of the endoscope, for example, to inflate the flexible outer sheath. This can help anchor, navigate, and / or secure the endoscope within the body. Both collapse (e.g., applying negative pressure) and inflation (e.g., applying positive pressure) can help indicate that the sheath device maintains a fluid-impermeable contamination barrier relative to the human body.

[0100] For example, an endoscope sheath device can include: a flexible tubular outer sheath configured to extend over an endoscope; a cap configured to be coupled to a distal end of the endoscope, wherein a distal region of the flexible tubular outer sheath is sealed to the cap; and a proximal sealing collar, wherein a proximal region of the flexible tubular outer sheath is sealed to the proximal sealing collar, further wherein the proximal sealing collar is configured to form an airtight seal against the endoscope such that the tubular outer sheath can be inflated or collapsed by applying fluid pressure (e.g., air pressure, saline pressure, etc.) between the flexible tubular outer sheath and an exterior surface of the endoscope. Any of these devices can include a pressure port in fluid communication with an interior region of the flexible tubular outer sheath and configured to apply positive or negative pressure between the flexible tubular outer sheath and the exterior surface of the endoscope. For example, the pressure port on the proximal sealing collar can be configured to apply positive or negative pressure between the flexible tubular outer sheath and the exterior surface of the endoscope. The flexible outer sheath can include an elastomeric material. The flexible outer sheath can have a non-uniform diameter along the length of the flexible outer sheath. In some examples, the flexible outer sheath has one or more inflation regions along the length of the flexible outer sheath, the one or more inflation regions being configured to expand to a larger expanded radius when the flexible outer sheath is inflated by applying positive pressure.

[0101] The cap can be configured to seal to the distal end of the endoscope. In some examples, the cap is configured to be secured to the distal end of the endoscope and includes one or more of: a friction fitting configured to secure the cap to the distal end of the endoscope; a snap fitting 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.

[0102] Any of these devices may include a tubular inner sheath configured to extend within the lumen of an endoscope, the tubular inner sheath having one or more lumens, wherein a distal region of the inner sheath is sealed to a cap such that the one or more lumens of the tubular inner sheath open externally through the cap.

[0103] For example, an endoscope sheath device may include: a flexible tubular outer sheath configured to extend over an endoscope; a tubular inner sheath configured to extend within a lumen of the endoscope, the tubular inner sheath having one or more lumens; a cap configured to be coupled to a distal end of the endoscope, wherein a distal region of the flexible tubular outer sheath is sealed to the cap, and further wherein a distal region of the inner sheath is sealed to the cap such that the one or more lumens of the tubular inner sheath are open to the outside through the cap; and a proximal sealing collar, wherein a proximal region of the flexible tubular outer sheath is sealed to the proximal sealing collar, further wherein the proximal sealing collar is configured to form an airtight seal against the endoscope such that the tubular outer sheath can be inflated or collapsed by applying fluid pressure between the flexible tubular outer sheath and an exterior surface of the endoscope. In some examples, the fluid pressure can be applied as air pressure. Alternatively, other gases (eg, carbon dioxide, etc.) or liquids (eg, saline) may be used.

[0104] Also described herein are methods and apparatus for confirming that an endoscope is not contaminated after use. Generally, these methods may include pressurizing an endoscope sheath device to confirm that the outer sheath has not been compromised, as might occur if it were to tear or rupture. For example, the methods may include: performing a medical procedure within the body using an endoscope while the endoscope is encased within the endoscope sheath device; withdrawing the endoscope from the body; applying positive pressure between the endoscope and the outer sheath of the endoscope sheath device; and indicating that the endoscope sheath device is contaminated or not contaminated based on a decrease in pressure between the outer sheath and the endoscope.

[0105] The procedure can be performed using any of the devices described herein. For example, the procedure can 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 endoscope sheath device and an interior lumen of the endoscope is covered by an inner sheath, wherein the outer sheath and the inner sheath form a continuous, fluid-impermeable contamination barrier.

[0106] Pressure can be applied from a pressure port on the endoscope or from a pressure port separate from the endoscope. In some examples, 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 endoscope 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 to the proximal region of the endoscope. In any of these devices and methods, the distal end of the endoscope sheath device (e.g., the distal region of the cap and / or outer sheath) can be configured to seal to the distal region of the endoscope.

[0107] Indication can include determining whether the outer sheath has developed a leak based on a decay in pressure between the outer sheath and the endoscope. Pressure can be monitored by a pressure sensor coupled to a pressure port or applied pressure source and / or an endoscope sheath device. In some examples, a pressure indicator (e.g., a gauge, sensor, instrument panel, etc.) can be included. In some cases, the method can include manually observing the inflated outer sheath to detect a loss of pressure (indicating a leak and possible contamination).

[0108] Typically, the indication can include issuing a signal. Alternatively or additionally, the indication can include transmitting a signal (e.g., a pressure profile, a 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 indication includes issuing an alarm, such as an audible and / or visual alarm, if the pressure decay between the outer sheath and the endoscope exceeds a threshold.

[0109] For example, a method of confirming that an endoscope is not contaminated may include: performing a medical procedure using an endoscope while the distal end of the endoscope is covered by a cap, wherein an inner sheath sealingly connected to the cap extends through the lumen of the endoscope from the distal end to the proximal end, and having one or more inner sheath lumens extending through the lumen of the endoscope and opening outwardly through the cap, further wherein an outer sheath is sealingly connected to the cap and extends proximally over the endoscope; withdrawing the endoscope from the body; applying positive pressure between the endoscope and an outer sheath of an endoscope sheath device; and indicating whether the endoscope sheath device is contaminated or not contaminated based on a decay in pressure from between the outer sheath and the endoscope.

[0110] Any of the devices and methods herein may include an applicator for applying and / or removing an endoscopic sheath device to a catheter. For example, any of these methods and devices may include a mounting handle. The mounting handle may include an interior region for holding the outer sheath of the device in a compressed or folded (e.g., pleated, accordion-folded, crimped, etc.) configuration for deployment. Once the procedure is complete, the same mounting handle may be used to remove and flip the outer sheath. For example, a system including a mounting handle can be configured as an endoscope sheath device to prevent contamination of an endoscope, the device comprising: a cap configured to be coupled 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, wherein each inner sheath is sealingly coupled to the cap at a distal end and opens outwardly through the cap; and a mounting handle, wherein at least a portion of the outer sheath is retained in a retracted configuration within a cavity of the mounting handle, further wherein one or more of the inner sheaths extend distally through the retracted outer sheath and cavity and protrude from the distal end of the mounting handle.

[0111] The cap can be positioned at the distal end of the mounting handle. The mounting handle can include a coupler at the proximal end of the mounting handle that is configured to couple to a matching attachment on the endoscope. The outer sheath can be retained within the chamber in a collapsed configuration such that the outer sheath is compressed. In some examples, the outer sheath is retained within the chamber in a collapsed configuration such that the distal end of the catheter can fit within the outer sheath when inserted from the distal end of the mounting handle. The mounting handle can include an outer gripping surface. In some examples, the mounting handle includes a cylindrical shape. The outer sheath can be collapsed in a bellows (e.g., circular or cylindrical pleats) configuration.

[0112] The mounting handle may include a distally facing tapered surface on the distal end of the mounting handle. The distally facing tapered surface (e.g., a funnel shape) may help capture any waste within the inverted outer sheath and may help guide the outer sheath to invert onto itself when removing the outer sheath from the endoscope.

[0113] Also described herein are methods of mounting an endoscope sheath device onto an endoscope, the methods comprising: 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, the outer sheath being held in a collapsed configuration within a mounting handle; coupling a cap of the endoscope sheath device to a distal region of the endoscope; and pulling the mounting handle proximally on the endoscope to deploy the outer sheath on the endoscope. Any of these methods may include coupling the mounting handle to the endoscope and / or removing the endoscope sheath device from the endoscope by advancing the mounting handle distally on the endoscope to flip the outer sheath proximally onto itself.

[0114] Generally, as described above, any of the methods for removing an endoscope sheath device can include sealing a proximal region of the inner sheath prior to withdrawing the inner sheath from the lumen of the endoscope. For example, one or more inner sheaths can be sealed at a proximal sealing region configured to seal by mechanical sealing (e.g., crimping), by heat sealing, etc. Any of these methods can also include disengaging the cap from the endoscope and pulling the sealed inner sheath out of the lumen of the endoscope.

[0115] Any combination of all methods and apparatus described herein is contemplated herein and can be used to achieve the benefits described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0117] A better understanding of the features and advantages of the methods and apparatus described herein will be obtained by referring to the following detailed description and accompanying drawings which set forth illustrative embodiments:

[0118] Figure 1A-1C An example of a general purpose endoscope that may be used with the devices and methods described herein is schematically shown.

[0119] Figure 2A-2C An example of a telescoping assembly including an endoscope that may be used with the devices and methods described herein is schematically illustrated.

[0120] Figure 3A-3C An example of an endoscopic sheath as described herein is schematically shown. Figure 3A An example is shown having a relatively short outer sheath that is securable to the distal region of the outer tube. Figure 3B An example is shown that includes a proximal attachment on the outer sheath. Figure 3C An example is shown having a long outer sheath that may extend beyond the length of the outer tube and / or endoscope member.

[0121] Figures 4A-4C An example of an endoscope sheath shown attached to a telescoping (eg, mother / daughter) endoscope assembly is schematically illustrated.

[0122] Figures 5A-5C An example of an endoscope sheath attached to a telescoping endoscope assembly is shown.

[0123] Figure 6A An example of a telescoping endoscope assembly is schematically shown.

[0124] Figure 6B An example of a telescopic endoscope assembly with a partial sheath is schematically shown.

[0125] Figure 7A Schematically illustrates an example of a cap of a sheath assembly shown frontally.

[0126] Figure 7B is an example of a cross section taken through an example of an endoscope.

[0127] Figure 7C A cross section taken through one example of a sheath assembly is shown.

[0128] Figure 7D and Figure 7E Shown Figure 7C The sheath assembly is connected to Figure 7B A side cross-sectional view of an example of an endoscope.

[0129] Figure 8A-8B An example use of a port adapter as described herein for coupling to a multi-lumen catheter (of an inner sheath) is shown.

[0130] Figure 9A Schematically shows a process similar to Figure 8A-8B An example cut-away cross-section of a port adapter is shown in FIG.

[0131] Figure 9B A cross section taken through one example of a port adapter is shown.

[0132] Figure 9C-9D An example of a port adapter that may be used as described herein is shown.

[0133] Figure 9E is a cross-sectional view taken through one example of a port adapter including a tuohy-like connector for securing and sealing a multi-lumen catheter as described herein (eg, configured as an inner sheath of a multi-lumen catheter).

[0134] Figures 10A-10C One example of a proximal end of a sealed inner sheath is shown.

[0135] Figure 11 is a cross-section taken through one example of a multi-lumen catheter that may be used as an inner sheath as described herein.

[0136] Figure 12 is an example of a port adapter for coupling to the proximal end of a multi-lumen catheter forming an inner sheath.

[0137] Figure 13 An example of a port adapter for coupling to the proximal end of a multi-lumen catheter forming an inner sheath is shown.

[0138] Figure 14 The proximal end of the inner sheath is shown including a crimp area to seal the inner sheath prior to removing the endoscope from the sheath assembly.

[0139] Figures 15A-15D Shown is a diagram including an endoscope ( Figure 15A)、Sheath device( Figure 15B ) and external endoscopes ( Figure 15D ) system.

[0140] Figures 16A-16B A system including a sheath device, a separate external rigidification device, and an external working channel is shown. Figure 16B A schematic diagram of the system is shown, illustrating the use of an external working channel.

[0141] Figures 17A-17D Shown is a diagram including an endoscope ( Figure 17A ), rigid sheath device ( Figure 17B ) and external endoscopes ( Figure 17D ) system.

[0142] Figure 18 An example of a sheath on an endoscope is shown, the sheath having a steerable distal region.

[0143] Figures 19A-19B Examples of inner sheaths that are reinforced over part or all of their length are shown.

[0144] Figures 20A-20D An example of a cap for an endoscopic sheath device is shown. Figure 20A shows a front view, Figure 20B shows a side perspective view, Figure 20C A side view is shown, and Figure 20D A rear view of the cap is shown.

[0145] Figure 21A and Figure 21B The distal region of the endoscope is shown, which is configured to receive Figures 20A-20D The cap of the sheath device is shown. Figure 21A is the distal view of the endoscope, and Figure 21B It's a perspective drawing.

[0146] Figure 21C Shown Figures 21A-21B An end view of the endoscope shown in FIG, wherein a similar Figures 21A-21B The cap shown in FIG is attached to the distal region of the catheter.

[0147] Figures 22A-22C An example of an endoscope sheath device is shown having a cap including a plurality of LED light sources integrated therein. The endoscope sheath device is shown attached to an endoscope. Figure 22A , the device and endoscope are shown in a front perspective view. Figure 22B A front (end) view is shown, and Figure 22C A side view is shown.

[0148] Figure 23Aand Figure 23B An example of a cap of an endoscope sheath device is shown, the cap being transparent and including a plurality of LED lights disposed thereon.

[0149] Figure 24A and Figure 24B An example of a cap is shown that includes a multi-cavity extrusion that holds wires used to control (eg, power) integrated LEDs on the cap.

[0150] Figure 25 Schematically shown is a cap comprising multiple LEDs of different wavelengths (eg, colors), which can be controlled to illuminate in different colors or combinations of colors.

[0151] Figures 26A-26B One example of attaching a cap for an endoscope sheath is shown; for convenience, the inner and outer sheaths are not shown.

[0152] Figures 27A-27C One example of a method of disengaging a cap of an endoscopic sheath device is shown, which may be part of a method of removing an endoscopic sheath device.

[0153] Figures 28A-28D Another example of a method for applying a cap of an endoscopic sheath device is schematically shown, which method may be part of a method of applying an endoscopic sheath device to an endoscope.

[0154] Figure 29A-29B Schematically illustrates a method of mating the cylindrical mating surface of an endoscopic sheath device's cap with the distal end of an endoscope by compressing the sides of the cylindrical mating surface of the cap to transform the cap from an oval resting cross-sectional configuration to a circular mating cross-sectional configuration.

[0155] Figure 30A-Figure 30B Shows something like Figure 29A-29B An example of a transparent cap for an endoscopic sheath device is shown in .

[0156] Figure 31A-Figure 31B The operation of a multi-lumen inner sheath and cap for an endoscopic sheath device is shown. Figure 31A is a perspective view, and Figure 31B is a front (end) view showing the use of a multi-lumen inner sheath to apply each of an insufflant, a cleaning fluid, and an irrigation fluid while maintaining the sterility of an endoscope covered by an endoscope sheath device.

[0157] Figure 32A-Figure 32B In side perspective ( Figure 32A ) and sectional views ( Figure 32B ) shows Figure 31A-Figure 31B The endoscope sheath device delivers cleaning fluid to clean the optics of the cap. Figure 32A-Figure 32BIn FIG, for convenience, the tip cleaning fluid is shown as a cylindrical flow; the actual tip cleaning fluid may take on a different shape when passing through the tip.

[0158] Figure 33A-Figure 33B In side perspective ( Figure 33A ) and sectional views ( Figure 33B ) shows Figure 31A-Figure 31B The endoscope sheath device delivers the insufflant from the cap. Figure 33A-Figure 33B In FIG, the insufflant is shown as a flat triangle for convenience; an actual insufflant (eg, a gas such as air) may assume a different shape as it passes through the tip.

[0159] Figure 34A-Figure 34B In side perspective ( Figure 34A ) and sectional views ( Figure 34B ) shows Figure 31A-Figure 31B The endoscope sheath device delivers irrigation fluid from the cap. Figure 34A-Figure 34B In the figures, the irrigation fluid is shown as a cylindrical stream for convenience; the actual irrigation fluid may take on a different shape when it is ejected from the tip.

[0160] Figure 35A An example of a port adapter that can be used with a multi-lumen catheter that forms an inner sheath is shown. Figure 35A In FIG, the port adapter is shown as partially transparent and engaged with the inner jacket.

[0161] Figures 35B-35D Shown Figure 35A Example of an end view of a (transparent) port adapter, showing separately the port for flushing fluid ( Figure 35B )、Cleaning fluid( Figure 35C ) and insufflations ( Figure 35D ) for each port.

[0162] Figure 36A and Figure 35B An example of a cap for an endoscopic sheath device is shown, the cap including an integrated optical lens as part of the cap. Figure 36A A front (end) view is shown, and Figure 36B Shown through Figure 36A A side sectional view of the cap.

[0163] Figures 37A-37C A removable component (eg, an endoscope cap) is shown that may be used with any of the endoscope sheath devices described herein. Figure 37A and Figure 37B A side cross-sectional view is shown with the endoscope cap closed and open, respectively, with the distal end of the endoscope sheath device applied to the endoscope. Figure 37B A side cross-sectional view is shown.

[0164] Figure 38 An example of an endoscopic sheath device with an integrated (eg, molded or overmolded) end cap is shown.

[0165] Figure 39A An example of a prior art endoscope is shown.

[0166] Figure 39B An example of a manual endoscope suitable for use with an endoscope sheath as described herein is schematically shown.

[0167] Figures 40A-40C An example of an endoscopic sheath device is shown in which the outer sheath can be inflated and / or collapsed (eg, deflated). Figure 40A An example of a catheter is shown schematically. Figure 40B Schematically illustrated are examples of endoscope sheath devices configured to form a proximal seal with an endoscope such that the outer sheath can maintain positive or negative pressure. Figure 40C An endoscope sheath device coupled to (and sealed to) an endoscope is schematically shown.

[0168] Figure 41A An example of an endoscope sheath device coupled to (and sealed to) an endoscope is schematically shown. The tubular outer sheath of the endoscope sheath device has a uniform profile along the length of the sheath and is shown with a tube that can be used to assist in mounting the endoscope, thereby allowing vacuum expansion of the outer sheath during mounting.

[0169] Figure 41B An example of an endoscope sheath device (having a tapered profile) coupled to (and sealed to) an endoscope is schematically shown.

[0170] Figure 41C An example of an endoscope sheath device coupled to (and sealed to) an endoscope is schematically shown.The tubular outer sheath of the endoscope sheath device has a stepped profile along the length of the sheath.

[0171] Figure 42 An example of an endoscope sheath device coupled to (and sealed to) an endoscope after application of negative pressure is schematically illustrated, showing the tubular outer sheath pressed down against the outer surface of the endoscope due to the vacuum.

[0172] Figures 43A-43B is a schematic diagram of an example of an endoscope sheath device coupled to (and sealed to) an endoscope, wherein positive pressure has been applied between the outer sheath and the endoscope to inflate the tubular outer sheath. Figure 43A In the embodiment, the outer sheath comprises a single expandable (e.g., balloon) region, while in Figure 43B In the embodiment, the outer sheath has a pair of expandable (eg, balloon) regions.

[0173] Figure 44 is a schematic diagram of an example of an endoscope sheath device that is configured to be everted upon itself after use for removal from an endoscope.

[0174] Figure 45 The problem of buckling of an endoscope (eg, catheter) when advanced within tortuous anatomy is illustrated.

[0175] Figures 46A-46B The use of an endoscopic sheath device to deploy (e.g., advance) an endoscopic member as described herein is shown. Figure 46A In the embodiment of the present invention, the inner (nested) endoscope is coupled to the sheath at the distal end, and the cover extends over the inner endoscope and the outer endoscope; applying positive pressure between the outer sheath and the endoscope causes the outer sheath to deploy distally, thereby driving the inner endoscope distally, as shown in FIG. Figure 46B shown.

[0176] Figure 47 Another example of an endoscope sheath device is shown that includes an inflatable sheath applied to a nested endoscope.

[0177] Figure 48 Similar to Figure 45 , and illustrates the use of an inflatable endoscopic sheath device to help guide the positioning of an endoscope within tortuous anatomy.

[0178] Figure 49 An example of an inflatable endoscopic sheath for use where the endoscope includes a sensor (eg, an ultrasound sensor) is schematically shown.

[0179] Figures 50A-50C One example of an endoscopic sheath device (eg, an endoscopic sheath assembly) including a mounting handle is shown. Figure 50A A side view of one example of an endoscopic sheath device including a mounting handle in a pre-deployed configuration is shown. Figure 50B Shown in top front perspective Figure 50A Endoscope sheathing equipment, and Figure 50C The endoscope sheath device is shown in a rear side perspective view.

[0180] Figures 51A-51D One example of a method of applying an endoscopic sheath device using a mounting handle over an endoscope as described herein is shown.

[0181] Figure 52A-52B A rear (proximal) view of an endoscope sheath device including a mounting handle is shown, illustrating the coupling of the mounting handle to the proximal end of the endoscope.

[0182] Figure 53An example of a method of packaging an endoscopic sheath device described herein is shown. A compact coiled configuration is shown.

[0183] Figures 54A-54C Removal of the endoscope sheath device from the endoscope using the mounting handle is shown.

[0184] Figure 55 A method of manufacturing an endoscopic sheath device as described herein is schematically illustrated.

[0185] Detailed description

[0186] In general, endoscope sheath assemblies (e.g., endoscope sheath devices and systems) are described herein that include a cap configured to couple to a distal end of an endoscope, an outer sheath that extends over the endoscope (and optionally is sealed to or covers an outer elongated member coaxial with the endoscope), and one or more inner sheaths that extend within one or more lumens of the endoscope. Both the outer sheath and the inner sheath are configured to seal to the cap. These devices can be configured to prevent contamination of the endoscope without impeding any of the functions of the endoscope, including the ability of the endoscope to deliver material into or out of the distal end of the endoscope through an inner lumen or working channel and / or to image from the distal end of the endoscope and / or to move relative to the outer elongated member.

[0187] Any of these devices can be used with an endoscope coaxially arranged within a rigidified outer sleeve (external elongated member). Either or both of the external elongated member and the endoscope can be configured to be rigidified. Any suitable rigidification can be used, including but not limited to rigidification by applying positive and / or negative pressure. Generally, the rigidized member described herein can transition from a flexible configuration (i.e., a relaxed, soft or floppy configuration) to a rigid configuration (i.e., a configuration that is hard and / or maintains its shape when rigidified). The devices and methods described herein are particularly well suited for use with rigidized devices, but can also be used with non-rigidized devices. In some examples, the rigidized member (also equivalently referred to as a rigidizing device, a selective rigidizing device or a selective rigidizing member) can include multiple layers (e.g., coils or reinforcement layers, sliding layers, braided layers, bladder layers and / or sealing layers) that together form the wall of the rigidized member. For example, by applying positive or negative pressure to the wall of the rigidized device or within the layer forming the wall of the rigidized device, the rigidized member can be transformed from a flexible configuration to a rigid configuration. When the positive or negative pressure is removed, the layers can readily shear or move relative to each other. When a vacuum or positive pressure is applied, the layers can transform into a state in which they exhibit significantly increased resistance to shear, movement, bending, torque, and buckling, thereby providing system rigidification.Examples of rigidifying members that may be used with any of the devices and methods herein may include, but are not limited to, those described below: International Patent Application No. PCT / US2016 / 050290, filed on September 2, 2016, entitled “DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE” (published as WO 2017 / 041052); International Patent Application No. PCT / US2018 / 042946, filed on July 19, 2018, entitled “DYNAMICALLY RIGIDIZING OVERTUBE” (published as WO 2019 / 018682); International Patent Application No. PCT / US2018 / 042946, filed on July 19, 2018, entitled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL and PCT / US2021 / 034292 (published as WO 2021 / 242884), entitled “RIGIDIZING DEVICES,” filed on May 26, 2021. Each of these applications is incorporated herein by reference in its entirety.

[0188] Any suitable rigidifying member may be used, including rigidifying members that are not formed of layers and / or are not actuated by pressure (positive and / or negative pressure). For example, a rigidifying member as described herein may refer to any suitable rigidifying device, including members that can be rigidified by plugging particles, by phase change and / or shape memory alloys, by interlocking components (e.g., cables with disks or cones, etc.), EAPs (electroactive polymers), or any other rigidifying mechanism.

[0189] As mentioned above, the sheath assemblies described herein can be used with one or more robotic systems, including, for example, those disclosed in U.S. Patent Application No. 17 / 152,706 (entitled “DYNAMICALLY RIGIDIZING COMPOSITEMEDICAL STRUCTURES,” now U.S. Patent No. 11,135,398), U.S. Patent Application 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

[0014] The telescopic rigidified robotic system described in DEVICES (Layered Walls of Rigidified Devices), each of which is incorporated herein by reference in its entirety.

[0190] The endoscope sheath assembly described herein can be used with a single endoscope. An endoscope can refer to an elongated instrument that can be introduced into the body and can include one or more lumens extending therethrough, and can be used to examine, treat, and / or diagnose internal areas of the human body. Any of these endoscopes can include imaging (e.g., typically via a CCD, CMOS chip, or fiber optic material) to provide a view from the distal end of the device. An endoscope can typically be a catheter that includes one (or more than one) lumen extending the length of the endoscope. For example, in Figure 1A , endoscope 100 includes an elongated flexible (or in some examples, optionally rigidified) body extending from a distal end 113 to a proximal end 111. The endoscope includes a first lumen 105 (e.g., a working channel) and 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 force application lumen, a fluid (air, water, etc.) application 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 formed from a biocompatible material. Figure 1B Shown through Figure 1A endoscopic cross-section, and Figure 1C Shown Figure 1A Distal view of the endoscope.

[0191] Figure 2A-2CAn example of an assembly comprising an inner endoscope 201 coaxially disposed within an outer tube 203 is shown. The endoscope 201 may be coupled to Figure 1A-1C The endoscope shown in FIG. 1 is similar or identical to the endoscope shown in FIG. 1 and includes one or more lumens 105 , 107 (eg, working channel 105 ) and can be configured to slide axially 220 within an outer tube 203 . Figure 2B Shown through Figure 2A The cross section of the component is taken, and Figure 2C Shown Figure 2A In some examples, the assembly can be a telescopic assembly including the endoscope 201 and the outer tube 203, which is configured to be flexible but can be selectively rigidified. Figure 1A-1C and Figure 2A-2C The endoscope or endoscope assembly schematically shown in FIG can be used with any of the endoscope sheaths (sheath devices) described herein.

[0192] Figure 3A-3C An example of an endoscope sheath as described herein is shown. Figure 3A-3C The sheath shown in FIG is shown not attached or connected to an endoscope or any of the endoscope components (e.g., outer tube and inner endoscope member). Figure 3A For example, endoscope assembly 300 includes a cap 327 configured to be secured to and attached to the distal end region of an endoscope. For example, cap 327 can snap onto the distal end, e.g., the cap can be connected to the distal end of a catheter via a deflectable snap on the cap, the distal end of the endoscope, or both. For example, the cap can include a bendable or flexible member to releasably lock (e.g., via a "snap fit") the cap to the distal end of the endoscope. In some examples, the cap can be secured (releasably secured) to the distal end of the endoscope via a clamping or spring-loaded mechanism. In some examples, the cap can be coupled via an engaging screw or threaded region. In some examples, cap 327 can be coupled via 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 examples, the cap can be magnetically coupled to the distal end region of the endoscope to secure the cap to the distal end. In some examples, the cap can be secured to the distal end of the endoscope via a bayonet connector.

[0193] exist Figure 3A , outer sheath 302 is shown as being sealingly connected (e.g., fused, welded, integrally formed, etc.) to cap 327. The outer sheath can be flexible, and in particular can be sufficiently thin or thin-walled so that it can be lightweight and can move relative to an outer tube (not shown) as the endoscope is moved into and out of the outer tube and / or rotated relative to the outer tube. Figure 3AThe example shown in includes a single inner sheath 315 extending proximally within the outer sheath and sealingly connected to a cap 327. The sealed connection between the cap and the inner sheath leaves the lumen of the inner sheath open to the body so that fluids can be applied through the endoscope without breaching the barrier between the patient and the endoscope. Figure 3A-3C In this example, an inner sheath forming only a single lumen is shown, but in other examples, a multi-lumen structure, such as a multi-lumen catheter, may be used. Figure 3A As shown, the inner sheath may define an opening 315 ′ through the cap, with the opening 315 ′ being continuous with the inner sheath 315 as shown.

[0194] In this example, the outer sheath 302 is shorter than the inner sheath 315, and the inner sheath 315 extends beyond the outer sheath and extends proximally 331. In some examples, the short outer sheath can be coupled to an external tube such as an outer cannula ( Figure 3A ), and can be sealed to the outside so that the outer tube can work with the outer sheath to protect the endoscope extending within the outer tube.

[0195] Figure 3B Shows something like Figure 3A Another example of an endoscope sheath device 300' (e.g., sheath assembly) is shown in FIG, but has a second inner sheath 317 having a distal opening 317' through a cap 327 that allows materials or tools to be passed into and out of the endoscope to treat tissue. Figure 3B In the embodiment of the present invention, the second inner sheath 317 can form a working channel liner, which can line the working channel of the endoscope. The inner sheath can be a catheter, including a multi-lumen catheter. Figure 3B The outer sheath 315 in may be similar to Figure 3A , and can be relatively short, for example, can be coupled to an external tube (not shown). In any of the sheath assemblies described herein, the outer sheath can include a proximal attachment on the outer sheath configured to secure the outer sheath to an outer surface of an external tube coaxially disposed on the endoscope.

[0196] Figure 3C Shows something like Figure 3B The sheath assembly 300' shown in the figure includes a first inner sheath 315 that passes through an opening 315' of the cap 327 and a second inner sheath 317 (e.g., a working channel liner) that also passes through an opening 317' of the cap 327, both of the first inner sheath 315 and the second inner sheath 317 being sealingly attached to the cap, and the sheath assembly 300' includes an outer sheath 302' that is elongated and sealingly coupled to the cap at a distal end and may optionally include a proximal attachment region or proximal attachment 321 for attachment to an endoscope or an external tube configured to be coaxially mounted on an endoscope.

[0197] In any of these examples, the cap can be light transmissive (transparent) to allow imaging through the cap, or the cap can include a window area that is configured to align with a camera area of ​​the endoscope. In some examples, the cap has an anti-reflective coating or an anti-glare coating.

[0198] Figures 4A-4C Schematically illustrated is an example of a sheath assembly shown coupled to an endoscope and an external tube, the sheath assembly being coaxially disposed on the endoscope to allow telescopic movement between the endoscope and the external tube.

[0199] In any of these devices, the sheath assembly can include an outer tube, whereby the outer tube can be a disposable component that can be coupled to the outer sheath. For example, Figure 4A A cross-section through a sheath device is shown that is configured as a system that includes a flexible outer tube 403 for use with an inner endoscope 401 in a telescoping arrangement. In this example, the elongated outer tube 403 is coupled (e.g., sealingly coupled 428) to an outer sheath 402 at a distal region. The outer sheath 402 is, in turn, sealingly coupled 429 to a cap 427 at the distal end of the outer sheath. The cap 427 can then be removably coupled to the endoscope 401 at the distal end of the endoscope. As shown, the outer sheath 402 can be sealingly coupled around the outer periphery of the cap. A pair of inner sheaths 415, 417, each having one or more inner sheath lumens, extend within the outer sheath and within the lumen of the endoscope 401. Both inner sheaths are sealingly coupled to the cap so that the inner sheath lumens are open outwardly through the cap to allow material to pass through the endoscope. For example, one of the inner sheath lumens may be connected to a water supply, while the other may be connected to a suction device and / or may provide a working channel, eg, for a tool.

[0200] In this example, the outer tube can be connected to the sheath tip using a thin, flexible outer sheath that allows for substantial movement of the sheath tip away from and toward the distal tip of the outer tube, e.g., allowing for axial (reciprocating) movement as well as torsional ("roll axis") movement, even with the outer sheath. The internal working channel and supply lines of the endoscope contain a liner (e.g., an inner sheath), which is essentially a long tube the length of the endoscope, such that the endoscope lumen is enclosed by the inner sheath, which serves as a tube for delivering gases and liquids or as an internal working channel through which surgical tools can be delivered or vacuum can be drawn. The inner and outer sheaths are joined together at a cap (e.g., sheath tip 427). The cap provides a transparent surface and lighting for the endoscope's camera and may also incorporate nozzles (e.g., outlets for tip cleaning) and pass-through ports for delivering the contents of the inner sheath through the cap. As described above, the cap can be configured to be fastened to the endoscope tip so that the endoscope tip remains well attached during surgery, but can then be detached 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.

[0201] Figure 4B 1 is shown without the endoscope 401, including an attached outer tube 403, a cap 427, and a pair of inner sheaths 415, 417. The sheath assembly 400 can be releasably coupled to an endoscope, such as by inserting the inner sheaths 415, 417 through a lumen of the endoscope and snapping or otherwise coupling the cap 427 to the distal end of the endoscope.

[0202] Figure 4C Shows something like Figure 3C An alternative example is shown in which outer sheath 402 is not coupled to outer tube 403 and extends proximally along most or all (or more) of the length of outer tube 403. As shown in this example, outer sheath 402 extends proximally to the proximal region of the endoscope and / or outer tube.

[0203] Figures 5A-5C An example of an outer sheath 502 attached to an outer tube 503 is shown, and includes two inner sheaths 517, 515 (at Figure 5A 503). Figures 5A-5C The outer sheath in the device shown in FIG includes a base 522 at the proximal end of the outer sheath that can be sealed to an outer endoscope 503 (e.g., an outer cannula). The outer tube shown in this example is shown shorter than normal but represents a full-length version. A cap 527 of the sheath assembly is coupled to the distal end of the outer sheath 502. Figure 5A In the embodiment, the sheath assembly has not yet been coupled to the endoscope. Figure 5BEndoscope 501 is shown inserted into outer tube 503, with endoscope 501 fully extended to the limit of outer sheath 502. The end of the outer sheath (cap 527) is secured to the distal region of the endoscope and extends and retracts with the endoscope as described above.

[0204] Figure 5C Endoscope 501 is shown 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 is bunched together and does not restrict retraction or extension or bending of the endoscope.

[0205] In operation, such as Figures 5A-5C The illustrated configuration of the sheath assembly incorporating the outer tube can be single-use and / or disposable. In this example, the endoscope can be inserted through the outer tube and fully inserted into the outer sheath, where it is attached to the end of the sheath. The outer tube and / or endoscope in this example can be selectively rigidified devices activated by the application of positive or negative pressure. In this example, after connecting the endoscope, outer tube, and inner sheath to external control, vacuum, and supply lines, the system is ready for use during surgery, such as insertion into the body. The sheath protects the endoscope 501 from any materials that could contaminate the endoscope. After the procedure, both the inner sheath and outer tube can be disconnected 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 with both inner and outer sheaths and be immediately reused. High-level sterilization of the endoscope is not required between procedures, saving time and expense. As described herein, the removal process can include sealing the inner sheath to prevent contamination.

[0206] In any of these devices and methods, after use of a sheath assembly (e.g., an endoscope sheath device), it can be pressure tested to confirm that it remains leak-free and, therefore, that the underlying structure (e.g., the endoscope) remains clean. To this end, the outer sheath can be at least partially inflated, for example, by injecting pressurized air through a pressure port. The outer sheath can be sealed at either or both ends. The inner sheath can be sealed proximally (e.g., when it is free from the liner). The method or device can monitor pressure, for example, using a pressure sensor configured to detect pressure within the outer sheath during inflation. The pressure sensor can track a pressure decay curve that can be reported and / or analyzed to determine whether a leak, i.e., an indication of contamination, is present. The pressure data can be reported to an operator and / or the device can automatically or semi-automatically determine whether a leak is present based on the pressure data. For example, the device can include software, hardware, and / or firmware for receiving pressure data, the software, hardware, and / or firmware being configured to analyze the pressure data (e.g., the decay curve) and compare the pressure response to a predetermined value to determine whether a leak is present.

[0207] In some examples, the outer sheath extends the entire length of the outer tube, and the outer tube is not incorporated into the outer sheath, e.g. Figure 4C In this configuration, the outer tube is also completely isolated from contaminants and can be reused with a new sheath without the need for sterilization.

[0208] Figure 6A 6 shows a schematic example of a telescoping assembly comprising an outer tube 603 and an endoscope 601, shown without a sheath assembly attached. Figure 6B An example of a system is shown that includes only a portion of the 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, although the space between the endoscope 601 and the outer tube 603 can remain contaminant-free, both the outer surface of the outer tube and the inner lumen of the endoscope can become contaminated.

[0209] As mentioned above, any suitable cap may be used. For example, Figure 7A An example of a cap 727 shown in an end elevation view is shown. The cap can be formed of a transparent material, such as a transparent polymer material (e.g., polycarbonate (PC), polymethyl methacrylate (PMMA), acrylate, polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyethylene (PE), cyclic olefin copolymer (COC), etc.). In some examples, such as Figure 7A As shown, a transparent camera window area 736 may be included. The cap may also include a sealing joint 739 for a fixed inner sheath ("fixed sleeve") (such as a multi-lumen extrusion sheath 717 and / or a working channel sheath 715). As shown, the interior of these inner sheaths are open to allow access to a body region at the distal end of the device. For example, the multi-lumen extrusion sheath 717 includes three sub-lumens 737, 738, 738', for example, a lumen 737 for water, a lumen 738 for air, and / or a lumen 738' for vacuum (or additional air / water channels). In Figure 7A In the embodiment of the present invention, the working channel sheath also includes an open channel 748 that can be used to pass tools through the endoscope.

[0210] Figure 7B A cross section is shown through the distal region of one example of an endoscope 701 that can be used with a sheath assembly as described herein. Figure 7B In FIG, endoscope 701 includes a lumen 785 that extends the length of the endoscope and opens at the distal end of the endoscope. Figure 7C7. A cross-sectional view is shown through an example of a sheath assembly 700 comprising a cap 727, an outer sheath 702, 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 ( Figure 7C ), or may be long enough to extend along the entire length of a separate elongated external tube and / or endoscope.

[0211] Figure 7D-7E Shown Figure 7C The sheath assembly 700 in Figure 7B The proximal end of the inner sheath 717 can be first inserted into the lumen 785 of the endoscope, and the endoscope can be advanced distally 749 until the cap 727 of the sheath assembly 700 can be coupled to the endoscope 701. For example, Figure 7D 7. A cross-sectional view taken through the distal end region of the sheath assembly 700 is shown with the endoscope 701 partially inserted. The outer sheath 702 of the sheath assembly is sealed around the exterior of the cap 727, and the inner sheath 717 is also sealed to the interior of the cap 727. As described above, the inner sheath 717 in this example has two lumens 738, 737 that are open through the cap so that materials (e.g., air, water, saline, etc.) can pass through the endoscope into or out of the lumen of the sheath without contaminating the lumen of the endoscope 701. In this example, the cap 727 is optically transparent at least in the camera window region 736, although in some examples, the entire cap can be transparent so that the imaging camera 786 of the endoscope 701 can be imaged through the cap 727.

[0212] exist Figure 7D , the sheath assembly is shown where the cap 727 has not yet been connected to the endoscope 701. The endoscope 701 can be driven distally 749 (or alternatively and / or additionally, the cap can be driven proximally) to engage with the cap 727, as shown. Figure 7E In this example, a recessed area 714 at the distal region of the endoscope can engage 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. Figure 7C As shown. The recessed area 714 can be a groove and / or it can be a lip, ridge, or edge. In some examples, the connector can 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 area configured to secure the cap to the distal end of the endoscope, etc. Because the connection occurs within the outer sheath or between the outer sheath and the inner sheath, the connection does not need to form a seal, but should be secure so that the cap remains at the distal end of the endoscope when the endoscope is moved axially and / or rotationally.

[0213] As described above, to prevent contamination of the endoscope and / or the outer tube, in any of the exemplary devices described herein, the inner sheath (e.g., working channel, multi-lumen catheter, etc.) can be sealed prior to removal from the endoscope (and in some cases from the outer tube). This can be accomplished in several ways. For example, one or more inner sheaths (which can be configured as catheters) can be plugged, crimped, blocked with an adhesive or other occlusive material, heat sealed, etc. The sealing method used can stay within the outer diameter of the inner sheath so that the inner sheath can be withdrawn through the endoscope. For example, see Figures 10A-10C and Figure 14 .

[0214] The devices described herein can incorporate the internal working channel and supply lines into a disposable sheath. This can effectively make those elements of the endoscope disposable, single-use components that protect the patient and the endoscope equipment. As described above, these working channels (working channel liners) can be sealed before they are removed.

[0215] Typically, the sheath devices described herein are configured such that the endoscope and outer tube can roll relative to each other in addition to axial sliding. In some examples, the outer sheath can be intentionally twisted as the outer sheath accommodates 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 various longitudinal / axial movements and rotational movements between the inner endoscope and outer tube.

[0216] Also described herein are port adapters for easy fluid connection to small bore multilumen catheters (extrusions) that can be used as inner sheaths (working channel linings). For example, Figure 11 A cross section of one example of an inner sheath (multi-lumen extrusion (MLE)) (1117) is shown that combines the working channel 1116 with three other water / gas channels 1118, 1119, 1120 into a single extrusion. Thus, in some configurations, only one inner sheath may be required.

[0217] Multi-lumen sheaths (such as Figure 11A multi-lumen inner sheath as shown) can be used with a port adapter to allow communication of all of the lumens within the inner sheath. Some of the lumens can be connected in one direction (i.e., out to the side) and some of the lumens can be connected in other directions (e.g., axially or coaxially). In any of these devices and methods, the proximal end of the multi-lumen catheter can be sealed, but the one or more openings into the lumens can be arranged along the sides of the distal region, for example for use with a port adapter as described herein. In some examples, the port adapter can alternatively be configured to couple to and access the distal end of the multi-lumen catheter forming an inner sheath (e.g., a liner), for example, to form a seal with the various lumens of the multi-lumen catheter. Note that any of the port adapters described herein can be configured for use with a single-lumen inner sheath (e.g., a single-lumen catheter) by making sealing contact with the lumens of the inner sheath either through the side opening or at the distal end (or both).

[0218] Now return to Figure 8A-8B , an inner sheath 817 configured as a multi-lumen extrusion (MLE) is shown together with one example of a port adapter. Figure 8A , the inner sheath includes a rigid or semi-rigid connector end 885 including lateral openings 808 into each lumen of the inner sheath 817, the rigid or semi-rigid connector end 885 being shown attached to the proximal end 887 of the inner sheath 817 at an optional joint 886. The joint may or may not be required, i.e., the inner sheath 817 may have an exit port without being a separate connector end 885. The proximal end may also include an engagement structure (e.g., a neck region 889) that may engage with a port adapter, such as Figure 8B As shown. Figure 8B In FIG. 8 , the connector end 885 of the inner sheath 817 is inserted into the receptacle manifold of the port adapter 869, which provides a connection for each cavity (or channel) in the inner sheath, such as Figures 9A-9B As shown. In this configuration, the system is not limited to radial position, that is, it can be inserted so that any radial configuration can be properly connected to the mating cavity. There is a spacer and a sealing gasket (e.g., O-ring) between each radial port. There is a spacer ring between each sealing gasket to allow flow.

[0219] Figure 9A An example of connecting the inner sheath 817 to a port adapter 869 is shown, which provides a separate straight-through connection to each individual lumen in a multi-lumen catheter. In any of these port connectors, the proximal end of the inner sheath can engage the port connector to secure it in place and / or align the opening 808 of the inner sheath with the connector of the port connector. Figure 8AIn the embodiment, port connector 869 includes an inner sheath connector receptacle having a releasable locking mechanism 992 that engages engagement structure 889 at the proximal region of the inner sheath. In alternative embodiments, 885 may not have the special end geometry 889, and there may be, for example, angled metal tangs that "grab" the exterior of 885 for retaining 885. For removal, the tangs may be deflected to the side so that they no longer contact 885.

[0220] Figure 9B Shown Figure 9A In this example, the proximal connector 885 of the inner sheath is inserted and latched into the receptacle manifold of the port adapter, as shown in FIG. Figure 9A The flow from each cavity can be kept separate and pass to separate ports 971, 972, 973 to connect to the supply line. A three channel embodiment is shown, but more or fewer channels (or cavities) can be accommodated using this technology.

[0221] exist Figure 9B In the embodiment, each individual port includes an annular sealing area 994, for example, by using O-rings 993, which create two or more radial seals. Between the O-rings 993 is a space for the transmission flow: for example, a ring with a channel and a cross-drilled geometry. When the inner sheath 817 is fixed in the port connector, the lateral openings 808 to each lumen are aligned along the length of the proximal end so that the lateral openings 808 are positioned so that each lumen has a dedicated annular sealing area. Figure 9B 8, 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 enter or exit the openings from the annular sealing areas in fluid communication with ports 972, 973 on the port connector 869. These ports can be standardized to fit any suitable connector.

[0222] Figure 9C and 9D Shown is a diagram of a multi-lumen catheter forming an inner sheath of an endoscopic sheath device before insertion ( Figure 9C ) and after ( Figure 9D ) two examples of port adapters 969, 969'. Figure 9C In, similar to Figure 9A As shown in FIG, the first port adapter 969 is configured so that the multi-lumen catheter 917 can be inserted into the inlet 966 and can be easily slid all the way until the distal end of the multi-lumen catheter reaches the rear portion (e.g., the stop 988) in the port adapter, as shown. Figure 9E. In this example, the interior of the port adapter can be divided into regions or zones corresponding to the number of lumens in the multi-lumen catheter. These regions can be separated by one or more gaskets 983. The multi-lumen catheter can include one or more openings or holes through the wall of the multi-lumen catheter into each lumen of the multi-lumen catheter, the one or more openings or holes being arranged along the length so that the opening into a particular lumen of the multi-lumen catheter will fall within a particular distance range from the end of the multi-lumen catheter so that once inserted into the port adapter, all holes corresponding to the particular lumen will be within the corresponding region or zone, as shown. Figure 9A As described in.

[0223] 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 be exposed to high compressive loads because the inner diameter of the O-ring will be smaller than the outer diameter of the multi-lumen catheter in order to seal. Although this tight fit can help form a radial seal with the O-ring, it may cause buckling of the multi-lumen catheter. Figure 9C and Figure 9D At the top and in Figure 9E The example port adapter 969 shown in cross section can avoid this problem by increasing the radial clearance of the O-ring and applying force to squeeze the O-ring downward by axially compressing the component stack (e.g., gasket stack), which translates into the necessary radial compression of the seal against the multi-lumen catheter. This motion (e.g., axial advancement due to rotating threads translates into radial compression) is similar to the motion made by a tuohy (e.g., TuohyBorst adapter) to a device at the rear of the catheter (typically used to adjust the rear end seal against the guidewire).

[0224] exist Figure 9C-9E In the port adapter 969 shown, the gasket 983 that forms the seal between each of these separate zones can be an O-ring having an inner diameter that can be larger than the outer diameter of the multi-lumen catheter. This can allow even very flexible multi-lumen catheters to be easily inserted and can help ensure complete insertion of the multi-lumen catheter. Figure 9EAs shown in , the port adapter can include a compression mechanism, such as a tuohy connector for securing the multi-lumen catheter within the port adapter. For example, a knob 913 can be twisted clockwise to compress a gasket in a gasket stack (e.g., a receptacle manifold) onto the multi-lumen catheter; tightening the knob drives a pusher 981 into the receptacle manifold (e.g., stack) of gaskets 983 to axially compress the gasket 983 and thereby radially compress it 985, and press the gasket 983 against the multi-lumen catheter, thereby forming a seal. To remove the multi-lumen catheter, the knob 913 can be loosened to release the compression force 985 applied by driving the pusher 981 986 into the gasket of the receptacle 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, which can then automatically turn the knob, or simply slide the knob axially using a linear actuator, thereby compressing the O-ring and creating a seal.

[0225] Figure 9C and Figure 9D It also shows something like Figure 9A-9B The port adapter 969' of the port adapter 869 shown in FIG. 1 may include a catch or lock for securing the multi-lumen catheter within the port adapter. In any of the port adapters described herein, the device may include a spring detent or catch-like device for securing the multi-lumen catheter within the port adapter. The port adapter may be one-way or releasable.

[0226] Figure 12 An alternative port adapter 1269 is shown. Figure 12 In the example, the port adapter uses a face seal strategy. Male connector 1212 is inserted into female connector 1215. Each cavity in the male connector (three cavities in this illustration) is fed by its own separate supply channel. The supply channel is sealed to the end of the male connector via a face seal so that there is no cross transmission between the channels. Figure 13 Another example of this type of port adapter is shown. In this example, the front face of the multi-lumen extruded inner sheath can align each channel with the port, which may require rotational orientation of the input tube. In either of these examples, the axis of the inner sheath 1212 can be keyed to guide the orientation of the inner sheath relative to the port connector.

[0227] exist Figure 13 In the embodiment, the inner sheath 1317 is keyed to the port adapter 1369 so that the inner lumens can each engage a connector in the port connector that can seal to an opening at the distal end of the inner sheath to allow entry into and exit from the lumen within the inner sheath. Figure 13In the example shown, upper port connector 1369 is shown engaged with inner sheath 1317, while lower port connector 1369' is not engaged with inner sheath 1317'. Each port connector includes three standard connectors 1368 that can be coupled to tubing for applying / removing material.

[0228] As described above, before removing the sheath assembly, the inner sheath can be blocked to prevent contamination. The inner sheath can be sealed by any suitable means, including heat sealing (e.g., melting by force applied by a heated die), mechanical (e.g., crimping, clamping, stapling, etc.), etc. Figure 14 A crimp-based sealing method is shown. A crimp 1442 may be included on the inner sheath, preferably near the proximal region. This crimp 1442 can be crimped closed after the procedure. The compressed crimp 1442' seals the sheath to prevent contaminating fluids from leaking out of the sheath, and when compressed, the crimp's diameter is smaller than the outer diameter of the inner sheath 1417, allowing the crimp to be pulled through. The inner sheath 1417 can then be wiped clean and removed by pulling it through the endoscope without contaminating the endoscope.

[0229] Now return to Figures 10A-10C , these figures show an alternative to crimping where the inner sheath 1015 is sealed after the procedure by heat sealing. The heat seal hygienically seals the inner sheath to keep any contaminants safely within the sheath. The internal volume of the tube can be driven locally to zero, which greatly reduces the possibility of contamination. The heat seal can further reduce any problems associated with any potential residual material. In Figure 10A In the embodiment, the inner sheath 1015 is inserted into the heat sealing device 1042 so that the inner sheath 1015 can be ... Figure 10B Heat (and / or mechanical pressure) is applied to melt the material of the inner sheath, thereby producing Figure 10C The seal portion 1016 is shown. 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. For blood sampling and other applications, it is common to heat seal tubes with liquids in them.

[0230] It may be advantageous to use an inner sheath for the sheath assembly, wherein the inner sheath itself becomes the supply line and working channel of the endoscope and still passes through the interior volume of the endoscope. The outer sheath portion can not only bend from side to side, but also be flexible enough to support extension and retraction of the endoscope relative to the outer tube while maintaining a physical barrier to contamination.

[0231] Any of the endoscope sheath devices described herein can be used with either robotic or manual nested endoscopes. For example, the endoscope sheath device can be part of a system that includes an elongated outer endoscope and an inner endoscope arranged in a telescopic arrangement. The endoscope sheath device can be configured to fit over both an inner endoscope (i.e., fit into an outer endoscope) and an outer endoscope. Alternatively, as Figures 15A-15D As shown, the endoscopic sheath device can be configured to fit over an inner endoscope and then be inserted through an outer endoscope. Figure 15A An example of an endoscope 1500 is shown, in which example the endoscope 1500 includes a first lumen 1501 and a second lumen 1505 . Figure 15B An example of an endoscope sheath device 1535 that can be used with a first (internal) endoscope is shown. The endoscope sheath device includes a cap 1525 to 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 so that the cap is open to allow access to the lumens of the first sheath 1515 and the second sheath 1517.

[0232] Figure 15C Shown Figure 15B The device 1535 is attached to Figure 15A The cap can be attached (e.g., latched, friction fit, snapped, etc.) to the distal region of the endoscope 1500. Figure 15C In the present invention, an endoscope can be inserted into the body without risk of contamination because the endoscope sheath device forms a complete barrier for both the outer surface and the inner (luminal) surface of the endoscope. The endoscope sheath device does not prevent or restrict (but rather enhances) the operation of the lumen of the endoscope, while still maintaining a fluid-impermeable contamination barrier to prevent contamination. Therefore, as described herein, the internal endoscope can be reused after the procedure by removing the endoscope sheath device without contaminating the endoscope. For example, the inner sheath can be sealed at its proximal end (by crimping or other means), and the outer sheath can be flipped over by partially or completely pulling it proximally, thereby preventing contamination and trapping any contaminants within the flipped sleeve of the sheath.

[0233] The cap can include one or more transparent sections to allow access to a camera and lighting device built into the endoscope 1500. Both inner sheaths of the endoscope sheath device can include lumens that can be used to pass material through the endoscope by passing the material through the cap into the lumen of the inner sheath. A multi-lumen catheter can be used in one or both of the inner sheaths and can include sub-lumens for flushing lines, tip wash lines, and / or insufflation lines, for example, which can be directed by the shape of the tip region, which can include deflectors, nozzles, etc. For example, the tip can include a tip wash deflector or nozzle that can direct fluid from the tip wash sub-lumen of the multi-lumen catheter forming one of the inner sheaths to clean the window of a camera on the tip. As described herein, in some examples, the tip can include lighting devices built into the cap rather than on the endoscope.

[0234] Figure 15D Also shown is the use of the endoscope with an applied endoscope sheath device and a second (e.g., external) endoscope. Figure 15D In the embodiment of the present invention, an external endoscope 1539 includes a lumen into which an internal endoscope covered by an endoscope sheath device can be inserted. In this example, the external endoscope 1539 can be configured to serve as an outer cannula and can be single-use or limited-use (e.g., disposable). The endoscope 1500 can be a reusable removable endoscope core. The endoscope 1500 can include one or more cameras, lighting devices, traction cables (e.g., for steering the distal region), a coil assembly, a bend, etc. As described above, the endoscope can be inserted into a new endoscope sheath device and secured in place by coupling a cap to the distal region of the endoscope and, in some examples, inserting it into the external endoscope to perform the procedure.

[0235] Generally, these methods and apparatuses thus allow for the replacement of less durable components, including the endoscope sheath device and any associated hydrophilic coating on the exterior (e.g., configured to be positioned between the outer endoscope / outer cannula and the inner endoscope), before each new procedure, while the inner endoscope can be reused multiple times. Thus, the inner endoscope can be hygienically covered by the endoscope sheath device, allowing the inner endoscope to be reused without the need for high-level disinfection (HLD). The inner endoscope can be completely shielded from any exposure to water and contaminants, which contributes to a simpler and more cost-effective design and construction. Furthermore, 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 endoscope's most expensive components, such as the camera and components of the bending section. This configuration can also allow the inner endoscope to be removed and replaced during surgery while leaving the outer endoscope / outer cannula in place. These methods can also be adapted to utilize the outer surface of the outer sleeve to add accessories, such as external working channels, as shown in reference Figures 16A-16B As stated.

[0236] Generally, any of the devices described herein may include the use of an external working channel on an endoscope sheath device and / or on an endoscope used in conjunction with an endoscope sheath device. Figure 16A Shown in which Figure 15D The illustrated apparatus (including endoscope 1500, endoscope sheath device 1535, and outer overtube 1539) also includes an example of an external working channel 1545. Examples of external working channels can be found, for example, in U.S. patent application Ser. No. 17 / 940,906, filed Sep. 8, 2022, entitled “EXTERNAL WORKING CHANNELS,” and U.S. patent application Ser. No. 18 / 000,062, filed May 26, 2021, entitled “RIGIDIZING DEVICES,” the contents of each of which are incorporated herein by reference in their entirety.

[0237] One or more external working channels 1545 can expand from an outer surface of the outer endoscope 1539 and can include a proximal insertion guide region 1547 for inserting one or more devices through the external working channel. Figure 16B An example of a system is shown, which includes a Figures 15A-15D 15. An endoscope is depicted in FIG. 15, which is covered by an endoscope sheath device 1535 that is slidably disposed within an outer endoscope 1539. As described above, the outer surface of the endoscope sheath device may be coated with a hydrophilic coating to assist in axial movement between the outer endoscope and the inner endoscope. Figure 16B The system shown in also includes an external working channel 1545 that is configured as a covering on an external endoscope that includes a proximal insertion guide 1547. Figure 16B , tools 1549, 1549' are shown inserted through insertion guide 1547, into the working channel of the external working channel and extending distally from the distal end of the external endoscope. The proximal end of the internal endoscope 1558 is shown extending from the proximal end of the external endoscope. In this example, an inner sheath (not shown) can extend proximally and can be coupled to, for example, a suction source, a fluid source, an insufflation source, etc. These working channels can coexist with the sheath system so that the underlying endoscope maintains its cleanliness even as tools are passed through its working channel and tools are passed through the external working channel.

[0238] In any of these examples, the external working channel can be mounted on an outer sleeve, such as Figure 16B As shown, for example, using Figure 4A In this case, the working channel can be discarded together with the outer sleeve and the distal outer sheath after each operation.

[0239] In some examples, the external working channel can be mounted on an outer sheath of an endoscope sheath device. For example, one or more external working channels (including an expandable working channel) can be incorporated into an outer sheath, such as a full-length outer sheath, which can be fitted over the exterior of an endoscope or endoscope assembly (e.g., Figure 4C In this configuration, the working channel can be discarded after each procedure along with the full-length outer sheath, but there is no need to dispose of the outer cannula (which is protected beneath the full length of the outer sheath).

[0240] Any of the endoscopic sheath devices described herein can be configured as a rigidized endoscopic sheath. The endoscopic sheath device can be rigidized in any suitable manner, including but not limited to a pressure rigidization device. For example, the endoscopic sheath devices described herein can include a rigidized outer sheath configured to extend over an endoscope and can include a rigidizing layer and a compression layer, the rigidizing layer including a plurality of strand lengths that cross each other, the compression layer configured to apply a force to the rigidizing layer upon application of pressure to rigidize the rigidized outer sheath from a flexible configuration to a rigid configuration.

[0241] For example, Figures 17A-17DA system is shown including an endoscope 1700 having one or more lumens (e.g., in this example, a first lumen 1701 and a second lumen 1705) and a rigidized endoscope sheath device 1735. The rigidized endoscope sheath device includes a cap 1727 configured to be attached to a distal region of the endoscope 1700 and includes one or more inner sheaths (in this example, a first inner sheath 1715 and a second inner sheath 1717) configured to fit within the endoscope 1700. The rigidized endoscope sheath device also includes a rigidizable outer sheath 1702. The rigidizable outer sheath 1702 is a tubular sheath sealed to the cap 1727. The outer sheath 1702 can have an inner diameter slightly larger than the outer diameter of the inner endoscope 1700.

[0242] The rigidizable outer sheath 1702 may include a rigidizing layer or region coupled to a compression layer (which may be or include a bladder) that applies a force to the rigidizing layer to rigidify the rigidizing layer or, in some cases, de-rigidize (e.g., release) the rigidizing layer. In some examples, these rigidizable outer sheaths 1702 may include a rigidizing layer that may include a braid, knit, woven, cut, randomly distributed or randomly oriented wires or strands, adapters, links, scales, plates, segments, particles, granules, crossing wires, or other materials that form a rigidizing layer. For example, the rigidizing layer may include multiple strand lengths or strand segments that cross each other (e.g., as part of a braid, knit, woven, etc.); the compression layer may apply a force to drive the crossing strand lengths or strand segments against each other. In some examples, the rigidizing layer can be a braided layer, however, any of these devices can alternatively or additionally include a general rigidizing layer that includes intersecting strand lengths or strand segments. Examples of the rigidizing devices described herein can selectively and controllably rigidify using pressure (positive pressure) and / or negative pressure. In some examples, the methods described herein can be used with any suitable rigidizing device.

[0243] Figure 17C An example of an assembled inner catheter 1700 and rigidified endoscope sheath arrangement 1735 is shown. The inner rigidized sheath is inserted into the lumen of an endoscope, the cap is coupled to the distal end of the endoscope, and the outer rigid endoscope sheath 1702 extends over the outer surface of the endoscope.

[0244] Any of these systems may also optionally include a second external endoscope 1739, such as Figure 17D As shown. Thus, these devices can be used in a nested configuration. In some configurations, the outer endoscope can also be rigidized.

[0245] As described above, the outer endoscope 1739 (e.g., outer cannula) can be disposable / disposable and / or reusable (e.g., by cleaning or by sheathing). Similarly, the endoscope sheath device can be disposable / disposable or reusable (e.g., by cleaning). The endoscope can be reusable and can include, for example, a camera, lighting, pull cables, a coil assembly, a bending section, etc. The inner endoscope can be inserted into a new endoscope sheath device and secured in place for the procedure, and then unsecured and removed after the procedure.

[0246] In any of the devices described herein and methods of using and making the same, the inner sheath can be configured to both prevent contamination and allow one or more materials or objects to pass through. Generally speaking, the inner sheath is typically a tubular sheath that is sealed such that the distal outer edge is circumferentially sealed within the opening through the cap. Furthermore, the inner sheath can typically be stiffer than the outer sheath and can be stiff enough so that the inner sheath can be screwed into the lumen of the catheter. Furthermore, the inner sheath can be stiff enough so that when used as an internal working channel (e.g., when the inner sheath is used as a working channel liner), the inner sheath can allow material to pass through unimpeded. However, in some cases, particularly when used with devices such as Figure 18 When used with a steerable endoscope as shown, the internal working channel must be flexible enough to allow bending of the endoscope.

[0247] For example, in Figure 18 In the endoscope shown, different regions have different bending radii. As shown, the distal region ("distal region") 1851 can be highly flexible because the distal tip 1543 of the endoscope can be steered by bending the bending region 1541 of the endoscope, wherein the cap of the endoscope sheath device can be coupled to the distal tip 1543. The endoscope can be steered or bent by any suitable technique or structure, including tendons / pull wires, etc. Bending in the distal region can be particularly challenging for the inner sheath because bending beyond a specific radius of curvature can cause clamping or collapse of the lumen of the inner sheath. Therefore, these devices can include tube reinforcements, particularly in the distal end region corresponding to the distal region 1851. However, it should be understood that other regions can also be reinforced, including the middle or intermediate region 1853, which can extend to or nearly to the proximal end of the catheter. The proximal region 1835 can include an extension of the inner sheath 1817 that extends beyond the catheter and / or outer sheath 1828 and can extend to, for example, a port adapter 1868.

[0248] In some examples, the entire endoscope can be highly flexible, and the inner sheath can be highly flexible to match. To achieve both high flexibility and sufficient stiffness / radial strength to prevent collapse and allow easy insertion of the inner sheath, in any of these devices, the inner sheath can be reinforced. Any suitable reinforcement and degree of reinforcement can be used. For example, the inner sheath can be reinforced by one or more coils helically wrapped around and / or within the inner sheath to prevent local buckling during tight curvatures of bends (e.g., bends having a radius of curvature of less than, for example, 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.).

[0249] Figure 19A An example of a first tubular inner sheath is shown. This example is a single lumen inner sheath, which may be referred to as a tube liner because it lines the lumen of an endoscope. Figure 19A In FIG, inner sheath 1650 includes a reinforced distal region 1651 and an unreinforced middle region 1653. Reinforced distal region 1651 can be reinforced by including an inner coil wound tube or by forming a more flexible but collapse or buckling resistant material (e.g., a polymeric material). Figure 19B As shown in , the entire length of the inner sheath 1650 is reinforced by the coil. Other inner sheaths may include more than one lumen and may also be reinforced. In some examples, a multi-lumen inner sheath may not need to be reinforced because dividing the inner lumen into multiple lumens can provide internal reinforcement.

[0250] In some examples, the inner sheath is formed from a medium-durometer elastomer, for example, by extrusion. A slip additive may be included to help smooth the inner sheath, allowing it to slide easily within the lumen of an endoscope and against tools passing within its inner diameter. In some examples, the inner sheath can be formed as a composite structure. For example, a laminated coil-wound tube can be used, where the coil spacing varies along the length, and the coils can be formed from flat wire. The flat wire can be wound more densely in the distal region to prevent bending when the curved section passes through a tight radius of curvature. The matrix material forming the main body of the inner sheath can be a low-durometer elastomer (70A polyurethane). The inner surface of the tubular inner sheath can have a hydrophilic coating to facilitate tool sliding. This can result in significantly better sliding than standard PTFE tubing. For example, a reusable endoscope with standard PTFE tubing can allow a tool to be inserted and two complete wraps (e.g., 2 x 360 degrees) performed. Using a hydrophilic coating, this can be increased to up to six wraps (e.g., 6 x 360 degrees). The drag in this case is exponentially reduced, especially in long curved / bendable tubes, thus greatly reducing drag and being an advantage of the endoscopic sheath device described herein. The resulting low drag can enhance the tactile feel of the instrument. This is another example of how the sheath system is superior to reusable systems.

[0251] Thus, the inner sheath can be reinforced as described herein and / or can be formed of a material having sufficient properties (e.g., wall thickness, bending stiffness, bending flexion, flexion along length, etc.) to prevent pinching or collapse of the endoscope during operation. Generally, the inner sheath can be made of the same material as the outer sheath, or they can be made of different materials. 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 amides (e.g., Pebax TM ), expanded polytetrafluoroethylene (EPTFE, such as Fluroflex TM ), urethane, etc. These materials can be extruded and can be combined with other materials, such as, for example, with heat-set metal coils, coils wound with round wire, flat wire, etc. Examples of materials for the outer sheath may include (but are not limited to): LDPE, polyolefin plastomers, nylon, composite materials (e.g., films laminated with polyurethane, including interdispersed high-performance fibers (e.g., Dyneema, Technora, carbon fiber, glass fiber, etc.), silicone, and polyurethane. These can be manufactured by a variety of methods, including but not limited to: extrusion, blow molding (including bellows designs), lamination, heat sealing.

[0252] Generally, the endoscopic sheath devices described herein may include a tip that includes features that allow the endoscopic sheath device to be easily and effectively secured to the distal region of an endoscope, to allow the outer sheath and inner sheath to form a seal with the cap, and may include integrated features to assist in the function of the endoscope to which the endoscopic sheath device is attached. For example, the endoscopic sheath device may include a tip that includes features that allow the endoscopic sheath device to be easily and effectively secured to the distal region of an endoscope, to allow the outer sheath and inner sheath to form a seal with the cap, and may include integrated features to assist in the function of the endoscope to which the endoscopic sheath device is attached. Figures 20A-20D 、 Figure 21C 、 Figures 22A-22C 、 Figures 23A-23B 、 Figures 24A-24B 、 Figure 25 、 Figures 26A-26B 、 Figures 27A-27C 、 Figures 28A-28D 、 Figure 29A-29B 、 Figure 30A-Figure 30B 、 Figure 31A-Figure 31B 、 Figure 32A-Figure 32B 、 Figure 33A-Figure 33B 、 Figure 34A-Figure 34B 、 Figure 36A-Figure 36B or Figure 38 The end of any feature shown in .

[0253] For example, Figures 20A-20D An example of a cap that includes features that may be included in any of the sheath devices in the endoscopes herein is shown. The cap shown includes a distal side that may be fully or partially transparent and may include a transparent camera area 2026 through which a camera on the endoscope may be imaged. Figure 36A-Figure 36B As shown, in some examples, the cap may include an integrated lens or camera. In some examples, the cap may also include a transparent light-transmitting area 2024 that allows light from the endoscope to propagate through the cap. The cap 2018 may also include one or more optical components (e.g., a diffuser, a lens, etc.) for modifying the illumination light. In some examples, the cap may alternatively or additionally include one or more light sources, such as LEDs. The cap may include one or more openings corresponding to the inner sheath regions, including openings into the cavities of the first inner sheath 2023 and / or the second inner sheath 2022. Any of these devices may also include one or more flow guides or displacers 2020 that can guide (or redirect) the flow of one or more reagents (e.g., a cleaning solution, air, etc.) from the proximal end of the device. For example, the cap may include a cleaning nozzle or cleaning guide outlet 2021, which may be part of the fluid displacer 2020 on the cap.

[0254] For example, Figure 20A An end view of the cap in this example is shown. Figure 20A An end view of the cap is shown. Figure 20BA side perspective view is shown including a cylindrical mating area 2033, which may initially be oval, such as Figure 20D In the unconstrained configuration, the oval mating region can have an oval cross-section transverse to the long axis of the device. Figure 20B The side view also shows that the cap may include one or more regions for coupling with all or a portion of the cylindrical outer sheath; Figure 20B and Figure 20C In FIG. 2 , the cap includes a recessed fitting area 2049 into which the outer sheath can be sealed, for example, with a resilient member (resilient retaining ring, not shown) and / or an adhesive and / or a heat seal.

[0255] like Figure 20D As shown in , the cap 2018 may include an oversized rim 2036 extending around the cylindrical mating surface 2033. Figure 20D The interior of the cap region is shown. Recessed or cut-out entries 2022, 2023 are shown for receiving and sealingly coupling to the inner sheath. The interior of the cap also includes a recessed area 2039 for receiving optics (e.g., camera, lens, light guide, etc.) from an endoscope.

[0256] Figures 20B-20D The end cap shown in FIG also includes a latch region 2038 extending through a mating surface that is configured to mate with the distal end of the endoscope by compressing the mating surface from an oval resting cross-sectional configuration to a circular mating cross-sectional configuration. In this example, the latch 2038 can be formed as an opening into which a protruding latch member, such as on the distal end region of the endoscope, can engage. Alternatively, in some examples, a protruding latch member can be on the cap and can engage with a latch opening on the distal end of the endoscope.

[0257] Any of these caps may also include one or more stress relief areas 2039, including stress relief cutout areas, which may make compressing the cylindrical fitting area 2033 (e.g., the wall) easier and more reliable.

[0258] For example, Figure 21A and 21B An example of a distal end of an endoscope is shown, comprising a camera 2106, a light source 2104, and a first lumen 2108 and a second lumen 2109 through the endoscope. The endoscope in this example also includes an outer diameter surface 2174 that engages a latching member (e.g., Figure 21B The inclined latch protrusions 2112, 2112') are present on the outer diameter surface 2174. Figure 21C Shown is attached to the distal end of the endoscope Figures 20A-20DIn this example, the cap 2118 can be applied by first applying pressure (e.g., squeezing the cap) to round the oval mating walls and then sliding it over the distal end and engaging the latches 2112 on the upper and lower regions. Figures 26A-26B . In this example, the cap 2613 includes a cylindrical mating surface 2033 that is formed into an oval cross-sectional shape (when at rest). Transitioning from an oval cross-sectional shape to a more rounded shape that matches the circumference of the catheter can allow the endoscope sheath device to slide over the more rounded distal end of the endoscope and engage with the latch component. Once pressure is released, the cap can return to a slightly more oval configuration, thereby applying force to retain the cap on the distal end region.

[0259] like Figure 21C As shown in , the cap may include one or more structures, such as a fluid displacer 2120, which may allow the cap to direct the flow of material (e.g., cleaning fluid) from the lumen of the inner sheath. Figure 21C In the ® , the inner sheath in this lumen of the catheter is a multi-lumen catheter divided into three zones: insufflation, cleaning, and irrigation.

[0260] As described above, any of these caps, and therefore any of the endoscopic sheath devices described herein, may include one or more light sources integrated into the cap. For example, Figures 22A-22C An example of an endoscope sheath device is shown that includes a cap 2218 having an integrated set of LEDs in the lens (instead of or in addition to transmitting light from the endoscope). Figure 22A , an endoscope sheath device includes an outer sheath 2228 sealed to the periphery of a cap 2218 (e.g., within a channel secured to the outer sheath by a gasket 2241). A pair of inner sheaths 2210 extend from the cap (e.g., through the cap and seal around the inner surface of an opening through the cap) and into the lumen of an endoscope 2222. The cap may include other features, including a fluid displacer 2220.

[0261] Figures 22A-22C The cap 2218 shown in FIG also includes a plurality of LED lights 2243 arranged at least partially around the perimeter of the cap. The LEDs are attached to a substrate 2244 that is held or formed within the cap. The LEDs can be powered by including one or more electrical contacts on the interior of the cap that can make contact with corresponding contacts on the end of the endoscope. For example, Figure 22CAn area of ​​multiple electrical contacts 2239 on the endoscope is shown, which, once the cap is applied, make electrical connections with one or more solder joints, pins, and / or contacts on the cap. In this example, the oval-shaped mating wall can include one or more electrical contacts required to power the LED. These contacts can also be configured on an area of ​​the wall near the minor axis of a cross-section through the oval (e.g., elliptical) mating wall; this same area can include a latch 2238 (e.g., a latch opening and / or latch protrusion).

[0262] Figures 23A-23B Shows something like Figures 22A-22C Another example of a cap portion of an endoscope sheath device including a plurality of LEDs 2343 arranged in a manner similar to that shown in FIG. Figures 23A-23B In the embodiment of the present invention, the cap is configured as a disposable cap with a transparent window. The endoscope sheath device can be placed on the endoscope during use. However, if the endoscope has a camera and an illumination port, this may cause reflected light from the illumination port to produce reflection artifacts in the camera image. To avoid this problem, in some examples, the cap may include an illumination port, for example, including an LED as described above. For example, the LEDs can be placed along the outer edge of the disposable cap. Arranging the lighting on the disposable cap will also free up valuable space on the front of the endoscope to support other features, or reduce the diameter of the endoscope. One embodiment may include one to three white light LEDs. In the case of multiple LEDs, the different LEDs can be arranged at equal intervals around the outer periphery of the cap (facing forward), but can also be arranged in other patterns.

[0263] Some imaging arrangements can use illumination other than white light. For example, green light, blue light, and ultraviolet (UV) light can be used to highlight surface features of tissue. Infrared illumination can be used in conjunction with fluorescence, with or without other illumination bands. The alternative illumination scheme can be "steady state," where the vision system switches to an alternative imaging mode and stays there until the user switches back to white light illumination. Alternatively, the vision system can change the illumination mode at a frame rate, alternatively illuminating a frame with white light first and then with the alternative illumination, or using other time-varying patterns. The systems described herein can use image interpolation to display an alternative image overlaid with a white light image. An array of LEDs, lasers, or other lighting devices on a disposable cap can implement these alternative imaging methods. For example, a cap with three LEDs, one each for red, green, and blue, and UV light can allow a vision system to image in both white light and alternative modes to highlight details on the surface of tissue. In Figure 25 In the example shown in , the LEDs 2543 are arranged in three clusters 120 degrees apart on the front face of the cap 2513, with each cluster containing closely spaced red, green, blue, and UV LEDs. Other configurations can be used.

[0264] In some examples, wires (e.g., wire leads) can be used to power the LEDs. As described above, these wires can be routed through the endoscope, with electrical contacts between the cap and the endoscope body. Alternatively, the wires can be integrated into an outer sheath attached to the cap, for example, extending helically around the outer sheath to prevent limited movement of the endoscope. Alternatively, in some examples, the wires can extend down or through an inner sheath (or more than one inner sheath). For example, the wires can be encapsulated thin wires.

[0265] Figure 24A and Figure 24B An example of a multi-lumen extrusion with embedded wires is shown (in this example, the wires are enclosed in a pair of 0.013" lumens). Figure 24A In, the embedded wires 2481 can be connected to one or more LEDs (not shown), and the frame can be configured to fit over the distal end of a device as described above, including a cutout area to allow imaging and / or light to pass through.

[0266] As described above, in some examples, the cap can be applied to and / or removed from the endoscope by applying compression to the long axis of the oval cylindrical mating wall. Figures 27A-27C Removal of the cap is shown (the outer sheath has been removed to illustrate the application of compressive force to remove the device from the tip). The cap is disengaged by squeezing the cap to deform the mating walls, allowing the latch members to disengage as shown. Figure 27B ), so that the cap can be pulled off and removed from the endoscope, leaving the endoscope clean and ready for another use.

[0267] Figures 28A-28D and Figure 29A-29B The method is schematically shown. For example, Figure 28A In the embodiment of the present invention, the first set is used to attach the endoscope sheath device to the endoscope 2800. The inner sheaths 2815, 2817 of the endoscope sheath device can be inserted into the lumen of the endoscope, and the endoscope sheath device can be slid proximally 2883 until the cap 2813 is near the distal region of the endoscope, as shown in FIG. Figure 28B Once the cap 2813 is in place, the user can use their fingers to compress the cap and deform the shape of the cylindrical mating wall 2884 so that the cylindrical mating wall 2884 can fit over the distal region of the endoscope, as shown. Figure 28C As shown; pressure applied to the long axis of the cylinder can round the oval cross-sectional area until the cylinder can be fitted on an endoscope having a circular cross-sectional area, as shown Figure 28DAs shown. The location and extent of the stress relief windows 2893 cut through the cylindrical mating channel on opposite sides of the minor axis of the cross-section through the cylindrical wall can facilitate the change of the cross-sectional shape of the cylindrical mating wall from an oval to a more circular shape. The application of this compressive force 2985 can also help engage or disengage the latch 2992. Figure 30A-Figure 30B The application of a compressive force 2985 as described above is shown to elastically deform a cylindrical wall having an oval cross-section.

[0268] As described above, any of the caps for an endoscope sheath device may include one or more features for directing the flow of material into or out of the endoscope. For example, including a cap such as Figure 31A and Figure 31B The endoscopic sheath device of FIG. 31 may include integrated or attached features to direct the flow of cleaning fluid, flushing fluid, and / or insufflants. In this example, the endoscopic sheath device includes a multi-lumen catheter 3115 forming one of two tubular inner sheaths. A second single-lumen sheath 3117 is also included. In this example, the multi-lumen sheath 3115 is divided into three sub-lumens that can be accessed at the proximal end of the device through a port adapter to apply each of the following: insufflants 3142, cleaning fluid 3143, and flushing fluid 3144. This is shown in FIG. Figures 35A-35D , which illustrates the operation of an example of a port adapter 3569. In this example, the multi-lumen inner sheath 3516 is fully inserted into the port adapter until the latch engages with the distal end of the port adapter, which indicates that the lateral openings into the different lumens arranged at different longitudinal positions along the length of the inner sheath are aligned with the appropriate sealing areas of the receptacle manifold of the port adapter. For example, in Figure 35A 35. An irrigation port 3576 to the first lumen is accessed from this location so that irrigation fluid can be applied through the port adapter input for irrigation fluid 3571. A cleaning fluid port 3577 to the second lumen is accessed from an intermediate location so that cleaning fluid can be applied through the port adapter input for cleaning fluid 3573. An insufflant port 3579 to the third lumen is accessed from a more proximal location so that insufflant can be applied through the port adapter input for insufflant 3574. Figure 35B-Figure 35C End views of these various ports are shown.

[0269] Now return to Figure 31A-Figure 31B , the insufflants 3142 can be directed out of the multi-lumen catheter forming the inner sheath 3115 via the deflector 3120 so that the insufflants 3142, 3242 are directed across the camera area. Figure 33A-Figure 33BThe flat triangular component indicates the approximate location of the insufflator. Similarly, the cleaning fluid 3143, 3243 is directed out of the multi-channel cavity of the inner sheath by the deflector 3120 on the cap 3113, which can direct the cleaning fluid across the outer surface of the cap 3213 to clear debris that might otherwise obstruct the camera. Figure 32A-Figure 32B The curved cylindrical shape shown as representing the cleaning fluid 3243 indicates the general flow direction of the cleaning fluid. The flushing fluid 3144, 3442 can be drawn from the multi-lumen catheter forming the inner sheath, such as Figure 31A-Figure 31B and Figure 34A-Figure 34B The representation of the two flushing solutions is shown.

[0270] As described above, the cap may also include one or more optical components integrated into the cap (including integrally formed in the cap). For example, any of these endoscope sheath devices may include a cap with one or more integrated lenses for a camera of the endoscope, such as Figure 36A-Figure 36B In this example, dome lens 3652 is formed as part of cap 3600, which may include other components such as fluid displacer 3620. When the cap is attached to the distal region of the endoscope, as shown Figure 36B As shown in the cross-section in FIG, the camera of the endoscope 3688 is directly connected to the lens 3652 formed on the cap. Figure 36A-Figure 36B The endoscopic sheath device 3600 also includes a second inner tubular sheath 3617 configured as an inner working channel and lined by the second inner tubular sheath 3617 .

[0271] Any of the devices herein may include one or more accessory elements configured for use with an endoscope sheath device, such as an endoscope cap or the like. These accessories may be added or coupled to the endoscope sheath device after or before the endoscope sheath device has been applied to the endoscope, or these accessories may be integrated into the endoscope sheath device, such as as part of the cap. For example, Figures 37A-37C An example of a removable endoscope cap 3700 including a retention feature 3708 (configured as a bayonet-type attachment in this example) is shown. Figure 37A In the embodiment, the removable endoscope cap 3700 is independent of the endoscope sheath device (e.g., the cap 3713 of the endoscope sheath device), and in Figure 37B In FIG, a removable endoscope cap 3700 is coupled to the cap of the endoscope sheath device. Figure 37C Shown Figure 37B Side sectional view of .

[0272] Generally, the methods described herein can include attaching, removing, and / or replacing different endoscope caps according to the needs of the user.In some examples, an endoscope sheath device can be configured to integrate one or more of these features, such as an endoscope cap extending from the distal end. Figure 38 An example of a cap 3813 is shown in which the endoscope cap portion 3800 is integrally formed with the remainder of the cap.

[0273] Also described herein are endoscopes that can be modified to more easily operate with the endoscope sheath devices described herein. For example, Figure 39A An example of a prior art endoscope comprising an elongated body 3928 is shown having a distal region 3918 and a plurality of lumens 3957. In this example, the lumens are coupled to a suction source 3958 and an air / water source 3959. The device may also include valves, such as a suction valve 3953 and an air / water valve 3951, that can regulate the suction force, air, and / or water flow within the lumens. A handle region 3966 may be coupled to the elongated body 3928 and to an adapter line that may be connected to a suction source and / or air source, for example, via a suction source connector 3960 or an air tube 3962.

[0274] Any of the devices described herein may include an endoscope adapted for use with an endoscope sheath device; these systems may include an endoscope device in which valves controlling the flow of material (e.g., vacuum, water, air, etc.) in the lumen of the endoscope may be independent and / or disposable. For example, a catheter adapted for use with an endoscope sheath device may include a handle region configured to pass through an inner sheath. In some examples, the endoscope has an elongated member having a lumen extending from the handle. The system may also include an endoscope sheath device comprising an outer sheath, an inner sheath comprising one or more lumens, and a cap as described above. The system may also include a multi-way valve block removably coupled to the handle of the endoscope, wherein the multi-way valve block includes one or more valves in fluid communication with the lumen of the endoscope. The inner sheath may be configured to engage with the multi-way valve block such that the one or more valves control the flow of fluid through the one or more lumens of the inner sheath.

[0275] For example, Figure 39B An endoscope as described herein is schematically shown. In this example, the endoscope comprises an elongated shaft (endoscope shaft) having two lumens. The first lumen is for receiving a working channel and / or a suction channel. The second lumen is for receiving a multi-lumen channel that can be coupled to an insufflator, a cleaning fluid, and an irrigation fluid. Figure 39BIn the embodiment of the present invention, the elongated shaft is connected to the handle area. The handle area can also include a disposable multi-way valve block, which can include multiple valves and / or controllers for engaging with the inner cavity and / or for controlling the flow in the cavity. For example, the disposable multi-way valve block can include a manual push button valve and / or a check valve that prevents reverse flow but allows fluid to flow from the handle to the distal end of the shaft. The device can also include a sealing / crimping area (e.g., a heat seal access point) to allow the internal shaft to be sealed when use is completed. Finally, the device can also include a pipeline ("umbilical" pipeline) and a connector for connecting to a flushing (water) source, a cleaning source, an insufflating agent (air / CO2) source and / or a suction source.

[0276] generally, Figure 39B The device shown in is configured for use with an endoscopic sheath device such that an outer sheath can cover the distal end and the exterior of the shaft (and in some examples, the handle and optionally the umbilical cord), and an inner sheath can extend within the lumen and through the multi-way valve block to couple with the connector. Thus, the multi-way valve block can be adapted to receive the inner sheath, and the valves and controller can operate on the inner sheath.

[0277] Any of the devices and methods described herein can be configured to apply positive or negative pressure between the outer sheath of an endoscope sheath device and the outer surface of an endoscope. Thus, any of these devices can be configured to apply negative pressure (e.g., a vacuum) to adhere the outer sheath to the exterior of the endoscope, which can make it easier to hold and use (e.g., apply torque). The use of pressure (including negative pressure) can also alert the user to any 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, deployment, and / or leak detection.

[0278] In any of these devices and methods, the endoscope sheath device can be configured to allow pressurization of the outer sheath by forming a seal at a proximal region of the outer sheath (e.g., on the endoscope sheath and / or handle.) The distal region, including the cap, can also form a seal, or in some examples, may not seal, but can seal around the more proximal end of the inner sheath.

[0279] Figures 40A-40C A first example of a system is shown that includes an endoscope sheath device configured to pressurize an outer sheath of the endoscope sheath device. Figure 40AAn example of an endoscope 4000 is schematically shown, including an elongated shaft 4001 and a handle region 4003. In this example, the endoscope handle can include a pressure line 4007 (e.g., for positive or negative pressure) that can be used to apply pressure between the endoscope and the outer sheath. In some examples, the pressure line is coupled to an endoscope sheath device, such as at a proximal collar on the sheath. The pressure line can be integrated into either the endoscope or the endoscope sheath device, or the pressure line can be a separate and separately positioned line.

[0280] Figure 40B An endoscope sheath device is schematically shown comprising a pressurized outer sheath 4002 and a pair of inner sheaths, and a cap 4027 sealed to the outer and inner sheaths. The endoscope sheath device also comprises a proximal collar 4044 configured to maintain a seal between the endoscope and the proximal end of the outer sheath.

[0281] Figure 40C Shows the applied Figure 40B After the endoscope sheath device Figure 40A An endoscope is provided that creates a sealing zone or region between the outer sheath and the endoscope, which sealing zone or region can be pressurized, for example, by applying a vacuum to collapse the sheath onto the endoscope or applying positive pressure to expand or inflate the outer sheath. The collar 4044 can be activated to form an airtight seal 4043. Figure 40B In the embodiment of the present invention, the outer sheath of the endoscopic sheath device has a substantially uniform diameter along the length from the proximal side to the distal side. In some cases, it may be beneficial to have regions with different radial diameters and / or regions with different elasticities along the length so that different regions can be inflated differently.

[0282] For example, Figures 41A-41C Examples of endoscopic sheath devices with different configurations of outer sheaths are shown. These different configurations may be particularly helpful during inflation. The flexible outer sheath portion of the endoscopic sheath device may have a constant cross-section, such as Figure 40B Alternatively, the cross-section may be nominally larger than the shaft so that it can slide easily through a small annular gap. Any of these outer sheaths may be relatively elastic so that they can be suctioned to expand them (e.g. by sealing into a rigid tube at either end, with the annular space between them being the space that is then evacuated). Once in place, e.g. with the sheath fully positioned on the shaft, the vacuum may be released, causing the sheath to elastically spring back and then fit snugly against the shaft. This is shown in FIG. Figure 41A This is shown in , which shows an outer sheath having a constant diameter but held within an outer (eg rigid) tube. The outer sheath is then vacuumed into the space to allow it to expand during installation. Figure 41AIn the embodiment shown in FIG40, the outer sheath 4027 has a constant width. Once in place, the vacuum can be released and the outer sheath can elastically return to the released size to conform closely to the shaft.

[0283] In some examples, the outer sheath can be significantly larger than the shaft (e.g., greater than 1.5x diameter, 2x diameter, 2.5x diameter, 3x diameter, 3.5x diameter, 4x diameter, 5x diameter, etc.) Once inflated by positive pressure, this configuration can be advantageous as it can help position, stabilize, anchor, and / or guide the device within the anatomy, particularly within tortuous anatomy.

[0284] In some examples (see e.g. Figure 41B ), the outer sheath may have a tapered cross section or a stepped cross section that is larger at the proximal end (see e.g. Figure 41C This type of profile can aid in removal, as it will turn back on itself during removal, thereby "catching" external biological debris and making it cleaner and easier to dispose of. This can also facilitate the installation and sanitary removal of replaceable sheaths. In some examples, the endoscope sheath device can be configured to seal at either end so that it can then be vacuumed down against the elongated shaft.

[0285] In any of these methods and devices, the sheath can be mounted on a device that is either a manual device (endoscope or catheter) or a robotic device (teleoperated device).

[0286] During use, the outer sheath can be snug, or it can be loose relative to the endoscope shaft. Once the outer sheath is connected to other structures (including the shaft or installation tool), the outer sheath can become a sealed structure. At the proximal end, the outer sheath can have a port that allows access to this (annular) space. Positive or negative pressure can be applied through this space. When negative pressure is applied, the sheath will be sucked down into the underlying structure so that it is vacuum-connected to the structure. If the device is manually operated, this allows the hand to better grip the surface and allow the sheath and the underlying shaft to move as a whole. If the sheath is not vacuumed, such movement will be difficult because the sheath will move and shear relative to the elongated shaft during attempted movement.

[0287] During installation, the sheath can be co-connected with the installation tool. Once they are co-engaged, a vacuum can be drawn into the annular space between them (the installation tool and the sheath), causing the sheath to elastically expand. This will give the sheath a larger inner diameter, allowing it to expand more easily on the shaft. Once the sheath is installed on the shaft, the vacuum will be released and the sheath will elastically reduce its diameter, allowing it to fit snugly onto the shaft.

[0288] In any of these methods and devices, the sheath can be inflated under positive pressure. When inflated, the sheath can contact the anatomical structure. For example, the sheath can contact the inside of the lungs, the inside of the GI tract, etc. This can similarly work in other anatomical structures, including but not limited to gynecological, abdominal, orthopedic, vascular, neurovascular and peripheral vascular. The application of this positive pressure and its interaction with the anatomical structure produce the stability of the common connection. This contact can exist locally (i.e., as a single balloon), at multiple locations (series balloons) or over a long length (constant diameter interaction, tapered geometry interaction, etc.).

[0289] The endoscopic sheath device can be packaged in a variety of configurations, including straight and coiled. These packaging configurations can be created to reduce the difficulty and time of installation, and to reduce packaging, shipping and sterilization costs. The endoscopic sheath device can be configured to be easily removed. For example, after use, the outer surface of the device may become contaminated with feces, blood and other body fluids. This may be difficult or cumbersome to handle. The device can be configured so that it everts (i.e., flips back onto itself). By doing so, it thereby reduces the effective sheath length (everting folds the wall in half and thereby reduces the length by half). Everting also serves to face the outer (contaminated) surface inwardly while the clean surface faces outwardly so that the sheath can be removably handled in a more sanitary manner. For example, Figure 44 An everted sheath 4407 is shown configured for easy removal.

[0290] In some examples, it may be important to electronically register the sheath with the base device. This registration can transmit information including information regarding the device type, device operation, device manufacture, device certification, device sterility, or the legality of the device's overall use. A reader and / or transmitter (e.g., RFID) can be mounted on the base, for example. When the sheath proximal loop is in proximity, it can register or transmit information.

[0291] Figure 42 An example of an outer sheath 4227 being evacuated onto an endoscope 4201 is shown. Due to the vacuum 4007 applied between the sheath and the shaft, the sheath is sealed to the endoscope shaft. Applying negative pressure (vacuum) pulls the outer sheath inward against the endoscope. Applying a vacuum (e.g., between the shaft and sheath) shrink-fits the flexible sheath onto the endoscope flexible shaft. 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 the shaft. The vacuum can be released to remove the sheath. Additionally, measuring vacuum leakage can be used to determine if there is a leak in the sheath.

[0292] Figures 43A-43B The application of positive pressure is shown. Figure 43A An example of an endoscopic sheath device is shown having a single distal "balloon" shape when the outer sheath 4227' is inflated. Figure 43B Examples of endoscopic sheath devices with multiple annular balloon shapes are shown. In these examples, the sheath 4227" can be inflated like 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 expanded balloon profiles can be used, including but not limited to: a single distal balloon shape, multiple annular annular balloon shapes, a spiral balloon shape, a constant diameter, etc. The expanded balloon can help stabilize and center the device in the anatomical cavity.

[0293] Also described herein are flexible devices (endoscopes, catheters) that can penetrate deep into anatomical structures (e.g., lung periphery, GI tract). However, when they are small and flexible enough, kinematic problems become apparent, including looping, prolapse, "tram-tracking," and buckling. Although there are many strategies to overcome these problems, including by reducing clinical expectations, changing patient position, pushing on local anatomical structures, and attempting to solve these problems through the use of steering devices, sheaths, and overtubes, in many cases (e.g., in the lungs), the overtubes may become too large to be advanced. Buckling of this type, as depicted in the lungs, is not a problem. Figure 45 The figure shows the buckling of the endoscope when trying to reach the periphery of the lung. The use of a sheath, coupled with the use of positive pressure to inflate the sheath, may help solve this problem. Figure 45 A- Figure 46B As shown, the device can have an outer sheath 4607 covering the device and an outer sleeve 4674. The accordion-shaped serrated areas on the sheath represent the extender material.

[0294] At the point where the outer sleeve 4674 cannot be advanced further without pulling the endoscope back, because the anatomy is too tight, the sheath can be pressurized (by applying positive pressure) to the area between the sheath and the endoscope / outer sleeve. Inflating the sheath potentially does two things: the sheath stabilizes the outer diameter of the device through local anatomical contact, and the sheath turns the device into a pneumatic or hydraulic cylinder, thereby facilitating forward movement of the tip by applying positive pressure. This can minimize the risk of buckling of a very flexible endoscope being pushed forward from the proximal end. This is particularly useful in Figure 46A and 46B Shown in.

[0295] The outer cannula 4674 (e.g., the outer endoscope of a nested pair of endoscopes) can be moved forward in tight anatomy, but rather than dragging the device backward by further inflating the sheath, the device remains stationary. This can cause the sheath 4607' to inflate outward and act as an anchor against the anatomy, and the device then becomes similar to a more stable guidewire that can guide the outer cannula forward without itself being pulled back. This is particularly advantageous in Figure 47Once the clinician has reached their anatomical target, they may choose to "lock" the end of the device in place, which may be similar to the technique of inflating a distal balloon. Alternatively, they may choose to inflate their sheath 4807 over a longer length to gain traction on more anatomical structures, such as Figure 48 Positive pressure can be applied using a gas or using a liquid such as saline.

[0296] like Figure 49 As shown, these devices can be used with a side-mounted ultrasound. Thus, when combined with ultrasound, the saline-inflated outer sheath can act as a saline-filled balloon, which can help locate targets that are not visible visually. Figure 49 A side-mounted ultrasound device comprising an ultrasound transducer 4906 within an inflated outer sheath 4907 is shown.

[0297] Installing the handle

[0298] Any of the endoscope sheath devices described herein (e.g., an endoscope sheath device) can include a mounting handle for applying and / or removing the device to an endoscope. For example, Figure 50A An endoscope sheath device is shown that includes a cap 5027 configured to be securely coupled to an endoscope, an outer sheath 5002 , 5002 ′, a pair of inner sheaths 5015 , 5017 , and a mounting handle 5081 .

[0299] Typically, the mounting handle is configured to hold or stow the flexible / compressible outer sheath in a compact and easily maneuverable form while allowing easy placement of one or more inner sheath components. Figures 50A-50C The outer sheath 5002′ can be collapsed by pleating, folding (e.g., accordion folding, bellows folding, etc.), crimping, etc. The outer sheath can be collapsed so that when the inner sheath 5015, 5017 is inserted into the lumen of the endoscope, there is still a passage through the collapsed outer sheath through which the endoscope can be inserted, as will be seen in FIG. Figures 51A-51D As shown in .

[0300] The mounting handle 5081 may include an outer gripping area 5087 that may be configured to fit into the hand of a user. The mounting handle may also include a distally facing tapered surface (or distal funnel) 5088 that may be particularly useful when removing the outer sheath, such as Figures 54A-54CAny of the mounting handles described herein can be configured to couple or attach to an endoscope, such as to a proximal end of an endoscope. Thus, in some examples, the mounting handle can include a coupler at a distal end of the mounting handle that is configured to couple to a mating attachment on the endoscope. Figures 50A-50C In the embodiment shown, the connector 5085 is configured as a BNC type connector that can engage a pin on the endoscope, but any suitable connector (and complementary attachment on the endoscope) can be used.

[0301] In the illustrated example of mounting handle 5081 , the mounting handle includes a window or opening 5083 that may open into an interior chamber that holds a portion of the outer sheath 5002 ′.

[0302] Figures 51A-51D Shows the Figures 50A-50C The endoscope sheath device is shown applied to an endoscope assembly 5100. The endoscope assembly shown in this example includes a nested pair of endoscopes, including an inner endoscope nested within and slidably coupled to an outer endoscope 5201 (e.g., an outer cannula). In this example, inner sheaths 5015, 5017 extending proximally from the endoscope sheath device are first inserted from the distal end of the endoscope into a pair of lumens in the endoscope, as shown. Figure 51B The distal end of the endoscope is inserted through the proximal end of the mounting handle 5081 and into the lumen of the tubular outer sheath, which remains retracted in the lumen of the mounting handle until Figure 51C As shown, the distal end of an endoscope (e.g., inner endoscope 5103) is engaged with the cap 5027 of the endoscope sheath assembly. The user can then pull 5189 the mounting handle 5081 proximally so that the outer sheath 5002 is pulled over the endoscope, as shown in FIG. Figure 51D Pulling the mounting handle proximally relative to the endoscope causes the outer sheath to be dispensed distally out of the mounting handle. Figure 51D In the figures, the outer sheath is shown to match the outer diameter of different areas of the inner endoscope 5103 nested on the outer endoscope 5101 (e.g., as described above, this can be the case when negative pressure is applied between the outer sheath and the endoscope). 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 endoscope and the outer endoscope. The same devices and techniques described herein can be used with a single (e.g., non-nested) endoscope.

[0303] exist Figure 51D , the mounting handle 5081 can be coupled to the external endoscope 5101 by engaging the coupling 5085 with a complementary attachment on the endoscope, as shown in FIG. Figure 52A-52BAs shown in this example, the proximal end of the external endoscope 5287 includes an attachment 5286 (shown as a pin in this example) that can engage with a connector 5085 (shown as a channel in this example, such as having a BNC type configuration) of the mounting handle. Figure 52B A mounting handle is shown engaging a pin of an endoscope.Any suitable coupling (eg, magnetic, mechanical, etc.) may be used.

[0304] The endoscope sheath devices described herein can generally be packaged in a ready state, ready to be applied to an endoscope or endoscope assembly. This may include packaging with an installation handle. The ready state may include flipping and / or compressing (e.g., pleating, folding, crimping, etc.) the outer sheath and / or loading the outer sheath into the installation handle. For example, Figure 53 An example of an endoscopic sheath device is shown that includes an everted and compressed outer sheath 5302 (but in this example, no handle is mounted), a tip 5327, a proximal base 5335, and a pair of inner sheaths 5315, 5317. The endoscopic sheath device is shown coiled and positioned within packaging (e.g., box 5366).

[0305] As mentioned above, the mounting handle described herein can also be used to remove an endoscope sheath device from an endoscope. For example, Figures 54A-54C Shown from Figures 51A-51D The endoscope assembly is shown as removing the device. The mounting handle 5081 can be first disengaged from the proximal region 5287 of the endoscope and then driven distally 5490 (by pushing, pulling, etc.), as shown. Figure 54B As the installation handle is moved distally, the outer sheath is pulled upon itself and inverted so that any contaminants are retained between the folded (inverted) portions of the outer sheath 5002", leaving only the inner (uncontaminated) portion exposed proximally. A distal funnel shape 5088 on the installation handle can help collect any contaminant material and invert the outer sheath 5002.

[0306] As mentioned above, the inner sheaths 5015, 5017 can be sealed at their proximal ends (e.g., by crimping, heating, etc.) to prevent contamination before the caps are disengaged and they are withdrawn distally, as shown. Figure 54C Thereafter, the endoscope sheath assembly can be discarded. Prior to removing the endoscope sheath assembly, the assembly can be pressurized to confirm that no leaks have occurred, which could indicate that contamination of the endoscope may have occurred.

[0307] Manufacturing method

[0308] Methods of making any of these devices are also described herein. Figure 55Schematically depicted are methods for manufacturing an endoscope sheath device configured to prevent contamination of an endoscope. Generally, these methods may include, at 5503, sealing a distal region of a tubular inner sheath to a cap having an opening, the cap configured to couple to the distal region of an endoscope. Sealing may be performed by any suitable technique, including adhesive bonding, laser bonding (welding), and the like. The tubular inner sheath may be sealed by inserting it into a hole through the cap and securing it with the outer surface of the inner sheath bonded to the inner diameter of the hole. The tubular inner sheath may be configured to be inserted through the lumen of an endoscope. Thereafter, at 5505, the distal region of the tubular outer sheath may be sealed to the cap, including sealing around the outer periphery of the cap. The tubular outer sheath may be configured to fit over the outer surface of the endoscope. The tubular outer sheath may be sealed to the cap by adhesive and / or welding, among others. In some examples, a gasket or ring (e.g., of an elastomeric material) may be used to seal and secure the tubular outer sheath to the cap.

[0309] In some cases, the components may be formed and / or assembled first. Figure 55 As shown in , an optional step may include 5501: coating the device, such as the inner sheath and / or cap and / or outer sheath, with a material such as a hydrophilic coating. In particular, the inner tubular member can be coated with a hydrophilic coating by first coating a flat layer of material (e.g., a sheet) and then forming the tubular inner sheath. In some examples, a cap may also be formed. Optionally, in some examples, the inner sheath may be reinforced along a portion (e.g., distal end) or all of its length to prevent collapse when bent.

[0310] Optionally, at 5557, the assembly comprising the cap, tubular outer sheath, and tubular inner sheath can be prepared or prepared by loading into a mounting handle, as described above. For example, the tubular outer sheath can be compressed (e.g., crumpled, folded, etc.) into a chamber of the mounting handle, with the inner sheath extending proximally from the cap through the mounting handle and outer sheath. The assembly (with or without the mounting handle) can be sterilized. Finally, the endoscope sheath device assembly can be packaged at 5559. In some examples, the endoscope sheath device can be packaged in a compact, coiled configuration.

[0311] Those skilled in the art will recognize that any process or method disclosed herein can be modified in a variety of ways. The process parameters and order of the steps described and / or illustrated herein are provided as examples only and can be changed as needed. For example, although the steps shown and / or described herein may be shown or discussed in a particular order, the steps do not necessarily need to be performed in the order shown or discussed.

[0312] The various exemplary methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein, or include other steps in addition to the disclosed steps. Additionally, the steps of any method disclosed herein may be combined with any one or more steps of any other method disclosed herein.

[0313] A processor as described herein may be configured to perform one or more steps in any method disclosed herein. Alternatively or in combination, a processor may be configured to combine one or more steps of one or more methods as disclosed herein.

[0314] When a feature or element is described herein as "on another feature or element", it can be directly on the other feature or element, or there may be intermediate features or elements. On the contrary, when a feature or element is described as "directly on another feature or element", there are no intermediate features or elements. It should also be understood that when a feature or element is described as "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element, or there may be intermediate features or elements. On the contrary, when a feature or element is described as "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intermediate features or elements. Although described or shown for one embodiment, the features and elements described or shown in this way can be applied to other embodiments. Those skilled in the art will also understand that the structure or feature mentioned as being "adjacent" to another feature setting may have a portion overlapping with or below an adjacent feature.

[0315] The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the present invention. For example, unless the context clearly indicates otherwise, as used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well. It should also be understood that the terms "comprises" and / or "comprising", when used in this specification, specify the presence of stated features, steps, operations, elements, and / or parts, but do not preclude the presence or addition of one or more other features, steps, operations, elements, parts, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the relevant listed items and may be abbreviated as " / ".

[0316] Spatially relative terms, such as "under," "below," "lower," "over," "upper," and the like, may be used herein to describe the relationship of one element or feature to another element or feature as illustrated in the accompanying drawings. It should be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the accompanying drawings. For example, if the device in the accompanying drawings is inverted, if an element is described as "below" or "beneath" other elements or features, the element would be oriented "over" the other elements or features. Thus, the exemplary term "below" would encompass both orientations of "above" and "below." The device may be otherwise oriented (rotated 90 degrees or in other orientations), and the spatially relative descriptors used herein should be interpreted accordingly. Similarly, unless otherwise specifically stated, the terms "upwardly," "downwardly," "vertical," "horizontal," and the like are used herein for illustrative purposes only.

[0317] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms can be used to distinguish one feature / element from another feature / element. Thus, without departing from the teachings of the present invention, a first feature / element discussed below may be referred to as a second feature / element, and similarly, a second feature / element discussed below may be referred to as a first feature / element.

[0318] Throughout this specification and the appended claims, unless the context requires otherwise, the term "comprise" and variations such as "comprises" and "comprising" mean that various components can be used together in methods and articles of manufacture (e.g., compositions and apparatus, including devices and methods). For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0319] In general, any apparatus and method described herein should be understood to be inclusive, but all or a subset of components and / or steps may alternatively be exclusive and may be expressed as "consisting of" or alternatively "consisting essentially of" the various components, steps, subcomponents, or substeps.

[0320] As used herein in the specification and claims, including those used in the examples, and unless otherwise expressly stated, all numbers can be read as if beginning with the word "about" or "approximately", even if the term does not explicitly appear. The phrase "about" or "approximately" can be used when describing amplitude and / or position to indicate that the value and / or position described are within a reasonable expected range of value and / or position. For example, a numerical value can 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 given 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 listed herein is intended to include all subranges contained therein. It will also be understood that, as will be understood by those skilled in the art, when a value is disclosed, then "less than or equal to" that value, "greater than or equal to that value," and possible ranges between values ​​are also disclosed. For example, if the value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It will also be understood that throughout this application, data is provided in a variety of different formats, and that the data represents endpoints and starting points for any combination of data points, as well as ranges. For example, if a specific data point "10" and a specific data point "15" are disclosed, then it will be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, as well as between 10 and 15, are considered disclosed. It will also be understood that every unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0321] Although various illustrative embodiments have been described above, any of several changes may be made to the various embodiments without departing from the scope of the invention as described in the claims. For example, in alternative embodiments, the order in which the various described method steps are performed may generally be changed, and in other alternative embodiments, one or more method steps may be skipped altogether. Optional features of the various apparatus and system embodiments may be included in some embodiments and not included in other embodiments. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0322] The examples and descriptions included herein show, by way of illustration and not limitation, specific embodiments in which the subject matter can be practiced. As mentioned, other embodiments can be utilized and derived therefrom so that structural and logical replacements and changes can be made without departing from the scope of this disclosure. For convenience only, such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term "invention," and if in fact more than one is disclosed, it is not intended that the scope of this application be actively limited to any single invention or inventive concept. Therefore, although specific embodiments have been illustrated and described herein, any arrangement that is considered to achieve the same purpose may replace the specific embodiments shown. This disclosure is intended to cover any and all modifications or variations of the various embodiments. After reading the above description, those skilled in the art will understand that the combination of the above embodiments and other embodiments not specifically described herein are understood.

Claims

1. An endoscope sheath device, the endoscope sheath device is configured to prevent contamination of an endoscope, the device comprising: Outer sheath; a cap sealingly coupled to the distal end of the outer sheath; and One or more inner sheaths each extend within the outer sheath, wherein each inner sheath has one or more lumens, and further wherein each inner sheath is sealingly coupled to the cap such that the one or more lumens open outwardly through the cap.

2. The device according to claim 1, wherein: The outer sheath is durable.

3. The device according to claim 1, wherein: The outer sheath has a composite structure.

4. The device according to claim 1, wherein: The outer sheath is a dynamically rigidified structure.

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

6. The device according to claim 1, wherein: The cap is at least partially transparent.

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

8. The device according to claim 1, wherein: The cap is configured to be secured to the distal end of the endoscope.

9. The device according to claim 1, wherein: The cap is configured to be secured to the distal end of the endoscope and includes one or more of: a friction fitting configured to secure the cap to the distal end of the endoscope; a snap fitting 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 according to claim 1, wherein: At least one of the one or more inner sheaths comprises a multi-lumen catheter.

11. The device according to claim 10, wherein: At least one of the one or more inner sheaths is configured to mate with a port adapter to create an isolated plurality of ports fluidly connected to each lumen of the multi-lumen catheter.

12. The device according to claim 1, wherein: At least one of the one or more inner sheaths comprises a multi-lumen catheter having a plurality of side openings at a proximal region of the inner sheath, wherein each side opening leads to one lumen of the multi-lumen catheter.

13. The device according to claim 1, wherein: At least one of the one or more inner sheaths comprises a multi-lumen catheter having a plurality of radially spaced side openings at a proximal region of the inner sheath, wherein each side opening opens into one lumen of the multi-lumen catheter.

14. The device according to 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 apparatus of claim 1, further comprising a proximal attachment on the outer sheath configured to secure the outer sheath to an exterior surface of the endoscope.

16. The device according to claim 15, wherein: The proximal attachment comprises an elastic attachment.

17. The device according to claim 15, wherein: The proximal attachment includes a sealing attachment.

18. The device according to claim 1, wherein: The outer sheath is flexible and configured to form a contamination barrier that is impermeable to external fluids.

19. The device according to 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 according to 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 internal fluid-impermeable contamination barrier.

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

22. The device according to claim 21, wherein The crimping area is configured to heat seal and / or pressure seal.

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

24. An endoscope sheath device, the endoscope sheath device being configured to prevent contamination of an endoscope, the device comprising: a cap configured to be coupled to a distal end of the endoscope; an outer sheath sealingly coupled to the cap at a distal end; and One or more inner sheaths extend within the outer sheath, wherein each inner sheath is sealingly coupled to the cap at a distal end and opens outwardly through the cap.

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

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

27. An endoscope sheath device, the endoscope sheath device being configured to prevent contamination of an endoscope, the device comprising: Outer sheath; a cap sealingly coupled to the distal end of the outer sheath; and an inner sheath comprising a multi-lumen catheter extending within the outer sheath, wherein the inner sheath is sealingly coupled to the cap such that the lumens of the multi-lumen catheter open outwardly through the cap; and A sealing region is provided at a proximal end of the one or more inner sheaths, the sealing region being 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. The endoscopic sheath device of claim 27, further comprising a plurality of radially spaced side openings at a proximal region of the inner sheath, wherein each side opening opens into one lumen of the multi-lumen catheter.

29. The endoscopic sheath device according to claim 27, wherein: The proximal region of the inner sheath is configured to mate with a port adapter to create an isolated plurality of ports fluidly connected to each lumen of the multi-lumen catheter.

30. The device according to claim 27, wherein: The sealing area includes a crimping area.

31. The apparatus of claim 27, wherein: The sealing area is configured to heat seal.

32. The apparatus of claim 27, wherein: The sealing area is configured to be pressure-tight.

33. The apparatus of claim 27, wherein: The outer sheath is durable.

34. The apparatus of claim 27, wherein: The outer sheath has a composite structure.

35. The apparatus of claim 27, wherein: The outer sheath is a dynamically rigidified structure.

36. The apparatus of claim 27, wherein: The outer sheath is shorter than the inner sheath.

37. The apparatus of claim 27, wherein: The cap is at least partially transparent.

38. The apparatus of claim 27, wherein: The cap includes a transparent area configured to align with a camera of the endoscope.

39. The apparatus of claim 27, wherein: The cap is configured to be secured to the distal end of the endoscope.

40. The apparatus of claim 27, wherein: The cap is configured to be secured to the distal end of the endoscope and includes one or more of: a friction fitting configured to secure the cap to the distal end of the endoscope; a snap fitting 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 area configured to secure the cap to the distal end of the endoscope.

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

42. The apparatus of claim 27, further comprising a proximal attachment on the outer sheath configured to secure the outer sheath to an exterior surface of the endoscope.

43. The device according to claim 42, wherein: The proximal attachment comprises an elastic attachment.

44. The device according to claim 42, wherein: The proximal attachment includes a sealing attachment.

45. The apparatus of claim 27, wherein: The outer sheath is flexible and configured to form a contamination barrier that is impermeable to external fluids.

46. ​​The apparatus of claim 27, 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.

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

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

49. A method of manufacturing an endoscope sheath device, the endoscope sheath device being configured to prevent contamination of an endoscope, the method comprising: sealing a distal region of the tubular inner sheath to a cap having an opening, the cap being configured to be coupled to the distal region of the endoscope, wherein the tubular inner sheath is configured to be inserted through a lumen of the endoscope; and A distal region of a tubular outer sheath is sealed to the cap, wherein the tubular outer sheath is configured to fit over an exterior surface of the endoscope.

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

51. The method of claim 50, wherein: The hydrophilic coating is applied as an additive to the matrix material.

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

53. The method of claim 49, further comprising sealing a distal region of a second tubular inner sheath to the second opening via the cap, wherein the second tubular inner sheath comprises a multi-lumen tube.

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

55. The method of claim 49, further comprising reinforcing the tubular inner sheath such that a distal region of the tubular inner sheath is prevented from collapsing when bent.

56. The method of claim 55, wherein: Strengthening includes adding reinforcing coils.

57. The method of claim 55, wherein: Reinforcing includes adding reinforcement members to the distal region.

58. The method of claim 49, wherein: Sealing the distal region of the tubular inner sheath to the cap and sealing the distal region of the tubular outer sheath includes forming a continuous fluid-impermeable contamination barrier.

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

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

61. The method of claim 49, further comprising durableizing the tubular outer sheath.

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

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

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

65. The method of claim 49, further comprising attaching a proximal attachment to the tubular outer sheath, the proximal attachment configured to secure the tubular outer sheath to an exterior surface of the endoscope.

66. A method of manufacturing an endoscope sheath device, the endoscope sheath device being configured to prevent contamination of an endoscope, the method comprising: coating a layer of inner sheath material with a hydrophilic coating and laminating the inner sheath material into a tubular inner sheath such that the hydrophilic coating extends within the lumen of the tubular inner sheath; sealing a distal region of the tubular inner sheath to a cap having an opening, the cap being configured to be coupled to a distal region of the endoscope, wherein the tubular inner sheath is configured to be inserted through a lumen of the endoscope; and sealing a distal region of a 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, the cap and the tubular inner sheath form a continuous fluid-impermeable contamination barrier.

67. A method of manufacturing an endoscope sheath device, the endoscope sheath device being configured to prevent contamination of an endoscope, the method comprising: reinforcing the tubular inner sheath to prevent a distal region of the tubular inner sheath from collapsing when bent; sealing a distal region of the inner sheath to a cap having an opening, the cap being configured to be coupled to a distal region of the endoscope, wherein the inner sheath is configured to be inserted through a lumen of the endoscope; and sealing a distal region of a tubular outer sheath to the cap, wherein the outer sheath is configured to fit over an exterior surface of the endoscope, Therein, the outer sheath, cap and inner sheath form a continuous fluid-impermeable contamination barrier.

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

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

70. The apparatus of claim 68, wherein: The one or more light sources include light emitting diodes (LEDs).

71. The apparatus 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. The apparatus of claim 68, wherein: The one or more light sources include a plurality of light sources arranged at least partially around a perimeter of the cap.

73. 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 in the outer sheath.

74. 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 in an inner sheath extending within the outer sheath, wherein each inner sheath has one or more lumens, and further wherein, Each inner sheath is sealingly coupled to the cap such that the one or more lumens open externally through the cap.

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

76. The apparatus of claim 68, wherein: The cap includes a lens area configured to be positioned over a camera of the endoscope.

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

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

79. An endoscope sheath device, the endoscope sheath device being configured to prevent contamination of an endoscope, the device comprising: a rigidized outer sheath configured to extend over the endoscope, the rigidized outer sheath comprising a rigidizing layer and a compression layer, the rigidizing layer comprising a plurality of strand lengths crossing one another, the compression layer configured to be actuated to apply a force to the rigidizing layer to rigidify the rigidized outer sheath from a flexible configuration to a rigid configuration; a cap configured to be coupled to a distal end of the endoscope, wherein the cap is sealingly coupled to a distal region of the outer sheath; An inner sheath extends within the rigidized outer sheath and is configured to extend through a lumen of the endoscope, wherein the inner sheath has one or more lumens and is sealingly coupled to the cover such that the one or more lumens of the inner sheath open outwardly through the cover.

80. The apparatus of claim 79, wherein: The rigidifying layer includes a plurality of strand lengths that cross one another.

81. The apparatus of claim 80, wherein: The plurality of strand lengths include one or more of: a braid, a knit, a woven, chopped segments, randomly distributed and / or randomly oriented filaments, or a splicer.

82. The apparatus of claim 79, wherein: The compression layer includes a bladder.

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

84. The apparatus of claim 79, wherein: The rigidizing outer sheath is configured to be rigidified by application of positive pressure.

85. The apparatus of claim 79, wherein: The rigidizing outer sheath is configured to be rigidified by application of negative pressure.

86. The apparatus of claim 79, wherein: The cap is at least partially transparent.

87. An endoscope sheath device, the endoscope sheath device being configured to prevent contamination of an endoscope, the device comprising: a rigidized outer sheath configured to extend over the endoscope, the rigidized outer sheath comprising a rigidizing layer and a compression layer, the rigidizing layer comprising a plurality of strand lengths crossing one another, the compression layer configured to be actuated to apply a force to the rigidizing layer to rigidify the rigidized outer sheath from a flexible configuration to a rigid configuration; a cap sealingly coupled to a distal region of the outer sheath and configured to engage a distal end of the endoscope; An inner sheath extends within the rigidized outer sheath and is configured to extend through a lumen of the endoscope, wherein the inner sheath is sealingly coupled to the cap such that the inner sheath opens outwardly through the cap.

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

89. The apparatus of claim 88, wherein: The distal region of the tubular inner sheath includes a reinforcing coil.

90. The apparatus of claim 88, wherein: Only the distal region of the tubular inner sheath is reinforced.

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

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

93. The apparatus of claim 91, wherein: The second tubular inner sheath is unreinforced.

94. The apparatus of claim 88, wherein: The tubular inner sheath includes a working channel liner having a working channel lumen.

95. The apparatus of claim 94, wherein: The working channel lumen includes a hydrophilic coating.

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

97. The apparatus of claim 94, wherein: The cap is at least partially transparent.

98. An endoscope sheath device, the endoscope sheath device being configured to prevent contamination of an endoscope, the device comprising: a cap configured to be coupled to a distal end of the endoscope; a flexible outer sheath configured to extend over the endoscope, wherein a distal region of the outer sheath is sealingly coupled to the cap; and a tubular inner sheath including a working channel liner configured to be inserted through the lumen of the endoscope, the tubular inner sheath extending proximally from the cap and within the outer sheath, wherein a distal region of the tubular inner sheath is sealingly coupled to the cap such that the lumen of the tubular inner sheath is open outwardly through the cap, further wherein the distal region of the tubular inner sheath is reinforced to prevent collapse of the tubular inner sheath when bent, Therein, the flexible outer sheath, cap and tubular inner sheath form a fluid-impermeable contamination barrier to prevent contamination of the endoscope.

99. An endoscope sheath device, the endoscope sheath device being configured to prevent contamination of an endoscope, the device comprising: a cap configured to be coupled to a distal end of the endoscope; a flexible outer sheath configured to extend over the endoscope, wherein a distal region of the outer sheath is sealingly coupled to the cap; and a first tubular inner sheath including a working channel liner configured to be inserted through the lumen of the endoscope, the tubular inner sheath extending proximally from the cap and within the outer sheath, wherein a distal region of the tubular inner sheath is sealingly coupled to the cap such that the lumen of the tubular inner sheath opens outwardly through the cap, further wherein the distal region of the tubular inner sheath is reinforced to prevent collapse of the tubular inner sheath when bent; and a second tubular inner sheath comprising a multi-lumen catheter 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 within the outer sheath, Wherein the flexible 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. An endoscope sheath device, the device comprising: an outer sheath configured to extend over the endoscope; an inner sheath configured to extend within a lumen of the endoscope, the inner sheath having one or more lumens; and a cap configured to be coupled to the distal end of the endoscope, wherein a distal region of the outer sheath is sealed to the cap, and further wherein a distal region of the inner sheath is sealed to the cap such that the one or more lumens of the inner sheath open outwardly through the cap, Wherein the cover is configured to be removed by squeezing two sides of the cover.

101. The device according to claim 100, 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.

102. The apparatus of claim 101 further comprising a stress relief cutout region configured to reduce a force necessary to transform the cylindrical mating surface into the circular mating cross-section.

103. The device according to claim 100, wherein: The cap includes one or more of: a snap fitting, a friction fitting, a magnetic coupling, a bayonet connector, or a threaded region.

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

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

106. The apparatus of claim 100, wherein: The cap is at least partially transparent.

107. An endoscope sheath device, the device comprising: a tubular outer sheath configured to extend over the endoscope; a tubular inner sheath configured to extend within the lumen of the endoscope, the tubular inner sheath having one or more lumens; and a cap configured to be coupled to the distal end of the endoscope, wherein a distal region of the tubular outer sheath is sealed to the cap, and further wherein a distal region of the inner sheath is sealed to the cap such that the one or more lumens of the tubular inner sheath open outwardly through the cap, 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; and a latch connector configured to secure the cap to a distal region of the endoscope, Wherein the flexible 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. An endoscope sheath device, the device comprising: a tubular outer sheath configured to extend over the 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; and a cap configured to be coupled to the distal end of the endoscope, wherein a distal region of the tubular outer sheath is sealed to the cap, and further wherein a distal region of each of the first inner sheath and the second inner sheath is sealed to the cap such that the one or more lumens of the tubular inner sheath open outwardly through the cap, 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; and a latch connector configured to secure the cap to a distal region of the endoscope, Wherein the flexible 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. An endoscope system comprising a fluid-impermeable contamination barrier for preventing contamination of an endoscope, the system comprising: an endoscope having a lumen and a handle; and An endoscope sheath device, the endoscope sheath device comprising: an outer sheath configured to extend over the endoscope, an inner sheath comprising one or more lumens, the inner sheath configured to extend through the lumens of the endoscope, the cap configured to be coupled to a distal end of the endoscope, wherein a distal region of the outer sheath is sealed to the cap, and further, wherein a distal region of the inner sheath is sealed to the cap such that the one or more lumens of the inner sheath are open to the outside through the cap; and a multi-way valve block removably coupled to the handle of the endoscope, wherein the multi-way valve block includes one or more valves in fluid communication with the lumens of the endoscope, wherein the inner sheath is configured to engage with the multi-way valve block such that the one or more valves control the passage of fluid through the one or more lumens of the inner sheath.

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

111. The system of claim 110, further comprising a port adapter configured to cooperate with the multi-lumen catheter to create a plurality of isolated ports fluidly connected to each lumen in the multi-lumen catheter.

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

113. The system of claim 109, wherein: The endoscope sheath device also includes a second outer sheath configured to extend through a second lumen of the endoscope, wherein a distal region of the second inner sheath is sealed to the cap such that one or more lumens of the second inner sheath open outwardly through the cap.

114. The system of claim 113, wherein: The multi-way valve block includes a lumen connector configured to engage with the second lumen of the inner sheath.

115. The system of claim 109, wherein: The multi-way valve block is disposable.

116. The system of claim 109, wherein: The multi-way valve block also includes an umbilical connection connecting the one or more valves of the multi-way valve block to one or more connectors configured to couple to one or more of: a flushing fluid source, an air source, and a vacuum source.

117. A system comprising an elongated external tube for use with an internal endoscope in a telescoping arrangement, the system comprising: an elongated outer tube comprising an outer lumen; an outer sheath coupled to a proximal region of the elongated outer tube at a first end region; a cap sealingly coupled to the second end of the outer sheath; and An inner sheath having one or more inner sheath lumens and extending within the outer sheath and within the outer lumen, wherein the inner sheath is sealingly coupled to the cap such that the one or more inner sheath lumens open outwardly through the cap.

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

119. The system of claim 117, wherein: The elongated outer tube is configured to be selectively rigidified.

120. The system of claim 118, wherein: The elongated outer tube is configured to be selectively rigidified by application of positive or negative pressure.

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

122. The device according to claim 121, wherein The crimping area is configured to heat seal.

123. The device according to claim 121, wherein The crimping area is configured to be pressure-tight.

124. The apparatus of claim 117, wherein: The outer sheath is durable.

125. The apparatus of claim 117, wherein: The outer sheath has a composite structure.

126. The apparatus of claim 117, wherein: The outer sheath is shorter than the inner sheath.

127. The apparatus of claim 117, wherein: The cap is at least partially transparent.

128. The apparatus of claim 117, wherein: The cap includes a transparent area configured to align with a camera of the endoscope.

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

130. The apparatus of claim 117, wherein: The cap is configured to be secured to the distal end of the endoscope and includes one or more of: a friction fitting configured to secure the cap to the distal end of the endoscope; a snap fitting 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. The apparatus of claim 117, wherein: The inner sheath is less flexible than the outer sheath.

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

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

134. The apparatus of claim 133, wherein: The proximal attachment comprises an elastic attachment.

135. The apparatus of claim 133, wherein: The proximal attachment includes a sealing attachment.

136. The apparatus of claim 117, wherein: The outer sheath is flexible and configured to form a contamination barrier that is impermeable to external fluids.

137. The apparatus 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. A method of attaching a sanitary sheath to an endoscope, the method comprising: inserting an inner sheath 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 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 A cap is attached to 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 lumen opens outwardly through the cap.

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

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

141. The method of claim 138, further comprising 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. The method of claim 138, wherein: The inner sheath includes a multi-lumen catheter and further includes a port adapter coupling the inner sheath to a distal region of the inner sheath to create an isolated plurality of ports fluidly connected to each lumen of the multi-lumen catheter.

143. The method of claim 138, wherein: Attaching 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 fitting, a friction fitting, a magnetic coupling, a bayonet connector, or a threaded region.

144. The method of claim 138, wherein: Attaching the cap to 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. The method of claim 138, wherein: Positioning the outer sheath over the endoscope includes positioning the endoscope within an elongated outer tube such that the endoscope is telescopically movable relative to the elongated outer tube.

146. A method for maintaining the cleanliness of an endoscope, the method comprising: performing a medical procedure using an endoscope while the distal end of the endoscope is covered by a cap, wherein an inner sheath sealingly connected to the cap extends through the lumen of the endoscope from the distal end to the proximal end and such that one or more inner sheath lumens extend through the lumen of the endoscope and open outwardly through the cap, and further wherein an outer sheath sealingly connected to the cap and extends proximally over the endoscope; removing the cap from the distal end of the endoscope; and The endoscope is proximally withdrawn from the outer sheath such that the inner sheath extends out of the distal end of the lumen of the endoscope, wherein the proximal region of the inner sheath has been sealed closed.

147. The method of claim 146, wherein: Performing the medical procedure includes passing material through the cap into or out of the one or more inner sheath lumens.

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

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

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

151. The method of claim 147, wherein: Proximally withdrawing the endoscope from the outer sheath includes proximally withdrawing the endoscope from the outer tube.

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

153. The method of claim 152, wherein: Sealing the proximal region includes mechanically crimping the proximal region.

154. The method of claim 152, wherein: Sealing the proximal region includes heat sealing the proximal region.

155. An endoscope sheath device, the device comprising: a flexible tubular outer sheath configured to extend over the endoscope; a cap configured to be coupled to a distal end of the endoscope, wherein a distal region of the flexible tubular outer sheath is sealed to the cap; and A proximal sealing collar, wherein a proximal region of the flexible tubular outer sheath is sealed to the proximal sealing collar, further wherein the proximal sealing collar is configured to form an airtight seal against the endoscope such that the tubular outer sheath can be inflated or collapsed by applying fluid pressure between the flexible tubular outer sheath and the exterior surface of the endoscope.

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

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

158. The apparatus of claim 155, wherein: The flexible outer sheath comprises an elastomeric material.

159. The apparatus of claim 155, wherein: The flexible outer sheath has a non-uniform diameter along the length of the flexible outer sheath.

160. The apparatus of claim 155, wherein: The flexible outer sheath has one or more inflation regions along the length of the flexible outer sheath, the inflation regions being configured to expand to a larger expanded radius when the flexible outer sheath is inflated by application of positive pressure.

161. The apparatus of claim 155, wherein: The cap is configured to seal to the distal end of the endoscope.

162. The apparatus of claim 155, wherein: The cap is configured to be secured to the distal end of the endoscope and includes one or more of: a friction fitting configured to secure the cap to the distal end of the endoscope; a snap fitting 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. The device according to claim 155 further includes a tubular inner sheath, which is configured to extend within the lumen of the endoscope, and the tubular inner sheath has one or more lumens, wherein a distal region of the inner sheath is sealed to the cap so that the one or more lumens of the tubular inner sheath are open to the outside through the cap.

164. An endoscope sheath device, the device comprising: a flexible tubular outer sheath configured to extend over the endoscope; a tubular inner sheath configured to extend within the lumen of the endoscope, the tubular inner sheath having one or more lumens; a cap configured to be coupled to a distal end of the endoscope, wherein a distal region of the flexible tubular outer sheath is sealed to the cap, and further wherein a distal region of the inner sheath is sealed to the cap such that the one or more lumens of the tubular inner sheath open outwardly through the cap; and A proximal sealing collar, wherein a proximal region of the flexible tubular outer sheath is sealed to the proximal sealing collar, further wherein the proximal sealing collar is configured to form an airtight seal against the endoscope such that the tubular outer sheath can be inflated or collapsed by applying fluid pressure between the flexible tubular outer sheath and the exterior surface of the endoscope.

165. An endoscope sheath system, the endoscope sheath system being configured to prevent contamination of an endoscope, the device comprising: An endoscope sheath device, comprising: --Outer sheath; a cap sealingly coupled to the distal end of the outer sheath; and an inner sheath comprising a multi-lumen catheter extending within the outer sheath, wherein the inner sheath is sealingly coupled to the cap such that the lumens of the multi-lumen catheter open outwardly through the cap; and A port adapter is configured to couple to the proximal 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. The system of claim 163, wherein: The multi-lumen catheter includes a plurality of radially spaced side openings at a proximal region of the inner sheath, wherein each side opening opens into one lumen of the multi-lumen catheter.

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

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

169. A method for confirming that an endoscope is not contaminated, the method comprising: performing a medical procedure in vivo using the endoscope when the endoscope is enclosed in the endoscope sheath device; withdrawing the endoscope from the body; applying positive pressure between the endoscope and an outer sheath of the endoscope sheath device; and Whether the endoscope sheath device is contaminated is indicated based on a decay in pressure from between the outer sheath and the endoscope.

170. The method of claim 169, wherein: Execution includes performing the medical procedure wherein the endoscope is sheathed such that an exterior surface of the endoscope is surrounded by an outer sheath of the endoscope sheath device and an interior lumen of the endoscope is covered by an inner sheath, wherein the outer sheath and the inner sheath form a continuous fluid-impermeable contamination barrier.

171. The method of claim 169, wherein: Applying a positive pressure between the endoscope and an outer sheath of the endoscope sheath device includes at least partially inflating the outer sheath.

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

173. The method of claim 169, wherein: The step of indicating includes determining whether the outer sheath has developed a leak based on a pressure decay from between the outer sheath and the endoscope.

174. The method of claim 169, wherein: The step of indicating includes transmitting a signal.

175. The method of claim 169, wherein: The step of indicating includes sounding an alarm if a pressure decay from between the outer sheath and the endoscope exceeds a threshold.

176. A method for confirming that an endoscope is not contaminated, the method comprising: performing a medical procedure using an endoscope while the distal end of the endoscope is covered by a cap, wherein an inner sheath sealingly connected to the cap extends through the lumen of the endoscope from the distal end to the proximal end and such that one or more inner sheath lumens extend through the lumen of the endoscope and open outwardly through the cap, and further wherein an outer sheath sealingly connected to the cap and extends proximally over the endoscope; withdrawing the endoscope from the body; applying positive pressure between the endoscope and an outer sheath of the endoscope sheath device; and Whether the endoscope sheath device is contaminated is indicated based on a decay in pressure from between the outer sheath and the endoscope.

177. An endoscope sheath device, the endoscope sheath device being configured to prevent contamination of an endoscope, the device comprising: a cap configured to be coupled to a distal end of the endoscope; an outer sheath sealingly coupled to the cap at a distal end; one or more inner sheaths extending within the outer sheath, wherein each inner sheath is sealingly coupled to the cap at a distal end and opens outwardly through the cap; and A mounting handle wherein at least a portion of the outer sheath is retained in a stowed configuration within a cavity of the mounting handle, and further wherein the one or more inner sheaths extend distally through the stowed outer sheath and cavity and out of a distal end of the mounting handle.

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

179. The apparatus of claim 177, wherein: The mounting handle includes a coupler at a distal end of the mounting handle configured to couple to a mating attachment on the endoscope.

180. The apparatus of claim 177, wherein: The outer sheath is retained in the collapsed configuration within the chamber such that the outer sheath is compressed.

181. The apparatus of claim 177, wherein: The outer sheath is retained in the collapsed configuration within the chamber such that the distal end of the catheter can fit within the outer sheath when inserted from the distal end of the mounting handle.

182. The apparatus of claim 177, wherein: The mounting handle includes an outer gripping surface.

183. The apparatus of claim 177, wherein: The mounting handle comprises a cylindrical shape.

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

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

186. A method of mounting an endoscope sheath device on an endoscope, the method comprising: inserting an inner sheath from a distal end of an endoscope through a lumen of the endoscope; advancing the distal end of the endoscope through an outer sheath, the outer sheath being retained in a stowed configuration within a mounting handle; coupling a cap of the endoscope sheath device to a distal region of the endoscope; and The mounting handle is pulled proximally on the endoscope to deploy the outer sheath on the endoscope.

187. The method of claim 186 further comprising coupling the mounting handle to the endoscope.

188. The method of claim 186, further comprising removing the endoscope sheath device from the endoscope by advancing the mounting handle distally on the endoscope to flip the outer sheath proximally onto itself.

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

190. The method of claim 189, wherein: Sealing includes crimping.

191. The method of claim 189, wherein: Sealing includes heat sealing.

192. The method of claim 189 further comprising disengaging the cap from the endoscope and pulling the sealed inner sheath out of the lumen of the endoscope.

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