Rigidizing endoscope shield

Abstract

Rigidizing endoscope shield assemblies may be used with endoscopes to reversibly convert the endoscope into a rigidizing endoscope. Described herein are examples of rigidizing endoscope shield assemblies that are optimized for ease of use and rapid application when combined with an endoscope. These rigidizing endoscope shield assemblies may prevent contamination, including cross-contamination between patients and contamination of the endoscope. These rigidizing endoscope shield assemblies may reduce or eliminate the need for endoscope cleaning and may include both an external shield member and one or more internal shield members that may extend through lumen of the endoscope.

Description

RIGIDIZING ENDOSCOPE SHIELDCLAIM OF PRIORITY

[0001] This patent application claims priority to U.S. provisional patent application no. 63 / 566,889, titled “RIGIDIZING ENDOSCOPE SHIELD,” filed March 18, 2024, herein incorporated by reference in its entirety.INCORPORATION BY REFERENCE

[0002] 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.BACKGROUND

[0003] Reusable endoscopes (‘scopes’), both manually and robotically operated, perform important diagnostic and therapeutic functions, but have numerous issues. Endoscopes may be difficult to clean because they may be a long length (an enteroscope may be over two meters long), may have one or more very long and very small lumens, and they include a multitude of small, ornate parts constructed from a wide variety of materials that have regions that may shelter microbes. These regions may include regions where parts meet, in cracks and connections, and regions where there are scratches and localized damage. The use of most endoscopes typically requires them to be immersed in pathogen-rich contaminants, including blood, feces, urine, and diseased and infected tissue. Further, current techniques for cleaning and sterilizing scopes are woefully inadequate.

[0004] The use of sleeves, sheaths or drapes have been proposed for use with scopes in order to allow them to be reused multiple times. Surgical drapes, sheaths, and shrouds are used to create a sterile field around a surgical site and establish a physical barrier that reduces the risk of device contamination and surgical site infections. Sheathing can be a key enabler to freeing technicians required to clean waste (e.g., feces) from endoscopes to pursue more meaningful and important work. Hygienic draping, including for both manual and robotic / telerobotic endoscopy, may effectively physically isolate the device from the patient during surgical procedures.

[0005] Unfortunately, sleeves and sheaths for scopes tend to add bulk and may undesirably change the flexibility and maneuverability of the endoscope.

[0006] Recently, scopes that may be rigidized, e.g., converted from a highly flexible to a less flexible, e.g., more rigid, configuration have been developed. For example see US 11,478,608 and US 11,554,248. These apparatuses may use pressure to control the relative flexibility / rigidity of the scope. These devices provide an integrated solution, in which the scope incorporates the rigidizing components. However, it may be particularly useful to provide apparatuses and methods in which a scope, e.g., an endoscope, can be converted, in the field (e.g., in an operating room or medical environment), into a rigidizing endoscope. These methods and apparatuses may further protect or shield the endoscope and allow it to be re-used, while the rigidizing component may be single-use. Described herein are methods, components, systems, and apparatuses that may address these uses.SUMMARY OF THE DISCLOSURE

[0007] Described herein are methods and apparatuses, e.g., components, accessories, devices and systems, including shield systems (also referred to equivalently as sheath systems), that may be used with endoscopes, and in particular, manual endoscopes or robotic endoscopes and / or telescoping endoscopes, as well as method of using these shields to prevent cross-contamination between patients and contamination of the endoscope and to convert the endoscope into a rigidizing (e.g. pressure rigidizing) endoscope. In general, these shields may reduce or eliminate the need for endoscope cleaning. The shields described herein may also or alternatively be referred to as sheaths and may advantageously be quickly and easily applied to (and, after use, removed from) an endoscope system for a new patient without a lengthy reprocessing procedure that would otherwise include HLD and / or sterilization. These rigidizing shields may protect the outside of the endoscope as well as any internal working channels and supply lines of the endoscope, which may critically prevent contamination of endoscopes with internal working channels and supply lines during medical procedures. These shields may easily and rapidly mate with a non-rigidizing scope and convert it into a rigidizing endoscope. The apparatuses (e.g., components, accessories, devices and systems, including shield devices and shield systems) and methods described herein may protect patients from cross-contamination including cross-contamination from other patients, may be faster, easier, and lower cost, may result in less landfill, and may be more effective than reprocessing (cleaning of the endoscope). By reducing or eliminating additional cleaning cycles, the endoscopes may have less wear and associated damage. By effectively sheathing and protecting (e.g., shielding) the devices, important scope elements can be reused multiple times, thereby reducing per-case cost and reducing landfill.

[0008] The method and apparatuses (e.g., systems and devices, including shield systems) described herein may include reusable elements, disposable elements, semi -disposable elements (i.e., resposable elements, elements that are reused a modest number of times), and / or rigidizing shielding elements that may address the issues raised above.

[0009] As used herein the term “endoscope” is intended to be understood broadly. In general, an endoscope may refer to an instrument which can be introduced into the body and may include one or more lumens extending therethrough. An endoscope may include a catheter, trocar, tube, or the like. An endoscope may refer to an instrument for use in examining, accessing, treating and / or diagnosing the interior of a body, including an organ, lumen, body cavity or vessel. Any of these endoscopes may include imaging (e.g., typically by a CCD, CMOS chip, or fiber optic material) to give a view from the distal end or sides of the device. The endoscopes described herein may include sensing (e.g., electrical sensing, magnetic sensing, shape sensing, mechanical sensing, ultrasonic sensing, etc.). The endoscope may generally be a catheter including one (or more than one) internal lumen extending the length of the endoscope. In some examples the endoscope may include one or more internal lumens extending the length of the endoscope (e.g., an internal working channel, fluid channels, insufflation channels, wash channels, etc.). For example, any of these endoscopes may include a channel or channels for applying or removing liquid and / or gas (e.g., aspiration / suction, spray, wash, insufflation). These channels may be co-joined with electrical elements, including wiring for lighting, vision, the delivery of energy, or sensing. These endoscopes may include a channel or channel for tools or instruments. This channel may be multi-use, including for aspiration or wash. Any of the endoscopes described herein may include an internal lumen configured as an internal working channel, e.g., for passing one or more accessory devices. Any of the apparatuses described herein may also include one or more external working channels.

[0010] In general, an endoscope as described herein may refer to any appropriate type of scope. Thus, the rigidizing shield apparatuses described herein may be used with any appropriate endoscope. Examples of endoscopes may include, but are not limited to colonoscopes, arthroscopes, bronchoscopes, cystoscopes, hysteroscope, enteroscopes, esophagogastroduodenoscopes, hysteroscopes, neuroendoscopes, sinuscopes, laparoscopes, laryngoscopes, mediastinoscopes, sigmoidoscopes, nasopharyngoscopes, thoracoscopes, ureteroscopes, etc. Endoscopes are typically long compared to their diameter, are typically either rigid or flexible, and are configured for inserting into a body.

[0011] The methods and apparatuses described herein may be particularly well suited for manual endoscopes. A manual endoscope may be manually steered using a control (e.g.,knob, button, lever, dial, etc.) to steer a region (typically the distal tip region) or regions, and may be advanced or retracted manually. The shields described herein may be configured to work on or with a manual endoscope, so that the distal cap may fit over the distal end of the manual endoscope, the external shield (sealed to the cap) may fit over the outer surface of the endoscope and the one or more internal shields (also sealed to the cap) may fit through and line any inner lumen of the endoscope.

[0012] The methods and apparatuses described herein may be particularly well suited for use with telescoping systems in which an inner endoscope is concentrically arranged with an outer tube. The inner endoscope and the other endoscope may be moved together (e.g., to advance) and / or separately. All operations of the inner endoscope (also referred to herein as the “child”) may be protected by the shields described herein and may therefore be reusable a certain number of times, or semi-disposable or resposable (meaning that it is reused a certain number of times, for example 2 to 200 times). In some examples, the outer endoscope tube (which may also be referred to herein equivalently as a “mother,” an outer member or as an overtube) may be reusable or may be disposable. The mother may be reusable the same number of times as the child, or it may be reusable a different number of times than the child, or one of the elements may be single use. For example, the outer tube may be completely or partially covered by the external shield. In variations in which the outer tube is extensively covered by the external shield (e.g., completely or mostly covered, or covered within the sterile field) the outer tube may be reused after removing the shield following a procedure. In variations in which the external shield is connected only distally (e.g., sealed to the distal end or distal end region of the outer tube) the outer tube may be single-use or may require cleaning and / or sterilizing before reuse. Since the outer tube may be easier, faster, and / or cheaper to clean than the endoscope this may still be a net savings. The outer tube may also be an endoscope.

[0013] As mentioned, the endoscope may equivalently include (and / or be replaced with) a catheter. In examples including an inner endoscope and an outer tube, the majority of the length of the inner member (equivalently referred to herein as an endoscope, inner endoscope, or “child”) may be ensheathed by the outer tube, which may be of special construction such that it is referred to as a ‘ruggedized’ shield. As used herein, a ruggedized device may have multiple layers, and one or more of those layers may be augmented by the addition of materials, typically metal, plastic or fiber. These additional layers and materials may provide enhanced puncture, tear and leak-proof performance. Whereas a typical sheath is a thin film, a ruggedized shield is a more highly engineered structure that provides this additional clinical safety, performance, and utility. Ruggedized devices can have clinicalbenefits: for example, when the endoscope is configured for insertion into the rectum, a ruggedized device should provide decreased wear, reduced potential for damage, and increased reliability.

[0014] The shield apparatuses described herein are ruggedized to prevent contamination of an endoscope held within the shield apparatus. For example the shield may include multiple layers, including one or more reinforced layers (e.g., coil -reinforced outer layer), one or more rigidizing layers a single- or double- bladder layer. These multiple layers reduce the likelihood of contamination and / or leakage between the endoscope and the shield. The systems described herein may also include the use of an overtube, in addition to the shield apparatus, which may further protect the endoscope within the shield.

[0015] In general, the apparatuses and methods described herein may convert a flexible endoscope into a rigidizing endoscope by coupling the rigidizing sheath (shield) over (and in some case into) the endoscope. The endoscope may then be selectively rigidized, e.g., converted between highly flexible and less flexible (e.g., rigid) states by the application of pressure (e.g., positive and / or negative pressure). In examples the converted “rigidizing endoscope” may be used with a second rigidizing member, e.g., a rigidizing overtube. Flexible may refer to the ability of the endoscope to flex and bend.

[0016] For example, described herein are shield apparatuses configured to act as field- deployable shields to convert a non-rigidizing endoscope into a rigidizing endoscope. These apparatuses may be configured to be efficiently and easily coupled with an endoscope. In some examples the external shield apparatus configured to make an endoscope rigidizing comprises: an elongate shield body having a lumen and comprising a plurality of cylindrical layers including: an outer wall layer, a rigidizing layer and a bladder layer, wherein the bladder layer forms an exposed wall of the lumen; a cap covering the distal end of the lumen of the elongate shield body, wherein the cap is configured to couple the elongate shield body the endoscope (e.g., couple the a distal end of the elongate shield body to the distal end region of the endoscope); a proximal attachment configured to mate with a proximal end of the endoscope, wherein the bladder is configured so that when a distal end of the endoscope is coupled with the cap and the proximal attachment is coupled with the proximal end of the endoscope, pressure may be applied through a pressure port to compress and increase the stiffness of the rigidizing layer.

[0017] Thus, in general, these apparatuses may be configured so that the innermost layer, e.g., forming the surface of the inner lumen into which the endoscope is held, is formed by the deformable bladder layer. The bladder layer may be a single layer or an ‘out-and-back’ bladder having a double layer, in which the two layers are continuous and / or as separatelayers that are sealed together at the distal end. In any of these apparatuses a pressure port may be in fluid communication with the bladder layer. Thus, the bladder layer may comprise an out-and-back bladder layer forming a pressure-receiving chamber. The bladder may therefore be configured so that when a distal end of the endoscope is coupled with the cap and the proximal attachment is coupled with the proximal end of the endoscope, pressure applied through the pressure port drives the bladder against an outer surface of the endoscope to compress and increase the stiffness of the rigidizing layer. Described herein, as well as incorporated by reference herein, are various examples of rigidizing layers, any of which may be used with the methods and apparatuses described herein.

[0018] The apparatus may be configured to slidably receive and release an endoscope within and against the bladder layer. For example, the bladder layer may include a coating (e.g., hydrophilic coating, hydrophobic coating), powder, or an engineered material or surface that exhibits low tack, e.g., low grabbiness, or is ‘silky’, so as to reduce friction between the endoscope and the endoscope-receiving lumen of the apparatus. One potential example of such a material is a TPSiV, a vulcanized silicone in a thermoplastic matrix.

[0019] Any of these apparatuses may include one or more internal shields extending proximally through the lumen of the external shield from an opening through the cap. The one or more internal shields may be sealed at the proximal end region with a removable seal. The elongate shield body may be shorter than the one or more internal shields. In some case, at least one of the one or more internal shields may comprise a working channel liner having a working channel lumen.

[0020] As described herein, the cap may be at least partially transparent. In some cases the cap may comprise a transparent region configured to align with a camera of the endoscope. The cap may comprise an engagement region configured to secure the cap to the distal end of the endoscope comprising one or more of: a friction fitting, a snap fitting, a magnet, a bayonet connector, or a threaded region.

[0021] At least one of the one or more internal shields may comprise a multi-lumen catheter.

[0022] The proximal attachment may comprise a seal configured to seal the region between an outer surface of the endoscope and the bladder layer. The elongate shield body may be configured to form an external fluid-impermeable contamination barrier.

[0023] The cap may comprise a substantially cylindrical mating surface configured to mate with a distal end of the endoscope when compressed from an oval resting cross- sectional configuration into a substantially circular mating cross-sectional configuration. Theone or more internal shields may comprise a working channel liner configured to form an internal fluid-impermeable contamination barrier within a working channel of the endoscope.

[0024] Any of these apparatuses may include a sealing region at a proximal end region of the internal shield that is configured to be crimped to seal to close off the one or more internal lumens after use to prevent contamination during removal of the oner or more internal shields from within a lumen of the endoscope. The sealing region may be configured to be heat sealed, adhesively sealed and / or pressure sealed.

[0025] An external shield apparatus to make an endoscope rigidizing may include: an external shield configured to be transitioned from a flexible configuration to a less flexible configuration by modulation of pressure within the external shield; a cap covering the distal end of the external shield the lumen, wherein the cap is configured to couple the external shield to the endoscope (e.g., couple the distal end region of the endoscope to the cap and therefore the distal end of the external sheath); and one or more internal shields extending proximally through the lumen of the external shield from an opening through the cap.

[0026] The one or more internal shields may be sealed at the proximal end region with a removable seal. The external shield may be shorter than the one or more internal shields. The cap may be at least partially transparent. The cap may comprise a transparent region configured to align with a camera of the endoscope. The cap may comprise an engagement region configured to secure to the cap to the distal end of the endoscope comprising one or more of a friction fitting, a snap fitting, a magnet, a bayonet connector, or a threaded region. At least one of the one or more internal shields may comprise a multi-lumen catheter. For example, at least one of the one or more internal shields comprises a working channel liner having a working channel lumen.

[0027] Any of these apparatuses may include a proximal attachment on the external shield configured to seal the external shield to an outer surface of the endoscope. The proximal attachment may comprise an elastic attachment. The external shield may be configured to form an external fluid-impermeable contamination barrier.

[0028] The cap may comprise a substantially cylindrical mating surface configured to mate with a distal end of the endoscope when compressed from an oval resting cross- sectional configuration into a substantially circular mating cross-sectional configuration. The one or more internal shields may comprise a working channel liner configured to form an internal fluid-impermeable contamination barrier within a working channel of the endoscope.

[0029] Any of these apparatuses may include a sealing region at a proximal end region of the internal shield that is configured to be crimped to seal to close off the one or more internal lumens after use to prevent contamination during removal of the oner or more internal shieldsfrom within a lumen of the endoscope. The sealing region may be configured to be heat sealed, adhesively sealed and / or pressure sealed. An internal lumen of the one or more internal shields may comprise a coating (e.g., a hydrophilic coating).

[0030] Also described herein are methods of using any of these apparatuses, including in particular methods of forming the field-deployable rigidizing endoscope (e.g., by installing the external shield apparatus) and methods of operating the rigidizing endoscope formed by coupling it with the external shield apparatus. In any of these methods the external shield apparatus may be disposable, e.g., intended for single use, while the endoscope may be configured to be reused.

[0031] For example, described herein are method of using a field-deploy able rigidizing endoscope. These methods may include inserting an endoscope into a rigidizing shield so that a distal end region of the rigidizing shield engages with a distal end of the endoscope, to form a rigidizing endoscope; operating the rigidizing endoscope, wherein the rigidizing endoscope is configured to be steered while advancing or withdrawing the rigidizing endoscope within a body region, further wherein operating the rigidizing endoscope comprises modulating the stiffness of the rigidizing endoscope by applying and / or releasing a pressure within the rigidizing shield; and disposing of the rigidizing shield after disengaging the distal end region of the endoscope from the distal end region of the rigidizing shield.

[0032] Any of these methods may include inserting the endoscope into a second rigidizing shield to re-form the rigidizing endoscope. Inserting the endoscope into the rigidizing shield may comprise rigidly engaging the distal end region of the rigidizing shield with the distal end of the endoscope to form the rigidizing endoscope. The endoscope and the rigidizing shield may be reliably locked together so that they move together. Inserting the endoscope into the rigidizing shield may comprise coupling the rigidizing shield to the rigidizing shield so that the rigidizing shield forms a contamination barrier over and inside of the endoscope. Inserting the endoscope into the rigidizing shield may comprise inserting an elongate inner shield extending from a distal end cap of the rigidizing shield through a working channel of the endoscope.

[0033] Any of these methods may include removing a seal occluding the proximal end region of the elongate inner shield after inserting the elongate inner shield through the working channel of the endoscope. For example, any of these methods may an initially sealed inner shield member (or members) that are sealed off at the proximal end to prevent contamination when inserting the rigidizing shield into the endoscope. Separately, any of these apparatuses may be sealed before removing the inner shield(s) from the endoscope to prevent or limit contamination following use.

[0034] The methods described herein may generally include preventing contamination of the endoscope by the rigi dizing shield through a plurality of barriers forming the rigi dizing shield. The multiple barriers may include an out-and-back bladder layer. The multiple barriers may include an outer coil-wound tube (OCWT) layer. Any of these methods may include applying negative pressure within the rigidizing shield to enlarge a lumen of the rigidizing shield that receives the endoscope before and / or during insertion of the endoscope. Inserting the endoscope into the limited-use rigidizing shield may comprise inserting a reusable endoscope into a limited-use rigidizing shield.

[0035] For example, a method may include: inserting a reusable endoscope into a limiteduse rigidizing shield so that a distal end region of the limited-use rigidizing shield engages with a distal end of the reusable endoscope, to form a rigidizing endoscope wherein the limited-use rigidizing shield forms a contamination barrier over and inside of the reusable endoscope; and operating the rigidizing endoscope, wherein the rigidizing endoscope is configured to be steered while advancing or withdrawing the rigidizing endoscope within a body region, further wherein operating the rigidizing endoscope comprises modulating the stiffness of the rigidizing endoscope by applying and / or releasing a pressure within the rigidizing shield.

[0036] The method may further comprise sealing a proximal end region of an inner portion rigidizing shield to prevent contamination when removing the limited-use rigidizing shield from the reusable endoscope. In any of these methods, the method may include disposing of the limited-use rigidizing shield after disengaging the distal end region of the reusable endoscope from the distal end region of the limited-use rigidizing shield. The method may include inserting the reusable endoscope into a second limited-use rigidizing shield to re-form the rigidizing endoscope.

[0037] Also described herein are methods of assembling a field-deployable rigidizing endoscope. For example, a method of forming a rigidizing endoscope in a clinical setting may include: inserting an endoscope into a rigidizing shield until a distal end region of the limiteduse rigidizing shield engages with a distal end of the reusable endoscope, to form the rigidizing endoscope, wherein the rigidizing endoscope may be rigidized by modulating pressure within the limited-use rigidizing shield, further wherein the limited-use rigidizing shield forms a protective barrier over the reusable endoscope.

[0038] Any of these methods may further comprise disengaging, after use, the distal end region of the endoscope from the distal end region of the rigidizing shield and withdrawing the rigidizing shield off of the endoscope. The method may include inserting the endoscope into a second rigidizing shield to re-form the rigidizing endoscope. Inserting may comprisemodulating pressure within the rigidizing shield while inserting endoscope into the rigidizing shield, for example, applying a negative pressure to expand a lumen of the rigidizing shield. Inserting may comprise inserting the endoscope against a slip material within the rigidizing shield to reduce friction between the rigidizing shield and the endoscope. In some cases inserting comprises inserting the endoscope in which a lubricant reduces friction between the rigidizing shield and the endoscope. Inserting may comprise inserting the endoscope in which a powder material reduces friction between the rigidizing shield and the endoscope. Inserting may comprise inserting the endoscope in which an engineered material or surface that exhibits low tack or grabbiness, or is ‘silky’ reduces friction between the rigidizing shield and the endoscope. Inserting may comprise inserting the endoscope in which a hydrophilic coating reduces friction between the rigidizing shield and the endoscope. Inserting may comprise assisting insertion by modulating a surface texture between the endoscope and the rigidizing shield.

[0039] In any of these methods and apparatuses, the rigidizing shield may comprise one or more columnar buckling resistance layers. The columnar buckling resistance layers may be arranged in a longitudinal direction within the rigidizing shield to augment rigidization during pressurization.

[0040] As mentioned, any of these methods may include removing a seal occluding the proximal end region of the elongate inner shield after inserting the elongate inner shield into the working channel of the endoscope. This may help ensure that, even if the lumen of the endoscopes are contaminated, the introduction of any inner shield(s) still allow the sealed-off inner shield(s) to be fully inserted and, after the seal is removed, the inner shield(s) provide an uncontaminated inner lumen.

[0041] In general, also described herein are apparatuses (e.g., external shield apparatuses) having sealed or capped internal shields, for example, sealed or capped at the proximal end, to prevent contamination when inserting the shield within an endoscope that may have already been used with a patient. For example, an external shield apparatus to make an endoscope rigidizing may include: an elongate external shield body configured to be transitioned from a flexible configuration to a less flexible configuration by modulation of pressure within the external shield; a lumen extending within the external shield; a distal cap covering the distal end of the external shield and the lumen, wherein the distal cap is configured to couple the external shield to the endoscope; an internal shield having an internal shield lumen, the internal shield extending proximally from the distal cap through the lumen of the external shield so that a distal end of the internal shield lumen is open through the distal cap; and a removable seal sealing a proximal end of the internal shield.

[0042] The removable seal may comprise a plug. The removable seal may comprise a frangible seal. The removable seal may comprise a sacrificial layer. In some examples, the removable seal comprises a removable cap.

[0043] Any of these apparatuses may be configured so that the cap of the external shield apparatus enhances the optics of the endoscope, for example, by blacking out regions around the camera and / or light sources so that the light source does not pass through the cap material. For example, an external shield apparatus for an endoscope may include: an elongate external shield body configured to be transitioned from a flexible configuration to a less flexible configuration by modulation of pressure within the external shield; a lumen extending within the external shield; and a distal cap covering the distal end of the external shield and the lumen, wherein the distal cap is configured to couple the external shield to the endoscope (e.g., distal end region of the endoscope to the distal end region of the external shield), further wherein the distal cap comprises one or more transparent regions surrounded by one or more light-bocking regions.

[0044] The one or more transparent regions may be configured to transmit light. The one or more light-bocking may be configured to block transmission of light. They may be configured to block transmission of light along the primary axis of the scope (for example, the distal and proximal faces of the cap). They may be configured to block transmission of light along the perpendicular axis (for example, through the material in an axis parallel to the cap faces).

[0045] Any of these apparatuses may be configured so that the cap applies tension (axial tension) by pre-loading the cap when attached to the distal end of the endoscope to reliably hold the window(s) of the cap at a fixed distance from the endoscope distal end region. For example, an external shield apparatus for an endoscope may include: an elongate external shield body configured to be transitioned from a flexible configuration to a less flexible configuration by modulation of pressure within the external shield; a lumen extending within the external shield; and a distal cap covering the distal end of the external shield and the lumen, wherein the distal cap is configured to couple the external shield to the endoscope (e.g., distal end region of the endoscope to the distal end region of the external shield), the distal cap comprising an elastomeric region (e.g., elastomeric layer, elastomeric cuff, elastomeric link, etc.) that maintains tension holding the distal cap is coupled to the distal end of the endoscope when the distal cap is latched to the endoscope, so as to hold an imaging window of the distal cap at a relatively constant distance from an imaging sensor of the endoscope, for example, snugly against the end of the scope with a compressive load between the two elements.

[0046] Any of these apparatuses may include a latch (or lock, e.g. releasable latch / lock) on the distal cap that is configured to releasably secure the distal cap to the distal end of the endoscope. For example, the apparatus may include a latch on the more proximal region of the distal cap that is configured to releasably secure the distal cap to the distal end of the endoscope.

[0047] The elastomeric link may comprise an annular layer between a distal end region of the distal cap and a more proximal region of the distal cap.

[0048] Any of these apparatuses may include an elastomeric gasket configured to seal the distal end cap to the distal end of the endoscope. This gasket may be separate from the elastomeric link.

[0049] The imaging window may comprise a transparent window. The elastomeric link may be configured to hold the imaging window against the distal end of the endoscope. The elastomeric link may be configured to stretch when the distal cap is coupled to the distal end of the endoscope to apply the axially compressive force.

[0050] Described herein are endoscope shield apparatuses (e.g., systems, devices, etc.) comprising: an external shield; a cap sealingly coupled to a distal end of the external shield; and an internal shield having one or more lumens and extending within the external shield, wherein the internal shield is sealingly coupled to the cap so that the one or more lumens are open through the cap.

[0051] For example, an endoscope shield device configured to prevent contamination of an endoscope may include: an external shield; a cap sealingly coupled to a distal end of the external shield; and one or more internal shields each extending within the external shield, wherein each internal shield has one or more internal lumens, further wherein each internal shield is sealingly coupled to the cap so that the one or more internal lumens is open through the cap.

[0052] In some examples an endoscope shield device configured to prevent contamination of an endoscope may include: a flexible external shield configured to extend over the endoscope to form an impermeable external barrier; a cap sealingly coupled to a distal end of the external shield, wherein the cap is configured to mate with a distal end of the endoscope; and one or more internal shields each having one or more internal lumens, each of the one or more internal shields extending within the flexible external shield, wherein each of the one or more internal shields are configured to pass through a lumen of the endoscope to form an impermeable internal barrier, wherein each of the one or more internal shields is sealingly coupled to the cap so that the one or more internal lumens are open through the cap.

[0053] Thus, in general the shield devices (including the cap, outer and internal shield devices) described herein may form an impermeable contamination barrier. The impermeable contamination barrier may be impermeable to fluid and / or solids. The barrier may be sterile or sterilized, for example by methods that include but are not limited to: EtO, radiation, hydrogen peroxide, or chlorine dioxide gas. Optionally the barrier does not have to be sterile, but may be clean and may prevent contamination of the endoscope to which it is attached. The endoscope does not need to be sterile or remain sterile, but may be kept clean and free of contaminants by the shield devices described herein. In particular both external and internal (e.g., channels, lumen, etc.) of the endoscope may be kept clean and free of contaminant as the shield devices described herein may effectively generate a barrier to prevent contamination. Importantly, these shield devices are configured to be removed without contamination of the endoscope covered by the shield, either externally or internally.

[0054] An endoscope shield device configured to prevent contamination of an endoscope may include: a flexible external shield configured to fit over the endoscope; a cap sealingly coupled to a distal end of the external shield; one or more internal shields each extending within the external shield and configured to fit within a lumen extending through the endoscope, wherein each internal shield has one or more internal lumens, further wherein each internal shield is sealingly coupled to the cap so that the one or more internal lumens is open through the cap; and a sealing region at a proximal end of each of the one or more internal shields that is configured to be sealed after use to prevent contamination during removal of the oner or more internal shields from within the lumen extending through the endoscope.

[0055] For example, in some examples, the external shield comprises a flexible, thin, resilient material. The external shield may be comprised of one or more materials, including plastics, elastomers, plastomers, or composite materials. Plastomers include polymer materials which combine qualities of elastomers and plastics, such as rubberlike properties with the processing ability of plastic. Plastomers may include ethylene-alpha olefin copolymers. Appropriate materials may include latex, polyvinylchloride, polyurethane, polyethylene, polypropylene, silicone, or other similar materials. The material may be reinforced through lamination, including with fibers or metals. In some examples the distal end (e.g., distal 10% or more, distal 15% or more, distal 20% or more, distal 25% or more, distal 30% or more, distal 35% or more, etc.) of the external shield may be a thin-walled sheath, while the rest of the external shield may be ruggedized. A ruggedized shield may be thicker (e.g. having a wall thickness of 0.1 mm or greater, 0.2 mm or greater, 0.25 mm or greater, 0.3 mm or greater, 0.35 mm or greater, 0.4 mm or greater, 0.5 mm or greater, 0.55mm or greater, 0.6 mm or greater, 0.7 mm or greater, 0.8 mm or greater, 0.9 mm or greater, 1mm or greater, etc.). Depending on the material forming the shield, a thin-walled shield may have a thickness of, e.g., 0.2 mm or thinner, 0.15 mm or thinner, 0.1 mm or thinner, 0.05 mm or thinner, 0.04 mm or thinner, 0.02 mm or thinner, between about 0.25 mm to 0.01 mm thick, between about 0.2 mm to 0.02 mm thick, etc.). The shield may be formed of a single material having different regions (e.g., thin-walled region and thicker-walled or ruggedized region) or a shield may be formed of different materials that are coupled (e.g., fused, sealed, etc.) together.

[0056] In general, the external shield may be shorter than the internal shield. For example, the external shield may extend just to the tip of an elongate outer tube (e.g., an elongate outer tube); in some examples the external shield may extend along the length of the elongate outer tube.

[0057] The cap may be polymeric material that may be transparent and / or may include a transparent window configured to align with a camera of an endoscope to allow imaging therethrough. The cap may be configured to couple to a distal end of an endoscope. In some examples the cap is configured to secure to an endoscope. The cap may secure to multiple points along the length of the endoscope, including but not limited to the distal end of an endoscope. For example, there are multiple methods that could be used to attach at the region of 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 fit configured to secure the cap to the distal end of the endoscope, a magnet configured to secure the cap to the distal end of the endoscope, a bayonet connector configured to secure the cap to the distal end of the endoscope, or a threaded region configured to secure the cap to the distal end of the endoscope.

[0058] In any of the apparatuses described herein the external shield may have a lower buckling resistance than the internal shield(s). Thus, the internal shield(s) may have a higher axial compression stiffness than the external shield; the external shield may be configured to buckle (e.g., to scrunch, pleat, gather, stack up on itself, etc.) whereas the internal shield(s) are configured to resist buckling. In some examples the internal shield comprises a multilumen catheter. For example, the internal shield may be formed as an elongate, flexible single-lumen or multi-lumen catheter. The internal shield may be formed of a polymeric material such as polyvinylchloride, polyurethane, polyethylene, polypropylene, etc. The internal shield(s) may be a composite structure, including wire or fiber reinforced. The internal shield(s) may have elements to facilitate sliding (either along its inside surface or along its outer surface), during install, during use (including allowing tools to pass), and during un-install / removal. The constituents of the internal shield may vary along its length,including material and / or durometer. In general, the internal shield may also be referred to as an internal shield and may be longer than the endoscope into which it is to be inserted so that the internal shield 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 internal shield.

[0059] For example, when the internal shield has multiple lumens (e.g., is configured as a multi-lumen catheter), the proximal end of the internal shield may include one or more openings into an internal lumen of the one or more lumens at a proximal end region of the internal shield. For example, this could be end openings and / or side openings. In some examples, the internal shield includes a plurality of radially spaced-apart (and optionally laterally or axially spaced-apart) side openings at a proximal end region of the internal shield, wherein each radially spaced-apart side openings open into a lumen of the multi-lumen catheter. The port adapter may couple to the end of the inner lumen (e.g., the multi-lumen catheter) to align the opening(s) of the internal shield with ports or directly with a source of suction, pressurized air (‘insufflation’), a source fluid (e.g., saline), etc. In general, a port adapter may be configured to couple with the multi-lumen catheter to create isolated ports in fluid connection with each lumen of the multi-lumen catheter. The internal shield, therefore, despite being a disposable component that may be thin and small and with multiple lumens, can be quickly, easily, and accurately attached, retained, (and subsequently detached) to a structure such as a port adapter that can readily plumb to a multitude of inputs. This adaption with the port adapter can work with single lumen internal shields, and with multiple lumen internal shields.

[0060] Any of these apparatuses may include multiple internal shields. In some examples, the apparatus includes a second internal shield configured as a working channel liner. The working channel liner may have a working channel lumen and extend within the external shield adjacent to the internal shield, wherein the working channel liner is sealingly coupled to the cap so that the working channel lumen is open through the cap. A working channel may include a single lumen and may permit one or more tools to enter proximally and then exit distally. The working channel may be used for suction or for irrigation.

[0061] Both the external shield and the one or more internal shields may be sealingly attached to the cap to prevent a barrier to fluid and / or microorganisms preventing access to the endoscope. In some examples the external shield and / or the internal shield (including a working channel lumen) may be coupled to the cap with a weld, an ultrasonic weld, and / or an adhesive to form the sealing attachment.

[0062] Any of these apparatuses may include a proximal attachment on the external shield configured to secure the external shield to an outer surface of an endoscope. Theproximal attachment may be an elastic material that may elastically attach or secure the external shield to the outer surface of the endoscope. The proximal attachment may be a comparatively rigid structure that has elastomeric elements co-joined such that it can readily seal to another structure, for example a radial o-ring seal or an o-ring face seal. In some examples the proximal attachment may comprise a sealing attachment (e.g., a gasket, such as but not limited to an O-ring; an adhesive material; etc.). In general, the proximal attachment for the external shield may hold the external shield over the endoscope and / or against the endoscope (in examples in which the shield is used with a single endoscope by itself) or against an elongate outer tube (in examples in which the shield is used with a telescoping assembly including an elongate outer tube and an inner endoscope that are coaxially arranged).

[0063] After the internal shield has been used, it must be withdrawn so that it can be disposed of, such that the endoscope is ready for a fresh and new shield system. Given that contaminated fluids have passed through the internal shield, the internal shield should be cleanly and effectively terminated, so that it does not present a contamination risk. To do so, the internal shield can be crimped, including with a metal tube that is radially compressed. It could be sealed with an adhesive that cures (for example, with UV curing). It could be heat sealed, such that the lumen is effectively sealed and terminated. The diameter of the sealed unit must be no larger than that of the lumen through which it will be pulled, or otherwise it would not be removeable. In any of these examples, once the one or more internal shields are sealed, it / they may be cut while still remaining contaminant-free - with a short portion staying behind in the port adapter, and the long portion subsequently sliding out distally. These methods may seal off the internal shield to prevent contamination when removing the endoscope shield device from an endoscope.

[0064] For example, described herein are endoscope shield devices comprising: a flexible external shield; a cap sealingly coupled to a distal end of the flexible external shield, wherein the cap is configured to be sealed to a distal end of an endoscope; an internal shield having one or more lumens and extending within the flexible external shield, wherein the internal shield is sealingly coupled to the cap so that the one or more lumens are open through the cap; and a working channel liner (e.g., a second internal shield) having a working channel lumen and extending within the flexible external shield adjacent to the internal shield, wherein the working channel liner is sealingly coupled to the cap so that the working channel lumen is open through the cap.

[0065] Any of the apparatuses described herein may be configured as a shield assembly including the shield components described above, e.g., rigidizing external shield, internalshield(s) and cap integrated with an outer tube of a telescoping arrangement (e.g., an outer catheter, overtube, or other outer elongate member having an inner lumen into which the endoscope may be positioned). For example the external shield may be fused or otherwise connected (including sealingly connected) to the outer surface of the elongate outer tube to form the shield assembly. Multiple such shield assemblies may be used with the same endoscope so that it may be attached and removed without dirtying or compromising the cleanliness of the endoscope, as described herein.

[0066] For example, described herein are systems comprising a flexible outer tube for use with an inner endoscope in a telescoping arrangement, the system comprising: an elongate outer tube, the elongate outer tube comprising an outer tube lumen; an external shield coupled to a proximal end region of the elongate outer tube at a first end region; a cap sealingly coupled to a second end of the external shield; and an internal shield having one or more internal shield lumen and extending within the external shield and within the outer tube lumen, wherein the internal shield is sealingly coupled to the cap so that the one or more internal shield lumen are open through the cap.

[0067] These systems may include any of the features described above. Further, the cap may be configured to couple to a distal end region of the inner endoscope and the internal shield may be configured to extend through a lumen of the inner endoscope. As mentioned, in general the shield apparatuses described herein may be used with non-rigidizing members, as well as rigidizing members (e.g., rigidizing endoscopes, catheters, and / or overtubes). For example, the elongate outer tube may be configured to be selectively rigidized. The elongate outer tube may be configured to be selectively rigidized by multiple techniques, including the application of positive pressure or negative pressure. Devices may be robotically operated, or they may be manually operated.

[0068] Also described herein are methods of using any of these apparatuses, which may include methods of applying and / or removing the shields from the endoscope or assemblies (e.g., telescoping assemblies) including endoscopes, and methods of keeping an endoscope clean using the shield apparatus. For example, a method of attaching a sanitary shield to an endoscope may include: inserting an internal shield through a lumen of the endoscope from a distal end to a proximal end so that one or more internal shield lumen extend through the endoscope from the distal end to the proximal end; positioning an external shield over the endoscope so that the external shield extends proximally from the distal end; and securing a cap to the distal end of the endoscope, wherein the external shield is sealingly connected to the cap and the internal shield is sealingly connected to the cap so that the internal shield lumen are open through the cap.

[0069] Positioning the external shield over the endoscope may include positioning the endoscope within an elongate outer tube so that the endoscope may move telescopically relative to the elongate outer tube. Inserting the internal shield through the lumen of the endoscope may comprise inserting a multi-lumen catheter forming the internal shield through the lumen of the endoscope.

[0070] Once positioned, in some examples these methods may include coupling the internal shield to a port adapter at a proximal end region of the internal shield. Any of these methods may include coupling each of the lumen of the multi -lumen catheter to a port adapter at a proximal end region of the internal shield to provide isolated access to each lumen.

[0071] The methods and apparatuses described herein may be particularly well suited for robotic endoscopes. For example, the proximal end of the flexible outer tube may be connected, including to the base of an endoscope (for a manual procedure) or to mating geometry on a capital base (for a robotic procedure). Once the procedure is completed, this feature may then be disconnected or disengaged.

[0072] In some examples attaching the cap to the distal end of the endoscope comprises securing the cap to the distal end of the endoscope using one or more of: a snap fit, a friction fit, a magnet coupler, a bayonet connector or a threaded region.

[0073] For example, a method of maintaining cleanliness of an endoscope may include: performing a medical procedure with an endoscope, such that a distal end of the endoscope is covered by a cap, wherein an internal shield that is sealingly connected to the cap extends through a lumen of the endoscope from a distal end to a proximal end so that one or more internal shield lumen extends through the lumen of the endoscope and are open through the cap, further wherein an external shield is sealingly connected to the cap and extends proximally over the endoscope and connects to lumens at the proximal end; removing the cap from the distal end of the endoscope; and withdrawing the endoscope proximally out of the external shield so that the internal shield is extended out of the distal end of the lumen of the endoscope, wherein a proximal end region of the internal shield has been sealed closed.

[0074] Performing the medical procedure may comprise passing material into or out of the one or more internal shield lumen through the cap and / or imaging through the cap (e.g., through an imaging window and / or through a transparent cap or region of the cap). The external shield may be coupled to an outer surface of an outer tube and the endoscope is telescopically arranged within the outer tube. Performing the medical procedure may comprise moving the endoscope proximally or distally relative to the outer tube. In any ofthese apparatuses, withdrawing the endoscope proximally out of the external shield may comprise withdrawing the endoscope proximally from the outer tube.

[0075] Any of these methods may include sealing the proximal end region of the internal shield. For example, sealing the proximal end region may comprise crimping the proximal end region. Sealing the proximal end region may comprise heat-sealing the proximal end region.

[0076] Any of the apparatuses (e.g., devices) described herein may include an internal shield that is a multi-lumen extrusion (e.g., a multi-lumen catheter) having 2 or more sublumen (e.g., 3 lumen, 4 lumen, etc.). An internal shield comprising a multi-lumen catheter may be used to convert a single lumen of an endoscope into multiple separate lumen. Apparatuses, e.g., devices, including multi-lumen internal shields may be used to deliver a variety of different things, such as suction, insufflation, rinse solution, etc. These apparatuses may be adapted for use with a port adapter that may provide reliable access to the different lumen of the multi-lumen internal shield. For example, an endoscope shield device configured to prevent contamination of an endoscope may include: an external shield; a cap sealingly coupled to a distal end of the external shield; and an internal shield comprising a multi-lumen catheter extending within the external shield, wherein the internal shield is sealingly coupled to the cap so that the lumen of the multi-lumen catheter are open through the cap; and a plurality of radially spaced-apart side openings at a proximal end region of the internal shield, wherein each side opening opens into an internal lumen of the multi-lumen catheter. The proximal end region of the internal shield may be configured to mate with a port adapter to create isolated ports in fluid connection with each lumen of the multi-lumen catheter.

[0077] For example, a method of attaching a sanitary shield to an endoscope may include: inserting an internal shield through a lumen of the endoscope from a distal end to a proximal end so that one or more internal shield lumen extends through the endoscope from the distal end to the proximal end; positioning an external shield over the endoscope so that the external shield extends proximally from the distal end; and attaching a cap to the distal end of the endoscope, wherein the external shield is sealingly connected to the cap and the internal shield is sealingly connected to the cap so that the internal shield lumen is open through the cap.

[0078] The internal shield comprises a multi-lumen catheter and wherein inserting the internal shield through the lumen of the endoscope comprises inserting the multi-lumen catheter through the lumen of the endoscope. The internal shield may include a working channel liner and wherein inserting the internal shield through the lumen of the endoscopecomprises inserting the working channel liner through the lumen of the endoscope. Any of these methods may include inserting a second internal shield through a second lumen of the endoscope from the distal end to the proximal end so that an internal shield lumen of the second internal shield extends through the endoscope from the distal end to the proximal end. The internal shield may include a multi-lumen catheter and further comprising coupling the internal shield to a port adapter at a distal end region of the internal shield to create isolated ports in fluid connection with each lumen of the multi-lumen catheter.

[0079] Attaching the cap to the distal end of the endoscope may include securing the cap to the distal end of the endoscope using one or more of: a snap fit, a friction fit, a magnet coupler, a bayonet connector or a threaded region. Attaching the cap to the distal end of the endoscope may comprise manually compressing (e.g., using two or more fingers to compress) a cylindrical mating surface of the cap that is configured to mate with a distal end of the endoscope from an oval resting cross-sectional configuration into a circular mating cross-sectional configuration.

[0080] Positioning the external shield over the endoscope may include positioning the endoscope within an elongate outer tube so that the endoscope may move telescopically relative to the elongate outer tube.

[0081] For example, a method of maintaining cleanliness of an endoscope may include: performing a medical procedure with an endoscope while a distal end of the endoscope is covered by a cap, wherein an internal shield that is sealingly connected to the cap extends through a lumen of the endoscope from a distal end to a proximal end and so that one or more internal shield lumen extends through the lumen of the endoscope and are open through the cap, further wherein an external shield is sealingly connected to the cap and extends proximally over the endoscope; removing the cap from the distal end of the endoscope; and withdrawing the endoscope proximally out of the external shield so that the internal shield is extended out of the distal end of the lumen of the endoscope, wherein a proximal end region of the internal shield has been sealed closed. Performing the medical procedure may include passing material into or out of the one or more internal shield lumen through the cap. Performing the medical procedure may include imaging through the cap (e.g., a lens on the cap). The external shield may be coupled to an outer surface of an outer tube and the endoscope is telescopically arranged within the outer tube.

[0082] Performing the medical procedure may comprise moving the endoscope proximally or distally relative to the outer tube. Withdrawing the endoscope proximally out of the external shield may include withdrawing the endoscope proximally from the outer tube. As mentioned, any of these methods may include sealing the proximal end region of theinternal shield. For example, sealing the proximal end region may comprise crimping the proximal end region. In some examples sealing the proximal end region comprises heatsealing the proximal end region.

[0083] As mentioned above, any of these apparatuses (e.g., shields) may be configured to include a crimping region at a proximal end region of the internal shield that is configured to be crimped to seal the one or more lumens after use to prevent contamination during removal of the internal shield from within a lumen of the endoscope. The crimping region may include a region that is formed of material (e.g., a metallic material, such as a cuff or link region) that is able to hold a crimp without leaking. In some examples the crimping region may be configured to melt. For example, the crimping region may be configured to be heat sealed and / or pressure sealed. The crimping region may be formed of or supplemented with a different material than the reasons proximal and / or distal to the crimping region. As used herein crimping may include both mechanical crimping (e.g., pinching off of the lumen) as well as thermal crimping (e.g., heating / melting the lumen so that it closes), or some combination of these. Crimping may deform the material forming the lumen and / or an additional material on or around the lumen.

[0084] For example, an endoscope shield device configured to prevent contamination of an endoscope may include: a flexible external shield; a cap sealingly coupled to a distal end of the external shield; and an internal shield comprising a multi-lumen catheter extending within the external shield, wherein the internal shield is sealingly coupled to the cap so that the lumen of the multi-lumen catheter are open through the cap, further wherein the internal shield is less flexible than the external shield and is configured to extend through a lumen of the endoscope; and a plurality of radially and / or axially spaced-apart side openings at a proximal end region of the internal shield, wherein each side opening opens into an internal lumen of the multi-lumen catheter, further wherein the proximal end region of the internal shield is configured to mate with a port adapter to create isolated ports in fluid connection with each lumen of the multi -lumen catheter.

[0085] An endoscope shield device configured to prevent contamination of an endoscope may include: a flexible external shield configured to extend over the endoscope; a cap sealingly coupled to a distal end of the external shield; and an internal shield comprising a multi-lumen catheter extending within the external shield, wherein the internal shield is sealingly coupled to the cap so that the lumen of the multi-lumen catheter are open through the cap, further wherein the internal shield is configured to extend through a lumen of the endoscope; a plurality of radially and / or axially spaced-apart side openings at a proximal end region of the internal shield, wherein each side opening opens into an internal lumen of themulti-lumen catheter; and a crimping region at a proximal end region of the internal shield that is configured to be crimped to seal the one or more lumens after use to prevent contamination during removal of the internal shield from within the lumen of the endoscope.

[0086] Any of the endoscope shield devices described herein (or method of making and using them and / or system including them) may be configured to prevent contamination of an endoscope and may include: an external shield; a cap sealingly coupled to a distal end of the external shield; and an internal shield comprising a multi-lumen catheter extending within the external shield, wherein the internal shield is sealingly coupled to the cap so that the lumen of the multi-lumen catheter are open through the cap; and a sealing region at a proximal end region of the internal shield that is configured to seal the lumen of the multi-lumen catheter after use to prevent contamination during removal of the internal shield from within a lumen of the endoscope. As mentioned, any of these methods may include a plurality of radially spaced-apart side openings at a proximal end region of the internal shield, wherein each side opening opens into an internal lumen of the multi-lumen catheter. The proximal end region of the internal shield may be configured to mate with a port adapter to create isolated ports in fluid connection with each lumen of the multi-lumen catheter. The sealing region may comprise a crimping region (e.g., a mechanical sealing / crimping region) configured to be mechanically crimped. Thus, the sealing region may be configured to be pressure sealed. The sealing region may be configured to be heat sealed.

[0087] For example, an endoscope shield device configured to prevent contamination of an endoscope, may include: a flexible external shield; a cap sealingly coupled to a distal end of the external shield; and an internal shield comprising a multi-lumen catheter extending within the external shield, wherein the internal shield is sealingly coupled to the cap so that the lumen of the multi-lumen catheter are open through the cap, further wherein the internal shield is configured to extend through a lumen of the endoscope; and a crimping region at a proximal end region of the internal shield that is configured to be crimped to seal the one or more lumens after use to prevent contamination during removal of the internal shield from within the lumen of the endoscope.

[0088] An endoscope shield device configured to prevent contamination of an endoscope may include: a flexible external shield configured to extend over the endoscope; a cap sealingly coupled to a distal end of the external shield; and an internal shield comprising a multi-lumen catheter extending within the external shield, wherein the internal shield is sealingly coupled to the cap so that the lumen of the multi-lumen catheter are open through the cap, further wherein the internal shield is configured to extend through a lumen of the endoscope; a plurality of radially spaced-apart side openings at a proximal end region of theinternal shield, wherein each side opening opens into an internal lumen of the multi-lumen catheter; and a crimping region at a proximal end region of the internal shield that is configured to be crimped to seal the one or more lumens after use to prevent contamination during removal of the internal shield from within the lumen of the endoscope.

[0089] Also described herein are methods of making any of the endoscope shields described herein. For example, a method of making an endoscope shield device configured to prevent contamination of an endoscope may include: sealing a distal end region of a tubular internal shield to an opening through a cap that is configured to couple to a distal end region of the endoscope, wherein the tubular internal shield is configured to be inserted through a lumen of the endoscope; and sealing a distal end region of a tubular external shield to the cap, wherein the tubular external shield is configured to fit over an outer surface of the endoscope. In general a tubular external shield and / or a tubular internal shield may have any cross- sectional shape, not limited to circular or oval (e.g., square, triangular, octagonal, etc.).

[0090] Any of these methods may include coating the inside (and in some examples the outside) of the internal shield or shields with a hydrophilic coating, as any of these apparatuses may include an internal shield with a hydrophilic coating on the inside of the full length of the internal shield and / or on the outside of the internal shield. In some examples, the method may include coating a sheet of an internal shield material with a hydrophilic coating and forming the sheet of internal shield material into a tube to form the tubular internal shield so that the hydrophilic coating extends within a lumen of the tubular internal shield. In some examples the hydrophilic coating is applied as an additive to a matrix material. The internal shield with the coating may be a single-lumen shield (e.g., a working channel liner) or a multi-lumen shield. For example, any of these methods may include sealing a distal end region of a second tubular internal shield to a second opening through the cap, wherein the second tubular internal shield comprises a multi-lumen tube. In some examples the tubular internal shield may comprise a working channel liner having a working channel lumen.

[0091] Any of the apparatuses (e.g., shields) described herein may include a reinforced internal shield or shields, in particular at the distal end regions of the internal shield(s). This may be particularly helpful in variations in which the distal end region (e.g., the distal tip region) of the catheter is configured to be bent, steered, etc. Thus, it may be beneficial to provide an apparatus having a reinforced distal end region (or all of the length of the endoscope or just the distal end region, such as the distal 5 cm, distal 4 cm, distal 3 cm, distal 2 cm, distal 1 cm, etc. Reinforcing the distal end region of the single-lumen internal shields (e.g., working channel liner) may be particularly helpful to prevent pinching closed at the bending distal end region. Thus, any of the methods of forming the apparatuses describedherein may also include reinforcing the tubular internal shield so that the distal end region of the tubular internal shield is prevented from collapse when bending.

[0092] In any of these examples the internal shield may include a reinforcing structure such as a reinforcing coil; thus the method of forming the apparatus may include adding a reinforcing coil. In some example the method may include adding a reinforcing just the distal end region (e.g., just to the distal 5 cm, distal 4 cm, distal 3 cm, distal 2 cm, distal 1.5 cm, distal 1 cm, etc.).

[0093] In any of these methods sealing the distal end region of the tubular internal shield to the cap and sealing the distal end region of the tubular external shield may comprise forming a continuous fluid-impermeable contamination barrier.

[0094] Any of these methods may include packaging the endoscope shield device in a coiled configuration. This configuration may make it easier to store and apply the shield device onto an endoscope, including taking up less space and less landfill, and reducing any necessary sterilization costs.

[0095] Any of these methods may including packaging the endoscope shield device or overtube in a linear configuration, with multiple units shipped together in a package, for example a reinforced tubular device. This should reduce packaging and shipping costs.

[0096] Any of these methods may include forming a crimping region at a proximal end region of the internal shield (or each of the shields in variations with multiple shields) that is configured to be crimped to seal the one or more lumens after use to prevent contamination during removal of the internal shield from within a lumen of the endoscope. In some examples, the crimping region may include a cuff or ring formed of a relatively ductile material, such as a metal, which may be pinched closed to seal the one or more lumens of the internal shield(s). In some example, the internal shield may include a region formed of a material that may be crimped as described herein.

[0097] The methods of forming the devices described herein may also include ruggedizing the tubular external shield. The tubular external shield may be formed to be shorter than the tubular internal shield (e.g., the internal shield(s) may extend beyond the tubular external shield). The devices described herein may be formed using any of the caps described herein, including caps that are all or partially transparent. The cap may include a cylindrical mating surface having an oval configuration 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. Any of these methods may include attaching a proximal attachment on the tubular external shield that is configured to secure thetubular external shield to an outer surface of the endoscope. The cap may include an inner elastomeric seal that sealingly couples to the outside of the endoscope, so as to create a seal.

[0098] For example, a method of making an endoscope shield device configured to prevent contamination of an endoscope may include: coating a layer of an internal shield material with a hydrophilic coating and laminating the internal shield material into a tubular internal shield so that the hydrophilic coating extends within a lumen of the tubular internal shield; sealing a distal end region of the tubular internal shield to an opening through a cap that is configured to couple to a distal end region of the endoscope, wherein the tubular internal shield is configured to be inserted through a lumen of the endoscope; and sealing a distal end region of a tubular external shield to the cap, wherein the tubular external shield is configured to fit over an outer surface of the endoscope, wherein the tubular external shield, the cap and the tubular internal shield form a continuous fluid-impermeable contamination barrier.

[0099] For example, a method of making an endoscope shield device configured to prevent contamination of an endoscope may include: reinforcing a tubular internal shield, including with a higher density of reinforcement distally so that a distal end region of the tubular internal shield is prevented from collapse when bending; sealing a distal end region of the internal shield to an opening through a cap that is configured to couple to a distal end region of the endoscope, wherein the internal shield is configured to be inserted through a lumen of the endoscope; and sealing a distal end region of a tubular external shield to the cap, wherein the external shield is configured to fit over an outer surface of the endoscope, wherein the external shield, cap and internal shield form a continuous fluid-impermeable contamination barrier.

[0100] As mentioned above, any of these shield apparatuses may include a distal cap configured to couple to the endoscope that that include one or more light sources. These light sources may be light emitting diodes (LEDs), fiber optics, laser light sources, etc. For example, described herein are endoscope shield devices configured to prevent contamination of an endoscope that include: an external shield; a cap sealingly coupled to a distal end of the external shield, wherein the cap is at least partially transparent and configured to couple to a distal end of the endoscope; (optionally) one or more internal shields each extending within the external shield, wherein each internal shield has one or more internal lumens, further wherein each internal shield is sealingly coupled to the cap so that the one or more internal lumens is open through the cap; and one or more light sources on the cap configured to project light distally of the cap.

[0101] In some examples the one or more light sources comprises a light-emitting diode (LED). For example, the one or more light sources may include a red light source, a green light source and a blue light source. The apparatus may be configured to apply white light, e.g., by illuminating each of the red, green and blue, light sources, and / or applying a specific wavelength or range of wavelengths (e.g., red or green or blue) to interrogate the anatomy differentially using different wavelengths of light. The one or more light sources may include a plurality of light sources arranged at least partially around a perimeter of the cap. The light sources may be arranged around the full perimeter or portion of the perimeter. In some examples the apparatus may include a plurality of conductive members (e.g., traces, wires, etc.) coupled to the one or more light sources on the cap and extending on or in the external shield or on or in the internal shield. For example, wires may extend helically around the external sheath to couple with a control and / or power on the proximal end of the device.

[0102] In some examples the apparatus includes one or more electrical contacts on an inner 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 may be on an inner surface of the cap and may be pads or pins that contact pins or pads on the distal end region of the endoscope.

[0103] In general, the cap may include a lensing region configured to be positioned over a camera of the endoscope. The lensing region may be formed in the cap (of the cap material) and / or it may include an additional material added to the cap. The lensing region may be a lens formed as a concave and / or convex region. The lensing region may expand the field of view.

[0104] In general, the cap is configured to be secured to the distal end of the catheter. For example, the cap may include one or more of a friction fitting configured to secure the cap to the distal end of the endoscope, a snap fit configured to secure the cap to the distal end of the endoscope, a magnet configured to secure the cap to the distal end of the endoscope, a bayonet connector configured to secure the cap to the distal end of the endoscope, or a threaded region configured to secure the cap to the distal end of the endoscope. In some examples the cap may include a cylindrical engagement region that fits over the endoscope and may include one or more latches.

[0105] For example, described herein are endoscope shield devices configured to prevent contamination of an endoscope, the device comprising: a flexible and tubular external shield; a cap sealingly coupled to a distal end of the external shield, wherein the cap is at least partially transparent; a tubular elongate internal shield extending within the external shield and having one or more internal lumens, further wherein a distal end region of the tubularelongate internal shield is sealingly coupled to the cap so that the one or more internal lumens of the tubular elongate shield is open through the cap; and one or more light sources on the cap configured to project light distally of the cap.

[0106] An endoscope shield device configured to prevent contamination of an endoscope may include: a flexible and tubular external shield; a cap sealingly coupled to a distal end of the external shield, wherein the cap is at least partially transparent; a tubular elongate internal shield extending within the external shield and having one or more internal lumens, further wherein a distal end region of the tubular elongate internal shield is sealingly coupled to the cap so that the one or more internal lumens of the tubular elongate shield is open through the cap; one or more light sources on the cap configured to project light distally of the cap; and one or more electrical contacts on an inner surface of the cap, wherein the one or more electrical contacts are in electrical communication with the one or more light sources.

[0107] As discussed above, any of the shield apparatuses described herein may be configured as rigi dizing shields. For example, described herein are rigi dizing shields in which the external shield is rigidizing and may be transitioned from a flexible configuration to a rigid configuration, e.g., by the application of pressure; in some examples positive pressure may be applied, in some examples negative pressure may be applied, and in some examples either positive or negative pressure may be applied.

[0108] The rigidizing shield devices described herein can transition from a flexible configuration to a rigid configuration. In some examples, e.g., based on the pressure applied, the rigidity (e.g., the stiffness) may be considered “variable stiffness” as it may be selected by the user or system. For example, a rigidizing external shield may be rigidized by applying a positive or negative pressure to rigidize a rigidizing layer within the rigidizing external shield by driving a compression layer (e.g., bladder) against a rigidizing layer, preventing or limiting movement of the rigidizing layer. With the positive or negative pressure removed (or reversed), the layers can easily shear or move relative to each other; the release of the positive or negative pressure may allow the layers to transition to a condition in which they exhibit a substantially enhanced ability to resist shear, movement, bending, torque and buckling, thereby providing system rigidization. In some configurations, positive pressure is used for rigidization. In some configurations, negative pressure is used for rigidization. In some configurations negative pressure on one side of a bladder can be used simultaneously with positive pressure (for example, on the other side of the bladder) to create enhanced rigidization. Although the examples described herein primarily illustrate rigidizing by the application of pressure (e.g., positive or negative pressure), the methods and apparatuses described herein may be used with any appropriate rigidizable shield(s), not limited topositive or negative pressure rigidizing apparatuses. For example, the rigidizable shield as described herein may refer to any appropriate rigidizing shield, including shields that may be rigidized by jamming particles, by phase change and / or shape memory alloys, by interlocking components (e.g., cables with discs or cones, etc.), EAP (electro-active polymers) or any other rigidizing mechanism.

[0109] As mentioned, any of the rigidizable shields described herein may include rigidizing layers or regions that engage with a compression layer (which may be or may include a bladder) that applies force to the rigidizing layer to rigidize the rigidizing layer or in some cases to de-rigidize (e.g., release from rigidization) the rigidizing layer. In some examples, these rigidizable apparatuses may include a rigidizing layer that could include a braid, knit, woven, chopped segments, randomly distributed or randomly oriented filaments or strands, engagers, links, scales, plates, segments, particles, granules, crossing filaments, tendons, or other materials forming the rigidizing layer. For example, the rigidizing layer may comprise multiple strand lengths or strand segments that cross over each other (e.g., as part of a braid, knit, woven, etc.); the compression layer may apply force to drive the crossing strand lengths or strand segments against each other, the rigidizing layer may include one or more longitudinal members (e.g., extending proximal-do-distal). Although many of the examples shown herein are braids, any of these apparatuses may instead or in addition include a general rigidizing layer comprising crossing strand lengths or strand segments. The examples of rigidizing apparatuses described herein may use pressure (positive pressure) and / or negative pressure to selectively and controllable rigidize. In some examples the method described herein may be used with any appropriate rigidizing apparatus. Examples of rigidizing structures that may be included as part of a rigidizing shield may include those described in PCT patent application no. PCT / US2023 / 064999, filed March 27, 2023, and titled “METHODS AND APPARATUSES FOR NAVIGATING USING A PAIR OF RIGIDIZING DEVICES,” U.S. patent application no. 17 / 902,770, tiled “NESTED RIGIDIZING DEVICES,” filed on September 2, 2022, U.S. patent application no. 18 / 000,062, titled “RIGIDIZING DEVICES,” filed on May 26, 2021, patent application no.PCT / US2022 / 014497, titled, “DEVICES AND METHODS TO PREVENT INADVERTENT MOTION OF DYNAMICALLY RIGIDIZING DEVICES,” filed on January 31, 2022, patent application no. PCT / US2022 / 082300, titled “METHODS AND APPARATUSES FOR REDUCING CURVATURE OF A COLON,” filed on December 22, 2022, patent application no. PCT / US2023 / 062206, titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” filed on February 8, 2023. Each of these applications are herein incorporated by reference in their entirety.

[0110] For example, an endoscope shield device configured to prevent contamination of an endoscope may include: a rigidizing external shield configured to extend over the endoscope, the rigidizing external shield including: a rigidizing layer comprising multiple strand lengths that cross over each other, and a compression layer that is configured to be actuated to apply force to the rigidizing layer to rigidize the rigidizing external shield from a flexible configuration to a rigid configuration; a cap configured to couple to a distal end of the endoscope, wherein the cap is sealingly coupled to a distal end region of the external shield; an internal shield extending within the rigidizing external shield and configured to extend through a lumen of the endoscope, wherein the internal shield has one or more internal lumens and is sealingly coupled to the cap so that the one or more internal lumens of the internal shield is open through the cap.[OHl] As mentioned, in some examples, the rigidizing layer may include multiple strand lengths that cross over each other. The multiple strand lengths may comprise one or more of: a braid, a knit, a weave, chopped segments, randomly distributed and / or randomly oriented filaments, tendons, or engagers. The compression layer may comprise a bladder. The internal shield may be less flexible than the flexible configuration of the rigidizing external shield. Any of these apparatuses may include a pressure port coupled to the rigidizing external shield and configured to receive pressure to actuate the compression layer. The rigidizing external shield may be configured to rigidizing by the application of positive pressure. The rigidizing external shield may be configured to rigidizing by the application of negative pressure.

[0112] For example, an endoscope shield device configured to prevent contamination of an endoscope, may include: a rigidizing external shield configured to extend over the endoscope, the rigidizing external shield including: a rigidizing layer comprising multiple strand lengths that cross over each other, and a compression layer that is configured to be actuated to apply force to the rigidizing layer to rigidize the rigidizing external shield from a flexible configuration to a rigid configuration; a cap sealingly coupled to a distal end region of the external shield and configured to engage a distal end of the endoscope; and an internal shield extending within the rigidizing external shield and configured to extend through a lumen of the endoscope, wherein the internal shield has one or more internal lumens and is sealingly coupled to the cap so that the one or more internal lumens of the internal shield is open through the cap.

[0113] Any of the apparatuses described herein may be configured to be reinforced, and in particular the internal shield(s) may be reinformed at their distal ends, in order to prevent pinching of the one or more lumens of the tubular internal shield(s). Endoscopes may be steerable and may therefore bend at their distal end region. Thus, the shield apparatusesdescribed herein may be configured to prevent, reduce or minimize the impact of the internal shield(s) on the overall flexibility, and therefore steering, of the distal ends of the apparatuses. In some examples the internal shield(s) may be configured to be relatively flexible. However, these internal shields may also be configured to resist pinching of the lumen when bending or flexing, which may otherwise occur with highly flexible structures. For example, the internal shields described herein may be reinforced, e.g., by a reinforcing coil, etc., to prevent collapse while maintaining a high degree of flexibility.

[0114] For example, an endoscope shield device configured to prevent contamination of an endoscope may include: a cap configured to couple to a distal end of the endoscope; a flexible external shield configured to extend over the endoscope, wherein a distal end region of the external shield is sealingly coupled to the cap; and a tubular internal shield configured to be inserted through a lumen of the endoscope, the tubular internal shield extending proximally from the cap and within the external shield, wherein a distal end region of the tubular internal shield is sealingly coupled to the cap so that a lumen of the tubular internal shield is open through the cap, further wherein the distal end region is of the tubular internal shield is reinforced to prevent the tubular internal shield from collapsing when bending.

[0115] The distal end region of the tubular internal shield may comprise a reinforcing coil. In some examples just the distal end region of the tubular internal shield is reinforced; alternatively the majority (or all) of the length of the internal shield may be reinforced. In some examples, where multiple internal shields are used, only those internal shields having a single lumen (e.g., a working channel liner) are reinforced as described herein. For example, any of these apparatuses may include a second tubular internal shield sealingly coupled to the cap and configured to be inserted through a lumen of the endoscope, the second tubular internal shield extending proximally from the cap and within the external shield. The second tubular internal shield may comprise a multi-lumen catheter. This second tubular internal shield may not be reinforced.

[0116] The tubular internal shield may include a working channel liner having a working channel lumen. The working channel lumen may include a hydrophilic coating. The flexible external shield, cap and tubular internal shield may form a fluid-impermeable contamination barrier to prevent contamination of the endoscope.

[0117] For example, an endoscope shield device configured to prevent contamination of an endoscope may include: a cap configured to couple to a distal end of the endoscope; a flexible external shield configured to extend over the endoscope, wherein a distal end region of the external shield is sealingly coupled to the cap; and a tubular internal shield comprising a working channel liner that is configured to be inserted through a lumen of the endoscope,the tubular internal shield extending proximally from the cap and within the external shield, wherein a distal end region of the tubular internal shield is sealingly coupled to the cap so that a lumen of the tubular internal shield is open through the cap, further wherein the distal end region is of the tubular internal shield is reinforced to prevent the tubular internal shield from collapsing when bending, wherein the flexible external shield, cap and tubular internal shield form a fluid-impermeable contamination barrier to prevent contamination of the endoscope.

[0118] For example, an endoscope shield device configured to prevent contamination of an endoscope, the device may include: a cap configured to couple to a distal end of the endoscope; a flexible external shield configured to extend over the endoscope, wherein a distal end region of the external shield is sealingly coupled to the cap; and a first tubular internal shield comprising a working channel liner that is configured to be inserted through a lumen of the endoscope, the tubular internal shield extending proximally from the cap and within the external shield, wherein a distal end region of the tubular internal shield is sealingly coupled to the cap so that a lumen of the tubular internal shield is open through the cap, further wherein the distal end region is of the tubular internal shield is reinforced to prevent the tubular internal shield from collapsing when bending; and a second tubular internal shield comprising a multi-lumen catheter that is sealingly coupled to the cap and configured to be inserted through a lumen of the endoscope, the second tubular internal shield extending proximally from the cap and within the external shield, wherein the flexible external shield, cap and the first and second tubular internal shields form a barrier to prevent contamination of the endoscope during use.

[0119] In any of the methods and apparatuses described herein the cap configured to couple to the distal end of the apparatus may be a removable cap that is configured to be squeezed between two fingers to fit over the distal end of the endoscope and may be squeezed to remove from the distal end of the endoscope. Therefore, the device can be installed and removed without the need for any extra tools. For example, an endoscope shield device may include: a tubular external shield configured to extend over the endoscope; a tubular internal shield configured to extend within a lumen of the endoscope, the tubular internal shield having one or more lumens; and a cap configured to couple to a distal end of the endoscope, wherein a distal end region of the tubular external shield is sealed to the cap, and further wherein a distal end region of the internal shield is sealed to the cap so that the one or more lumens of the tubular internal shield is open 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 a distal end of the endoscope whencompressed from an oval resting cross-sectional configuration into a substantially circular mating cross-sectional configuration. These caps may or may not include a stress-relief cutout region configured to decrease the force necessary to transition the cylindrical mating surface to the circular mating cross-section.

[0120] As used herein a substantially cylindrical surface may have approximately parallel sides (e.g., may deviate by a percentage, such as + / - 10%, 9%, 8%, 7%, 6%, 5%, etc.). A substantially circular cross-sectional configuration may be approximately circular, and need not be perfectly circular, e.g., the radius may vary by a 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 a cap is compressed from an oval resting cross-sectional configuration into a substantially circular mating cross-sectional configuration, the cap may be compressed from an oval resting cross-sectional configuration into mating cross-sectional configuration that is more circular than the oval resting configuration, but may still be somewhat oval.

[0121] In general, the cap may include one or more of: a snap fit, a friction fit, a magnet coupler, a bayonet connector or a threaded region. Any of these caps may include a latching connector configured to secure the cap to the distal end region of the endoscope. The latching connector may include an opening in the cap configured to engage with a projection on the distal end reign of the endoscope. Alternatively or additionally the latching connector may include a projection that mates with an opening on the endoscope.

[0122] In some examples the endoscope shield device configured to prevent contamination of an endoscope includes: a cap configured to couple to a distal end of an endoscope; an external shield sealingly coupled at a distal end to the cap; and one or more internal shields extending within the external shield, wherein each internal shield is sealingly coupled at a distal end to the cap and opens through the cap.

[0123] For example, an endoscope shield device may include: a tubular external shield configured to extend over the endoscope; a tubular internal shield configured to extend within a lumen of the endoscope, the tubular internal shield having one or more lumens; and a cap configured to couple to a distal end of the endoscope, wherein a distal end region of the tubular external shield is sealed to the cap, and further wherein a distal end region of the internal shield is sealed to the cap so that the one or more lumens of the tubular internal shield is open through the cap, wherein the cap comprises a cylindrical mating surface configured to mate with a distal end of the endoscope when compressed from an oval resting cross-sectional configuration into a circular mating cross-sectional configuration; and a latching connector configured to secure the cap to the distal end region of the endoscope,wherein the flexible external shield, cap and the first and second tubular internal shields form a fluid-impermeable contamination barrier to prevent contamination of the endoscope during use.

[0124] An endoscope shield device may include a tubular external shield configured to extend over the endoscope; a first tubular internal shield configured to extend within a first lumen of the endoscope, the first tubular internal shield having one or more lumens; a second tubular internal shield configured to extend within a second lumen of the endoscope; and a cap configured to couple to a distal end of the endoscope, wherein a distal end region of the tubular external shield is sealed to the cap, and further wherein a distal end region of each of the first internal shield and the second internal shield are sealed to the cap so that the one or more lumens of the tubular internal shield is open through the cap, wherein the cap comprises a cylindrical mating surface configured to mate with a distal end of the endoscope when compressed from an oval resting cross-sectional configuration into a circular mating cross- sectional configuration; and a latching connector configured to secure the cap to the distal end region of the endoscope, wherein the flexible external shield, cap and the first and second tubular internal shields form a fluid-impermeable contamination barrier to prevent contamination of the endoscope during use.

[0125] As mentioned above, also described herein are systems that may include any of the devices described herein. In particular, described herein are systems including a catheter adapted for use with a shield as described herein. These catheters may include a handle region configured to pass the internal shield(s). For example, described herein are endoscope systems including a fluid-impermeable contamination barrier to prevent contamination of an endoscope, the system comprising: an endoscope having a lumen and a handle; and an endoscope shield device comprising: an external shield configured to extend over the endoscope, an internal shield comprising one or more lumens, the internal shield configured to extend through the lumen of the endoscope, and a cap configured to couple to a distal end of the endoscope, wherein a distal end region of the external shield is sealed to the cap, and further wherein a distal end region of the internal shield is sealed to the cap so that one or more lumens of the internal shield is open through the cap; and a manifold block removably coupled to the handle of the endoscope, wherein the manifold block comprises one or more valves in fluid communication with the lumen of the endoscope, wherein the internal shield is configured to engage with the manifold block so that the one or more valves control passage of fluid through the one or more lumens of the internal shield.

[0126] The internal shield may comprise a multi-lumen catheter, and / or may comprise a single-lumen shield (e.g., a working channel liner).

[0127] Any of these systems may include a port adapter configured to mate with the multi-lumen catheter to create isolated ports in fluid connection with each lumen of the multilumen catheter. These methods may include a sealing device configured to seal the one or more lumens of the internal shield. The endoscope shield device may further comprise a second external shield configured to extend through a second lumen of the endoscope, wherein a distal end region of the second internal shield is sealed to the cap so that one or more lumens of the second internal shield is open through the cap. The manifold block may comprise a lumen connection configured to engage with the second lumen of the internal shield. In some of these examples the manifold block is disposable. The manifold block may further comprise an umbilical linking the one or more valves of the manifold block to one or more connectors configured to couple to one or more of: a source or irrigation fluid, a source of air, and a source of vacuum.

[0128] Any of the shield apparatuses (devices, systems, etc.) may optionally be used with a robotic endoscope, as described, including nested robotic endoscopes. The shield devices described herein may be applied over an inner endoscope member (e.g., an inner rigidizing endoscope) before it is coupled with an outer endoscope member (e.g., a mother device or an overtube), so that the external shield covers just the inner member, and the outer member may be separately cleaned or sterilized. In some examples the shield device may be attached to the inner endoscope member after it is coupled with the outer endoscope member, so that the flexible external shield may cover both the inner and outer endoscopes.

[0129] For example, a system comprising an elongate outer tube for use with an inner endoscope in a telescoping arrangement may include: an elongate outer tube, the elongate outer tube comprising an outer tube lumen; an external shield coupled to a proximal end region of the elongate outer tube at a first end region; a cap sealingly coupled to a second end of the external shield; and an internal shield having one or more internal shield lumen and extending within the external shield and within the outer tube lumen, wherein the internal shield is sealingly coupled to the cap so that the one or more internal shield lumen is open through the cap. The cap may be configured to couple to a distal end of the inner endoscope and the internal shield is configured to extend through a lumen of the inner endoscope. The elongate outer tube may be configured to be selectively rigidized, e.g., by applying positive pressure or negative pressure.

[0130] Also described herein are methods and apparatuses for inflating or collapsing the external shield of the endoscope shield device configured to prevent contamination of an endoscope. For example, any of these apparatuses may include a flexible tubular external shield that is configured to be collapsed against the endoscope by applying suction (e.g.,negative pressure) between the flexile tubular external shield and the outside of the endoscope. The shield device may be configured to maintain a seal between the flexible external shield and the endoscope. In some examples the apparatus and / or method may be configured to apply positive pressure between the flexible tubular external shield and the outside of the scope, e.g., to inflate the flexible external shield. This may help anchor, navigate and / or secure the endoscope within the body. Both collapsing (e.g., applying negative pressure) and inflating (e.g., applying positive pressure), and observing leak rate, may be helpful for indicating that the shield device remains hermetically intact, thereby maintaining a fluid-impermeable contamination barrier relative to the body.

[0131] For example an endoscope shield device may include: a flexible tubular external shield configured to extend over the endoscope; a cap configured to couple to a distal end of the endoscope, wherein a distal end region of the flexible tubular external shield is sealed to the cap; and a proximal sealing collar, wherein a proximal end region of the flexible tubular external shield is sealed to the proximal sealing collar, further wherein the proximal sealing collar is configured to form an airtight seal against the endoscope, so that the tubular external shield may be inflated or deflated by the application of fluid pressure (e.g., air pressure, saline pressure, etc.) between the flexible tubular external shield and the outer surface of the endoscope. Any of these apparatuses may include a pressure port in fluid communication with an inner region of the flexible tubular external shield and configured to apply positive or negative pressure between the flexible tubular external shield and the outer surface of the endoscope. For example, a pressure port on the proximal sealing collar may be configured to apply positive or negative pressure between the flexible tubular external shield and the outer surface of the endoscope. The flexible external shield may comprise an elastomeric material. The flexible external shield may have a non-uniform diameter along the length of the flexible external shield. In some examples the flexible external shield has one or more inflation regions along the length of the flexible external shield configured to expand to a larger expanded radius when the flexible external shield is inflated by the application of positive pressure.

[0132] The cap may be configured to seal to the distal end of the endoscope. In some examples the cap is configured to secure to the distal end of the endoscope and comprises one or more of: a friction fitting configured to secure the cap to the distal end of the endoscope, a snap fit configured to secure the cap to the distal end of the endoscope, a magnet configured to secure the cap to the distal end of the endoscope, a bayonet connector configured to secure the cap to the distal end of the endoscope, or a threaded region configured to secure the cap to the distal end of the endoscope.

[0133] Any of these devices may include a tubular internal shield configured to extend within a lumen of the endoscope, the tubular internal shield having one or more lumens, wherein a distal end region of the internal shield is sealed to the cap so that the one or more lumens of the tubular internal shield is open through the cap.

[0134] For example, an endoscope shield device may include: a flexible tubular external shield configured to extend over the endoscope; a tubular internal shield configured to extend within a lumen of the endoscope, the tubular internal shield having one or more lumens; a cap configured to couple to a distal end of the endoscope, wherein a distal end region of the flexible tubular external shield is sealed to the cap, and further wherein a distal end region of the internal shield is sealed to the cap so that the one or more lumens of the tubular internal shield is open through the cap; and a proximal sealing collar, wherein a proximal end region of the flexible tubular external shield is sealed to the proximal sealing collar, further wherein the proximal sealing collar is configured to form an airtight seal against the endoscope, so that the tubular external shield may be inflated or deflated by the application of fluid pressure between the flexible tubular external shield and the outer surface of the endoscope. In some examples the fluid pressure may be applied as air pressure. Alternatively other gas (e.g., carbon dioxide, etc.) or liquids (e.g., saline) may be used.

[0135] Also described herein are methods and apparatuses for confirming that an endoscope is uncontaminated after use. In general, these methods may include pressurizing the endoscope shield device to confirm that the external shield is not compromised, as might occur if it is torn or ruptured. For example, a method may include: performing a medical procedure in a body with the endoscope while the endoscope is ensheathed within an endoscope shield device; withdrawing the endoscope from the body; applying pressure between the endoscope and an external shield of the endoscope shield device; and indicating, based on a careful monitoring of the decay of pressure from between the external shield and the endoscope, if the endoscope shield device is contaminated or not contaminated.

[0136] The procedure may be performed using any of the apparatuses described herein. For example, performing may comprise performing the medical procedure wherein the endoscope is enshielded so that an outer surface of the endoscope is enclosed by the external shield of the endoscope shield device and an inner lumen of the endoscope is covered by an internal shield, wherein the external shield and the internal shield form a continuous fluid- impermeable barrier.

[0137] The pressure may be applied from a pressure port on the endoscope or separate from the endoscope. In some examples the proximal end of the external shield may include a port for applying pressure. Any of these methods may include applying positive pressurebetween the endoscope and an external shield of the endoscope shield device by at least partially inflating the external shield. In any of these methods a proximal portion of the external shield may be sealed to a proximal region of the endoscope. In any of these apparatuses and methods, a distal end of endoscope shield device (e.g., the cap and / or the distal end region of the external shield) may be configured to seal to the distal end region of the endoscope.

[0138] Indicating may include determining if the external shield has developed a leak based on a decay of pressure from between the external shield and the endoscope. The pressure may be monitored by a pressure sensor coupled to the pressure port or the applied pressure source, and / or the endoscope shield device. In some examples a pressure indicator (e.g., gauge, sensor, dial, etc.) may be included. In some cases the method may include manually observing the inflated external shield to detect a loss of pressure (indicating leak and possible contamination).

[0139] In general, indicating may comprise emitting a signal. Alternatively or additionally, indicating may include transmitting the signal (e.g., the pressure profile, pressure signal, and / or a processed signal based on the pressure signal) to a remote processor for storage, further processing and / or presentation to the user or a third party. In some examples indicating includes emitting an alert if the decay of pressure from between the external shield and the endoscope exceeds a threshold, e.g., audible and / or visible alert.

[0140] For example, a method of confirming that an endoscope is uncontaminated may include: performing a medical procedure with an endoscope while a distal end of the endoscope is covered by a cap, wherein an internal shield that is sealingly connected to the cap extends through a lumen of the endoscope from a distal end to a proximal end and so that one or more internal shield lumen extends through the lumen of the endoscope and are open through the cap, further wherein an external shield is sealingly connected to the cap and extends proximally over the endoscope; withdrawing the endoscope from the body; applying pressure (either positive or negative pressure could be used to ascertain leak-down) between the endoscope and an external shield of the endoscope shield device; and indicating, based on a decay of pressure from between the external shield and the endoscope, if the endoscope shield device is contaminated or not contaminated.

[0141] The methods and apparatuses described herein may be used with, and may modify and improve, any of the apparatuses and methods described in PCTUS2023066293, titled “HYGIENIC SHEATH FOR ENDOSCOPY,” filed on 4 / 27 / 2023, and herein incorporated by reference in its entirety.

[0142] All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0143] A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:

[0144] FIGS. 1A-1C schematically illustrate an example of a generic endoscope that may be used with the apparatuses and methods described herein.

[0145] FIGS. 2A-2C schematically illustrate an example of a telescoping assembly including an endoscope that may be used with the apparatuses and methods described herein.

[0146] FIGS. 3A-3C schematically illustrate examples of endoscope sheaths (e.g. shields) as described herein. FIG. 3 A shown an example having a relatively short external sheath that may be secured to the distal end region of an outer tube. FIG. 3B shows an example including a proximal attachment on the external sheath. FIG. 3C shows an example having a long external sheath that may extend beyond the length of the outer tube and / or endoscope member.

[0147] FIGS. 4A-4C schematically illustrate examples of endoscope sheaths shown attached to a telescoping (e.g., mother / child) endoscope assembly.

[0148] FIGS. 5A-5C show an example of an endoscope sheath attached to a telescoping endoscope assembly.

[0149] FIG. 6A schematically illustrates an example of a telescoping endoscope assembly.

[0150] FIG. 6B schematically illustrates an example of a telescoping endoscope assembly with a partial sheath.

[0151] FIG. 7A schematically illustrates an example of a cap of a shield assembly shown en face.

[0152] FIG. 7B is an example of a section through an example of an endoscope.

[0153] FIG. 7C shows a section through one example of a shield assembly.

[0154] FIGS. 7D and 7E show side sectional views through one example of a shield assembly of FIG. 7C coupling to the endoscope of FIG. 7B.

[0155] FIGS. 8A-8B illustrate the use of an example of a port adapter for coupling to a multi-lumen catheter (of an internal shield) as described herein.

[0156] FIG. 9A schematically illustrates a section through an example of a port adapter similar to that shown in FIGS. 8A-8B.

[0157] FIG. 9B shows a section through one example of the port adapter.

[0158] FIGS. 9C-9D show examples of port adapters that may be used as described herein.

[0159] FIG. 9E is a sectional view through one example of a port adapter including a tuohy-like connector for securing and sealing a multi-lumen catheter (e.g., an internal shield configured as a multi-lumen catheter) as described herein.

[0160] FIGS. 9F-9G illustrate another example of a port adapter including a manifold as described herein.

[0161] FIGS. 10 A- 10C illustrate one example of sealing a proximal end of an internal shield.

[0162] FIG. 11 is a section through one example of a multi-lumen catheter that may be used as an internal shield as described herein.

[0163] FIG. 12 is an example of a port adapter for coupling to a proximal end of a multilumen catheter forming an internal shield.

[0164] FIG. 13 A shows an example of a port adapter for coupling to a proximal end of a multi-lumen catheter forming an internal shield.

[0165] FIG. 13B illustrates a proximal end of an internal shield including a crimping region to seal off the internal shield before removing the endoscope from the shield assembly.

[0166] FIGS. 14A-14F illustrate an example of a port adapter for coupling to a proximal end of a multi-lumen catheter of an internal shield.

[0167] FIGS. 15A-15D illustrate an example of a system including an endoscope (FIG.15 A), a shield device (FIG. 15B), which may be combined, as shown in FIG. 15C. FIG. 15D shows the combined (‘rigidizing endoscope’) of FIG. 15C with and an outer endoscope.

[0168] FIGS. 16A-16B illustrate a system including a shield device, a separate outer rigidizing device and external working channels. FIG. 16B shows a schematic illustration of the system illustrating the use of the external working channels.

[0169] FIGS. 17A-17D illustrate an example of a system including an endoscope (FIG. 17 A), a rigidizing shield device (FIG. 17B), and an outer endoscope (FIG. 17D) over a combined endoscope and rigidizing shield (e.g., a ‘rigidizing endoscope, as shown in FIG. 17C).

[0170] FIG. 18 illustrates an example of a shield over an endoscope having a steerable distal end region.

[0171] FIGS. 19A-19B illustrate examples of internal shields that are reinforced over a portion or all of their length.

[0172] FIGS. 20A-20D illustrate an example of a cap for an endoscope shield device. FIG. 20A shows a front view, FIG. 20B shows a side perspective view, FIG. 20C shows a side view and FIG. 20D shows a back view of the cap.

[0173] FIGS. 21A and 21B shows a distal end region of an endoscope configured to receive the cap of the shield device shown FIGS. 20A-20D. FIG. 21 A is a distal end view of the endoscope and FIG. 2 IB is a perspective view.

[0174] FIG. 21C shows an end view of the endoscope shown in FIGS. 21A-21B with a cap similar to that shown in FIGS. 21 A-21B attached to the distal end region of the catheter.

[0175] FIGS. 22A-22C illustrate an example of an endoscope shield device having a cap including a plurality of LED light sources integrated therein. The endoscope shield device is shown attached to an endoscope. IN FIG. 22A the device and endoscope are shown in a front perspective view. FIG. 22B shows a front (end) view, and FIG. 22C shows a side view.

[0176] FIGS. 23A and 23B illustrate an example of a cap of an endoscope shield device that is transparent and includes a plurality of LED lights arranged thereon.

[0177] FIGS. 24 A and 24B illustrate examples of caps including multi-lumen extrusions holding the wires for controlling (e.g., powering) the integrated LEDs on the cap.

[0178] FIG. 25 schematically illustrates a cap including a plurality of LEDS of different wavelengths (e.g., colors) that may be controlled to illuminate in different colors or color combinations.

[0179] FIGS. 26A-26B illustrate attaching one example of a cap for an endoscope shield; for convenience the inner and external shield are not shown.

[0180] FIGS. 27A-27C illustrate one example of a method of disengaging a cap of an endoscope shield device, which may be part of the method of removing the endoscope shield device.

[0181] FIGS. 28A-28D schematically illustrate another example of a method for applying a cap of an endoscope shield device which may be part of the method of applying the endoscope shield device to an endoscope.

[0182] FIGS. 29A-29B schematically illustrate a method of mating a cylindrical mating surface of a cap of an endoscope shield device with a distal end of the endoscope by compressing the sides of the cylindrical mating surface of the cap to transition the cap from an oval resting cross-sectional configuration into a circular mating cross-sectional configuration.

[0183] FIGS. 30A-30B show an example of a transparent cap for an endoscope shield device similar to that shown in FIGS. 29A-29B.

[0184] FIGS. 31A-31B illustrate operation of the multi-lumen internal shield and cap for an endoscope shield device. FIG. 31 A is a perspective view and FIG. 3 IB is a front (end) view illustrating the application of each of insufflation, wash fluid and irrigation fluid using the multi-lumen internal shield, while maintaining the sterility of the endoscope covered by the endoscope shield device.

[0185] FIGS. 32A-32B illustrate the endoscope shield device of FIGS. 31 A- 3 IB delivering a wash fluid to wash the optics of the cap in a side perspective view (FIG. 32A) and a sectional view (FIGS. 32B). In FIGS. 32A-32B the tip wash fluid is shown as a cylindrical stream for convenience; actual tip wash fluid may assume a different shape as it is passed over the tip.

[0186] FIGS. 33 A-33B illustrate the endoscope shield device of FIGS. 31 A- 3 IB delivering insufflation from the cap in a side perspective view (FIG. 33A) and a sectional view (FIGS. 33B). In FIGS. 33A-33B the insufflation is shown as a flattened triangle for convenience; actual insufflation (e.g., a gas such as air) may assume a different shape as it is passed over the tip.

[0187] FIGS. 33C-33E illustrate a cap of a shield apparatus configure to deliver wash fluid across the transparent viewing window that is laminar and sufficiently powerful to was the window quickly and effectively. FIG. 33C shows a perspective view of the cap. FIG. 33D shows a partial sectional view of the wash port. FIG. 33E shows a top perspective view of the wash port.

[0188] FIGS. 34A-34B illustrate the endoscope shield device of FIGS. 31 A- 3 IB delivering an irrigation fluid from the cap in a side perspective view (FIG. 34A) and a sectional view (FIGS. 34B). In FIGS. 34A-34B the irrigation fluid is shown as a cylindrical stream for convenience; actual irrigation fluid may assume a different shape as it is emitted from the tip.

[0189] FIG. 35 A illustrates one example of a port adapter that may be used with a multilumen catheter forming an internal shield. In FIG. 35 A the port adapter is shown partially transparent and engaged with an internal shield.

[0190] FIGS. 35B-35D show examples of end views of the (transparent) port adapter of FIGS. 35A, illustrating the separation of ports for each of irrigation fluid (FIG. 35B), wash fluid (FIG. 35C) and insufflation (FIG. 35D).

[0191] FIGS. 36A and 36B illustrate examples of a cap for an endoscope shield device that includes an integrated optical lens as part of the cap. FIG. 36A shows a front (end) view and FIG. 36B shows a side sectional view through the cap of FIG. 36 A.

[0192] FIGS. 37A-37C illustrate removable components (e.g., scope caps) that may be used with any of the endoscope shield devices described herein. FIGS. 37A and 37B show side perspective views with the scope cap off and on, respectively, the distal end of the endoscope shield device applied over an endoscope. FIG. 37B shows a side sectional view.

[0193] FIG. 38 shows an example of an endoscope shield device with an integrated (e.g., molded or overmolded) end cap.

[0194] FIGS. 39A-39C illustrate examples of an external shield apparatus configured to be field-installable to convert an endoscope to a rigi dizing endoscope. FIGS. 39A-39B show perspective views. FIG. 39C shows a side view.

[0195] FIG. 40 is a side view of an endoscope.

[0196] FIG. 41 shows an example of an endoscope converted into a rigi dizing endoscope by releaseably mating with an external shield apparatus similar to that shown in FIGS. 39A- 39C.

[0197] FIGS. 42A-42C show examples of sectional views of an external shield apparatus coupled with an endoscope to form a rigidizing endoscope. FIG. 42A shows the entire apparatus, while FIG. 42B shows the proximal end region in greater detail. FIG. 42C shows an enlarged view of the distal end region of the rigidizing endoscope.

[0198] FIGS. 43A-43B illustrate examples of an external shield apparatus as described herein. FIG. 43 A shows an example of a distal end region of an external shield apparatus. FIG.43B shows an example of a section through an external shield apparatus.

[0199] FIG. 43 C shows an enlarged detail of a portion of a wall of the external shield apparatus of FIG. 43B.

[0200] FIG. 43D shows an alternative enlarged detail of a portion of the wall of the external shield apparatus of FIG. 43B.

[0201] FIG. 43E shows the external shield apparatus of FIG. 43B with an endoscope inserted therein.

[0202] FIG. 43F shows an enlarged detail of a portion of a wall of the external shield and inserted apparatus of FIG. 43E in a flexible configuration.

[0203] FIG. 43 G shows the enlarged detail of the portion of a wall of the external shield and inserted apparatus similar to FIG. 43F in a rigidized configuration.

[0204] FIG. 43H shows an enlarged detail of a portion of a wall of the external shield and inserted apparatus of FIG. 43E having a dual bladder layer, in a flexible configuration.

[0205] FIG. 431 shows the enlarged detail of the portion of a wall of the external shield and inserted apparatus similar to FIG. 43H in a rigidized configuration.

[0206] FIGS. 44A-44F illustrate one example of a distal end cap of an external shield apparatus. FIGS. 44A and 44C show examples of an optically clear sub-assembly that may be combined with an optically opaque sub-assembly as shown in FIGS. 44B and 44D. FIG. 44E shows the assembled distal end region of the cap. FIG. 44F shows the full cap assembly.

[0207] FIGS. 45A-45D illustrate an example of a cap configured to apply an axial biasing force to maintain one or more imaging windows through a distal end of the cap of the external shield apparatus at a constant distance, e.g., by biasing the two together.

[0208] FIGS. 46A-46D show another example of assembly of a distal end region of an external shield apparatus coupling with an endoscope.

[0209] FIGS. 47A-47D illustrate one example of a method of assembling an external shield apparatus.

[0210] FIGS. 48A-48C illustrate an example of assembly of a distal end region of an external shield apparatus coupling with an endoscope.

[0211] FIGS. 49A-49B illustrate sections through an external shield apparatus coupled to an endoscope. FIG. 49B is similar to the example shown in FIGS. 48A-48D, and includes an axial bias.

[0212] FIG. 50A shows an enlarged end view of a distal end of an external shield apparatus coupled to an endoscope.

[0213] FIG. 50B shows an enlarged end view of an example of a proximal end of an apparatus.

[0214] FIGS. 51A-51B show an example of a removable seal that may be used on a proximal end of an internal shield of a shield apparatus.

[0215] FIGS. 52A-52D show examples of removable seals that may be used on a proximal end of an internal shield of a shield apparatus.

[0216] FIGS. 53 A and 53B show an example of a removable seal that may be used on a proximal end of an internal shield of a shield apparatus.

[0217] FIG. 54 illustrates one example of a method of using an external sheath apparatus as described herein.

[0218] FIGS. 55A-55B illustrate an example of a cap for a sheath apparatus as described herein. FIG. 55A shows an exploded view of a cap. FIG. 55B shows the cap of FIG. 55A in the assembled configuration.

[0219] FIGS. 56A-56C illustrate one example of a portion of a cap for a sheath apparatus, showing an optically transparent portion of the cap that may be co-fabricated with a light-blocking region (see FIGS. 44A-44F and FIG. 55A-55B) and proximal region. FIG. 56A shows a perspective view of the imaging region through which imaging may be controlled. FIG. 56B is a graph showing the surface profile of the imaging region in a single cross- sectional slice. FIG. 56C is a heat map of the surface profile (showing relatively little changes in height across the optically transparent portion.

[0220] FIG. 57 A is an example of a rigidizing shield for engaging with an endoscope, to convert the endoscope into a rigidizing endoscope.

[0221] FIG. 57B is a section through a portion of the wall of the rigidizing shield such as the rigidizing shield shown in FIG. 57A.

[0222] FIG. 57C shows a section through a region of the wall of a rigidizing shield shown in FIG. IB in which the rigidizing shield is in a flexible state.

[0223] FIGS. 57D-57E show examples of the rigidizing shield of FIGS. 57A-57C in a rigid state, in which a bladder is driven against a reinforced outer layer to compress a rigidizing layer. In FIG. 57D the bladder is collapsed to compress the rigidizing layer against a reinforced outer layer by the application of negative pressure, reducing the inner diameter of the shield. In FIG. 57E the bladder layer is configured as an out-and-back (e.g., two layer) bladder through which air pressure is injected to drive the bladder (e.g., bladder layer(s)) against the rigidizing layer and the reinforced outer layer.

[0224] FIG. 58 A illustrates an example of an endoscope that may be used with any of the nested rigidizing covers (e.g. assembled rigidizing shield and rigidizing overtube) described herein.

[0225] FIG. 58B illustrates another example of an endoscope. FIG. 58C illustrates coupling of the endoscope of FIG. 58B with an example of a nested rigidizing cover as described herein.

[0226] FIGS. 59A-59C illustrate one example of a method of forming a portion of a shield apparatus including the bladder layer, configured as a double-layered (e.g., out and back) bladder.

[0227] FIG. 59D shows an example of an out-and-back bladder layer similar to that shown in FIGS. 59A-59C.

[0228] FIGS. 60A-60D illustrate one example of a proximal handle for a shield.

[0229] FIGS. 61 A-61C schematically illustrate an example of a proximal handle for a shield assembly as described herein, similar to that shown in FIGS. 60A-60D.DETAILED DESCRIPTION

[0230] In general, described herein are rigidizing endoscope shield assemblies (e.g.,endoscope shield apparatuses) that may convert an endoscope into a rigidizing endoscope. The combined rigidizing endoscope shield assembly and endoscope may be referred to herein for convenience as a rigidizing endoscope, as a converted rigidizing endoscope, or as a transiently converted rigidizing endoscope. The rigidizing endoscope shield assemblies described herein are configured to be field-deployable, meaning that they may be combined with, e.g., assembled onto, an endoscope both quickly and easily, including immediately before and / or during a medical procedure, and may be easily and quickly removed, or removed and replaced. These rigidizing endoscope shield assemblies may allow a single, durable, endoscope to be reused multiple times without requiring sterilization, or even cleaning, of the endoscope between uses. The rigidizing endoscope shield assembly may be configured as a single-use, e.g., disposable, apparatus (e.g., device, system, etc.) that may have minimal components. The shield apparatuses described herein may be equivalently referred to as sheaths or sheath apparatuses.

[0231] For example, a rigidizing endoscope shield assembly may be configured to couple and / or decouple to / from an endoscope easily and quickly, e.g., in mere minutes (e.g., in less than 5 minutes, less than 3 minutes, less than 2 minutes, less than 1 minute, etc.), while maintaining the cleanliness and sterility of the rigidizing endoscope shield assembly, so that the assembled rigidizing endoscope, formed by the rigidizing endoscope shield assembly, e.g., the rigidizing endoscope shield, presents a clean and uncontaminated apparatus for insertion into the body. Having a sacrificial system (the shield) serves to protect the endoscope not only from contamination, and from the rigors and chaos of cleaning, but also from wear. We believe that this should result in an endoscope use experience that is far more consistent than is currently possibly with manual endoscopes and the processes that they require.

[0232] Any appropriate endoscope may be reversibly converted into rigidizing endoscope using the rigidizing endoscope shield assemblies described herein. Examples of endoscopes that may be used with the rigidizing endoscope shield assemblies described herein may include, but are not limited to colonoscopes, arthroscopes, bronchoscopes, cystoscopes, hysteroscope, enteroscopes, esophagogastroduodenoscopes, hysteroscopes, neuroendoscopes, sinuscopes, laparoscopes, laryngoscopes, mediastinoscopes, sigmoidoscopes, nasopharyngoscopes, thoracoscopes, ureteroscopes, etc. Endoscopes are typically long and flexible and configured for inserting into a body. Any of these endoscopes may include one or more imaging systems, which may include one or more cameras, lights, etc., one or more internal working channels, one or more fluid channels, e.g., providing irrigation, tip washing, insufflation, venting, etc. The endoscope may be a commercially available endoscope or acustomized endoscope. The endoscope may be steerable, e.g., by the use of one or more steering components, such as tendons, wires, pneumatics, etc. The endoscope may be flexible, or it may be rigid, along all or a portion of its length.

[0233] The rigidizing endoscope shield assemblies described herein may be configured as external shield apparatuses that are configured to make an endoscope rigidizing. Thus, the rigidizing endoscope shield assembly may include an outer shield region having an elongate shield body having a lumen to receive the endoscope. The shield body may include a plurality of cylindrical layers including: an outer wall layer, a rigidizing layer and a bladder layer. In some examples the bladder layer forms an exposed wall of the lumen. Thus, the inner surface of the endoscope-receiving lumen may be formed of the bladder layer, surprisingly without the need for a separate inner wall against with the bladder layer may be supported. The bladder layer may be a single layer or a double layer (e.g., an ‘in-and-back’ layer that extends distally and can be either two separate pieces combined to form two distinct layers, or one piece that inverts over itself to form an internal bladder lumen).

[0234] The rigidizing endoscope shield assembly may include a distal cap covering the distal end of the lumen of the elongate shield body, wherein the cap is configured to couple a distal end of the elongate shield body to a distal end the endoscope. The connection between the distal end of the elongate shield body and the distal end of the endoscope may be rigid, so that the cap and distal end region of the rigidizing endoscope shield assembly is fixed to the distal end of the endoscope. The rigidizing endoscope shield assembly (e.g., the cap of the rigidizing endoscope shield assembly) may be configured so that the connection between the two is kept under tension in order to keep the optics of the cap, such as one or more clear / transparent imaging windows, in fixed alignment with the optics of the endoscope to which the rigidizing endoscope shield assembly is coupled, even as the converted rigidizing endoscope, moves with use.

[0235] The rigidizing endoscope shield assembly may couple to the endoscope at the proximal end. For example, the rigidizing endoscope shield assembly may include a proximal attachment configured to mate with a proximal end of the endoscope.

[0236] Once coupled, the rigidity or flexibility of the converted rigidizing endoscope may be modulated by the application of pressure, including positive and / or negative pressure. For example, the bladder layer (“bladder”) may be configured so that when a distal end of the endoscope is coupled with the cap and the proximal attachment is coupled with the proximal end of the endoscope, pressure may be applied through a pressure port of the rigidizing endoscope shield assembly to drive the bladder layer against the rigidizing layer, increasing the stiffness of the rigidizing layer.

[0237] A cap portion of a rigidizing endoscope shield assembly may generally be configured to couple to the distal end of the endoscope. The cap may be integrated into the distal end region of the external portion, referred to herein as the external shield, of the rigidizing endoscope shield assembly. The external shield may be formed of a plurality of layers that are configured to be rigidizing. In some cases the rigidizing endoscope shield assembly may also include one or more internal shield(s) that are configured to be inserted through and extend within one or more lumens of the endoscope. Both the external shield and the internal shield portions of the rigidizing endoscope shield assembly are configured to seal to the cap. For example, an inner edge of the external shield seals to the cap (e.g. sealing off the distal end of the lumen into which the endoscope is inserted), while the outer perimeter of the one or more internal shields may be sealed to the cap, exposing the inner lumen of the internal shields to the external environment. The rigidizing endoscope shield assembly apparatus may be configured to prevent contamination of the endoscope without inhibiting functions of the endoscope, including the ability of the endoscope to pass material into or out the distal end of the endoscope through an internal lumen or working channel and / or imaging from the distal end of the endoscope and / or moving relative to an outer elongate member.

[0238] Any of these rigidizing endoscope shield assembly apparatuses may be used with a rigidizing overtube (an outer elongate member). In some examples both the outer elongate member and the converted rigidizing endoscope are configured to rigidize. Any appropriate rigidization technique may be used, including, but not limited to rigidization by applying positive and / or negative pressure. In general the rigidizing apparatuses described herein can transition from a more flexible configuration (i.e., in some examples one that is relaxed, limp, or floppy) to a less flexible, more rigid, configuration (i.e., one that is stiff and / or shape stable when it comes to holding the shape against an applied force). The apparatuses and methods described herein may be particularly well suited for use as rigidizing devices but may be used with non-rigidizing devices.

[0239] A rigidizing member (also referred to equivalently as a rigidizing device, a selectively rigidizing device or a selectively rigidizing member), including the rigidizing endoscope shield assembly and / or a rigidizing overtube, may include a plurality of layers (e.g., coil or reinforced layers, slip layers, rigidizing layers, bladder layers and / or sealing layers) that can together form the wall of a rigidizing member. The rigidizing members can transition from one or more flexible configurations to one or more less flexible (e.g., rigid) configurations, for example, by applying a positive and / or negative pressure to a bladder layer of the rigidizing device or within the bladder layer of the rigidizing device. In some examples the application of positive and / or negative pressure may cause the bladder layer tocompress against the rigi dizing layer (e.g., braid, overlapping filaments, strands, strand segments, strand lengths, tendons, etc.), in some cases preventing or reducing the ability of a plurality of lengths of filaments from sliding (e.g., shear) against each other and / or relative to other layers, including the bladder layer. In any of these apparatuses the rigidizing layer may include one or more longitudinal members (e.g., extending proximal -do-distal). With the applied pressure, e.g., positive or negative pressure removed, the layers can easily shear / move relative to each other restoring flexibility. Thus, in some examples, with the pressure (e.g., positive or negative pressure) applied, the layers can transition to a state in which they exhibit substantially enhanced ability to resist shear, movement, bending, torque and buckling, etc., thereby providing rigidization. Examples of rigidizing members that may be used with any of the devices and methods described herein may include (but are not limited to) those described, for example in described in international patent application no. PCT / US2016 / 050290, filed September 2, 2016, titled “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, titled “DYNAMICALLY RIGIDIZING OVERTUBE,” published as WO 2019 / 018682, international patent application No. PCT / US2019 / 042650, filed on July 19, 2019, titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” published as WO 2020 / 018934, international patent application No. PCT / US2020 / 013937, filed on January 16, 2020, titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” published as WO 2020 / 214221, and PCT / US2021 / 034292, filed on May 26, 2021, entitled “RIGIDIZING DEVICES,” published as WO 2021 / 242884. Each of these applications are herein incorporated by reference in its entirety.

[0240] Although the examples shown herein primarily include rigidizing by driving a bladder layer against a rigidizing layer comprising a plurality of lengths of filaments to alter the ability of the lengths of filaments to shear relative to each other, any appropriate rigidizing technique may be used, including rigidizing members that are not formed of layers and / or are not (or not exclusively) actuated by pressure. For example, the rigidizing endoscope shield assemblies described herein may be configured to be rigidized by jamming particles, by phase change and / or shape memory alloys, by interlocking components (e.g., cables with discs or cones, etc.), EAP (electro-active polymers) or any other rigidizing mechanism. The rigidizing layer may include one or more longitudinal members (e.g., extending proximal-do-distal)

[0241] The rigidizing endoscope shield assemblies described herein may be used with one or more robotic systems, including telescoping, rigidizing robotic system as described,for example, in U.S. patent application no. 17 / 152,706 (titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” now U.S. patent no. 11,135,398), U.S. patent application no. 17 / 493,785 (titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” now U.S. patent no. 11,478,608), and international patent application nos. PCT / US2021 / 034292 (titled, “RIGIDIZING DEVICES”) and PCT / US2021 / 024582 (titled “LAYERED WALLS FOR RIGIDIZING DEVICES”), each of which is herein incorporated by reference in its entirety.

[0242] As mentioned above, the rigidizing endoscope shield assemblies described herein may be used with any appropriate endoscope. An endoscope may be an elongate instrument which can be introduced into the body and may include one or more lumens extending therethrough and may be used for examining, treating and / or diagnosing an interior region of a body. Any of these endoscopes may include imaging (e.g., typically by a CCD, CMOS chip, or fiber optic material) to give a view from the distal end of the device. The endoscope may generally be a catheter including one (or more than one) internal lumen extending the length of the endoscope. For example, in FIG. 1 A, the endoscope 100 includes an elongate flexible (or in some examples, selectively rigidizable) body that extends from a distal end 113 to a proximal end 111. The endoscope includes a first lumen 105 (e.g., a working channel) and a second lumen 107 and a camera 109. The first lumen may be a working channel through which one or more tools may be inserted or / or manipulated for acting on tissue at the distal end of the endoscope within the body. The second lumen may be, e.g., a suction, a fluid (air, water, etc.) application lumen, or the like. The lumen (e.g., the internal working channel) may extend the length of the endoscope. The endoscope may be any appropriate length and width and may generally be formed of a biocompatible material. FIG. IB shows a cross-section through the endoscope of FIG. 1 A, and FIG. 1C shows a distal end view of the endoscope of FIG. 1A.

[0243] FIGS. 2A-2C illustrate an example of an assembly including an inner endoscope 201 that is coaxially arranged within an outer tube 203. The endoscope 201 may be similar or identical to the endoscope shown in FIG. 1 A-1C, and include one or more internal lumens 105, 107 (e.g., working channel 105) and may be configured to slide axially 220 within the outer tube 203 and / or rotate freely 222. FIG. 2B show a section through the assembly of FIG. 2A and FIG. 2C shows a distal end view of the assembly of FIG. 2A. In some examples the assembly may be a telescoping assembly including the endoscope 201 and the outer tube 203 configured to be flexible but may be selectively rigidized. For example, the endoscope may be reversible converted into a rigidizing endoscope as described below. The outer tube (e.g., overtube) 203 may be a rigidizing overtube. An endoscope or endoscope assembly such asthose shown schematically in FIGS. 1A-1C and 2A-2C may be used with any of the rigidizing endoscope shield assemblies (shield devices) described herein.

[0244] Any of the features described herein for the rigidizing endoscope shield assemblies may also be used with shield assemblies that protect the endoscope from contamination, but may not necessarily be rigidizing. FIGS. 3A-3C illustrate examples of an endoscope shield that may not be rigidizing. The shields illustrated in FIGS. 3A-3C are shown unattached or unconnected to either an endoscope or an endoscope assembly (e.g., an outer tube and an inner endoscope member). In FIG. 3 A for example the endoscope assembly 300 includes a cap 327 that is configured to secure to and over a distal end region of an endoscope. For example, the cap 327 may snap onto the distal end, e.g., the cap may connect to the distal end of the catheter (e.g., endoscope) by a deflectable snap on either the cap, the distal end of the endoscope, or both. For example, the cap may include a bendable or flexing member to releasably lock (e.g., by a “snap fit”) the cap onto the distal end of the endoscope. In some examples the cap may secure (releasably secure) to a distal end of an endoscope by a clamping or spring-loaded mechanism. In some examples the cap may couple by engaging a screw-on or threaded region. In some examples the cap 327 may couple by a friction fit (e.g., the cap may include one or more shear surfaces that are configured to secure the cap to the distal end of the endoscope). In some examples the cap may couple magnetically to the distal end region of the scope to secure the cap to the distal end. In some examples the cap may be secured to the distal end of the scope by a bayonet connector.

[0245] In FIG. 3A an external shield 302 is shown sealing connected (e.g., fused, welded, integrally formed, etc.) to the cap 327. The external shield may be flexible and in particular may be sufficiently thin or thin-walled that it may be lightweight and may move relative to the outer tube (not shown) as the endoscope moves in and out of the outer tube and / or rotates relative to the outer tube. It may or may not be ruggedized. The example shown in FIG. 3 A includes a single internal shield 315 extending proximally within the external shield, and sealing connected to the cap 327. The sealing connection between the cap and the internal shield is such that the internal lumen of the internal shield is open to the body so that fluids may be applied through the endoscope without compromising the barrier between the patient and the endoscope. In FIGS. 3A-3C the internal shield forms only a single lumen is shown in this example, in other examples multiple lumen structures may be used, such multi-lumen catheters. Thus, as shown in FIG. 3 A the internal shield may form an opening 315’ through the cap that is continuous with the internal shield 315 shown.

[0246] In this example the external shield 302 is shorter than the internal shield 315, and the internal shield 315 extends proximally 331 from out of the external shield. In someexamples, a short external shield may couple to an outer tube (not shown in FIG. 3 A) such as an overtube, and may seal to the outside so that the outer tube may act with the external shield to protect the endoscope extending within the outer tube.

[0247] FIG. 3B illustrates another example of an endoscope shield device 300’ (e.g., shield assembly) similar to that shown in FIG. 3 A, but with a second internal shield 317, having a distal opening 317’ through the cap 327 that may pass material or tools into and out of the endoscope to treat tissue. In FIG. 3B the second internal shield 317 may form a working channel liner that may line the working channel of the endoscope. The internal shields may be catheters, including multi-lumen catheters. The external shield 315 in FIG. 3B may be similar to that shown in FIG. 3 A and may be relatively short, e.g., may couple to an outer tube (not shown). In any of these shield assemblies described herein the external shield may include a proximal attachment on the external shield configured to secure the external shield to an outer surface of an outer tube that is coaxially arranged over the endoscope.

[0248] FIG. 3C shows a shield assembly 300” similar to that shown in FIG. 3B, including a first internal shield 315 that opens 315’ through the cap 327 and a second internal shield 317 (e.g., working channel liner) that also opens 317’ through the cap 327, both sealingly attached to the cap, and an external shield 302’ that is elongate and sealingly coupled to the cap at a distal end and may optionally include a proximal attachment region or proximal attachment 321 for attaching to either the endoscope or an outer tube that is configured to coaxially fit over the endoscope.

[0249] In any of these examples the cap may be clear (transparent) to allow imaging through or may include a window region configured to align with a camera region of an endoscope. In some examples, the cap has an anti -reflective or anti-glare coating. In some examples, the cap has a coating that makes it more slippery, so that debris is less likely to adhere or stick, or can be easily removed or cleaned.

[0250] FIGS. 4A-4C schematically illustrate examples of shield assemblies shown coupled to endoscopes and outer tubes that are coaxially arranged over the endoscopes to allow telescoping movement between the endoscope and outer tube.

[0251] In any of these apparatuses the shield assembly may include the outer tube, which may therefore be a single-use component that may be coupled to the external shield. For example, FIG. 4A shows a section through a shield apparatus configured as a system including a flexible outer tube 403 for use with an inner endoscope 401 in a telescoping arrangement. In this example the elongate outer tube 403 is coupled (e.g., sealingly coupled 428) at a distal end region to an external shield 402. The external shield 402 is in turn sealingly coupled 429 to a cap 427 at the distal end of the external shield. The cap 427 maythen removably coupled to the endoscope 401 at the distal end of the endoscope. The external shield 402 may be sealingly coupled around the outer perimeter of the cap, as shown. A pair of internal shields 415, 417 having one or more internal shield lumen extend within the external shield and within a lumen of the endoscope 401. The internal shields both sealingly couple to the cap so that the internal shield lumen are open through the cap to allow material to pass through the endoscope. For example, one of the internal shield lumen may connect to a water supply and the other may connect to a suction and / or may provide a working channel, e.g., for tools.

[0252] In this example, the outer tube may be connected to the shield tip with a thin flexible external shield which permits substantial movement of the shield tip both away and towards the distal tip of the outer tube, e.g., allowing a certain amount (but not unlimited, as they are coupled) of axial (reciprocating) and well as torsional (‘roll axis’) movement even with the external shield. The internal working channels and supply lines of the endoscope contain the liner (e.g., internal shields) that are essentially long tubes the length of the endoscope so that the endoscope lumen shielded with the internal shields that function as the tubes that deliver gasses and liquids or as the internal working channel through which surgical tools or suction vacuum may be delivered. The internal shields and external shield are joined together at the cap (e.g., the shield tip 427). The cap provides a transparent face for the endoscope’s camera and illumination light, and may also incorporate nozzles (e.g., an exit for tip washing) and pass-through ports for the contents of the internal shields to be delivered through the cap. As mentioned, the cap may be configured to fasten to the endoscope tip so that it remains well attached during procedures but can then be decoupled to change out the shield assembly. The combination of the outer tube sealed to the external shield, the external shield sealed to the cap, and the cap sealed to the internal shields therefore fully isolates the endoscope from the patient.

[0253] FIG. 4B shows the shield assembly 400 of FIG. 1 without the endoscope 401, including the attached outer tube 403, cap 427, and the pair of internal shields 415, 417. The shield assembly 400 may releasably couple to the endoscope, e.g. by inserting the internal shields 415, 417 through lumen of the endoscope and snapping or otherwise coupling the cap 427 to the distal end of the endoscope.

[0254] FIG. 4C shows an alternative example, similar to that shown in FIG. 3C, in which the external shield 402 is not coupled to the outer tube 403, and extends proximally along much or all (or more than) the length of the outer tube 403. As shown in this example, the external shield 402 extends proximally to the proximal end region of the endoscope and / or outer tubes.

[0255] FIGS. 5A-5C illustrate an example of an external shield 502 attached to an outer tube 503, and includes two internal shields 517, 515 (shown sticking out of the proximal end of the outer tube 503 in FIG. 5A). The external shield in the device shown in FIGS. 5A-5C includes a base 522 at the proximal end of the external shield that may seal to the outer endoscope 503 (e.g., overtube). The outer tube in this example is shown shorter than normal but is representative of the full-length version. The cap 527 of the shield assembly is coupled to the distal end of the external shield 502. In FIG. 5 A the shield assembly is not yet coupled to an endoscope. FIG. 5B shows an endoscope 501 inserted into the outer tube 503 with the endoscope 501 extended fully to the limit of the external shield 502. The tip (cap 527) of the external shield fastens to the distal end region of the endoscope and extends and retracts with the endoscope as described above.

[0256] FIG. 5C shows the endoscope 501 protected within the external shield 502 and fully retracted into the outer tube 503 with the external shield tip 527 still attached to the endoscope tip. Note that the external shield 502 bunches up but is designed to only minimally retard the endoscope’s bending section movement.

[0257] In operation, the configuration of the shield assembly incorporating the outer tube as shown in FIGS. 5A-5C may be a one-time use and / or disposable. In this example, the endoscope may be inserted through the outer tube and fully into the external shield and attached to the shield tip. The outer tube and / or the endoscope in the example may be selectively rigidizing devices that are actuated by the application of positive pressure or negative pressure. In this example, after the endoscope, outer tube and internal shields are connected to external control, vacuum and supply lines, the system is ready to be used in a procedure, e.g., inserted into a body. The shield may protect the endoscope 501 from contacting any material that may contaminate the endoscope. After the procedure, the internal shields and the outer tube may both be disconnected from the rest of the system and removed from the endoscope and then discarded. The endoscope can then receive a new shield which incorporates a new outer tube with internal and the external shields and be immediately reused. No high-level disinfection of the endoscope is required between procedures, which saves time and expense. As described herein, the removal process may include sealing the internal shields to prevent contamination.

[0258] In any of these apparatuses and method, after using the shield assembly (e.g., endoscope shield device), it can be pressure tested to confirm that it has remained leak-free and that the underlying structures (e.g., endoscope) therefore remains clean. This may also apply to rigidizing endoscope shield assemblies described herein. To do so, the external shield can be inflated at least partially, e.g., by injecting pressurized media (e.g., air or otherfluid) through a pressure port. The external shield may be sealed at either or both ends. The internal shield can be sealed (for example, proximally, as it exits the liners). The method or apparatus may monitor pressure, e.g., using a pressure sensor configured to detect pressure decay within the external shield when inflated. The pressure sensor may track a pressure decay curve that may be reported and / or analyzed to determine if there is a leak, suggesting contamination. The pressure data may be reported to the operator and / or the apparatus may automatically or semi-automatically determine if there is a leak based on the pressure data. For example the apparatus may include software, hardware and / or firmware to receive pressure data configured to analyze the pressure data (e.g., decay curve), compare the pressure response to predetermined values to determine if there is a leak.

[0259] Alternatively, rather than applying positive pressure, e.g., between the endoscope and the shield, as described above, and looking for a leak, in any of these apparatuses negative pressure may be applied between the endoscope and the shield and a loss in the negative pressure (vacuum) may be detected over time, indicating a leak and therefore possible contamination. In some cases, the use of negative pressure may be preferred, as it may prevent or limit further contamination.

[0260] In some examples the external shield extends the entire length of the outer tube, and the outer tube is not incorporated into the external shield, as described in FIG. 4C. In this configuration, the outer tube is also fully isolated from contamination and can be reused with a new shield without needing to be disinfected.

[0261] FIG. 6A shows a schematic example of a telescoping assembly, including an outer tube 603 and endoscope 601 shown without a shield assembly attached. In contrast to the shield assemblies described above, FIG. 6B shows an example of a system including only a partial external shield portion 672 that is coupled between the outer tube 603 and endoscope 601, but does not include a cap or internal shields. In this example, although the space between the endoscope 601 and outer tube 603 may be kept fee of contamination, the outer surface of the outer tube and the inner lumen of the endoscope may both become contaminated.

[0262] As mentioned above, any appropriate cap may be used for any of the shields described herein, including but not limited to a rigi dizing endoscope shield assembly. For example, FIG. 7A illustrates one example of a cap 727 shown in an end-on view. The cap may be formed of a clear material, such as clear polymeric material (e.g., polycarbonate (PC), polymethylmethacrylate (PMMA), acrylic, polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyethylene (PE), cyclic olefin copolymer (COC), etc.). In some examples it may include an inlaid piece of glass. In some examples, as shown in FIG. 7A, a transparentcamera window region 736 may be included. The cap may also include a sealed junction 739 to the fixed internal shield (“fixed sleeve”) such as a multi -lumen extrusion shield 717 and / or a working channel shield 715. The insides of these internal shields are open, as shown, to allow access to the body region at the distal end of the apparatus. For example, the multilumen extrusion shield 717 includes three sub-lumen 737, 738, 738’, e.g., a lumen for water 737, for air 738, and / or for vacuum 738’ (or an additional air / water channel). In FIG. 7Athe working channel shield also include an open channel 748 that may be used to pass tools through the endoscope.

[0263] FIG. 7B shows a section through a distal end region of one example of an endoscope 701 that may be used with a shield assembly as described herein. In FIG. 7B the endoscope 701 includes an internal lumen 785 that extends the length of the endoscope and opens at the distal end of the endoscope. FIG. 7C shows a sectional view through an example of a shield assembly 700 including a cap 727, an external shield 702, an interior shield 717 that is configured as a multi-lumen 738, 737 extrusion shield. The external shield 702 may be coupled to an elongate outer tube (not shown in FIG. 7C) or may be long enough to extend down the full length of a separate elongate outer tube and / or endoscope.

[0264] FIGS. 7D-7E illustrate the application of the shield assembly 700 of FIG. 7C over the endoscope 701 of FIG. 7B. The proximal end of the interior shield 717 may be first inserted into the internal lumen 785 of the endoscope and the endoscope may be advanced distally 749 until the cap 727 of the shield assembly 700 can couple to the endoscope 701. For example, FIG. 7D shows a sectional view through the distal end region of the shield assembly 700 with the endoscope 701 partially inserted. The external shield 702 of the shield assembly is sealed around the outside of the cap 727, and the internal shield 717 is also sealed to the inside of the cap 727. As mentioned, the internal shield 717 in this example has two lumen 738, 737 that open through the cap so that material (e.g., air, water, saline, etc.) may pass into or out of the lumen of the shield, through the endoscope without contaminating the lumen of the endoscope 701. The cap 727 in this example is optically transparent at least over the camera window region 736, although in some examples the entire cap may be transparent, so that the imaging camera 786 of the endoscope 701 may image through the cap 727.

[0265] In general the endoscopes described herein are illustrated as optical (e.g., lightbased) imaging; it should be understood than other imaging modes may be used, such as, but not limited to, ultrasound. For example, any of these apparatuses may be configured so that the endoscope may include one or more ultrasound transducer and the cap portion of the shield may be configured to provide ultrasound imaging therethrough over at least one or more window regions.

[0266] In FIG. 7D the shield assembly is shown with the cap 727 not yet connected to the endoscope 701. The endoscope 701 may be driven distally 749 (or alternatively and / or additionally the cap may be driven proximally) to engage with the cap 727, as shown in FIG. 7E. In this example recessed region 714 at the distal end region of the endoscope may engage with a connector 716 (e.g., a deformable or deflectable connector) on the cap to secure the cap to the distal end of the endoscope, as shown in FIG. 7C. The recessed region 714 may be a cavity and / or it may be a lip, ridge or rim. In some examples the connector may include a shear surface configured to secure the cap to the distal end of the endoscope, a magnet configured to secure the cap to the distal end of the endoscope, a bayonet connector configured to secure the cap to the distal end of the endoscope, a threaded region configured to secure the cap to the distal end of the endoscope, or the like. Because the connection occurs within the external shield or between the external shield and the internal shield(s), this connection does not need to form a seal, but should be secure so that as the endoscope is moved axially and / or in rotation, the cap remains at the distal end of the endoscope.

[0267] As mentioned above, in order to prevent contamination of the endoscope and / or the outer tube, in any of these example apparatuses described herein, the internal shields (e.g., working channels, multi-lumen catheters, etc.) may be sealed before they are removed from the endoscope (and in some cases the outer tube). This can be done in several ways. For example the one or more internal shields (which may be configured as catheters) may be plugged, crimped, blocked by an adhesive or other plug, heat sealed, etc. The sealing methods used may stay within the outside diameter of the internal shield so that it can be withdrawn through the endoscope. For example, see FIGS. 10A-10C and 14.

[0268] The apparatuses described herein may incorporate internal working channels and supply lines into the disposable shield. This may effectively make those elements of an endoscope disposable one-time-use elements which protects the patient as well as the endoscope equipment. As mentioned, these working channels (working channel liners) may be sealed before their removal.

[0269] In general, these shield apparatuses described herein are configured so that the endoscope and the outer tube may roll relative to each other in addition to sliding axially. In some examples the external shield can be intentionally torqued as it accommodates the rotation of one relative to the other. Movement of the inner endoscope and / or outer tubes may be done manually or robotically, and the shield assemblies described herein may advantageously accommodate a variety of both longitudinal / axial movement as well as rotational movement between the inner endoscope and outer tubes. Thus, described herein are shielded endoscopes that can have an overtube that slides relative to it with a ruggedized andnon-scrunching or axially collapsing surface, in which the endoscope can roll relative to the overtube and is not coupled by a sheath.

[0270] Also described herein are port adapters for the easy fluid connectivity to smallbore, multi-lumen catheters (extrusions) that may be used as internal shields (working channel liners). For example, FIG. 11 illustrates a cross section of one example of an internal shield (multi-lumen extrusion, MLE) 1117 that incorporates a working channel 1116 with 3 other water / gas channels 1118, 1119, 1120 into a single extrusion. Thus, in some configurations, only one internal shield may be needed.

[0271] A multi-lumen internal shield such as that shown In FIG. 11 may be used with a port adapter to allow access to all of the internal lumen within the internal shield. Some of the lumens may connect in one direction (i.e., out the side), and some may connect in other directions (for example, axially or in-line). In any of these apparatuses and methods the proximal end of the multi-lumen catheter may be sealed, but one or more openings into the lumens may arranged along the sides of the distal end region, e.g., for mating with a port adapter, as described herein. In some examples the port adapter may instead be configured to couple with and access the distal end of the multi-lumen catheter forming the internal shield (e.g., inner liner), for example, forming seals with the individual lumens of the multi-lumen catheter. Note that any of the port adapters described herein may be configured for use with a single lumen internal shield (e.g.,. single-lumen catheter), by making a sealing contact with the lumen of the internal shield, either through a side opening or at the distal end (or both).

[0272] Returning now to FIGS. 8A-8B, an internal shield 817 configured as a multilumen extrusion (MLE) is shown with one example of a port adapter. In FIG. 8A, the internal shield includes a rigid or semi-rigid connector tip 885 including lateral openings 808 into each of the lumen of the internal shield 817, shown attached to the proximal end 887 of the internal shield 817 at an optional joint 886. The joint may or may not be necessary, i.e., 817 may have the exit holes without the need for as a separate connector tip 885. The proximal end may also include an engagement structure (e.g., neck region 889) that may engage with a port adapter, as shown in FIG. 8B. In FIG. 8B, the connector tip 885 of the internal shield 817 is inserted into a receptacle manifold of the port adapter 869 which provides connections for each lumen (or channel) in the internal shield, as shown in FIGS. 9A-9B. In this configuration, the system is not radially positionally dependent, i.e., it may be inserted such that any radial configuration properly ports to the mating lumens. Between each of the radial ports is a separating and sealing gasket (e.g., O-ring). Between each sealing gasket is a spacer ring that permits through-flow.

[0273] FIG. 9 A show an example of connection of the internal shield 817 into a port adapter 869 which provides individual passthrough connections to each independent lumen in the multi-lumen catheter. In any of these port connectors, the proximal end of the internal shield may engage with the port connector to secure it in place, and / or to align the openings 808 of the internal shield with connectors of the port connector. In FIG. 8 A the port connector 869 includes an internal shield connector receptacle with a releasable locking mechanism 992 that engages with the engagement structure 889 at the proximal end region of the internal shield. In alternative embodiments, 885 may have no special end geometry 889, and there could be, for example, an angled metal tang that ‘grabs’ the outside of the 885, serving to keep it retained. To remove, the tang could be deflected out of the way, such that it no longer contacts 885.

[0274] FIG. 9B shows an example of a cross section of the port adapter of FIG. 9 A. In this example, the proximal end connector 885 of an internal shield is inserted and latched into a receptacle manifold of a port adapter as shown in FIG. 9A. Flow from each lumen may be kept separate and passed through to individual ports 971, 972, 973 for connection to supply lines. A three-channel implementation is shown, but more or fewer channels (or lumens) could be accommodated using this technique.

[0275] In FIG. 9B, each individual port includes an annular sealing region 994 (for example, by the use of O-rings 993, which create two or more radial seals. In between the Firings 993 are spaces that transmit flow: for example, rings with channels and cross-drilled geometry. When the internal shield 817 is secured in the port connector, the lateral openings 808 into each lumen are aligned along the length of the proximal end so that they are positioned with an annular sealing region specific to each lumen. In FIG. 9B, the two annular sealing regions on the right side of the figure are each aligned with an opening 808 in the internal shield. Thus, fluid may pass into or out of the opening from this annular sealing region that is fluid communication with a port 972, 973 on the port connector 869. These ports may be standardized for fitting any appropriate connector.

[0276] FIGS. 9C and 9D illustrate two examples of port adapters 969, 969’ before (FIG. 9C) and after (FIG. 9D) insertion of the multi-lumen catheter forming an internal shield of an endoscope shield device. In FIG. 9C, similar to that shown in FIG. 9A, the first port adapter 969 is configured so that the multi-lumen catheter 917 may be inserted into the inlet 966 and may easily slide all the way until the distal end of the multi-lumen catheter is reaches the back (e.g., a stop 988) in the port adapter, as shown by the cross-sectional view of FIG. 9E. In this example, the inside of the port adapter may be divided up into regions or zones corresponding to the number of lumen in the multi-lumen catheter. The regions may beseparated by one or more gaskets 983. The multi-lumen catheter may include one or more openings or holes through the walls of the multi-lumen catheter into each of the lumen of the multi-lumen catheter that are arranged along the length, so that openings into a particular lumen of the multi-lumen catheter will fall within a particular range of distance from the end of the multi-lumen catheter so that, once inserted into the port adapter, all of the holes corresponding to the particular lumen will be within a corresponding region or zone, as described in FIG. 9A.

[0277] As the multi-lumen catheter (e.g., a multi-lumen channel liner) enter the receptacle manifold 970 of the port adapter, it may face high compression loads as, to seal, the O-ring inner diameter would be less than the outer diameter of the multi-lumen catheter. Although such a tight fit may help form the radial seals from the O-rings, this may lead to buckling of the multi-lumen catheter. The example port adapter 969 shown in the top of FIGS. 9C and 9D and in cross-section in FIG. 9E may avoid this problem by increasing the radial clearance of the O-rings and applying force to squeeze the O-rings down by axially compressing the component stack (e.g., the gasket stack), which translates into the requisite radial compression of the seals against the multi-lumen catheter. This motion (e.g., axial advancement by rotating a thread translating into a radial squeeze) is similar to what is done with a device at the back of a catheter (typically to adjust the back-end seal against a guidewire) by a tuohy (e.g., a Tuohy Borst adapter).

[0278] In the port adapter 969 shown in FIGS. 9C-9E, the gaskets 983 forming a seal between each of these separate zones may be o-shaped rings that have an inner diameter that may be larger than the outer diameter of the multi-lumen catheter. This may allow easy insertion of even very flexible or multi-lumen catheters and may help ensure full insertion of the multi-lumen catheter. As shown in FIG. 9E the port adapter may include a compression mechanism, such as a tuohy connector for securing the multi-lumen catheter within the port adapter. For example, the knob 913 may be twisted clockwise to compress the gaskets in the gasket stack (e.g., receptacle manifold) onto the multi-lumen catheter; tightening the knob drives a pusher 981 into the receptacle manifold (e.g., stack) of gaskets 983, axially compressing them and therefore radially compressing them 985, and tightening them over the multi-lumen catheter, forming seals. To remove the multi-lumen catheter, the knob 913 may be untwisted to release the compressive force 985 applied by driving 986 the pusher 981 into the gaskets of the receptacle manifold. In any of these devices and methods the port adaptor may be automated. For example, the port adapter may include one or more sensors so that insertion of the multi-lumen catheter could trigger a sensor at the end 988 of the port adapter,which may then automatically turn the knob or, with a linear actuator, simply slide it axially, thereby compressing the O-rings and creating a seal.

[0279] FIGS. 9C and 9D also illustrate a port adapter 969’ similar to the port adapter 869 shown in FIGS. 9A-9B, which may include a catch or lock to secure the multi-lumen catheter within the port adapter. In any of the port adapters described herein the device may include a sprung pawl or catch-like means for securing the multi-lumen catheter within the port adapter. The port adapter may be one-way or releasable.

[0280] FIGS. 9F-9G illustrate another example of a port adapter / manifold for an inner shield of an apparatus as described herein. In FIG. FIG. 9F an example of a cross section of the port adapter is shown. In this example, the proximal end connector 885 of an internal shield is inserted and latched into the manifold of the port adapter 912. Flow from each lumen may be kept separate and passed through to individual ports 971’, 972’, 973’ for connection to supply lines. A three-channel implementation is shown, but more or fewer channels (or lumens) could be accommodated. In this case, each individual port includes a filter or valve 991, 991’, 991”. In this example the filters provide one-way flow, preventing flow in one direction (e.g., from the inner shield lumen out of the manifold, and permitting flow in the opposite direction (e.g., from the source into the inner shield lumen. FIG. 9G shows an alternative view of the manifold of FIG. 9F. The filters may be configured as flap valves or other one-way valves, in which fluid pressure in the permitted direction drives the flap away from the orifice of the valve, allowing flow, while fluid pressure in the opposite (e.g., prohibited) direction prevents flow and seals the flap against a seating region (sealing it against the seating region). The use of these valves has multiple advantages, including cleanliness, the ability to reuse certain components, and therefore the potential reduction in landfill.

[0281] FIG. 12 illustrates an alternative port adapter 1269. In FIG. 12, the port adapter uses a face seal strategy. A male connector 1212 inserted into the female connector 1215. Each lumen in the male connector (three of them in this illustration) is fed by its own separate supply channel. The supply channels seal to the end of the male connector via a face seal so that there is no cross transmission between the channels. FIG. 13 A shows another example of this type of port adapter. In this example, the face of the multi-lumen extrusion internal shield may align each channel with a port, which may require rotational orientation of the input tube. In any of these examples, the shaft of the internal shield 1212 may be keyed to guide orientation of the internal shield relative to a port connector.

[0282] In FIG. 13 A, the internal shield 1317 engages with the port adapter 1369 in a keyed manner so that the internal lumen may each engage a connector in the port connectorthat may seal to opening at the distal end of the internal shield to permit access into and out of the lumen within the internal shield. In the example shown in FIG. 13 A, the upper port connector 1369 is shown engaged with the internal shield 1317, while the lower port connector 1369’ is not engaged with an internal shield 1317’. Each port connector includes three standard connectors 1368 that may be coupled to tubing for applying / removing material.

[0283] As mentioned above, before removal of the shield assembly, the internal shields may be blocked to prevent contamination. The internal shield(s) may be sealed off by any appropriate manner, including thermal (e.g., melting with forces applied by heated dies), mechanical (e.g., crimping, pinching, stapling, etc.), adhesively filled (for example, the insertion of a UV-curing adhesive which can be rapidly cured), or the like. FIG. 13B illustrates a crimp-based sealing method. A crimp 1442 may be included on the internal shield, preferably near the proximal end region. This crimp 1442 may be crimped shut after a procedure. The compressed crimp 1442’ seals the shield to prevent contaminated fluids from leaking out of the shield, and when compressed the crimp is smaller in diameter than the outside diameter of the internal shield 1417, so that it can be pulled through. The internal shield 1417 can then be wiped clean and removed by pulling it through the endoscope without contaminating the endoscope.

[0284] FIGS. 14A-14F illustrate another example of an adapter 1469 (e.g., port adapter) that may be used with a multi-lumen extrusion, including with one or more of the shields including a multi-lumen extrusion forming an internal shield of the shield device. The adapter 1469 shown in this example is configured as a clamshell or folding manifold into which a multi-lumen extrusion may be placed, and then folded over. In FIG. 14Athe adapter 1469 has a clamshell body 1471 that may be formed of a polymeric material having a living hinge 1472 allowing folding of a top portion 1472 against a bottom portion 1473. The adapter may include one or more gaskets or seals 1475, 1475’ within to top and / or bottom portions. In FIGS. 14A-14F, both the top and bottom include gaskets. These gaskets may be over-molded into the manifold. The gaskets or seals may form multiple different regions 1490, 1490’, 1490” that may be coupled (e.g. via individual ports 1471, 1471’, 1471”) to fluid lines for applying or removing fluid through the multi-lumen catheter 1417, as described herein.

[0285] In any of these examples the adapter may optionally be configured to hold and / or engage with an additional inner shield. In FIGS. 14A-14F the second inner shield 1419 is shown and is also secured (e.g., sealed) within the adapter when the top and bottom clamshell portions are closed together.

[0286] As shown in FIGS. 14B-14D a multi-lumen catheter (and / or another inner shield 1419) may be sealed within the adapter 1469 by closing (and in some cases, latching) the clamshell adapter over the catheter, to make a reliable fluid connection between different lumen of the multi-lumen catheter with different fluid input lines, which may be connected to fluid ports 1481, 1481’, 1481”. As described above, the multi-lumen catheter 1417 may have openings along its length arranged to positioned with the sealed regions 1490, 1490’, 1490” formed by the gaskets and the body of the adapter (manifold 1469) after closing the top and bottom together. In FIG. 14B the top 1472 of the adapter body is shown closing against the bottom 1473 of the adapter body by folding over the hinged region, which in this example is a living hinge. FIG. 14C shows the adapter fully closed, with a latch 1485 unlatched. In FIG. 14D the latch 1485 is engaged, sealing the manifold closed.

[0287] Any appropriate latch may be used. In the example shown, the latch is also formed of a living hinge region that allows a set of protrusions (in this example, protrusion are included on the top 1472 body portion) to engage with openings 1487, 1487’, 1487” in a hinged plate 1488 that is connected by the living hinge to the bottom 1473 body portion.

[0288] FIGS. 14E-14F shows bottom and side views, respectively, of the manifold with the latch 1485 engaged. In this example, the ports 1481, 1481’, 1481” are located on the bottom of the manifold. Note that the bottom and top are relative, and either side of the clamshell body may be referred to as the top or bottom, respectively. The clamshell manifolds described herein may provide advantages over other adapters / manifolds, including the example shown in FIGS. 9A-9G, 12 and 13A, in which the multi-lumen catheter is inserted into the adapter which may require the catheter to withstand the axial push loads into the o- rings in these devices. Further, the clamshell manifolds (adapters) described herein may substantially flat, and may be fabricated by overmolding features such that the part count and assembly time is reduced.

[0289] Returning now to FIGS. 10 A- 10C, these figures illustrate an alternative to crimping in which an internal shield 1015 is sealed by heat sealing after a procedure. Heat sealing hygienically seals the internal shield keeping any contamination safely inside the shield. Internal volume of the tube can locally be driven to zero, which greatly reduces the potential for contamination. This method is similar to how blood bags are sealed. Heat sealing could further reduce any problem associated with any potential residual matter. In FIG. lOAthe internal shield 1015 is inserted into the heat-sealing device 1042, so that heat (and / or mechanical pressure) may be applied as shown in FIG. 10B to melt the material of the internal shield, resulting in a seal 1016 as shown in FIG. 10C. After heat sealing, or as part of the heat sealing operation, the internal shield can be cut and withdrawn back through theendoscope with no risk of contamination. Heat sealing of tubes with liquids in them is routinely done for blood sampling and other applications.

[0290] The use of internal shields for the shield assembly where the internal shields themselves become the supply lines and working channel for the endoscope and still run through the internal volume of the endoscope may be advantageous. The external shield part cannot only bend side to side, but also is flexible enough to support extension and retraction of the endoscope relative to the outer tube while maintaining a physical barrier to contamination.

[0291] Any of the endoscope shield devices described herein may be used with nested endoscopes, either robotic or manual. For example an endoscope shield device may be part of a system including an elongate outer endoscope and an inner endoscope arranged in a telescoping arrangement. The endoscope shield device may be configured to fit over both the inner endoscope (that is fit into the outer endoscope) and the outer endoscope. Alternatively, as shown in FIGS. 15A-15D, the endoscope shield device may be configured to fit over the inner endoscope and then inserted through the outer endoscope. FIG. 15A shows an example of an inner endoscope 1500 that, in this example, includes a first lumen 1501 and a second lumen 1505. FIG. 15B shows an example of an endoscope shield device 1535 that may be used with the first (inner) endoscope. The endoscope shield device includes a cap 1527 to which an elongate, flexible and tubular external shield 1502 is sealed. A pair of internal shields, e.g., a first internal shield 1515 and a second internal shield 1517 extend within the length of the external shield and are also sealed at their distal end regions to the cap so that the cap is open to allow passage into the lumen of the first 1515 and second 1517 shields.

[0292] FIG. 15C shows the endoscope shield device 1535 of FIG. 15B attached over the inner endoscope of FIG. 15 A. the cap may be attached (e.g., latched, friction fit, snapped on, etc.) to the distal end region of the endoscope 1500. In FIG. 15C the endoscope may be inserted into a body without risk of contamination, because the endoscope shield device forms a complete barrier for both the outer surface and the inner (luminal) surfaces of the endoscope. The endoscope shield device does not prevent or limit (and may instead enhance) the operation of the lumen of the endoscope (for example, it can fully slide axially and rotationally), while still maintaining a fluid-impermeable contamination barrier to prevent contamination. Thus, the inner endoscope may be reused after a procedure by removing the endoscope shield device, as described herein, without contaminating the endoscope. For example, the internal shields may be sealed (by crimping, or otherwise) at their proximal end and the external shield may be inverted over itself by pulling it proximally partially orcompletely, preventing contamination and trapping any contaminants within the inverted sleeve of the shield.

[0293] The cap may include one or more transparent sections to allow use of the camera and illumination built into the endoscope 1500. The endoscope shield device’s two internal shields may include lumen that may be used to pass material through the endoscope by passing though the cap into the lumen of the internal shields. A multi-lumen catheter may be used for one of or both of the internal shields, and may include sub-lumen for irrigation, tip wash and / or insufflation lines, for example, which may be directed by the shape of the tip region, which may include a deflector, nozzle, etc. For example, the tip may include a tip wash deflector or nozzle that may direct fluid from the tip wash sub-lumen of the multilumen catheter forming one of the internal shields to direct fluid to clean a window for the camera on the tip. As described herein, in some examples the tip may include illumination built into the cap instead of being on the endoscope.

[0294] FIG. 15D also illustrates the use of the endoscope with the applied endoscope shield device with a second (e.g. outer) endoscope (e.g., overtube). In FIG. 15D the outer endoscope 1539 includes a lumen into which the inner endoscope covered by the endoscope shield device may be inserted. In this example, the outer endoscope 1539 may be configured to act as an overtube, and may be single-use or limited use (e.g., disposable). The endoscope 1500 may be a removable endoscope core that may be reusable. The endoscope 1500 may include one or more cameras, illumination, pull cables (e.g., for steering the distal end region), coil pipe assembly, bending section, etc. As mentioned, the endoscope may be inserted into a fresh endoscope shield device and secured in place by coupling the cap to the distal end region of the endoscope and in some examples inserting into the outer endoscope for performing a procedure.

[0295] In general, these methods and apparatuses may therefore replace components having lower durability before each new procedure, including replacing the endoscope shield device and any associated hydrophilic coatings on the outside (e.g., configured to be positioned between the outer endoscope / overtube and the inner endoscope), while the inner endoscope can be reused multiple times. The inner endoscope may therefore be hygienically draped by the endoscope shield device, so that it can be reused without requiring high level disinfection (HLD). The inner endoscope may be fully shielded from any exposure to water and contamination which facilitates simpler and more cost-effective design and construction. Further, the patient is therefore fully shielded from the second endoscope, potentially simplifying biocompatibility and cleaning requirements for the endoscope. The use of the endoscope shield device may also extend the lifetime of the endoscope, including some of thecostliest components of the endoscope, such as the camera and bending section components. This configuration may also permit the removal and replacement of the inner endoscope during a procedure, while leaving the outer endoscope / overtube in place. These methods may also accommodate utilization of the exterior surface of the overtube for adding accessories, such as external working channels, as described in reference to FIGS. 16A-16B.

[0296] In general, any of the apparatuses described herein may include the use of external working channels over the endoscope shield device and / or over an endoscope used in conjunction with the endoscope shield device. FIG. 16A illustrates an example in which the apparatus shown in FIG. 15D (including an endoscope 1500, endoscope shield device 1535 and outer overtube 1539) also includes external working channel 1545. Examples of external working channels may be found, for example, in U.S. patent application no. 17 / 940,906, titled “EXTERNAL WORKING CHANNELS,” and filed on September 8, 2022, and U.S. patent application no. 18 / 000,062, titled “RIGIDIZING DEVICES,” and filed on May 26, 2021, each of which is herein incorporated by reference in its entirety.

[0297] The one or more external working channels 1545 may be expandable from the outside surface of the outer endoscope 1539 and may include a proximal insertion guide region 1547 for inserting one or more device through the external working channel. FIG. 16B shows an example of a system including an inner endoscope covered by an endoscope shield device 1535 such as that described in FIGS. 15A-15D, that is slidably arranged within the outer endoscope 1539. As mentioned, the outer surface of the endoscope shield device may be coated with a hydrophilic coating to assist in axial movement between the outer and inner endoscopes. The system shown in FIG. 16B also includes external working channels 1545 configured as a cover over the outer endoscope that includes a proximal insertion guide 1547. In FIG. 16B a tool 1549, 1549’ is shown inserted through the insertion guide 1547 passing into the working channel of the external working channel and extending distally from the distal end of the outer endoscope. The proximal end of the inner endoscope 1558 is shown extending from the proximal end of the outer endoscope. In this example, the internal shields (not shown) may extend proximally and may couple to, e.g., a source of aspiration, fluid, insufflation, etc. These working channels can co-exist with a shielding system, such that the underlying endoscope maintains its cleanliness, even as tools go through its working channels and tools go through the external working channels.

[0298] In any of these examples the external working channels may be mounted on the overtube, as shown in FIG. 16B, e.g., using an overtube as described in FIG. 4A. In this case, the working channels may be disposed of out after each procedure, together with the overtube and the distal external shield.

[0299] In some examples the external working channels may be mounted on the external shield of the endoscope shield device. For example one or more external working channels (including expandable working channels) may be incorporated into the external shield, such as the full length external shield, which may fit over the outside of the endoscope or endoscope assembly (e.g., FIG. 4C). In this configuration the working channels may be disposed of after each procedure together with the full length external shield, but without requiring disposal of the overtube (which is protected under the full length of the external shield).

[0300] As described above, any of the endoscope shield devices described herein may be configured as rigidizing endoscope shields, referred to herein as rigidizing endoscope shield assemblies. The endoscope shield devices may be rigidized in any appropriate manner, including, but not limited to, pressure rigidizing devices. For example, the endoscope shield devices describe herein may include a rigidizing external shield configured to extend over an endoscope and may include a rigidizing layer comprising multiple strand lengths that cross over each other and a compression layer that is configured to apply force to the rigidizing layer when pressure is applied in order to rigidize the rigidizing external shield from a flexible configuration to a rigid configuration.

[0301] For example, FIGS. 17A-17D illustrate a system 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 rigidizing endoscope shield device 1735 (e.g., rigidizing endoscope shield assembly). The rigidizing endoscope shield device includes a cap 1727 that is configured to attach to the distal end region of the endoscope 1700 and includes one or more internal shields (in this example, a first internal shield 1715 and a second internal shield 1717) that are configured to fit within the endoscope 1700. The rigidizing endoscope shield device also include a rigidizable external shield 1702. The rigidizable external shield 1702 is a tubular shield that is sealed to the cap 1727. The external shield 1702 may have an inner diameter that is slightly greater than the outer diameter of the inner endoscope 1700.

[0302] The rigidizable external shield 1702 may include a rigidizing layer or region that engages with a compression layer (which may be or may include a bladder) that applies force to the rigidizing layer to rigidize the rigidizing layer or in some cases, to de-rigidize (e.g., release from rigidization) the rigidizing layer. In some examples, these rigidizable external shields 1702 may include a rigidizing layer that could include a braid, knit, woven, chopped segments, randomly distributed or randomly oriented filaments or strands, engagers, links, scales, plates, segments, particles, granules, crossing filaments, tendons, or other materials forming the rigidizing layer. For example, the rigidizing layer may comprise multiple strandlengths or strand segments that cross over each other (e.g., as part of a braid, knit, woven, etc.); the compression layer may apply force to drive the crossing strand lengths or strand segments against each other. In some examples the rigidizing layer may be a braided layer, however any of these apparatuses may instead or in addition include a general rigidizing layer comprising crossing strand lengths or strand segments. The rigidizing layer may include one or more longitudinal members (e.g., extending proximal -do-distal). The examples of rigidizing apparatuses described herein may use pressure (positive pressure) and / or negative pressure to selectively and controllable rigidize. In some examples the method described herein may be used with any appropriate rigidizing apparatus.

[0303] FIG. 17C shows an example of the assembled inner catheter 1700 and the rigidizing endoscope shield device 1735. The inner rigidizing shields are inserted into the lumen of the endoscope, the cap is coupled to the distal end of the endoscope, and the outer rigidizing endoscope shield 1702 extends over the outer surface of the endoscope.

[0304] Any of these systems may also optionally include a second, outer, endoscope 1739, as shown in FIG. 17D. Thus, these apparatuses may be used in a nested configuration. The outer endoscope may also be rigidizing in some configurations.

[0305] As mentioned, the outer endoscope 1739 (e.g., overtube) may be one- time / disposable, and / or may be reusable (e.g., by cleaning or by shielding).. Similarly, the endoscope shield device may be single use / disposable or may be reusable (e.g., by cleaning). The endoscope may be reusable, and may include, e.g., a camera, illumination, pull cables, coil pipe assembly, bending section, etc. The inner endoscope may be inserted into a fresh endoscope shield device and secured in place for a procedure, and then unsecured and removed after a procedure.

[0306] In any of the apparatuses and method of using and making them described herein, the internal shield(s) may be configured to both prevent contamination and to pass one or more materials or objects. In general, the internal shields are typically tubular shields that are sealed so that the distal outer edge is sealed circumferentially within an opening through the cap. Further the internal shield(s) may be generally stiffer than external shield and may sufficiently stiff so that they may be threaded into the lumen of the catheter without buckling, so as to facilitate ease of install Further, the internal shield may be sufficiently stiff so that it can allow unobstructed passage of a material when acting as an internal working channel (e.g., when the internal shield is acting as a working channel liner). In some cases, however, particularly when used with a steerable endoscope, such as the one shown in FIG. 18, the internal working channel must be sufficiently flexible to allow bending of the endoscope.

[0307] For example, in endoscopes such as the one shown in FIG. 18, have different bend radiuses at the different zones. The distal end region (“distal zone”) 1851 may be highly flexible, as shown, as the distal tip 1543 of the endoscope, to which the cap of the endoscope shield device may be coupled may be steered by bending a bending section 1541 of the endoscope. The endoscope may be steered or bent by any appropriate technique or structure, including tendons / pullwires, etc. The bending of the tip region may be particularly challenging for the internal shield, as bending beyond a particular radius of curvature may result in pinching or collapse of the lumen of the internal shield. Thus, these apparatus may include tube reinforcement - particularly in the distal end region corresponding to this distal zone 1851. However, it should be appreciated that other regions may also be reinforced, including the intermediate or middle zone 1853, which may extend to, or almost to, the proximal end of the catheter. The proximal zone 1835 may include the extension of the internal shield 1817 beyond the catheter and / or the external shield 1828 and may extend, for example, to a port adapter 1868.

[0308] In some examples, the entire endoscope may be highly flexible, and the internal shields may be highly flexible to match. To achieve both high flexibility and sufficient stiffness / radial strength to prevent collapse and allow easy insertion of the internal shield(s), in any of these apparatuses the internal shield may be reinforced. Any appropriate reinforcement and extent of reinforcement may be used. For example, the internal shield may be reinformed by one or more coils that are wound helically around and / or within the internal shield to prevent localized buckling during tight curvature of bending (e.g., bending having a radius of curvature that is less than, e.g., 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.).

[0309] FIG. 19A illustrates an example of a first tubular internal shield. This example is a single-lumen internal shield, which may be referred to as a tube liner, as it lines the lumen of the endoscope. In FIG. 19Athe internal shield 1650 includes a reinforced distal region 1651 and an un-reinforced middle region 1653. The reinforced distal region 1651 may be reinforced by including an inner coil wound tube or by forming of a more flexible, yet collapse or buckling-resistant material (e.g., polymeric material). In some examples, as shown in FIG. 19B the entire length of the internal shield 1650 is reinforced by a coil. Other internal shields may include more than one lumen and may be reinforced as well. In some example, multi-lumen internal shields may not need to be reinforced, as the division of the inner lumen into the multiple lumens may provide internal reinforcement.

[0310] The internal shield in some examples is formed of an intermediate durometer elastomeric by, e.g., extrusion. A slip additive may be included to help make the internal shield slippery so that it slides in easily, e.g., within the lumen of the endoscope, and relative to tools that pass within its inner diameter. In some examples the internal shield may be formed as a composite structure. For example, a laminated coil wound tube may be used, with the coil pitch changing along the length, and the coils may be formed from a flat wire. The flat wires may be wound more densely in the distal zone to prevent buckling as the bending section is brought through a tight radius of curvature. The matrix material forming the body of the internal shield may be a low durometer elastomer (70A urethane) material. The inner surface of the tubular internal shield may have a hydrophilic coating so that tools can slide easily. This can make the sliding far superior to that possible with standard PTFE tubing. For example, a reusable scope with the standard PTFE tube may allow a tool to be inserted and perform two complete wraps (e.g., 2 * 360 degrees). With a hydrophilic coating, this can be increased to up to six wraps (e.g., 6 * 360 degrees). The drag in this situation scales exponentially (see, e.g., the capstan drag formula), particularly in long, bend / bendable tubes, thus this is a major reduction is drag, and an advantage of the endoscope shield devices described herein. The resulting low drag may enhance the tactile feel for the instrument. This is yet another example of how a shielded system can outperform a reusable system.

[0311] Thus, the internal shields may be reinforced as described herein, and / or may be formed of a material having sufficient properties (e.g., wall thickness, stiffness in bending, bucking in bending, buckling along length, etc.) to prevent pinching or collapse when manipulating the endoscope. In general, the interior shield may be made of the same material as the external shield, or they may be made of different materials. Examples of appropriate materials for the internal shield may include, but are not limited to: polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxy (PF A), high-density polyethylene (HPDP), low-density polyethylene (LDPE), polyether block amide (e.g., Pebax™), expanded Polytetrafluoroethylene (EPTFE, e.g., Fluroflex™), Urethane, TPU, etc. These materials may be extruded and may be combined with other materials, such as, for example, with a heat set metal coil, coil wound with round wire, flat wire, etc. Examples of materials for the external shield may include (but are not limited to): LDPE, polyolefin plastomers, nylon, composite materials (for example, thin films laminated with a urethane, including high performance fibers inter-dispersed (for example, Dyneema, Technora, carbon fiber, Dyneema, PET, basalt, fiberglass, etc.), silicone, and urethane. These may be manufactured by multiple methods, including, but not limited to: extrusion, extrusion blow molding (including bellows designs), lamination, heat sealing.

[0312] In general, the endoscope shield devices described herein may include a tip that includes features that permit the endoscope shield device to easily and effectively secure to the distal end region of the endoscope, the permit the external shield and the internal shield(s) to form a seal with the cap, and that may include integrated features to assist in the functioning of the endoscope to which the endoscope shield device is attached. For example, an endoscope shield device may include a tip having any of the feature shown in FIGS. 20 A- 20D, 21C, 22A-22C, 23A-23B, 24A-24B, 25, 26A-26B, 27A-27C, 28A-28D, 29A-29B, 30A- 30B, 31A-31B, 32A-32B, 33A-33B, 34A-34B36A-36B or 38.

[0313] For example, FIGS. 20A-20D illustrate one example of a cap including features that may be included in any of the endoscope shield devices described herein. The cap shown includes a distal face that may be all or partially transparent, and may include a transparent camera region 2026 through which a camera on the endoscope may image. Light blocking between the light sources and the camera may improve the performance and optical characteristics. As shown in FIGS. 36A-36B, in some examples the cap may include integrated lenses or cameras. In some examples the cap may further include a transparent light-passing region 2024 allowing transmission of light through the cap from the endoscope. The cap 2018 may also include one or more optical components (e.g. diffuser, lens, etc.) for modifying the illumination light. In some examples the cap may alternatively or additionally include one or more light sources, e.g., LEDs. The cap may include one or more openings corresponding to the internal shield regions, including the opening into the lumen of the first internal shield 2023 and / or the second internal shield 2022. Any of these apparatuses may also include one or more flow directors or displacers 2020 that may direct (or re-direct) flow of one or more agents (e.g., wash solution, air, etc.) from the proximal end of the device. For example, the cap may include a wash nozzle or wash director outlet 2021 which may be part of the fluid displacer 2020 on the cap.

[0314] For example, FIG. 20A shows an end view of the cap in this example. FIG. 20A shows an end-on view of the cap. FIG. 20B shows a side perspective view, including a cylindrical mating region 2033 that may initially be oval, as shown in FIG. 20D. The ovalshaped mating region may, in an unconstrained configuration, have an oval cross-section, transverse to the long axis of the device. The side view of FIG. 20B also shows that the cap may include one or more regions for coupling with all or a portion of the cylindrical external shield; in FIGS 20B and 20C, the cap may include an optional recessed mating region 2049 into which the external shield may be sealed, for example, with an elastic member (elastic retaining ring, not shown) and / or adhesive and / or a heat seal.

[0315] As shown in FIG. 20D the cap 2018 may include an oversized rim 2036 extending around the cylindrical mating surface 2033. FIG. 20D shows the inside of the cap region. Showing the recessed or cut-out inlets 2022, 2023 for receiving and sealingly bonding to the internal shields. The inside of the cap also includes an optional recessed or notched region 2039 to make the material easier to deflect.

[0316] The end cap shown in FIGS. 20B-20D also includes a latch region 2038 extending through the mating surface that is configured to mate with a distal end of the endoscope, by compressing the mating surface from an oval resting cross-sectional configuration into a circular mating cross-sectional configuration. The latch 2038 may be formed in this example as an opening into which a protruding latching member, e.g., on the distal end region of the endoscope, may engage. Alternatively in some examples the protruding latching member may be on the cap and may engage with a latch opening on the distal end of the endoscope. The latch feature may be a negative feature on the cap or it may be a positive feature, with commensurate mating features on the mating part.

[0317] Any of these caps may also include one or more stress relief regions 2039, including stress-relief cutout regions, that may make it easier and more reliable to compress the cylindrical mating region 2033 (e.g., wall). In subsequent versions, this feature may or may not be present, as the cap not having cut-outs could help to ensure that the system elements are more easily hermetically sealed.

[0318] For example, FIGS. 21 A and 21B show examples of the distal end of an endoscope including a camera 2106, light 2104, and first 2108 and second 2109 lumen through the endoscope. The endoscope in this example also includes an outer diameter surface 2174 on which the mating latch component (e.g., a ramped latch protrusion 2112, 2112’ in FIG. 21B) is present. FIG. 21C shows a front view of the endoscope shield device of FIGS. 20A-20D attached to a distal end of an endoscope. The cap 2118 in this example may be applied by first applying pressure (e.g., squeezing the cap) to circularize the oval mating wall then sliding it over the distal end and engaging the latches 2112 on upper and lower regions. This is illustrated in FIGS. 26A-26B. In this example, the cap 2613 includes a cylindrical mating surface 2033 that is formed in an (at-rest) oval cross-sectional shape. Transitioning from the oval cross-sectional shape to a more round shape matching the perimeter of the catheter may allow the endoscope shield device to be slid onto the more circular endoscope distal end and mate with the latching components. Once pressure is released, the cap may return to a slightly more oval configuration, applying force to the hold cap onto the distal end region.

[0319] As in shown in FIG. 21C the cap may include one or more structures, such as an integrated fluid displacer 2120 that may allow the cap to direct the flow of material (e.g., wash) from the lumen of the internal shield. In FIG. 21C the internal shield in this lumen of the catheter is a multi-lumen catheter partitioned into three regions: insufflation, wash and irrigation.

[0320] As mentioned, any of these caps and therefor any of the endoscope shield devices described herein may include one or more light sources integrated into the cap. For example, FIGS. 22A-22C illustrate one example of an endoscope shield device that includes a cap 2218 with an integrated set of LEDs in the lens (rather than, or in addition to, transmitting light from the endoscope). In FIG. 22Athe endoscope shield device includes an external shield 2228 sealed to the perimeter of the cap 2218, e.g., within a channel that secures the external shield by a gasket 2241. 2228 extends fully over the features 2039 and 2038, so that the outer surface is hermetically contiguous. An internal shield 2210 extends from the cap (e.g. through the cap and sealed around the inner surface of the openings through the cap) and into the lumen of the endoscope 2222. The cap may include other features, including a fluid displacer 2220.

[0321] The cap 2218 shown in FIGS. 22A-22C also includes a plurality of LED lights 2243 that are 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 may be powered by including one or more electrical contracts on the inside of the cap that may make contact with corresponding contacts on the end of the endoscope. For example, FIG. 22C shows a region of multiple electrical contacts 2239 on the endoscope that make electrical connection with one or more pads, pins and / or contacts on the cap once the cap is applied. In this example, the oval mating wall may include one or more of the electrical contacts needed to power the LEDs. These contacts may also be configured to be on the regions of the walls near the minor axis of the cross-section through the oval (e.g., elliptical) mating wall; this same region may include the latch 2238 (e.g., latch opening and / or latch projection).

[0322] FIGS. 23A-23B illustrate another example of a cap portion of an endoscope shield device including a plurality of LEDs 2343, similar to the arrangement of FIGS 22A-22C. In FIGS. 23 A-23B the cap is configured as a disposable cap with a transparent window. The endoscope shield device may be placed over an endoscope in use. However if the endoscope has a camera and illumination ports, this may cause reflected light from the illumination ports to create reflection artifacts in the camera image. To avoid this problem, in some examples the cap may include illumination ports, for example, including LEDs as described above. For example, the LEDs can be placed along the outside edge of the disposable cap. Arrangingillumination on the disposable cap would also free up valuable space on the face of the endoscope to support other features, or to decrease the diameter of the endoscope. One embodiment may include one to three white light LEDs. In the case of multiple LEDs, the different LEDs may be arranged at equidistant intervals around the outside perimeter of the cap (facing forward), but could be arranged in other patterns.

[0323] Some imaging arrangements may use illumination other than white light. For example, green, blue, and ultraviolet (UV) light may be used to highlight surface features of the tissue. Infrared illumination may be used with fluorescence, with or without other bands of illumination. Alternate illumination schemes may be “steady state,” with the vision system switched into an alternate imaging mode and staying there until the user switches back to white light illumination. Alternatively, the vision system may change illumination patterns at frame rates, alternatively illuminating a frame with white light, then with alternative illumination, or using other temporally varying patterns. Image interpolation may be used by the systems described herein to display an alternative image overlaid with a white light image. An array of LED’s, lasers, or other illumination devices on the disposable cap could enable these alternative imaging approaches. For example, a cap with three LEDs each of red, green, blue, and UV light could allow the vision system to image both in white light, and in an alternative mode to highlight details on the surface of the tissue. In the example shown in FIG. 25, these LEDs 2543 are arranged in three clusters spaced 120 degrees apart on the face of the cap 2513, with each cluster containing a red, green, blue, and UV LED closely spaced. Other configurations may be used.

[0324] In some examples wires (e.g., wire leads) may be used to power the LEDs. These wires may be routed through the endoscope, with electrical contacts between the cap and endoscope body as mentioned above. Alternatively, wire leads could be integrated into the external shield that is attached to the cap, for example, running in a spiral around the external shield in order to prevent limiting movement of the endoscope. Alternatively, in some examples the wires may run down or through the internal shield (or more than one internal shield). For example, the wires may be encapsulated thin wires.

[0325] FIGS. 24A and 24B illustrate examples of multi-lumen extrusions with embedded wires (in this example, the wires are enclosed in twin .013” lumens). In FIG. 24Athe embedded wires 2481 may be coupled to one or more LEDs (not shown) and the frame may be configured to fit over the distal end of the device as described above, including cut-our regions to allow imaging and / passage of light.

[0326] As mentioned above, in some examples the caps may be applied and / or removed from the endoscope by applying compression across the large axis of the oval, cylindricalmating wall. For example, FIGS. 27A-27C illustrate removal of a cap (the external shield has been removed to show the application of a compression force to remove the device from the tip). As shown, the cap is disengaged by squeezing the cap to deform the mating wall to allow the latch members to uncouple (FIG. 27B) so that the cap can be pulled up and off of the endoscope, leaving the endoscope clean and ready for another use.

[0327] FIGS. 28A-28D and 29A-29B schematically illustrate this method. For example, in FIG. 28Athe first set for attaching the endoscope shield device to the endoscope 2800. The internal shield(s) 2815, 2817 of the endoscope shield device may be inserted into the lumen of the endoscope and the endoscope shield device may be slid 2883 proximally until the cap 2813 is near the distal end region of the endoscope, as shown in FIG. 28B. Once the cap 2813 is in position, the user may use their fingers to compress the cap and deform the shape of the cylindrical mating wall 2884 so that it may fit over the distal end region of the endoscope, as shown in FIG. 28C; the pressure applied to the large axis of the cylinder may circularize this otherwise oval cross-sectional area until it can fit over the endoscope, which has a round cross-sectional area, shown in FIG. 28D. The position and extent of the stress-relief window 2893, cut through the cylindrical mating way on the opposite sides of the minor axis of the transverse section through the cylindrical wall, may make changing the cross-sectional shape of the cylindrical mating way from the oval to a more circular shape easier. The application of this compressive force 2985 may also help engaging or disengaging the latch 2992. FIGS. 30A-30B illustrate the application of compressive force 2985 to elastically deform the cylindrical wall having an oval cross-section, as described above.

[0328] As mentioned above, any of the caps for the endoscope shield device may include one or more features for directing the flow of material into or out of the endoscope. For example, the endoscope shield device including a cap such as the one shown in FIGS. 31A and 3 IB may include integrated or attached features to direct the flow of fluid wash, fluid irrigation, and / or insufflation. In this example the endoscope shield device includes a multilumen catheter 3115 forming one of two tubular internal shields. A second single-lumen shield 3117 is also included. The multi-lumen shield 3115 in this example is divided up into three sub-lumen that may be accessed at the proximal end of the device by a port adapter to apply each of: insufflation 3142, wash fluid 3143 and irrigation fluid 3144. This is illustrated in FIGS. 35A-35D, showing the operation of an example of a port adapter 3569. In this example the multi-lumen internal shield 3516 is inserted fully into the port adapter until a latch engages with the distal end of the port adapter, indicating that the lateral openings into the different lumen arranged at different longitudinal positions along the length of the internal shield are aligned with the appropriate sealing regions of the receptacle manifold of the portadapter. For example, in FIG. 35Athe irrigation port 3576 into the first lumen is accessed from the position so that irrigation fluid may be applied through the port adapter input for irrigation fluid 3571. The wash fluid port 3577 into the second lumen is accessed from the middle position so that wash fluid may be applied through the port adapter input for wash fluid 3573. The insufflation port 3579 into the third lumen is accessed from the more proximal position so that insufflation may be applied through the port adapter input for insufflation 3574. FIGS. 35B-35C show end views of these different ports.

[0329] Returning now to FIGS. 31 A- 3 IB, the insufflation 3142 may be directed out of the multi-lumen catheter forming the internal shield 3115 by the deflector 3120 so that the insufflation 3142, 3242 is directed across the camera region. This is shown in greater detail in FIGS. 33A-33B. The flattened triangular component is representative of the general location of the insufflation. Similarly, the wash fluid 3143, 3243 is directed out of the multi-channel lumen of the internal shield by a deflector 3120 on the cap 3113 that may direct the wash fluid across the outer surface of cap 3213 to clear debris that may otherwise occlude the camera. This is shown in greater detail in FIGS. 32A-32B. The bent cylindrical shape shown to represent the wash fluid 3243 is representative of the general direction of flow of the wash fluid. Irrigation fluid 3144, 3442 may be directed from out of the multi-lumen catheter forming the internal shield as shown by the representation of irrigation in both FIGS. 31 A- 3 IB and 34A-34B.

[0330] FIGS. 33C-33E show another example of a cap having a wash port 3320 for directing wash fluid out of the cap and across the visualization window. In the example shown in FIGS. 33C-33E, the wash port 3320 is configured to be integrated into the cap (e.g., part of the light-blocking region described in greater detail below) for molding as part of the same piece. These wash ports may also be configured to have an enhanced flow by increasing the flow width from the wash so that the wash flow covers the entire window area. The wash port may also be configured to control the flow rate so that a jet of water is applied at sufficiently high speed to remove contaminants from the window but slowly enough to prevent damage or disruption of the cap.

[0331] In FIGS. 33C-33E the cap shown includes a wash port 3320 integrally formed as part of the cap. The wash port includes a channel 3341 in fluid communication with a lumen of an internal shield (e.g., a lumen of a multi-lumen catheter). The wash port 3320 has a distal cover 3331 that extend across the lumen, but has a side opening out of a portion of the wash port 3320 that extends proud of the end face of the cap. This side opening is perpendicular to the flow of fluid into the channel. An inner surface 3321 of the distal cover 3331 (the surface of the distal cover that faces the channel 3341 is angled relative to the long axis of thechannel, e.g., between 2 and 20 degrees (between 2 and 17.5 degrees, between 2 and 15 degrees, between 2 and 12 degrees, etc.) relative to the plane perpendicular to the long axis of the channel, e.g., the direction of flow. This downward angle, shown in FIG. 33D, deflects the was fluid downward and against the viewing window 3322.

[0332] In addition, the dimensions of the wash port aperture on the lateral side of the wash port 3320 may be specific in order to optimize flow direction and rate. For example caps having an aperture height of between about 0.15 and 0.45 mm (e.g., between about 0.2 and 0.35 mm, between about 0.25 and 0.35 mm, etc.) and aperture widths between about 1 and 4 mm (e.g., between about 1 mm and 3 mm, between about 1.5 mm and 2.5 mm, etc.) may result in optimal flow for washing the entire window region of the cap. Outside of these dimensions, the wash fluid may not sufficiently wash the transparent window region 3322. In some cases the aperture surface area may be between about 0.2 and about 1 mm2(e.g., between about 0.3 mm and 0.9 mm2, between about 0.3 mm and about 1.3 mm2, etc.). These dimensions may result in particularly optimal performance where the washing flow rate is between about 20 and 100 mL / min (e.g., between about 30 and 90 mL / min, between about 40-80 mL / min, between about 40-70 mL / min, etc.). In some cases the aspect ratio of the wash fluid aperture may be, e.g., between about 4 and about 12 (e.g., between about 4 and about 10, between about 4 and about 8, etc.). These dimensions, along with the range of flow rates described (e.g., between about 20-100 mL / min) may result in laminar flow and flow that is sufficiently powerful to clear / clean the window during use.

[0333] As discussed above, the cap may also include one or more optical components integrated into (including formed integrally in) the cap. For example, any of these endoscopic shield devices may include a cap having an integrated lens or lenses for the camera of the endoscope, as shown in FIGS. 36A-36B. In this example a domed lens 3652 is formed as part of the cap 3600, which may include other components such as a fluid displacer 3620. When the cap is attached to the distal end region of an endoscope as shown in FIG. 36B by crosssection, the camera of the endoscope 3688 is in direct communication with the lens 3652 formed on the cap. The endoscope shield device 3600 of FIGS. 36A-36B also includes a second internal tubular shield 3617 that is configured as an internal working channel and is lined by the second internal tubular shield 3617.

[0334] Any of the apparatuses described herein may include one or more accessory elements that are configured to be used with the endoscope shield device, such as scope caps and the like. These accessories may be added or coupled to the endoscope shield device after or before it has been applied to an endoscope, or they may be integrated into the endoscope shield device, e.g., as part of the cap. For example, FIGS. 37A-37C illustrate an example of aremovable scope cap 3700 that include a retention feature 3708 (in this example, configured as a bayonet type attachment). In FIG. 37Athe removable scope cap 3700 is separate from the endoscope shield device (e.g., the cap 3713 of the endoscope shield device) and in FIG. 37B the removable scope cap 3700 is coupled to the cap of the endoscope shield device. FIG. 37C show a side sectional view of FIG. 37B. The system shown has a male feature on the endoscope and a female feature on the cap: these could be inverted or other attach methods could be utilized.

[0335] In general, the methods described herein may include attaching, removing and / or swapping out of different scope caps depending as necessary to the user. In some examples the endoscope shield device may be configured to integrate one or more of these features, such as a scope cap extending from the distal end. FIG. 38 illustrates an example of a cap 3813 in which the scope cap portion 3800 is integrally formed with the rest of the cap.EXAMPLES

[0336] FIGS. 39A-39C illustrate an example of a rigi dizing endoscope shield assembly similar to that shown in FIG. 17B. In this example, the rigidizing endoscope shield assembly 3900 includes an elongate external shield body 3902 that is configured to be transitioned from a flexible configuration to a less flexible configuration by modulation of pressure within the external shield body. The elongate external shield include a lumen extending from the proximal end to the distal end surrounded by the external shield body, into which an endoscope may fit. The distal end of the rigidizing endoscope shield assembly includes a distal cap 3927 that closes off the distal end of the lumen. The cap also engages with the distal end region of the endoscope inserted into the lumen of the rigidizing endoscope shield assembly, as described above. In FIG. 39A, the rigidizing endoscope shield assembly also include a pair of internal shields 3915, 3917 that are coupled to the distal cap 3927 so that the lumen of the internal shields are open to the distal end through the cap, and the outer perimeter of the internal shields. The internal shields extend, unconstrained, through the lumen of the outer shield of the rigidizing endoscope shield assembly, and extend distally out of the proximal end. In this example the proximal end of the outer shield of the rigidizing endoscope shield assembly includes a proximal attachment 3920 that is configured to couple to the proximal portion (e.g., handle) of the catheter. One or more ports (e.g., pressure ports 3929) may be included at the proximal end region of the rigidizing endoscope shield assembly. In FIG. 39Athe pressure port 3929 may be fluidly connected to the inner wall of the elongate shield body 3902, including a bladder layer (not visible in this example) for modulating pressure and therefore the flexibility / rigidity of the apparatus.

[0337] FIG. 39B shows another perspective view of the rigidizing endoscope shield assembly of FIG. 39 A. The rigidizing endoscope shield assembly may be any appropriate length, and may match the length of the endoscope over which it is to be inserted. FIG. 39C shows a side perspective view of the rigidizing endoscope shield assembly including the external shield 3902 extending proximally-to-distally, and enclosing a lumen into which the endoscope may fit. Thus, the length of the rigidizing endoscope shield assembly may be matched to the length of the endoscope so that the distal end of the rigidizing endoscope shield assembly may couple with the distal end region of the endoscope and the proximal attachment 3929 of the rigidizing endoscope shield assembly may couple with the proximal end region (e.g., handle) of the endoscope, as shown in FIG. 41, showing the endoscope of FIG. 40 engaged with the rigidizing endoscope shield assembly of FIGS. 39A-39B.

[0338] The endoscope 4000 shown in FIG. 40 includes a distal end 4030 that may be inserted into the lumen of the rigidizing endoscope shield assembly so that it can engage with the cap 3927 of the proximal end of the apparatus. The endoscope may also include an elongate body 4001 ending in a proximal end (e.g., handle 4008) that may be configured to be handheld or manipulated, e.g., robotically, etc.). In this example, a pair of internal lumen 4005, 4007, such as a first lumen of a working channel and / or a second lumen configured to pass a fluid.

[0339] In FIG. 41, the rigidizing endoscope shield assembly 3900 of FIGS. 39A-39C is shown fully coupled with the endoscope 4000 of FIG. 40, forming a field-deployed transiently converted rigidizing endoscope 4100, in which the distal cap 4127 of the rigidizing endoscope shield assembly is releasably fixed to the distal end of the endoscope so that the optical input / outputs of the endoscope, such as the camera and lights, are aligned with corresponding optical features on the cap. In some cases the alignment may include maintaining axial tension between the cap 4127 and the distal end of the endoscope 4030 in order to prevent relative movement between an optical window (e.g., camera window, light source window, etc.) of the rigidizing endoscope shield assembly and the camera and light source output / inputs of the endoscope. Such movement may degrade the optical quality of the imaging through the device.

[0340] In the transiently converted rigidizing endoscope 4100, the rigidizing endoscope shield assembly 3900 completely encloses the endoscope from the distal end to the proximal end, both outside (e.g., over the external length of the endoscope 4100) and the inside lumen (e.g., the first lumen 4005 and the second lumen 4007, as shown in FIG 40. A pair of inner shields 3915, 3917 that extend from the cap and proximally through the lumen of the rigidizing endoscope shield assembly may each be inserted into a corresponding lumen of theendoscope, and extend distally from them. The proximal attachment 3920 of the rigidizing endoscope shield assembly may be engaged with the proximal end (e.g., handle) 4008 of the endoscope. In some cases the proximal attachment may include a plurality of ports 3929 each in fluid access to one or more region within the rigidizing endoscope shield assembly. In some cases the rigidizing endoscope shield assembly may include a port in fluid communication with the lumen of the external shield of the rigidizing endoscope shield assembly (e.g., external shield lumen access port). When an endoscope is inserted into the lumen, this proximal port may be in fluid communication with the region between around the endoscope and between the endoscope and the inner lumen wall (e.g., bladder layer) of the rigidizing endoscope shield assembly. In some cases the rigidizing endoscope shield assembly may include a proximal port that is in fluid communication with the region holding the rigidizing layer, e.g., between the outer layer (e.g. an outer reinforced layer) and the bladder layer, or between the bladder layer out surface and the rigidizing layer. In examples in which the bladder layer comprises an out-and-back bladder layer that extends distally and doubles back over itself, e.g., which may form a walled sleeve or pocket structure that also includes a proximal port that may be used to apply pressure (e.g. positive and / or negative pressure.

[0341] For example, the rigidizing endoscope shield assembly 3900 of FIGS. 39A-39C and 41 may include an external shield 3902 configured to be transitioned from a flexible configuration to a less flexible configuration by modulation of pressure within the external shield, as well as a cap 3927 covering the distal end of the external shield the lumen. The cap may be configured as any of the caps described herein. The cap may be configured to couple a distal end of the external shield 3902 to a distal end the endoscope 4030. The rigidizing endoscope shield assembly may also include one or more (two are shown) internal shields 3915, 3917 extending proximally through the lumen of the external shield from an opening through the cap. The cap seals around the outer surfaces of the internal shields so that the distal end of the external shield and lumen holding the endoscope is completely sealed off distally, both inside and out.

[0342] In the example shown, the external shield 3902 is shorter than the one or more internal shields 3915, 3917. The cap 3927 may include an engagement region configured to releasably secure to the cap to the distal end of the endoscope. For example, the cap may include a friction fitting, a snap fitting, a magnet, a bayonet connector, and / or a threaded region. In some cases the attachment is a lock, so that the cap may lock the rigidizing endoscope shield assembly onto the distal end region of the endoscope. More than one typeof attachment may be used. The attachment may be configured to maintain a force holding the cap in place on the end of the endoscope.

[0343] As described above the internal shield may be multi-lumen shield. In some examples, the internal shield may include a working channel liner having a working channel lumen.

[0344] The rigidizing endoscope shield assembly may be any appropriate length, including between about 20 cm and 2 meters or more (e.g., between about 30 cm and 2 m, between about 50 cm and 1.8 m, etc.).

[0345] In any of these examples the proximal attachment may be configured to engage with the handle 4008 of the endoscope, as shown in FIG. 41. In some cases the proximal attachment may seal to the endoscope. For example, the proximal attachment may be configured to seal the external shield to an outer surface of the endoscope. In some examples the proximal attachment comprises an elastic attachment.

[0346] The proximal attachment 3920 may be coupled to the external shield. In some cases the proximal attachment may be a handle-like structure configured to be held, e.g., by a machine (e.g., mount, robotic, manipulator, actuator, etc.) and / or handheld. Thus, the proximal attachment may be referred to as the base and / or handle of the rigidizing endoscope shield assembly. In FIGS. 39A-39C the proximal attachment 3920 is shown having two parts that are coupled together. This configuration may allow the various cylindrical layers forming the rigidizing endoscope shield assembly to be secured together, e.g., between the two portions, a distal part and a proximal part. As mentioned the proximal attachment of the rigidizing endoscope shield assembly may include one or more ports in fluid communication with one or more regions (e.g., lumen, layers, regions between layers, etc.) of the rigidizing endoscope shield assembly.

[0347] FIGS. 42A-42C illustrate fluid ports for accessing regions within the rigidizing endoscope shield assembly and / or the assembled transiently converted rigidizing endoscope 4100. FIG. 42A shows a section through the transiently converted rigidizing endoscope 4100 of FIG. 41, illustrating the connection at the distal end, in which the cap 4127 of the rigidizing endoscope shield assembly is engaged with the distal end region of the endoscope. The proximal end of the rigidizing endoscope shield assembly, e.g., proximal attachment 3920, is engaged with proximal handle 4008 of the endoscope. The inner shields 3915, 3917 are shown inserted through and protecting the inner lumen extending through the endoscope. In some examples the bladder layer distal end, e.g., in FIG. 42C, the out-and-back bladder layer, may be configured to seal and / or couple to the inside of the cap. This may help seal andform the contained bladder volume. In some cases a negative pressure may be applied to both Pl and P2 regions; the bladder layer may be relatively small and may be pulled outwards.

[0348] FIGS. 42B-42C illustrates some of the proximal ports that may be used to control the rigidizing endoscope shield assembly and once assembled onto the endoscope, the transiently converted rigidizing endoscope. For example, the first port (Pl) 4231 is shown extending through the proximal attachment 3920 of the rigidizing endoscope shield assembly and is in fluid communication with the bladder layer 4247 of the rigidizing endoscope shield assembly (as shown by dashed line 4236. This port may be used to apply negative pressure (e.g., vacuum) during installation of the endoscope into the rigidizing endoscope shield assembly. In FIG. 42B, the example shown includes an out-and-back bladder in which the bladder layer includes two layers forming a chamber that may be inflated, e.g., an out-and- back layer that extends distally and doubles back over itself 4247’ to form a dual layer. In this example Pl is in fluid communication with the region between the dual layers. The distal end of the bladder layer may be sealed to the cap. For example, in FIG. 42C, the distal end of the out-and-back bladder layer is sealed by an annular seal 4297 to the cap. As mentioned, during installation, negative pressure may be (optionally) applied within this region to help collapse the two layers together, assisting in expanding the inner diameter of the rigidizing endoscope shield assembly. The lumen of the rigidizing endoscope shield assembly that is configured to hold the endoscope is formed by the bladder layer. During operation of the transiently converted rigidizing endoscope, positive pressure may be applied through the Pl port 4231 and into the Pl region 4251 of the bladder layer, so that the bladder may be driven against the rigidizing layer 4216. In the example shown in FIGS. 42A-42C, the opposite side of the two- layer bladder 4247 may be supported against the outside of the endoscope within the lumen of the rigidizing endoscope shield assembly, locking the endoscope in position and enhancing the security in which the rigidizing endoscope shield assembly holds the endoscope rigid.

[0349] A second pressure port 3929, P2, is also shown in FIGS. 42A and 42B, and is on the proximal attachment 3920. This second port is in fluid communication with the rigidizing layer 4216, as shown by the dotted line 4237. The rigidizing layer typically allows passage of fluid (e.g., air) in the un-rigidized configuration, in some examples having sufficient space around the filaments to allow relative movement, e.g., sliding, between them. As described above, in some examples the rigidizing layer may be formed of a plurality of crossing lengths of filament (the same filament or multiple filaments), such as a braid, knit, woven, tendons or chopped segments, randomly distributed or randomly oriented filaments or strands. Alternatively or additionally the rigidizing layer may include a plurality of engagers, links, scales, plates, segments, particles, granules, crossing filaments, tendons, or other materialsforming the rigidizing layer. See, e.g., PCTUS2023071543, herein incorporated by reference in its entirety. As mentioned, the second (P2) port 3929 is in fluid communication with the rigidizing layer 4216 and / or the region holding the rigidizing layer, as shown in FIGS. 42B- 42C. The rigidizing layer may form the P2 region 4252 and may generally be positioned between the bladder layer 4247 and the outer support layer 4245. When inserting the endoscope into the lumen of the rigidizing endoscope shield assembly, the P2 port may also be used to apply negative pressure (vacuum) during installation in order to assist in increasing the inner diameter of the lumen, making it significantly easier to insert the endoscope into the lumen. This may also mildly rigidize the rigidizing endoscope shield assembly, which may also make insertion of the endoscope more stable and easier. During operation of the transiently converted rigidizing endoscope, the P2 port may be used to apply negative pressure to assist in rigidizing the apparatus (e.g., converting from a more flexible to a less flexible state), so that the system rigidizes with both positive pressure and negative pressure in different regions, simultaneously applied.

[0350] The transiently converted rigidizing endoscope apparatuses described herein may also include a third port, P3, at the proximal end (proximal to the proximal attachment) that is in fluid communication with the lumen 4220 of the inner shield 3917 (an additional port, e.g., P3’, may be used for each inner shield to access the lumen). In the example shown in FIGS. 42A-42C, this lumen may be an irrigation lumen 4235, in communication with a deflector 4228 at the cap 4227. In this example an additional port, P3’ is in fluid communication (as shown by dashed line 4242 with the working channel lumen 4224).

[0351] The apparatus may also include a fourth pressure port, P4, 4234 in fluid communication (as shown by the dash-dot line 4238) with the region 4254 between the endoscope’s outer surface and the bladder layer 4247 forming the inner diameter of the lumen of the rigidizing endoscope shield assembly. This region may be referred to as the P4 region. In some examples this region may be sealed and may be used to apply positive pressure, e.g., to rigidize the assembled transiently converted rigidizing endoscope. This may be particularly helpful when the bladder layer is a single layer, rather than an out-and-back structure. Alternatively, in some examples the P4 region 2554 may be vented, e.g., to air; during rigidization of the apparatus the P4 port may be open to atmosphere. Like other regions, this could also be a driven plenum, i.e., actively supplied with either positive or negative pressure. This, coupled to the other pressure ports being utilized, could prove to be advantageous for transitioning between states as we look to optimize speed of inflation and deflation.

[0352] FIGS. 43A-43B illustrate another example of a rigidizing endoscope shield assembly 4300. FIG. 43A shows an example of a distal portion (including the distal endregion) of the rigidizing endoscope shield assembly, without an endoscope inserted. The distal end of the rigidizing endoscope shield assembly includes a cap 4327 that seals the distal end of the inner lumen formed by the outer shield 4302. A pair of inner shields 4315, 4317 extend through the lumen 4390. Each of these inner shields includes a lumen as well, that is fluidly connected through the cap to the region of the rigidizing endoscope shield assembly distal to the cap. For example, the working channel inner shield 4317 includes a working channel lumen 4324 that is open through the cap 4327, and the irrigation channel shield 4315 includes an irrigation channel lumen 4335 that opens through the cap 4327 at a deflector 4328.

[0353] The outer shield 4302 in this example is formed for a plurality of cylindrical layers, including an outer support layer 4345, a rigidizing layer 4316, and a bladder layer 4347. FIG. 43B shows a section through the rigidizing endoscope shield assembly at B in FIG. 43 A, showing the layers (not necessarily shown to scale) forming the outer shield, the lumen 4355 formed by the outer shield 4302 and the two inner shields 4315, 4317 extending within this lumen. The layers are shown in greater detail for region 4320 in FIGS. 43C and alternative construction 43D. The layers in this example forming the outer shield include an outer reinforced support layer 4345, which may include reinforcing members 4346, such as a reinforcing coil (show in cross-section in FIGS. 43C and 43D), and a rigidizing layer 4316, and a bladder layer 4347.

[0354] The cylindrical outer support layer 4345 may be an external surface of the device, against which the rigidizing layer and / or bladder layer (e.g. compression layer) may contact. The outer region may be formed of a material having a durometer, e.g., of between about 50A on the Shore A scale and 80D on the Shore D scale, and may include a reinforcing material, such a ring, coil, wire, ribbon, etc. In some examples the reinforcing material (reinforcement) comprises a wound coil (e.g., wire, ribbon, filament, etc.). The reinforcement 4346 may be helically wound around the tube, and in some examples may be referred to as a radially reinforcing member. The reinforcing material (e.g., wound coil) may be between embedded within the outer support layer. In some examples the reinforcement is a coil; one or more coils may be used. In some examples a wound coil reinforcement is laminated within the layer. In any of these examples, the bladder layer (also referred to herein as a compression layer) may be configured to push the rigidizing layer against the inner surface of the outer support layer when pressure (e.g., positive pressure) is applied to rigidize the apparatus.

[0355] The rigidizing layer 4316 may correspond to any of those described above. For example, the rigidizing layer 4316 may comprise a plurality of filament lengths crossing over and under each other and configured shear relative to each other.

[0356] The bladder layer 4347, which may be referred to herein as a compression layer, may comprise an elastomeric material, or in some cases a non-elastomeric material (for example, polyethylene, nylon, or PET). In some cases, particularly when using a non- elastomeric material, the bladder layer 4347 may be oversized relative to the radial diameter and length. Oversizing the bladder layer may allow it to expand / collapse when positive and / or negative pressure is applied and while bending.

[0357] In some examples the bladder layer 4347 is a single layer, as shown in FIG. 43C, showing an example of an enlarged view of the region 4320 of FIG. 43B. In this example, bladder layer forms the inner surface of the lumen 4355 into which the endoscope is to be inserted. Alternatively, in some cases the bladder layer may have two (or more) layers, such as when the bladder layer (compression layer) 4347’ is formed as an out-and-back cylindrical layer. The region between the two layers may be used to apply positive and / or negative pressure, e.g., to modulate the rigidity of the apparatus.

[0358] FIGS. 43E and 43F-G illustrate the apparatus of FIGS. 43A-43B with an endoscope engaged, e.g., inserted within the lumen 4355 formed by the outer shield. In FIG. 43E, the endoscope 4301 is shown in section surrounded on the outside by the outer shield, including the outer support layer 4345, rigi dizing layer 4316, and bladder layer 4347. The endoscope includes a first inner lumen 4313 into which the first inner shield 4315 is inserted, and a second inner lumen 4314, into which the second inner shield 4317 is inserted. Thus, the first inner lumen 4335 of the first inner shield 4115 may shield and replace the first inner lumen of the endoscope 4313 and the inner lumen 4324 of the second inner shield 4317 may shield and replace the second lumen 4314 of the endoscope (e.g., fluid channel). The endoscope may also include one or more internal structures 4306 extending through the endoscope, such as channel s / lumen for pull wires, lights, camera lines, fiber optic lines, etc.

[0359] Once inserted, there may be a relatively tight clearance between the inner diameter (e.g., the bladder layer) and the endoscope 4301; in FIG. 43E this gap 4356 may be very tight unless pressure (e.g., negative pressure) is applied within the outer shield in order to enlarge the inner diameter. As described above, negative pressure may be applied within the bladder layer (e.g., when a two-layer bladder, such as an out-and-back bladder layer), and / or within the rigidizing layer, e.g., the region between the outer support layer and the bladder layer.

[0360] FIGS. 43F and 43G are enlarged views of a portion 4320’ of the section shown in FIG. 43E through the transiently converted rigidizing endoscope apparatus, in which an endoscope 4301 is engaged with the rigidizing endoscope shield assembly, as described above. In FIG. 43F, the transiently converted rigidizing endoscope apparatus is shown in aflexible configuration, in which the strand lengths forming the rigi dizing layer 4316 may freely slide / shear over each other, the bladder layer 4347, and outer layer 4345. The bladder layer 4347 in this example is a single layer. The outer edge of the endoscope wall 4301 is shown relatively close to the bladder layer, but separated by a small gap 4356. In FIG. 43 G, pressure is applied to compress the bladder layer 4347 against the rigi dizing layer 4316’ resulting in compression of the rigi dizing layer, restricting the sliding / shear movement of the rigidizing layer relative to the bladder layer 4347 and the outer support layer 4345, and converting the apparatus from a flexible to a less flexible (e.g., rigid) configuration. The greater the absolute pressure differential applied, the more rigid the resulting apparatus may be. This may be accomplished as described above, by applying positive pressure into the gap / lumen 4356 (enlarging this gap region 4356’ as shown in FIG. 43G) and / or by applying a negative pressure within the rigidizing layer 4316’ to pull the bladder layer 4347’ against the rigidizing layer and the outer support layer 4345.

[0361] FIGS. 43H and 431 illustrate an alternative example in which the bladder layer 4347’ is a dual-layer bladder (as described in FIG. 43D), also referred to as an out-and-back bladder configuration. In this example, in the flexible (more flexible) configuration, shown in FIG. 43H, no pressure differential is being applied, and the rigidizing layer 4316 is not compressed, so that the lengths of filaments forming the rigidizing layer 4316 may freely slide / shear over each other, may slide relative to the bladder layer 4347, and may slide relative to the reinforced outer layer 4345. The outer edge of the endoscope wall 4301 is shown separated from the bladder layer by a slight gap 4356. In FIG. 431, pressure is applied to compress the rigidizing layer 4316’ resulting, restricting the sliding / shear movement of the lengths of filament forming the rigidizing layer. With the out-and-back bladder layer shown, this may be accomplished by applying positive pressure between the two layers forming the bladder, expanding the bladder layer(s) against the rigidizing layer and the outer surface of the endoscope 4301, eliminating the gap region. Alternatively or additionally, this may be accomplished by applying a negative pressure within the rigidizing layer 4316’ to pull the bladder layer 4347’ against the rigidizing layer and the outer support layer 4345.Improved optics

[0362] In general, any of these apparatuses may include cap that is configured to engage with the optics at the distal end of the endoscope. The optics may include one or more cameras, and / or one or more light sources. However, it may be particularly challenging to provide optics that permit the transmission of light without introducing distortions, glare and other optical degradation of the signal, particularly when coupling the endoscope behind thecap of the shield (e.g., the rigidizing endoscope shield assembly cap). For example, as the apparatus moves through the body, and as the flexibility of the apparatus is modulated, if the distal end region of the endoscope moves even slightly relative to the cap, the resulting transmission path of the optics may change, altering the image quality. In addition, the additional optical path through the cap may result in reflection and diffusion, even when using optically transparent material. Thus, the apparatuses described herein may be configured to minimize or eliminate reflection, glare and other optical problems that may result when mating a cap of the rigidizing endoscope shield assembly to the endoscope. Additionally, should the light sources pass through the cap material, and into the clear window ahead of the camera, the camera’s functionality will be impeded.

[0363] In addition, it may be particularly beneficial to limit the optically transparent regions of the cap in order to enhance the material properties of the cap. For example, FIGS. 44A-44F illustrate one example of a cap for a rigidizing endoscope shield assembly in which the cap is formed by interlocking optically transparent regions (FIGS. 44A and 44C) and light blocking regions (FIGS. 44B and 44D) so that the light blocking regions may separate the transparent regions. In other embodiments, the optically transparent regions (in this case, four: three for lighting and one for a camera) may be isolated individually or in paired sets or not in one contiguous piece, unlike the version shown.

[0364] In FIGS. 44A-44F, the cap may be part of an external shield apparatus for an endoscope including an elongate external shield body configured to be transitioned from a flexible configuration to a less flexible configuration by modulation of pressure within the external shield, and a lumen extending within the external shield to receive the endoscope. The distal cap may cover the distal end of the external shield and the lumen, and the distal cap may be configured to couple a distal end of the external shield to a distal end the endoscope. In general, the cap may comprise one or more transparent regions forming a unitary transparent piece that is interlocking with a unitary light-bocking piece so that a majority of transparent regions are at least partially surrounded by light-blocking regions.

[0365] For example, in FIG. 44Athe unitary transparent piece 4470 includes a plurality of window regions that extend up from a frame 4471 and form flat surfaces that may be polished to a high degree to transmit light. Each window region may be configured to match (and / or mate with) an optical component at a distal end of the endoscope, such as regions configured to be positioned over one or more lights 4472 and / or a camera 4473. The window regions are connected to the ring-shaped frame 4471 by an arm or neck region that extends up and curve inward relative to the frame. The transparent piece is configured so that the frame, windows and arms engage with cut-out regions on a light-bocking piece, such as the light-blocking piece shown in FIGS. 44B and 44D. FIG. 44A also shows two indentations 4493, 4493’ having a geometry that may impede the transmission of light, so that it is less likely to transmit through the clear material and then into the region of the camera. In this example, the portion of the frame connecting the camera window to the rest of the frame may include an indentation or bend region 4493, 4493 ’taking a turn of more than 90 degrees, making it difficult to pass light to / from the camera window portion from along the frame. The lightblocking piece 4475 is configured as a disc-shaped cap having cut-out (negative) regions 4473 or voids for receiving the windows and arms of the transparent piece. The two pieces may fit together so that the edges of the windows, and arms can be bonded against the edges of the cut-out regions. The base 4491 of the light-blocking piece of the cap may engage with, and lock into, the frame 4471 of the transparent cap piece 4470. This is illustrated in FIG. 44E, showing the combined transparent cap piece and the light-blocking cap piece. This part (as shown, this cap could be dual-shot injection molded, hermetically sealed as one unit) has construction provides numerous advantages, including maintaining a relatively low profile (e.g., thickness) while preventing reflection and glare. This construction may also be sufficiently strong and lightweight so that it does not inhibit movement of the apparatus. The light blocking piece may be light-blocking throughout its entire volume (rather than simply coated), in order to ensure that no internal reflection can occur, which may otherwise degrade the optical properties of the cap.

[0366] In general, the one or more transparent regions are configured to transmit light and may be formed of an optically clear material, such as polycarbonate. The light-blocking piece may be formed of a material that does not pass light sensed by the endoscope and may be formed of a light-absorbing material (e.g., a black material) such as black Acrylonitrile butadiene styrene (ABS). Plastics with fillers serve to retard the passage of light.

[0367] FIG. 44F illustrates the assembled cap 4427 in which two additional pieces are shown coupled, the deflector 4428 and a cap body 4439.

[0368] FIGS. 55A-55B and 56A-56C illustrate another example of a cap assembly for an endoscope shield, similar to that shown in FIGS. 44A-44F. For example, in FIG. 55 A, the cap assembly includes a transparent piece 5570 that is combined with a light-blocking piece 5575, forming distal face of the cap, that is then combined (e.g., fused) to a cap body portion 5539. The cap assembly shown in FIGS. 55A-55B includes all of the features described above, including the transparent imaging window for imaging through, as well as illumination windows. In FIGS. 55A-55B the cap assembly also includes an integrated wash port nozzle (e.g., a fluid dispenser that emits a wash fluid across the imaging window), formed in the light-blocking portion. In general, the cap must be formed to be leakproof, sothat the transparent portion 5570 is sealing fused with the light-blocking portion 5575. In addition, the materials should ideally be selected so that the optical properties of the cap do not degrade imaging by the endoscope, which must image through the cap. In some cases it may be particularly beneficial to select materials that may be compatible with forming, e.g., by micromachining, with high reliability, the cap assembly that does not require significant post-processing (e.g., polishing) and that does not leak. For example, the cap assembly may be formed by a two-shot or three-shot micromachining processes in which the first shot is the light-blocking portion 5575, which may be, for example, a first material having a fist melting temperature. The second shot, forming the optically transparent portion 5570 having a second melting temperature. It may be important to forming a sufficiently smooth imaging window that the optically transparent (imaging window) be processed as the second shot, so that the additional heat and pressure used to form the light-blocking portion does not warp or modify the optically transparent portion. It may also be critical (e.g., to forming a sufficiently smooth imaging window, as described below) that the melting temperature of the transparent material for the second shot have a melting temperature that is between 10-70 degrees lower than the melting temperature of the first shot, e.g., between about 20-60 degrees lower, between about 25-55 degrees lower, about 40 degrees lower, etc. For example, the first shot may be a lightblocking (e.g., black) polycarbonate material having a melting temperature of between about 280-300 degrees C, while the second shot may be a clear PMMA (acrylic) material with a melt temperature of between about 210-240 degrees C. This differential may allow the second shot to bond to the first shot material without melting the first shot material and warping or modifying either piece. In examples formed by a third molding “shot” (e.g., a third shot), e.g., forming the cap body portion, the material used may be a TPE. In some examples the first shot (the light-blocking injection mold) may be a high density polyethylene (HDPE) and the second (transparent / imaging window) shot may be a cyclic olefin copolymer (COC), while the third shot (the cap body portion) may be formed of an Oelfin compatible TPE. These compositions may allow heat bonding of components to the cap.

[0369] In some cases the portion of the cap forming the transparent / imaging window and / or the light-blocking portion may be formed of a polycarbonate. Although polycarbonate is more scratch resistant than other polymeric materials (and may be more optically clear, and have less color distortion), it is substantially more difficult to form a seal when bonding to other materials. However, by controlling the melting point (including by adding one or more additives) so that the different injected molded components are within the predetermined temperature ranges mentioned above for melting points, and by controlling the pressure andtemperature when micro-molding, these materials may be sealed by fusing at the edges (edge / butt to edge / butt).

[0370] It may be particularly advantageous to the cap of the shield that the optical window, through which the endoscope camera images, be free of optical defects and prevent distortion. In particular, it may be particularly advantageous that at least the optical window portion of the cap have a smoothness that is less than one wavefront distortion at 633 nm, e.g., on both the inner and outer surfaces of the window should have a deviation from the flat plane of less than 0.7 microns (e.g., 0.7 microns or less, 0.6 microns or less, 0.5 microns or less, 0.4 microns or less, 0.3 microns or less, 0.25 microns or less, 0.2 microns or less, between about 0.1 to 0.7 microns, between about 0.2 to 0.6 microns, between about 0.1 to 0.5 microns, etc.). In particular, both the inner and outer surfaces should be substantially flat and parallel to each other. In manufacturing these caps, the smoothness may be achieved without requiring polishing, e.g., by controlling the pressure and temperature during micro-molding. Thus, and of these shield distal caps may include an imaging window portion that is substantially flat (both internal and external surfaces of the window) with less than a 0.7 micron deviation from a substantially flat plane. This may prevent or avoid distortion. In some cases the light emitting transparent region of the cap are less critical, and may have a surface that is less regular (e.g., less flat).

[0371] FIG. 56A shows an example of a transparent region (e.g., transparent piece or portion, which may be injection molded second to fuse with the light-blocking portion) of the cap as described above in reference to FIG. 55A-55B. The transparent region 5670 includes a viewing window region 5673 that is configured to align with a camera of an endoscope when the shield is engaged with an endoscope. The transparent region includes an inner surface and an outer surface. The outer surface of the transparent region may be formed (e.g., by injection micro-molding) to have both inner and outer surfaces that vary from a flat plane by less than 0.7 microns. This is illustrated in FIG. 56B, showing a shape profile 5601 for a virtual slide through the transparent viewing window region 5673. In FIG. 56B the profile shows the deviation of the surface over the viewing region (between about 100 um and 300 um is less than 0.7 (e.g., between 0.4 and -0.2, or about 0.6 microns in absolute distance). FIG. 56C shows a heat map representing the change in the surface over the entire region of the transparent piece including the window. As shown, although some defects may be present, in general, and particularly over the viewing window region, the surface is substantially flat, having a deviation from the flat plane of less than 0.7 microns.

[0372] Any of these apparatuses may be configured to bias the one or more windows on the cap against a corresponding optical component on the distal end of the endoscope, and / orto maintain a constant distance between the window(s) and the corresponding optical components on the endoscope. Thus, any of the caps described herein may be configured with a biasing element, such as spring and / or elastomeric material that is configured to apply an axial force to secure the cap to the endoscope. For example, any of these apparatuses may be configured so that the apparatus is axially pre-loaded when the cap of the rigidizing endoscope shield assembly engaged with the distal end of the endoscope. Pre-loading may be achieved by placing a biasing element, including in some case and elastomeric coupling, under tension when coupling the cap to the endoscope, for example.

[0373] Thus, an external shield apparatus for an endoscope (e.g., a rigidizing endoscope shield assembly) may include an elongate external shield body configured to be transitioned from a flexible configuration to a less flexible configuration by modulation of pressure within the external shield; a lumen extending within the external shield; and a distal cap covering the distal end of the external shield and the lumen, wherein the distal cap is configured to couple a distal end of the external shield to a distal end the endoscope, the distal cap comprising an elastomeric coupling that is configured such that a tensile load applied to the elastomeric element applies an axially compressive force when the distal cap is coupled to the distal end of the endoscope to hold an imaging window of the distal cap at a relatively constant distance from an imaging sensor of the endoscope. The elastomeric coupling may be an elastomeric link. In some examples the cap may include one or more laches that lock in or maintain the bias. For example, the apparatus may include a latch on the distal cap that is configured to releasably secure the distal cap to the distal end of the endoscope. For example, the apparatus may include a latch on the more proximal region of the distal cap that is configured to releasably secure the distal cap to the distal end of the endoscope. The elastomeric coupling (e.g., elastomeric link, elastomeric layer, etc.) may comprise an annular layer between a distal end region of the distal cap and a more proximal region of the distal cap.

[0374] In general, the apparatus may be configured to secure the cap, and particularly the windows on the cap, close up against the end of the endoscope. As mentioned, if the cap moves relative to the end of the endoscope, including separating from it axially, even a few thousandths of an inch, the imaging and lighting for the endoscope may be adversely effected. FIGS. 45A-45D illustrate one example of a cap that includes a bias, configured as an elastomeric coupler configured as a built-in elastomeric layer, which is configured to provide an axial pre-load holding the cap against the distal end of the endoscope, which may pull the cap against the endoscope tip.

[0375] FIG. 45 A shows a perspective view of the back of the cap assembly of FIG. 44E, showing an elastomeric link 4558 (forming a sealing surface similar to the utility of an o-ring) that is overmolded to the inner diameter (ID) of distal end cap assembly 4537. FIG. 45B shows a side view of the elastomeric link 4558 (configured as an o-ring in this example) that is coupled to the inner portion of the distal cap assembly 4537. The cap body portion 4539 which may connect to the endoscope may be coupled to the distal cap assembly 4537. Thus, the distal cap assembly may be connected to the cap body (and therefore to the endoscope) through the elastomeric coupling, as illustrated in FIGS. 45C and 45D. In this example, the elastomer forming the bias (the elastomeric link) 4558 is thermally bonded to the proximal portion of cap (cap body 4539) creating hermetic seal 4562. The unbonded portion of elastomer may allow for slight elongation to provide tolerance between distal face of endoscope and the inner diameter of the cap 4527. As shown in FIG. 45D, the elastomeric coupling is bonded between the assembled cap 4537, where it may be attached at an overmolded region 4565 and thermally bonded 4562 to the proximal portion of the cap body 4539 while leaving an elastic elongation region 4564 of the elastic layer 4558 that may be tensioned when the distal end of the endoscope is driven against the inner face of the distal cap assembly 4537 and a more proximate portion of the endoscope engages with a latch 4544 on the cap body portion 4539. Latch features may be toggled from male to female features on either the scope or the cap, provided that the solution provides a matched interfacing set. The elastic elongate region 4564 may stretch or contract as when the cap is engaged with the endoscope. In FIG. 45D the latch is shown as a ramp-shaped latch that is oriented so that a complementary latch region on the distal end region of the endoscope may slide up the ramp (deforming radially inward somewhat and / or deforming the ramp region radially outward slightly) until it engaged with the distal side of the latch. This is illustrated in FIGS. 46A- 46D.

[0376] For example, FIG. 46A shows the distal end of the rigidizing endoscope shield assembly including the cap 4665 engaging with a distal end region of an endoscope 4663. In this case, the outer shield has been made transparent (shown by dashed lines 4602). The distal end region of the endoscope includes a latch mating region 4661 that is complementary to the inner latch 4662 formed on the cap body of the rigidizing endoscope shield assembly. In FIG. 46Athe distal end of the endoscope 4663 has been inserted into the rigidizing endoscope shield assembly from a proximal end of the rigidizing endoscope shield assembly and the two inner shields 4615, 4617 are inserted in through the lumen of the endoscope, which holds the aligned position between the latch mating region and the latch on the cap. FIG. 46B shows the endoscope advancing further towards the cap. In FIG. 46C (also shown in sectional view in FIG. 46D), the cap 4665 has flexed over the endoscope 4663, and the latch on the cap body 4662 may engage with the latch mating portion 4661 of the distal end of the endoscopecompressing the distal end of the endoscope against the distal cap region until the latch engages the mating portion and the force driving the cap together against the distal end of the endoscope may be released, resulting in the compression force holding the cap against the distal end of the endoscope. This compression may compress the elastomeric coupling (e.g., the elastomeric link / o-ring shown in FIGS. 45A-45C). Thus, the cap distal end region is maintained under a preloaded compression relative to the distal end of the endoscope, which may maintain the fixed relationship between the optical components of the endoscope (e.g., camera, lights, etc.), and the complimentary window regions covering them in the cap. The elastomeric link may be configured to stretch when the distal cap is coupled to the distal end of the endoscope to apply the axially compressive force.

[0377] Other types of biases may be used to maintain the pre-loaded bias, including, e.g. springs, etc.

[0378] In any of these apparatuses described herein one or more separate elastomeric gaskets may be included in addition to the elastomeric coupling described above. For example, an of these apparatuses may include an elastomeric gasket that is configured to seal the distal end cap to the distal end of the endoscope.Assembling the transiently converted rigidizing endoscope

[0379] Also described herein are methods of combining any of the shield apparatuses (e.g., rigidizing endoscope shield assemblies) with an endoscope, which may be performed as a field deployment, e.g., immediately before or during a medical procedure. FIGS. 47A-47D illustrate one example of a method of field deploying the apparatus. In FIG. 47A an endoscope 4701, having an elongate endoscope body extending from a base (e.g., handle) region 4008 is shown. The endoscope includes a first lumen 4005 and a second lumen 4007, optionally shown as extending proximally from the handle region 4008. The endoscope may be combined with the rigidizing endoscope shield assembly 4700 configured as any of the shield assembly devices described above. In FIG. 47A the rigidizing endoscope shield assembly includes an elongate shield body 3902 coupled to a cap region 4127 extending proximally to a proximal attachment region 3920.

[0380] FIGS. 47B-47C show intermediate configurations as the endoscope is drawn into the lumen of the rigidizing endoscope shield assembly. In general, the methods described herein for loading the endoscope into the lumen configured to receive the endoscope may include applying pressure (e.g., negative pressure / vacuum) to increase the inner diameter as mentioned above, e.g., to draw the bladder layer outwards, towards the outer diameter. In addition, in any of these methods and apparatuses, the lumen formed by the bladder within the rigidizing endoscope shield assembly may be configured to more easily accommodate therelative install and removal sliding of the endoscope. In some examples the endoscope has surface elements that enable improved sliding or, alternatively, in other embodiments the inner diameter of the lumen may be coated with one or more coating materials, e.g., hydrophilic coating, hydrophobic coating, lubricious coating, etc.

[0381] Thus, in general between steps 47A-47D, negative pressure may be applied to the rigidizing endoscope shield assembly, e.g., through port 4734, as the endoscope is slid 4733 into the rigidizing endoscope shield assembly lumen (e.g., the lumen formed by the outer shield. Once, as shown in FIG. 47D, the proximal end of the endoscope is engaged with the proximal attachment 3920 of the rigidizing endoscope shield assembly and the distal end cap of the rigidizing endoscope shield assembly in engaged with the distal end of the endoscope, as shown in FIGS. 46A-46C and in additional detail in FIGS. 48A-48C. FIGS. 48A and 48B show the distal end region of the endoscope 4001 (FIG. 48 A) and the distal end region of the rigidizing endoscope shield assembly 3901 (FIG. 48B) prior to engagement between the two. The rigidizing endoscope shield assembly may include a latch as described above, that may engage with the endoscope, as illustrated in FIG. 48C, showing the distal end region of the endoscope held under a compressive pre-load with the cap of the rigidizing endoscope shield assembly (the latch is not shown in this example).

[0382] The pre-load is illustrated in FIGS. 49A-49B, which compares a cap that is initially not preloaded (FIG. 49A), to the same cap when engaged with the endoscope so that the elastomeric coupler is preloaded (FIG. 49B).

[0383] In FIG. 49Athe cap 4927 includes a cap body 4939 having a latch 4972. In this example the cap includes an elastomeric coupling, comprising an elastomeric link 4958 (e.g., forming an elastomeric gasket or o-ring) that is configured to receive an axial preload when the cap is coupled to the endoscope, as shown in FIG. 49B. In FIG. 49Athe latch 4972 is not engaged with a latch receiving region 4976 on the endoscope body. The elastomeric link 4985 is not tensioned, and has a first (un-tensioned) length 4964. The distance between the cap 4927 and the distal end face of the endoscope 4971 may therefore vary slightly, particularly as the device is bent along the length of the endoscope. This may result in unreliable or poor quality imaging, as it may introduce reflections and optical distortion between the optical regions of the cap and the endoscope within the cap. In FIG. 49B the cap distance between the cap and the endoscope may be very strictly maintained by applying tension from the elastomeric link 4958, such that there is constant (e.g., no gap or a very small gap) between the inside of the cap 4971 and the distal end of the endoscope. In this example the cap 4927 is latched to the distal end region of the endoscope. The latch may have very low tolerance in the axial dimension (e.g., proximal-to-distal).

[0384] For example, in FIG. 49B, as in FIG. 49A, the cap 4927 includes a distal cap portion 4937 is connected to the elastomeric link 4958’ to the cap body 4939. When the latch of the cap 4972 is engaged against the latch receiving region 4976 of the endoscope, the elastomeric link 4958 is stretched and held under tension, so that the length of the elastomeric region 4964’ is longer. Because the elastomeric link (forming the elastomeric coupling) 4958’ allows for axial compliance, the tolerances between the cap and the endoscope do not need to be as precise, and the pre-biased force between the cap and the endoscope may better maintain the precise separation of the cap relative to the endoscope.

[0385] Thus, any of the shield apparatuses described herein may be configured to maintain a more precise separation between the transparent surface of the cap of the shield apparatus and the camera of an endoscope by including an element to maintain an axial compressive force between the distal end region of the cap and the distal end of the endoscope, such as but not limited to a cap including an elastomeric link. For example, the shield shown in FIGS. 49A-49B includes an elongate external shield body (shown as dashed line 4930) configured to be transitioned from a flexible configuration to a less flexible configuration by modulation of pressure within the external shield, a lumen extending within the external shield (e.g., configured to receive the endoscope, as shown); a distal cap 4927 covering the distal end of the external shield and the lumen, wherein the distal cap comprises a distal end region 4937, a proximal cap body region 4939, and an elastomeric link 4958 coupling the distal end region to the proximal cap body region; and one or more latches 4972 on the proximal cap body region configured to secure the distal end region against a distal end of the endoscope by applying an axially compressive force between the distal end region and the distal end of the endoscope when the distal cap is latched to the distal end of the endoscope, so as to hold an imaging window of the distal cap at a relatively constant distance from an imaging sensor of the endoscope.

[0386] The elastomeric link may be configured to stretch when the distal cap is coupled to the distal end of the endoscope to apply the axially compressive force, as described above. In some cases the elastomeric link is a cylindrical or ring-shaped region of the cap. The distal end region, proximal cap body region and elastomeric link may be formed as a single, e.g., integrated piece. In some case the elastomeric link may be bonded to the distal end region and the proximal cap body region.

[0387] In general, the elastomeric link may be configured to apply an axially compressive force holding the cap to the distal end of the endoscope. The cap and / or elastomeric link may be specifically configured to maintain a predetermined range of compressive force that holds the cap in place without damaging either the endoscope or cap, while maintaining sufficientforce to prevent relative movement between the cap and the endoscope that may negatively impact the optical properties of the endoscope imaging. For example, in some cases the cap (e.g., the elastomeric link) may be configured to apply an axially compressive force of about 0.5 pounds of force or greater (e.g., about 0.75 pounds of force or greater, about 1.25 pounds of force or greater, about 1.5 pounds of force or greater, about 1.75 pounds of force or greater, about 2 pounds of force greater, about 2.25 pounds of force greater, about 2.5 pounds of force greater, about, between about 0.25 and 4 pounds of force, between about 1 pound of force and 3.5 pounds of force, between about 1.25 pounds of force and 3.25 pounds of force, between about 1.5 pounds of force and 3 pounds of force, etc.).

[0388] In practice the distal end of the apparatus may be similar to that shown in FIG. 50A, showing the optical components of the endoscope held in tight alignment with the windows of the assembled cap. The windows through the assembled cap 5027 are tracked over the optical components (e.g., camera 5073 input, and light outputs 5072). The distal end of the assembly may also include one or more inlets / outlets. In FIG. 50Athe distal end of the apparatus includes a fluid displacer 5020 (e.g., nozzle) as well as an opening into a working channel.

[0389] FIG. 50B shows a perspective view of a proximal end region of the assembly, showing that the proximal base of the endoscope is engaged with the proximal end of the rigidizing endoscope shield assembly. The first 4005 and second 4007 internal lumen of the endoscope may have received the first inner shield 3915 and second inner shield 3917, respectively. As mentioned, the proximal handle 4008 of the apparatus may be coupled with the proximal attachment 3920 of the rigidizing endoscope shield assembly.Protection of the proximal ends of the Inner Shield

[0390] As mentioned, these apparatuses may include applying multiple disposable rigidizing endoscope shield assemblies over the same, durable / reusable endoscope. Although coverage of the endoscope by the rigidizing endoscope shield assembly may prevent contamination, there remains a risk of cross-contamination when inserting one or more inner shields through the lumen of the endoscope. For example, contamination within the inner channel(s) of the endoscope may occur when withdrawing the rigidizing endoscope shield assembly from the endoscope, in which any contamination on the distal ends of the inner shields may be spread to the lumen of the endoscope, which may, in turn, contaminate a new (e.g., clean) rigidizing endoscope shield assembly, including within the lumen of the otherwise-open internal shield(s) when attaching the rigidizing endoscope shield assembly to the endoscope.

[0391] Thus, it may be safer to reduce even this low-risk contamination by removable occluding or blocking the proximal end of the inner shield(s) with a removable member. In some cases the removable member may be or include a plug or other occlusive body that may be secured to the proximal end of the inner shield. For example, in some cases the cover may be a pull-away sealing cap that may be frangibly sealed. The sealing cap or plug may have a sufficiently low profile so that it is able to pass through the lumen of the endoscope. In any of these examples the sealing cap may be configured to have an outer diameter that is less than the inner diameter of the endoscope lumen; in some case the outer diameter of the sealing cap may be approximately the same as the outer diameter of the inner shield.

[0392] FIG. 51 A shows a first example of a frangible sealing cap, configured with one or more tabs (e.g. pull tabs 5118) extending proximally from the inner shield that may be inserted through the lumen of the endoscope, and once through, may be removed by pulling distally 5114 causing the sealing region to detach from the end 5114 of the inner shield. FIG. 5 IB shows a section through a region (B) of the example shown in FIG. 51 A. In the section shown, the walls of the inner shield may be scored 5119 to provide detachment of the breakaway portion. This pulling or removal motion - backwards, away from the end that is being opened - is similar to how a sealed sterile pouch is removed, while maintaining sterility of the devices withing the pouch.

[0393] In any of these apparatuses the removable seal may include one or more pullwires, strings, etc. that may include a gripping region (e.g., ball, handle, etc.) on one end to assist in pulling. This may allow the user to pull the pull wire to unseal the proximal end of the apparatus.

[0394] FIGS. 52A-52D show additional examples of removable seals (e.g., plugs) at the proximal ends of the inner shield(s) that are configured to be removed once inserted through the lumen of the endoscope. In FIG. 52 A a removable plug 5236 occludes the proximal end of the inner shield 5232 and may be removed by pulling the plug out / off of the end of the inner shield. In some cases, as shown in FIG. 52B, the end of the inner shield 5232 may be pre-sealed 5231, and a tool (e.g., cutter 5233, such as a knife, etc. may simply cut the inner shield distal to the sealed region. The inner shield may be sealed by crimping, by melting (e.g., thermal sealing), buy blocking with a polymeric material (e.g., glue, etc.), or the like. In general, the outside surface of the inner shield proximal end may be cleaned (e.g., wiped) prior to removing the removable seal.

[0395] FIG. 52C shows an example in which the proximal end of the inner shield is occluded by a cover 5235 that may be removed. The cover (as in the plug example in FIG. 52A) may be adhesively secured over the proximal end, and may be pulled off. In FIG. 52Dthe seal comprises a tear-away seal 5239 including a split-off cover 5238 that may be removed by pulling opposite sides of the cover to split it and peel it off of the end of the inner shield.

[0396] FIGS. 53A-53B illustrate another example of a removable seal covering the distal end region of the inner shield. In this example the shield may include one or more side / lateral openings 5241 that may be occluded using a wrapping cover 5243 that may be peeled off of the end of the inner shield 5232. FIG. 53B shows a side view of the wrapping cover 5243 indicating the direction that the peel-off cover may be pulled 5244 to remove it from the inner shield.Example

[0397] The shields herein may include any of the features described above, including the various bladder layer configurations (e.g., out-and-back bladders, bladders configured to directly contact the endoscope, etc.), cap configurations (e.g., tensioning / axially compressive force applying, distortion-minimizing windows, leak-free, etc.). FIGS. 57A-57E show an example of a shield apparatus including many of these features.

[0398] FIG. 57A shows an example of a rigi dizing shield 5701 that is configured to couple to an endoscope to convert the endoscope into a rigidizing endoscope. In FIG. 57A the rigi dizing shield 5701 includes an elongate body, a distal cap 5705 at the distal end, and a proximal handle 5709 having a venting port 5713 and a pressure port 5711. The pressure port may be used to apply pressure (positive and / or negative pressure) between layers forming the rigidizing shield. Similarly, the vent 5713 (venting port) may be used to passively (by applying suction) or actively (by applying negative pressure) vent another region between layers forming the rigidizing shield. The roles of the pressure port and venting port may be switched, applying negative pressure to the pressure port 5711 and positive pressure to the venting port 5713.

[0399] In general, the rigidizing shield 5701 may rigidize with the application of positive and / or negative pressure between two or more layers of the rigidizing shield 5701. FIG. 57B shows a section B through the rigidizing shield 5701 shown in FIG. 57B. The rigidizing shield 5701 includes an outer layer, which may be reinforced (e.g., as a coil reinforced layer), that is both highly flexible in bending but may also limit or prevent expansion radially outwards. The rigidizing shield can be coated with and / or may be formed of a lubricous material. For example an outer layer may include a lubricious material, such as, but not limited to, a hydrophilic coating. The rigidizing shield also includes an inner rigidizing layer 5727 formed of a plurality of lengths of filament that cross over each other. This layer may be a knitted, braided, and / or woven layer of material. The rigidizing shield also includes bladderlayer 5723 that may be driven against the reinforced outer layer 5721, e.g., by the application of pressure, to compress the rigidizing layer against the reinforced outer layer. In some cases the bladder layer 5723 may be an out-and-back bladder layer in which the bladder layer is doubled-back on itself to form a dual-layer structure within which pressure may be applied. FIG. 57C shows an enlarged section through the wall of the rigidizing shield 5701 shown in FIGS. 57A-57B. In FIG. 57C, the wall of the rigidizing shield 5701 includes an outer, reinforced layer 5721. In this example the reinforced layer is an outer coil-wound tube (OCWT) that includes a metallic coil 5723 within the outer layer 5721 to prevent it from expanding outwards, without significantly decreasing the flexibility of the layer and device. The outer layer coil could be comprised of other materials, including polymers and fibers. The rigidizing shield 5701 also includes a rigidizing layer 5727 between the outer, reinforced layer 5721 and a bladder layer 5723 (shown as an out-and-back, dual layer bladder with one of the layers indriven against the reinforced layer 5721 and another of the layers at the inner perimeter of the rigidizing shield 5701). The rigidizing layer may include a plurality of filaments that cross over each other (e.g., a braid) and are free to slide relative to each other when pressure is not being applied or maintained within gap regions 5725, 5725’ on either side of the rigidizing layer 5727, when the rigidizing shield 5701 is in the flexible configuration. The outer layer 5721 may include an optional coating 5761, such as a lubricous coating (e.g., hydrophilic coating) layer.

[0400] To rigidize the rigidizing shield 5701, negative pressure 5730 may be applied between the outer coil-wound tube 5721 and the bladder layer 5723, as shown in FIG. 57D. In FIG. 57E an alternative configuration is shown in which positive pressure 5731 is applied within the bladder layer 5723. The region between the bladder layer 5723 and the outer layer 5721 may be vented 5730’ (actively or passively) or negative pressure may be applied to assist in rigidizing the rigidizing shield 5701 by driving the rigidizing layer 5727 against the outer layer 5721. Optionally, in any of these examples the rigidizing shield 5701 may further include an inner reinforced layer (not shown).

[0401] The rigidizing shield 5701 may be applied over an endoscope and secured to the distal end of the endoscope by the tip region 5705; the proximal end 5709 may also be coupled to the endoscope, or to a mount to which the endoscope is attached, so that the two may move together. The tip region may be any of the tips described herein, including those that hold the tip coupled to the endoscope under axial tension, e.g., applying an axial force within the predetermined range.

[0402] The example of the rigidizing shield 5701 shown in FIGS. 57A-57E also includes a pair of internal shields 5707, 5707’, one or both of which may be a multi-lumen catheter,which are configured to be inserted through the endoscope lines (e.g., suction / vacuum line, fluid line, working channel).

[0403] As described in FIGS. 47A-47D, the shield may be coupled to an endoscope. This is further illustrated in FIGS. 58B-58C. FIG. 58A shows one example of an endoscope 5807 that may be used with any of the nested rigidizing covers described herein. The endoscope shown in FIG. 58A is steerable and is not configured to rigidize on its own. FIG. 58B shows a schematic illustration of an endoscope 5807 having an elongate body (only a portion of which is shown) and a proximal handle region as well as a distal end. The endoscope in this example includes two internal lumen, such a working channel and a fluid / aspiration channel. FIG. 58C schematically illustrates the insertion of the endoscope into the rigidizing shield 5701.

[0404] In some examples the inner surface of the lumen formed by the shield 5701 may be the out-and-back bladder and thus the bladder may be driven directly against the outer surface of the endoscope. The outer surface of the endoscope may be configured so that the bladder layer does not snag or see a high degree of freedom when the endoscope is inserted into the shield. For example, the outer surface of the endoscope may be lubricous and may be relatively smooth.Out-and-back Bladder

[0405] As described above, any of these apparatuses may include an out-and-back bladder meaning that the bladder layer may form a double layer that is inverted over itself. In some cases the bladder layer may be formed of an elastomeric material. In some cases it may be more preferable that the bladder layer is formed of a non-elastomeric material. Although it is the role of the bladder layer to expand or contract against the rigidizing layer (and therefore rigidize / make flexible the rigidizing layer), surprisingly the use of a non-elastomeric material may work particularly well and may permit rapid and robust transitions between highly rigid configurations and highly flexible configurations. As used herein a non-elastomeric material may refer to a material that does not exhibit significant elastic properties (e.g., does not return to an original shape when deformed), and may have an elastic modulus of greater than 0.1 GPa (e.g., 1 GPa or greater, 2 GPa or greater, 5 GPa or greater, 10 GPa or greater, etc.) and / or a stretch percentage (e.g., elastic elongation) of 50% or less (e.g., 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, etc.).

[0406] In general, the non-elastomeric bladder layer may comprise a plastic material. The non-elastomeric bladder layer may comprise non-elastic polymer, such as a polyamide resin, a plastomer, etc. In some cases the non-elastomeric bladder layer comprises an extrusion blown film. The non-elastic bladder layer may be formed of a polyethylene (PE) (e.g., low-density polyethylene (LDPE), high-density polyethylene (HDPE), etc.), polypropylene (PP), polystyrene (PS), ethylene vinyl acetate (EVA), ethylene vinyl alcohol (EVOH), polyvinyl chloride (PVC), polyamide (PA), polyurethane (PU), etc.

[0407] Thus, a bladder layer as described herein may be an out-and-back bladder, and may be formed as illustrated in FIGS. 59A-59C, by inverting one end of a tubular non- elastomeric material into or over itself. In this example, the ends of a tube of material (e.g., a non-elastomeric material) may be coupled (welded, fused, sealed, bonded, etc.) to a pair of bladder end connectors 5931, 5932 that are configured to engage and may interlock. The first bladder end connector 5931 has a slightly smaller outer diameter than the inner diameter of the tube of non-elastomeric material forming the bladder 5934. As shown in FIG. 59A and 59B this first bladder end connector 5931 is inserted into the inner lumen of the tube of non- elastomeric material forming the bladder 5934 and moved proximally towards the second bladder end connector 5932, as shown by the arrow 5929. Once the first (inner) bladder end connector 5931 is within the second bladder end connector 5932, the two may be configured to couple together, and / or be sealed, e.g., annularly) to forma proximal bladder connector 5935 so that the region formed between the inverted layers of the tube of non-elastomeric material forms a bladder region that may be inflated / deflated through an access port 5933 which may be on the second bladder end connector 5932. Once formed, this out-and-back bladder layer 5930 may then be coupled to other components of the rigidizing shield, including the cap region 5927 (as shown in FIG. 59D), a rigidizing layer (not shown in FIG. 59D), OCWT layer, etc.Shield Proximal Handle

[0408] Also described herein are proximal ends for any of the rigidizing shields described, which may be referred to for convenience as proximal handles, but which are not necessarily for holding. These proximal handles may be proximal couplers for coupling the proximal end of the rigidizing shield to the endoscope proximal end and / or to a robotic manipulator. For example, FIGS. 60A-60D and 61A-61C illustrate examples of proximal end regions. In FIG. 60A the proximal handle includes an inner housing 6080 and an outer housing 6081. The inner housing may couple to the proximal end of the rigidizing shield 6002 (see FIG. 61 A) and may couple to the outer housing so that the access port 6083, which is in fluid communication with a region between the outer support layer of the shield (e.g., an OCWT) and the bladder, e.g., holding the rigidizing layer. This access port 6083 may be a leak path that is in fluid communication with the space between the outer support layer of the shield and the bladder, to allow collapse of this region when the bladder is activated by the application of positive and / or negative pressure. Alternatively or additionally, negativepressure may be applied to this path (‘leak path’) through the access port 6083 to pull the bladder layer against the outer support layer and / or rigidizing layer during insertion of the endoscope.

[0409] The handle may couple to a proximal handle assembly including a proximal outer housing 6091, as shown in FIGS. 60C-60D, to form the handle assembly. In FIG. 60C the inner housing 6080 and the outer housing 6081 are shown adjacent to the proximal outer housing 6091 and may sealingly engage with, and couple to, the proximal outer housing 6091 to form a handle assembly that may removably couple to an endoscope proximal end region (e.g., endoscope handle). The proximal outer housing 6091 may also include a bladder access port 6093 that is configured to couple with the inside of the out-and-back bladder. In operation negative and / or positive pressure may be applied to the bladder access port 6093 to either expand or contract the bladder. For example, in some cases, during insertion of the endoscope, the access port 6038 may be coupled to a source of negative pressure to enlarge the inner diameter and / or may be open to atmosphere (leak) when negative pressure is applied to the access port 6083 of the leak path. During operation of the rigidizing shield, positive pressure may be applied to the bladder access port 6093 to expand the bladder against the endoscope and against the rigidizing layer to rigidize the shield. FIG. 60D shows the assembled bladder handle assembly. In this example the bladder access port 6093 is shown coupled to the leak access port 6083 for storage. In practice, these ports are not typically coupled together.

[0410] FIGS. 61 A-61C schematically illustrate examples of a rigidizing shield proximal handle, similar to that shown in FIGS. 60A-60D. In FIG. 61 A the handle region is shown assembled and coupled to a handle of an endoscope 6095. FIG. 6 IB shows an example of a section through one variation of a proximal handle of a shield as described herein. In FIG. 61B, fluid pathways connect each access port (e.g., the leak port 6083) and the bladder access port (not shown in FIG. 6 IB) to the respective regions within the layers forming the shield 6002. FIG. 61C shows an example of a distal end view of the rigidizing shield, including the handle as described above, coupled to the handle of an endoscope. The two handles may be releasably locked together securely so that they move together and prevent contamination of the endoscope by the rigidizing shield.Methods of use

[0411] In general, these apparatuses may be used to convert a non-rigidizing endoscope into rigidizing endoscope. FIG. 54 schematically illustrates one example of a method of using a transiently converted rigidizing endoscope. Any of these methods may include or incorporate the methods of coupling / connecting the endoscope and the shields as describedabove. For example, a method of using a transiently converted rigi dizing endoscope may include first forming the transiently converted rigidizing endoscope by converting an endoscope into the transiently converted rigidizing endoscope. The method may include inserting an endoscope into a rigidizing shield so that a distal end region of the rigidizing shield engages with a distal end of the endoscope, to form the rigidizing endoscope (e.g., the transiently converted rigidizing endoscope) 5403. In some cases, prior to inserting the endoscope, the inner diameter of the rigidizing shield may be expanded (increased), e.g., by applying a negative pressure within the rigidizing layer and / or in some examples within the bladder layer (e.g., when a 2 layer, e.g., out-and-back bladder configuration is used) 5401.

[0412] Optionally, the method may include removing a sterile barrier (e.g. plug) covering the inner shield(s) of the rigidizing endoscope shield assembly 5405, as described above, after the inner shield(s) has / have been inserted through the endoscope. The methods may also optionally include applying negative pressure to the rigidizing endoscope shield assembly prior and / or while inserting the endoscope in order to enlarge the diameter of the endoscopereceiving lumen of the rigidizing endoscope shield assembly. The proximal end of the endoscope (e.g., the handle region) may be coupled to the rigidizing sheath 5406. The one or more ports may be coupled to the fluid and / or pressure lines 5408.

[0413] Once assembled, the transiently converted rigidizing endoscope may be manipulated within the body, including using pressure to rigidize the transiently converted rigidizing endoscope during insertion, manipulation and / or removal. For example, the method may include operating the rigidizing endoscope (e.g., transiently converted rigidizing endoscope), wherein the rigidizing endoscope is configured to be steered while advancing or withdrawing the rigidizing endoscope within a body region, further wherein operating the rigidizing endoscope comprises modulating the stiffness of the rigidizing endoscope by applying and / or releasing a pressure within the rigidizing shield 5407.

[0414] Once the transiently converted rigidizing endoscope has been positioned and / or operated within the body, it may be removed from the body and the rigidizing endoscope shield assembly safely separated from the endoscope without contaminating the endoscope. The rigidizing endoscope shield assembly may then be disposed of after disengaging the distal end region of the endoscope from the distal end region of the rigidizing shield 5409. A...

Claims

CLAIMSWhat is claimed is:

1. A shield apparatus configured to convert an endoscope into a rigi dizing endoscope, the apparatus comprising: an elongate shield body having a lumen and comprising a plurality of cylindrical layers including: an outer wall layer, a rigidizing layer and a bladder layer, wherein the bladder layer forms an exposed wall of the lumen; a cap covering the distal end of the lumen of the elongate shield body, wherein the cap is configured to couple the elongate shield body to the endoscope; a proximal attachment configured to mate with a proximal end of the endoscope, wherein the bladder layer is configured so that pressure applied to the bladder layer modulates a stiffness of the rigidizing endoscope.

2. The apparatus of claim 1, further comprising a pressure port in fluid communication with the bladder layer, through which pressure may be applied to the bladder layer.

3. The apparatus of any of claims 1-2, wherein the bladder layer comprises an out-and- back bladder layer forming a pressure-receiving chamber.

4. The apparatus of any of claims 1-3, wherein the bladder is further configured so that when the endoscope is coupled with the cap and the proximal attachment is coupled with the proximal end of the endoscope, pressure applied through a pressure port compresses a rigidizing layer so as to increase the stiffness system stiffness.

5. The apparatus of any of claims 1-4, further comprising one or more internal shields extending proximally through the lumen of the external shield from an opening through the cap.

6. The apparatus of claim 5, wherein the one or more internal shields are sealed at the proximal end region with a removable seal.

7. The apparatus of claim 5, wherein the elongate shield body is shorter than the one or more internal shields.

8. The apparatus of claim 5, wherein at least one of the one or more internal shields comprises a working channel liner having a working channel lumen.

9. The apparatus of any of claims 1-8, wherein the cap is configured to engage with a distal end of the endoscope.

10. The apparatus of any of claims 1-9, wherein the cap comprises a transparent region configured to align with a camera of the endoscope.

11. The apparatus of any of claims 1-10, wherein the cap comprises an engagement region configured to secure to the cap to the distal end of the endoscope comprising one or more of: a friction fitting, a snap fitting, a magnet, a bayonet connector, or a threaded region.

12. The apparatus of any of claims 1-11, wherein at least one of the one or more internal shields comprises a multi-lumen catheter.

13. The apparatus of any of claims 1-12, wherein the proximal attachment comprises a seal configured to seal the region between an outer surface of the endoscope and the bladder layer.

14. The apparatus of any of claims 1-13, wherein the elongate shield body is configured to form an external fluid-impermeable contamination barrier.

15. The apparatus of any of claims 1-14, wherein the cap comprises a substantially cylindrical mating surface configured to mate with a distal end of the endoscope when compressed from an oval resting cross-sectional configuration into a substantially circular mating cross-sectional configuration.

16. The apparatus of any of claims 1-15, wherein the cap comprises a wash port having an aperture that has an inner deflection surface that is angled by between about 2 and 15 degrees relative to a perpendicular plane through a long axis of a channel of the was port extending proximally, wherein the aperture has a width between 1 and 3 mm and a height of between 0.15 and 0.45 mm to provide laminar wash flow out of the aperture when a wash fluid is provided at a flow rate of between 30 and 90 mL / min through the channel.

17. The apparatus of any of claims 1-16, further comprising a sealing region at a proximal end region of the internal shield that is configured to be crimped to seal to close off the one or more internal lumens after use to prevent contamination during removal of the oner or more internal shields from within a lumen of the endoscope.

18. The apparatus of claim 17, wherein the sealing region is configured to be heat sealed and / or pressure sealed.

19. The apparatus of any of claims 1-18, wherein a lumen of the elongate shield body comprises a hydrophilic coating.

20. An external shield apparatus to make an endoscope rigidizing, the apparatus comprising: an external shield configured to be transitioned from a flexible configuration to a less flexible configuration by modulation of pressure within the external shield; a cap covering the distal end of the external shield, wherein the cap is configured to couple the external shield to the endoscope; and one or more internal shields extending proximally through the lumen of the external shield from an opening through the cap.

21. The apparatus of claim 20, wherein the one or more internal shields are sealed at the proximal end region with a removable seal.

22. The apparatus of any of claims 20-21, wherein the external shield is shorter than the one or more internal shields.

23. The apparatus of any of claims 20-22, wherein the cap is at least partially transparent.

24. The apparatus of any of claims 20-23, wherein the cap comprises a transparent region configured to align with a camera and / or a light of the endoscope.

25. The apparatus of any of claims 20-24, wherein the cap comprises a wash port having an aperture that has an inner deflection surface that is angled by between about 2 and 15 degrees relative to a perpendicular plane through a long axis of a channel of the was port extending proximally, wherein the aperture has a width between 1 and 3 mm and a height of between 0.15 and 0.45 mm to provide laminar wash flow out of theaperture when a wash fluid is provided at a flow rate of between 30 and 90 mL / min through the channel.

26. The apparatus of any of claims 20-25, wherein the cap comprises an engagement region configured to secure to the cap to the distal end of the endoscope comprising one or more of: a friction fitting, a snap fitting, a magnet, a bayonet connector, or a threaded region.

27. The apparatus of any of claims 20-26, wherein at least one of the one or more internal shields comprises a multi-lumen catheter.

28. The apparatus of any of claims 20-27, wherein at least one of the one or more internal shields comprises a working channel liner having a working channel lumen.

29. The apparatus of any of claims 20-28, further comprising a proximal attachment on the external shield configured to seal the external shield to an outer surface of the endoscope.

30. The apparatus of claim 29, wherein the proximal attachment comprises an elastic attachment.

31. The apparatus of any of claims 20-30, wherein the external shield is configured to form an external fluid-impermeable contamination barrier.

32. The apparatus of any of claims 20-31, wherein the cap comprises a substantially cylindrical mating surface configured to mate with a distal end of the endoscope when compressed from an oval resting cross-sectional configuration into a substantially circular mating cross-sectional configuration.

33. The apparatus of any of claims 20-32, wherein the one or more internal shields comprises a working channel liner configured to form an internal fluid-impermeable contamination barrier within a working channel of the endoscope.

34. The apparatus of any of claims 20-33, further comprising a sealing region at a proximal end region of the internal shield that is configured to be crimped to seal to close off the one or more internal lumens after use to prevent contamination during removal of the oner or more internal shields from within a lumen of the endoscope.

35. The apparatus of claim 34, wherein the sealing region is configured to be heat sealed and / or pressure sealed and / or adhesively sealed.

36. The apparatus of any of claims 20-35, wherein an internal lumen of the one or more internal shields comprises a hydrophilic coating.

37. The apparatus of any of claims 20-36, wherein the one or more internal shields comprises an additive within enhancing lubricity.

38. A method, the method comprising: inserting an endoscope into a rigidizing shield to form a rigidizing endoscope; operating the rigidizing endoscope, wherein the rigidizing endoscope is configured to be steered while advancing or withdrawing the rigidizing endoscope within a body region, further wherein operating the rigidizing endoscope comprises modulating the stiffness of the rigidizing endoscope by applying and / or releasing pressure within the rigidizing shield; and disposing of the rigidizing shield after disengaging the endoscope from the rigidizing shield.

39. The method of claim 38, further comprising inserting the endoscope into a second rigidizing shield to re-form the rigidizing endoscope.

40. The method of any of claims 38-39, wherein inserting the endoscope into the rigidizing shield comprises rigidly engaging the distal end region of the rigidizing shield with the distal end of the endoscope to form the rigidizing endoscope.

41. The method of any of claims 38-40, wherein the endoscope and the rigidizing shield are locked together so that they move together.

42. The method of any of claims 38-41, wherein inserting the endoscope into the rigidizing shield comprises coupling the rigidizing shield to the rigidizing shield so that the rigidizing shield forms a contamination barrier outside and inside of the endoscope.

43. The method of claim 42, wherein inserting the endoscope into the rigidizing shield comprises inserting an elongate inner shield extending from a distal end cap of the rigidizing shield through a working channel of the endoscope.- Ill -44. The method of claim 43, further comprising removing a seal occluding the proximal end region of the elongate inner shield after inserting the elongate inner shield into the working channel of the endoscope.

45. The method of any of claims 38-44, further comprising sealing a proximal end region of an inner portion rigidizing shield to prevent contamination when removing the rigidizing shield from the endoscope.

46. The method of any of claims 38-45, wherein operating the rigidizing endoscope comprises preventing contamination of the endoscope by the rigidizing shield through a plurality of barriers forming the rigidizing shield.

47. The method of any of claims 38-46, wherein the multiple barriers include an out-and- back bladder layer.

48. The method of claim 47, wherein the multiple barriers include an outer coil-wound tube (OCWT) layer.

49. The method of any of claims 38-48, wherein inserting further comprises applying negative pressure within the rigidizing shield to enlarge a lumen of the rigidizing shield that receives the endoscope.

50. The method of any of claims 38-49, wherein inserting the endoscope into the limiteduse rigidizing shield comprises inserting a reusable endoscope into a limited-use rigidizing shield.

51. A method, the method comprising: inserting a reusable endoscope into a limited-use rigidizing shield to form a rigidizing endoscope wherein the limited-use rigidizing shield forms a contamination barrier outside and inside of the reusable endoscope; and operating the rigidizing endoscope, wherein the rigidizing endoscope is configured to be steered while advancing or withdrawing the rigidizing endoscope within a body region, further wherein operating the rigidizing endoscope comprises modulating the stiffness of the rigidizing endoscope by applying and / or releasing pressure.

52. The method of claim 51, further comprising sealing a proximal end region of an inner portion rigidizing shield to prevent contamination when removing the limited-use rigidizing shield from the reusable endoscope.

53. The method of any of claims 51-52, further comprising disposing of the limited-use rigidizing shield after disengaging the distal end region of the reusable endoscope from the distal end region of the limited-use rigidizing shield.

54. The method of any of claims 51-53, further comprising inserting the reusable endoscope into a second limited-use rigidizing shield to re-form the rigidizing endoscope.

55. A method of forming a rigidizing endoscope in a clinical setting, the method comprising: inserting an endoscope into a rigidizing shield until a distal end region of the limited-use rigidizing shield engages with a distal end of the reusable endoscope to form the rigidizing endoscope, wherein the rigidizing endoscope may be rigidized by modulating pressure, further wherein the limited-use rigidizing shield forms a protective barrier over the reusable endoscope.

56. The method of claim 55, further comprising disengaging, after use, the distal end region of the endoscope from the distal end region of the rigidizing shield and removing the rigidizing shield from the endoscope.

57. The method of any of claims 55-56, further comprising inserting the endoscope into a second rigidizing shield to re-form the rigidizing endoscope.

58. The method of any of claims 55-57, wherein inserting comprises modulating pressure within the rigidizing shield while inserting endoscope into the rigidizing shield.

59. The method of claim 58, wherein modulating pressure comprises applying a negative pressure to expand a lumen of the rigidizing shield.

60. The method of any of claims 55-59, wherein inserting comprises a slip material to reduce friction between the rigidizing shield and the endoscope.

61. The method of any of claims 55-60, wherein inserting comprises a lubricant to reduce friction between the rigidizing shield and the endoscope.

62. The method of any of claims 55-61, wherein inserting comprises a powder material to reduce friction between the rigidizing shield and the endoscope.

63. The method of any of claims 55-62, wherein inserting comprises a hydrophilic coating to reduce friction between the rigidizing shield and the endoscope.

64. The method of any of claims 55-63, wherein inserting comprises assisting insertion by modulating a surface texture between the endoscope and the rigidizing shield.

65. The method of any of claims 55-64, wherein the rigidizing shield comprises one or more columnar buckling resistance layers.

66. The method of any of claims 55-65, wherein inserting comprises a low tack or ‘silky’ material to reduce friction between the rigidizing shield and the endoscope.

67. The method of claim 66, wherein the columnar buckling resistance layers are arranged in a longitudinal direction within the rigidizing shield to augment rigidization during pressurization.

68. The method of any of claims 55-67, further comprising removing a seal occluding the proximal end region of the elongate inner shield after inserting the elongate inner shield into the working channel of the endoscope.

69. An external shield apparatus to make an endoscope rigidizing, the apparatus comprising: an elongate external shield body configured to be transitioned from a flexible configuration to a less flexible configuration by modulation of pressure; a lumen extending within the external shield; an internal shield having an internal shield lumen, the internal shield extending proximally from the distal cap through the lumen of the external shield so that a distal end of the internal shield lumen is open through the distal cap; and a removable seal sealing a proximal end of the internal shield.

70. The apparatus of claim 69, wherein the removable seal comprises a plug.

71. The apparatus of any of claims 69-70, wherein the removable seal comprises a frangible seal.

72. The apparatus of any of claims 69-71, wherein the removable seal comprises a sacrificial layer.

73. The apparatus of any of claims 69-72, wherein the removable seal comprises a removable cap.

74. An external shield apparatus for an endoscope, the apparatus comprising: an elongate external shield body configured to be transitioned from a flexible configuration to a less flexible configuration by modulation of pressure; a lumen extending within the external shield; and a distal cap covering the distal end of the external shield and the lumen, wherein the distal cap is configured to couple a distal end of the external shield to a distal end the endoscope, further wherein the distal cap comprises one or more transparent regions forming a transparent piece or pieces that are interlocking with a light-bocking piece so that a majority of transparent regions are at least partially surrounded by light-blocking regions.

75. The apparatus of claim 74, wherein the one or more transparent regions are configured to transmit light.

76. The apparatus of any of claims 74-75, wherein the one or more light-bocking are configured to block transmission of light.

77. The apparatus of any of claims 74-76, wherein the light-bocking piece is a unitary light-bocking piece.

78. A rigidizing shield apparatus for an endoscope, the apparatus comprising: an elongate external shield body configured to be transitioned from a flexible configuration to a less flexible configuration by modulation of pressure within the external shield; a lumen extending within the external shield; and a distal cap covering the distal end of the external shield and the lumen, wherein the distal cap is configured to couple a distal end of the external shield to a distal end the endoscope, the distal cap comprising an elastomeric link that is configured to apply an axially compressive force between the distal cap and the distal end of the endoscope, so as to hold animaging window of the distal cap at a relatively constant distance from an imaging sensor of the endoscope.

79. The apparatus of claim 78, further comprising a latch on the distal cap that is configured to releasably secure the distal cap to the distal end of the endoscope.

80. The apparatus of any of claims 78-79, wherein the elastomeric link comprises an annular layer between a distal end region of the distal cap and a more proximal region of the distal cap.

81. The apparatus of any of claims 78-80, further comprising a latch on the more proximal region of the distal cap that is configured to releasably secure the distal cap to the distal end of the endoscope.

82. The apparatus of any of claims 78-81, further comprising an elastomeric gasket configured to seal the distal end cap to the distal end of the endoscope.

83. The apparatus of any of claims 78-82, wherein the elastomeric link comprises an elastomeric cylinder.

84. The apparatus of any of claims 78-83, wherein the imaging window comprises a transparent window.

85. The apparatus of any of claims 78-84, wherein the elastomeric link is configured to hold the imaging window against the distal end of the endoscope.

86. The apparatus of any of claims 78-85, wherein the elastomeric link is configured to stretch when the distal cap is coupled to the distal end of the endoscope to apply the axially compressive force.

87. The apparatus of any of claims 78-86, wherein the elastomeric link is configured to apply an axially compressive force of greater than 1.5 pounds of force.

88. A rigidizing shield apparatus for an endoscope, the apparatus comprising: an elongate external shield body configured to be transitioned from a flexible configuration to a less flexible configuration by modulation of pressure within the external shield; a lumen extending within the external shield; anda distal cap covering the distal end of the external shield and the lumen, wherein the distal cap comprises a distal end region, a proximal cap body region, and an elastomeric link coupling the distal end region to the proximal cap body region; and one or more latches on the proximal cap body region configured to secure the distal end region against a distal end of the endoscope by applying an axially compressive force between the distal end region and the distal end of the endoscope when the distal cap is latched to the distal end of the endoscope, so as to hold an imaging window of the distal cap at a relatively constant distance from an imaging sensor of the endoscope.

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