Hydration interface for nested endoscope

Abstract

Disclosed herein are methods and apparatuses for maintaining lubriciousness between an overtube and an endoscope within the overtube. In particular, described herein are nested systems including an overtube with a lumen, a hydrophilic coating within the lumen, and a wetting portal at a proximal end of the overtube, in which the wetting portal has an annulus formed of a compressible and porous material (e.g., sponge). The overtube may be rigidizing and / or the endoscope may be rigidizing (or a cover over the endoscope may be rigidizing). Also described herein are methods of using these apparatuses. These methods and apparatuses may be partially or fully automated, and the wetting portal may be pre-hydrated or hydrated via fluid lines.

Description

HYDRATION INTERFACE FOR NESTED ENDOSCOPEPRIORITY CLAIM

[0001] This patent application claims priority to U.S. provisional patent application no. 63 / 697,497, titled “HYDRATION INTERFACE FOR NESTED ENDOSCOPE,” and filed on September 21, 2024, and is 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] During medical procedures using an endoscope, both manual and robotic, various cables or tubing lines may be utilized to provide light, suction, fluids, insufflation or other features for navigation and visualization of the human body. Problematically, frictional forces, for example between the endoscope and an overtube nesting the endoscope, or between the endoscope and anatomy may hinder movement and dexterity of the endoscope as well as causing abrasion or shearing between interfaces involving the endoscope. Such issues may also disrupt tubing lines couple to an endoscope for delivery of fluids or pressure and may also disrupt optics, lighting, and endoscopic navigation coupled to such tubing lines.

[0004] Accordingly, there is a need for apparatuses and methods that may provide reliable and controlled hydration of nested endoscopes while avoiding fluid leakage (e.g. liquid leaking) during endoscopic or other medical procedures.SUMMARY OF THE DISCLOSURE

[0005] Described herein are methods and apparatuses for hydrating nested endoscopes during endoscopic or other medical procedures. In particular, these methods and apparatuses may be used with rigidizing apparatuses that include a rigidizing overtube and a rigidizing endoscope within the overtube; the overtube and endoscope may alternate between rigid and more flexible configurations to allow shape copying, so that a more flexible endoscope is moved against a more rigid overtube and vice versa. However, this type of movement may be much more susceptible to friction between the inner endoscope and outer overtube, as friction may make it difficult to reliably control and drive movement of the apparatus. Thus, in- 1 -SG Docket No.: 13668-738.600general these apparatuses may include a lubricous coating on either or both the inner surface of the overtube and the outer surface of the endoscope. It may be particularly beneficial to use a hydrophilic coating that may be activated by an aqueous solution (e.g., water, saline, etc.). However, too much water may interfere with operation of the system and may add complexity to the procedure and may damage the apparatus. Thus, the methods and apparatuses described herein may provide a controlled amount of aqueous solution between an overtube and endoscope in a manner that may enhance the operation while limiting the amount of aqueous fluid necessary.

[0006] For example, described herein are overtube apparatuses including a wetting surface, which may be configured as an aqueous wetting portal (which may also be referred to as a wetting lock), that applies an aqueous solution to the outside of the endoscope within the body. The wetting surface may receive fluid (e.g., liquid such as water, saline, etc.) to maintain the wetting surface in a hydrated state so that it may wet or re-wet the outer surface of the endoscope as it moves relative to the overtube. In some case the wetting surface may be limited to the proximal end. However, in any of these methods and apparatuses the wetting surface may be anywhere within the lumen of the overtube and / or on the outer surface of the endoscope). For example an annular wetting surface may be within the lumen of the overtube distal to the proximal end or more than one annular wetting surface may be present. Preferably, and without limiting the invention, the annular wetting surface may be at a proximal end of the overtube.

[0007] For example, described herein are nested systems comprising: an endoscope assembly; and an overtube having a lumen extending from a proximal end to a distal end, the overtube comprising: a lubrication port; and a wetting portal at a proximal end of the overtube in fluid communication with the lubrication port, wherein the wetting portal comprises a wetting surface formed of a compressible and porous material, further wherein the wetting surface is configured to receive the endoscope assembly therethrough so that the wetting surface applies a lubrication fluid to an outer surface of the endoscope assembly from the compressible and porous material as the endoscope assembly moves relative to the overtube.

[0008] The wetting surface may comprise an annuls. The overtube may comprise a hydrophilic coating within the lumen. In some examples the overtube is a rigidizing overtube. The endoscope assembly may be a rigidizing endoscope assembly. The endoscope assembly may be a shield (e.g., a rigidizing shield) for an endoscope and / or an endoscope. Any of these apparatuses may include a fluid line between the lubrication port and the compressible and- 2 -SG Docket No.: 13668-738.600porous material of the wetting portal. The lubrication port may be integrated into a handle of the overtube.

[0009] Any of these apparatuses may include a fluid trap around the wetting portal at a radially offset distance from the wetting surface, the fluid trap configured to receive liquid leaked by the wetting portal. In some cases the fluid trap comprises a fluid-absorbent material. The fluid trap may be (or may be configured to be) in fluidic communication with a source of suction.

[0010] In any of these examples the wetting surface of the wetting portal may comprise a wetting ring. The wetting portal may further comprise a lumen seal adjacent to the wetting surface. The lumen seal may comprise a plurality of leak openings configured to pass lubrication fluid to the wetting surface. The leak openings may comprise a plurality of radially arranged slits on the lumen seal. The compressible and porous material may comprises a sponge or a foam. The overtube may comprise a rigidizing overtube; for example, the overtube may comprise a plurality of layers including a rigidizing layer, a bladder layer and a support layer. The endoscope assembly may comprise a rigidizing shield for an endoscope and / or an endoscope.

[0011] For example, an overtube apparatus may include: an elongate flexible body having a lumen extending from a proximal end to a distal end; a hydrophilic coating within the lumen; a lubrication port on a proximal end of the overtube apparatus; a wetting portal at a proximal end of the overtube apparatus in fluid communication with the lubrication port, wherein the wetting portal comprises a compressible and porous material forming a wetting surface; wherein the wetting portal is configured to receive an endoscope assembly therethrough so that the wetting surface applies a lubrication fluid from the lubrication port to an outer surface of the endoscope assembly from the compressible and porous material as the endoscope assembly moves relative to the overtube apparatus.

[0012] Any of these apparatuses may include a fluid line in fluid communication with the compressible and porous material of the wetting portal and the lubrication port. The fluid line may be integrated into a handle of the overtube apparatus.

[0013] Any of these apparatuses may include a fluid trap at least partially around the wetting portal at a radially offset distance, the fluid trap configured to receive lubrication fluid leaked by the wetting portal. The fluid trap may comprise a fluid-absorbent material. In some cases the fluid trap is in fluidic communication with a source of suction.

[0014] The wetting portal may further comprise a lumen seal adjacent to a distal side of the compressible and porous material. The lumen seal may comprise a plurality of leak- 3 -SG Docket No.: 13668-738.600openings configured to pass lubrication fluid to the wetting surface. The compressible and porous material may comprise a sponge material or a foam material.

[0015] As mentioned, the overtube apparatus may comprise a rigidizing overtube, e.g., in some examples including a plurality of layers including a rigidizing layer, a bladder layer and a support layer.

[0016] An overtube apparatus may include: an elongate flexible body having a lumen extending from a proximal end to a distal end; a hydrophilic coating within the lumen; a wetting portal comprising a ring-shaped wetting ring at a proximal end of the overtube apparatus, wherein the wetting ring comprises a porous material having an opening and / or one or more radial slits configured to form a passage for an endoscope assembly therethrough; a lubrication port on a proximal end region of the overtube apparatus, the lubrication port in fluid communication with the ring-shaped wetting ring to wet the porous material of the ring-shaped wetting ring with a lubrication fluid; wherein the passage of the wetting ring is configured to receive an endoscope assembly therethrough and to wet an outer surface of the endoscope assembly with lubrication fluid when the endoscope assembly moves relative to the overtube apparatus.

[0017] Also described herein are methods comprising: applying a lubrication fluid to a lubrication port of an overtube to wet a wetting surface of an annular wetting portal of the overtube, wherein the wetting surface is formed of a compressible and porous material; and lubricating an outer surface of an endoscope assembly as the endoscope assembly is moved through the annular wetting portal by transferring the lubrication fluid from the wetting surface to the outer surface of the endoscope assembly.

[0018] Any of these methods may include capturing leakage from the annular wetting portal in a fluid trap at least partially surrounding the annular wetting portal. The method may include pumping the lubrication fluid through the lubrication port. Any of these methods may include maintaining a wetness of the annular wetting portal during operation of the overtube. Wetting the annular wetting portal may comprise saturating the compressible and porous material with the lubrication fluid. Applying the lubrication fluid may comprise applying saline. Any of these methods may include rigidizing the overtube to transition the overtube from a flexible configuration to a more rigid configuration by applying pressure within a plurality of layers forming the overtube.

[0019] For example, described herein are apparatuses including an overtube having: an elongate flexible body having a lumen extending from a proximal end to a distal end; a hydrophilic coating within the lumen; and a wetting portal at a proximal end of the overtube, in which the wetting portal has an annulus formed of a compressible and porous material that - 4 -SG Docket No.: 13668-738.600is configured to absorb and release liquid (e.g., sponge, hydrogel, etc.). Any of these apparatuses may include a fluid line delivering aqueous fluid into the lumen of the overtube and in particular delivering liquid to the wetting portal. In some cases the apparatus may also include a seal (which may be leaky seal, that is configured to limit, but not prevent, the passage of liquid (e.g., water) while preventing large particles (e.g., fecal matter) from passing therethrough. The seal may be referred to as a lumen seal. In some cases the seal is adjacent to the wetting portal, and the seal may comprise an annulus arranged so that the annulus of the wetting portal and the annulus of the lumen seal are configured to receive an endoscope therethrough so that the inner diameter of the seal annulus rests against an outer surface of the endoscope while the wetting portal wets the outer surface with the liquid.

[0020] As mentioned, the apparatus (e.g., overtube) may include a fluid line in communication with the compressible and porous material of the wetting portal, in which the fluid line is configured to deliver a liquid thereto. The fluid line may be integrated into a handle of the overtube. Any of these apparatuses may include a fluid trap around the wetting portal at an offset distance, the fluid trap configured to receive liquid leaked by the wetting portal. The fluid trap may comprise a fluid-absorbent material. In some cases the fluid trap is in fluidic communication with a source of suction.

[0021] For example described herein are nested systems including an overtube with a wetting surface such as a wetting portal. For example, a nested system may include: an endoscope; and an overtube having a lumen extending from a proximal end to a distal end, the overtube comprising: a hydrophilic coating within the lumen; and a wetting portal at a proximal end of the overtube, wherein the wetting portal comprises an annulus formed of a compressible and porous material, further wherein the annulus is configured to receive the endoscope therethrough while wetting an outer surface of the endoscope with a liquid from the compressible and porous material.

[0022] Either or preferably both the overtube and the endoscope (or a sheath / cover over the endoscope) may be rigidizing. For example, the overtube may be a rigidizing overtube. The endoscope may be a rigidizing endoscope; in some examples the endoscope is ensheathed in a protective cover that covers and seals the endoscope to protect it from contamination, allowing it to be re-used; this cover may be rigidizing.

[0023] Any of these apparatuses may include a fluid line in fluid communication with the compressible and porous material of the wetting portal. The fluid line may be configured to deliver a liquid to the inside of the overtube and / or to the wetting portal directly. In some cases the fluid line may extend through a handle or cartridge at the proximal end of the overtube. The fluid line may include a port (e.g., fluid port) to which a fluid source may be - 5 -SG Docket No.: 13668-738.600coupled, such as a syringe or other fluid source. The fluid line and / or fluid source may be metered, to control, either passively or actively, the amount of fluid (e.g., liquid) delivered. In some cases the fluid line is integrated into a handle of the overtube.

[0024] Any of these apparatuses and methods may be configured to capture liquid that may leak proximally from the wetting portal. For example, the proximal end of the overtube may include a fluid-capturing ‘trap’ at the proximal end. In some cases a fluid trap may extend around the wetting portal at a radially offset distance and or may extend proximally. The fluid trap may generally be configured to receive liquid leaked by the wetting portal and may include a channel, ledge, lip, etc. the fluid tramp may include a material to hold or contain leaked liquids, such as a fluid-absorbent material, in some cases the fluid trap is in fluidic communication with a source of suction.

[0025] Optionally any of these apparatuses and methods may include a lumen seal adjacent to a distal side of the wetting portal. As mentioned, this seal may be a leaky seal (or filter) that includes slits or openings. These seals may be referred to equivalently as a managed leak seal or a controlled leak seal. The seal may be formed of an elastomeric material. In some examples the seal may include a plurality of radially arranged slits on the lumen seal. The seal may be configured to allow air but may limit the amount of liquid and / or may prevent solid material (or solid materials over a certain size, such as, e.g., 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, etc. which may corresponding to the slits or openings through the seal.

[0026] The seal may include a lumen through which the endoscope may be inserted, and the seal may be positioned adjacent to either the distal or proximal sides of the wetting portal. The diameter of the annulus of the wetting portal may be equal to or less than the diameter of the lumen seal, which may be equal to or just smaller than the outer diameter of the endoscope.

[0027] As mentioned above, the wetting surface (e.g., the wetting portal) may comprise any material that is able to hold and release liquid, typically a porous material, such as a sponge or a foam. The porous material may have an open cell configuration. The porous material may have a pore size between about 10 pm and 1 mm (e.g. on average), for example, between 10-130 um, between about 300-700 pm, between about 250-500 pm, between about 100-300 pm, between about 10-100 pm, etc. In some examples the wetting surface may comprise a hydrogel.

[0028] As mentioned, the nested apparatus may include a rigidizing overtube. The rigidizing overtube may be configured to rigidize by the application of pressure, e.g., positive- 6 -SG Docket No.: 13668-738.600and / or negative pressure. For example, the rigidizing surface may comprise a plurality of layers, such as but not limited to a rigidizing layer, a bladder layer and a support layer; for example the application of positive and / or negative pressure may drive the bladder layer against (and in some case into) the rigidizing layer, supported by the support layer. The rigidizing layer may comprises a plurality of filaments that cross over each other, e.g., as a knit, woven, braid, etc. The lengths of filament may be the part of a single filament (e.g., a knit) or multiple filaments.

[0029] Also described herein are overtube apparatuses that may be provided by themselves, e.g., for use with one or more commercially available endoscope. Thus, described herein are overtube apparatuses that include: an elongate flexible body having a lumen extending from a proximal end to a distal end; a hydrophilic coating within the lumen; a wetting portal at a proximal end of the overtube apparatus, wherein the wetting portal comprises an annulus formed of a compressible and porous material; wherein the annulus is configured to receive an endoscope therethrough while wetting the endoscope’s outer surface with a liquid.

[0030] Any of the features described above as part of the rigidizing overtube of the nested pair of device may be included as part of the rigidizing overtube. For example, any of the overtube apparatuses described herein may include a fluid line in fluid communication with the compressible and porous material of the wetting portal, configured to deliver a liquid thereto. The fluid line may be integrated into a handle of the overtube. The overtube may include a fluid trap around the wetting portal and configured to receive liquid leaked by the wetting portal. The fluid trap may comprise a fluid-absorbent material and / or be in fluid communication with a source of suction. The overtube apparatus may include a lumen seal adjacent to a distal side of the wetting portal, on the distal or the proximal side of the wetting portal. The diameter of the annulus of the wetting portal may be equal or less than a diameter of the lumen seal. The compressible and porous material may comprise a sponge or a foam. In general, these overtube apparatuses may be rigidizing overtubes, and may include a plurality of layers including a rigidizing layer, a bladder layer and a support layer.

[0031] For example, an overtube apparatus may include: an elongate flexible body having a lumen extending from a proximal end to a distal end; a hydrophilic coating within the lumen; a ring-shaped wetting portal at a proximal end of the overtube, wherein the wetting portal comprises a sponge material having an annulus formed therethrough; a fluid line at the proximal end of the elongate flexible body in communication with the ring-shaped wetting portal configured to wet the sponge material of the ring-shaped wetting portal with a liquid;- 7 -SG Docket No.: 13668-738.600wherein the annulus of the wetting portal is configured to receive an endoscope therethrough while wetting the outer surface of the endoscope with the liquid.

[0032] Also described herein are methods of operating any of these apparatuses, and / or method of maintaining the lubricity between an overtube and an endoscope (or a cover of an endoscope). For example, a methods may include: wetting an annular wetting portal of an overtube with a liquid, wherein the annular wetting portal in fluid communication with a lumen of the overtube and comprises an annulus formed of a compressible and porous material; inserting a hydrophilic coated endoscope through the annulus of the wetting portal so that an outer surface of the endoscope is wetted by the liquid from the compressible and porous material, and sliding the endoscope within the lumen of the overtube.

[0033] Any of these methods may include capturing leakage from the annular wetting portal in a fluid trap at least partially surrounding the annular wetting portal. For example, leakage may be captured by a trap, as described above.

[0034] In some cases, wetting comprises wetting from a fluid line coupled to the overtube. The fluid line and / or fluid source may be metered to limit or control the amount of liquid released. In some cases the amount of liquid may be metered based on the time (e.g., x ml / min, such as 0.1 ml / min, 0.2 ml / min, 0.3 ml / min, 0.4 ml / min, 0.5 ml / min, 0.6 ml / min, 0.7 ml / min, 0.8 ml / min, 0.9 ml / min, 1 ml / min, 2 ml / min, 3 ml / min, 4 ml / min, 5 ml / min, etc. between 0.1 ml / min and 10 ml / min, etc.). The amount of liquid may be metered based on the movement of the endoscope relative to the overtube, e.g., for every x units of axial movement (e.g., 10 cm, 50 cm, 100 cm, 1 m, 1.5 m, etc.) the apparatus may apply an additional volume, y, of liquid (e.g., 1 ml saline, 5 ml saline, 10 ml saline, 15 ml saline, 20 ml saline, 25 ml saline, 30 ml saline, 40 ml saline, 50 ml saline, etc.). The method may include providing an initial bolus of liquid to wet the wetting surface (e.g., the annular wetting portal).

[0035] Any of these methods may include maintaining the wetness of the annular wetting portal during operation of the overtube. Any of these methods may include pre-wetting the annular wetting portal, either directly or via the fluid line, as mentioned. Wetting the annular wetting portal may comprise wetting a sponge material forming the compressible and porous material of the annular wetting portal.

[0036] In any of these methods, wetting the annular wetting portal may comprise wetting with an appropriate liquid material (e.g., water, saline, etc.).

[0037] Any of these methods may include rigidizing the overtube to transition the overtube from a flexible configuration to a more rigid configuration by applying pressure within a plurality of layers forming the overtube.- 8 -SG Docket No.: 13668-738.600

[0038] In some examples a method may include: wetting an annular wetting portal of an overtube with a liquid, in which the annular wetting portal is adjacent to a lumen seal having an annular port at a distal end of the overtube and in which an annulus of the annular wetting portal and the annular port of the lumen seal are in fluid communication with a lumen of the overtube. The method continues with inserting an endoscope through an annular port of the seal and the annular wetting portal so that an outer surface of the endoscope is wetted by the liquid, in which the wet outer surface of the endoscope maintains lubricious contact with a hydrophilic coating with the lumen of the overtube. The method may include capturing leakage from the annual wetting portal in a fluid trap at least partially surrounding the annular wetting portal.

[0039] 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

[0040] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[0041] FIG. 1 A schematically illustrates one example of a dynamically rigi dizing robotic system having a nested endoscope assembly including a rigi dizing outer member (e.g., overtube) and a rigidizing inner member (e.g., endoscope).

[0042] FIG. IB shows an exemplary cross-sectional view of a handle for an overtube apparatus configured to receive and hydrate an endoscope.

[0043] FIGS. 2A-2E schematically illustrate examples of wetting portals. FIG. 2A shows a side cross-sectional view of a wetting portal in a handle of an overtube apparatus. FIG. 2B shows an alternative section of a wetting portal, illustrating the flow of lubricating fluid. FIGS. 2C and 2E show exploded views of a portion of a wetting portal. FIG. 2D shows an assembled view of the wetting portal of FIG. 2D.

[0044] FIG. 3 illustrates an end of the overtube assembly including the wetting portal having a porous wetting ring and a seal.

[0045] FIG. 4 illustrates an embodiment of the overtube apparatus having an endoscope attached through a wetting portal.

[0046] FIGS. 5A-5E illustrate schematic views of examples of wetting rings.

[0047] FIGS. 6A-6D are schematic views of an example of a lumen seal.- 9 -SG Docket No.: 13668-738.600

[0048] FIG. 7 schematically illustrates an example of a method for hydrating an outer surface of an endoscope.DETAILED DESCRIPTION

[0049] In general, described herein are methods and apparatuses for maintaining lubrication between a nested outer member, e.g., overtube, and an inner member (e.g., endoscope). The nested inner and outer members may form a nested rigidizing endoscope assembly. In particular, these methods and apparatuses may be used as part of a rigidizing endoscope assembly for robotic endoscopy, including (but not limited to) colonoscopy. In use, a nested rigidizing endoscope assembly may move the inner member (e.g,. the endoscope) in and out of the outer member (e.g., overtube) during normal operation. Initially the inner member may be inserted into the lumen of the outer member to slide through the lumen until the tip of the inner member is at the distal end region and / or may extend distally from out of the distal end region of the outer member. Further, when operating the nested rigidizing endoscope assembly, the inner member (e.g., endoscope) may be moved axially both distally and proximally through the outer member (e.g., overtube), even as the nested rigidizing endoscope assembly is bent or curved as it traverses the body. Thus active lubrication between the outer and inner members may significantly enhance operation, allowing easier relative movement. Thus, water or other lubrication fluid (saline, water, glycerin, glycerol, propylene glycol, oil, etc.) may be applied between the inner and outer member. Unfortunately, as the inner member is moved relative to the outer member, the surface of the inner member (e.g., endoscope) may dry at the proximal end region, since this region of the inner member may be exposed to the open air when the inner member is retracted proximally, making re-insertion of this region distally into the outer member more difficult. The methods and apparatuses described herein may greatly enhance the lubrication between the inner and outer members, while also preventing leaking and reducing the amount of lubricating fluid needed.

[0050] Any appropriate lubrication fluid may be used, including just water or saline, or water-based lubricants (e.g., water with a humectant, such as a but not limited to glycerin, propylene glycol, sorbitol, and / or a surfactant, e.g., polysorbate, etc.).

[0051] For context, the nested rigidizing endoscope assemblies described herein may be part of a robotic system, e.g., a robotic medical apparatus, and / or may be used for manual, automatic, or semi-automatically controlled procedures. For example, the methods and apparatuses (e.g., devices, system, etc.) may be part of a colonoscopy apparatus, as the inner member may be a colonoscope. However these methods and apparatuses may be used with- 10 -SG Docket No.: 13668-738.600any type of endoscope, including flexible endoscopes (including but not limited to gastroscope, colonoscope, bronchoscope, duodenoscope, enteroscope, nasopharyngoscope, etc.), rigid endoscopes (e.g., laparoscope, arthroscope, cystoscope, hysteroscope, proctoscope, etc.). In general, these methods and apparatuses may be used as part of any endoscopic procedure, not limited to colonoscopy. “Endoscopy” or “endoscopic procedure” as used herein refers to any medical procedure which uses an endoscope of any kind. Examples include, without limitation, angioscopy, arthroscopy, bronchoscopy, colonoscopy, cystoscopy, duodenoscopy, enteroscopy, esophagogastroduodenoscopy, gastroscopy, hysteroscopy, laparoscopy, laryngoscopy, mediastinoscopy, sigmoidoscopy, thoracoscopy, and ureteroscopy. “Endoscopic system” as used herein refers to a system used to perform an endoscopic procedure. It should also be understood that these methods and apparatuses may be part of a cardiac procedure, e.g., for inserting an inner member into an outer (overtube) member), including for use in removing (e.g., aspirating) clot material.

[0052] For example, the nested rigidizing endoscope assemblies described herein may generally include an outer member referred to for convenience as an overtube, or more specifically as a rigidizing overtube. In some cases the nested rigidizing endoscope assemblies described herein may be part of a robotic medical apparatuses comprising a dynamically rigidizing system that may include autonomous or semi -autonomous control. As used herein, dynamic rigidization refers to the ability to convert between one or more “more rigid” configurations and one or more “less rigid” configurations. These robotic medical apparatuses (devices, systems, etc.) and methods may allow navigation within the body, such as but not limited to the human colon, by integrating a dynamically rigidizing composite structure in which at least the overtube can be immediately transitioned between a more flexible (e.g., less rigid) and a more rigid (e.g., less flexible) configuration, by the controlling the pressure, e.g. positive and / or negative pressure, within a wall of the overtube, e.g., to control compression of one or more rigidizing layers. The rigidizing layer(s) may include a plurality of filaments, fibers, wires, etc. that may slide freely within the wall in the more flexible configuration but are compressed and constrained from sliding in the more rigid configurations. In some cases both the outer member (overtube) and the inner member (e.g., endoscope, or a rigidizing shield engaged with the endoscope) may be rigidizable. A pair of nested rigidizing elongate members (outer and inner members) may be referred to herein as a nested rigidizing endoscope assembly. For example, the dynamically rigidizing nested rigidizing endoscope assembly may include an outer overtube and an inner endoscope (which may be covered by a shield configured to make the endoscope rigidizable); this nested pair of elongate members may be controllably converted between a more rigid (e.g., less flexible)- 11 -SG Docket No.: 13668-738.600configuration and a less rigid (e.g., more flexible) configuration along all or a portion of the length of the elongate member. Examples of nested rigidizing endoscope assemblies that may benefit from the methods and apparatuses described herein include those in, e.g., U.S. patent no. 12,102,289, U.S. patent no. 12,324,565, and international patent application PCTUS2025020479, each of which is herein incorporated by reference in its entirety.

[0053] FIG. 1 A schematically illustrates one example of an apparatus including a nested rigidizing endoscope assembly as described herein. The nested rigidizing endoscope assembly in FIG. 1A includes an inner (e.g., endoscope) rigidizing elongate member 131 and an outer (e.g., overtube) rigidizing elongate member 130. A fluid line 158 connects a source of lubricating fluid 156 (e.g., water, saline, glycerol, etc.) to the proximal end (e.g., handle 140) of the overtube 130. The apparatus also includes a robotic drive (e.g., drive system or robotic drive system) 134 having a controller (e.g., driver) 135. The controller 135 and robotic drive system 134 may couple to the nested assembly of the inner and outer rigidizing elongate members 130, 131 and may control and coordinate the movements of both the inner rigidizing elongate member 131 and the outer rigidizing elongate member 130 (e.g., insertion / withdrawal, steering, roll, etc.) as well as the rigidity of either or both the inner member 131 and the outer member 130. In some cases the controller may also control or regulate (e.g. turn on / off, pump, etc.) the application of lubrication fluid into the nested rigidizing endoscope assembly, e.g., the overtube.

[0054] In FIG. 1A, the overtube 130 may be dynamically rigidized. In some examples the outer member 130 may be fully flexible along its entire length (or most of the length, e.g., >80%, >85%, > 90%, > 95%, etc.) in a flexible state and may be rigidized along all or a portion of its length, e.g., by the application of pressure (e.g., positive and / or negative pressure) within the lumen of the apparatus. In some cases the rigidity may be different along the length; for example, the distal end region may be made more rigid than the more proximal region. In FIG. 1 A the nested assembly also includes the inner member 131, which may be configured as an endoscope, and in particular as a rigidizing endoscope. In some cases the rigidizing endoscope may be configured to be rigidizing along all or a portion of its length (e.g., >80%, >85%, > 90%, > 95%, etc.).

[0055] In some examples the apparatuses shown in FIG. 1 A may be configured for robotic control, including robotic control of movement of the inner member 131 relative to the outer member 130 or vice versa. Either or both members (e.g., overtube and endoscope) may include a steerable distal end region. In particular, the inner member 131 may have a distal steerable region (e.g., the distal x cm may be steerable, such as the distal 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 1-10 cm, 2-15 cm, 2-10 cm, 3-10 cm, 3-15 cm,- 12 -SG Docket No.: 13668-738.600etc.). The distal end region may be steerable by including one or more tendons or wires (e.g., pull wires). This distal end region may be extended distally out of the distal end of the overtube; a corresponding proximal length may extend / retract into the overtube 151. The inner member may include one or more cameras on the distal end 133 (e.g., end cap, etc.), including one or more forward and / or side-facing cameras.

[0056] The exemplary apparatus 100 shown in FIG. 1A also includes a robotic drive system 134. The robotic drive may include one or more mounts (e.g., carriage, stages, clamp, etc.) configured to mount or couple with the proximal ends of the inner member and outer member and interface to control operation of the first or second rigidizing elongate members. For example, in FIG. 1 A, a proximal end of the rigidizing overtube 130 may include or couple to a handle 140 (in some cases a proximal cartridge) that may include and / or may interface with a source or pressure (e.g. positive and / or negative pressure) as well as the source of lubrication 156, and may couple to the mount 123. The mount 123 may include one or more connectors to connect to the pressure interface and / or may include one or more control lines for controlling operation of the source of pressure (in examples including an integrated pressure source, such as a bellows, syringe, etc.). The mount may also include a steering interface in variations including a steerable outer rigidizing elongate member (e.g., overtube). The steering interface may couple to one or more tendons to steer the distal end region. In some cases the steering interface may include a rotating member (e.g. post, gear, etc.) to apply tension to each of the one or more steering tendons (e.g., cables) in the rigidizing elongate member. The mount may generally include a mounting surface for removably engaging the proximal end region, e.g., handle, cartridge, etc., of the rigidizing elongate member.

[0057] In FIG. 1 A the first mount 133 is configured to couple to the inner rigidizing elongate member 131 (e.g., endoscope) and the second mount 123 is configured to couple to the outer rigidizing elongate member 130 (e.g., overtube). The first and second mounts may be different. The first and / or second mounts may also be configured to roll 153 the respective first and / or second rigidizing elongate members. For example, a portion of the first and / or second mount may rotate relative to the rest of the mount. The first and second mounts may also be configured to move linearly 151, in / out of the insertion axis. As mentioned, one or both of the rigidizing elongate members may include a steerable distal end region and mount may interface with the steering components on the rigidizing elongate member. The first and / or second mounts may include or couple to a source of pressure, for rigidizing the rigidizing elongate member(s) (or a source of pressure may be directly coupled to the inner and / or outer elongate members).- 13 -SG Docket No.: 13668-738.600

[0058] The mounts may also optionally provide an interface for one or more sensors on the rigi dizing elongate member. In general, sensors may provide input to the controller 135 either directly or through the first and / or second mounts. Sensors may include, but are not limited to, shape sensors, force sensors, position sensors, power (e.g., voltage and / or current) sensors, pressure sensors, etc. These sensors may provide feedback to control operation of the apparatus. The robotic drive 134 (drive system) may include drives for driving the movement of the rigidizing elongate members and the controller may command and coordinate operation of these drives, as well as the application of pressure to control the rigidization state of the rigidizing elongate members. The apparatus may include one or more control lines 444 connecting to the controller 135. The control lines may include pressure, power, and / or data lines.

[0059] Thus, the inner rigidizing elongate member 130 (e.g., endoscope) may be coupled to a robotic drive system such as a motion-controlling telescoping link assembly via the mount 123 and controlled by the controller to move axially (e.g., forward / b ackward). The outer rigidizing elongate member 130 (e.g., overtube) may be axially moved or rotationally torqued. In an embodiment, the outer member 130 or a portion of the second member 130 can be rolled.

[0060] A proximal end of the endoscope 131 is coupled to a proximal handle 141 (e.g., endoscope cartridge) that may interface with a pressure source (not shown) and / or controller via one or more control lines 146. The control lines may include pressure, power, and / or data lines. The endoscope 131 may also couple to the motion-controlling telescoping link assembly (e.g., drive system 134) via a mount 124 that may be controlled by the controller to move axially (e.g., forward / backward) relative to the overtube. The endoscope 131 may be axially moved and / or rotationally torqued. In an embodiment, the endoscope 131 or a portion of the endoscope 131 can be rolled. In an embodiment, the endoscope 131 is a rigidizing endoscope or an assembly including a rigidizing shield or sleeve that converts a non- rigidizing endoscope into a rigidizing endoscope, also referred to as a rigidizing endoscope assembly.

[0061] Thus, the overtubes described herein may be used with an endoscope and / or an endoscope covered in a shield (or sheath) to maintain a lubricous surface between the overtube and the endoscope and / or shield. Any one or more of the overtube, endoscope and / or shield may include a hydrophilic coating on a surface between the overtube and the endoscope / shield.

[0062] In general, the methods and apparatuses described herein may be configured to maintain a fluid, e.g., a liquid such as water, saline, etc., between the inner surface of the- 14 -SG Docket No.: 13668-738.600overtube and the outer surface of the endoscope / shield. Any of the overtube apparatuses described herein may include a wetting surface, e.g., a wetting portal, at the proximal end of the overtube that is configured to wet the endoscope (or shield over an endoscope) as it inserted into the overtube.

[0063] FIG. IB shows an exemplary cross-sectional view of a proximal end region (e.g., handle 150) for an overtube apparatus configured to receive and hydrate an endoscope 131. As shown here, the overtube includes an elongate flexible body 102 having a lumen extending from a proximal end to a distal end configured to receive 104 an endoscope at one of the ends. There may also be a hydrophilic coating within the lumen of flexible body 102 configured to assist with hydration of an outer surface of the endoscope.

[0064] In certain examples discussed herein, the overtube apparatus 100 may include a wetting portal 152 at a proximal end of the lumen 154 in communication through the flexible body 102 (e.g., at the proximal end of the handle region 150) to receive an endoscope or a shield / sheath over the endoscope to maintain the lubricity between the overtube lumen and the endoscope / shield. In some cases the water may activate an outer hydrophilic coating on the endoscope and / or a shield / sheath covering the endoscope, and / or within the lumen of the overtube. The proximal end of the overtube may include one or more ports 130 for coupling to the source of lubrication fluid (as shown in FIG. 1A). In FIG. IB the port is on the proximal handle and may include a connector (e.g., Luer connector, etc.), for coupling to a fluid line. In some cases the apparatus may include a valve and / or pump for delivering lubrication fluid to the overtube handle (e.g., port 130). Alternatively or additionally, fluid may be passively applied, e.g., by gravity.

[0065] FIG. 2 schematically illustrates a side view cross-sectional view of a handle for an overtube apparatus including a wetting portal 152, including a porous material, configured as porous ring (also referred to herein as a wetting ring or a porous wetting ring) 206. In this example the handle also includes a lumen seal 208 (e.g., a leaky seal) . In certain examples, wetting portal 152 may include a wetting ring 206 located at a distal end of the overtube. In some cases the wetting ring 206 may be configured as a porous annulus (e.g., an annular sponge). Wetting ring 206 may be comprised of compressible and porous material such as a foam and / or a sponge or sponge-like material and may be an annulus or annular (e.g., ring) shaped or have an annulus formed therethrough, and / or may be configured to form an annular ring around an endoscope when inserted, e.g., by including one or more radial slits or cuts instead or in addition to the opening. The compressible and porous material of the wetting ring 206 may be in fluid communication with one or more fluid lines, for example via integration into the overtube handle, to deliver liquid to the wetting portal including the- 15 -SG Docket No.: 13668-738.600wetting ring 206 from a liquid source to hydrate an outer surface of the endoscope as it moves relative to the overtube (e.g., axially in / out). The wetting ring 206 of the wetting portal 152 may be pre-hydrated and / or moistened. In some cases the porous wetting ring 206 may be disposable. Wetting portal 152 (including the wetting ring 206) may be partially or entirely located inside the lumen of the elongate flexible body or in other examples may be located entirely or substantially outside of the lumen of the elongate flexible body, for example interfacing around a distal opening of the lumen of the elongate flexible body or a distal end of the overtube. The wetting portal 152 shown in FIG. 2A also includes a lumen seal 208 which may be comprised of an elastomeric material and be configured to prevent large particulate matter (e.g., fecal matter) from moving out of the lumen of the elongate flexible body (overtube) and out of the proximal end of the overtube or from contaminating the wetting surface of the wetting portal. Lumen seal 208 may have a plurality of radially arranged slits on one or more surface, and the slits may extend through lumen seal 208 and be arcuate in shape. Lumen seal 208 may be adjacent to wetting ring 206 and may also comprise an annulus or be annular shaped, and / or may include radial slits or cuts configured to form an annual opening when the endoscope is inserted therethrough. In certain examples, lumen seal 208 may be adjacent to a distal side or a proximal side of the wetting ring 206.

[0066] In any of these examples, the annulus of wetting ring 206 and the annulus of the (optional) lumen seal 208 may be aligned or co-centric and configured to receive the endoscope therethrough and to lumen seal 208 against an outer surface of the endoscope while wetting (hydrating) the outer surface of the endoscope with a liquid. In any of these apparatuses, the diameter of the annulus of the wetting ring 206 may be equal or less than a diameter of lumen seal 208.

[0067] In general, the wetting ring 206 may have an inner passage / opening 216 that may be round, oval or irregularly shaped. Although the wetting ring 206 is illustrated as an O- shaped ring in FIGS. 2A-2E, 3, 5 and 5A-5C, e.g., having a pre-formed opening region 216, it should be understood that the wetting ring 206 may assume a ring shape only when the endoscope is inserted therethrough. For example, the annular ring may include cuts or slits 505 formed through the center of the porous ring 206, as shown in FIGS. 5D-5E. Any number of cuts may be included. In variations of the wetting ring 206 that include a cut-out region, the cut-out region may have a diameter that is less than the outer diameter of the endoscope that will be inserted through the porous ring 206. In some cases the wetting ring 206 may include both a cut-out region and one or more slits extending radially outward. The cut-out region may be radially centered and / or aligned with the insertion axis for the endoscope. In general, the wetting ring 206 may be relatively soft and displaced by the endoscope once- 16 -SG Docket No.: 13668-738.600inserted, while wetting the outer surface of the endoscope as it passes through the wetting portal 152 including the wetting ring 206.

[0068] Any of the apparatuses described herein, including in particular overtubes having a proximal wetting portal 152, may include a 158 chamber (e.g., a wetting chamber) within the proximal end of the overtube, e.g., within the handle and / or cartridge at the proximal end of the overtube, that receives lubrication fluid from the lubrication port 130. This chamber is in fluid communication with both the wetting portal 152 (e.g., with the wetting ring 206) on the proximal side of the wetting chamber and with an opening into the inner lumen 154 of the overtube 130 on the distal side of the wetting chamber. In some variations the wetting chamber may be considered part of the wetting portal 152. In general, the wetting chamber may include an opening in fluid communication with the lubrication port.

[0069] In some variations the wetting chamber 158 may be separated from the lumen of the overtube on the distal side by an inner porous ring or seal 288 through which the endoscope may pass when inserted and through which the lubrication fluid may pass. This optional inner porous ring or seal (e.g. “leaky seal”) may be configured in some examples as an internal wetting ring that may be included in addition to (or instead of) the proximal porous ring 206. Alternatively or additionally the inner porous ring or leaky seal may be an elastomeric material that includes opening or holes for passing lubrication fluid in addition to the central opening to pass the endoscope.

[0070] In some variations the apparatus includes just the inner wetting ring 288 and does not include a proximal wetting ring 206. For example, the proximal end of the wetting portal 152 include a seal (e.g., o-ring, elastomeric seal, etc.), which may be lubricous, and may be configured to allow passage of the endoscope into the wetting chamber and through the internal porous ring (wetting ring) 288 at the distal side of the chamber.

[0071] In general, the wetting chamber 158 may receive wetting fluid 285 from the lubrication port and may pass fluid distally 289 into the lumen of the overtube, between the overtube and the endoscope to lubricate the interface (e.g., wet the interface) with the endoscope inserted into the overtube. In some cases the lubrication fluid (e.g., water) may be injected 285 into the chamber 158 and passed both distally 289 into the lumen and proximally 287 to wet the wetting ring 206.

[0072] As shown in FIG. 2B, the wetting ring 206 may absorb fluid from the wetting chamber 158 and may be sufficiently saturated so that it wets the circumference of the endoscope as it passe through the opening or annulus of the wetting ring 206 when the endoscope is moved relative to the overtube. The wetting ring 206 may be fixed to the overtube.- 17 -SG Docket No.: 13668-738.600

[0073] FIGS. 2C and 2E show exploded views of a portion of the wetting portal 152 including a proximal lumen seal 208, a seal cap 218 and wetting ring 206. FIG. 2C shows an exploded sectional view. The seal 208 may be an elastomeric seal that may be retained in position by the seal cap 218. The seal cap forms a full or partial ring around the seal 208, securing it to the proximal end of the overtube. The seal cap may also secure the wetting ring 206. For example the wetting ring 206 may be adhesive and / or mechanically coupled to the seal cap and therefore to the proximal end of the overtube. In The example shown in FIG. 2C the wetting ring 206 may be, e.g., a polyurethane foam configured as an o-shaped ring. FIG. 2D shows the exploded view of FIG. 2C assembled showing the arrangement of the lumen seal 208, seal cap 218 and wetting ring 206. With the wetting ring 206 secured to the seal cap 218, the wetting ring 206 may be spaced apart from a rim or lip at least partially surrounding the wetting ring 206. This spacing may form a gap or channel 299 that may collect fluid and prevent dripping from the wetting portal 152 during operation. In any of these examples the gap or channel 299 may include a proximal face that at least partially extends radially inward to further prevent leaking; this proximal face may be formed by the rim or lip 297. The gap / channel 299 may form a fluid trap. In any of these devices and methods the gap or channel 299 may be connected to a source of aspiration that may withdraw fluid that leaks from the wetting portal 152, including the wetting ring 206.

[0074] FIG. 3 illustrates an end of the overtube assembly 300 with a wetting portal including a wetting ring 306 and lumen seal 308. As shown in this example, the wetting ring 306 may be coupled directly to the lumen seal 308 (or indirectly, e.g., through a cap 218 as shown in FIGS. 2B-2E). As previously discussed, some or all of wetting portal may be located with the lumen of the elongate flexible body of the overtube apparatus, and the lumen seal 308 may be adjacent to a distal side or a proximal side of the wetting portal 306.

[0075] FIG. 3 also shows a fluid trap 310 around the wetting ring 306 and / or lumen seal 308 configured to receive liquid leaked by wetting portal, for example before, during, or after an endoscope passing through and compressing wetting ring 306 to wet the outside of the endoscope. Fluid trap 310 may take various forms and shapes and may be configured at an offset distance from wetting ring 306. In certain examples, fluid trap 310 may be comprised of a liquid-absorbent material, and / or may be in fluid communication with a source of suction to withdraw liquid from or empty fluid trap 310. In FIG. 3 the opening into the fluid trap 310 shown may be coupled to a suction (e.g., aspiration) line.

[0076] FIG. 4 illustrates an embodiment of an overtube apparatus including a rigidizing elongate body extending distally from a proximal handle 400. An endoscope 412 is shown inserted into the wetting portal 452. In this example the endoscope 412 in shown inserted- 18 -SG Docket No.: 13668-738.600through the wetting ring 406 of and lumen seal 408 of the wetting portal 452. Thus, the outer surface of endoscope 412 may be hydrated (wetted) as it passes through wetting portal 406 when moved axially and / or rotationally relative to the overtube. Leakage of lubricating fluid (e.g., water) outside of the overtube apparatus may be limited or prevented by lumen seal 408. The apparatus may also include a fluid trap 404 which may trap leakage of fluid from the wetting portal 452. In some examples, the proximal end 404 of the overtube may be a handle or body portion of the overtube assembly that may mount to the robotic assembly as described in reference to FIG. 1 A, above.

[0077] FIGS. 5A-5C illustrate schematic views of one example of a wetting ring 506 including a central opening 516 into which an endoscope may pass. The wetting ring may be formed or a porous material. In some cases the porous material may comprise open cell pores, forming a sponge-like, interconnected network of voids within the material, allowing fluid to pass through. Examples of porous materials may include natural or synthetic sponge material (cellulose sponge, synthetic polymer sponges formed of, e.g., polyester, polyurethane, polyvinyl alcohol, etc.). In some cases the porous material may comprise a gel, such as a hydrogel.

[0078] FIG. 5A shows a cross-sectional schematic of a wetting ring 506, which may have an outer diameter 504 and inner diameter 502. Any appropriate inner and outer diameter may be used, so that the wetting ring may contact the source of lubricating fluid and may contact the outer surface of the endoscope as the endoscope is passed through the ring. For example the outer diameter may be within a between about 17.5 - 18.5 mm and the inner diameter 502 may between about 7.5 - 8.3 mm.

[0079] FIG. 5B illustrates a schematic perspective view of the wetting ring 506 of FIG. 5 A, showing the annular opening 516 through the wetting ring. FIG. 5C is a schematic side view of the wetting ring 506. The wetting ring may have any appropriate thickness. In some cases the wetting ring may have a thickness that is between about 10% and about 200% of the outer diameter of the wetting ring (e.g., between about 15% and 150%, 15% and 100%, 15% and 80%, 15% and 75%, 15% and 65%, 20% and 80%, 20% and 75%, 20% and 70%, 20% and 65%, etc. of the outer diameter). In the example shown in FIG. 5C, the wetting ring has a height of 508 between about 5.85 - 6.85 mm.

[0080] As mentioned above the wetting ring may not include a preformed (e.g., cut-out) annulus or ring but may form the passage for the endoscope from one or more (preferably a plurality of) radial slits or cuts, as shown in FIGS. 5D-5E. Also, although the wetting portals described herein include an wetting ring configured to encircle the endoscope as a ring, in some cases the wetting portal may include a wetting surface that is not ring-shaped, but is- 19 -SG Docket No.: 13668-738.600configured to partially (e.g., between 50% and 99%, 60%-90%, 70%-95%, 75%- 90%, etc.) surround the endoscope to wet the outer surface of the endoscope. The wetting surface may be ring-shaped (as in the wetting rings described above), or spiral shaped along the length of the endoscope, which may reduce friction while still wetting the outer surface of the endoscope.

[0081] FIGS. 6A-6C are schematic views of a lumen seal 608. In general the seal may be configured to pass fluid (e.g., water). For example, FIG. 6A shows a schematic of a lumen seal which may have an inner diameter 602 (e.g., in this example between about 10 - 10.2 mm), an outer diameter 604 (e.g., between about 21.9 - 22.2 mm), and a plurality of fluid openings 603 (referred to as leak openings) through the seal, which may be arcuate shaped. These leak openings 603 may be evenly spaced around inner diameter 602 of the seal and may be concentric with inner diameter 602. Leak openings 603 may be punched out, e.g., with a 0.035” needle. Any number of leak openings (e.g., between 1-100, 2-50, 3-25, etc.) may be formed through the seal, particularly over the region of the seal that is configured to abut the wetting ring, so that fluid passing through the small openings in the seal may be absorbed into the wetting ring. In the examples shown in FIGS. 6A-5D, the small openings 603 are arranged around the central opening 616 through the seal with a spacing 605 between the central opening (e.g. forming the inner diameter 602 of the seal) and the small openings 603 at a distance of between about 0.38 mm - 1.55 mm. In general the small openings are configured to “weep” lubricating fluid (e.g., water, saline, etc.) through the seal into the wetting ring. Six small openings are shown in FIG. 6A-6B. Increasing the pressure of the lubrication fluid into the lubrication port may increase the internal pressure with the wetting chamber and therefore the flow of wetting fluid into the wetting ring when the endoscope is inserted through the wetting portal. The small openings 603 may be formed as slits or smaller cut-out regions (e.g., having a diameter of less than 1 mm in some cases).

[0082] FIG. 6C illustrates a schematic side view of the lumen seal. In this example, the seal has a height 606 of between about 0.27 - 0.52 mm. FIG. 6D shows another example of a seal 608’ including a central opening 516 and a plurality of small openings 603 to pass wetting fluid to an adjacently arranged wetting ring.

[0083] FIG. 7 schematically illustrates an example of a method 700 for hydrating an endoscope as part of a nested system including an overtube and an endoscope. As mentioned, any of these methods may optionally include wetting (e.g., pre-wetting) the annular wetting surface of the wetting portal, such as the wetting ring 705. This may be achieved in some cases by applying lubricating fluid through the handle of the overtube (e.g., through the lubrication port). In some cases the flow of lubrication fluid through the port and- 20 -SG Docket No.: 13668-738.600subsequently to the wetting ring may be controlled by one or more valves and / or pumps. In some cases this may be controlled by the controller. Alternatively or additionally, the lubricating fluid may be applied directly to the wetting ring of the wetting portal, e.g., manually.

[0084] In some cases the endoscope may then be inserted through the wetting portal and into the lumen of the overtube 710. Alternatively, in some cases the endoscope, or a shield connected to the endoscope, may be preloaded into the overtube when the wetting portal is dry (e.g. lacks lubrication). Thus, the wetting of the wetting portal surfaces (e.g., the wetting ring) may be performed after a structure, such as the shield and / or the endoscope, is already inserted. In cases where the shield is preloaded into the overtube lumen (and through the wetting portal), the endoscope may still be inserted immediately prior to use, and after the optional prewetting step.

[0085] Once the endoscope (with or without a rigidizing shield) is inserted into the overtube the wetting portal may be maintained wetted with lubrication fluid. In some cases the system may be configured to maintain (or try to maintain) the wetting portal, and in some cases the wetting ring of the wetting portal specifically, saturated, so that it continuously applies lubrication fluid to the outer surface of the endoscope assembly. In general herein when describing wetting of the outer surface of the endoscope it should be understood that this includes wetting a shield or other outer covering over the endoscope that moves with the endoscope within the lumen of the overtube.

[0086] Thus, any of these methods may include adding lubrication fluid to the wetting portal. This may include adding lubrication fluid through the lubrication port and into a lubrication channel to allow flow of the lubrication fluid proximally to the wetting ring (including the wetting surfaces) and distally into the lumen of the overtube between the overtube inner diameter and the endoscope assembly (e.g., the endoscope and / or endoscope shield over the endoscope). The flow of lubrication fluid into the wetting portal may be continuous, e.g., delivered at a continuous rate during operation of the apparatus. The continuous flow may be at a constant flow rate or may be adjusted (e.g., based on movement of the endoscope assembly within the overtube). Alternatively the flow of lubrication fluid may be variable and may be controlled by the apparatus (e.g., the controller). As mentioned, the controller may adjust the flow of lubrication fluid into the lubrication port by controlling one or more pumps and / or valves. For example the lubrication fluid may be pumped using a peristaltic pump that may be part of the apparatus (e.g., medical robot). In some cases the flow lubrication fluid may be gravity fed. In some cases the apparatus (e.g., controller) may adjust the flow of lubrication fluid based on the movement of the endoscope relative to the- 21 -SG Docket No.: 13668-738.600overtube. For example, each time the endoscope is moved relative to the overtube a bolus of additional lubrication fluid may be added (e.g., 0.1 mL, 0.5 mL, ImL, 2mL, 3 mL, 4 mL, 5 mL, etc.), or increased, in variations in which a constant ‘drip’ of lubrication fluid is maintained.

[0087] According to an example of the methods described herein, wetting the annular wetting portal includes wetting with lubrication fluid by a user (e.g., manually), automatically, or semi-automatically. For example, the wetting may be algorithmically controlled, e.g., delivering a predetermined volume at a given time interval, and / or for a given amount of shaft motion, etc. For example, the apparatus described herein may track the relative movement between the outer and inner member, and particularly the longitudinal (sliding) movement between the inner and outer members (e.g. endoscope / overtube) and may apply additional liquid to the annular wetting portal accordingly. In some cases for every x units of axial movement (e.g., 10 cm, 50 cm, 100 cm, 1 m, 1.5 m, etc.) the apparatus may apply an additional volume, y, of liquid (e.g., 1 ml saline, 5 ml saline, 10 ml saline, 15 ml saline, 20 ml saline, 25 ml saline, 30 ml saline, 40 ml saline, 50 ml saline, etc.).

[0088] Thus, in any of these methods, lubrication fluid may be added to the wetting surface, e.g., wetting ring, during operation of the apparatus, including but not limited to during movement of the endoscope assembly relative to the overtube 715.

[0089] Any of these methods may also include capturing leaking lubrication fluid (and any associated waste) from the wetting portal 720. As described above, lubrication fluid may be captured in a channel at least partially surrounding the wetting portal (e.g., the wetting ring of the wetting portal) and drained (by gravity and / or by suction) to a waste container from the capture channel. In some cases where suction is applied, the suction may be applied at a constant, relatively low rate. Alternatively or additionally, suction may be applied on demand, e.g., corresponding to periods where additional lubrication fluid is added and / or when sensed by the apparatus (e.g., detecting waste fluid in the channel).

[0090] As mentioned above, these methods and apparatuses may be particularly important for rigidizing systems, as described herein, in which one member (the endoscope or overtube) may be advanced in a flexible state against the other member in a rigid state; this may result in greater frictional forces between the two than would be the case if they are both in a flexible state.

[0091] According to an example of method 700, method 700 further includes moving the endoscope axially within the overtube as the overtube is transitioned between a less rigid and a more rigid configuration by applying pressure within the plurality of layers forming the overtube. Alternatively or additionally, the endoscope (or a cover / shield over the endoscope) - 22 -SG Docket No.: 13668-738.600may be rigidizing. The state (rigid state / flexible state, etc.) of the overtube and / or endoscope / endoscope cover may be used to control the amount of liquid applied to the wetting portal.

[0092] 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.

[0093] 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. Furthermore, it should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0094] Any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like. For example, any of the methods described herein may be performed, at least in part, by an apparatus including one or more processors having a memory storing a non-transitory computer-readable storage medium storing a set of instructions for the processes(s) of the method.

[0095] While various embodiments have been described and / or illustrated herein in the context of fully functional computing systems, one or more of these example embodiments may be distributed as a program product in a variety of forms, regardless of the particular type of computer-readable media used to actually carry out the distribution. The embodiments disclosed herein may also be implemented using software modules that perform certain tasks. These software modules may include script, batch, or other executable files that may be stored on a computer-readable storage medium or in a computing system. In some embodiments, these software modules may configure a computing system to perform one or more of the example embodiments disclosed herein.

[0096] As described herein, the computing devices and systems described and / or illustrated herein broadly represent any type or form of computing device or system capable of executing computer-readable instructions, such as those contained within the modules- 23 -SG Docket No.: 13668-738.600described herein. In their most basic configuration, these computing device(s) may each comprise at least one memory device and at least one physical processor.

[0097] The term “memory” or “memory device,” as used herein, generally represents any type or form of volatile or non-volatile storage device or medium capable of storing data and / or computer-readable instructions. In one example, a memory device may store, load, and / or maintain one or more of the modules described herein. Examples of memory devices comprise, without limitation, Random Access Memory (RAM), Read Only Memory (ROM), flash memory, Hard Disk Drives (HDDs), Solid-State Drives (SSDs), optical disk drives, caches, variations or combinations of one or more of the same, or any other suitable storage memory.

[0098] In addition, the term “processor” or “physical processor,” as used herein, generally refers to any type or form of hardware-implemented processing unit capable of interpreting and / or executing computer-readable instructions. In one example, a physical processor may access and / or modify one or more modules stored in the above-described memory device. Examples of physical processors comprise, without limitation, microprocessors, microcontrollers, Central Processing Units (CPUs), Field-Programmable Gate Arrays (FPGAs) that implement softcore processors, Application-Specific Integrated Circuits (ASICs), portions of one or more of the same, variations or combinations of one or more of the same, or any other suitable physical processor.

[0099] Although illustrated as separate elements, the method steps described and / or illustrated herein may represent portions of a single application. In addition, in some embodiments one or more of these steps may represent or correspond to one or more software applications or programs that, when executed by a computing device, may cause the computing device to perform one or more tasks, such as the method step.

[0100] In addition, one or more of the devices described herein may transform data, physical devices, and / or representations of physical devices from one form to another. Additionally or alternatively, one or more of the modules recited herein may transform a processor, volatile memory, non-volatile memory, and / or any other portion of a physical computing device from one form of computing device to another form of computing device by executing on the computing device, storing data on the computing device, and / or otherwise interacting with the computing device.

[0101] The term “computer-readable medium,” as used herein, generally refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media comprise, without limitation, transmission-type media, such as carrier waves, and non-transitory-type media, such as - 24 -SG Docket No.: 13668-738.600magnetic-storage media (e.g., hard disk drives, tape drives, and floppy disks), optical-storage media (e.g., Compact Disks (CDs), Digital Video Disks (DVDs), and BLU-RAY disks), electronic-storage media (e.g., solid-state drives and flash media), and other distribution systems.

[0102] A person of ordinary skill in the art will recognize that any process or method disclosed herein can be modified in many ways. The process parameters and sequence of the steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed.

[0103] The various exemplary methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or comprise additional steps in addition to those disclosed. Further, a step of any method as disclosed herein can be combined with any one or more steps of any other method as disclosed herein.

[0104] The processor as described herein can be configured to perform one or more steps of any method disclosed herein. Alternatively or in combination, the processor can be configured to combine one or more steps of one or more methods as disclosed herein.

[0105] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0106] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, - 25 -SG Docket No.: 13668-738.600steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0107] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as "under”, or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0108] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.

[0109] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps may alternatively be exclusive and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.

[0110] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated- 26 -SG Docket No.: 13668-738.600value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value " 10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X" is disclosed the "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0111] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0112] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.- 27 -SG Docket No.: 13668-738.600

Claims

CLAIMSWhat is claimed is:

1. A nested system, the system comprising: an endoscope assembly; and an overtube having a lumen extending from a proximal end to a distal end, the overtube comprising: a lubrication port; and a wetting portal at a proximal end of the overtube in fluid communication with the lubrication port, wherein the wetting portal comprises a wetting surface formed of a compressible and porous material, further wherein the wetting surface is configured to receive the endoscope assembly therethrough so that the wetting surface applies a lubrication fluid to an outer surface of the endoscope assembly from the compressible and porous material as the endoscope assembly moves relative to the overtube.

2. The system of claim 1, wherein the wetting surface comprises an annuls.

3. The system of claim 1, wherein the overtube comprises a hydrophilic coating within the lumen.

4. The nested system of claim 1, wherein the overtube is a rigi dizing overtube.

5. The nested system of claim 1, wherein the endoscope assembly is a rigi dizing endoscope assembly.

6. The nested system of claim 1, further comprising a fluid line between the lubrication port and the compressible and porous material of the wetting portal.

7. The nested system of claim 1, wherein the lubrication port is integrated into a handle of the overtube.

8. The nested system of claim 1, further comprising a fluid trap around the wetting portal at a radially offset distance from the wetting surface, the fluid trap configured to receive liquid leaked by the wetting portal.- 28 -SG Docket No.: 13668-738.6009. The nested system of claim 8, wherein the fluid trap comprises a fluid-absorbent material.

10. The nested system of claim 8, wherein the fluid trap is configured to be in fluidic communication with a source of suction.

11. The nested system of claim 1, wherein the wetting surface of the wetting portal comprises a wetting ring.

12. The nested system of claim 1, wherein the wetting portal further comprises a lumen seal adjacent to the wetting surface.

13. The nested system of claim 12, wherein the lumen seal comprises a plurality of leak openings configured to pass lubrication fluid to the wetting surface.

14. The nested system of claim 13, wherein the leak openings comprise a plurality of radially arranged slits on the lumen seal.

15. The nested system of claim 1, wherein the compressible and porous material comprises a sponge or a foam.

16. The nested system of claim 1, wherein the overtube comprises a rigi dizing overtube.

17. The nested system of claim 16, wherein the overtube comprises a plurality of layers including a rigidizing layer, a bladder layer and a support layer.

18. The nested system of claim 1, wherein the endoscope assembly comprises a rigidizing shield for an endoscope and / or an endoscope.

19. An overtube apparatus, the apparatus comprising: an elongate flexible body having a lumen extending from a proximal end to a distal end; a hydrophilic coating within the lumen; a lubrication port on a proximal end of the overtube apparatus; a wetting portal at a proximal end of the overtube apparatus in fluid communication with the lubrication port, wherein the wetting portal comprises a compressible and porous material forming a wetting surface; wherein the wetting portal is configured to receive an endoscope assembly therethrough so that the wetting surface applies a lubrication fluid from the- 29 -SG Docket No.: 13668-738.600lubrication port to an outer surface of the endoscope assembly from the compressible and porous material as the endoscope assembly moves relative to the overtube apparatus.

20. The apparatus of claim 19, further comprising a fluid line in fluid communication with the compressible and porous material of the wetting portal and the lubrication port.

21. The apparatus of claim 20, wherein the fluid line is integrated into a handle of the overtube apparatus.

22. The apparatus of claim 19, further comprising a fluid trap at least partially around the wetting portal at a radially offset distance, the fluid trap configured to receive lubrication fluid leaked by the wetting portal.

23. The apparatus of claim 22, wherein the fluid trap comprises a fluid-absorbent material.

24. The apparatus of claim 22, wherein the fluid trap is configured to be in fluidic communication with a source of suction.

25. The apparatus of claim 19, wherein the wetting portal further comprises a lumen seal adjacent to a distal side of the compressible and porous material.

26. The apparatus of claim 25, wherein the lumen seal comprises a plurality of leak openings configured to pass lubrication fluid to the wetting surface.

27. The apparatus of claim 19, wherein the compressible and porous material comprises a sponge or a foam.

28. The apparatus of claim 19, wherein the overtube apparatus comprises a rigidizing overtube.

29. The apparatus of claim 28, wherein the rigidizing overtube comprises a plurality of layers including a rigidizing layer, a bladder layer and a support layer.

30. An overtube apparatus, the apparatus comprising: an elongate flexible body having a lumen extending from a proximal end to a distal end;- 30 -SG Docket No.: 13668-738.600a hydrophilic coating within the lumen; a wetting portal comprising a ring-shaped wetting ring at a proximal end of the overtube apparatus, wherein the wetting ring comprises a porous material having an opening and / or one or more radial slits configured to form a passage for an endoscope assembly therethrough; a lubrication port on a proximal end region of the overtube apparatus, the lubrication port in fluid communication with the ring-shaped wetting ring to wet the porous material of the ring-shaped wetting ring with a lubrication fluid; wherein the passage of the wetting ring is configured to receive an endoscope assembly therethrough and to wet an outer surface of the endoscope assembly with lubrication fluid when the endoscope assembly moves relative to the overtube apparatus.

31. A method, the method comprising: applying a lubrication fluid to a lubrication port of an overtube to wet a wetting surface of an annular wetting portal of the overtube, wherein the wetting surface is formed of a compressible and porous material; and lubricating an outer surface of an endoscope assembly as the endoscope assembly is moved through the annular wetting portal by transferring the lubrication fluid from the wetting surface to the outer surface of the endoscope assembly.

32. The method of claim 31, further comprising capturing leakage from the annular wetting portal in a fluid trap at least partially surrounding the annular wetting portal.

33. The method of claim 31, further comprising pumping the lubrication fluid through the lubrication port.

34. The method of claim 31, further comprising maintaining a wetness of the annular wetting portal during operation of the overtube.

35. The method of claim 31, wherein wetting the annular wetting portal comprises saturating the compressible and porous material with the lubrication fluid.

36. The method of claim 31, wherein applying the lubrication fluid comprises applying saline.- 31 -SG Docket No.: 13668-738.6007. The method of claim 31, further comprising rigidizing the overtube to transition the overtube from a flexible configuration to a more rigid configuration by applying pressure within a plurality of layers forming the overtube.- 32 -SG Docket No.: 13668-738.600

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