Systems and methods for continuous balloon assisted endoscopy

Abstract

Methods and systems for navigating an endoscope through a lumen are disclosed. The system comprises: a) an inflatable sheath having a proximal end; a distal end opposite the proximal end; and a channel formed therethrough for receiving the endoscope, the channel having an inner surface circumferentially wrapping the endoscope, wherein the inner surface frictionally engages the endoscope; and b) a pressure control system fluidly coupled to the proximal end of the sheath configured to inflate the sheath and evert the distal end of the sheath when pressure is applied, the pressure control system having a barrel extruder for receiving an outer surface of the proximal end of the sheath, the outer surface compressed along a length of the barrel extruder and wherein the outer surface decompresses to advance the sheath through the lumen with the endoscope such that the distal end of the sheath and the distal end of the endoscope are aligned.

Description

TITLE: SYSTEMS AND METHODS FOR CONTINUOUS BALLOON ASSISTED ENDOSCOPYFIELD

[0001] The present disclosure generally relates to medical robotics, and in particular, to pneumatic-driven eversion methods and systems for guiding an endoscope through a lumen.INTRODUCTION

[0002] The following is not an admission that anything discussed below is part of the prior art or part of the common general knowledge of a person skilled in the art.

[0003] Within the field of gastroenterology, endoscopic devices are medical tools used to examine the digestive tract. They are inserted through the mouth or rectum, and facilitate viewing of the esophagus, stomach, large intestine, and parts of the small bowel. These procedures, referred to as upper endoscopies and colonoscopies, involve the insertion of semi-rigid tubes that houses a camera and light source to visualize internal anatomy and diagnose diseases, and an instrument channel that can be used to take tissue samples for biopsy and perform endoscopic procedures.

[0004] Generally, there are two main devices that are currently used in clinical practice to assess deeper diseases in the small bowel: (1 ) capsule endoscopy, and (2) double balloon endoscopy. In capsule endoscopy, the patient swallows a pill with a built-in camera. This allows for limited visualization of the small bowel and does not allow for any interventions. Further, it has a detection rate of 61 % for small bowel bleeds, and in 1 in 50 patients, the capsule becomes lodged in the small bowel (capsule retention), requiring surgical removal.

[0005] In double balloon endoscopy, an inchworm-like motion is used to advance an endoscope through the gastrointestinal tract. This approach requires significant additional training, is time consuming and, in 30-80% of cases, the device cannot travel the full length of the small bowel.SUMMARY

[0006] The following introduction is provided to introduce the reader to the more detailed discussion to follow. The introduction is not intended to limit or define any claimed or as yet unclaimed invention. One or more inventions may reside in any combination or sub-combination of the elements or process steps disclosed in any part of this document including its claims and figures.

[0007] In one broad aspect, in accordance with some embodiments, there is generally provided a system for navigating an endoscope having a distal end through a lumen. The system includes a) an inflatable sheath having a proximal end; a distal end opposite the proximal end; and a channel formed therethrough for receiving the endoscope, the channel having an inner surface circumferentially wrapping the endoscope, wherein the inner surface fictionally engages the endoscope; and b) a pressure control system fluidly coupled to the proximal end of the sheath configured to inflate the sheath and evert the distal end of the sheath when pressure is applied, the pressure control system having a barrel extruder for receiving an outer surface of the proximal end of the sheath, the outer surface compressed along a length of the barrel extruder and wherein the outer surface decompresses to advance the sheath through the lumen with the endoscope such that the distal end of the sheath and the distal end of the endoscope are aligned.

[0008] In some embodiments, the system comprises a hollow overtube having a proximal opening positioned at the pressure control system and having a distal opening placed at an entrance of the lumen for receiving the sheath therethrough.

[0009] In some embodiments, the overtube comprises an inflatable cuff surrounding the distal opening of the overtube for securing the distal opening at the entrance of the lumen.

[0010] In some embodiments, the sheath comprises a plurality of notches indenting the sheath circumferentially and spaced at set intervals along the outer surface of the sheath.

[0011] In some embodiments, the sheath comprises one or more tendon wires disposed along a length of the sheath for selectively controlling the direction of the sheath when actuated.

[0012] In some embodiments, the sheath comprises one or more shape memory alloy (SMA) wires disposed along the length of the sheath for selectively controlling the direction of the sheath when actuated.

[0013] In some embodiments, the sheath comprises one or more selectively inflatable segments, each segment controllable to stiffen the sheath when inflated.

[0014] In some embodiments, the pressure control system comprises one or more pressure sensors positioned along a length of the sheath for monitoring the pressure applied to the sheath.

[0015] In some embodiments, the pressure control system comprises a pressure relief valve for releasing excess pressure in the sheath.

[0016] In some embodiments, the pressure control system comprises motorized rollers for enabling the selective release of the outer surface.

[0017] In some embodiments, the inner surface folds inwardly along the length of the sheath forming a plurality of pleats, wherein each pleat unfolds to advance the sheath through the lumen with the endoscope such that the distal end of the sheath and the distal end of the endoscope are aligned.

[0018] In some embodiments, the outer surface is compressed along the distal end of the sheath adjacent the distal end of the endoscope, wherein the outer surface decompresses along the distal end to advance the sheath through the lumen with the endoscope such that the distal end of the sheath and the distal end of the endoscope are aligned.

[0019] In some embodiments, a proximal end of the sheath is secured to a proximal end of the barrel extruder, the barrel extruder being housed within a pressurized chamber, and a distal end of the sheath is attached to an O-ring seal.

[0020] In some embodiments, the sheath comprises evertable segments along the length of the sheath, each evertable segment independently controlling the proportional advancement of the sheath with the endoscope.

[0021] In another broad aspect, in accordance with some embodiments, there is generally provided a method for navigating an endoscope having a distal end through a lumen. The method comprises wrapping the endoscope with an inflatable sheath having a distal end to frictionally engage the endoscope, the sheath having a channel formed therethrough for receiving the endoscope; compressing an outer surface of the sheath along a barrel extruder configured to receive a proximal end of the sheath along a length of thebarrel extruder; applying a pressure using a pressure control system fluidly coupled to the sheath to inflate the sheath causing eversion.

[0022] In some embodiments, the method comprises activating rollers to selectively release the outer surface of the sheath to advance the sheath through the lumen with the endoscope such that the distal end of the sheath and the distal end of the endoscope are aligned.

[0023] In some embodiments, the method comprises folding the inner surface inwardly along the length of the sheath to form a plurality of pleats, wherein the inner surface unfolds to advance the sheath through the lumen with the endoscope such that the distal end of the sheath and the distal end of the endoscope are aligned.

[0024] In some embodiments, the method comprises compressing the outer surface along the distal end of the sheath adjacent the distal end of the endoscope, wherein the compressed outer surface decompresses to advance the sheath through the lumen with the endoscope such that the distal end of the sheath and the distal end of the endoscope are aligned.

[0025] In some embodiments, the method comprises securing a proximal end of the sheath to the proximal end of the barrel extruder and attaching a distal end of the sheath to an O-ring seal, wherein the proximal end of the barrel extruder is housed within a pressurized chamber.

[0026] In some embodiments, the method comprises positioning a hollow overtube having a proximal opening positioned at the pressure control system and having a distal opening placed at an entrance of the lumen for receiving the sheath and endoscope therethrough.BRIEF DESCRIPTION OF THE DRAWINGS

[0027] For a better understanding of the embodiments described herein and to show more clearly how they may be carried into effect, reference will now be made, by way of example only, to the accompanying drawings which show at least one exemplary embodiment, and in which:

[0028] FIG. 1 shows an example system for navigating an endoscope having a distal end through a lumen, in accordance with some embodiments

[0029] FIG. 2 shows an illustration of an example system for navigating an endoscope having a distal end through a lumen using an overtube, in accordance with some embodiments.

[0030] FIG. 3 shows an illustration of an example system for coordinating the advancement of an inflatable sheath and an endoscope through a lumen, in accordance with some embodiments.

[0031] FIG. 4A shows an illustration of another example system for coordinating the advancement of an inflatable sheath and an endoscope through a lumen, in accordance with some embodiments.

[0032] FIG. 4B shows an illustration of another example system for coordinating the advancement of an inflatable sheath and an endoscope through a lumen, in accordance with some embodiments.

[0033] FIG. 5 shows an illustration of another example system for coordinating the advancement of an inflatable sheath and an endoscope through a lumen, in accordance with some embodiments.

[0034] FIG. 6 shows an illustration of an example inflatable sheath, in accordance with some embodiments.

[0035] FIG. 7 shows an illustration of another example inflatable sheath, in accordance with some embodiments.

[0036] FIG. 8 shows an illustration of another example system for coordinating the growth of an inflatable sheath and an endoscope using a spooled approach, in accordance with some embodiments.DESCRIPTION OF VARIOUS EMBODIMENTS

[0037] Various embodiments in accordance with the teachings herein will be described below to provide an example of at least one embodiment of the claimed subject matter. No embodiment described herein limits any claimed subject matter. The claimed subject matter is not limited to devices, systems or methods having all of the features of any one of thedevices, systems or methods described below or to features common to multiple or all of the devices, systems or methods described herein. It is possible that there may be a device, system or method described herein that is not an embodiment of any claimed subject matter. Any subject matter that is described herein that is not claimed in this document may be the subject matter of another protective instrument, for example, a continuing patent application, and the applicants, inventors or owners do not intend to abandon, disclaim or dedicate to the public any such subject matter by its disclosure in this document.

[0038] For simplicity and clarity of illustration, reference numerals may be repeated among the figures to indicate corresponding or analogous elements. In addition, numerous specific details are set forth in order to provide a thorough understanding of the subject matter described herein. However, it will be understood by those of ordinary skill in the art that the subject matter described herein may be practiced without these specific details. In other instances, well-known methods, procedures and components have not been described in detail so as not to obscure the subject matter described herein. The description is not to be considered as limiting the scope of the subject matter described herein.

[0039] Various embodiments in accordance with the teachings herein will be described below to provide an example of at least one embodiment of the claimed subject matter. No embodiment described herein limits any claimed subject matter. The claimed subject matter is not limited to devices, systems or methods having all of the features of any one of the devices, systems or methods described below or to features common to multiple or all of the devices, systems or methods described herein. It is possible that there may be a device, system or method described herein that is not an embodiment of any claimed subject matter. Any subject matter that is described herein that is not claimed in this document may be the subject matter of another protective instrument, for example, a continuing patent application, and the applicants, inventors or owners do not intend to abandon, disclaim or dedicate to the public any such subject matter by its disclosure in this document.

[0040] For simplicity and clarity of illustration, reference numerals may be repeated among the figures to indicate corresponding or analogous elements. In addition, numerous specific details are set forth in order to provide a thorough understanding of the subject matter described herein. However, it will be understood by those of ordinary skill in the art that thesubject matter described herein may be practiced without these specific details. In other instances, well-known methods, procedures and components have not been described in detail so as not to obscure the subject matter described herein. The description is not to be considered as limiting the scope of the subject matter described herein.

[0041] It should also be noted that the terms “coupled” or “coupling” as used herein can have several different meanings depending on the context in which these terms are used. For example, the terms coupled or coupling can have a logical, mechanical, fluidic or electrical connotation. For example, as used herein, the terms coupled or coupling can indicate that two elements or devices can be directly connected to one another or connected to one another through one or more intermediate elements or devices via an electrical or magnetic signal, electrical connection, an electrical element or a mechanical element depending on the particular context. Furthermore, coupled electrical elements may send and / or receive data.

[0042] Unless the context requires otherwise, throughout the specification and claims which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense, that is, as “including, but not limited to”.

[0043] It should also be noted that, as used herein, the wording “and / or” is intended to represent an inclusive-or. That is, “X and / or Y” is intended to mean X or Y or both, for example. As a further example, “X, Y, and / or Z” is intended to mean X or Y or Z or any combination thereof.

[0044] It should be noted that terms of degree such as "substantially", "about" and "approximately" as used herein mean a reasonable amount of deviation of the modified term such that the end result is not significantly changed. These terms of degree may also be construed as including a deviation of the modified term, such as by 1 %, 2%, 5% or 10%, for example, if this deviation does not negate the meaning of the term it modifies.

[0045] Furthermore, the recitation of numerical ranges by endpoints herein includes all numbers and fractions subsumed within that range (e.g. 1 to 5 includes 1 , 1.5, 2, 2.75, 3, 3.90, 4, and 5). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term "about" which means a variation of up to a certainamount of the number to which reference is being made if the end result is not significantly changed, such as 1 %, 2%, 5%, or 10%, for example.

[0046] Reference throughout this specification to “one embodiment”, “an embodiment”, “at least one embodiment” or “some embodiments” means that one or more particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments, unless otherwise specified to be not combinable or to be alternative options.

[0047] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. It should also be noted that the term “or” is generally employed in its broadest sense, that is, as meaning “and / or” unless the content clearly dictates otherwise.

[0048] Similarly, throughout this specification and the appended claims the term “communicative” as in “communicative pathway,” “communicative coupling,” and in variants such as “communicatively coupled,” is generally used to refer to any engineered arrangement for transferring and / or exchanging information. Exemplary communicative pathways include, but are not limited to, electrically conductive pathways (e.g., electrically conductive wires, electrically conductive traces), magnetic pathways (e.g., magnetic media), optical pathways (e.g., optical fiber), electromagnetically radiative pathways (e.g., radio waves), or any combination thereof. Exemplary communicative couplings include, but are not limited to, logical couplings, electrical couplings, magnetic couplings, optical couplings, radio couplings, or any combination thereof.

[0049] Throughout this specification and the appended claims, infinitive verb forms are often used. Examples include, without limitation: “to detect,” “to provide,” “to transmit,” “to communicate,” “to process,” “to route,” and the like. Unless the specific context requires otherwise, such infinitive verb forms are used in an open, inclusive sense, that is as “to, at least, detect,” to, at least, provide,” “to, at least, transmit,” and so on.

[0050] The example systems and methods described herein may be implemented as a combination of hardware or software. In some cases, the examples described herein may be implemented, at least in part, by using one or more computer programs, executing on one or more programmable devices comprising at least one processing element, and a datastorage element (including volatile memory, non-volatile memory, storage elements, or any combination thereof). These devices may also have at least one input device (e.g. a keyboard, mouse, touchscreen, or the like), and at least one output device (e.g. a display screen, a printer, a wireless radio, or the like) depending on the nature of the device.

[0051] Some elements that are used to implement at least part of the systems, methods, and devices described herein may be implemented via software that is written in a high-level procedural language such as object-oriented programming. The program code may be written in C++, C#, JavaScript, Python, or any other suitable programming language and may comprise modules or classes, as is known to those skilled in object-oriented programming. Alternatively, or in addition thereto, some of these elements implemented via software may be written in assembly language, machine language, or firmware as needed. In either case, the language may be a compiled or interpreted language.

[0052] At least some of these software programs may be stored on a computer readable medium such as, but not limited to, a ROM, a magnetic disk, an optical disc, a USB key, and the like that is readable by a device having at least one processor, an operating system, and the associated hardware and software that is used to implement the functionality of at least one of the methods described herein. The software program code, when read by the device, configures the device to operate in a new, specific, and predefined manner (e.g., as a specific-purpose computer) in order to perform at least one of the methods described herein.

[0053] Furthermore, at least some of the programs associated with the systems and methods described herein may be capable of being distributed in a computer program product including a computer readable medium that bears computer usable instructions for one or more processors. The medium may be provided in various forms, including non- transitory forms such as, but not limited to, one or more diskettes, compact disks, tapes, chips, and magnetic and electronic storage. Alternatively, the medium may be transitory in nature such as, but not limited to, wire-line transmissions, satellite transmissions, internet transmissions (e.g. downloads), media, digital and analog signals, and the like. The computer usable instructions may also be in various formats, including compiled and uncompiled code.

[0054] Current endoscopic devices are limited in their ability to reliably access the small bowel and treat medical conditions in the small bowel. For example, in patients with bleeding in the small bowel, constraints with conventional devices often necessitate long hospital stays and multiple tests and attempted therapies. These delays result in increased patient morbidity and mortality, and increased rates of surgical interventions. For instance, Gl bleeding in the small bowel that cannot be accessed endoscopically or treated by another means typically requires resection of a large portion of the affected bowel. Similar challenges are faced with other small bowel conditions, where limited access impedes timely and effective treatment.

[0055] Further, a major challenge limiting endoscopic access to the small bowel using conventional endoscopes is looping, which occurs in 91 % of cases when exploring the large bowel and at even higher frequencies over longer distances travelled. Looping occurs when an endoscope stretches and distends the wall of the digestive tract in response to efforts of the operator to advance the endoscope forward. Specifically, looping involves the endoscope forming unintended coils or loops within the digestive tract, which impedes its linear advancement. Looping can occur at any point in the digestive tract, although it becomes a more pressing issue within the small bowel, as the small bowel is only loosely tethered into place by connective tissue and has a great degree of freedom of movement. Specifically, while the initial portions of the duodenum can be reached by traditional upper endoscopes, travelling to the end of the duodenum, or into the jejunum or ileum (the distal portion of the small bowel), is precluded due to endoscopic looping and loss of endoscope tip control.

[0056] Looping can cause discomfort, and substantially increases the risk of perforating the wall of the digestive tract. The predominant cause of looping during the advancement of semi-rigid endoscopes is that the propulsive force is applied proximally. During deep endoscopy, the application of propulsive force from the proximal end over extensive lengths exacerbates looping, making it a particularly pressing issue. To this end, systems have been developed to reduce endoscopic looping. For example, by employing pressure-driven eversion that exerts a pulling force from the distal end to complement the traditional pushing force applied proximally. In doing so, such systems can provide a more safe, reliable, and timely method of accessing the entire length of the small bowel from an oral approach.

[0057] However, this form of tip-based growth commonly occurs in an unfavorable 2:1 manner, wherein the endoscope advances two feet for every one foot that the everting plastic grows. This occurs due to the differential speed between the endoscope and the everting plastic. When the endoscope advances, it moves only itself, whereas the everting plastic must grow on both the internal and external sides. Since dual wall material is required for tip advancement, twice the material is required, so the everting plastic advances at half the rate compared to the endoscope. One potential solution is to periodically depressurize the system with the introduction of air or a fluid between the endoscope and everting plastic, and then withdraw the endoscope so that their leading edges match. However, this would be both time consuming and would result in an undesirable non-continuous and interrupted procedure. Additionally, given the significant lengths of the small bowel, significant cumulative frictional forces between the endoscope and inner lining of the everting plastic make this strategy difficult.

[0058] The present disclosures describe pneumatic eversion driven systems for generating a forward-propelling force, effectively advancing an endoscope from a distal end. The presently disclosed systems describe the endoscope wrapped in an outer sheath, which inflates and everts close to the end tip of the endoscope, and in doing so, pulls the endoscope forwards with it. The presently disclosed systems implement methods for ensuring proportional growth of the outer sheath with the endoscope.

[0059] Reference is first made to FIG. 1 which shows an illustration of a system for navigating an endoscope having a distal end through a lumen in accordance with some embodiments. The system 100 shown in FIG. 1 comprises an inflatable sheath 110 having proximal end 111 a; a distal end 111 b; a channel formed therethrough for receiving an endoscope 120. A pressure control system 130 can control the inflation of the inflatable sheath 110 by applying pressure to the inflatable sheath 110 to cause eversion. As the inflatable sheath 110 everts, the inflatable sheath 110 controls the movement of the endoscope 120. Pneumatic eversion advances the endoscope 120 through the lumen. As the everting inflatable sheath 110 grows, it advances the endoscope 120 along with it from the distal end 111 b such that the distal end of the endoscope 120 and the distal end 111 b of the inflatable sheath 110 are aligned. This can reduce the formation of loops and allow fordeeper access into the lumen the system 100 is navigating. The inflatable sheath 110 creates sufficient friction between lumen to enable stability without slippage.

[0060] In some embodiments, the inflatable sheath can be constructed of a soft plastic such as but not limited to polyethylene plastics, polyurethane, silicone, and Ethylene-vinyl acetate (EVA). The outer diameter of the inflatable sheath can have an outer diameter sized to fit the lumen it is designed to navigate. For example, the diameter of the inflatable sheath may be reduced to enable consistent access within pediatric patients or those with more narrow or delicate gastrointestinal features.

[0061] In some embodiments, internal lubrication can be used between the internal and external surfaces of the everting plastic to minimize friction as the endoscope advances. The endoscope may have a hydrophobic coating which further reduces the friction between the outer plastic surface and the inner endoscope.

[0062] In some embodiments, the endoscope may include one or more of an objective lens, light sources, auxiliary water channels, air / water nozzles, and an instrument channel. The instrument channel may be configured with, for example, a clip or a cautery tool for managing bleeding, biopsy forceps for taking tissue samples.

[0063] The pressure control system 130 controls and monitors the pressure applied to the inflatable sheath 110. In some embodiments, the pressure control system 130 can include one or more pressure sensors. The pressure sensors can be positioned along the inflatable sheath 110 to monitor the pressure of the inflatable sheath 110. In this way, both the inflatable sheath 110 and endoscope 120 advancement can be controlled in real-time. For example, any significant unexpected decline in air pressure when the endoscope 120 is not being advanced may signal air leakage or inappropriate system function. The pressure sensor may be, for example, a digital pressure sensor, an analog pressure sensor a micro- electro-mechanical systems (MEMS) pressure sensor, a silicon-based sensor, a piezoelectric sensor, a piezo-resistive sensor, a miniature capacitive sensor, or a fiber optic pressure sensor.

[0064] In some embodiments, the pressure control system 130 can include motorized rollers. The motorized rollers can enable the selective release of the outer surface tocoordinate the growth of the distal end of the inflatable sheath with the distal end of the endoscope as the sheath and the endoscope advance through the lumen.

[0065] In some embodiments, the pressure control system 130 includes a pressure relief valve. If the system 100 malfunctions, the pressure relief valve may be engaged to depressurize the inflatable sheath 110. The pressure control system 130 may further include a rupture disk to regulate and limit internal pressures. In some embodiments, a compressor can be used to pressurize a compressed air cylinder to provide an ongoing source of pneumatic drive.

[0066] Reference is next made to FIG. 2, which shows an illustration of another example system for navigating an endoscope through a lumen using an overtube in accordance with some embodiments. The system 200 includes an inflatable sheath 210 and an endoscope 220.

[0067] In some embodiments, the system 200 can include a hollow overtube 240. The overtube 240 can have a proximal opening positioned at the pressure control system. The overtube 240 can have a distal opening 242 placed at an entrance of a lumen. For example, the distal opening 242 can be placed at the entrance of a small bowel during a small bowel endoscopy. In some cases, the overtube 240 may be lubricated before being inserted into the body. The overtube 240 can receive the inflatable sheath 210 and the endoscope 220 therethrough to enable rapid access of the endoscope 220 to the lumen.

[0068] The overtube can be transparent or semi-transparent and constructed, for example, of a semi-rigid plastic material such as but not limited to polyurethane, poly propylene, or nylon. In other embodiments, the overtube may be opaque and constructed of non-plastic materials, depending on the specific procedural requirements. Inserting the overtube prior to inserting the inflatable sheath and endoscope avoids accidental endoscope insertion into the trachea during its descent. The overtube also limits the capacity for the endoscope to loop in the stomach. Portions of the gastrointestinal tract (e.g., upper esophageal sphincter, lower esophageal sphincter, and pylorus) are also protected by the overtube from pressure-related injuries caused by inflation of the everting plastic.

[0069] In some embodiments, the overtube 240 can include an inflatable cuff 244. The inflatable cuff 244 can surround the distal opening 242. The inflatable cuff 244 secures thedistal opening 242 and the overtube 240 to an entrance of the lumen. For example, the inflatable cuff can be positioned at the pyloric sphincter. When inflated, the inflatable cuff can hold the pyloric sphincter open to permit both shortening and / or straightening of the overtube, as well as entrance of the inflatable sheath and endoscope to perform endoscopy.

[0070] Reference is next made to FIG. 3, which shows an illustration of an example system for coordinating the advancement of an inflatable sheath and an endoscope through a lumen, in accordance with some embodiments. The system 300 includes an inflatable sheath 310 having a channel 312 formed therethrough for receiving an endoscope 320. The sheath has an inner surface 310a that circumferentially wraps the endoscope 320. The inner surface 310a frictionally engages the endoscope 320 and everts when inflated. As the inflatable sheath 310 everts, the endoscope 320 is advanced in direction D.

[0071] The system 300 also includes a pressure control system 330 that is fluidly coupled to the proximal end 311 a of the inflatable sheath 310. The pressure control system 330 is configured to inflate the inflatable sheath 320 when pressure is applied. The pressure control system 330 includes a barrel extruder 332. The outer surface 310b of the proximal end 311 a end of the inflatable sheath 310 can be compressed along a length of the barrel extruder 332 and decompressed along the barrel extruder 332 to advance the inflatable sheath 310 through the lumen with the endoscope 320 such that the distal end 311 b of the inflatable sheath 310 and the distal end of the endoscope 320 are aligned (also referred to as proportional growth or proportional advancement).

[0072] To ensure coordinated advancement of the inflatable sheath 310 with the endoscope 320, the inflatable sheath 310 is externally overwrapped along the barrel extruder 332. Excess everting plastic material from the outer surface 310b of the inflatable sheath 310 is compressed along the length of a barrel extruder 332 and is released in a gradual manner through the use of motorized rollers 334 turning in the direction indicated. The release of the outer surface 310b of the outer sheath 310 is synchronized with the advancement of the endoscope 320 to achieve proportional growth.

[0073] In this configuration, the inflatable sheath 310 primarily everts by flipping its inner surface 310a outward. Excess everting material from the outer surface 310b is folded and stored along the length of the barrel extruder 332 to manage growth rates. When therollers 334 release the excess plastic, this allows for the everting plastic to grow independently of the endoscope 320 advancement, with the everting plastic folding inward from the outer surface 310b. This adjustment is actively monitored and controlled by integrated control systems, preventing disproportionate growth between the endoscope 320 and the inflatable sheath 310 and ensuring controlled forward advancement.

[0074] Reference is next made to FIGS. 4A and 4B, which show illustrations of example systems for coordinating the advancement of an inflatable sheath and an endoscope through a lumen, in accordance with some embodiments. The system 400 includes an inflatable sheath 410 and an endoscope 420. The system 400 illustrates another means of ensuring proportional growth between the inflatable sheath 410 and the endoscope 420. The system can be used independently or in combination with any other system described herein for achieving proportional growth between an endoscope and an inflatable sheath in a pneumatic driven eversion system. For example, the system 400 can be used in combination with the system 300 to ensure the distal end of the endoscope 420 and the distal end of the inflatable sheath 410 are aligned.

[0075] In some embodiments, an inner surface 410a can fold inwardly at set intervals along a length of the inflatable sheath to form a plurality of pleats 412. Each pleat 412 unfolds to achieve proportional growth between the inflatable sheath 410 and the endoscope 420. For example, excess everting material from the inner surface 410a of the inflatable sheath 410 can be wrapped and bound around the endoscope 420. The folded everting material unravels as the endoscope 420 advances. Since the inner surface 410a of the everting material is pressure clamped (i.e., the circumferential pressure cases the everting material to collapse tightly around the endoscope 420 when pressurized), the frictional forces between the inner surface 410a of the inflatable sheath 410 and the endoscope 420 prevents the early release or advancement of the everting material.

[0076] As shown in FIG. 4B, in some embodiments, the system 400b comprises evertable segments 450a, 450b along the length of an inflatable sheath 430. The evertable segments 450 can be disposed along the length of the sheath 430. Each evertable segment 450 can independently control the advancement of the sheath 430 proportionally with the endoscope 440. Each evertable segment 450 can utilize any of the methods for enablingproportional advancement, as described herein. For example, evertable segment 450a may include excess everting material from the inner surface 430a folded inwardly to form pleats; and evertable segment 450b may include excess everting material from the outer sheath 430b, compressed along the length of the evertable segment 450. Both evertable segments 450 control the advancement of the sheath 430 to ensure that the distal end of the sheath 430 is aligned with the distal end of the endoscope 440 as the endoscope 440 advances. The evertable segments 450 can act independently (i.e., via a separate control system) or in combination (i.e., via the same control system). Although only two evertable segments are shown in FIG. 4B, it will be understood that there may be more than two evertable segments in other embodiments.

[0077] Reference is next made to FIG. 5, which shows an illustration of another example system for coordinating the advancement of an inflatable sheath and an endoscope through a lumen, in accordance with some embodiments. The system 500 includes an inflatable sheath 510 and an endoscope 520. In some embodiments, a proximal end 514 of the inflatable sheath 510 can be secured to a proximal end 534a of a barrel extruder 532. The barrel extruder 532 is housed within a pressurized chamber 536. A distal end 516 of the inflatable sheath 510 is attached to an O-ring seal.

[0078] This configuration is similar to the system 300. However, in system 500, the endoscope 520 enters the barrel extruder 532 without being wrapped in everting material. The everting material is added as it passes beyond the distal end 534b of the barrel extruder 532. The inflatable sheath 510 everts exclusively by flipping the inner surface 510a outward. The barrel extruder 532 is housed within a pressurized chamber 536b with an optional partitioning wall 538. The partitioning wall 538 can connect to the barrel extruder 532 via, for example, an O-ring seal to provide a depressurized chamber 536a to house the barrel extruder 532 and the rollers 534. In some embodiments, the system 500 may include a depressurized section to accommodate the barrel extruder, roller, and plastic supply.

[0079] In this configuration, the excess everting material is strategically folded and stored along the length of the barrel extruder 532. The storage can be variably positioned. In some embodiments, excess everting material is stored close to the proximal end 534a within the pressurized chamber 536a. Alternatively, or in other embodiments, the excess evertingmaterial can be located nearer to the distal tip of the endoscope, depending on the specific operational or clinical needs. The proximal end of the inflatable sheath 510 can be secured to the proximal end 534a of the extruder 532 while the distal end 534b, can be attached to an 0-ring seal. This configuration enables the controlled eversion of the everting material from the barrel extruder 532. In addition, this configuration enables the use of higher operating pressures by minimizing pressure clamping of the everting plastic to the barrel extruder 532 with the associated friction limiting sliding.

[0080] FIG. 6 shows an example illustration of an inflatable sheath, in accordance with some embodiments. In some embodiments, the sheath can include a plurality of notches 610. The notches can indent the sheath circumferentially and can be spaced at set intervals along the outer surface of the sheath. For example, circumferential notches 610 can be disposed along the outer surface of an example system 600. Each circumferential notch 610 acts as a flexion point for the design to increase the compliance around the turns of the lumen the system is navigating.

[0081] In some embodiments, the sheath can include selectively inflatable segments. The selectively inflatable segments control the direction of the sheath when inflated. For example, increasing pressure at a selectively inflatable segment can stiffen the inflatable sheath and straighten the endoscope.

[0082] FIG. 7 shows another example illustration of an inflatable sheath, in accordance with some embodiments. In some embodiments, the sheath can include one or more tendon wires 710. The tendon wires 710 can be disposed along the length of the sheath. Each tendon wire can selectively control the direction of the sheath as the sheath is inflated. For example, an inflatable sheath may include one or more tendon wires 710 to control the steering. Due to the extended length of the endoscope, the tensile forces required to be applied on the tendon wires may be significantly greater than that of conventional endoscopes to overcome the increased longitudinal friction.

[0083] In some embodiments, the sheath can include shape memory alloy (SMA) actuation wires. The SMA wires can be disposed along the length of the sheath. Similar to the tendon wires, the SMA wires can be used for precise tip control to steer the endoscope. SMA wires can leverage the shape-memory effect, which allows the alloy to change shapein response to temperature variations. In other embodiments, the sheath can include one or more of piezoelectric actuators, hydraulic systems, or external magnetic fields to guide a magnetized tip.

[0084] Reference is next made to FIG. 8, which shows an illustration of a spooled approach for use with the system. A pressurized chamber 850 can contain a rotating spool 852. An endoscope 810 can be wrapped around the spool 852. The spool 852 is rotated inside the base of the device. An increase in chamber pressure causes the sheath 810 surrounding the endoscope to evert, pulling the endoscope 820 forward with it as the sheath 820 lengthens. In some cases, additional force may be manually applied to the endoscope to assist with overcoming friction of navigational challenges that cannot be addressed by eversion alone. The everting sheath 810 is then inserted into an opening created by an overtube 840. The everting sheath 810 can be pre-inflated prior to opening of the path created by the overtube 810.

[0085] The systems and methods described herein can be used for application such as but not limited to, identifying and treating bleeds, autoimmune conditions, and malignancies of the small bowel. The proposed device may have also have applications in (1 ) small bowel biopsies (gut microbiome sampling, mucosal biopsies, testing for infectious diseases); (2) dilation / stenting of strictures and / or bowel obstructions (e.g., ischemic, malignant), increasing access to deeper regions of the small bowel to allow for the delivery of therapeutic interventions such as stenting or balloon dilations; (3) endoscopic access to the biliary tree and facilitation of Endoscopic Retrograde Cholangiopancreatography (ERCP), particularly in patients with altered gastrointestinal anatomy (e.g., postpancreaticoduodenectomy, Roux-en-Y), improving the ability to reach the bile and pancreatic ducts for removal of stones, stenting of strictures, or addressing other ductal conditions; (4) difficult colonoscopies by offering improved navigation and control in anatomically challenging cases; (5) incorporation of endoscopic ultrasound to provide enhanced imaging and diagnostic capabilities during procedures; and (6) functional gastrointestinal disorders, such as Irritable Bowel Syndrome, to rule out underlying organic pathologies. Additionally, tools such as a duodenoscope can be utilized with the system for enhanced diagnostic and therapeutic capabilities.

[0086] Beyond its application in gastroenterology, the system may also be adapted for procedures in fields such as urology, gynecology, nasopharyngoscopy, and colorectal surgery, as well as Natural Orifice Transluminal Endoscopic Surgery (NOTES), offering benefits for minimally invasive interventions in a variety of anatomical regions. In the context of NOTES procedures, these procedures are currently limited by the use of flexible endoscopes outside of the digestive tract, where there is no longer a natural lumen to assist with directing the endoscope in the proper direction during advancement. Through the use of a continuous everting balloon, optionally designed with a predetermined shape (i.e. some sides being longer than others) such a balloon would create an artificial lumen to direct the endoscope outside of the digestive tract, such as during a transgastric or transrectal approach. This would facilitate a wide array of intra-abdominal applications to replace otherwise laparoscopic procedures, such as cholecystectomies, solid organ tissue sampling, lysis of adhesions, etc.

Claims

CLAIMS:

1. A system for navigating an endoscope having a distal end through a lumen, comprising: a) an inflatable sheath having a proximal end; a distal end opposite the proximal end; and a channel formed therethrough for receiving the endoscope, the channel having an inner surface circumferentially wrapping the endoscope, wherein the inner surface fictionally engages the endoscope; and b) a pressure control system fluidly coupled to the proximal end of the sheath configured to inflate the sheath and evert the distal end of the sheath when pressure is applied, the pressure control system having a barrel extruder for receiving an outer surface of the proximal end of the sheath, the outer surface compressed along a length of the barrel extruder and wherein the outer surface decompresses to advance the sheath through the lumen with the endoscope such that the distal end of the sheath and the distal end of the endoscope are aligned.

2. The system of claim 1 , further comprising a hollow overtube having a proximal opening positioned at the pressure control system and having a distal opening placed at an entrance of the lumen for receiving the sheath therethrough.

3. The system of claim 2, wherein the overtube comprises an inflatable cuff surrounding the distal opening of the overtube for securing the distal opening at the entrance of the lumen.

4. The system of any one of claims 1 to 3, wherein the sheath comprises a plurality of notches indenting the sheath circumferentially and spaced at set intervals along the outer surface of the sheath.

5. The system of any one of claims 1 to 4, wherein the sheath comprises one or more tendon wires disposed along a length of the sheath for selectively controlling the direction of the sheath when actuated.

6. The system of any one of claims 1 to 5, wherein the sheath comprises one or more shape memory alloy (SMA) wires disposed along the length of the sheath for selectively controlling the direction of the sheath when actuated.

7. The system of claims 1 to 6, wherein the sheath comprises one or more selectively inflatable segments, each segment controllable to stiffen the sheath when inflated.

8. The system of any one of claims 1 to 7, wherein the pressure control system comprises one or more pressure sensors positioned along a length of the sheath for monitoring the pressure applied to the sheath.

9. The system of any one of claims 1 to 8, wherein the pressure control system comprises a pressure relief valve for releasing excess pressure in the sheath.

10. The system of any one of claims 1 to 9, wherein the pressure control system further comprises motorized rollers for enabling the selective release of the outer surface.11 . The system of claim any one of claims 1 to 10, wherein the inner surface folds inwardly along the length of the sheath forming a plurality of pleats, wherein each pleat unfolds to advance the sheath through the lumen with the endoscope such that the distal end of the sheath and the distal end of the endoscope are aligned.

12. The system of any one of claims 1 to 11 , wherein the outer surface is compressed along the distal end of the sheath adjacent the distal end of the endoscope, wherein the outer surface decompresses along the distal end to advance the sheath through the lumen with the endoscope such that the distal end of the sheath and the distal end of the endoscope are aligned.

13. The system of any one of claims 1 to 12, wherein a proximal end of the sheath is secured to a proximal end of the barrel extruder, the barrel extruder being housed within a pressurized chamber, and a distal end of the sheath is attached to an O-ring seal.

14. The system of any one of claims 1 to 13, wherein the sheath further comprises evertable segments along a length of the sheath, each evertable segment independently controlling the advancement of the sheath through the lumen with the endoscope such that the distal end of the sheath and the distal end of the endoscope are aligned.

15. A method for navigating an endoscope having a distal end through a lumen, comprising:a) wrapping the endoscope with an inflatable sheath having a distal end to fictionally engage the endoscope, the sheath having a channel formed therethrough for receiving the endoscope; b) compressing an outer surface of the sheath along a barrel extruder configured to receive a proximal end of the sheath along a length of the barrel extruder; c) applying a pressure using a pressure control system fluidly coupled to sheath to inflate the sheath causing eversion.

16. The method of claim 15, further comprising activating rollers to selectively release the outer surface of the sheath to advance the sheath through the lumen with the endoscope such that the distal end of the sheath and the distal end of the endoscope are aligned.

17. The method of claim 15, further comprising folding the inner surface inwardly along the length of the sheath to form a plurality of pleats, wherein the inner surface unfolds to advance the sheath through the lumen with the endoscope such that the distal end of the sheath and the distal end of the endoscope are aligned.

18. The method of claim 15, further comprising compressing the outer surface along the distal end of the sheath adjacent the distal end of the endoscope, wherein the compressed outer surface decompresses to advance the sheath through the lumen with the endoscope such that the distal end of the sheath and the distal end of the endoscope are aligned.

19. The method of claim 15, further comprising securing a proximal end of the sheath to the proximal end of the barrel extruder and attaching a distal end of the sheath to an 0-ring seal, wherein the proximal end of the barrel extruder is housed within a pressurized chamber.

20. The method of claim 15, further comprising positioning a hollow overtube having a proximal opening positioned at the pressure control system and having a distal opening placed at an entrance of the lumen for receiving the sheath and endoscope therethrough.

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