US20080183038A1

Movatterモバイル変換

Info

Publication number: US20080183038A1
Application number: US12/023,986
Authority: US
Inventors: Alexander Quillin Tilson; Eugene Duval
Original assignee: Loma Vista Medical Inc
Current assignee: Loma Vista Medical Inc
Priority date: 2007-01-30
Filing date: 2008-01-31
Publication date: 2008-07-31

Abstract

A biological navigation device that can be attached or integrated with an elongated element, such as a colonoscope, is disclosed. The device can be used for navigation through a biological lumen. The device can have an everting tube controllably tearable substantially in the direction of the long axis of the device. The elongated element can be deployed through a channel formed in the inner virtual space of the channel extending along the long axis.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of PCT Application Nos. PCT/US08/52535, filed 30 Jan. 2008; and PCT/US08/52542, filed 30 Jan. 2008; which claim the benefit of U.S. Provisional Application Ser. Nos. 60/887,319, filed 30 Jan. 2007; 60/887,323, filed 30 Jan. 2007; and 60/949,219, filed 11 Jul. 2007, all of which are incorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The presented invention relates generally to devices for the exploration of luminal cavities. One such device example is an endoscope, which can be used to explore body passages. Such passages typically include, but are not limited to, the GI tract, the pulmonary and gynecological systems, urological tracts, and the coronary vasculature. One application is directed towards the exploration of the lower part of the GI tract, for example the large intestine or colon.

2. Description of the Related Art

Colonoscopy is a diagnostic and sometimes therapeutic procedure used in the prevention, diagnosis and treatment of colon cancer, among other pathologies. With colonoscopy, polyps can be harvested before they metastasize and spread. With regular colonoscopies, the incidence of colon cancer can be substantially reduced.

A simplified typical large intestine or colon is shown inFIG. 1. Theanus12 can provide entry into the colon for a colonoscopy. Thecolon10 extends from the rectum to thececum24 and hassigmoid16, descending18, transverse20 and ascending portions. The sigmoid colon is the s-shaped portion of the colon between the descending colon and the rectum.

Colonoscopy typically involves the anal insertion of a semi-flexible shaft. To typically navigate the colon, the forward few inches of tip are flexed or steered as the shaft is, alternately pushed, pulled, and twisted in a highly skill-based attempt to advance to the end of the colon: the cecum. The medical professional imparts these motions in close proximity to the anus, where the device enters. Tip flexure has typically been accomplished by rotating wheels—one that controls cables that move the tip right-left, and one that controls cables that move the tip up-down.

A shown inFIG. 2, colonoscopes typically utilize various conduits or channels. The conduits or channels often contain elements that enable vision (e.g., fiber optics, CCD cameras, CMOS camera chips) and lighting (e.g., fiber optic light sources, high power LEDs (Light Emitting Diodes)), such as energy delivery and/or

receipt conduits

26,28 and29. They have conduits that provide suction or pressurization, fluid irrigation, the delivery of instruments (e.g. for cutting, coagulation, polyp removal, tissue sampling) and lens cleaning elements (typically a right angle orifice that exits near the camera, such that a fluid flush provides a cleansing-wash), such as

conduits

30,32,34,36,38,40 and42.

Colonoscopes include articulating sections at their tip, which allow the user to position the tip. These articulating sections have rigid link bodies that rotate relative to each other through the use of pins at their connecting joints. As tensile cables pull from the periphery of the articulating sections, they impart torques, which rotate the link sections on their pins, articulating the tip section. The links are usually rotated by two or four tensile cables.

Typical commercially available colonoscopes are currently reusable. However, as disposable and other lower-cost colonoscopes are developed, these articulatable sections are no longer practical. Their high part count creates total costs that are exorbitant for a lower cost, disposable device. The pivot pins can also fall out, which can create a patient danger. Their design geometries, while suited for long life, high cost, high strength metals elements, don't readily suit themselves to the design goals of lower-cost and more readily mass-produced parts.

Suction can be utilized to remove debris or fluid. The colon can be pressurized to reconfigure the colon into an expanded cross-section to enhance visualization.

During advancement of the colonoscope through the colon, landmarks are noted and an attempt is made to visualize a significant portion of the colon's inside wall. Therapeutic actions call occur at any time, but are typically performed during withdrawal.

Navigating the long, small diameter colonoscope shaft in compression through the colon—a circuitous route with highly irregular anatomy—can be very difficult. Studies have shown a learning curve for doctors performing colonoscopies of greater than two-hundred cases. Even with the achievement of such a practice milestone, the cecum is often not reached, thereby denying the patient the potential for a full diagnosis.

During colonoscopy, significant patient pain can result. This is typically not the result of colon wall contact or of anal entry. The primary cause of pain is thought to be stretching and gross distortion of the mesocolon (the mesentery that attaches the colon to other internal organs). This is commonly referred to as ‘looping’ and is a result of trying to push a long, small diameter shaft in compression as the clinician attempts to navigate a torturous colon. While attempting to advance the tip by pushing on the scope, often all that occurs is that intermediate locations are significantly stretched and grossly distorted. Due to this pain, various forms of anesthesia are typically given to the patient. Anesthesia delivery results in the direct cost of the anesthesia, the cost to professionally administer, the costs associated with the capital equipment and its facility layouts, and the costs associated with longer procedure time (e.g., prep, anesthesia administration, post-procedure monitoring, and the need to have someone else drive the patient home). It has been estimated that forty percent of the cost of a colonoscopy can be attributed to the procedure's need for anesthesia.

Cleaning of colonoscopes is also an issue. Cleaning is time consuming, and lack of proper cleaning can result in disease transmission. Cleaning can utilize noxious chemicals and requires back-up scopes (some in use while others being cleaned). Cleaning also creates significant wear-and-tear of the device, which can lead to the need for more servicing.

It would therefore be desirable to create a system that is less painful—possibly not even requiring anesthesia—is significantly easier to use, and does not require cleaning.

Everting tube systems have been proposed for use as colonoscopes. However, multiple challenges exist for everting systems. One typical challenge is the differential speed between the center lumen and the tip. For example, as the typical everting tube is advanced, the center lumen of the colonoscope advances 2″ for every 1″ of eversion front advancement. When the center advances it moves only itself, whereas tip movement advances material on both sides. Because there is this dual wall material requirement for tip advancement, two times as much material is required, so it inherently must travel at half the rate.

Anything that is in the center of the typical everting tube is ‘pressure clamped,’ as the tube's inner diameter collapses to no cross sectional area as the tube is pressurized. This can make it difficult to try to solve the 2:1 problem in a typical everting tube by sliding elements in the inner diameter or central region.

This 2:1 advancement issue and the pressure clamping can make it difficult to locate traditional colonoscope tip elements at the everting tip's leading edge. Given that the tube is often long and pressurized, it therefore often precludes the ability to create a functioning center working channel.

Another issue is internal drag. Material (e.g., tube wall) fed to the tip can cause increased capstan drag, for example the overall system advance force can be retarded to the point of stopping extension.

Optimal material selection is a highly significant challenge. The desired structure must have a rare combination of features: softness, strength, radial stiffness, low thickness, freedom from leaks, flex-crack resistance, puncture resistance, appropriate coefficient of friction, the potential for modifiable geometry as a function of length, and appropriate manufacturability and cost. Monolithic materials have proven insufficient at providing the variety of requisite specifications.

It can be difficult to create a system that is of adequately low stiffness. Larger diameters create higher propulsive forces, but they also do not typically readily conform to the colon in a lumen-centric manner and can be overly stiff.

Historically, several solutions have been suggested. One involves periodically depressurizing the system then withdrawing elements so that their leading edges match. This is time consuming and creates an undesirably non-continuous and geometrically interrupted procedure. It is also very difficult to create ‘correct’ undesirable relative motion to a deflated structure that essentially is no longer a structure. Another approach involves driving the inner lumen (typically with a special, thicker, anti-buckle wall). Because it is driven in compression rather than through pressure, the everting front can be inflated to a lower pressure such that its pressure clamping forces are less significant. This approach, augmented by the significant infusion of liberal amounts of interluminal lubricants, should enable advance. However, it has yet to be commercialized, it is very complicated, creates an undesirably larger diameter instrument, has lubrication leakage issues, and breaks down at longer advance lengths.

Additionally, colonoscopic devices have found it notably challenging to create methods to appropriately navigate through torturous geometries, particularly without undue colon wall stresses and subsequent mesocolon stretch. Steering kinematics are critical and have been an ongoing challenge—certainly for existing colonoscopes (which result in ‘looping’), but also to more effective next-generation devices.

Numerous driven tubes have been proposed for colonoscopy. Some utilize tube inlaid elements driven in compression. Others utilize tubes that are pressure driven, with their tubes being of multiple varieties, including the bellows variety, or everting types, or other stored material varieties, including scrunch, fold, or spooled versions.

The systems proposed to-date have geometries that create suboptimal steering efficacies. When a propulsion tube section's leading edge then has a steering section more distal, with typically a camera, lighting source, and working channel exit at the tip, the steering is less than effective when going around a corner: A situation is created in which the tip is retroflexed and is pointing in one desired direction of advance, but the system's advance is in an exactly opposite direction. The driven section presumes a vector—typically an axial manner—with the steering tip only having efficacy as it relates to its interaction with luminal walls. In a colonoscopy, this wall interaction is undesirable—it creates unnecessary wall stress and trauma, and can be a significant contributor to gross wall distortion, known as looping.

It would therefore be desirable to have system designs that enable more lumen-centric steering as the unit is advanced through colon curvature. Other improvements are also desired.

BRIEF SUMMARY OF THE INVENTION

A device for navigation of passageways is disclosed. The device can be utilized for biological passageways. The device can be a colonoscope for navigating the colon. The colonoscope can be attached or integral with other elements to form a colonoscopy system. The colonoscopy system can continuously examine and/or treat the colon. The colonoscopy system can have a deployment or ‘base’ system, a driven everting tube system, a controllable tip with multiple utility elements, system controls, and combinations thereof.

The colonoscope can be substantially round in cross section. The colonoscope can substantially elongate or deform along its longitudinal axis in a multitude of manners. The colonoscope can have thin walls. The colonoscope can be configured to stretch. The colonoscope can be configured to be deployed to reach the cecum. The colonoscope can have an everting tube or otherwise pressure driven tube system.

The everting tube system can have a thin wall, flexible (e.g., but still radially stiff) tube that can unfurl or roll back on itself for example from the inside out. The everting tube can be driven forward with a push tubes (e.g., an everting element cavity support), by driving or pushing the wall along its central axis, or through pressurization (e.g., pressurizing gas or fluid, such as air or water, in the everting element cavity). As the tube is driven forward, the tube's tip (e.g., a tip distal end and/or the everting element tip) can be “fed” with more material that can come from several potential location sources: internally or externally, near the tip or near the base. The system can evert continuously or sequentially.

The everting tube outer section (278) can have the highly minimized lack of motion relative to the biological luminal (e.g., colon) wall during the System's advancing process. If the everting tube system were to be reversed by retracting the everting tube inner section, the everting tube can be configured to have either motion or no motion relative to the luminal wall during withdrawal of the everting element. The everting tube can be used in the GI tract (e.g., colon), the coronary vasculature, the brain, and in urologic lumens.

The everting tube system can have male geometric features that create voids (e.g., female geometries), to create one or more channels, inside the center lumen of the tube system. The one or more channels (e.g., working channels) can enable the passage of deployable elements therethrough. The deployable elements to be passed can be instruments, electronics (e.g., power and signal wires), fluids (e.g., water, saline solution, air, carbon dioxide, suction), biomatter captured from within the colon, and combinations thereof.

The geometries can be robust with regard to certain load applications. For example the features can be strong enough relative to pressure loads such that when the everting tube driving pressure is applied, the channel can remain substantially patent. The system or sheath can be flexible enough to deconstruct or ‘open up’ and evert at the tip, such that the sheath can navigate the colon while providing a full-length working channel. Once the sheath has everted, the sheath can have atraumatic configurations on the outside of the wall, in proximity to the inside surface on the colon wall.

When the tube system is reversed (e.g., when an outer everting element is extended or when an inner everting element is retracted), the sheath can reform to again form luminal elements, or not reform.

The sheath can have elements that interface from one side to another (e.g., such as a zipper lock seal, or other interlocking seal), or a planar element interfacing on another planar element (e.g., creating a face seal). The sheath can have tubular geometries—with radial symmetry or not—which can be deconstructed as portions of the sheath evert at or near the system's tip.

The sheath can have tear or break-away geometries which remain integral until deployment to the tip, after which they separate into disparate parts.

The sheath can stay clamped together, for example, for the face sealed sheath, and/or for example when the everting tube driving, pressure exceeds internal pressures and forces (e.g., fluid/air/solid element passage forces). The sheath can have indexing elements that can minimize or prevent lateral motion or sliding, for example, to further prevent the sheath from separating. As the sheath everts at the tip, there are geometries which interface such that the everting tube lumens connect to tip geometries and their lumens. For example, a short, thin wall tube section can extend backwards from the tip, penetrating one of the lumens. This interaction ensures the relatively continuous passage of lumen elements through to the proper tip interaction and ultimate exit.

The colonoscope can have a tip region and system. The tip can have a controllable frontal or distal end that can have the terminus of working channels, lighting, and vision systems. The tip can be in a tip channel in the tube (e.g., everting element). The tip channel can be patent while the everting element is fully inflated. Tips, tools, fluids and other electronics can be deployed through the tool channel.

The tip can be used for tissue characterization imaging. The tip can perform an optical, non-invasive, “biopsy” on tissue. The tip can have an element to locally dispense pharmaceutical elements, for example for local drug delivery.

As the colonoscope advances, the tip can skew to die horizon. This can create disorienting, skewed images for the user. The colonoscope can have a dedicated actuator for rotating the tip about the tip's central axis. The tip can feature a ‘plane’ or ‘horizon’ indexing feature. As the view becomes skew relative to that plane, the actuator for rotating the tip can rotate the tip and/or software can rotate the image.

The tip can have remote or local (i.e., in the tip) actuators. The tip actuators can include pull cables. The tip actuators can include local or remote hydraulic members that act as cylinders. When used with valves, the hydraulic members can create flexed tip structures. The tip actuators can include one or more local motors, for example, servo motors, open-loop motors, piezo motors, ultrasonic motors, or combinations thereof. Electric tip actuators can be powered by local battery sources, by long, small gage wires extending to a power source at the base, or combinations thereof. The tip actuators can be resilient or heat memory alloys, such as Nitinol-based.

The tip can be actuated by multi-axis actuators. The tip can point or flex in a range or cone of motion, including distally, laterally, proximally, or combinations thereof. For example, the tip can retroflex.

The tip can have lighting, for example LEDs. The tip lighting can be powered by small gage wires extending from the tip to a power source at or near the base. The tip lighting can be powered locally (e.g., by a battery).

Data signals (e.g., image electric signals) can be transmitted by small gage wires extending from the tip to an imaging processor at or near the base. The data signals can be transmitted by wires or wirelessly.

The colonoscope can be removed from the colon. The colonoscope can be fully or partially deflated and withdrawal. An actuator (e.g., motor) can withdraw the colonoscope from the colon. The colonoscope, can be manually withdrawn from the colon. The colonoscope can be withdrawn while inflated.

The colonoscopy system can have a controller. The controller can control the pump. The controller can execute one or more algorithms to modulate the operating pressure of the pump. The controller can be connected to pressure sensors in the colonoscopy system. The controller can be connected to sensors that detect the length that the colonoscope has extended. For example, these algorithms can start the operating pressure at a given value, then increase the pressure as the extended length of the colonoscope increases. The algorithms can reduce the pressure during retraction or withdrawal of the colonoscope. The algorithms can increase system reliability and efficacy, and reduce the operators cognitive load.

The colonoscope can be withdrawn by applying a tensile load to the outer member, for example to the everting element outer section. The colonoscope can be withdrawn by pulling on the everting element-outer and/or inner sections, for example the central lumen or umibical(s). The colonoscope and its umbilical(s) can be released and/or withdrawn into a substantially linear orientation, or into a substantially rotary (‘spooled’) orientation. During withdrawal, the colonoscope's everting tube component can be split after the colonoscope passes a pressurization spool, such that a portion of the tube is on a first spool, and a portion is on a second spool. The spools can be actuator, motor, or manually driven. The colonoscope can be withdrawn by actuating mechanisms that retract the tube, sliding, folding, bunching or scrunching the tube onto a guide tube. The folded, scrunched or bunched length of the tube can be compressed compared to the unfolded, unbunched or unscrunched length of the tube. One or more high friction wheels and/or levers can retract the tube, for example by applying a tensile force to the tube.

The everting tube system can be driven with solids (e.g., granular or beads), gels, liquids, gasses, or combinations thereof. The fluid can have a low viscosity. The fluid can be piston-driven or otherwise driven by a solid displacement pump.

The sheath and/or everting element can be made from PTFE, a plastic, LDPE, including multiple ‘low stiction’ blends, Nylon (including use of Nylon-on-Nylon), or of composite construction, including with reinforced members. Lubricants can be applied to the sheath and/or everting element, for example to reduce drag/friction. The lubricants can include fluids such as water, glyercine (glycerol), other glycol-based fluids, vegetable oils, silicones, graphites (e.g., with superlubricity properties), PAO (poly-alpha-olefin), dispersions including of lubrous materials such as Boron Nitride (BN), colloidal dispersions of PTFE. Molybdenum disulfide coatings and additives in lubricants can be applied to the sheath and/or everting element. Dry film coatings can be applied to the sheath and/or everting element. Synthetic fluids and mineral (petroleum-based) fluids can be applied to the sheath and/or everting element. The fluids can be biocompatible and non-toxic, such as skin-contact friendly.

The sheath and/or everting element can have one or more geometric elements that can have varying cross sections as a function of length. For example, the sheath and/or everting element can be tapered or locally bulbous.

The sheath and/or everting element can have material stowed along the length of the sheath and/or everting element, at or near the base, or at or near the tip. The stowed material can be released in a manner to substantially create 1:1 eversion front to tip motion. The material can be stowed in various forms, including oriented substantially parallel to the umbilical's central axis, or substantially perpendicular. The material can be stowed in a random manner, or in a pre-determined manner. The stowed material can be orderly stowed as multiple folds, parallel to the umbilical's central axis, that deploy in an intentional sequential manner. The stowed material can be in otherwise compacted form.

The tube can have radially internal and/or external channels for carrying a tool. For example, the channels can be formed by one or more coils or clips.

The tube of the everting system can be disposable and delivered in a modified ‘spool’ or ‘cassette’. The tube can be loaded, snapped in, or otherwise be readily and quickly attached to the base structure. Once the procedure is complete, the utilized spool or cassette can be removed.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is not the invention and illustrates a colon.

FIG. 2 is not the invention and illustrates a variation of a perspective view of a transverse cross-section of a colonoscope.

FIG. 3 is a perspective view of a variation of the end of the colonoscope.

FIG. 4 is cross-section A-A of a variation of the colonoscope ofFIG. 3.

FIG. 5 is a perspective view of a variation of the end of the colonoscope shown without the tip.

FIGS. 6,8 and9 illustrate cross-section C-C of variations of the colonoscope ofFIG. 5.

FIG. 7 illustrates a variation of the colonoscope in which the central lumen opens and tearably everts at its leading edge.

FIGS. 10athrough10iillustrate cross-section C-C of variations of the reinforcement and the surrounding everting element layer.

FIG. 10jillustrates a perspective view of a section of a variation of the reinforcement and the surrounding everting element layer.

FIG. 11 is a perspective view of a variation of the end of the colonoscope.

FIG. 12 is cross-section D-D of a variation of the colonoscope ofFIG. 11.

FIG. 13 is a perspective view of a variation of the end of the colonoscope.

FIGS. 14aand14bare cross-section E-E of variations of the colonoscope ofFIG. 13.

FIG. 15 illustrates an embodiment of a coil configured to allow side exit of a tool within the coil.

FIG. 16 is a perspective view of a variation of the end of the colonoscope.

FIGS. 17athrough17eillustrate variations of the clips.

FIG. 18 is a perspective view of a variation of the end of the colonoscope.

FIGS. 19 through 22 illustrate cross-section G-G of variations of the colonoscope ofFIG. 18.

FIGS. 23a,23b,24aand24billustrate cross-section C-C of variations ofFIG. 5.

FIGS. 25 and 26 illustrate cross-section B-B of variations of the colonoscope ofFIG. 3.

FIG. 27 illustrates cross-section B-B of a variation of a method of everting a variation of the colonoscope ofFIG. 3.

FIG. 28 illustrates cross-section B-B of a variation of the colonoscope ofFIG. 3.

FIG. 29 illustrates cross-section B-B of a variation of a method of everting a variation of the colonoscope ofFIG. 28.

FIG. 30 illustrates cross-section B-B of a variation of the colonoscope ofFIG. 3.

FIGS. 31 and 32 illustrate variations of the colonoscope.

FIG. 33 illustrates a variation of the colonoscope, for example that can have a two-piece structure created with an inner film tube and an outer cloth tube.

FIGS. 34 and 35 illustrate a perspective view of a circular or spooled version of the deployment system.

FIGS. 36aand36billustrate a variation of a cross-section of the deployment system and a cross-section A-A of the system therein, respectively.

FIG. 37 illustrates a top perspective view of a cassette with the cassette lid removed.

FIGS. 38 and 39 illustrate variations of methods for everting and deverting the colonoscope.

FIGS. 40 and 41 illustrate a variation for retracting the colonoscope in which the outer member is put in tension so as to not buckle. As the material is withdrawn it is split and then drawn onto spools. As the outer member is retracted, the inner umbilical(s) can be retracted in a manner, for example, to not put substantial compressive loads on the sheath.

FIG. 42 is a side view of a variation of a system for driving the everting systems in which the everting tube is stowed in a small volume, and in which the everting tube's pulled umbilical is stored in a substantially not-spooled and not-pressurized manner.

FIG. 43 is a perspective view of the system for driving the everting system ofFIG. 42.

FIG. 44 is a close-up and partial cut-away view of the system for driving the everting system ofFIG. 42.

FIG. 45 illustrates a cross-section of a variation of the colonoscope loaded into a substantially rotary cassette.

FIG. 46athrough46fillustrates a variation of cross-section Z-Z ofFIG. 45.

FIG. 47aillustrates a perspective view of a variation of the colonoscope with two tools deploying therethrough.

FIG. 47billustrates a variation of cross-section Y-Y ofFIG. 91a.

FIG. 47cillustrates a variation of cross-section X-X ofFIG. 91c.

FIG. 48aillustrates a variation of a colonoscope system in a first configuration.

FIG. 48billustrates a variation of a colonoscope system ofFIG. 48ain a second configuration.

FIG. 49 is a schematic view of a variation of the base and a fluid system.

FIG. 50aillustrates a variation of the system base station capital equipment.

FIG. 50billustrates a variation of a method for using the colonoscope, in which a piston or otherwise extensible displacement member is manipulated to control load volume to exert a corresponding pressure onto an everting tube.

FIGS. 51 through 57 illustrate a variation of a method for using the colonoscope.

DETAILED DESCRIPTION

FIGS. 3 and 4 illustrate an elongated element for navigation of biological passageways, such as an endoscope for navigating the esophagus and stomach or acolonoscope44 for navigating thecolon10. The colonoscope can be used to treat and/or diagnose polyps, lesions, tumors, ulcers, trauma, colitis, infarction, displasia, diverticulosis, diverticulitis, impactation, Crohn's disease, or combinations thereof. The colonoscope can be configured to translate and/or rotate along the colon by everting.

The colonoscope can have a biological navigation device such as an evertingelement46 or tube. The everting element can be a tube configured to evert when the everting element is deployed.

The colonoscope or everting element can have a sheath. The sheath can be an elastic, non-elastic, distensible, expandable sheath and/or aseparatable sheath54. The sheath can cover most or substantially the entire everting element. The separatable sheath can have a higher, lower, or equally frictional surface than the surface of the everting element.

The colonoscope can have a tool emergence tip. The tip can be located radially inside the everting element and/or the separatable sheath. The tip can serve as the effective exit locale of one or more diagnosis and/or treatment elements, such as any or all of the conduits shown in the colonoscope inFIG. 2.

The everting element can have an everting elementinner section50, an everting front52 and an everting elementouter section48. The everting element inner section, everting front and everting element outer section can be integral with each other. The everting element inner section can be in the radial center of the everting element. The everting element inner section can translate distally (i.e., toward or beyond the everting front) as the everting element is deployed. The everting front can rotate or roll in a radial outward direction. The already everted portion of the everting tube can be substantially motionless relative to local anatomy as the leading edge's everting system elements are deploying. The everting element outer section can have material (i.e., rolling over from the everting element inner section via the everting front) added to the length of the everting element outer section when the everting element is deploying. When the everting element is retracted, the everting element's outer elements can be imparted with a tensile load. Alternatively, the umbilical can receive the system's tensile load to enable retraction.

A tool channel (shown inFIGS. 5 and 6) can be defined by the radial center of the everting element.

The everting element can define aneverting element cavity82. The everting element cavity can be pressurized, for example when the everting element is deploying or deployed. The everting element cavity can be sealed fluid-tight. The everting element cavity can be filled with saline solution, water, air, carbon-dioxide, oxygen, or other elements and combinations thereof.

The separatable sheath can have a separatable sheathinner section55 and a separatable sheathouter section57. The separatable sheath can have a separatable sheath firstinner section66 and a separatable sheath secondinner section68. The separatable sheath can have a separatable sheath firstouter section56 and a separatable sheath secondouter section58. The separatable sheathinner section55 can be between the everting elementinner section50 and thetool channel72. The separatable sheathouter section57 can be radially outside of the everting elementouter section48.

The separatable sheath can have one; two or more seams. The seams can be even distributed angularly around the longitudinal axis. For example, the separatable sheath can have two seams on opposite sides of the separatable sheath. Along the separatable sheath inner section, the seam can be aclosed seam62. Along the everting front, the seam can expand and open. Along the separatable sheath outer section, the seam can be anopen seam60. The seam can be configured to be recloseable or not recloseable. The closed seam can be fluid-tight, such as water-tight or air-tight.

The tip can have atip body70. The tip can have adistal end64 and a tip proximal end and can be the distal terminus of an umbilical(s) whose other terminus is a base structure. The umbilical(s) can have wires, cables, conduits, and combinations thereof that can extend proximally from the tip and/or tip body and/or tip distal end.

The tip can be comprised of multiple elements that move slidably relative to each other. This can serve to enable local motion without having to manipulate a larger macro structure.

FIGS. 5 and 6 illustrate thelongitudinal axis76 of the colonoscope. Thetool channel72 of the colonoscope can be a real patent space (or a virtual space. A virtual space can be a potential space between one or more flexible surfaces that can be opened when an element or pressurization is placed into the virtual space). The tool channel can be substantially round, such as cylindrical or oval. The tool channel can be configured to fit thetip body70. The tool channel can be open at the distal and/or proximal ends of the everting element.

The colonoscope (shown with the tip missing for illustrative purposes) can have one, two, three, ormore reinforcements74. The reinforcements can be integral with and/or attached to the everting element. The reinforcements can be substantially evenly angularly distributed with respect to the longitudinal axis. The reinforcements can be ribbons, filaments, tubes, one or more meshes, or combinations thereof. The reinforcements in the everting element outer section and everting element inner section can be substantially parallel with the longitudinal axis.

FIG. 7 illustrates a variation of the separatable (e.g., splittable) sheath. The separatable sheath (e.g., a secondary tube), for example made from PTFE, can be bonded or otherwise attached to the inside of the everting tube. The separatable sheath can have linear tear propagation properties. The linear tear propagation effect can be created in other materials through multiple manufacturing methods, including necked-down regions and scoring. As the separatable sheath inside the everting tube reaches the eversion front, the separatable sheath can split and/or tear to either side. The separatable sheath can be an end-to-end conduit for tool or umbilical elements, for example with one or more appropriate end-termination geometries for the tip. The separatable sheath can be substantially smaller than the everting element. The separatable sheath outer sections can be unattached to the everting element outer section.

The tool channel can be a virtual space. The tool channel can expand, for example, when filled with an element (e.g., the tip body). The tool channel can be substantially closed, for example, when not filled with an element.

FIG. 8 illustrates that the everting element can have one or more inner layers and one or more outer layers. The everting element can have an everting element inner sectioninner layer53 and an everting element inner sectionouter layer55. The evertingelement46 can have an everting element outer sectioninner layer51 and an everting element outer sectionouter layer49.

The reinforcements can be between the everting element inner layer and the everting element outer layer. The reinforcements can be attached to and/or integral with the everting element inner layer and/or the everting element outer layer.

The reinforcements can be solid and/or hollow. The reinforcements haveintra-reinforcement channels78.Extra-reinforcement channels80 can be defined between the reinforcements, the everting element inner layer and the everting, element outer layer. The intra-reinforcement channels and/or extra-reinforcement channels can be real and/or virtual spaces. The reinforcements can be added to the tube surface, or created integral with the tube surface.

The intra-reinforcement channels and/or extra-reinforcement channels can be filled with fluid (e.g., pressurized or non-pressurized air, water, saline solution, carbon dioxide, or combinations thereof), and/or sensing, and/or treating equipment, such as heating wires, thermal sensing wires, light-emitting wires, or combinations thereof.

FIG. 9 illustrates that the everting element can have an angularly asymmetric configuration with respect to the longitudinal axis, for example the everting element can have a substantially oval cross-section. The reinforcements can be angularly asymmetrically located with respect to the longitudinal axis. For example, the reinforcements can all be located on half (angularly with respect to the longitudinal axis) of the everting element.

FIG. 10aillustrates that the reinforcements can have a substantially round cross-section, such as a circular or oval cross-section. The reinforcements can have male standoff geometries. The male standoff geometries can abut the everting tube to form female channels, for example in which tools (e.g., elongated elements) can be received. As the tube everts, these geometries transition from the inner surface of the tube to the outer surface of the tube. When the tube is reversed, they can reform to continue to create end-to-end lumen(s).FIG. 10billustrates that the reinforcement can have a reinforcement slot118. The reinforcement slot can be located away from theeverting element layer84. The reinforcement slot86 can have a length of all or part of the reinforcement. A single reinforcement can have one or more reinforcement slots.

FIG. 10cillustrates that the reinforcement can have a substantially square or rectangular cross-section.FIG. 10dillustrates that the reinforcement slot can be in the everting element layer. The reinforcement slot can be the width of the reinforcement. The reinforcement slot can be the width of the union of the reinforcement and the everting element layer.

FIG. 10cillustrates that the reinforcement can have anintra-reinforcement width88. Anextra-reinforcement width89 can be between adjacent reinforcements. The intra-reinforcement width can be greater than, equal to, or less than the extra-reinforcement width. The intra-reinforcement widths can be constant or vary for all the reinforcements of a single everting element. The extra-reinforcement width can be constant or vary between all the reinforcements of a single everting element.

FIG. 10fillustrates that the reinforcements can be vanereinforcements90. The vane reinforcements can extend perpendicular or at a non-right angle to the everting element layer. The vane reinforcements can be about as thick as, thinner than, or thicker than the everting element layer.

FIG. 10gillustrates that the vane reinforcements can have a substantive thickness, significantly thicker than the everting element layer. Two or more reinforcements can be attached or integral with each other separate from attachment or integration via the everting element layer. For example, a single reinforcement can have two, three, four or more vanes.

FIG. 10hillustrates that the reinforcement can have a tapered configuration as the reinforcement extends away from the everting element layer. The reinforcements can haveflanges92 at the ends of the reinforcements away from the everting element layer.FIG. 10iillustrates that the reinforcement can have aspine94. The spine can have a substantive thickness. The spine can be substantially parallel with the everting element layer. The spine can be integral with and/or attached to the remainder of the reinforcement (e.g., vanes).

FIG. 10jillustrates that the reinforcement can have one or more hinges, such as afirst hinge96 and asecond hinge98. The hinges can be evenly or unevenly spaced or distributed along the length of the reinforcement. The hinges can be cut, removed, or otherwise missing material from the reinforcements. The hinges can be cut, removed, or otherwise missing material transverse to the longitudinal axis. The hinges can serve to maintain an end-to-end lumen during pressurization, but also to enable lower-force eversion.

FIGS. 10a-10jillustrate the reinforcements attached to and/or integral with a single everting element layer, however the reinforcements can also be attached to and/or integral with multiple everting element layers.

FIGS. 11 and 12 illustrate that the separatable sheath can have a single seam.

FIGS. 13 and 14aillustrate that the separatable sheath can have one or more separate or integral tensile elements across the seam, for example, for providing tension. The tensile elements can form external carriers or conduits. The tensile elements can be placed through the separatable sheath and/or the everting element regardless of whether the tensile element bridges a seam or not. The tensile elements can be in tension or not in tension. The tensile elements can beexpandable attachers102. The tensile elements can be resilient or deformable. The tensile elements can be coils100. The coils can be filaments and/or springs. The coils can expand across the open seam. The coils can contract across the closed seam.

The coils can be attached to the sheath and/or the everting element. The coils can be driven (e.g., sewn or punched) through the separatable sheath first section and the separatable sheath second section, and/or through the everting element first section and the everting element second section. The coils can apply tension across the open seam or the coils can be relaxed across the open seam. The coils can apply tension across the closed seam or the coils can be relaxed across the closed seam. The coils can serve to provide a tube or conduit along the length of the system, such that an umbilical(s) could be slidably manipulated along its axis. A single coil can extend the length of the everting element. Once the tube is everted at its tip, this conduit then goes inside of the everting tube.

FIG. 14billustrates that the coils can be configured to createintra-coil channels104 and/ortool subchannels104 within the coils. Tools can be deployed in the inner or outer intra-coil channels. The colonoscope can have, or be absent of any, sheath.

FIG. 15 illustrates that the coils can haveside ports106. The side ports can be used to introduce or remove a tool, umbilical, or other device in the intra-coil channel (e.g., tool subchannel).

FIG. 16 illustrates that the tensile elements can be one ormore clips108. The clips can be parallel or non-parallel with respect to each other. The clips can be perpendicular, parallel, or non-perpendicular and non-parallel with respect to the longitudinal axis of the seam and/or the longitudinal axis of the colonoscope. The clips can be resilient and/or deformable. The clips can have a relaxed configuration and a flexed configuration. The dimensions, materials, and resiliency of the clips can vary between different clips. The clips can be configured to form intra-clip channels and/ortool subchannels104 within the clips, similar to those shown for the coils inFIG. 14b. These clips provide elements of an external ‘track’ upon which an umbilical(s) could slide.

FIG. 17aillustrates that the clip can have a “c” configuration. The clip can be curved along the entire length of the clip.FIG. 17billustrates that the clip can have an extended clip back110. The clip back can have a straight length.FIG. 17cillustrates that a clipfirst arm112 can cross a clipsecond arm114. The clip first arm can be in contact with the clip second arm when the clip is in a relaxed and/or flexed configuration. The clip first arm and/or clip send arm can have straight lengths. These coils can have ‘split’ or ‘c’ channel geometries to enable entry at the eversion front, particularly when used in conjuction with an eversion front opening wedge.

FIG. 17dillustrates that the clip can have a substantially square configuration. The clip can be configured with sharp angles, such as right angles. The clip can have all straight lengths.FIG. 17eillustrates that the clip can have multiple right angles, all straight lengths, and an extended clip back.

FIGS. 18 through 22 illustrate that the seam can have an interlocking seal, such is a sealable slide fastener or zip-fastener, such as a zipper. The interlocking seal can have or be without a separate sliding tab. The interlocking seal can have one or more resilient strips configured to fit into one or more respective grooves in the face of a gasket or o-ring.

FIG. 19 illustrates that the interlocking seal of the seam can be configured to extend radially inward, with respect to the longitudinal axis of the colonoscope, from the separatable sheath inner section and radially outward, with respect to the longitudinal axis of the colonoscope, from the separatable sheath outer section.FIG. 19 illustrates that the interlocking seal of the seam can be configured substantially in a constant radius plane with respect to the longitudinal axis of the colonoscope. The interlocking seal of the seam can be substantially unobtrusive of the tool channel or radially outside of the everting element.

FIGS. 21 and 22 illustrate that the interlocking seal of the seam can be configured to extend radially outward, with respect to the longitudinal axis of the colonoscope, from the separatable sheath inner section. The interlocking seal of the seam can be configured to extend radially inward, with respect to the longitudinal axis of the colonoscope, from the separatable sheath outer section, and/or be configured substantially in a constant radius plane with respect to the longitudinal axis of the colonoscope.

FIG. 21 illustrates that the separatable sheath inner sections can be configured to lie substantially flush against the everting element inner section, for example except for directly adjacent to and including the closed seam. The separatable sheath inner section can extend from the seal at an acute or right angle.

FIG. 22 illustrates that the separatable sheath inner section can be configured to partially distance itself away from the everting element inner section, for example forming aseam channel116. The separatable sheath inner section can extend from the seal at an obtuse or right angle.

FIG. 23aillustrates that the colonoscope can have reinforcements extending, radially with respect to the longitudinal axis of the everting element, from the separatable sheath. The reinforcements can interdigitate with other reinforcements. The reinforcements can extend directly from the everting element, for example if the colonoscope has no separatable sheath. The separatable sheath can be sufficiently elastic to expand. The separatable sheath can have no seam. The reinforcements can be evenly or unevenly distributed around the everting element, angularly with respect to the longitudinal axis of the everting element.

FIG. 23billustrates that the reinforcements can have intra-reinforcement channels or tool subchannels. The reinforcements can have reinforcement slots. The colonoscope can have a sheath or be absent of a sheath. The reinforcements can have substantially square or rectangular cross-sections.

FIG. 24aillustrates that the colonoscope can have reinforcements that do no, not interdigitate. The reinforcements can be evenly or unevenly distributed around one half of the everting element, angularly with respect to the longitudinal axis of the everting element.

FIG. 24billustrates that the reinforcements can have intra-reinforcement channels or tool subchannels. The reinforcements can have reinforcement slots. The colonoscope can have a sheath or be absent of a sheath. The reinforcements can have substantially round or oval cross-sections.

FIG. 25 illustrates that theeverting front122 can abut the tip, for example at the tip head. The everting front can be in contact with or not in contact with the tip, for example at the tip head.

FIG. 26 illustrates that the everting element can have a reinforcing coil, shown as a distal reinforcingcoil174. The distal reinforcing coil can increase the axial and/or radial rigidity of the everting element. The reinforcing coil can encircle the everting element inner section. The reinforcing coil can be pulled onto the inner radial side of the everting element outer section. The reinforcing coil can be in the everting element cavity. The reinforcing coil can be slidably attached to the everting element. The reinforcing coil cab be fixedly attached, for example by sewing, interweaving, glue, staples, or a combination thereof, to the everting element. The reinforcing coil can extend a portion of, or the entire length of, the everting element.

FIG. 27 illustrates that the everting element inner section can translate distally, as shown byarrows128. The translation of the everting element inner section can be from, for example, pressure in the everting element cavity in addition to slack provided for the everting element inner section. The everting element outer section can remain substantially translation-less. When a point on the everting element inner section translates to the everting front, that point can rotate radially outward and stop translating when that point becomes static on the everting element outer section. As the everting element expands distally, the tip can translate, as shown byarrow126, distally.

A force can also be separately applied to the tip body during deployment (and withdrawal) of the everting element. The tip body can be maintained at, for example, a 1:1 translation ratio with the everting front. The tip body can slide within the separatable sheath. For example the tip body can slide against a low friction surface contact with the separatable sheath inner sections.

FIG. 28 illustrates that the colonoscope can have agasket130 between the everting element and the tip body. The gasket can be on either side of the separatable sheath inner sections. The gasket can be a low friction interface between the tip body and the everting element. The gasket can fluidly seal between the everting element and the tip body.

FIG. 29 illustrates that the tip can be translated distally (and proximally) with respect to the everting element. A distal force can be applied to the tip relative to the everting element, resulting in distal translation, as shown by arrow, of the tip body and tip head. The gasket can roll or slide between the everting element and the tip body when the tip body is translated with respect to the everting element.

FIG. 30 illustrates that the everting element cavity can have an evertingelement cavity support83. The everting element cavity support can be a rigid or resiliently or deformably flexible tube that can fit in theeverting element cavity82. Distal translational forces can be transmitted through the everting element cavity-support, for example, to drive the everting element. The everting element cavity support can have treatment and/or diagnostic instruments. For example, the everting element and separatable sheath can be transparent to specific RF wavelengths emitted by diagnostic or therapeutic instruments in the everting element cavity support.

FIGS. 31 and 32 illustrate that additional, pre-loaded length of the everting element inner section can be stowed or held; along the length of the everting element. The everting element inner section can stowed along the length of the tip body and/or tool channel. As pressure is increased in the everting element cavity, for example, the stowed material can extend its length, thereby driving forward the tip and its towed umbilical(s).

FIG. 33 illustrates that the everting element can be covered and/or made from a fabric or other mesh. The everting element can have a fabric, mesh, or filament reinforcement. The fabric can be a cloth sewn together, for example with astitch132. The fabric can be or have nylon film liner, such as rip-stop nylon parachute ‘sportchute’ cloth.

Alternately, it can be comprised of a substantially one-piece composite structure.

The everting element can be made from one or more layers of film and/or fabric (e.g., cloth). The everting element can be air-tight. A fiber-based element can provide tensile carry loads, and the other elements can provide a unifying and sealing utility. Films or other types of sealant utility can attained from multiple material disclosed herein including LDPE, PET, and/or nylon. The everting element can be configured to be smooth and non-irritating and/or to provide abrasion against the colon wall.

Fibers and cloths in the everting element can include those made from Kevlar, spectra, nylon, Dyneema, or combinations thereof. The fibers can be coated with polyesters, or a range of other sealants, such as DWRs (durable water repellants). The fiber-based elements can be deployed either as laminated unidirectional material, or woven or knitted. The layers of the everting element can be sewn together, bonded by wet adhesives or film adhesives.

FIG. 34 illustrates a variation of thedeployment system152. The deployment system can be attached to the colonoscope to form a colonoscope system. The deployment system can define a sealabledeployment system cavity144. Thedeployment system cavity144 can be bounded by aseal134. The deployment system cavity can be in a deployment system base. The deployment system can form a sealed element in multiple form factors, for example a circular spool based system, a linear system, a purely locally pressurized system, hand-held system, scope-mounted system, table-based system, table-mount-based system, patient-based system, or combinations thereof.

The deployment system cavity can be in communication with an inlet port150 or base pressure port and an outlet port orexit port148. The outlet port can have anexit fitting146. The exit fitting can be configured to attach to a colonoscope, and/or to deploy a colonoscope therethrough. The inlet port can be configured to be attached to a fluid and or gas source, and/or a pump (not shown). The pump can deliver a controllably variable or constant pressurized media. The deployment system cavity can be in fluid communication with more than one inlet port. For example, additional inlet ports can be used to controllably introduce other fluids (e.g., lubricant) or solids (e.g., additional length of colonoscope).

FIG. 35 illustrates that thedeployment system base154 can be attached to a deployment system lid, for example with a fluid-tight seal. The cassette can have acassette spool136. The drive spool138 can be attached to the drive shaft140 on the outside of thedeployment system cavity144. Thedeployment system lid160 can be fixed to amotor mount156 adjacent to the drive spool. Alternatively, the spool can be remote from the lid (for example, affixed to the bottom of the base and connected with a radial seal) to allow for the easy transfer of cartridges without having to disturb the drive motor configuration. The motor mount can be attached to a deployment motor (not, shown), that can attach to thedrive spool158. The deployment motor can rotate the drive shaft, causing deployment of the colonoscope.

FIGS. 36aand36billustrate that thedeployment system base162 can have a toroidal orring pressure chamber144. The toroidal or ring pressure chamber can minimize pressure area while allowing the use of large-diameter spools or cartridges. Large-diameter cartridges or spools can reduce the capstan drag that develops-before the system has left the deployment system.

The deployment system cavity can have a drive shaft onto which a motor drive can be attached. The drive shaft can be attached to or integral with a drive spool.

The deployment system cavity can have a cassette spool. The cassette spool can be loaded with a length of the colonoscope (not shown for illustrative purposes), for example fed into the everting tubeinner section276. The cassette spool can be removably attached to the deployment system cavity, for example, removably attached to the drive shaft. The motor drive cog can be configured to rotate the spooled colonoscope in the cassette spool, and/or to otherwise deploy the colonoscope length in the cassette spool. The motor drive cog can be in the cassette spool.

FIG. 37 illustrates that thecassette164 can be an easy load cassette system. The cassette can readily be loaded into place, then connected through the utilization of an multi-element electrical fitting, through channel connections, and steering controls. The cassette can have a cassettedrive shaft port166. The cassette can have acassette lid168. The cassette can have acassette base178. The cassette can have afeed channel176. For example, the everting element inner section can be pushed or drawn through the feed channel and out acassette exit port180.

The everting element inner section can be held in and delivered from aneverting element holder174. The separatable sheath can be held in and delivered from aseparatable sheath holder172. The holders can have closed canisters or drums. The holders can have one or more circular or conical spools or reels, or longitudinal elements, for example, for holding the everting element and/or separatable sheath. The everting element inner section and/or the separatable sheath inner sections170 (shown coaxially at their terminal ends for illustrative purposes) can be deployed from separate holders (as shown) and be coaxially attached to each other after the everting element and separatable sheath exit the respective holders, for example by a joining mechanism in the cassette. The everting element inner section and the separatable sheath inner sections can be pre-attached to each other and, for example, deployed from a single holder.

FIG. 38 illustrates that one or more rotational drivers, such as gears, levers, or wheels, can rotate to apply a distal force to drive the everting element inner section. The rotational drivers can be configured to rotate in only one direction, for example, the rotational drivers can be ratcheted. The rotational drivers can be in direct contact with the everting element inner section. The everting element inner section can have a high-friction interface with the rotational drivers. The rotational drivers can be padded. The rotational drivers can squeeze the everting element.

As described similarly elsewhere herein,FIG. 39 illustrates that the colonoscope system can have afluid pressure186 applied to thepressurizer182. The fluid pressure can cause the everting element inner section to translate distally.

FIG. 40 illustrates that colonoscope system can have one or morerotational drivers184 configured to reverse the everting element outer section back towards the deployment system. The rotational drivers can apply a tensile force to the everting element outer sections. The rotational drivers can be activated to withdraw the colonoscope from a deployed configuration. The withdrawn everting element outer section can bunch, scrunch, or fold between the rotational driver and the deployment system.

FIG. 41 illustrates that the everting element outer section can spool onto the one or more rotational driver. The everting element can be cut along two lines about 180° apart from each other. The everting element can be split or cut by one or morebladed gaskets188 or a blade without a gasket. The gasket can seal the everting element cavity. The blades can be located adjacent to the rotational drivers. The blades can be configured to cut the everting element outer sections.

FIGS. 42 through 44 illustrate that an alternative system form embodiment. In this embodiment the everting tube is pressurized and the overall pressurized volume is much smaller volume than previously depicted, and the system is non-pressurized as it goes through the depicted “U” shape, with the opposinglegs192 of the “U” varying with the tip's corresponding insertion or advancement depth. This form factor can reduce the need for capital equipment, make the procedure more manual, and significant reduces the capstan wraps of the system before anal entry (as compared to spooled systems). An alternative version of this concept can be not ‘U’ orientated, but rather a layout that utilizes other components mentioned, including the shaft seal, the colonoscope shaft, and the base controls, in a substantially linear manner. This can be used in conjunction with an existing, commercially available colonoscope, or with a custom-built low-stiffness, low-mass, small-diameter, small-drag colonoscope. Theminimum storage radius190 can be more than about 8 cm (3 in.), more narrowly more than about 15 cm (6 in.), more narrowly more than about 23 cm (9 in.), for example about 30 cm (12 in.). The everting element inner section can have one, two or more substantially straight lengths. The everting element inner section can make one, two, or more about 180° turns before exiting the outlet port.

The system can have a connection to a pressure reservoir that is connected to thepressurization channel200. That reservoir can be local or remote and then connected through a tube umbilical.

Thepressurization channel200 can be in communication with the everting element cavity. The pressurization channel can be in fluid communication with the pump. The pump can be within the deployment system (as shown), or separate from the deployment system. For example, the pressurization channel can be placed in fluid communication with a pump central to the building (e.g., connected to a wall outlet for a central pressure system driven by a compressor elsewhere in a hospital or other medical facility).

The deployment system can have acontrol interface194, such as one or more, overlapping (as shown) or adjacent knobs, buttons, switches, levers, toggles, or combinations thereof. The control interfaces can be configured to automatically and/or manually control the length of the everting element inner section extending from the deployment system, the inflation pressure of the everting element cavity, the length of the tip extending from the deployment system, control or individual diagnostic and/or therapeutic elements within the tip, including the delivery of a flushing (e.g., saline) and/or anesthetic fluid through the tip. If the tip actuation is controlled by local actuators, those can be controlled by various ‘swappable’ interfaces. For example, one clinician might prefer the standard colonoscope knob interface, whereas another might prefer to steer with a joystick. These interfaces could be changed as per the user's preference, with each interface serving to appropriately manipulate the said actuators. The deployment system can have a deployment systemauxiliary channel198. Aneverting element connector202 can slidably receive the everting element.

FIG. 45 illustrates that the everting element inner section can be stored on a circular, oval, or conical cassette spool that has varying storage radius. The loops or coils of the spool can be “stacked” along a stackingaxis204.

FIG. 46aillustrates that the transverse cross-section of the channel for the everting element in the cassette spool can be square. The cross-section of the channel for the everting element in the cassette spool can be circular, oval, rectangular, pentagonal, hexagonal or combinations thereof. The transverse cross-section for the everting element inner section (and/or the everting element outer section, not shown) can be square, circular, oval, rectangular, pentagonal, hexagonal, or combinations thereof. The transverse cross-section for the separatable sheath can be square, circular, oval, rectangular, pentagonal, hexagonal, or combinations thereof. The transverse cross-section for the tip body can be square, circular, oval, rectangular, pentagonal, hexagonal, or combinations thereof.

FIG. 46aillustrates that the everting element inner section, separatable sheath inner section and tip body can have square or rectangular transverse cross-sections.FIG. 46billustrates that the everting element inner section call have a square transverse cross-section and the separatable sheath inner section and tip body can have circular transverse cross-sections.FIG. 46cillustrates that the everting element inner section can have a circular transverse cross-section and the separatable sheath inner section and tip body can have square transverse cross-sections.FIG. 46dillustrates that the everting element inner section and the separatable sheath inner section can have square transverse cross-sections and the tip body can have a circular transverse cross-section.FIG. 46eillustrates that the everting element inner section and the tip body can have circular transverse cross-sections and the separatable sheath inner section can have a circular transverse cross-section.FIG. 46fillustrates that the cassette spool, everting element inner section, separatable sheath inner section, and tip body can have transverse circular cross-sections.

FIGS. 47a,47band47cillustrate that the

tools

206 and208 can be deployed through the reinforcements and exit through thereinforcement slots210. The reinforcements can flex around the tools, opening the reinforcement slot wider for the tools to exit through.

FIGS. 48aand48billustrate a variation of thecolonoscopy system224 and a method of using the same. The deployment system of the colonoscopy system can have the umbilical212, extending away from the outlet port and making zero, one or more about 180° turns, for example around a pulley. Thepulley216 can be on apulley cart218 slidably attached to the remainder of the deployment system. The pulley cart can be attached to acart cable222. The umbilical can have a linearly extendingportion214.

FIG. 48billustrates that the pulley cart can be translated (e.g., driven by the cart cable), as shown by arrow, toward the outlet port. The umbilical can then be slackened and able to extend, as shown by arrow, out of the outlet port. For example, the pulley cart can be translated as shown, as the everting element is extended (e.g., inflated).

The umbilical can be attached at a first end to the everting element. The umbilical can be attached at a second end to controls, sensing andactuating mechanisms220.

FIG. 49 illustrates that the base can have anelongated element feeder238. The elongated element feeder or linearized system can have a linearizing extender that can travel back and forth to linearly control umbilical extension. The linear travel of the elongated element feeder can be controlled by amotor230 that can turn alead screw226 and/or driveshaft228 connected to the elongated element feeder. Before being deployed, the umbilical can be substantially straight in a pressure chamber, for example to reduce capstan drag in the elongated element (as compared to a spooled configuration). As the elongated element feeder is moved linearly, it can provide control of the device in one direction, with pressurization providing a force in the opposing direction. The pressure chamber can be sealed with the base and pressurized. The base is shown without a top for illustrative purposes. Apressure gauge232 can be attached to the pressure chamber and/or the base and can sense and display pressure therein.

Steering controls234 can include one, two ormore motors230 thereby allowing an electronic input interface (e.g., joystick, buttons, paddles, pedals) to control the deployment of theelongated element237. Another motor can provide axial movement for actuation of the distal component of the elongated element, for actuation of tools at the distal component and/or for steering and other motion (e.g., vibration, rotation, drilling) of the distal component itself. The base can have feed throughports236 for example to feed tools such as electronics and/or mechanical devices through the elongated element. The feed through ports can be configured so the tools can be transitioned to or from a pressurized region from or to a non-pressurized (e.g., outside) region without pressure leakage. The feed through ports can negate the need for a base seal around the elongated element, shaft, but a base seal can still be used in addition to the feed through ports.

FIG. 50aillustrates that the base can be in fluid communication with afluid control system240. The base, for example at the base pressure port, can be connected to apressure delivery line256. The pressure delivery line can be connected to an outgoing second valve and/or an incoming first valve.

The first valve242 can be configured to open manually and/or automatically. The first valve can open when the tube pressure exceeds a maximum desired tube pressure. The first valve can be connected to avacuum pump244. The vacuum pump can be activated to deflate the tube and withdraw the tube or reduce the tube pressure. The vacuum pump can be attached to an exhaust tank246 and/or directly to a bleed ordrain line248. The exhaust tank can be connected to the drain line, for example to exhaust overflow from the exhaust tank.

Controls

250 can be in data communication with the first valve and the second valve. The controls can be on the base (e.g., a button or switch on the base).

Thesecond valve252 can be attached to apump260, for example a cylinder262 with adisplacement component264, such as a piston. Apressure regulator254 can be in the flow path between the pump and the second valve. The pressure regulator and/or the first valve can open and release pressure from the pump when the tube pressure exceeds a maximum desired tube pressure.

Anintake tank258 can be fed in line (as shown) or through the pump to the second valve, for example through the pressure regulator. The fluid in the intake tank can be fed into the pressurized tube. The intake tank can have a fill line266 for filling the intake tank with fluid. The fill line can be fed directly to the second valve, pressure regulator or pump without the intake tank.

The biological navigation device can have capital equipment which can provide utility to the remainder of the device. The capital equipment can include, for example, the elements in the fluid control system. The fluid control system can have a fluid source (e.g., the intake tank and/or fill line), a pressurize source such as the pump, a conduit for delivery of the pressurization media (e.g., the pressure delivery line), controls, system monitoring elements (e.g., can be in the controls). The capital equipment can reduce the profile of the tube, for example, in which tools can be inserted. The integrated tools can create elements that reduce waste, thereby allowing for higher value capture and less refuse.

The fluid pressurization can be controlled by a variety of user inputs, for example a button on the elongated element or base, voice commands, foot pedals, or combinations thereof.

FIG. 50billustrates that an extensible displacement member, such as a piston, can be used to pressurize the deployment system. Afluid supply268 can be attached to the inlet port, for example via connectingtubing270. Theinlet port272 can have a one-way (i.e., check) valve preventing backflow. The outlet port can have a one-way (i.e., check) valve preventing backflow. The fluid supply can be filled with fluid. The fluid can be delivered to the deployment system under no pressure or positive pressure. The pump can be separate from or attached to the inlet port. For example, the fluid supply can be routed through the pump before or after passing through the inlet port and into the deployment system.

FIG. 51 illustrates that the colonoscope can be positioned before entry into the colon, for example via the rectum after passing theanus12.FIG. 52 illustrates that the pressure in the everting element cavities can be increased and/or the colonoscope can be otherwise deployed, and the colonoscope can translate, as shown by arrow, into therectum14.

The colonoscope is shown having an outer diameter smaller than the inner diameter of the colon for exemplary purposes. The colonoscope can have an outer diameter about equal to the inner diameter of the colon. For example, the colonoscope can have an inflatably expandables everting element that can flexibly expand to substantially fill the cross-section of the length of the colon occupied by the colonoscope.

FIG. 53 illustrates that the distal end of the colonoscope can actively or passively flex in a cone of motion, with one portion of that plane of motion depicted by the arrow. The distal end of the colonoscope can actively rotate, for example by actuation of control wires and/or actuators in or attached to the tip.

The distal end of the colonoscope can passively rotate, for example if the colonoscope (e.g., the everting element, such as the everting front and/or the everting element outer section) contacts a wall of the colon (e.g., the superior wall of the rectum).

FIG. 54 illustrates that after making a turn in the rectum the distal end of the colonoscope can be further extended, as shown by arrow, or translated into and through thesigmoid colon16, for example as the everting element continues to evert.

FIG. 55 illustrates that the colonoscope can make a turn, as shown by arrow for example as the colonoscope passes from the sigmoid colon to the descendingcolon18.FIG. 56 illustrates that the colonoscope can be further advanced, extended or translated, as shown by arrow, for example by everting the everting element, through the descending colon after the colonoscope has made two previous turns.

The colonoscope can be repeatedly turned and advanced, for example by everting the everting element, to extend as far along the colon as desired.

At any length in the colon, the colonoscope, for example at the tip, can gather diagnostic (e.g., sensing) data, such as data for visualization, tissue inductance, RF absorption or combinations thereof. The colonoscope can also gather tissue samples (e.g., by performing a biopsy or removing a polyp). At any length in the colon, the colonoscope, for example at the tip, can perform treatment or therapy, such as delivery of a drug onto or into tissue, tissue removal (e.g. polyp or tumor removal), or combinations thereof.

FIG. 57 illustrates that the colonoscope can be advanced along the entire colon, passing through therectum14,sigmoid colon16, descendingcolon18,transverse colon20, ascendingcolon72, and having the tip distal end in thececum24. The colonoscope can be withdrawn, as shown by arrows, from the colon, for example by applying a tensile force against the everting element outer section, as shown by arrows. The colonoscope can be withdrawn, as shown byarrows274, from the colon, for example by applying a tensile force to the umbilical(s).

The colonoscope (e.g., the tube) can be made from PTFE (Teflon), ultra high molecular weight polyethylene (UHMW), LDPE, FEP, nylon copolymer (such as Nylon 6), a thermoplastic elastomer (TPE), such as Santoprene, Flexible PVCs (FPVCs), or combinations thereof. For example, the tube and/or the sheath can be made from PTFE. The tube can be made as a composite or reinforced structure. The colonoscope (e.g., the tube) can be made from a material that can have unidirectionally oriented properties, such as directional tear properties. The directional tear property can be augmented by applying preferential tear location properties, such as scoring or skirting. A blade can be run partially through the tube wall, such that the wall can tear with less force and in a more predictable location. The colonoscope (e.g., the tube) can be made from materials that are not unidirectionally oriented, for example those with effective tear properties (e.g., those that have, been scored). The colonoscope can be made from a highly lubricious material. The colonoscope and elements thereof can be made from RF welding additives to a substrate, such as a LDPE substrate. The colonoscope (e.g., the tube) can be made from a readily bondable material, and/or a low friction material, and/or biocompatible materials, and/or flexible materials.

The colonoscope (e.g., the tube) can be made from layflat tubing. The colonoscope (e.g., the tube) can be tear and puncture resistant. The colonoscope (e.g., the tube) can be lubricious during use. Any elements of the colonoscope can be extruded as one continuous element or multiple joined elements. The colonoscope elements can be heat joined tubing, sheet, extrusions, and combinations thereof. The colonoscope elements can be bonded, heat joined, RF welded, or connected by other methods known in the art.

The colonoscope can have inlaid deformable members in the tube. The reinforcements can be inlaid deformable members. For example, the everting element, sheath, reinforcements, other tube wall, or combinations thereof, can be or have one or more deformable aluminum fibers, filaments, ribbons, beams, or combinations thereof. The deformable members can be made from a metal, for example aluminum, NiTi alloy, or combinations thereof.

Still or motion rearward (i.e., proximal), forward (i.e., distal), side (i.e., lateral) images can be captured from the tip (e.g., from one or more CMOS chips, other cameras, and/or optical fibers). Still or motion view about 360° around the tip can be captured. The rearward and forward images can be concurrently viewed (e.g., on a split screen or with an inset vie % on one monitor or with separate dedicated monitors), or exclusive of one another (the ability to switch back and forth between the views).

A full, locationally-indexed mosaiced image of the entire inside of the colon can be created. The visualization (and other) data can then be archived and referenced at a later date, for example to compare polyp growth and other changes that could indicate biologically relevant phenomenon. Locational indexing can be created by comparing x,y,z tip locations from a tip sensor to an outside-placed sensor detecting element. Axial location can be recorded, for example by measuring play-out from the anal entry point.

The tip body and/or tip distal end can have the umbilical(s) connected thereto and extending proximally therefrom.

The colonoscopy system can be manually and/or actuator controlled. Control inputs can be delivered through a manually actuated controllable module, such as a joystick (e.g., for tip control) and/or a series of linear and rotary potentiometers and switches. The colonoscopy system can be programmed to be controlled by voice commands. The colonoscopy system can be controlled by a foot pedal (e.g., for tube extension or translation), and/or a combinational interface (e.g., hand controlled), for example for tip control. The user interface can be attached as part of the deployment system, and/or the user interface can be a control unit that is attached by wires to the deployment system, and/or the user interface can communicate wirelessly with the remainder of the colonoscopy system.

The colonoscope tube (e.g., everting element) can be made from an unsupported plastic film, PET, any other material disclosed herein, or combinations thereof. The colonoscope tube can be reinforced, such as by metal filaments or fibers, or a metal mesh.

Any or all elements of the colonoscope system and/or other devices or apparatuses described herein can be made from, for example, a single or multiple stainless steel alloys, nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys (e.g., ELGILOY® from Elgin Specialty Metals, Elgin, Ill.; CONICHROME® from Carpenter Metals Corp., Wyomissing, Pa.), nickel-cobalt alloys (e.g., NP35N® from Magellan Industrial Trading Company, Inc., Westport, Conn.), molybdenum alloys (e.g., molybdenum TZM alloy, for example as disclosed in International Pub. No. WO 03/082363 A2, published 9 Oct. 2003, which is herein incorporated by reference in its entirety), tungsten-rhenium alloys, for example, as disclosed in International Pub. No. WO 03/082363, polymers such as polyethylene teraphthalate (PET), polyester (e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, Del.), polypropylene, aromatic polyesters, such as liquid crystal polymers (e.g., Vectran, from Kuraray Co., Ltd., Tokyo, Japan), ultra high molecular weight polyethylene (i.e., extended chain, high-modulus or high-performance polyethylene) fiber and/or yarn (e.g., SPECTRA® Fiber and SPECTRA® Guard, from Honeywell International, Inc., Morris Township, N.J., or DYNEEMA® from Royal DSM N.V., Heerlen, the Netherlands), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ketone (PEK), polyether ether ketone (PEEK), poly ether ketone ketone (PEKK) (also poly aryl ether ketone ketone), nylon, polyether-block co-polyamide polymers (e.g., PEBAX® from ATOFINTA, Paris, France), aliphatic polyether polyurethanes (e.g., TECOFLEX® from Thermedics Polymer Products, Wilmington, Mass.), polyvinyl chloride (PVC), polyurethane, thermoplastic, fluorinated ethylene propylene (FEP), absorbable or resorbable polymers such as polyglycolic acid (PGA), poly-L-glycolic acid (PLGA), polylactic acid (PLA), poly-L-lactic acid (PLLA), polycaprolactone (PCL), polyethyl acrylate (PEA), polydioxanone (PDS), and pseudo-polyamino tyrosine-based acids, extruded collagen, silicone, zinc, echogenic, radioactive, radiopaque materials, a biomaterial (e.g., cadaver tissue, collagen, allograft, autograft, xenograft) any of the other materials listed herein or combinations thereof. Examples of radiopaque materials are barium sulfate, zinc oxide, titanium, stainless steel, nickel-titanium alloys, tantalum and gold.

The systems, devices, elements and methods disclosed herein can be used in conjunction or substituted with any of the systems, devices, elements and methods disclosed in Provisional Patent Application Nos. 60/887,323, filed 30 Jan. 2007; and 60/949,219, filed 11 Jul. 2007; and PCT Application Nos. PCT/US08/52535, filed 30 Jan. 2008; and PCT/US08/52542, filed 30 Jan. 2008, which are all incorporated herein by reference in their entireties. The everting element can be merely representative of any pressurized tube, including those disclosed in the references incorporated, supra.

The term colonoscope is used for exemplary purposes and can be any deployable elongated element for use in a body lumen, such as an endoscope. The pressurizer can be the deployment system. The terms tip, tool tip, tip distal end, and tool head are used interchangeably herein. Any elements described herein as singular can be pluralized (i.e., anything described as “one” can be more than one). Any species element of a genus element can have the characteristics or elements of any other species element of that genus. The above-described configurations, elements or complete assemblies and methods and their elements for carrying out the invention, and variations of aspects of the invention can be combined and modified with each other in any combination.

Claims

1. A device for navigation through a biological lumen comprising:

a first everting tube having a long axis, wherein the first everting tube comprises a tube wall, and wherein the tube wall is controllably tearable substantially in the direction of the long axis; and

a channel configured to receive a tool, wherein the channel extends along the long axis.

2. The device ofclaim 1, wherein the channel is formed by the inside of the first everting tube.

3. The device ofclaim 1, wherein the channel is a virtual space.

4. The device ofclaim 1, wherein a seam is formed in the first everting tube, and wherein the controllable tear follows the seam.

5. The device ofclaim 4, wherein the seam comprises perforations.

6. The device ofclaim 1, further comprising a second everting tube, and wherein the first everting tube is inside the second everting tube

7. The device ofclaim 6, wherein the second everting tube is configured to be pressurized.

8. A device for navigation through a biological lumen comprising:

an everting tube having an inside and an outside; and

a conduit having a channel formed within the conduit, and wherein the channel is configured to receive a tool for use in the biological lumen, and wherein the conduit is configured to releasably attach to the tool, and wherein the conduit is on the outside of the everting tube.

9. The device ofclaim 8, wherein the conduit is resilient.

10. The device ofclaim 8, wherein the conduit is attached to the outside of the everting tube, along a long axis of the everting tube.

11. The device ofclaim 8, wherein the conduit comprises a male standoff geometry.

12. The device ofclaim 8, wherein the conduit comprises an extruded configuration integral with the everting tube.

13. The device ofclaim 8, wherein the conduit, comprises two opposed and offset fingers, wherein the at least two fingers are resilient, and wherein the fingers are configured to resiliently deform to allow the egress of the tool out of the channel.

14. A device for navigation through a biological lumen comprising:

an everting tube having an inside and an outside;

a first conduit having a sidewall, wherein the first conduit is fixed to the outside of the everting tube along the long axis of the everting tube, and wherein the first conduit comprises an open slot along a length of the sidewall, and wherein the open slot is substantially parallel with the long axis of the first conduit, and wherein the first conduit is configured to releasably attach to a tool for use in the biological lumen.

15. The device ofclaim 14, wherein the open slot is configured to release the tool from attachment to the first conduit.

16. The device ofclaim 14, wherein the first conduit is integral with the everting tube.

17. The device ofclaim 14, wherein the first conduit further comprises a male configuration integral fixed to the sidewall, wherein the male configuration is substantially along the long axis of the sidewall, and wherein a length of the male configuration is configured to engage a length of the first conduit.

18. The device ofclaim 17, wherein a length of the male configuration is configured to engage the length of the first conduit through the open slot.

19. The device ofclaim 14, wherein the sidewall is resilient.