US20150133731A1

US20150133731A1 - Biological navigation device

Info

Publication number: US20150133731A1
Application number: US14/498,424
Authority: US
Inventors: Alexander Quillin Tilson; Gene DUVAL; Mitchell C. Barham; David P. Knight; Roland J. Downs; Christopher Michael ADAMS; Stephen J. Morris; Mark Christopher SCHEEFF
Original assignee: Loma Vista Medical Inc
Current assignee: Loma Vista Medical Inc
Priority date: 2007-01-30
Filing date: 2014-09-26
Publication date: 2015-05-14
Also published as: WO2008095052A2; US11426058B2; US20100198016A1; WO2008095046A2; WO2008095052A3; WO2008095046A3; US20190150705A1; US10188273B2; US20100099949A1

Abstract

Biological navigation devices and methods are disclosed. The devices can be used as or to support colonoscopies or endoscopes. The devices can have one or more releasable, and/or everting, and/or pressurized tubes. The devices can be removably attached to elongated elements, such as colonoscopes or other endoscopes.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of prior PCT Application No. PCT/US2008/052535 filed 30 Jan. 2008, which claims priority to 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, which are all 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.
The anus can provide entry into the colon for a colonoscopy. The colon extends from the rectum to the cecum and has sigmoid, descending, transverse 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 articulated 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.
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)). 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).
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 coloninto 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 can 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, aesthesia 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 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.
Evening tube systems have been proposed for use as colonoscopes. However, multiple challenges exist for evening 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 steer through torturous geometries, particularly without undue colon wall stresses and subsequent mesocolon stretch. Steering kinematics 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.
Additionally, during colonoscopy, a common kinematic procedure is called ‘reduction’ or ‘reducing.’ In this maneuver, the colonoscope shaft is withdrawn such that there is a reduced amount of colonoscope shaft for a given colon length. For example, before reducing the sigmoid colon, there can be fifteen inches of colonoscope shall threaded through this portion of the patient's anatomy. After reduction, the same portion of colon can be threaded with only a few inches of colonoscope shaft length. This reduction procedure is an important maneuver that allows the endoscopist to straighten out and maneuver though what was previously circuitous colon.
When this procedure is done in conjunction with a system that utilizes a pressure sleeve, the pressure sleeve is put into compression. During some reduction maneuvers, the reduced length of pressure sleeve for a given colonoscope shaft length can be upwards of twelve inches. As a result, the pressure sleeve is compressed and, when subsequently repressurized or otherwise again moved forward, it tends to propel itself forward from these compressed or buckled regions. Given that these regions tend to occur in regions close to the anus, the end effect is subsequent propulsion that is anus-based, rather than colonoscope tip-based. This effect compromises subsequent kinematics and the desired tip-based propulsion, which can lead to undesirable affects such as looping. Pressure sleeve wall thicknesses are typically only a few thousandths of an inch thick. When the through-center colonoscope shaft is withdrawn in tension, the pressure sleeve walls are loaded in compression, and they may buckle.
It would therefore be desirable to have pressure sleeve system elements that preferentially buckled, so that the reduced or compressed pressure sleeve regions were most typically located more distal than the anus and moved closer to the system's tip.

SUMMARY OF THE INVENTION

A device for navigating biological lumen is disclosed. The device can be used for treatment and/or diagnosis. For example, the device can have or be attached to a visualization element and can be used as a colonoscope and/or an endoscope. The device can also have a biopsy element. The device can also resect tissue and/or deliver drugs or other agents.
The device can have a removable cartridge. The cartridge can have a pressurizable tube at least partially stored in a head. The cartridge can be attached to a base through which an elongated element can be deployed.
The device can have one or more pressurizable tubes. The tubes can be ‘scrunched’ or folded at the front. The tube material can all be located distal or proximal to an ariticulatable steering section on the elongated element. The tube material can be partially located distal to the tip steering section. The tube material can be entirely located proximal to the tip steering section. The tubes can be sequentially staggered. After each lengthwise portion, the tube can have a sudden step-wise reduction in diameter, including equivalent to the previous section's diameter minus the walls thicknesses. This could create a steadily sequentially smaller diameter tube that packs well. The tubes can have tapered segments coupled with other elements, including staggers or straight sections. The tube can be configured to minimize creasing and have high packing densities during tube storage.
These cartridges can be attached via the head to the tip of an elongated element. The tube can then be pressurized to be propelled. The base or manifold can deliver pressure into the tube. The base can seal between the tube and the elongated element. The head can seal between the tube and the elongated element.
High pressure fluid can be delivered to the base. The fluid can be water or saline. The fluid can be delivered via a pump. The fluid can be delivered by a piston that is moved by an actuator; this method serves to minimize stored system energy. As the piston is driven, it can increase pressure which, when released to the tube can lead to the extension of the pressure tube. When the piston is withdrawn, it can create a vacuum that serves to evacuate a significant portion of the fluid in the tube.
The development of disposable cartridges can reduce or eliminate cleaning costs, cleaning trouble, and the risk inherent to reused devices. The risk of a poorly cleaned elongated element can be reduced because the elongated element can be substantially covered by the pressurizable tube.
The disclosed system, device or elements thereof can be used as elements that are combined into dedicated systems, as portions of dedicated systems (portions that can be reusable and portions that can be separable on a case-by-case basis, with some reused and some disposed of, sometimes referred to as ‘semisposables’ or ‘resposables’), or as additive elements to existing systems (i.e., retrofit device). Disposable systems only need to function for limited life, and they do not have to interface with other components again and again. Semisposable varieties can utilize a very high-quality, higher-cost core device portion, and lower cost, single-use portions. The single use portions can negate the need for most of the typical cleaning, for example for the sheath exposed portions. Adding to existing systems can leverage large installed bases, methods, and usage patterns.

SUMMARY OF THE FIGURES

FIG. 1 illustrates a distal end of variation of the biological navigation device and an elongated element.

FIGS. 2 a and 2 b illustrate a variation for deploying the biological navigation device having a locally, tip-based bunched or scrunched tube.

FIG. 3 a is a perspective view of cross-section A-A of a variation of the device and the elongated element of FIG. 1.

FIG. 3 b is a side view of cross-section A-A of the variation of the device and the elongated element of FIG. 3 a.

FIG. 3 c is a perspective view of cross-section A-A of the variation of the device of FIG. 3 a.

FIG. 4 a illustrates a cross-section of a variation of the biological navigation device.

FIG. 4 b illustrates cross-section a variation of a method for using the biological navigation device of FIG. 4 a.

FIG. 5 illustrates is a perspective view of cross-section A-A of a variation of the biological navigation device and the elongated element of FIG. 1.

FIGS. 6 a through 6 g illustrate transverse cross-sections of variations of shaft seals.

FIGS. 7 a and 7 b illustrate a longitudinal cross-section of a variation of the biological navigation device and the elongated element in first and second configurations, respectively.

FIG. 8 a illustrates a longitudinal cross-section of a variation of the biological navigation device and the elongated element.

FIG. 8 b illustrates a close-up of the distal end of the biological navigation device and elongated element of FIG. 8 a.

FIG. 9 a illustrates a longitudinal cross-section of a variation of the biological navigation device and the elongated element.

FIG. 9 b illustrates a close-up of the distal end of the colonoscope of FIG. 9 a.

FIG. 10 illustrates a variation of the head and cap.

FIG. 11 illustrates a perspective view of a variation of the clamp on the head.

FIG. 12 illustrates a variation of a method of assembling the head with a shear clip and an elongated element.

FIG. 13 a illustrates a variation of a method of assembling the head with a shear clip and an elongated element.

FIG. 13 b illustrates the head, shear clip and elongated element of FIG. 13 a in an assembled configuration.

FIG. 13 c is a variation of cross-section B-B of FIG. 13 b.

FIG. 14 is a perspective view of cross-section A-A of a variation of the biological navigation device of FIG. 1

FIGS. 15 and 16 illustrate variations of the biological navigation device and elongated element.

FIG. 17 is a variation of cross-section C-C of FIG. 16.

FIG. 18 a illustrates a variation of the base, the tube and the elongated element.

FIG. 18 b is a variation of cross-section D-D of FIG. 18 a.

FIG. 18 c is a variation of cross-section D-D of FIG. 18 a without the elongated element.

FIG. 19 a illustrates a variation of the base and the elongated element.

FIG. 19 b illustrates the variation of the base and the elongated element from FIG. 19 b with the tube.

FIG. 20 a illustrates a variation of the biological navigation device in an assembled configuration

FIG. 20 b illustrates the biological navigation device of FIG. 20 a in a disassembled configuration.

FIG. 21 illustrates a variation of the biological variation device of FIG. 20 a in an elongated configuration.

FIG. 22 a is a perspective view of a variation of the base with the tube connector.

FIG. 22 b is a top perspective view of the base of FIG. 22 a.

FIG. 23 a illustrates a variation of the base with the tube and the elongated element.

FIG. 23 b is a variation of cross-section E-E of FIG. 23 a.

FIG. 24 a is a partial cross-section of a variation of the biological navigation device in a retracted configuration.

FIG. 24 b is a cross-section of the variation of the biological navigation device of FIG. 24 a in an extended configuration.

FIG. 25 illustrates a cross-sectional view of a variation of a biological navigation device system.

FIGS. 26 a through 26 e are close-up views of variations of section W of FIG. 25.

FIG. 27 a illustrates a variation of a cartridge or cassette.

FIG. 27 b illustrates a variation of a cartridge or cassette with a working channel sleeve.

FIG. 27 c illustrates a variation of the threaded tip of the elongated element.

FIG. 27 d illustrates a variation of a method for assembling the elongated element and the cartridge.

FIG. 27 e is a perspective distal end view of the cartridge and elongated element in an assembled configuration.

FIG. 27 f illustrates a cross-section of a variation of the biological navigation device.

FIG. 28 a illustrates a variation of a method for fitting the female exit port and the tube connector.

FIG. 28 b illustrates a variation of a method for locking the tube connector in the female exit port with a quick-release shear pin.

FIGS. 29 and 30 illustrate a variation of the biological navigation device and the elongated element.

FIG. 31 illustrates a variation of cross-section F-F of FIG. 30.

FIG. 32 a illustrates a longitudinal cross-section of a variation of the tube in a longitudinally elongated configuration.

FIG. 32 b is an end view of a variation of the tube in a longitudinally contracted configuration.

FIG. 33 a illustrates a longitudinal cross-section of a variation of the tube in a longitudinally elongated configuration.

FIG. 33 b is an end view of the tube of FIG. 33 a in a longitudinally contracted configuration

FIG. 33 c is a longitudinal cross-section of half of a variation of the tube of FIG. 33 a longitudinally contracted configuration

FIG. 34 a illustrates a longitudinal cross-section of a variation of the tube in a longitudinally elongated configuration.

FIG. 34 b illustrates a longitudinal cross-section of a variation of the tube in a longitudinally elongated configuration.

FIG. 34 c is an end view of the tube of FIG. 34 a or 34 b in a longitudinally contracted configuration.

FIG. 34 d is a longitudinal cross-section of half of a variation of the tube of FIG. 34 a or 34 b in a longitudinally contracted configuration.

FIG. 35 is a schematic view of a variation of the base and a fluid system.

FIG. 36 illustrates a variation of the system base station capital equipment.

FIG. 37 illustrates a variation of the sheet that comprises the tube.

FIGS. 38 a through 38 c are variations of cross-section G-G of the sheet of FIG. 37.

FIG. 39 is a longitudinal cross-section of a variation of the tube.

FIG. 40 is an end view of a variation of the tube.

FIGS. 41 a through 41 d illustrate variations of reinforcing members.

FIG. 42 a illustrates a section of the base and length of the tube in a first configuration.

FIG. 42 b illustrates the section of the base and length of the tube of FIG. 42 a in a compressed configuration.

FIG. 43 illustrates a variation of a perspective view of a transverse cross-section of an elongated element.

FIG. 44 illustrates a variation of a method for using the base.

FIG. 45 illustrates a method for using the biological navigation device in a patient.

FIG. 46 is not the invention and illustrates a colon.

FIGS. 47 a through 47 g illustrate a variation of a method for using the biological navigation device.

FIGS. 48 a through 48 g illustrate a method of folding the tube.

DETAILED DESCRIPTION

FIG. 1 illustrates a biological navigation device 10. The device can be used for navigation through a biological anatomy, such as a biological lumen, for example any or all of the GI tract (e.g., colon, stomach, esophagus) or cardiovascular vessels (e.g., arteries, veins, heart chambers).
The navigation device can be removably attached or integrated (e.g., permanently fixed, welded, glued, fused, or otherwise substantially permanently fixed) with an elongated element. The elongated element can be, for example, an endoscope or colonoscope. For example, the elongated element can be a CF-Q160 series, PCF-160 series, or CF-2T160 series colonoscope (from Olympus America, Inc., Center Valley, Pa.), a Pentax EC-series colonoscope (from Pentax of America, Inc., Montvale, N.J.), a Fujinon HD Super CCD colonoscope, or a G-5 endoscope (from Fujinon Inc., Wayne, N.J.).
The biological navigation device 10 can have a head 12, a tube 14 or a combination thereof. The head 12 can have a cap 22. The cap 22 can be attached to the remainder of the head 12, for example with cap screws 24. The cap 22 can be atraumatic (as shown) or traumatic (e.g., with a sharp edge). The cap 22 can have a hemi-toroidal configuration, as shown. The cap 22 can be attached to the remainder of the head 12 with one or more cap screws 24.
The head 12 can have a longitudinal axis 18. The head 12 can have a head channel 20 passing through the head 12, for example along the longitudinal axis 18. The head channel 20 can have a cylindrical configuration. The head channel 20 can be configured to fixed or releasably attach to or integrate with the elongated element 16.
The head channel 20 can be adjacent to or surrounded by an attachment element, such as an adjustable or non-adjustable clamp 52. The attachment element can be configured to attach the head 12 to the elongated element 16. The attachment element can be adjustable, for example, by one or more clamp screws.
The distal end of the tube 14 can be attached to or loosely enclosed in the head 12. The tube 14 can extend out of the proximal end of the head 12. The tube 14 can be flexible. The tube 14 can be resilient or non-resilient. The tube 14 can be made from a sheet of fiber-reinforced substrate. The tube 14 can be non-porous. The tube 14 can be substantially fluid impermeable. The tube 14 can have an engineered coefficient of friction (COF) on both its inner and outer surfaces. The tube 14 can be pressurizable. The tube 14 can have a tube channel through the center of the tube 14 configured to receive the elongated element 16.
FIGS. 2 a and 2 b illustrate that the tube 14 can be stored or stowed (e.g., rolled, bunched, scrunched, pleated) in a compressed configuration at or near the distal end of the tube 14. The tube 14 can be stowed in the head 12 (not shown in FIGS. 2 a and 2 b) or not in the head 12 (e.g., the head 12 can be absent). Bunched tube configurations can include scrunched configurations, for example can include transverse and irregular folding and compaction of the wall of the tube 14. The tube 14 can be passively or actively longitudinally distributed as the colonoscope longitudinally extends or advances, as shown by arrow in FIG. 2 b. The tube 14 can have elements that serve to recapture parts of the tube 14 as the colonoscope is used for a reduction of the colon. The elongated element 16 can have a distal component 32 attached to or integrated with the distal end of a umbilical 28. The distal component 32 can have therapeutic and/or diagnostic instrumentation (e.g., CMOS camera, one or more other sensors, ablation elements). The umbilical 28 can be flexible. The umbilical 28 can have conduits for power or data electricity, fluids, elongated tools, mechanical control lines or combinations thereof.
FIGS. 3 a through 3 c illustrate that a length of the distal end of the tube 14 can be stored in a head chamber 44 in the head 12. The head chamber 44 can be substantially defined by a head inner wall 42 and a head outer wall 40. The chamber-side of the head inner wall 42 and/or head outer wall 40 can be coated by a lubricant and/or a low friction material, such as Teflon.
The space in the head chamber 44 between the tube 14 and the head outer wall 40 can be vented to the atmospheric pressure outside the head 12.
The tube 14 can be foldable. A foldable tube 14 can be, for example, folded to have a minimum of about five about 180 degree folds 82. A foldable tube 14 can also have a wall thickness, for example, of less than about 0.2 mm (0.007 in.). The tube 14 can have folds 82 or scrunches that can be regular (as shown for illustrative purposes) or irregularly shaped. The folds 82 can be parallel, perpendicular, or randomly oriented with respect to the longitudinal axis 18.
The attachment element, such as a clamp 52, can be in the head 12. The clamp 52 can have a clamp ring 38 substantially surrounding the head channel 20. The clamp 52 can have a clamp head 36 configured to receive a clamp screw 26 for adjusting the tension of the clamp 52. The clamp 52 can be tightened (e.g., the clamp screw 26 can be turned) to attach the head 12 to the elongated element 16, for example when the elongated element 16 is in the head channel 20 and is longitudinally concurrent or even with the clamp 52. The clamp screw 26 can be loosened to detach the head 12 from the elongated element 16.
The radially inner side of the head inner wall 42 can have an elongated element seal 50 configured to seal between the head inner wall 42 and the elongated element 16. The elongated element seal 50 can prevent or minimize pressure loss from within the tube 14 during pressurization of the tube 14. The elongated element seal 50 can be one or more gaskets or o-rings surrounding the head channel 20.
When the tube 14 is pressurized, the head 12 can be pressurizably advanced through a target site. Pressurizably advancing systems and devices can be configured to deliver at least a majority of the force causing advancement of the head 12 due to the fluid pressure in the tube 14.
The head 12 can have a labyrinth geometry having a circularizer 46 and/or a fold restrictor 48, for example to control egress of the tube 14 from the head chamber 44. The circularizer 46 can extend radially outwardly from the head inner wall 42 proximal to the head chamber 44. The circularizer 46 can be configured to prevent or minimize premature and/or undesired release of tube material from the head chamber 44. The fold restrictor 48 can extend radially inwardly from the head outer wall 40 proximal to the circularizer 46. The fold restrictor 48 can be configured to shape the tube 14 as the tube 14 extends proximal to the fold restrictor 48.
FIG. 4 a illustrates that the tube 14 can be an everting tube. The evening tube can have an evening element inner section 54 and an everting element outer section 56, and an everting element cavity 66 therebetween. The tube 14 can have a separatable sheath lining the evening element inner section 54. The separatable sheath can split at the distal end of the tube 14 from having a separatable sheath first inner section 58 attached to a second inner section 60 into a sheath first outer section 62 separated from a sheath second outer section 64. The sheath first and second outer sections 62 and 64 can line the evening element outer section. The separatable sheath can have a low friction surface.
The tube 14 can have the elongated element seal 50 between the evening element inner section 54 and the tip body 146. The elongated element seal 50 can be on either side of the separatable sheath inner sections 58 and/or 60. The elongated element seal 50 can be a low friction interface between the umbilical 28 and the everting element inner section 54. The elongated element seal 50 can fluidly seal between the tube 14 and the umbilical 28.
FIG. 4 b illustrates that the elongated element 16 can be translated distally (and proximally) with respect to the tube 14. A distal force can be applied to the elongated element 16 relative to the tube 14, resulting in distal translation, as shown by arrow, of the elongated element 16 and distal component 32. The elongated element seal 50 can roll or slide between the tube 14 and the elongated element 16 when the umbilical 28 is translated with respect to the tube 14.
FIG. 5 illustrates that the head 12 can have a head seal 70 in a head seal seat 68 proximal of the head chamber 44. The head seal 70 can be configured to create a fluid-tight seal between the head 12 and the inside of the tube 14 as the tube 14 exits the head chamber 44. The head seal 70 can create two regions that can be pressurized to different pressures. The seal can be a two-way seal or a substantially one-way seal, for example allowing movement of the tube 14 out of the head chamber 44.
FIGS. 6 a through 6 g illustrate cross-sections of variations of shaft seals 72. FIG. 6 a illustrates a seal having a substantially circular cross-section. FIG. 6 b illustrates a seal having a substantially x-shaped cross-section. The seal can have four cantilever arms 74 extending therefrom. FIG. 6 c illustrates a seal having a substantially C-shaped cross-section. The seal can have two cantilever arms 74 extending therefrom.
FIG. 6 d illustrates that the seal 72 can be a cup seal. Cup seals can have cantilevered sealing surfaces, which can be lower drag and more compliant against irregular surfaces than o-ring (compression) seals.
FIG. 6 e illustrates that the seal 72 can have one or more separate seal heads 76 with a single cantilever arm extending from the seal head 76. The cantilever arms 74 can all be unidirectional. FIG. 6 f illustrates that the seal 72 can have a number of unidirectional cantilever arms 74 extending from a single backing 78. FIG. 6 g illustrates that the seal 72 can have a seal spring 80 inserted into the seal 72 to pressurize the cantilever arms 74 outward.
Seal designs can be modulated to reduce the seal drag for the head 12 and/or base seals 72. The seal durometer, material surface friction, squeeze pressure, size, pressure area, and combinations thereof can be varied to modulate desired seal drag. Seal materials can be low durometer to be more compliant and seal with lower forces and lower drag. The seals 72 can have in-seal lubricants. Fluid lubrication can be applied to the seal 72. The seal 72 can have a geometry that limits directional variation, such as a cup seal. Lubricants or other low friction elements can be added to the seals 72, to the elongated element 16, or to the pressurization fluid or media.
FIGS. 7 a and 7 b illustrate that the tube 14 (everting—as shown—or directly releasing, as shown in FIGS. 1-3 inter alia) can have one or more folds 82 extending at a fold angle 84 or pitch from the head channel 20 or umbilical 28. The fold angle 84 can be obtuse, acute, or right. The folds 82 can be stowed to hold additional, pre-loaded length of the tube 14. The folds 82 can overlap each other. The folds 82 can unfold and distally extend the tube 14, for example, as pressure is increased in the tube 14. The folds 82 can unfold sequentially when pressure is increased in the tube 14.
The tube material can be stowed along the length of the head 12. When then released in this manner it can substantially enables a 1:1 ratio of motion of the elongated element 16 to the tube advancement. The tube material can be stowed in the form of folds 82 that are staggered by varying angles.
The distal component 32 can have one or more shoulders 86, for example, to prevent excessive release of the folds. The shoulder 86 can be configured to prevent over-extension of the tube 14 during deployment. The shoulder 86 can have a larger outer diameter than the outer diameter of the inflated tube 14. The shoulder 86 can be a fender washer or other geometric abutment.
FIGS. 8 a and 8 b illustrate that the folds 82 can extend from the distal end 34 of the tube 14. The tube 14 can be stowed along the length of the tube 14, then released in a manner that substantially enables a 1:1 ratio of advancement of the distal end 34 of the tube 14 and the elongated element 16. The tube 14 can be stowed in the form of non or minimally staggered folds 82. The folds 82 can have substantially no pitch. The folds 82 can lay substantially parallel with the longitudinal axis of the elongated element 16 and/or the tube 14. The terminal end of the radial outermost fold 82 of the tube 14 can be fixed and sealed to a deployment mechanism (e.g., pressurizer, such as a pressure box) not shown. The other terminal end of the tube 14 (radial innermost) can be fixed and sealed to the umbilical 28 or other portion of the elongated element 16, for example minimally proximal to the termination of the fold's proximal edge.
FIGS. 9 a and 9 b illustrate that the folds 82 can be stacked in one or more fold series. The tube 14 can be stowed along the length of the elongated element 16 and/or tube 14, then released in a manner that substantially enables a 1:1 ratio of advancement of the distal end 34 of the tube 14 and the elongated element 16. The tube 14 can be stowed in the form of non or minimally staggered series of folds 82 that are connected sequentially to other fold series 88. The fold series 88 can be between the radially outermost portion of the tube 14 and the elongated element 16. The fold series 88 can unfold sequentially from most distal to most proximal. The fold series 88 can be slidably or fixedly attached to the elongated element 16 at fold mounts 90. The fold mounts 90 can have low friction. More proximal fold mounts 90 can have higher friction (e.g., equal frictional coefficients with more surface area, or larger frictional coefficients with equal surface area) against the fold series 88 than more distal fold mounts 90, for example to sequentially release the fold series 88.
FIG. 10 illustrates that the cap 22 can have a bulleted atraumatic configuration. The head 12 can have a clamp screw port 92. The clamp screw port 92 can be configured to allow access by a tool to the clamp screw 26 contained inside of the head 12. For example, the clamp screw port 92 can be configured to receive an Allen wrench. The head channel 20 can have an elongated element seal 50 at the distal end of the cap 22.
FIG. 11 illustrates that the clamp 52 can be seated in a clamp frame 94 in the head 12. The clamp 52 can be a split clamp. The clamp screw 26 can pull the separate sides of the clamp head 36 together, as shown by arrows. Although the cap 22 is not shown in FIG. 11, the cap 22 can be over the clamp 52.
FIG. 12 a illustrates the distal end of the elongated element 16 with a shear clip 96 and the head 12. The shear clip 96 can be configured to use shear resistance to attach at least two elements. The head 12 can be slid, as shown by arrow, onto the elongated element 16 and the shear clip 96 can be inserted, as shown by arrow, through a corresponding clip seat 98 and shear groove 100 on the head 12 and the elongated element 16, respectively.
FIGS. 13 a through 13 c illustrate a variation of the clip 96 being inserted into a clip seats 98 on the head 12 and a corresponding shear groove 100 in the elongated element 16. The clip 96 can have internal reinforcing struts 102.
FIG. 13 b illustrates the elongated element 16, shear clip 96 and head 12 in an assembled configuration. The elements of FIG. 13 b can be ready for pressurization of the tube (not shown for illustrative purposes). The shear clip 96 can mechanically join the head 12 to the elongated element 16, and enable simultaneous motion of the head 12 and the elongated element 16.
The head 12 can be lowered onto the elongated element 16 and can seal radially or over the entire face. Sealing over the face can increase the effective pressure area and therefore the effective propulsion force, because its pressure area is the full cross sectional area. Though it creates a smaller propulsion area (a substantially annular pressure area), sealing radially can be advantageous in that it can enable therapeutic or diagnostic elements of the elongated element 16 to exit the distal end of the elongated element 16 without any significant modification. The elongated element seal 50 (e.g., o-rings, cup-seals, boss seals, face seals) can help seal the head 12 to the elongated element 16.
As the tube 14 is pressurized, the stored tube 14 in the head 12 can naturally exert a force load pushing the elongated element 16 along as the load is transferred through the attached structure.
During or after use, the clip 96 can be removed and the head 12 can be removed from the elongated element 16.
The head 12 can join the elongated element 16 by friction, bonding, shear, or combinations thereof. For example, the attachment elements used to join the head 12 to the elongated element 16 can be a bayonet, threads (parts threading together or set screws from the side), shear wire, a snap ring, metal lateral shear clips 96 (as shown in FIGS. 12 through 13). The attachment elements can be high-strength, predictable, and reliable. Threads create material in shear. Tabs can create material in shear. A head installation and/or removal tool (e.g., an allen wrench) can be used.
The elongated element seal 50 can be one or more o-rings. The elongated element seal 50 can be a radial seal, a face seal, an o-ring boss type seal, or combinations thereof.
The head 12 can be configured to encompass the full distal face of the elongated element 16. Fully encompassing the distal face can create a complete pressure area and higher propulsion forces (at any given cross section). The head 12 can partially encompass the distal face of the elongated element (not shown). Partially encompassing the face can leave vision and working channels of the elongated element 16 unimpeded.
FIG. 14 illustrates that the attachment element can be a collet 104. The collet 104 can have collet panels 106 or tabs oriented radially inward. The collet panels 106 can be separated by collet slots 108 to allow flexing of the collet panels 106 when an elongated element 16 is inserted into the head channel 20. The collet panels 106 can squeeze against the elongated element 16, friction fitting the elongated element 16 to the head 12. The elongated element 16 can have slots to attachably engage the collet panels 106.
FIG. 15 illustrates that the elongated element 16 can have an articulating length 110 proximal to the head 12. The tube 14 can passively articulate with the elongated element 16. The elongated element 16 can not extend distal to the head 12.
FIG. 16 illustrates that the elongated element 16 can extend distal to the head 12. The elongated element can have an articulating length 110 distal to the head 12. FIGS. 16 and 17 illustrate that the bullet-shaped cap 22 can be used when the elongated element 16 extends beyond the head 12. Any configuration of cap 22 can be used with an elongated element 16 extends distal to, or does not extend distal to the head 12.
FIGS. 18 a through 18 c illustrates that the base 30 can be ergonomically configured to be of low mass and volume. In this configuration the base 30 can rest by itself in anal proximity, or the base 30 can be hand held. For example, the base 30 can have a generally cylindrical outer case sized to fit into a hand.
The base 30 can have a base channel 122 passing through the base 30. The base channel 122 can be configured to slidably receive the elongated element 16. The tube 14 can be permanently or removably attached or integrated to the distal end of the base 30 surrounding the base channel 122.
The base 30 can have a base distal flange 114 and/or a base proximal flange 116. The base flanges 114 and/or 116 can be trumpeted to guide the elongated element 16 into the base channel 122 when the elongated element 16 is inserted into the base 30 from either end. The base distal flange 114 can be configured to comfortably stop against the patient before getting to the anus 268.
The base 30 can have a base pressure port 112 configured to attach to a pressure source or sources. The base pressure port 112 can be in communication with a base pressure channel (s) 118. The base pressure channel(s) 118 can be configured to deliver pressure from the pressure source into the base channel 122. During use the pressure can pressurize the tube 14.
The base 30 can have a base seal 120 configured to seal between the wall of the base channel 122 and the elongated element 16. The base seal 120 can be any of the seals 72 shown supra (shown as a cup seal). The base seal 120 can be located proximal to where the base pressure channel 118 enters the base channel 122.
FIG. 19 a illustrates that the base 30 can have a rigid or flexible proximal stiffener extending distally from the distal end of the base 30. The proximal stiffener can be configured to enter the anus 268. The proximal stiffener 124 can provide the tube 14 with an increased rigidity, for example at the proximal end of the tube 14. The proximal stiffener 124 can deliver force to introduce the tube 14 and the head 12 into the anus 268. FIG. 19 b illustrates that the tube 14 can slide over the proximal stiffener.
FIGS. 20 a and 20 b illustrate that the proximal end of the tube 14 can be fixed to a tube connector 128. The tube connector 128 can be removably attached to the base 30. The tube connector 128 can have one or more tube connector interlocks 130, such as keys or pegs (i.e., a bayonet connector). The base 30 can have one or more base interlocks 132, such as slots or channels. The tube connector interlocks 130 can be configured to removably attach to the base interlocks 132.
The tube 14, head 12 and tube connector 128 can form a cartridge or cassette. The cartridge can be quickly removed from the base 30 and replaced with another cartridge. The cartridge can seal to the base 30 with a fluid seal that is located in either the base unit or in the cartridge or cassette.
The head channel 20 can be aligned with a channel (not shown) in the tube 14 and the base channel 122.
FIG. 21 illustrates that the tube 14 in an expanded configuration can actively (i.e., designed to form the specific shape) or passively (i.e., designed to flexibly fit the surrounding shape) form tube straights 136 and tube curves 134. For example, the tube 14 can be sufficiently flexible to accommodate various anatomical configurations.
The base 30 can have an attached cartridge (shown only as the tube connector 128 for illustrative purposes). FIG. 22 a illustrates the cartridge separated from the hand manifold. The tube connector interlocks 130 can be one or more wings or panels extending radially from the tube connector 128. The tube connector 128 can mount and seal against the distal face of the base 30. The base interlock 132 can be retractable pegs or shear prongs or shear pins configured to hold the tube connector 128. The base 30 can have one or more controls for releasing the tube connector 128 and/or for controlling the fluid pressure through the base pressure channel 118.
FIG. 22 b illustrates that as the control is activated (i.e., the button is depressed), the base interlocks 132 can be actuated and released. The base interlocks 132 can release the tube connector 128. During pressurization the shear prongs can keep the tube connector 128 in the base 30 and leak-free.
The cartridge for the biological navigation device 10 can be replaced with a new cartridge for each patient. All or part of the base 30 can be reusable and cleanable or disposable—for example minimizing the need for the cartridge to be released, as the cartridge can be fixedly attached to the base 30 and be thrown away, with the base 30, after use.
FIGS. 23 a and 23 b illustrate that the base 30 can have sets of one or more rollers 140 above and below the elongated element 16. The elongated element 16 can have seal drag against the base seal 120.
The base 30 can have guide wheels or rollers 140. The rollers 140 can be used to guide the elongated element 16 on a straight path to the base seal 120, for example to minimize drag between the elongated element 16 and the base seal 120. The rollers 140 can be powered friction wheels, to help move the elongated element 16 forward or backward. The rollers 140 can provide base-delivered propulsive of the elongated element 16. The base-delivered propulsion or braking or reversing can be used in combination or separately from the propulsion of the elongated element 16 due to fluid pressurization. Alternately, the wheels can have sensors which pick up on forward or reverse motion to trigger an event, such a change in system pressure.
The base 30 can have more than one control 138. The controls 138 can be, for example, press buttons and/or slides. The controls 138 can control the base interlocks 132, the roller speed (e.g., including locking the rollers 140 and allowing the rollers 140 to roll freely), pressure through the base pressure channel 118, and combinations thereof.
FIGS. 24 a and 24 b illustrate that the tube 14 can be tapered, for example, the tube 14 can have a conical configuration when extended. The tube 14 can utilize a locally tip stowed material on a tapered eversion tube. This version utilizes locally folded material. In a longitudinally contracted configuration, the tube 14 can be folded into folds 82. For example, a six foot long tube could have six folds 82, each fold at about six inches in each direction. The tube 14 can have from about five to about twenty folds 82, for example about six folds 82.
The tube 14 can be tapered at a taper angle 144. The taper angle 144 can be measured between the taper axis 142 and the longitudinal axis 18. The taper angle can be more than about 0° and less than about 90°. For example, the tube 14 can have a taper of about 3/16^thof an inch of diameter over six feet of length. This taper can reduce or eliminate the creases that can be created during a stowage or folding process. Other varying cross section geometries can have locally repeating bulbous features 152 that serve to control fold unfurling sequencing.
The elongated element 16 can have the umbilical(s) 28 that extends therefrom. A control wire in the umbilical 28 can communicate data and/or power and/or fluid. The control wire can be attached, for example, to a controller. Excess length of undeployed umbilical 28 can be stored on a spool 148.
As shown in FIG. 24 b, the tube 14 can be extended, translating the tube distally, thereby towing the umbilical 28 and distal component 32. The umbilical(s) 128 can be stowed in either a substantially linear or a substantially rotary manner on the spool 148. The tube 14 can be extended, for example by the base 30 pressurizing the tube 14.
FIG. 25 illustrates the colonoscopy system that can have a folded tube 14. The tube 14 can be attached or integral with the elongated element 16, for example along the umbilical 28, the distal component 32, or combinations thereof.
FIG. 26 a illustrates that the folds 82 can have bulbous portions 152, for example one or more or less bulbous portions 152 per fold 82. The bulbous portions 152 can extend radially inward toward the longitudinal axis 18.
FIG. 26 b illustrates that the folds 82 can be staggered distally. The elongated element 16 can be tapered. FIG. 26 c illustrates that the folds 82 can be staggered distally as radius increases. The folds 82 and the tip body 146 can be substantially parallel with the longitudinal axis 18. FIG. 26 d illustrates that the folds 82 can be staggered proximally as radius increases. FIG. 26 e illustrates that the elongated element 16 can be tapered radially outward with respect to the longitudinal axis 18. The folds 82 can be staggered proximally as radius increases.
FIG. 27 a illustrates a variation of a cassette or cartridge 126 (cassette and cartridge are terms used interchangeably herein). The cartridge 126 can have an exit fitting, a pressure sleeve with multiple folds 82, or tube sliding receptacle (not shown, but can be located underneath the tube 14), a cassette seal 154 and a clear cassette tip 156. For example, the cassette or cartridge 126 can be used for a semisposable system, in which some system portions have a life that can be used for multiple times before it is disposed of, while other system portions have a substantially disposable product life. The cassette or cartridge 126 can have a thin shell upon which the extensible pressure sleeve can be mounted. The cassette or cartridge 126 can include a tip 156 or cap region. The tip 156 or cap region can cover the tip of the elongated element 16, or radially encompass tip of the elongated element 16 (e.g., radially, with an open center area for the through passage of scope elements to exit).
Through the use of the cartridge 126, for example, an elongated element 16 can be coupled and the elongated element 16 could be pulled along with what serves as a propulsive element. As the propulsive elements stowed material is pressurized and spent out from its stored location, the elongated element 16 is pulled along. After the procedure is complete, this cartridge 126 could then be disposed of. This cartridge 126 also serves to protect the elongated element 16 from contamination, including potentially the use of working channel sleeves.
FIG. 27 b illustrates that the cassette can have a sleeve for working channel(s) and/or to enable tip washing and/or for pressurization of the working channel sleeves and/or biological anatomy. The cassette can be loaded and attached to a base region. The base region can be fixed in space, or go over a colonoscope shaft to enable reciprocating motion. As the tube 14 is inflated, the tube 14 can utilize pneumatic or hydraulic pressure to linearly expand, thereby applying a load (typically at or near the tip) that can serves to propel the scope forward.
FIG. 27 c illustrates that the elongated element 16 can have a threaded elongated element connector 158. The elongated element distal component 32 can have lighting (e.g., one or more LEDs) and a camera lens. The elongated element 16 can be attached to the cassette, for example, by screwing the elongated element connector 158 into a threaded receptacle in the tube 14.
FIG. 27 d illustrates a method for entering the elongated element 16 into the cartridge 126. FIG. 27 e illustrates that the distal component 32 (e.g., camera lens and LED) can show through the clear tip.
FIG. 27 f illustrates that the device can have or be attached to (e.g., in the elongated element 16) a steerable section, for example articulating links 170 or an otherwise articulatable section 110. A distal end of the biological navigation device 10 can be distal to all or a substantial portion of the steerable section. Alternatively, the distal end of the biological navigation device 10 can be proximal to all or a substantial portion of the steerable section.
The articulatable links 170 can be individually and/or concurrently articulatable. The tube 14 can be configured to be an everting tube. The tube 14 can have stowed tube material at a distal end 34 of the tube 14. For example, the stowed material can be scrunched, bunched or folded. The folds 82 can be substantially parallel (as shown) or perpendicular to the longitudinal axis of the tube 14. The proximal end of the tube 14 can be attached to or integral with a tube connector 128.
The device can have a base 30. The base 30 can have an exit port 162. The tube connector 128 can be removably attachable to the base 30 at the exit port 162. For example, the tube connector 128 can have a tube connector interlock 130 that can removably attach to a base interlock 132 on the base. The interlocks 132 can be a peg, rail, hole or other receiver, snap, thread, or combinations thereof. The tube 14 and tube connector 128 can form a cartridge 126. The cartridge 126 can seal to a base unit with a fluid seal that is located in either the base unit or in the cartridge 126 or cassette (e.g., along the tube connector 128, for example at the tube connector interlock 130 and/or base interlock 132). The cartridge 126 can have a substantially disposable product life.
The base 30 can controllably deliver fluid pressure to the inside of the tube 14. For example, the base 30 can controllably deliver pressure independently to the different fluid channels of the device. The base 30 can control the articulating links 170, for example via one or more control leads, wires, cables, or combinations thereof.
The distal component 32 of the elongated element 16 can have a camera or other visualization element 166. The distal component 32 can have one or more elements that enable vision (e.g., fiber optics, CCD cameras, CMOS camera chips) and/or lighting 168 (e.g., fiber optic light sources, high power LEDs (Light Emitting Diodes)). The distal component 32 can have the working channel port 164, for example to 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 tool or orifice that can exit near the camera, such that a fluid flush provides a cleansing wash).
In an exemplary variation, the elements, in order from the proximal end of the device to the distal end of the device (including the elongated element 16), can include: the base 30, the tube 14, the steering mechanism, the distal end of the tube 14, and the distal component 32, for example, including lighting and vision and working channel exit.
FIG. 28 a illustrates that the tube connector 128 can be attached to or integral with the tube 14. The umbilical 28 can pass through the tube connector 128. The base 30 can have a female exit port 162 configured to receive the tube connector 128. The female exit port 162 can be fit on the tube connector 128.
FIG. 28 b illustrates a method for locking the exit fitting in the female exit port 162 with a separable base interlock 132, such as a quick-release shear pin 160.
FIGS. 29 through 31 illustrate that the elongated element 16 have a base or other component configured to translate the elongated element 16. The elongated element 16 can enter the base directly (straight), or it can be looped in a U-shape (as shown). Through the use of a sliding shaft seal against the elongated element's shaft, the system can be advanced without the need for full volume pressurization of the elongated element 16.
The tube 14 can be pressurized locally, for example to enable a design for the system that is smaller and more compact. The pump 204 can be in or directly attached to the base. The pump 204 can be in fluid communication with the base via the base pressure channel 118. The navigation device can be substantially entirely contained a hand-held unit (e.g., the base or a component attached to or separate from the base).
FIGS. 32 a through 34 d illustrate variations of tube packing configurations. Tube layout (i.e., tube packing configuration) can affect the kinematics, size, stability, and aesthetics of the biological navigation device 10.
FIG. 32 a illustrates that the tube 14 can be straight in cross section. The tube 14 can have a tube length 176 and a tube outer diameter 178. The tube length 176 can be about 1.0 m (40 in.) to about 2.0 m (79 in.), for example about 1.6 m (63 in.). The tube outer diameter 178 can be from about 18 mm (0.71 in.) to about 23 mm (0.91 in.).
FIG. 32 b illustrates that as the straight tube 14 is folded into itself, folds 82 are formed. The tube 14 also has compressive deformations 180 to allow for the shrinking radius of the folds 82. The sheet forming the tube 14 can be configured (e.g., by altering the reinforcement fibers accordingly or weakening the sheet at those points) so that the compressive deformations 180 are aligned at a single angle.
FIGS. 33 a, 34 a and 34 b illustrate that the tube 14 can be tapered. FIG. 33 a illustrates that the tube 14 can have steps 182 or discrete changes in radius along the length.
FIG. 33 b illustrates that the folded tube 14 with steps 182 can have no compressive deformations. FIG. 33 c illustrates that the tube 14 can fold at the location of the steps 182.
FIGS. 34 a and 34 b illustrate that the tube 14 can be tapered. The tube 14 can have a larger diameter at the proximal end of the tube 14 and a smaller diameter at the distal end of the tube 14. FIG. 34 b illustrates that the tube 14 can have a smaller diameter at the proximal end of the tube 14 and a larger diameter at the distal end of the tube 14. FIGS. 34 c and 34 d illustrate that the tapered tubes can be folded multiple times without compressive deformation.
The longer the elongated element 16 extends through the tube 14, the larger the capstan drag. The tube 14 can be tapered to create an increasingly higher or lower capstan drag force with distance or extension of the elongated element 16 and biological navigation device 10 through the anatomy (e.g., colon).
FIG. 35 illustrates that the base can be in fluid communication with a fluid control system 184. The base, for example at the base pressure port 112, can be connected to a pressure delivery line 200. The pressure delivery line 200 can be connected to an outgoing second valve 196 and/or an incoming first valve 186.
The first valve 186 can be configured to open manually and/or automatically. The rust valve 186 can open when the tube pressure exceeds a maximum desired tube pressure. The first valve 186 can be connected to a vacuum pump 188. The vacuum pump 188 can be activated to deflate the tube 14 and withdraw the tube 14 or reduce the tube pressure. The vacuum pump 188 can be attached to an exhaust tank 190 and/or directly to a bleed or drain line 192. The exhaust tank 190 can be connected to the drain line 192, for example to exhaust overflow from the exhaust tank 190.
Controls 194 can be in data communication with the first valve 186 and the second valve 196. The controls 194 can be on the base (e.g., a button or switch on the base).
The second valve 196 can be attached to a pump 204, for example a cylinder 206 with a displacement component 208, such as a piston. A pressure regulator 198 can be in the flow path between the pump 204 and the second valve 196. The pressure regulator 198 and/or the first valve 186 can open and release pressure from the pump 204 when the tube pressure exceeds a maximum desired tube pressure.
An intake tank 202 can be fed in line (as shown) or through the pump 204 to the second valve 196, for example through the pressure regulator 198. The fluid in the intake tank 202 can be fed into the pressurized tube 14. The intake tank 202 can have a fill line 210 for filling the intake tank 202 with fluid. The fill line 210 can be fed directly to the second valve 196, pressure regulator 198 or pump 204 without the intake tank 202.
The biological navigation device 10 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 184. The fluid control system 184 can have a fluid source (e.g., the intake tank 202 and/or fill line 210), a pressurize source such as the pump 204, a conduit for delivery of the pressurization media (e.g., the pressure delivery line 200), controls 194, system monitoring elements (e.g., can be in the controls). The capital equipment can reduce the profile of the tube 14, 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 16 or base, voice commands, foot pedals, or combinations thereof.
FIG. 36 illustrates that the base can have an elongated element feeder 220. The elongated element feeder 220 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 220 can be controlled by a motor that can turn a lead screw 216 and/or drive shaft 218 connected to the elongated element feeder 220. Before being deployed, the umbilical 28 can be substantially straight in a pressure chamber 214, for example to reduce capstan drag in the elongated element 16 (as compared to a spooled configuration). As the elongated element feeder 220 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 214 can be sealed with the base and pressurized. The base is shown without a top for illustrative purposes. A pressure gauge 224 can be attached to the pressure chamber 214 and/or the base and can sense and display pressure therein.
Steering controls can include one, two or more motors 212 thereby allowing an electronic input interface (e.g., joystick, buttons, paddles, pedals) to control the deployment of the elongated element 16. Another motor can provide axial movement for actuation of the distal component 32 of the elongated element 16, for actuation of tools at the distal component 32 and/or for steering and other motion (e.g., vibration, rotation, drilling) of the distal component 32 itself. The base can have feed through ports 222 for example to feed tools such as electronics and/or mechanical devices through the elongated element 16. The feed through ports 222 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 222 can negate the need for a base seal around the elongated element shall, but a base seal can still be used in addition to the feed through ports 222.
FIG. 37 illustrates a flat panel of a sheet 226 that can be used to make the tube 14. The sheet 226 can be made from a composite including thin films, resins, and fibers 230. The thin films can include PET, nylon, or any other material disclosed herein, or combinations thereof. The sheet 226 can be reinforced, such as by integral metal filaments or fibers 230, or an integral metal mesh.
The sheet 226 can be a laminate as describe in U.S. Pat. No. 5,333,568 or 5,470,632, both of which are herein incorporated by reference in their entireties. The sheet 226 can have a substrate 228 and fibers 230 in the substrate 228. The fibers 230 can be oriented to desired relative angles, with one or more layers of tape (i.e., unidirectionally oriented fiber array in each layer), weave, braid, matte (i.e., randomly oriented fibers), or combinations thereof.
One or more films can be applied to either and/or both sides of the fibers 230, with a resultant thin laminate that can be formed. The fibers 230 can be embedded in a resin polymer matrix.
The sheet 226 can be configured to contain at least about 6 psi (48 kPa) in a 0.80″ diameter configuration, more narrowly at least about 7 psi (48 kPa), yet more narrowly, at least about 100 psi (690 kPa) even in a very thin wall configuration (e.g., 0.002 in.), even yet more narrowly at least about 200 psi (1380 kPa).
The sheet 226 can have one or more reinforcement fibers 230. The fibers 230 can be high strength and low elasticity. The low elasticity fibers 230 can be very flexible and have very low radial compliance. The fibers 230 can be made from, for example, Kevlar, Vectran (spun from Liquid Crystal Polymer (LCP)), Spectra, Dacron, Twaron, Pentex, Technora, Dyneema, Teflon (PBT), Zylon (PBO), Polyimide (PIM), Boron/ceramic boron, Nylon, fiberglass, carbon, graphite, polyester, extended chain polyethylenes, or hybrids or combinations thereof
The substrate 228 can be made from a flexible resin matrix.
The sheet 226 can be thinner than about 0.1 mm (0.004 in.), yet more narrowly thinner than about 0.05 mm (0.002 in.).
The sheet 226 can have a sheet coefficient of friction on either or both sides equal to or greater than about 0.3, more narrowly equal to or greater than about 0.4. The sheet coefficient of friction can be equal to or lower than about 0.2, more narrowly equal to or lower than about 0.15. The sheet coefficient of friction can be equal to or greater than about is greater than 0.1 and equal to or less than about 0.6. The sheet coefficient of friction can be equal to or greater than about a coefficient of friction to maintain a deformed expanded configuration of the tube 14.
The sheet strength can result in the tube 14 having a radial stiffness equal to or lower than about a 0.05% change in diameter per 1 psi, more narrowly radial stiffness equal to or lower than about a 0.01% change in diameter per 1 psi, even when these values are observed from a tube 14 of very low wall thickness (e.g., less than about 0.002 in.).
The sheet strength can result in a tube 14 delivering a propulsive force of up to about 4 N (1 lbs.) or, for example, up to about 9 N (2 lbs.), for example, or for example, up to about 18 N (4 lbs.), or for example, up to about 27 N (6 lbs.), with these values typically taken from an annular pressure area design with an o.d. of approximately 0.8″.
FIG. 38 a illustrates that the reinforcing fiber can have a substantially equivalent diameter to the thickness of the substrate 228 (a single layer is shown, but the sheet 226 can also have multiple layers). The sheet 226 can have a top film 232 and/or a bottom film 234. The films can be made from, for example, PET and/or Nylon. The films can be attached to or integrated with the substrate 228 and/or the fiber 230. FIG. 38 b illustrates that the fiber can have a substantially smaller diameter to the thickness of the substrate 228. FIG. 38 c illustrates that the fiber can have a substantially larger diameter than the thickness of the substrate 228
FIG. 39 illustrates that the tube 14 can have variable wall thicknesses along the length of the tube 14. For example, the tube 14 can have a first length 236 adjacent to a second length adjacent to a third length 240. The tube wall along the first length 236 can have the smallest thickness of the lengths. The tube wall along the second length 238 can have a larger wall thickness than the tube wall along the first length 236. The tube wall along the third length 240 can have a larger wall thickness than the wall along the second length 238. The differential of the wall thicknesses between the lengths can be discrete or gradual.
FIG. 40 illustrates that the inner surface of the tube 14 can have an attached or integral reinforcing member 242 along all or part of the length of the tube 14.
FIG. 41 a illustrates that the reinforcing member 242 can have a rectangular transverse cross-section.
FIG. 41 b illustrates that the reinforcing member 242 can have a variable transverse cross-section along the length of the reinforcing member.
FIG. 41 c illustrates that the reinforcing member 242 can have a circular transverse cross-section. For example, the reinforcing member 242 can be a rod. FIG. 41 d illustrates that the reinforcing member 242 can have a trapezoidal transverse cross-section.
By adding geometric and or modulus-enhancing reinforcing elements to local portions of the pressure sleeve, the sleeve's local resistance to buckling can be enhanced.
Attaching the reinforcing members to the tube 14 can decrease the buckling of the tube 14.
The reinforcing members can have tube, rod, rectangular, trapezoidal configurations, or combinations thereof. The reinforcing members can be bonded or otherwise attached to the tube wall. One, two, three, four or more local reinforcements, for example radially spaced, can be attached to the tube 14. Alternatively, reinforcing members can be added to the entirety of the tube wall.
The reinforcing members can be made by extrusion, injection molding, or additional laminates of pressure sleeve material. The reinforcing member 242 can be configured to not substantially change the tube's inflated bending properties, yet enhance the tube's local buckling resistance. The enhanced buckling resistance can be designed into a variety of locations on the tube 14. The locations of higher buckling resistance in the tube 14 can be located near the patient's anus 268. The pressure sleeve can buckle more distally than the anus 268, for example, to reduce looping in more proximal regions, including the sigmoid.
The selectively enhanced buckling resistance regions along the tube 14 can be fixed to the tube 14, or the enhanced buckling resistance regions can move relative to the tube 14. The enhanced buckling resistance regions can follow a few inches behind the distal tip or head 12 of the device. For example, any tube wall buckling can be shifted to occur close to the distal tip or head 12 of the device. After retraction, once the device is driven forward, the propulsion can be more closely tip-based (e.g., due to the buckling near the distal tip due to the enhanced buckling resistance farther away from the distal tip). For example, a small diameter rod can be pulled along by tensile members attached to the distal end of the device or the head 12. The tensile members can be in pockets on either side of the tube 14. During a reducing maneuver, the tensile members can be vacuumed in their pockets, providing enhanced buckling resistance where the tensile members' pockets are located, and preferentially low buckling resistance where the pockets are not located (e.g., near the distal tip or head 12). This ability to reduce proximal buckling in favor of more distal tube wall buckling serves to minimize looping after a reduction procedure.
FIG. 42 a illustrates that the reinforcing member 242 can be attached to the radial inside to the proximal end of the tube 14. For example, the reinforcing member 242 can be adjacent to the base.
FIG. 42 b illustrates that when the tube 14 is subject to longitudinal compressive forces, as shown by arrows, a length of the tube 14 distal to the reinforcing member 242 can buckle before the length of the tube 14 with the reinforcing member 242 buckles.
FIG. 43 illustrates a cross-section of an elongated element 16, such as a tool, for example a colonoscope. Colonoscopes can have various conduits or working channels. The conduits or channels can 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 conduits 244 and 246. The colonoscopies can have conduits that can 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 248, 250, 252, 254, 256, 258 and 260.
Suction can be utilized to remove debris or fluid. The colon can be pressurized to reconfigure the colon into a more circular cross-section to enhance visualization.
During advancement of the colonoscope through the colon, landmarks can be noted and a significant portion of the colon's inside wall can be visualized. Therapeutic actions can occur at any time, for example during withdrawal of the colonoscope.
FIG. 44 illustrates that a pump 204 having an extensible displacement component 208, such as a piston, can be used to pressurize the base. The piston or otherwise extensible displacement component 208 can be manipulated to control load volume to exert a corresponding pressure out of the exit port 162 and into the pressurizable tube 14 of the navigation device. A fluid supply 262 can be attached to the base pressure port 112, for example via connecting tubing 264. The inlet port can have a one-way (i.e., check) valve preventing backflow. The exit port 162 can have a one-way (i.e., check) valve preventing backflow. The fluid supply 262 can be filled with fluid. The fluid can be delivered to the deployment system under no pressure or positive pressure. The fluid can be air, saline, water, carbon dioxide, nitrogen, or combinations thereof. The pump 204 can be separate from or attached to the base pressure port 112. For example, the fluid supply 262 can be routed through the pump 204 before or after passing through the base pressure port 112 and into the base.
FIG. 45 illustrates that the proximal stiffener of the base can be inserted into the anus 268. The base pressure port 112 can be connected to a pressure source before or after inserting the proximal stiffener.
A simplified typical large intestine or colon 266 is shown in FIG. 46. The anus 268 can provide entry into the colon 266 for a colonoscopy. The colon 266 extends from the rectum 270 to the cecum 280 and has sigmoid, descending, transverse and ascending portions. The sigmoid colon 272 is the s-shaped portion of the colon 266 between the descending colon 274 and the rectum 270.
A colonoscopy can include inserting the proximal stiffener and/or elongated element 16 into the anus 268. To navigate the colon 266, the forward few inches of the proximal stiffener or the elongated element 16 can be flexed or steered and alternately pushed, pulled, and twisted. Once inserted, the biological navigation device 10 can navigate to the end of the colon 266: the cecum 280.
FIG. 47 a illustrates that the biological navigation device 10 (i.e., colonoscope) can be positioned before entry into the colon 266, for example via the rectum 270 after passing the anus 268. FIG. 47 b illustrates that the pressure in the tube 14 can be increased and/or the biological navigation device 10 can be otherwise deployed. The biological navigation device 10 can translate, as shown by arrow, into the rectum 270, attached to the elongated element 16.
The biological navigation device 10 is shown having an outer diameter smaller than the inner diameter of the colon 266 for exemplary purposes. The biological navigation device 10 can have an outer diameter about equal to the inner diameter of the colon 266. For example, the tube 14 can flexibly expand to substantially fill the cross-section of the length of the colon 266 occupied by the biological navigation device 10.
FIG. 47 c illustrates that the distal end of the biological navigation device 10 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 biological navigation device 10 can actively rotate, for example by actuation of control wires and/or actuators in or attached to the distal component 32 or head 12.
The distal end of the biological navigation device 10 can passively rotate, for example if the biological navigation device 10 (e.g., the tube 14 and/or the head 12) contacts a wall of the colon 266 (e.g., the superior wall of the rectum 270), the biological navigation device 10 can then track to the wall of the colon 266.
FIG. 47 d illustrates that after making a turn in the rectum 270, the distal end of the biological navigation device 10 can be further extended, as shown by arrow, or translated into and through the sigmoid colon 272, for example as the tube 14 continues to release from the head 12.
FIG. 47 e illustrates that the biological navigation device 10 can make a turn, as shown by arrow, for example as the biological navigation device 10 passes from the sigmoid colon 272 to the descending colon 274. FIG. 47 f illustrates that the biological navigation device 10 can be further advanced, extended or translated, as shown by arrow, for example by everting the everting element, through the descending colon 274 after the biological navigation device 10 has made two previous turns.
The biological navigation device 10 can be repeatedly turned and advanced, for example by inflating the tube 14 and/or controlling the head 12 and/or the elongated element 16, to extend as far along the colon 266 as desired.
At any length in the colon 266, the biological navigation device 10 or elongated element 16, for example at the distal component 32 of the elongated element 16, can gather diagnostic (e.g., sensing) data, such as data for visualization, tissue inductance, RF absorption or combinations thereof. The biological navigation device 10 and/or elongated element 16 can also gather tissue samples (e.g., by performing a biopsy or removing a polyp). At any length in the colon 266, the biological navigation device 10 and/or elongated element 16, for example at the distal component 32, 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. 47 g illustrates that the biological navigation device 10 can be advanced along the entire colon 266, passing through the rectum 270, sigmoid colon 272, descending colon 274, transverse colon 276, ascending colon 278, and having the tip distal end in the cecum 280. The biological navigation device 10 can be withdrawn, as shown by arrows, from the colon 266, for example by applying a tensile force against the tube 14 and/or elongated element 16, as shown by arrows 282. The biological navigation device 10 can be withdrawn, as shown by arrows, from the colon 266, for example by applying a tensile force to the umbilical(s) 28.
FIGS. 48 a and 48 b illustrate that for a method of constructing the folded tube 14, an inner construction cylinder 284 can be inserted, as shown by arrow, into the tube 14.
FIG. 48 c illustrates a first split sleeve or grip half 286 and a second split sleeve or grip half 288. The first and second grip halves 286 and 288 can be configured in a partially or completely cylindrical shape when adjacent.
FIG. 48 d illustrates that the grip halves 286 and 288 can be placed, as shown by arrows, around the tube 14 on the inner construction cylinder 284.
FIG. 48 e illustrates that a tapered outer construction cylinder 290 can be translated, as shown by arrow, on top of the inner construction cylinder 284 and under the tube 14. The outer construction cylinder 290 can be positioned to end from about 10 in. to about 20 in., for example about 12 in., from the end of the tube 14. The inner construction cylinder 284 can be positioned to end from about 5 in. to about 10 in., for example about 6 in., from the end of the tube 14.
FIG. 48 f illustrates that two semi-cylindrical grip halves 286 and 288 can be diametrically oppositely compressed, as shown by arrows, onto the tube 14 on the inner construction cylinder 284. The grip halves 286 and 288 can then be translated, as shown by arrow, toward the outer construction cylinder 290, for example, until the grip halves 286 and 288 abut the outer construction cylinder 290. The wrinkles in the tube 14 can be removed during translation of the grip halves 286 and 288. The inner construction cylinder 284 and/or the tube 14 can have one or more markings to provide guidance for translation lengths.
FIG. 48 g illustrates that the outer construction cylinder 290 and the grip halves 286 and 288 can then be removed once the set of folds 82 are properly formed. The tube 14 can then be repositioned with respect to the inner and outer construction cylinders 284 and 290.
The inner and outer construction cylinders 284 and 290 can be removed from the folded tube 14 when the desired number of folds 82 are formed.
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 Ser. Nos. 60/887,319, filed 30 Jan. 2007; 60/887,323, filed 30 Jan. 2007; and 60/949,219, filed 11 Jul. 2007; U.S. patent application Ser. No. titled “Biological Navigation Device”, attorney docket number LMVSNZ00200, filed concurrently herewith; and PCT Application titled “Biological Navigation Device”, attorney docket number LMVSNZ00600WO, filed concurrently herewith, which are all incorporated herein by reference in their entireties. The everting element can be merely representative of any pressurized tube 14, including those disclosed in the references incorporated, supra.
The term colonoscope is used for exemplary purposes and can be any deployable elongated element 16 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 can be used interchangeably herein.
The tube 14 can have wide medical applicability, including, but not limited to, endoscopy and the dilation of anatomical structures. One such dilation application is for use in the field of interventional cardiology, where they can be used for lesion dilation, as a stand-alone procedure, for pre-stent deployment (‘pre-dia’), for post-stent deployment, as part of a stent-expansion inflatable structure used as a stent delivery system, or combinations thereof.
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

We claim:

1. A device for navigation through biological anatomy comprising:

an everting tube comprising a tube wall with a plurality of folds configured to be pressurizably unfolded; and

a tube channel in the everting tube, wherein the tube channel is configured to receive an elongated element such that the elongated element can be pressurizably advanced when the plurality of folds are pressurizably unfolded.

2. The device of claim 1, wherein the tube is configured to contain a fluid pressure of about 6 psi to about 200 psi.

3. The device of claim 1, wherein the tube wall comprises a sheet integrated with reinforcement fibers.

4. The device of claim 3, wherein at least some of the reinforcement fibers comprise a unidirectional fiber array.

5. The device of claim 3, wherein the reinforcement fibers are arranged in the tube such that the tube has a radial stiffness that results in equal to or lower than a 0.05% change in diameter per psi of fluid pressure in the tube.

6. The device of claim 3, wherein the reinforcement fibers are arranged in the sheet such that the tube has a strength that allows a distal propulsive force of about 4N to about 27N to be delivered.

7. The device of claim 1, wherein the sheet has a coefficient of friction that is equal to or greater than 0.1 and equal to or less than 0.6.

8. The device of claim 1, wherein a first length of tube entering at least one fold the plurality of folds and wherein a second length of tube exiting the at least one fold are substantially parallel with the long axis of the tube.

9. The device of claim 1, wherein the everting tube includes an inner section and an outer section, and wherein the plurality of folds is included in the inner section.

10. The device of claim 1, wherein the plurality of folds comprises a first set of folds and a second set of folds, and wherein the first set of folds are separated from the second set of folds by a non-folded section of the tube wall.

11. A device for navigation through biological anatomy comprising:

a pressurazably everting tube including a tube wall with inner section and an outer section, said tube wall including a plurality of folds; and

a channel within the tube, wherein the channel is configured to receive an elongated element such that the elongated element can be advanced distally when the plurality of folds are unfolded;

wherein each of the plurality of folds extends at a fold angle with respect to a longitudinal axis of the tube.

12. The device of claim 11, wherein the plurality of folds are included in the inner section of the tube wall.

13. The device of claim 11, wherein the fold angle is acute.

14. The device of claim 11, wherein the plurality of folds overlap one another.

15. A device for navigation through biological anatomy comprising:

a pressurazably everting tube including a tube wall with inner section and an outer section, said tube wall including a plurality of folds;

a channel within the tube, wherein the channel is configured to receive an elongated element such that the elongated element can be advanced distally when the plurality of folds are unfolded; and

at least one fold mount for providing a frictional engagement between at least one of the plurality of folds and the elongated element for sequentially releasing the plurality of folds.

16. The device of claim 15, wherein the at least one fold mount comprises first and second fold mounts adapted to frictionally engage first and second folds, respectively.

17. The device of claim 16, wherein the first fold mount is adapted to provide a first level of friction between the first fold and the elongated element and the second fold mount is adapted to provide a second level of friction between the second fold and the elongated element, and wherein the first level of friction is less than the second level of friction.

18. The device of claim 16, wherein the first fold mount has a smaller surface area than the second fold mount.

19. The device of claim 16, wherein the first fold mount has a lower coefficient of friction than the second fold mount.

20. The device of claim 16, wherein the plurality of folds includes a first and a second fold series separated by a non-folded portion of the tube wall, and wherein the first fold mount is associated with the first fold series and the second fold mount is associated with the second fold series.