Patent Description:
Exemplary embodiments of the present disclosure relate to arrangements and methods for effecting an endoluminal anatomical structure, and more particularly to arrangements and methods for treatment of gastrointestinal lesions that currently require open abdominal surgery. The exemplary embodiment of at least one of the arrangements can provide an endoluminal colon chamber and a variety of maneuverable operating tools inside that chamber. For example, the exemplary embodiment of such arrangement can function as a miniature operating room inside the colon.

Current endoscopic technologies may not facilitate treating colon perforations, large polyps and tumors, and a significant colon bleeding effectively and safely. A gastrointestinal bleeding is a common and potentially life-threatening medical condition, which can complicate any polypectomy (polyp removal), and excision of colonic tumors. A colon perforation can occur when excessive mechanical force or excessive energy is inadvertently applied to a colonic wall. A colon perforation is a life-threatening condition and currently requires major emergency surgery to close the colon perforation and preclude fecal contamination of an abdominal cavity and resulting sepsis.

Consequently, many patients who develop large polyps, colon perforation, colon bleeding and other significant colon pathology currently have to undergo a major surgery and endure a significant operative trauma and, typically, painful and prolong recovery. Currently there are no effective and safe devices and methods for replacing major abdominal surgery in case of colon perforation or when large wide-based polyps need to be removed.

Thus, there may be a need to address at least some of the deficiencies described herein above.

<CIT> and entitled "Detachable Balloon Catheter" describes exemplary embodiments of device and method for treatment of a gastrointestinal perforation and/or a gastrointestinal bleeding. The exemplary device can include a balloon catheter that can control bleeding by pressing on a bleeding area or/and prevents the gastrointestinal contents trespassing outside a gastrointestinal lumen into a body cavity by blocking an opening in the luminal wall or blocking the colon distal to the perforation. Such exemplary device can be inserted using an endoscope, and can allow a partial or complete withdrawal of an endoscope, while leaving the balloon at the target area. More specifically, the exemplary device and method can facilitate ceasing a colonic bleeding and blocking a colon perforation.

The Minos Megachannel is a large bore flexible reinforced tube, which is designed to be inserted over the standard colonoscope. After the colonoscope is removed, the tube can be used as a passage for insertion of different instruments into the colon.

Further, conventional endoscopes generally have one to two working channels, which likely do not have independent movements from the main body of the endoscope. As a result, when conventional flexible endoscopic instruments are inserted via such channels into the intestinal lumen, an operator can only manipulate these instruments axially (e.g., forward and backward movements), and possibly somewhat rotationally. In addition, since the conventional instruments can only be advanced from the tip of the endoscope towards the target lesion axially and in front of the endoscopic image, the conventional instruments have only limited functionality. <CIT> discloses a device for treating an intracranial vascular aneurysm located on an intracranial blood vessel, the blood vessel having a lumen and the aneurysm having a lumen, the device comprising: a catheter including a central lumen therethrough, a first inflation conduit having a distal end, and a first inflation balloon in communication with the distal end of the inflation conduit; the catheter further including means for visualizing the blood vessel lumen adjacent the aneurysm lumen, the means for visualizing in combination with the central lumen; and the catheter further including means for delivering a liquid sealing agent to the lumen of the aneurysm, the means for delivering in combination with the central lumen. <CIT> discloses an endoscopic retractor instrument assembly comprising: an insertion or deployment tube insertable through a channel of an endoscopic instrument; a balloon or bladder having a pair of expandable or inflatable end members and at least one expandable or inflatable spacer member connecting said end members to one another, said balloon or bladder being disposed in a collapsed configuration inside said tube; and inflation means operatively coupled with said balloon or bladder for inflating said balloon or bladder from said collapsed configuration to an expanded use configuration in which said spacer member pushes said end members apart from one another.

Accordingly, there may be a need to address at least some of the deficiencies described herein above.

Exemplary embodiments of the present disclosure can address most if not all of the above-described needs by providing device and method for a treatment of, e.g., a gastrointestinal perforation, bleeding, removal of large polyps, and/or other significant endoluminal pathology, for example, colonic pathology.

According to one exemplary embodiment of the present disclosure, the device can function as a miniature operating room inside the lumen, for example, colon, and providing an operator with advanced endoluminal functionalities replicating capabilities of a surgical suite. The exemplary device of the present disclosure can provide such miniature endoluminal operating room, chamber or at least partial enclosure, and the ability to utilize a variety of articulating surgical instruments, which can operate within, at or around the chamber.

According to one exemplary embodiment of the present disclosure, the exemplary arrangement/device can be introduced after a standard diagnostic colonoscopy is performed. An exemplary balloon guide catheter, as described in <CIT>, or a large endoluminal channel such as a Minos Megachannel manufactured by, e.g., Minos Inc. , can be used to facilitate the insertion of the exemplary device according to the present disclosure.

Further objects, features and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying figures showing illustrative embodiments of the present disclosure, in which:.

Throughout the figures, the same reference numerals and characters, unless otherwise stated, are used to denote like features, elements, components or portions of the illustrated embodiments. Moreover, while the subject disclosure will now be described in detail with reference to the figures, it is done so in connection with the illustrative embodiments.

According to one exemplary embodiment of the present disclosure, a device, an arrangement and a method can be provided for treatment of, e.g., conditions associated with body lumen(s) or/and cavities, for example, gastro-intestinal conditions, including but not limited to a gastrointestinal perforation, bleeding, large polyps or/and tumors, diverticuli, appendix, and others.

The exemplary embodiments of the arrangement/device according to the present disclosure can provide various functions, which may be the same and/or similar to the surgical functions provided in the surgical operating room, therefore, thus representing a miniature operating room within a lumen (e.g., of a body), such as, e.g., colon and allowing to replace a major surgery, e.g., an open abdominal surgery.

For example, as shown in <FIG>, the exemplary embodiment of the arrangement/device <NUM> according to the present disclosure can provide an endoluminal chamber which can also be at least partial enclosure, such as, e.g., an endoluminal colon or an intra-colon chamber/enclosure, and include various maneuverable operating instruments and/or tools <NUM> within the chamber <NUM>. The exemplary arrangement/device <NUM> can be inserted after one or more relevant lesions is/are identified, e.g., during standard colonoscopy. A particular balloon guide catheter <NUM>, e.g., such as described in <CIT>Mega-channel, can be used to facilitate an insertion of the exemplary arrangement/device <NUM>.

According to certain exemplary embodiments of the present disclosure, the arrangement/device <NUM> can be a particularly-designed endoscope, such as, e.g., a colonoscope. As shown in <FIG>, according to certain exemplary embodiments, the arrangement/device <NUM> can include, e.g., an exemplary handle <NUM> (see Figs. (see <FIG>), an exemplary multi-lumen tube <NUM> (see <FIG>, <FIG>, <FIG>, <FIG> and <FIG>), and an exemplary expandable chamber <NUM> (see <FIG>, <FIG>, <FIG> and <FIG>). In addition, the arrangement/device <NUM> can include standard and particular exemplary instruments/tools <NUM> (see <FIG>, <FIG> and <FIG>) and/or exemplary tool channels (see <FIG>).

As indicated herein above, the exemplary arrangement/device <NUM> can include the multi-lumen tube <NUM>. Such exemplary multi-lumen tube <NUM> can be made from a single extrusion polymer tube <NUM> having multiple lumens {see Fig. la}, and/or made in a standard endoscopic equipment configuration using a collection of single or multi-lumen tubes <NUM> of different sizes that are enclosed by a single, large, flexible tube <NUM> (see <FIG>). External and internal tubes can be simple polymer tubes and/or reinforced tubes or braided tubes, as known in the art. The external tube <NUM> can have a diameter that is large enough to contain all inner tubes <NUM> provided for the exemplary arrangement/device <NUM>. The exemplary multi-lumen tube <NUM> can include at least one lumen, and, e.g., possibly <NUM> to <NUM> or more lumens for <NUM> to <NUM> or more exemplary instruments/tools <NUM> and/or tool-channels <NUM>, and possibly additional lumens, for example, for a air insufflation <NUM>, water irrigation <NUM>, vacuum <NUM>, lumen for wiring and/or fibers for cameras and illumination <NUM>, lumen for a balloon guide catheter <NUM>, lumen for chamber expansion control <NUM>, and/or lumen for proximal balloon inflation <NUM>, as shown in the exemplary embodiment of <FIG>.

For example, according to particular exemplary embodiments of the present disclosure, the arrangement/device <NUM> can contain a distal chamber <NUM> that can be expanded to different sizes inside the colon, thus likely creating relatively large or sufficient working space near the lesion to be treated. The exemplary chamber <NUM> can provide a space for manipulations of multiple tools and / or tool-channels in such a way that several tools can approach the lesion from all sides and directions, as shown in, e.g., <FIG>, <FIG>, <FIG> and <FIG>. The exemplary multi-lumen tube <NUM>, e.g., having a diameter between <NUM> to <NUM>, can accommodate at least one tool-channel, which can in turn accommodate, e.g., a non-standard instrument, for example, an endoscopic stapler, both having a sufficient size for a particular purposes thereof.

According to one exemplary embodiment of the present disclosure, the exemplary chamber <NUM> can be constructed from at least one, and possibly two or more flexible metal strips, fibers or wires <NUM>, which can be made from a flexible material, such as, e.g., Nitinol, as shown in <FIG> and <FIG>. These exemplary strips, fibers or wires can be composed of other materials as well, including but not limited to surgical plastic or other materials. The exemplary strips, fibers or wires <NUM> can be substantially straightened (or slightly-to-moderately bent as needed during steering the device through the lumen) when the chamber <NUM> (providing a working space) is in non-deployed position (see <FIG> and <FIG>), and are substantially bent when actuated by a control lever <NUM> in the handle <NUM>, hence, enlarging the chamber <NUM> and creating a larger working space inside the colon, as shown in <FIG>, <FIG>, <FIG> and <FIG>. For example, pushing or pulling the exemplary strips, fibers or strips <NUM> can be performed with a tube <NUM> that can slide in the lumen <NUM> by pulling and/or pushing the tube <NUM> proximal end lever <NUM> in the handle <NUM>, as shown in <FIG>, <FIG>, <FIG>. Further, the guide catheter <NUM> can be inserted inside the tube <NUM>. The exemplary strips <NUM> can be covered by a soft polymer cover to avoid possible inner colon tissue damage.

According to an exemplary embodiment of the present disclosure, as shown in <FIG>, the chamber <NUM> it can be deflected by pulling on the exemplary strips, fibers or wires <NUM>, or the chamber <NUM> can be opened when the exemplary strips, fibers or wires <NUM> are pushed forward from the handle <NUM>. In thus manner, the exemplary strips, fibers or wires <NUM> increase working space with in the chamber <NUM> to facilitate the anatomical structure to be pulled into the chamber <NUM> by other instruments/tools <NUM> being manipulated from the handle <NUM>, as described in further details herein, and shown in, e.g., in <FIG>.

Further, as shown in <FIG> and <FIG>, the exemplary strips, fibers or wires <NUM> can be covered with a protective cover portions <NUM> so as to reduce damage being caused by the exemplary strips, fibers or wires <NUM> when they are actuated to expand the chamber <NUM> (i.e., which causes the exemplary strips, fibers or wires <NUM> to push on the surrounding tissue). As shown in <FIG>, the arrangement/device <NUM> can also include an overtube <NUM> which can be pushed forward toward the front of the arrangement/device <NUM> so as to cover the collapsed chamber <NUM> (e.g., to facilitate insertion and removal and containing the specimen), and pulled back to prepare for the chamber <NUM> for its expansion. <FIG> shows an illustration of the arrangement/device <NUM> of <FIG> with a scope <NUM> (including a camera and at least one light illuminating source) that is provided in one of the working channels <NUM> and facilitating a field of view <NUM> for positioning and propelling the exemplary arrangement/device <NUM>.

When the instrument <NUM> reaches the desired position within the body, the scope <NUM> can be retracted inside the chamber <NUM>, e.g., via the working channel <NUM> to facilitate visualization inside and/or near the chamber <NUM>. According to another embodiment of the present disclosure, an articulating scope (which can perform similar functions as that of the scope <NUM>) can be provided through one or more of the working channels <NUM> into the chamber <NUM>. Such articulating scope can be configured to illuminate and/or provide images of the anatomical structure and tools inside and/or near the chamber <NUM>. The articulating scope can have a distal portion that can rotate in <NUM> degrees and bend to provide an end part thereof so as to illuminate and visualize any portion of the anatomical structure and the tools inside and/or near the chamber <NUM> at any angle.

In another exemplary embodiment of the present disclosure, as shown in <FIG>, the strips <NUM> can be proximally connected to a first cap <NUM>, which can be made from a solid material. The first cap <NUM> can have multiple holes for most or all lumens <NUM>. The strips <NUM> can also be distally connected to a second cap <NUM> which can be smaller in diameter than the first cap <NUM>, to facilitate a passage of large specimens, for example, polyps into the area of the chamber <NUM>. The distal second cap <NUM> can include a hole for insertion of the balloon guide catheter <NUM>. Alternatively or in addition, the exemplary chamber <NUM> can be made from two asymmetrical balloons <NUM>, <NUM>, as shown in the exemplary embodiment of <FIG>. For example, the balloons <NUM>, <NUM> can create space for the chamber <NUM> and the exemplary instruments/tools <NUM> when inflated. Alternatively or in addition, the exemplary chamber <NUM> can be provided using the proximal balloon <NUM> and the distal balloon <NUM>, being connected to one another via their attachment to the balloon guide catheter <NUM>, as shown in <FIG>. Further alternatively or in addition, the exemplary chamber <NUM> can be provided by a braided metal wire net <NUM> having an opening <NUM> at desired location, as shown in <FIG>.

In another exemplary embodiment of the present disclosure, at least one, and possibly two or more balloons can be used with the chamber <NUM> that is made from strips <NUM> made from a bendable material (e.g., metal). The exemplary balloon(s) <NUM>, <NUM> can assist in blocking and/or isolating the chamber <NUM> from the rest of the colon, hence, minimizing and/or preventing the inflow and outflow of liquids and solids from and/or to the chamber <NUM>, while the exemplary strips <NUM> can provide a substantially rigid and stable working space and facilitate treatment of the lesion. For example, as shown in <FIG>, the first symmetric or asymmetric balloon <NUM> can be provided in proximal to the chamber <NUM> or the position of the strips <NUM>. The second balloon <NUM> can be provided at the position that is distal to the strips <NUM>. Alternatively, the second balloon <NUM> that can be connected to the guide catheter <NUM>.

According to still another exemplary embodiment of the present disclosure, the arrangement/device <NUM> can include at least one camera and an illumination apparatus to provide sufficient light to the area of interest. For example, camera or cameras and illuminating component can be movable or fixed in the arrangement/device <NUM>, for example, to the chamber <NUM>. In one exemplary embodiment shown in <FIG>, the scope/front camera <NUM> can be used to facilitate the insertion of the arrangement/device <NUM> into the colon. Referring to <FIG>, e.g., at least one, two or more additional and possibly fixed cameras <NUM> can be positioned so to facilitate image capture at a location of the lesion. Exemplary field views <NUM> of the cameras <NUM> can overlap, and such overlap may facilitate visualization if one or more instruments/tools blocks or adversely affects view of one of the cameras. For example, illumination can be provided by a variety of ways, e.g., by LEDs <NUM>, <NUM>. Exemplary front LEDs <NUM> can be used for the front camera <NUM>, and in-chamber LEDs <NUM> can be used for the illumination in or at the chamber <NUM>. Alternatively or in addition, a conventional flexible endoscope, having distal bendable section, can be used instead of or together with the fixed camera(s) <NUM> and illumination via the LEDs <NUM>, <NUM>.

As shown in <FIG>, the exemplary arrangement/device <NUM> according to a further exemplary embodiment of the present disclosure can include a control handle <NUM> at or about its proximal end. The exemplary handle <NUM> can have similar shape and configuration with respect to other conventional endoscope's handles, while likely having additional channel ports and actuators than standard endoscope. For example, the ports in the handle <NUM> can include at least one, and possibly <NUM>-<NUM> or even more ports for the tool-channels <NUM>, balloon guide catheter port <NUM> and particular lever <NUM> to control the opening and closing of the chamber <NUM>. Additional ports can include, but not limited to, a luer port <NUM> for a proximal balloon inflation, and a port <NUM> of a vacuum catheter <NUM> or an irrigation catheter. The handle <NUM> can include switches <NUM>, <NUM> for air insufflations, water irrigation and vacuum activation, as well as switch (not shown) for switching camera(s) between frontal and inner locations.

As illustrated in <FIG>, the exemplary arrangement/device <NUM> according to a still further exemplary embodiment of the present disclosure can include a vacuum catheter with a bent tip <NUM>, inserted in a vacuum lumen <NUM> through a vacuum port <NUM>. The vacuum catheter can operate as a standalone (as describe herein), and/or may be inserted into tool channel <NUM> and deflect. Further, the vacuum catheter can be manipulated to reach all or most areas inside and around the chamber <NUM>, hence, providing an access for elimination of liquids and solids from and around the chamber <NUM>. In another exemplary embodiment of the present disclosure, the chamber <NUM> can include bendable and steerable section, which can be actuated at the lever <NUM>, which when pulled, the instrument <NUM> is articulated, and when pushed, the chamber <NUM> is opened (or increased in size). Thus, movements of the exemplary arrangement/device <NUM> in the colon can be facilitated. According to a further exemplary embodiment, a locking mechanism can be provided which can , e.g., rotate one or more times (e.g., counterclockwise or counter-clockwise) to lock the lever <NUM>.

According to still another exemplary embodiment of the present disclosure, the exemplary arrangement/device <NUM> can include the instruments/tools <NUM> and/or tool- channels <NUM>, as shown in <FIG>. When the exemplary instruments/tools <NUM> are inserted in the tool channels <NUM>, distal ends <NUM> thereof change the position(s) and/or shapes of the instruments/tools <NUM>, for example, rotated, axially moved, bent at desired angles, whenever the position and shape of the associated tools channels <NUM> are changed, as shown in <FIG>. The tool channels <NUM> can be actuated and manipulated at or about proximal end of the exemplary arrangement/device of the present disclosure. The described maneuverability of the tool-channels <NUM>, for example, their distal ends <NUM> provide and/or facilitate multidirectional and multiangular approach to the target lesion.

For example, the tool-channels <NUM> can include at least one, and preferably two, three or more lumen tubes <NUM>, which can be made of polymer, possibly having high torque-ability, low friction, connected at or about their distal ends to an additional section <NUM>, which can have "elevators" <NUM>. The exemplary polymer tube(s) <NUM> can be reinforced with other materials to change its/their structural or/and functional properties. The elevator <NUM> can be a flexible bendable section, made, e.g., from a laser cut nitinol tube <NUM>, and/or actuated, e.g., bent, using one or two metal wires <NUM>. The instruments/tools <NUM> can be inserted in the first (e.g., relatively large) lumen of the tube <NUM>, and the wire <NUM> can be inserted in the second (e.g., relatively small) lumen of the tube <NUM>.

As shown in <FIG>, the ability of the tool-channel tubes <NUM> to move, independently or simultaneously, axially (e.g., pushing, pulling directions), rotate and bend using the elevator <NUM>, facilitates the instruments/tools <NUM> or/and the tool-channels <NUM> in reaching any point within and around the chamber <NUM>, and can provide possibly an unlimited range of instrumental freedom within the working space. For example, as shown in <FIG>, the tool channel <NUM> can include one or more handles <NUM> connected to the tube <NUM> at or about a proximal side of the tube <NUM>, and can be used for a manipulation of the elevator <NUM>, and utilize a port <NUM> for an insertion of the exemplary instrument/tool. The exemplary tool-channel handle <NUM> can include a slider or knob <NUM> which can be used to actuate, e.g., pull and release a wire <NUM>, as shown in <FIG>. Any standard tool(s) can be used with the exemplary tool-channel(s) <NUM>. Alternatively or in addition, articulating tools having maneuverable distal ends, e.g., with at least two degrees of freedom, can be used.

According to yet a further exemplary embodiment of the present disclosure, a method for implementing the exemplary arrangement/device <NUM> according to the present disclosure can be provided. Such exemplary method can be utilized as follows:.

Claim 1:
A multi-lumen endoscope receiving tube (<NUM>), comprising:
a proximal balloon (<NUM>) disposed along a distal portion of the multi-lumen endoscope receiving tube (<NUM>), a distal balloon (<NUM>) positioned distal of the proximal balloon (<NUM>), a plurality of elongated members (<NUM>) extending between the proximal and distal balloons (<NUM>, <NUM>), and a handle (<NUM>) for manipulating the plurality of elongated members (<NUM>),
wherein the proximal and distal balloons (<NUM>, <NUM>) are inflatable to form a chamber (<NUM>) therebetween, at least a portion of the chamber (<NUM>) extending beyond a distal end of the endoscope receiving tube (<NUM>), the endoscope receiving tube (<NUM>) having a first lumen dimensioned to receive an endoscope and a second lumen dimensioned to receive a first instrument (<NUM>),
wherein the elongated members (<NUM>) are strips, fibers or wires.