WO2016014999A1 - Lighted endoscopy for identifying anatomical locations - Google Patents

Abstract

Devices, systems, and methods are provided herein for identifying an anatomical location inside a lumen or a space in the body of a subject undergoing endoscopic surgery. A catheter includes a proximal end and a distal end. The distal end includes one or more light emission areas. The shape of the catheter can be determined based on light transmitted from the one or more light emission areas through a wall of a lumen or space within the body of a subject. Also disclosed herein are methods for conducting an endoscopic procedure using any one of the disclosed catheters. These methods facilitate identification of the anatomical location associated with the surgery to aid in the performance various operations, for example, removing anatomic structures or debris from the anatomical location, dilating the lumen or the space, and, for placing a second device.

Description

LIGHTED ENDOSCOPY FOR IDENTIFYING ANATOMICAL LOCATIONS

RELATED APPLICATION

[0001] This application claims priority to U.S. Provisional Application No. 62/028,588 filed July 24, 2014, the content of which is incorporated by reference herein in its entirety.

FIELD OF INVENTION

[0002] The present disclosure relates to devices and methods to facilitate identification of anatomical locations during endoscopic procedures.

BACKGROUND

[0003] During endoscopic surgical procedures, it is often difficult for the surgeon to determine the precise location of target anatomical structures that are ambiguous. Anatomical structures that are ambiguous are, to name a few, the thoracic duct, the urinary tract, the biliary tree, and various blood vessels. One surgical procedure, which is demanding with respect to identification of an anatomical location, is laparoscopic cholecystectomy, in which a gallbladder is removed through a small incision in the abdomen. The procedure is carried out with the aid of a laparoscope which enables the surgeon to see the gallbladder on a television screen. Laparoscopic cholecystectomy is a significant advance over the open surgical approach which required inpatient admission and carried significant morbidity and cost.

[0004] The advent of laparoscopic instrumentation has revolutionized laparoscopic cholecystectomy, reducing operative time, post-operative recovery time, complications, cost, and the need for hospitalization. However, one aspect of this operation has not improved - a persistently high rate of common bile duct injury. Despite the advanced techniques used in a laparoscopic approach, including advanced optics and the use of intraoperative

cholangiogram (IOC), the approach has been plagued by the high incidence of common bile duct injury. Adequate methods and tools to decrease the occurrence of common bile duct injury are currently unavailable. Common bile duct injury produces a life changing effect on the patient and requires a major open hepatobiliary operation to correct the damage caused by the injury. The repair comes at a great cost, requires multiple hospitalizations, has long-term impact on a patient's quality of life, has long-term sequelae, and is also a major source of malpractice suits.

[0005] The "classical" biliary injury usually involves misidentification of the common bile duct as the cystic duct. The cystic duct may be hidden or altered in appearance in some patients having laparoscopic cholecystectomy, especially in the presence of inflammation, adhesions from prior surgery, or in situations of variations in the native anatomy. In these situations a surgeon may be deceived into misidentifying a structure in the vicinity as the gallbladder infundibulum, which may then lead to the misidentification of the common bile duct as the cystic duct. Biliary injury is more likely when cystic duct identification is made by relying solely on the appearance of the junction of the cystic duct with the infundibulum of the gallbladder, i.e., in the absence of the so-called "critical view of safety", in which the cystic duct, cystic artery, and common bile duct are clearly seen with a view of the liver behind these structures. Bile duct injury (BDI) is a serious complication of laparoscopic cholecystectomy, with an incidence about 0.3-0.7%. Given that over a million laparoscopic cholecystectomies are performed in United States alone, the small percentage translates into a large number of injuries. Prevention of BDI requires adequate identification of the cystic duct-common bile duct (CBD) junction, part of the "critical view of safety", which is the main surgical landmark in gallbladder surgeries. To reduce the risk of BDI during

cholecystectomy, intraoperative cholangiography is performed in many centers. While there are some advantages to using IOC, there are disadvantages as well, and the practice is not routinely employed, and is sometimes employed improperly.

[0006] A surgeon carrying out an endoscopic procedure often faces a major risk of falling prey to "confirmation bias" once the surgeon has become committed to a mental picture of the anatomy of a region as shown by the incorrect identification of an anatomic structure in the vicinity of the gallbladder as the gallbladder infundibulum, which leads to the

misidentification of the common bile duct as the cystic duct due, and to BDI. Confirmation bias manifests itself as the rejection of any disconfirmatory evidence in favor of confirmatory evidence about anatomy, for example, the biliary anatomy. As is clear from the above, confirmation bias can lead to serious injury. Therefore, there is a need for an anatomic identification tool with the ability to aid in the location of ambiguous anatomical structures during an endoscopic procedure. SUMMARY

[0007] Some devices, systems and methods described herein enable a rapid, simple, real-time identification of anatomic landmarks during a surgical procedure, without requiring the use of complex imaging technology. These devices, systems and methods can reduce the risk of confirmation bias on the part of the surgeon by enabling the surgeon to easily and

unambiguously trace the path of difficult to dissect, ambiguous, or otherwise difficult to visualize anatomic structures.

[0008] In an embodiment a catheter for identifying an anatomical location inside a body of a subject includes a proximal end and a distal end configured to be introduced into a lumen or space in the body of the subject. The catheter includes at least one channel extending along the catheter and at least one port providing access to the at least one channel. The catheter also includes one or more light emission areas extending over a portion of the length of the catheter at or adjacent to the distal end, the one or more light emission areas configured to emit light detectable through a wall of the lumen or through a wall of the space in the body of the subject.

[0009] In some embodiments the one or more light emission areas include one or more light emitters. In some embodiments the one or more light emission areas are configured to emit visible light. In some embodiments the one or more light emission areas include a plurality of light emitters distributed along the portion of the length of the catheter. In some embodiments the plurality of emitters are arranged in the form of a linear array or a two dimensional array. In some embodiments the plurality of emitters include a plurality of multicolor light emitters. In some embodiments the plurality of emitters include one or more of light emitting diodes, organic light emitting diodes, solid state lasers, and diode lasers.

[0010] In some embodiments the position and orientation of a portion of the catheter is identifiable from light detectable through a wall of the lumen or through a wall of the space in the body of the subject.

[0011] In some embodiments the catheter also includes an internal sheath configured to deliver the catheter into the lumen or an internal organ. In some embodiments the catheter also includes an inflatable balloon located on the distal end of the internal sheath configured to anchor the internal sheath to the lumen or internal organ when inflated. In some embodiments, the catheter also includes a balloon located at the distal end of the catheter. In some embodiments inflation of the balloon located at the distal end of the catheter permits external visualization of specific regions of the lumen. In some embodiments the balloon at the distal end of the catheter is configured such that, when inflated, it creates motion visible from outside the wall of the lumen. In some embodiments the balloon at the distal end of the catheter is configured such that, when inflated, the balloon takes the shape of the lumen to provide information about the orientation, size, or trajectory of the lumen. In some embodiments the balloon at the distal end of the catheter is configured such that, when inflated, the balloon aids in positioning a tip of the catheter to reach or thread down a cystic duct of the subject.

[0012] In some embodiments the one or more light emission areas include one or more light emitters, and the catheter further includes one or more wires disposed within the catheter configured to transmit electrical control signals to or deliver power to the one or more light emitters.

[0013] In some embodiments the one or more light emission areas include a first light emitter configured to emit visible light and a second light emitter configured to emit light in non- visible wavelengths. In some embodiments the catheter also includes a controller operatively coupled to the proximal end of the catheter with the controller configured to control operation of the first or second light source.

[0014] In some embodiments the catheter also includes one or more fiber optics extending to the one or more light emission areas to transmit light to the light emission areas.

[0015] In some embodiments the at least one port includes a plurality ports. In some embodiments at least one of the plurality of ports has a fitting configured couple with one or more syringes. In some embodiments the plurality of ports provide access to one or more channels of the multichannel catheter an the channel include at least one of: a channel for passing a wire; a channel for placing an additional device; a channel for injecting a liquid; an evacuation channel for removing a liquid; a channel to inflate one or more balloons; a channel for delivery of a stent, hydrogel, foam or other material; a channel for introducing a tool; and a channel for introducing an energy source. In some embodiments at least one of the plurality of ports provides access to a channel for introducing at least one of a basket for retrieval, a grasper, a balloon dilator, a clip, or another catheter based instrument. In some embodiments at least one of the plurality of ports provides access to a channel for introducing a laser, an electrocautery device, a coagulation source, a heat source, a cooling source, or a hydroelectric source. In some embodiments at least one of the plurality of ports provides access to a channel for introducing a dilator, a stent, or a drain. In some embodiments at least one of the plurality of ports provides access to a channel for injecting one or more of: saline, a contrast, a medication, and a first agent. In some embodiments the port and channel are configured for injection of a first agent including a hydrogel or a first plug.

[0016] In some embodiments the distal end of the catheter includes a radio-opaque portion for visualizing the catheter under fluoroscopy.

[0017] In some embodiments the catheter further includes a bumper located at a distal tip of the catheter, where a size of the bumper is determined based on a diameter of a duct associated with the lumen or space.

[0018] In some embodiments at least the distal end of the catheter is flexible. [0019] In some embodiments the catheter is a rigid catheter.

[0020] In another embodiment, a system for identifying an anatomical location inside a body of a subject includes any of the catheters described herein and an internal sheath configured to deliver the catheter into the lumen or an internal organ.

[0021] In some embodiments the internal sheath is further configured to aid in forming a seal with the internal organ or the lumen. In some embodiments the internal sheath is configured to prevent spillage of fluid contained within the internal organ or facilitate retraction of the internal organ or the lumen by anchoring the internal sheath to the organ or the lumen.

[0022] In some embodiments the system also includes includes an external sheath configured to deliver the catheter into the space inside the body of the subject.

[0023] In some embodiments, the system also includes a controller operatively coupleable to the proximal end of the catheter. In some embodiments the one or more light emission areas include a plurality of light emitters, and the controller is configured to control the plurality of light emitters to emit light in a sequence of patterns. In some embodiments the sequence of patterns includes at least one of: constant emission with or without modulation of brightness; patterned emission of one or more colors; and a patterned emission of one or more brightness levels. In some embodiments the controller is programmed to instruct generation of the sequence of patterns upon recognition of the shape of the catheter. In some embodiments the sequence of patterns includes emission of light in a specific order of color or brightness corresponding to the shape of the catheter. In some embodiments the controller is programmed to control movement of the catheter in a desired manner, or to initiate preprogrammed movements to aid identification of the location of the within the lumen.

[0024] In some embodiments the system also includes a display surface configured to render a graphical representation of a shape of the distal end of the catheter.

[0025] In some embodiments the distal end of the catheter also includes an imaging modality. In some embodiments the imaging modality is suitable for imaging the lumen to facilitate one or more of: passage or steering of the catheter, imaging walls of the lumen, identification of lesions in the walls of the lumen, and imaging of structures beyond the wall of the lumen or within the lumen. In some embodiments the imaging modality is selected from the group consisting of: a camera, an ultra-sound probe, a piezoelectric probe, a radiofrequency probe, and a microwave probe; and, wherein the display surface is configured to provide an image of the lumen obtained from the imaging modality.

[0026] In an embodiment, a method of performing a laparoscopic cholecystectomy on a subject includes passing a flexible catheter having a proximal and a distal end into the abdomen of the subject; inserting the flexible catheter into a body or infundibulum of a gallbladder of the subject; emitting light from one or more light emission areas extending over a portion of the length of the flexible catheter at or adjacent to the distal end of the flexible catheter; observing through a wall of the gallbladder or cystic duct, light emitted from the one or more light emission areas and transmitted through the wall of the gallbladder or cystic duct; advancing the flexible catheter into the cystic duct of the subject; confirming the location of the cystic duct based on light observed through a wall of the cystic duct; dissecting and ligating the cystic duct; and removing the gallbladder from the abdomen of the subject.

[0027] In some embodiments at least a portion of the distal end of the flexible catheter includes a radiopaque material and the method further includes confirming a location of the cystic duct based on fluoroscopy.

[0028] In some embodiments the method also includes identifying based on light observed through the wall of the cystic duct the Triangle of Calot of the subject to facilitate locating the cystic duct, wherein the Triangle of Calot is an anatomic space bordered by the common bile duct medially, the cystic duct laterally, and the liver superiorly. [0029] In some embodiments the method also includes injecting a contrast through at least one port of the flexible catheter; and performing an intraoperative cholangiogram to enhance identification of the cystic duct, a cystic artery, or a common biliary duct of the subject.

[0030] In some embodiments light observed through the wall of the cystic duct facilitates distinguishing the cystic duct from a common biliary duct.

[0031] In some embodiments the method also includes producing a first image on a display surface indicative of a shape of the distal end of the flexible catheter, the first image generated based on visible light emitted by the one or more light emission areas and transmitted through a wall of a biological lumen into which the distal end is inserted; and producing a second image on the display surface indicative of the shape of the distal end of the flexible catheter, the second image generated based on light in non- visible wavelengths emitted by the one or more light emission areas and transmitted through the wall of the biological lumen into which the distal end is inserted. In some embodiments the first image and the second image are produced concurrently. In some embodiments the first image and the second image are produced sequentially. In some embodiments the method also includes superimposing the first image and the second image to generate a merged image on the display surface.

[0032] In an embodiment, a method of conducting an endoscopic procedure includes using any of the catheters described herein for one or more of: facilitating identification of an anatomical location of the catheter within the subject; removing anatomic structures or debris from the subject; dilating the lumen, or the space; or placing a second device.

[0033] In some embodiments the method also includes using the catheter as a sheath over an endoscope for directing the catheter within the subject.

[0034] In some embodiments removing anatomic structures or debris includes removing stones from the cystic duct or the biliary system.

[0035] In some embodiments placing the second device includes includes a cholecystostomy tube under ultrasound, fluoroscopy, or computed tomography guidance.

[0036] In some embodiments the lumen is selected from the group consisting of: trachaea; bronchi and subsegmental bronchi; thoracic duct; urethra; prostate; bladder; uterus; kidney and associated anatomy; biliary and pancreatic system; peripheral, visceral, cerebral, and cardiac vascular structures; uterus, fallopian tubes and ovaries; internal auditory canals, lacrimal ducts, salivary glands and ducts, oral, pharyngeal, laryngeal, sinus structures; and the fore, hind, and the mid- gut lumens.

[0037] In some embodiments the endoscopic procedure is selected from the group consisting of: esophagogastroduodenoscopy; enteroscopy; colonoscopy; sigmoidoscopy; endoscopic retrograde cholangiopancreatography; rectoscopy; anoscopy; protoscopy; rhinoscopy;

bronchoscopy; arthroscopy; laparoscopy; cystocopy; and otoscopy.

[0038] In some embodiments the method also includes occluding tracts created due to insertion of the catheter. In some embodiments occluding tracts includes deploying an agent into the lumen or space. In some embodiments the agent includes a plug made of a mesh or another material. In some embodiments the deployment is performed using an external trigger that is engaged upon the withdrawal of an internal or external sheaths used to deliver the catheter inside the subject or the lumen or space.

[0039] In so far as the devices and methods in the present disclosure are described in connection with prevention of severe injury during laparoscopic cholecystectomy, this is done merely for the purpose of illustration, the devices and methods being useful for prevention of injury to body parts lying adjacent to a region targeted in any invasive procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0040] The skilled artisan will understand that the drawings primarily are for illustrative purposes and are not intended to limit the scope of the inventive subject matter described herein. The drawings are not necessarily to scale; in some instances, various aspects of the inventive subject matter disclosed herein may be shown exaggerated or enlarged in the drawings to facilitate an understanding of different features. In the drawings, like reference characters generally refer to like features (e.g., functionally similar and/or structurally similar elements).

[0041] The foregoing and other features and advantages provided by the present disclosure will be more fully understood from the following description of exemplary embodiments when read together with the accompanying drawings.

[0042] FIG. 1 schematically depicts a flexible catheter in accordance with an embodiment. [0043] FIG. 2 schematically depicts system for identifying an anatomical location inside a body of a subject in accordance with an embodiment.

[0044] FIG. 3 schematically depicts an internal sheath disposed around a flexible catheter in accordance with an embodiment.

[0045] FIG. 4 schematically depicts a control panel in accordance with an embodiment.

[0046] FIG. 5 schematically depicts a display surface showing various graphical representations of shapes of a distal portion of a flexible catheter during use in accordance with an embodiments.

[0047] FIG. 6 schematically depicts a distal end of the flexible catheter of FIGs. 1 or 2 in accordance with an embodiment.

[0048] FIG. 7 schematically depicts a flexible catheter in use with the distal end of the flexible catheter inserted into the gall bladder and positioned within the lumen of the cystic duct in accordance with some embodiments.

[0049] FIG. 8 is an image of an example flexible catheter with an atraumatic tip in accordance with some embodiments.

[0050] FIG. 9 is an image of an example flexible catheter with a working length of 50 cm in accordance with some embodiments.

[0051] FIG. 10 is an image of the illuminated distal portion of an example flexible catheter.

[0052] FIG. 11 is another image of the illuminated distal portion of an example flexible catheter.

[0053] FIG. 12 is an image of an example flexible catheter with light emitting area on the distal portion of the catheter illuminated in accordance with an example embodiment.

[0054] FIG. 13 is an image of the example flexible catheter of FIG. 12 showing the light emitting areas illuminated while the distal end of the flexible catheter is held within a person's hand.

[0055] FIG. 14 is an image of the example flexible catheter of FIG. 12 showing the illuminated light emitting areas in a dark environment.

[0056] FIG. 15 is an image of the distal portion of the example flexible catheter illuminated within a tubular structure [0057] FIG. 16 is an image of the distal portion of the example flexible catheter illuminated within a section of surgical tubing.

[0058] FIG. 17 is an image of the distal portion of the example flexible catheter inserted within a section of surgical tubing filled with bile-colored liquid.

[0059] FIG. 18 is an image of the distal portion of the example flexible catheter illuminated within the section of surgical tubing filled with bile-colored liquid..

[0060] FIG. 19 is an image of the distal portion of the example flexible catheter illuminated within a partially opaque bottle.

[0061] FIG. 20 is an image of the distal portion of the example flexible catheter illuminated within another partially opaque bottle.

[0062] FIG. 21 is an image of a distal portion of an example flexible catheter within a looped tube illustrating the flexibility of the example catheter.

[0063] FIG. 22 is an image showing experimental measurement of a deflection force for the distal portion of the example flexible catheter.

[0064] FIG. 23 is an image of a laboratory simulation of surgery showing insertion of the distal end of an example flexible catheter into a lumen.

[0065] FIG. 24 is an image of an illuminated distal portion of an example flexible catheter entering a gallbladder wall during live animal testing.

[0066] FIG. 25 is an image of the illuminated distal end of the example flexible catheter within the cystic duct as viewed through the wall of the cystic duct during live animal testing.

[0067] FIG. 26 is an image of the example flexible catheter in use during live animal testing of a surgical procedure.

[0068] FIG. 27 is a block diagram schematically depicting a computer system for use with some embodiments.

DETAILED DESCRIPTION OF THE INVENTION

[0069] Described herein are a devices, systems and methods for intraoperative imaging of anatomical structures using light emitted from the distal region of an endoscopic tool, and methods of performing surgery aided with the device. [0070] Exemplary embodiments are described below with reference to the drawings. One of ordinary skill in the art will recognize that exemplary embodiments are not limited to the illustrative embodiments, and that components of exemplary systems, devices and methods are not limited to the illustrative embodiments described below.

[0071] Some embodiments are describe below with respect to a catheter. The skilled artisan will appreciate that aspects and features described and depicted herein with respect to a catheter are also applicable to other type of endoscopic devices and tools, such as, any type of endoscope, either upper endoscope, colonoscope, sigmoidoscope, bronchoscope, a laparoscope, ureteroscope, cystoscope, side-viewing endoscopic retrograde

cholangiopancreatogram (ERCP) scope or any type of endovascular catheter for venous or arterial cannulation, and that other such endoscopic devices and tools also fall within the scope of the invention.

[0072] Some embodiments are described below with respect to a flexible catheter in which at least the distal end of the catheter is flexible (e.g., a flexible catheter used for laparoscopic cholecystectomy). The skilled artisan will appreciate that many aspects and features described and depicted herein with respect to a flexible catheter are also applicable to rigid catheters.

[0073] FIG. 1 shows a device that is a flexible catheter 100 for imaging of anatomical structures during surgical procedures in accordance with some embodiments. The flexible catheter 100 includes a flexible shaft structure 109 and one or more light emission areas 103 extending over a portion of the length of the catheter at or adjacent to a distal end 107 of the catheter. In some embodiments, the flexible catheter 100 also includes a wire or fiber bundle 101 passing through a channel within the catheter and configured to provide power and/or electrical control signals to the one or more light emission areas. In some embodiments, the one or more light emission areas 103 include one or more light emitters, such as LED' s, organic LED' s, or solid state lasers. The flexible catheter may also include one or more side ports 105 suitable for accessing one or more channels within the catheter. The side port 105 may include a fitting capable of being attached to one or more syringes (e.g., a Luer-lock) in some embodiments. In some embodiments, a three way stopcock may be attached to the side port or another port for injection of various liquids (e.g., saline or a contrast agent).

[0074] In some embodiment, the flexible catheter described herein is effective for identifying an anatomical location inside the body of a subject during surgery. The flexible catheter is a multichannel catheter for introducing into a lumen in the body of the subject in some embodiments.. The flexible catheter has a proximal end and a distal end. The flexible catheter includes one or more light emitting areas at or adjacent to the distal end. An anatomical location is identified by light transmitted from the light emitting areas through a wall of an anatomical structure (e.g., a wall of a lumen) and detected or observable outside the anatomical structure combined with knowledge of the anatomy of the anatomical structure (e.g., the lumen). The emitted light transmitted through the wall of the anatomical structure extends along a portion of the length of the flexible catheter indicating a location and a trajectory of the lumen in which the distal portion of the flexible catheter is inserted.

[0075] The one or more light emission areas 103 at or adjacent to the at the distal end 107 of the flexible catheter aid in dissection of overlying tissue and provide a more efficient and safer means of dissection. In some embodiments, the flexible catheter is configured to emit a motion signal, or include an external location mechanism (i.e. RFID, etc.). In some embodiments, the flexible catheter is part of a system that produces a 3D representation of the distal portion of the catheter on an external screen along with information and/or images of anatomical structures in proximity to the distal portion of the flexible catheter.

[0076] In use, the catheter 100 is introduced into the body externally and guided into a lumen, an organ, or a channel of known anatomy. It is passed from an area of known anatomy to an unknown anatomy. Light from the one or more light emission areas 103, which is visible from outside the lumen, organ or channel, aid in localization of an anatomy related to the surgery, thereby improving the surgeon's ability to perform dissection in a more precise manner. The presence of the distal end of the catheter within a lumen also stiffens the lumen aiding in identification of the lumen by palpation.

[0077] In some embodiments, the device described herein includes one or more ports for use during a surgery. The port may be a gallbladder (GB) introducer/port for use in a

laparoscopic cholecystectomy. A port used during surgery, i.e., a surgical port, refers to an apparatus for permitting access to a tissue, and includes an elongated introducer to breach a plane of tissue or skin. The elongated introducer is dimensioned for at least partial introduction within an opening in the tissue. The surgical port includes a port body having leading and trailing ends, an intermediate segment disposed between the leading and trailing ends and at least one passageway for reception and passage of a surgical instrument. In some embodiments, the GB port has a degree of angulation/bend that directs the catheter along the wall of the lumen, for example along the wall of the gallbladder toward the infundibulum, to minimize manipulation and ease directionality.

[0078] FIG. 2 illustrates a system for identifying an anatomical location inside a body of a subject in accordance with an embodiment. The system includes a flexible catheter incorporating a flexible syringe 200, a power supply 211, a controller 213, and a display device 215. In various embodiments, the controller 213 is configured for varying the color and intensity or type of the light emitted from the flexible catheter to penetrate thickness of tissue that may be overlying the catheter as well as to overcome interference due to the presence of blood, bile or other fluid/material. In some embodiments, the display surface 215 is configured to render a graphical representation of the shape of the catheter based on detection or images of light emitted from the catheter. In some embodiments, the distal portion of the catheter may include a camera or an ultrasound probe. The display surface can provide a graphical representation of the shape of the catheter to define an anatomical location associated with a surgery; as well as images received from the camera or ultrasound unit.

[0079] The flexible catheter 200 can include a flexible shaft structure 209 and one or more light emission areas 203 extending over a portion of the length of the catheter proximal to a distal end 207 of the catheter. In some embodiments, the flexible catheter 200 also includes a wire or fiber bundle 201 passing through a channel within the catheter and configured to provide electrical control signals to the one or more light emission areas 203. In some embodiments, the one or more light emission areas 203 include one or more light emitters, such as LED's, organic LED's, or small lasers (e.g., solid state lasers, diode lasers, etc.). In some embodiments, the light emission areas 203 can include a light emitter at the distal tip of the catheter.

[0080] In the example embodiment shown in FIG. 3, a system includes the catheter and a skin level or percutaneous introducer or sheath 311 having a sharp blade such as a scalpel blade, or a needle such as a trocar with central obdurator, for piercing the skin. The introducer, when inserted within the lumen facilitates placement of the catheter inside the body of the patient. The sharp blade or the needle may be removed once the catheter is properly placed. In some embodiments, a needle is used to puncture the structure and a guide wire is threaded through the needle; when the needle is withdrawn, a catheter is threaded over the wire; the wire is then withdrawn, leaving the catheter in place. In the depicted

embodiment, the sheath 311 includes a balloon 313 and the flexible catheter includes a balloon 309. The sheath balloon 313 can be inflated within the gallbladder to prevent spillage of fluid contained within the gallbladder or facilitate retraction of the gallbladder by anchoring the internal sheath to the gallbladder. The catheter sheath 309 can be inflated, in some embodiments, in order to aid in the identification of the cystic duct, or anchor the catheter in place within the gallbladder or cystic duct.

[0081] In some embodiments, one or more balloons 309 of the catheter can be positioned at the distal tip, mid-portion, or at other portions of the catheter. In some embodiments he balloons 309, when inflated, aid in identification of the anatomical location of the catheter by creating motion within the underlying tissues being dissected, thereby permitting external visualization of the lumen. In some embodiments, the catheter includes a longitudinally oriented balloon that once inflated, dilates the walls of the lumen that catheter resides in and provides structural visualization of the shape, size and trajectory of the lumen in which it is inserted.

[0082] The skin level introducer or sheath 311, once introduced at the skin level inside the body, may be placed into the wall of the lumen, for example, the gallbladder wall. In one embodiment, the tip of this introducer is angulated or optionally could be variably angulated once inside the lumen. For example, in the case of gallbladder, the introducer may be directed toward a distinct adjacent location such as the infundibulum and opening of the cystic duct. An introducer with the tip so angulated permits catheters of the present disclosure, once inserted into the introducer, to be directed toward a desired location. In one example embodiment, the flexible catheter is at least partially rigid, such that rigidity of the catheter helps identify the lumen or structure within the body.

[0083] In certain embodiments, the distal end of the catheter may include radio-opaque material/coating/embedded strip or marker to allow confirmation of location of the catheter tip or facilitate control and advancement of the catheter to the correct location or in the proper direction. This could be performed with a modality including but not limited to fluoroscopy or ultrasound.

[0084] In some embodiments, the light emitting area at or near the distal end of the catheter is a provide a visual signal. For example, the light emitting areas arranged on the outside or along the central catheter/telescope can be configured for providing variable

wavelengths/colors, and/or patterns that allows different light sources to be turned on at different times to optimally identify the shape, orientation and location of the catheter through the underlying tissue or bodily fluid or other fluid that was introduced, including but not limited to saline or water. For example, light of a specific color may be more suited for penetrating a particular kind of tissue or fluid encountered in a procedure, and may therefore, be the light of choice for optimal visualization of the catheter in that procedure or during a portion of that procedure.

[0085] In certain embodiments, at least the distal portion of the catheter is flexible. The flexibility is either of a static (static flexibility) or dynamic (dynamic flexibility/rigidity) nature.

[0086] In certain embodiments, the device includes a mechanism for deflection of the tip at the distal end to aid in guiding the catheter along the wall of the lumen, for example, along the gallbladder wall into the cystic duct in a laparoscopic cholesystectomy. In another embodiment, the movement of the distal length of the catheter creates motion within the lumen indicating the location of the catheter in the underlying anatomy as seen with another device being used in the procedure, for example, as seen with a laparoscope.

[0087] In certain embodiments, a flexible catheter could be placed over the shaft of an endoscopic or laparoscopic device that contains a light source, camera and one or more functional channels to allow the endoscope to provide steering control and aid in the advancement and placement of the catheter in the correct location while taking advantage of the endoscopic insufflation, water injection and optics.

[0088] In some embodiments, a device includes multiple ports for communicating with the channels of the multi-channel catheter. Each port may have a, for example, a Luer-lock attached to it. Each Luer-lock is capable of being attached to one or more syringes. Individual channels of the multi-channel catheter are effective for various functions such as: suctioning off or withdrawal of fluid present in the lumen, for example, bile; injection of contrast;

injection of a medication; delivery of a stent, hydrogel, foam or other material; introduction of a tool, including, but not limited to a basket for retrieval, a grasper, a balloon dilator, a clip or another catheter based instrument; introduction of an energy source including but not limited to a laser, an electrocautery device, a coagulation source, a heat source, a cooling source, or a hydroelectric source.

[0089] In some embodiments, the device includes an external sheath/port, in addition to the sheath 311, similar to an angiocath. For example, in some embodiments, the external sheath is smaller than a 5 mm port. The external sheath provides delivery of the catheter into the body cavity of the subject, for example, into an insufflated abdomen. The external sheath may have internal portion that is ribbed or flexible, and of stable form factor to allow the port to be moved into a specific position and direct/vector the catheter.

[0090] In certain embodiments, the internal sheath 311 is used to stabilize and seal the lumen while allowing the flexible catheter to be delivered. The sheath aids in retraction of the lumen, e.g., gallbladder, once the sheath is in place. In certain embodiments, the device includes a balloon/bumper mechanism 313 (similar to a G-tube) to hold the sheath in place and prevent spillage of the contents of the lumen (e.g., bile in the gallbladder). The internal sheath may also include an internal portion that is ribbed/flexible to facilitate vectoring the catheter towards an adjacent distinct anatomical location (e.g., infundibulum in the case of laparoscopic cholecystectomy). In some embodiments, the internal sheath and the external sheath may be connected to provide a continuous channel from cutaneous level to lumen. The internal and external sheath may also include a mechanism to facilitate closure of the opening made in the body upon completion of the surgery. This includes but is not limited to deployment of a mesh or another kind of a plug to occlude tracts created on insertion of the catheter. The closure mechanism may be deployed using an external trigger that could be engaged upon withdrawal of the internal and external sheaths. Closure performed according to this method is helpful, for example, to close the peritoneum and prevent hernia.

[0091] FIG. 4 schematically illustrates an example control panel 400 for a controller that provides control of light emitted from the light emission areas. In some embodiments, the example control panel 400 includes optics controls 405 to turn light system on/off or control the brightness of the one or more light emission areas. The control panel 400 can also include a plurality of light sequence selectors 401 configured to control one or more light sequences, and/or a plurality of color selectors 403 configured to control the color of the one or more light emission areas, in some embodiments. In some embodiments, the controller is configured for creating specific optical patterns on an array of light emitters at the distal tip of the catheter; controlling the motion of the catheter in a specified manner; and/or initiating pre-programmed movements to assist with identification of an anatomical location. In some embodiments, controls for the controller may be incorporated into software or into a computer interface associated with another device or system used during surgery.

[0092] In various embodiments, the catheter permits multiple forms of visualization for aiding in the location of an anatomical location associated with a surgery. These include: optical; physical/motion; and 3D representation of the catheter shape (conformation of the lumen it resides in). In addition, in one embodiment the catheter includes a sheath over wire format to allow access to locations under fluoroscopic guidance (similar to Seldinger technique).

[0093] FIG. 5 illustrates an example display surface 500 showing various graphical representations of shapes of the catheter, according to some embodiments. As discussed above, a display surface 500 can be configured to render a graphical representation of the shape of the catheter based on detection or images of light from the light emitted areas that is transmitted through a wall of an anatomical lumen. In this particular embodiment, the display surface is rendering four graphical representations 501, 503, 505, and 507

corresponding to different shapes of by the catheter.

[0094] The catheter of the present disclosure may be designed to have specified rigidity to allow enough flexibility to pass without significant risk of injuring surrounding structures or perforating the wall of the lumen through which it is being passed.

[0095] FIG. 6 illustrates an distal tip 600 of a flexible catheter, according to some embodiments. The distal tip 600 can include a rounded distal tip bumper 607, at the distal end of a catheter shaft 601, with the diameter of the rounded distal tip bumper being maximum size needed to pass through the smallest region of the lumen. The distal tip 600 can also include a fillet portion 609 distal tip 600. A shape of the bumper 607 may be selected such that it is not pointed or too narrow to avoid injury to the lumen. In some embodiments, the distal tip 600 includes a suction port 603 and an injection port 605. The injection port 605 may be suitable for injecting a contrast, saline, a medication, or other substance; while the suction port 603 may be suitable for suctioning off or withdrawing fluid within the lumen such as bile, contrast, saline, etc.

[0096] As described above, a flexible catheter includes one or more light emitting areas extending over at least a portion of the length of the catheter at or proximal to the distal end. In some embodiments, the one or more light emitting areas include one or more emitters. In some embodiments, the one or more light emitting areas include a plurality of emitters distributed along the portion of the length of the catheter. In some embodiments, the catheter includes an embedded optical array that of emitting surfaces along the portion of the length. The array may be linear (e.g., a single line of emitting surfaces lengthwise along the catheter) or may be a two dimensional array (e.g., a two dimensional rectangular array or hexagonal array of emitting surfaces wrapping around the catheter lengthwise and circumferentially). The array facilitates external visualization of the location of the catheter under a tissue during dissection, for example, the dissection of the Triangle of Calot in laparoscopic

cholecystectomy when the laparoscope light is turned off or dimmed. In some embodiments the optical array includes a linear arrangement of emitters such that one or more colors of light may be emitted in a plurality of sequences or colors, for example, all emitters on;

emitters producing light of variable brightness, in different patterns, static or variable including variable colors. The light emitting areas disclosed herein allow light to be visualized despite likely dispersion of light into surrounding tissues, i.e. the light emitting areas are configured for imaging and visualizing specific points of light transmitted through tissue as opposed to a generalized glow in the tissue.

[0097] In some embodiments one or more fiber optics deliver light to the light emitting areas of the catheter. In some embodiments, the fiber optics are coupleable to a controllable light source for supplying light to the light emitting areas. In some embodiments, a controllable light source for supplying light to the fiber optics is incorporated into the flexible catheter device or is part of a system that includes the flexible catheter.

[0098] The functionality of some embodiments of the devices described herein is illustrated in the following using laparoscopic cholecystectomy as an exemplary endoscopic procedure. A catheter, as described in any of the various embodiments of the device herein, is inserted through a trocar/port, an angiocatheter, or directly through the skin, or through another anatomic or surgically created access point, and passed into the insufflated abdomen. Using the control panel display surface the catheter is advanced from the infundibulum into the cystic duct before dissection of the structures of the Triangle of Calot or Triangle of Safety ("Triangle", common bile duct, cystic artery and cystic duct) is attempted. The dissection of the Triangle is commenced guided by information obtained from the signals and/or the balloons of the catheter._A port provided by the device is utilized to evacuate bile from the gallbladder in order to decompress the gallbladder, if enlarged, or otherwise to assist with retraction. A port is used also to inject a contrast at a specified time in the procedure to allow for the performance of an intraoperative cholangiogram to further enhance the identification of the anatomy, or to assist with the diagnosis of a gallstone within the cystic duct, the common bile duct, or other location. The latter capability is helpful for guiding the management of the patient and for enhanced decision making regarding the need for any of: an intraoperative common bile duct exploration, use of peri-operative or post-operative endoscopic cholangiopancreatography ("ERCP"), and post-operative Magnetic resonance cholangiopancreatography (MRCP) to diagnose the presence and location of a retained gallstone. Upon identification of the Triangle, using the devices of the present disclosure, the transecting/ligating of the cystic duct and the cystic artery is performed following standard procedures. Next, the gallbladder is dissected off and the gallbladder fossa removed in the standard manner.

[0099] FIG. 7 illustrates a flexible catheter 701 inserted within the lumen of the cystic duct 705 of a subject, according to some embodiments of the present disclosure. In some embodiments, the flexible catheter 701 can be introduced into the abdomen of a subject and then inserted into the body or infundibulum of the gallbladder at an insertion point 703. Once inserted into the gallbladder, one or more light emission areas, which extend over a portion of the length of the flexible catheter 701, are illuminated. The light emitted from the one or more light emission areas can then be observed through a wall of the gallbladder. The flexible catheter can then be advanced into the cystic duct 705 of the subject, guided at least in part by the light observable through the wall of the gallbladder and the wall of the cystic duct 705. The location of the cystic duct 705 can then be confirmed based on the light observed through the wall of the cystic duct 705. In some embodiments, confirming the location of the cystic duct 705, which is located proximal to the common bile duct 707 and the common haptic duct 711, can involve identifying Calot's Triangle 709, which is an anatomical space bordered by the common bile duct 707 medially, the cystic duct 705 laterally, and the liver 713 superiorly. Once the location of the cystic duct 705 has been confirmed, the cystic duct can be dissected an ligated, and the gallbladder removed from the abdomen of the subject.

[00100] In some embodiments a catheter includes a telescoping feature such that one portion of the catheter, with a smaller diameter, could be telescoped forward. In some embodiments the portion that is telescoped is made of a more flexible/soft material than the remainder of the catheter to allow it to advance down a lumen and/or inflate and fill the lumen or the space.

[00101] Also provided herein is a method of conducting an endoscopic procedure on a subject in need of a surgery that employs any one of the devices or systems described herein for facilitating identification of the anatomical location of the subject; for removing anatomic structures or debris from the anatomical location; for dilating the lumen, or the space; or for placing a second device. [00102] The anatomic locations that may be identified and the anatomic structures that may be removed using the method are: pulmonary structures including but not limited to the trachea, bronchi and subsegmental bronchi, and thoracic duct; urologic structures including but not limited to the urethra, prostate, bladder, ureters, kidney and associated anatomy; biliary and pancreatic system; arterial or venous structures including but not limited to peripheral, visceral, cerebral and cardiac vascular structures; gynecologic structures including but not limited to the uterus, fallopian tubes and ovaries; and head and neck structures including but not limited to external and internal auditory canals, lacrimal ducts, salivary glands and ducts, oral, pharyngeal, laryngeal, and sinus structures.

[00103] Exemplary endoscopic procedures in which the devices and systems described herein may be used are: esophagogastroduodenoscopy; enteroscopy; colonoscopy;

sigmoidoscopy; endoscopic retrograde cholangiopancreatography; rectoscopy; anoscopy; protoscopy; rhinoscopy; bronchoscopy; arthroscopy; laparoscopy; cystocopy; and otoscopy.

[00104] Removal of anatomic structures or debris includes removal of stones from the cystic duct or the biliary system. Further, placing the second device includes placement of a cholecystostomy tube under ultrasound, fluoroscopy, or computed tomography guidance.

[00105] In one embodiment the method of conducting an endoscopic procedure includes using the catheter of any one of the devices herein as a sheath over an endoscope for directing the catheter to the anatomic location.

[00106] In embodiments in which the device includes an external sheath for delivery of the catheter into the lumen or the space inside the body of the subject, and/or an internal sheath to aid forming a seal with an internal organ, the lumen, or with any one of the one or more structures surrounding the space, the method herein may include withdrawing the internal and external sheath followed by occluding tracts created due to insertion of the catheter. Occluding may, for example, include deploying a second agent into the lumen or the space. The second agent may be a plug made of a mesh or another material. The second agent may be deployed using an external trigger that is engaged upon the withdrawal of the internal and external sheaths.

[00107] The exemplary devices and apparatus of the present disclosure provide several advantages. For example, as applied to laparoscopic cholecystectomy, the catheter fits within the confines of the surgery as currently performed and is placed at the initial retraction of the gallbladder. In addition, due to a faster identification of the Triangle of Calot, the devices and methods herein reduce the time required for the surgery, which reduces the incidence of common bile duct injury/transection. Furthermore, it is within the contemplation of the present disclosure that it is possible to perform a relatively limited dissection and transection of the cystic duct by dissecting the cystic duct at a region relatively more proximal to the infundibulum because of the ease with which the cystic duct is identified using the devices and methods herein, thereby reducing or eliminating the need to identify the Triangle of Calot. The devices and methods herein enhance the anatomy being visualized, and therefore, limit the need for an IOC, provided no stone is present. Should an IOC be required, catheters described herein permit an IOC to be performed without any additional step, or a cyclic ductotomy and placement of a cholangiogram catheter. Further, devices and methods herein also minimize the use of post-operative MRCP and ERCP except in instances when a stone passage is suspected, or an IOC demonstrates the presence of a stone in the common biliary duct. Moreover, the risk of bile spillage or of perforating the gallbladder during dissection is minimized, leading to: a reduction in the need for a postoperative placement of a drain, reduction in the risk of abscess formation from bile spillage, and improved dissection due to decreased incidence of bile-obscured field. Further, the devices and methods provide for improved retraction of the gallbladder and for enhanced exposure of the anatomy to the surgeon. Additionally, the need for an endobag, a sac in which tissue is placed to facilitate removal or morcellation, is eliminated, because upon removal of the gallbladder from the gallbladder fossa, the bile could be evacuated using the catheter, and the gallbladder removed through a 10 mm port without the bag (provided no stones are present). These advantages are realized without a significant increase in the cost of the procedure.

Examples

[00108] Various example flexible catheters were made and evaluated and tested both in laboratory simulations of procedures and in procedures performed on animal models. Some example catheters incorporated embedded light emitting diodes (LEDs) and some example catheters incorporated fiber optics for delivering light to the light emitting areas of the catheter. Example Flexible Catheter with Fiber-Optics for Light Emitting Areas

[00109] In an example, a flexible catheter was produced having a fiber-optic bundle

1.5 meters long. The catheter included four ports. The first port was positioned 0.5 cm from the distal tip, and the remaining three were spaced one centimeter on center from the first distal port. The port diameter was 0.5 mm (0.020"). The catheter was manufactured of a PEBAX 45d material with 30% BaS0₄ radiopacifyer filler by weight. The distal tip of the catheter was 1.5 mm and manufactured of a PEBAX 25d material. PEBAX is trademark Arkema for polymer materials.

Example Flexible Catheter with LEDs for Light Emitting Areas

[00110] In another example, a flexible catheter was produced having an array of light emitting diodes (LEDs) spaced along a portion of the catheter at or adjacent to the distal end of the catheter. The LED's were spaced over a 2.5 cm portion of the length of the catheter. The first LED was located 1.0 mm from the distal tip of the catheter, the second LED was spaced 1.0 mm from the first LED toward the proximal end of the catheter, the third LED was spaced 1.75 mm from the second LED toward the proximal end of the catheter, and the fourth LED was spaced between 4-3 mm from the third LED toward the proximal end of the catheter. The catheter also included a side delivery port accessing a channel within the flexible catheter. The catheter had a distal covering of ultra-thin, clear polyester heat sink tubing that had a 30% shrink ratio at 410°F. The catheter was 4 French size (4F), which corresponds to a diameter of 1.33 mm, had a working length of 50 cm, and was made of medical grade 55d PEBAX polymer, which is a trademark of Arkema. The LED array was powered by a 3 Volt inverted DC power supply with an in-line switch. A female power coupling was used leading from the catheter wiring to connect with the power supply. The LEDs ultra-compact LEDs, specifically PICOLEDs from Rohm, and had two 34 American Wire Gauge (AWG) magnet wire leads and a cold white light. The catheter further included support rings made of 3/32" polyolefin block heat shrink tubing that had a 2: 1 shrink ratio at 385°F.

[00111] Various example catheters incorporating LED elements were produced. FIG.

23 shows an example catheter with an atraumatic tip. FIG. 24 shows an example catheter with a working length of 50 cm. FIGs. 10 and 11 are images of the illuminated distal portion of an example catheter. Example flexible catheters incorporating LED were images in various background lighting environments and within various objects. For example, FIGS. 12-14 include images an of illuminated example flexible catheter with different ambient lighting conditions. FIGs. 15-18 show example flexible catheters within different structures. FIG. 15 shows an example catheter illuminated within a tubular structure having an inner diameter of four inches and a length of two feet, according to embodiments of the present disclosure. FIG. 16 shows an example catheter illuminated within a section of empty surgical tubing, FIG. 17 shows an example catheter inserted within a section of surgical tubing filled with bile-colored liquid, and FIG. 18 shows an example catheter illuminated within a section of surgical tubing filled with bile-colored liquid, according to various embodiments of the present disclosure. The surgical tubing had an inner diameter of 3/8" and a wall thickness of 0.130" (3.5 mm). FIG. 18 demonstrates how the emitted illumination is transmitted through bile colored liquid and surgical tubing and visible outside the structure into which it is inserted. FIGS. 19 and 20 show various views of an example catheter illuminated within a partially opaque bottle.

[00112] FIGs. 21 and 22 show the flexibility of the distal end of example catheters.

FIG. 21 illustrates the flexibility of an example catheter by showing it inserted into a bent tubular structure. An example catheter was experimentally measure to have a relatively low tip deflection force of 17.490 g as shown in FIG. 22.

[00113] FIG. 23 is an image taken during a laboratory simulation of a surgical procedure showing insertion of the distal end of a catheter into a lumen.

[00114] Live animal testing was conducted during which an illuminated distal end of an example flexible catheter was inserted into the gallbladder and guided into the cystic duct of a pig. The illuminated distal end provided a visual and tactile guide during a laparoscopic cholecystectomy procedure to surgically remove the gall bladder of a pig. FIG. 24 shows the illuminated distal end of the example catheter entering a gallbladder wall during live animal testing. FIG. 25 shows the illuminated distal end of the catheter within the cystic duct during live animal testing. FIG. 26 shows the example catheter in use during live animal testing.

[00115] FIG. 27 is a block diagram of an exemplary computing device 1100 that may be used to implement exemplary embodiments of a system including a catheter. The system may include any or all of a controller for controlling light emission from the distal end of the catheter, one or more imaging devices for imaging a distal end of the catheter during use, and one or more display devices for displaying images of a distal end of the catheter and relevant anatomical structures during use. The computing device 1100 includes one or more non- transitory computer-readable media for storing one or more computer-executable instructions or software for implementing exemplary embodiments. The non-transitory computer- readable media may include, but are not limited to, one or more types of hardware memory, non-transitory tangible media (for example, one or more magnetic storage disks, one or more optical disks, one or more flash drives), and the like. For example, memory 1106 included in the computing device 1100 may store computer-readable and computer-executable instructions or software for implementing exemplary embodiments. The computing device 1100 also includes configurable and/or programmable processor 1102 and associated core 1104, and optionally, one or more additional configurable and/or programmable processor(s) 1102' and associated core(s) 104' (for example, in the case of computer systems having multiple processors/cores), for executing computer-readable and computer-executable instructions or software stored in the memory 1106 and other programs for controlling system hardware. Processor 1102 and processor(s) 1102' may each be a single core processor or multiple core (1104 and 1104') processor.

[00116] Virtualization may be employed in the computing device 1100 so that infrastructure and resources in the computing device may be shared dynamically. A virtual machine 1114 may be provided to handle a process running on multiple processors so that the process appears to be using only one computing resource rather than multiple computing resources. Multiple virtual machines may also be used with one processor.

[00117] Memory 1106 may include a computer system memory or random access memory, such as DRAM, SRAM, EDO RAM, and the like. Memory 1106 may include other types of memory as well, or combinations thereof.

[00118] A user may interact with the computing device 1100 through a visual display device 1118, such as a computer monitor, which may display one or more graphical user interfaces 1122 that may be provided in accordance with exemplary embodiments. The computing device 1100 may include other I/O devices for receiving input, for example, a keyboard or any suitable multi-point touch interface 1108, a pointing device 1110 (e.g., a mouse), a microphone 1128, an image capturing device 1132 (e.g., a camera), an interface to the catheter, and/or an interface to another medical device (e.g., an ultrasound device or fluoroscopic light source). The multi-point touch interface 1108 (e.g., keyboard, pin pad, scanner, touch-screen, etc.) and the pointing device 1110 (e.g., mouse, stylus pen, etc.) may be coupled to the visual display device 818. The computing device 1100 may include other suitable conventional I/O peripherals. The computing device 1100 may include or interface with a controller 1134 that controls illumination of the light emitting areas of a catheter or other device associated with the system.

[00119] The computing device 1100 may also include one or more storage devices

1124, such as a hard-drive, CD-ROM, or other computer readable media, for storing data and computer-readable instructions and/or software that implement exemplary embodiments. Exemplary storage device 1124 may also store one or more databases for storing any suitable information required to implement exemplary embodiments. For example, patent

information, previously acquired images of relevant portions of the patent, images acquired during a surgical procedure, information regarding anatomical structures of interest, and/or any other information to be used by embodiments of the system. The databases may be updated manually or automatically at any suitable time to add, delete, and/or update one or more items in the databases.

[00120] The computing device 1100 can include a network interface 1112 configured to interface via one or more network devices 1120 with one or more networks, for example, Local Area Network (LAN), Wide Area Network (WAN) or the Internet through a variety of connections including, but not limited to, standard telephone lines, LAN or WAN links (for example, 802.11, Tl, T3, 56kb, X.25), broadband connections (for example, ISDN, Frame Relay, ATM), wireless connections, controller area network (CAN), or some combination of any or all of the above. In exemplary embodiments, the computing device 1100 can include one or more antennas 1130 to facilitate wireless communication (e.g., via the network interface) between the computing device 1100 and a network. The network interface 1112 may include a built-in network adapter, network interface card, PCMCIA network card, card bus network adapter, wireless network adapter, USB network adapter, modem or any other device suitable for interfacing the computing device 1100 to any type of network capable of communication and performing the operations described herein. Moreover, the computing device 1100 may be or may include any computer system or computing device, such as a workstation, desktop computer, server, laptop, handheld computer, tablet computer (e.g., the IP AD tablet computer from Apple), mobile computing or communication device, a dedicated computing device associated with any instrument or tool used in surgery or any other form of computing device that has sufficient processor power and memory capacity to perform the operations described herein. [00121] The computing device 1100 may run any operating system 1116, such as any of the versions of the MICROSOFT WINDOWS operating systems, the different releases of the Unix and Linux operating systems, any version of the MACOS for Macintosh computers, any embedded operating system, any real-time operating system, any open source operating system, any proprietary operating system, or any other operating system capable of running on the computing device and performing the operations described herein. In exemplary embodiments, the operating system 1116 may be run in native mode or emulated mode. In an exemplary embodiment, the operating system 1116 may be run on one or more cloud machine instances.

[00122] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present belongs. In case of conflict, the present specification, including definitions, will control. Other features and advantages of the invention will be apparent from the claims that follow this description.

[00123] While exemplary embodiments have been described herein, it is expressly noted that these embodiments should not be construed as limiting, but rather that additions and modifications to what is expressly described herein also are included within the scope of the invention. Moreover, it is to be understood that many of the features of the various embodiments are not mutually exclusive, and can exist in various combinations and permutations, even if such combinations or permutations are not made express herein, without departing from the spirit and scope of the technology.

Claims

CLAIMS What is claimed is:

1. A catheter for identifying an anatomical location inside a body of a subject, the catheter comprising:

a proximal end and a distal end configured to be introduced into a lumen or space in the body of the subject;

at least one channel extending along the catheter;

at least one port providing access to the at least one channel; and

one or more light emission areas extending over a portion of the length of the catheter at or adjacent to the distal end, the one or more light emission areas configured to emit light detectable through a wall of the lumen or through a wall of the space in the body of the subject.

2. The catheter of claim 1, wherein the one or more light emission areas comprise one or more light emitters.

3. The catheter of claim 1, wherein the one or more light emission areas are configured to emit visible light.

4. The catheter of claim 1, wherein the one or more light emission areas comprise a plurality of light emitters distributed along the portion of the length of the catheter.

5. The catheter of claim 4, wherein the plurality of emitters are arranged in the form of a linear array or a two dimensional array.

6. The catheter of claim 4, wherein the plurality of emitters comprise a plurality of multi-color light emitters.

7. The catheter of claim 4, wherein the plurality of emitters comprise one or more of light emitting diodes, organic light emitting diodes, solid state lasers, and diode lasers.

8. The catheter of claim 1, wherein the position and orientation of a portion of the catheter is identifiable from light detectable through a wall of the lumen or through a wall of the space in the body of the subject.

9. The catheter of claim 1, further comprising an internal sheath configured to deliver the catheter into the lumen or an internal organ.

10. The catheter of claim 9, further comprising an inflatable balloon located on the distal end of the internal sheath configured to anchor the internal sheath to the lumen or internal organ when inflated.

11. The catheter of claim 1, further comprising a balloon located at the distal end of the catheter.

12. The catheter of claim 11, wherein the balloon is configured such that, when inflated, the balloon enables external visualization of specific regions of the lumen.

13. The catheter of claim 11, wherein the balloon is configured such that, when inflated, the balloon creates motion visible from outside the wall of the lumen.

14. The catheter of claim 11, wherein the balloon is configured such that when inflated, the balloon takes the shape of the lumen to provide information about the orientation, size, or trajectory of the lumen.

15. The catheter of claim 11, wherein the balloon is configured such that, when inflated, the balloon aids in positioning a tip of the catheter to reach or thread down a cystic duct of the subject.

16. The catheter of claim 1, wherein the one or more light emission areas comprise one or more light emitters, and wherein the catheter further comprises a wire disposed within the catheter configured to transmit electrical control signals to or deliver power to the one or more light emitters.

17. The catheter of claim 1, wherein the one or more light emission areas comprise a first light emitter configured to emit visible light and a second light emitter configured to emit light in non-visible wavelengths.

18. The catheter of claim 17, further comprising a controller operatively coupled to the proximal end of the catheter, wherein the controller is configured to control operation of the first or second light source.

19. The catheter of claim 1, further comprising one or more fiber optics extending to the one or more light emission areas to transmit light to the light emission areas.

20. The catheter of claim 1, wherein the at least one port comprises a plurality ports.

21. The catheter of claims 20, wherein at least one of the plurality of ports has a fitting configured to couple with one or more syringes.

22. The catheter of claim 20, wherein the plurality of ports provide access to one or more channels of the multichannel catheter, the channels comprising at least one of: a channel for passing a wire; a channel for placing an additional device; a channel for injecting a liquid; an evacuation channel for removing a liquid; a channel to inflate one or more balloons; a channel for delivery of a stent, hydrogel, foam or other material; a channel for introducing a tool; and a channel for introducing an energy source.

23. The catheter of claim 20, wherein at least one of the plurality of ports provides access to a channel for introducing at least one of a basket for retrieval, a grasper, a balloon dilator, a clip, or another catheter based instrument.

24. The catheter of claim 20, wherein at least one of the plurality of ports provides access to a channel for introducing a laser, an electrocautery device, a coagulation source, a heat source, a cooling source, or a hydroelectric source.

25. The catheter of claim 20, wherein at least one of the plurality of ports provides access to a channel for introducing a dilator, a stent, or a drain.

26. The catheter of claim 20, wherein at least one of the plurality of ports provides access to a channel for injecting one or more of: saline, a contrast, a medication, and a first agent.

27. The catheter of claim 26, wherein the port and channel are configured for injection of a first agent comprising a hydrogel or a first plug.

28. The catheter of claim 1, wherein the distal end further comprises a radio-opaque portion for visualizing the catheter under fluoroscopy.

29. The catheter of claim 1, further comprising a bumper located at a distal tip of the catheter, wherein a size of the bumper is determined based on a diameter of a duct associated with the lumen or space.

30. The catheter of any one of claims 1-29, wherein at least the distal end of the catheter is flexible.

31. The catheter of any one of claims 1-29, wherein the catheter is a rigid catheter.

32. A system for identifying an anatomical location inside a body of a subject, the system comprising:

a catheter comprising:

a proximal end and a distal end configured to be introduced into a lumen or space in the body of the subject;

at least one channel extending along the catheter;

at least one port providing access to the at least one channel; and one or more light emission areas extending over a portion of the length of the catheter at or adjacent to the distal end, the one or more light emission areas configured to emit light detectable through a wall of the lumen or through a wall of the space in the body of the subject; and

an internal sheath configured to deliver the catheter into the lumen or an internal organ.

33. The system of claim 32, wherein the internal sheath is further configured to aid in forming a seal with the internal organ or the lumen.

34. The system of claim 32, wherein the internal sheath is configured to prevent spillage of fluid contained within the internal organ or facilitate retraction of the internal organ or the lumen by anchoring the internal sheath to the organ or the lumen.

35. The system of claim 32 further comprising an external sheath configured to deliver the catheter into the space inside the body of the subject.

36. The system of claim 32 further comprising a controller operatively coupleable to the proximal end of the catheter.

37. The system of claim 36, wherein the one or more light emission areas comprise a plurality of light emitters, and wherein the controller is configured to control the plurality of light emitters to emit light in a sequence of patterns.

38. The system of claim 37, wherein the sequence of patterns includes at least one of: constant emission with or without modulation of brightness; patterned emission of one or more colors; and a patterned emission of one or more brightness levels.

39. The system of claim 37, wherein the controller is programmed to instruct generation of the sequence of patterns upon recognition of the shape of the catheter.

40. The system of claim 37, wherein the sequence of patterns comprises emission of light in a specific order of color or brightness corresponding to the shape of the catheter.

41. The system of claim 36, wherein the controller is programmed to control movement of the catheter in a desired manner, or to initiate pre-programmed movements to aid identification of the location of the within the lumen.

42. The system of claim 32, further comprising a display surface configured to render a graphical representation of a shape of the distal end of the catheter.

43. The system of claim 42, wherein the distal end of the catheter further comprises an imaging modality.

44. The system of claim 43, wherein the imaging modality is suitable for imaging the lumen to facilitate one or more of: passage or steering of the catheter, imaging walls of the lumen, identification of lesions in the walls of the lumen, and imaging of structures beyond the wall of the lumen or within the lumen.

45. The system of claim 43, wherein the imaging modality is selected from the group consisting of: a camera, an ultra-sound probe, a piezoelectric probe, a radiofrequency probe, and a microwave probe; and, wherein the display surface is configured to provide an image of the lumen obtained from the imaging modality.

46. The system of any one of claims 32-45, wherein at least a distal end of the catheter is flexible.

47. The system of any one of claims 32-45, wherein the catheter is a rigid catheter.

48. A method of performing a laparoscopic cholecystectomy on a subject, the method comprising:

passing a flexible catheter having a proximal and a distal end into the abdomen of the subject;

inserting the flexible catheter into a body or infundibulum of a gallbladder of the

subject;

emitting light from one or more light emission areas extending over a portion of the length of the flexible catheter at or adjacent to the distal end of the flexible catheter;

observing through a wall of the gallbladder or cystic duct, light emitted from the one or more light emission areas and transmitted through the wall of the gallbladder or cystic duct;

advancing the flexible catheter into the cystic duct of the subject;

confirming the location of the cystic duct based on light observed through a wall of the cystic duct;

dissecting and ligating the cystic duct; and

removing the gallbladder from the abdomen of the subject.

49. The method of claim 48, wherein at least a portion of the distal end of the flexible catheter comprises a radiopaque material and the method further comprises confirming a location of the cystic duct based on fluoroscopy.

50. The method of claim 48, further comprising, identifying based on light observed through the wall of the cystic duct the Triangle of Calot of the subject to facilitate locating the cystic duct, wherein the Triangle of Calot is an anatomic space bordered by the common bile duct medially, the cystic duct laterally, and the liver superiorly.

51. The method of claim 48 further comprising:

injecting a contrast through at least one port of the flexible catheter; and

performing an intraoperative cholangiogram to enhance identification of the cystic duct, a cystic artery, or a common biliary duct of the subject.

52. The method of claim 48, wherein light observed through the wall of the cystic duct facilitates distinguishing the cystic duct from a common biliary duct.

53. The method of claim 48 further comprising:

producing a first image on a display surface indicative of a shape of the distal end of the flexible catheter, the first image generated based on visible light emitted by the one or more light emission areas and transmitted through a wall of a biological lumen into which the distal end is inserted; and

producing a second image on the display surface indicative of the shape of the distal end of the flexible catheter, the second image generated based on light in non- visible wavelengths emitted by the one or more light emission areas and transmitted through the wall of the biological lumen into which the distal end is inserted.

54. The method of claim 53, wherein the first image and the second image are produced concurrently.

55. The method of claim 53, wherein the first image and the second image are produced sequentially.

56. The method of claim 53, further comprising superimposing the first image and the second image to generate a merged image on the display surface.

57. A method of conducting an endoscopic procedure, the method comprising:

using the catheter of any of claims 1-29 for one or more of: facilitating identification of an anatomical location of the catheter within the subject; removing anatomic structures or debris from the subject; dilating the lumen, or the space; or placing a second device.

58. The method of claim 57, further comprising using the catheter as a sheath over an endoscope for directing the catheter within the subject.

59. The method of claim 57, wherein removing anatomic structures or debris comprises removing stones from the cystic duct or the biliary system.

60. The method of claim 57, wherein placing the second device comprises placing a cholecystostomy tube under ultrasound, fluoroscopy, or computed tomography guidance.

61. The method of claim 57, wherein the lumen is selected from the group consisting of: trachaea; bronchi and subsegmental bronchi; thoracic duct; urethra; prostate; bladder; uterus; kidney and associated anatomy; biliary and pancreatic system; peripheral, visceral, cerebral, and cardiac vascular structures; uterus, fallopian tubes and ovaries; internal auditory canals, lacrimal ducts, salivary glands and ducts, oral, pharyngeal, laryngeal, sinus structures; and the fore, hind, and the mid- gut lumens.

62. The method of claim 57, wherein the endoscopic procedure is selected from the group consisting of: esophagogastroduodenoscopy; enteroscopy; colonoscopy; sigmoidoscopy; endoscopic retrograde cholangiopancreatography; rectoscopy; anoscopy; protoscopy;

rhinoscopy; bronchoscopy; arthroscopy; laparoscopy; cystocopy; and otoscopy.

63. The method of claim 57, further comprising:

occluding tracts created due to insertion of the catheter.

64. The method of claim 63, wherein occluding tracts comprises deploying an agent into the lumen or space.

65. The method of claim 64, wherein the agent comprises a plug made of a mesh or another material.

66. The method of claim 64, wherein the deployment is performed using an external trigger that is engaged upon the withdrawal of an internal or external sheaths used to deliver the catheter inside the subject or the lumen or space.