Endoscopic retrograde cholangiopancreatography (ERCP) catheter systems and methods

Abstract

Provided herein are catheter systems and methods for positioning a distal end of the catheter system within a body cavity. The catheter system includes a guidewire, a catheter having a controllably bendable distal portion and one or more sensors disposed at or near a distal end of the catheter and / or the guidewire to sense electrical parameters of a surrounding environment and generate data indicative of a location of the distal end of the catheter and / or the guidewire. The systems and methods may be used in endoscopic procedures, including endoscopic retrograde cholangiopancreatography (ERCP), as well as other navigational applications.

Description

[0001] ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CATHETER SYSTEMS AND METHODS

[0002] FIELD OF THE INVENTION

[0003] The present disclosure relates to improved catheter systems, and more specifically, to improved endoscopic retrograde cholangiopancreatography (ERCP) catheter systems having catheters and guidewires with improved maneuverability and positioning capabilities, as well as methods of using the same.

[0004] BACKGROUND

[0005] Endoscopic Retrograde CholangioPancreatography (ERCP) is a diagnostic and therapeutic procedure for various pathologies of the bile and pancreatic systems.

[0006] ERCP is performed when the bile or pancreatic ducts have become narrowed or blocked because of, for example, gallstones that form in the gallbladder and obstruct the common bile duct, infection, acute pancreatitis, chronic pancreatitis, trauma or surgical complications in bile or pancreatic ducts, pancreatic pseudocysts, tumors or cancers of the bile ducts, tumors or cancers of the pancreas, and other indications.

[0007] The procedure involves insertion of an endoscope through the upper gastrointestinal system into the second part of the duodenum (proximal part of the small intestine). Once the endoscope is in the duodenum, a catheter is passed through the working channel of the endoscope and is inserted into the Ampulla of Vater through the Major Duodenal Papilla. A guidewire is then passed through the catheter into the common bile duct (CBD), a catheter is passed on top of the guidewire into the CBD, and the guidewire is removed. Radiopaque dye is then injected through the catheter to visualize the bile duct, and the diagnostic and / or therapeutic procedure is performed.

[0008] Although ERCP is considered more beneficial than surgical treatments, various serious complications, including pancreatitis can occur as a result of the procedure. Some of these complications can be attributed to, among others, insertion of the guidewire or other mechanical manipulations inside the pancreatic duct thereby injuring the pancreas, and post-procedural obstruction of the pancreatic duct with a stone.Thus, there is a need for improved systems and methods to allow a safer ERCP procedure, by reducing mechanical manipulation near the pancreas.

[0009] SUMMARY

[0010] Aspects of the disclosure, according to some embodiments, relate to an improved endoscopic retrograde cholangiopancreatography (ERCP) catheter system including a catheter and guidewire which allow minimizing the risk involved with the ERCP and reduce its complications and side effects, such as, for example, Post-ERCP Pancreatitis (PEP), and optionally, bleeding, bowel holes and infections.

[0011] According to some embodiments, the disclosure relates to a catheter system which includes one or more sensors disposed at or near the distal end of a guidewire and / or the distal end of a catheter of the catheter system. The sensor(s) may be configured to sense the conductivity and / or resistivity and / or impedance at an internal body cavity in which they are located. In some embodiments, the location of the distal end of the catheter and / or the guidewire within the subject’ s body may be determined, either by the disclosed system or by the operator thereof based on data received from the sensor(s). In some embodiments, the sensor data may indicate where within the body cavity the distal end of the catheter and / or the guidewire is located. For example, in ERCP procedures the sensor data may indicate where within the Ampulla of Vater, in relation to the bile duct and the pancreatic duct, the distal end of the catheter and / or the guidewire is located, based on the differences in conductivity and / or resistivity and / or impedance between the contents (e.g., juices) of the ducts.

[0012] Thus, according to an aspect of some embodiments, there is provided a catheter system for use in a medical procedure, the catheter system includes:

[0013] a guidewire having a proximal end and a distal end;

[0014] an elongated catheter comprising:

[0015] a proximal end and a distal end, the distal end being configured for insertion into a body cavity and for controlled bending thereof;

[0016] one or more internal lumens comprising at least a first lumen configured to allow passage of the guidewire therethrough; and

[0017] one or more sensors positioned on or at the distal end of the guidewire and / or the distal end of the catheter.According to some embodiments, the distal end of the catheter may be flexible, so as to enable bending thereof.

[0018] According to some embodiments, the distal end of the catheter includes a plurality of vertebrae coupled to each other.

[0019] According to some embodiments, each vertebra of the plurality of vertebrae includes a body portion and a head portion.

[0020] According to some embodiments, the body portion includes an opening having a shape substantially corresponding to a shape of the head portion.

[0021] According to some embodiments, a first vertebra of the plurality of vertebrae may be coupled to an adjacent second vertebra of the plurality of vertebrae by the head portion of the first vertebra being received within the opening in the body portion of the second vertebra.

[0022] According to some embodiments, the head portion may include one or more side projections and the opening of the body portion comprises one or more side slots.

[0023] According to some embodiments, the one or more sensors are configured to sense at least one electrical property of at least one bodily fluid.

[0024] According to some embodiments, the one or more sensors are configured to sense one or more of impedance, resistance and conductance.

[0025] According to some embodiments, data received from the one or more sensors is indicative of a location of the distal end of the guidewire and / or the distal end of the catheter within the body cavity.

[0026] According to some embodiments, the catheter system may further include at least one control unit.

[0027] According to some embodiments, the at least one control unit may be functionally associated with at least one processing unit configured to analyze data received from the one or more sensors in real-time or near real-time.

[0028] According to some embodiments, the at least one processing unit may be configured to determine the location of the distal end of the guidewire and / or the distal end of thecatheter within the body cavity in real-time or near real-time, based on the data received from the one or more sensors.

[0029] According to some embodiments, the catheter system may include at least one display. According to some embodiments, the medical procedure is endoscopic retrograde cholangiopancreatography (ERCP).

[0030] According to some embodiments, there is provided a method for positioning a distal end of the catheter system as disclosed herein, within a target location in a body of a subject, the method includes:

[0031] (a) inserting a distal end of a catheter of the catheter system into a body cavity; (b) inserting a guidewire through a lumen of the catheter such that the distal end of the guidewire extends beyond the distal end of the catheter;

[0032] (c) receiving sensor data from one or more sensors positioned on or at the distal end of the guidewire and / or the distal end of the catheter;

[0033] (d) determining the location of the distal end of the guidewire and / or the distal end of the catheter within the body cavity;

[0034] (e) determining if the location of the distal end of the guidewire and / or the distal end of the catheter is in a region of interest within the body cavity;

[0035] (f) if it is determined that the location of the distal end of the guidewire and / or the distal end of the catheter is in the region of interest within the body cavity, distally extending the guidewire until the distal end of the guidewire is positioned within the target location;

[0036] (g) if it is determined that the location of the distal end of the guidewire and / or the distal end of the catheter is not in the region of interest within the body cavity, adjusting a bend state of the distal end of the catheter such that the distal end of the guidewire and / or the distal end of the catheter is moved to a different location within the body cavity, and repeating steps (c)-(g).

[0037] According to some embodiments, the sensor data includes conductivity, resistivity and / or impedance.

[0038] According to some embodiments, determining if the distal end of the guidewire and / or the distal end of the catheter is located within the region of interest includes comparingthe sensor data to one or more predetermined electrical parameter profiles and / or thresholds.

[0039] According to some embodiments, the method may further include providing feedback to a user indicative of a recommended adjustment to the bend state and / or orientation of the distal end of the catheter based on the sensor data.

[0040] According to some embodiments, the method may further include presenting the sensor data and / or information derived from the sensor data to a user via a visual, auditory and / or haptic output.

[0041] According to some embodiments, the region of interest within the body cavity corresponds to an entry region of a biliary duct.

[0042] According to some embodiments, there is provided herein a catheter for use in a medical procedure, the catheter having a proximal end and a distal end, the distal end being configured for insertion into a body cavity and for controlled bending thereof; one or more internal lumens including at least a first lumen configured to allow passage of the guidewire therethrough.

[0043] In some embodiments, the distal end of the catheter may be flexible, so as to enable bending thereof. In some embodiments, the distal end of the catheter may include a plurality of vertebrae coupled to each other. In some embodiments, each vertebra of the plurality of vertebrae includes a body portion and a head portion. The body portion may include an opening having a shape substantially corresponding to a shape of the head portion, and a first vertebra of the plurality of vertebrae is coupled to an adjacent second vertebra of the plurality of vertebrae by the head portion of the first vertebra being received within the opening in the body portion of the second vertebra. In some embodiments, the head portion of each vertebra may include one or more side projections and the opening of the body portion of each vertebra may include one or more side slots. In some embodiments, one or more sensors may be embedded or positioned on or at the distal end of the catheter. In some embodiments, the one or more sensors are configured to sense one or more electrical properties of a bodily tissue and / or a bodily fluid. The electrical properties may include impedance, resistance and / or conductance. In some embodiments, data received from the one or more sensors may be indicative of a location of the distal end of the catheter within the body cavity.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 this disclosure pertains. In case of conflict, the patent specification, including definitions, governs. As used herein, the indefinite articles “a” and “an” mean “at least one” or “one or more” unless the context clearly dictates otherwise.

[0044] BRIEF DESCRIPTION OF THE FIGURES

[0045] Some embodiments of the disclosure are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the disclosure. For the sake of clarity, some objects depicted in the figures are not to scale. In the Figures:

[0046] Figs. 1A-1C show perspective (Fig. 1A), side (Fig. IB) and cross-sectional (Fig. 1C) views of a catheter system, according to some exemplary embodiments;

[0047] Figs. 2A-2C show a catheter of the catheter system, according to some exemplary embodiments;

[0048] Figs. 3A-3D schematically depict a tip / distal end of a catheter of the catheter system, according to some exemplary embodiments;

[0049] Figs. 4A-4B show a portion of a tip / distal end of a catheter of the catheter system at different bending states, according to some exemplary embodiments;

[0050] Figs. 5A-5C show a tip / distal end of the catheter of Figs. 4A-4C at different bending states, with a guidewire extending therethrough, according to some exemplary embodiments;

[0051] Figs. 6A-6D show optional sensor arrangements at the distal end of a guidewire and / or a catheter, according to some exemplary embodiments;

[0052] Fig- 7 shows a flowchart of a medical procedure executed using the disclosed catheter system, according to some exemplary embodiments;Figs. 8A-8F schematically depict an ERCP executed using the disclosed catheter system, according to some exemplary embodiments; and

[0053] Figs. 9A-9B show a schematic illustration (Fig. 9A) and results (Fig. 9B) of an in-vivo experiment demonstrating the ability of the catheter system to determine differences between the bile and pancreatic juices in-vivo, in an animal test model.

[0054] DETAILED DESCRIPTION

[0055] The principles, uses and implementations of the teachings herein may be better understood with reference to the accompanying description and figures. Upon perusal of the description and figures present herein, one skilled in the art will be able to implement the teachings herein without undue effort or experimentation. In the figures, same reference numerals refer to same parts throughout.

[0056] Although the catheter systems and methods described herein are exemplified primarily in the context of endoscopic retrograde cholangiopancreatography (ERCP), it is to be understood that the disclosed systems and methods are not essentially limited to biliary or pancreatic applications. In some embodiments, the catheter system may be used for positioning within other luminal or cavity structures of a subject in which differentiation between adjacent anatomical regions, tissues, or fluid environments is desirable. The disclosed systems and methods may be used, for example, but not limited to: urological procedures (e.g., ureteral or renal access), vascular procedures (e.g., navigation within blood vessels or between vascular branches), gastrointestinal procedures (e.g., esophageal, gastric, intestinal, or colonic navigation), pulmonary procedures (e.g., bronchial access), gynecological procedures, and the like. In such embodiments, one or more sensors disposed at or near the distal end of the catheter and / or guidewire may be configured to sense electrical and / or other physical parameters characteristic of the local tissue or fluid environment, enabling determination of device location and assisting controlled positioning / navigation within a target region while reducing unintended contact / localization with adjacent, non-target tissues. The steerable distal portion of the systems and devices disclosed herein, can thus facilitate selective access and reduced mechanical manipulation in any such anatomical context.Reference is now made to Figs. 1A-1C which show a perspective view (Fig. 1A), a side view (Fig. IB) and a longitudinal cross-sectional view (Fig. 1C) of a catheter system 10, according to some embodiments. The catheter system 10 includes a catheter 102 having a tip / distal end 104, which is configured to be placed within a body cavity, and a proximal end, configured to be located externally to the subject body, within a housing 105 of the catheter system. The tip / distal end 104 of the catheter 102 may be flexible to allow bending of the catheter’s tip / distal end 104 in one or more planes, as described in further detail hereinbelow. In some embodiments, the tip 104 of the catheter 102 may be transitioned between flexible and rigid states. For example, the distal end may be transitioned to, and optionally locked in, a substantially rigid state while penetrating the Major Duodenal Papilla, and transitioned into a substantially flexible state following Major Duodenal Papilla penetration.

[0057] In some embodiments, the catheter 102 includes multiple lumens (shown in Fig. 2B hereinbelow) that extend along the length of the catheter 102. One or more of the lumens may extend from the proximal end to the tip of the catheter 102, while other one or more of the lumens may extend along only a portion of the catheter’s length. In some embodiments, the catheter system includes a guidewire (not shown) configured to be inserted into the body cavity through one of the catheter lumens. In some embodiments, any of the catheter lumens may allow passage of one or more suitable medical instruments and / or substances therethrough. In some embodiments, the one or more suitable medical instruments and / or substances may be selected from: stent systems, sphincterotomes, cytology sheaths, dilators balloons, stent extraction devices, miniscopes, contrast dye, medication, or any combination thereof. Each possibility is a separate embodiment. In some embodiments, the catheter system may include one or more handles and / or ports to allow the user (e.g., physician) to control functions of the system and / or to insert and / or maneuver the guidewire, medical instruments and / or substances. System handles may include, for example, a rotating handle 106, which can be rotated clockwise and / or counterclockwise to rotate the catheter 102 about its axis. An additional handle may be a bowing handle 108. Pushing / pulling of the bowing handle 108 controls a pullwire 118, resulting in bowing of the catheter 102 or at least a portion thereof (for example, the portion distal to line A-A’ shown in Fig. 2A below). In some embodiments, the bowing handle 108 and the rotating handle 106 may both be rigidly coupled to each other via theproximal portion of housing 105, such that the user may grab and rotate the bowing 108 (or any other portion of the proximal portion of the housing 105), instead of the rotating handle, in order to rotate the catheter 102 about its axis. The system may further include a rotating knob 110. Rotation of the rotating knob 110 clockwise and / or counterclockwise may result in bending of the distal end / tip 104 of the catheter 102. In some embodiments, an indicator 112 may show the bending degree of the tip 104 (for example, between 0-90 degrees). System ports may include a guide port 113, which allows insertion of a guidewire into a lumen of the catheter. Additional ports may include, for example, an injection port 114 and a diathermy port 116. In some embodiments, pullwire 118 may further function as a cutting wire, i.e., to cut tissue (e.g., sphincter) through which the catheter 102 is to be inserted. In such embodiments, the diathermy port may be used for passing an electric current through pullwire 118.

[0058] Reference is now made to Figs. 2A-2C, which show a catheter of the catheter system, according to some embodiments. Fig. 2A shows a perspective view of a catheter 202. In some embodiments, a connector 203 may couple between the tip / distal end 204 of the catheter and the body 205 of the catheter 202. Further shown in Fig. 2A is a portion of the cutting wire 218 which runs externally to the catheter. Fig.2B shows a cross-sectional view of the catheter body 205 taken along line A- A’ (Fig. 2A). In some embodiments, the catheter 202 includes multiple lumens / channels which extend along at least a portion of the catheter’s length. The catheter 202 may include a guidewire lumen 230 through which a guidewire can be inserted to a desired body cavity. The catheter may include at least one pullwire lumen 232, for housing at least one pullwire therein. The catheter 202 may further include a cutting wire lumen 234, for housing a cutting wire therein. In some embodiments, the catheter may include a fluid delivery lumen 236. As shown in Fig. 2B, the catheter 202 may include several layers. For example, the catheter may include (from innermost layer to outermost layer) a flexible metal core, a polymer (e.g., Pebax®) layer, a metal adaptor and a heat shrink protective layer. Fig. 2C shows a front view of the catheter 202, depicting the distal openings of the guidewire lumen 230 and the fluid delivery lumen 236, which terminate at the catheter’s tip 204.

[0059] Reference is now made to Figs. 3A-3D, which schematically depict a tip / distal end of a catheter, according to some embodiments. Fig. 3A shows a perspective view of the tip 304 of the catheter. Fig. 3B shows a side (flattened) view of the tip 304. In someembodiments, the catheter tip 304 may have a vertebrae structure, which includes a plurality of vertebrae 342 coupled to each other. The vertebrae structure may include laser-cut metal. Each vertebra 342 may include a body portion 344 and a head portion 346. The head portion 346 may include one or more side project! ons / ears 3462. In some embodiments, the body portion 344 may include an opening 348 having one or more side slots 3482, such that the shape of the opening 348 substantially corresponds to the shape of the head portion of the adjacent vertebra. In some embodiments, the coupling between adjacent vertebrae is achieved by the head portion of each vertebra 342 being received within the opening in the body portion of the adjacent vertebra. The size of the opening 348 may be slightly larger than the size of the head portion of the adjacent vertebra, so as to allow movement of the head portion within the opening, but prevent decoupling of the head portion from the opening and thus decoupling of adjacent vertebrae, as described in further detail hereinbelow. In some embodiments, the relative movement between the vertebrae may enable bending of the tip 304 of the catheter in one plane. In some embodiments, the cutting profile may enable bending of the tip up to a maximal angle, for example up to 90 degrees, and resist / prevent bending of the tip after reaching the preselected maximal bending angle. The above-described structure provides a proper flexibility -rigidity balance in a specific plane to maintain the catheter tip’s bending capabilities, while maintaining proper rigidity in all other planes to enable penetration of the Papilla by the tip 304. In some embodiments, the tip 304 may be configured to transition between flexible and rigid states. For example, the tip 304 may be transitioned to, and optionally locked in, a substantially rigid state (i.e., a state in which bending of the tip is disabled) while penetrating the Papilla, and transitioned into a substantially flexible state (i.e., a state in which bending of the tip is enabled) following Papilla penetration. In some embodiments, the tip 304 may be structured so as to allow bending thereof in more than one plane. Figs 3C-3D show transverse cross-sectional views of the catheter. As shown, a gap 3484 exists between the head portion 346 of one vertebra 342’ (more specifically, the side projection 3462 of the head portion 346) and the body portion 344 of a second vertebra 344”, adjacent to the first vertebra. The gap 3484 is part of the side slot 3482 of the opening 348 of the second vertebra 344”. Gap 3484 enables movement of side projection 3462 of the first vertebra 342’ within the side slot 3482 of the second vertebra 342”. In some embodiments, the cutting profile (e.g., conical profile) of the vertebrae structure allows for stability when applying shear forces on the vertebrae.Specifically, if the first vertebrae 342’ is pulled in the direction of arrow “A”, as shown in Fig. 3D, the conical edge of the second vertebrae 342” will prevent side projection 3462 of the first vertebra 342’ from sliding down, thus preventing the whole structure from falling apart.

[0060] Reference is now made to Figs. 4A-4B, which show a portion of a tip / distal end of a catheter at different bending states, according to some embodiments. Fig. 4A shows the tip 404 in a substantially straight state. Fig.4B shows the tip 404 in a bent state. As shown, as the tip 404 of the catheter bends, the position of a side projection / ear 4462’ of one vertebra 442’ within a side slot 4482” of a second (adjacent) vertebra changes. For example, in Fig. 4A ear 4462’ is positioned at or near the left edge of side slot 4482”, and in Fig. 4B ear 4462’ is positioned at or near the right edge of side slot 4482”.

[0061] Reference is now made to Figs. 5A-5C, which show a tip / distal end of a catheter at different bending states, with a guidewire extending therethrough, according to some embodiments. Fig. 5A shows tip 504 in a substantially straight state. Fig. 5B shows tip 504 in a partially bent state. Fig. 5C shows tip 504 in a maximal bent state, according to some embodiments. Also shown in Figs. 5A-5C is a guidewire 550 inserted within the catheter and protruding from the opening of the guidewire lumen (not shown) at the distal end of the tip 504. In some embodiments, the flexibility and bending capability of the tip 504 of the catheter enables high maneuverability of the guidewire extended therethrough, thus overcoming access difficulties associated with ERCP.

[0062] According to some embodiments, the tip may be bent at any angle (e.g., 0-180 degrees), relative to a longitudinal axis of the catheter. In some exemplary embodiments, at an articulation angle of about 90 degrees, the length of the tip of the catheter may be about 11mm. For example, at an articulation angle of about 60 degrees, the catheter tip length may be about 9mm. For example, at an articulation angle of about 30 degrees, the catheter tip length may be about 7mm. In the above examples, the length of the catheter tip is measured from the distal end of the external portion of the cutting wire, shown in Fig.

[0063] 2 A, to the distal end of the catheter tip.

[0064] In some embodiments, the tip of the catheter and / or the distal end of the guidewire includes one or more sensors. The sensor(s) may be configured to sense, for example, the conductivity and / or resistivity and / or impedance at an internal body cavity in which thetip of the catheter and / or the distal end of the guidewire on which the sensor(s) are positioned is located. In some embodiments, the sensor(s) may include, for example, electrodes, electrical wires and / or optical sensors. In some embodiments, the sensors may include impedance spectroscopy sensors, which can measure complex impedance across a range of frequencies, to provide more detailed information about the tissue and / or fluidic medium in the internal body cavity. In some embodiments, the sensors may include multimodal sensors, which combine electrical measurements with other sensing modalities (e.g., temperature, pressure), for comprehensive characterization of the internal body cavity (or specific location therein). Additionally or alternatively, sensors which measure one or more of the following parameters may be employed: temperature, pressure, flow, pH, composition (e.g., chemical composition), motility (e.g., accelerometers or strain gauges may be used to assess bile duct motility and contractility), and the like, or any combinations thereof. In some embodiments, biomarkers may be employed. In some embodiments, the impedance measuring may include real-time impedance magnitude and phase.

[0065] In some embodiments, the location of the tip of the catheter and / or the distal end of the guidewire within the subject’s body may be determined based on the sensor readings, as disclosed, for example, in U.S. Patent Application Publication No. US 2022 / 0241555, which is incorporated herein by reference in its entirety.

[0066] Reference is now made to Figs. 6A-6D, which show optional sensor arrangements at the distal end of a guidewire and / or a catheter tip, according to some embodiments. Fig. 6A shows annular sensors 662 surrounding the distal end of a guidewire 650. Fig. 6B shows sensors in the form of electrical wires 664 wound around the guidewire. Fig. 6C shows a plurality of electrodes / pads 666 disposed along the distal end of the guidewire. The electrodes may be round, rectangular, or any other suitable shape. Fig. 6D shows two electrodes 668 disposed at the distal tip (forward-facing) of the distal end of the guidewire. In some embodiments, the sensor arrangement may include one or more segmented sensors. Each segmented sensor may include two or more discrete sensing elements arranged in a spaced relation along the distal end of the guidewire, with each sensing element defining an independent sensor segment. The sensor segments may be axially separated, circumferentially offset, or both (e.g., in a helical or spiral pattern), such that each segment is associated with a distinct spatial position and orientationrelative to the guidewire tip. Each segmented sensor is configured to independently detect a local parameter, and to generate a corresponding signal representative of conditions at its respective segment. The segmented configuration enables differential analysis of signals among the sensor segments, allowing determination of both the special location and the orientation of the distal end of the guidewire within the body lumen or cavity, thereby providing directionality of the guidewire. Although described with respect to the distal end of a guidewire, it can be appreciated that some or all of the described arrangements may be applicable to a distal end of a catheter.

[0067] In some embodiments, the electrodes may be constructed from various materials, such as, without limitation: gold-plated stainless steel (SS 304V), stainless steel (SS 316L), tungsten, platinum and / or combinations thereof. Additional materials, which exhibit suitable electrical conductivity, biocompatibility and durability for use in physiological environments, and meet the specific requirements of the sensing functionality and operating conditions, may be employed. In some embodiments, all electrodes are constructed from the same material(s). In some embodiments, each or several of the electrodes are constructed from different materials.

[0068] In some embodiments, the parameter (e.g., impedance) measured by the sensors (e.g., electrodes) may be checked across a range of frequencies, to provide detailed information about the properties of the surrounding tissue or fluid. By applying signals at different frequencies, it is possible to differentiate between various biological components and conditions, as the impedance response can vary with frequency. This multi -frequency approach enables enhanced characterization and monitoring of the internal body cavity (or specific location therein) in which the distal end of the guidewire (and / or catheter) is positioned, providing valuable data for diagnostic and / or therapeutic purposes.

[0069] In some embodiments, the measurements by the sensors may be performed in real-time, or near real-time. As use herein, the term “real-time” refers to processing, analysis, and / or output of data with sufficiently low latency such that the resulting information is available during performance of the procedure and is usable to influence or assist ongoing operation, navigation, positioning and / or control of the catheter system. Real-time processing may include processing performed at regular intervals, intermittently, or upon occurrence of predefined events, provided that the latency is short enough to be clinically or operationally relevant to the procedure being performed.Reference is now made to Fig. 7, which shows a flowchart of a medical procedure executed using the disclosed catheter system, according to some embodiments.

[0070] At step 702, a catheter is inserted into a body cavity. In some embodiments, the medical procedure is ERCP and the body cavity is the Ampulla of Vater. In such embodiments, an endoscope is first inserted through the patient’s mouth into the duodenum, and the catheter is then extended through the working channel of the endoscope and inserted through the Papilla into the Ampulla of Vater.

[0071] At step 704, a guidewire is inserted through the catheter, until the guidewire tip extends beyond the distal end of the catheter.

[0072] At step 706, sensor data from the sensor(s) positioned at or along the tip of the guidewire is received by a processor of the system. Sensor readings may relate to, or be indicative of, the conductivity and / or resistivity and / or impedance of the contents of the body cavity at the location of the tip of the guidewire.

[0073] At step 708, the location of the guidewire tip is determined based on the received sensor data. In some embodiments, a processor of the system can automatically determine the location of the guidewire tip based on the sensor data, and the determined location is then indicated to the user of the system (e.g., physician), for example using visual and / or auditory means. In some embodiments, the location of the tip of the guidewire is determined by the user based on the data received by the sensor(s). In such embodiments, the sensor readings and / or data derived from the sensor readings may be presented to the user visually, for example, via a display. The data may be displayed in the form of numbers, text, shapes, graphs, charts, and any combination thereof. In some embodiments, the data may be indicated to the user using auditory means, such as speakers and / or headphones. In case the medical procedure is ERCP and the body cavity to which the catheter tip and / or the guidewire tip has been inserted is the Ampulla of Vater, the determined location may be, for example, entry regions into the bile duct or the pancreatic duct, and the determination may be based on known / pre-determined differences in conductivity and / or resistivity and / or impedance between the contents of the two ducts. For example, the bile juice has lower resistivity and impedance values and higher conductivity values than the pancreatic juice. In some embodiments, past measurements may be used to determine one or more thresholds (values and / or ranges).Each threshold may correspond to a defined area within the body cavity (e.g., Ampulla of Vater), such that the location of the guidewire tip within the body cavity is determined by comparing the obtained sensor data and / or data derived from the sensor data to the one or more thresholds.

[0074] At step 710, it is determined if the location of the guidewire tip is in a region of interest. In case the medical procedure is ERCP, the region of interest may be the entry region into the bile duct or the entry region into the pancreatic duct. The determination may be made by the system (e.g., a processor of the system) and / or by the user.

[0075] If it is determined that the guidewire tip is not located in the region of interest (e.g., it is located at the entry region of the pancreatic duct whereas the region of interest is the entry region of the bile duct) then, at step 712, the user may bend the catheter tip, e.g., using one or more handles at the proximal end of the catheter, so as to change the position and / or orientation of the guidewire tip within the body cavity. Steps 706, 708 and 710 are then repeated until it is determined that the guidewire tip is located in the region of interest.

[0076] Once it is determined that the guidewire tip is located in the region of interest (e.g., entry region of the bile duct) then, at step 714, the guidewire is further extended distally until it reaches the target location, i.e., a location within the bile duct in which a diagnostic and / or therapeutic is to be performed.

[0077] In some embodiments, the user may “sweep” the body cavity, i.e., move the guidewire tip within the body cavity by moving and / or bending the catheter tip to different angles. In some embodiments, the user may determine a preferred location in which to maintain the position of the catheter tip and extend the guidewire distally towards the target location, based on the data received from the sensor(s) during the performed sweep. In some embodiments, the sensors are positioned at or along the tip of the catheter. In such cases, it is the location of the catheter tip within the body cavity which is determined throughout the described method. Further, in such cases, the guidewire may be inserted and / or extended through the catheter only after it is determined that the catheter tip is located in the region of interest within the body cavity.In some embodiments, the sensor data may further be used to identify an inflammatory condition at or near the target location.

[0078] According to some embodiments, the catheter systems and methods disclosed herein may be used to identify / characterize various conditions, based on sensed physical and / or electrical parameters and / or navigation behavior within a body cavity or lumen. In some embodiments, sensor data obtained from the one or more sensors may be indicative of differences in tissue type, fluid composition, ductal patency, structural abnormalities, and the like. Such conditions may include, for example, but not limited to: inflammation, ductal obstruction or narrowing (e.g., strictures or stenoses), the presence of calculi or other intraluminal deposits, neoplastic or pre-neoplastic tissue, fibrotic tissue, post-surgical anatomical alterations, ischemic regions, or regions exhibiting altered fluid flow or composition.

[0079] According to some embodiments, differences in measured electrical parameters may be used to distinguish between inflamed and non-inflamed tissue, between normal (or benign) tissue and abnormal tissue, between open and obstructed lumens, between fluid-filled and solid / partially solid regions.

[0080] According to some embodiments, the catheter systems and methods disclosed herein may be used in oncologic and pre-oncologic applications to assist, for example, in identifying, characterizing, or navigating relative to neoplastic or pre-neoplastic tissue. By way of non-limiting example, sensor data obtained from the one or more sensors (disposed at or near the distal end of the catheter and / or guidewire) may be indicative of differences in electrical and / or physical properties between healthy / normal / benign tissue and tissue associated with, for example, dysplasia, benign neoplasms, malignant tumors, or tumor margins. In some embodiments, such differences may arise from variations in cellular density, tissue architecture, vascularization, extracellular matrix composition, fluid content, and the like, or any combinations thereof. In some embodiments, the disclosed systems may assist in localizing suspected lesions, differentiating tumor tissue from adjacent non-tumorous tissue, identifying tumor boundaries, guiding placement of diagnostic or therapeutic instruments / formulations, while minimizing unnecessary mechanical interaction with surrounding healthy tissue. In some embodiments, the systems may be used in conjunction with biopsy tools, ablation devices, stents and / or drug delivery instruments.According to some embodiments, the disclosed systems and methods may be used to detect or localize intraluminal deposits or solid structures, including calculi, stones, sludge, or other accumulations of material within a lumen. The presence of such structures may be inferred from differences between solid or semi-solid material and surrounding fluid environments, as determined based on changes / differences in electrical parameters, flow characteristics, and the like.

[0081] Reference is made to Figs. 8A-8F schematically depicting an ERCP executed using the disclosed catheter system, according to some embodiments. As shown in Figs. 8A-8F, a catheter of the catheter system has a distal end configured for insertion into a lumen or cavity region of a subject. Further shown is guidewire having sensors at a distal end thereof. Based on sensing one or more electrical properties at the end / tip of the guidewire (and / or the catheter end), the location thereof may be estimated, as detailed herein. The location may be presented to a user (e.g., a health care provider) via one or more displays or by any other suitable format. Based on the determination of the real-time location of the tip, the location of the tip may be adjusted, as detailed herein, to facilitate the tip reaching the required target region. For example, for the ERCP, the distal end (tip) of the guidewire is aimed into the common bile duct (CBD) rather than to the pancreatic duct, according to essentially real time localization determination based on electrical properties sensed by the sensors (e.g., conductivity and / or resistivity and / or impedance).

[0082] Fig. 8A shows a distal end 802 of a catheter 800 being extended from an endoscope (e.g., duodenoscope) 80, through the Papilla 2, into the Ampulla of Vater 4. Fig. 8B shows a distal end of a guidewire 810 being extended from the distal end 802 of the catheter until it is positioned in the Ampulla of Vater 4. A close-up view shows a plurality of sensors 812 positioned along the tip of the guidewire 810. By driving a current through the sensors or applying / inducing a voltage across the sensors, an electrical property of the fluid within the Ampulla of Vater 4 can be measured. The chemical composition of the fluid within the Ampulla of Vater 4 is unique, depending on its origin. Measuring the conductivity, for example, of the fluid can reveal the source of the secretion. Figs. 8C-8D show the tip of the guidewire 810 being moved within the Ampulla of Vater 4 by bending the distal end 802 of the catheter 800. Also shown is the sensor data and / or information derived from the sensor data being displayed to the physician via one or more displays 820. The displayed information may include, for example, sensed values, fluid compositions,guidewire tip location, etc., and the information may be displayed in the form of text, numbers, shapes, graphs, charts, and any combination thereof. In some embodiments, the physician may “sweep” the Ampulla of Vater 4, entirely or a portion thereof, by moving the guidewire tip therewithin, to continuously receive data from the sensor before proceeding with the procedure. In some embodiments, the physician may position the guidewire tip in discrete locations to obtain discrete sensor measurements. In some embodiments, the physician may change the position of the guidewire tip within the Ampulla of Vater 4 only if the measurements obtained at a certain location show or indicate that the guidewire tip is in an undesired position and / or orientation. A desired position and / or orientation of the tip of the guidewire 810 within the Ampulla of Vater 4 may be that which lead the guidewire 810, if it is further extended out of the catheter, to the target region, e.g., the bile duct. Once it is determined, either by the system or by the physician, that the tip of the guidewire is located at a desired position and / or orientation within the Ampulla of Vater 4, the guidewire 810 is extended further out of the catheter, until it reaches its target region, as shown in Figs.8E-8F. The physician can then advance the catheter or any other medical tool over the guidewire, and perform the required diagnostic and / or therapeutic procedure (not shown).

[0083] According to some embodiments, the systems and methods disclosed herein can be used to determine exact localization at or within a tissue, estimated localization at or within a tissue, or interim regions between tissues. For example, the determination may include determining if the tip of the catheter and / or the guidewire is in the bile duct, the pancreatic duct and / or in a transition region therebetween the ducts. In some embodiments, the catheter system may thus further aid a user in determining the direction of advancement of the catheter / guidewire tip.

[0084] According to some embodiments, the systems disclosed herein may include or be associated with one or more processing units. The processing units may be separate or part of a control unit associated with the catheter and / or the guidewire. The processing unit(s) may be used to receive data from the sensors. The processing unit(s) may be further used to determine, based on the data from the sensors, the location of the tip of the catheter and / or the guidewire. In some embodiments, the processing unit may be used to determine, in real time, if the tip is located in a specific tissue, a specific region between tissues, a specific fluid, and the like. In some embodiments, the processor(s) may beimplemented as part of one or more local computing devices integrated with or coupled to the system, as one or more remote computing devices in communication with the system via a wired or wireless network, as part of a cloud-based computing infrastructure, or as a distributed combination thereof. Processing tasks may be performed entirely at a single location or may be partitioned among multiple processors operating at different locations. In some embodiments, the system software may be stored in any type of a suitable non-transitory storage medium, or transitory storage medium (e.g., electrical, optical, acoustical or other form of propagated signals such as carrier waves, infrared signals, or digital signals). Examples of a non-transitory storage medium may include, but are not limited or restricted to a programmable circuit, semiconductor memory, non-persistent storage such as volatile memory (e.g., any type of random access memory “RAM”), or persistent storage such as non-volatile memory (e.g., read-only memory “ROM,” power-backed RAM, flash memory, phase-change memory, etc.), a solid-state drive, hard disk drive, an optical disc drive, or a portable memory device. The storage medium may be used for storing one or more data bases of past measurements, determined thresholds (e.g., measurement thresholds for indicating the location of the sensors), etc. In some embodiments, past measurements of patients may be used for determining patient-specific thresholds, patient-tailored procedures, etc. In some embodiments, communication between the processing unit(s) or computing devices and the sensors may include any communication route, e.g., wired or wireless (e.g., using Bluetooth, WI-FI, NFC, or any other suitable wireless communication route). In some embodiments, information transfer between the sensors and the processing unit may be direct or indirect. According to some embodiments, the catheter system includes a control unit operatively coupled to the catheter, the guidewire and, optionally, to the one or more sensors. The control unit may include one or more processors, memory, input / output interfaces, and the like, configured to receive data from the catheter system and to provide information and / or control signals to a user and / or to facilitate operation of the catheter. In some embodiments, the control unit is configured to process received data to determine positional, directional, or environmental information associated with the distal end of the catheter and / or the guidewire, and to generate corresponding outputs indicative of such information. The control unit may further be configured to control or assist actuation of the steerable distal portion of the catheter, for example by providing guidance, feedback, or recommended adjustments to bending or orientation based on the received data. Insome embodiments, the control unit may present information to the user via a display, visual indicators, auditory signals, or haptic feedback, and may optionally store, transmit, or log data associated with a procedure. The control unit may be implemented as a standalone module, integrated into a handle or housing of the catheter system, or implemented at least in part on an external computing device.

[0085] According to some embodiments, the catheter system may employ one or more algorithms executed by the processing unit or control unit to process data received from sensors associated with the catheter system and to assist operation, navigation, or positioning of the catheter. Such algorithms may include, without limitation, signal conditioning, filtering, normalization, feature extraction, pattern recognition, comparison to reference profiles, comparison to stored thresholds (values and / or ranges of values) or estimation of transitions between different anatomical or fluid environments. In some embodiments, the algorithm(s) can process real-time sensor data obtained from sensors positioned at the distal end of the catheter and / or guidewire to generate outputs indicative of relative position, proximity to anatomical structures, or changes in the surrounding environment, and to provide guidance, feedback, or control assistance related to steering, flexibility, advancement, orientation, and the like, of the catheter and / or guidewire. In some embodiments, the algorithms may be rule-based, model-based, or data-driven, including adaptive or learning-based, and may be configured to update parameters over time based on accumulated sensor data. The algorithms may be implemented as part of a technical system interacting with the physical sensors and the mechanical components / elements of the catheter system.

[0086] According to some embodiments, the system may include or be associated with a display configured to present information to a user. The display may be implemented as any suitable display device, including but not limited to a liquid crystal display (LCD), a lightemitting diode (LED) display, an organic light-emitting diode (OLED) display, a touchscreen display, or any other suitable visual output device. The display may be integrated with the system or communicatively coupled thereto, and may be implemented as part of, or displayed on a desktop computer, laptop computer, tablet, smartphone, television, or any other suitable user interface device.According to some embodiments, the excitation voltage range of the system may be adjustable in the range from about 50 mV to about 600 mV AC. In some embodiments, the signal type may include sine wave having single frequency per test cycle.

[0087] According to some embodiments, the frequency range may be from about 100 Hz to about 180kHz.

[0088] According to some embodiments, the sampling rate of the system may be over about 200kS / s (e.g., over about 500kS / s), to enable accurately capturing signals across a full frequency range.

[0089] According to some embodiments, the catheter system disclosed herein may be used for navigation, positioning and / or localization within a body cavity or lumen independently of a guidewire. In such embodiments, the elongated catheter itself may include one or more sensors at or along its steerable distal portion and it may be advanced and navigated without insertion of a guidewire through the catheter. Sensor data obtained from the distal end of the catheter may be used to determine a location, orientation, or proximity of the catheter relative to anatomical structures, luminal branches, tissue boundaries, or regions of interest, and to assist navigation decisions based on such determinations. The steerable distal portion may be actuated to selectively direct the catheter tip toward a desired pathway, branch, or target region based on the sensed parameters, thereby enabling controlled navigation, mapping and / or positioning using the catheter alone. Such guidewire-independent navigation may be particularly advantageous in confined, tortuous, or sensitive anatomical environments, or in procedures in which minimizing the number of inserted instruments is desirable.

[0090] According to some embodiments, the catheter disclosed herein, including the steerable distal portion having a plurality of interconnected vertebrae, may be used for navigation and positioning within a body cavity or lumen independently of a sensing functionality and / or independently of a guidewire. The vertebra-based distal structure enables controlled, directional bending of the catheter tip while maintaining sufficient axial rigidity for advancement through anatomical pathways. Such a configuration allows the catheter to be selectively steered toward a desired pathway, branch, target region, and the like, based on, for example, mechanical manipulation from the proximal end, optionally without reliance on a guidewire for directional control. In some embodiments, thevertebrae structure can facilitate navigation through tortuous, branching or anatomically constrained lumens by enabling incremental adjustment of the catheter tip orientation, thereby improving access and positional stability. The catheter may thus be used as a primary navigation instrument in a variety of medical procedures, such as, but not limited to: gastrointestinal, vascular, pulmonary, urological, gynecological procedures, and the like, where controlled mechanical steering and reduced instrument exchanges are advantageous. In some embodiments, once the catheter is steered to a target region within the body, or near the target location, a standard guidewire may be extended to the target region through the catheter. The steering catheter may then be retracted, to allow insertion of other medical tools over the guidewire.

[0091] According to some embodiments, there is provided a guidewire for use in a medical procedure, comprising a proximal portion, a distal portion, and one or more sensors disposed at the distal portion, the sensors being configured to sense at least one electrical parameter of a surrounding fluid or tissue environment.

[0092] According to some embodiments, there is provided a catheter for use in a medical procedure, including an elongated catheter body having a proximal end, a distal end, and at least one internal lumen; the distal end of the catheter body including a steerable distal portion; and one or more sensors disposed at or near the distal end of the catheter body, wherein the one or more sensors are configured to sense at least one electrical parameter of a surrounding environment to provide data indicative of a location of the distal end within a body cavity.

[0093] According to some embodiments, there is provided a catheter system for guiding or steering a guidewire to a target region in a body of a patient, the catheter system including a guidewire having one or more sensors disposed at or near a distal end of the guidewire; a catheter having a proximal end, a distal end and at least one internal lumen, the distal end of the catheter being controllably bendable; wherein the one or more sensors are configured to sense at least one electrical parameter of a surrounding environment to provide data indicative of a location of the distal end of the guidewire within a body cavity.

[0094] According to some embodiments, there is provided a method of positioning a catheter system or an element thereof within a body cavity and / or guiding or steering a cathetersystem or an element thereof to a target region in a body of a patient, the method includes: inserting a catheter having a steerable distal portion into the body cavity; advancing a guidewire through the catheter; receiving sensor data from one or more sensors disposed at or near a distal end of the catheter or guidewire; determining, based on the sensor data, whether the distal end is located within a region of interest in the body cavity; and adjusting a bend state of the steerable distal portion if the distal end is not located within the region of interest.

[0095] As used herein, the terms "bile duct", "common bile duct", "CBD" and "biliary duct" may interchangeably be used.

[0096] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the disclosure. No feature described in the context of an embodiment is to be considered an essential feature of that embodiment, unless explicitly specified as such.

[0097] Although steps of methods according to some embodiments may be described in a specific sequence, methods of the disclosure may include some or all of the described steps carried out in a different order. A method of the disclosure may include a few of the steps described or all of the steps described. No particular step in a disclosed method is to be considered an essential step of that method, unless explicitly specified as such.

[0098] Although the disclosure is described in conjunction with specific embodiments thereof, it is evident that numerous alternatives, modifications and variations that are apparent to those skilled in the art may exist. Accordingly, the disclosure embraces all such alternatives, modifications and variations that fall within the scope of the appended claims. It is to be understood that the disclosure is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth herein. Other embodiments may be practiced, and an embodiment may be carried out in various ways.The phraseology and terminology employed herein are for descriptive purpose and should not be regarded as limiting. Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the disclosure. Section headings are used herein to ease understanding of the specification and should not be construed as necessarily limiting.

[0099] As used herein, the term “about” may be used to specify a value of a quantity or parameter (e.g. the length of an element) to within a continuous range of values in the neighborhood of (and including) a given (stated) value. According to some embodiments, “about” may specify the value of a parameter to be between 80% and 120% of the given value. For example, the statement “the length of the element is equal to about Im” is equivalent to the statement “the length of the element is between 0.8m and 1.2m”. According to some embodiments, “about” may specify the value of a parameter to be between 90% and 110% of the given value. According to some embodiments, “about” may specify the value of a parameter to be between 95% and 105% of the given value.

[0100] In the description and claims of the application, each of the words “comprise” “include” and “have”, and forms thereof, are not necessarily limited to members in a list with which the words may be associated.

[0101] EXAMPLES

[0102] Example 1: Determining differences between the Bile and Pancreatic ducts in-vivo In order to determine the differences in electrical properties of Bile and Pancreatic ducts the resistance of the fluid (juice) of each of bile duct and pancreatic duct was measured, using the catheter system, in test animals (pig).

[0103] The results demonstrated that the catheter system is able to differentiate between the bile duct (measuring an average of 3500 ohms at the tested frequency) and the pancreatic duct (measuring an average of 5000 ohms at the tested frequency).Next, the system was tested to determine if it can detect in real-time a transition between biliary and pancreatic zones. Since in pig anatomy the bile duct and the pancreatic duct are separate from each other, i.e., there is no common path which includes both bile and pancreatic juices similarly to the Ampulla of Vater in human anatomy, in order to test the ability of the system to detect transition zones between the two ducts, bile juice was injected deep into the pancreatic duct of the test animal. A schematic illustration of the experiment is presented in Fig. 9A. The guidewire tip with electrodes embedded thereon was then inserted through the pancreatic duct, to sense, in real time, the electrical properties, during the transition along the pathway. The results are presented in Fig. 9B, demonstrating that the catheter system is able to detect in real-time transitions between bile juice and pancreatic juice, and is thus able to aid in determining the real-time localization of the catheter / guidewire tip within a common path, such as the Ampulla of Vater, based on sensing electrical properties thereat.

[0104] The results thus clearly demonstrate the ability of the catheter system to assist in determining localization, not only within specific tissues or bodily fluids, but also at transition areas therebetween.

[0105] While a number of exemplary aspects and embodiments have been discussed above, those of skill in the art will recognize certain modifications, permutations, additions and subcombinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced be interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope.

Claims

CLAIMSWhat is claimed is:

1. A catheter system for use in a medical procedure, the catheter system comprising:a guidewire having a proximal end and a distal end;an elongated catheter comprising:a proximal end and a distal end, the distal end being configured for insertion into a body cavity and for controlled bending thereof;one or more internal lumens comprising at least a first lumen configured to allow passage of the guidewire therethrough; andone or more sensors positioned on or at the distal end of the guidewire and / or the distal end of the catheter.

2. The catheter system of claim 1, wherein the distal end of the catheter comprises a plurality of vertebrae coupled to each other.

3. The catheter system of claim 2, wherein each vertebra of the plurality of vertebrae comprises a body portion and a head portion.

4. The catheter system of claim 3, wherein the body portion comprises an opening having a shape substantially corresponding to a shape of the head portion.

5. The catheter system of either one of claims 3 or 4, wherein a first vertebra of the plurality of vertebrae is coupled to an adjacent second vertebra of the plurality of vertebrae by the head portion of the first vertebra being received within the opening in the body portion of the second vertebra.

6. The catheter system of any of claims 3 to 5, wherein the head portion comprises one or more side projections and the opening of the body portion comprises one or more side slots.

7. The catheter system of any one of claims 1 to 6, wherein the one or more sensors are configured to sense at least one electrical property of at least one bodily fluid.

8. The catheter system of any one of claims 1 to 7, wherein the one or more sensors are configured to sense one or more of impedance, resistance and conductance.

9. The catheter system of any one of claims 1 to 8, wherein data received from the one or more sensors is indicative of a location of the distal end of the guidewire and / or the distal end of the catheter within the body cavity.

10. The catheter system of any one of claims 1 to 9, further comprising at least one control unit.

11. The catheter system of claim 10, wherein the at least one control unit is functionally associated with at least one processing unit configured to analyze data received from the one or more sensors in real-time or near real-time.

12. The catheter system of claim 11, wherein the at least one processing unit is configured to determine the location of the distal end of the guidewire and / or the distal end of the catheter within the body cavity in real-time or near real-time, based on the data received from the one or more sensors.

13. The catheter system of any one of claims 1 to 12, further comprising at least one display.

14. The catheter system of any one of claims 1 to 13, wherein the medical procedure is endoscopic retrograde cholangiopancreatography (ERCP).

15. A method for positioning a distal end of the catheter system of any one of claims 1 to 14 within a target location in a body of a subject, the method comprising:(a) inserting a distal end of a catheter of the catheter system into a body cavity; (b) inserting a guidewire through a lumen of the catheter such that the distal end of the guidewire extends beyond the distal end of the catheter;(c) receiving sensor data from one or more sensors positioned on or at the distal end of the guidewire and / or the distal end of the catheter;(d) determining the location of the distal end of the guidewire and / or the distal end of the catheter within the body cavity;(e) determining if the location of the distal end of the guidewire and / or the distal end of the catheter is in a region of interest within the body cavity;(f) if it is determined that the location of the distal end of the guidewire and / or the distal end of the catheter is in the region of interest within the body cavity, distally extending the guidewire until the distal end of the guidewire is positioned within the target location;(g) if it is determined that the location of the distal end of the guidewire and / or the distal end of the catheter is not in the region of interest within the body cavity, adjusting a bend state of the distal end of the catheter such that the distal end of the guidewire and / or the distal end of the catheter is moved to a different location within the body cavity, and repeating steps (c)-(g).

16. The method of claim 15, wherein the sensor data comprises conductivity, resistivity and / or impedance.

17. The method of either one of claims 15 or 16, wherein determining if the distal end of the guidewire and / or the distal end of the catheter is located within the region of interest comprises comparing the sensor data to one or more predetermined electrical parameter profiles and / or thresholds.

18. The method of any one of claims 15 to 17, further comprising providing feedback to a user indicative of a recommended adjustment to the bend state and / or orientation of the distal end of the catheter based on the sensor data.

19. The method of any one of claims 15 to 18, further comprising presenting the sensor data and / or information derived from the sensor data to a user via a visual, auditory and / or haptic output.

20. The method of any one of claims 15 to 19, wherein the region of interest within the body cavity corresponds to an entry region of a biliary duct.

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