Medical device with biliary diagnostic device

Abstract

The biliary diagnostic device includes a tubular body having an outer wall and an inner lumen, and a biliary diagnostic sensor for analyzing biological material adjacent to the tubular body. A method for guiding an endoscope through a bile duct includes inserting the endoscope into the duodenum, engaging the sensor with the biological material, electrically analyzing the biological material using the sensor to identify an electrical parameter, identifying liver bile in the biological material from the electrical parameter, and guiding the endoscope through the duodenum based on the presence of bile. A method for identifying the biological material includes engaging a sensor of the medical device with the biological material in the bile duct, electrically analyzing the biological material using the sensor to identify an electrical parameter, identifying the biological material from the liver, pancreas, or gallbladder from the electrical parameter, and outputting an indication of the biological material to a user of the medical device.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims priority to U.S. Provisional Patent Application No. 63 / 037,098, filed June 10, 2020, entitled “Medical Devices with Biliary Diagnostic Devices,” and further claims priority to U.S. Provisional Patent Application No. 62 / 966,710, filed January 28, 2020, entitled “Endoscope with a Biliary Diagnostic Device,” the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to medical devices that include an elongate body configured to be inserted into an incision or opening in a patient's anatomy to provide a diagnostic or therapeutic operation.

[0003] In particular, the present disclosure relates to endoscopes for imaging various anatomical portions and / or for providing passage of therapeutic devices to anatomical portions, including the gastrointestinal tract (e.g., esophagus, stomach, duodenum, pancreatic biliary tract, intestines, colon, etc.), renal region (e.g., kidney(s), ureter, bladder, urethra), and other organs (e.g., reproductive system, paranasal sinuses, submucosal regions, respiratory tract), etc. The present application further relates to stents and other medical devices that may be used in the treatment and management of the gastrointestinal tract. [Background technology]

[0004] Conventional endoscopes may be involved in a variety of clinical procedures, including, for example, illuminating, imaging, detecting, and diagnosing one or more pathologies; providing fluid delivery (e.g., saline or other preparations via fluid channels) to an anatomical region; providing a passage for one or more therapeutic devices for sampling or treating an anatomical region (e.g., via a working channel); and providing an aspiration passage for collecting fluids (e.g., saline or other preparations) and the like.

[0005] In conventional endoscopy, the distal portion of the endoscope may be configured to support and direct the therapeutic device, for example, using an elevator. In some systems, two endoscopes may be configured to work together, with the first endoscope guiding the second endoscope inserted therein with the aid of an elevator. Such a system may be useful in guiding a small diameter endoscope to hard-to-reach anatomical locations within the body. For example, some anatomical locations may only be accessible with the endoscope after insertion through a circuitous path. Furthermore, the tissue of some anatomical locations may be sensitive. As such, it may be undesirable to guide the endoscope to an unintended anatomical location. Summary of the Invention [Problem to be solved by the invention]

[0006] The present inventors have recognized that problems to be solved with conventional medical devices, particularly endoscopes and duodenoscopes, include, among others, 1) the difficulty of navigating an endoscope to difficult-to-reach anatomical locations, 2) the increased time and associated costs of navigating an endoscope to an incorrect location, and 3) the risk of potential tissue damage from impacting sensitive tissue with the endoscope. Such problems may be particularly present in duodenoscope procedures (e.g., endoscopic retrograde cholangiopancreatography, hereafter "ERCP" procedures), in which an auxiliary scope (also called a daughter scope or cholangioscope) may be attached and advanced through the working channel of a "main scope" (also called a mother scope or duodenoscope). The present disclosure may help provide solutions to these and other problems by providing systems, devices, and methods for sensing biological materials, such as biological fluids and solids, which may be used to diagnose medical conditions and guide the insertion of medical devices into desired anatomical regions. In particular, the present application relates to a biliary diagnostic device that can evaluate biological fluids, such as hepatic bile, to guide an endoscope toward anatomical features where medical intervention is desired. For example, the presence of hepatic bile can facilitate guiding an endoscope toward the common bile duct and into the duodenum and away from the main pancreatic duct.

[0007] The inventors have also recognized that problems to be solved in conventional medical procedures, particularly duodenoscope procedures, include, among other things, the potential desire to utilize fluoroscopy to facilitate navigation of complex anatomical structures. It may be desirable to avoid the use of fluoroscopy to minimize radiation exposure for the surgeon and patient. The present disclosure may help provide a solution to these and other problems by providing systems, devices, and methods that utilize non-fluoroscopic navigational aids in the form of biliary diagnostic devices, which may be used to perform biological or chemical analysis of anatomical materials to provide composition-guided navigation.

[0008] The inventors have further recognized that a problem to be solved in conventional treatments of stone, e.g., gallstone, formation in the gastrointestinal system is that it can be difficult to diagnose biological conditions that may lead to stone formation in a patient. For example, in many cases, the formation of the stone itself provides the first indication of the condition. Furthermore, procedures to remove the stone may result in the destruction of the stone. As such, it can be difficult to diagnose the specific condition in a patient that leads to stone formation. The present disclosure may help provide a solution to these and other problems by providing systems, devices, and methods that utilize a biliary diagnostic device to analyze the composition of gastrointestinal stones, thereby helping to identify biological conditions that lead to stone formation, thereby providing the basis for a treatment plan, such as changes in dietary habits or medications, to reduce the risk of future recurrence of the problem. [Means for solving the problem]

[0009] In one example, a biliary diagnostic device can include a tubular body including an outer wall and an interior lumen, and a first biliary diagnostic sensor coupled to a medical device configured to analyze biological material in contact with the tubular body.

[0010] In another example, a method of guiding an endoscope from the duodenum to the common bile duct may include inserting an endoscope into the duodenum, engaging a sensor of the endoscope with biological material in the duodenum, electrically analyzing the biological material using the sensor to identify an electrical parameter, identifying hepatic bile in the biological material from the electrical parameter, and guiding the endoscope through the duodenum based on the presence of hepatic bile.

[0011] In a further example, a method of identifying a composition of biological material in a bile duct may include engaging a sensor of a medical device with biological material in the bile duct, electrically analyzing the biological material using the sensor to identify an electrical parameter, identifying biological material from at least one of the liver, pancreas, and gallbladder in the biological material from the electrical parameter, and outputting an indication of the biological material to a user of the medical device. [Brief description of the drawings]

[0012] [Figure 1] FIG. 1 is a schematic diagram of an endoscopy system including an imaging and control system and an endoscope, such as a duodenoscope. [Diagram 2] FIG. 2 is a schematic diagram of the endoscopy system of FIG. 1 including an endoscope connected to a control unit of the imaging and control system. [Figure 3A] 3 is a schematic top view of a distal portion of the endoscope of FIG. 2, including a camera module containing optics and an elevator mechanism for a side-viewing endoscope. [Figure 3B] FIG. 3B is an enlarged cross-sectional view taken along plane 3B-3B of FIG. 3A showing the optical component. [Figure 3C] FIG. 3C is an enlarged cross-sectional view taken along plane 3C-3C of FIG. 3A showing the elevator mechanism. [Figure 4] FIG. 5 is a schematic diagram of a modular endoscope suitable for use as the endoscope of FIGS. 1-3C, including a camera module, an insertion section module, and a navigation and control module configured to be detachable from one another. [Diagram 5]1 is a schematic diagram of a distal portion of an endoscope including a biliary diagnostic device according to the present disclosure positioned in the duodenum. [Figure 6A] FIG. 1 is a perspective view of a first example of a biliary diagnostic device of the present disclosure including a single electrode ring configured to function as a positive electrode. [Figure 6B] 6B is a schematic cross-sectional view taken along plane 6B-6B of FIG. 6A showing a first example of an electrode shape. [Figure 6C] 6B is a schematic cross-sectional view taken along plane 6B-6B of FIG. 6A showing a second example of an electrode shape. [Figure 7] FIG. 13 is a perspective view of a second example of a biliary diagnostic device of the present disclosure including a single electrode ring configured to function as a negative electrode and a guidewire configured to function as a positive electrode. [Figure 8] FIG. 13 is a perspective view of a third example of a biliary diagnostic device of the present disclosure, including a pair of electrode rings configured to function as positive and negative electrodes. [Figure 9] FIG. 13 is a perspective view of a fourth example of a biliary diagnostic device of the present disclosure, including multiple electrode rings that can be configured as separate or combined biliary diagnostic sensors. [Figure 10] FIG. 13 is a perspective view of a fifth example of a biliary diagnostic device of the present disclosure, including a single electrode pad configured to function as either a positive or negative electrode. [Figure 11] FIG. 2 is a schematic diagram of an output device suitable for use with the biliary diagnostic device disclosed herein. [Figure 12A] FIG. 1 is a perspective view of a stent incorporating the biliary diagnostic device of the present disclosure. [Figure 12B] 12B is a cross-sectional view of the stent of FIG. 12A taken in plane 12B-12B showing the electrodes of the biliary diagnostic device. [Figure 13] FIG. 1 is a block diagram showing a first method for performing chemical analysis using the biliary diagnostic device of the present disclosure, including single-stage impedance analysis for pathway sensing. [Figure 14]FIG. 13 is a block diagram showing a second method for performing chemical analysis using the biliary diagnostic device of the present disclosure, including two-stage impedance analysis for pathway and stone detection. [Figure 15] FIG. 13 is a block diagram showing a third method for performing chemical analysis using the biliary diagnostic device of the present disclosure, including two-stage impedance and phase angle analysis for pathway and stone detection. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] FIG. 1 is a schematic diagram of an endoscopy system 10 including an imaging and control system 12 and an endoscope 14. The system of FIG. 1 is an illustrative example of an endoscopy system suitable for use with the systems, devices, and methods described herein, such as a biliary diagnostic device that may be used for navigational assistance and chemical composition analysis. According to some examples, the endoscope 14 may be insertable into an anatomical region to image pathologies associated with the anatomical region and / or provide for the passage of one or more sampling devices for biopsy or one or more therapeutic devices for treatment. The endoscope 14 may advantageously interface and connect with the imaging and control system 12. In the illustrated example, the endoscope 14 includes a duodenoscope, although other types of endoscopes may be used with the features and teachings of the present disclosure.

[0014] The imaging and control system 12 may include a controller 16 , an output unit 18 , an input unit 20 , a light source 22 , a fluid source 24 , and a suction pump 26 .

[0015] The imaging and control system 12 may include various ports for coupling with the endoscopy system 10. For example, the controller 16 may include a data input / output port for receiving data from and communicating data to the endoscope 14. The light source 22 may include an output port for transmitting light to the endoscope 14, for example, via a fiber optic link. The fluid source 24 may include a port for transferring fluid to the endoscope 14. The fluid source 24 may include a pump and a tank of fluid or may be connected to an external tank, container, or storage unit. The suction pump 26 may include a port used to draw a vacuum from the endoscope 14, generating suction to, for example, withdraw fluid from the anatomical region into which the endoscope 14 is inserted. The output unit 18 and the input unit 20 may be used by an operator of the endoscopy system 10 to control functions of the endoscopy system 10 and to observe the output of the endoscope 14. The controller 16 may further be used to generate signals or other output from treating the anatomical region into which the endoscope 14 is inserted. In examples, the controller 16 may generate electrical outputs, acoustic outputs, fluid outputs, etc. to treat anatomical regions with cauterization, cutting, freezing, etc.

[0016] Endoscope 14 may include an insertion section 28, a function section 30, and a handle section 32, which may be coupled to a cable section 34 and a coupler section 36.

[0017] The insertion section 28 can extend distally from the handle section 32, and the cable section 34 can extend proximally from the handle section 32. The insertion section 28 can be elongated and can include a bending section and a distal end to which the functional section 30 can be attached. The bending section can be controllable (e.g., by a control knob 38 on the handle section 32) to manipulate the distal end through a tortuous anatomical passageway (e.g., stomach, duodenum, kidney, ureter, etc.). The insertion section 28 can also include one or more working channels (e.g., internal lumens), which can be elongated and can support insertion of one or more therapeutic tools of the functional section 30. The working channels can extend between the handle section 32 and the functional section 30. Additional functions, such as fluid passageways, guidewires, and pullwires, can also be provided by the insertion section 28 (e.g., via suction or irrigation passageways, etc.).

[0018] Handle section 32 may include a knob 38 and a port 40. Knob 38 may be coupled to a pull wire that extends through insertion section 28. Port 40 may be configured to couple various electrical cables, fluid tubes, etc. to handle section 32 for coupling with insertion section 28.

[0019] The imaging and control system 12, by way of example, may be disposed on a moving platform (e.g., cart 41) that includes shelves for housing the light source 22, suction pump 26, image processing unit 42, etc. Alternatively, some components of the imaging and control system 12 shown in Figures 1 and 2 may be disposed directly on the endoscope 14, making the endoscope "self-contained."

[0020] The functional section 30 may include components for treating and diagnosing the patient's anatomy. The functional section 30 may include an imaging device, an illumination device, and an elevator, as further described with reference to FIGS. 3A-3C. The functional section 30 may further include a biliary diagnostic device as described herein. For example, the functional section 30 may include one or more electrodes conductively connected to the handle section 32 and operably connected to the imaging and control system 12, and biological material in contact with the electrodes may be analyzed based on comparative biological data stored in the imaging and control system 12.

[0021] Figure 2 is a schematic diagram of the endoscopy system 10 of Figure 1, including an imaging and control system 12 and an endoscope 14. Figure 2 shows the components of the imaging and control system 12 coupled to the endoscope 14, which in the illustrated example includes a duodenoscope. The imaging and control system 12 may include a controller 16, which may include or be coupled to an image processing unit 42, a treatment generator 44 and a drive unit 46, as well as a light source 22, an input unit 20 and an output unit 18. As discussed in more detail below, the controller 16 may include or be in communication with a biliary diagnostic device 132, which may include electrodes disposed in the functional section 30 or the insertion section 28.

[0022] The image processing unit 42 and the light source 22 may each interface with the endoscope 14 (e.g., at the functional unit 30) by a wired or wireless electrical connection. Thus, the imaging and control system 12 may illuminate an anatomical region, collect signals representative of the anatomical region, process the signals representative of the anatomical region, and display an image representative of the anatomical region on the display unit 18. The imaging and control system 12 may include a light source 22 and illuminate the anatomical region using a desired spectrum of light (e.g., broadband white light, narrowband imaging using a preferred electromagnetic wavelength, etc.). The imaging and control system 12 may connect to the endoscope 14 (e.g., via an endoscope connector) for signal transmission (e.g., light output from the light source, video signals from the imaging system at the distal end, diagnostic and sensor signals from the biliary diagnostic device).

[0023] Fluid source 24 may include one or more sources of air, saline, or other fluids and associated fluid paths (e.g., air channels, irrigation channels, aspiration channels) and connectors (barb fittings, fluid seals, valves, etc.). Imaging and control system 12 may also include a drive unit 46, which may be an optional component. Drive unit 46 may include a motorized drive for advancing the distal section of endoscope 14 and is described at least in PCT Publication No. WO 2011 / 140118 A1, entitled "Rotate-to-Advance Catheterization System" by Frassica et al., which is incorporated herein by reference in its entirety.

[0024] 3A-3C show a first example of a functional section 30 of the endoscope 14 of FIG. 2. FIG. 3A shows a top view of the functional section 30, and FIG. 3B shows a cross-sectional view of the functional section 30 taken along section 3B-3B of FIG. 3A. FIGs. 3A and 3B each show a "side-viewing endoscope" (e.g., duodenoscope) camera module 50. In the side-viewing endoscope camera module 50, the illumination and imaging system are positioned such that the viewing angle of the imaging system corresponds to a target anatomical structure lateral to the central longitudinal axis A1 of the endoscope 14.

[0025] In the example of FIG. 3A and FIG. 3B, the side-viewing endoscopic camera module 50 may include a housing 52, an elevator 54, a fluid outlet 56, an illumination lens 58, and an objective lens 60. The housing 52 may form a fluid-tight coupling with the insertion section 28. The housing 52 may include an opening for the elevator 54. The elevator 54 may include a mechanism for moving a device inserted through the insertion section 28. In particular, the elevator 54 may include a device capable of bending an elongated device extending through the insertion section 28 along the axis A1, which will be discussed in more detail with reference to FIG. 3C. The elevator 54 may be used to bend the elongated device at an angle relative to the axis A1, thereby treating an anatomical region adjacent to the side-viewing endoscopic camera module 50. The elevator 54 may be disposed, for example, radially outward of the axis A1, along with the illumination lens 58 and the objective lens 60.

[0026] As seen in FIG. 3B, the insertion section 28 may include a central lumen 62 through which various components (e.g., electrode leads 162 and 166 (FIG. 5) of the biliary diagnostic device 132) may extend to connect the functional section 30 to the handle section 32 (FIG. 2). For example, the illumination lens 58 may be connected to a light transmitter 64, which may include a fiber optic cable or cable bundle that extends to the light source 22 (FIG. 1). Similarly, the objective lens 60 may be coupled to a prism 66 and an imaging unit 67, which may be coupled to wiring 68. Also, the fluid outlet 56 may be coupled to a fluid line 69, which may include a tube that extends to the fluid source 24 (FIG. 1). Other elongated elements, such as tubes, wires, and cables, may extend through the lumen 62 to connect the functional section 30 to components of the endoscopy system 10, such as the suction pump 26 (FIG. 1) and the treatment generator 44 (FIG. 2).

[0027] FIG. 3C is a schematic cross-sectional view taken along section 3C-3C of FIG. 3A showing elevator 54. Elevator 54 can include deflector 55, which can be disposed in space 53 of housing 52. Deflector 55 can be connected to wire 57, which can extend through tube 59 to connect to handle section 32. Wire 57 can be actuated by turning a knob, pulling a lever, pressing a button on handle section 32, or the like. Movement of wire 57 can cause rotation, for example, clockwise, of deflector 55 about pin 61 from a first position of deflector 55 to a second position of deflector 55, indicated by 55′. Deflector 55 can be actuated by wire 57 to move a distal portion of instrument 63 extending through window 65 of housing 52.

[0028] The housing 52 may include a receiving space 53 for receiving the deflector 55. The instrument 63 may include a forceps, catheter, or the like extending through the lumen 62. The proximal end of the deflector 55 may be attached to the housing 62 with a pin 61 provided on the hard tip 21. The distal end of the deflector 55 may be disposed below a window 65 in the housing 62 when the deflector 55 is in a lowered or unactuated state. The distal end of the deflector 55 may extend at least partially from the window 65 when the deflector 55 is lifted or actuated by the wire 57. The instrument 63 may slide on the angled inclined surface 51 of the deflector 55 to initially deflect the distal end of the instrument 63 toward the window 65. The angled inclined surface 51 may encourage the expansion of a distal portion of the instrument 63 extending from the window 65 at a first angle relative to the axis of the lumen 62. The angled inclined surface 51 may include a groove 69, e.g., a v-shaped notch, to receive and guide the instrument 63. The deflector 55 may be actuated to bend the instrument 63 at a second angle relative to the axis of the lumen 62, the second angle being closer to perpendicular than the first angle. Once the wire 57 is released, the deflector 55 may be rotated, e.g., counterclockwise, back to the lowered position by either pushing or releasing the wire 57. In an example, the instrument 63 may include a cholangioscope or an auxiliary scope 134 (FIG. 5).

[0029] The side-viewing endoscopic camera module 50 of FIGS. 3A-3C may include optical components (e.g., objective lens 60, prism 66, imaging unit 67, wiring 68) for collection of image signals, and illumination components (e.g., illumination lens 58, light transmitter 64) for transmission or generation of light. The endoscopic camera module 50 may also include a light-sensitive element, such as a charge-coupled device ("CCD" sensor) or a complementary metal-oxide semiconductor ("CMOS") sensor. In either example, the imaging unit 67 may be coupled (e.g., via a wired or wireless connection) to the image processing unit 42 (FIG. 2) to transmit signals from the light-sensitive element (e.g., video signals) representative of an image to the image processing unit 42 for subsequent display on a display such as the output unit 18. In various examples, the imaging and control system 12 and the image processing unit 67 may be configured to provide an output at a desired resolution suitable for an endoscopic procedure (e.g., at least 480p, at least 720p, at least 1080p, at least 4K UHD, etc.).

[0030] For ease of customization, assembly, disassembly, cleaning and sterilization, the endoscope 14 may be constructed with modular components, as described with reference to FIG.

[0031] FIG. 4 is a schematic diagram of a modular endoscope 100 suitable for use as an endoscope 14 and with the endoscopic camera module 50 of FIGS. 3A-3C. The modular endoscope 100 may include a modular removable functional module 102, an insertion section module 104, and a navigation and control module 106. The modules 102, 104, and 106 may include components that include customizable functions and components. Thus, the modular endoscope 100 may be custom built to perform a specific procedure on a specific patient. Individual modular components may be configured as reusable or disposable components. Thus, less expensive or difficult to clean components may be discarded and more expensive or easier to clean components may be reused after proper cleaning and sterilization.

[0032] The functional module 102 may include a functional section 30, a camera module 50, or other types of modules. The functional module 30 may include an imaging device, a therapeutic device, an auxiliary therapeutic device, and / or a biliary diagnostic device, as well as other devices described herein.

[0033] In an example, the functional module 102 may include an endoscopic camera module as described in U.S. Provisional Patent Application No. 63 / 024,674, filed May 14, 2020, entitled “Endoscope with a Low-Profile Distal Section,” the entire contents of which are incorporated herein by reference.

[0034] The navigation and control module 106 may include the handle section 32, the cable section 34, and the coupler section 36 of FIGS.

[0035] In an example, the navigation and control module 106 may include an endoscopic navigation and control module described in U.S. Provisional Patent Application No. 62 / 951,157, filed December 20, 2019, entitled “Modular Endoscope with Detachable and Selectively Disposable Components,” the entire contents of which are incorporated by reference into this specification.

[0036] The insertion section module 104 may include a tubular element, sheath, or shaft upon which and within which the functional module 102 may be mounted for insertion into the patient's anatomy.

[0037] In an example, the insertion section module 104 may include an insertion section 28, which may be configured to include one or more of the sheath and shaft components of U.S. Provisional Patent Application No. 63 / 017,901, filed April 30, 2020, entitled “Insertion Sheath for Modular Endoscope with Detachable and Selectively Disposable Components,” the entire contents of which are incorporated herein by reference.

[0038] As previously mentioned, the components of the endoscope 14 may be modular, as shown by the modular endoscope 100 of FIG. 4, so that they may be installed by an operator to configure the device for initial use on a patient, and may be removed by the operator after use on a patient. In another example, the modular components may be assembled and disassembled by a manufacturer or a decommissioning service, without operator manipulation. In one example, FIG. 4 illustrates the endoscope 14 of FIG. 2, where its components are shown in a separated state. Although FIG. 4 illustrates the endoscope 14 constructed from three modular components (functional module 102 [functional section 30], navigation and control module 106 [handle section 32], and insertion section module 104 [insertion section 28]), additional or fewer components are contemplated depending on the surgical procedure to be performed in the configuration of the endoscope 14 constructed or designed by the operator. Each of the functional module 102, navigation and control module 106, and insertion section module 104 may be detachable from one another. Additionally, each of the modules 102, 104, and 106 may be disposed of after a single clinical use. Alternatively, each of the modules 102, 104, and 106 may be constructed using materials that allow for several clinical uses. In such cases, the modules 102, 104, and 106 may be constructed to withstand sterilization after each clinical use.

[0039] In certain advantageous aspects, the modular construction of the endoscope 14 of FIG. 2 and the modular endoscope 100 of FIG. 4, as discussed herein, allows for mixing and matching of disposable and reusable modules, such that some modules, such as expensive and / or easy to clean modules, can be reused, and some modules, such as simple and / or difficult to clean modules, can be disposable. For example, certain modules can be removed from the endoscope after clinical use for sterilization, reprocessing, and reuse for subsequent clinical use, and the remaining modules can be discarded. For example, there are concerns regarding improper reprocessing of portions of duodenoscopes (e.g., elevator portions). As a result, disposable endoscopes that can be discarded after one clinical use (to prevent infection between uses) have been developed. However, currently available disposable endoscopes, in which the entire endoscope is discarded, are constructed using lower cost materials, resulting in a lower-cost endoscope and remaining competitive per clinical use. In many clinical cases, lower cost materials can lead to poor clinical performance (e.g., poor quality images, poor maneuverability, damage to the insertion section module during insertion, poor ergonomic performance of the endoscope handle, etc.). As such, inferior components may cause practitioners to avoid using such devices.

[0040] Thus, the modular endoscopes 14 and 100 of Figures 2 and 4, as well as others described or incorporated herein, are advantageously constructed to allow end users (e.g., healthcare providers and facilities) to retrieve certain modules of the endoscope 14 for reuse while disposing of areas susceptible to infection after a single clinical use. Furthermore, the portions of the endoscope intended for reuse may be constructed (e.g., fully encapsulated) to reduce accumulation of biological material and may additionally be fluidly isolated from areas susceptible to infection. Such a configuration encourages the use of a combination of high quality (high cost) reusable components that can be used over multiple clinical uses, and low cost disposable portions, while simultaneously reducing infection risk and achieving desired clinical performance. Disposable components may be constructed to include features only required for a custom procedure, as well as materials and constructions constructed to withstand only a single use, both of which help reduce the cost of disposable components. For example, an insertion sheath may be constructed to withstand the stresses of only a single operation, and does not need to be robustly constructed to withstand the repeated stresses of multiple procedures.

[0041] In an example, the endoscope 100 of FIG. 4 may include a duodenoscope, the functional module 102 may be configured as a reusable camera module, the navigation and control module 106 may include a reusable handle module, and the insertion section module 104 may include a disposable unit having multiple lumens. Thus, the camera module and the navigation and control module may each include a connector to maintain the camera module and the navigation and control module, respectively, attached to the insertion section module during use on a patient. After each use, the camera module and the navigation and control module may be separated (e.g., using a connector or attachment mechanism) and reprocessed for later use with a new insertion section module. Conversely, a used insertion module may be discarded after a single use.

[0042] Additionally, the connectors between the camera module and the navigation and control module, as well as the camera module and the navigation and control module, may be constructed of materials and designed to reduce the ingress of biological matter, and may be constructed to be fluid-tight if desired.

[0043] Modular endoscope 100 may be configured for either a "side-viewing" configuration (as shown in FIGS. 3A-3C) or an "end-viewing" configuration. In an example, when modular endoscope 100 is configured as a side-viewing device (e.g., a side-viewing duodenoscope), the distal modular section (e.g., a camera module) may be offset from the longitudinal axis of the central modular section (e.g., an insertion module) to accommodate additional components (e.g., an elevator mechanism, etc.). In another example, when modular endoscope 100 is configured as an end-viewing device (e.g., a gastroscope, colonoscope, cholangioscope, etc.), the distal modular section (e.g., a camera module) may be generally coaxially positioned along the longitudinal axis of the central modular section (e.g., an insertion module).

[0044] 5 is a schematic diagram of a distal portion of an endoscope 100 according to the present disclosure positioned in the duodenum D. The duodenum D may include a duct wall 120, a sphincter of Oddi 122, a common bile duct 124, and a main pancreatic duct 126. The duodenum D includes an upper portion of the small intestine. The common bile duct 124 carries bile from the gallbladder and liver (not shown) and drains the bile into the duodenum D via the sphincter of Oddi 122. The main pancreatic duct 126 carries pancreatic juice from the exocrine pancreas (not shown) to the common bile duct 124.

[0045] The endoscope 100 may include an insertion section module 104 and a functional module 102. The functional module 102 may include an elevator portion 130. The endoscope 100 may further include a biliary diagnostic device 132 and an auxiliary scope 134. The biliary diagnostic device 132 may include a processor 136, a memory 138, and a power source 140. As discussed below, the biliary diagnostic device 132 may be integrated into the endoscope 100, such as on the functional module 102, the insertion section module 104, or in the auxiliary scope 134, such as via electrodes 144.

[0046] In certain duodenoscope procedures (e.g., endoscopic retrograde cholangiopancreatography, hereafter "ERCP" procedures), an auxiliary scope (also called a daughter scope or cholangiopancreatoscope), for example, the auxiliary scope 134, may be attached and advanced through a working channel (e.g., within the insertion section module 104) of a "main scope" (also called a mother scope or duodenoscope) such as the endoscope 100. As described in more detail below, the auxiliary scope 134 may be guided to the sphincter of Oddi 122. From there, a surgeon manipulating the auxiliary scope 134 may navigate the auxiliary scope 134 toward the gallbladder or liver to perform various procedures. Thus, the surgeon may navigate the auxiliary scope 134 past an entrance 128 of the main pancreatic duct 126 and into a passageway 129 of the common bile duct 124. The biliary diagnostic device 132 may facilitate navigation to the gallbladder or liver, and bypass of the main pancreatic duct 126, by sensing biological material originating from the gallbladder or liver in the common bile duct 124. Small auxiliary endoscopes may have their own functional devices, such as light sources, accessories, and biopsy channels for therapeutic procedures.

[0047] According to some examples, the endoscope 100 may be suitable for cholecystectomy (e.g., removal of gallstones that may accumulate as stones in the gallbladder or other parts of the pancreaticobiliary duct). The gallbladder, which is located under the liver on the right side of the abdomen, can store and release bile through the common bile duct, for example, during digestion. During bile storage, the gallbladder can concentrate the bile from the liver (e.g., draw out water), and crystals may develop from the bile solution, which can aggregate and / or take many shapes, such as forming granular particles. The formation of these crystals depends on the solubility of three components present in the bile, such as cholesterol, bile acids, and phospholipids. When the balance of components such as cholesterol, bile acids, and phospholipids begins to change, one or more elements of the bile may move out of solution and form crystals.

[0048] In some examples, the crystals can aggregate and grow into particles and may continue to develop in the gallbladder (e.g., if not excreted) and may develop through the "gravel" and "stone" stages. According to some aspects, the size of the crystals may be smaller than the size of the particles. Further, in some aspects, the size of the crystals and / or particles may be smaller than the size of the gravel. Additionally, in some cases, the size of the crystals may be smaller than the size of the stone. In one example, the size of the crystals can be smaller than the size of the particles, gravel, and stone. In another example, the size of the particles may be smaller than the size of the gravel and stone, and in a further example, the size of the gravel may be smaller than the size of the stone. In yet another example, the sizes of the crystals, particles, gravel, and stone can follow the relationship (Dcrystals < Dparticles < Dgravel < Dstone), where "D" represents the size (characteristic dimension, e.g., length, surface area, one or more cross-sectional areas, etc.).

[0049] In some embodiments, larger gravel or stone-sized growths move through the gallbladder. If they are too large to pass through a single gallbladder bile duct, the growths pass in front of the gallbladder bile duct and create an intermittent blockage. This blockage can prevent the gallbladder from being able to empty, which causes inflammation and irritation of the gallbladder. In some cases, this can lead to an infection of the gallbladder, which can cause the gallbladder to fill with pus.

[0050] In some cases, even if the stone or gravel migrates away from the bile duct and the pressure is relieved, the gallbladder may be affected by experiencing strong localized scarring, which then increases the severity of the stone's passage through the duct. Some such events may lead to cholelithiasis (also called "gallbladder disease"). The stone may become trapped in the bile duct itself. Depending on the location of this blockage, the stone may cause a blockage of all hepatic bile secretions, and even worse, if the stone is lodged in the ampulla of Vater, it may block pancreatic juices as well. This may lead to pancreatitis and cholelithiasis, since the common bile duct is shared between the pancreas and the liver / gallbladder as a way to communicate the associated fluids to the digestive tract.

[0051] One surgical procedure to address stone formation and / or simultaneously remove calcifications is called a cholecystectomy, which may be performed invasively through the skin and in some cases may be performed laparoscopically (unless there are associated complications such as irritation and multiple stones in the bile duct, an open procedure may be performed). An alternative to a cholecystectomy may use a natural orifice entrance for the procedure but leave the gallbladder in place. This procedure may in some cases be called an endoscopic retrograde cholangiopancreatography (ERCP). ERCP uses a viewing system (e.g., a duodenoscope as shown in Figures 3A-3C) in combination with a functional ability (inherent in or associated with a camera) to be introduced into the patient via the mouth, esophagus, stomach, and / or duodenum, which may allow access to the biliary system without the need for, for example, a surgical access incision.

[0052] With continued reference to Figure 5, during biliary procedures (such as ERCP), the cystic duct and common bile duct may be enlarged by a variety of surgical means, ranging from dilation by cannulation to energy devices (such as sphincterotomy) that cut tissue within the duct to increase the ductal diameter, allowing for extraction and evacuation of gallstones during the procedure and reducing the risk of future stone entrapment.

[0053] With continued reference to Figure 5, the common bile duct is a shared duct between the liver, gallbladder, and pancreas. The common bile duct may have many branches, which may pose a challenge to a practitioner attempting to identify the correct ductal pathway to the gallbladder during, for example, a biliary procedure (such as ERCP).

[0054] The clinician must either rely on prior knowledge of the patient's anatomy (and the expected angle difference between the two ducts) or use available techniques or a combination to reliably identify the common bile duct. Surgeons may use fluoroscopy to identify the bile duct from the pancreatic duct. However, if not required for other elements of the procedure, fluoroscopy may be an invasive procedural technique and may involve specific set-up conditions and associated personal protective equipment.

[0055] Some implementations of the present disclosure aim not only to provide an alternative method to facilitate identification of the correct duct (e.g., prior to dilation), but also to predict what type of stone formation is occurring. Understanding the type of stone formation via liver secretions may also provide the surgeon insight into whether changes in dietary habits or medications may reduce the risk of future recurrence of the problem.

[0056] 6A-10, in accordance with an embodiment of the present disclosure, a biliary diagnostic device 132 is provided that takes advantage of the differences in properties between bile and pancreatic juice. The biliary diagnostic device 132 according to some embodiments may facilitate navigating, cannulating, or cutting the area near the common bile duct, for example, before, during, or after a biliary (e.g., ERCP) procedure. Bile produced by the liver and stored in the gallbladder and communicated via the bile duct may have unique properties than those that can be used to reliably distinguish the bile duct from the pancreatic duct(s).

[0057] Biliary diagnostic devices of the present disclosure, such as biliary diagnostic device 132 and biliary diagnostic device 222 (FIG. 12B), may, according to some embodiments, rely on the electrical properties of bile. For example, bile may have a higher electrical conductivity than some fluids or parts of the human body. The biliary diagnostic device, in one or more implementations, may include a component capable of sensing electrical conductivity, such as electrode 144, to reliably distinguish the bile duct from the pancreatic duct. In another example, the biliary diagnostic device may determine the phase angle of the fluid.

[0058] 6A-10 show various examples of the biliary diagnostic device 132 of the present disclosure, which may be provided as part of the endoscope 14 or endoscope 100. In an example, the biliary diagnostic device 132 may be disposed on a distal portion of the endoscope 100. In some examples, the biliary diagnostic device 132 may be disposed on a duodenoscope and / or a cholangioscope. In yet another aspect, the biliary diagnostic device 132 may be in communication with and / or attached to one or more endoscopic therapeutic accessories (e.g., guidewires, sphincterotomes, dilatation balloons, guide catheters, access sheaths, biliary stents, etc.) usable during a biliary procedure (e.g., an ERCP procedure or other type of biliary procedure). As shown in FIGS. 12A and 12B, in an example, the biliary diagnostic device 222 may be provided on a stent 220.

[0059] According to one embodiment, the biliary diagnostic device 132 may include one or more sensors, as shown in FIGS. 6A-10. In an example, the sensor may include an electrical component (e.g., an electrode) in a portion of the anatomy where the auxiliary scope 134 is inserted. Each sensor may include a positive electrode and a negative electrode. As shown in FIG. 6A, the electrode 144 may be configured as a positive electrode and the tissue may be configured as a negative electrode. As shown in FIG. 7, the electrode 144 may be configured as a negative electrode and the guidewire 154 may be configured as a positive electrode. In another example, as shown in FIGS. 8 and 9, multiple electrodes may be provided to function as one or more sensors. The positive and negative electrodes may include conductive rings or pads and may be connected to an energy source, such as a power source 140, that can direct a current between the electrodes. The sensors may be electrically insulated from one another, for example. For example, the positive and negative electrodes may be insulated using a dielectric material disposed along the shaft 150. The sensors may be disposed on a surface (e.g., an outer surface, an inner surface, a working channel, etc.) of an endoscope, such as the auxiliary scope 134. In an alternative example, the sensor may be located at, on or around the distal surface of the endoscopic instrument.

[0060] According to some implementations, an electrical signal, for example from generator 140, may pass between two electrodes, for example electrode 144, and the anatomical structure. Additionally, electrical properties and / or variations thereof (e.g., tissue impedance, resistance, or phase angle) at one or more locations (e.g., between the tips of the device) may be detected by sensors to identify the presence of bile and further facilitate guiding, cannulating, or identifying the bile duct from the pancreatic duct with an endoscopic therapeutic instrument. Some implementations of the biliary diagnostic device may reduce instances where fluoroscopy may be involved to identify the appropriate duct.

[0061] Bile may have different properties than pancreatic juice or other anatomical features (e.g., tissue, etc.). For example, it is known that a sensor detects one or more electrical properties of the bile and surrounding anatomical structures (e.g., tissue, pancreatic duct, pancreatic juice, etc.) and when one or more electrical properties (e.g., resistance, impedance, phase angle, etc.) of the tip of the device are utilized to demarcate the bile duct from the surrounding areas (e.g., tissue, pancreatic duct, pancreatic juice, etc.), the electrical properties (e.g., conductivity) of the bile may then be detected. For example, the conductivity of the bile may be greater than the conductivity of the surrounding tissue or pancreatic juice.

[0062] In one example, the bile diagnostic device 132 may be calibrated to use electrical properties (e.g., resistance, impedance, phase angle, etc.) as an indicator of the presence of bile. In some cases, tissue near the bile may be more conductive than any other tissue in the pancreaticobiliary region.

[0063] In an example, the biliary diagnostic device 132 may use electrical conductivity, for example, optionally with either low power DC or low power RF output from a power source 142 or the like. In a further optional implementation, the biliary diagnostic device 132 may be in operative communication with one or more output devices, such as the output device 142, which may include, for example, an endoscopy or endoscopic treatment system with an integrated display, or a physician console, a touch input device, the imaging and control system 12, or the like. In particular, the output device 142 may include the output unit 18 of the imaging and control system 12. The output device 142 may actively, for example, continuously, report to the user whether the tissue encountered increases or decreases electrical conductivity in some instances during the pancreaticobiliary procedure, as shown in FIGS. 13-15.

[0064] One or more optional implementations may provide different reports to the user, as seen in the flow charts of FIGS. 13-15 and the output device 142 of FIG. 11. Another example option may report to the user if the conductivity reaches a predetermined level indicative of bile in the liver and notify the user accordingly. Additionally, if the conductivity reaches a value indicative of concentrated fluid retained in the gallbladder, the user may be notified if a more concentrated version has been identified (more conductive). Another optional implementation may notify the user if concentrated bile material is detected. Another optional implementation may notify the user if no bile (concentrated or not) is detected. Another implementation may provide a combination or selection of the above informational feedback elements.

[0065] Further optional implementations may use the unique properties of bile to provide additional characterization, for example, instead of sensing conductivity, the device may sense impedance, or the phase difference between bile and surrounding anatomical features (e.g., surrounding tissue, pancreatic juices, etc.) may be detected.

[0066] Referring again to Figures 6A-10, in some embodiments, the location and number of electrodes and sensors formed therefrom may be varied. For example, as shown in Figures 6A and 10, one electrode may be placed in vivo at the distal section of the endoscope or endoscopic treatment instrument, and a second electrode may be placed elsewhere (e.g., outside the body) or electrically coupled to a natural or floating ground. In another embodiment, as seen in Figures 7-10 and 12B, multiple electrodes may be placed on or near the forward (distal) end of the endoscope or endoscopic treatment instrument. In either scenario, the interrogation signal associated with one or more sensors formed by the electrodes may be suitable for identifying a particular fluid characteristic.

[0067] As mentioned above, different types of crystals are generated when different chemical imbalances occur in the liver bile. Chemical differences can result in different electrical properties. By sampling the electrical properties of the concentrated gallbladder fluid, chemical imbalances can be identified and, if desired, the user can be notified, for example, via one or more reports. This can subsequently lead to a greater understanding of the cause of crystal formation. Furthermore, this can be combined with pharmaceutical or lifestyle modification options for the patient to reduce future incidence of various biliary conditions. In some implementations, the identification as disclosed herein can be reported to the user (e.g., directly or indirectly) by comparing the measured diagnosis (e.g., the sensed electrical property) to another preset value in the system. In an optional embodiment, the diagnosis value can be provided directly to a surgeon, specialist, or diagnostic algorithm for further analysis and reporting.

[0068] As with many surgical and diagnostic instruments, the devices according to some implementations may be disposable after use in a single procedure and / or with one patient, and may be reusable and / or reusable after a single procedure (e.g., with the same patient or with a different patient). Aspects and features of the devices disclosed herein may be provided as self-contained devices (e.g., inserted into the working channel of an endoscope and / or provided as a diagnostic device) and / or as part of an endoscope and / or endoscopic therapeutic instrument (e.g., attachable, detachable, and / or integrated into a distal portion).

[0069] In instances where a device may be provided as part of a set of similar devices, each device may have a unique identifier system for each device type, so that the sensor may specifically calibrate readings according to the device. For example, an identification circuit (e.g., a chip) may be provided in the device to identify the type of device and automatically configure device-specific parameters (e.g., sensor calibration, configuration of connections to other devices, device performance data, etc.) as needed. Some implementations may make the procedure more "plug and play," reducing the need for clinical staff intervention in setting up the device.

[0070] Although Figures 5-10 show a biliary diagnostic device disposed on an elongated tubular element (e.g., an endoscope or access sheath), a similar configuration may also be provided as part of various endoscopic therapeutic instruments, such as a guidewire, a sphincterotome, a monopolar, bipolar or cold cutting instrument (or a combination of the disclosed instruments), or a stent as shown in Figures 12A and 12B.

[0071] In some optional implementations, the report to the user may include a visual output (e.g., a light illuminating diode or other visual, graphical display, including on the console of an endoscopy or surgical system), as shown in Figure 11. Alternatively, another type of report, such as an audio or detailed display of sensor readings and / or diagnostic status (determined from a previous diagnosis), may be displayed.

[0072] The systems described herein may also include multiple sensed quantities, such as phase angle and resistance, or resistance and reactance, or impedance and phase angle, to improve accuracy of diagnosis and detection, or the more sensor feedback, the more accurately the path direction and stone type can be predicted. A multi-sensory feedback system as disclosed herein may be envisioned to indicate the correct tube identification, the stone type, or a combination of tube identification and stone type. The sensor check system may be included within the device and be part of a stand-alone unit or integrated into another piece of the main equipment used for such procedures, such as a surgical system or an endoscopy system. The sensor system may also be a separate reusable / disposable system or part of the main system.

[0073] Implementations disclosed herein may provide many advantages, including improved identification of common bile duct and / or gallstones and facilitating prevention of gallstone formation (e.g., through dietary, medicinal, lifestyle changes, etc.).

[0074] FIG. 6A is a perspective view of the biliary diagnostic device 132 incorporated into the auxiliary scope 134. The auxiliary scope 134 may include an elongated shaft 150, a guidewire 154, and the biliary diagnostic device 132. The elongated shaft 150 may include a lumen 158 through which the guidewire 154 can be inserted. The biliary diagnostic device 132 may include an electrode 144, a lead 162, a ground 164, and a lead 166. The biliary diagnostic device 132 may be connected to a processor 136, a memory 138, a power source 140, and an output device 142 as previously described. In the example of FIG. 6A, the electrode 144 may be configured to function as a positive electrode. The ground 164 may be configured to function as a negative electrode. The ground 164 may simply include a patient's tissue, with sensing occurring between the tissue and the electrode 144.

[0075] Leads 162 and 166 may include conductors that may extend from electrode 144 and ground 164 through elongate shaft 150 to control module 106. Leads 162 and 166 may include elongate metal wires that may be joined at a distal end to electrode 144 or any other electrode via a suitable method, such as welding or soldering. Proximal ends of leads 162 and 166 may be connected to processor 136.

[0076] The elongated shaft 150 may include an elongated body that is sufficiently rigid to support the leads 162, 166, and electrodes 144, but is also sufficiently flexible to provide guided insertion through the anatomy. In an example, the elongated shaft 150 may include a medical grade polymer. The elongated shaft 150 may include one or more structures and layers, such as reinforcing structures and coating layers. In an example, the elongated shaft 150 may include a reinforcing wire embedded therein. In yet another example, the elongated conductor may be provided by a helical winding disposed inside the elongated shaft 150, such as those used in endotracheal tubes that include an embedded helical winding for reinforcement.

[0077] Additionally, the elongate shaft 150 may include a coating to prevent or inhibit adhesion of biological material to the auxiliary scope 134. Such a coating may facilitate insertion of the auxiliary scope 134 through the anatomy, such as by reducing friction. Additionally, a coating applied over exposed conductive components may prevent biological material from adhering to the electrical components and interfering with electrical signals generated or interpreted by sensing components, such as the electrodes 144. In one example, the auxiliary scope 134 may be coated with polydimethylsiloxane. In examples, the auxiliary scope 134 may be coated with other coatings, including nanoparticles. Such coatings may be applied at thicknesses or made of compositions that do not inhibit or substantially do not inhibit sensing.

[0078] The metal wire conductors may be covered with an insulating coating that may be removed at locations to contact electrodes or perform sensing. The metal wire conductors may be embedded within the wall of the elongate shaft 150, and selected portions of the elongate shaft 150 may be removed to provide insulation and allow sensing by the metal wire conductors or coupling to the electrodes 144. In additional examples, the leads 162 and 166 may include traces printed along the side or inside the elongate shaft 150. For example, metal ribbons may be printed or otherwise formed on the surface of the elongate shaft 150. In yet additional examples, the metal traces may be co-extruded with the material of the elongate shaft 150. In any example, the elongate conductors may be selectively exposed during the manufacturing process at locations where it is desired to produce sensing, or the material of the elongate shaft 150 may be removed after the manufacturing process to selectively expose the elongate conductors in a separate step.

[0079] The processor 136 may be configured to execute instructions stored in the memory 138. The memory 138 may include instructions for processing signals from the positive and negative electrodes. For example, the instructions may include instructions for performing the methods illustrated in FIGS. 13-15. The memory 138 may further include storing therein threshold, baseline or benchmark levels for the conductivity, impedance, resistance and phase angle of the liver, pancreas and gallbladder, which may be compared to signals obtained from the electrodes 144 and ground 164. The memory 138 may include therein diagnostic information related to different types of stones that may form in the duodenum D and common bile duct 124. The memory 138 may further include storing therein identification information of the auxiliary scope 134 and the biliary diagnostic device 132. Alternatively, the biliary diagnostic device 132 may further include a separate chip, e.g., a radio frequency identification device (RFID), which may contain identification information for the auxiliary scope 134 and the biliary diagnostic device 132, e.g., make, model, calibration, etc.

[0080] The processor 136 may include, for example, a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof. The memory 138 may include one or more volatile, non-transitory, or non-volatile tangible computer-readable media. Examples of these tangible computer-readable media may include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memory (RAM), read-only memory (ROM), and the like. The power source 140 may include a generator for generating electrical current, such as in the form of a low-power DC output or a low-power RF output.

[0081] 6B, the electrode 144 can include an electrode ring 170 configured to completely surround the lumen 158. In an example, the ring 170 can surround the elongate shaft 150. In another example, the ring 170 can be fully or partially embedded within the elongate shaft 150. In an example, at least a portion of the ring 170 can be exposed to the exterior of the elongate shaft 150 and in contact with tissue or biological material.

[0082] As shown in FIG. 6C, the electrode 144 may include one or more ring segments 172A and 172B that only partially surround the lumen 159. The ring segments 172A and 172B may be disposed outside the elongate shaft 150 and may be partially embedded within the elongate shaft 150 or may be completely embedded within the elongate shaft 150. The ring segments 172A and 172B may include arc segments, e.g., segments of a circle. FIG. 6C illustrates the ring segments 172A and 172B as including segments that extend through approximately 90°. However, larger or smaller arc segments may be used. Additionally, only one ring segment or more than two ring segments may be used.

[0083] 6A , or multiple ring segments extending around a majority of the circumference of elongate shaft 150 may be advantageous to increase sensor input. Ring 170 and ring segments 172A and 172B may comprise a metallic material suitable for conducting current from power source 140 through leads 162 and 166.

[0084] The biliary diagnostic device of the present disclosure may additionally be configured to perform other procedures. In an example, the biliary diagnostic device may be configured to perform a medical intervention, such as cauterization. Sensing performed with the electrode 144, and other components configured to contact tissue as disclosed herein, may be performed by applying a voltage between the electrode, for example, the electrode 144 shown in FIG. 6A, and ground 164. The voltage may be applied by the power source 140. Typically, such voltage is fairly low, such that only a current sufficient to generate an electrical signal for sensing is applied. Thus, as described above, the lead 162 does not need to provide additional insulation beyond that which may be provided by the elongated shaft 150. Thus, the conductive components may simply be exposed to contact tissue and perform sensing. In an additional example, the voltage may be increased to provide a cauterization function, for example by desiccating the tissue, to heat the tissue sufficiently to stop bleeding.

[0085] Voltages sufficient for such cauterization functions may remain low enough to avoid excessive alteration of tissue beyond that required for cauterization without requiring additional insulation. However, additional insulation may be included in the example. Voltages sufficient for sensing and cauterization may depend on multiple factors, such as the resistance of the tissue being sensed. The resistance of the tissue being sensed depends on the surface area of ​​the electrodes and the distance the electrodes are separated. For example, about 10 watts of power may impact the tissue sufficiently to cauterize. The electrode configurations disclosed herein may have a resistance of about 250 ohms or less, although other resistances may occur or be used. Thus, the applied voltage may be on the order of 50 V or less, based on the formula P=V2 / R. In an example, sensing without cauterization may be performed at a voltage of about 50 volts or less, while cauterization may be performed at a voltage of about 50 volts or more. In addition, an upper limit on the applied voltage, such as 60 volts, may be set to prevent excessive tissue damage. Thus, in one example, sensing may be performed using a voltage in the range of 35 to 45 V, and ablation may be performed using a voltage in the range of 45 to 55 V. The above range values ​​are exemplary and other voltages and ranges, or combinations of ranges, may be suitable for different examples and configurations.

[0086] Figure 7 is a perspective view of a second example of the biliary diagnostic device 132 of Figure 5 with an electrode 144 including a single electrode ring 170 configured to function as a negative electrode. The biliary diagnostic device 132 of Figure 7 may be configured similarly to the biliary diagnostic device 132 of Figure 6A, except that the lead 166 is connected to a guidewire 154 instead of a ground 164. Additionally, the electrode 144 may be configured as a negative electrode with the guidewire 154 configured as a positive electrode.

[0087] FIG. 8 is a perspective view of a third example of the biliary diagnostic device 132 of FIG. 5 including an electrode 144 and a second electrode 180 including a pair of electrode rings configured to function as a positive electrode and a negative electrode. The biliary diagnostic device 132 of FIG. 8 may be configured similarly to the biliary diagnostic device 132 of FIG. 6A, except that the lead 166 is connected to the electrode 180 instead of the ground 164. Additionally, the electrode 144 may be configured as a positive electrode and the electrode 180 may be configured as a negative electrode. The leads 162 and 166 may include elongated metal wires that may be coupled at a distal end to the electrodes 144 and 180 and at a proximal end to the processor 136. The processor 136 may be configured to determine the conductivity, impedance, resistance, and phase angle between the electrodes 144 and 180 using input from the memory 138.

[0088] FIG. 9 is a perspective view of a fourth example of the biliary diagnostic device 132 of FIG. 5, including electrodes 190 and 192 in addition to electrodes 144 and 180, and including pairs of electrodes configurable for separate or combined biliary diagnostic sensing. As shown in FIG. 9, electrodes 144 and 190 can be connected to lead 162, and electrodes 180 and 192 can be connected to lead 166. The inclusion of two electrodes on each of leads 162 and 166 can increase the sensitivity of a single sensor functioning as biliary diagnostic device 132. Leads 162 and 166 can be connected to processor 136 as shown in FIGS. 6A, 7, and 8. In another example, electrodes 190 and 192 can be provided on separate leads such that biliary diagnostic device 132 includes two separate sensors. Thus, with four electrodes functioning as a single sensor, the output of each pair of electrodes, e.g., electrodes 144 and 180 and electrodes 190 and 192, is automatically averaged. However, when four electrodes are used as a dual sensor, the output of each sensor may be averaged or weighted as desired by the processor 136. For example, a leading pair of electrodes, e.g., electrodes 144 and 180, may be weighted more heavily than a trailing pair of electrodes, e.g., electrodes 190 and 192, to provide directionality to the output of the biliary diagnostic device 132.

[0089] The same sensor (e.g., the sensor formed by electrodes 144 and 180 and electrodes 190 and 192) may be used for multiple evaluation checks. Alternatively, individual sensors (e.g., the sensor formed by electrodes 144 and 180 and the sensor formed by electrodes 190 and 192) may be used for separate checks (e.g., one sensor may be used for resistance measurements and another sensor may be used for phase angle). In yet another example, multiple (e.g., all) electrodes may be used for resistance measurements and multiple separate sensors may be used for phase angle. Thus, any combination of one or more sensors may be used to sense conductivity, impedance, resistance, and phase angle.

[0090] FIG. 10 is a perspective view of a fifth example of the biliary diagnostic device 132 of FIG. 5, including a single electrode pad 198 configured to function as a positive electrode. The biliary diagnostic device 132 of FIG. 10 may be configured similarly to the biliary diagnostic device 132 of FIG. 6A or FIG. 7, except that the ring electrode 144 is replaced with a pad electrode 198. The pad electrode 198 may include a flat, thin body that extends around a portion of the elongated shaft 150. The surface area of ​​the pad electrode 198 may be configured to facilitate interaction with tissue to improve the sensitivity of the sensor. For example, the pad electrode 198 may be knurled or textured to facilitate engagement with biological material. In an additional example, the pad 198 may be configured as an elongated strip that extends along the length of the elongated shaft 150. Also, although only one pad 198 is illustrated, multiple pads 198 may be included in the elongated shaft 150.

[0091] 11 is a schematic diagram of an output device 142 suitable for use with the biliary diagnostic device 132 disclosed herein. The output device 142 may include a visual display 200 and an audio driver 202. The visual display 200 may include output displays 204A-204E and a dial 206. The visual display 200 may include an active display unit, such as a liquid crystal display, a plasma screen, an organic light emitting diode display, or the like. The visual display 200 may include a touch screen device. In an example, the processor 136 may include or be part of the control unit 16 of the imaging and control system 12 (FIG. 2). Thus, the visual display 200 may be programmed to provide various outputs and receive various user inputs.

[0092] Activation of at least one of the displays 204A-204E may provide an indication of the conductivity, impedance, resistance, and phase angle sensed between the electrodes of the sensor of the biliary diagnostic device 132. With reference to FIG. 5, for example, the displays 204A-204E may be responsive to electrical parameters sensed between the electrodes 144 and 180. As seen in FIG. 5, the endoscope 100 may be inserted into the duodenum D and the auxiliary scope 134 may be positioned for insertion into the common bile duct 124. Thus, the electrode 144 may contact tissue of the common bile duct 124, fluid within the common bile duct 124, and solids, such as stones, within the common bile duct 124.

[0093] In one example, each of the light emitters 204A-204E may be activated to indicate an increasing magnitude or level of the electrical parameter. For example, the light emitter 204E at the bottom of the output device 142 and the light emitter 204A at the top of the output device 142 may be activated in an opposing manner to indicate opposite ends of a spectrum of the electrical characteristic. For example, the light emitter 204E may be activated to indicate a first level of the electrical characteristic, such as a magnitude of the electrical characteristic just above zero, and the light emitter 204A may be activated to indicate a second level of the electrical characteristic, such as a magnitude of the electrical characteristic at a saturated, maximum, or threshold level. The light emitters 204B-204D may be activated to indicate various levels between the first and second levels, thereby providing a continuous spectrum or gradual change in light emission activation. The light emitters 204A-204E may update in real time to indicate the magnitude of the electrical parameter. Thus, the surgeon may manipulate the endoscope 100 or auxiliary scope 134 to receive an indication of the type of biological material being engaged by the electrode 144.

[0094] In another example, all of the lights 204A-204E may be activated or lit and may change color to indicate the magnitude of the electrical parameter.

[0095] In one example, the visual display 200 may include a dial 206. The dial 206 may include a scale to indicate different magnitudes of the electrical parameter, and a needle may move to indicate the magnitude being actively sensed. For example, a light color may be used to indicate low conductivity and a dark color may be used to indicate high conductivity.

[0096] In an example, lights 204A-204E and dial 206 may be provided with labels to translate the magnitude of the sensed electrical parameter into an anatomical description, e.g., high levels of conductivity translate into hepatic bile and low levels of conductivity translate into pancreatic juice.

[0097] In an example, an audible alarm may be used to provide feedback indicative of the magnitude of the sensed parameter. For example, a steady signal may be emitted and vary in pitch, volume, or tone based on the magnitude of the sensed electrical parameter. In another example, an intermittent signal may be emitted and vary in frequency based on the magnitude of the sensed electrical parameter.

[0098] FIG. 12A is a perspective view of a stent 220 incorporating a biliary diagnostic device 222 according to the present disclosure. The stent 220 may include a tubular body 224, an internal lumen 226, and barbs 228. The biliary diagnostic device 222 may include electrodes 220A, 220B, and 220C. Each of the electrodes 230A-C may include a sensor configured to sense an electrical parameter of a fluid or solid material within the tubular body 204. FIG. 12B is a cross-sectional view of the stent 220 of FIG. 12A taken at section 12B-12B showing the electrodes 230A-B of the biliary diagnostic device 222. FIG. 12A and FIG. 12B will be described simultaneously.

[0099] The stent 220 may be placed within the abdominal passageway to strengthen the duct or prevent blockage of the abdominal passageway. Barbs 228 may be used to anchor or attach the tubular body 224 to the abdominal passageway. The tubular body 224 may be sized for placement in different sized abdominal passageways, such as the duodenum D, common bile duct 124, and main pancreatic duct 126 (FIG. 5).

[0100] The electrodes 230A-C may be connected to the biliary diagnostic device 132, for example, at the processor 136 (FIG. 6A), via mechanical leads. The leads may then be connected to the stent 220 during treatment or examination of the patient at a medical facility. In another example, the stent 220 may be provided with a wireless communication device, for example, a radio frequency chip, that is implanted in the patient along with the stent 220 and may take readings from the electrodes 230A-C.

[0101] 13 is a block diagram illustrating a method 300 for performing chemical analysis using the biliary diagnostic device of the present disclosure. In step 302, the method 300 begins. For example, the endoscope 100 and auxiliary scope 134 may be inserted into the duodenum D (FIG. 5). The electrode 144 and any of the electrodes 180, 190, and 192 may be positioned to engage tissue of the duodenum D or any abdominal passages leading thereto, such as the common bile duct 124 and the main pancreatic duct 126. Additionally, the biliary diagnostic device 132 may be powered, such as via the power source 140 (FIG. 11) or the imaging and control system 12.

[0102] In step 304, a sensor of the biliary diagnostic device 132 may be activated. For example, electricity from the power source 140 may be directed to the electrodes 144, 180, 190, and 192. The processor 136 of the biliary diagnostic device 132 may be activated based on instructions from the memory 138 to read a magnitude of an electrical parameter (conductivity, impedance, phase angle, etc.) between the electrode 144 and tissue or another electrode. In the example of FIG. 13, impedance may be measured using a sensor that includes the electrode 144.

[0103] At step 306, the impedance may assess biological material in contact with the electrodes 144. The processor 136 may compare the sensed impedance to a threshold or baseline impedance X stored in the memory 138. The impedance X may indicate the presence of hepatic bile.

[0104] If the sensed impedance is greater than X, the method 300 may proceed to step 308. In step 308, the output device 142 may be actuated by the processor 136 to operate one or more of the visual display 200, audio driver 202, and dial 206 to indicate that the biliary diagnostic device 132 has sensed a level of impedance indicative of hepatic bile present in the passageway 129 (FIG. 5). The surgeon may then continue to advance the auxiliary scope 134 toward the gallbladder or liver.

[0105] If the sensed impedance is less than X, the method 300 may proceed to step 310. In step 310, the output device 142 may be actuated by the processor 136 to operate one or more of the visual display 200, audio driver 202, and dial 206 to indicate that the biliary diagnostic device 132 has sensed a level of impedance indicative of an absence or lower concentration of hepatic bile that may be present near the entrance (ampulla of Vater) 128 (FIG. 5). The surgeon may then manipulate the auxiliary scope 134 away from the entrance 128 and toward the passageway 129.

[0106] Thereafter, the method 300 may return to start 302 or to step 304 and continuous real-time impedance measurements may be performed.

[0107] 14 is a block diagram illustrating a method 320 for performing a chemical analysis using the biliary diagnostic device 132 of the present disclosure. The method 320 may include steps 302, 304, 306, and 310 as described with reference to the method 300 of FIG. 13. However, instead of step 308, the method 320 may include step 322, where if the sensed impedance is greater than X, the method 320 may compare the sensed impedance to a second threshold or baseline impedance Y stored in the memory 138. The second impedance Y may indicate the presence of a different type of stone that may be found in the common bile duct 124.

[0108] If the sensed impedance is greater than Y, the method 320 may proceed to step 324. In step 324, the output device 142 may be actuated by the processor 136 to operate one or more of the visual display 200, audio driver 202, and dial 206 to indicate that the biliary diagnostic device 132 has sensed a level of impedance indicative of a first type of stone in the passageway 129 (FIG. 5). Additionally, the surgeon may receive confirmation that the correct path of the auxiliary scope 134 has been detected, and the auxiliary endoscope may continue to advance toward the gallbladder or liver.

[0109] If the sensed impedance is less than Y, the method 320 may proceed to step 326. At step 326, the output device 142 may be actuated by the processor 136 to operate one or more of the visual display 200, audio driver 202, and dial 206 to indicate that the biliary diagnostic device 132 has sensed a level of impedance indicative of a second type of stone in the passageway 129 (FIG. 5). Additionally, the surgeon may receive information that an erroneous path of the auxiliary scope 134 was detected, and the auxiliary endoscope may be re-routed toward the gallbladder or liver.

[0110] The method 320 may then return to start 302 or step 304 and repeated impedance measurements may be performed. Thus, the output of the processor 136 may be repeatedly updated at short intervals to provide the operator with continuous or near real-time impedance measurements.

[0111] 15 is a block diagram illustrating a method 340 for performing a chemical analysis using the biliary diagnostic device 132 of the present disclosure. The method 340 may include steps 302, 304, 306, and 310 as described with reference to the method 300 of FIG. 13. However, instead of step 308, the method 320 may include step 342, in which the biliary diagnostic device 132 may sense a phase angle of biological material in contact with the electrodes 144. The sensed phase angle may be compared to a threshold or baseline phase angle Z stored in the memory 138. The phase angle Z may indicate the presence of different types of stones that may be found in the common bile duct 124.

[0112] If the sensed phase angle is greater than Z, the method 340 may proceed to step 344. In step 344, the output device 142 may be actuated by the processor 136 to operate one or more of the visual display 200, audio driver 202, and dial 206 to indicate that the biliary diagnostic device 132 has sensed a level of phase angle indicative of a first type of stone in the passageway 129 (FIG. 5). Additionally, the surgeon may receive confirmation that the correct path of the auxiliary scope 134 has been detected and may continue to advance the auxiliary endoscope toward the gallbladder or liver.

[0113] If the sensed phase angle is less than Z, the method 340 may proceed to step 346. At step 346, the output device 142 may be actuated by the processor 136 to operate one or more of the visual display 200, audio driver 202, and dial 206 to indicate that the biliary diagnostic device 132 has sensed a level of phase angle indicative of a second type of stone in the passageway 129 (FIG. 5). Additionally, the surgeon may receive information that an erroneous path of the auxiliary scope 134 was detected, and the auxiliary endoscope may be re-routed toward the gallbladder or liver.

[0114] Thereafter, the method 340 may return to start 302 or step 304 and continuous real-time impedance measurements may be taken.

[0115] Although methods 300, 320, and 340 have been described with respect to sensing impedance as a primary indicator and phase angle as a secondary indicator, methods 300, 320, and 340 may be operated to sense any combination of conductivity, impedance, resistance, and phase angle. Similarly, methods 300, 320, and 340 have been described with respect to a biliary diagnostic device and method for sensing bile in the liver, but other diagnostic processes may be performed, such as chemical analysis of the pancreas and gallbladder.

[0116] Various notes and examples Example 1 may include or use subject matter such as a biliary diagnostic device including a tubular body including an outer wall and an interior lumen, and a first biliary diagnostic sensor coupled to a medical device, the first biliary diagnostic sensor including a first electrode configured to analyze biological material in contact with the tubular body.

[0117] Example 2 may include, or optionally combine, the subject matter of Example 1, and optionally include a first electrode configured to determine an electrical property of the biological material.

[0118] Example 3 may include, or optionally combine, the subject matter of one or any combination of Examples 1 or 2, and may optionally include a first biliary diagnostic sensor further including a lead extending from the first electrode and a power source connected to the lead.

[0119] Example 4 may include, or optionally combine, the subject matter of one or any combination of Examples 1-3, and may optionally include an output device configured to provide at least one of an audio output and a visual output of the indication of the electrical property.

[0120] Example 5 may include, or optionally combine, the subject matter of one or any combination of Examples 1-4, and may optionally include electrical properties including at least one of conductivity, impedance, resistance, and phase angle.

[0121] Example 6 may include, or optionally combine, the subject matter of one or any combination of Examples 1-5, and may optionally include a memory having stored therein a database of electrical properties of liver bile.

[0122] Example 7 may include, or optionally combine, the subject matter of one or any combination of Examples 1-6, and may optionally include an identification chip coupled to the biliary diagnostic device that contains information related to the type of medical device to which the first biliary diagnostic sensor is coupled and calibration of the first biliary diagnostic sensor.

[0123] Example 8 can include, or optionally combine, the subject matter of one or any combination of Examples 1-7, and can optionally include a first electrode comprising a ring circumscribing the inner lumen.

[0124] Example 9 may include, or optionally combine, the subject matter of one or any combination of Examples 1-8, and may optionally include a first electrode including a partial ring attachable to the tubular body.

[0125] Example 10 may include, or optionally combine, the subject matter of one or any combination of Examples 1-9, and may optionally include a first electrode comprising a pad attached to the tubular body.

[0126] Example 11 may include, or optionally combine, the subject matter of one or any combination of Examples 1-10, and may optionally include a first biliary diagnostic sensor further including a second electrode spaced apart from the first electrode.

[0127] Example 12 can include, or optionally combine, the subject matter of one or any combination of Examples 1-11, and can optionally include a second electrode that includes a guidewire extending through the internal lumen.

[0128] Example 13 may include, or optionally combine, the subject matter of one or any combination of Examples 1-12, and may optionally include a biliary diagnostic device further including a second biliary diagnostic sensor.

[0129] Example 14 may include, or optionally combine, the subject matter of one or any combination of Examples 1-13, and may optionally include a second biliary diagnostic sensor including a pair of electrodes electrically coupled to and spaced apart from the first biliary diagnostic sensor along the tubular body.

[0130] Example 15 may include, or optionally combine, the subject matter of one or any combination of Examples 1-14, and may optionally include a first biliary diagnostic sensor including a plurality of electrodes.

[0131] Example 16 may include, or optionally in combination with, the subject matter of one or any combination of Examples 1-15, and may optionally include a tubular body including a stent.

[0132] Example 17 may include, or optionally combine, the subject matter of one or any combination of Examples 1-16, and may optionally include a tubular body including an endoscope.

[0133] Example 18 may include, or optionally combine, the subject matter of one or any combination of Examples 1 to 17, and may optionally include an endoscope including an elevator.

[0134] Example 19 may include, or optionally in combination with, the subject matter of one or any combination of Examples 1-18, and may optionally include an endoscope, including a cholangioscope.

[0135] Example 20 may include, or optionally combine, the subject matter of one or any combination of Examples 1 to 19, and may optionally include an endoscope including at least one of an imaging unit, an illumination unit, and a therapeutic or diagnostic device.

[0136] Example 21 may include or use subject matter such as a method of guiding an endoscope from the duodenum to the common bile duct, the method including inserting an endoscope into the duodenum, engaging a sensor of the endoscope with biological material in the duodenum, electrically analyzing the biological material using the sensor to identify an electrical parameter, identifying hepatic bile in the biological material from the electrical parameter, and guiding the endoscope through the duodenum based on the presence of hepatic bile.

[0137] Example 22 may include or optionally combine the subject matter of Example 21 and may optionally include engaging a sensor of the endoscope with the biological material by engaging an electrode of the sensor with the biological material.

[0138] Example 23 can include, or optionally combine, the subject matter of one or any combination of Examples 21 or 22, and optionally include electrical parameters including at least one of conductivity, impedance, resistance, and phase angle.

[0139] Example 24 can include, or optionally combine, the subject matter of one or any combination of Examples 21-23, and can optionally include identifying hepatic bile in the biological material by comparing a baseline electrical parameter to a sensed electrical parameter.

[0140] Example 25 may include, or optionally combine, the subject matter of one or any combination of Examples 21-24, and may optionally include guiding the endoscope through the duodenum by directing a distal end of the endoscope toward a more concentrated hepatic bile based on the presence of hepatic bile.

[0141] Example 26 may include, or optionally combine, the subject matter of one or any combination of Examples 21-25, and may optionally include directing a distal end of the endoscope toward the bile of the liver by identifying the sphincter of Oddi in the duodenum.

[0142] Example 27 can include, or optionally combine, the subject matter of one or any combination of Examples 21-26, and can optionally include calibrating the sensor by electrically analyzing the duodenum with the sensor and identifying electrical parameters from the sphincter of Oddi.

[0143] Example 28 may include, or optionally combine, the subject matter of one or any combination of Examples 21-27, and may optionally include directing the distal tip of the endoscope toward the bile of the liver by identifying the intersection of the main pancreatic duct and the common bile duct.

[0144] Example 29 may include, or optionally combine, the subject matter of one or any combination of Examples 21-28, and may optionally include outputting an indication of the electrical parameter to an operator of the endoscope.

[0145] Example 30 may include, or optionally combine, the subject matter of one or any combination of Examples 21-29, and may optionally include analyzing stones formed in the common bile duct based on electrical parameters.

[0146] Example 31 may include, or optionally include in combination, the subject matter of one or any combination of Examples 21-30, and may optionally include cauterizing tissue with a biliary diagnostic device.

[0147] Example 32 may include or use subject matter such as a method for identifying a composition of biological material in a bile duct, the method including engaging a sensor of a medical device with biological material in the bile duct, electrically analyzing the biological material using the sensor to identify an electrical parameter, identifying the biological material from at least one of the liver, pancreas, and gallbladder from the electrical parameter, and outputting an indication of the biological material to a user of the medical device.

[0148] Example 33 may include, or optionally combine, the subject matter of Example 32, and may optionally include engaging a sensor of the medical device with the biological material by engaging an electrode of the sensor with the biological material.

[0149] Example 34 can include, or optionally combine, the subject matter of one or any combination of Examples 32 or 33, and optionally include electrical parameters including at least one of conductivity, impedance, resistance, and phase angle.

[0150] Example 35 can include, or optionally combine, the subject matter of one or any combination of Examples 32-34, and can optionally include identifying biological material by comparing baseline electrical parameters to sensed electrical parameters.

[0151] Example 36 can include, or optionally combine, the subject matter of one or any combination of Examples 32-35, and can optionally include identifying the biological material by determining the concentration of the fluid containing the biological material.

[0152] Example 37 may include, or optionally combine, the subject matter of one or any combination of Examples 32-36, and may optionally include a bile-containing fluid from the liver.

[0153] Example 38 may include, or optionally combine, the subject matter of one or any combination of Examples 32-37, and may optionally include diagnosing a condition leading to stone formation.

[0154] Example 39 can include, or optionally combine, the subject matter of one or any combination of Examples 32-38, and can optionally include identifying biological material by determining stone structure containing biological material.

[0155] Example 40 may include, or optionally combine, the subject matter of one or any combination of Examples 32-39, and may optionally include a stone structure including at least one of a gallstone and a kidney stone.

[0156] Example 41 may include, or optionally combine, the subject matter of one or any combination of Examples 32-40, and may optionally include outputting an indication of the biological material to a user of the medical device by outputting a visual or audio indication of the magnitude of the electrical parameter.

[0157] Each of these non-limiting examples can stand by itself or can be combined with one or more of the other examples in various permutations or combinations.

[0158] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of example, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as "examples." Such examples may include elements in addition to those shown or described. However, the inventor also contemplates examples in which only those elements shown or described are provided. Furthermore, the inventor also contemplates examples in which any combination or permutation of those elements (or one or more aspects thereof) shown or described is used either in conjunction with a particular example (or one or more aspects thereof) or with another example (or one or more aspects thereof) shown or described herein.

[0159] In the event of inconsistent usage between this document and a document incorporated by reference, the usage of this document shall control.

[0160] In this document, the terms "a" or "an" are used to include one or more, as is common in patent documents, regardless of any other examples or the use of "at least one" or "one or more." In this document, the term "or" is used to refer to an inclusive or, unless otherwise indicated, "A or B" includes "A but not B," "B but not A," and "A and B." In this document, the terms "including" and "in which" are used as the plain English equivalents of the respective terms "comprising" and "wherein." Also, in the claims that follow, the terms "including" and "comprising" are open-ended, i.e., a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such terms in the claim are still considered to be within the scope of the claim. Moreover, in the claims that follow, the terms "first," "second," and "third," etc. are used merely as labels and are not intended to impose numerical requirements on their objects.

[0161] Examples of the methods described herein may be at least partially machine or computer implemented. Some examples may include computer readable or machine readable media encoded with instructions operable to configure an electronic device to perform the methods described in the above examples. An implementation of such a method may include code, such as microcode, assembly language code, high level language code, etc. Such code may include computer readable instructions for performing various methods. The code may form part of a computer program product. Further, in one example, the code may be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer readable media, such as during execution or at other times. Examples of these tangible computer readable media may include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memory (RAM), read only memory (ROM), etc.

[0162] The above description is intended to be illustrative, not restrictive. For example, the foregoing examples (or one or more aspects thereof) may be used in combination with each other. Alternative embodiments may be used, such as upon review of the above description by one of ordinary skill in the art. The Summary is provided to enable the reader to quickly ascertain the nature of the technical disclosure. The Summary is presented with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be construed as intending that any unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as an example or embodiment, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations and permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

1. A tubular body extending from a proximal end to a distal end, an outer wall extending between the proximal end and the distal end; and a tubular body including an internal lumen extending at least partially through the tubular body between the proximal end and the distal end and forming a working channel opening to an exterior of the tubular body at the proximal end; a first biliary diagnostic sensor including a first electrode coupled to an outer surface at the distal end of the outer wall of the tubular body, the first electrode being configured to analyze biological material in contact with the outer surface at the distal end; an output device configured to provide at least one of an audio output and a visual output of an indication of the presence of hepatic bile of the first biliary diagnostic sensor to provide navigational guidance past the entrance of the patient's main pancreatic duct and into the passage of the common bile duct; A biliary tract diagnostic device comprising:

2. The biliary diagnostic device of claim 1 , wherein the first electrode is configured to determine an electrical property of the biological material.

3. The first biliary tract diagnostic sensor includes: a lead wire extending from the first electrode; a power source connected to the lead; The biliary diagnostic device of claim 2 , further comprising:

4. The biliary diagnostic device according to any one of claims 2 to 3, wherein the electrical property includes at least one of conductivity, impedance, resistance and phase angle.

5. The biliary diagnostic device according to any one of claims 2 to 4, further comprising a memory storing a database of electrical properties of liver bile.

6. The biliary diagnostic device of any one of claims 2 to 5, further comprising an identification chip coupled to the biliary diagnostic device that contains information related to the type of medical device to which the first biliary diagnostic sensor is coupled and the calibration of the first biliary diagnostic sensor.

7. The biliary diagnostic device of any one of claims 2 to 6, wherein the first electrode comprises a ring circumscribing the internal lumen.

8. The biliary diagnostic device of any one of claims 2 to 6, wherein the first electrode comprises a partial ring attachable to the tubular body.

9. The biliary diagnostic device of any one of claims 2 to 6, wherein the first electrode comprises a pad attached to the tubular body.

10. The biliary diagnostic device of any one of claims 2 to 9, wherein the first biliary diagnostic sensor further comprises a second electrode spaced apart from the first electrode.

11. The biliary diagnostic device of claim 10 , wherein the second electrode extends through the inner lumen and includes a guidewire protruding from the tubular body.

12. The biliary diagnostic device of any one of claims 2 to 11, further comprising a second biliary diagnostic sensor.

13. 13. The biliary diagnostic device of claim 12, wherein the second biliary diagnostic sensor includes a pair of spaced apart electrodes electrically coupled to the first biliary diagnostic sensor along the tubular body.

14. The biliary diagnostic device of any one of claims 2 to 13, wherein the first biliary diagnostic sensor includes a plurality of electrodes.

15. The biliary tract diagnostic device according to any one of claims 1 to 14, wherein the tubular body is a stent.

16. The biliary diagnostic device of any one of claims 1 to 14, wherein the tubular body comprises an endoscope configured to receive an auxiliary device through the working channel.

17. The biliary diagnostic device of claim 16 , wherein the endoscope includes an elevator configured to receive an instrument through the working channel.

18. The biliary diagnostic device of claim 16 or 17, wherein the endoscope comprises a cholangioscope.

19. The biliary diagnostic device according to any one of claims 16 to 18, wherein the endoscope comprises at least one of an imaging unit, an illumination unit, and a therapeutic or diagnostic device.

20. Further, a memory storing a first parameter related to an electrical characteristic of the bile of the liver, The tubular body is insertable into a duodenoscope, the first biliary diagnostic sensor identifies the electrical characteristic of the biological material and determines the presence of bile in the liver using the first parameter; The biliary diagnostic device of claim 1 .

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