Medical device equipped with biliary tract diagnostic device

Abstract

To provide a composition-guided navigation by performing biological or chemical analysis of an anatomical matter.SOLUTION: A biliary diagnostic device 132 comprises a biliary diagnostic sensor 144 for analyzing biological matter in contact with a tubular body including an internal lumen 158. A method of guiding an endoscope to a bile duct comprises inserting the endoscope into a duodenum, engaging a sensor with biological matter, electrically analyzing biological matter with the sensor to identify an electrical parameter, identifying liver bile in the biological matter from the electrical parameter, and guiding the endoscope through the duodenum based on the bile. A method of identifying biological matter comprises engaging a medical device sensor with biological matter in a bile duct, electrically analyzing biological matter with the sensor to identify an electrical parameter, identifying biological matter from a liver, pancreas or gall bladder from the electrical parameter, and outputting indicia of the biological matter to a user of the medical device.SELECTED DRAWING: Figure 6A

Description

Technical Field

[0001] Cross - Reference to Related Applications This patent application claims the priority of U.S. Provisional Patent Application No. 63 / 037,098, filed on June 10, 2020, entitled "Medical Devices with Biliary Diagnostic Devices", and further claims the priority of U.S. Provisional Patent Application No. 62 / 966,710, filed on January 28, 2020, entitled "Endoscope with a Biliary Diagnostic Device", and all of their contents are incorporated herein by reference.

[0002] The present disclosure generally relates to medical devices including an elongate body configured to be inserted into an incision or opening in a patient's anatomical structure to provide diagnostic or therapeutic operations.

[0003] In particular, the present disclosure relates to endoscopes for imaging various anatomical parts and / or providing passage for a treatment device to an anatomical part, where the anatomical parts include the gastrointestinal tract (e.g., esophagus, stomach, duodenum, pancreaticobiliary duct, intestine, colon, etc.), the renal region (e.g., kidney(s), ureter, bladder, urethra), and other organs (e.g., genital system, nasal sinuses, submucosal region, respiratory tract), etc. This application further relates to stents and other medical devices that can be used in the treatment and treatment of the gastrointestinal tract.

Background Art

[0004] Conventional endoscopes can be involved in various clinical procedures, 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 passage for one or more treatment devices (e.g., via a working channel) for sampling or treating an anatomical region, and providing a suction channel for collecting fluids (e.g., saline or other preparations).

[0005] In conventional endoscopy, the distal portion of the endoscope may be configured to support and direct the treatment 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, which is inserted into it, with the help of an elevator. Such systems can be useful in guiding small-diameter endoscopes to anatomical locations within the body that are difficult to reach. For example, some anatomical locations can only be accessed by an endoscope inserted through a detour route. Furthermore, the tissue at some anatomical locations may be sensitive. Therefore, it may be undesirable to guide the endoscope to an unintended anatomical location. [Overview of the Initiative] [Problems that the invention aims to solve]

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

[0007] The inventors also recognize that problems to be solved in conventional medical procedures, particularly duodenoscopy, include, among other things, the potential need to utilize fluoroscopy to facilitate navigation of complex anatomical structures. In some cases, it is desirable to avoid the use of fluoroscopy to minimize radiation exposure for both the surgeon and the patient. This disclosure may assist in providing solutions to these and other problems by providing systems, devices, and methods that utilize non-fluoroscopic navigation assistance in the form of biliary diagnostic devices, which can be used to perform biological or chemical analysis of anatomical materials and provide composition-guided navigation.

[0008] The inventors further recognize that a problem to be addressed in conventional treatments for the formation of gastrointestinal stones, such as gallstones, is that it can be difficult to diagnose the underlying biological conditions in a patient that may lead to stone formation. For example, in many cases, the formation of the stone itself provides the first sign of the condition. Furthermore, procedures to remove stones may result in stone fragmentation. Therefore, it can be difficult to diagnose the specific conditions in a patient that lead to stone formation. This disclosure may help to provide solutions to these and other problems by providing a system, device, and method that uses a biliary diagnostic device to analyze the composition of gastrointestinal stones, thereby helping to identify the underlying biological conditions that lead to stone formation, and thereby providing a basis for treatment plans such as changes in diet or medications, thereby reducing the risk of future recurrence of the problem. [Means for solving the problem]

[0009] In one example, a biliary tract diagnostic device may include a tubular body comprising an outer wall and an internal lumen, and a first biliary tract diagnostic sensor coupled to a medical device configured to analyze biomaterials in contact with the tubular body.

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

[0011] In further examples, a method for identifying the composition of biomolecules within a bile duct may include engaging a sensor of a medical device with the biomolecules within the bile duct, electrically analyzing the biomolecules using the sensor to identify electrical parameters, identifying biomolecules from at least one of the liver, pancreas, and gallbladder within the biomolecules based on the electrical parameters, and outputting an index of the biomolecules to the user of the medical device. [Brief explanation of the drawing]

[0012] [Figure 1] This is a schematic diagram of an endoscopic examination system, including an imaging and control system and an endoscope such as a duodenoscope. [Figure 2] Figure 1 is a schematic diagram of the endoscopic examination system, including an endoscope connected to a control unit of the imaging and control system. [Figure 3A] Figure 2 is a schematic top view of the distal portion of the endoscope, including a camera module with optical components and an elevator mechanism for side-view endoscopy. [Figure 3B] This is an enlarged cross-sectional view taken along the plane 3B-3B in Figure 3A, which shows the optical components. [Figure 3C] This is an enlarged cross-sectional view taken along the line 3C-3C in the plane of Figure 3A, which shows the elevator mechanism. [Figure 4] Figures 1-3C show schematic diagrams of a modular endoscope suitable for use as an endoscope, which includes a camera module configured to be detachable from one another, an insertion section module, and a navigation and control module. [Figure 5]This is a schematic diagram of the distal portion of an endoscope, including the biliary tract diagnostic device according to this disclosure, positioned in the duodenum. [Figure 6A] A perspective view of a first example of a biliary tract diagnostic device of the present disclosure, which includes a single electrode ring configured to function as a positive electrode. [Figure 6B] This is a schematic cross-sectional view taken along the plane 6B-6B in Figure 6A, showing a first example of electrode shape. [Figure 6C] This is a schematic cross-sectional view taken along the plane 6B-6B in Figure 6A, showing a second example of electrode shape. [Figure 7] A perspective view of a second example of a biliary tract diagnostic device of the present disclosure, which includes a single electrode ring configured to function as a negative electrode and a guidewire configured to function as a positive electrode. [Figure 8] A perspective view of a third example of a biliary tract diagnostic device of the present disclosure, which includes a pair of electrode rings configured to function as a positive and negative electrode. [Figure 9] A perspective view of a fourth example of a biliary diagnostic device of the present disclosure, which includes a plurality of electrode rings that can be configured as separate or combined biliary diagnostic sensors. [Figure 10] A perspective view of a fifth example of a biliary tract diagnostic device of the present disclosure, which includes a single electrode pad configured to function as either a positive or negative electrode. [Figure 11] This is a schematic diagram of an output device suitable for use with the biliary tract diagnostic devices disclosed herein. [Figure 12A] This is a perspective view of a stent incorporating a biliary tract diagnostic device as disclosed herein. [Figure 12B] This is a cross-sectional view of the stent shown in Figure 12A, taken from planar 12B-12B, indicating the electrodes of the biliary tract diagnostic device. [Figure 13] Block diagram showing a first method for performing chemical analysis using the biliary diagnostic device of the present disclosure, including single-step impedance analysis for pathway sensing. [Figure 14]FIG. 0 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 path and calculus sensing. [Figure 15] FIG. 3 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 path and calculus sensing.

BEST MODE FOR CARRYING OUT THE INVENTION

[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 exemplary example of an endoscopy system suitable for use with the systems, devices, and methods described herein, such as a biliary diagnostic device that can be used for navigation assistance and analysis of chemical composition. According to some examples, the endoscope 14 can be inserted into an anatomical region, image a pathological condition associated with the anatomical region, and / or provide passage for one or more sampling devices for biopsy or one or more treatment devices for treatment. The endoscope 14 can interface and connect with the imaging and control system 12 in an advantageous manner. In the illustrated example, the endoscope 14 includes a duodenoscope, but other types of endoscopes can be used with the features and teachings of the present disclosure.

[0014] The imaging and control system 12 can 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 data input / output ports for receiving data from the endoscope 14 and communicating data to the endoscope 14. The light source 22 may include output ports for transmitting light to the endoscope 14, for example, via an optical fiber link. The fluid source 24 may include ports for transferring fluid to the endoscope 14. The fluid source 24 may include a pump and a fluid tank, or may be connected to an external tank, container, or storage unit. The suction pump 26 includes ports used to draw vacuum from the endoscope 14, generating suction to remove fluid, for example, from the anatomical region into which the endoscope 14 is inserted. Output units 18 and input units 20 are used by the operator of the endoscopy system 10 to control the 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 outputs from treating the anatomical region into which the endoscope 14 is inserted. In this example, the controller 16 can generate electrical, acoustic, or fluid outputs to treat anatomical areas using methods such as cauterization, cutting, or freezing.

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

[0017] The insertion section 28 may extend distally from the handle section 32, and the cable section 34 may extend proximal to the handle section 32. The insertion section 28 may be elongated and may include a bendable section and a distal end to which the functional section 30 may be attached. The bendable section may be controllable (e.g., by a control knob 38 on the handle section 32) to operate through a meandering anatomical passage (e.g., stomach, duodenum, kidney, ureter, etc.). The insertion section 28 may also include one or more working channels (e.g., internal lumen) which may be elongated and may support the insertion of one or more therapeutic tools of the functional section 30. The working channels may extend between the handle section 32 and the functional section 30. Additional functions, such as fluid passages, guidewires, and pullwires, may also be provided by the insertion section 28 (e.g., via aspiration or irrigation passages, etc.).

[0018] The handle section 32 may include a knob 38 and a port 40. The knob 38 may be coupled to a pull wire extending through the insertion section 28. The port 40 may be configured to connect to the handle section 32 for various electrical cables, fluid tubes, etc., to the insertion section 28.

[0019] The imaging and control system 12 may, for example, be mounted on a mobile platform (e.g., a cart 41) equipped with shelves for housing a light source 22, a suction pump 26, an image processing unit 42, and the like. Alternatively, some components of the imaging and control system 12 shown in Figures 1 and 2 may be mounted directly on the endoscope 14 to make the endoscope "self-contained".

[0020] Functional section 30 may include components for treating and diagnosing the anatomical structures of a patient. Functional section 30 may include imaging devices, illumination devices, and elevators, as further described with reference to Figures 3A to 3C. Functional section 30 may further include biliary diagnostic devices such as those described herein. For example, functional section 30 may include one or more electrodes conductively connected to the handle section 32 and functionally connected to the imaging and control system 12, allowing for the analysis of biological material in contact with the electrodes based on comparative biological data stored in the imaging and control system 12.

[0021] Figure 2 is a schematic diagram of the endoscopic examination system 10 of Figure 1, including an imaging and control system 12 and an endoscope 14. Figure 2 schematically shows the components of the imaging and control system 12 coupled to the endoscope 14, the endoscope 14 including a duodenoscope in the illustrated example. 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 will be discussed in more detail below, the controller 16 may include or be able to communicate with a biliary diagnostic device 132, the biliary diagnostic device 132 may include electrodes located in the functional section 30 or the insertion section 28.

[0022] The image processing unit 42 and the light source 22 may interface with the endoscope 14 (e.g., at the function unit 30) by wired or wireless electrical connections. Thus, the imaging and control system 12 may illuminate anatomical regions, collect signals representing anatomical regions, process signals representing anatomical regions, and display images representing anatomical regions on the display unit 18. The imaging and control system 12 includes the light source 22 and may illuminate anatomical regions using light of a desired spectrum (e.g., broadband white light, narrowband imaging using preferred electromagnetic wavelengths, etc.). The imaging and control system 12 may be connected 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 tract diagnostic device).

[0023] The fluid source 24 may include one or more sources of air, saline solution, or other fluids, and associated fluid pathways (e.g., air channels, irrigation channels, suction channels) and connectors (e.g., reverse spine fittings, fluid seals, valves). The imaging and control system 12 may also include a drive unit 46, which may be an optional component. The drive unit 46 may include an electric drive for advancing the distal section of the endoscope 14, which is described at least in PCT Publication WO2011 / 140118A1, by Frassica et al., entitled “Rotate-to-Advance Catheterization System,” the entirety of which is incorporated herein by reference.

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

[0025] In the examples of Figures 3A and 3B, the side-view endoscope 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-seal 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 that can bend an elongated device extending through the insertion section 28 along axis A1, which will be discussed in more detail with reference to Figure 3C. The elevator 54 may be used to bend an elongated device at an angle with respect to axis A1, thereby treating an anatomical region adjacent to the side-view endoscope camera module 50. The elevator 54 may be positioned, for example, radially outward of axis A1, along the illumination lens 58 and the objective lens 60.

[0026] As shown in Figure 3B, the insertion section 28 may include a central lumen 62 through which various components (e.g., electrode leads 162 and 166 of the biliary diagnostic device 132 (Figure 5)) can extend to connect the functional section 30 to the handle section 32 (Figure 2). For example, the illumination lens 58 may be connected to an optical transmitter 64, which may include an optical fiber cable or cable bundle extending to a light source 22 (Figure 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. The fluid outlet 56 may also be coupled to a fluid line 69, which may include a tube extending to a fluid source 24 (Figure 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 a suction pump 26 (Figure 1) and a treatment generator 44 (Figure 2).

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

[0028] The housing 52 may include a housing space 53 for accommodating the deflector 55. The instrument 63 may include forceps, catheters, etc., extending through the lumen 62. The proximal end of the deflector 55 may be attached to the housing 62 by a pin 61 provided on a rigid tip 21. The distal end of the deflector 55 may be positioned below the window 65 in the housing 62 when the deflector 55 is in a lowered or deactivated state. The distal end of the deflector 55 may extend at least partially from the window 65 when the deflector 55 is lifted by the wire 57 or activated. The instrument 63 may slide on the angled inclined surface 51 of the deflector 55, initially deflecting the distal end of the instrument 63 toward the window 65. The angled inclined surface 51 may facilitate the expansion of the distal portion of the instrument 63 extending from the window 65 at a first angle with respect to the axis of the lumen 62. The angled inclined surface 51 includes a groove 69, for example, a V-shaped notch, which can receive and guide the instrument 63. The deflector 55 can be actuated to bend the instrument 63 at a second angle with respect to the axis of the lumen 62, the second angle being closer to perpendicular than the first angle. When the wire 57 is released, the deflector 55 can be returned to the lowered position by either pushing or releasing the wire 57, for example, by rotating it counterclockwise. In this example, the instrument 63 may include a cholangioscopy or an auxiliary scope 134 (Figure 5).

[0029] The side-view endoscope camera module 50 shown in Figures 3A to 3C may include optical components (e.g., objective lens 60, prism 66, imaging unit 67, wiring 68) for acquiring image signals, and illumination components (e.g., illumination lens 58, optical transmitter 64) for transmitting or generating light. The endoscope camera module 50 may also include a photosensitive element, such as a charge-coupled device ("CCD" sensor) or a complementary metal-oxide-semiconductor ("CMOS") sensor. In any example, the imaging unit 67 may be coupled (e.g., via a wired or wireless connection) to an image processing unit 42 (Figure 2) to transmit a signal from the photosensitive element representing the image (e.g., a video signal) to the image processing unit 42, which will then display it on a display such as an output unit 18. In various examples, the imaging and control system 12 and the image processing unit 67 may be configured to provide output at a desired resolution suitable for endoscopic procedures (e.g., at least 480p, at least 720p, at least 1080p, at least 4K UHD, etc.).

[0030] To facilitate customization, assembly, disassembly, cleaning, and sterilization, the endoscope 14 may be configured using modular components, as described with reference to Figure 4.

[0031] Figure 4 is a schematic diagram of a modular endoscope 100 suitable for use as endoscope 14 and in conjunction with the endoscope camera module 50 shown in Figures 3A-3C. The modular endoscope 100 may include a modular, removable function module 102, an insertion section module 104, and a navigation and control module 106. Modules 102, 104, and 106 may include components with customizable functions and components. Thus, the modular endoscope 100 can be custom-built to perform specific procedures for specific patients. Individual modular components may be configured as reusable or disposable components. Thus, inexpensive or difficult-to-clean components can be discarded, while expensive or easy-to-clean components can be reused after proper cleaning and sterilization.

[0032] Functional module 102 may include functional section 30, camera module 50, or other types of modules. Functional module 30 may include imaging devices, therapeutic devices, auxiliary therapeutic devices, and biliary diagnostic devices, or one or both of the other devices described herein.

[0033] In the example, the functional module 102 may include a camera module for an endoscope as described in U.S. Provisional Patent Application No. 63 / 024,674, filed on 14 May 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 shown in Figures 1 and 2.

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

[0036] The insertion section module 104 may include a tubular element, a sheath, or a shaft, on which the functional module 102 may be attached for insertion into the patient's anatomical structure.

[0037] In the example, insert section module 104 may include insert section 28, which may be configured to include one or more sheath and shaft components of U.S. Provisional Patent Application No. 63 / 017,901, filed on 30 April 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 in Figure 4, and as a result, they may be assembled by the operator to constitute a device for initial use on a patient and then disassembled by the operator after use on a patient. In another example, the modular components may be assembled and disassembled by the manufacturer or decommissioning service, without operator intervention. In one example, Figure 4 shows the endoscope 14 of Figure 2, where its components are shown in a separated state. Figure 4 shows the endoscope 14 constructed from three modular components (function module 102 [function section 30], navigation and control module 106 [handle section 32], and insertion section module 104 [insertion section 28]), but additional or fewer components may be intended, depending on the surgical procedure performed with the configuration of the endoscope 14 constructed or designed by the operator. The function module 102, the navigation and control module 106, and the insertion section module 104 may each be detachable from one another. Furthermore, each of modules 102, 104, and 106 may be discarded after a single clinical use. Alternatively, each of modules 102, 104, and 106 may be constructed using materials that allow for multiple clinical uses. In such cases, modules 102, 104, and 106 may be constructed to withstand sterilization after each clinical use.

[0039] In certain advantageous embodiments, the modular structure of the endoscope 14 in Figure 2 and the modular endoscope 100 in Figure 4, as discussed herein, allow for the mixing and matching of disposable and reusable modules, resulting in the reuse of some modules, such as expensive and / or easily cleanable modules, and the disposable nature of some modules, such as simple and / or difficult-to-clean modules. For example, certain modules may be removed from the endoscope after clinical use for sterilization, reprocessing, and reuse for subsequent clinical use, while the remaining modules may be discarded. For example, there are concerns regarding the improper reprocessing of parts of a duodenoscope (e.g., the elevator section). As a result, disposable endoscopes that can be discarded after a single clinical use have been developed (to prevent infection during use). However, currently available disposable endoscopes are those in which the entire endoscope is discarded, constructed using lower-cost materials to result in lower-priced endoscopes while maintaining competitiveness per clinical use. In many clinical cases, lower-cost materials may lead to inadequate clinical performance (e.g., poor image quality, improper handling, damage to the insertion section module during insertion, inadequate ergonomic performance of the endoscope handle, etc.). Therefore, due to inferior components, general practitioners may avoid using such devices.

[0040] Therefore, the modular endoscopes 14 and 100 in 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 collect specific modules of the endoscope 14 for reuse and simultaneously dispose of the infection-prone areas after a single clinical use. Furthermore, the endoscope parts intended for reuse may be constructed to reduce the accumulation of biomaterial (e.g., by being fully encapsulated), and additionally, they may be fluidly isolated from the infection-prone areas. Such configurations encourage the use of a combination of high-quality (high-cost) reusable components that can be used over multiple clinical uses and low-cost disposable parts, while simultaneously reducing the risk of infection and achieving desirable clinical performance. Disposable components may not only be constructed to include functions necessary only for specially specified procedures, but the materials and construction may also be constructed to withstand only a single use, both of which help reduce the cost of disposable components. For example, the insertion sheath may be constructed to withstand the stress of only one operation and does not need to be built robustly to withstand the repeated stress of multiple procedures.

[0041] In the example, the endoscope 100 in Figure 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 connectors, and each of the camera module and the navigation and control module may be kept attached to the insertion section module while in use on a patient. After each use, the camera module and the navigation and control module may be separated (e.g., using connectors or attachment mechanisms) and reprocessed for later use with a new insertion section module. Conversely, a used insertion module may be discarded after a single use.

[0042] Furthermore, the connectors between the camera module and the navigation and control modules, as well as the camera module and the navigation and control modules themselves, may be made of materials designed to reduce the intrusion of biological material and may be constructed to be fluid-sealed as needed.

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

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

[0045] The endoscope 100 may include an insertion section module 104 and a function module 102. The function module 102 may include an elevator section 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, memory 138, and a power supply 140. As discussed below, the biliary diagnostic device 132 may be integrated into the endoscope 100, for example, on the function module 102, the insertion section module 104, or into the auxiliary scope 134, for example, via an electrode 144.

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

[0047] In some examples, the endoscope 100 may be suitable for cholecystectomy (e.g., removal of gallstones that may accumulate as stones within 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 on 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 within 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 may follow a relationship (Dcrystals < Dparticles < Dgravel < Dstone), where "D" represents size (characteristic dimension, e.g., length, surface area, one or more cross-sectional areas, etc.).

[0049] In some aspects, larger, gravel- or stone-sized growths can move within the gallbladder. If they are too large to pass through a single bile duct, the growths can pass in front of it, creating intermittent obstruction. This obstruction can prevent the gallbladder from emptying, leading to inflammation and irritation of the gallbladder. In some cases, this can even lead to infection of the gallbladder, which may result in the gallbladder filling with pus.

[0050] In some cases, even if a stone or gravel moves away from the bile duct and the pressure is released, the gallbladder may be affected by the experience, resulting in severe localized scarring, which can then increase the severity of the stone's passage through the duct. Some such events can lead to cholelithiasis (also known as "gallbladder disease"). Stones can sometimes become trapped in the bile duct itself. Depending on the location of this obstruction, the stone may cause an obstruction of all hepatic bile secretions, and even worse, if the stone adheres to the ampulla of Vater, pancreatic juice may also be obstructed. This can lead to pancreatitis and cholelithiasis, because the common bile duct is shared between the pancreas and the liver / gallbladder as a way to communicate the relevant fluids with the digestive tract.

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

[0052] Continuing to refer to Figure 5, during biliary tract procedures (such as ERCP), the cystic duct and common bile duct can be enlarged by various surgical means, ranging from dilation by cannula insertion to the use of energy devices (such as sphincterotomy) to enlarge the internal diameter of the duct by incising the tissue within the duct. This allows for the extraction and removal of gallstones during the procedure and reduces the risk of future stone inclusion.

[0053] Continuing to refer to Figure 5, the common bile duct is a shared tube between the liver, gallbladder, and pancreas. The common bile duct may have many branches, which can make it difficult for practitioners to identify the correct ductal route to the gallbladder, for example, during biliary procedures (such as ERCP).

[0054] Clinicians must rely on prior knowledge of the patient's anatomical structure (and the expected angular difference between the two ducts) or use available techniques or combinations to reliably identify the common bile duct. Surgeons may use fluoroscopy to identify the bile duct from the pancreatic duct. However, fluoroscopy can be an invasive procedure if not required by other elements of the procedure and may involve specific setups and associated personal protective equipment.

[0055] Some implementations of this disclosure not only provide alternative methods for facilitating the identification of the correct tubule (e.g., before dilation), but also aim to predict what type of calculus formation is occurring. Understanding the type of calculus formation through hepatic secretions may also provide surgeons with insights into whether changes in diet or medications could reduce the risk of future recurrence of the problem.

[0056] In aspects of this disclosure, with reference to Figures 6A to 10, the biliary diagnostic device 132 is provided by taking advantage of the differences in properties between bile and pancreatic juice. In some embodiments, the biliary diagnostic device 132 may facilitate, for example, navigating, cannula insertion, or cutting of areas near the common bile duct before, during, or after a biliary procedure (e.g., ERCP). Bile, produced by the liver and stored in the gallbladder and communicated through the bile ducts, may have more distinctive properties than those that can be used to reliably distinguish the bile ducts from the pancreatic ducts.

[0057] The biliary tract diagnostic devices of this disclosure, for example, biliary tract diagnostic device 132 and biliary tract diagnostic device 222 (Figure 12B), may, according to several embodiments, depend on the electrical properties of bile. For example, bile may have higher conductivity than some fluids or parts of the human body. The biliary tract diagnostic device may, in one or more implementations, include conductive sensing components such as electrodes 144, which can reliably distinguish the bile duct from the pancreatic duct. In another example, the biliary tract diagnostic device may determine the phase angle of the fluid.

[0058] Figures 6A to 10 show various examples of the biliary diagnostic device 132 of the present disclosure, which may be provided as part of an endoscope 14 or endoscope 100. In examples, the biliary diagnostic device 132 may be mounted on the distal portion of the endoscope 100. In some examples, the biliary diagnostic device 132 may be mounted on a duodenoscope and / or cholangioscopy. In yet another embodiment, the biliary diagnostic device 132 may operate in communication with and / or be attached to one or more endoscopic treatment accessories (e.g., guidewires, sphincterotomators, dilation balloons, guide catheters, access sheaths, biliary stents, etc.) that can be used during biliary procedures (e.g., ERCP procedures or other types of biliary procedures). As shown in Figures 12A and 12B, in an example, the biliary diagnostic device 222 may be mounted on a stent 220.

[0059] In one embodiment, the biliary tract diagnostic device 132 may include one or more sensors, as shown in Figures 6A to 10. In this example, the sensor may include an electrical component (e.g., an electrode) in a portion of the anatomical structure into which the auxiliary scope 134 is inserted. Each sensor may include a positive and a negative electrode. As shown in Figure 6A, electrode 144 may be configured as the positive electrode and tissue as the negative electrode. As shown in Figure 7, electrode 144 may be configured as the negative electrode and the guidewire 154 as the positive electrode. In another example, as shown in Figures 8 and 9, multiple electrodes may be arranged 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 supply 140 that can direct current between the electrodes. The sensors may be electrically insulated from each other, for example. For example, the positive and negative electrodes may be insulated using dielectric material arranged along the shaft 150. The sensors may be located on the surface of an endoscope such as the auxiliary scope 134 (e.g., outer surface, inner surface, working channel, etc.). In an alternative example, the sensor may be positioned on, on, or around the tip surface of the endoscopic treatment instrument.

[0060] According to some implementations, for example, an electrical signal from a power source 140 may pass between two electrodes, for example, electrode 144 and an anatomical structure. Furthermore, electrical characteristics 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) can be detected by the sensor to identify the presence of bile, and further guide endoscopic treatment instruments, cannula insertion, or identification of the bile duct from the pancreatic duct. Some implementations of biliary tract diagnostic devices may reduce instances where fluoroscopy may be involved to identify the appropriate duct.

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

[0062] For 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 bile may be more conductive than any other tissue in the pancreaticobiliary region.

[0063] In the example, the biliary tract diagnostic device 132 can use conductivity via either a low-power DC or low-power RF output from, for example, a power supply 142, or other optional source. In an optional implementation, the biliary tract diagnostic device 132 may operably communicate with one or more output devices, such as output device 142, which may include, for example, an endoscopic examination or endoscopic treatment system with an integrated display, or a physician console, touch input device, imaging and control system 12, etc. In particular, output device 142 may include an output unit 18 of the imaging and control system 12. As shown in Figures 13 to 15, output device 142 may actively, for example, continuously, report to the user in several cases during pancreaticobiliary procedures whether the tissue encountered increases or decreases conductivity.

[0064] Implementing one or more options can provide the user with different reports, as seen in the flowcharts in Figures 13–15 and the output device 142 in Figure 11. Another example of an option could report to the user whether the conductivity has reached a predetermined level indicating liver bile and notify the user of this. Furthermore, if the conductivity reaches a value indicating the concentrated fluid held in the gallbladder, the user may be notified whether a more concentrated version has been identified (higher conductivity). Another implementation of an option could notify the user if concentrated bile material is detected. Another implementation of an option could notify the user if no bile (concentrated or not) is detected. A different implementation may offer a combination or selection of the above information feedback elements.

[0065] Further optional implementations could utilize the unique properties of bile to provide alternative features. For example, instead of sensing conductivity, the device could sense impedance, or detect a phase difference between bile and surrounding anatomical features (e.g., surrounding tissue, pancreatic juice, etc.).

[0066] Referring again to Figures 6A to 10, in some embodiments, the position and number of electrodes and the sensors formed therefrom can be changed. For example, as shown in Figures 6A and 10, one electrode may be placed in vivo in the distal section of the endoscope or endoscopic treatment instrument, and a second electrode may be placed in another location (e.g., outside the body) or electrically coupled to intrinsic or floating ground. In another embodiment, as seen in Figures 7 to 10 and 12B, multiple electrodes may be placed on or near the anterior (distal) end of the endoscope or endoscopic treatment instrument. In any scenario, the interrogative signals associated with one or more sensors formed by the electrodes may be suitable for identifying specific fluid properties.

[0067] As mentioned above, different types of crystals are formed when different chemical imbalances occur in hepatic bile. Chemical differences can result in different electrical properties. Chemical imbalances can be identified by sampling the electrical properties of concentrated gallbladder fluid, and the user may be notified, if necessary, through one or more reports. This can then lead to a deeper understanding of the causes of crystal formation. Furthermore, this can be combined with medication or lifestyle change options for the patient to reduce the future incidence of various biliary conditions. In some implementations, identifications such as those disclosed herein may be reported to the user (e.g., directly or indirectly) by comparing the measured diagnosis (e.g., sensed electrical properties) with another preset value in the system. In optional embodiments, the diagnostic value may be provided directly to a surgeon, specialist, or a diagnostic algorithm for further analysis and reporting.

[0068] Like many surgical and diagnostic instruments, some implementations of the device may be disposable after use in a single procedure and / or on a single patient, and may be reusable after a single procedure (e.g., on the same patient or a different patient). The embodiments and features of the device disclosed herein may be provided as a self-contained device (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 treatment instrument (e.g., attached, detachable and / or integrated into the distal portion).

[0069] In cases where devices may be provided as part of a set of similar devices, each device may have a unique identifier system for each device type, and as a result, sensors may be calibrated specifically according to the device. For example, an identification circuit (e.g., a chip) may be provided in the device to identify the device type and, if necessary, automatically set device-specific parameters (e.g., sensor calibration, connection settings to other devices, device performance data, etc.). Some implementations can make the procedure more "plug and play" and reduce the need for clinical staff intervention in device setup.

[0070] Figures 5 to 10 show biliary diagnostic devices arranged on elongated tubular elements (e.g., endoscopes or access sheaths), but similar configurations may also be provided as part of various endoscopic treatment instruments, such as guidewires, sphincterotomators, unipolar, bipolar, or cold cutting instruments (or combinations of the disclosed instruments), or as stents as shown in Figures 12A and 12B.

[0071] In some implementation options, reporting to the user may include visual output (e.g., light illumination diodes or other visual, graphical displays, including consoles for endoscopy or surgical systems), as shown in Figure 11. Alternatively, other types of reporting may be displayed, such as auditory, or detailed displays of sensor readings and / or diagnostic status (determined from previous diagnoses).

[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 the accuracy of diagnosis and detection, or the more sensor feedback there is, the more accurately the path direction and stone type can be predicted. Multisensory feedback systems, such as those disclosed herein, may be intended to indicate the correct tube identification, the stone type, or a combination of tube identification and stone type. The sensor check system may be contained within a device and be part of a standalone unit, or integrated into another part of a main instrument used in such a procedure, such as a surgical system or an endoscopic system. The sensor system may also be a separate reusable / disposable system or part of a main system.

[0073] The implementations disclosed herein may offer several advantages, including improved identification of the common bile duct and / or gallstones, and easier prevention of gallstone formation (e.g., through dietary changes, medications, lifestyle modifications, etc.).

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

[0075] Leads 162 and 166 may include conductors that can extend from electrodes 144 and ground 164 through an elongated shaft 150 to the control module 106. Leads 162 and 166 may include elongated metal wires that can be joined at their distal ends to electrodes 144 or any other electrodes by suitable means such as welding or soldering. The proximal ends of leads 162 and 166 may be connected to the processor 136.

[0076] The elongated shaft 150 may include an elongated body that is rigid enough to support the leads 162, 166, and electrodes 144, but is also flexible enough to provide guided insertion through anatomical structures. In one 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 a reinforcing structure and a coating layer. In one 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 provided inside the elongated shaft 150, for example, used in an endotracheal tube that includes a helical winding embedded for reinforcement.

[0077] Additionally, the elongated shaft 150 may include a coating to prevent or inhibit the adhesion of biomaterials to the auxiliary scope 134. Such a coating may facilitate the insertion of the auxiliary scope 134 through its anatomical structure by reducing friction, among other things. Furthermore, a coating applied to exposed conductive components may prevent biomaterials from adhering to electrical components and interfering with electrical signals generated or interpreted by sensing components such as the electrode 144. In one example, the auxiliary scope 134 may be coated with polydimethylsiloxane. In another example, the auxiliary scope 134 may be coated with another coating containing nanoparticles. Such a coating may be applied or made in a composition to a thickness that does not inhibit or substantially inhibit sensing.

[0078] The metal wire conductor may be covered with an insulating coating, which may be removed at the location where it contacts the electrode or performs sensing. The metal wire conductor may be embedded within the walls of the elongated shaft 150, and the elongated shaft 150 may be provided by removing a selected portion of the elongated shaft 150 to provide insulation and allow sensing by the metal wire conductor or coupling to the electrode 144. In additional examples, leads 162 and 166 may include traces printed along or inside the elongated shaft 150. For example, a metal ribbon may be printed on the surface of the elongated shaft 150 or formed in another manner. In yet additional examples, the metal trace may be co-extruded with the material of the elongated shaft 150. In any example, the elongated conductor may be selectively exposed during the manufacturing process at the location where sensing is desired, or the material of the elongated shaft 150 may be removed after the manufacturing process and the elongated conductor may be selectively exposed 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 executing the methods shown in Figures 13 to 15. The memory 138 may further include storing therein thresholds, baselines, or benchmark levels for conductivity, impedance, resistance, and phase angle of the liver, pancreas, and gallbladder, which can be compared with signals obtained from 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 for the auxiliary scope 134 and the biliary diagnostic device 132. Alternatively, the biliary tract diagnostic device 132 may further include a separate chip, such as a radio frequency identification device (RFID), which may include identification information for the auxiliary scope 134 and the biliary tract diagnostic device 132, such as manufacturer, 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-temporary, or non-volatile tangible computer-readable media. Examples of these tangible computer-readable media include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact discs and digital video discs), magnetic cassettes, memory cards or sticks, random access memory (RAM), read-only memory (ROM), and the like. The power supply 140 may include a generator for generating current, such as in the form of a low-power DC output or a low-power RF output.

[0081] As shown in Figure 6B, the electrode 144 may include an electrode ring 170 configured to completely surround the lumen 158. In this example, the ring 170 can surround the elongated shaft 150. In another example, the ring 170 may be completely or partially embedded within the elongated shaft 150. In this example, at least a portion of the ring 170 may be exposed to the outside of the elongated shaft 150 and may come into contact with tissue or biological material.

[0082] As shown in Figure 6C, the electrode 144 may include one or more ring segments 172A and 172B that partially enclose the lumen 159. The ring segments 172A and 172B may be positioned outside the elongated shaft 150 and partially or completely embedded within the elongated shaft 150. The ring segments 172A and 172B may include arc segments, for example, circular segments. Figure 6C shows the ring segments 172A and 172B as including segments extending over approximately 90°. However, larger or smaller arc segments may be used. In addition, only one ring segment or three or more ring segments may be used.

[0083] A complete ring, as shown in Figure 6A, or multiple ring segments extending around a large portion of the elongated shaft 150, may be advantageous for increasing the sensor input. The ring 170 and ring segments 172A and 172B may include a metallic material suitable for conducting current from the power supply 140 through leads 162 and 166.

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

[0085] A voltage sufficient for such cauterization remains sufficiently low, eliminating the need for additional insulation and avoiding excessive tissue alteration beyond what is necessary for cauterization. However, additional insulation may be included as an example. The voltage sufficient for sensing and cauterization may depend on several 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 between them. For example, about 10 watts of power can have a sufficient effect on the tissue to cauterize it. The electrode configurations disclosed herein may have a resistance of about 250 ohms or less, although other resistances may arise or be used. Therefore, the applied voltage can be on the order of 50V 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. Therefore, in one example, sensing may be performed using a voltage in the range of 35 to 45 volts, and cauterization may be performed using a voltage in the range of 45 to 55 volts. The above range values ​​are illustrative, and other voltages and ranges, or combinations of ranges, may be suitable for other examples and configurations.

[0086] Figure 7 is a perspective view of a second example of the biliary tract diagnostic device 132 of Figure 5, comprising an electrode 144, the electrode 144 including a single electrode ring 170 configured to function as the negative electrode. The biliary tract diagnostic device 132 of Figure 7 may be configured similarly to the biliary tract 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 the negative electrode and comprise a guidewire 154 configured as the positive electrode.

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

[0088] Figure 9 is a perspective view of a fourth example of the biliary tract diagnostic device 132 of Figure 5, which includes electrodes 190 and 192 in addition to electrodes 144 and 180, and includes pairs of electrodes configurable for separate or combined biliary tract diagnostic sensing. As shown in Figure 9, electrodes 144 and 190 may be connected to lead 162, and electrodes 180 and 192 may be connected to lead 166. By including two electrodes on each of leads 162 and 166, the sensitivity of a single sensor functioning as the biliary tract diagnostic device 132 can be increased. Leads 162 and 166 may be connected to a processor 136 as shown in Figures 6A, 7 and 8. In another example, the biliary tract diagnostic device 132 may include two separate sensors by arranging separate leads for electrodes 190 and 192. Thus, with four electrodes functioning as a single sensor, the outputs of each pair of electrodes, e.g., electrodes 144 and 180 and electrodes 190 and 192, are automatically averaged. However, when the four electrodes are used as a dual sensor, the output of each sensor can be averaged by the processor 136 or weighted as needed. For example, the tip pair of electrodes, e.g., electrodes 144 and 180, can be weighted more heavily than the posterior 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 (for example, a sensor formed by electrodes 144 and 180 and electrodes 190 and 192) can be used for multiple evaluation checks. Alternatively, individual sensors (for example, a sensor formed by electrodes 144 and 180 and a sensor formed by electrodes 190 and 192) can be used for separate checks (for example, one sensor may be used for resistance measurement and another for phase angle). In yet another example, multiple (for example, all) electrodes may be used for resistance measurement and multiple other sensors may be used for phase angle. Thus, conductivity, impedance, resistance, and phase angle can be sensed using any combination of one or more sensors.

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

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

[0092] The operation of at least one of the display units 204A to 204E may provide indicators of conductivity, impedance, resistance, and phase angle sensed between the electrodes of the sensor of the biliary diagnostic device 132. With respect to Figure 5, for example, the display units 204A to 204E may respond to electrical parameters sensed between electrode 144 and electrode 180. As seen in Figure 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, electrode 144 may come into contact with the tissue of the common bile duct 124, the fluid within the common bile duct 124, and solids within the common bile duct 124, such as gallstones.

[0093] In one example, each of the light emitters 204A to 204E can be activated to show a gradual increase in the magnitude or level of an electrical parameter. For example, light emitters 204E located below the output device 142 and light emitters 204A located above the output device 142 can be activated in a counter-clockwise manner to show both ends of the electrical characteristic spectrum. For example, light emitter 204E can be activated to show a first level of the electrical characteristic, e.g., the magnitude of the electrical characteristic just above zero, and light emitter 204A can be activated to show a second level of the electrical characteristic, e.g., the magnitude of the electrical characteristic at saturation, maximum, or threshold levels. Light emitters 204B to 204D can be activated to show various levels between the first and second levels, thereby providing a continuous spectrum or gradual change in the luminescence operation. Light emitters 204A to 204E can be updated in real time to show the magnitude of the electrical parameter. Thus, a surgeon can operate the endoscope 100 or auxiliary scope 134 to receive an indicator of the type of biomaterial engaged by the electrode 144.

[0094] In another example, all light-emitting elements 204A-204E can be activated or lit, changing color to indicate the magnitude of electrical parameters.

[0095] In one example, the visual display 200 may include a dial 206. The dial 206 may include a scale for indicating different magnitudes of electrical parameters, and a needle may move to indicate the actively perceived magnitude. 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 the example, the light emitters 204A-204E and dial 206 may provide labels for translating the magnitude of the sensed electrical parameters into anatomical descriptions. For example, high levels of conductivity are translated into hepatic bile, and low levels of conductivity are translated into pancreatic juice.

[0097] In one example, an audible alarm could be used to provide feedback indicating the magnitude of a perceived parameter. For instance, a steady signal could be emitted, changing the pitch, volume, or tone based on the magnitude of the perceived electrical parameter. In another example, an intermittent signal could be emitted, changing the frequency based on the magnitude of the perceived electrical parameter.

[0098] Figure 12A is a perspective view of a stent 220 incorporating the biliary diagnostic device 222 according to this disclosure. The stent 220 may include a tubular body 224, an internal lumen 226, and a reverse spine 228. The biliary diagnostic device 222 may include electrodes 220A, 220B, and 220C. Electrodes 230A-230C may each include a sensor configured to sense the electrical parameters of a fluid or solid substance within the tubular body 204. Figure 12B is a cross-sectional view of the stent 220 of Figure 12A, taken in section 12B-12B showing electrodes 230A-230B of the biliary diagnostic device 222. Figures 12A and 12B are described together.

[0099] The stent 220 can be placed within the abdominal passage to reinforce tubular tissue or prevent obstruction of the abdominal passage. The tubular body 224 can be fixed or attached to the abdominal passage using the reverse spine 228. The tubular body 224 can be sized to fit into abdominal passages of different sizes, such as the duodenum D, common bile duct 124, and main pancreatic duct 126 (Figure 5).

[0100] Electrodes 230A-230C may be connected to the biliary tract diagnostic device 132 via mechanical lead wires, for example, in a processor 136 (Figure 6A). Thus, the lead wires may be connected to the stent 220 during patient treatment or examination in a medical facility. In another example, the stent 220 may be equipped with a wireless communication device, for example, a radio frequency chip, which may be implanted in the patient together with the stent 220 and capable of taking readings from electrodes 230A-230C.

[0101] Figure 13 is a block diagram showing a method 300 for performing a chemical analysis using the biliary diagnostic device of the present disclosure. In step 302, the method 300 is initiated. For example, an endoscope 100 and an auxiliary scope 134 may be inserted into the duodenum D (Figure 5). Electrodes 144 and any of electrodes 180, 190, and 192 may be positioned to engage with the tissue of the duodenum D, or any abdominal passage connected thereto, such as the common bile duct 124 and the main pancreatic duct 126. Furthermore, the biliary diagnostic device 132 can be powered on via a power supply 140 (Figure 11) or an imaging and control system 12, etc.

[0102] In step 304, the sensors of the biliary tract diagnostic device 132 may be activated. For example, electricity from the power supply 140 can be directed to electrodes 144, 180, 190, and 192. The processor 136 of the biliary tract diagnostic device 132 is activated based on instructions from memory 138 and can read the magnitude of electrical parameters (conductivity, impedance, phase angle, etc.) between electrode 144 and tissue or another electrode. In the example in Figure 13, impedance may be measured using a sensor including electrode 144.

[0103] In step 306, the impedance can be used to evaluate the biomaterial in contact with electrode 144. The processor 136 can compare the sensed impedance with a threshold or baseline impedance X stored in memory 138. The impedance X may indicate the presence of bile from the liver.

[0104] If the sensed impedance is greater than X, method 300 may proceed to step 308. In step 308, the output device 142 may be activated 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 an impedance level indicating hepatic bile present in passage 129 (Figure 5). The surgeon can then continue to advance the auxiliary scope 134 toward the gallbladder or liver.

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

[0106] Subsequently, method 300 may return to start 302 or step 304 to perform continuous real-time impedance measurements.

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

[0108] If the sensed impedance is greater than Y, method 320 may proceed to step 324. In step 324, the output device 142 may be activated 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 an impedance level indicating a first type of stone in the passage 129 (Figure 5). Furthermore, the surgeon may receive confirmation that the correct path for the auxiliary endoscope 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, method 320 may proceed to step 326. In step 326, the output device 142 may be activated 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 an impedance level indicating a second type of stone in the passage 129 (Figure 5). Furthermore, the surgeon may receive information that an incorrect path has been detected for the auxiliary endoscope 134, and the auxiliary endoscope may be rerouted toward the gallbladder or liver.

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

[0111] Figure 15 is a block diagram showing a method 340 for performing a chemical analysis using the biliary diagnostic device 132 of the present disclosure. Method 340 may include steps 302, 304, 306, and 310, as described with reference to method 300 in Figure 13. However, instead of step 308, method 320 may include step 342, in which the biliary diagnostic device 132 may sense the phase angle of the biomaterial in contact with the electrode 144. The sensed phase angle may be compared to a threshold or baseline phase angle Z stored in 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 detected phase angle is greater than Z, method 340 may proceed to step 344. In step 344, the output device 142 may be activated 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 detected a phase angle level indicating a first type of stone in the passage 129 (Figure 5). Furthermore, the surgeon can receive confirmation that the correct path for the auxiliary scope 134 has been detected and can continue to advance the auxiliary endoscope toward the gallbladder or liver.

[0113] If the detected phase angle is less than Z, method 340 may proceed to step 346. In step 346, the output device 142 may be activated 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 detected a phase angle level indicating a second type of stone in the passage 129 (Figure 5). Furthermore, the surgeon may receive information that an incorrect route of the auxiliary endoscope 134 has been detected, and the auxiliary endoscope may be rerouted toward the gallbladder or liver.

[0114] Subsequently, method 340 may return to start 302 or step 304 to perform continuous real-time impedance measurements.

[0115] Methods 300, 320, and 340 have been described in relation to sensing impedance as a primary indicator and phase angle as a secondary indicator, but 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 in relation to biliary diagnostic devices and methods for sensing hepatic bile, but other diagnostic processes, such as the diagnosis of chemical analysis of the pancreas and gallbladder, may be performed.

[0116] Various Notes and Examples Example 1 includes or may use a subject such as a biliary tract diagnostic device, which includes a tubular body having an outer wall and an internal lumen, and a first biliary tract diagnostic sensor coupled to a medical device, wherein the first biliary tract diagnostic sensor includes a first electrode configured to analyze biological material in contact with the tubular body.

[0117] Example 2 may optionally include a first electrode configured to determine the electrical properties of a biomaterial, either by including or optionally combining the themes of Example 1.

[0118] Example 3 may optionally include a first biliary tract diagnostic sensor that includes, or optionally combines, one of the themes of Example 1 or 2 or any combination thereof, further including a lead wire extending from a first electrode and a power supply connected to the lead wire.

[0119] Example 4 may optionally include an output device configured to provide at least one of an audio output and a visual output of an indicator of electrical characteristics, by including one or any combination of the themes of Examples 1 to 3, or by any combination thereof.

[0120] Example 5 may include a subject from one or any combination of Examples 1 to 4, or optionally include an electrical characteristic comprising at least one of conductivity, impedance, resistance, and phase angle, in an optional combination.

[0121] Example 6 may optionally include a memory containing a database of the electrical properties of liver bile, either by including one or any combination of the themes from Examples 1 to 5, or by any choice of combination thereof.

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

[0123] Example 8 may include a subject from one or any combination of Examples 1 to 7, or optionally include a first electrode including a ring that circumscribes an internal lumen, in an optional combination.

[0124] Example 9 may include, or optionally combine, a subject from one or any combination of Examples 1 to 8, and optionally include a first electrode including a partial ring that can be attached to a tubular body.

[0125] Example 10 may include a subject from one or any combination of Examples 1 to 9, or optionally include a first electrode including a pad attached to a tubular body, in an optional combination.

[0126] Example 11 may optionally include a first biliary tract diagnostic sensor that includes, or optionally combines, one of the themes of Examples 1 to 10 or any combination thereof, and further includes a second electrode separated from the first electrode.

[0127] Example 12 may include a subject from one or any combination of Examples 1 to 11, or optionally a combination thereof, and may optionally include a second electrode including a guidewire extending through an internal lumen.

[0128] Example 13 may include, or optionally include, a biliary diagnostic device further comprising, a second biliary diagnostic sensor, by including, one or any combination of the themes of Examples 1 to 12, or an optionally selected combination thereof.

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

[0130] Example 15 may optionally include a first biliary tract diagnostic sensor comprising multiple electrodes, either by including one or any combination of the themes from Examples 1 to 14, or by any choice of combination.

[0131] Example 16 may include a subject from one or any combination of Examples 1 to 15, or optionally include a tubular body containing a stent in an optionally selected combination.

[0132] Example 17 may include the subject of one or any combination of Examples 1 to 16, or optionally include a tubular body including an endoscope in an optionally selected combination.

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

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

[0135] Example 20 may optionally include an endoscope comprising at least one of the following themes from Examples 1 to 19, or any combination thereof, or an optional combination thereof, and including an imaging unit, an illumination unit, and a treatment or diagnostic device.

[0136] Example 21 includes or may use a subject such as a method for guiding an endoscope from the duodenum to the common bile duct, the method comprising inserting the endoscope into the duodenum, engaging the endoscope's sensors with a biomaterial in the duodenum, electrically analyzing the biomaterial using the sensors to identify electrical parameters, identifying hepatic bile in the biomaterial from the electrical parameters, and guiding the endoscope through the duodenum based on the presence of hepatic bile.

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

[0138] Example 23 may include, or optionally include, a subject from one or any combination of, Examples 21 or 22, and optionally include, an electrical parameter including at least one of conductivity, impedance, resistance, and phase angle.

[0139] Example 24 may optionally include, or optionally combine, a subject from one or any combination of Examples 21-23, the identification of hepatic bile in a biological material by comparing baseline electrical parameters with sensed electrical parameters.

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

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

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

[0143] Example 28 may optionally include, or optionally combine, the subject of one or any combination of, of Examples 21-27, guiding 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 optionally include, or optionally combine, the themes of one or any combination of, of Examples 21-28, and output an index of electrical parameters to the endoscope operator.

[0145] Example 30 may optionally include, or optionally include, the analysis of gallstones formed in the common bile duct based on electrical parameters, a subject from one or any combination of Examples 21-29.

[0146] Example 31 may optionally include, or optionally combine, the subject of one or any combination of, of Examples 21-30, and may optionally include, the ablation of tissue using a biliary diagnostic device.

[0147] Example 32 includes or may use a subject such as a method for identifying the composition of biomolecules in a bile duct, comprising engaging a sensor of a medical device with biomolecules in a bile duct, electrically analyzing the biomolecules using the sensor to identify electrical parameters, identifying biomolecules from at least one of the liver, pancreas, and gallbladder from the electrical parameters, and outputting an index of the biomolecules to the user of the medical device.

[0148] Example 33 may optionally include, or optionally combine, the subject matter of Example 32, by engaging the electrodes of the sensor with a biomaterial, thereby engaging the sensor of the medical device with a biomaterial.

[0149] Example 34 may include a subject from one or any combination of Examples 32 or 33, or optionally include an electrical parameter, at least one of conductivity, impedance, resistance, and phase angle, in an optional combination.

[0150] Example 35 may optionally include identifying a biomolecule by comparing baseline electrical parameters with sensed electrical parameters, by including, or optionally including, a subject from one or any combination of Examples 32-34.

[0151] Example 36 may optionally include identifying a biomaterial by determining the concentration of a fluid containing a biomaterial, by including, or optionally including, one or any combination of the subjects from Examples 32 to 35.

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

[0153] Example 38 may optionally include, or optionally include, a subject from one or any combination of, Examples 32-37, or a combination of such subjects, the diagnosis of a condition leading to calculus formation.

[0154] Example 39 may optionally include a subject from one or any combination of Examples 32-38, or an optional combination thereof, to identify biomaterial by determining a calculus structure containing biomaterial.

[0155] Example 40 may include a subject from one or any combination of Examples 32-39, or optionally include a calculus structure comprising at least one of gallstones and kidney stones, in an optional combination.

[0156] Example 41 may optionally include, or optionally combine, themes from one or any combination of Examples 32-40, to output indicators of biomaterials to the user of a medical device by outputting visual or audio indicators of the magnitude of electrical parameters.

[0157] Each of these non-restrictive examples can exist on its own or can be combined with one or more other examples in various permutations or combinations.

[0158] The above detailed description includes references to the accompanying drawings, which constitute part of the detailed description. The drawings illustrate, for illustrative purposes, specific embodiments in which the present invention may be carried out. These embodiments are also referred to herein as “Examples.” Such examples may include elements in addition to those shown or described. However, the inventors also consider examples in which only those elements shown or described are provided. Furthermore, the inventors also consider examples in which any combination or substitution of those elements shown or described (or one or more embodiments thereof) is used in relation to either a specific example (or one or more embodiments thereof) or another example (or one or more embodiments thereof) shown or described herein.

[0159] In the event of any inconsistency in usage between this document and any documents referenced herein, the usage in this document shall prevail.

[0160] In this document, the terms “a” or “an” are used to include one or more, as is common in patent literature, 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 view, or, unless otherwise indicated, “A or B” is used to include “A but not B,” “B but not A,” and “A and B.” In this document, the terms “including” and “in which” are used as plain English synonyms for “comprising” and “wherein,” respectively. Furthermore, in the claims below, the terms “including” and “comprising” are open-ended, meaning that systems, devices, articles, compositions, formulations, or processes that include elements in addition to those listed after such terms in the claims are still considered to fall within the scope of the claims. Furthermore, in the claims below, terms such as “first,” “second,” and “third” are used merely as labels and are not intended to impose any numerical requirements on those objects.

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

[0162] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more of them) may be used in combination with one another. Other embodiments may be used by those skilled in the art when considering the above description. A summary is provided so that readers can quickly grasp the essence of the technical disclosure. The summary is presented with the understanding that it will not be used to interpret or limit the claims or their meaning. Also, in the forms for carrying out the above invention, various features may be grouped together to streamline this disclosure. This should not be considered as intended that any unclaimed disclosed features are essential to any claim. Rather, the subject matter of the invention may lie in fewer features than all the features of a particular disclosed embodiment. Accordingly, the following claims are incorporated by this specification as examples or embodiments into the forms for carrying out the invention, and each claim is considered to exist as a separate embodiment in itself, and such embodiments may be combined with one another in various combinations and permutations. The scope of the present invention should be determined by reference to the appended claims, along with the full scope of the equivalents to which such claims are granted.

Claims

1. It is a tubular body, Exterior walls, and A tubular body including an internal lumen, A first electrode bonded to the tubular body, the first electrode configured to determine the electrical properties of a biological substance in contact with the first electrode, An output device configured to provide at least one of an audio output and a visual output of an indicator for identifying the type of gallstone, based on the magnitude of the electrical characteristics sensed by the first electrode, A medical device equipped with the following features.

2. The medical device according to claim 1, wherein the electrical characteristics include at least one of conductivity, impedance, resistance, and phase angle.

3. moreover, A lead wire extending from the first electrode, The power supply connected to the aforementioned lead wire, An output device configured to provide at least one of the audio output and visual output of the aforementioned electrical characteristic indicator, The medical device according to claim 1, further comprising the above.

4. moreover, An identification chip containing information relating to the type of medical device to which the first electrode is coupled and the calibration of the first electrode, The medical device according to claim 1, comprising:

5. moreover, The medical device according to claim 1, wherein the first electrode includes at least one of a ring that circumsects the internal lumen, a partial ring that can be attached to the tubular body, and a pad attached to the tubular body.

6. moreover, Including a second electrode separated from the first electrode, The second electrode is a guide wire extending through the internal lumen. The medical device according to claim 1.

7. moreover, The medical device according to claim 1, comprising a pair of electrodes electrically coupled to and separated from the first electrode along the tubular body.

8. The tubular body is part of an endoscope, The endoscope includes at least one of an imaging unit, an illumination unit, and a treatment or diagnostic device. The medical device according to claim 1.

9. The power supply is A first electrical output is provided to the first electrode to perform sensing. The first electrode is configured to provide a second electrical output to perform cauterization, The medical device according to claim 3.

10. A method for operating a medical device that detects the characteristics of bile from the liver using an endoscope, The aforementioned endoscope, A tubular body including an outer wall and an inner lumen, A sensor provided on the tubular body, The sensor is configured to determine the electrical properties of a biological substance that has come into contact with the sensor, and the method is Based on the magnitude of the electrical characteristics sensed by the sensor, an output device is configured to provide at least one of an audio output and a visual output as an indicator for identifying the type of gallstone, to which an electrical signal is provided from the sensor. A method of operation that includes the following.

11. The electrical signal includes parameters related to the detection of bile from the liver, The aforementioned parameter includes at least one of conductivity, impedance, resistance, and phase angle. The method according to claim 10.

12. moreover, The method according to claim 10, comprising detecting liver bile in a biological substance by comparing baseline electrical parameters with sensing electrical parameters obtained from the electrical signal.

13. The method according to claim 10, further comprising analyzing the gallstone based on the electrical signal.

14. Furthermore, The method according to claim 10, comprising a power supply connected to the sensor, configured to provide the sensor with a first electrical output to perform sensing and to provide the sensor with a second electrical output to perform cauterization.

15. A method for operating a medical device that identifies the composition of biological substances in the bile duct, The aforementioned medical device is A tubular body including an outer wall and an inner lumen, A sensor provided on the tubular body, Equipped with, The sensor is configured to determine the electrical properties of the biological material that comes into contact with the sensor, and the sensor is configured to determine the electrical properties of the biological material that comes into contact with the sensor. The first electrode is connected to the tubular body, The tubular body is coupled to a second electrode which is separated from the first electrode, The aforementioned method, Based on the magnitude of the electrical characteristics sensed by the sensor, an output device is configured to provide at least one of an audio output and a visual output as an indicator for identifying the type of gallstone, to which an electrical signal is provided from the sensor. A method that includes doing so.

16. The aforementioned electrical parameters include at least one of conductivity, impedance, resistance, and phase angle. The method according to claim 15.

17. moreover, The method according to claim 15, comprising comparing baseline electrical parameters with the electrical parameters from the sensor.

18. Furthermore, the method according to claim 15, further comprising determining that the properties of the biomaterial lead to stone formation.

19. The method according to claim 15, wherein identifying the properties of the biomaterial includes determining the properties of the calculus structure.

20. The method according to claim 15, wherein outputting the display of the characteristics includes outputting a visual or auditory display of the magnitude of the electrical parameter.

21. Furthermore, The method according to claim 15, comprising a power supply connected to the first electrode and the second electrode, configured to provide a first electrical output to at least one of the first electrode or the second electrode to perform sensing, and to provide a second electrical output to at least one of the first electrode or the second electrode to perform cauterization.

Images