Medical devices with biliary diagnostic devices

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 benefit 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 benefit of U.S. Provisional Patent Application No. 62 / 966,710, filed on January 28, 2020, entitled "Endoscope with a Biliary Diagnostic Device", the entire contents of which are hereby incorporated by reference into this application.

[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., kidneys (plural), ureters, 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 management 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 a fluid channel) to an anatomical region, providing passage for one or more treatment devices for sampling or treating an anatomical region (e.g., via a working channel), and providing a suction channel for collecting fluids (e.g., saline or other preparations).

[0005] In conventional endoscopy, the distal portion of the endoscope can be configured to support and direct a treatment device, for example using an elevator. In some systems, two endoscopes can be configured to work together, with a first endoscope guiding a second endoscope inserted therein with the aid of an elevator. Such a system can be useful for guiding a small-diameter endoscope to an anatomically difficult-to-reach location within the body. For example, some anatomical locations can only be accessed with an endoscope after insertion through a tortuous path. Additionally, the tissue at some anatomical locations can be sensitive. Therefore, it may not be desirable to direct the endoscope to an unintended anatomical location. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0006] The inventors recognize that problems to be solved by conventional medical devices, particularly endoscopes and duodenoscopes, include, among other things: 1) the difficulty of navigating an endoscope to anatomically difficult-to-reach locations; 2) the increased time and associated costs due to navigating the endoscope to the wrong location; and 3) the risk of potential tissue damage by impacting sensitive tissue with the endoscope. Such problems can be particularly present in duodenoscopy procedures (e.g., endoscopic retrograde cholangiopancreatography, hereinafter "ERCP" procedures), where an accessory scope (also called a daughter scope or cholangioscope) can be attached and advanced through the working channel of the "main scope" (also called a mother scope or duodenoscope). The present disclosure can 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, and using them to diagnose medical conditions and guide the insertion of a medical device to a desired anatomical region. In particular, the present application relates to a biliary diagnostic device that can evaluate a biological fluid, such as bile from the liver, and guide an endoscope towards anatomical features where a medical intervention is desired. For example, the presence of bile from the liver can facilitate directing the endoscope towards the common bile duct and away from the main pancreatic duct from within the duodenum.

[0007] The inventors also recognize that the problems to be solved in conventional medical procedures, particularly endoscopic examination procedures of the duodenum, include, among other things, the potential desire to utilize fluoroscopy to facilitate navigation through complex anatomical structures. In some cases, it may be desirable to avoid the use of fluoroscopy to minimize radiation exposure to the surgeon and the patient. The present disclosure may assist in providing solutions to these and other problems by providing a system, device, and method that utilize non-fluoroscopic navigation assistance in the form of a biliary diagnostic device, which can be used to perform biological or chemical analysis of anatomical substances to provide composition-guided navigation.

[0008] The inventors further recognize that the problems to be solved in conventional treatments of calculi in the gastrointestinal system, such as gallstones, are that it may be difficult to diagnose the biological state that may lead to calculus formation in the patient's body. For example, in many cases, the formation of the calculus itself provides the first sign of the disease state. Additionally, a procedure to remove the calculus may cause destruction of the calculus. Therefore, it may be difficult to diagnose the specific state of the patient that leads to calculus formation. The present disclosure may assist in providing solutions to these and other problems by providing a system, device, and method that utilize a biliary diagnostic device to analyze the composition of gastrointestinal calculi, thereby helping to identify the biological state that leads to calculus formation, and thereby providing a basis for a treatment plan, such as a change in diet or medication, to reduce the risk of future recurrence of the problem. **Means for Solving the Problems**

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

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

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

Brief Description of the Drawings

[0012]

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DETAILED DESCRIPTION OF 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 insertable 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 therapy. 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 to the endoscopy system 10. For example, the controller 16 may include a data input / output port for receiving data from and communicating data to the endoscope 14. The light source 22 may include an output port for transmitting light to the endoscope 14, e.g., via an optical fiber link. The fluid source 24 may include a port for transferring fluid to the endoscope 14. The fluid source 24 can include a pump and a fluid tank, or can be connected to an external tank, container, or storage unit. The suction pump 26 includes a port used to draw a vacuum from the endoscope 14 and can generate suction to remove fluid from, e.g., the anatomical region into which the endoscope 14 is inserted. The output unit 18 and the input unit 20 can be used by an operator of the endoscopy system 10 to control the functions of the endoscopy system 10 and observe the output of the endoscope 14. The controller 16 can further be used to generate a signal or other output resulting from treating the anatomical region into which the endoscope 14 is inserted. In the example, the controller 16 can generate an electrical output, an acoustic output, a fluid output, etc. to treat the anatomical region using cauterization, cutting, freezing, etc.

[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 can extend distally from the handle section 32, and the cable section 34 can extend proximally from the handle section 32. The insertion section 28 can be elongated and can include a flexible section and a distal end to which the functional section 30 can be attached. The flexible section can be controllable (e.g., by the control knob 38 of the handle section 32) to be maneuvered through an anatomical passage (e.g., the stomach, duodenum, kidney, ureter, etc.) that meanders at the distal end. The insertion section 28 can also include one or more working channels (e.g., internal lumens), which can be elongated and can support the insertion of one or more treatment tools of the functional section 30. The working channels can extend between the handle section 32 and the functional section 30. Additional features, such as fluid passages, guide wires, and pull wires, can also be provided by the insertion section 28 (e.g., via a suction or irrigation passage, etc.).

[0018] The handle section 32 can include a knob 38 and a port 40. The knob 38 can be coupled to a pull wire that extends through the insertion section 28. The port 40 can be configured to couple the handle section 32 to various electrical cables, fluid tubes, etc. to couple them to the insertion section 28.

[0019] The imaging and control system 12 can be disposed, according to an example, on a mobile platform (e.g., a cart 41) having a shelf for accommodating components such as a light source 22, a suction pump 26, an image processing unit 42, etc. Alternatively, some components of the imaging and control system 12 shown in FIGS. 1 and 2 can be disposed directly on the endoscope 14 to make the endoscope "self - contained".

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

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

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

[0023] The fluid source 24 can include one or more sources of air, saline, or other fluids, and associated fluid paths (e.g., air channels, irrigation channels, suction channels) and connectors (e.g., luer fittings, fluid seals, valves, etc.). The imaging and control system 12 can also include a drive unit 46, which can be an optional component. The drive unit 46 can include an electric drive for advancing the distal section of the endoscope 14 and is described at least in PCT Publication No. WO2011 / 140118A1, titled "Rotate-to-Advance Catheterization System" by Frassica et al., which is hereby incorporated by reference in its entirety.

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

[0025] In the examples of FIGS. 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-tight connection with the insertion section 28. The housing 52 may include an opening for the elevator 54. The elevator 54 can 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 elongate device extending through the insertion section 28 along axis A1, which is discussed in more detail with reference to FIG. 3C. Using the elevator 54, the elongate device can be bent 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 is disposed, for example, radially outward of axis A1, along the illumination lens 58 and the objective lens 60.

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

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

[0028] Housing 52 can include a receiving space 53 for receiving deflector 55. Instrument 63 can include forceps, a catheter, etc. that extend through lumen 62. The proximal end of deflector 55 can be attached to housing 62 by pin 61 provided on rigid tip 21. The distal end of deflector 55 can be disposed below window 65 in housing 62 when deflector 55 is in a lowered or inoperative state. The distal end of deflector 55 can extend at least partially out of window 65 when deflector 55 is lifted or actuated by wire 57. Instrument 63 can slide on angled ramp 51 of deflector 55 to initially deflect the distal end of instrument 63 towards window 65. Angled ramp 51 can encourage expansion of the distal portion of instrument 63 extending from window 65 at a first angle relative to the axis of lumen 62. Angled ramp 51 can include groove 69, e.g., a v-notch, to receive and guide instrument 63. Deflector 55 can be actuated to bend instrument 63 at a second angle relative to the axis of lumen 62, and the second angle is closer to perpendicular than the first angle. When wire 57 is released, deflector 55 can be rotated, for example, counterclockwise, by either pushing or loosening wire 57 to return to the lowered position. In the example, instrument 63 can include a choledochoscope or auxiliary scope 134 (FIG. 5).

[0029] The side-view endoscope camera module 50 of FIGS. 3A-3C may include optical components (e.g., an objective lens 60, a prism 66, an imaging unit 67, a wiring 68) for collecting an image signal, and illumination components (e.g., an illumination lens 58, an 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 is coupled to an image processing unit 42 (FIG. 2) (e.g., via a wired or wireless connection) to transmit a signal from the photosensitive element representing an image (e.g., a video signal) to the image processing unit 42, which can then be displayed 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 an output at a desired resolution suitable for an endoscopic examination procedure (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 FIG. 4.

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

[0032] The functional module 102 may include a functional section 30, a camera module 50, or other types of modules. The functional module 30 may include one or both of an imaging device, a treatment device, an adjunctive treatment device, and a biliary diagnostic device, and another device described herein.

[0033] In an example, the functional module 102 can include the camera module of the endoscope described in U.S. Provisional Patent Application No. 63 / 024,674, filed on May 14, 2020, entitled "Endoscope with a Low-Profile Distal Section", the entire content of which is incorporated herein by reference.

[0034] The navigation and control module 106 may include the handle section 32, the cable section 34, and the cap section 36 of FIGS. 1 and 2.

[0035] In an example, the navigation and control module 106 can include the navigation and control module of the 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 content of which is incorporated herein by reference.

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

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

[0038] As described above, the components of the endoscope 14 may be modular as shown by the modular endoscope 100 of FIG. 4, and as a result, they may be attached by an operator to configure a device for initial use on a patient and removed by the operator after use on the patient. In another example, the modular components may be assembled and disassembled by a manufacturer or a decommissioning service without operator manipulation. In one example, FIG. 4 shows the endoscope 14 of FIG. 2, where its components are shown in a separated state. FIG. 4 shows an endoscope 14 constructed from three modular components (functional module 102 [functional section 30]), navigation and control module 106 [handle section 32], insertion section module 104 [insertion section 28]), although additional or fewer components are contemplated depending on the surgical procedure performed with the endoscope 14 configured by an operator. Each of the functional module 102, the navigation and control module 106, and the insertion section module 104 may be removable from each other. Further, each of the modules 102, 104, and 106 may be discarded after a single clinical use. Alternatively, each of the modules 102, 104, and 106 may be constructed using materials that allow for multiple clinical uses. In such a case, the modules 102, 104, and 106 may be constructed to withstand sterilization after each clinical use.

[0039] In certain advantageous aspects, the modular structure of the endoscope 14 of FIG. 2 and the modular endoscope 100 of FIG. 4 enable a mix and match of disposable and reusable modules, as discussed herein, such that some modules, such as expensive and / or easily cleanable modules, can be reused and some modules, such as simple and / or difficult-to-clean modules, can be made disposable. For example, certain modules can be removed from the endoscope after clinical use for sterilization, reprocessing, and reuse for subsequent clinical use, and the remaining modules can be discarded. For example, there are concerns regarding improper reprocessing of a portion of a duodenoscope (e.g., the elevator portion). 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 ones in which the entire endoscope is discarded, are constructed using lower-cost materials, result in lower-cost endoscopes, and maintain competitiveness per clinical use. In many clinical cases, the lower-cost materials may lead to insufficient clinical performance (e.g., low-quality images, improper operability, damage to the insertion section module during insertion, insufficient ergonomic performance of the endoscope handle, etc.). Therefore, due to inferior components, practitioners may avoid using such devices.

[0040] Accordingly, the modular endoscopes 14 and 100 of FIGS. 2 and 4, as well as others described or incorporated herein, are advantageously constructed such that an end user (e.g., a healthcare provider and facility) can retrieve specific modules of the endoscope 14 for reuse while simultaneously disposing of areas prone to infection after a single clinical use. Further, portions of the endoscope intended for reuse can be constructed to reduce the accumulation of biological substances (such as being fully encapsulated), and additionally, can be fluidly isolated from areas prone to infection. Such a configuration promotes 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. The disposable components can be constructed to include only the functions necessary for a particular specification treatment and can be constructed such that the materials and structure can withstand only a single use, both of which serve to reduce the cost of the disposable components. For example, the insertion sheath can be constructed to withstand the stress of only a single procedure and does not need to be robustly constructed to withstand the repeated stress of multiple procedures.

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

[0042] Furthermore, the connectors between the camera module and the navigation and control module, as well as the camera module and the navigation and control module, may be composed of materials and designed to reduce the intrusion of biological substances, and may also be constructed as a fluid seal if necessary.

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

[0044] FIG. 5 is a schematic view of the distal portion of the endoscope 100 according to the present disclosure disposed in the duodenum D. The duodenum D may include a tube wall 120, an Oddi sphincter 122, a common bile duct 124, and a main pancreatic duct 126. The duodenum D includes the upper part of the small intestine. The common bile duct 124 transports bile from the gallbladder and the liver (not shown) and discharges the bile into the duodenum D through the Oddi sphincter 122. The main pancreatic duct 126 transports pancreatic juice from the pancreatic exocrine 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 portion 130. The endoscope 100 can further include a biliary diagnostic device 132 and an auxiliary scope 134. The biliary diagnostic device 132 may include a processor 136, a memory 138, and a power source 140. As discussed below, the biliary diagnostic device 132 can be integrated on the endoscope 100, such as on the function module 102, the insertion section module 104, or on the auxiliary scope 134, for example via an electrode 144.

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

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

[0048] In some examples, the crystals can aggregate and grow into particles and may continue to develop in the gallbladder (e.g., if not excreted) and may develop through the "gravel" and "stone" stages. According to some aspects, the size of the crystals may be smaller than the size of the particles. Further, in some aspects, the size of the crystals and / or particles may be smaller than the size of the gravel. Additionally, in some cases, the size of the crystals may be smaller than the size of the stone. In one example, the size of the crystals can be smaller than the size of the particles, gravel, and stone. In another example, the size of the particles may be smaller than the size of the gravel and stone, and in a further example, the size of the gravel may be smaller than the size of the stone. In yet another example, the sizes of the crystals, particles, gravel, and stone 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 embodiments, growths of larger gravel or stone sizes move within the gallbladder. If they are too large to pass through a single cystic duct, the growths pass in front of the cystic duct, creating an intermittent blockage. This blockage can prevent the gallbladder from emptying, which causes inflammation and irritation of the gallbladder. In some cases, it can lead to an infection of the gallbladder, and the gallbladder may become filled with pus.

[0050] In some cases, even when the stone or gravel moves away from the bile duct and the pressure is released, the gallbladder is affected by the experience of strong local scarring occurring, and then the severity may increase when the calculus passes through the duct. Some of such events can lead to cholelithiasis (also called "gallbladder disease"). The calculus may be trapped in the bile duct itself. Depending on the location of this blockage, the calculus can cause a blockage of all hepatic bile secretions, and even worse, if the calculus adheres to the Vater ampulla, pancreatic fluid may also be blocked. This can cause 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 to the digestive tract.

[0051] One surgical procedure for dealing with calculus formation and / or removing calcification simultaneously is called cholecystectomy, which can be performed invasively through the skin and may be performed laparoscopically (an open procedure may be performed if there are no related complications such as irritation and multiple calculi in the bile duct). An alternative to cholecystectomy may use the entrance of the natural orifice for the procedure but may leave the gallbladder in place. This procedure may be called, in some cases, endoscopic retrograde cholangiopancreatography (ERCP). ERCP combines the functional ability (inherent to or related to the camera) of an observation system (e.g., the duodenoscope shown in FIGS. 3A - 3C) introduced into the patient through the mouth, esophagus, stomach, and / or duodenum to enable access to the biliary system without the need for, for example, a surgical access incision.

[0052] Continuing to refer to FIG. 5, during biliary tract procedures (such as ERCP), the cystic duct and the common bile duct can be enlarged by various surgical means, from dilation by cannula insertion to energy devices (such as sphincterotomy) that incise the tissue inside the duct to expand the duct diameter. This enables the extraction and drainage of gallstones during the procedure and can reduce the risk of future stone encapsulation.

[0053] Continuing to refer to FIG. 5, the common bile duct is a shared duct between the liver, gallbladder, and pancreas. The common bile duct may have many branches, which can pose difficulties for the practitioner trying to identify the correct duct path to the gallbladder, for example, during biliary tract procedures (such as ERCP).

[0054] The clinician needs to reliably identify the common bile duct, either relying on previous knowledge of the patient's anatomical structure (and the expected angular difference between the two ducts) or using available techniques or combinations. The surgeon can use fluoroscopy to distinguish the bile duct from the pancreatic duct. However, fluoroscopy can be an invasive procedure technique and may involve specific setup situations and associated personal protective equipment if not required for other elements of the procedure.

[0055] Some implementations of the present disclosure not only provide alternative methods for facilitating the correct duct identification (e.g., prior to dilation) but also aim to predict which type of stone formation is occurring. Understanding the type of stone formation through the secretions of the liver can also provide the surgeon with insights into whether changes in diet or medications can reduce the risk of future recurrence of the problem.

[0056] According to aspects of the present disclosure, referring to FIGS. 6A - 10, a biliary diagnostic device 132 is provided by utilizing the differences in characteristics between bile and pancreatic juice. The biliary diagnostic device 132 according to some aspects can, for example, facilitate navigating, cannulating, or cutting an area near the common bile duct before, during, or after a biliary (e.g., ERCP) procedure. Bile, which is produced by the liver, stored in the gallbladder, and communicated through the bile ducts, can have unique characteristics compared to those that can be used to reliably distinguish the bile ducts from the pancreatic duct(s).

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

[0058] FIGS. 6A - 10 show various examples of the biliary diagnostic device 132 of the present disclosure, which can be provided as part of the endoscope 14 or endoscope 100. In an example, the biliary diagnostic device 132 can be disposed at the distal portion of the endoscope 100. In some examples, the biliary diagnostic device 132 can be disposed on a duodenoscope and / or a cholangioscope. In yet another aspect, the biliary diagnostic device 132 can operate in communication with and / or be attached to one or more endoscopic treatment accessories (such as a guide wire, sphincterotome, dilation balloon, guide catheter, access sheath, bile duct stent, etc.) that can be used during a biliary procedure (e.g., an ERCP procedure or other types of biliary procedures). As shown in FIGS. 12A and 12B, in an example, the biliary diagnostic device 222 can be provided on the stent 220.

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

[0060] According to some implementations, for example, an electrical signal from the power source 140 may pass between two electrodes, such as the electrode 144 and the anatomical structure. Further, the 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) may be detected by the sensor to identify the presence of bile and further guide the endoscopic treatment device, facilitate cannula insertion, or facilitate the identification of the bile duct from the pancreatic duct. Some implementations of the biliary diagnostic device may reduce cases where fluoroscopy is involved in identifying the appropriate duct.

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

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

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

[0064] The implementation of one or more options can provide different reports to the user, as seen in the flowcharts of FIGS. 13-15 and the output device 142 of FIG. 11. Another example of an option can report to the user whether the conductivity has reached a predetermined level indicating bile in the liver and notify the user of that. Further, when the conductivity reaches a value indicating the concentrated fluid retained in the gallbladder, it can notify the user whether a more concentrated version (more conductive) has been identified. The implementation of another option can notify the user when a concentrated bile substance is detected. In the implementation of another option, when bile (concentrated or not) is not detected, the user can be notified. Another implementation can provide a combination or selection of the above information feedback elements.

[0065] The implementation of further options can provide another feature using a unique property of bile. For example, instead of sensing conductivity, the device can sense impedance, or the phase difference between bile and surrounding anatomical features (e.g., surrounding tissue, pancreatic fluid, etc.) can be detected.

[0066] Referring again to FIGS. 6A-10, in some aspects, the position and number of electrodes and the sensors formed therefrom can be changed. For example, as shown in FIGS. 6A and 10, one electrode can be disposed in vivo at the distal section of an endoscope or an endoscopic treatment device, and the second electrode can be disposed at another location (e.g., outside the body) or electrically coupled to a common or floating ground. In another aspect, as seen in FIGS. 7-10 and 12B, a plurality of electrodes can be disposed on or near the front (distal) end of an endoscope or an endoscopic treatment device. In any scenario, the interrogation signal associated with one or more sensors formed by the electrodes may be suitable for identifying a particular fluid property.

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

[0068] As with many surgical and diagnostic instruments, devices according to some implementations are disposable after a single procedure and / or after being used on a single patient, can be reused after a single procedure (e.g., on the same patient or a different patient), and / or can be repairable. The aspects and features of the devices disclosed herein can be provided as self - contained in the device (e.g., inserted into the working channel of an endoscope and / or provided as a diagnostic device), and / or can be provided as part of an endoscope and / or an endoscopic treatment instrument (e.g., attachable, detachable, and / or integrated into the distal portion).

[0069] In an example where a device can be provided as part of a set of similar devices, each device can have a unique identifier system for each device type, such that the sensor can calibrate the readings specifically according to the device. For example, an identification circuit (e.g., a chip) can be provided in the device to identify the type of the device and, if necessary, automatically set device-specific parameters (e.g., sensor calibration, settings for connections to other devices, device performance data, etc.). With some implementations, the procedure can be made more "plug and play", reducing the need for clinical staff intervention in the setup of the device.

[0070] Figures 5 - 10 show a biliary diagnostic device disposed on an elongate tubular element (e.g., an endoscope or access sheath), although a similar configuration can also be provided as part of various endoscopic treatment instruments, such as a guide wire, sphincterotome, monopolar, bipolar or cold cutting instrument (or combinations of the disclosed instruments), or as a stent as shown in FIGS. 12A and 12B.

[0071] In some alternative implementations, the report to the user can include a visual output (e.g., an optical illumination diode or other visual, graphical display, including the console of an endoscopy or surgical system) as shown in FIG. 11. Alternatively, another type of report, such as an auditory, or a detailed display of sensor readings and / or diagnostic status (determined from previous diagnoses) can be presented.

[0072] The systems described herein may also include a plurality of sensed quantities for improving the accuracy of diagnosis and detection, such as phase angle and resistance, or resistance and reactance, or impedance and phase angle, etc., or the more sensor feedback there is, the more accurately the path direction and the type of calculus can be predicted. A multisensory feedback system as disclosed herein can be envisioned to indicate the correct tube identification, or a combination of calculus type or tube identification and calculus type. The sensor check system may be included within the device, be part of a stand-alone unit, or be integrated into another part of the major equipment used in such procedures, such as a surgical system or an endoscopic system. The sensor system can also be part of a separate reusable / disposable system or part of the major system.

[0073] The implementations disclosed herein can provide many advantages, including improving the identification of the common bile duct and / or gallstones and facilitating the prevention of gallstone formation (e.g., diet therapy, pharmaceuticals, lifestyle changes, etc.).

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

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

[0076] Elongated shaft 150 can include an elongated body, which is rigid enough to support leads 162, lead 166, and electrode 144, but also flexible enough to provide guided insertion through anatomical structures. In an example, elongated shaft 150 can include a medical grade polymer. Elongated shaft 150 can include one or more structures and layers, such as reinforcement structures and coating layers. In an example, elongated shaft 150 can include reinforcing wires embedded therein. In yet another example, an elongated conductor can be provided by a helical winding provided inside elongated shaft 150, such as that used in an endotracheal tube including helical windings embedded for reinforcement.

[0077] Additionally, elongated shaft 150 includes a coating, which can prevent or inhibit the attachment of biological substances to auxiliary scope 134. Such a coating can facilitate the insertion of auxiliary scope 134 through anatomical structures, such as by reducing friction. In addition, a coating applied over exposed conductive components can prevent biological substances from attaching to the electrical components and interfering with electrical signals generated or interpreted by sensing components such as electrode 144. In one example, auxiliary scope 134 can be coated with polydimethylsiloxane. In an example, auxiliary scope 134 can be coated with other coatings including nanoparticles. Such coatings can be applied at a thickness that does not inhibit or substantially inhibit sensing, or can be made of a composition.

[0078] The metal wire conductor can be covered with an insulating coating, which can be removed at the position where it contacts the electrode or performs sensing. The metal wire conductor can be embedded within the wall of the elongated shaft 150, and the elongated shaft 150 can remove a selected portion of the elongated shaft 150 to provide insulation and enable sensing by the metal wire conductor or connection to the electrode 144. In an additional example, the leads 162 and 166 can include traces printed along or inside the elongated shaft 150. For example, a metal ribbon can be printed on the surface of the elongated shaft 150 or formed in another way. In a further additional example, the metal trace can be co-extruded with the material of the elongated shaft 150. In any example, the elongated conductor can be selectively exposed at the position where it is desirable to produce sensing during the manufacturing process, or the material of the elongated shaft 150 can be removed after the manufacturing process and the elongated conductor can be selectively exposed in a separate step.

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

[0080] Processor 136 can include, for example, a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof. Memory 138 can include one or more volatile, non-transitory, or non-volatile tangible computer-readable media. Examples of such tangible computer-readable media include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memory (RAM), read only memory (ROM), and the like. Power supply 140 can 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 FIG. 6B, electrode 144 can include an electrode ring 170 configured to completely surround lumen 158. In an example, ring 170 can surround elongated shaft 150. In another example, ring 170 can be completely or partially embedded within elongated shaft 150. In an example, at least a portion of ring 170 is exposed outside of elongated shaft 150 and can contact tissue or biological material.

[0082] As shown in FIG. 6C, electrode 144 can include one or more ring segments 172A and 172B that only partially surround lumen 159. Ring segments 172A and 172B can be disposed outside of elongated shaft 150 and can be partially or completely embedded within elongated shaft 150. Ring segments 172A and 172B can include arc segments, such as segments of a circle. FIG. 6C shows ring segments 172A and 172B as including segments that extend over approximately 90°. However, larger or smaller arc segments can be used. Additionally, only one ring segment, or three or more ring segments, can be used.

[0083] A complete ring as shown in FIG. 6A, or a plurality of ring segments extending around most of the perimeter of the elongated shaft 150, may be advantageous for increasing sensor input. The ring 170 and the ring segments 172A and 172B may include a metallic material suitable for conducting current from the power source 140 to the leads 162 and 166.

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

[0085] A voltage sufficient for such a cauterizing function remains low enough that no additional insulation is required and can avoid excessive tissue change beyond what is necessary for cauterization. However, additional insulation can be included as an example. The voltage sufficient for sensing and cauterization may depend on multiple factors, such as the resistance of the tissue being sensed. The resistance of the tissue being sensed depends on the surface area of the electrode and the distance the electrode is away. For example, about 10 watts of power can have a sufficient impact on the tissue to cauterize it. The electrode configurations disclosed herein may have a resistance of 250 ohms or less, although other resistances may occur 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 can be performed at a voltage of about 50 volts or less, while cauterization can be performed at a voltage of about 50 volts or more. Additionally, an upper limit of the applied voltage, such as 60 volts, can be set to prevent excessive tissue damage. Thus, in one example, sensing can be performed using a voltage in the range of 35 - 45 volts, and cauterization can be performed using a voltage in the range of 45 - 55 volts. The values in the above ranges are exemplary, and other voltages and ranges, or combinations of ranges, may be suitable for other examples and configurations.

[0086] FIG. 7 is a perspective view of a second example of the biliary diagnostic device 132 of FIG. 5 including the electrode 144, which includes a single electrode ring 170 configured to function as a negative electrode. The biliary diagnostic device 132 of FIG. 7 can be configured similarly to the biliary diagnostic device 132 of FIG. 6A, except that the lead 166 is connected to the guide wire 154 instead of the ground 164. Additionally, the electrode 144 can be configured as a negative electrode and include a guide wire 154 configured as a positive electrode.

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

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

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

[0090] FIG. 10 is a perspective view of a fifth example of the biliary diagnosis device 132 of FIG. 5 and includes a single electrode pad 198 configured to function as a positive electrode. The biliary diagnosis device 132 of FIG. 10 can be configured similarly to the biliary diagnosis device 132 of FIG. 6A or FIG. 7, except that the ring electrode 144 is replaced by the pad electrode 198. The pad electrode 198 can include a flat and thin body extending around a portion of the elongated shaft 150. The surface area of the pad electrode 198 can be configured to facilitate interaction with tissue and improve the sensitivity of the sensor. For example, the pad electrode 198 can be knurled or textured to facilitate engagement with biological substances. In an additional example, the pad 198 can 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 can be included on the elongated shaft 150.

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

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

[0093] In one example, each of the light emitters 204A - 204E can be activated to show that the magnitude or level of an electrical parameter gradually increases. For example, the light emitter 204E at the bottom of the output device 142 and the light emitter 204A at the top of the output device 142 can be activated in an opposing manner to show both ends of the electrical characteristic spectrum. For example, the light emitter 204E can be activated to show a first level of electrical characteristics, e.g., the magnitude of the electrical characteristics just above zero, and the light emitter 204A can be activated to show a second level of electrical characteristics, e.g., the magnitude of the electrical characteristics at saturation, maximum, or threshold level. The light emitters 204B - 204D can be activated to show various levels between the first level and the second level, and as a result, a continuous spectrum or a gradual change in the light emission operation can be provided. The light emitters 204A - 204E can be updated in real - time to show the magnitude of the electrical parameter. Thus, the surgeon can operate the endoscope 100 or the auxiliary scope 134 to receive an indication of the type of biological material engaged by the electrode 144.

[0094] In another example, all of the light emitters 204A - 204E can be activated or lit and change color to show the magnitude of the electrical parameter.

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

[0096] In an example, the light emitters 204A - 204E and the dial 206 can be provided with labels for converting the magnitude of the sensed electrical parameter into an anatomical description. For example, a high level of conductivity is converted to bile in the liver and a low level of conductivity is converted to pancreatic juice.

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

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

[0099] The stent 220 may be disposed within an abdominal passageway to reinforce the duct tissue or prevent blockage of the abdominal passageway. The barbs 228 may be used to secure or attach the tubular body 224 to the abdominal passageway. The tubular body 224 may be sized to be disposed in different sized abdominal passageways, such as the duodenum D, the common bile duct 124, and the main pancreatic duct 126 (FIG. 5).

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

[0101] FIG. 13 is a block diagram showing a method 300 for performing chemical analysis using the biliary diagnostic device of the present disclosure. At step 302, method 300 is initiated. For example, the endoscope 100 and the auxiliary scope 134 can be inserted into the duodenum D (FIG. 5). The electrode 144 and any one of the electrodes 180, 190, and 192 can be arranged to engage 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. Further, the biliary diagnostic device 132 can be powered on via a power source 140 (FIG. 11) or an imaging and control system 12, etc.

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

[0103] At step 306, the impedance can evaluate the biological material in contact with the electrode 144. The processor 136 can compare the sensed impedance with a threshold value or a baseline impedance X stored in the memory 138. The impedance X can indicate the presence of bile in the liver.

[0104] If the sensed impedance is greater than X, method 300 can proceed to step 308. At step 308, the output device 142 is 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 a level of impedance indicating the presence of bile in the liver in the passage 129 (FIG. 5). Then, the surgeon can continue to advance the auxiliary scope 134 towards the gallbladder or the liver.

[0105] If the sensed impedance is less than X, method 300 may proceed to step 310. In step 310, output device 142 is actuated by processor 136 to operate one or more of visual display 200, audio driver 202, and dial 206, indicating that the biliary diagnostic device 132 has sensed a level of impedance indicating a lack or lower concentration of bile in the liver that would be present near the inlet (farthest dilated portion) 128 (FIG. 5). Then, the surgeon may operate the auxiliary scope 134 away from the inlet 128 and towards the passage 129.

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

[0107] FIG. 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 of FIG. 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 a different type of stone 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, output device 142 is actuated by processor 136 to operate one or more of visual display 200, audio driver 202, and dial 206 to indicate that the biliary diagnostic device 132 has sensed a level of impedance indicating a first type of stone within the passage 129 (FIG. 5). Further, the surgeon can receive confirmation that the correct path of the auxiliary scope 134 has been detected, and the auxiliary endoscope can continue to advance towards the gallbladder or the liver.

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

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

[0111] FIG. 15 is a block diagram showing a method 340 for performing chemical analysis using 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 of FIG. 13. However, instead of step 308, method 320 may include step 342, where biliary diagnostic device 132 may sense the phase angle of a biological substance in contact with electrode 144. The sensed phase angle may be compared to a threshold or baseline phase angle Z stored in memory 138. Phase angle Z may indicate the presence of different types of stones that may be found in common bile duct 124.

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

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

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

[0115] Methods 300, 320, and 340 have been described with respect to sensing impedance as a primary metric and phase angle as a secondary metric, 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 with respect to biliary diagnostic devices and methods for sensing liver bile, but another diagnostic process, such as a chemical analysis diagnosis of the pancreas and gallbladder, may be performed.

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

[0117] Example 2 may optionally include, including or in any combination with the subject matter of Example 1, a first electrode configured to determine the electrical properties of a biological substance.

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

[0119] Example 4 may optionally include, including or in any combination with the subject matter of Examples 1 to 3, an output device configured to provide at least one of an audio output and a visual output of an indicator of electrical properties.

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

[0121] Example 6 may optionally include, including or in any combination with the subject matter of Examples 1 to 5, a memory storing therein a database of electrical properties of bile in the liver.

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

[0123] Example 8 may optionally include a first electrode including a ring circumscribing an internal lumen, including the subject matter of one or any combination of Examples 1 to 7, or optionally combined.

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

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

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

[0127] Example 12 may optionally include a second electrode including a guide wire extending through an internal lumen, including the subject matter of one or any combination of Examples 1 to 11, or optionally combined.

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

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

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

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

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

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

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

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

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

[0137] Example 22 may include the subject matter of Example 21, or optionally include, in combination, engaging the sensor of the endoscope with the biological substance by engaging an electrode of the sensor with the biological substance.

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

[0139] Example 24 may include the subject matter of one or any combination of Examples 21 to 23, or optionally in combination, may optionally include identifying the bile of the liver in a biological substance by comparing the electrical parameters sensed with the baseline electrical parameters.

[0140] Example 25 may include the subject matter of one or any combination of Examples 21 to 24, or optionally in combination, may optionally include guiding the endoscope through the duodenum by guiding the distal end of the endoscope towards a higher concentration of the bile of the liver based on the presence of the bile of the liver.

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

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

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

[0144] Example 29 may include the subject matter of one or any combination of Examples 21 to 28, or optionally include, in any combination, outputting an indicator of electrical parameters to an endoscope operator.

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

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

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

[0148] Example 33 may include the subject matter of Example 32, or optionally include, in any combination, engaging the sensor of the medical device with the biological substance by engaging the electrodes of the sensor with the biological substance.

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

[0150] Example 35 may include the subject matter of one or any combination of Examples 32 to 34, or optionally include, in any combination, identifying the biological substance by comparing the baseline electrical parameters with the sensed electrical parameters.

[0151] Example 36 may include the subject matter of one or any combination of Examples 32 to 35, or optionally include, in combination, identifying a biological substance by determining the concentration of a fluid containing the biological substance.

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

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

[0154] Example 39 may include the subject matter of one or any combination of Examples 32 to 38, or optionally include, in combination, identifying a biological substance by determining a stone structure containing the biological substance.

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

[0156] Example 41 may include the subject matter of one or any combination of Examples 32 to 40, or optionally include, in combination, outputting a visual or audio indicator of the magnitude of an electrical parameter to output an indicator of a biological substance to a user of a medical device.

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

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

[0159] In the event of inconsistent usage between this document and the documents incorporated by reference, the usage of 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 documents, regardless of any other instances, or the use of "at least one" or "one or more". In this document, the term "or" is used to refer to an inclusive one, or, unless otherwise indicated, "A or B" includes "A but not B", "B but not A", and "A and B". In this document, the terms "including" and "in which" are used as plain English synonyms of the respective terms "comprising" and "wherein". Also, in the following claims, the terms "including" and "comprising" are open-ended, i.e., a system, device, article, composition, formulation, or process that includes elements in addition to those recited after such terms within the claims is still considered to fall within the claims. Further, in the following claims, terms such as "first", "second", and "third" are used merely as labels and are not intended to impose numerical requirements on their objects.

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

[0162] The above description is intended to be exemplary and not restrictive. For example, the above examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be used when considering the above description by those skilled in the art. A summary is provided to enable the reader to quickly ascertain the essence of the technical disclosure. The summary is presented with the understanding that it is not to be used to interpret or limit the scope or meaning of the claims. Also, in the forms for carrying out the above invention, various features may be grouped to streamline the disclosure. This should not be regarded as intending that the disclosed features not claimed are essential to any of the claims. Rather, the subject matter of the invention may lie in less than all the features of a particular disclosed embodiment. Accordingly, the following claims are hereby incorporated by reference into the forms for carrying out the invention, as examples or embodiments, with each claim standing on its own as a separate embodiment, and such embodiments are contemplated to be combinable with each other in various combinations and permutations. The scope of the present invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

[Claim 1] A tubular body, Exterior walls, and a tubular body including an internal lumen; a first biliary diagnostic sensor coupled to a medical device, the first biliary diagnostic sensor including a first electrode configured to analyze a biological material in contact with the tubular body; A biliary tract diagnostic device comprising:

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