Position Tracking Device Assemblies and Components

Abstract

The assembly of the medical device may include an elevator configured to raise and lower to adjust the orientation of an instrument inserted through a working channel of the medical device. The elevator may include a magnet. The assembly may also include a sensing element configured to measure the magnetic field of the magnet and output a signal indicative of a configuration of the elevator.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to devices, systems, and methods for medical device assemblies and components. More particularly, aspects of the disclosure relate to devices, systems, and / or methods that include position tracking assemblies or components of medical devices. [Background technology]

[0002] In a medical procedure, an operator may insert a medical device, such as a duodenoscope or other type of scope, into a body lumen of a subject. The operator may guide the distal tip of the medical device to a desired location in the subject's anatomy. For example, in an endoscopic retrograde cholangiopancreatography (ERCP) procedure, the operator may guide the distal tip of the medical device (e.g., the distal tip of a duodenoscope) to the subject's duodenum. The operator may then attempt to cannulate the subject's papilla. Papilla cannulation may require repeated attempts to insert a catheter, sphincterotome, or other instrument into the opening of the papilla. Such repeated attempts may cause trauma to the subject and may cause pancreatitis. An imager (e.g., a camera) at the distal tip of the medical device may facilitate navigation of the instrument for cannulating the papilla, but the imager may not be able to visualize the trajectory of the bile duct, making it difficult for the operator to align the instrument for optimal insertion. For example, the imager may be limited to viewing areas within the wall of a body lumen (e.g., within the wall of the duodenum). Furthermore, the imager may not be able to convey information that an operator desires to use the instrument for a procedure (e.g., a procedure in a duct, such as one of the ducts accessed through a papilla). Thus, a need exists for systems, devices, and / or methods that include a position tracking assembly or component of a medical device. Summary of the Invention

[0003] Each of the aspects disclosed herein may include one or more of the features described in association with any of the other disclosed aspects. The assembly of the medical device may include an elevator configured to raise and lower to adjust the orientation of an instrument inserted through a working channel of the medical device. The elevator may include a magnet. The assembly may also include a sensing element configured to measure the magnetic field of the magnet and output a signal indicative of a configuration of the elevator.

[0004] Any of the aspects disclosed herein may include any of the following features, alone or in combination: The magnet may be diametrically magnetized. The magnet may be disposed in a recess in the shaft of the elevator. The magnet may be generally cylindrical. The magnet may rotate about its longitudinal axis as the elevator is raised and lowered. The sensing element may be further configured to generate a signal indicative of an orientation of the distal tip of the medical device. The sensing element may be configured to measure an alternating external magnetic field to output a signal indicative of an orientation of the distal tip. The sensing element may be configured to measure a static magnetic field of the magnet. The sensing element may include a magnetoresistive sensor. The sensing element may be configured to measure a component of the magnetic field of the magnet along a sensing direction of the magnetoresistive sensor. The axis of the magnet may be configured to be offset from the sensing direction of the magnetoresistive sensor by a first amount in a first configuration of the elevator. The axis of the magnet may be configured to be offset from the sensing direction of the magnetoresistive sensor by a second amount in a second configuration of the elevator. The sensing element may be mounted on a substrate at the distal tip of the medical device. The magnet may be a permanent magnet. The sensing element may be a first sensing element, and the assembly may further include a second sensing element configured to measure a magnetic field of the magnet. The sensing element may be configured to measure a magnetic field of a different magnitude in a fully raised configuration of the elevator than in a fully lowered configuration of the elevator.

[0005] In another example, the assembly of the medical device may include an elevator configured to rise and fall to adjust the orientation of an instrument inserted through the working channel of the medical device. The elevator may include a magnet or an elevator sensor. The sensing element may be configured to provide a signal indicative of a position or orientation of the distal tip of the medical device. At least one of the sensing element or the elevator sensor may be configured to provide a signal indicative of a configuration of the elevator.

[0006] Any of the examples disclosed herein can include any of the following features, alone or in combination: The assembly can include an elevator sensor, which can include a gyroscope sensor; The assembly can include a magnet, and the sensing element can be configured to measure an alternating external magnetic field to output a signal indicative of an orientation of the distal tip; The sensing element can be configured to measure a static magnetic field of the magnet.

[0007] In another example, the medical device assembly may include a distal tip including at least one sensing element configured to measure an alternating magnetic field and a static magnetic field. The alternating magnetic field may be generated external to the subject. The distal tip may include a magnet that generates the static magnetic field. The at least one sensing element is configured to generate a signal indicative of (a) a position or orientation of the distal tip, and (b) an elevator configuration of the distal tip.

[0008] Any of the examples disclosed herein can include any of the following elements, either alone or in combination: The elevator can include a magnet. [Brief description of the drawings]

[0009] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate examples of the present disclosure and, together with the description, serve to explain the principles of the disclosure. [Figure 1A] FIG. 1A is a side view of an exemplary distal tip of a medical device. [Figure 1B] 1B-1C are partially transparent side views of the distal tip of FIG. 1A in a first configuration (FIG. 1B) and a second configuration (FIG. 1C) of the distal tip. [Figure 1C] 1B-1C are partially transparent side views of the distal tip of FIG. 1A in a first configuration (FIG. 1B) and a second configuration (FIG. 1C) of the distal tip. [Diagram 2] FIG. 2 is a side view of a portion of the exemplary distal tip of FIGS. 1A-1C. [Figure 3A] 3A-3C show an exemplary elevator of the exemplary distal tip of FIGS. 1A-1C. [Figure 3B] 3A-3C show an exemplary elevator of the exemplary distal tip of FIGS. 1A-1C. [Figure 3C] 3A-3C show an exemplary elevator of the exemplary distal tip of FIGS. 1A-1C. [Figure 4A] 4A-4C are plan (FIG. 4A), side (FIG. 4B), and perspective (FIG. 4C) views of the elevator of FIGS. 3A-3C and the electronic components of the exemplary distal tip of FIGS. 1A-1C. [Figure 4B] 4A-4C are plan (FIG. 4A), side (FIG. 4B), and perspective (FIG. 4C) views of the elevator of FIGS. 3A-3C and the electronic components of the exemplary distal tip of FIGS. 1A-1C. [Figure 4C] 4A-4C are plan (FIG. 4A), side (FIG. 4B), and perspective (FIG. 4C) views of the elevator of FIGS. 3A-3C and the electronic components of the exemplary distal tip of FIGS. 1A-1C. [Diagram 5] FIG. 5 illustrates an exemplary medical device that can include the exemplary distal tip of FIGS. 1A-1C. [Figure 6A] 6A and 6B are diagrams illustrating an exemplary magnetic field of the exemplary distal tip magnet of FIGS. 1A-1C. [Figure 6B]6A and 6B are diagrams illustrating an exemplary magnetic field of the exemplary distal tip magnet of FIGS. 1A-1C. [Figure 7] FIG. 7 illustrates an exemplary expected output from the exemplary distal tip position sensing system of FIGS. 1A-1C. [Figure 8] FIG. 8 illustrates an alternative distal tip elevator and electronic components. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] It should be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not intended to limit the invention as claimed. As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or device comprising a list of elements does not include only those elements, but may include other elements not expressly listed or elements inherent to such process, method, article, or device. The term "exemplary" is used in the sense of "example" rather than "ideal." The term "distal" refers to a direction away from the operator / toward the treatment site, and the term "proximal" refers to a direction toward the operator. The term "approximately" or similar terms (e.g., "substantially") include values ​​of + / - 10% of the stated value.

[0011] A distal assembly of a medical device, such as a duodenoscope, may include an elevator for adjusting the orientation of an instrument inserted through a working channel of the medical device. The elevator may include a magnet, such as a permanent magnet, disposed thereon or the elevator itself may be a permanent magnet. The distal assembly may include a substrate (e.g., a circuit board) on which elements, such as an imaging element and / or an illumination element, may be mounted. The imaging element may include one or more image sensors or cameras. The illumination element may include one or more (e.g., two) light emitting diodes ("LEDs") or fiber optic light guides. The circuit board may have one or more position sensing systems mounted thereon. For example, the position sensing system may include one or more magnetoresistive ("MR") sensors (i.e., MR elements), one or more diodes (e.g., two diodes), and / or one or more capacitors (e.g., one capacitor). For example, the MR sensor may include a tunneling magnetoresistive ("TMR") sensor (i.e., TMR element). The position sensing system can measure the position and / or orientation of the elevator and / or the distal tip assembly, including the position and / or orientation of those components relative to an external magnetic field generator. For example, the position sensing system can measure the magnetic field emitted by the elevator magnet, and the controller can utilize the measurements to determine the position and / or orientation of the elevator. Information regarding the elevator position and / or orientation can be presented to an operator of the medical device to facilitate positioning of an instrument to be inserted through the working channel of the medical device.

[0012] Due to the elasticity of the mechanical control system (e.g., actuator) for controlling the shaft and elevator of the medical device, the position of the elevator control (e.g., lever or knob) may not reliably reflect the position of the elevator. This can be particularly problematic when using the elevator to adjust the position of a large caliber instrument, because while a large force may be applied to the actuator to displace it, the movement of the elevator itself may be limited. Thus, without the position sensing system of the present disclosure, an operator may rely on images (e.g., video feed) from a camera to observe the position of the instrument as the elevator moves. The camera may provide incomplete information about the position of the instrument, as well as incomplete information about the anatomical structures surrounding the medical device.

[0013] For digital or robotic procedures (or procedures performed by a human operator), feedback on the position of the elevator may be desired to determine the angle of the accessory instruments and assist in the alignment of the bile duct. However, as explained above, the position of the actuator controlling the elevator may not accurately reflect the elevator's position, and the orientation of the instruments inside the elevator would not be accurately known when using a monocular camera view. The disclosed position sensing system can address this issue by providing information regarding the position of the distal tip assembly and / or the elevator. With respect to a human operator (or robotic procedure), the position sensing system can enable the use of an augmented camera view or an augmented three-dimensional ("3D") view in which the operator can see the instrument trajectory, the papilla position, and / or the bile duct trajectory in real time and / or in the same coordinate system. The position sensing system can assist in the cannulation of the papilla with minimal changes to the current ERCP workflow. Thus, the disclosed position sensing system can address one or more problems in the art. For example, the position and / or orientation information can facilitate the cannulation of the subject's papilla and / or the positioning of the instruments operated by the elevator.

[0014] 1A-1C are side views illustrating an embodiment of a distal tip assembly 10 for use with a medical device, such as medical device 100 (FIG. 5) described below. The distal tip assembly 10 may include a core 12 and a cover 14. The core 12 may include the elements of the distal tip assembly 10 mounted therein or thereon, and the cover 14 may be disposed about the core 12. In FIGS. 1A and 1B, a portion of the cover 14 is depicted as transparent to show the features of the distal tip assembly 10. FIG. 2 shows the core 12 and elements of the distal tip assembly 10 without the cover 14.

[0015] The distal tip assembly 10 may also include an elevator 16. The elevator 16 may have any of the characteristics of an elevator, a pivot stand, a swing stand, or a similar structure known in the art. FIGS. 3A-3C show an exemplary embodiment of the elevator 16. FIG. 3A shows a perspective view of the elevator 16, FIG. 3B shows a side view of the elevator 16, and FIG. 3C shows a top view of the elevator 16. The elevator 16 may be rotatable about an axle 18. The axle 18 may be rotatably retained within the distal tip assembly 10 (e.g., within the cover 14 or another portion of the distal tip assembly 10). The elevator 16 may include a guide surface 20 for contacting a medical instrument. The elevator 16 may also include an arm 22 for connecting to a control mechanism, which may include a wire (not shown) of a Bowden cable 24 (FIGS. 1A and 1B). An operator can use an actuator (e.g., actuator 112 of medical device 100 shown in FIG. 5 and described below) on a handle (e.g., handle 110 of medical device 100 shown in FIG. 5 and described below) to move the wire proximally or distally. The distal end of the wire can be attached to arm 22. Proximal movement of the wire can thus rotate elevator 16 to a first, raised configuration (FIGS. 1A and 1B). Distal movement of the wire can rotate elevator 16 to a second, lowered configuration (FIG. 1C).

[0016] As shown in FIGS. 1A-1C, the substrate 30 (e.g., a rigid or flexible circuit board or other type of substrate) can be at least partially disposed within or on the core 12. In some examples, the substrate 30 is rigid and includes multiple layers. The substrate 30 and its elements are shown in particular detail in FIGS. 4A-4C. Each of FIGS. 4A-4C shows the substrate 30 and the elevator 16, with the elevator 16 in a raised configuration. The core 12 and cover 14 are not depicted in FIGS. 4A-4C, but the substrate 30 and the elevator 16 are depicted in the position they would have within the core 12 / cover 14 in the distal tip assembly 10. FIG. 4A shows a plan view of the substrate 30 and the elevator 16 in a raised position, FIG. 4B shows a side view of the substrate 30 and the elevator 16, and FIG. 4C shows a perspective view of the substrate 30 and the elevator 16. An embodiment of the substrate 30 can also be seen in FIGS. 1B, 1C, and 2. The substrate 30 may have electronic components mounted thereon. For example, an imaging device 32 (e.g., a camera including one or more lenses and / or imagers) may be mounted to the substrate 30 by any suitable method (e.g., wire bonding, surface mount assembly, electromechanical assembly, and / or plated through hole techniques). The camera 32 may be configured to capture video and / or still images. The imaging device 32 may provide a signal to a display (e.g., a display of the controller 130 described below with respect to FIG. 5, or a separate display) so that an operator can view visual images provided by the imaging device 32 while navigating the distal tip assembly 10 through the subject's body.

[0017] As shown in particular in FIGS. 2 and 4A-4C, one or more lighting elements 34 (e.g., light emitting diodes ("LEDs"), fibers, or other elements for providing light) may be mounted to the substrate 30 by any suitable method (e.g., wire bonding, surface mount assembly, electromechanical assembly, and / or plated through hole techniques). Although two lighting elements 34 are shown in FIG. 2, any suitable number of lighting elements 34 (e.g., one, three, four, or more lighting elements 34) may be utilized. Alternatively, the lighting elements 34 and the imaging device 32 may be combined into a single device. The conduits 36 may include one or more wires or cables attached to the substrate 30 or elements mounted on the substrate 30 for transmitting power and / or signals to the substrate 30 and / or elements mounted on the substrate 30.

[0018] As shown in Figures 2 and 4A-3C, the lighting elements 34 may be disposed distal to the imaging device 32. For example, the lighting elements 34 may be disposed at the distal-most end of the substrate 30. The lighting elements 34 may be arranged approximately along a longitudinal axis of the distal tip assembly 10 / substrate 30. One lighting element 34 may be distal to another lighting element 34, and the lighting elements 34 may be arranged in a line. Each of the imaging device 32 and the lighting elements 34 may be directly adjacent to one another, or there may be a gap between the imaging device 32 and / or the lighting elements 34.

[0019] As depicted in FIGS. 1A-1C and 2, the distal tip assembly 10 may be "side facing". In other words, the features of the distal tip assembly 10 (e.g., the imaging device 32 and the illumination element 34) may face radially outward (i.e., to the side of the distal tip assembly 10) transversely (e.g., approximately perpendicularly) to the longitudinal axis of the distal tip assembly 10 (and the shaft of the medical device, such as the shaft 114 of the medical device 100 described below). The present disclosure encompasses other configurations of the distal tip 42. For example, the distal tip assembly 10 may be "forward facing" (i.e., facing distally). An instrument exiting a distal opening (not shown) of a working channel (e.g., the working channel 116 of the medical device 100, described below) may also face radially outward. The operator may raise / lower the elevator 16 to change the orientation and / or position of the instrument. As used herein, the term "orientation" includes the rotational configuration of an element (e.g., how an element has been rotated around an axis). As used herein, the term "position" includes the location of an element in a coordinate system. An element can change position and orientation simultaneously.

[0020] The elements of the position sensing system 50 may be disposed on the substrate 30 and may be mounted according to any of the techniques described above for the imaging device 32 and the illumination element 34. The position sensing system 50 may incorporate any of the features described in U.S. Patent Application No. 15 / 846,846, filed December 19, 2017 and issued September 22, 2020 as U.S. Patent No. 10,782,114, or U.S. Patent Application No. 16 / 248,352, filed January 15, 2019 and issued October 12, 2021 as U.S. Patent No. 11,141,567, which are incorporated herein by reference in their entirety. The position sensing system 50 may include one or more magnetic field sensing elements 52a, 52b, 52c disposed on the substrate 30. For example, as shown in FIGS. 4A-4C, three magnetic field sensing elements 52a, 52b, 52c may be disposed on the substrate 30. Any alternative number of sensors may be utilized, and the three magnetic field sensing elements 52a, 52b, 52c shown are merely exemplary. The magnetic field sensing elements 52a, 52b, 52c may have the ability to measure a static magnetic field, which may facilitate tracking the position of the elevator 16, as described below. The magnetic field sensing elements 52a, 52b, 52c may have the ability to measure an alternating magnetic field, which may facilitate tracking the position / orientation of the distal tip assembly 10, as described below. The magnetic field sensing elements 52a, 52b, 52c may include, for example, MR elements, such as TMR elements, anisotropic magnetoresistance sensing elements, giant magnetoresistance sensing elements, colossal magnetoresistance sensing elements, extraordinary magnetoresistance sensing elements, or semiconductor magnetoresistance elements. Additionally or alternatively, the magnetic field sensing elements 52a, 52b, 52c may include one or more fluxgate or Hall effect sensing elements. Although TMR sensors and characteristics of TMR sensors may be mentioned herein, it will be understood that any type of magnetic field sensor, including those listed above, may be utilized. The magnetic field sensing elements 52a, 52b, 52c may have any characteristics of a magnetic field sensing element known in the art (including, for example, an MR element such as a TMR element). For example, the magnetic field sensing elements 52a, 52b, 52c may include a pinned layer, a tunnel layer, and a free layer.The resistance can change when the free layer is aligned with the pinned layer.

[0021] In some examples, the magnetic field sensing elements 52a, 52b, 52c may be arranged in a two-axis, six-degree-of-freedom arrangement, as shown in FIGS. 4A-4C. In such an arrangement, the magnetic field sensing elements 52a, 52b may be oriented such that their primary sensing direction C (FIG. 4B) is aligned (approximately parallel) with the longitudinal axis of the distal tip assembly 10 and the substrate 30, as shown in FIG. 4B. The magnetic field sensing elements 52a, 52b may together generate one signal. As a non-limiting example, a full Wheatstone bridge configuration may be utilized by the two magnetic field sensing elements 52a, 52b. The third magnetic field sensing element 52c may be arranged such that its primary sensing direction is transverse (e.g., approximately orthogonal / perpendicular) to the longitudinal axis. In some non-limiting examples, a half Wheatstone bridge configuration may be utilized by the magnetic field sensing element 52c. The Wheatstone bridge may have any of the characteristics of a Wheatstone bridge known in the art. The magnetic field sensing elements 52a, 52b, 52c can detect the orientation / position of the distal tip assembly 10 and can transmit signals indicative of the orientation / position of the distal tip assembly 10. A controller (such as controller 130 of FIG. 5 described below) can receive the signals and use measurements from the magnetic field sensing elements 52a, 52b, 52c across a primary sensing direction (from magnetic field sensing elements 52a, 52b) and a direction transverse (e.g., perpendicular) to the primary sensing direction (from magnetic field sensing element 52c) to calculate the position of the distal tip assembly 10.

[0022] The position sensing system 50 may optionally include a capacitor 54 (shown in FIG. 4A ) to reduce noise in the voltage supplied to the position sensing system 50. For example, the capacitor 54 may function as a decoupling capacitor and act as a low pass filter for any electromagnetic interference ("EMI") on the supply voltage. The position sensing system 50 may optionally include one or more diodes 56 (shown in FIG. 4A ). The diodes 56 may provide high voltage protection, such as electrostatic discharge ("ESD") protection. The diodes 56 may prevent damage to the magnetic field sensing elements 52a, 52b, 52c from electrostatic discharge. The diodes 56 may additionally or alternatively provide protection for aspects of the camera 32.

[0023] Other components, such as one or more integrated circuits, may also be disposed on the substrate 30. In some examples, the integrated circuits may digitize and / or multiplex signals from multiple elements of the substrate 30, including, for example, elements of the position sensing system 50. Such integrated circuits may reduce the number of wires required to pass through the conduit 36.

[0024] The elevator 16 may include a magnet 60, which may include a permanent magnet. As shown in FIG. 3A in particular, the magnet 60 may have a generally cylindrical or disk shape. The magnet 60 may be diametrically magnetized such that the axis of the magnet 60 (line B extending between the south and north poles of the magnet 60, shown in FIG. 4B) may extend along the diameter of a cross-section of the magnet 60, the cross-section being perpendicular to the longitudinal axis of the magnet 60. As shown in FIG. 3A in particular, the magnet 60 may include a first polarized portion 62 (e.g., a north polarized portion) and a second polarized portion 64 (e.g., a south polarized portion). As shown in FIG. 3A in particular, each of the first polarized portion 62 and the second polarized portion 64 may have a generally semicircular cross-sectional shape, the cross-section being perpendicular to the longitudinal axis of the magnet 60. The magnet 60 may be made of any suitable material. For example, magnet 60 may include a neodymium magnet (e.g., a grade N52 neodymium magnet) or another type of rare earth magnet. Magnet 60 may be coupled to elevator 16 in any suitable manner and may be located on or in various portions of elevator 16.

[0025] As shown in FIGS. 3A-3C, the shaft 18 of the elevator 16 may have a recess 66 formed therein. The recess 66 may have a generally cylindrical shape. The shape of the recess 66 may be complementary to the shape of the magnet 60. The recess 66 may be formed on an end of the shaft 18 opposite the arm 22 (the side of the shaft 18 closer to the substrate 30, including the position sensing system 50). In other words, the recess 66 may be formed on an end of the shaft 18 that faces in a radially inward direction of the distal tip assembly 10. The magnet 60 may be disposed within the recess 66. The material of the magnet 60 may be biocompatible. For example, the magnet 60 may not be nickel coated because the subject may be allergic to nickel. Additionally or alternatively, the magnet 60 may be fully encapsulated within the elevator 16 and / or medical grade epoxy. For example, the magnet 60 may be disposed within the recess 60, which may be coated with medical grade epoxy. The magnet 60 may include materials or other properties that enable the magnet 60 to withstand sterilization procedures (e.g., heat) that a medical device having the distal tip assembly 10 (e.g., medical device 100) may be subjected to.

[0026] The position sensing system 50 may be configured to measure changes in the magnetic field of the magnet 60 as the elevator 16 moves between a raised and lowered configuration (i.e., rotates about the shaft 18 of the elevator 16). For example, as described in more detail below, one or more of the magnetic field sensing elements 52a, 52b, 52c may measure the magnetic field of the magnet 60, including changes in the magnetic field, as the elevator 16 moves. In the example shown in FIGS. 1A-4C, the magnetic field sensing elements 52a, 52b (magnetic field sensing elements having a major axis aligned along the longitudinal axis of the distal tip assembly 10) may measure the magnetic field of the magnet 60. For example, the north and south poles of the diametrically magnetized magnet 60 shown may rotate with the shaft 18, changing the magnetic field of the magnet 60 as the elevator 16 moves.

[0027] In one example, in a first configuration of the elevator 16 (e.g., a fully raised configuration of the elevator 16), the axis B of the magnet 60 may be offset from the primary sensing direction C of the magnetic field sensing elements 52a, 52b by about 0 degrees. In a second configuration of the elevator 16 (e.g., a fully lowered configuration of the elevator 16), the axis B of the magnet 60 may be offset from the primary sensing direction C of the magnetic field sensing elements 52a, 52b by about 63 degrees. The distance between (a) the top of the magnet 16 in FIG. 4B and (b) the magnetic field sensing elements 52a, 52b (e.g., the midpoint between the magnetic field sensing elements 52a, 52b) may be approximately constant (e.g., about 4.1 mm along the z-axis of FIG. 4B and / or about 1 mm along the y-axis of FIG. 4B, or any other suitable distance). The distances and angles provided above are merely exemplary and any suitable distances and angles may be utilized.

[0028] Although a cylindrical, diametrically magnetized magnet 60 is shown in FIGS. 1B-3A, the magnet 60 may have any suitable shape and pole arrangement. The magnet 60 may be suitable for use with an elevator 16 where the magnetic field emitted by the magnet 60 changes as the elevator 16 moves between a raised and lowered configuration. Although the magnet 60 is shown disposed within the shaft 18, the magnet 60 may alternatively be disposed on or within other portions of the elevator 16. Additionally or alternatively, a portion or the entire elevator 16 may include a magnet. In one example, the elevator 16 may be formed from a single monolithic piece and may be magnetic. The type of magnet 60 (e.g., shape, pole arrangement, material, etc.) may be selected based on the location where the magnet 60 is disposed on or within the elevator 16. The strength of the magnet 60 may be selected such that the magnetic field of the magnet 60 can be measured by the magnetic field sensing elements 52a, 52b, 52c without saturating the position sensing system 50. For example, it may be desirable for the magnet 60 to emit a strong magnetic field, but not so strong that the magnetic field saturates the position sensing system 50. Relatedly, the relative positions of the elements of the position sensing system 50 (e.g., one or more magnetic field sensing elements 52a, 52b, 52c) and the magnet 60 (including, e.g., the distance between the one or more magnetic field sensing elements 52a, 52b, 52c and the magnet 60) may be selected to avoid saturation of the position sensing system 50 while providing a strong magnetic field from the magnet 60 at the locations of the one or more magnetic field sensing elements 52a, 52b, 52c and the magnet 60.

[0029] The elements of the position sensing system 50 can be placed anywhere on the substrate 30, close enough to the magnet 60 and far enough away from high permeability materials that may alter the magnetic field of the magnet 60. For example, referring to the coordinates of FIG. 4B, a portion or all of the magnet 60 may be generally under the portion of the substrate 30 having the magnetic field sensing elements 52a, 52b, and / or 52c. In one example, the magnet 60 may be about 4.1 mm away from the magnetic field sensing elements 52a, 52b, and / or 52c. The small size of the elements of the position sensing system 50 allows the elements to be placed in free areas of the substrate 30 without reconfiguring the substrate 30. Thus, the position sensing system 50 can be added to an existing device with minimal design changes. Because the magnetic field sensing elements 52a, 52b can be used to generate one signal, the magnetic field sensing elements 52a, 52b may be placed on the substrate 30 such that the midpoint between the elements 52a, 52b is the point at which the magnetic field of the magnet 60 is measured. For example, the magnet 60 may be approximately below the midpoint between the magnetic field sensing elements 52a, 52b in the coordinate system of FIG. 4B (i.e., a coordinate system in which the camera 32 and / or the lighting element 34 face generally upward). For example, the magnet 60 may be approximately 4.1 mm below the midpoint in the z-direction of FIG. 4B. The magnet 60 may be radially offset from the magnetic field sensing elements 52a, 52b or may be directly below the magnetic field sensing elements 52a, 52b. In one example, as shown in FIGS. 4A-4C, the magnet 60 may be offset from the magnetic field sensing elements 52a, 52b by approximately 1 mm in the y-direction of FIG. 4B. The distance between the magnet 60 and the midpoint between the magnetic field sensing elements 52a, 52b is merely exemplary and any suitable arrangement may be utilized.

[0030] Alternative configurations (not shown) of the substrate 30 and magnet 60 may allow for measurement of stronger regions of the magnetic field of the magnet 60 along the dipole axis of the magnet 60. For example, one or more of the magnetic field sensing elements 52a, 52b, 52c may be configured to sense the z-direction of FIG. 4B or other directions. Alternatively or additionally, one or more of the magnetic field sensing elements 52a, 52b, 52c may measure along different directions from each other. Alternatively or additionally, the magnet 60 may be moved such that the axis B (see FIG. 4B) of the magnet 60 is aligned with the one or more magnetic field sensing elements 52a, 52b, 52c (i.e., not offset along the z-axis of FIG. 4B). The above alternative configurations are merely exemplary and other configurations may be utilized.

[0031] The position sensing system 50 may have other configurations within the scope of the present disclosure. For example, a three-axis configuration may be utilized for the magnetic field sensing elements 52a, 52b, 52c, with each of the magnetic field sensors positioned such that its primary sensing direction is aligned with a different axis (e.g., the primary sensing directions of the magnetic field sensing elements 52a, 52b, 52c are aligned orthogonal to each other). For example, the magnetic field sensing element 52a may have a primary sensing direction of the X-axis. The magnetic field sensing element 52b may have a primary sensing direction of the Y-axis, and the magnetic field sensing element 52c may have a primary sensing direction of the Z-axis. In such a three-axis configuration, each of the magnetic field sensing elements 52a, 52b, 52c may utilize a half-Wheatstone bridge configuration. In another example, only two magnetic field sensors (e.g., the magnetic field sensing elements 52a, 52b) may be utilized to measure six degrees of freedom, with each of the magnetic field sensing elements 52a, 52b having a half-Wheatstone bridge configuration (or a full Wheatstone bridge configuration). In a further example, two magnetic field sensors (e.g., magnetic field sensing elements 52a, 52b) can be used to measure five degrees of freedom. In such an example, the position sensing system 50 may not be able to measure roll. In an additional example, a single magnetic field sensing element 52a can measure five degrees of freedom using a half Wheatstone bridge.

[0032] All or a subset of the magnetic field sensing elements 52a, 52b, 52c may be used to measure the magnetic field of the magnet 60, depending on the configuration of the position sensing system 50. For example, three magnetic field sensing elements (e.g., 52a, 52b, 52c), two magnetic field sensing elements (e.g., 52a, 52b as shown in FIGS. 1A-4C), or one magnetic field sensing element (e.g., 52a) may be used to measure the magnetic field of the magnet 60. In the configuration shown in FIGS. 1A-4C, each magnetic field sensing element 52a, 52b can measure the magnetic field only along a single axis (and the magnetic field sensing elements 52a, 52b have the same sensing axis), so the magnetic field sensing elements 52a, 52b cannot measure the magnetic field perpendicular to the surface of the substrate 30 on which the magnetic field sensing elements 52a, 52b are mounted.

[0033] The above examples are merely illustrative and other configurations of magnetic field sensors may be utilized. As shown in Figures 1A-4C, a system utilizing three magnetic field sensing elements 52a, 52b, 52c in a two-axis, six-degree-of-freedom configuration may be beneficial to measure six degrees of freedom as well as the position / orientation of the elevator 16. Alternative configurations for the lighting elements 34 and imaging elements 32 may also be used.

[0034] The distal tip assembly 10 may include multiple components in addition to or as an alternative to the components described above. For example, the distal tip assembly 10 may include additional or alternative illumination sources and / or additional or alternative imaging components (e.g., additional cameras). The distal tip assembly 10 may include additional types of sensors, such as moisture sensors, temperature sensors, pressure sensors, or other types of sensors that may be useful during a medical procedure.

[0035] FIG. 5 illustrates an exemplary medical device 100. In some examples, the medical device 100 may include a duodenoscope or endoscope. Although the present disclosure may refer to a duodenoscope or endoscope at different points, it should be understood that a bronchoscope, endoscope, gastroscope, endoscopic ultrasound ("EUS") scope, colonoscope, ureteroscope, laparoscope, cytoscope, suction scope, sheath, catheter, or any other suitable delivery device or medical device may be used in conjunction with the elements and assemblies described herein unless otherwise specified. The exemplary medical device 100 may include a handle 110 and a shaft 114. The shaft 114 may extend distally from the handle 110. The shaft 114 may terminate distally at a distal tip 118 and may have any of the properties of the distal tip assembly 10. The working channel 116 can extend from the handle 110, through the shaft 114, to an opening (not shown) at the distal tip 118. The handle 110 can include actuators and / or other controls. For example, the handle 110 can include an actuator 112. The actuator 112 can include, for example, a lever or other type of actuator (e.g., a button, slider, knob, or joystick). The actuator 112 can be actuated to raise and / or lower the elevator 16. The handle 110 can also include an actuator 120. The actuator 120 can include, for example, a knob or other type of actuator (e.g., a button, slider, lever, or joystick). Although FIG. 5 shows two actuators 120 (e.g., one actuator 120 for up / down movement and one actuator 120 for left / right movement), any suitable number of actuators 120 can be utilized. The actuator 120 may be utilized to steer (e.g., articulate) a distal portion of the shaft 114. An umbilicus 132 may extend between the medical device 100 and the controller 130. The umbilicus 132 may transmit power, signals, air, water, suction, or other fluids between the controller 130 and the medical device 100.In one example, air / water and / or suction provided by controller 130 via umbilicus 132 may be delivered to distal tip assembly 10 via conduit 80 (see FIG. 1A).

[0036] 6A and 6B illustrate the magnetic field of a diametrically magnetized cylindrical magnet 60 and the position of a magnetic field sensing element (e.g., one or more of magnetic field sensing elements 52a, 52b, 52c) relative to the magnet 60. FIG. 6A is drawn from the reference frame of the magnet 60. In particular, the reference frame of FIG. 6A shows the south pole of the magnet 60 on the left and the north pole of the magnet 60 on the right, as shown in inset 212 of FIG. 6A. Inset 212 shows a cross-sectional view of the magnet 60 with axis B extending from the south pole of the magnet 60 to the north pole of the magnet 60. Although the magnetic field illustrated in FIGS. 6A and 6B is for a diametrically magnetized cylindrical magnet 60, similar diagrams can be created for other types of magnets, and the steps described below for calibrating the controller 130 and / or position sensing system 50 apply to various types of magnets 60 and configurations of the magnet 60 and sensing system 50.

[0037] FIG. 6A shows a graph 200 in which the horizontal and vertical axes represent distance (mm) from the center of the circular cross section of the magnet 60. For example, FIG. 6A can show the magnetic field 210 of the magnet 60 at the location of one or more magnetic field sensing elements 52a, 52b, 52c. The shaded areas indicate areas of magnetic field 210 of different strength, as shown in the key 220 on the right side of FIG. 6A. The arrows indicate the direction of the magnetic field. The rectangle 230 represents one or more magnetic field sensing elements 52a, 52b, 52c. For example, the rectangle 230 can represent one magnetic field sensing element 52a or two magnetic field sensing elements 52a, 52b. The dashed arc 240 can show the path of the magnetic field sensing elements 52a, 52b, and / or 52c relative to the magnet 60.

[0038] Rectangle 230 may represent the position of magnetic field sensing elements 52a, 52b, and / or 52c when elevator 16 is in an elevated position / configuration / orientation (e.g., fully elevated position). The opposite end of arc 240 of rectangle 230 may represent the position of magnetic field sensing elements 52a, 52b, and / or 52c when elevator 16 is in a lowered position / configuration / orientation (e.g., fully lowered position). The distance between the top of magnet 60 in FIG. 4B and magnetic field sensing elements 52a, 52b, and / or 52c in the distal assembly configuration shown in FIGS. 1A-4C may be about 4.6 mm (along the z-axis in FIG. 4B). Magnetic field sensing elements 52a, 52b, and / or 52c may be offset from magnet 60 by about 1 mm in the y-direction in FIG. 4B. However, any alternative distance may be utilized and the distance need not remain constant.

[0039] FIG. 6B shows diagram 250 in which magnet 60 has been rotated to show magnetic field 260 of magnet 60 when elevator 16 is in an intermediate position / configuration / orientation between a fully raised configuration and a fully lowered configuration. The shaded areas indicate areas of magnetic field 260 of different strengths (as shown in key 220 on the right side of FIG. 6A). The arrows indicate the direction of the magnetic field. Key 220 also applies to diagram 250. Rectangle 270 represents one or more magnetic field sensing elements 52a, 52b, 52c. For example, rectangle 270 can represent one magnetic field sensing element 52a or two magnetic field sensing elements 52a, 52b. Dashed arc 280 can show the path of magnetic field sensing elements 52a, 52b, and / or 52c relative to magnet 60. Although magnetic field 260 has been rotated relative to magnetic field 210, arcs 240 (FIG. 6A) and 290 (FIG. 6B) can intersect the same portion of the magnetic field of magnet 60. Figure 6A can represent the position of the magnet 60 at a first time, and Figure 6B can represent the position of the magnet at a second time. Rectangle 230 can represent the position of the one or more magnetic field sensing elements 52a, 52b, 52c at a first time, and rectangle 270 can represent the position of the one or more magnetic field sensing elements 52a, 52b, 52c at a second time.

[0040] Computer modeling software (e.g., MATLAB and / or Python) may be used to determine the magnetic fields measured by one or more of the magnetic field sensing elements 52a, 52b, 52c along the arcs 240, 280. This information may be utilized to interpret signals received by one or more of the magnetic field sensing elements 52a, 52b, 52c during operation of the device 100 including the distal tip assembly 10. For example, the controller 130 may be programmed with information correlating readings from one or more of the magnetic field sensing elements 52a, 52b, 52c with the position of the elevator 16.

[0041] In one example, arcs 240 (FIG. 6A) and 280 (FIG. 6B) may each depict a path of magnet 60 having axis B of magnet 60 offset by approximately 0 degrees from the primary sensing direction C of magnetic field sensing elements 52a, 52b when elevator 16 is in a fully raised configuration. In a fully lowered configuration of elevator 16, axis B of magnet 60 may be offset by approximately 63 degrees from the primary sensing direction C of magnetic field sensing elements 52a, 52b. The angles provided above are merely exemplary and any suitable angles may be utilized.

[0042] In one example, as shown in Figures 6A and 6B, the magnetic field of the elevator 16 at the location of the magnetic field sensing elements 52a, 52b may be stronger when the elevator 16 is in a fully lowered position than when the elevator 16 is in a fully raised position. However, the angle between the magnetic field and the magnetic field sensing elements 52a, 52b may change as the elevator 16 moves from a fully raised configuration to a fully lowered configuration. The angle between the axis B of the magnet 60 and the sensing direction C of the magnetic field sensing elements 52a, 52b may be smaller in the fully raised configuration (e.g., about 0 degrees) than in the fully lowered configuration (e.g., about 63 degrees), so that the component of the magnetic field of the magnet 60 along the sensing direction C may be larger in the fully raised configuration than in the fully lowered configuration. In other words, the sensing direction C may be more aligned with the magnetic field of the magnet 60 in the raised configuration than in the lowered configuration.

[0043] FIG. 7 illustrates a graph 700 showing the output 710 (in volts) of one or more of the magnetic field sensing elements 52a, 52b, 52c versus the angle of the elevator 16 (0 degrees being the fully raised / closed position of the elevator 16). As mentioned above, in one example, the output 710 shown in FIG. 7 may be the output of the magnetic field sensing elements 52a, 52b. Although two magnetic field sensing elements 52a, 52b are mentioned above and below, the use of two magnetic field sensing elements 52a, 52b is merely exemplary and any suitable number (as little as one magnetic field sensing element 52a) may be utilized. In the above example, at the location of the magnetic field sensing elements 52a, 52b, the strength (i.e., magnitude) of the magnetic field may be greater when the elevator 16 is in a fully lowered configuration than when the elevator 16 is in a fully raised configuration. However, as explained above, the magnetic field sensing elements 52a, 52b only measure the magnetic field along their sensing direction C. Also, because the vector component of the magnetic field of magnet 60 along sensing direction C may be greater in the fully up configuration than in the fully down configuration, as explained above, magnetic field sensing elements 52a, 52b may actually measure a greater magnetic field magnitude in the fully up configuration than in the fully down configuration because the magnetic field is more aligned with sensing direction C in the fully up configuration than in the fully down configuration.

[0044] The expected output 710 from the magnetic field sensing elements 52a, 52b can be calculated by multiplying the vector component of the magnetic field aligned with the sensing direction C by the linear sensitivity of the magnetic field sensing elements 52a, 52b (which can be a known value). As shown in FIG. 7, the output 710 (e.g., voltage) from the magnetic field sensing elements 52a, 52b can be maximum in the fully up configuration of the elevator 16, and the voltage from the magnetic field sensing elements 52a, 52c can be minimum in the fully down configuration of the elevator 16. The signal response of the magnetic field sensing elements 52a, 52b can be nonlinear. The signal response of the magnetic field sensing elements 52a, 52b (or other combinations of magnetic field sensing elements) can be modeled to make design choices for optimal measurement.

[0045] Prior to using the medical device 100 including the position sensing system 50, the controller 130 and / or the position sensing system 50 may be calibrated. For example, as described above with respect to FIGS. 6A-6B, the magnetic field (including magnitude and direction) of the magnet 60 at various relative positions of the magnetic field sensing elements 52a, 52b, and / or 52c may be determined. As described with respect to FIG. 7, the response of the magnetic field sensing elements 52a, 52b, and / or 52c to various magnetic fields may be determined. The determined response may be used to interpret signals from the position sensing system 50 during a procedure. Based on the signals of the magnetic field sensing elements 52a, 52b, and / or 52c, the magnetic field of the magnet 60 and / or the position of the elevator 16 may be determined.

[0046] The medical device 100 including the distal tip assembly 10 may be used to perform a medical procedure on a subject. The procedure may be performed robotically and / or by a human operator. For example, the medical device 100 may be inserted into a body lumen (e.g., the duodenum) of the subject. During the procedure, an external device may be used to generate a magnetic field near the subject. The generated magnetic field may be, for example, an alternating magnetic field (e.g., 1250 Hz frequency). For example, the external device may be placed on a table or other surface near the subject (e.g., near a part of the body where the body lumen is located). The operator may activate the actuator 112 to adjust the position of the elevator 16.

[0047] During a procedure, the position sensing system 50 (including magnetic field sensing elements 52a, 52b, 52c) can transmit signals through the shaft 114 to the handle 110 and through the umbilicus 132 to the controller 130. The signals from the position sensing system 50 can indicate the position and / or orientation of the distal tip 118 (including the distal tip assembly 10) within the body. The signals from the position sensing system 50 can also indicate the position of the elevator 16.

[0048] As explained above, the one or more magnetic field sensing elements 52a, 52b, 52c may be capable of measuring a static magnetic field. Although the elevator 16 may move, the magnetic field emitted by the magnet 60 may be essentially static compared to the alternating magnetic field of the external magnetic field generating device described above. Thus, the one or more magnetic field sensing elements 52a, 52b, 52c may be capable of simultaneously measuring the alternating external magnetic field and the static magnetic field of the magnet 60. For example, the controller 130 may be programmed to separate the output from the magnetic field sensing elements 52a, 52b, 52c into (a) a component associated with the external alternating magnetic field and (b) a component associated with the elevator 16. The controller 130 may be programmed to identify and filter out a portion of the output from the magnetic field sensing elements 52a, 52b, 52c that is due to the earth's magnetic field. Thus, the controller 130 may determine the position and / or orientation of the distal tip assembly 10 and / or the position of the elevator 16 based on the output from the magnetic field sensing elements 52a, 52b, 52c.

[0049] The position and / or orientation information of the distal tip assembly 10 and / or information regarding the elevator 16 position may be fused with imaging (e.g., 3D imaging) performed prior to the procedure. For example, the position sensing system 50 may enable the use of an extended camera view or an extended three-dimensional ("3D") view that allows the operator to view the instrument trajectory, the papilla position, and / or the bile duct trajectory in real time and / or in the same coordinate system. The position sensing system may assist in cannulation of the papilla with minimal modification to the current ERCP workflow. Information from the position sensing system 50 may provide the operator with information regarding anatomical structures near the device 100 (including anatomical structures outside the body lumen in which the device 100 is placed) that cannot be visualized by the camera 32 alone. For example, the position sensing system 50 may provide information regarding the common bile duct and pancreatic bile duct through the wall of the duodenum. The position sensing system 50 may assist in the positioning of the distal tip assembly 10 and the positioning of the instrument with the elevator 16 to facilitate cannulation of the papilla and / or performance of the procedure with the instrument.

[0050] Additionally, the pre-treatment images may be used to automatically segment a mesh of the anatomical structure to provide a map (e.g., a 3D map) for tracking the medical device 100 in real time. Such real-time tracking may reduce the amount of time, skill, and / or effort required to reach the target anatomical structure. In the absence of pre-treatment images, the position sensing system 50 may enable software to track the position of the device 100 and the movement of the device 100 to generate a map (e.g., a 3D map) in real time during the procedure. The generated map may guide the medical device 100 (and any EM-enabled accessories) through the subject's anatomy. The medical device 100 may be utilized with any technology now known or to become known, including MR image fusion, pre-operative CT image fusion, electromagnetic (EM) tracking, artificial intelligence-based automatic tissue segmentation, augmented reality, 3D visualization, and / or fully robotically controlled endoscopy.

[0051] The controller 130 may include a display or may send signals to an external display (not shown). The display may present information to the operator regarding the position and / or orientation of the distal tip assembly 10 and / or the position of the elevator 16. For example, the display may present a 3D view and / or a virtual reality view to the operator. The display may also present information regarding the position of the elevator 16. For example, the display may present information regarding the angle of the elevator 16 and / or the relative position between the instrument and the nipple or other structure.

[0052] FIG. 8 illustrates elements of an alternative distal tip assembly 810 that may include any of the characteristics of the distal tip assembly 10, except as specified below. Elements such as the core 12 and cover 14 are not shown, but it will be understood that the distal tip assembly 810 may include such elements, as well as other elements shown and / or discussed with respect to the distal assembly 10. The distal tip assembly 810 may include an elevator 816 that may include any of the features of the elevator 16, except as specified herein. The elevator 816 may have an elevator sensor 860 coupled thereto. The elevator sensor 860 may include, for example, any type of gyro sensor, including, by way of example, an inertial measurement unit. The elevator sensor 860 may be located in any suitable location on the elevator 816, such as on a side of the elevator 816 (as shown in FIG. 8), on the shaft 818 of the elevator 816, or on the lever arm 817 of the elevator 816. The elevator sensor 860 may be coupled (e.g., mechanically coupled) to the elevator 816, may be enclosed within the elevator 816, or may be otherwise disposed on or within the elevator 816.

[0053] The substrate 830 can have a position sensing system 850 mounted thereon. The position sensing system 850 can include a plurality of sensing elements 852a, 852b, 852c (or other elements of the distal tip assembly 810) having any suitable location / configuration on the substrate 830. The sensing elements 852a, 852b, 852c can include, for example, accelerometer and / or gyroscope sensors. Although three sensing elements 852a, 852b, 852c are shown, any suitable number and arrangement of sensing elements can be utilized (including fewer or more sensors). The sensing elements 852a, 852b, and / or 852c can generate a signal indicative of the position / orientation of the distal tip assembly 810 (e.g., substrate 860).

[0054] A controller (e.g., controller 130) may have the capability to analyze the output from the position sensing system 850 and / or elevator sensor 860. For example, controller 130 may determine which component(s) of the signal from elevator sensor 860 is due to the overall motion of the distal tip assembly 810, rather than only from elevator 816. In some examples, data from sensing elements 852a, 852b, and / or 852c may be used to identify the overall motion of the distal tip assembly 810. Controller 130 may be programmed with an algorithm to determine which motions identified by elevator sensor 860 are due to the elevator 816 rising / lowering (i.e., independent motion of elevator 816 relative to elements such as substrate 830 and components mounted thereon) rather than due to the motion of distal tip assembly 810 as a whole, and to undo the overall motion of the distal tip. In comparison to the use of distal tip assembly 10, the use of distal tip assembly 810 may not involve the generation of an external magnetic field.

[0055] Because the elevator sensor 860 and / or position sensing system 850 may only measure acceleration (used to approximate displacement), cumulative errors may occur. The distal tip assembly 810 may be periodically calibrated to compensate for cumulative errors. For example, the calibration may set a baseline measurement of a known position. In one example, to calibrate the elevator sensor 860, an operator may bring the elevator 816 all the way up (or all the way down). An additional sensor (not shown) may indicate (e.g., provide an indication signal) when the elevator 816 is all the way up (or all the way down). Additionally or alternatively, the operator may press a button to confirm that the elevator 816 is all the way up (or all the way down) to calibrate (e.g., "zero") the position of the elevator sensor 860. In one example, to calibrate position sensing system 850 of substrate 830, software (e.g., in controller 130) can correlate information shown by camera 32 with, for example, 1) information previously mapped into a three-dimensional coordinate system (which may be generated from simultaneous localization and mapping ("SLAM") or another algorithm) and / or 2) information obtained from pre-operative images, such as a computed tomography ("CT") or magnetic resonance imaging ("MRI") scan.

[0056] Any method or portion of a method described in this disclosure may be executed by one or more processors of a computer system (e.g., of the controller 130). The one or more processors may be configured to execute such a method by accessing instructions (e.g., software or computer readable code) that, when executed by the one or more processors, configure the one or more processors to execute the method and / or cause the one or more processors to execute the method. Such instructions may be stored in a memory of the computer system.

[0057] The instructions executable by one or more processors may be stored in a non-transitory computer-readable medium. Thus, whenever a computer-implemented method is described in this disclosure, the present disclosure should also be understood as describing a non-transitory computer-readable medium that stores instructions that, when executed by one or more processors of a computer system, configure the one or more processors to perform the computer-implemented method and / or cause the one or more processors to perform the computer-implemented method. Examples of non-transitory computer-readable media include RAM, ROM, solid-state storage media (e.g., solid-state drives), optical storage media (e.g., optical disks), and magnetic storage media (e.g., hard disk drives). The non-transitory computer-readable medium may be part of the memory of the computer system or may be separate from the computer system.

[0058] A computer system may include one or more computing devices. When a computer system includes multiple processors, the multiple processors may be included in a single computing device or distributed among multiple computing devices. A processor may be a central processing unit (CPU), a graphics processing unit (GPU), or another type of processing unit. As used in this disclosure, the term "computing device" is interchangeable with "computing device." An "electronic storage device" may include any of the non-transitory computer-readable media described above.

[0059] Although the principles of the present disclosure are described herein with reference to illustrative examples for particular applications, it should be understood that the present disclosure is not limited thereto. Those skilled in the art with access to the teachings provided herein will recognize additional modifications, applications, and equivalent substitutions that are all within the scope of the examples described herein. Thus, the present invention should not be considered as limited by the foregoing description.

Claims

1. A medical device assembly, An elevator configured to move up and down to adjust the orientation of an instrument inserted through the working channel of the medical device, the elevator including a magnet, A sensing element configured to measure the magnetic field of the magnet and output a signal indicating the configuration of the elevator, An assembly comprising:

2. The assembly according to claim 1, wherein the magnet is magnetized in the diametrical direction.

3. The assembly according to claim 1 or 2, wherein the magnet is disposed within a recess in the shaft portion of the elevator.

4. The assembly according to claim 1 or 2, wherein the magnet is substantially cylindrical.

5. The assembly according to claim 1 or 2, wherein the magnet rotates about its longitudinal axis when the elevator is raised and lowered.

6. The assembly according to claim 1 or 2, wherein the sensing element is further configured to generate a signal indicating the orientation of the distal tip of the medical device.

7. The assembly according to claim 6, wherein the sensing element is configured to measure an alternating external magnetic field in order to output the signal indicating the orientation of the distal tip.

8. The assembly according to claim 7, wherein the sensing element is configured to measure the static magnetic field of the magnet.

9. The assembly according to claim 1 or 2, wherein the sensing element includes a magnetoresistive sensor.

10. The assembly according to claim 9, wherein the sensing element is configured to measure the component of the magnetic field of the magnet along the sensing direction of the magnetoresistive sensor.

11. The assembly according to claim 10, wherein the axis of the magnet is configured to be offset by a first amount from the sensing direction of the magnetoresistive sensor in the first configuration of the elevator, and the axis of the magnet is configured to be offset by a second amount from the sensing direction of the magnetoresistive sensor in the second configuration of the elevator.

12. The assembly according to claim 1 or 2, wherein the sensing element is mounted on a substrate at the distal tip of the medical device.

13. The assembly according to claim 1 or 2, wherein the magnet is a permanent magnet.

14. The assembly according to claim 1 or 2, wherein the sensing element is a first sensing element, and the assembly further comprises a second sensing element configured to measure the magnetic field of the magnet.

15. The assembly according to claim 1 or 2, wherein the sensing element is configured to measure a magnetic field of a different magnitude in the fully raised configuration of the elevator than in the fully lowered configuration of the elevator.

Images