Position tracking device assemblies and components

Abstract

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

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 362,763, filed on April 11, 2022, and U.S. Provisional Application No. 63 / 374,107, filed on August 31, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present disclosure generally relates to apparatus, systems and methods for medical device assemblies and components. More specifically, aspects of the present disclosure relate to apparatus, systems and / or methods that include position tracking assemblies or position tracking components of medical devices. Background Art

[0003] In a medical procedure, an operator may insert a medical device (e.g., a duodenoscope or other type of endoscope) into a body cavity of a subject. The operator may guide the distal tip of the medical device to the desired position of the subject's anatomical structure. For example, in an endoscopic retrograde cholangiopancreatography ("ERCP") procedure, an operator may guide the distal tip of a medical device (e.g., the distal tip of a duodenoscope) to the duodenum of a subject. The operator may then attempt to cannulate the subject's mastoid. Cannulation of the mastoid may require repeated attempts to insert a catheter, sphincterotomy device, or other instrument into the mastoid orifice. Repeated attempts may cause trauma to the subject, which may lead to pancreatitis. An imager (e.g., a camera) at the distal tip of the medical device may help guide the instrument to cannulate the mastoid, but the imager may not be able to display 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 the body cavity (e.g., within the wall of the duodenum). Additionally, the imager may not convey information needed by an operator to perform a procedure using an instrument, such as performing a procedure in a duct, such as one of the ducts passing through the mastoid. Therefore, there is a need for systems, devices, and / or methods that include position tracking assemblies or position tracking components of medical devices. Summary of the invention

[0004] Each aspect disclosed herein may include one or more features described in relation to any other disclosed aspect.

[0005] The medical device assembly 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 indicating the configuration of the elevator.

[0006] Any aspect disclosed herein may include any of the following features, alone or in combination. The magnet may be magnetized in a diametrical direction. The magnet may be arranged in a groove of a shaft of the lifter. The magnet may be substantially cylindrical. When the lifter is raised and lowered, the magnet may rotate about a longitudinal axis of the magnet. The sensing element may be further configured to generate a signal indicating the 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 indicating the 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. In a first configuration of the lifter, the axis of the magnet may be configured to be offset by a first amount from the sensing direction of the magnetoresistive sensor. In a second configuration of the lifter, the axis of the magnet may be configured to be offset by a second amount from the sensing direction of the magnetoresistive sensor. 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 the magnetic field of the magnet. The sensing element may be configured to measure a different magnitude of the magnetic field in the fully raised configuration of the elevator than in the fully lowered configuration of the elevator.

[0007] In another example, a component of a 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 or an elevator sensor. The sensing element may be configured to provide a signal indicating the position or orientation of a distal tip of the medical device. At least one of the sensing element or the elevator sensor may be configured to provide a signal indicating the configuration of the elevator.

[0008] Any of the examples disclosed herein may include any of the following features, alone or in combination. The assembly may include a lifter sensor, which may include a gyroscope sensor. The assembly may include a magnet, and the sensing element may be configured to measure an alternating external magnetic field to output a signal indicating the orientation of the distal tip. The sensing element may be configured to measure a static magnetic field of the magnet.

[0009] In another example, a component of a medical device 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 a static magnetic field. The at least one sensing element is configured to generate a signal indicating: (a) the position or orientation of the distal tip; and (b) the configuration of an elevator of the distal tip.

[0010] Any of the examples disclosed herein may include any of the following elements, alone or in combination: The lifter may include a magnet. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] 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 present disclosure.

[0012] Figure 1A A side view of an exemplary distal tip of a medical device is depicted.

[0013] Figure 1B-Figure 1C Shows Figure 1A The distal side top in the first configuration of the distal side top ( Figure 1B ) and the second configuration ( Figure 1C ) in a partially transparent side view.

[0014] Figure 2 Depicted Figure 1A-Figure 1C Side view of a portion of an exemplary distal tip.

[0015] Figure 3A-3C Depicted Figure 1A-Figure 1C View of an exemplary elevator of an exemplary distal tip in FIG.

[0016] Figure 4A-4C Shows Figure 3A-3C The lift and Figure 1A-Figure 1C A plan view of the electronic components of an exemplary distal tip ( Figure 4A )、Side view( Figure 4B ) and stereograms ( Figure 4C ).

[0017] Figure 5 An exemplary medical device is shown, which may include Figure 1A-Figure 1C An exemplary distal tip of .

[0018] Fig. 6A and 6B Depicted Figure 1A-Figure 1C An exemplary magnetic field of a magnet at an exemplary distal tip.

[0019] Figure 7 Depicted Figure 1A-Figure 1C An exemplary expected output of an exemplary distal tip position sensing system.

[0020] Figure 8 An alternative distal tip elevator and electronics are shown. DETAILED DESCRIPTION

[0021] It will be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and do not limit the claimed invention. As used herein, the terms "comprises," "comprising," or any other variations thereof are intended to encompass non-exclusive inclusions such that a process, method, article, or device comprising a series of elements may include not only these elements, but may also include other elements not expressly listed or inherent in such process, method, article, or device. The term "exemplary" is used as an "example" rather than an "ideal" meaning. The term "distal" refers to the direction away from the operator / toward the treatment site, and the term "proximal" refers to the direction toward the operator. The term "approximately" or similar terms (e.g., "substantially") include values ​​of + / - 10% of the stated value.

[0022] The distal assembly of a medical device (e.g., a duodenoscope) may include an elevator for adjusting the orientation of an instrument inserted through an operating channel of the medical device. The elevator may include a magnet (e.g., a permanent magnet) disposed thereon or therein, or the elevator itself may be a permanent magnet. The distal assembly may also include a substrate (e.g., a circuit board) on which components such as imaging elements and / or lighting elements may be mounted. The imaging element may include one or more image sensors or cameras. The lighting element may include one or more (e.g., two) light emitting diodes ("LEDs") or fiber optic light guides. One or more position sensing systems may also be mounted on the circuit board. 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 tunnel magnetoresistive ("TMR") sensor (i.e., a TMR element). The position sensing system may measure the position and / or orientation of the elevator and / or the position and / or orientation of the distal tip assembly, including the position and / or orientation of these components relative to an external magnetic field generator. For example, the position sensing system can measure the magnetic field emitted by the magnet of the elevator, and the controller can use the measured value to determine the position and / or orientation of the elevator. Information about the position and / or orientation of the elevator can be presented to the operator of the medical device to facilitate positioning of instruments inserted through the working channel of the medical device.

[0023] Due to elasticity in the shaft of the medical device and the mechanical control system (e.g., actuator) used to control the elevator, the position of the elevator controller (e.g., a lever or knob) may not reliably reflect the position of the elevator. This may be particularly problematic when using the elevator to adjust the position of a large diameter instrument, as greater forces may be applied to the actuator to move the actuator, but the elevator itself may only move to a limited extent. Therefore, in the absence of the position sensing system of the present disclosure, the operator may rely on images from a camera (e.g., a video feed) 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.

[0024] In the case of digital or robotic procedures (or procedures performed by a human operator), feedback about the position of the elevator may be needed to determine the angle of the accessory instruments and help align the bile duct. However, as described above, the position of the actuator that controls the elevator may not accurately reflect the position of the elevator, and if a monocular camera view is used, the orientation of the instrument inside the elevator cannot be accurately known. The disclosed position sensing system can solve this problem by providing information about the position of the distal tip assembly and / or the elevator. For a human operator (or robotic procedure), the position sensing system can use an enhanced camera view or an enhanced three-dimensional ("3D") view, where the operator can see the trajectory of the instrument, the position of the mastoid, and / or the trajectory of the bile duct in real time and / or in the same coordinate system. The position sensing system can assist in cannulation of the mastoid with minimal changes to the current ERCP workflow. Therefore, the disclosed position sensing system can solve one or more problems in the art. For example, position and / or orientation information can facilitate cannulation to the subject's mastoid and / or positioning of instruments manipulated by the elevator.

[0025] Figure 1A-Figure 1C is a diagram depicting a method for use with a medical device (e.g., medical device 100 (discussed below) Figure 5 )) is a side view of an aspect of a distal tip assembly 10. The distal tip assembly 10 may include a core 12 and a cap 14. The core 12 may include elements of the distal tip assembly 10 mounted therein or thereon, and the cap 14 may be disposed around the core 12. Figure 1A and 1B , portions of the cover 14 are depicted as transparent to show features of the distal tip assembly 10 . Figure 2 The core 12 and components of the distal tip assembly 10 are depicted without the cap 14 .

[0026] The distal tip assembly 10 may also include an elevator 16. The elevator 16 may have any characteristics of an elevator, a pivot bracket, a swing bracket, or similar structures known in the art. Figure 3A-3C Aspects of an exemplary lifter 16 are depicted. Figure 3A A perspective view of the lifter 16 is shown, Figure 3B A side view of the lifter 16 is shown, Figure 3C A plan view of the elevator 16 is shown. The elevator 16 is rotatable about an axis 18. The axis 18 is rotatably held 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 wire 24 ( Figure 1A and 1B The operator can use the handle (e.g. Figure 5 As shown and described below, the actuator (e.g., Figure 5 As shown and described below, the actuator 112 of the medical device 100 can be used to move the wire proximally or distally. The distal end of the wire can be connected to the arm 22. The proximal movement of the wire can thus cause the elevator 16 to rotate to the first raised configuration ( Figure 1A and 1B Distal movement of the wire may cause the elevator 16 to rotate to a second lowered configuration ( Figure 1C ).

[0027] like Figure 1A-Figure 1C As shown, a substrate 30 (e.g., a rigid or flexible circuit board or other type of board) may be at least partially disposed within or on the core 12. In an example, the substrate 30 is rigid and includes a plurality of layers. The substrate 30 and its components are Figure 4A-4C Specific details are shown in FIG. Figure 4A-4C Each of the figures depicts a base plate 30 and a lifter 16, wherein the lifter 16 is in a raised configuration. Figure 4A-4C The core 12 and cover 14 are not depicted in FIG. 1 , but the base plate 30 and elevator 16 are depicted as they are positioned within the core 12 / cover 14 in the distal tip assembly 10 . Figure 4A A plan view showing the base plate 30 and the lifter 16 in a raised position, Figure 4B A side view of the base plate 30 and the lifter 16 is shown, and Figure 4C A perspective view of the base plate 30 and the lifter 16 is shown. Aspects of the base plate 30 may also be Figure 1B , Figure 1C and Figure 2 Electronic components may be mounted on substrate 30. For example, imaging device 32 (e.g., a camera, including, for example, one or more lenses and / or imagers) may be mounted to substrate 30 by any suitable method (e.g., wire bonding, surface mount assembly, electromechanical assembly, and / or plated through hole techniques). Camera 32 may be configured to capture video and / or still images. Imaging device 32 may display a video image to a display (e.g., as described below with respect to Figure 5The display of controller 130 discussed above or a separate display) provides signals so that the operator can view the visual images provided by imaging device 32 while guiding distal tip assembly 10 through the body of a subject.

[0028] like Figure 2 and Figure 4A-4C As particularly shown in FIG. 1 , one or more lighting elements 34 (e.g., light emitting diodes (“LEDs”), optical fibers, or other elements for providing light) may be mounted to substrate 30 by any suitable method (e.g., wire bonding, surface mount assembly, electromechanical assembly, and / or plated through hole techniques). Figure 2 30 , two lighting elements 34 are depicted, but any suitable number of lighting elements 34 may be used (e.g., one, three, four, or more lighting elements 34). Alternatively, the lighting elements 34 and the imaging device 32 may be combined into a single device. The conduit 36 ​​may include one or more wires or cables that are attached to the substrate 30 or an element mounted on the substrate 30 to transmit power and / or signals to the substrate 30 and / or an element mounted on the substrate 30.

[0029] like Figure 2 and Figure 4A-Figure 3C As shown, the lighting element 34 can be disposed distally of the imaging device 32. For example, the lighting element 34 can be disposed at the distal-most end of the base plate 30. The lighting element 34 can be arranged generally along the longitudinal axis of the distal tip assembly 10 / base plate 30. One lighting element 34 can be located distally of another lighting element 34, and the lighting elements 34 can be arranged linearly. The imaging device 32 and each lighting element 34 can be directly adjacent to each other, or there can be a gap between the imaging device 32 and / or the lighting element 34.

[0030] like Figure 1A-Figure 1C and Figure 2 As shown, the distal tip assembly 10 can be "facing sideways". In other words, features of the distal tip assembly 10 (e.g., the imaging device 32 and the lighting element 34) can be radially outward (i.e., facing a side of the distal tip assembly 10) and transverse (e.g., substantially perpendicular) to the longitudinal axis of the distal tip assembly 10 (and the axis of the medical device, such as the axis 114 of the medical device 100 described below). The present disclosure also encompasses other configurations of the distal tip 42. For example, the distal tip assembly 10 can be "facing forward" (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) can also face radially outward. The operator can raise / lower the elevator 16 to change the orientation of the instrument. As used herein, the term "orientation" includes the rotational disposition of an element (e.g., how an element rotates about an axis). As used herein, the term "position" includes the position of an element in a coordinate system. An element can change both position and orientation.

[0031] Elements of the position sensing system 50 may also 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 lighting element 34. The position sensing system 50 may incorporate any of the features described in U.S. Patent Application No. 15 / 846,846 (filed on December 19, 2017 and published as U.S. Patent No. 10,782,114 on September 22, 2020) or U.S. Patent Application No. 16 / 248,352 (filed on January 15, 2019 and published as U.S. Patent No. 11,141,567 on October 12, 2021), the entire contents of which are incorporated herein by reference. 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 Figure 4A-4C As shown. Three magnetic field sensing elements 52a, 52b, 52c may be disposed on the substrate 30. Any alternative number of sensors may be used, 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 static magnetic fields, which may help track the position of the lifter 16, as described below. The magnetic field sensing elements 52a, 52b, 52c may also have the ability to measure alternating magnetic fields, which may help track 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 magnetoresistive sensing elements, giant magnetoresistive sensing elements, super giant magnetoresistive sensing elements, super magnetoresistive sensing elements, or semiconductor magnetoresistive 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 properties of TMR sensors may be mentioned herein, it should be understood that any type of magnetic field sensor may be used, including those listed above. Magnetic field sensing elements 52a, 52b, 52c may have any properties of magnetic field sensing elements known in the art (including, for example, MR elements, such as TMR elements). For example, magnetic field sensing elements 52a, 52b, 52c may include a fixed layer, a tunnel layer, and a free layer. When the free layer is aligned with the fixed layer, the resistance may change.

[0032] In some examples, such as Figure 4A-4C As shown, the magnetic field sensing elements 52a, 52b, 52c can be arranged in a dual-axis, six-degree-of-freedom arrangement. In this arrangement, the magnetic field sensing elements 52a, 52b can be oriented so that their main sensing direction C ( Figure 4B ) is aligned (substantially parallel) with the longitudinal axis of the distal tip assembly 10 and the base plate 30, such as Figure 4BAs shown. The magnetic field sensing elements 52a, 52b can generate a signal together. As a non-limiting example, the two magnetic field sensing elements 52a, 52b can use a full Wheatstone bridge configuration. The third magnetic field sensing element 52c can be arranged so that its main sensing direction is transverse to (e.g., approximately orthogonal / perpendicular to) the longitudinal axis. In some non-limiting examples, the magnetic field sensing element 52c can adopt a half Wheatstone bridge configuration. The Wheatstone bridge can have any 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 a signal indicating the orientation / position of the distal tip assembly 10. A controller (e.g., Figure 5 A controller 130 in the embodiment of the present invention, as described below, can receive signals and can calculate the positioning of the distal tip assembly 10 using measurements from the magnetic field sensing elements 52a, 52b, 52c across a primary sensing direction (from the magnetic field sensing elements 52a, 52b) and laterally (e.g., orthogonal) to the primary sensing direction (from the magnetic field sensing element 52c).

[0033] The position sensing system 50 may also optionally include a capacitor 54 ( Figure 4A ) to reduce noise in the supply voltage of the position sensing system 50. For example, capacitor 54 can be used as a decoupling capacitor and as a low pass filter for any electromagnetic interference ("EMI") on the supply voltage. The position sensing system 50 can also optionally include one or more diodes 56 ( Figure 4A ). The diode 56 can provide high voltage protection, such as electrostatic discharge (“ESD”) protection. The diode 56 can prevent electrostatic discharge from damaging the magnetic field sensing elements 52a, 52b, 52c. The diode 56 can additionally or alternatively provide protection for various aspects of the camera 32.

[0034] Other components, such as one or more integrated circuits, may also be positioned on the substrate 30. In an example, the integrated circuits may digitize and / or multiplex signals from elements of the substrate 30, including, for example, elements of the position sensing system 50. Such integrated circuits may reduce the number of wires that need to be passed through the catheter 36.

[0035] The lifter 16 may include a magnet 60, which may include a permanent magnet. Figure 3A As specifically shown in FIG. 1 , the magnet 60 may have an approximately cylindrical or disk shape. The magnet 60 may be magnetized in the diameter direction so that the axis of the magnet 60 (eg Figure 4B As shown in , a line B) extending between the south pole and the north pole of the magnet 60 may extend along a diameter of a cross section of the magnet 60, wherein the cross section is perpendicular to the longitudinal axis of the magnet 60. Figure 3AAs shown in FIG. 1 , the magnet 60 may include a first polarized portion 62 (eg, a north polarized portion) and a second polarized portion 64 (eg, a south polarized portion). Figure 3A As shown, each of the first polarized portion 62 and the second polarized portion 64 can have a cross-sectional shape that is approximately semicircular, wherein the cross section is perpendicular to the longitudinal axis of the magnet 60. The magnet 60 can be made of any suitable material. For example, the magnet 60 can include a neodymium magnet (e.g., a grade N52 neodymium magnet) or another type of rare earth magnet. The magnet 60 can be coupled to the lifter 16 in any suitable manner and can be arranged on or within various portions of the lifter 16.

[0036] like Figure 3A-3C As shown, a groove 66 may be formed in the shaft 18 of the lifter 16. The groove 66 may have an approximately cylindrical shape. The shape of the groove 66 may be complementary to the shape of the magnet 60. The groove 66 may be formed at the end of the shaft 18 opposite to the arm 22 (the side of the shaft 18 closer to the substrate 30, including the position sensing system 50). In other words, the groove 66 may be formed at the end of the shaft 18 facing the radially inward direction of the distal top assembly 10. The magnet 60 may be arranged in the groove 66. The material of the magnet 60 may be biocompatible. For example, the magnet 60 may not have a nickel coating because the subject may be allergic to nickel. In addition or alternatively, the magnet 60 may be completely encapsulated in the lifter 16 and / or medical grade epoxy. For example, the magnet 60 may be arranged in the groove 60, and the groove 60 may be covered with medical grade epoxy. The magnet 60 may also include materials or other properties that enable the magnet 60 to withstand sterilization procedures (eg, heating) to which a medical device having the distal tip assembly 10 (eg, the medical device 100 ) may be subjected.

[0037] The position sensing system 50 may be configured to measure changes in the magnetic field of the magnet 60 as the lifter 16 moves between the raised configuration and the lowered configuration (i.e., rotates about the axis 18 of the lifter 16). For example, as discussed in further detail below, one or more magnetic field sensing elements 52a, 52b, 52c may measure the magnetic field of the magnet 60, including changes in the magnetic field, as the lifter 16 moves. Figure 1A-Figure 4C In the example shown, magnetic field sensing elements 52a, 52b (with their major axes aligned along the longitudinal axis of the distal tip assembly 10) can measure the magnetic field of magnet 60. For example, the north and south poles of magnet 60, which are shown to be magnetized in the diametric direction, can rotate with shaft 18, thereby causing the magnetic field of magnet 60 to change as elevator 16 moves.

[0038] In one example, in a first configuration of the lifter 16 (e.g., a fully raised configuration of the lifter 16), the axis B of the magnet 60 may be offset by about 0 degrees from the main sensing direction C of the magnetic field sensing elements 52a, 52b. In a second configuration of the lifter 16 (e.g., a fully lowered configuration of the lifter 16), the axis B of the magnet 60 may be offset by about 63 degrees from the main sensing direction C of the magnetic field sensing elements 52a, 52b. Figure 4B The distance between (a) the top of the magnet 16 and (b) the magnetic field sensing elements 52a, 52b (e.g., the midpoint between the magnetic field sensing elements 52a, 52b) may be substantially constant (e.g., along Figure 4B The z-axis is about 4.1 mm and / or along Figure 4B The distances and angles provided above are merely exemplary, and any suitable distances and angles may be used.

[0039] although Figure 1B-Figure 3A , a cylindrical, diametrically magnetized magnet 60 is depicted, but the magnet 60 may have any suitable shape and pole arrangement. The magnet 60 may be suitable for use with the lifter 16 if the magnetic field emitted by the magnet 60 changes when the lifter 16 moves between the raised and lowered configurations. Although the magnet 60 is shown as being located within the shaft 18, the magnet 60 may alternatively be located on or within other portions of the lifter 16. Additionally or alternatively, a portion or all of the lifter 16 may include a magnet. In one example, the lifter 16 may be formed from a single, integral piece and may be magnetic. Depending on the location of the magnet 60 on or within the lifter 16, the type of magnet 60 (e.g., shape, pole configuration, material, etc.) may be selected. The strength of the magnet 60 may be selected so 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 as to saturate the position sensing system 50. Relatedly, the relative positions of elements of the position sensing system 50 (e.g., one or more magnetic field sensing elements 52a, 52b, 52c) and the magnet 60 (including, for example, the distance between the one or more magnetic field sensing elements 52a, 52b, 52c and the magnet 60) can 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.

[0040] The elements of the position sensing system 50 may be arranged at any position on the substrate 30 as long as they are close enough to the magnet 60 and keep a sufficient distance from the high magnetic permeability material that may change the magnetic field of the magnet 60. Figure 4Bcoordinates, a portion or all of the magnet 60 may generally be located below a portion of the substrate 30 having the magnetic field sensing elements 52a, 52b, and / or 52c. In one example, the magnet 60 may be approximately 4.1 millimeters from the magnetic field sensing elements 52a, 52b, and / or 52c. The small size of the elements of the position sensing system 50 may allow the elements to be positioned on an open area of ​​the substrate 30 without having to reconfigure the substrate 30. Thus, the position sensing system 50 may be added to an existing device with minimal design modifications. Since the magnetic field sensing elements 52a, 52b may be used to generate a signal, the magnetic field sensing elements 52a, 52b may be positioned on the substrate 30 such that a midpoint between the elements 52a, 52b is the point at which the magnetic field of the magnet 60 will be measured. For example, at Figure 4B In a coordinate system (i.e., a coordinate system in which the camera 32 and / or the lighting element 34 are generally facing upward), the magnet 60 may be located approximately below the midpoint between the magnetic field sensing elements 52a, 52b. Figure 4B In the z-direction of FIG. 1 , the magnet 60 may be located approximately 4.1 mm below the midpoint. The magnet 60 may be radially offset from the magnetic field sensing elements 52a, 52b, or may be located directly below the magnetic field sensing elements 52a, 52b. In one example, as shown in FIG. Figure 4A-4C As shown, the magnet 60 can be Figure 4B The magnet 60 is offset from the magnetic field sensing elements 52a, 52b by about 1 mm in the y-direction. 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 used.

[0041] Alternative configurations of the substrate 30 and magnet 60 (not shown) may allow for stronger regions of the magnetic field of the magnet 60 to be measured along the dipole axis of the magnet 60. For example, one or more magnetic field sensing elements 52a, 52b, 52c may be configured along the dipole axis of the magnet 60. Figure 4B Alternatively or additionally, one or more magnetic field sensing elements 52a, 52b, 52c may measure in different directions from each other. Alternatively or additionally, magnet 60 may be moved so that axis B (see Figure 4B ) is aligned with one or more magnetic field sensing elements 52a, 52b, 52c (i.e., not along Figure 4B The above alternative configurations are merely exemplary, and other configurations may be employed.

[0042] The position sensing system 50 may have other configurations within the scope of the present disclosure. For example, a three-axis configuration may be used for the magnetic field sensing elements 52a, 52b, and 52c, wherein each magnetic field sensor is arranged so that its main sensing direction is aligned with a different axis (e.g., the main sensing directions of the magnetic field sensing elements 52a, 52b, and 52c are aligned orthogonally to each other). For example, the magnetic field sensing element 52a may have a main sensing direction of the X axis. The magnetic field sensing element 52b may have a main sensing direction of the Y axis, and the magnetic field sensing element 52c may have a main sensing direction of the Z axis. In this three-axis configuration, each magnetic field sensing element 52a, 52b, and 52c may adopt a half-Wheatstone bridge configuration. In another example, only two magnetic field sensors (e.g., magnetic field sensing elements 52a, 52b) can be used to measure six degrees of freedom, wherein each magnetic field sensing element 52a, 52b has 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 may measure five degrees of freedom using a half-Wheatstone bridge.

[0043] 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, 52c), or a plurality of magnetic field sensing elements (e.g., 52a, 52b, 52c) may be used to measure the magnetic field of the magnet 60. Figure 1A-Figure 4C ) or a magnetic field sensing element (e.g., 52a) can be used to measure the magnetic field of magnet 60. Figure 1A-Figure 4C In the configuration shown, because each magnetic field sensing element 52a, 52b can only measure the magnetic field along a single axis (and the magnetic field sensing elements 52a, 52b have the same sensing axis), the magnetic field sensing elements 52a, 52b may not be able to measure the field perpendicular to the surface of the substrate 30 on which the magnetic field sensing elements 52a, 52b are mounted.

[0044] The above examples are illustrative only, and other configurations of magnetic field sensors may be used. Figure 1A-Figure 4C As shown, a system employing three magnetic field sensing elements 52a, 52b, 52c in a dual axis six degrees of freedom arrangement may be beneficial because it is able to measure six degrees of freedom as well as the position / orientation of the elevator 16. Alternative arrangements of the illumination element 34 and the imaging element 32 may also be used.

[0045] The distal tip assembly 10 may also include components in addition to or in place of the components described above. For example, the distal tip assembly 10 may also include additional or alternative light sources and / or additional or alternative imaging components (e.g., additional cameras). The distal tip assembly 10 may also include additional types of sensors, such as humidity sensors, temperature sensors, pressure sensors, or other types of sensors that may be useful in medical procedures.

[0046] Figure 5 An exemplary medical device 100 is shown. In an example, the medical device 100 may include a duodenoscope or an endoscope. Although the present disclosure may refer to a duodenoscope or an endoscope at different points, it should be understood that unless otherwise specified, a bronchoscope, an endoscope, a gastroscope, an endoscopic ultrasound ("EUS") scope, a colonoscope, a ureteroscope, a laparoscope, a cytoscope, an aspirator, a sheath, a catheter, or any other suitable delivery device or medical device may be used in combination with the elements and assemblies described herein. 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 at a distal tip 118 at the distal end, which may have any characteristics of the distal tip assembly 10. The working channel 116 may extend from the handle 110, through the shaft 114, to an opening (not shown) at the distal tip 118. The handle 110 may include an actuator and / or other controls. For example, the handle 110 may include an actuator 112. The actuator 112 may include, for example, a lever or other type of actuator (e.g., a button, a slider, a knob, or a joystick). The actuator 112 may be actuated to raise and / or lower the lift 16. The handle 110 may also include an actuator 120. The actuator 120 may include, for example, a knob or other type of actuator (e.g., a button, a slider, a lever, or a joystick). Although Figure 5 Two actuators 120 are shown (e.g., one actuator 120 for up and down movement and one actuator 120 for left and right movement), but any suitable number of actuators 120 may be used. The actuator 120 may be used to manipulate (e.g., articulate) the distal portion of the shaft 114. The 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, the air / water and / or suction provided by the controller 130 via the umbilicus 132 may be delivered to the distal tip assembly 10 via the catheter 80 (see Figure 1A ).

[0047] Fig. 6A and 6B The magnetic field of a diametrically magnetized cylindrical magnet 60 and the positions of magnetic field sensing elements (eg, one or more magnetic field sensing elements 52a, 52b, 52c) relative to the magnet 60 are depicted. Fig. 6A is depicted from the reference frame of magnet 60. Specifically, Fig. 6A The reference frame depicts the south pole of magnet 60 on the left and the north pole of magnet 60 on the right, as shown in FIG. Fig. 6A As shown in illustration 212. Illustration 212 depicts a cross-sectional view of magnet 60, wherein axis B extends from the south pole of magnet 60 to the north pole of magnet 60. Although Fig. 6A and 6B The fields depicted in FIG. 6 relate to a cylindrical magnet 60 magnetized in a diametrical direction, but similar diagrams may be created for other types of magnets, and the steps described below for calibrating the controller 130 and / or position sensing system 50 are applicable to various types of magnets 60 and configurations of magnets 60 and sensing systems 50.

[0048] Fig. 6A A graph 200 is shown, wherein the transverse axis and the longitudinal axis represent the distance (in mm) from the center of the circular cross-section of the magnet 60. For example, Fig. 6A The magnetic field 210 of the magnet 60 at the location of one or more magnetic field sensing elements 52a, 52b, 52c can be depicted. The shaded areas depict different strength areas of the magnetic field 210, such as Fig. 6A The list 220 on the right is shown. The arrows depict 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 depict the path of the magnetic field sensing elements 52a, 52b and / or 52c relative to the magnet 60.

[0049] Rectangle 230 may represent the position of magnetic field sensing elements 52a, 52b, and / or 52c when lifter 16 is in a raised position / configuration / orientation (e.g., a fully raised position). The end of arc 240 opposite rectangle 230 may represent the position of magnetic field sensing elements 52a, 52b, and / or 52c when lifter 16 is in a lowered position / configuration / orientation (e.g., a fully lowered position). Figure 1A-Figure 4C In the distal assembly configuration shown, Figure 4B The distance between the top of the magnet 60 and the magnetic field sensing elements 52a, 52b and / or 52c is about 4.6 mm (along the Figure 4B The magnetic field sensing elements 52a, 52b and / or 52c may be located at Figure 4B The y-direction of the magnet 60 is offset by about 1 mm. However, any alternative distance may be used, and the distance need not remain constant.

[0050] Figure 6BA diagram 250 is shown in which the magnet 60 is rotated to show the magnetic field 260 of the magnet 60 when the lifter 16 is in an intermediate position / configuration / orientation between the fully raised and fully lowered configurations. The shaded areas represent different strength areas of the magnetic field 260 (eg, Fig. 6A 220 on the right). The arrows indicate the direction of the magnetic field. List 220 also applies to diagram 250. Rectangle 270 represents one or more magnetic field sensing elements 52a, 52b, 52c. For example, rectangle 270 may represent one magnetic field sensing element 52a or two magnetic field sensing elements 52a, 52b. Dotted arc 280 may depict the path of magnetic field sensing elements 52a, 52b, and / or 52c relative to magnet 60. Although magnetic field 260 rotates relative to magnetic field 210, arc 240 ( Fig. 6A ) and arc 290( Figure 6B ) can pass through the same portion of the magnetic field of magnet 60. Fig. 6A may represent the position of the magnet 60 at the first time, and Figure 6B Rectangle 230 may represent the position of one or more magnetic field sensing elements 52a, 52b, 52c at a first time, and rectangle 270 may represent the position of one or more magnetic field sensing elements 52a, 52b, 52c at a second time.

[0051] Computer modeling software (e.g., MATLAB and / or Python) may be used to determine the magnetic field measured by one or more magnetic field sensing elements 52a, 52b, 52c along arcs 240, 280. This information may be used to interpret signals received by one or more 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 that correlates readings from one or more magnetic field sensing elements 52a, 52b, 52c with the position of the elevator 16.

[0052] In one example, arc 240 ( Fig. 6A ) and 280( Figure 6B ) can respectively depict the path of the magnet 60, wherein when the lifter 16 is in a fully raised configuration, the axis B of the magnet 60 is offset by about 0 degrees from the main sensing direction C of the magnetic field sensing elements 52a, 52b. In the fully lowered configuration of the lifter 16, the axis B of the magnet 60 can be offset by about 63 degrees from the main sensing direction C of the magnetic field sensing elements 52a, 52b. The angles provided above are merely examples, and any suitable angle can be utilized.

[0053] In one example, if Fig. 6A and 6BAs shown, when the lifter 16 is in the fully lowered position, the magnetic field of the lifter 16 may be stronger at the location of the magnetic field sensing elements 52a, 52b than when the lifter 16 is in the fully raised position. However, when the lifter 16 moves from the fully raised configuration to the fully lowered configuration, the angle between the magnetic field and the magnetic field sensing elements 52a, 52b may also change. Since 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., approximately 0°) than in the fully lowered configuration (e.g., approximately 63°), the component of the magnetic field of the magnet 60 along the sensing direction C may be greater 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.

[0054] Figure 7 A graph 700 is depicted showing the output 710 (in volts) of one or more magnetic field sensing elements 52a, 52b, 52c versus the angle of the lifter 16 (where zero degrees is the fully raised / closed position of the lifter 16). As described above, in one example, Figure 7 The output 710 shown in can 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) can be used. In the above example, at the position of the magnetic field sensing elements 52a, 52b, when the lifter 16 is in a fully lowered configuration, the strength (i.e., amplitude) of the magnetic field can be greater than when the lifter 16 is in a fully raised configuration. However, as described above, the magnetic field sensing elements 52a, 52b only measure the magnetic field along their sensing direction C. Because, as described above, the vector component of the magnetic field of the magnet 60 along the sensing direction C can be greater in the fully raised configuration than in the fully lowered configuration, the magnetic field sensing elements 52a, 52b can actually measure a greater amplitude of the magnetic field in the fully raised configuration than in the fully lowered configuration. This is because the magnetic field is more aligned with the sensing direction C in the fully raised configuration than in the fully lowered configuration.

[0055] The expected output 710 of the magnetic field sensing elements 52a, 52b may 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 may be a known value). Figure 7As shown, the output 710 (e.g., voltage) from the magnetic field sensing elements 52a, 52b can be maximum in the fully raised configuration of the lifter 16, while the voltage from the magnetic field sensing elements 52a, 52c can be minimum in the fully lowered configuration of the lifter 16. The signal response of the magnetic field sensing elements 52a, 52b can be non-linear. 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.

[0056] 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. Figure 6A-6B As described above, the magnetic field (including magnitude and direction) of the magnet 60 at each relative position of the magnetic field sensing elements 52a, 52b and / or 52c can be determined. Figure 7 As described above, the response of magnetic field sensing elements 52a, 52b, and / or 52c to each magnetic field can be determined. The determined response can be used to interpret the signal from position sensing system 50 during surgery. Based on the signal of magnetic field sensing elements 52a, 52b, and / or 52c, the magnetic field of magnet 60 and / or the position of lifter 16 can be determined.

[0057] The medical device 100 (including the distal tip assembly 10) can be used to perform a medical procedure on a subject. The procedure can be performed by a robot and / or a human operator. For example, the medical device 100 can be inserted into a body cavity (e.g., the duodenum) of a subject. During the procedure, an external device can be used to generate a magnetic field near the subject. The generated magnetic field can be, for example, an alternating magnetic field (e.g., with a frequency of 1250 Hz). For example, the external device can be placed on a table or other surface near the subject (e.g., near a body part where the body cavity is located). The operator can actuate the actuator 112 to adjust the position of the lifter 16.

[0058] During surgery, the position sensing system 50 (including the magnetic field sensing elements 52a, 52b, 52c) can transmit signals to the handle 110 through the shaft 114 and to the controller 130 through the umbilicus 132. 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) in the body. The signals from the position sensing system 50 can also indicate the position of the elevator 16.

[0059] As described above, one or more magnetic field sensing elements 52a, 52b, 52c can measure a static magnetic field. Although the lifter 16 can move, the magnetic field emitted by the magnet 60 can be substantially static compared to the alternating magnetic field of the external magnetic field generating device described above. Therefore, one or more magnetic field sensing elements 52a, 52b, 52c can simultaneously measure the alternating external field and the static field of the magnet 60. For example, the controller 130 can 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 lifter 16. The controller 130 can also be programmed to identify and filter out the portion of the output from the magnetic field sensing elements 52a, 52b, 52c caused by the earth's magnetic field. Therefore, the controller 130 can determine the position and / or orientation of the distal tip assembly 10 and / or the position of the lifter 16 based on the output of the magnetic field sensing elements 52a, 52b, 52c.

[0060] The position and / or orientation information of the distal tip assembly 10 and / or the position information of the elevator 16 can be fused with imaging (e.g., 3D imaging) performed prior to surgery. For example, the position sensing system 50 can use an enhanced camera view or an enhanced three-dimensional ("3D") view in which the operator can see the trajectory of the instrument, the location of the mastoid, and / or the trajectory of the bile duct in real time and / or in the same coordinate system. The position sensing system can assist in cannulation of the mastoid with minimal changes to the current ERCP workflow. Information from the position sensing system 50 can provide the operator with information about anatomical structures near the device 100 that may not be visible using only the camera 32 (including anatomical structures outside the body cavity in which the device 100 is located). For example, the position sensing system 50 can provide information about the common bile duct and pancreaticobiliary duct passing through the wall of the duodenum. The position sensing system 50 can assist in positioning the distal tip assembly 10 and positioning the instrument using the elevator 16 to facilitate cannulation of the mastoid and / or surgery with instruments.

[0061] In addition, the anatomical structure grid can be automatically segmented using preoperative images, thereby providing a map (e.g., a 3D map) to track the medical device 100 in real time. Such real-time tracking can reduce the time, skill, and / or effort required to reach the target anatomical structure. In the absence of preoperative images, the position sensing system 50 can enable the software to track the position of the device 100 and the movement of the device 100 so as to generate a map (e.g., a 3D map) in real time during surgery. The generated map can guide the medical device 100 (and any EM-enabled accessories) through the anatomical structure of the subject. The medical device 100 can be used with any known or becoming known technology (including MR image fusion, preoperative CT image fusion, electromagnetic (EM) tracking, artificial intelligence-based automatic tissue segmentation, augmented reality, 3D visualization, and / or a fully robotically controlled endoscope).

[0062] Controller 130 may include a display, or may transmit signals to an external display (not shown). The display may present information to the operator regarding the position and / or orientation of distal tip assembly 10 and / or the position of 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 elevator 16. For example, the display may present information regarding the angle of elevator 16 and / or the relative position of the instrument to the mastoid or other structure.

[0063] Figure 8 Elements of an alternative distal tip assembly 810 are shown, which may include any of the features of the distal tip assembly 10, except as described below. Although elements such as the core 12 and the cover 14 are not shown, it should be understood that the distal tip assembly 810 may include such elements, as well as other elements depicted and / or discussed with respect to the distal assembly 10. The distal tip assembly 810 may include an elevator 816, which may include any of the features of the elevator 16, except as described herein. The elevator 816 may have an elevator sensor 860 coupled thereto. The elevator sensor 860 may include, for example, any type of gyroscope sensor, such as an inertial measurement unit. The elevator sensor 860 may be positioned at any suitable location on the elevator 816, such as on a side of the elevator 816 (such as Figure 8 816), on shaft 818 of lifter 816, or on lever arm 817 of lifter 816. Lifter sensor 860 may be coupled (e.g., mechanically coupled) to lifter 816, encapsulated within lifter 816, or otherwise disposed on or within lifter 816.

[0064] A position sensing system 850 may be mounted on the substrate 830. The position sensing system 850 may include a plurality of sensing elements 852a, 852b, 852c having any suitable position / configuration on the substrate 830 (or another element of the distal tip assembly 810). The sensing elements 852a, 852b, 852c may include, for example, accelerometers and / or gyroscope sensors. Although three sensing elements 852a, 852b, 852c are shown, any suitable number and arrangement of sensing elements (including fewer or more sensors) may be used. The sensing elements 852a, 852b, and / or 852c may generate a signal indicating the position / orientation of the distal tip assembly 810 (e.g., of the substrate 860).

[0065] The controller (e.g., controller 130) may have the functionality to analyze the output of the position sensing system 850 and / or the elevator sensor 860. For example, the controller 130 may determine which components of the signal of the elevator sensor 860 are attributable to the movement of the entire distal tip assembly 810, rather than just the elevator 816. In an example, data from the sensing elements 852a, 852b, and / or 852c may be used to identify the movement of the entire distal tip assembly 810. The controller 130 may be programmed with an algorithm to negate the movement of the entire distal tip, determining which movements identified by the elevator sensor 860 are due to the raising / lowering of the elevator 816 (i.e., independent movement of the elevator 816 relative to elements such as the base plate 830 and components mounted thereon), rather than due to the movement of the entire distal tip assembly 810. Compared to the use of the distal tip assembly 10, the use of the distal tip assembly 810 may not involve the generation of an external magnetic field.

[0066] Since the elevator sensor 860 and / or the position sensing system 850 can only measure acceleration (for approximate displacement), cumulative errors may be generated. The distal tip assembly 810 can be calibrated periodically to compensate for cumulative errors. For example, the calibration can set a baseline measurement of a known position. In one example, to calibrate the elevator sensor 860, the operator can fully raise (or fully lower) the elevator 816. An additional sensor (not depicted) can indicate (e.g., provide an indication signal) when the elevator 816 is fully raised (or fully lowered). Additionally or alternatively, the operator can press a button to confirm that the elevator 816 has been fully raised (or fully lowered) in order to calibrate (e.g., "zero") the position of the elevator sensor 860. In one example, to calibrate the position sensing system 850 of the substrate 830, software (e.g., software of the controller 130) may associate information displayed by the camera 32 with, for example, 1) information previously mapped into a three-dimensional coordinate system (which may be generated by a simultaneous localization and mapping (“SLAM”) or other algorithm), and / or 2) information obtained from a pre-operative image (e.g., a computed tomography (“CT”) or magnetic resonance imaging (“MRI”) scan).

[0067] Any method or portion of a method described in the present disclosure may be performed by one or more processors of a computer system (e.g., controller 130). The one or more processors may be configured to perform the methods by accessing instructions (e.g., software or computer readable code) that, when executed by the one or more processors, configure and / or cause the one or more processors to perform the methods. The instructions may be stored in a memory of the computer system.

[0068] Instructions executable by one or more processors may also be stored on a non-transitory computer-readable medium. Therefore, whenever a computer-implemented method is described in this disclosure, the disclosure should also be understood to describe a non-transitory computer-readable medium storing instructions that, when executed by one or more processors of a computer system, configure 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 drives). The non-transitory computer-readable medium may be part of a computer system memory or may be separate from any computer system.

[0069] The computer system may include one or more computing devices. If the computer system includes multiple processors, the multiple processors may be included in a single computing device or distributed in multiple computing devices. The processor may be a central processing unit (CPU), a graphics processing unit (GPU), or other types of processing units. The term "computing device" used in this disclosure is interchangeable with "computing device". "Electronic storage device" may include any non-transient computer-readable medium described above.

[0070] Although the principles of the present disclosure are described herein with reference to illustrative examples of specific applications, it should be understood that the present disclosure is not limited thereto. Those of ordinary skill in the art and the teachings provided herein will recognize that additional modifications, applications, and equivalent replacements are within the scope of the examples described herein. Therefore, the present invention should not be considered to be limited by the foregoing description.

Claims

1. A medical device assembly, the assembly comprising: an elevator configured to raise and lower to adjust the orientation of an instrument inserted through a working channel of the medical device, wherein the elevator includes a magnet; and A sensing element is configured to measure the magnetic field of the magnet and output a signal indicative of the configuration of the lifter.

2. The assembly of claim 1, wherein the magnet is magnetized in a diametrical direction.

3. An assembly according to any one of the preceding claims, wherein the magnet is arranged in a groove of a shaft of the lifter.

4. An assembly according to any preceding claim, wherein the magnet is substantially cylindrical.

5. An assembly according to any preceding claim, wherein the magnet rotates about a longitudinal axis of the magnet as the riser is raised and lowered.

6. The assembly of any of the preceding claims, wherein the sensing element is further configured to generate a signal indicative of the position of the distal tip of the medical device.

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

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

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

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

12. An assembly according to any one of the preceding claims, wherein the sensing element is mounted on a substrate at a distal tip of the medical device.

13. An assembly according to any preceding claim, wherein the magnet is a permanent magnet.

14. An assembly according to any one of the preceding claims, wherein the sensing element is a first sensing element, the assembly further comprising a second sensing element configured to measure the magnetic field of the magnet.

15. An assembly according to any preceding claim, wherein the sensing element is configured to measure a different magnitude of a magnetic field in a fully raised configuration of the riser to that measured in a fully lowered configuration of the riser.

Images