Medical device assemblies and components

Abstract

A medical assembly may include a substrate configured to be disposed in a body located at a distal tip of a medical device; and a position sensing system including a magnetic field sensor mounted to the substrate. The magnetic field sensor may be configured to provide a signal indicative of a position or orientation of the distal tip of the medical device. The medical assembly may also include at least one camera mounted to the substrate; and at least one lighting element mounted to the substrate.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 364,062, filed on May 3, 2022, which is incorporated herein by reference in its entirety. Technical Field

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

[0003] In a medical procedure, an operator may insert a medical device, such as a bronchoscope or other types of scopes, into a body cavity of a subject. The operator may navigate the distal tip of the medical device to the desired location of the subject's anatomical structure. Prior to the medical procedure, a region of interest in the patient's anatomical structure may be predefined. The operator may then attempt to navigate the medical device to the predefined region of interest. This navigation may be challenging, particularly in tortuous pathways or complex anatomical regions (e.g., lungs). An imager (e.g., camera) at the distal tip of the medical device may facilitate this navigation, but may not provide information about regions beyond the walls of the body cavity. Using only an imager for effective navigation may require a high level of skill, time, and / or effort.

[0004] Endoscopic robotic systems may rely on position information of the distal tip of a medical device. Some robotic systems utilize position encoders in the motor system of the robotic system. However, such sensors do not provide useful information of a flexible tool (such as a bronchoscope, other types of scopes, a biopsy tool for passing through a working channel of an endoscope, or another type of flexible tool). Therefore, there is a need for electronic assemblies or components for medical devices, including systems, devices, and / or methods for position tracking assemblies or components. Summary of the invention

[0005] A medical assembly may include: a substrate configured to be disposed in a body located at a distal tip of a medical device; and a position sensing system including a magnetic field sensor mounted to the substrate. The magnetic field sensor may be configured to provide a signal indicating a position or orientation of the distal tip of the medical device. The medical assembly may also include at least one camera mounted to the substrate; and at least one lighting element mounted to the substrate.

[0006] In any of the exemplary assemblies herein, the magnetic field sensor may include a magnetoresistive ("MR") sensor. The MR sensor may be a first MR sensor, and the position sensing system may also include a second MR sensor and a third MR sensor. The first MR sensor may have a first main sensing direction, the second MR sensor may have a second main sensing direction, and the third MR sensor may have a third main sensing direction. The first MR sensor and the second MR sensor may be arranged such that each of the first main sensing direction and the second main sensing direction is substantially parallel to the longitudinal axis of the substrate. The third TMR sensor may be arranged such that the third main sensing direction is transverse to the longitudinal axis of the substrate. The position sensing system may be configured to measure at least five degrees of freedom. The first MR sensor, the second MR sensor, and the third MR sensor may collectively include at least one Wheatstone bridge configuration. The system may also include six wires electrically connected to the position sensing system. The system may also include two wires electrically connected to at least one lighting element. Each of the six wires electrically connected to the position sensing system and each of the two wires electrically connected to the at least one lighting element may be connected to the first side of the substrate. The assembly may also include a body. The body may include a cavity configured to receive the substrate. The cavity may include a proximal portion and a distal portion. The width of the distal portion may be less than the width of the proximal portion. The width may be measured in a direction perpendicular to the longitudinal axis of the medical device and across the face of the substrate. At least one camera and at least one lighting element may be at least partially received within the distal portion of the cavity. The cavity may define a shoulder extending between the proximal portion of the cavity and the distal portion of the cavity. The distal surface of the substrate may be configured to contact the shoulder. The distal opening of the cavity may have a contour shape complementary to the at least one camera and the at least one lighting element.

[0007] In another example, a medical assembly may include: a body at a distal tip of a medical device. The body may define a cavity. The assembly may also include a substrate disposed in the cavity, the substrate having a magnetic field sensor mounted thereto, the magnetic field sensor configured to provide a signal indicating a position or orientation of the distal tip of the medical device. The assembly may also include at least one camera.

[0008] Any of the exemplary assemblies disclosed herein may include any of the following features. The magnetic field sensor may be a first MR sensor. The substrate may have a second MR sensor and a third MR sensor mounted thereto. The cavity may include a proximal portion and a distal portion. The width of the distal portion may be less than the width of the proximal portion. The width may be measured in a direction perpendicular to the longitudinal axis of the medical device and across the face of the substrate. At least one camera may be at least partially received within the distal portion of the cavity.

[0009] In another example, a medical assembly may include: a body at a distal tip of a medical device. The body may define a cavity. The assembly may also include a substrate disposed in the cavity; and a magnetic field sensor mounted to the substrate. The magnetic field sensor may be configured to provide a signal indicating a position or orientation of the distal tip of the medical device. The substrate may include a plurality of contact pads disposed on a first side of the substrate. At least a first one of the plurality of contact pads may be configured to provide an electrical connection between (a) a first conductor and (b) a magnetic field sensor. At least a second one of the plurality of contact pads may be configured to provide an electrical connection between (a) a second conductor and (b) a camera and lighting element.

[0010] Any of the assemblies disclosed herein may have any of the following features.The magnetic field sensor may include an MR sensor.

[0011] It is understood that the foregoing general description and the following detailed description are merely exemplary and explanatory of the invention as claimed, rather than restrictive descriptions. As used herein, the terms "include," "comprises," or any other variations thereof are intended to encompass non-exclusive contents, so that a process, method, article, or device comprising a list of elements may include not only those elements, but may include other elements that are not explicitly listed or are not inherent to such a process, method, article, or device. The term "exemplary" is used in the sense of "example" rather than "exemplary." The term "distal" refers to the direction away from the operator / towards 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 value. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate examples of the present invention and, together with the description, serve to explain the principles of the present invention.

[0013] Figure 1A and Figure 1B An exemplary medical device is depicted.

[0014] FIG. 2A to FIG. 2C Depicted with Figure 1A and Figure 1B An exemplary distal component assembly for use with a medical device.

[0015] FIG. 3A to FIG. 3F Depicted with Figure 1A and Figure 1B An exemplary distal tip body of a medical device in combination with FIG. 2A to FIG. 2C The distal component assembly. DETAILED DESCRIPTION

[0016] Robot-assisted and electromagnetic (EM)-guided medical surgeries can utilize EM tracking to provide information about the position and / or orientation of a medical device within a subject's anatomical structure. When a medical device has a camera but does not utilize EM tracking, the operator cannot see beyond the endothelial wall or other types of walls or body structures. Using EM tracking, the position and / or orientation information can be fused with imaging (e.g., three-dimensional (3D) imaging) performed before surgery. The operator can have more information about the anatomical structure near the medical device, which may not be visualized using only a camera (including anatomical structures outside the body cavity in which the medical device is disposed). In addition, the mesh of the anatomical structure can be automatically segmented using preoperative images to provide a map (e.g., a 3D map) to track the medical device in real time. This real-time tracking may help reduce the amount of time, skill, and / or effort required to reach the target anatomical structure. In the absence of preoperative images, EM sensors can enable software to track the position and movement of the medical device so that a map (e.g., a 3D map) is generated in real time during surgery. The generated map can guide the medical device (and any EM-enabled accessories) through the subject's anatomical structure. Unlike conventional robotic systems that may rely on position encoders in the motor system to provide the necessary position information for a medical device, such as a rigid medical device or the tip of a rigid portion of a medical device, an EM-based system can provide position information for flexible medical devices.

[0017] A single circuit board at the distal end of the medical device may include elements such as a position sensing system, an imaging element, and an illumination element. The position sensing element may enable EM tracking of the medical device. For example, the position sensing system may include one or more tunnel magnetoresistance ("TMR") sensors (i.e., TMR elements), one or more diodes (e.g., two diodes), and / or one or more capacitors (e.g., a capacitor). The imaging element may include one or more cameras. The illumination element may include one or more (e.g., two) light emitting diodes ("LEDs") or fiber optic light guides. Wires, cables, or other conductors for delivering power and / or signals to elements of the circuit board may extend proximally from the circuit board toward the proximal end of the medical device. Various elements may be arranged on the circuit board to arrange for an effective connection between the circuit board and the conductors that deliver power and / or signals.

[0018] The distal tip body (e.g., housing) of a medical device can be configured to receive a circuit board. Including position sensing elements, imaging elements, and / or lighting elements on a single circuit board can, for example, promote cost-effective manufacturing by reducing the number of steps in assembling the medical device, reducing the possibility of errors in assembly, and / or reducing waste. For example, all of these elements (and conductors that provide power and / or signals thereto) can be assembled to the distal tip body in a single step, rather than assembling the lighting elements, imaging elements, and / or sensing elements separately on or in the distal tip body.

[0019] Figure 1A and Figure 1B Aspects of an exemplary medical device 10 are depicted. Figure 1A A proximal portion of the medical device 10 is depicted. Figure 1B The distal tip 44 of the medical device 10 is depicted. The medical device 10 may include a handle portion 12 for grasping and manipulating by an operator, and an insertion portion 14 for at least partially inserting into a subject's body (e.g., into a body cavity). Figure 1A and Figure 1B As shown, the medical device 10 may include a bronchoscope. Although the present invention may refer to a bronchoscope or an endoscope at various points, it should be understood that unless otherwise specified, a duodenoscope, an endoscope, a gastroscope, an endoscopic ultrasonography ("EUS") scope, a colonoscope, a ureteroscope, a bronchoscope, a laparoscope, a cytoscope, an aspirator, a sheath, a catheter, or any other suitable delivery device or medical device may be used in conjunction with the elements and assemblies described herein.

[0020] The handle portion 12 can include a lever 22, for example, located on a proximal portion of the handle portion 12. The lever 22 can help facilitate articulation / steering of the insertion portion 14, including the distal tip 44. Figure 1A22 is depicted in the figure, but it should be understood that any suitable actuator, such as one or more knobs, buttons, sliders or joysticks, can be used in addition to or in place of the rod 22. The port 24 of the handle portion 12 (e.g., located on the proximal portion of the handle portion 12) can provide access to the cavity or working channel of the medical device 10. The operator can insert an instrument or other device into the port 24 and can extend the instrument or other device distally through the working channel. The working channel can extend longitudinally through the length of the insertion portion 14. The handle portion 12 can also include a suction valve 26, for example, located on the proximal portion of the handle portion 12 and on the side opposite to the rod 22. The operator can connect the suction valve 26 to a suction source and can operate the suction valve 26 to generate suction through the insertion portion 14 (e.g., through the working channel). The handle portion 12 can additionally or alternatively include other types of valves, such as air valves and / or water valves, or valves that perform a combination of functions. The image capture button 28 of the handle portion 12 enables the operator to capture a still image (e.g., Figure 1B 2 and described in further detail below). An image capture button 28 can be positioned on a proximal portion of the handle portion 12, e.g., adjacent the aspiration valve 26. Additionally or alternatively, the image capture button 28 can enable an operator to capture video or perform other functions to control the medical device 10. An umbilicus 30 can extend from the handle portion 12 (e.g., from a distal portion of the handle portion 12) and can carry wires, cables, and / or conduits to provide, e.g., power, signals, or fluids to or from the handle portion 12. For example, the umbilicus 30 can connect the handle portion 12 to one or more user interfaces, monitors, displays, and the like.

[0021] The insertion portion 14 may include a shaft 42 extending distally from the handle portion 12. The shaft 42 may have any suitable properties. For example, the shaft 42 may be flexible and may have wires, tubes, or other features passing therethrough. Figure 1B The distal tip 44 of the medical device 10 depicted in FIG. 4 can be disposed at the distal end of the shaft 42. Figure 1B As shown, distal tip 44 may include a distal-most side 46. Distal-most side 46 may define a working channel opening 48. A working channel may extend between port 24 and working channel opening 48 such that an instrument or other device may pass through port 24, through the working channel, and out of working channel opening 48. Instruments extending distally of working channel opening 48 may be used to perform a medical procedure on a subject.

[0022] Distal tip 44 may also include imaging components, such as one or more lighting elements 50 and camera 52. Figure 1B, two lighting elements 50 and one camera 52 are depicted, but it should be understood that an alternative number of lighting elements 50 and cameras 52 may be utilized. Alternatively, the lighting elements 50 and cameras 52 may be combined into a single device. The lighting elements 50 may include LEDs or any suitable alternative light sources. The camera 52 may be configured to capture video and / or still images. The camera 52 may provide a signal to a monitor (not shown) so that an operator can view the visual images provided by the camera 52 while navigating the medical device 10 through the subject's body.

[0023] like Figure 1B , and as described above, the medical device 10 can be "front facing". In other words, the features of the distal tip 44 (e.g., the working channel opening 48, the lighting element 50, and the camera 52) can face distally (i.e., in front of the distal-most side 46). The present invention also encompasses other configurations of the distal tip 44. For example, the medical device 10 can be "sideways facing". In a sideways facing embodiment, the working channel opening 48, the lighting element 50, and / or the camera 52 can be disposed on the radially outer side of the distal tip 44 so that they point in a radially outward direction, substantially perpendicular to the longitudinal axis of the insertion portion 14.

[0024] FIG. 2A to FIG. 2C Depicted are various views of a distal component assembly 100 that may constitute or be included in a medical assembly. Figure 3A and Figure 3B As discussed in further detail, the distal component assembly 100 can be disposed in the distal tip 44 of the medical device 10. The distal component assembly 100 can include a substrate 102 (e.g., a circuit board or other type of board). The substrate 102 can include, for example, a rigid or flexible printed circuit board, and can include one or more layers. In one example, the substrate 102 is rigid and includes multiple layers. The distal end 104 of the distal component assembly 100 can be FIG. 2A to FIG. 2C The proximal end 103 of the distal component assembly 100 may be FIG. 2A to FIG. 2C When the distal component assembly 100 is assembled in the distal tip 44 of the medical device 10, the first surface of the substrate 102 (at Figure 2A and a second surface (opposite to the first surface and Figure 2C ) can face radially outward. Figure 2C The view relative to Figure 2A The view is rotated 180 degrees. Figure 2B Shows from Figure 2A and Figure 2C Rotate the view 90 degrees. Figure 2B, the first side of the substrate 102 faces upward and the second side of the substrate 102 faces downward. The distal component assembly 100 can have a length (along the distal tip 44 and the longitudinal axis of the device 10) of about 0.1" to about 0.3" (e.g., about 0.237"). The distal component assembly 100 can have a width (across the first or second side, perpendicular to the longitudinal axis) of about 0.09" to about 0.12" (e.g., about 0.101").

[0025] The lighting element 50 and the camera 52 may be mounted to the substrate 102. FIG. 2A to FIG. 2C As shown, the distal ends of the lighting element 50 and the camera 52 can extend distally of the distal end of the substrate 102. In some examples, the lighting element 50 can be mounted to the distal edge of the substrate 102. Figure 2A 1 , a portion of the lighting element 50 may contact the distal edge of the substrate 102. Other portions of the lighting element 50 may contact the first and second sides of the substrate 102. In some examples, the lighting element 50 may be bonded to the substrate 102 (e.g., directly bonded to the substrate 102) with a transparent material (e.g., adhesive or other material) assembled on top of the lighting element 50. In some aspects, the transparent material may act as a light guide to direct or redirect light from the lighting element 50 to the front of the camera 52 (i.e., distally thereof).

[0026] The base plate 102 may include a recess or opening formed therein for receiving the camera 52 (or other component of the distal component assembly 100). The camera 52 may extend distally beyond the illumination element 50 and may extend radially outward from the first and second faces of the base plate 102. The camera 52 may extend radially outward farther than the illumination element 50. The camera 52 may include a camera capacitor 54 or any other suitable accessory component, which may be integrally formed with the camera 52 or as a separate component.

[0027] The camera 52 can be disposed approximately centrally along the width of the substrate 102. The lighting elements 50 can be symmetrically arranged on either side of the camera 52. The lighting elements 50 can be directly adjacent to (contacting) the camera 52, or there can be a gap between the camera 52 and the lighting elements 50. A portion of the substrate 102 can extend beyond each of the lighting elements 50 along the width, such that the substrate 102 is the widest component of the distal component assembly 100. The amount of the substrate 102 that extends beyond each of the lighting elements 50 along the width can be approximately equal, such that the distal end of the distal component assembly is approximately symmetrical.

[0028] The twisted pair wires 56 can provide power to the lighting elements 50. Each of the wires 56 can be electrically connected to a contact pad 57 on a proximal end of a first side of the substrate 102 such that the wires 56 are electrically connected to the lighting elements 50. Electrical traces or wires can extend from the contact pads 57 to the lighting elements 50. Including the lighting elements 50 on the substrate 102 can allow for the use of fewer wires than other systems. For example, without the substrate 102, multiple wires may be required to power multiple individual lighting elements 50. Using a set of twisted pair wires 56 connected to the substrate 102 can save space in the shaft 42 and / or reduce costs compared to using multiple wires or cables (e.g., multiple twinax wires) to power each of the lighting elements 50. Although in FIG. 2A to FIG. 2C Shields are not depicted in FIG. 5 , but one or more shields may be positioned around the wires 56 .

[0029] One or more cables 58 may transmit power and signals to and from the camera 52. The cables 58 may include, for example, micro-coaxial cables or other suitable cables or wires. Figure 2A and Figure 2C As shown in FIG, distal component assembly 100 may include two cables 58. Figure 2A and Figure 2C The number of cables 58 shown in FIG. 5 is exemplary only, and other suitable numbers of cables may be utilized. Figure 2C As specifically shown in , the distal end of each of the cables 58 can be secured to one or more of the contact pads 59 on the proximal end of the second side of the substrate 102 (e.g., via bonding or welding) to provide an electrical connection between the cables 58 and the camera 52 (via, for example, electrical traces or wires between the contact pads 59 and the camera 52). FIG. 2A to FIG. 2C , the contact pad 59 for attaching to the cable 58 and the contact pad 57 for attaching to the wire 56 can be located on opposite sides of the substrate 102. In one example, the contact pad 59 for attaching to the cable 58 can be roughly opposite to the contact pad 57 for attaching to the cable 58. For example, the contact pad 59 and the contact pad 57 can be located on opposite sides of the substrate 102, but can be directly opposite to each other to save space on the substrate 102. However, this arrangement is merely exemplary, and other arrangements can be utilized. For example, the wire 56 can be connected to the contact pad 57 on the same side of the substrate 102 as the contact pad 59 for connecting to the cable 58.

[0030] In the alternative, twisted pair 56 may be replaced with twinaxial wire or cable, such as micro-coaxial cable, to allow the conductors powering lighting element 50 to be soldered or bonded using the same process used to attach cable 58 and / or reduce noise generated by electromagnetic interference.

[0031] Elements of the position sensing system 108 may also be disposed on the substrate 102. The position sensing system 108 may include any of the features described in U.S. Patent Application No. 15 / 846,846 filed on December 19, 2017 (which was issued on September 22, 2020 as U.S. Patent No. 10,782,114), the entire contents of which are incorporated herein by reference. The position sensing system 108 may include one or more magnetic field sensors 110a, 110b, 110c disposed on the substrate 102. For example, Figure 2A and Figure 2B As shown, three magnetic field sensors 110a, 110b, 110c can be arranged on substrate 102. Any alternative number of sensors can be utilized, and the three sensors 110a, 110b, 110c depicted are exemplary only. Magnetic field sensors 110a, 110b, 110c can include, for example, magnetoresistive elements, such as TMR elements, anisotropic magnetoresistive sensing elements, giant magnetoresistive sensing elements, super giant magnetoresistive sensing elements, abnormal magnetoresistive sensing elements (extraordinary magneto-resistive) or semiconductor magnetoresistive elements. Additionally or alternatively, magnetic field sensors 110a, 110b, 110c can include one or more inductive sensors (e.g., inductive coil sensors), planar coil sensors, spin Hall sensing elements (or other Hall sensing elements) or magnetic gradiometers. Although TMR sensors and properties of TMR sensors may be mentioned herein, it should be understood that any type of magnetic field sensor can be utilized, including those listed above. The magnetic field sensors 110a, 110b, 110c may have any properties of magnetic field sensors known in the art (including, for example, TMR sensors). For example, the magnetic field sensors 110a, 110b, 110c 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 2AAs shown in , magnetic field sensors 110a, 110b, 110c can be arranged in a dual-axis, six-degree-of-freedom arrangement. In such an arrangement, two magnetic field sensors 110a, 110b can be oriented so that their main sensing directions are aligned (approximately parallel) with the longitudinal axis of the device 10 (also the longitudinal axis of the component assembly 100 / substrate 102). The two magnetic field sensors 110a, 110b can be configured using a full Wheatstone bridge. The third magnetic field sensor 110c can be arranged so that its main sensing direction is transverse to (e.g., approximately orthogonal / perpendicular to) the longitudinal axis. The magnetic field sensor 110c can be configured using a half Wheatstone bridge. The Wheatstone bridge can have any characteristics of a Wheatstone bridge known in the art. Sensors 110a, 110b, 110c can detect the orientation / position of the distal component assembly 100, and can transmit a signal indicating the orientation / position of the distal component assembly 100. A controller (not shown) may receive the signals and may calculate the positioning of distal component assembly 100 using measurements from magnetic field sensors 110a, 110b, 110c across a primary sensing direction (from magnetic field sensors 110a, 110b) and a direction orthogonal to the primary sensing direction (from magnetic field sensor 110c).

[0033] The position sensing system 108 may also optionally include a capacitor 114 for reducing noise in the voltage supplying the position sensing system 108. For example, the capacitor 114 may be used as a decoupling capacitor, acting as a low pass filter for any electromagnetic interference ("EMI") on the supply voltage. The position sensing system 108 may also optionally include one or more diodes 112. The diodes 112 may provide high voltage protection, such as electrostatic discharge ("ESD") protection. The diodes 112 may prevent electrostatic discharge from causing damage to the magnetic sensors 110a, 110b, 110c. The diodes 112 may additionally or alternatively provide protection for various aspects of the camera 52.

[0034] like Figure 2AAs particularly shown in , each wire 116 of the three twisted pairs of wires 116 can be electrically connected to a contact pad 117 on a first side of the substrate 102 (on the same side of the substrate 102 as the contact pad 57 of the wire 56). The wires and / or traces can electrically connect the contact pads 117 and elements of the position sensing system 108. In some configurations, the contact pads 117 for electrically connecting to the wires 116 can also be provided on the same side of the substrate 102 as the contact pads 59 for connecting to the cable 58. The wires 116 can provide power and / or signals to and / or from various aspects of the position sensing system 108. The three twisted pairs of wires 116 can include six individual wires 116. Two of those wires 116 can be used to provide power to the position sensing system 108. Two of the remaining four wires 116 can be connected to the full Wheatstone bridge of the magnetic field sensors 110a, 110b. The remaining two wires can be connected to the half Wheatstone bridge of the magnetic field sensor 110c. Although in FIG. 2A to FIG. 2C Shields are not depicted, but may be positioned around the wires 116. In an alternative example, the twisted pair wires 116 may be replaced with twinaxial wires or cables, such as micro-coaxial cables, to allow the conductors that power the position sensing system 108 to be welded or bonded using the same process used to attach the cable 58 and / or reduce noise generated by electromagnetic interference.

[0035] The position sensing system 108 may have other configurations within the scope of the present invention. For example, a three-axis configuration may be employed for the magnetic field sensors 110a, 110b, 110c, wherein each of the magnetic field sensors is arranged so that its primary sensing direction is aligned with a different axis (e.g., the primary sensing directions of the magnetic field sensors 110a, 110b, 110c are aligned orthogonally to each other). For example, the magnetic field sensor 110a may have a primary sensing direction of the X axis. The magnetic field sensor 110b may have a primary sensing direction of the Y axis, and the magnetic field sensor 110c may have a primary sensing direction of the Z axis. In this three-axis configuration, each of the magnetic field sensors 110a, 110b, 110c may utilize a half-Wheatstone bridge configuration. This three-axis configuration will require a total of eight wires 116—two for powering the position sensing system 108, and two for each of the three half-Wheatstone bridges of the magnetic field sensors 110a, 110b, 110c. In another example, six degrees of freedom may be measured using only two magnetic field sensors (e.g., magnetic field sensors 110a, 110b), where each of magnetic field sensors 110a, 110b has a half-Wheatstone bridge configuration (or a full-Wheatstone bridge configuration). In another example, five degrees of freedom may be measured using two magnetic field sensors (e.g., magnetic field sensors 110a, 110b). In such an example, position sensing system 108 may not be able to measure roll. In an additional example, a single magnetic field sensor 110a may use a half-Wheatstone bridge to measure five degrees of freedom.

[0036] The above examples are illustrative only, and other magnetic field sensor configurations may be utilized. FIG. 2A to FIG. 2C As shown, a system utilizing three magnetic field sensors 110a, 110b, 110c in a dual-axis, six-degree-of-freedom arrangement may be beneficial due to the ability to measure six degrees of freedom while requiring only six wires 116. Alternative arrangements may also be used for the lighting element 50 and the camera 52. FIG. 2A to FIG. 2C As shown and described above, all of the contact (eg, solder) pads 57, 117 for the wires 56, 116 may be disposed on a single side of the substrate 102 (eg, as shown in FIG. Figure 2A 116 to the substrate 102 in a single manufacturing process without having to flip the distal component assembly 100 .

[0037] Distal component assembly 100 may also include components in addition to or in place of the components described above. For example, distal component assembly 100 may also include additional or alternative illumination sources and / or additional or alternative imaging components (e.g., additional cameras). Distal component assembly 100 may also include additional types of sensors, such as humidity sensors, temperature sensors, pressure sensors, or other types of sensors, which may be useful during medical procedures.

[0038] Although the magnetic field sensors 110a, 110b, 110c are described above as TMR sensors, other types of sensors on the substrate 102 may also be utilized. For example, one or more inductive sensors may be utilized. The inductive sensors may include one or more coils for measuring the magnetic field and determining the location and / or orientation of the distal tip 44. Any suitable arrangement of inductive sensors may be utilized to measure the desired number of degrees of freedom. For example, the inductive sensors may be positioned at least 11 degrees tilted from each other (e.g., may be angled relative to the longitudinal axis of the distal tip 44).

[0039] In some examples, a TMR sensor may have a lower cost and / or a smaller size than an inductive sensor. An inductive sensor array may require two inductive sensors (each of which may be greater than 0.25" in length) to be placed at an angle relative to each other to create an array measuring approximately 0.06-0.08" (e.g., approximately 0.071") by approximately 0.25-0.26" (e.g., approximately 0.255"). The TMR die may have dimensions such as approximately 0.015-0.03" (e.g., approximately 0.024") by approximately 0.01 -0.025" (e.g., approximately 0.018"). If placed in a linear configuration, an array of elements such as position sensing system 108 may occupy a footprint of approximately 0.01-0.03" (e.g., approximately 0.018") by approximately 0.1-0.2" (e.g., approximately 0.156"). Because the TMR die and associated elements (e.g., diodes and capacitors) are modular, they may be arranged in a variety of patterns, for example, to minimize space and / or to accommodate other features of distal component assembly 100. For example, as Figure 2A As shown, the magnetic field sensors 110a, 110b, 110c and the diode 112 may be arranged substantially linearly. Figure 2A As shown, one diode 112 can be located proximal to the magnetic field sensors 110a, 110b, 110c, and one diode 112 can be located distal to the magnetic field sensors 110a, 110b, 110c. The arrangement of the components of the distal component assembly 100 can be selected to save space and provide a smaller footprint and size of the substrate. The capacitor 114 can be positioned between the proximal end of the camera 52 and the contact pad 57 for the wire 56. Although a TMR sensor can be used in the distal component assembly 100, the present invention is not limited to TMR sensors and can include any type of sensor, including those listed above.

[0040] To assemble the distal component assembly 100, the substrate 102 (e.g., a multilayer PCB) can be assembled with the magnetic field sensors 110a, 110b, 110c, the diode 112, and the capacitor 114 using, for example, a pick-and-place machine. Once in place, the magnetic field sensors 110a, 110b, 110c, the diode 112, and the capacitor 114 can be wire bonded to the substrate 102 and electrically tested. Thereafter, the camera 52 and the lighting element 50 can be held in place using a fixture and their electrical contacts can be bonded (e.g., at a 90 degree angle) to the solder pads of the substrate 102. The process of soldering the camera 52 and the lighting element 50 can be performed on both sides of the substrate 102. Finally, the wires 56, the cables 58, and the wires 116 can be bonded to the appropriate sides of the substrate 102 via the respective contact pads 57, 59, 117. For example, the wires 56 for connecting to the lighting element 50 and the wires 116 for connecting to the position sensing system 108 can be bonded to the first side of the substrate 102 in a single step. The above steps and sequence are exemplary only. The wires 56, cables 58, and wires 116 may be formed into a single bundle for passing through the shaft 42. Additional or alternative steps may be utilized, and the steps may be performed in a different order.

[0041] FIG. 3A to FIG. 3F An exemplary distal tip 44 is shown having a distal tip body 244 and a distal component assembly 100 . Figure 3A The distal tip body 244 and the distal component assembly 100 are shown prior to being assembled together. Figure 3B A cross-sectional view of distal tip 44 (taken along a longitudinal axis of distal tip 44 ) is shown illustrating a first side of distal component assembly 100 . Figure 3C Detailed views of various aspects of distal tip body 244 and distal component assembly 100 are shown. Figure 3D and Figure 3E A perspective view of the distal tip 44 is shown, wherein the distal tip body 244 has a transparent portion. Figure 3F A perspective view of distal tip 44 is shown.

[0042] The distal tip body 244 can define a distal portion of the working channel, which can terminate distally in the working channel opening 48 (see in particular Figure 3D and Figure 3F ). The distal tip body 244 may further define a cavity 246. The cavity 246 may extend from the proximal end of the distal tip body 244 to the distal end of the distal tip body 244. The cavity 246 may be sized and shaped to receive the distal component assembly 100. For example, the cavity 246 may include a contoured shape (e.g., a contoured surface) having a recess for accommodating the camera 52 and the lighting element 50. Figure 3BAs shown, cavity 246 can have a proximal portion 248 and a distal portion 250. The width of proximal portion 248 (the dimension extending across the first and second faces of substrate 102 perpendicular to the longitudinal axis of substrate 102 and device 10) can be greater than the width of distal portion 250. In other words, the width of distal portion 250 can be less than that of proximal portion 248.

[0043] The distal portion 250 may terminate in a distal opening 254 (see Figure 3D and Figure 3F ), which shape can be designed to receive the camera 52 and the lighting element 50. For example, the surface of the distal opening 254 can have a shape that is complementary or substantially complementary to the outer surface of the camera 52 and the lighting element 50. In other words, the shape of the distal opening 254 can be used to align and maintain the camera 52 and the lighting element 50 in a desired position. The shape of the distal opening 254 can also limit the size of the edge around the camera 52 and the lighting element 50 to allow for easier sealing (as discussed below) of the distal opening 254 and reduce the chance of fluid entering / exiting the distal opening 254. In one example, because the camera 52 can extend radially outward from the first face farther than the lighting element 50, the first side of the distal opening 254 (toward the distal side) is Figure 3D and Figure 3F The second side of the distal opening 254 (opposite to the first side and toward the top) can have a central portion that extends radially outward farther than the lateral outer portion of the distal opening 254 to accommodate the shape of the camera 52 and the lighting element 50. In this example, since the lighting element 50 can extend radially outward farther from the second side than the camera 52, the second side of the distal opening 254 (opposite to the first side and toward the top) can have a central portion that extends radially outward farther than the lateral outer portion of the distal opening 254 to accommodate the shape of the camera 52 and the lighting element 50. Figure 3D and Figure 3F The bottom of the camera 52 may have a lateral outer portion that extends radially outward farther than the central portion to accommodate the shape of the camera 52 and the lighting element 50.

[0044] A symmetrical shoulder 252 may define an interface between the proximal portion 248 and the distal portion 250. The shoulder 252 may define a distal surface of the cavity 246 between the proximal portion 248 and the distal portion 250. FIG. 2A to FIG. 2CAs shown and described above, the substrate 102 can extend along the width beyond each of the lighting elements 50 in a symmetrical manner. The distal portion 250 can be wide enough to accommodate the camera 52 and the lighting element 50, but can be narrower (smaller) than the substrate 102. The proximal portion 248 can be wide enough to accommodate the substrate 102. In order to assemble the distal tip 44, the distal end 104 of the distal component assembly 100 can be inserted into the proximal opening of the cavity 246. The camera 52 and the lighting element 50 can enter the distal portion 250 of the cavity 246 so that the camera 52 and the lighting element 50 are at least partially received within the distal portion 250 of the cavity 246. On either side of the lighting element 50, the substrate 102 can abut the shoulder 252. Thus, the shoulder 252 can serve as a stop that is used to help align the distal component assembly 100 in a desired position and help prevent the distal component assembly 100 from being advanced distally beyond the desired position. As shown in FIG. Figure 3C As shown, the width E of the shoulder 252 can abut against either side of the base plate 102. The width E can be about 0.005" or greater. For example, the width E can be about 0.005" to about 0.010". When the distal component assembly 100 is positioned within the cavity 246, it may accidentally be positioned slightly asymmetrically, so the width E may be slightly different on either side of the base plate 102.

[0045] When assembling, Figure 3B As shown, the length of the distal tip 44 from the proximal end of the distal tip body 244 to the distal end of the camera 52 (which may extend distally beyond the distal end of the distal tip body 244) may be approximately 0.300-0.400". For example, the length C of the distal tip 44 may be approximately 0.330". The width D (e.g., diameter) of the distal tip 44 at the widest point may be approximately 0.100-0.250". For example, the width of the distal tip 44 at the widest point may be approximately 0.155", approximately 0.197", or approximately 0.231". Each of the dimensions provided herein is merely exemplary, and any other suitable dimension may be selected. For example, different types of devices may utilize different widths (e.g., a duodenoscope may be wider than a bronchoscope).

[0046] To assemble the distal component assembly 100 and the distal tip body 244, the distal end 104 of the distal component assembly 100 can be inserted into the proximal opening of the cavity 246. The distal component assembly 100 can be advanced distally until the edge of the substrate 102 abuts against the shoulder 252. An epoxy adhesive can be applied to the camera 52 and / or the lighting element 50 to help seal the distal opening 254 to prevent fluid ingress / egress and to help keep the distal component assembly 100 (including the substrate 102) in place. Other techniques can also be used to fix the distal component assembly 100. For example, other types of adhesives, screws, pins, crimps, snap fits, or other features can be used to fix the distal component assembly 100 to the distal tip body 244. Such fixing features can be used, for example, at the proximal end of the cavity 246, the distal end of the cavity 246, or via an opening extending from the distal tip body 244 (e.g., the radial outer surface of the distal tip body 244) to the cavity 246. Overmolding or similar techniques may also be used to secure the distal component assembly 100 to the distal tip body 244 or to secure elements of the distal component assembly 100 to the substrate 102. Overmolding may also be used to form the distal tip 44 around the distal component assembly 100 without using the distal tip body 244. For example, the distal component assembly 100 may be loaded into an injection mold and material may be injected into the mold to form the distal tip 44. For example, a portion of the distal segment end 44 may be molded directly onto the substrate 102, the camera 52, the lighting element 50, the camera capacitor 54, the magnetic sensors 110a, 110b, 110c, the diode 112, and / or the capacitor 114 and combined with other preformed or overmolded components to form the distal tip 44. The distal tip 44, such as elements of the distal tip body 244, may be constructed using 3D printing.

[0047] In an alternative example, the substrate 102 can include a flexible circuit board that is manufactured with the substrate 102 in a flat configuration and then folded prior to insertion into the distal tip body 244. In examples that include a flexible circuit board, the lighting element 50 can be positioned on a different plane of the substrate 102 than the camera 52. The components can be surface mounted on the substrate 102 and then bent at an angle (e.g., approximately 90 degrees) to face forward (distalward) or in any other direction. In a further alternative, instead of mounting components on the substrate 102 (such as, the lighting element 50, the camera 52, the camera capacitor 54, the magnetic sensors 110a, 110b, 110c, the diode 112, or the capacitor 114) (e.g., FIG. 2A to FIG. 3E Components may be embedded in substrate 102 according to any suitable method (as shown and described above).

[0048] The distal tip 44 may be further assembled by performing steps such as connecting the hinge wire to the distal tip 44 and assembling the distal tip 44 onto the shaft 42. The wires 56, 116 and the cable 58 may be fed back through the shaft 42. The handle portion 12 may include connections for connecting to the proximal ends of the wires 56, 116 and the cable 58. For example, the handle portion 12 may include a circuit board, such as a printed circuit board, having connections for the wires. Such connections may include six passive connections for connecting to the wires 116 of the position sensing system 108 (including the magnetic field sensors 110a, 110b, 110c). Depending on the configuration of the distal component assembly 100, an alternative number of connections may be utilized as appropriate. The umbilicus 30 may include conductors (e.g., wires) for carrying power and / or signals from the distal component assembly 100. For example, the umbilicus 30 may include six wires 116 in a twisted pair to transmit power and / or signals to and from the position sensing system 108 through the umbilicus 30.

[0049] Once assembled, the device 10 can be used to perform medical surgery on a subject. For example, the device 10 can be inserted into a body cavity (e.g., an airway) of a subject. During surgery, an external device can be used to generate a magnetic field near the subject. For example, the external device can be positioned on a table or other surface near the subject (e.g., near the body part where the body cavity is located). During surgery, a position sensing system 108 (including magnetic field sensors 110a, 110b, 110c) can transmit signals to the handle portion 12 through the shaft 42 and to the controller through the umbilicus 30. The signal from the position sensing system 108 can indicate the position and / or orientation of the distal tip 44 in the body. This position and / or orientation information can be fused with imaging (e.g., 3D imaging) performed before surgery. Information from the position sensing system 108 can provide the operator with information about anatomical structures near the device 10, which may not be visualized with the camera 52 alone (including anatomical structures outside the body cavity where the device 10 is disposed). In addition, a mesh of anatomical structures can be automatically segmented using pre-operative images to provide a map (e.g., a 3D map) to track the device 10 in real time. Such real-time tracking can reduce the amount of time, skill, and / or effort required to reach the target anatomical structure. In the absence of pre-operative images, the EM sensors can enable software to track the position of the device 10 and the movement of the device 10 in real time during surgery to generate a map (e.g., a 3D map). The generated map can guide the device 10 (and any EM-enabled accessories) through the anatomical structure of the subject.

[0050] In an alternative, the distal tip 44 may include an element for generating a magnetic field, and the external device may include an element for measuring the magnetic field and determining the location and / or orientation of the distal tip 44. For example, the distal tip 44 may include one or more coils (e.g., solenoids). Circuit elements, such as wires, circuit boards, and / or one or more other components mounted on the circuit board can transmit current through the coils. The coils can thus generate a magnetic field. The external device may include one or more sensors (including, for example, any of the above-mentioned types of sensors) or components for measuring the magnetic field emitted by the coils. The measurements from the sensors or components of the external device can be used (e.g., by a controller) to determine the position of the distal tip 44.

[0051] Any method or part of a method described in the present invention may be performed by one or more processors of a computer system (e.g., a controller). One or more processors may be configured to perform such a method by accessing instructions (e.g., software or computer readable code) that, when executed by one or more processors, configure and / or cause one or more processors to perform the method. Such instructions may be stored in a memory of a computer system.

[0052] 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 the present invention, the present invention should also be understood as describing a non-transitory computer-readable storage medium storing instructions that, when executed by one or more processors of a computer system, configure and / or cause one or more processors to perform the computer-implemented method. Examples of non-transitory computer-readable storage 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 the memory of a computer system or separate from any computer system.

[0053] A 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 another type of processing unit. As used in the present invention, the term "computing device" is interchangeable with "computing device". "Electronic storage device" may include any of the above-mentioned non-temporary computer-readable storage media.

[0054] Although the principle of the present invention is described with reference to the illustrative examples for specific applications, it should be understood that the present invention is not limited thereto. Personnel with ordinary skills in the art and access to the teachings provided herein will recognize that additional modifications, applications, and replacements of equivalents all fall 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 component comprising: a base plate configured to be disposed in a body located at a distal tip of the medical device; a position sensing system comprising a magnetic field sensor mounted to the substrate, wherein the magnetic field sensor is configured to provide a signal indicative of a position or orientation of the distal tip of the medical device; at least one camera mounted to the substrate; as well as At least one lighting element is mounted to the substrate.

2. The assembly of claim 2, wherein the magnetic field sensor comprises a magnetoresistive ("MR") sensor.

3. The assembly of claim 2, wherein the MR sensor is a first MR sensor, and wherein the position sensing system further comprises a second MR sensor and a third MR sensor.

4. The assembly of claim 3, wherein the first MR sensor has a first main sensing direction, wherein the second MR sensor has a second main sensing direction, wherein the third MR sensor has a third main sensing direction, wherein the first MR sensor and the second MR sensor are arranged such that each of the first main sensing direction and the second main sensing direction is substantially parallel to a longitudinal axis of the substrate. 5 . The assembly of claim 4 , wherein the third MR sensor is arranged such that the third main sensing direction is transverse to the longitudinal axis of the substrate.

6. An assembly according to any one of claims 4 or 5, wherein the position sensing system is configured to measure at least five degrees of freedom.

7. The assembly of any one of claims 4 to 6, wherein the first MR sensor, the second MR sensor, and the third MR sensor collectively comprise at least one Wheatstone bridge configuration.

8. An assembly according to any one of claims 4 to 6, further comprising six electrical wires electrically connected to the position sensing system.

9. The assembly of claim 8, further comprising two electrical wires electrically connected to the at least one lighting element.

10. The assembly of claim 9, wherein each of the six wires electrically connected to the position sensing system and each of the two wires electrically connected to the at least one lighting element are connected to the first side of the substrate.

11. The assembly of any preceding claim, further comprising the body, wherein the body comprises a cavity configured to receive the substrate.

12. The assembly of claim 11, wherein the cavity comprises a proximal portion and a distal portion, wherein the width of the distal portion is less than the width of the proximal portion, and wherein the width is measured in a direction perpendicular to the longitudinal axis of the medical device and across the face of the substrate.

13. The assembly of claim 12, wherein the at least one camera and the at least one lighting element are at least partially received within the distal portion of the cavity.

14. An assembly according to any one of claims 12 or 13, wherein the cavity defines a shoulder extending between the proximal portion of the cavity and the distal portion of the cavity, and wherein the distal surface of the base plate is configured to contact the shoulder.

15. The assembly of any one of claims 11 to 14, wherein the distal opening of the cavity has a contour shape complementary to the at least one camera and the at least one lighting element.

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