Medical system

Abstract

A medical system is described, including a medical system including a first medical device and a second medical device. The first medical device includes a handle and an insertion portion having a first working channel. A distal portion of the insertion portion of the first medical device includes a first tracking element and at least one camera. The second medical device includes a handle and an insertion portion. A distal portion of the insertion portion of the second medical device includes a second tracking element. The first tracking element is configured to provide a signal indicative of a position or orientation of a distal portion of the first medical device. The second tracking element is configured to provide a signal indicative of a position or orientation of a distal portion of the second medical device.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This patent application claims priority to U.S. Provisional Application No. 63 / 349,608, filed on June 7, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates generally to medical systems, devices, and related methods. More specifically, aspects of the present disclosure relate to medical systems, devices, and related methods, including medical devices having position tracking and / or mapping components. Background Art

[0004] During a medical procedure, an operator may insert a medical device (such as a ureteroscope or other types of scopes) into a subject's body cavity. The operator may navigate the distal tip of the medical device to a desired location of the subject's anatomical structure, for example, through the subject's urethra, bladder, ureter and / or kidney. Prior to the medical procedure, a region of interest in the subject'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 passages or complex anatomical regions (e.g., urethra, bladder, ureter, kidney, etc.). An imager (e.g., a camera) at the distal tip of the medical device may facilitate this navigation, but may not provide information about areas outside the body cavity wall. Effective navigation using only an imager may require a high level of skill, time, and / or effort. In addition, navigation using only an imager may not allow the user to determine the position and / or direction of the distal tip of the medical device, for example, relative to one or more anatomical regions and / or objects (i.e., kidney stones) in the subject's body. Navigation may be assisted by one or more external imaging techniques, but such external imaging techniques may increase the cost, duration, risk, etc. of the operation.

[0005] 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 may not provide useful information for flexible tools such as ureteroscopes, other types of scopes, biopsy catheters, biopsy tools for passing through an endoscope working channel, or another type of flexible tool. Therefore, there is a need for systems, devices, and / or methods that include position tracking and / or mapping components. Summary of the invention

[0006] A medical system may include a first medical device and a second medical device. The first medical device may include a handle and an insertion portion having a first working channel. A distal portion of the insertion portion of the first medical device may include a first tracking element and at least one camera. The second medical device may include a handle and an insertion portion. A distal portion of the insertion portion of the second medical device may include a second tracking element. The first tracking element may be configured to provide a signal indicating a position or orientation of a distal portion of the first medical device. The second tracking element may be configured to provide a signal indicating a position or orientation of a distal portion of the second medical device.

[0007] The medical system may include one or more of the following aspects. The distal portion of the first medical device may also include one or more lighting elements. The first tracking element, at least one camera, and the one or more lighting elements may be coupled to a substrate within the distal portion of the first medical device. The substrate may include a first face and a second face. The first face and the second face may be arranged substantially orthogonally to each other within the distal portion of the first medical device. The proximal portion of the substrate may include a plurality of contact pads.

[0008] The first tracking element may include a position sensing system including one or more position or orientation sensors. The position sensing system may include a first magnetoresistive sensor, a second magnetoresistive sensor, and a third magnetoresistive sensor. The first magnetoresistive sensor, the second magnetoresistive sensor, and the third magnetoresistive sensor may be coupled to the substrate. The first magnetoresistive sensor may have a first main sensing direction. The second magnetoresistive sensor may have a second main sensing direction. The third magnetoresistive sensor may have a third main sensing direction. The first magnetoresistive sensor and the second magnetoresistive sensor may be arranged so that each of the first main sensing direction and the second main sensing direction is approximately parallel to the longitudinal axis of the substrate. The third magnetoresistive sensor may be arranged so 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 distal portion of the first medical device may also include one or more diodes and one or more capacitors. The one or more diodes and the one or more capacitors may be coupled to the substrate.

[0009] The handle of the first medical device may include a control rod configured to control the articulation or deflection of the distal portion of the first medical device. The handle of the first medical device may include a port connected to the first working channel. The handle of the first medical device may include a suction valve to control the suction applied through the first working channel. The first medical device may include an optical fiber extending from the handle portion to the distal portion of the insertion portion of the first medical device. The distal end of the optical fiber may be adjacent to at least one camera. The first medical device may also include a pressure sensor positioned at the distal portion of the first medical device. The second medical device may be a nephroscope. The nephroscope may include a working channel. The medical system may also include a retrieval device configured to be delivered through the working channel of the nephroscope. The first medical device may include an end cap located at the distal portion. The end cap may at least partially surround the first tracking element.

[0010] In another aspect, a medical device may include a handle and an insertion portion. The handle may include a port. The insertion portion may include a working channel connected to the port. A distal portion of the insertion portion may include a tracking element and at least one camera. The tracking element may include a plurality of magnetoresistive sensors. The tracking element may be configured to provide a signal indicating a position or orientation of the distal portion of the medical device. The tracking element and the at least one camera may be mounted on a substrate within the distal portion of the insertion portion.

[0011] The medical device may include one or more of the following aspects. The substrate may include a first face and a second face. The first face and the second face may be arranged substantially orthogonally to each other within a distal portion of an insertion portion of the medical device. At least one camera may be mounted on the first face of the substrate. A plurality of magnetoresistive sensors may include a first magnetoresistive sensor, a second magnetoresistive sensor, and a third magnetoresistive sensor. The first magnetoresistive sensor, the second magnetoresistive sensor, and the third magnetoresistive sensor may be coupled to the second face of the substrate. The handle may also include an image capture button, a control lever, a port, and a suction valve. The image capture button may be configured to control activation of a camera at a distal portion of the insertion portion. The control lever may be configured to control articulation or deflection of a distal portion of the medical device. The suction valve may be configured to control suction applied through a working channel.

[0012] In yet another aspect, a method may include delivering a first medical device into a subject. The first medical device may include a handle and an insertion portion. The insertion portion may include a working channel. A distal portion of the insertion portion may include a camera and a tracking element. The tracking element may include one or more magnetoresistive sensors. The method may also include delivering a distal portion of the insertion portion of the first medical device into a body cavity or body cavity of the subject. The method may include identifying and / or mapping one or more objects within the body cavity or body cavity with a camera. In addition, the method may include determining whether one or more objects can be removed from the body cavity or body cavity using the working channel of the first medical device. The method may include, upon determining that one or more objects cannot be removed using the working channel of the first medical device, providing a second medical device with a suggested access path to the body cavity or body cavity of the subject. The method may include aiming and inserting the second medical device into the body cavity or body cavity of the subject. The method may also include tracking the position of the second medical device in the subject. In addition, the method may include removing or otherwise treating one or more objects within the body cavity or body cavity with the second medical device.

[0013] The method may include one or more of the following aspects. The method may include an initial step of preparing the subject for surgery by performing one or more of an ultrasound, CT scan, or MRI scan of the subject's kidney. The method may include overlaying one or more aspects of the kidney or one or more kidney stones on the subject prior to providing access for a second medical device.

[0014] It will be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and do not limit the invention as claimed. As used herein, the terms "comprises," "comprising," or any other variations thereof, are intended to cover non-exclusive inclusions such that a process, method, article, or device that includes a list of elements includes not only those elements, but may also include other elements that are not explicitly listed or inherent to the process, method, article, or device. The term "exemplary" is used in the sense of "example," not "ideal." 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 + / - 10% of the stated value. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] 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.

[0016] Figure 1 An exemplary medical system comprising a first medical device and a second medical device is depicted.

[0017] Figures 2A-2D are side, perspective, and cross-sectional views of a distal portion of a first medical device, including a distal component assembly.

[0018] Figures 3A-3E Depicted Figures 2A-2D Various views of the distal component assembly.

[0019] Figure 4 is a flow chart of an exemplary method according to aspects of the present disclosure. DETAILED DESCRIPTION

[0020] Robot-assisted and electromagnetic ("EM")-navigated medical procedures can utilize EM tracking to provide information about the position and / or orientation of a medical device within a subject's anatomical structure. When the medical device has a camera, the operator cannot see the endothelial wall or other types of walls or body structures. Through EM tracking, the position and / or orientation information can be fused with imaging (e.g., three-dimensional ("3D") imaging) performed before surgery and / or imaging received from the camera. The operator can have more information about the anatomical structure near the medical device, which may not be visible to the camera alone (including anatomical structures outside the body cavity in which the medical device is disposed). In addition, preoperative images and / or imaging from a camera at the distal tip of the medical device can be used to automatically segment a mesh of the anatomical structure in order to provide a drawing (e.g., 3D drawing) that tracks the medical device in real time, for example, to construct a 3D representation (e.g., 3D drawing) of the anatomical structure to help navigate the medical device within the anatomical structure. This real-time tracking and / or guidance can help reduce the time, skill, and / or effort required to reach the target anatomical structure. In the absence of preoperative images, EM sensors can enable one or more controllers (i.e., including stored software) to track the position, orientation, and / or motion of a medical device in order to generate a map (e.g., a 3D map) in real time during surgery. In addition, EM sensors can help accelerate the generation of the map (e.g., a 3D map). The generated map can guide the medical device (and any EM-supported accessories and / or any EM-tracked accessories) through the anatomy of the subject. Unlike traditional robotic systems that may rely on position encoders in the motor system to provide the necessary position information for the tip of a medical device (such as a rigid medical device or a rigid portion of a medical device), EM-based systems can provide position information for flexible medical devices.

[0021] In addition, in some aspects, 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 can 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) or other magnetoresistance ("MR") sensors (i.e., MR 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 light emitting diodes ("LEDs") and / or fiber optic light guides. Wires, cables, or other conductors for carrying power and / or signals to circuit board elements 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 an effective connection between the circuit board and the conductors carrying power and / or signals.

[0022] The distal portion of the medical device (e.g., a housing or end cap) can be configured to receive a circuit board. Including position sensing elements, imaging elements, and / or lighting elements on a single circuit board can facilitate cost-effective manufacturing by, for example, reducing the number of steps to assemble the medical device, reducing the likelihood of errors in assembly, and / or reducing waste. For example, rather than assembling lighting elements, imaging elements, and / or sensing elements separately on or within the distal tip body, all of these elements (and conductors to provide power and / or signals thereto) can be assembled to the distal tip body in a single step.

[0023] Examples of the present disclosure include systems, devices and methods for promoting and / or improving the efficacy, efficiency, cost and / or safety of medical procedures. Embodiments of the present disclosure may relate to systems, devices and methods for performing various medical procedures and / or treating any other part of the kidney, ureter, bladder, urethra or urinary tract. In addition, embodiments of the present disclosure may relate to systems, devices and methods for performing various medical procedures and / or treating any other part of the large intestine (colon), small intestine, cecum, esophagus, stomach or gastrointestinal tract or biliary tree. In addition, embodiments of the present disclosure may relate to systems, devices and methods for performing various medical procedures and / or treating parts of anatomical structures, for example, via body cavities, such as larynx, trachea, bronchi (main bronchi), lobar bronchi (secondary bronchi), segmental bronchi (tertiary bronchi) or any other part of the respiratory system. In these aspects, the systems, devices and methods discussed herein may be used to treat any other suitable subject anatomical structure (collectively referred to herein as "treatment site").

[0024] Various embodiments described herein include single-use or disposable medical devices. Some aspects of the present disclosure may be used to perform endoscopic, arthroscopic, bronchoscope, ureteroscope, colonoscope or other types of procedures. Some aspects of the present disclosure may be used to perform neuromodulation procedures, for example, to help locate one or more electrodes used in treatment or procedures (e.g., in deep brain stimulation). For example, the disclosed aspects may be used with ureteroscopes, endoscopes, duodenoscopes, gastroscopes, endoscopic ultrasonography ("EUS") scopes, colonoscopes, bronchoscopes, laparoscopes, arthroscopes, cystoscopes, suction scopes, sheaths, catheters, diagnostic or therapeutic tools or equipment, or any other suitable delivery device or medical device, for example, for treatment through a body cavity. Alternatively, various embodiments described herein may be delivered to a treatment site alone and / or used separately from another scope or medical device. One or more elements discussed herein may be metallic, plastic, or include any combination of shape memory metals (such as nitinol), shape memory polymers, polymers, or biocompatible materials.

[0025] Reference will now be made in detail to examples of the disclosure described above and shown in the accompanying drawings. Wherever possible, the same reference numerals will be used throughout the accompanying drawings to refer to the same or similar parts. It should be noted that one or more aspects of the medical systems, devices, and methods discussed herein may be combined and / or used together with one or more aspects of other medical systems, devices, and methods discussed herein.

[0026] Figure 1 Aspects of an exemplary medical system 2 are depicted. The medical system 2 includes a first medical device 10 and a second medical device 20. The first medical device 10 may include a handle portion 12 for grasping and operating by an operator, and an insertion portion 14 for at least partially inserting into a subject's body (e.g., a body cavity). A distal portion 16 of the insertion portion 14 may include one or more tracking elements 18 (e.g., EM-based sensors). Figure 1As shown, the first medical device 10 may include a ureteroscope. Although the present disclosure may refer to a ureteroscope or an endoscope in different places, it should be understood that unless otherwise stated, a bronchoscope, a duodenoscope, an endoscope, a gastroscope, an endoscopic ultrasound ("EUS") scope, a colonoscope, a ureteroscope, a bronchoscope, a laparoscope, a cystoscope, a suction scope, a sheath, a catheter, or any other suitable delivery device or medical device may be used in combination with the elements and components described herein. The second medical device 20 may be a nephroscope, which may include a handle portion 22 and an insertion portion 24. The distal end 26 of the insertion portion 24 may include one or more tracking elements 28 (e.g., an EM-based sensor). In addition, the second medical device 20 may receive one or more retrieval devices 42. One or more of the first medical device 10 and / or the second medical device 20 can be used to track and / or map the position of corresponding distal portions of the insertion portions 14, 24, map one or more internal cavities of a subject, locate one or more objects or tissues to be removed from one or more internal cavities of a subject, and / or remove one or more objects or tissues from one or more internal cavities of a subject.

[0027] The handle portion 12 of the first medical device 10 may include a control lever 30, for example, on a proximal portion of the handle portion 12. The control lever 30 may help facilitate articulation, steering, deflection, or other movement of the insertion portion 14 (including the distal portion 16). Figure 1 A control rod 30 is depicted in FIG. 3 , but it should be understood that any suitable actuator, such as one or more knobs, buttons, sliders, or joysticks, may be used in addition to or in place of the control rod 30 .

[0028] The port 32 of the handle portion 12 (eg, on a proximal portion of the handle portion 12) may provide access to a lumen or working channel 40 (eg, Figure 2D and Figure 3A ) inlet. In some aspects, port 32 can be a T-shaped port, and / or can include one or more valves, Luer connectors, etc. An operator can insert an instrument or other device into port 32 and can extend the instrument or other device distally through working channel 40. Working channel 40 can extend longitudinally through the length of insertion portion 14.

[0029] The handle portion 12 may also include a suction valve 34, for example, on a proximal portion of the handle portion 12 and on an opposite side from the control rod 32. An operator may connect the suction valve 34 to a suction source and may operate the suction valve 34 to generate suction through the insertion portion 14 (e.g., through the working channel 40). The handle portion 12 may additionally or alternatively include other types of valves, such as an air valve and / or a water valve, or valves that perform a combination of functions.

[0030] The handle portion 12 may also include an image capture button 36. The image capture button 36 enables the operator to view images from the camera 52 (e.g., Figure 2B and Figure 2C The image capture button 36 can be positioned at a proximal portion of the handle portion 12, for example, adjacent to the suction valve 34. Additionally or alternatively, the image capture button 36 can enable an operator to capture a video or perform other functions to control the first medical device 10.

[0031] The handle portion 12 of the first medical device 10 can be coupled to an umbilicus 38. The umbilicus 38 can extend from the handle portion 12 (e.g., from a distal portion of the handle portion) and can carry wires, cables, and / or conduits for providing power, signals, or fluids to or from the handle portion 12. For example, the umbilicus 38 can connect the handle portion 12 to one or more user interfaces, monitors, displays, fluid sources, fluid storage containers (i.e., removed from a subject via aspiration), etc.

[0032] The insertion portion 14 of the first medical device 10 may include a shaft 44 extending distally from the handle portion 12. The shaft 44 may have any suitable properties. For example, the shaft 44 may be flexible and may have a wire, tube, or other feature passing therethrough. The distal portion 16 of the first medical device 10 may be disposed at the distal end of the shaft 44. Figure 2A and Figure 2C As shown, distal portion 16 can include a distal-most face 46. Distal-most face 46 can define a working channel opening 48. Working channel 40 can extend between port 32 and working channel opening 48, such that instruments or other equipment can pass through port 24, through working channel 40, and out of working channel opening 48. Instruments extending distally from working channel opening 48 can be used to perform a medical procedure on a subject.

[0033] The distal portion 16 may also include imaging components, such as one or more lighting devices or lighting elements 50 and one or more imaging devices or cameras 52 ( Figure 2B-2D ). Figure 2B-2D, but it should be understood that an alternative number of lighting elements 50 and cameras 52 may be utilized. Alternatively, the lighting element 50 and the camera 52 may be combined into a single device. The lighting element 50 may include an LED, an optical fiber, or any suitable alternative light source. The camera 52 may be configured to capture or otherwise take video and / or still images. The camera 52 may provide a signal to a monitor (not shown), for example, via one or more cables or wires passing through the shaft 44 and / or the umbilicus 38, so that an operator can view the visual image provided by the camera 52 while navigating and / or manipulating the first medical device 10 through a subject's internal cavity or body cavity. In addition, a control unit or controller (not shown) integrated with the first medical device 10 or separated from the first medical device 10 may analyze one or more images and / or video signals, for example, to create a drawing (e.g., a three-dimensional drawing) of one or more internal cavities or body cavities in the subject's body.

[0034] like Figure 2A and Figure 2C As depicted and described above, the first medical device 10 can be "forward facing." In other words, features of the distal portion 16 (e.g., the working channel opening 48, the lighting element 50, and the camera 52) can face distally (i.e., forward of the distal-most end face 46). The present disclosure also includes other configurations of the distal portion 16. For example, the first medical device 10 can be "side-facing." In side-facing embodiments, one or more of the working channel opening 48, the lighting element 50, and / or the camera 52 can be disposed radially outward of the distal portion 16. In these aspects, one or more of the working channel opening 48, the lighting element 50, and / or the camera 52 can point or face in a radially outward direction, substantially perpendicular to or otherwise transverse to a longitudinal axis of the insertion portion 14 of the first medical device 10.

[0035] As described above, the second medical device 20 can be a nephroscope, for example, including a handle portion 22 and an insertion portion 24. The handle portion 22 can receive one or more instruments, such as a retrieval device 42. The retrieval device 42 may include one or more actuating members 60, for example, movable to open and / or close an end effector (e.g., a grabber, an expandable basket, etc.), which can extend through the second medical device 20 and extend distally to the distal portion 26 of the insertion portion 24. In addition, as described above, the distal portion 26 may include a tracking element 28. In addition, although not shown, one or more portions of the second medical device 20 can be delivered to the lumen of the subject via the insertion device. For example, a portion of the insertion portion 24 can be delivered to the kidney of the subject via one or more of a guidewire, a tubular member, or a sheath, for example for a percutaneous nephrolithotomy ("PCNL") procedure.

[0036] Figures 2A-2D Different views of the distal portion 16 of the insertion portion 14 of the first medical device 10 are depicted. Figure 2A is a side view of the distal portion 16 of the insertion portion 14, and Figure 2B 1 is a perspective view of the distal portion 16 of the insertion portion 14 (ie, looking distally from a position proximal to the distal portion 16). Figure 2A and Figure 2B A portion of the insertion portion 14 is shown, wherein the outer sheath or covering ( Figure 1 ) was removed.

[0037] like Figure 2A As shown, the insertion portion 14 can include an end cap 54, for example, located at the distal end of the insertion portion 14. The end cap 54 can be coupled to the distal end of the insertion portion 14, or can be formed integrally with the insertion portion 14. In some aspects, the end cap 54 can form the distal-most end surface 46. Additionally, in some aspects, the end cap 54 can include a flat distal end surface 54A and an angled or tapered surface 54B, for example, extending proximally from the flat distal end surface 54A at a certain angle. In some aspects, the end cap 54 can include a longitudinal length L of about 0.2 inches to about 0.3 inches, such as about 0.25 inches, about 0.21 inches, etc. The end cap 54 can at least partially surround one or more portions of the tracking element 18.

[0038] In these aspects, such as Figure 2A and Figure 2B As shown, the insertion portion 14 can include a working channel lumen 56 and an optical fiber 58. As described above, the working channel lumen 56 can form the working channel 40 and can connect the port 32 to the working channel opening 48. The optical fiber 58 can extend generally parallel to at least a portion of the working channel lumen 56, for example, from the handle portion 12 to (or just proximate to) the distal-most end face 46. The optical fiber 58 can form or be coupled to the lighting element 50.

[0039] Additionally, the insertion portion 14 may include one or more cables or wires 62, for example, to electrically and / or communicatively couple one or more portions of the distal portion 16 to the handle portion 12, the umbilicus 38, etc. Figure 2A and Figure 2B As shown, the wires 62 may be twisted, for example, to form a bundle. Figure 2A and Figure 2B As shown, the end cap 54 may include one or more coupling elements 64 (e.g., screws, bolts, etc.), for example, to couple portions of the end cap 54 together and / or allow portions of the end cap 54 to be disengaged to provide access to the interior of the end cap 54. Alternatively, the portions of the end cap 54 may be coupled using an adhesive, a snap fit, etc.

[0040] like Figure 2BAs shown, as discussed in more detail below, the distal end 16 can include a distal component assembly 100, which can be constructed or included in a medical assembly. Figures 3A-3E , the distal component assembly 100 can be disposed in the distal portion 16 of the first medical device 10 , for example, within the end cap 54 .

[0041] Distal component assembly 100 may include substrate 102 (e.g., a circuit board or other type of board). Substrate 102 may include, for example, a rigid or flexible printed circuit board, and may include one or more layers. In one example, substrate 102 is flexible and includes multiple layers. Proximal end 103 of distal component assembly 100 may be Figure 2B The distal end 104 of the distal component assembly 100 may be Figure 2B One or more of the lighting element 50 and / or the camera 52 may be supported by or otherwise coupled to the substrate 102. Additionally, the pressure sensor 66 may be supported by or otherwise coupled to the substrate 102, such as via the distal extension 103a.

[0042] As discussed in more detail below, one or more elements of the position sensing system 108 may also be disposed on the substrate 102. The position sensing system 108 may incorporate any of the features described in U.S. 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.

[0043] The position sensing system 108 may include one or more magnetic field sensors 110a, 110b, 110c disposed on the substrate 102. For example, Figure 2BAs shown, three magnetic field sensors 110a, 110b, 110c can be disposed on the substrate 102 and can form the tracking element 18. Any alternative number of sensors can be utilized, and the three sensors 110a, 110b, 110c depicted are exemplary only. The magnetic field sensors 110a, 110b, 110c can include, for example, MR elements, such as TMR elements, anisotropic magnetoresistive sensing elements, giant magnetoresistive sensing elements, giant magnetoresistive sensing elements, very magnetoresistive sensing elements, or semiconductor magnetoresistive elements. Additionally or alternatively, the 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 characteristics of TMR sensors may be mentioned herein, it will be understood that any type of magnetic field sensor may be utilized, including those listed above. The magnetic field sensors 110a, 110b, 110c may have any characteristics 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.

[0044] Although not shown in detail, the tracking element 28 on the distal portion 26 of the second medical device 20 may include one or more details of the tracking element 18. For example, a distal component assembly similar to the distal component assembly 100, including the position sensing system 108 and sensors 110a, 110b, and 110c, may be positioned on or within the distal portion 26.

[0045] Figure 2C is an end view of the distal portion 16 of the first medical device 10, and Figure 2D For example, from the farthest end face 46 ( Figure 2A and Figure 2C ) a cross-sectional view of the distal portion 16 of the first medical device viewed from a proximal position toward the distal direction (along Figure 2B In these aspects, such as Figure 2C As shown, the distal portion 16 includes a distal-most end face 46. In addition, the distal-most end face 46 includes a working channel opening 48, an illumination element 50, and a camera 52. As described above, the illumination element 50 can be formed by an optical fiber 58 or otherwise coupled to an optical fiber 58 ( Figure 2A and Figure 2B ).

[0046] like Figure 2DAs shown, one or more of the lighting element 50, the camera 52, and the pressure sensor 66 can be coupled to the substrate 102. The lighting element 50 can be formed by or coupled to the optical fiber 58. In addition, the substrate 102 can include a curved configuration, such as an L-shaped configuration, for example, such that the first face 102a and the second face 102b are arranged substantially orthogonal to each other. Figure 2B and Figure 2D As shown, the pressure sensor 66 can be positioned on the base plate 102. The configuration of the base plate 102 can allow for various connections and installations without requiring the lateral width of the distal end 16 to accommodate the entire width of the base plate 102. The operator can determine the position of the distal portion 16 via the position sensing system 108. In addition, the working channel 40 ( Figure 2D and Figure 3A ) can be free to receive one or more medical devices. In this regard, the various distal components (illumination element 50, camera 52, optical fiber 58, pressure sensor 66, distal component assembly 100, including substrate, position sensing system 108 with sensors 110a, 110b, 110c, etc.) are positioned outside of working channel 40 (e.g., which can be formed by working channel lumen 56). In addition, in some aspects, distal end 16, such as end cap 54, can include an outer diameter D of about 0.1 inches to about 0.2 inches, such as about 0.15 inches, about 0.125 inches, etc.

[0047] Figures 3A-3E Additional features of the distal portion 16 of the first medical device 10 including the distal component assembly 100 are shown. Figure 3A The distal component assembly 100 and the wires 62 are depicted separately from the other portions of the distal portion 16 (e.g., the end cap 54, the working channel lumen 56, and the optical fiber 58). As shown, the distal component assembly 100 can be coupled to and / or removed from the other portions of the distal portion 16. In addition, as described above, the camera 52 can be mounted on or otherwise coupled to the substrate 102. In addition, the distal component assembly 100 can include a pressure sensor 66, for example, mounted on or otherwise coupled to the distal portion of the substrate 102. For example, as described above, the distal component assembly 100 can include a pressure sensor 66. Figure 2B , Figure 3B and Figure 3D As shown, the base plate 102 may include a distal extension 103a, for example, to support the base plate 102 and / or otherwise couple the pressure sensor 66 to the base plate 102. In these aspects, the pressure sensor 66 may be electrically and / or communicatively coupled to a controller (not shown) to detect and / or provide a user with a pressure within a body cavity or lumen.

[0048] The substrate 102 may include a first surface 102a (shown Figure 3C) and a second face 102b (oriented perpendicular to the first face and shown in FIG. Figure 3D ). When the distal component assembly 100 is assembled in the distal portion 16 of the first medical device 10, the first face 102a and the second face 102b of the substrate 102 can face radially outward. Figure 3C , the first side 102a of the substrate 102 faces out of the page, and the second side 102b of the substrate 102 faces downward. The distal component assembly 100 may have a length A (along the longitudinal axis of the distal portion 16 and the first medical device 10) of approximately 0.1" to approximately 0.3" (e.g., approximately 0.210"). The substrate 102 may have a width B (across the first side or the second side, perpendicular to the longitudinal axis) of approximately 0.09" to approximately 0.12" (e.g., approximately 0.101"). In addition, the distal component assembly 100 including the camera 52 may have a height H (perpendicular to the length A and width B) of approximately 0.05" to approximately 0.15" (e.g., approximately 0.077").

[0049] Portions of the camera 52 and / or pressure sensor 66 may be mounted to the substrate 102. For example, the camera 52 may be mounted to the first side 102a of the substrate, and the pressure sensor 66 may be mounted to the second side 102b. Figures 3A-3D As shown, the distal ends of the camera 52 and / or pressure sensor 66 can extend distally of the distal end 104 of the substrate 102. In some examples, although not shown, one or more lighting elements 50 can be mounted to the distal edge of the substrate 102 (e.g., mounted to the first face 102a). Alternatively or additionally, the optical fiber 58 can help illuminate the distal region of the distal portion 16 of the first medical device 10. In addition, although not shown, the optical fiber 58 and / or lighting element 50 can include a transparent material, such as at the distal portion, and the transparent material can act as a light guide to direct or redirect light from the lighting element 50 and / or optical fiber 58 to the front of the camera 52 (i.e., the distal end).

[0050] For example, Figure 3C As shown, the camera 52 can be disposed approximately centrally along the width of the substrate 102. The lighting element 50 and / or the optical fiber 58 can be positioned adjacent to the camera 52 (i.e., on either side of the camera 52). In addition, the camera 52 can extend distally beyond the distal ends of the lighting element 50 and / or the optical fiber 58. The camera 52 can include a camera capacitor (not shown) or any other suitable accessory component, which can be integrally formed with the camera 52 or as a separate component, such as mounted on the substrate 102.

[0051] One or more pairs (e.g., twisted pairs) of wires 62 may transmit power and / or signals to and / or from various portions of distal component assembly 100. Figure 3C As shown, each wire 62 can be electrically connected to a corresponding contact pad 116 on the substrate 102 (e.g., on the first side 102a) so that the wire 62 is electrically connected to the corresponding portion of the distal component assembly 100. Electrical traces or wires (not shown) can extend from each contact pad 116 to the corresponding portion of the distal component assembly 100. Including the various portions of the distal component assembly 100 on the substrate 102 can allow for the use of fewer wires than other systems. For example, in the absence of the substrate 102, multiple wires may be required to power multiple separate lighting elements 50. Using a set of twisted wires 62 connected to the substrate 102 can save space in the shaft 44 and / or reduce costs compared to using multiple wires or cables (e.g., multiple twin-axial wires) to transmit power and / or signals to and / or from the various portions of the distal component assembly 100. Although Figures 3A-3D Shields are not depicted, but one or more shields may be positioned around the wires 62. Additionally, although not shown, one or more cables may transmit power and / or signals to and from the camera 52. The one or more cables may include, for example, a micro coaxial cable or other suitable cable or wire. Additionally, the distal end of each of the one or more cables may be secured to one or more contact pads 116 (e.g., by bonding or welding).

[0052] Furthermore, although only one pair of wires 62 is shown, it should be noted that the distal component assembly 100 may include additional wires, cables, electrical and / or communication connections, etc. For example, Figure 3B and Figure 3C As shown, the base plate 102 may include a plurality of contact pads 116, for example, such that each contact pad 116 may be coupled to a corresponding wire 62, cable, electrical and / or communication connector, etc., for example, to operably couple the handle portion 12 and / or the umbilicus 38.

[0053] like Figure 3C As shown, the substrate 102 may include thirteen contact pads 116. The contact pads 116 may be positioned on the first side 102a of the substrate 102, for example, in three columns of four contact pads 116, five contact pads 116, and four contact pads 116, respectively. However, the number and / or arrangement of the contact pads 116 are merely exemplary, and other numbers and / or arrangements of the contact pads 116 may be utilized. For example, the substrate 102 may include more or fewer contact pads 116, and one or more contact pads 116 may be arranged on the second side 102b. In an alternative, the twisted pair 62 may be replaced with a twinaxial wire or cable (such as a micro coaxial cable) to allow the conductors that power one or more portions of the distal component assembly 100 to be welded or bonded with the same process as used to attach the cable (described above), and / or to reduce noise from electromagnetic interference.

[0054] As described above, elements of the position sensing system 108 may also be disposed on the substrate 102. The position sensing system 108 may incorporate any of the features described in U.S. Patent Application No. 15 / 846,846, filed on December 19, 2017, 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 3A , Figure 3B and Figure 3D As shown, three magnetic field sensors 110a, 110b, 110c may be disposed on the second side 102b of the substrate 102. However, any alternative number of sensors may be utilized, and the three sensors 110a, 110b, 110c shown are merely exemplary.

[0055] In some examples, such as Figure 3D As shown, magnetic field sensors 110a, 110b, 110c can be arranged in a dual-axis, six-degree-of-freedom arrangement. In this 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 first medical device 10 (which is 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 (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 200. A controller (not shown) may receive the signals and may calculate the position of distal component assembly 100 using measurements from magnetic field sensors 110a, 110b, 110c in a primary sensing direction (from magnetic field sensors 110a, 110b) and a direction orthogonal to the primary sensing direction (from magnetic field sensor 110c).

[0056] The position sensing system 108 may optionally include one or more diodes 112, such as two diodes 112. The diodes 112 may provide high voltage protection, such as electrostatic discharge ("ESD") protection. The diodes 112 may help prevent damage to the magnetic sensors 110a, 110b, 110c, such as from electrostatic discharge. The diodes 112 may additionally or alternatively provide protection for various aspects of the camera 52. The position sensing system 108 may also optionally include a capacitor 114, for example, to help reduce noise in the voltage supply 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").

[0057] Within the scope of the present disclosure, the position sensing system 108 can have other configurations. For example, a three-axis configuration can be used for the magnetic field sensors 110a, 110b, 110c, 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 sensors 110a, 110b, 110c are approximately orthogonally aligned to each other). For example, the magnetic field sensor 110a can have a main sensing direction of the X axis. The magnetic field sensor 110b can have a main sensing direction of the Y axis, and the magnetic field sensor 110c can have a main sensing direction of the Z axis. In this three-axis configuration, each of the magnetic field sensors 110a, 110b, 110c can utilize a half-Wheatstone bridge configuration. This three-axis configuration will require a total of eight wires-two to power the position sensing system 108, and two to power each of the three half-Wheatstone bridges of the magnetic field sensors 110a, 110b, 110c. In another example, only two magnetic field sensors (e.g., magnetic field sensors 110a, 110b) may be used to measure six degrees of freedom, where each of the magnetic field sensors 110a, 110b has a half-Wheatstone bridge configuration (or a full-Wheatstone bridge configuration). In another example, two magnetic field sensors (e.g., magnetic field sensors 110a, 110b) may be used to measure five degrees of freedom. In such an example, the position sensing system 108 may not be able to measure rolling. In another example, a single magnetic field sensor 110a may use a half-Wheatstone bridge to measure five degrees of freedom.

[0058] The above examples are illustrative only, and other configurations of magnetic field sensors may be utilized. Figures 3A-3D As shown, a system utilizing three magnetic field sensors 110a, 110b, 110c in a dual-axis, six-degree-of-freedom arrangement may be beneficial because it is able to measure six degrees of freedom while requiring only six wires 62. Alternative arrangements may also be used for the lighting element 50 and the camera 52. Figures 3A-3DAs shown and described above, all of the contact (e.g., solder) pads 116 for the wires 62 can be disposed on a single side (e.g., the first side 102a) of the substrate 102, which can allow the wires 62 to be bonded to the substrate 102 in a single manufacturing process without flipping the distal component assembly 100.

[0059] Distal component assembly 100 may also include components in addition to or in place of the components described above. For example, although not shown, 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 other types of sensors, such as humidity sensors, temperature sensors, or other types of sensors that may be useful in a medical procedure.

[0060] Although the magnetic field sensors 110a, 110b, 110c are described above as MR sensors (e.g., TMR sensors), other types of sensors may also be utilized on the substrate 102. 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 the inductive sensors may be utilized to measure the desired degrees of freedom. For example, the inductive sensors may be positioned to be tilted at least 11 degrees from each other (e.g., may be angled relative to the longitudinal axis of the distal tip 44).

[0061] In some examples, TMR sensors may be lower cost and / or smaller in size than inductive sensors. An inductive sensor array may require two inductive sensors (each sensor may be greater than 0.25" in length) positioned at an angle relative to one another to produce 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 positioned 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 to, for example, minimize space and / or 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 approximately linearly. Figure 3BAs shown, diode 112 can be located proximal to magnetic field sensors 110a, 110b, 110c. The arrangement of the components of distal component assembly 100 can be selected, for example, to save space and provide a smaller footprint and size of substrate 102. Capacitor 114 can be positioned adjacent to one of magnetic field sensors 110a, 110b, 110c, for example, adjacent to third magnetic field sensor 110c. Although TMR sensors can be used in distal component assembly 100, the present disclosure is not limited to TMR sensors and can include any type of sensor, including those listed above.

[0062] To assemble the distal component assembly 100, a substrate 102 (e.g., a multilayer PCB) may be assembled with the magnetic field sensors 110a, 110b, 110c, the diodes 112, and the capacitors 114 using, for example, a pick and place machine. Once in place, the magnetic field sensors 110a, 110b, 110c, the diodes 112, and the capacitors 114 may be wire-bonded to the substrate 102 and electrically tested. Thereafter, a fixture may be used to hold the camera 52 and the lighting element 50 in place, and their electrical contacts may be bonded (e.g., at a 90 degree angle) to the pads of the substrate 102. The process of soldering the camera 52 and the lighting element 50 may be performed on both sides of the substrate 102. Finally, the wires 62, any cables, etc. may be bonded to the appropriate side of the substrate 102 via the corresponding contact pads 116. For example, the wires 62 for connecting to the lighting element 50 and the different wires (not shown) for connecting to the position sensing system 108 may be bonded to the first side of the substrate 102 in a single step. The above steps and sequence are exemplary only. The wires 62, any cables, etc. may be formed into a single bundle to pass through the shaft 44. Additional or alternative steps may be utilized, and the steps may be performed in a different order.

[0063] Additionally, as described above, although not shown, second medical device 20 may include a distal component assembly similar to distal component assembly 100. In this regard, second medical device 20 may include a position sensing system similar to position sensing system 108, e.g., in communication with one or more controllers, user interfaces, etc.

[0064] To assemble the distal component assembly 100 and the distal portion 16 (e.g., the end cap 54), the distal end 104 of the distal component assembly 100 can be inserted into the proximal opening of the end cap 54. An epoxy resin adhesive can be applied to the lighting element 50 and / or the camera 52 to help seal the distal end of the end cap 54, such as the distal-most end face 46, to prevent fluid ingress / egress, and to help hold the distal component assembly 100 (including the base plate 102) in place. Other techniques can also be used to secure the distal component assembly 100. For example, other types of adhesives, screws, pins, crimping, snap fits, or other features can be used to secure the distal component assembly 100 to the distal portion 16 (e.g., the end cap 54). Overmolding or similar techniques can also be used to secure the distal component assembly 100 to the distal portion 16 (e.g., the end cap 54) or to secure elements of the distal component assembly 100 to the base plate 102. Overmolding may also be used to form the distal portion 16 (e.g., the end cap 54) around the distal component assembly 100. 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 portion 16 (e.g., the end cap 54). In this example, a portion of the distal portion 16 (e.g., the end cap 54) may be molded directly onto the substrate 102, the lighting element 50, the camera 52, 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 portion 16 (e.g., the end cap 54). One or more elements of the distal portion 16, such as the end cap 54, may be constructed using additive manufacturing or 3D printing.

[0065] 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 portion 16 (e.g., the end cap 54). 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 (distal) or in any other direction. In a further alternative, instead of mounting a component (such as the lighting element 50, camera 52, magnetic sensor 110a, 110b, 110c, diode 112, or capacitor 114) on the substrate 102 (e.g., the end cap 54) Figure 2B , Figures 3A-3E As shown and described above), components may be embedded in substrate 102 according to any suitable method.

[0066] The distal portion 16 can be further assembled by performing the following steps, such as connecting the joint line to one or more portions of the distal portion 16 and assembling the end cap 54 to the shaft 44. The wire 62 can be fed back through the shaft 44. The handle portion 12 may include a connector for connecting to the proximal end of the wire 62. For example, the handle portion 12 may include a circuit board, such as a printed circuit board, having a connector for the wire. Such a connector may include six passive connectors for connecting to the wire 62 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 connectors may be used as appropriate. The umbilicus 38 may include conductors (e.g., wires) for carrying power and / or signals from the distal component assembly 100. For example, the umbilicus 38 may include six wires 62 in the form of twisted pairs to route power and / or signals to and from the position sensing system 108 through the umbilicus 38.

[0067] After assembly, the first medical device 10 can be used to perform a medical procedure on a subject, such as alone or together with the second medical device 20. For example, one or more of the first medical device 10 and the second medical device 20 can be inserted into a body cavity or body cavity of the subject. As described below, during surgery, an external device can be used to generate a magnetic field near the subject. For example, the external device can be placed on a table or other surface near the subject (e.g., near the part of the body where the body cavity is located). During surgery, the position sensing system 108 (including magnetic field sensors 110a, 110b, 110c) can transmit signals to the handle portion 12 via the shaft 44 and transmit signals to the controller via the umbilical tube 38.

[0068] The signal from the position sensing system 108 can indicate the position and / or orientation of the distal portion 16 in the body. This position and / or orientation information can be fused with imaging (e.g., 2D and / or 3D imaging) performed before or during surgery. Information from the position sensing system 108 can provide the operator with information about anatomical structures near the first medical device 10, which the camera 52 alone may not be able to visualize (including anatomical structures outside the body cavity in which the device 10 is set). In addition, preoperative images can be used to automatically segment a portion of the anatomical structure in order to provide a drawing (e.g., a 3D drawing, a 3D model, or a mesh) to help track or help guide the first medical device 10 in real time. This real-time tracking or guidance can reduce the time, skill, and / or effort required to reach the target anatomical structure. In the absence of preoperative images, the EM sensor can enable the software to track the position and / or orientation of the first medical device 10 and the movement of the first medical device so that a drawing (e.g., a 3D drawing) is generated in real time during surgery. The generated drawing can guide the first medical device 10 (and any EM-supported accessories) through the anatomical structure of the subject. As described below, the second medical device 20 may also include a position sensing system similar to the position sensing system 108 so that the position, orientation, and / or movement of the second medical device 20 may also be tracked.

[0069] Figure 4 An exemplary method or process 400 is shown that can be performed by one or more operators using any medical system, device, or system portion discussed herein (e.g., medical system 10). Method 400 can be performed to locate, fragment, remove, or otherwise treat one or more objects, tissues, etc. within a lumen or cavity of a subject, for example, to locate, fragment, remove, or otherwise treat a kidney stone within the urethra, ureter, kidney (i.e., within a calyx) of a subject.

[0070] In some aspects, method 400 may include an initial step 402, which includes preparing the subject for surgery. For example, step 402 may include applying a tracking patch to the subject's skin. The tracking patch may be an electromagnetic sensor in an adhesive patch. The electromagnetic sensor may sense the position of one or more medical devices (i.e., the first medical device 10 and / or the second medical device 20) in multiple degrees of freedom. The tracking patch may be positioned at a location of the subject near the treatment site. For example, if the treatment site is a kidney of the subject, the tracking patch may be positioned on the subject's abdomen. The tracking patch may help track the movement of the subject or a portion of the subject during surgery (i.e., the movement of the subject's chest when the subject inhales and / or exhales).

[0071] In some optional aspects, step 402 may also include additional or alternative procedures. For example, step 402 may include positioning one or more optical, fluorescent opaque, or magnetic resonance imaging ("MRI") targets on or in the subject. In some aspects, step 402 may include delivering a contrast agent (i.e., for fluoroscopy), performing one or more scans (i.e., MRI scans, computed tomography ("CT") scans, etc.), or performing one or more initial mapping and / or imaging steps. In addition, in some aspects, step 402 may include setting up one or more of an augmented reality headset (i.e., for a user to wear and use during surgery), an augmented reality projector (i.e., projecting one or more images onto or adjacent to the subject), or other augmented reality elements.

[0072] In some aspects, step 402 may include mapping a body cavity or lumen with tracked ultrasound. For example, an ultrasound transducer array may be hand-held by a user and / or automatically controlled, for example, to perform two-dimensional or three-dimensional ultrasound. In these aspects, step 402 may include mapping a body cavity or lumen (i.e., a kidney) with ultrasound. In some aspects, one or more other steps of method 400 may also include ultrasound, for example, to track the position of the first medical device 10 (i.e., distal portion 16) and / or the position of the second medical device 20 (i.e., distal portion 26).

[0073] In some aspects, step 402 may include manually, automatically, or semi-automatically planning an access path to one or more objects in a body cavity or body cavity. In this regard, a user may manually plan one or more access paths to multiple kidney stones, such as within multiple calyces. The user may also mark one or more structures (e.g., ribs, blood vessels, organs, etc.) to be avoided, for example, when one of the first medical device 10 or the second medical device 20 is delivered to a body cavity or body cavity. In some aspects, software in the handle 12 or another display, one or more controllers, one or more control units, or other software may automatically identify one or more access paths and / or one or more structures to be avoided, and display one or more access paths and / or one or more structures to be avoided to the user accordingly.

[0074] Method 400 includes step 404, which includes delivering (i.e., inserting) a first medical device 10 into a subject. Step 404 may include inserting the first medical device 10 through a natural orifice (e.g., a urethra), or may be formed by an operator, such as via an incision. For example, step 404 may include delivering an insertion portion 14 of the first medical device 10 distally through the subject's urethra and bladder toward the subject's ureters and kidneys. Step 404 may include delivering the first medical device 10 using an insertion sheath, a guidewire, or the like.

[0075] Next, method 400 includes step 406, which includes delivering (i.e., navigating) the first medical device 10 into a body cavity or body cavity of the subject. For example, the insertion portion 14 of the first medical device 10 can be advanced distally through and / or to the body cavity or body cavity. The insertion portion 14 of the first medical device 10 can be advanced distally manually (i.e., by a user), automatically, or semi-automatically. For example, step 406 may include advancing the insertion portion 14 of the first medical device 10 distally through the subject's urethra and bladder, and into the subject's ureter and / or kidney. Step 406 may include inserting a sheath, a guidewire, etc. Alternatively or additionally, step 406 may include one or more user-controlled actions, for example, using a control lever 30 on the handle portion 12 to control the movement (i.e., articulation or deflection) of the distal portion 16 of the first medical device 10.

[0076] In addition, optional step 408 includes mapping one or more portions of a body cavity or body cavity. For example, the camera 52 can be activated during step 406. The optical fiber 58 and / or the lighting element 50 can also be activated during step 406, for example, to illuminate the distal region of the distal portion 16, and thus illuminate the field of view of the camera 52. In addition, one or more aspects of the position sensing system 108 can be activated during step 406. In addition, a control unit or controller (not shown) integrated with the first medical device 10 or separated from the first medical device 10 can analyze one or more images and / or video signals, for example, together with the sensed position of the distal portion 16 (via the position sensing system 108) to create a drawing (e.g., a three-dimensional map) of one or more body cavities or body cavities in the subject's body. A drawing can be created based on the obtained images and / or video signals. Alternatively or additionally, a drawing can be created based on the sensed position of the distal portion 16 and / or the sensed contact with the body cavity or body cavity in the subject's body. For example, if distal portion 16 is delivered through a subject's urethra, bladder, and ureters to a kidney, optional step 408 may help create a mapping of one or more of the subject's ureters and kidneys, including one or more calyces, for example.

[0077] Optional step 408 may include measuring and / or mapping the subject's bladder. For example, the control unit or controller may include stored software (i.e., in a memory), and the software may automatically create a mapping (i.e., a three-dimensional mapping) of the bladder. The mapping of the bladder may be created, for example, in a non-contact manner based on images and / or video signals from the camera 52. In some aspects, the mapping may also be based on position and / or orientation information from the position sensing system 108. The mapping of the subject's bladder may be displayed to the user, for example, on a graphical user interface or display, which may help the user determine the spatial orientation of the distal portion 16. In some aspects, the mapping of the bladder that may be created by the software (i.e., a stored algorithm) may include, for example, a three-dimensional point cloud of surface points or surface grids of the bladder (i.e., with or without the texture of the bladder surface). In some aspects, the mapping of the bladder may include, for example, an image mosaic formed by overlaying and / or otherwise combining image signals and / or video signals from the camera 52. In some aspects, the mapping of the bladder may be continuously updated in real time (i.e., updated more than once per second) or updated regularly in other ways.

[0078] Optional step 408 may include measuring, identifying and / or mapping one or more ureters. For example, the control unit or controller may include stored software (i.e., in a memory), and the software may automatically create a mapping (i.e., a three-dimensional mapping) of the ureters. The mapping of the ureters may be created, for example, in a non-contact manner based on image signals and / or video signals from the camera 52. In some aspects, the mapping may also be based on position and / or orientation information from the position sensing system 108. The mapping of the subject's ureters may be displayed to a user, for example, on a graphical user interface or display, which may help the user determine the spatial orientation of the distal portion 16.

[0079] In some aspects, a drawing of the ureter that can be created by the software (i.e., a stored algorithm) can include, for example, a three-dimensional point cloud of surface points or a surface mesh (i.e., with or without texture of the ureter surface) of the ureter. In some aspects, the drawing of the ureter can include, for example, an image mosaic formed by overlaying and / or otherwise combining images and / or video signals from the camera 52. The drawing of the ureter can be based on an assumed cylindrical or tubular shape. In some aspects, the drawing of the ureter can be continuously updated in real time (i.e., more than once per second) or otherwise updated regularly. In some aspects, the drawing of the bladder and / or ureter can be merged with one or more other imaging modalities, such as images obtained from a CT scan, an MRI scan, fluoroscopy, etc. In addition, the drawing of the bladder and / or ureter can help the software and / or user to delineate between the bladder and one or more ureters, for example, when the distal portion 16 enters the ureter from the bladder. Alternatively, one or more ureters may be manually identified, e.g., based on a user identifying one or more ureters in an image signal and / or video signal from the camera 52. The user may provide one or more inputs to the controller to reflect the identification, e.g., via a user interface or display (i.e., a touch screen user interface).

[0080] Next, step 410 includes identifying and / or mapping one or more objects within a body cavity or body lumen. In this step, the distal portion 16 can be positioned within or near a body cavity or body lumen, for example, within one or more portions of a subject's kidney. As described above, the camera 52 can be activated during step 410. The optical fiber 58 and / or the lighting element 50 can also be activated during step 410, for example, to illuminate the distal region of the distal portion 16 and, therefore, illuminate the field of view of the camera 52. In addition, one or more aspects of the position sensing system 108 can be activated during step 410. In this regard, the distal portion 16 can be manipulated (i.e., manually or automatically) to traverse at least a portion of the body cavity or body lumen.

[0081] In addition, the image and / or video signal from the camera 52, as well as the position signal from the positioning sensing system 108, can be used to locate one or more objects within the body cavity or body cavity. For example, the distal portion 16 can traverse and / or survey one or more calyces or other portions of the subject's kidney (i.e., manually, automatically, or semi-automatically). The control unit or controller may include software that automatically identifies one or more portions of the body cavity or body cavity and / or automatically identifies when the distal portion 16 enters or is adjacent to the body cavity or one or more portions of the body cavity (e.g., identifying one or more calyces in the kidney) based on the image signal and / or video signal from the camera 52. The control unit or controller may alert the user when the body cavity or one or more portions of the body cavity are identified and / or entered.

[0082] In addition, one or more transition points (i.e., between different parts of a body cavity or body cavity, such as from the renal pelvis to the renal calyx) can be used as one or more landmarks, for example, for registration and / or combination with one or more other imaging modalities (i.e., CT scan, MRI scan, ultrasound scan, fluoroscopy, etc.). The image signal and / or video signal from the camera 52, and the position signal from the positioning sensing system 108, can be used to locate one or more stones in the subject's kidney, for example, in one or more renal calyces. In addition, the location of the one or more stones can be mapped in a drawing (i.e., a three-dimensional drawing), which can be displayed to the user, for example, on a graphical user interface or display, which can help the user determine the spatial orientation of the distal portion 16. As described above, the drawing of the subject's kidney can be displayed in real time or updated periodically, and can include one or more features discussed above with respect to the bladder drawing and the ureter drawing. In addition, step 410 can include estimating the size, shape, density, etc. of one or more objects (e.g., stones).

[0083] Next, optional step 412 may include compensating for the movement of an intracavity or body cavity and / or combining a drawing of one or more parts of an intracavity or body cavity with a drawing of one or more objects. For example, the drawing of the subject's kidney and one or more stones may be compensated based on the subject's movement (i.e., in real time or periodically). In this regard, when the subject inhales and exhales, the position and / or orientation of the subject's kidney and one or more stones may change. In this optional step 412, information from one or more tracking patches positioned on the subject, for example, as discussed with respect to optional step 402, can be used as a dynamic reference to automatically compensate and / or adjust the drawing of one or more parts of an intracavity or body cavity and / or the identified position of one or more objects, for example, based on the movement of one or more tracking patches. For example, in some aspects, software in handle 12 or another display, one or more controllers, one or more control units, or other software may automatically compensate and / or adjust the drawing and / or identified position.

[0084] In addition, optional step 412 may include registering, fusing, or otherwise combining the images and / or videos obtained from the first medical device 10 with, for example, one or more preoperative images or other preoperative information obtained during optional step 402. Step 412 may include one or more rigid and / or elastic methods. The registered, fused, or otherwise combined images and / or videos may be displayed to a user, for example, via a graphical user interface or other display (i.e., as two-dimensional and / or three-dimensional images or videos). In this regard, the graphical user interface or other display may indicate information in one or more ways, for example, as a multi-planar reconstruction (MPR) display, a pin-aligned image, a full-scene image, etc.

[0085] Next, step 414 includes determining whether one or more objects can be removed from the body cavity or body lumen using the first medical device. For example, as described above, step 410 may include determining the size and / or shape of one or more objects (e.g., one or more stones in the subject's kidney). Step 414 may include determining whether the one or more objects are small or of an appropriate size or shape to be removed through, for example, working channel 40 ( Figure 3A ) can be removed with the first medical device 10. Step 414 can include a video and / or image-based analysis performed by the controller, for example, to determine one or more of the size, shape, dimensions, center of mass, etc. of the one or more objects. Alternatively or additionally, step 414 can include determining a classification and / or type (i.e., the type of kidney stone) of the one or more objects. For example, any of these aspects of the one or more objects can be displayed to the user on a user interface or other display. If the one or more objects can be removed with the first medical device 10, the method 400 proceeds to step 416. However, if the one or more objects cannot be removed with the first medical device, step 418 includes continuing the method 400, for example, proceeding to step 420.

[0086] Step 416 includes removing one or more objects with the first medical device 10. For example, suction (i.e., from a vacuum source and controlled by, for example, a suction valve 34 on the handle portion 12) can be applied through the working channel 40 so that one or more objects (i.e., stones) can be pulled toward the working channel opening 48 of the first medical device 10. In some aspects, one or more objects can be removed proximally, such as through the working channel 40. Alternatively or additionally, one or more objects can be removed proximally by withdrawing the first medical device 10 from the subject. In other aspects, one or more retrieval devices (e.g., baskets, grabbers, or other retrieval devices) can be delivered to a body cavity or body cavity, such as through the port 32, through the working channel 40, and out of the working channel opening 48. One or more retrieval devices can be manipulated (i.e., moved, expanded, retracted, etc.) to capture one or more objects. Then, one or more retrieval devices can be removed, such as retracted proximally, to remove one or more objects from the body cavity or body cavity.

[0087] Furthermore, alternatively or additionally, an energy delivery device (i.e., a laser fiber) can be delivered to the body cavity or body cavity (i.e., through the working channel 40). Energy (i.e., laser energy) can then be delivered toward one or more objects to fragment the one or more objects. In some aspects, the fragmented objects can then be removed from the body cavity or body cavity (e.g., via suction, one or more retrieval devices, etc.). Throughout the removal step, the position of the distal portion 16 can be tracked via the position sensing system 108. In some aspects, a mapping of the body cavity or body cavity (including one or more objects) can be continuously or periodically updated, which can help track the position of the distal portion 16 and the position and / or removal of one or more objects.

[0088] As described above, if one or more objects cannot be removed from the body cavity or body cavity using the first medical device 10, the method 400 can proceed to optional step 420. Optional step 420 overlays one or more objects, one or more aspects of the body cavity or body cavity onto the subject. For example, optional step 420 can include overlaying one or more objects, one or more aspects of the body cavity or body cavity onto the subject. For example, step 420 can include projecting one or more images or drawings of the body cavity or body cavity and / or one or more objects to be removed. In one aspect, step 420 can include projecting one or more images or drawings of a kidney, a calyx, a kidney stone, an access site, etc. onto the subject (i.e., onto the subject's skin), for example, an insertion location and / or insertion route from the outside of the subject to the kidney or a calyx within the kidney. Step 420 can include a light projector that projects one or more images onto the subject's body (i.e., onto the subject's skin).

[0089] Next, step 422 includes providing a suggested access path to the subject's internal cavity or body cavity for the second medical device 20. Step 422 may include one or more drawings, images, etc., for example, based on information received in one or more of steps 402, 404, 406, 408, 410, etc. Step 422 may include displaying one or more drawings, images, etc. on a display or user interface. Alternatively or additionally, step 422 may include displaying one or more drawings, images, etc. to a user using augmented reality, for example, using an augmented reality headset. Alternatively or additionally, step 422 may include one or more alignment marks or other registration elements, for example, to help ensure tracking in the system coordinate space (i.e., of the subject's body).

[0090] Next, step 424 includes aiming and / or inserting the second medical device 20 into a body cavity or body cavity of the subject. Step 424 may include making one or more incisions on the subject and / or using one or more insertion devices (i.e., guidewires, guide sheaths, dilation sheaths, etc.). Step 424 may include, for example, delivering a portion of the distal portion 26 and insertion portion 24 of the second medical device 20 into the subject using one or more insertion devices. In some aspects, step 424 may include inserting the second medical device 20 through an incision in the back or side (i.e., lateral) of the subject. Step 424 may include inserting the second medical device 20 into a kidney (i.e., one or more calyces) of the subject.

[0091] Additionally, step 426 may include tracking the position of the second medical device 20 within the subject. In this regard, for example, during targeting and / or insertion of the second medical device 20 into a body lumen or cavity of the subject (i.e., during step 424), a tracking element 28 on the distal portion 26 of the second medical device 20 may be used to track the position of the distal portion 26. As described above, the tracking element 28 may include one or more position sensing systems, for example, similar to the positioning sensing system 108. Tracking the position of the second medical device 20 (i.e., the position of the distal portion 26) in step 426 can help ensure that the second medical device 20 is effectively and efficiently delivered to the body lumen or cavity (i.e., the appropriate calyx of the subject's kidney).

[0092] Then, step 428 includes: removing or otherwise treating one or more objects in the body cavity or body cavity with the second medical device 20. For example, the insertion portion 24 of the second medical device 20 may include one or more internal lumens or working channels. As discussed above with respect to the first medical device 10, step 428 may include applying suction through the lumen or working channel of the second medical device 20 (i.e., from a vacuum source) so that one or more objects (i.e., stones) can be pulled toward the working channel or lumen opening of the second medical device 20. For example, the second medical device 20 may be a nephroscope. In some aspects, one or more objects can be removed from the proximal side, such as through the lumen or working channel. Alternatively or additionally, one or more objects can be removed from the proximal side by withdrawing the second medical device 20 from the subject. In other aspects, one or more retrieval devices 42 (e.g., a basket, a grabber, or other retrieval device) can be delivered to the body cavity or body cavity, such as through the lumen or working channel of the second medical device 20. For example, by manipulating the actuation member 60, one or more retrieval devices can be manipulated (i.e., moved, expanded, contracted, etc.) to capture one or more objects. The one or more retrieval devices 42 can then be removed, for example, retracted proximally, to remove one or more objects from the body cavity or body cavity. In addition, alternatively or additionally, an energy delivery device (i.e., a laser fiber) can be delivered to the body cavity or body cavity (i.e., through the lumen or working channel of the second medical device 20). Energy (i.e., laser energy) can then be delivered toward one or more objects to fragment one or more objects. In some aspects, the fragmented objects can then be removed from the body cavity or body cavity (e.g., via suction, one or more retrieval devices, etc.).

[0093] Throughout the removal step, the position of the distal portion 26 can be tracked via a position sensing system similar to the position sensing system 108. In addition, a map of the body cavity or cavities (including one or more objects) can be continuously or periodically updated, for example, via the camera 52 of the first medical device 10, which can help track the position of the distal portion 26 of the second medical device 20 and / or the position and / or removal of one or more objects.

[0094] In addition, method 400 can include repeating one or more steps. For example, if the body cavity or body cavity includes more than one object, one or more of steps 416, 420, 422, 424, 426, or 428 can be repeated as many times as necessary to ensure that the object is removed from the body cavity or body cavity. In addition, one or more of the first medical device 10 and the second medical device 20 can be repositioned, for example, to another portion of the body cavity or body cavity (i.e., another calyx within the subject's kidney) to update the mapping of the object within the body cavity or body cavity, remove one or more objects from the body cavity or body cavity, ensure that one or more objects have been removed from the body cavity or body cavity, and so on.

[0095] As described above, the first medical device 10 and / or the second medical device 20 can be used to perform a medical procedure on a subject. For example, the first medical device 10 can be inserted into a body cavity or body cavity (e.g., urethra) of the subject, and / or the second medical device 20 can be inserted into the subject (e.g., through an incision toward a kidney). 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 or body cavity is located).

[0096] During surgery, the position sensing system 108 (including the magnetic field sensors 110a, 110b, 110c) can transmit signals to the handle portion 12 via the shaft 44 and to the controller via the umbilicus 38. The signals from the position sensing system 108 can indicate the position and / or orientation of the distal portion 16 within the body. Similarly, the tracking element 28 on the distal portion 26 of the second medical device 20 can include a position sensing system that can transmit one or more signals to the controller to indicate the position and / or orientation of the distal portion 26 within the body. This position and / or orientation information can be fused with imaging performed prior to surgery (e.g., 3D imaging) and / or imaging received from the camera 52 of the first medical device 10 (e.g., 2D imaging or video).

[0097] Information from the position sensing system 108 and / or the positioning sensing system of the second medical device 20 can help provide information to the user about anatomical structures near the first medical device 10 and / or the second medical device 20 that may not be visualized by the camera 52 alone (including anatomical structures outside the body cavity in which the first medical device 10 and / or the second medical device 20 is disposed). For example, the position sensing system 108 and / or the positioning sensing system of the second medical device 20 can provide information about the position of the first medical device 10 and / or the second medical device 20 relative to one or more reference locations. In some aspects, the information from the positioning sensing system 108 and / or the positioning sensing system of the second medical device 20 can be aligned with one or more preoperative images, for example, as described below. In addition, the information from the positioning sensing system 108 and / or the positioning sensing system of the second medical device 20 can provide anatomical context to the user, for example, information about the position, position, and / or orientation of the first medical device 10 and / or the second medical device 20. In addition, if a 3D map is available (e.g., via a preoperative or intraoperative imaging procedure), the position, position and / or orientation of the first medical device 10 and / or the second medical device 20 can be displayed relative to the 3D map, for example, to help guide the first medical device 10 and / or the second medical device 20 during surgery.

[0098] In addition, preoperative images can be used to automatically segment a mesh of anatomical structures in order to provide a mapping (e.g., a 3D mapping) to track the first medical device 10 and / or the second medical device 20 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 EM sensor can enable the software to track the position of the first medical device 10 and / or the second medical device 20 and the movement of the first medical device 10 and / or the second medical device 20 in order to generate a mapping (e.g., a 3D mapping) in real time during surgery. The generated mapping can guide the first medical device 10 and / or the second medical device 20 (and any EM-enabled accessories) through the anatomical structure of the subject.

[0099] In an alternative embodiment, the distal portion 16 of the first medical device 10 and / or the distal portion 26 of the second medical device 20 may include an element that generates a magnetic field, and the external device may include an element that measures the magnetic field and determines the position and / or orientation of the distal portion 16 or the distal portion 26. For example, the distal portion 16 of the first medical device 10 and / or the distal portion 26 of the second medical device 20 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 coil. Therefore, the coil can generate a magnetic field. The external device may include one or more sensors (e.g., including any of the above-mentioned types of sensors) or components for measuring the magnetic field emitted by the coil. The measurement results of the sensors or components of the external device can be used to determine the position of the distal portion 16 of the first medical device 10 and / or the distal portion 26 of the second medical device 20 (e.g., by a controller).

[0100] Any method or part of a method described in the present disclosure may be performed by one or more processors of a computer system. 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.

[0101] 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 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 the memory of a computer system, or may be separate from any computer system.

[0102] 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 between multiple computing devices. The processor may be a central processing unit (CPU), a graphics processing unit (GPU), or another type of processing unit. The term "computational device" used in this disclosure is interchangeable with "computing device". "Electronic storage device" may include any of the above-mentioned non-temporary computer-readable media.

[0103] Although the principles of the present disclosure are described herein with reference to the 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 those who obtain 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 system comprising: a first medical device, wherein the first medical device comprises a handle and an insertion portion having a first working channel, wherein a distal portion of the insertion portion of the first medical device comprises a first tracking element and at least one camera; and a second medical device, wherein the second medical device comprises a handle and an insertion portion, wherein a distal portion of the insertion portion of the second medical device comprises a second tracking element; Wherein the first tracking element is configured to provide a signal indicative of a position or orientation of a distal portion of the first medical device, and wherein the second tracking element is configured to provide a signal indicative of a position or orientation of a distal portion of the second medical device.

2. The medical system according to claim 1, wherein: The distal portion of the first medical device also includes one or more lighting elements.

3. The medical system according to claim 2, wherein: The first tracking element, the at least one camera, and the one or more lighting elements are coupled to a substrate within a distal portion of the first medical device.

4. The medical system according to claim 3, wherein: The substrate includes a first face and a second face, wherein the first face and the second face are arranged substantially orthogonal to each other within a distal portion of the first medical device, and wherein a proximal portion of the substrate includes a plurality of contact pads.

5. The medical system according to claim 3 or 4, wherein: The first tracking element includes a position sensing system including one or more position or orientation sensors.

6. The medical system according to claim 5, wherein: The position sensing system includes first, second, and third magnetoresistive sensors, wherein the first, second, and third magnetoresistive sensors are coupled to the substrate.

7. The medical system according to claim 6, wherein: The first magnetoresistive sensor has a first main sensing direction, wherein the second magnetoresistive sensor has a second main sensing direction, wherein the third magnetoresistive sensor has a third main sensing direction, wherein the first magnetoresistive sensor and the second magnetoresistive sensing sensor are arranged such that each of the first main sensing direction and the second main sensing direction is approximately parallel to the longitudinal axis of the substrate.

8. The medical system according to claim 7, wherein: The third magnetoresistive sensor is arranged such that the third main sensing direction is transverse to the longitudinal axis of the substrate.

9. The medical system according to claim 8, wherein: The position sensing system is configured to measure at least five degrees of freedom.

10. The medical system according to any one of claims 6 to 9, wherein: The distal portion of the first medical device also includes one or more diodes and one or more capacitors, wherein the one or more diodes and the one or more capacitors are coupled to the substrate.

11. A medical system according to any preceding claim, wherein: The handle of the first medical device includes a control rod configured to control the articulation or deflection of a distal portion of the first medical device, wherein the handle of the first medical device includes a port connected to the first working channel, and wherein the handle of the first medical device includes a suction valve to control the suction applied through the first working channel.

12. A medical system according to any preceding claim, wherein: The first medical device includes an optical fiber extending from the handle portion to a distal portion of an insertion portion of the first medical device, wherein a distal end of the optical fiber is adjacent to the at least one camera, and wherein the first medical device also includes a pressure sensor positioned at the distal portion of the first medical device.

13. A medical system according to any preceding claim, wherein: The second medical device is a nephroscope, and wherein the nephroscope comprises a working channel.

14. The medical system of claim 13, further comprising a retrieval device configured to be delivered through a working channel of the nephroscope.

15. A medical system according to any preceding claim, wherein: The first medical device includes an end cap located at the distal portion, and wherein the end cap at least partially surrounds the first tracking element.

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