Curve tracing working channel tool

Abstract

The curve-tracking working channel tool includes: a processor / controller; an elongated body including at least one flexible printed circuit (FPC); and a curve sensor mounted on the FPC, the curve sensor being configured to sense the position and orientation of the tool along a defined reference frame, wherein the curve sensor is configured to communicate with the processor / controller via the FPC when inserted into the body cavity to calculate a curve of the tool positioned in the defined reference frame, and wherein the processor / controller is configured to perform curve tracking of the elongated working channel tool by receiving multiple magnetic field readings from multiple locations along the curve sensor.

Description

[0001] Related applications This application claims priority to U.S. Provisional Patent Application No. 63 / 537,847, filed September 12, 2023, the entire contents of which are incorporated herein by reference.

[0002] Technical Field and Background Technology In some embodiments, the present invention relates to elongated probe tools with full shape / curve tracking and methods of manufacturing thereof, such as working channel tools, for example for catheter and / or endoscopic interventional procedures.

[0003] Electromagnetic tracking systems are widely used in clinical applications to track certain devices inside a patient's body in three-dimensional space. A typical electromagnetic tracking system usually consists of an electromagnetic transmitter that generates multiple different alternating electromagnetic fields, typically at different frequencies (e.g., three different fields at 1 kHz, 2 kHz, and 3 kHz), and an electromagnetic sensor, which typically includes one or more electromagnetic coils (e.g., three small, concentric electromagnetic coils). The alternating fields generate an electromotive force (EMF) in the sensor's coils and are sensed at the receiver. The measured field is then used to calculate the position and orientation of the electromagnetic sensor. Solving for the sensor's position and / or orientation relative to the transmitter is based on the known values ​​of the generated EMF at each point in space relative to the transmitter. Knowing the generated field, the receiver can determine the sensor's position and / or orientation in space relative to the transmitter, such that the measured field corresponds to its solved position and / or orientation.

[0004] There are medical devices that integrate electronics within the device itself. For example, many endoscopes contain an electrical image sensor (e.g., a CMOS sensor) at the tip of the endoscope, which is often accompanied by one or more light-emitting diodes (LEDs). In this case, the image sensor and LEDs are typically powered by a power source located outside the endoscope, for example, in a host station and connected to the endoscope using electrical conductors (such as insulated wires in a cable), and the sensor images are transmitted to the host station using one or more electrical conductors (such as insulated shielded wires).

[0005] Other types of devices also exist that utilize passive electronics. For example, in conventional EM-based tracking systems, EM coil-based sensors may comprise ultrafine enameled copper wires wound around a small magnetic core (e.g., ferrite) and placed at the tip of the EM conduit being tracked. This wire can then be twisted at both ends back to the connected host system as a differential signal. Typically, each EM coil requires two differential wires. A standard 3D EM coil-based sensor, for example, consists of three mutually perpendicular coils, requiring a total of six wires. For standard multi-sensor EM applications, the number of wires increases linearly with the number of EM sensors in the device.

[0006] Other devices and tools that combine electronic components and sensors exist, such as, but not limited to, pressure sensors, strain sensors, force sensors, imaging sensors, and temperature sensors. Such devices and tools, for example in the medical field, can be: intracavitary ultrasound devices (e.g., REBUS, IVUS); other intracavitary imaging devices (e.g., OCT and spectroscopy devices); ablation devices (e.g., RF probes, microwave probes, cryoablation devices); electronic thrombectomy and foreign body retrieval; flexible intracavitary surgical instruments; tissue fragmentation and other types of therapeutic ultrasound devices, and electrocautery. Most electronic devices and tools require a power supply, connectivity, and internal housing of electronic components.

[0007] Further background technology includes U.S. Patent No. 11,712,309, which discloses an EM curve sensor comprising a sensor array made of multiple discrete digital 3D magnetometers assembled on a flexible printed circuit (FPC). This sensor array can be embedded in an endoscope (or other tubular device) to enable EM curve tracking of the endoscope.

[0008] For electromagnetic-based positioning, objects in the device's environment can introduce electromagnetic distortions in space, affecting the accuracy of the position and orientation calculated relative to the transmitter. For example, certain ferromagnetic, paramagnetic, and / or diamagnetic materials (collectively referred to as magnetic materials) may be magnetized by the electromagnetic field generated by the transmitter and become sources of electromagnetic fields (of similar frequencies). Conductive materials can act as receivers because they experience electromotive forces due to the generated electromagnetic fields. These electromotive forces induce currents (eddy currents) within the conductive metal, which generate secondary fields, allowing the conductive metal itself to become a source of electromagnetic fields (of similar frequencies).

[0009] In some clinical applications, such as endoscopic or endovascular (collectively referred to as endovascular) procedures, long, thin tubular devices (such as catheters or endoscopes) are inserted into cavities within a patient's body (e.g., the gastrointestinal system, lungs, or blood vessels). These devices can be very thin to pass through narrow cavities and can be flexible to pass through tight bends without damaging the cavity wall tissue. Preferably, the device is durable enough to withstand the mechanical forces exerted by the physician and patient tissues during use.

[0010] In some cases, once the device is navigated to the desired target, interaction is required, such as a biopsy or ablation. Therefore, some endocavitary devices include an internal lumen or working channel to allow insertion of biopsy or ablation tools. This lumen or working channel needs to have the largest possible diameter to allow insertion of large-sized tools.

[0011] To achieve the minimum outer diameter and maximum inner diameter, intracavity devices are designed with minimal wall thickness. Integrating electronic components or wiring into the walls of such devices could require increased wall thickness or negatively impact the device's mechanical properties, such as flexibility and durability. Therefore, many devices do not include such components, instead featuring electronics only at the tip.

[0012] Navigation systems exist that provide navigation instructions to guide equipment to specific locations within a patient's organs. For example, in electromagnetic navigation bronchoscopy, an EM position sensor is located inside the endoscope tip and is used by the navigation system to provide instructions to the physician to reach a target within the patient's lungs. In these systems, the equipment can be tracked using electromagnetic (EM) position sensors, EM shape and / or position sensors, or fiber optic shape sensors. Tracking the equipment during endoluminal procedures allows for navigation guidance instructions based on shape and / or position sensors to navigate the equipment to specific, potentially peripheral, targets within potentially complex luminal structures. Furthermore, tracking the shape and / or position of the equipment during endoluminal procedures can support the equipment's steering; for example, in robotic endoscopy, by tracking the shape and / or position of the distal curved portion of the equipment, the equipment can be deflected in a controlled manner based on feedback from shape and / or position sensors. Summary of the Invention

[0013] The following is a non-exclusive list that includes some examples of embodiments of the invention. The invention also includes embodiments that include fewer than all the features in the examples, as well as embodiments that use features from multiple examples, even if not explicitly listed below.

[0014] Example 1. An endoscope system comprising: a. Endoscopic equipment, including the working channel; b. A working channel tool, configured for insertion into the working channel of an endoscopic device, the working channel tool comprising: i. An elongated body, including a proximal end and a distal end; ii. One or more flexible printed circuits (FPCs) extending along an elongated body; and iii. A curve / shape sensor, comprising multiple sensor elements positioned on one or more FPCs; c. One or more transmitters; d. A controller including a processor; the processor includes instructions for calculating a fully localized curve relative to one or more transmitters along the tracked portion of the working channel tool.

[0015] Example 2. An endoscope system according to Example 1, wherein the processor further includes instructions for allocating an energy function based on sensing values ​​of sensor elements at corresponding points along the working channel tool, the sensing values ​​incorporating relevant constraints.

[0016] Example 3. An endoscope system according to Example 1, wherein the processor further includes instructions for the following: a. Acquire multiple pre-known points and / or intervals along the tracked portion of the working channel tool; b. The energy function is assigned based on the position and direction of the points along the working path tool, and the energy function incorporates relevant constraints; c. Generate a synthetic joint energy function for the complete shape and / or position of the entire tracked portion of the working channel tool.

[0017] Example 4. An endoscope system according to Example 1, wherein one or more FPCs are twisted about the longitudinal axis of an elongated body.

[0018] Example 5. An endoscope system according to Example 1, wherein a plurality of sensor elements are positioned on one or more FPCs at known intervals.

[0019] Example 6. An endoscope system according to Example 1, wherein at least one of a plurality of sensor elements is located at the distal end of an elongated body.

[0020] Example 7. An endoscope system according to Example 1, wherein the working channel tool further includes at least one LED located at the distal end of the elongated body.

[0021] Example 8. An endoscope system according to Example 1, wherein the working channel tool further includes at least one camera positioned at the distal end of the elongated body.

[0022] Example 9. An endoscope system according to Example 1, wherein the working channel tool further includes at least one camera support for at least one camera.

[0023] Example 10. An endoscope system according to Example 9, wherein at least one camera support is configured to be manipulated during the manufacture of the working channel tool.

[0024] Example 11. An endoscope system according to Example 10, wherein the manipulation is folding.

[0025] Example 12. An endoscope system according to Example 11, wherein folding positions at least one camera toward the distal side from the distal end of the elongated body.

[0026] Example 13. An endoscope system according to Example 1, wherein the working channel tool further includes a second working channel extending within an elongated body.

[0027] Example 14. An endoscope system according to Example 1, wherein the working channel tool further includes a mounting base configured to accommodate at least one camera and at least one LED.

[0028] Example 15. An endoscope system according to Example 14, wherein the mount is configured to allow directional positioning of at least one camera and at least one LED.

[0029] Example 16. An endoscope system according to Example 1, wherein one or more FPCs further include at least one reinforcing material.

[0030] Example 17. An endoscope system according to Example 1, wherein one or more FPCs are wound around a core, mandrel, or fiber.

[0031] Example 18. An endoscope system according to Example 17, wherein the core is hollow or solid.

[0032] Example 19. An endoscope system according to Example 1, wherein the working channel tool includes at least two FPCs, and wherein the first FPC is configured to accommodate a plurality of sensor elements and the second FPC is configured to accommodate at least one camera and at least one LED.

[0033] Example 20. An endoscope system according to Example 19, wherein at least two FPCs are assembled by stacking them one on top of the other.

[0034] Example 21. An endoscope system according to Example 1, wherein one or more FPCs are covered by a protective sleeve.

[0035] Example 22. An endoscope system according to Example 21, wherein the protective sleeve is configured for one or more of the following: a. Provide biocompatibility for the working tool passages; b. Provide protection for electronic components within the tool passageway; c. Enhance the mechanical properties of the tool channel; and d. To provide protection for the working access of the organization and / or endoscopic equipment.

[0036] Example 23. An endoscope system according to Example 21, wherein a protective sleeve makes the distal end of the elongated body rounded.

[0037] Example 24. A working channel tool configured for insertion into the working channel of an endoscope, the working channel tool comprising: a. A slender body, including a proximal end and a distal end; b. One or more flexible printed circuits (FPCs) extending along an elongated body; c. A curve / shape sensor, comprising multiple sensor elements positioned on one or more FPCs; and d. A controller including a processor; the processor includes instructions for allocating an energy function based on sensing values ​​of sensor elements at corresponding points along the working channel tool, and instructions for calculating a fully localized curve relative to one or more transmitters along the tracked portion of the working channel tool, the sensing values ​​incorporating relevant constraints.

[0038] Example 25. The working channel tool according to Example 24, wherein the processor also includes instructions for the following: a. Acquire multiple pre-known points and / or intervals along the tracked portion of the working channel tool; b. The energy function is assigned based on the position and direction of the points along the working path tool, and the energy function incorporates relevant constraints; c. Generate a synthetic joint energy function for the complete shape and / or position of the entire tracked portion of the working channel tool.

[0039] Example 26. A working channel tool based on Example 24, wherein one or more FPCs are twisted about the longitudinal axis of an elongated body.

[0040] Example 27. A working channel tool according to Example 24, wherein multiple sensor elements are positioned on one or more FPCs at known intervals.

[0041] Example 28. A working channel tool according to Example 24, wherein at least one of a plurality of sensor elements is positioned at the distal end of an elongated body.

[0042] Example 29. A working channel tool according to Example 24, wherein the working channel tool further includes at least one LED positioned at the distal end of the elongated body.

[0043] Example 30. A working channel tool according to Example 24, wherein the working channel tool further includes at least one camera positioned at the distal end of the elongated body.

[0044] Example 31. A working channel tool according to Example 24, wherein the working channel tool further includes at least one camera support for at least one camera.

[0045] Example 32. A working channel tool according to Example 31, wherein at least one camera support is configured to be manipulated during the manufacture of the working channel tool.

[0046] Example 33. The working channel tool according to Example 32, where the manipulation is folding.

[0047] Example 34. A working channel tool according to Example 33, wherein folding positions at least one camera toward the far side from the far end of the elongated body.

[0048] Example 35. A working channel tool according to Example 24, wherein the working channel tool further includes a second working channel extending within an elongated body.

[0049] Example 36. A working channel tool according to Example 24, wherein the working channel tool further includes a mounting base configured to accommodate at least one camera and at least one LED.

[0050] Example 37. A working channel tool according to Example 36, wherein the mount is configured to allow directional positioning of at least one camera and at least one LED.

[0051] Example 38. The working channel tool according to Example 24, wherein one or more FPCs further include at least one reinforcing material.

[0052] Example 39. A working channel tool according to Example 24, wherein one or more FPCs are wound around a core, mandrel, or fiber.

[0053] Example 40. A working channel tool based on Example 39, wherein the core is hollow or solid.

[0054] Example 41. A working channel tool according to Example 24, wherein the working channel tool includes at least two FPCs, and wherein the first FPC is configured to accommodate a plurality of sensor elements and the second FPC is configured to accommodate at least one camera and at least one LED.

[0055] Example 42. A working channel tool according to Example 41, wherein at least two FPCs are assembled by stacking them one on top of the other.

[0056] Example 43. A working channel tool based on Example 24, in which one or more FPCs are covered by a protective sleeve.

[0057] Example 44. A working channel tool according to Example 43, wherein the protective sleeve is configured for one or more of the following: a. Provide biocompatibility for the working tool passages; b. Provide protection for electronic components within the tool passageway; c. Enhance the mechanical properties of the tool channel; and d. To provide protection for the working access of the organization and / or endoscopic equipment.

[0058] Example 45. A working channel tool according to Example 43, wherein the protective sleeve makes the distal end of the elongated body rounded.

[0059] Example 46. A method of manufacturing a work channel tool, the work channel tool including one or more sensor arrays; the one or more sensor arrays including one or more flexible printed circuits (FPCs) and a plurality of electronic components positioned on the one or more FPCs; the method includes helically winding the one or more sensor arrays around the work channel tool; One method involves positioning multiple electronic components along one or more FPCs such that when one or more sensor arrays are wound around a working channel tool, the multiple electronic components are aligned with respect to the longitudinal axis of the working channel tool.

[0060] Example 47. According to the method of Example 46, at least one of the plurality of FPCs has a spiral FPC design and is capable of being wound into the working channel tool in a spiral form.

[0061] Example 48. A method for curve / shape tracing of a work channel tool, comprising: a. Acquire multiple pre-known points and / or intervals along the tracked portion of the working channel tool; b. The energy function is assigned based on the position and direction of the points along the working path tool, and the energy function incorporates relevant constraints; c. Generate a synthesized joint energy function for the complete shape and / or position of the tracked portion of the working channel tool; and d. Calculate the fully localized curve relative to the tracked portion of the tool along the working channel relative to the transmitter.

[0062] According to aspects of some embodiments of the present invention, a curve-tracking working channel tool is provided, comprising: a processor / controller; an elongated body including at least one flexible printed circuit (FPC); and a curve sensor mounted on the FPC, the curve sensor being configured to sense the position and orientation of the tool in a defined reference frame, wherein the curve sensor is configured to communicate with the processor / controller via the FPC while inserted into a body cavity to calculate a curve of the tool positioned in the defined reference frame, and wherein the processor / controller is configured to perform curve tracking of the elongated working channel tool by receiving multiple magnetic field readings from multiple locations along the curve sensor.

[0063] According to some embodiments of the invention, the tool includes a tip portion for holding an operating unit, which optionally includes one or more sensors and / or cameras and / or LEDs.

[0064] According to some embodiments of the present invention, the operable unit / operation unit includes a camera and a lighting source.

[0065] According to some embodiments of the present invention, the tool is configured to be inserted into a catheter.

[0066] According to some embodiments of the present invention, the curve sensor is configured to detect and / or sense a local magnetic field along the device.

[0067] According to some embodiments of the present invention, the determined reference frame is based on the magnetic field of an external transmitter.

[0068] According to some embodiments of the present invention, the curve sensor includes a plurality of magnetic field sensing elements assembled on an FPC and located at a known position along the tool.

[0069] According to some embodiments of the present invention, at least one of the sensing elements is mounted on the tip portion of the tool.

[0070] According to some embodiments of the invention, the tip portion includes a camera support that is spatially manipulated to position the camera toward the direction of the tool's movement.

[0071] According to some embodiments of the invention, the tool includes a bend before the camera support to position the camera toward the direction of travel of the tool.

[0072] According to some embodiments of the invention, the tool includes a mounting base for holding the tip portion of the FPC in a stable and correctly positioned manner for intended operation.

[0073] According to some embodiments of the invention, the mount is configured to position the camera toward the direction of the tool's movement.

[0074] According to some embodiments of the present invention, the mounting base includes: a platform, wherein one side of the platform is configured to support a camera support portion of the FPC; a wall; and a groove located between the platform and the wall, wherein a pointed portion can be inserted into the groove, and wherein the platform and the wall define a recess in which a magnetic field sensor element is mounted.

[0075] According to some embodiments of the invention, the FPC is twisted about its longitudinal axis.

[0076] According to some embodiments of the invention, the FPC is reinforced below the sensor elements of the curve sensor to protect these components attached to the FPC.

[0077] According to some embodiments of the present invention, the tool comprises two FPCs that are at least partially overlapping vertically.

[0078] According to some embodiments of the present invention, a curve sensor, a camera, and an illumination source (LED) are assembled on one side of the FPC, and then the FPC is twisted and / or bent as needed.

[0079] According to some embodiments of the present invention, the FPC is covered by a protective sleeve and / or a dome.

[0080] According to some embodiments of the present invention, the processor controller is configured to: acquire a plurality of predetermined points along the tracked portion of the tool; for the plurality of predetermined points, assign a local energy function based on the estimated position and orientation of the tool at the point, the local energy function incorporating mechanical constraints and sensor measurement constraints associated with the point; generate a synthetic joint energy function for the complete shape and position of the entire tracked portion of the tool, the joint energy function being constructed based on the assigned local energy function and a region energy function related to constraints on the mechanical properties of the tool, relative to the relative position and orientation of adjacent points among the plurality of predetermined points; and calculate a fully localized curve along the tracked portion of the tool by minimizing the energy function.

[0081] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While similar or equivalent methods and materials described herein may be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification (including definitions) shall prevail. Furthermore, materials, methods, and examples are illustrative only and are not necessarily intended to be limiting.

[0082] Those skilled in the art will understand that some embodiments of the present invention can be embodied as systems, methods, or computer program products. Therefore, some embodiments of the present invention may take the form of entirely hardware embodiments, entirely software embodiments (including firmware, resident software, microcode, etc.), or embodiments combining software and hardware aspects, which are generally referred to herein collectively as “circuit,” “module,” or “system.” Furthermore, some embodiments of the present invention may take the form of computer program products embodied on one or more computer-readable media having computer-readable program code. Implementation of methods and / or systems of some embodiments of the present invention may involve manually, automatically, or in combination thereof, performing and / or completing selected tasks. Furthermore, in practical instruments and apparatus according to some embodiments of methods and / or systems of the present invention, several selected tasks may be implemented by hardware, software, or firmware and / or combinations thereof, for example, using an operating system.

[0083] For example, according to some embodiments of the invention, the hardware for performing the selected task can be implemented as a chip or circuit. As software, according to some embodiments of the invention, the selected task can be executed by a plurality of software instructions, which are executed by a computer using any suitable operating system. In exemplary embodiments of the invention, one or more tasks in some exemplary embodiments of the methods and / or systems described herein are performed by a data processor, such as a computing platform for executing multiple instructions. Optionally, the data processor includes volatile and / or non-volatile storage, such as a magnetic hard disk and / or removable media, for storing instructions and / or data. Optionally, a network connection is also provided. A display and / or a user input device (such as a keyboard or mouse) are also optionally provided.

[0084] Some embodiments of the present invention may use any combination of one or more computer-readable media. A computer-readable medium may be a computer-readable signal medium or a computer-readable storage medium. A computer-readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination thereof. More specific examples (a non-exhaustive list) of computer-readable storage media include: an electrical connection having one or more wires, a portable computer floppy disk, a hard disk, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, portable optical disc read-only memory (CD-ROM), optical storage device, magnetic storage device, or any suitable combination thereof. In the context of this document, a computer-readable storage medium may be any tangible medium capable of containing or storing a program for use in conjunction with an instruction execution system, apparatus, or device.

[0085] Computer-readable signal media may include propagated data signals in which computer-readable program code is embedded, such as signals propagated in baseband or signals as part of a carrier wave. The propagated signal may take any of a variety of forms, including but not limited to electromagnetic, optical, or any suitable combination thereof. A computer-readable signal medium may be a computer-readable medium of any non-computer-readable storage medium, and it may be used in conjunction with an instruction execution system, apparatus, or device to communicate, propagate, or transmit programs.

[0086] Program code embedded in a computer-readable medium and / or data used therein may be transmitted using any suitable medium, including but not limited to wireless, wired, fiber optic cable, RF, or any suitable combination thereof.

[0087] Computer program code used to perform operations of some embodiments of the present invention can be written in any combination of one or more programming languages, including object-oriented programming languages ​​such as Java, Smalltalk, and C++, and traditional procedural programming languages ​​such as the "C" programming language or similar programming languages. This program code can be executed entirely on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter case, the remote computer can be connected to the user's computer via any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection can be to an external computer (e.g., using the Internet through an Internet service provider).

[0088] Some embodiments of the present invention can be described in conjunction with flowcharts and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the present invention. It is understood that each block in the flowcharts and / or block diagrams, and combinations of blocks in the flowcharts and / or block diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing apparatus to create a machine such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, produce means for implementing the functions / actions specified in the blocks of the flowcharts and / or block diagrams.

[0089] These computer program instructions may also be stored in a computer-readable medium that can direct a computer, other programmable data processing apparatus or other device to operate in a particular manner, such that the instructions stored in the computer-readable medium produce an article of manufacture comprising instructions that implement the functions / actions specified in the flowchart and / or block diagram blocks or boxes.

[0090] These computer program instructions may also be loaded onto a computer, other programmable data processing apparatus or other device to cause a series of operational steps to be performed on the computer, other programmable apparatus or other device, thereby producing a computer-implemented process, such that the instructions, which execute on the computer or other programmable apparatus, provide a process for implementing the functions / actions specified in the flowchart and / or block diagram blocks or boxes.

[0091] Some of the methods described in this article are typically designed for computer use only and may not be suitable or practical for manual execution by human experts. Human experts who wish to perform similar tasks manually would expect to employ entirely different approaches, such as utilizing expert knowledge and / or the pattern recognition capabilities of the human brain, which would be far more efficient than manually executing the steps described in this article. Attached Figure Description

[0092] This document describes some embodiments of the invention by way of example only, in conjunction with the accompanying drawings. Reference is now made in detail to the drawings, and it should be emphasized that the details shown are merely illustrative and intended to illustrate embodiments of the invention. In this regard, the specification, by way of the accompanying drawings, will make it clear to those skilled in the art how embodiments of the invention can be practiced.

[0093] In the attached image: Figure 1 This is a schematic diagram of a system for full-curve tracking of a working channel tool according to some embodiments of the present invention; Figure 2A-2H This is a schematic diagram of a tool assembly according to some embodiments of the present invention, which is included in a working channel tool and configured to enable full curve / shape tracking. Figure 3 This is a schematic diagram of the tracked portion of a working channel tool according to some embodiments of the present invention; Figure 4 This is a flowchart according to some embodiments of the present invention, which illustrates an exemplary method for curve / shape tracking for a work channel tool 20. Detailed Implementation

[0094] In some embodiments, the present invention relates to elongated probe tools with full shape / curve tracking and methods of manufacturing thereof, such as working channel tools, for example for catheter and / or endoscopic interventional procedures.

[0095] Before detailing at least one embodiment of the present invention, it is understood that the application of the present invention is not necessarily limited to the structural details and the arrangement of components and / or methods shown and / or described in the following description and / or drawings and / or examples. The present invention can have other embodiments, or can be implemented or performed in various ways.

[0096] Overview and exemplary principles of the invention Given the above background, there is a need for shape sensing / curve tracking devices that can be inserted into the working channels of existing devices, such as endoscopes that do not necessarily have shape sensing or curve tracking capabilities, thereby enhancing their capabilities, such as navigation and / or steering capabilities, while maintaining their size and mechanical properties.

[0097] In other applications, intracavitary devices may have shape sensing, curve tracking, or tip tracking capabilities, but working channel tools (such as biopsy needles, forceps, brushes, or other types of instruments) may not contain sensors and therefore cannot be tracked. Adding tracking capabilities, particularly shape tracking and / or curve tracking capabilities, to working channel tools allows them to be tracked independently relative to the intracavitary device, for example, enabling tracking of the working channel tool as it extends out of the working channel of the intracavitary device toward a target (e.g., a lesion). By curve tracking of the working channel tool as it extends out of the working channel, the instrument can then be guided and navigated away from the tip of the intracavitary device toward the target, and during interaction with the target. This enables guided target interaction, while potentially using the tracked shape and / or position of the instrument to compensate for organ movement, for example, by applying deformation tracking algorithms based on the tracked shape of the instrument. Furthermore, by tracking the shape and / or position of the instrument as it extends out of the working channel of the intracavitary device, the instrument can be driven by a robot based on its tracked shape and directed toward a target that may move (deformation / breathing), such as a lesion.

[0098] Some aspects of embodiments of the present invention relate to a probe tool for curve tracking of a working channel (hereinafter referred to as a working channel tool), which can be used to add shape and / or position tracking capabilities to an untracked intracavitary device, and to provide tracking and guidance (navigation capabilities) all the way to a target, as well as tracking and guidance during interaction with the target (even in the case of a tracked intracavitary device).

[0099] In some embodiments, curve sensing methods use multiple magnetic sensors along an elongated flexible device, and use the determined position and orientation of each sensor, or local magnetic field measurements, or other local measurements, to determine an estimated curve of the elongated device. These methods are prone to errors in estimation, such as those caused by sensor inaccuracies and the need to estimate the shape of the device between the sensors in a certain way.

[0100] In a static environment, where all magnetic and conductive materials are statically positioned and oriented relative to the transmitter and / or receiver, the distortion field generated by nearby metals can be modeled and learned through mapping and / or calibration processes before the tracking system is operational. For example, in a clinical setting, if the transmitter is fixed to a hospital bed, the conductive metal on the bed is stationary relative to the transmitter. In this case, the distortion field caused by eddy currents flowing in the conductive metal or by magnetization of the ferromagnetic metal is static, meaning that the distortion field does not change during the operation of the tracking system.

[0101] In some embodiments, by mapping the total field generated in the sensing volume around the transmitter, the system is configured to perform tracking using the mapped field (rather than a “neutral” or theoretically expected field). In another example, when the electromagnetic sensing coil is wrapped inside the endoscope and around a magnetic stainless steel metal, the magnetic metal produces a distorted field as described above. Since the sensing coil is fixed to the distorted field, the distorted field “moves” with the sensing coil, and its effect is static relative to the receiver, so this effect can be modeled during calibration. For example, its effect can be modeled as an increased sensing gain of the EM sensing coil, or more generally, as a gain matrix (applied to the measurement result of the sensing coil), independent of the sensor’s position and orientation in space.

[0102] As mentioned above, static electromagnetic distortion effects can be modeled during mapping or calibration. However, dynamic electromagnetic distortion takes into account the distorted field generated by a dynamically moving distorting object (relative to the transmitter and / or receiver). This dynamic electromagnetic distortion requires a different solution and cannot be addressed during pre-calibration or mapping. In a clinical setting, dynamic electromagnetic distortion can, for example, be caused by a C-arm positioned around the patient and rotating and / or moving during manipulation. Inside a tracked endoscope (or other tubular device), a tool made of magnetic metal may be introduced into the endoscope's working channel, and dynamic electromagnetic distortion may occur as the tool moves and manipulates within the endoscope's working channel. Such tools can include, for example: biopsy tools (e.g., forceps, needles, cell brushes); intracavitary ultrasound devices (e.g., REBUS, IVUS); other intracavitary imaging devices (e.g., OCT and spectroscopy devices); ablation devices (e.g., RF probes, microwave probes, cryoablation devices, drug delivery needles and probes, brachytherapy devices and particles, lasers, and fibers); stents and stent placement tools; thrombus and foreign body retrieval tools (e.g., mechanical baskets, electrical devices, aspiration microcatheters); embolization devices (e.g., coils, catheters, and aneurysm management devices); markers and their placement mechanisms; flexible endocavitary surgical instruments; lithotripsy and other types of therapeutic ultrasound devices.

[0103] Other forms of dynamic distortion can be caused by electrocautery. Still other forms of dynamic electromagnetic distortion can be caused by positioning an EM sensor array close to metallic or electronic implantable devices, such as pacemakers or electrical stimulation devices, orthopedic implants, stents and prostheses, or dental implants. This dynamic distortion can affect the accuracy of solving for the position and orientation of electromagnetic sensors within the endoscope. During endoscopic procedures, this can affect the tracking accuracy of the endoscope during biopsies or treatments, thus impacting outcome benefits. Therefore, it is desirable for electromagnetic tracking systems to be highly immune to electromagnetic distortion, especially in clinical applications.

[0104] As mentioned above, when using standard EM coil-based sensors, the number of wires in an EM tracking device increases linearly with the number of sensors used. Therefore, most EM tracking devices use a single EM position and orientation sensor (typically consisting of three mutually perpendicular EM coils). Using multiple coil-based EM sensors in a single device would require handling a large number of wires (e.g., three pairs of twisted pairs per EM sensor), which could be cumbersome or impractical under certain space constraints.

[0105] To address this issue, and for other reasons, U.S. Patent No. 11,712,309 discloses an EM curve sensor comprising a sensor array of multiple discrete sensor elements. Each sensor element may be an SMT 3D digital magnetometer assembled on a flexible printed circuit (FPC). While this solves the capacity limitation problem arising from the increasing number of wires threaded through a limited space, it may still introduce potential problems in maintaining the mechanical flexibility and desired space dimensions of the device. Special considerations are needed for electrical and mechanical constraints when embedding an FPC into an endoscope or working channel tool. For example, if the FPC is embedded as a long, straight FPC within the wall of an endoscope, the mechanical flexibility and maneuverability of the resulting device may be compromised because the FPC cannot elongate axially, or even laterally, to allow the endoscope to bend.

[0106] To overcome this, some embodiments of this disclosure, particularly those disclosed in U.S. Provisional Applications No. 63 / 415,696 and No. 63 / 438,583, involve helically winding the FPC within a catheter, for example, helically winding the FPC within an endoscope catheter or endoscope shaft, around the working channel of the endoscope. This helical FPC can then bend in all directions, overcoming the limitation of the FPC's inability to elongate. In other embodiments, as described herein, the FPC incorporating an EM sensor array can be twisted about its own axis to create flexibility in the torsional FPC in each axial direction.

[0107] Understandably, throughout this specification, the term "curve" refers to a shape along a position in space, i.e., a shape positioned in space within a known frame of reference, such as a shape positioned in a known stationary frame of reference, for example, in the frame of reference of a stationary magnetic field emitter. However, the term "curve" can also refer to a shape that does not possess spatial positional information, such as a shape sensed by a fiber optic shape sensor. In this case, positional information can optionally be added by using a single EM sensor at the tip of the device, or by anchoring the shape sensor at its proximal end to a mechanical reference with known coordinates in space.

[0108] This invention relates to working channel tools and methods of manufacturing the same, such as working channel tools for catheter and / or endoscopic interventional procedures.

[0109] In some embodiments, the working channel tool enables curve tracking of existing endoscopic devices, such as those without shape tracking or with only partial tracking (e.g., single-point EM tracking), or those that do not track shape and / or position at all. These endoscopic devices may, for example, be manual bronchoscopes for lung manipulation, guided / unguided robotic endoscopy systems that may only have single-point EM tracking at their distal end, or they may have fiber optic relative shape sensing but no information about the precise position of the tracked relative shape, or they may not be tracked at all (e.g., standard image-only manual or robotic endoscopes).

[0110] In some embodiments, existing devices are enhanced by the curve-tracking capabilities added by the introduced working channel tools, which are incorporated into the working channel of the present document, and these devices use curve-tracking-based navigation software and algorithms to navigate to specific locations within organs. In some embodiments, by combining deformation-based navigation software and algorithms, the working channel tool can subsequently transform any existing endoscopic device into a more accurate navigable device within anatomical structures. For example, one possible application could be guiding a bronchoscope to a lesion in the periphery of the lung for biopsy and / or local treatment. In some embodiments, for example, the deformation-based navigation software and algorithms use the tracked shape and / or position of the working channel tool to model organ deformation and / or respiration, and track it in real time during operation. In some embodiments, by tracking organ deformation, real-time registration of organ deformation and / or respiration can be achieved and used during operation, enabling the endoscopic device (working channel tool, and / or endoluminal device inserted into the working channel tool) to be accurately located and navigated within the luminal structure, which is enabled by the working channel tool.

[0111] In some embodiments, the working channel tool also functions as an instrument for biopsy and / or treatment of the working channel, such as forceps, needles, brushes, REBUS, ablation devices, or other suitable devices. For example, the working channel tool may be a curve-tracking forceps device (whether a custom-built device or an existing and off-the-shelf forceps device surrounding an EM shape sensor), which has both shape and / or position sensors and a biopsy forceps mechanism, and performs curve tracking during manipulation. In other embodiments, the working channel tool is a curve-tracking needle, brush, or other type of biopsy and / or treatment instrument.

[0112] In some embodiments, the working channel tool also has steering capability, such as a steerable curve-tracking needle, forceps, or brush instrument. In some embodiments, the steerable working channel tool (biopsy and / or therapeutic instrument) serves both to provide navigation capability to a carrier endoscopic device (in which the steerable working channel tool is inserted) and to navigate during its interaction with a target (e.g., a needle). In some embodiments, the steerable working channel tool is inserted into the working channel of an untracked endoscopic device. In some embodiments, the shape and / or position of the endoscope is tracked by the inserted working channel tool, and the endoscopic device is navigated to the lesion using a registration algorithm based on the tracked curve of the working channel tool and the patient's preoperative CT scan, using deformation and / or breathing. When the working channel tool reaches a cavity close to the target (e.g., an airway 3 mm, 1 cm, or 2 cm from the target lesion in the lung), the working channel tool is then further pushed out of the endoscopic device's working channel and toward the target lesion, possibly penetrating tissue, while still being curve-tracked. In some embodiments, the tracked curve of the tool is used to track organ deformation in real time to provide real-time registration of organ deformation and / or respiration, and the system steers the working channel tool and guides it to the target lesion, continuing this steering and guidance during interaction with the lesion. In some embodiments, this provides real-time tracking and guidance of the working channel tool during interaction with the target. Without real-time tracking of the working channel tool, it is typically manipulated, for example, under fluoroscopy, which can be inaccurate because it only provides a 2D projection and exposes patients and physicians to potentially harmful X-ray doses since the target (e.g., the lesion) is typically not visible under standard fluoroscopy. Furthermore, using a steerable working channel tool, the robot manipulates the working channel tool and drives it precisely to the target lesion by closing the loop between the tracked curve of the working channel tool and the robot's drive mechanism. In some embodiments, the working channel tool includes a traction line, enabling the steering of the tool's tip, thus making the working channel tool steerable. In some embodiments, the traction line can be manipulated by a manual lever in a proximal handle attached to the working channel tool, or by the robot via a proximal interface attached to the working channel tool. In some embodiments, the working channel tool may be non-stealable and can be guided toward the target by steerable to the endoscope device based on the tracked curve of the working channel tool during insertion, thereby affecting the insertion direction of the working channel tool so that it eventually reaches the target. In some embodiments, this is accomplished by a robot closing a loop between the tracked curve of the working channel tool and the endoscopic steering. In other embodiments, this is done manually, where the physician steers the endoscope device based on the tracked curve of the working channel tool relative to the target displayed by the system (e.g., using a lever).

[0113] In some embodiments, the working channel tool includes embedded electronic components and a flexible printed circuit (FPC). In some embodiments, the working channel tool includes a sensor array comprising discrete sensing elements assembled on the FPC. In some embodiments, the FPC may be manufactured in various configurations, such as a straight, elongated FPC, or a spiral FPC that unfolds and opens during assembly. In some embodiments, a plurality of electromagnetic sensing elements are optionally assembled on the FPC at known intervals. Preferably, at least one of the plurality of electromagnetic elements is positioned near the distal end of the working channel tool to enable tracking of the tip of the working channel tool. In some embodiments, the FPC further includes shielding conductors, such as for the electromagnetic sensing elements and / or a digital or analog endoscopic camera. In some embodiments, multiple signals from multiple sensing elements and optionally from the camera coexist on the same FPC, for example, in multiple different layers, or in two separate FPCs that can be bonded or positioned together. In some embodiments, the FPC is covered by a protective sheath, such as a polymer protective sheath. In some embodiments, the sheath provides biocompatibility, thereby potentially reducing the risk of damage to patient tissue and potentially enhancing mechanical properties (e.g., propulsion), and / or protecting the tool from moisture or liquids. In some embodiments, where the working channel tool does not include biopsy and / or therapeutic instruments (e.g., forceps, brushes, or needles, or ablation mechanisms), the tip of the working channel tool is rounded and / or dome-covered. In some embodiments, this rounding has the potential advantage of reducing the risk of damage to patient tissue or the inner wall of the working channel during insertion and facilitating easier passage over obstacles, steps, or other variations within the inner diameter of the working channel. In some embodiments, the polymer sheath is further enhanced, for example by using metal coils or braided layers embedded in the polymer sheath, to improve mechanical properties such as durability and propulsion.

[0114] In some embodiments, the sheath and / or dome may also provide a thin and / or integral cross-section, such as a working channel suitable for inserting catheters and / or endoscopic devices.

[0115] In some embodiments, the working channel tool includes a handle for ergonomic grip. In some embodiments, the handle includes a mechanism for securing the handle to an inserted endoscopic device. In some embodiments, such securing is configured to prevent axial, rotational, or axial and rotational movement of the working channel tool relative to the inserted endoscopic device. In some embodiments, such axial securing creates a positional alignment between the working channel tool and the endoscopic device, such that the curve measured by the working channel tool directly corresponds to the curve of the inserted endoscopic device, while rotational securing maintains the alignment of the camera roll between the working channel tool's camera and the inserted endoscopic device when both include camera sensors. In some embodiments, such securing mechanisms are adjustable to allow securing in different positions as needed by the user, or to be adjusted for different tools (e.g., different models of endoscopic devices). In some embodiments, the handle of the working channel tool includes one or more levers to manipulate a traction cable within the working channel tool, thereby allowing steering of the tip or distal curved portion of the working channel tool. In some embodiments, this may be useful for steerable working channel tools, for example, when navigating the working channel tool to a target lesion. In some embodiments, the handle of the working channel tool is an interface mounted to a robot drive mechanism. In this case, the working channel tool can be manipulated by the robot and can also be steered by the robot, for example, using a robot motor mechanism to manipulate the traction cable of the working channel tool. In some embodiments, the working channel tool is manually or robotically pushed or pulled into the working channel of the endoscope.

[0116] In some embodiments, the working channel tool is fixed relative to the tip of the endoscope device such that a known transformation (e.g., roll) exists between the tracked tip of the working channel tool and the tip of the endoscope device. For example, a known roll angle exists between the camera of the working channel tool and the camera of the endoscope device, or between the tip of the working channel tool and the turning line of the endoscope device. In some embodiments, by knowing the transformation between the tip of the working channel tool and the turning line of the endoscope device, robotic steering of the endoscope device can then be performed based on the tracked shape and / or position of the working channel tool. In some embodiments, the tracking shape and / or position of the working channel tool, and based on the known transformation between the coordinate system of the working channel tool tip and the coordinate system of the endoscope device turning line, determines the steering action to be applied to the endoscope device. According to some embodiments, this is achieved by fixing the tip of the working channel tool relative to the tip of the endoscope device using mechanical fasteners to ensure that the transformation between the tip of the working channel tool and the tip (or turning line, or camera) of the endoscope device does not change during operation.

[0117] In some embodiments, the working channel tool includes features that center it within the working channel of an inserted endoscope device, such as a set of rings or sleeves assembled to a polymer sheath to fill the gap between the sheath and the inner diameter of the working channel of the endoscope device. In some embodiments, these rings or sleeves may be applied locally, for example, specifically to an electromagnetic sensor, to a long section of the working channel tool (e.g., the entire curve sensing portion), or to the entire length of the working channel tool. In some embodiments, these centering features need to match different working channel diameters, and therefore they are flexible or rigid, and provide different shapes and sizes. In some embodiments, these centering features are removable or incorporated into the polymer housing of the working channel tool. In some embodiments, there are potential benefits to centering the working channel tool relative to the working channel of the endoscope device in order to track the center of the working channel of the endoscope device, and / or to prevent dynamic movement of the working channel tool relative to the metal in the endoscope device, thereby improving EM accuracy as described herein.

[0118] In some embodiments, the working channel tool includes additional sensing elements besides electromagnetic sensing elements, such as inertial gyroscopes and / or accelerometers. In some embodiments, readings from such sensing elements further reduce noise and improve the accuracy of curve sensing. In some embodiments, such sensors are used to track the rotation of the working channel tool relative to Earth's gravity and help align images from camera sensors with a real-world reference frame. In some embodiments, the distal end of the FPC further includes a camera. In some embodiments, as part of the assembly process, the camera is spatially manipulated via folding or the like and positioned at the tip of the working channel tool. In some embodiments, other sensing elements may also be incorporated into the working channel tool, such as temperature sensing elements. In some embodiments, the working channel tool includes combined sensing elements, such as a magnetic sensor and a temperature sensor in a single IC chip. In some embodiments, the magnetic sensor and temperature sensor are digital IC chips. In some embodiments, the sensor is a DC magnetometer with optional combined temperature sensing capability.

[0119] In some embodiments, the provided working channel tool includes a fiber optic shape sensor to track the relative shape of the working channel tool. In some embodiments, position information is acquired by adding one or more EM sensors along the working channel tool, such as adding a single EM sensor at the tip of the working channel tool, or by anchoring the working channel tool or the entire endoscope proximal to a mechanical anchor reference.

[0120] In some embodiments, the working channel tool includes a plurality of electromagnetic sensor elements along its length and can be inserted into an endoscope equipped with a camera, thereby, for example, adding curve tracking to the endoscope.

[0121] In some embodiments, the working channel tool includes a plurality of electromagnetic sensor elements along its length and optionally includes a camera at its distal end. The working channel tool is configured, for example, to be independently inserted into a body cavity without endoscopic equipment or other catheters, for example, to examine the body cavity under full-curve tracking and positioning, and optionally to utilize visual information. In some embodiments, one or more working channel tools are inserted using one or more sheaths. In some embodiments, multiple working channel tools are inserted into multiple body cavities to, for example, track organ deformation in real time, for example, for surgical procedures such as laparoscopic procedures.

[0122] In some embodiments, the working channel tool is configured to guide within a cavity, such as a cavity with multiple branches, and / or may be configured to enable selection of which branch the working channel tool should advance into among multiple possible branches of the cavity.

[0123] In some embodiments, the working channel tool includes a reinforcing layer and / or coating, for example, to improve the torque transmission capability of the working channel tool.

[0124] In some embodiments, a portion of the tip of the working channel tool may have a certain shape, such as a curve, to facilitate the orientation and / or guidance of the tool.

[0125] In some embodiments, the working channel tool is formed as a J-shaped conduit.

[0126] In some embodiments, the working channel tool includes a traction line to provide steerability, and the probe can then be steered and navigated within the cavity structure (with or without carrying intracavitary devices) by manipulating the traction line of the working channel tool, either manually (e.g., using a lever in the device handle) or robotically (e.g., via a robotic mounting interface).

[0127] In some embodiments, multiple working channel tools are inserted into an organ, such as different airways and lobes within a patient's lung. In some embodiments, lung deformation and / or respiration can then be tracked in real time based on the tracked curves of the multiple working channel tools. In some embodiments, the tracked deformation and / or respiratory movement of the lung can be used during laparoscopic procedures to track the lung while manipulating it during the laparoscopic procedure. In some embodiments, based on the work channel tools located within the organ and tracked by curves, features such as blood vessels, airways, or organ lesions can be displayed (e.g., overlaid) in a laparoscopic camera during laparoscopic procedures. In some embodiments, one or more inserted working channel tools can then be used as a real-time tracking structured skeleton of the organ. In some embodiments, one or more working channel tools are inserted into an organ during endoscopic or endovascular procedures. For example, one or more working channel tools are inserted into a patient's lung to provide real-time registration of the lung's deformation and / or respiration. Furthermore, the endoscopic device can then be registered with the lung based on real-time deformation and / or respiration, which has improved accuracy within the anatomical structures of deformation and / or respiration, and can navigate within the lung based on data from the inserted working channel tool.

[0128] In some embodiments, the camera is mounted on the tip of the working channel tool and aligned with the longitudinal axis and / or the forward axis direction of the working channel tool. For example, at the distal end of the working channel tool, the FPC is bent orthogonally relative to the longitudinal axis of the working channel tool, and the camera is then mounted on this bent portion, thus facing the forward direction of the working channel tool. In some embodiments, the camera circuitry is manufactured separately and then attached to the distal end of the FPC and / or electrically connected to the FPC (e.g., by soldering wires).

[0129] In some embodiments, the FPC is manufactured in a planar spiral shape and then opened and straightened to assemble the working channel tool. In some embodiments, for example, to allow the working channel tool to bend in all directions, the FPC is twisted about its longitudinal axis. In some embodiments, the working channel tool can be reinforced, for example, by providing an additional layer of material beneath the tool's components, such as beneath magnetic sensors, cameras, and / or LEDs, for example, to protect these components from assembly / soldering to the PCB, especially when the working channel tool is twisted.

[0130] In some embodiments, FPC is wound around the tube body to provide flexibility in all directions. In some embodiments, the tube body may be open to allow for further insertion of a smaller working channel tool through the working channel tool. In some embodiments, the tube body is braided. In some embodiments, the tube body is inserted into an endoscope (endoscope device) with a larger outer diameter and serves as the working channel of the endoscope device. In this case, the inserted working channel tool subsequently acts as the working channel of the endoscope device while adding shape and / or position tracking capability to the endoscope device. In some embodiments, the working channel tool is manufactured as a sub-component of the endoscope device, and the endoscope device and the embedded working channel tool are a single device / system, wherein the working channel tool is fixed inside the endoscope device. In some embodiments, the working channel tool is fixed to the distal tip and / or proximal end of the endoscope device. In some embodiments, manufacturing the working channel tool as a sub-component simplifies the construction of the shape and / or position of the tracked endoscope device by constructing the shape and / or position of the tracked working channel tool (independent of the endoscope device). In this case, the working channel tool no longer serves as an insertable tool for insertion into a larger outer diameter endoscope, but rather as a static sub-component of the endoscope, providing both a working channel for the endoscope and adding shape and / or position tracking capabilities to the endoscope.

[0131] In some embodiments, the working channel tool is assembled using at least two FPCs, one holding an electromagnetic sensor element and transmitting its signals back to a processor / controller, and the other carrying a camera and LEDs and transmitting camera signals back to the processor / controller. In some embodiments, the two FPCs are assembled by stacking them on top of each other (e.g., by bonding). In some embodiments, the electromagnetic sensor element, camera, and LEDs are assembled on a single FPC, for example, located in different layers, and transmit their signals to the processor / controller. In some embodiments, components of the working channel tool are assembled on one side of an FPC, and then the FPC is twisted and / or bent as needed. In some embodiments, the working channel tool includes a mounting base or fastener made of a rigid material such as a polymer or metal, on which the FPC is precisely bent, and, for example, the camera is then precisely positioned.

[0132] In some embodiments, the distal end of the working channel tool is rounded to minimize damage to tissue and the working channel. In some embodiments, tip rounding is achieved using an adhesive, molding polymer, or metallic material. In some embodiments, the rounding at the distal end forms a dome. In some embodiments, tip rounding is also configured to protect components of the working channel tool. In some embodiments, tip rounding is also configured to act as a camera anti-fouling mechanism.

[0133] Furthermore, the present invention also relates to a method for full-curve tracking of a working channel tool for catheter and / or endoscopic interventional procedures. In some embodiments, some methods use virtual auxiliary curve points between sensor elements of the working channel tool, and / or some methods include solving for a partial or overall curve of the working channel tool using a joint energy function based on mechanical constraints. In some embodiments, such methods constitute a solution to insufficient curve estimation accuracy. As mentioned above, inaccurate curve estimation can be caused by noise or faulty sensor measurements, magnetic field distortion, and / or large distances between sensors on the working channel tool, thereby hindering adequate curve interpolation. In some embodiments, solving for a partial or overall curve of the working channel tool using mechanical constraints can reduce the noise level of the solution of the tracked curve, allowing for a reduction in the intensity of the generated EM field, as further illustrated herein. In some embodiments, solving for a partial or overall curve of the working channel tool using mechanical constraints can improve the accuracy of the solution of the tracked curve, even in the presence of significant EM distortion.

[0134] In some embodiments, where curve estimation is based on individual calculations of the position and orientation of each sensor element, conventional methods struggle to incorporate constraints related to the overall curve of the working channel tool. In some embodiments, the methods presented herein address such problems by solving for the curve and / or position of a portion or the entire working channel tool based on measurements from multiple sensors, while taking into account various constraints that reduce the inaccuracies of the resulting curves; this is further illustrated herein.

[0135] Now refer to Figure 1 The diagram illustrates a system 100 for full-curve tracking of a working channel tool 20 according to some embodiments of the present invention.

[0136] In some embodiments, the working channel tool 20 is configured within a working channel for catheters and / or endoscopic devices during endoscopic interventional procedures. In some embodiments, an exemplary system 100 includes one or more of the following: a processor / controller 10, an electromagnetic field emitter 12, and a curve sensor 16 mounted on or within the working channel tool 20. In some embodiments, the working channel tool 20 is configured to bend into various positions and shapes, which are sensed by the curve sensor 16. In some embodiments, the curve sensor 16 is configured to detect and / or sense magnetic fields, such as those generated by the emitter 12, at multiple locations along the tool 20. In some embodiments, the system 100 includes an endoscopic interventional device 11 (hereinafter referred to as the endoscopic device 11) having a flexible shaft 15 (or elongated body) into which the working channel tool 20 (e.g., via an opening 22) is inserted. In some embodiments, the curve sensor 16 includes an array of sensor elements 18 that sense electromagnetic field values, which the processor / controller 10 algorithmically fits to a curve (i.e., shape and / or position) of the working channel tool 20 relative to the emitter 12. In some embodiments, the curve sensor 16 includes a camera 19, for example, positioned at the distal end of the curve sensor 16 and the working channel tool 20.

[0137] In some embodiments, the processor / controller 10 includes an FPGA / ASIC chip that samples the curve sensor 16 and / or sensor element 18 and / or camera 19. The processor / controller 10 is then configured to digitally transmit the sensor and / or camera data to a host computer (not shown), for example, via a Universal Serial Bus (USB). In some embodiments, the processor / controller 10 is located inside the handle (or robot mounting interface) 21 of the work channel tool 20. In some embodiments, the processor / controller 10 is configured to calculate the curve / shape of the work channel tool 20 and transmit it to a host computer (not shown).

[0138] In some embodiments, during operation, the working channel tool 20 is configured to be inserted into a body cavity as the transmitter 12 generates a magnetic field. In some embodiments, a flexible shaft 15 is positioned within the body cavity, and the working channel tool 20 is inserted into the flexible shaft 15. In some embodiments, a curve sensor 16 is configured to detect and / or sense a local magnetic field along the working channel tool 20. In some embodiments, a processor / controller 10 is configured to calculate the curve / shape of the tool 20, and in some embodiments, to calculate the position of the tool 20 relative to the transmitter 12. In some embodiments, the transmitter 12 is a flat-panel transmitter located under the patient's mattress or bed, or, for example, a separate housing located to the side of the patient.

[0139] Now refer to Figure 2A-2H , Figure 2A-2H This is a schematic diagram of a tool assembly 200 according to some embodiments of the present invention, which is included in a work channel tool 20 (e.g., such as...). Figure 1 As shown in the figure, it is configured to enable full curve / shape tracking.

[0140] In some embodiments, the tool assembly 200 includes one or more of the following: a flexible printed circuit (FPC) 30, a plurality of discrete sensing elements 38 ( Figure 1 (18) For example, multiple magnetic field sensing elements that collectively define a sensor array assembled on the FPC30. In some embodiments, the FPC30 may be manufactured in various configurations, such as a straight, elongated FPC or a spiral FPC, the latter unfolding and opening during assembly (as shown in U.S. Provisional Application No. 63 / 415,696).

[0141] In some embodiments, sensing elements 38 / 18 (e.g., at known intervals along FPC 30) are mounted on FPC 30. Preferably, at least one of the plurality of sensing elements 38 / 18 is positioned near or disposed at the distal end 31 of FPC 30. In some embodiments, camera 40 and LED 41 are mounted at the distal end 31, for example, on camera support 34 in FPC 30. In some embodiments, as part of the assembly process, camera support 34 is configured to spatially manipulate by folding at bend 32 to position camera 40 at the tip of tool assembly 200 and toward the direction of travel of working channel tool 20. It will be understood that other forms of bends may be employed in various embodiments of this disclosure, such as positioning camera 40 at the tip of tool assembly 200 and toward the direction of travel "A" of working channel tool 20.

[0142] In some embodiments, multiple cameras are mounted. For example, two cameras may be mounted on an FPC and wired to the controller via the FPC. A potential advantage of using two cameras in some embodiments is that it allows the generation of stereoscopic and / or wide-angle images, which can be beneficial for endoscopic manipulation. In some embodiments, multiple cameras may share the same clock signal. In some embodiments, the working channel tool 20 does not include cameras at all, but only performs curve / shape tracking. A potential advantage of not mounting cameras is that it may reduce manufacturing costs and process complexity.

[0143] In some embodiments, the working channel tool 20 includes an inner working channel (not shown). In some embodiments, the working channel tool 20 with the inner working channel is inserted into a larger working channel of an endoscope to enhance the shape sensing / curve tracking capabilities of the endoscope, while also providing the inner working channel to allow for flushing, aspiration, and insertion of small-diameter tools (e.g., smaller biopsy and / or therapeutic instruments).

[0144] In some embodiments, a working channel tool 20 with an internal working channel may be used as a sub-component and inserted into a larger-diameter endoscope (endoscopic device) during assembly. In some embodiments, the working channel tool may be secured to the larger-diameter endoscope device at its proximal and / or distal ends. In some embodiments, the working channel tool adds shape and / or position tracking to the larger-diameter endoscope device and may simplify the manufacturing and assembly process of an endoscope device integrating shape and / or position tracking.

[0145] In some embodiments, the working channel tool 20 includes a mounting base 50, for example... Figure 2D As shown, the distal portion of the FPC 30 optionally includes a camera 40 and / or an LED 41, and is positioned stably and desiredly on the mounting base 50. In some embodiments, the mounting base 50 is designed and / or includes geometry that facilitates bending of the FPC 30 in an accurate / desirable manner, for example, to accurately and stably position the camera 40. In some embodiments, the mounting base 50 includes a platform 52, a wall 53, and a slot 51. In some embodiments, the slot 51 is positioned between the platform 52 and the wall 53. In some embodiments, the distal end 31 of the FPC 30 is inserted into the slot 51. In some embodiments, a recess is defined on one side of the platform 52 and the wall 53, in which sensor elements 38 / 18 are optionally mounted, and optionally do not extend vertically outward beyond the wall 53. In some embodiments, one side of the platform 52 is optionally configured to support the camera 40, and, for example, positions the camera 40 perpendicular to the forward direction "A" of the tool 20, even if it is oriented toward the forward direction "A" of the working channel tool 20. In some embodiments, the FPC 30 is bent at the distal end of the working channel tool 20 and above one side of the platform 52, the bend being orthogonal to the longitudinal axis of the working channel tool 20, and the camera 40 is mounted on the bent portion, i.e., on the camera support 34, thus facing the forward direction "A" of the working channel tool 20. In some embodiments, the camera support 34 is manufactured separately and attached to the distal end 31 of the FPC 30 and / or electrically connected to the FPC 30 (e.g., by soldering wires).

[0146] In some embodiments, for example Figure 2D-2HAs shown, the FPC 30 is twisted about its longitudinal axis. In some embodiments, a potential advantage of twisting the FPC 30 is that it allows the working channel tool 20 to bend in all directions without optionally damaging the FPC 30. In some embodiments, the FPC 30 may be optionally reinforced, for example by adhering an additional material layer 33 beneath components such as sensing elements 38 / 18, cameras 40, and / or LEDs 41, for example to protect the attachment of these components to the FPC 30, especially when the working channel tool 20 is twisted. In some embodiments, the reinforcing material may include polymers, such as polyimide commonly used in FPC manufacturing, or metals, such as aluminum.

[0147] In some embodiments, the FPC30 is wound around a core, mandrel, fiber, or other substrate. In some embodiments, the core is hollow or solid. In some embodiments, a potential advantage of using a core is that it may simplify the assembly process and / or increase the bending radius of the FPC (relative to twisting the FPC along its axis).

[0148] In some embodiments, the working channel tool 20 is assembled using at least two FPCs 30, one holding the sensing element 38 / 18 and transmitting its signal back to the processor / controller 10, and the other holding the camera 40 and LED 41 and transmitting the camera signal back to the processor / controller 10, for example... Figure 1 As shown. In some embodiments, two FPCs are assembled stacked on top of each other. In some embodiments, sensing elements 38 / 18, camera 40, and LED 41 are assembled on a single multilayer FPC (e.g., 2-layer FPC, 4-layer FPC) and their signals are transmitted to processor / controller 10. In some embodiments, components of working channel tool 20 are assembled on one side of FPC 30, and then FPC 30 is twisted and / or bent as needed.

[0149] In some embodiments, the FPC 30 is covered by a protective sheath 60, such as a polymer protective sheath and / or a dome. In some embodiments, the sheath and / or dome provide biocompatibility, reduce the risk of tissue damage, enhance mechanical properties (e.g., propulsion), and / or protect the tool and its electrical components from moisture or liquids. In some embodiments, the sheath and / or dome provide a thin and / or integral cross-section, such as a working channel suitable for inserting catheters and / or endoscopes. In some embodiments, the distal end of the working channel tool 20 is covered by a dome or other circular cover 61. In some embodiments, the dome or other circular cover 61 is configured to protect the components of the working channel tool and / or protect the body cavity and / or working channel into which the working channel tool 20 is inserted.

[0150] Exemplary methods In some embodiments, the present invention also relates to a method for full-curve / shape tracking of working channel tools for catheter and / or endoscopic interventional procedures.

[0151] In some embodiments, as previously described, each of the plurality of sensing elements 38 / 18 is configured to sense the emitted magnetic field. For example, transmitter 12 (see Figure 1 The device can emit multiple magnetic fields with known frequencies and intensities. In some embodiments, the position and / or orientation of each sensing element 38 / 18 is determined individually based on the sensed magnetic fields, and a curve is fitted along the working channel tool 20 through the positions of all sensing elements 38 / 18 (e.g., using spline interpolation and / or extrapolation methods), thus estimating the shape / position of the working channel tool 20. As described herein, such methods may introduce errors and have lower accuracy and / or increased jitter due to EM field distortion, interference, and sensor noise.

[0152] For example, transmitter 12 may include Coils, to generate corresponding coils with different frequencies. Different magnetic fields, and the working channel tool 20 may include Sensing element 38 / 18. In various embodiments, the transmitter 12 may also include other means for generating different magnetic fields, such as rotating magnets of various configurations. In the sensor Theoretical results of magnetic field sensed at the location and orientation. Expected to be

[0153] in, Indicates sensor element Relative to the three-dimensional direction of transmitter 12, and Indicated in sensor element Three-dimensional position relative to transmitter 12 The magnetic fields generated at a location (emitted at different phases or frequencies) are represented as matrix columns. For Each of the sensor elements can minimize the magnetic field based on the modeled result. With sensor elements Measured magnetic field The energy function of the difference E i To find estimates of the six-dimensional position and orientation (e.g., represented by three Euler angles). For example, E i It can be in the following form:

[0154] In some embodiments, It can be a calibrated version of the original measurement field, for example, by applying the calibration matrix of the transmitter and / or receiver to the original measurement field to account for the distortion of the static transmitter and / or receiver, or to account for the intrinsic uncalibrated sensor gain, or for any other reason.

[0155] After determining the five / six-dimensional position and orientation of the sensing elements 38 / 18 (five degrees of freedom if the "roll" degree of freedom is not measured / solved, thus missing one Euler angle), a curve passing through all the sensing elements can be fitted. However, this curve may not be accurate enough, or the solution may be noisy. First, the determined position and orientation of the sensing elements may be incorrect due to noisy or faulty measurements performed by the sensing elements and / or due to magnetic field distortion, such as distortion caused by metal in the flexible shaft 15 (in which the working channel tool 20 can be inserted), or by metal outside the flexible shaft 15. Second, without further constraints, the curve shape between the sensing elements 38 / 18 (which may be arbitrarily interpolated and / or interpolated based on some predetermined assumptions) may be incorrect. Therefore, the fully calculated curve of the working channel tool 20 may have illogical properties. For example, the total length of the curve may not match the length of the working channel tool 20 known at the time of manufacture or calibration, or the solved curve may not be smooth enough (although it is known that the working channel tool 20 is generally smooth due to the mechanical nature of the working channel tool 20 or the mechanical nature of the endoscope device). Because the position and orientation values ​​of each sensor are solved separately, such constraints related to the entire curve / shape are not considered in the above calculations.

[0156] To address such problems, some embodiments of this disclosure provide methods for solving the overall curve and / or position of the working channel tool 20, while taking into account various constraints that can reduce the inaccuracy of the resulting curve / shape.

[0157] For reference Figure 3 This diagram illustrates a schematic representation 70 of the tracked portion of a working channel tool 20 according to some embodiments of the invention. The schematic representation 70 shows the dynamic position and / or curve of the tracked portion 72 of the working channel tool 20. The schematic representation 70 shows sensor points 78, which represent the positions of sensing elements 18 / 38 along the working channel tool 20, and / or their representations located at known positions and / or intervals along the tracked portion of the working channel tool 20. Furthermore, between every two adjacent sensing elements 18 / 38 represented by points 78, a predetermined number of virtual auxiliary curve points 76 may exist, located at predetermined positions and / or intervals along the schematic representation 70. The curve points 76, together with the sensor representation points 78, are used to calculate the curve and / or position of the tracked portion of the working channel tool 20.

[0158] For reference Figure 4 As shown in the diagram. In some embodiments, the shape and / or position of the working channel tool 20 is dynamically tracked by fitting the most energy-efficient curve based on various constraints. As shown in block 402, the processor / controller 10 is configured to acquire a plurality of pre-known points and / or intervals along the tracked portion of the working channel tool 20, such as sensor points 78 and curve points 76 at known intervals. In some embodiments, between every two adjacent sensing elements represented by point 78, there is a predetermined number of virtual auxiliary curve points 76 located at predetermined positions and / or intervals along the tracked portion of the working channel tool 20.

[0159] As shown in box 404, the processor / controller 10 includes instructions for assigning a local energy function to each sensor point 78, the local energy function being based on the position and orientation of the working channel tool 20 at that point and incorporating constraints associated with that point or point type. For example, the energy function for each sensor point 78 may incorporate constraints related to the magnetic field sensed at that point, similar to those discussed herein. E i In some embodiments, the processor / controller 10 includes instructions for further assigning weights to each local energy function, such as based on deterministic values, for example, deterministic values ​​related to the certainty of measurement accuracy. For example, the measurements obtained by the sensing elements 18 / 38 may have some variation over time, based on which deterministic values ​​can be determined.

[0160] As shown in box 406, the processor / controller 10 includes instructions for generating a synthetic joint energy function for the complete shape and / or position of the entire tracked portion of the working channel tool 20. In some embodiments, the joint energy function is constructed based on the local energy function of the assigned sensor point 78 and an energy function relating to constraints related to the mechanical properties of the working channel tool 20, with respect to the relative position and orientation of curve point 76 and sensor point 78. For example, each point 76 or 78 may have constraints relating to its position and orientation with respect to the other points 76 and / or 78, which may be incorporated into the energy function. For example, for the entire N Energy functions at points 76 and 78 E It can have the following forms:

[0161] in As described in this article. For example, It relates to the mechanical constraints between the two points. For example, Related to the mechanical constraints between the three points, etc. Indicates sensori All degrees of freedom. For example, In or In Corresponding to a 6-DoF (degrees of freedom) sensor, where q and θ These are quaternions and Euler angles, representing directions, respectively. Examples of mechanical constraints and related energy functions can be found, for instance, in provisional patent application No. 63 / 536,467, entitled “DISTORTION MODELING AND COMPENSATION IN A CURVE-TRACKED DETECTOR ARRAY,” which is incorporated herein by reference.

[0162] As a complete example, the total energy of the curve can be constructed as , in, i Covering all sensors, { i , j} Pervading adjacent sensor pairs, and different energies are defined as

[0163] Δ t It is the time difference between the current frame and the previous frame, and It is along the probe on the sensor i and j The distance or length between them is accurately determined from the mechanical design of the probe and / or from aseptic calibration performed prior to operation. middle, k = j +1= i +2, and implicitly assumes that the distance between the sensors is uniform, i.e. However, more complex situations may require generalization.

[0164] In the naive case of electromagnetic tracking without external magnetic field distortion, it is possible to achieve this simply by setting... Based on the absence of additional constraints and =1 The total energy obtained is And good tracking is expected up to the level permitted by the sensitivity of the magnetic sensor. This is because, for the general area around the transmitter... The measurement results can be derived from the theoretical results with a small error. To explain. However, this no longer holds true when the probe is inserted into the device and the device distorts the theoretical magnetic field around it.

[0165] One possible solution to this problem is to increase other types of energy ( Even if the measurement results cannot be accurately interpreted by theory, these energies can still keep the position and orientation "reasonable," meaning that they keep the solved position and orientation within the range of a credible solution under known mechanical constraints (such as length constraints and smoothness constraints). For example, higher... , , The value tends to decrease along the curve. The second derivative of .

[0166] More specific solutions for distortions occurring near sensors (e.g., in the case of tools inserted into the working channel of a magnetic endoscope) include revising theoretical models to account for potential distortions. This is achieved through new items. This energy is incorporated into the energy. For each sensor, It is a 3×3 matrix, typically based on the specific sensor, its position relative to the working channel, and the external endoscope (also known as an endoscopic device). This set of matrices can be learned / calculated during the initial calibration phase. For example, the working channel tool 20 can be fixed in a suitable position relative to the transmitter without distortion, such that the "clean" theoretical magnetic field measured by each sensor is known. Then, the distortion (endoscope) is slowly introduced onto the working channel tool 20, and the distorted magnetic field is measured. The relevant magnetic field can then be directly calculated (without optimization) by solving the following equation. matrix: .

[0167] This process only needs to be performed once. Apart from aberrant immunity (also referred to as tool immunity in this article), if... If the matrix is ​​stored together with the corresponding timestamp or the position of the working channel tool 20 of the endoscope, the algorithm can obtain the position tracking of the working channel tool (relative to a larger diameter endoscope). In some embodiments, the "working channel tool position tracking" algorithm enables the tracking and / or display of the position of the working channel tool within the working channel of the endoscope. In some embodiments, as the working channel tool 20 is introduced into the working channel of the endoscope, the working channel tool 20 can subsequently be displayed, for example, in 3D, because the position can be determined by analyzing the dynamic calibration matrix. And, for example, it is compared with a pre-calibrated calibration matrix with specified positions to track the position of the working channel tool 20 within the working channel of the endoscope device, as described above.

[0168] In some embodiments, by using dynamic The tool immunity algorithm of the calibration matrix enables accurate EM tracking of the inserted tool's shape and / or position, overcoming potential inaccuracies caused by metals in the carrier endoscope. For example, when the working channel tool 20 is inserted, potential inaccuracies may arise due to positional changes in the endoscope's braided layers, curved connecting rods, laser-cut components, or other conductive or ferromagnetic metals relative to the inserted working channel tool 20. Without compensation for these metals, the inserted working channel tool 20 may be inaccurately tracked by the EM tracking system, resulting in incorrect shape and / or position and / or orientation, potentially depending on its location within the working channel of the endoscope. Therefore, dynamic learning (in a supervised or unsupervised manner) is employed. The calibration matrix is ​​potentially beneficial in enabling the working channel tool 20 to achieve tool immunity and possibly also tool tracking.

[0169] In some embodiments, dynamics can be learned in a single step, for example during factory calibration, by inserting a working channel tool into a larger outer diameter endoscope of a particular configuration. A calibration matrix is ​​generated, and the learned calibration matrix can then be used to compensate for distortions caused by any endoscopic device. This is feasible because different configurations of endoscopic devices typically impose similar types of distortion on the inserted working channel tool. This is potentially beneficial because it allows the working channel tool to be calibrated during the factory process and then used with any type of larger outer diameter endoscopic device.

[0170] As shown in box 408, processor / controller 10 includes instructions for calculating (e.g., relative to transmitter 12) a fully localized curve along the tracked portion of working channel tool 20. For example, minimizing an energy function. E This minimizes the error (relative to the various constraints incorporated into the function). The resulting equations can then be solved for all positions and orientations along the working channel tool 20 at points 76 and 78.

[0171] It is understood that in some embodiments of this disclosure, such as when the sensor points 78 are sufficiently close to each other, the calculations described herein may be performed based on the sensor points 78 without adding virtual curve points in between, or setting a variable number of virtual curve points between different pairs of sensor points 78.

[0172] As used in this article, the term “about” means “within ±10% of”.

[0173] The terms “including,” “comprising,” “having,” and their variations mean “including but not limited to.”

[0174] The term "composed of" means "including and limited to".

[0175] The term "basically composed of" means that a composition, method, or structure may include additional ingredients, steps, and / or components, but only if such additional ingredients, steps, and / or components do not substantially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0176] As used herein, unless the context clearly indicates otherwise, the singular form includes the plural reference. For example, the terms "compound" or "at least one compound" may include multiple compounds, including mixtures thereof.

[0177] Throughout this application, embodiments of the invention are described using a range format. It should be understood that the range format is for convenience and brevity only and should not be construed as an inflexible limitation on the scope of protection of the invention. Therefore, a description of a range should be considered to specifically disclose all possible subranges within that range and each individual numerical value within that range. For example, a description of a range such as "from 1 to 6" should be considered to specifically disclose subranges such as "from 1 to 3," "from 1 to 4," "from 1 to 5," "from 2 to 4," "from 2 to 6," "from 3 to 6," etc.; and each individual number within that range, such as 1, 2, 3, 4, 5, and 6. This understanding applies regardless of the width of the range.

[0178] Whenever a range of numbers is given in this document (e.g., “10-15”, “10 to 15”, or any pair of numbers connected by these or other such range indications), unless the context clearly specifies otherwise, it means including any number (fraction or integer) within the range limit, and including the range limit. The phrases “range / variable range / multiple ranges between the first and second indicated numbers” and “range / variable range / multiple ranges from the first indicated number ‘to’, ‘until’, ‘until’ or ‘through’ (or other similar range indication terms) the second indicated number” are used interchangeably herein and both mean including the first and second indicated numbers and all fractions and integers in between.

[0179] Unless otherwise stated, the figures used herein, and any ranges of values ​​based thereon, are approximations within the reasonable measurement precision and rounding error range understood by those skilled in the art.

[0180] It is understood that, for clarity, certain features of the invention described in the context of a single embodiment may also be provided in combination in a single embodiment. Conversely, for brevity, various features of the invention described in the context of a single embodiment may also be provided separately, or in any suitable sub-combination, or as provided in any other described embodiment applicable to the invention. Certain features described in the context of various embodiments should not be considered essential features of those embodiments unless the embodiment would not be able to be practiced without these elements.

[0181] Although the invention has been described in conjunction with specific embodiments thereof, it will be apparent to those skilled in the art that many alternatives, modifications, and variations will occur. Therefore, the invention is intended to cover all such alternatives, modifications, and variations falling within the spirit and broad scope of the appended claims.

[0182] The applicant intends that all publications, patents, and patent applications mentioned in this specification be incorporated herein by reference in their entirety as if each individual publication, patent, or patent application had been specifically and individually attributed as incorporated herein by reference. Furthermore, any reference or designation of any reference in this application should not be construed as an admission that such reference is prior art to the invention. The use of section headings should not be construed as necessarily limiting. In addition, any priority documents of this application are also incorporated herein by reference in their entirety.

Claims

1. An endoscope system, comprising: a. Endoscopic equipment, including the working channel; b. A working channel tool configured to be inserted into the working channel of the endoscope device, the working channel tool comprising: i. An elongated body, including a proximal end and a distal end; ii. One or more flexible printed circuits (FPCs) extending along the elongated body; and iii. A curve / shape sensor, comprising a plurality of sensor elements positioned on one or more FPCs; c. One or more transmitters; d. A controller including a processor; the processor including instructions for calculating a fully localized curve relative to the one or more transmitters along the tracked portion of the working channel tool.

2. The endoscope system of claim 1, wherein the processor further includes instructions for allocating an energy function based on sensing values ​​of the sensor elements at corresponding points along the working channel tool, the sensing values ​​incorporating relevant constraints.

3. The endoscope system of claim 1, wherein the processor further comprises instructions for the following: a. Acquire multiple pre-known points and / or intervals along the tracked portion of the working channel tool; b. Assign an energy function based on the position and direction of a point along the working channel tool, the energy function incorporating relevant constraints; c. Generate a synthetic joint energy function for the complete shape and / or position of the entire tracked portion of the working channel tool.

4. The endoscope system of claim 1, wherein the one or more FPCs are twisted about the longitudinal axis of the elongated body.

5. The endoscope system of claim 1, wherein the plurality of sensor elements are positioned on the one or more FPCs at known intervals.

6. The endoscope system of claim 1, wherein at least one of the plurality of sensor elements is located at the distal end of the elongated body.

7. The endoscope system of claim 1, wherein the working channel tool further comprises at least one LED located at the distal end of the elongated body.

8. The endoscope system of claim 1, wherein the working channel tool further comprises at least one camera positioned at the distal end of the elongated body.

9. The endoscope system of claim 1, wherein the working channel tool further comprises at least one camera support for at least one camera.

10. The endoscope system of claim 9, wherein the at least one camera support is configured to be manipulated during the manufacture of the working channel tool.

11. The endoscope system of claim 10, wherein the manipulation is folding.

12. The endoscope system of claim 11, wherein the folding positions the at least one camera distally from the distal end of the elongated body.

13. The endoscope system of claim 1, wherein the working channel tool further comprises a second working channel extending within the elongated body.

14. The endoscope system of claim 1, wherein the working channel tool further comprises a mounting base configured to accommodate at least one camera and at least one LED.

15. The endoscope system of claim 14, wherein the mounting base is configured to allow directional positioning of the at least one camera and the at least one LED.

16. The endoscope system of claim 1, wherein the one or more FPCs further comprises at least one reinforcing material.

17. The endoscope system of claim 1, wherein one or more FPCs are wound around a core, mandrel, or fiber.

18. The endoscope system of claim 17, wherein the core is hollow or solid.

19. The endoscope system of claim 1, wherein the working channel tool comprises at least two FPCs, and wherein the first FPC is configured to accommodate the plurality of sensor elements, and the second FPC is configured to accommodate at least one camera and at least one LED.

20. The endoscopic system according to claim 19, wherein, The at least two FPCs are assembled by stacking them one on top of the other.

21. The endoscope system of claim 1, wherein one or more FPCs are covered by a protective sleeve.

22. The endoscope system of claim 21, wherein the protective sleeve is configured for one or more of the following: a. To provide biocompatibility for the channels of the working tool; b. Provide protection for the electronic components within the tool passage; c. Enhance the mechanical properties of the tool channel; as well as d. To provide protection for the working passage of the organization and / or the endoscope device.

23. The endoscope system of claim 21, wherein the protective sleeve makes the distal end of the elongated body rounded.

24. A working channel tool configured for insertion into the working channel of an endoscope, the working channel tool comprising: a. A slender body, including a proximal end and a distal end; b. One or more flexible printed circuits (FPCs) extending along the elongated body; c. A curve / shape sensor, comprising a plurality of sensor elements positioned on one or more FPCs; as well as d. A controller including a processor; the processor includes instructions for allocating an energy function based on sensing values ​​of the sensor elements at corresponding points along the working channel tool, and instructions for calculating a fully localized curve relative to one or more transmitters along a tracked portion of the working channel tool, the sensing values ​​incorporating relevant constraints.

25. The working channel tool of claim 24, wherein the processor further comprises instructions for: a. Acquire multiple pre-known points and / or intervals along the tracked portion of the working channel tool; b. Assign an energy function based on the position and direction of a point along the working channel tool, the energy function incorporating relevant constraints; c. Generate a synthetic joint energy function for the complete shape and / or position of the entire tracked portion of the working channel tool.

26. The working channel tool of claim 24, wherein the one or more FPCs are twisted about the longitudinal axis of the elongated body.

27. The working channel tool of claim 24, wherein the plurality of sensor elements are positioned on the one or more FPCs at known intervals.

28. The working channel tool of claim 24, wherein at least one of the plurality of sensor elements is positioned at the distal end of the elongated body.

29. The working channel tool of claim 24, wherein the working channel tool further comprises at least one LED positioned at the distal end of the elongated body.

30. The working channel tool of claim 24, wherein the working channel tool further comprises at least one camera positioned at the distal end of the elongated body.

31. The working channel tool of claim 24, wherein the working channel tool further comprises at least one camera support for at least one camera.

32. The working channel tool of claim 31, wherein the at least one camera support is configured to be manipulated during the manufacture of the working channel tool.

33. The working channel tool according to claim 32, wherein the manipulation is folding.

34. The working channel tool of claim 33, wherein the folding positions the at least one camera from the distal end of the elongated body toward the far side.

35. The working channel tool of claim 24, wherein the working channel tool further comprises a second working channel extending within the elongated body.

36. The working channel tool of claim 24, wherein the working channel tool further comprises a mounting base configured to accommodate at least one camera and at least one LED.

37. The working channel tool of claim 36, wherein the mounting base is configured to allow directional positioning of the at least one camera and the at least one LED.

38. The working channel tool of claim 24, wherein the one or more FPCs further comprises at least one reinforcing material.

39. The working channel tool of claim 24, wherein one or more FPCs are wound around a core, mandrel, or fiber.

40. The working channel tool of claim 39, wherein the core is hollow or solid.

41. The working channel tool of claim 24, wherein the working channel tool comprises at least two FPCs, and wherein the first FPC is configured to accommodate the plurality of sensor elements, and the second FPC is configured to accommodate at least one camera and at least one LED.

42. The working channel tool according to claim 41, wherein, The at least two FPCs are assembled by stacking them one on top of the other.

43. The working channel tool of claim 24, wherein one or more FPCs are covered by a protective sleeve.

44. The working channel tool of claim 43, wherein the protective sleeve is configured for one or more of the following: a. To provide biocompatibility for the channels of the working tool; b. Provide protection for the electronic components within the tool passage; c. Enhance the mechanical properties of the tool channel; as well as d. To provide protection for the working passage of the organization and / or the endoscope device.

45. The working channel tool of claim 43, wherein the protective sleeve makes the distal end of the elongated body circular.

46. ​​A method of manufacturing a work channel tool, the work channel tool including one or more sensor arrays; the one or more sensor arrays including one or more flexible printed circuits (FPCs) and a plurality of electronic components positioned on the one or more FPCs; the method including helically winding the one or more sensor arrays around the work channel tool; The method includes positioning the plurality of electronic components along the one or more FPCs such that the plurality of electronic components are aligned relative to the longitudinal axis of the work channel tool when the one or more sensor arrays are wound around the work channel tool.

47. The method of claim 46, wherein at least one of the plurality of FPCs has a helical FPC design and is capable of being wound into the working channel tool in a helical manner.

48. A method for curve / shape tracing for a work channel tool, comprising: a. Acquire multiple pre-known points and / or intervals along the tracked portion of the working channel tool; b. Assign an energy function based on the position and direction of a point along the working channel tool, the energy function incorporating relevant constraints; c. Generate a synthesized joint energy function for the complete shape and / or position of the tracked portion of the working channel tool; as well as d. Calculate the fully localized curve relative to the traced portion of the transmitter along the working channel tool.

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