WO2025057159A1 - Outil à canal opérateur à suivi de courbe - Google Patents
Outil à canal opérateur à suivi de courbe Download PDFInfo
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- WO2025057159A1 WO2025057159A1 PCT/IL2024/050914 IL2024050914W WO2025057159A1 WO 2025057159 A1 WO2025057159 A1 WO 2025057159A1 IL 2024050914 W IL2024050914 W IL 2024050914W WO 2025057159 A1 WO2025057159 A1 WO 2025057159A1
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- working channel
- working
- channel tool
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/005—Flexible endoscopes
- A61B1/009—Flexible endoscopes with bending or curvature detection of the insertion part
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00064—Constructional details of the endoscope body
- A61B1/0011—Manufacturing of endoscope parts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
- A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
- A61B5/062—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using magnetic field
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
- A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/005—Flexible endoscopes
- A61B1/0051—Flexible endoscopes with controlled bending of insertion part
- A61B1/0055—Constructional details of insertion parts, e.g. vertebral elements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
- A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2046—Tracking techniques
- A61B2034/2048—Tracking techniques using an accelerometer or inertia sensor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2046—Tracking techniques
- A61B2034/2051—Electromagnetic tracking systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2046—Tracking techniques
- A61B2034/2061—Tracking techniques using shape-sensors, e.g. fiber shape sensors with Bragg gratings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
- A61B2090/309—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using white LEDs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
- A61B2562/164—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
- A61B2562/166—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted on a specially adapted printed circuit board
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/36—Image-producing devices or illumination devices not otherwise provided for
- A61B90/361—Image-producing devices, e.g. surgical cameras
Definitions
- the present invention in some embodiments thereof, relates to fully shape/curve-tracked elongated probe tool and methods for manufacturing thereof, for example a working-channel tool, for example, for catheter and/or endoscopic interventional procedures.
- Electromagnetic tracking systems are widely used in clinical applications to track certain instruments inside the patient’s body in three dimensions.
- a common electromagnetic tracking system usually consists of an electromagnetic transmitter, which generates a number of different alternating electromagnetic fields, commonly at different frequencies (for example, 3 different fields at frequencies IKhz, 2Khz, 3Khz) and an electromagnetic sensor which usually consists of one or more electromagnetic coils (for example, 3 concentric small electromagnetic coils).
- the alternating fields generate Electromotive Force (EMF) in the sensor’s coils which are sensed on the receiving end.
- EMF Electromotive Force
- the measured fields are then used to compute the position and orientation of the electromagnetic sensor.
- the solution of a position and/or orientation of the sensor relative to the transmitter relies on the knowledge of the generated EM field values at each point in space relative to the transmitter. By knowing the generated fields, the receiver is able to determine the position and/or orientation of the sensor in space relative to the transmitter such that the measured fields correspond to its solved position and/or orientation.
- Certain medical devices exist which combine electronics inside the devices.
- many endoscopes which contain an electrical image sensor (for example, a CMOS sensor) at the endoscope’s tip, which is usually accompanied by one or more Light Emitting Diodes (LED).
- the image sensor and LEDs are usually powered by a power source which is external to the endoscope, for example, resides in a host station and connected to the endoscope using electrical conductors such as isolated electrical wires inside an electrical cable, and the sensor images are streamed to a host station using one or more electrical conductors, such as isolated shielded electrical wires.
- an EM coil-based sensor may comprise an ultra-thin enameled copper wire wrapped around a small magnetic core (for example, ferrite) and which is placed at the tip of a tracked EM catheter. The wire at its two ends may then be extended in a twisted-pair fashion back to a connected host system, as a differential signal.
- a small magnetic core for example, ferrite
- each EM coil requires two differential wires.
- a standard 3D EM coil-based sensor consists for example of three perpendicular coils, which amounts to six wires. For a standard multi-sensor EM application, the number of wires grows linearly with the number of EM sensors in the device.
- Such devices and tools may be: endoluminal ultrasound devices (such as REBUS, IVUS); other endoluminal imaging (such as OCT and spectroscopy devices); ablation devices (such as RF probes, Microwave probes, cryoablation devices); electrical clot and foreign-object retrieval; flexible endoluminal surgical tools; histotripsy and other types of therapeutic ultrasound devices, electrical cauterization.
- endoluminal ultrasound devices such as REBUS, IVUS
- other endoluminal imaging such as OCT and spectroscopy devices
- ablation devices such as RF probes, Microwave probes, cryoablation devices
- electrical clot and foreign-object retrieval such as RF probes, Microwave probes, cryoablation devices
- flexible endoluminal surgical tools histotripsy and other types of therapeutic ultrasound devices, electrical cauterization.
- Most electrical devices and tools require electrical powering, connectivity, and hosting of electrical components inside the devices.
- Additional background art includes U.S. Patent No. 11,712,309 disclosing an EM curve sensor which consists of a sensor-array made of multiple discrete digital 3D magnetometers assembled on a Flexible Printed Circuit (FPC).
- the sensor-array may be embedded in an endoscope (or other tubular device) to enable EM curve tracking of that endoscope.
- objects in the device environment may create an electromagnetic distortion in space and impact the accuracy of the solved position and orientation relative to the transmitter.
- certain ferromagnetic, paramagnetic, and/or diamagnetic materials may be magnetized due to the electromagnetic fields generated by the transmitter and become sources for electromagnetic fields (of similar frequencies).
- Conductive materials may serve as receivers in the sense that they experience electromotive forces due to the generated electromagnetic fields. These electromotive forces create electrical currents (eddy currents) inside the conductive metals which generate secondary fields, such that the conductive metals may also become sources for electromagnetic fields (of similar frequencies) on their own.
- a long thin tubular device for example catheter or endoscope
- a lumen in the patient’s body for example gastrointestinal system, lung, or endo-vascular lumen.
- a device can be thin in order to pass through the narrow lumens, and flexible in order to pass through tight curves without damaging the tissue in the lumen wall.
- the device is preferably durable to withstand the mechanical forces applied during its use by the physician and the patient’s tissue.
- some endoluminal devices include an inner lumen or working channel to allow insertion of biopsy or ablation tool.
- This inner lumen or working channel is required to have as large diameter as possible to allow insertion of large tools.
- endoluminal devices are designed with minimal wall thickness. Incorporating electrical components or wires in the wall of such device, may require an increase in wall thickness or negatively affect the device’s mechanical properties, for example flexibility and durability. For this reason, many devices do not include such components and instead have electrical components only at the tip.
- Navigation systems which provide navigational instructions to guide a device to a specific point inside a patient’s organ.
- an EM position sensor is located inside an endoscope’s tip and is used by the navigation system to provide instructions for a physician to reach a certain target inside the patient’s lung.
- a device may be tracked using electromagnetic (EM) position sensor or EM shape and/or position sensor or fiber-optic shape sensor. Tracking a device during an endoluminal procedure allows for providing navigational guidance instructions for that device, to navigate the device to a specific, potentially peripheral target, inside a potentially complex lumen structure, based on the shape and/or position sensor.
- EM electromagnetic
- tracking the shape and/or position of a device during endoluminal procedure can support the steering of that device, for example in a robotic endoscopic procedure, by tracking the shape and/or position of the distal bending section of the device, such that the device is deflected in controlled manner, based on feedback from the shape and/or position sensor.
- An endoscopic system comprising: a. an endoscopic device comprising a working channel; b. a working channel tool configured to be inserted within said working channel of said endoscopic device, said working channel tool comprising: i. an elongated body comprising a proximal end and a distal end; ii. one or more Flexible Printed Circuits (FPCs) extending along said elongated body; and iii. a curve/shape sensor comprising a plurality of sensor elements positioned on said one or more FPCs; c. one or more transmitters; d. a controller comprising a processor; said processor comprising instructions for calculating a full localized curve along a tracked portion of said working channel tool, relative to the one or more transmitters.
- FPCs Flexible Printed Circuits
- Example 2 The endoscopic system according to example 1, wherein said processor comprises further instructions for allocating energy functions dependent on sensed values by the sensor elements at respective points along said working channel tool, the sensed values incorporate relevant constraints.
- Example 3 The endoscopic system according to example 1, wherein said processor comprises further instructions for: a. obtaining a plurality of pre-known points and/or intervals along a tracked portion of said working channel tool; b. allocating energy functions dependent on the position and orientation of points along said working channel tool, that incorporate relevant constraints; c. generating a resultant united energy function for the full shape and/or position of the entire tracked portion of said working channel tool.
- Example 4 The endoscopic system according to example 1, wherein said one or more FPCs are twisted about a longitudinal axis of said elongated body.
- Example 5 The endoscopic system according to example 1, wherein said plurality of sensor elements are positioned at known intervals on said one or more FPCs.
- Example 6 The endoscopic system according to example 1, wherein at least one sensor element from said plurality of sensor elements is positioned at said distal end of said elongated body.
- Example 7 The endoscopic system according to example 1, wherein said working channel tool further comprises at least one LED positioned at said distal end of said elongated body.
- Example 8 The endoscopic system according to example 1, wherein said working channel tool further comprises at least one camera positioned at said distal end of said elongated body.
- Example 9 The endoscopic system according to example 1, wherein said working channel tool further comprises at least one camera support for said at least one camera.
- Example 10 The endoscopic system according to example 9, wherein said at least one camera support is configured to be manipulated during a manufacturing process of said working channel tool.
- Example 11 The endoscopic system according to example 10, wherein said manipulation is folding.
- Example 12 The endoscopic system according to example 11, wherein said folding positions said at least one camera facing distally from said distal end of said elongated body.
- Example 13 The endoscopic system according to example 1, wherein said working channel tool further comprises a second working channel extending within said elongated body.
- Example 14 The endoscopic system according to example 1, wherein said working channel tool further comprises a mount configured to house at least one camera and at least one LED.
- Example 15 The endoscopic system according to example 14, wherein said mount is configured to allow directional positioning of said at least one camera and said at least one LED.
- Example 16 The endoscopic system according to example 1, wherein said one or more FPCs further comprise at least one reinforcement material.
- Example 17 The endoscopic system according to example 1, wherein said one or more FPCs are wrapped around a core, a mandrel or a fiber.
- Example 18 The endoscopic system according to example 17, wherein said core is either hollow or full.
- Example 19 The endoscopic system according to example 1, wherein said working channel tool comprises at least two FPCs, and wherein a first FPC is configured to house said plurality of sensor elements and a second FPC is configured to house at least one camera and at least one LED.
- Example 20 The endoscopic system according to example 19, wherein said at least two FPCs are assembled one on top of another.
- Example 21 The endoscopic system according to example 1, wherein said one or more FPCs are covered with a protective jacket.
- Example 22 The endoscopic system according to example 21, wherein said protective jacket is configured for one or more of: a. providing biocompatibility to said working tool channel; b. providing protection to electronic component within said working tool channel; c. enhancing mechanical properties of said working tool channel; and d. providing protection to tissues and/or said endoscopic device working channel.
- Example 23 The endoscopic system according to example 21, wherein said protective jacket provides a round shape to said distal end of said elongated body.
- Example 24 A working channel tool configured to be inserted within a working channel of an endoscopic device, said working channel tool comprising: a. an elongated body comprising a proximal end and a distal end; b. one or more Flexible Printed Circuits (FPCs) extending along said elongated body; c. a curve/shape sensor comprising a plurality of sensor elements positioned on said one or more FPCs; and d.
- FPCs Flexible Printed Circuits
- a controller comprising a processor; said processor comprising instructions for allocating energy functions dependent on sensed values by the sensor elements at respective points along said working channel tool, the sensed values incorporate relevant constraints, and calculating a full localized curve along a tracked portion of said working channel tool, relative to one or more transmitters.
- Example 25 The working channel tool according to example 24, wherein said processor comprises further instructions for: a. obtaining a plurality of pre-known points and/or intervals along a tracked portion of said working channel tool; b. allocating energy functions dependent on the position and orientation of points along said working channel tool, that incorporate relevant constraints; c. generating a resultant united energy function for the full shape and/or position of the entire tracked portion of said working channel tool.
- Example 26 The working channel tool according to example 24, wherein said one or more FPCs are twisted about a longitudinal axis of said elongated body.
- Example 27 The working channel tool according to example 24, wherein said plurality of sensor elements are positioned at known intervals on said one or more FPCs.
- Example 28 The working channel tool according to example 24, wherein at least one sensor element from said plurality of sensor elements is positioned at said distal end of said elongated body.
- Example 29 The working channel tool according to example 24, wherein said working channel tool further comprises at least one LED positioned at said distal end of said elongated body.
- Example 30 The working channel tool according to example 24, wherein said working channel tool further comprises at least one camera positioned at said distal end of said elongated body.
- Example 31 The working channel tool according to example 24, wherein said working channel tool further comprises at least one camera support for said at least one camera.
- Example 32 The working channel tool according to example 31 , wherein said at least one camera support is configured to be manipulated during a manufacturing process of said working channel tool.
- Example 33 The working channel tool according to example 32, wherein said manipulation is folding.
- Example 34 The working channel tool according to example 33, wherein said folding positions said at least one camera facing distally from said distal end of said elongated body.
- Example 35 The working channel tool according to example 24, wherein said working channel tool further comprises a second working channel extending within said elongated body.
- Example 36 The working channel tool according to example 24, wherein said working channel tool further comprises a mount configured to house at least one camera and at least one LED.
- Example 37 The working channel tool according to example 36, wherein said mount is configured to allow directional positioning of said at least one camera and said at least one LED.
- Example 38 The working channel tool according to example 24, wherein said one or more FPCs further comprise at least one reinforcement material.
- Example 39 The working channel tool according to example 24, wherein said one or more FPCs are wrapped around a core, a mandrel or a fiber.
- Example 40 The working channel tool according to example 39, wherein said core is either hollow or full.
- Example 41 The working channel tool according to example 24, wherein said working channel tool comprises at least two FPCs, and wherein a first FPC is configured to house said plurality of sensor elements and a second FPC is configured to house at least one camera and at least one LED.
- Example 42 The working channel tool according to example 41, wherein said at least two FPCs are assembled one on top of another.
- Example 43 The working channel tool according to example 24, wherein said one or more FPCs are covered with a protective jacket.
- Example 44 The working channel tool according to example 43, wherein said protective jacket is configured for one or more of: a. providing biocompatibility to said working tool channel; b. providing protection to electronic component within said working tool channel; c. enhancing mechanical properties of said working tool channel; and d. providing protection to tissues and/or said endoscopic device working channel.
- Example 45 The working channel tool according to example 43, wherein said protective jacket provides a round shape to said distal end of said elongated body.
- Example 46 A method of manufacturing a working channel tool comprising one or more sensor arrays; said one or more sensor arrays comprising one or more Flexible Printed Circuits (FPCs) and a plurality of electronic components positioned on said one or more FPCs; the method comprising helically winding one or more sensor arrays around said working channel tool; wherein said method comprises positioning said plurality of electronic components along said one or more FPCs so when said one or more sensor arrays are wound around said working channel tool, said plurality of electronic components are aligned in relation to a longitudinal axis of said working channel tool.
- FPCs Flexible Printed Circuits
- Example 47 The method according to example 46, wherein at least one of the FPCs has a spiral shaped FPC design, and is windable as a helix onto a working channel tool.
- Example 48 A method for curve/shape-tracking of a working-channel tool, comprising: a. obtaining a plurality of pre-known points and/or intervals along a tracked portion of said working-channel tool; b. allocating energy functions dependent on a position and orientation of points along said working channel tool that incorporate relevant constraints; c. generating a resultant united energy function for a full shape and/or position of said tracked portion of said working channel tool; and d. calculating a full localized curve along said tracked portion of said working channel tool, relative to a transmitter.
- a curve-tracked working channel tool comprising: a processor/controller; an elongated body comprising at least one flexible printed circuit (FPC); and a curve sensor installed on the FPC, the curve sensor is configured to sense positions and orientations along the tool, in a determined frame of reference, wherein the curve sensor is configured to communicate with the processor/controller via the FPC while inserted into a body lumen, to calculate a curve of the tool, localized in the determined frame of reference, and wherein the processor/controller is configured to curve-track the elongated working channel tool, by receiving multiple magnetic field readings from a plurality of locations along the curve sensor.
- FPC flexible printed circuit
- the tool comprises a tip portion to hold an operational unit, optionally comprising one or more sensors and/or cameras and/or EEDs.
- the actionable/operational unit comprises a camera and an illumination source.
- the tool is configured to be inserted into a catheter.
- the curve sensor is configured to detect and or sense local magnetic fields along the device.
- the determined frame of reference is of an external transmitter of magnetic fields.
- the curve sensor includes a plurality of magnetic field sensing elements, assembled on the FPC at known locations along the tool.
- the at least one of the sensing elements is installed at a tip portion of the tool.
- the tip portion includes a camera support spatially manipulated to position the camera to face a progress direction of the tool.
- the tool comprises a fold before the camera support, to position the camera to face a progress direction of the tool.
- the tool comprises a mount to hold a tip portion of the FPC in a stable and correctly positioned manner, for an intended operation.
- the mount is configured to position the camera to face a progress direction of the tool.
- the mount comprises: a platform, wherein a side of the platform is configured to support a camera support portion of the FPC; a wall; and a slot between the platform and the wall, in which the tip portion may be inserted, and wherein the platform and the wall define a niche, in which a magnetic field sensor element is installed.
- the FPC is twisted about its longitudinal axis.
- the FPC is reinforced under sensor elements of the curve sensor to protect the attachment of these components to the FPC.
- the tool comprises two FPCs at least partially overlaying one on top of the other.
- the curve sensor, the camera and the illumination source (LED) are assembled on one side of the FPC and then the FPC is twisted and/or bent as required.
- the processor controller is configured to: obtain a plurality of predetermined points along a tracked portion of the tool; allocate, for a plurality of the predetermined points, a local energy function dependent on estimated position and orientation of the tool at this point, that incorporates relevant mechanical and sensor measurement constraints for the point; generate a resultant unified energy function for the full shape and position of the entire tracked portion of the tool, the unified energy function is constructed based on the allocated local energy functions, and regional energy functions that relate to constraints of mechanical properties of the tool, with respect to relative locations and orientation of adjacent plurality of the predetermined points; and calculate a full localized curve along the tracked portion of the tool by minimizing the energy function.
- a data processor such as a computing platform for executing a plurality of instructions.
- the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage, for example, a magnetic hard-disk and/or removable media, for storing instructions and/or data.
- a network connection is provided as well.
- a display and/or a user input device such as a keyboard or mouse are optionally provided as well.
- the 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 of the foregoing.
- a computer readable storage medium may be any tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.
- a computer readable signal medium may include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a 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 any computer readable medium that is not a computer readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.
- Program code embodied on a computer readable medium and/or data used thereby may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.
- Computer program code for carrying out operations for some embodiments of the present invention may be written in any combination of one or more programming languages, including an object-oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the "C" programming language or similar programming languages.
- the program code may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server.
- the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider).
- LAN local area network
- WAN wide area network
- Internet Service Provider for example, AT&T, MCI, Sprint, EarthLink, MSN, GTE, etc.
- 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 devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function/act specified in the flowchart and/or block diagram block or blocks.
- the computer program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.
- Figure 1 is a schematic representation of a system for full curve-tracking of a workingchannel tool, according to some embodiments of the invention
- Figures 2A-2H are schematic illustrations of a tool assembly, included in a workingchannel tool and configured for enabling full curve/shape tracking thereof, according to some embodiments of the invention
- Figure 3 is a schematic representation of a tracked portion of the working-channel tool, according to some embodiments of the invention.
- Figure 4 is a flowchart illustrating an exemplary method for curve/shape-tracking of the working-channel tool 20, according to some embodiments of the invention.
- the present invention in some embodiments thereof, relates to fully shape/curve-tracked elongated probe tool and methods for manufacturing thereof, for example a working-channel tool, for example, for catheter and/or endoscopic interventional procedures.
- an endoscope which does not necessarily possess shape-sensing or curve-tracking capabilities, thus enhancing its capabilities, such as navigational and/or steering capabilities, while maintaining dimensional and mechanical properties.
- an endoluminal device may possess shape-sensing or curve-tracking or tip-tracking capabilities, but a working channel tool (such as a biopsy needle, forceps, brush or other types of instruments) may not contain sensors and may thus not be tracked.
- Adding tracking capabilities to working channel tools enables tracking of the working channel tool separately from the endoluminal device, for example, such that working channel tools are being tracked while being extended outside of the working channel of the endoluminal device and towards a target (such as a lesion).
- a target such as a lesion
- the instrument can then be guided and navigated away from the endoluminal device’s tip and towards a target, and during its interaction with the target. This enables guided target interaction, while potentially using the instrument’s tracked shape and/or position to compensate for organ’s movement, for example, by applying deformation tracking algorithms based on the instrument’s tracked shape.
- the instrument can be driven robotically based on its tracked shape and towards a potentially moving (deforming/breathing) target, such as a lesion.
- An aspect of some embodiments of the invention relate to a working-channel curve-tracked probe tool (referred hereinafter just as working-channel tool) that can be used either for adding shape and/or position tracking capabilities to a non-tracked endoluminal device, as well as for providing tracking and guidance (navigation capabilities) all the way to the target and during the interaction with the target (even in the case of a tracked endoluminal device).
- working-channel tool referred hereinafter just as working-channel tool
- some curve sensing methods use multiple magnetic sensors along an elongated flexible device and the determined position and orientation or local magnetic field measurements or other local measurements of each sensor to determine an estimated curve of the elongated device. These methods are susceptible to include errors in the estimation, caused by, for example, inaccuracies in the sensors and the need to somehow estimate the shape of the device between the sensors.
- the distortion fields which are created by nearby metals can be modeled and learned in a mapping and/or calibration process prior to operating the tracking system.
- a transmitter is fixed to a patient’s bed
- conductive metals on the bed are located in a static position relative to the transmitter.
- the distortion fields caused by eddy currents flowing through the conductive metals or by magnetization of ferromagnetic metals are static in the sense that they do not change during operation of the tracking system.
- the system is configured to use the mapped fields (rather than the “neutral” or theoretically expected fields) to perform the tracking.
- the mapped fields (rather than the “neutral” or theoretically expected fields) to perform the tracking.
- the magnetic metal creates a distortion field as described above. Since the sensing coil is fixed to the distorter, the distortion field “moves” together with the sensing coil and its effect is static relative to the receiver and can be modeled in a calibration process. For example, its effect may be modeled as increased sensing gain of the EM sensing coil, or more generally, as a gain matrix applied to measurements of the sensing coils, regardless of the sensor’s position and orientation in space.
- dynamic electromagnetic distortion which accounts for distortion fields created by dynamically moving distorting objects (relative to the transmitter and/or the receiver) requires a different solution and cannot be addressed in a pre-calibration or mapping process.
- dynamic electromagnetic distortion can be caused for example by a C-arm which may be centered around the patient and may be rotated and/or moved during procedure.
- tools made of magnetic metals may be introduced into the endoscope’s working channel and may create dynamic electromagnetic distortion while they are moved and manipulated inside the endoscope’s working channel.
- Such tools may be for example: biopsy tools (such as forceps, needles, cytology brushes); endoluminal ultrasound devices (such as REBUS, IVUS); other endoluminal imaging (such as OCT and spectroscopy devices); ablation devices (such as RF probes, Microwave probes, cryoablation devices, drug delivery needles and probes, brachytherapy devices and seeds, laser and light fiber optics); stents and stent placement tools; clot and foreign-object retrieval tools (such as mechanical baskets, electronic devices, suction microcatheters); embolization devices (such as coils, catheters, and aneurism management devices); fiducials and their placement mechanisms; flexible endoluminal surgical tools; lithotripsy and other types of therapeutic ultrasound devices.
- biopsy tools such as forceps, needles, cytology brushes
- endoluminal ultrasound devices such as REBUS, IVUS
- other endoluminal imaging such as OCT and spectroscopy devices
- ablation devices such as RF probe
- dynamic distortion may be caused by electric cauterization.
- Other forms of dynamic electromagnetic distortion may be caused by positioning an EM sensor array in close proximity to metallic or electronic implanted devices, such as pacemakers or electrostimulation devices, orthopedic implants, stents and prosthetics, or dental implants.
- This dynamic distortion might impact the accuracy of the solved position and orientation of an electromagnetic sensor inside the endoscope. In an endoscopic procedure, this may impact the tracking accuracy of the endoscope during a biopsy or therapeutic process which may impact the yield. It is therefore desired for an electromagnetic tracking system to be highly immune to electromagnetic distortion, especially in a clinical use-case.
- the number of wires in the EM tracked device grows linearly with the number of used sensors. For that reason, in most EM tracked devices, a single EM position and orientation sensor is used (usually made of 3 perpendicular EM coils). Using multiple coil-based EM sensors in a single device requires the handling of many wires (for example, 3 twisted-pairs per EM sensor), which can be cumbersome or impractical under certain footprint constraints.
- an EM curve sensor comprising a sensor array, made of a plurality of discrete sensor elements.
- Each sensor element may be an SMT 3D digital magnetometer, assembled on a Flexible Printed Circuit (FPC).
- FPC Flexible Printed Circuit
- the resulting device’s mechanical flexibility and steerability may be impaired due to the FPC’s inability to stretch axially, and even more so - laterally, to allow endoscope bending.
- some embodiments of the present disclosure include a helix winding of the FPC in a catheter, e.g., wrapping of the FPC helically inside an endoscopic catheter or an endoscope’s shaft, around the endoscope’s working channel.
- the helical FPC is then able to bend in all directions, surmounting the FPC’s inability to stretch.
- an FPC containing EM sensor array may be twisted about its own axis to create flexibility of the twisted FPC in all axes.
- the term “curve” means a shape along with a position in space, i.e., a shape that is localized in space in a known frame of reference, for example a shape that is localized in space in a known stationary frame of reference, for example in a frame of reference of a stationary magnetic field transmitter.
- the term “curve” may also mean a shape without position information in space, such as a shape which is being sensed by a fiber-optics shape sensor. In this case position information may be optionally added by using a single EM sensor at the device’s tip, or by proximally anchoring the shape sensor to a mechanical reference of known coordinates in space.
- the invention relates to a working-channel tool and methods for manufacturing thereof, for example a working-channel tool for catheter and/or endoscopic interventional procedures.
- the working-channel tool is used to enable curve tracking of existing endoscope devices, for example, endoscope devices which do not have shape tracking or only have partial tracking (such as single-point EM tracking), or do not have shape and/or position tracking at all.
- endoscope devices can be for example, manual bronchoscopes used in lung procedures, guided/non-guided robotic endoscopic systems, which may only have single-point EM tracking at their distal end, or which may have fiber-optic relative shape sensing, without information about the accurate position of the tracked relative shape, or which may not be tracked at all (such as standard image-only manual or robotic endoscopes).
- a working-channel tool as disclosed herein, into the working channel of existing devices, these devices are enhanced by the added curve tracking capabilities of the introduced working-channel tool and navigated using curve tracking based navigational software and algorithms to specific locations inside organs.
- the working-channel tool is then able to transform any existing endoscopic device into a navigable device with superior accuracy inside the anatomy. For example, one possible application may be the guidance of a thin bronchoscope to a peripheral lung lesion, for biopsy and/or localized treatment.
- deformation-based navigational software and algorithms use the tracked shape and/or position of the working-channel tool to model the deformation and/or breathing of an organ and tracking it in real-time during procedure.
- real-time deformable and/or breathing registration of the organ is achieved and used during procedure, such that the endoscope device (the working channel tool and/or the endoluminal device into which the working-channel tool is inserted) is accurately localized and navigated inside the luminal structure, which is enabled by the working-channel tool.
- the working-channel tool also serves as a working-channel biopsy and/or therapeutic instrument, such as a forceps, needle, brush, REBUS, ablation or other suitable device.
- the working-channel tool may be a curve-tracked forceps device (either a custom-built device or an existing off-the-shelf forceps device with wrapped EM shape sensors) which has both shape and/or position sensors as well as biopsy forceps mechanism, and which is curve-tracked during manipulation.
- the working-channel tool is a curve- tracked needle, brush or other type of biopsy and/or therapeutic curve-tracked instrument.
- the working-channel tool also has steering capabilities, for example, a steerable curve-tracked needle, forceps or brush instrument.
- a steerable working-channel tool biopsy and/or therapeutic instrument
- a target such as a needle
- the steerable working-channel tool is inserted into the working channel of a non-tracked endoscopic device.
- the shape and/or position of the endoscope is tracked by the inserted working-channel tool and the endoscopic device is navigated to a lesion using deformable and/or breathing registration algorithms based on the tracked curve of the working-channel tool and a preoperative CT scan of the patient.
- the workingchannel tool is then pushed further outside of the working channel of the endoscopic device and towards the target lesion, potentially penetrating the tissue, while still being curve-tracked.
- the deformation of the organ is tracked in real-time to provide real-time deformable and/or breathing registration of the organ and the working-channel tool is steered and guided by the system towards the target lesion and during the interaction with the lesion.
- this provides real-time tracking and guidance of the workingchannel tool during its interaction with the target.
- the working-channel tool is usually manipulated for example under fluoroscopy, which may be inaccurate since it only provides a 2D projection, and also since the target (such as a lesion) is usually invisible under standard fluoroscopy, and exposes both the patient and the physician to potentially harmful X-ray doses.
- the working-channel tool can be manipulated robotically and drive accurately to a target lesion by closing the loop between the tracked curve of the working-channel tool and the robotic drive mechanism.
- the working-channel tool contains pull-wires which enable steering of the tip of the working-channel tool, to make the working-channel tool steerable.
- the pull- wires may be manipulated by a manual lever which exists in a proximal handle which is attached to the working-channel tool, or can be robotically manipulated through a proximal interface which is attached to the working-channel tool.
- the working-channel tool may not be steerable, and the working-channel tool may be guided to a target by steering the endoscopic device during the insertion of the working-channel tool based on the working-channel tool’s tracked curve, thus affecting the working-channel tool’s insertion direction such that the working-channel tool will eventually reach the target.
- this is done robotically by closing the loop between the working-channel tool’s tracked curve and the endoscope’s steering. In other embodiments, this is done manually where the physician steers the endoscopic device (for example, using a lever) based on the working-channel tool’s tracked curve relative to a target, as being displayed on a system display.
- the working-channel tool includes embedded electrical components, as well as a Flexible Printed Circuit (FPC).
- the working-channel tool includes a sensor array which comprises discrete sensing elements assembled on an FPC.
- the FPC may be manufactured in many configurations, such as a straight elongated FPC, or as a spiral FPC which is unpacked and opened in an assembly process.
- the plurality of electromagnetic sensing elements are optionally assembled in known intervals along the FPC. Preferably, at least one of the electromagnetic elements is positioned in proximity to the distal end of the working-channel tool, to enable tracking of the working-channel tool’s tip.
- the FPC further contains shielded conductors, for example for the electromagnetic sensing elements and/or for a digital or analog endoscopic camera.
- signals from the plurality of sensing elements, and optionally from a camera coexist on the same FPC, for example in multiple different layers, or in two separate FPCs which may be glued or positioned together.
- the FPC is covered with a protective jacket, for example a polymer protective jacket.
- the jacket provides biocompatibility, which can potentially reduce the risk of damage to patient tissue and potentially enhances mechanical properties, such as pushability, and/or may protect the tool from moisture or fluids.
- the tip of the working-channel tool is rounded and/or covered with a dome.
- a potential advantage of this rounding is that it may potentially reduce the risk of damaging patient tissue or the inner wall of the working channel as the working-channel tool is inserted through, as well as facilitate easier passage over obstacles, steps or other changes in the inner diameter of the working channel.
- the polymer jacket is further reinforced, for example using metallic coil or braid embedded in the polymer jacket, to improve mechanical properties such as durability and pushability.
- the jacket and/or dome may provide a thin and/or unified cross-section, for example suitable for insertion through a working channel of a catheter and/or an endoscopic device.
- the working-channel tool includes a handle for ergonomic grip.
- this handle includes mechanisms for fixing the handle to the endoscopic device it is inserted into.
- such fixings are configured for preventing axial, rotational, or axial and rotational motion of the working-channel tool relative to the endoscopic device into which it is inserted.
- such axial fixings generate positional alignment between the working-channel tool and the endoscopic device therefore the curve measured by the working-channel tool directly corresponds to the curve of the endoscopic device it is inserted into, while rotational fixing maintains alignment of the camera roll between the camera of the working-channel tool and the endoscopic device into which it is inserted, in case both include camera sensors.
- such fixing mechanisms are adjustable to allow for fixing in different positions as desired by the user, or to different tools, for example to different endoscopic device models.
- the handle of the working-channel tool contains one or more levers to manipulate pull- wires inside the working-channel tool to allow steering of the tip of the working-channel tool or distal bending section.
- a potential advantage of this is that it may be useful in the case of a steerable working-channel tool, for example, to navigate the working-channel tool to a target lesion.
- the handle of the working-channel tool is an interface which mounts onto a robotic drive mechanism.
- the working-channel tool can be manipulated robotically and may also be steered robotically, for example, using robotic motors mechanism which may manipulate pull-wires of the workingchannel tool.
- the working-channel tool is pushed or pull manually or robotically into the working channel of the endoscopic device.
- the working-channel tool is fixed relative to the endoscopic device’s tip, such that there is a known transformation (e.g., roll) between the working-channel tool’s tracked tip and the endoscopic device’s tip.
- a known transformation e.g., roll
- the endoscopic device can then be robotically steered based on the working-channel tool’s tracked shape and/or position.
- the working-channel tool’s tracked shape and/or position are used to determine the necessary steering actions to apply to the endoscopic device, based on a known transformation between the working-channel tool’ s tip coordinate system and the endoscopic device’s steering wires coordinate system. This is made possible, according to some embodiments, by fixing the working-channel tool’s tip relative to the endoscopic device’s tip using a mechanical fixture, to ensure that the transformation between the working-channel tool’s tip and the endoscopic device’s tip (or steering wires, or camera) does not change during the procedure.
- the working-channel tool includes features that keep it centered inside the working channel of the endoscopic device it is inserted into, for example a set of rings or sleeve(s) that are assembled over the polymer jacket to fill the gap between the jacket and the inner diameter of the working channel of the endoscopic device.
- these rings or sleeves are applied locally, for example specifically over the electromagnetic sensors, over a long portion of the working-channel tool, for example over the entire curve- sensing section, or over the entire length of the working-channel tool.
- these centering features are required to match different working channel diameters, therefore they are flexible, or rigid and provided in different shapes and sizes.
- these centering features are removable or incorporated in the polymer casing of the working-channel tool.
- keeping the working-channel tool centered relative to the working channel of the endoscopic device is potentially beneficial in order to track the center of the working channel of the endoscopic device and/or in order to avoid dynamic movement of the working-channel tool relative to metals in the endoscopic device, for increased EM accuracy as described herein.
- the working-channel tool includes additional sensing elements other than electromagnetic, for example inertial gyroscopes and/or accelerometers. In some embodiments, readings from such sensing elements are used to further reduce the noise and improve the accuracy of the 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 the camera sensor’s image with real world frame of reference.
- the FPC’s distal end further contains a camera. In some embodiments, the camera is spatiality manipulated, such as through folding, and positioned at the working-channel tool’s tip as part of the assembly process. In some embodiments other sensing elements may be added to the working-channel tool, for example temperature sensing elements.
- the working-channel tool contains combined sensing elements, such as magnetic and temperature sensors in a single IC chip.
- the magnetic and temperature sensor is a digital IC chip.
- the sensor is a DC magnetometer with optional combined temperature sensing capabilities.
- the provided working-channel tool includes a fiber-optics shape sensor to track the relative shape of the working-channel tool.
- position information is obtained by adding one or more EM sensors along the working-channel tool, for example, a single EM sensor at the working-channel tool’s tip, or by proximally anchoring the working-channel tool or the entire endoscopic device to a mechanical anchor reference point.
- the working-channel tool includes a plurality of electromagnetic sensor elements along its length and may be inserted into a camera-equipped endoscopic device, thus, for example, adding curve-tracking to the endoscopic device.
- the working-channel tool includes a plurality of electromagnetic sensor elements along its length, and optionally with a camera at the working-channel tool’s distal end, and, for example, the working-channel tool is configured be inserted independently, without an endoscopic device or another catheter into a body lumen, for example, for an examination of the body lumen with full-curve tracking and localization, and optionally with visual information.
- one or more working-channel tools are inserted using one or more sheaths.
- multiple working-channel tools are inserted to multiple body lumens, for example, to track the organ’s deformation in real-time, for example, for surgical procedures, such as laparoscopic procedures.
- the working-channel tool is configured to be guided in a lumen, for example a lumen that has multiple bifurcations, and/or may be configured for enabling selection between possible branches of the lumen, into which the working-channel tool should proceed.
- the working-channel tool includes a reinforcing layer and/or coating, for example to improve torqueability of the working-channel tool.
- a certain section at the tip of the working-channel tool may have a certain shape, for example, a curve, to facilitate directing and/or guiding of the tool.
- the working-channel tool is shaped as a J-catheter.
- the working-channel tool comprises pull-wires to provide steerability capability, and the probe can then be steered and navigated inside a lumen structure (with or without a carrier endoluminal device) by manipulating the working-channel tool’s pullwires, either manually (for example, using levers in the device’s handle) or robotically (for example, through a robotic mount interface).
- multiple working-channel tools are inserted into an organ, for example, to different airways and lobes inside a patient’s lung.
- the lung’s deformation and/or breathing can then be tracked in real-time based on the tracked curves of the multiple working-channel tools.
- the lung’s tracked deformation and/or breathing can be used during a laparoscopic procedure, to track the lung as it is being manipulated during a laparoscopic procedure.
- features such as blood vessels, airways or lesions of the organ can be displayed (for example, overlayed) on a laparoscopic camera during a laparoscopic procedure based on the deformation tracked organ, based on the curve-tracked working-channel tools inside that organ.
- one or more inserted workingchannel tools can then serve as a real-time tracked structured skeleton of an organ.
- one or more working-channel tools are inserted into an organ in an endoscopic or endovascular procedure.
- one or more working-channel tools are inserted into a patient’s lung to provide real-time deformable and/or breathing registration of that lung.
- an endoscopic device can then navigate in that lung based on the real-time deformable and/or breathing registration of the lung, with improved accuracy inside the deforming and/or breathing anatomy, based on the data received from the inserted working-channel tools.
- a camera is installed at the tip of the working-channel tool, aligned with the direction of the longitudinal axis and/or the progress axis of the working-channel tool.
- the FPC is bent at the distal end of the working-channel tool, orthogonally to the longitudinal axis of the working-channel tool, and the camera is then installed on the bent portion, so as to face towards the progress direction of the working-channel tool.
- the camera circuit is manufactured separately and then attached to the distal end of the FPC and/or connected electrically to the FPC, for example by soldering of electrical wires.
- the FPC is manufactured in a flat spiral form and then opened and straightened for assembling of the working-channel tool.
- the FPC is twisted about its longitudinal axis, for example in order to enable bending of the working-channel tool in all directions.
- the working-channel tool may be reinforced, for example, by additional material layers under components of the tool such as, for example, magnetic sensors, a camera, and/or LEDs, for example in order to protect the assembly/soldering of these components to the PCB, especially in case of twisting of the working-channel tool.
- the FPC is wrapped around a tube, to provide bending flexibility in all directions.
- the tube may be open to allow further insertion of smaller working channel tools through the working-channel tool.
- the tube is braided.
- the tube is inserted into a larger outer-diameter endoscope (endoscopic device) and serve as the endoscopic device’s working channel. In this case, the inserted workingchannel tool then serves as the endoscopic device’s working channel, while adding shape and/or position tracking capabilities to the endoscopic device.
- the working-channel tool is manufactured as a subassembly of the endoscopic device, and the endoscopic device and the embedded working-channel tool serve as a single device/system, where the working-channel tool is fixed inside the endoscopic device.
- the working-channel tool is fixed at the endoscopic device’s distal tip and/or at the proximal end of the endoscopic device.
- manufacturing of the working-channel tool as a subassembly simplifies the construction of a shape and/or position tracked endoscopic device, by building the shape and/or position of the tracked working-channel tool independently of the endoscopic device.
- the working-channel tool no longer serves as an insertable tool into a larger outer-diameter endoscopic device, but rather as a static subassembly of an endoscopic device, which provides both the working channel for that endoscopic device as well as adding shape and/or position tracking capabilities for that endoscopic device.
- the working-channel tool is assembled by using at least two FPCs, one holding electromagnetic sensor elements and carrying their signals back to a processor/controller, and the other carrying a camera and a LED, carrying the camera signals back to the processor/controller.
- the two FPCs are assembled (for example, glued) one on top of the other.
- the electromagnetic sensor elements, the camera and the LED are assembled on a single FPC, for example on different layers, which carry their signals to the processor/controller.
- the working-channel tool’s components are assembled on one side of a FPC, and then the FPC is twisted and/or bent as required.
- the working-channel tool includes a mount or fixture, made from rigid material such as polymer or metal, upon which the FPC is bent in an accurate manner, and, for example, the camera is then accurately positioned.
- the distal end of the working-channel tool is rounded to minimize tissue and working channel damage.
- tip rounding is implemented by adhesive, molded polymers or metallic material.
- the rounding at the distal end forms a dome.
- tip rounding is also configured for protecting the working-channel tool’s components.
- tip rounding is also configured to serve as camera fouling protection mechanism.
- the invention relates to methods for full curve-tracking of a working-channel tool for catheter and/or endoscopic interventional procedures.
- some methods use virtual auxiliary curve points between sensor elements of the working-channel tool, and/or include solving of the partial or entire curve of the working-channel tool with a unified energy function, based on mechanical constraints.
- such methods constitute a solution to insufficiently accurate curve estimations.
- inaccurate curve estimations may be resulted from noisy or faulty measurements by the sensors, from magnetic field distortions and/or from large distances between the sensors on the working-channel tool, that prevent sufficient curve interpolations.
- the noise levels of the tracked curve solution are decreased, which allow reducing the strength of the generated EM fields, as explained in more detail herein.
- the accuracy of the tracked curve solution is increased, even in cases where significant EM distortion is present.
- the curve estimation is based on individual calculations of location and orientation for each sensor element, it is difficult for the previous methods to incorporate constraints that relate to the entire curve of the working-channel tool.
- methods provided herein solve such issues, by solving the partial or entire curve and/or location of the working-channel tool based on measurements from multiple sensors, while taking into account various constraints that reduce the resulting curve inaccuracies, as explained in more detail herein.
- FIG. 1 showing a schematic representation of a system 100 for full curve-tracking of a working-channel tool 20, according to some embodiments of the invention.
- a working-channel tool 20 is configured to be used within a working-channel of a catheter and/or an endoscopic device in endoscopic interventional procedures.
- an exemplary system 100 comprises one or more of: a processor/controller 10, a transmitter 12 of electromagnetic fields and a curve sensor 16, which is installed on or inside the working-channel tool 20.
- the working-channel tool 20 is configured to be bent to various positions and shapes, which are sensed by the curve sensor 16.
- the curve sensor 16 is configured to detect and/or sense magnetic fields in multiple locations along the tool 20, for example magnetic fields produced by transmitter 12.
- the system 100 includes an endoscopic interventional device 11 (referred hereinafter just as endoscopic device 11) having a flexible shaft 15 (or elongated body), in which the working-channel tool 20 is inserted, for example via an opening 22.
- the curve sensor 16 includes an array of sensor elements 18, which sense electromagnetic field values, based on which a curve, i.e., a shape and/or a position of the working-channel tool 20 is algorithmically fitted by the processor/controller 10, relative to the transmitter 12.
- the curve sensor 16 includes a camera 19, positioned for example at a distal end of the curve sensor 16 and the working-channel tool 20.
- the processor/controller 10 includes a FPGA/ASIC chip, which samples the curve sensor 16 and/or the sensor elements 18 and/or the camera 19. Then, the processor/controller 10 is configured to transmit the sensor(s) and/or camera data digitally to a host computer (not shown), for example by Universal Serial Bus (USB). In some embodiments, processor/controller 10 is located inside a handle (or robotic mount interface) 21 of the workingchannel tool 20. In some embodiments, the processor/controller 10 is configured to calculate the curve/shape of the working-channel tool 20 and transmit it to a host computer (not shown).
- a host computer not shown
- USB Universal Serial Bus
- the working-channel tool 20 is configured to be inserted into a body lumen while the transmitter 12 generates magnetic fields.
- the flexible shaft 15 is positioned inside the body lumen, and the working-channel tool 20 is inserted into the flexible shaft 15.
- the curve sensor 16 is configured to detect and/or sense local magnetic fields along the working-channel tool 20.
- the processor/controller 10 is configured to calculate a curve/shape of the tool 20, and in some embodiments, a position of the tool 20 relative to the transmitter 12.
- the transmitter 12 is a flat transmitter which resides under the patient’s mattress or bed, or a standalone box which is located for example sideways to the patient.
- FIGs. 2A-2H are schematic illustrations of a tool assembly 200, included in a working-channel tool 20 (shown, for example, in Fig. 1), and configured for enabling full curve/shape tracking thereof, according to some embodiments of the invention.
- the tool assembly 200 comprises one or more of a Flexible Printed Circuit (FPC) 30, a plurality of discrete sensing elements 38 (18 in Figure 1), for example magnetic field sensing elements, which together define a sensor array, which is assembled on the FPC 30.
- FPC Flexible Printed Circuit
- the FPC 30 can be manufactured in many configurations, such as a straight elongated FPC or as a spiral FPC, which is unpacked and opened in an assembly process (as shown in US Provisional Application No. 63/415,696).
- the sensing elements 38/18 are installed on the FPC 30, for example in known intervals along the FPC 30.
- at least one sensing element from the plurality of sensing elements 38/18 is positioned in proximity to or upon a distal end 31 of the FPC 30.
- a camera 40 and a LED 41 are installed at the distal end 31, for example on a camera support 34 in the FPC 30.
- the camera support 34 is configured to be spatiality manipulated, as part of the assembly process, through folding in a fold 32, to position the camera 40 at the tip of the tool assembly 200 facing the progress direction of the working-channel tool 20. It will be appreciated that other forms of folds are possible under various embodiments of the present disclosure, for example so as to position the camera 40 at the tip of tool assembly 200 facing the progress direction “A” of the working-channel tool 20.
- more than one camera is installed.
- two cameras can be assembled on the FPC and wired through the FPC to a controller.
- a potential advantage of using two cameras is that it allows the generation of a stereoscopic image and/or wide-angle image, which may be beneficial in endoscopic procedures.
- multiple cameras can share a same clock signal.
- the workingchannel tool 20 does not comprise a camera at all, and is only curve/shape tracked. A potential advantage of not installing a camera is that it potentially reduces the manufacturing price and complexity of the manufacturing process.
- the working-channel tool 20 comprises an inner working channel (not shown).
- the working-channel tool 20 with the inner working channel is inserted into a larger working channel of an endoscopic device in order to enhance the endoscopic device with shape sensing/curve tracking capabilities, while still providing an inner working channel allowing for example flushing, suction and insertion of small-diameter tools, such as smaller biopsy and/or therapeutic instruments.
- the working-channel tool 20 with an inner working channel serves as a subassembly and is inserted into a larger outer-diameter endoscope (endoscopic device) in an assembly process.
- the working-channel tool can be fixed to the larger outerdiameter endoscopic device on its proximal and/or distal end.
- the workingchannel tool adds shape and/or position tracking of the larger outer-diameter endoscopic device and potentially simplifies the manufacturing and assembly process of the integrated shape and/or position tracking endoscopic device.
- the working-channel tool 20 comprises a mount 50, as shown for example in Figure 2D, onto which a distal portion of the FPC 30, optionally comprising the camera 40 and/or the LED 41 are positioned in a stable and desired manner.
- the mount 50 is designed and/or comprises a geometry that facilitates the bending of the FPC 30 in an accurate/desired manner, and, for example, allowing the accurate and stable positioning of the camera 40.
- the mount 50 comprises a platform 52, a wall 53, and a slot 51.
- the slot 51 is positioned between the platform 52 and the wall 53.
- the distal end 31 of the FPC 30 is inserted in the slot 51.
- the platform 52 and a side of the wall 53 define a niche at which a sensor element 38/18 is optionally installed, optionally without extending vertically past the wall 53.
- a side of the platform 52 is optionally configured to support the camera 40 and, for example, position the camera 40 perpendicularly to the progress direction “A” of the tool 20, i.e., so as to face the progress direction “A” of the working-channel tool 20.
- the FPC 30 is bent over a side of the platform 52 at the distal end of the working-channel tool 20, orthogonally to the longitudinal axis of the working-channel tool 20, and the camera 40 is installed on the bent portion, i.e., the camera support 34, so as to face towards the progress direction “A” of the working-channel tool 20.
- the camera support 34 is manufactured separately and is attached to the distal end 31 of the FPC 30 and/or connected electrically to the FPC 30, for example by soldering of electrical wires.
- the FPC 30 is twisted about its longitudinal axis.
- a potential advantage of twisting the FPC 30 is that it allows bending of the working-channel tool 20 in all directions, optionally without damaging the FPC 30.
- the FPC 30 is optionally reinforced, for example, by adhering additional material layers 33 under components such as, for example, the sensing elements 38/18, the camera 40, and/or the LED 41, for example in order to protect the attachment of these components to the FPC 30, especially in case of twisting of the working-channel tool 20.
- the reinforcing materials may include polymer, for example polyimide, which is commonly used in FPC manufacturing, or metallic, for example aluminum.
- the FPC 30 is wrapped around a core, mandrel, fiber, or other substrate.
- such core is either hollow or full.
- one potential advantage of using a core is to potentially simplify the assembly process and/or increase the bending radius of the FPC compared to twisting the FPC along its axis.
- the working-channel tool 20 is assembled by using at least two FPCs 30, one holding the sensing elements 38/18 and carrying their signals back to the processor/controller 10, and the other holding the camera 40 and the LED 41, carrying the camera signals back to the processor/controller 10, shown for example in Figure 1.
- the two FPCs are assembled one on top of the other.
- the sensing elements 38/18, the camera 40 and the LED 41 are assembled on a single multi-layer FPC (for example, 2- layer FPC, 4-layer FPC), which carry their signals to the processor/controller 10.
- the components of the working-channel tool 20 are assembled on one side of the FPC 30, and then the FPC 30 is twisted and/or bent as required.
- the FPC 30 is covered with a protective jacket 60, for example a polymer protective jacket and/or a dome.
- the jacket and/or dome provides biocompatibility, reduces risk of tissue damage, enhances mechanical properties, such as pushability, and/or protects the tool and its electric components from moisture or fluids.
- the jacket and/or dome provides a thin and/or unified cross-section, for example suitable for insertion through a working a channel of a catheter and/or an endoscope.
- the distal end of the working-channel tool 20 is covered by a dome or another rounded shape cover 61.
- the dome or another rounded shape cover 61 is configured to protect the working-channel tool’s components and/or to protect the body lumen and/or the working channel in which the working-channel tool 20 is inserted.
- the invention relates also to methods for full curve/shape-tracking of a working-channel tool for catheter and/or endoscopic interventional procedures.
- the sensing elements 38/18 are each configured to sense transmitted magnetic fields.
- the transmitter 12 shown in Fig. 1
- a shape/po sition of a working-channel tool 20 may be estimated by finding the position and/or orientation of each sensing element 38/18 individually, according to the sensed magnetic fields, and fitting a curve through all locations of the sensing elements 38/18 along the working-channel tool 20, for example, such as spline interpolation and/or extrapolation methods. As described herein, such methods may incorporate errors and may have low accuracy and/or increased jitter due to distorted EM fields, interference and sensor noise.
- the transmitter 12 may include N c coils to generate corresponding N c different magnetic fields with different frequencies, and the working-channel tool 20 may include N x sensing elements 38/18.
- the transmitter 12 may include other means to generate different magnetic fields, such as, for example, various formations of rotating magnets. The theoretical resulting magnetic field which is expected to be sensed at the location and orientation of the sensor i is
- R i is the three-dimensional orientation of the sensor element i with respect to the transmitter 12, and are the generated magnetic fields (transmitted at different phases or frequencies), as matrix columns, at the three-dimensional location of the sensor element i with respect to the transmitter 12.
- estimated six-dimensional values of location and orientation may be found by minimizing an energy function Ei, that depends on the difference between the resulting modeled magnetic field and the measured magnetic field by the sensor element i.
- Ei may have the form:
- the sensing elements 38/18 After the five/six-dimensional locations and orientations (five degrees of freedom in cases where the “roll” degree of freedom is not measured/solved, resulting in one less Euler angle) are found for the sensing elements 38/18, a curve may be fit to pass through all the sensing elements. However, such a curve may be insufficiently accurate, or the solution may be noisy. First, the found locations and orientations of the sensing elements may be erroneous, because of noisy or faulty measurements by the sensing elements and/or because of magnetic field distortions, for example distortions caused by metal in the flexible shaft 15, into which the working-channel tool 20 may be inserted, or by metals outside of the flexible shaft 15.
- the curve shapes between the sensing elements 38/18 may be interpolated arbitrarily and/or 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 known length of the working-channel tool 20 from manufacturing or from calibration of the working-channel tool 20, or the solved curve may not be smooth enough, although it is known that the working-channel tool 20 is generally smooth due to its mechanical properties or due to the mechanical properties of the endoscopic device.
- Such constraints that relate to the entire curve/shape are not considered in the above calculation, since the position and orientation values for each sensor are solved separately.
- some embodiments of the present disclosure provide a method for solving the entire curve and/or location of the working-channel tool 20, while considering various constraints that may reduce the resulting curve/shape inaccuracies.
- Fig. 3 is a schematic representation 70 of a tracked portion of the working-channel tool 20, according to some embodiments of the invention.
- the schematic representation 70 represents dynamic position and/or a curve of the tracked portion 72 of the working-channel tool 20.
- the schematic representation 70 shows sensor points 78, representing locations of sensing elements 18/38 along the working-channel tool 20, and/or located in known locations and/or intervals along the tracked portion of the working-channel tool 20. Additionally, between every two adjacent sensing elements 18/38, represented by points 78, there may be a pre-determined amount of virtual auxiliary curve points 76, at predetermined locations and/or intervals along the schematic representation 70. Curve points 76, along with sensor representation points 78, are used for calculation of a curve and/or position of the tracked portion of the working-channel tool 20.
- the shape and/or position of the working-channel tool 20 is tracked dynamically by fitting a curve that is the most energetically efficient, based on various constraints.
- the processor/controller 10 is configured for obtaining a plurality of pre-known points and/or intervals along a tracked portion of the working-channel tool 20, such as sensor points 78 and curve points 76 in known intervals.
- a pre-determined amount of virtual auxiliary curve points 76 between every two adjacent sensor elements, represented by points 78, there are a pre-determined amount of virtual auxiliary curve points 76, at predetermined locations and/or intervals along the tracked portion of the working-channel tool 20.
- the processor/controller 10 comprises instructions for allocating, for each sensor point 78, a local energy function dependent on the position and orientation of the working-channel tool 20 at this point, which incorporates relevant constraints for the point or for the type of point.
- the energy function for each sensor point 78 may incorporate constraints related to the sensed magnetic field at this point, similarly to Ei discussed herein.
- the processor/controller 10 comprises instructions for further allocating a weight for each local energy function, for example based on a certainty value, for example related to a certainty that a measurement is accurate. For example, a measurement value taken by a sensing element 18/38 may have a certain variation along time, according to which a certainty value may be determined.
- the processor/controller 10 comprises instructions for generating a resultant unified energy function for the full shape and/or position of the entire tracked portion of the working-channel tool 20.
- the unified energy function is constructed based on the allocated local energy functions of sensor point 78 and energy functions that relate to constraints related to mechanical properties of the working-channel tool 20, with respect to relative locations and orientation of curve points 76 and sensor points 78.
- each point 76 or 78 may have constraints related to its location and orientation relative to other points 76 and/or 78, which may be incorporated into energy functions.
- an energy function E for all N points 76 and 78 may have the form:
- E jk relates, for example, to mechanical constraints between two points.
- E jkl relates, for example, to mechanical constraints between three points, etc. denote all the degrees of freedom of sensor i.
- q and 0 are quaternions and Euler angles representing the orientation, respectively.
- Examples of mechanical constraints and related energy functions can be found, for example, in provisional patent application No. 63/536,467, titled “DISTORTION MODELING AND COMPENSATION IN A CURVE-TRACKED DETECTOR ARRAY”, incorporated herein by reference.
- the total energy of the curve may be constructed as
- At is the time difference between the current frame and the previous one and is the distance or length along the probe between sensors i and j, which is known accurately from the mechanical design of the probe and/or from a sterile calibration before the procedure.
- Ui is a 3 X 3 matrix per sensor which may, in general, depend on the specific sensor, its location with respect to the working channel and on the external endoscope (also referred to as endoscopic device).
- This set of matrices can be leamed/calculated during a preliminary calibration phase.
- the working-channel tool 20 may be held in place with respect to the transmitter with no distorter present, such that the “clean” theoretical magnetic field measured by each sensor is known. Then, the distorter (endoscope) is slowly introduced on top of the working-channel tool 20, and the distorted magnetic fields are measured.
- the relevant Ui matrices can then be computed directly (no optimization needed) by solving the equation:
- working-channel tool position tracking enables tracking and/or display of the working-channel tool’s position inside the endoscopic device’s working channel.
- the working-channel tool 20 can then be displayed as it’s introduced into the endoscopic device’s working channel, for example in 3D, since its position inside the endoscopic device’s working channel can be tracked by analyzing the dynamic calibration matrices Ui and comparing them, for example, to pre-calibrated calibration matrices with assigned positions, as described above.
- dynamic Ui calibration matrices can be learned once, for example in a factory calibration process, by inserting the working-channel tool into a larger outer-diameter endoscopic device of a certain configuration and then the learned calibration matrices can be used to compensate for the distortion caused by any endoscopic device.
- endoscopic devices of different configuration generally apply similar type of distortion upon the inserted working-channel tool. This is potentially beneficial as it allows for calibrating the working-channel tool in a factory process, but then use it with any type of larger outer-diameter endoscopic devices.
- the processor/controller 10 comprises instructions for calculating a full localized curve along the tracked portion of the working-channel tool 20, for example relative to the transmitter 12.
- the energy function E may be minimized, so as to minimize the errors with respect to the various constraints incorporated in the function.
- the resulting equations may be solved for all the locations and orientations of points 76 and 78 along the working-channel tool 20.
- the calculations described herein may be performed based on sensor points 78 with no in-between addition of virtual curve points, or with variable number of virtual curve points in-between different pairs of sensor points 78.
- compositions, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.
- a compound or “at least one compound” may include a plurality of compounds, including mixtures thereof.
- range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed 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.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
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Abstract
Un outil à canal opérateur à suivi de courbe comprend : un processeur/contrôleur ; un corps allongé comportant au moins un circuit imprimé souple (FPC) ; et un capteur de courbe installé sur le circuit imprimé souple, le capteur de courbe étant configuré pour détecter des positions et des orientations le long de l'outil, dans un cadre de référence déterminé, le capteur de courbe étant configuré pour communiquer avec le processeur/contrôleur par l'intermédiaire du circuit imprimé souple tandis qu'il est inséré dans une lumière corporelle, pour calculer une courbe de l'outil, localisée dans le cadre de référence déterminé, et le processeur/contrôleur étant configuré pour effectuer le suivi de courbe de l'outil à canal opérateur allongé, en recevant de multiples mesures de champ magnétique en provenance d'une pluralité d'emplacements le long du capteur de courbe.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202363537847P | 2023-09-12 | 2023-09-12 | |
| US63/537,847 | 2023-09-12 |
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| Publication Number | Publication Date |
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| WO2025057159A1 true WO2025057159A1 (fr) | 2025-03-20 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IL2024/050914 Pending WO2025057159A1 (fr) | 2023-09-12 | 2024-09-11 | Outil à canal opérateur à suivi de courbe |
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| WO (1) | WO2025057159A1 (fr) |
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| WO2001054567A1 (fr) * | 2000-01-27 | 2001-08-02 | Vision Sciences, Inc. | Ensemble endoscopique associe a un dispositif de localisation non visuelle |
| US20070238922A1 (en) * | 2004-10-26 | 2007-10-11 | Olympus Corporation | Endoscope shape detecting device |
| US20140121673A1 (en) * | 2012-10-25 | 2014-05-01 | Gyrus Acmi, Inc. D/B/A Olympus Surgical Technologies America | Impact lithotripsy tip |
| WO2019210227A1 (fr) * | 2018-04-26 | 2019-10-31 | Deka Products Limited Partnership | Endoscope à caméra rotative et procédés associés |
| US20220160218A1 (en) * | 2019-03-29 | 2022-05-26 | Coopersurgical, Inc. | Endoscopic devices and related methods |
| US20220175468A1 (en) * | 2019-09-09 | 2022-06-09 | Magnisity Ltd. | Magnetic flexible catheter tracking system and method using digital magnetometers |
| US20230072879A1 (en) * | 2020-06-03 | 2023-03-09 | Noah Medical Corporation | Systems and methods for hybrid imaging and navigation |
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2024
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001054567A1 (fr) * | 2000-01-27 | 2001-08-02 | Vision Sciences, Inc. | Ensemble endoscopique associe a un dispositif de localisation non visuelle |
| US20070238922A1 (en) * | 2004-10-26 | 2007-10-11 | Olympus Corporation | Endoscope shape detecting device |
| US20140121673A1 (en) * | 2012-10-25 | 2014-05-01 | Gyrus Acmi, Inc. D/B/A Olympus Surgical Technologies America | Impact lithotripsy tip |
| WO2019210227A1 (fr) * | 2018-04-26 | 2019-10-31 | Deka Products Limited Partnership | Endoscope à caméra rotative et procédés associés |
| US20220160218A1 (en) * | 2019-03-29 | 2022-05-26 | Coopersurgical, Inc. | Endoscopic devices and related methods |
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| US20230072879A1 (en) * | 2020-06-03 | 2023-03-09 | Noah Medical Corporation | Systems and methods for hybrid imaging and navigation |
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