Curved temperature and shape combined sensor

Abstract

The present invention relates, but is not limited to, to systems and methods for curved temperature-shape composite sensing, and more specifically to systems and methods for curved temperature-shape composite sensing in an interventional elongated device. One aspect of several embodiments of the present invention relates to monitoring the internal temperature of a patient before, during, and / or after the provision of a temperature-dependent treatment. In some embodiments, monitoring involves receiving multiple temperature measurement data from one or more elongated interventional devices and from multiple sensors arranged along the elongated interventional devices.

Description

[Technical Field]

[0001] Cross-reference of related applications This application claims priority to U.S. Provisional Patent Application No. 63 / 483,811, filed on 8 February 2023, which is incorporated herein by reference in its entirety.

[0002] Some embodiments of the present invention, without limitation, relate to systems and methods for curved temperature and shape combined sensing, and more specifically, to systems and methods for curved temperature and shape combined sensing in an interventional elongated device.

[0003] Ablation and cryoablation procedures can cause harm to patients due to the extreme temperatures at which these treatments are administered. Furthermore, applying the wrong temperature during such a process may render the treatment ineffective. Therefore, temperature monitoring can be beneficial to avoid excessive heat or cold. When ablation and cryoablation procedures are performed via endoscopes / catheters, monitoring the temperature at the treatment site and along the endoscope / catheter can be difficult. Applying extreme temperatures to remote locations via endoscopes / catheters can be detrimental to various components of the endoscope and / or catheter, and / or may cause distortion.

[0004] Certain electromagnetic (EM) tracking systems use a DC magnetometer to sense a low-frequency EM field for position and orientation tracking. One application of such tracking systems is EM position and shape sensing for medical devices such as endoscopes that are fully shape-tracked.

[0005] U.S. Patent No. 11712309B2, titled "MAGNETIC FLEXIBLE CATHETER TRACKING SYSTEM AND METHOD USING DIGITAL MAGNETOMETERS," discloses a system for magnetically tracking a flexible catheter device or other flexible elongated device, comprising: at least one generator, each configured to generate an alternating magnetic field, each generated having a determined source amplitude and frequency; a flexible tube and a device comprising a plurality of sensors positioned along the flexible tube and each configured to communicate sensing values ​​of local magnetic fields at least partially attributable to the generated magnetic field; and a host server configured to receive local magnetic field values ​​sensed from the corresponding sensors and to calculate the position of the flexible tube based on the magnetic field values ​​and the determined source amplitude and frequency, wherein the host server is optionally included in the control unit of the sensors. [Overview of the project]

[0006] The following are some non-limiting examples of embodiments of the present invention. The present invention includes embodiments that have fewer features than all of the features of the examples and embodiments, and also includes embodiments that combine features of multiple examples, even if not explicitly described below.

[0007] Example 1: A system for curved temperature and shape combined sensing, a) At least one elongated intervention device, b) comprising a processing / control module, The aforementioned elongated intervention device is i) A long, slender, flexible portion, ii) A curve sensor positioned along the elongated flexible portion and configured to sense the shape of the elongated flexible portion and the temperature along the elongated flexible portion, The aforementioned processing / control module is iii) Receiving one or more measured values ​​of the position and temperature along the curve of the elongated flexible portion from the curve sensor, iV) Instructions for calculating the shape of the elongated flexible portion along the curve and the continuous temperature curve based on the one or more measurements received, system.

[0008] Example 2 further includes displaying the calculated shape and the continuous temperature curve on a display, The system described in Example 1.

[0009] Example 3 The curved sensor comprises a plurality of sensor elements configured to measure one or more measurements of the position and temperature of the elongated flexible portion along the curve, The system described in Example 1 or 2.

[0010] Example 4: One or more of the multiple sensor elements are configured to communicate with the processing / control module via a mutual bus. The system described in one of Examples 1-3.

[0011] Example 5 The processing / control includes an instruction to calibrate the sensor element based on the measured value of the received temperature, The system described in one of Examples 1-4.

[0012] Example 6 The processing / control module further includes one or more calculated shape-temperature curves and instructions for calculating a volumetric temperature map of the organ based on the thermal diffusivity of the organ, The system described in one of Examples 1-5.

[0013] Example 7 The plurality of sensors include one or more of a temperature sensor, a Hall effect sensor, a magnetoresistive sensor, and a magnetic induction sensor. The system described in any one of Examples 1-6.

[0014] Example 8. The system further comprising the display, The system according to any one of Examples 1 to 7.

[0015] Example 9. The displaying includes displaying a continuous temperature curve as a sphere, The system according to any one of Examples 1 to 8.

[0016] Example 10. The displaying includes displaying a continuous temperature curve by coloring a shape tracking target device in 3D, The system according to any one of Examples 1 to 9.

[0017] Example 11. A method for curve temperature and shape composite sensing, a) Receiving one or more measurements of position and temperature along a curve of an elongated flexible portion from a curve sensor, b) Calculating the shape and continuous temperature curve along the curve of the elongated flexible portion based on the received one or more measurements, The method including the above steps. [[ID=2……]]

[0018] Example 12. The method further including displaying the calculated shape and the continuous temperature curve on a display,<000……]] The method according to Example 11.

[0019] Example 13. A system for curve temperature and shape composite sensing, a) At least one elongated intervention device, [……]]b) A processing / control module, and comprising, The elongated intervention device is, i) An elongated flexible portion, ii) A curve sensor arranged along the elongated flexible portion and configured to sense the shape of the elongated flexible portion and the temperature along the elongated flexible portion, having, The processing / control module is, iii) Receiving one or more measured values ​​of the position and temperature along the curve of the elongated flexible portion from the curve sensor, iV) Instructions for calculating the shape and temperature of the elongated flexible portion along the curve based on the one or more measurements received, system.

[0020] Example 14 further includes displaying the calculated shape and temperature on a display, The system described in Example 13.

[0021] Example 15 The curved sensor comprises a plurality of sensor elements configured to measure one or more measurements of the position and temperature of the elongated flexible portion along the curve, The system described in Example 13 or 14.

[0022] Example 16 One or more of the multiple sensor elements are configured to communicate with the processing / control module via a mutual bus. The system described in any one of Examples 13-15.

[0023] Example 17 The processing / control includes an instruction to calibrate the sensor element based on the measured value of the received temperature, The system described in any one of Examples 13-16.

[0024] Example 18 The processing / control module further includes one or more calculated shape-temperature curves and instructions for calculating a volume-temperature map of the organ based on the thermal diffusivity of the organ, The system described in any one of Examples 13-17.

[0025] Example 19 The plurality of sensors include one or more of a temperature sensor, a Hall effect sensor, a magnetoresistive sensor, and a magnetic induction sensor. The system described in any one of Examples 13-18.

[0026] Example 20 further comprising the aforementioned display, The system described in any one of Examples 13-19.

[0027] Example 21 The above display includes displaying a continuous temperature curve as a sphere. The system described in any one of Examples 13-20.

[0028] Example 22 The display includes displaying a continuous temperature curve by coloring the shape-tracking device in 3D. The system described in any one of Examples 13-21.

[0029] Example 23 A method for curved temperature and shape combined sensing, a) Receiving one or more measurements of position and temperature along the curve of an elongated flexible portion from a curve sensor, b) Calculating the shape of the elongated flexible portion along the curve based on the one or more measurements received, Methods that include...

[0030] Example 24 further includes displaying the calculated shape and temperature on a display, The method described in Example 23.

[0031] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which the invention pertains. Similar or equivalent methods and materials to those described herein may be used in the practice or testing of embodiments of the invention, but exemplary methods and / or materials are described below. In case of any conflict, the patent specification, including definitions, shall prevail. In addition, materials, methods, and examples are illustrative and not necessarily intended to be limiting.

[0032] Those skilled in the art will understand that some embodiments of the present invention can be embodied as systems, methods, or computer program products. Accordingly, some embodiments of the present invention may take the form of complete hardware embodiments, complete software embodiments (including firmware, resident software, microcode, etc.), or embodiments combining software and hardware aspects, all of which may be collectively referred to as “circuits,” “modules,” or “systems.” Furthermore, some embodiments of the present invention may take the form of computer program products embodied in one or more computer-readable media storing computer-readable program code. Implementation of some embodiments of the methods and / or systems of the present invention may include performing and / or completing selected tasks manually, automatically, or a combination of both. Furthermore, according to the actual instrumentation and apparatus of some embodiments of the methods and / or systems of the present invention, some selected tasks may be implemented using hardware, software, or firmware, and / or a combination thereof, such as an operating system.

[0033] For example, hardware for performing selected tasks according to some embodiments of the present invention may be implemented as a chip or circuit. Selected tasks according to some embodiments of the present invention may be implemented as software, as a set of software instructions executed by a computer using any suitable operating system. In an exemplary embodiment of the present invention, one or more tasks according to some exemplary embodiments of the methods and / or systems described herein are performed by a data processor, such as a computing platform for executing a set of instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data, and / or non-volatile storage for storing instructions and / or data, such as a magnetic hard disk and / or removable media. Optionally, network connectivity is also provided. A display device and / or user input device (e.g., a keyboard or mouse) is further provided as an option.

[0034] In some embodiments of the present invention, any combination of one or more computer-readable media may be used. The computer-readable media may be a computer-readable signal medium or a computer-readable storage medium. The computer-readable storage medium may be, for example, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or a suitable combination thereof. More specific examples of computer-readable storage media (non-exclusive list) include an electrical connection having one or more wires, a portable computer disk, a hard disk, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, portable compact disk read-only memory (CD-ROM), optical storage device, magnetic storage device, or a suitable combination thereof. In this specification, computer-readable storage medium means any tangible medium that may contain or store a program used by or in connection with an instruction execution system, instruction execution device, or instruction execution device.

[0035] A computer-readable signaling medium may include, for example, a propagated data signal incorporating computer-readable program code, either in the baseband or as part of a carrier wave. The signal propagated in this manner may take any of various forms, including electromagnetic, optical, or a suitable combination thereof. The computer-readable signaling medium may be any computer-readable medium, not a computer-readable storage medium, that can communicate, propagate, or transport programs used in connection with an instruction execution system, instruction execution unit, or instruction execution device.

[0036] Program code stored on a computer-readable medium and / or data used on a computer-readable medium may be transmitted using, but are not limited to, wireless, wired, fiber optic cables, RF, or any appropriate combination thereof.

[0037] Computer program code for performing operations for some embodiments of the present invention may be written in any combination of one or more programming languages, including object-oriented programming languages ​​such as Java, Smalltalk, and C++, and conventional procedural programming languages ​​such as the C programming language or similar programming languages. The program code may be executed entirely on the user's computer, partially on the user's computer, run as a standalone software package, partially run on the user's computer and partially on a remote computer, fully run on the user's computer, or fully run on a remote computer or server. In this case, the remote computer may be connected to the user's computer via any type of network, such as a local area network (LAN) or wide area network (WAN), or it may be connected to an external computer (for example, using the Internet via an Internet Service Provider (ISP)).

[0038] Some embodiments of the present invention may be described below with reference to flowcharts and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the present invention. It will be understood that each block and / or block diagram of a flowchart, and each combination of blocks in a flowchart and / or block diagram, can be realized by computer program instructions. These computer program instructions are provided to the processor of a general-purpose computer, a dedicated computer, or other programmable data processing device, and are executed via the processor of the computer or other programmable data processing device to generate a machine that produces means for performing the functions / operations shown in the flowcharts and / or block diagrams.

[0039] These computer program instructions may be stored in a computer-readable medium that can instruct a computer, other programmable data processing device, or other device to function in a particular way, thereby enabling the instructions stored in the computer-readable medium to produce a product containing instructions that implement specific functions / operations of flowcharts and / or block diagrams.

[0040] Computer program instructions may be loaded into a computer, other programmable data processing device, or other device, and a computer implementation process may be generated by causing a series of operational steps to be executed in the computer, other programmable device, or other device. This causes the instructions executed in the computer or other programmable device to provide processing for implementing specific functions / operations of flowcharts and / or block diagrams.

[0041] Some of the methods described herein are generally intended for computer use only and may not be feasible or practical to perform purely manually by a human expert. A human expert who wishes to perform similar tasks manually may be expected to use entirely different methods that are far more efficient than manually performing the steps of the methods described herein, for example, by leveraging their expertise and / or the pattern recognition capabilities of the human brain.

[0042] Several embodiments of the present invention are described herein with reference to the accompanying drawings for illustrative purposes only. Details shown here with particular detail in reference to the drawings are for illustrative purposes only and are intended to provide a detailed description of embodiments of the present invention. Similarly, by examining the description together with the drawings, it will be clear to those skilled in the art how embodiments of the present invention can be put into practice. [Brief explanation of the drawing]

[0043] [Figure 1] This is a schematic diagram of an exemplary system 100 for curved temperature-shape composite sensing according to some embodiments of the present invention. [Figure 2] This is a schematic diagram of an exemplary energy sphere 202 around the tip of a displayed representation 116 of an elongated flexible portion 106, according to some embodiments of the present invention. [Figure 3] This figure shows two exemplary displayed representations 302a / 302b of two respective tracked devices according to several embodiments of the present invention. [Figure 4] This is a flowchart illustrating an exemplary method according to several embodiments of the present invention. [Modes for carrying out the invention]

[0044] Some embodiments of the present invention, without limitation, relate to systems and methods for curved temperature and shape combined sensing, and more specifically, to systems and methods for curved temperature and shape combined sensing in an interventional elongated device.

[0045] overview One aspect of several embodiments of the present invention relates to monitoring a patient's internal body temperature before, during, and / or after the provision of a temperature-dependent treatment. In some embodiments, monitoring involves receiving multiple temperature measurement data from one or more elongated intervention devices and from multiple sensors positioned along the elongated intervention devices. In some embodiments, two or more elongated intervention devices are used simultaneously. In some embodiments, the temperature data is analyzed and utilized to generate one or more outputs. In some embodiments, exemplary outputs include one or more of the following: a temperature curve sensed along the elongated intervention device, a three-dimensional (3D) temperature map of one or more locations and / or organs, a four-dimensional (4D) temperature map of one or more locations and / or organs, and real-time temperature monitoring of one or more locations and / or organs while a dedicated treatment is being provided.

[0046] One aspect of several embodiments of the present invention relates to a system and method for curved temperature-shape composite sensing (including one or more of position and shape sensing, curve sensing, curve tracking, complete shape sensing, and any combination thereof), and to an intervention device having an elongated flexible portion and a curve sensor along the elongated portion. In some embodiments, the curve sensor is configured to sense at least the shape and temperature along the curve of the elongated portion. In some embodiments, the system comprises a processing / control module that includes instructions for performing one or more of the following: receiving position and temperature measurements along the curve of the elongated portion from the curve sensor; calculating the shape and continuous temperature curve along the curve of the elongated portion based on the received values; and displaying the calculated shape, temperature, and / or any other suitable output on a display.

[0047] In some embodiments, the curved sensor comprises multiple sensor elements that measure position and / or temperature measurements along the curve of an elongated portion, and one or more of the sensor elements are configured to communicate with a processing / control module via an inter-bus.

[0048] In some embodiments, the processing / control module is configured to calibrate the sensor element based on the received temperature reading.

[0049] In some embodiments, the processing / control module is configured to calculate a whole or partial volumetric temperature map of the organ based on the calculated temperature curve and the thermal diffusivity characteristics of the organ.

[0050] Before describing in detail at least one embodiment of the present invention, it should be understood that the applications of the present invention are not necessarily limited to the configuration details and arrangement of elements and / or methods shown in the following description and / or illustrated in the drawings and / or embodiments. Other embodiments of the present invention are possible and can be carried out or implemented by various means.

[0051] introduction In some embodiments, the present invention relates to a system for curved temperature and shape combined sensing, comprising a curved temperature and shape sensor. In some embodiments, the curved sensor may include a sensor array that measures both position and direction, and temperature, with discrete sensing elements. In some embodiments, the system comprises a processing module configured to algorithmically calculate the curve to provide smooth shape and temperature measurements along the entire curve of the sensor. In some embodiments, the curved sensor may include an electromagnetic (EM) shape sensor comprising multiple discrete sensors, such as digital electromagnetic sensors. In some embodiments, the processing module may receive magnetic field and sensor temperature measurements from various sensors, for example, via one or more interconnected digital buses, and multiple sensors along various positions on the curve may communicate with the processing module via a shared digital bus. In some embodiments, the calculated curved temperature may be displayed in real time, in various colors, along a three-dimensional representation of the tracked shape of the curved sensor. In some embodiments, the calculated curved temperature may be used in medical applications to assist in various treatments such as ablation, cryoablation, and cauterization.

[0052] Referring to Figure 1, a schematic diagram of an exemplary system 100 for curved temperature-shape composite sensing according to several embodiments of the present invention is shown. In some embodiments, the system comprises at least one processing / control module 102, an intervention device 104 having an elongated flexible portion 106, and a display 108. In some embodiments, the display 108 is configured to display a displayed representation 116 of the elongated portion 106, optionally colored (e.g., on a blue-red scale) according to temperature. In some embodiments, the elongated flexible portion 106 includes a curved sensor module 110 configured to sense at least the shape and temperature along the curve of the elongated flexible portion 106. In some embodiments, the curved sensor module 110 comprises a plurality of sensors 112. For example, the curved sensor module 110 comprises a digital EM shape sensing module including a plurality of sensors 112. In some embodiments, the curved sensor module 110 comprises a digital sensor array, for example, an array of digital magnetic sensors.

[0053] In some embodiments, during operation, the elongated flexible portion 106 is inserted into the patient's anatomical structure. In some embodiments, the processing / control module 102 is configured to receive position and temperature measurements along the curve of the elongated flexible portion 106 from the curve sensor module 110. In some embodiments, the processing / control module 102 is configured to calculate one or more of the shape and / or temperature changes along the elongated flexible portion 106 based on the received values, and to display the calculated shape, temperature and / or any other appropriate output on the display 108, and / or includes instructions for such calculation and display.

[0054] In some embodiments, the multiple sensors 112 include EM sensors configured to measure local magnetic fields. In some embodiments, the local magnetic field readings are then used by a processing / control module 102 to calculate the respective positions of each of the multiple sensors 112 and / or to calculate the position and shape of the entire or partial elongated flexible portion 106.

[0055] In some embodiments, multiple sensors 112 share a digital bus 114. In some embodiments, each sensor of the multiple sensors 112 is, for example, a digital magnetic sensor and comprises, for example, an integrated circuit (IC). In some embodiments, the digital bus 114 is an inter-integrated circuit bus (I2C), I3C, a serial peripheral interface (SPI), or other suitable digital bus. In some embodiments, one or more of the multiple sensors 112 are configured to communicate readings to a processing / control module 102 via the digital bus 114, and the processing / control module 102 is configured to use the readings to provide shape tracking in space of an elongated flexible portion 106 of full or partial length, and / or includes instructions for that purpose. In some embodiments, the curve sensor module 110 comprises a Hall effect sensor, a magnetoresistive sensor, a magnetic induction sensor, or any other sensor suitable for measuring a magnetic field. In some embodiments, as described above, the curve sensor module 110 is configured to sense temperature along an elongated flexible portion 106. In some embodiments, a plurality of sensors 112 include temperature sensors configured to sense local temperatures at their locations in space. In some embodiments, temperature readings are communicated to the processing / control module 102 via the same digital bus 114, either as independent readings or together with other readings, such as magnetic field readings. In some embodiments, the processing / control module 102 is configured to instruct the sensor module 110 to sample magnetic field values ​​and local temperatures, for example, periodically and / or alternately, and / or includes instructions for doing so. In some embodiments, all or some readings from the plurality of sensors 112 are communicated to the processing / control module 102 via the same digital bus 114.

[0056] In some embodiments, the processing / control module 102 is configured to dynamically calculate and / or track, for example in real time, the shape of the elongated flexible portion 106 along the curve of the elongated flexible portion 106 based, for example, magnetic readings sensed along the elongated flexible portion 106 and / or magnetic readings received via the digital bus 114, and / or includes instructions for such calculation and / or tracking. In some embodiments, the processing / control module 102 is configured to dynamically calculate and / or track, for example in real time, the temperature along the curve of the elongated flexible portion 106 and / or temperature changes based, for example, multiple sampled temperatures sensed along the elongated flexible portion 106 and / or received via the digital bus 114, and / or includes instructions for such calculation and / or tracking. In some embodiments, discrete temperatures at various locations of multiple sensors 112 may be displayed to the user for various applications. In some embodiments, a continuous temperature change along the elongated flexible portion 106 is calculated by the processing / control module 102 and / or displayed to the user for various applications.

[0057] Example of proofreading In some embodiments, the processing / control module 102 is configured to calibrate each of the multiple sensors 112 based on received temperature readings and / or includes commands for calibration. In some embodiments, since some magnetic field sensors are temperature sensitive, the electromagnetic (EM) tracking system uses EM calibration to convert the measured magnetic field to a 6-degrees-of-freedom (6-DOF) or 5-degrees-of-freedom (5-DOF) position of the sensor, or a 3-degrees-of-freedom (3-DOF, position only) position. In some embodiments, if the EM sensor is temperature sensitive, the calculated position and orientation of the EM sensor may be affected by temperature changes, potentially impacting EM tracking performance. In some embodiments, to overcome temperature-induced inaccuracies, a temperature-dependent EM calibration is provided and / or performed for each tracked sensor. In some embodiments, for example, multiple EM calibrations are performed at different room temperatures (e.g., in the range of about 10°C to about 40°C). In some embodiments, the processing / control module 102, for example, during operation, stores and / or applies various different calibrations for each of the multiple sensors 112, based on the temperature readings of the calibrated sensor and / or the temperature readings of the vicinity of the calibrated sensor.

[0058] For example, in a scenario where two calibrations are performed, namely a "low temperature" calibration at 10°C and a "high temperature" calibration at 40°C, during operation, interpolation between the two extreme calibrations can be applied based on the current temperature reading of the sensor.

[0059] In some embodiments, for example, to support a wider range of calibration temperatures, the temperature-dependent calibration process may include placing the curve sensor module 110 in an oven or any other device capable of controlling the temperature over a wide range (e.g., about -40°C to about 200°C). In some embodiments, the temperature is then changed within a predetermined range and the magnetic readings of the curve sensor module 110 are monitored. In some embodiments, this can be done, for example, while transmitting a known EM field at the location of the intervention device 104. In some embodiments, the curve sensor module 110 obtains EM field readings that may contain some errors due to the temperature change. In some embodiments, the processing / control module 102 is configured to correct for errors by discovering and / or storing EM sensing calibration parameter values ​​corresponding to the applied temperature, for example, based on a known difference between the EM field readings of the curve sensor module 110 and a known EM field, and / or includes instructions for such discovery and / or storage. In some embodiments, during operation, the processing / control module 102 is configured to correct the EM sensor readings using stored temperature-dependent EM sensing calibration parameter values ​​obtained in a temperature-dependent calibration process, and / or includes commands for such correction.

[0060] In some embodiments, the temperature-dependent variation of magnetic field readings can be modeled by fitting a temperature-dependent calibration model during the calibration process. In some embodiments, the error can be modeled as a linear, quadratic, cubic, or general polynomial function of temperature, or using any other suitable temperature-magnetic field error dependency. In some embodiments, after fitting the temperature-dependent calibration model (for example, using magnetic field readings for multiple temperatures as described above), the model can be used to correct magnetic readings in real time based on the temperature sensed during operation.

[0061] In some embodiments, some temperature sensors provide temperature readings that indicate the true sensor temperature but are not calibrated to a certain extent. For example, a temperature sensor may report the temperature with a constant error bias of 4°C. In some embodiments, the temperature sensor may not be linear and may require calibration over a range of operating temperatures. In some embodiments, the temperature sensing is calibrated in a manner similar to any of the calibration processes described above. In some embodiments, the temperature of the intervention device 104 is known in a temperature-controlled EM calibration process. However, the sensor may report uncalibrated temperature readings due to tolerances in the manufacturing process, for example. In some embodiments, the temperature reading of the sensor may be calibrated by using a known applicable temperature or by externally measuring the true temperature of the sensor or elongated device at the sensor's location using, for example, a thermocouple, thermal imaging, radiation thermometer, or any other suitable method. In some embodiments, a known temperature Θ i This applies to one or more sensors (or all sensors), but the sensor temperature readings may differ (be uncalibrated).

[0062]

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[0063] Exemplary operation of the sensor In some embodiments, the processing / control module 102 is configured to periodically, for example sequentially, request measurements from a plurality of sensors 112 via a shared digital bus 114 and / or read measurements from the plurality of sensors 112, and / or includes commands for such requests and / or reads. In some embodiments, communication between the processing / control module 102 and the plurality of sensors 112 occurs in periodic cycles, each cycle including a series of requests to the plurality of sensors 112 and a series of readings of the measurements requested from the plurality of sensors 112 in the previous cycle, or vice versa (i.e., a series of requests followed by a series of readings). In some embodiments, the time length of such a cycle is shorter than the full sampling period of the processing / control module 102, for example, it may be shorter than 1 millisecond, shorter than 1.5 milliseconds, or shorter than 2 milliseconds. In some embodiments, the processing / control module 102 is configured to sample the entire sensor array of the curve sensor module 110 at a rate of 1 kHz, or between 500 Hz and 5 kHz, and / or includes commands for such sampling.

[0064] Exemplary display In some embodiments, the processing / control module 102 is configured to display the temperature along a displayed curve of the elongated flexible portion 106 on a display 108 and / or includes instructions for such display. In some embodiments, the temperature is displayed quantitatively (e.g., by text) and / or using colors to represent various temperature values. In some embodiments, various positions along the displayed curve, e.g., positions corresponding to each of the positions of multiple sensors 112 along the elongated flexible portion 106, are marked with a color indicating the temperature measured by each sensor or the temperature measured in the vicinity of each sensor. In some embodiments, the color representing the temperature may vary along a scale from blue (e.g., indicating low temperature, e.g., 0°C) to red (e.g., indicating high temperature, e.g., 100°C), or along a scale from blue through green to red, or using other appropriate colormaps indicating the temperature measured along the elongated flexible portion 106. In some embodiments, the range of temperature colors displayed may vary based on the application. For example, the color may be adjusted to cover temperatures between -40°C and 30°C for cryoablation, or to cover temperatures between 30°C and 120°C for ablation.

[0065] In some embodiments, instead of displaying a set of discrete temperatures at the sensor locations, the entire curve temperature of the elongated flexible portion 106 is calculated and displayed to the user. For example, temperatures between sensor locations can be interpolated by fitting a smooth and / or continuous temperature change between discrete sensor-measured temperatures. In some embodiments, this can be done using linear interpolation, quadratic interpolation, cubic interpolation, cubic splines, piecewise cubic Hermite interpolating polynomials (PCHIP), polynomials of some degree, or other suitable curve fitting or interpolation methods between sensor locations. In some embodiments, the temperature change curve is fitted taking into account the dimensions and / or positions of multiple sensors 112 measured along the elongated device.

[0066] In some embodiments, as described above, the displayed representation 116 of the elongated flexible portion 106 may be colored according to temperature (e.g., on a blue-red scale). In some embodiments, the displayed representation of the elongated flexible portion 106 is displayed by a three-dimensional representation, for example, along with a change in color along the displayed representation, while the shape of the elongated flexible portion 106 is tracked in real time, and the change in color represents a change in temperature along the elongated flexible portion 106.

[0067] In some embodiments, the processing / control module 102 is configured to provide visual and / or audible instructions regarding the start and / or end of ablation, for example, by a display 108, LEDs, an audible alarm, and / or other appropriate indicators, and / or includes commands for such instructions. In some embodiments, the processing / control module 102 is configured to calculate and / or generate energy dissipation spheres (ablation or cryoablation) based, for example, on curve temperature tracking of one or more temperature-tracked devices, and / or includes commands for such calculation and / or generation. In some embodiments, the energy spheres can be displayed by the display 108, for example, to help a physician monitor and control the ablation process.

[0068] Referring to Figure 2, a schematic diagram of an exemplary energy sphere 202 around the tip of a displayed representation 116 of an elongated flexible portion 106 is shown according to several embodiments of the present invention. In some embodiments, the sphere 202 is optionally adorned with a color or spectrum of colors indicating a sensed temperature. In some embodiments, the size of the sphere 202 can be calculated, for example, from the sensed curved temperature along the elongated flexible portion 106. In some embodiments, the processing / control module 102 is configured to determine the radius of the sphere 202 by recognizing a length 204 along the representation 116, with the tip of the representation 116 as the center of the sphere 202, and / or includes instructions for such determination. The temperature of the sphere 202 is significantly different at the center, for example, significantly higher than the rest of the representation 116. In some embodiments, the recognized length is determined as the radius of the sphere 202. In some of the above calculations and representations, the sphere is centered on the tip of the device, since it is assumed that the tip of the device is the source of energy (e.g., an ablation catheter, or a cryoablation catheter, or cauterization). In this case, the tip of the device is a source of temperature (e.g., high or low temperature) that can spread spherically around the tip of the device. Therefore, the high / low temperature can be assumed to spread around the energy source as a symmetrical sphere centered on the tip of the device (where ablation, cryoablation, cauterization, or other energy source equipment may be located).

[0069] Example calculation In some embodiments, in an exemplary process for calculating a continuous temperature curve, the processing / control module 102 is configured to fit a temperature curve along an elongated flexible portion 106 through various temperature measurements at the locations of a plurality of sensors 112 and / or includes instructions for such fitting, such that the curve is continuous and smooth (has a continuous derivative).

[0070] In some embodiments, the processing / control module 102 is configured to minimize the curvature of the temperature curve along the elongated flexible portion 106, for example, by minimizing the sum of the second derivatives of the temperature curve along the elongated flexible portion 106, and / or includes instructions for such minimization.

[0071] In some embodiments, the processing / control module 102 is configured to divide the temperature curve into small segments, e.g., 1 mm segments, assign discrete temperature values ​​to each segment, and estimate the total curvature by, for example, summing the small elements between adjacent temperature values, and / or includes instructions for such estimation. In some embodiments, the total curvature is minimized by any suitable optimization method, e.g., gradient descent or Levenberg-Marckert method. In some embodiments, the optimal temperature values ​​at a corresponding set of locations along the elongated flexible portion 106 are determined to minimize the total curvature of the temperature curve by averaging adjacent temperature values ​​in an iterative process, which is optionally repeated until the optimal value is obtained.

[0072] In some embodiments, the temperature curve is estimated using a cubic spline, PCHIP (piecewise cubic Hermitian interpolation polynomial), a polynomial, or other appropriate analytical function or piecewise analytical function. In some embodiments, the processing / control module 102 is configured to optimize the estimation of the temperature curve by fitting the curve along an elongated flexible portion 106 via measured temperature values ​​at corresponding locations, and optionally to minimize the sum of the second derivative values ​​of the temperature curve and / or includes instructions for such optimization and minimization.

[0073] Exemplary applications of System 100 for curved temperature and shape combined sensing In some embodiments, as further illustrated in the following examples, the exemplary system 100 for curved temperature-shape combined sensing may be useful in certain medical procedures. In some embodiments, the exemplary system 100 for curved temperature-shape combined sensing is used to track temperature along a treatment device (e.g., an ablation or cryoablation catheter or cautery) or a procedure delivery device (e.g., an endoscope having a working channel into which a specific treatment instrument can be introduced), or temperature in a local 3D volume near an endoscopic target (e.g., a suspected lesion). In some embodiments, the exemplary system 100 for curved temperature-shape combined sensing is used in a combination of temperature and shape tracking, where the shape tracking capability of the device is used to guide the device to a specific location within the patient's organs. In some embodiments, the exemplary system 100 for curved temperature-shape combined sensing is used in navigation bronchoscopy, for example, to guide the endoscope to a specific location inside the lung using a shape-tracked endoscope. In some embodiments, the full temperature tracking of the exemplary system 100 for curved temperature-shape combined sensing is used to assist in localized treatment via a tracked endoscope. In some embodiments, the exemplary system 100 for curved temperature-shape combined sensing is used in localized ablation to track the heat dissipation of the ablation catheter as it performs ablation along the length of the endoscope, from the distal end to the proximal end. In some embodiments, the temperature information generated by the exemplary system 100 for curved temperature-shape combined sensing is used to understand the distribution of ablation energy during treatment in order to monitor and control the ablation process. Similarly, in some embodiments, the exemplary system 100 for curved temperature-shape combined sensing is used in localized cryoablation treatment, and tracking the temperature along the endoscope is used to understand the distribution of cryogenic energy during treatment.In some embodiments, the potential advantages of utilizing the exemplary system 100 for curved temperature-shape combined sensing are that it can help reduce treatment time, prevent unnecessary ablation of healthy tissue, localize treatment to specific points of interest (e.g., lesions), time energy delivery, verify that treatment has been performed efficiently (by sensing sufficient heat over a sufficient period of time), and generally, according to some embodiments of this disclosure, help monitor and control localized energy therapy. In some embodiments, it is assumed that the energy of a treatment device (e.g., an ablation catheter, cryoablation, or electrocautery) spreads spherically symmetrically. In this case, by measuring the spread (temperature distribution) of energy along the curve of the exemplary system 100 for curved temperature-shape combined sensing, the entire sphere can be reconstructed by assuming that the entire sphere spreads symmetrically around the tip of the device and has a temperature distribution measured along the curve of the device. In other embodiments, it may be assumed that the energy spreads asymmetrically according to a model derived based on tissue density measured in a registered CT scan, for example, as will be described in more detail below.

[0074] In some embodiments, energy and / or temperature distribution models are used to predict temperatures at locations other than the shape-tracked device where the curve temperature is measured along the device's shape. For example, in a spherically symmetric energy distribution model, it can be assumed that the energy source is located at the tracked tip of the device. For example, in the case of an apparatus for ablation or cryoablation, the energy source may be introduced through the device's working channel and can be assumed to extend several millimeters from the location of the device's tip. In some embodiments, it can be assumed that such an energy source generates a spherically symmetric spread of energy during operation. In some embodiments, under the assumptions of such an energy distribution model, by measuring the temperature along the device's curve, a sphere of temperature centered on the location of the energy source (near the tracked tip of the device) can be reconstructed, and the entire energy sphere can be reconstructed using a one-dimensional measured temperature curve along the device. In some embodiments, a potential advantage of this simplified energy distribution model is that it can be useful in the case of ablation and cryoablation where it is roughly estimated that energy is distributed as a symmetric sphere, and where the one-dimensional measured temperature along the device's curve is sufficient to estimate the spread of that sphere.

[0075] In some embodiments, the energy source does not necessarily have to be assumed to be located at the tracked tip of the device, or at a fixed position, or at a relative distance to the tip of the device. In some embodiments, for example, an ablation or cryoablation or other procedure instrument may be introduced into the working channel of the tracked device and extend a further variable or unknown distance from the tracked tip of the tracked device. In some embodiments, the tracked device may include an implanted imaging sensor (as in the case of a tracked endoscopic device). In this case, the camera of the device can be used to sense the instrument in the image and estimate the distance from the tip of the device by analyzing the image (for example, the distance can be estimated by sensing the tip position and size of the instrument in the image, assuming that the imaging sensor of the tracked device is at a known position relative to the tracked tip of the device). In some embodiments, the position of the tip of the instrument is sensed using an EM method. For example, in some embodiments, multiple EM sensors along the device being tracked are used both to track the shape and position of the device and to track the position of a tool (instrument) inserted into the working channel of the device, and in particular to track the position of the tool by sensing the EM strain caused by the introduced instrument, especially at the tip of the instrument.

[0076] In some embodiments, by using multiple shape and temperature tracking target devices, the reconstructed 3D / 4D temperature map can be enhanced. For example, in the case of a spherically symmetric energy distribution model, by combining the curve temperature measurements from multiple devices, the reconstructed energy sphere can be calculated with higher accuracy because each temperature curve provides additional measurements for the energy / temperature model, and the energy distribution model (e.g., the spherically symmetric model) can combine all available measurements to find the best fit for the model's measurements (e.g., the best fit in the least squares method). In some embodiments, this may reduce the risk of overfitting of the model.

[0077] In some embodiments, one or more shape-tracked temperature curves can be used to reconstruct a simplified spherically symmetric energy distribution 3D temperature map. Let the k-th position of the device be r k (σ) in 3D EM transmitter coordinates, let the length parameter starting from the tip of the device be σ, let the position of the tip of the device in 3D be r k (0), let the proximal position of the device be r k (L), and let the tracked length of the device be L in millimeters. Assuming that the ablation catheter functions as an energy source and is placed at the first position of the tip of the device, then r src = r1(0). Let the temperature of the device at the length parameter σ be Θ k (σ), which is due to the temperature measurement at the 3D position r k (σ). Assuming a spherically symmetric energy distribution, it can be assumed that for any r, Θ(r) is uniform at a fixed distance D from the energy source r src , that is,

Equation

number

[0078]

number

number

[0079] In some embodiments, r src It is not necessarily assumed that the device is located at the exact same position as the tracked tip of the device. For example, it may be assumed to be located a few millimeters ahead of the tracked tip of the device (e.g., forward along the tracking direction of the device's tip).

[0080] In some embodiments, a more general energy distribution model may be assumed. For example, a parameterized model has an N-dimensional parameter vector x, and under the assumption of model parameters x, the temperature at a 3D position r in space can be represented by Θ(x,r). As described above, Θ k By providing a curved temperature denoted as (σ), the model parameter x can be retrieved such that the model satisfies the measurements. Θ(x,r k (σ) = Θ k (σ)

[0081] The search for x that best satisfies the measurement can be carried out using linear or nonlinear local or global optimization methods such as gradient descent, Levenberg-Marquardt method, or any other arbitrary optimization method. By finding the model parameter x, the energy (temperature) can then be predicted by calculating Θ(x,r) for any r (not just the position along the shape-tracked device). In some embodiments, the energy distribution model can be made 4D by adding time t to the measurement equation above, in the energy distribution model Θ(x,r,t). Θ(x,r k t (σ),t)=Θ k t (σ)

[0082] Here, r k t (σ) indicates the k-th shape-tracked position of the device along the length parameter σ at time t, and Θ k t (σ) represents the temperature measurement of the k-th device along the length parameter σ at time t.

[0083] In some embodiments, the general energy distribution model may take into account tissue information that can be segmented from preoperative CT scans, as will be described in more detail below.

[0084] In such cases, by combining position / shape tracking with temperature curve sensing, it is possible to reconstruct a local 3D / 4D temperature map using the temperature curve according to a certain energy distribution model, which is particularly useful for measuring the energy distribution of ablation, cryoablation, or other treatment devices.

[0085] In some embodiments, an exemplary system 100 for curved temperature-shape composite sensing is used for temperature tracking to sense the start and stop events of a localized ablation process. For example, the processing / control module 102 is configured to sense a rapid rise or fall in temperature at the tip of the endoscope, which may be caused by the start or end of the ablation process, and / or includes commands for such sensing.

[0086] Illustrative use of multiple devices In some embodiments, multiple tracking devices are introduced simultaneously into the patient's organs. For example, two or more shape-temperature combined tracking endoscopes, catheters, or guidewires are inserted into the patient's bronchi or other types of tubular lumen. In some embodiments, each device is configured to track shape and temperature. In some embodiments, shape tracking is used to guide each device to a specific location within the patient's organs, e.g., the lungs. In some embodiments, full-curve temperature tracking is used to track temperature along specific known curve locations within the patient's anatomical structure. In some embodiments, this provides tracking of the patient's temperature along specific known curves within the patient's anatomical structure. In some embodiments, the 3D location of one or more tracked curves is known in the anatomical structure by supporting shape and / or location tracking and navigation algorithms (e.g., algorithms for registering and deforming anatomical structures). In some embodiments, further, in the EM shape tracking setup, the location of each device being tracked simultaneously is identified in the same coordinate system of a shared transmitter, so that the curves being tracked simultaneously are accurate in position and orientation to each other and all accurate to the same transmitter. In some embodiments, temperature tracking provides real-time tracking of organ temperature along an anatomical curve at a known location. In some embodiments, a temperature map of an anatomical structure or a partial anatomical structure is reconstructed by combining information from multiple temperatures tracked along a known curve in the anatomical structure.

[0087] Referring to Figure 3, two exemplary displayed representations 302a / 302b of two tracked devices according to several embodiments of the present invention are shown. In Figure 3, the tip of the displayed representation 302a is shown to be on the target 304. In some embodiments, a calculated energy sphere 306 is displayed around the tip of the representation 302a and the target 304. In some embodiments, a locally reconstructed three-dimensional or four-dimensional (3D / 4D) temperature map 308 is displayed around the target 304. In some embodiments, the map 308 is calculated and generated by a processing / control module 102, as described in more detail herein. In some embodiments, the sphere 306 is calculated according to the map 308 by fitting the sphere to a range of the map 308 that has a significantly different temperature compared to the rest of the map 308, for example, a significantly higher temperature. In other embodiments, the temperature map is displayed to the user in 3D using, for example, a ray tracing method through the 3D temperature map, and each position on the 3D temperature map is assigned a color via a color map indicating the temperature of that position.

[0088] In some embodiments, mathematical and / or physical models of organ temperature in three dimensions are used, as will be further described here.

[0089] In navigation procedures, it is common for preoperative CT scans of the patient's anatomical structure to be available. For example, in navigation bronchoscopy, the patient's preoperative CT scan is used during the navigation procedure to guide the physician through the patient's lungs based on the preoperative CT scan (used as a map).

[0090] In some embodiments, the processing / control module 102 is configured to use a CT scan to construct a map of anatomical structures having a corresponding three-dimensional coordinate system, and / or includes instructions for doing so. In some embodiments, the processing / control module 102 is configured to localize various tracked temperature curves within the patient's anatomical structures in the three-dimensional coordinate system of the CT scan, and / or includes instructions for doing so. In some embodiments, various temperature curves from various tracked devices are provided to the processing / control module 102. In some embodiments, the processing / control module 102 is configured to construct a three-dimensional (or four-dimensional, i.e., time-dependent) temperature map of an organ by treating various temperature curves as boundary conditions (which can also be thought of as constraints or submeasurements) of a three-dimensional temperature map model function, and / or includes instructions for such construction. For example, in a thermal steady state, the three-dimensional temperature function may be assumed to be harmonically consistent within a region (i.e., its Laplacian may be assumed to be zero), or harmonically consistent within a subregion. In some embodiments, the temperature at a particular location may be determined by finding a temperature at that location that matches the boundary temperature curve while minimizing a model function within the region of the constructed 3D map.

[0091] In some embodiments, the 3D temperature map model function is generated using, for example, a 3D polynomial function, thin-plate splines (TPS), a dense grid representation, or any other suitable method.

[0092] In some embodiments, the system is configured to determine the temperature in a three-dimensional volume portion within a patient's organ and / or includes instructions for such determination, which may be advantageous for monitoring and controlling local energy delivery procedures or the patient's condition by, for example, reconstructing a temperature map from curve measurements.

[0093] In some embodiments, the processing / control module 102 is configured to incorporate changes in temperature across the entire organ volume over time into the temperature mapping model and / or includes instructions for doing so, thereby enabling a more accurate modeling of the temperature map.

[0094] In some embodiments, the model includes the thermal diffusivity of different tissues within a patient's organs. For example, when ablating a lesion inside the lung, different lung tissues can be modeled with different diffusivity values, for example, calculated from the patient's CT scan. In some embodiments, different organ tissues are segmented and classified by an image processing method, for example, an AI segmentation neural network. For example, the processing / control module 102 is configured to sense and / or classify airways, blood vessels, lesions, bone, pleura, diaphragm, heart, and other types of tissue, and / or includes instructions for doing so. In some embodiments, this may be useful in assigning thermal diffusivity coefficients to any type of tissue within an organ such as the lungs.

[0095] In some embodiments, a spatial and temporal temperature map is modeled and updated according to measurements received from, for example, multiple sensors 112. In some embodiments, multiple shape- and temperature-tracked devices are inserted near a target lesion to be treated. For example, an endoscope may be inserted into the center of the target, and a second catheter may be inserted into a location selected (by the system or physician) near the target. In some embodiments, a navigation system assists in guiding and navigating the devices to specific selected locations, for example, by relying on the tracked shape of the devices. In some embodiments, once the devices are in place, an ablation tool is inserted into the center of the target through the working channel of the endoscope. In some embodiments, the shape and temperature of both devices are tracked. In some embodiments, once the ablation tool begins ablation of the tissue, the system monitors the curve temperatures of two (or more) tracked devices, the curve temperature of the endoscope, which is a primary device with its distal end at the target, and the curve temperatures of secondary devices (or more devices) near the target. In some embodiments, the system is configured to reconstruct a local three-dimensional or four-dimensional (3D / 4D) temperature map in the vicinity of the ablated object, as described above, and / or includes instructions for doing so. In some embodiments, the tracked temperature curve in the vicinity of the target allows the system to reconstruct an accurate 3D / 4D temperature map in the region of the ablated target, which is time-updated according to the temperature map model, as described above. In some embodiments, the reconstructed 3D / 4D temperature map is used to monitor and control the localized energy processing process to a high degree.For example, a reconstructed 3D / 4D temperature map can be used to monitor the diffusion of heat from a heat source (the center of the lesion, or the location where ablation, cryoablation, or other treatment instruments are intended, or where their location is determined by tracking) to prevent ablation of healthy tissue near the target, or to maximize the effectiveness and efficiency of treatment on the lesioned tissue. In some embodiments, the reconstructed 3D / 4D temperature map can also be used to prevent damage to other important anatomical features near the target, such as blood vessels, the heart, pleura, diaphragm, or other anatomical features that need protection.

[0096] In some embodiments, a potential benefit of the reconstructed 3D / 4D temperature map is that it can be useful for monitoring and controlling localized treatments.

[0097] In some embodiments, by combining knowledge of the precise location within an anatomical structure with temperature tracked in real time, the system can provide accurate and effective local treatment with minimal collateral damage.

[0098] Estimative method Referring to Figure 4, flowcharts of exemplary methods according to several embodiments of the present invention are shown. In some embodiments, for example, the method involves one or more of the following operations: 1. Receiving position and temperature measurements along the curve from the curve sensor (402), 2. Calculating the shape along the curve and the continuous temperature curve (404), 3. Display the calculated shape and temperature (406), Includes.

[0099] All of the above operations are described and disclosed in the paragraphs above.

[0100] Throughout this disclosure, digital sensors are used, but it should be understood that some of the methods described are applicable by using any elongated device capable of measuring multiple temperatures along a length, such as a resistance temperature sensor (which does not necessarily have to be digital). These sensors can be combined with, for example, fiber optic shape sensors, which do not necessarily have to be digital. Other alternative configurations may be curved resistance or curved inductance sensors that measure curved temperature along a length, or sensors that measure both temperature and shape using the magnetoresistance, magnetoinductance, thermal resistance, or thermal inductance properties of the sensor.

[0101] Furthermore, it should be understood that the local 3D / 4D temperature maps described above can be reconstructed from shape and temperature measurements obtained by appropriate methods, such as using an optical fiber shape sensor combined with any type of temperature sensor, without necessarily requiring a digital EM shape and temperature sensor.

[0102] Throughout this disclosure, magnetic and temperature sensors are used, but it should be understood that the digital EM shape sensor may include magnetic field sensors, IMU sensors (accelerometers and / or gyroscopes), temperature sensors, pressure / strain sensors, or any other suitable type of digital sensor that can be placed on the digital bus. Information from all sensors may be used to reconstruct 3D / 4D local temperature maps for controlling and monitoring localized treatment.

[0103] As used herein, "about" and "approximately" mean "within ±10%" with respect to quantity or value.

[0104] The verbs "comprises," "comprising," "includes," "including," "has," and "having," along with their conjugations, all mean "including but not limited to."

[0105] The term "consisting of" means "to include or be limited to."

[0106] The phrase "consisting essentially of" means that the composition, method, or structure may include additional components, steps, and / or parts, provided that these additional components, steps, and / or parts do not substantially alter the basic and novel properties of the composition, method, or structure described in the claim.

[0107] In this specification, the singular pronouns "a," "an," and "the" also refer to plural nouns unless the context clearly indicates otherwise. For example, "a compound" or "at least one compound" may include multiple compounds, and may also include mixtures thereof.

[0108] Throughout this application, various embodiments of the invention may be presented in range form. It should be understood that the use of range form is merely for convenience and brevity, and not as a limitation that restricts the flexibility of the scope of the invention. Therefore, a range description should be considered to specifically disclose all possible sub-ranges and the individual numerical values ​​within those ranges. For example, a range description such as 1-6 specifically discloses not only sub-ranges such as 1-3, 1-4, 1-5, 2-4, 2-6, 3-6, but also the individual numerical values ​​within that range, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the size of the range.

[0109] In this specification, whenever a numerical range is indicated (for example, any pair of numbers linked by “10 to 15,” “10 to 15,” or any other similar range indication), it means that any number (fractions or integers) within the indicated range limit, including the range limit, unless the context otherwise explicitly indicates otherwise. The expression “range between” an indicated first number and an indicated second number, and the expressions “range from” an indicated first number to an indicated second number, “range up to,” “range extending to,” or “range including” (or any other similar range indication terms) are used interchangeably in this specification and mean that the indicated first and second numbers, as well as all fractions and integers between them, are included.

[0110] Unless otherwise indicated, the numbers used herein and any range of numbers derived therefrom are approximations within reasonable measurement and rounding tolerances, as will be understood by those skilled in the art.

[0111] It should be understood that certain features of the present invention described in relation to separate embodiments for clarity may also be provided in combination in one embodiment. Conversely, several features of the present invention described in relation to one embodiment for brevity may also be provided separately, in any preferred partial combination, or in any other appropriate described embodiment. Certain features described in relation to various embodiments should not be considered essential requirements of an embodiment unless the particular embodiment is inoperable without that element.

[0112] Although the present invention has been described in relation to its specific embodiments, numerous alternatives, modifications, and variations will be apparent to those skilled in the art. Therefore, all such alternatives, modifications, and variations are intended to be included within the spirit and broader scope of the appended claims.

[0113] The applicant intends that all publications, patents, and patent applications referenced herein be incorporated herein by reference in whole to the same extent that each individual publication, patent, and patent application is incorporated herein by specific and individual reference. In addition, no citation or specification of any reference in this application should be construed as an acceptance that such reference can be used as prior art of the present invention. Nor should the titles of each section be construed as limitations to the extent in which they are used. Furthermore, if there are any priority documents for this application, they should be incorporated herein by reference in whole.

Claims

1. A system for curved temperature and shape combined sensing, a) At least one elongated intervention device, b) comprising a processing / control module, The aforementioned elongated intervention device is i) A long, slender, flexible portion, ii) A curve sensor positioned along the elongated flexible portion and configured to sense the shape of the elongated flexible portion and the temperature along the elongated flexible portion, The aforementioned processing / control module is iii) Receiving one or more measured values ​​of position and temperature along the curve of the elongated flexible portion from the curve sensor, iv) Instructions for calculating the shape and temperature of the elongated flexible portion along the curve based on the one or more measurements received, system.

2. The further includes displaying the calculated shape and temperature on a display. The system according to claim 1.

3. The curved sensor comprises a plurality of sensor elements configured to measure one or more measurements of the position and temperature of the elongated flexible portion along the curve. The system according to claim 1.

4. One or more of the aforementioned sensor elements are configured to communicate with the processing / control module via a mutual bus. The system according to claim 3.

5. The processing / control module includes an instruction to calibrate the sensor element based on the measured value of the received temperature, The system according to claim 1.

6. The processing / control module further includes one or more calculated shape-temperature curves and instructions for calculating a volumetric temperature map of the organ based on the thermal diffusivity of the organ. The system according to claim 1.

7. The aforementioned plurality of sensor elements include one or more of a temperature sensor, a Hall effect sensor, a magnetoresistive sensor, and a magnetic induction sensor. The system according to claim 3.

8. The display further comprises the aforementioned display, The system according to claim 1.

9. The aforementioned display includes displaying the continuous temperature curve as a sphere. The system according to claim 2.

10. The aforementioned display includes displaying a continuous temperature curve by coloring the shape-tracking device in 3D. The system according to claim 2.

11. A method for curve temperature and shape combined sensing, a) Receiving one or more measurements of position and temperature along the curve of an elongated flexible portion from a curve sensor, b) Calculating the shape and temperature of the elongated flexible portion along the curve based on the one or more measurements received, Methods that include...

12. The further includes displaying the calculated shape and temperature on a display. The method according to claim 11.

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