Systems for optical analysis and lesion prediction using ablation catheters

Abstract

To provide systems and methods for performing optical signal analysis and lesion predictions in ablations.SOLUTION: A computing device includes a memory and a processor. The processor is configured to receive optical measurement data of a portion of a tissue from a catheter. The processor identifies one or more optical properties of the portion of the tissue by analyzing the optical measurement data, and determines a time of denaturation of the portion of the tissue on the basis of the one or more optical properties. A model is created to represent a correlation between lesion depths and ablation times using the time of denaturation, the one or more optical properties, and a predetermined period of time. A predicted lesion depth for a predetermined ablation time is generated using the model.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a subsidiary of European Patent Application No. 20382014.7, filed on 13 January 2020. No. 6,313,935, filed on Dec. 13, 2003, the disclosure of which is hereby incorporated by reference in its entirety.

[0002] The present disclosure relates to a method for performing tissue ablation. , to perform optical signal analysis, and to predict lesion depth for ablation. Components, systems and methods for using catheter and console devices for , and methods. [Background technology]

[0003] Ablation is a medical technique for producing tissue necrosis. It is used to treat a variety of pathologies, including cancer, Barrett's esophagus, or cardiac arrhythmias, among others. For radio frequency (RF) ablation, The application of alternating current with an oscillation frequency above 100 kHz delivers heat via the Joule effect. Avoid stimulating excitable tissues while regulating the temperature of the tissue. It produces denaturation of biological molecules including collagen, myosin, or elastin. Traditionally, RF ablation involves placing external electrodes on the patient's body and The tip of the catheter is placed in contact with the tissue to be treated in the body. This is done by applying a flow potential.

[0004] In some cases, cryogenic cooling for cryoablation, radio frequency, Various energy sources, including microwave, laser, and photoacoustic / ultrasound, can be used for ablation in some cases, cryoablation can use extremely low temperatures to ablate tissue, while electroporation ablation can use pulsed electric fields to ablate specific tissue for the treatment of atrial fibrillation.

[0005] The ablation effect depends on many factors, including the applied power, the quality of electrical contact, local tissue characteristics, the presence of blood flow near the tissue surface, and the effect of irrigation. Due to the variability of these parameters, it may be difficult to obtain consistent results, and it may also be difficult to understand the ablation effect in tissue using current systems and methods for ablation.

[0006] Thus, such systems and methods are limited due to difficulties and challenges in evaluating the results of ablation in tissue, such as identifying lesions formed in the tissue and determining various characteristics of the lesions through a catheter.

[0007] SUMMARY OF THE INVENTION Therefore, there may be a need for new methods, devices, and systems for performing tissue ablation, tracking scar formation (e.g., lesion formation and progression in tissue), and predicting lesion depth.

[0008] ​​In the embodiments presented in this specification, an optical system, console or processing de vice, and a catheter are capable of monitoring changes in optical properties over time and prov iding optical measurements to understand optical properties (such as tissue complex refract ion, polarization, and / or phase retardation, etc.) in order to predict the depth of lesions in t issue.

[0009] In one embodiment, an exemplary method is described. The method includes the step of per forming ablation by applying energy from the catheter to a portion of tissue over a predet ermined period of time, wherein the catheter includes a proximal section, a distal section including a plurality of optical ports, and a sheath connected between the proximal secti on and the distal section. The method further includes the steps of obtaining optical meas urement data from a portion of tissue using at least one optical port in the catheter, an d identifying one or more optical properties of a portion of tissue by analyzing the opti cal measurement data using a processing device connected to the catheter, and determin ing the time of denaturation of a portion of tissue based on one or more optical propert ies of the portion of tissue.

[0010] In another embodiment, the system includes a catheter having a proximal section, a dista l section, and a sheath connected between the proximal section and the distal section. Th e catheter further includes a plurality of optical fibers positioned within the catheter and a computing device connected to the plurality of optical fibers through a connector. The computing device includes a memory and a processor, the processor comprising: During or after ablation, optical measurements of a portion of the tissue are taken from the optical fiber. The processor of the computing device is configured to receive the optical By analyzing the measured data, one or more optical properties of a portion of tissue are identified. based on one or more optical properties of the portion of the tissue. and determining a time to denaturation of the portion of the tissue, One or more optical properties and a predetermined time period are used to estimate lesion depth and ablation. and generating a model representing a correlation between the time of the first and second inputs and the time of the second inputs, The model is used to generate predicted lesion depths over a given ablation time. The present invention is further configured to

[0011] In another embodiment, a computer includes a memory and a processor coupled to the memory. A computing device is described. The ablation technique applies energy to a portion of tissue over a predetermined period of time. and receiving optical measurement data of the portion of the tissue from the catheter after the measurement. By analyzing the optical measurement data, one or more optical and configured to identify one or more optical properties of a portion of the tissue. and determining a time of denaturation of the portion of the tissue based on the time of denaturation, One or more optical properties and a predetermined time period are used to estimate lesion depth and ablation. and generating a model representing a correlation between the time of the first and second inputs and the time of the second inputs, configured to generate a predicted lesion depth over a predetermined period of time using it.

[0012] Additional features and advantages, as well as the structure and operation of various embodiments, are described in detail below with reference to the accompanying drawings. It should be noted that the specific embodiments described herein are not intended to be limiting. Such embodiments are presented herein for illustrative purposes only. Additional embodiments will become apparent to those skilled in the art based on the teachings contained herein.

[0013] The accompanying drawings (which are incorporated herein and form a part of this specification) illustrate embodiments of the disclosure along with the description and further serve to explain the principles of the disclosure and to enable one skilled in the art to make and use the disclosure.

Brief Description of the Drawings

[0014]

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[0015] Embodiments of the present disclosure will be described with reference to the accompanying drawings.

[0016] Although specific configurations and arrangements are discussed, this is for illustrative purposes only and it should be understood that. Those skilled in the art will recognize that other configurations and arrangements can be used without departing from the spirit and scope of the present disclosure. It will become apparent to those skilled in the art that the present disclosure can also be used in a variety of other applications .

[0017] References to "one embodiment", "an embodiment", "exemplary embodiment", etc. in this specification indicate that the embodiment described may include a particular feature, structure, or characteristic, but not necessarily all embodiments include that particular feature, structure, or characteristic. It should be noted that such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with an embodiment, whether explicitly described or not, it is possible to implement such a feature, structure, or characteristic in connection with other embodiments without regard to whether it is explicitly described in connection with other embodiments or not. Furthermore, when a particular feature, structure, or characteristic is described in connection with an embodiment, whether explicitly described or not, it is possible to implement such a feature, structure, or characteristic in connection with other embodiments , will be within the knowledge of one skilled in the art.

[0018] Although this application may refer specifically to cardiac ablation, the present invention is not limited to the disclosed subject matter. The disclosed embodiment also provides an additional energy source for ablation ( These include cryogenic, radio frequency (RF), microwave, laser, ultrasonic, and pulsed electric fields. It is possible that these drugs may be used to treat a range of conditions, including but not limited to: It should be noted that the principles of using energy to treat other conditions are Similar, and therefore similar, are the techniques used to apply the energy.

[0019] As used herein, the terms "electromagnetic radiation," "light," and "beam of radiation" are used interchangeably herein. , all of which are the same electric currents propagating through the various described elements and systems. It is used to describe magnetic signals.

[0020] Exemplary Catheter Embodiments FIG. 1 illustrates a catheter 100 according to an embodiment of the present disclosure. Catheter 100 The proximal section 102 and the distal section 104 are connected to each other. and a sheath 106 coupled between the catheter 102 and the catheter member 104. In one embodiment, The sheath 106 may include one or more radiopaque markers for navigation purposes. In one embodiment, the catheter 100 includes a catheter 100 and a processing device 1. 08. The communication interface 110 is One or more optical fibers and connectors between the device 108 and the catheter 100 In another example, the communication interface 110 may include a wireless communication For example, an interface that enables (such as Bluetooth, WiFi, and cellular) includes a face component and is capable of communicating with the catheter 100 or other processing components within the catheter system.

[0021] In one embodiment, the sheath 106 and the distal section 104 are disposable . As such, the proximal section 102 can be reused by attaching a new sheath 106 and proximal section 104 each time a new procedure is to be performed . In another embodiment, the proximal section 102 is also disposable .

[0022] The proximal section 102 can accommodate various electrical components and optical components used in the operation of the catheter 100. A first optical supply source is included within the proximal section 102 and can generate a beam of radiation for optical evaluation . The first optical supply source can include one or more laser diodes or light emitting diodes (LEDs). The beam of radiation generated by the optical supply source can have a wavelength within the infrared range . In one example, the beam of radiation has a central wavelength of 1.3 μm. The optical supply source can be designed to output a beam of radiation at only a single wavelength or it can be a swept source and be designed to output different wavelengths within a predetermined range . The beam of radiation generated is connected between the proximal section 102 and the distal section 104 within the sheath 106 by an optical fiber . fiber It can be guided towards the distal section 104 via a transmission medium. Any of the optical transmission media include, for example, single-mode optical fibers and / or multi-mode optical fibers. In one embodiment, the electrical transmission medium and the optical transmission medium are provided by the same hybrid medium that enables the propagation of both electrical signals and optical signals.

[0023] In some embodiments, the proximal section 102 includes a second optical source (such as, for example, a laser energy source, etc.), and is capable of generating laser energy to be applied in the distal section 104 for tissue ablation. In some embodiments, the laser energy source is capable of emitting an ablation beam of laser energy at a wavelength of 980 nm or at a wavelength of 1060 nm. The laser energy from the source in the proximal section 102 can propagate through the catheter 100 via the optical transmission medium connected between the proximal section 102 and the distal section 104 within the sheath 106, and the laser energy can be output from the distal section 104 of the catheter 100 to the target tissue. For example, the laser energy from the source can create an optical power of 5 W to 12 W applied to the target tissue over 20 to 30 seconds, creating a transmural lesion in the heart tissue. In another example, the laser energy from the source can create an optical power of 30 W to 50 W applied to the target tissue over 60 to 90 seconds. In some embodiments, the processing device 108 is described herein via the optical transmission medium connected between the proximal section 102 and the distal section 104 within the sheath 106, and the laser energy can be output from the distal section 104 of the catheter 100 to the target tissue. For example, the laser energy from the source can create an optical power of 5 W to 12 W applied to the target tissue over 20 to 30 seconds, creating a transmural lesion in the heart tissue. In another example, the laser energy from the source can create an optical power of 30 W to 50 W applied to the target tissue over 60 to 90 seconds. In some embodiments, the processing device 108 is described herein can create a transmural lesion in the heart tissue. In another example, the laser energy from the source can create an optical power of 30 W to 50 W applied to the target tissue over 60 to 90 seconds. In some embodiments, the processing device 108 is described herein is capable of creating. In some embodiments, the processing device 108 is described herein Optical circuit / system detectors, electronics, and / or other components such as those described may include one or more components such as a . In other embodiments, these one or more components (e.g., optical circuit / system detectors, electronics, and / or other components) may be included within proximal section 102.

[0024] In one embodiment, proximal section 102 includes one or more components of an interferometer for performing low coherence interferometry (LCI) using light generated from a second optical source. Due to the nature of interferometer data analysis, in one embodiment, the optical transmission medium used to guide light to and from distal section 104 does not affect the state and degree of polarization of the light. In another

[0025] embodiment, the optical transmission medium affects polarization in a certain reversible manner. Proximal section 102 may further include additional interface elements, and a user of catheter 100 may control the operation of catheter 100 via the additional interface elements. For example, proximal section 102 may include a deflection control mechanism that controls the deflection angle of distal section 104. The deflection control mechanism may The proximal section 102 can include various buttons or switches, and the buttons or switches enable a user to control and enable the acquisition of optical data when laser energy is applied in the distal section 104 or when a beam of radiation is transmitted from the distal section 104. In some embodiments, the proximal section 102 can include a deflection control mechanism for controlling one or more pull wires connected to the distal section 104. In some embodiments, the deflection control mechanism and one or more pull wires enable steering of the distal section of the catheter 100 and targeting specific tissue areas for ablation.

[0026] The distal section 104 includes a plurality of optical viewports. In some embodiments, the plurality of optical viewports can be referred to herein as orifices within the catheter tip. In one embodiment, one or more of the optical viewports are machined into the outer body portion of the distal section 104. The optical viewports are distributed across the outside of the distal section 104, resulting in a plurality of individual viewing directions. In some embodiments, the optical viewports can transmit and collect light (e.g., an optical signal) at various angles from the distal section 104. Also, the optical viewports can direct laser energy for tissue ablation in a plurality of directions (e.g., beams) through one or more of the optical viewports. - Enable the beam direction). In certain embodiments, each of the plurality of viewing directions is substantially not in the same plane. Also, the optical viewport can be designed to have an irrigation functionality for cooling the distal section 104 and the surrounding tissue during ablation.

[0027] Figures 2A and 2B illustrate cross-sectional views of a sheath 106 according to an embodiment of the present disclosure. The sheath 106 can include all of the elements interconnecting the proximal section 102 with the distal section 104. Sheath 106a illustrates an embodiment that houses an irrigation channel 202, a deflection mechanism 206, an electrical connection 208, and an optical transmission medium 210. Figure 2A illustrates a protective cover 212 wrapped around both the electrical connection 208 and the optical transmission medium 210. The electrical connection 208 can be used to provide signals to an optical modulation component positioned within the distal section 104. In other embodiments, the optical transmission medium 212 and components can be positioned within a separate protective cover from the protective cover 212 that houses the electrical connection 208. One or more optical transmission media 210 guide light generated from an optical source (exposed light) towards the distal section 104, while another subset of the optical transmission media 210 guides light returning from the distal section 104 (scattered or reflected light) back to the proximal section 102. In another example, the same one or more optical transmission media 210 guide light in both directions. In some embodiments, the optical transmission media 210 include one or more single-mode optical fibers and / or multimode optical fibers.

[0028] The irrigation channel 202 is used to guide the cooling fluid towards the distal section 104. The irrigation channel 202 may be a hollow tube that is used to heating and / or cooling elements disposed along the channel to affect In another embodiment, the irrigation channel 202 may include a distal section 1 102. The proximal section 102 is also used as a passageway to draw the fluid surrounding the proximal section 102 back toward the proximal section 102. It is possible.

[0029] The deflection mechanism 206 is configured to move the distal section 104 in a direction to change the deflection angle of the distal section 104. Any electrical or mechanical element designed to provide a signal to Section 104. The deflection system may include a proximal section 10, according to an embodiment. 2, the distal section 104 is operated by actuating a mechanical control located within the distal section 104. The system allows for the guidance of a deflection mechanism control in the proximal section 102. The catheter is connected to a wire at the distal section 104. , in a sheath 106 intended to provide unidirectional deflection of the distal section 104. Can be based on a series of aligned and evenly spaced cutouts In this way, a particular movement of the proximal section can be projected onto the distal section. Others include a combination of several control wires attached to the catheter tip. Embodiments can allow deflection of the catheter tip along different directions.

[0030] FIG. 2B illustrates a cross section of the sheath 106b. The sheath 106b provides electrical connection 2. An embodiment is shown that has substantially the same elements as sheath 106a from FIG. 2A, except that 08 is not present. Sheath 106b may be used in situations where modulation (e.g., multiplexing) of the generated radiation beam is performed in proximal section 102. In some embodiments, sheath 106b may be implemented within a diagnostic catheter used for laser or cryoablation. Example embodiments of catheter systems and consoles Optical Coherence Tomography (OCT) and / or Optical Coherence Reflectometry (OCR), refractometry, or other methods are used to perform tissue ablation, track scar formation in real time, and monitor / verify lesion geometry and isolation by directly observing the scar pattern in the tissue. Embodiments of ablation catheters and console systems are disclosed in this specification. To evaluate whether a scar has formed, the methods, devices, and systems described herein acquire optically reflected / refracted light from the tissue and determine the optical properties of the reflected light (e.g., by measuring intensity and polarization and by computer calculating the phase delay and / or birefringence of the tissue based on the measurements) and monitor for changes. This is because these optical properties change when the tissue is scarred compared to healthy tissue. By identifying changes in the optical properties of the tissue, the lesion depth and denaturation time in the tissue can be determined.

[0031] Optical Coherence Tomography (OCT) and / or Optical Coherence Reflectometry (OCR), refractometry, or other methods are used to perform tissue ablation, track scar formation in real time, and monitor / verify lesion geometry and isolation by directly observing the scar pattern in the tissue. Embodiments of ablation catheters and console systems are disclosed in this specification. To evaluate whether a scar has formed, the methods, devices, and systems described herein acquire optically reflected / refracted light from the tissue and determine the optical properties of the reflected light (e.g., by measuring intensity and polarization and by computer calculating the phase delay and / or birefringence of the tissue based on the measurements) and monitor for changes. This is because these optical properties change when the tissue is scarred compared to healthy tissue. By identifying changes in the optical properties of the tissue, the lesion depth and denaturation time in the tissue can be determined. using Optical Coherence Tomography (OCT) and / or Optical Coherence Reflectometry (OCR), refractometry, or other methods to perform tissue ablation, track scar formation in real time, and monitor / verify lesion geometry and isolation by directly observing the scar pattern in the tissue. Embodiments of ablation catheters and console systems are disclosed in this specification. To evaluate whether a scar has formed, the methods, devices, and systems described herein acquire optically reflected / refracted light from the tissue and determine the optical properties of the reflected light (e.g., by measuring intensity and polarization and by computer calculating the phase delay and / or birefringence of the tissue based on the measurements) and monitor for changes. This is because these optical properties change when the tissue is scarred compared to healthy tissue. By identifying changes in the optical properties of the tissue, the lesion depth and denaturation time in the tissue can be determined. assessed. To evaluate whether a scar has formed, the methods, devices, and systems described herein acquire optically reflected / refracted light from the tissue and determine the optical properties of the reflected light (e.g., by measuring intensity and polarization and by computer calculating the phase delay and / or birefringence of the tissue based on the measurements) and monitor for changes. This is because these optical properties change when the tissue is scarred compared to healthy tissue. By identifying changes in the optical properties of the tissue, the lesion depth and denaturation time in the tissue can be determined. acquired from the tissue and determine the optical properties of the reflected light (e.g., by measuring intensity and polarization and by computer calculating the phase delay and / or birefringence of the tissue based on the measurements) and monitor for changes. This is because these optical properties change when the tissue is scarred compared to healthy tissue. By identifying changes in the optical properties of the tissue, the lesion depth and denaturation time in the tissue can be determined. compared to healthy tissue, these optical properties change when the tissue is scarred. By identifying changes in the optical properties of the tissue, the lesion depth and denaturation time in the tissue can be determined. As described herein, it can be predicted for various ablation times .

[0032] Figure 3 illustrates an exemplary diagram of a system 300 for performing ablation and lesion prediction, according to an embodiment of the present disclosure. The system 300 includes a catheter 3 02, a console 310, a signal generator 320, a display 325, and an irrigation pump 3 30. The catheter 302, the console 310, the signal generator 320, the display 3 25, and the irrigation pump 330 can be communicatively coupled together via a wired connection and / or a wireless connection. In some embodiments, the catheter 302 can represent an exemplary embodiment of the catheter 100 shown in FIG. 1. In some embodiments the distal section of the catheter 302 is positioned at a portion of the tissue of the patient 304. It is understood that the embodiments described herein can be used in vivo and / or in vitro . In some embodiments, the catheter 302 can be positioned at a portion of the tissue to be ablated using the energy generated by the signal generator 320 . In some embodiments, the signal generator 320 can be an electronic device configured to generate radiofrequency (RF), cryogenic, or electroporation (e.g., pulsed electric field) signals for ablation. The signal generator 3 20 can be coupled to the catheter 302 directly or via the console 310, and send energy to the catheter 302 to ablate a portion of the tissue at the selected tissue site

[0033] In some embodiments, the catheter 302 can be positioned at a portion of the tissue to be ablated using the energy generated by the signal generator 320 . In some embodiments, the signal generator 320 can be an electronic device configured to generate radiofrequency (RF), cryogenic, or electroporation (e.g., pulsed electric field) signals for ablation. The signal generator 3 20 can be coupled to the catheter 302 directly or via the console 310, and send energy to the catheter 302 to ablate a portion of the tissue at the selected tissue site . The signal generator 3 20 can be coupled to the catheter 302 directly or via the console 310, and send energy to the catheter 302 to ablate a portion of the tissue at the selected tissue site late at the selected tissue site It is possible to rate. In some embodiments, a portion of the tissue can include myocardial tissue , cardiac muscle tissue, or skeletal tissue, etc. Energy can be applied to a portion of the tissue through an optical viewport in the distal section of the catheter 302 . After applying the energy, structural changes in the tissue can be observed by acquiring an optical signal through one or more optical viewports of the catheter 302.

[0034] The console 310 can include a computing device, and the computing device is configured to acquire an optical signal from the catheter 302 , analyze the optical signal, and is configured to detect changes in the optical properties of the tissue. In some embodiments, the console 310 can include hardware (e.g., circuitry), firmware , software, or any combination thereof, and as described herein, perform the analysis of the optical signal and generate a model for predicting lesion depth and ablation time . In some embodiments, the console 310 can send light into the tissue through optical circuits within itself and within the catheter 302 , monitor the progression of scarring, the contact between the tissue and the catheter 302, and other properties of the tissue . In some embodiments, the console 310 can be referred to herein as a control console, a processing device, and / or a controller . The console 310 can be coupled to a display 325, and the display 325 can present the results from the optical signal analysis and lesion prediction, and the catheter 302, console 310, and in this specification, can also be referred to as a control console, a processing device, and / or a controller. The console 310 can be coupled to a display 325, and the display 325 can present the results from the optical signal analysis and lesion prediction . related to the operation of the console 310, the signal generator 320, and / or the irrigation pump 330. The parameters can be selected / viewed, modified and / or controlled by the user. This makes it possible to control the

[0035] In some embodiments, the irrigation pump 330 is connected to a catheter via tubing. In some embodiments, the irrigation pump 330 may be coupled to the irrigation system 302. 302 (e.g., , through an optical viewport or through a separate optical viewport in the distal section of the catheter 302. irrigation slits) to allow the blood to be released at the tissue site. Fluid from irrigation pump 330 is pumped through the distal section of catheter 302 during ablation. It is possible to cool the ablation and surrounding tissue and during and / or after ablation. Or it is possible to wash away any debris afterwards.

[0036] In some embodiments, the catheter 302 may include one or more optical connections 3 12 and coupled to a console 310 via one or more electrical connections 314. An optical connection 312 connects the catheter 302 to a console 316 for further analysis. 310 , and / or 320 , and The optical fibers may include single-mode and / or multimode optical fibers. An electrical connection 314 is provided from the signal generator 320 to the catheter 302 for ablation. Wires, pins, and / or components used to deliver power and energy The component may include:

[0037] In some embodiments, the optical connection 312 and the electrical connection 314 can be connected to the console 310 via a communication interface 316. The communication interface 316 can enable the transmission of various signals (e.g., optical signals and electrical signals) between the catheter 302 and the console 310. In some embodiments the communication interface 316 can include a connector that facilitates proper alignment of the optical fiber between the catheter 302 and the console 310. In some embodiments, the connector design can include both electrical extension lines and optical extension lines.

[0038] Exemplary optical system and console embodiments FIG. 4 illustrates a diagram of an exemplary optical system 401 for imaging a sample 420 according to an embodiment of the present disclosure. In some embodiments, the components of the optical system 401 are implemented within the console 310 and can obtain optical measurements of the sample 420 using the catheter 30 2. In some embodiments, the sample 420 can be a tissue surface within a patient's body. .

[0039] In some embodiments, the optical system 401 can perform imaging using low coherence interferometry (LCI ), optical coherence tomography (OCT), and / or optical coherence refractometry, or other optical modalities. The optical system 401 includes an optical source 402, a polarization splitter 403, a coupler ​ Ring / splitting element 404, sample arm 406, polarization switch 407 , reference arm 408, optical switch 409, output fiber 410, delay unit 4 12, and detector 414. The optical system 401 can include any number of other optical elements not explicitly shown for the sake of clarity. It should be understood that in some embodiments, the optical system 401 can include mirrors, lenses, gratings, splitters, and micro - mechanical elements, etc., along the path of the sample arm 406 or the reference arm 408. It should be understood that the optical system 401 can include any number of other optical elements not explicitly shown for the sake of clarity. In some embodiments, the optical system 401 can include mirrors, lenses, gratings, splitters, and micro - mechanical elements, etc., along the path of the sample arm 406 or the reference arm 408. In some embodiments, the optical system 401 can include mirrors, lenses, gratings, splitters, and micro - mechanical elements, etc., along the path of the sample arm 406 or the reference arm 408. arm 406 or the reference arm 408. It can include elements such as mirrors, lenses, gratings, splitters, and micro - mechanical elements.

[0040] In some embodiments, the optical source 402 can generate a supply beam of radiation that is coupled to the coupling / splitting element 404 via one or more fibers. The coupling / splitting element 404 is used to direct the light received from the optical source 402 to both the sample arm 406 and the reference arm 408. The coupling / splitting element 404 can be, for example, a coupling element (e.g., a bidirectional coupler), an optical splitter, a coupler with an adjustable splitting ratio, or any other modulating optical device that converts a single light beam into two or more light beams. In some embodiments, the light from the optical source 402 can also pass through an optical attenuator. The coupling / splitting element 404 is used to direct the light received from the optical source 402 to both the sample arm 406 and the reference arm 408. The coupling / splitting element 404 can be, for example, a coupling element (e.g., a bidirectional coupler), an optical splitter, a coupler with an adjustable splitting ratio, or any other modulating optical device that converts a single light beam into two or more light beams. In some embodiments, the light from the optical source 402 can also pass through an optical attenuator. The coupling / splitting element 404 is used to direct the light received from the optical source 402 to both the sample arm 406 and the reference arm 408. The coupling / splitting element 404 can be, for example, a coupling element (e.g., a bidirectional coupler), an optical splitter, a coupler with an adjustable splitting ratio, or any other modulating optical device that converts a single light beam into two or more light beams. In some embodiments, the light from the optical source 402 can also pass through an optical attenuator. 04 is used to direct the light received from the optical source 402 to both the sample arm 406 and the reference arm 408. The coupling / splitting element 404 can be, for example, a coupling element (e.g., a bidirectional coupler), an optical splitter, a coupler with an adjustable splitting ratio, or any other modulating optical device that converts a single light beam into two or more light beams. In some embodiments, the light from the optical source 402 can also pass through an optical attenuator. arm 406 and the reference arm 408. The coupling / splitting element 404 can be, for example, a coupling element (e.g., a bidirectional coupler), an optical splitter, a coupler with an adjustable splitting ratio, or any other modulating optical device that converts a single light beam into two or more light beams. In some embodiments, the light from the optical source 402 can also pass through an optical attenuator. The coupling / splitting element 404 can be, for example, a coupling element (e.g., a bidirectional coupler), an optical splitter, a coupler with an adjustable splitting ratio, or any other modulating optical device that converts a single light beam into two or more light beams. In some embodiments, the light from the optical source 402 can also pass through an optical attenuator. optical splitter, a coupler with an adjustable splitting ratio, or any other modulating optical device that converts a single light beam into two or more light beams. In some embodiments, the light from the optical source 402 can also pass through an optical attenuator. beam into two or more light beams. In some embodiments, the light from the optical source 402 can also pass through an optical attenuator. In some embodiments, the light from the optical source 402 can also pass through an optical attenuator. It is also possible.

[0041] The light traveling through the sample arm 406 passes through the polarization switch 407 and the optical switch 4 By traveling through 09, it ultimately collides on sample 420. In some embodiments, the polarization switch 407 is included on the sample arm 406 but can also be at the input of the LCI system (e.g., before the splitting / coupling element 404). In some embodiments, after passing through the polarization switch 4 07, the optical switch 409 can direct the light to one or more of the plurality of output fibers 410. In some embodiments, the plurality of output fibers 410 represent the fibers in the console 310 that are coupled to the fibers of the catheter 302 via connectors.

[0042] In some embodiments, the sample 420 can be any suitable sample (e.g., tissue, etc.) to be imaged. Light is scattered and reflected back from various depths within the sample 42 0, and the scattered / reflected radiation is returned and collected into the sample arm 406. The scan depth can be selected via the delay imposed on the light in the delay unit 412.

[0043] In some embodiments, the delay unit 412 can include various optical modulation elements. These modulation elements perform phase and / or frequency modulation to cancel unwanted optical effects in the light and also to select one or more depths of the sample 420 to be imaged. In some embodiments, the delay unit 412 can also control the polarization of the light in the reference arm , it is possible to modulate the polarization. In some embodiments, the modulation scheme on the reference arm 408 can simplify the need for a switching element in the reference arm and enable a shift from time multiplexing to frequency / phase / code / polarization multiplexing . The use of the term "light" can refer to any range of the electromagnetic spectrum . In one embodiment, the term "light" refers to infrared radiation at a wavelength of about 1.3 μm .

[0044] In the illustrated embodiment, the delay unit 412 is positioned within the reference arm 408 . However, it should be understood that the delay unit 412 could instead be positioned within the sample arm 4 06. Alternatively, the various elements of the delay unit 412 may be present in both the sample arm 406 and the reference arm 4 08. For example, the element of the delay unit 412 that introduces a variable delay into the light could be positioned within the sample arm 406, while the element that modulates different polarization modes of the light could be positioned within the reference arm 4 08. In another example, the element of the delay unit 412 that modulates different polarization modes of the light could be positioned within the sample arm 406, while the element that introduces a variable delay into the light could be positioned within the reference arm 408. In one example, the sample arm 406 and the reference arm 408 are optical fibers. For example, other implementation forms such as an optical fiber system, a free-space optical system, a photonic integrated circuit, etc. can also be considered similarly.

[0045] In one embodiment, light is coupled from an optical source 40 through one or more fibers to a coupling / splitting element 404, and the light can be coupled from the splitting element 404 to a polarization splitter 403 and then to a detector 414 through one or more fibers or by direct free space coupling.

[0046] In some embodiments, an optical switch 409 enables selection of one or more beams passing through a plurality of output fibers 410. In some embodiments, it is possible for one beam to be active at a time, and the signal returning from the sample 420 is combined with the reference arm 408 and then can be split using the polarization splitter 403 into different channels in the detector 414. In some embodiments, this can enable measurement of the birefringence and other optical properties of the tissue from one channel at a time. In other embodiments, several beams can be active simultaneously and can be split by a multiplexer or other type of beam splitter, where each beam from each path is discriminated by its frequency, wavelength, amplitude, or other optical properties of the light of the beam.

[0047] In some embodiments, the light in the sample arm 406 and the reference arm 408 is recombined by a coupling / splitting element 404 (or by a different optical coupling element) and then at the detector 414. ​​Before being received by the polarizing beam splitter 403, it is split. In some embodiments the light can be polarized prior to coupling by the coupling / splitting element 404. In other embodiments, the light can be split in the reference arm 408. The detector 414 can include any number of photodiodes, charge-coupled devices, and / or CMOS structures and convert the received light into an electrical signal. The electrical signal can include depth-resolved optical data associated with the sample 420 and can be received by a processing device for further analysis and signal processing procedures. As used in this specification, the term "depth-resolved" defines data in which one or more portions of data associated with a particular depth of the imaged sample can be identified.

[0048] In some embodiments, the optical source 402, the detector 414, and the delay unit 412 are positioned within the proximal portion 102 of the catheter 100. In another embodiment, the optical source 402, the detector 414, and the delay unit 412 are positioned within the processing device 108. The coupling / splitting element 404, the polarizing beam splitter 403, the polarization switch 407, the optical switch 409, and at least a portion of one or both of the sample arm 406 and the reference arm 408 can be positioned within the processing device 108 or within either the proximal portion 102 or the distal portion 104 of the catheter 100. In another embodiment, any of the elements of the optical stem 401 are positioned within the Or, it is positioned within the console 310 of the catheter system 300 shown in FIG. 3. In some embodiments, the detector 414 may be positioned within the handle of the catheter 100, while the optical source 402 may be positioned within the processing device 108. The optical source 402 can include one or more light emitting diodes (LEDs) or laser diodes. For example, the LED can be used when performing analysis in the time domain and / or spectral domain, while the tunable laser can be used to sweep the wavelength of light over a predetermined range of wavelengths. In another embodiment, any of the components of the optical system 401 are positioned outside the catheter 100 or the catheter 302 (e.g., within the processing device 108 or within the console 310). In some embodiments, the optical system 401 is illustrated as an interferometer design similar to a Michelson interferometer. However, other interferometer designs including Mach-Zehnder interferometer design or Mireau interferometer design are equally possible. In some embodiments, the components within the optical system 402 can be adapted to an OCT configuration in the spectral domain. For example, the optical source 402 can be a superluminescent diode (SLED) or a light emitting diode (LED), and the detector 414 can be a spectrometer for performing optical spectroscopy of tissue. It is positioned. In some embodiments, the detector 414 can be positioned within the handle of the catheter 100, while on the other hand, the optical source 402 can be positioned within the processing device 108. The optical source 402 can include one or more light emitting diodes ( LEDs) or laser diodes. For example, the LED can be used when performing analysis in the time domain and / or spectral domain, while on the other hand, the tunable laser can be used to sweep the wavelength of light over a predetermined range of wavelengths. In another embodiment, any of the components of the optical system 401 are positioned outside the catheter 100 or the catheter 302 (e.g., within the processing device 108 or within the console 310). In some embodiments, the optical system 401 is illustrated as an interferometer design similar to a Michelson interferometer. However, other interferometer designs including Mach-Zehnder interferometer design or Mireau interferometer design are equally possible. In some embodiments, the components within the optical system 402 can be adapted to an OCT configuration in the spectral domain. For example, the optical (source 402 can be a superluminescent diode (SLED) or a light emitting diode (LED), and the detector 414 can be a spectrometer for performing optical spectroscopy of tissue.

[0049] FIG. 5 shows an example of a full chain of integration of data collection of optical signals according to an The shown block diagram is illustrated. The data collection and processing of the optical signal are performed by the console 310 and can be implemented. In some embodiments, multiple single-ended signals can be digitized and read by the console 310 in parallel or single processing stages together with a reference interferometer for signal processing purposes. In some embodiments, the processing can be implemented in real time or near real time (e.g., about 50 ms or similar values ). In some embodiments, any number of signals can be digitized. These signals can be combined and processed to measure the optical properties of the tissue (e.g., birefringence, tissue stability, and dragging speed, etc.). The processed signals can be presented on a display (e.g., display 325) or on a graphical user interface (GUI) shown thereon . In some embodiments, the GUI can be refreshed such that a plurality of channels of the detector (e.g., 15 channels ) are represented at once. In some embodiments, the console 310 can buffer the optical data from all or a plurality of channels , and when the data is processed, the data can be refreshed and presented in the GUI . In some embodiments, data transfer and data processing can be optimized in different software abstraction layers, and data integrity is maintained while improving the refresh time in the GUI . When optical data (e.g., OCT structure / polarization data) is acquired, a tissue detection algorithm using a clustering method or other methods can be used to detect other . In some embodiments, the console 310 can buffer the optical data from all or a plurality of channels , and when the data is processed, the data can be refreshed and presented in the GUI . In some embodiments, data transfer and data processing can be optimized in different software abstraction layers, and data integrity is maintained while improving the refresh time in the GUI . When optical data (e.g., OCT structure / polarization data) is acquired, a tissue detection algorithm using a clustering method or other methods can be used to detect other

[0050] . In some embodiments, data transfer and data processing can be optimized in different software abstraction layers, and data integrity is maintained while improving the refresh time in the GUI . When optical data (e.g., OCT structure / polarization data) is acquired, a tissue detection algorithm using a clustering method or other methods can be used to detect other optical data (e.g., OCT structure / polarization data) is acquired, a tissue detection algorithm using a clustering method or other methods can be used to detect other objects. After the optical data (e.g., OCT structure / polarization data) is acquired, a tissue detection algorithm using a clustering method or other methods can be used to detect other can be implemented to separate tissue from artifacts. In some embodiments , a 3D model of a lesion formed from ablation can be obtained from each of the individual beams from the optical fiber . In some embodiments, a dragging algorithm can be combined with a lesion model algorithm to accurately predict the lesion when the catheter is moving .

[0051] Moreover, an optimization algorithm can be applied to compensate for the non - linearity and phase noise of the optical source while switching using an external reference interferometer at different optical path delays . In some embodiments, an additional automatic calibration method is implemented to optimize the polarization state without manual interaction and automatically adjust the optical fiber length using a motor and retro - reflector, such that the coherence range is optimized for each fiber .

[0052] Exemplary connector embodiments FIG. 6 illustrates an exemplary cross - sectional diagram of a connector 600 according to an embodiment of the present disclosure . The connector 600 shown in FIG. 6 can be used in a face - to - face connector for connecting fibers between a console and a catheter (e.g., in a communication interface 316 between a console 310 and a catheter 302, etc.) . In some embodiments, in a console - catheter interface, a fiber having a small cross - section (e.g., 50 - 80 um) can be spliced to another fiber having a larger cross - section (e.g., 125 um) . . In some embodiments, in a console - catheter interface, a fiber having a small cross - section (e.g., 50 - 80 um) can be spliced to another fiber having a larger cross - section (e.g., 125 um) . For example, 125 um), and the catheter A standard-sized connector (e.g., a 125um fiber bar) is configured to fit and is thus used. However, splicing the fibers individually can be time-consuming and potentially expensive. Therefore, custom connectors (e.g., connector 600 having the cross-section shown in Figure 6, etc.) can be used to link the fibers together. In some embodiments, the connector 600 can be a multi- fiber connector with a plurality of V-shaped grooves 602, and the plurality of V-shaped grooves 602 assist in aligning the fibers at the connection between the catheter and the console. The V-shaped grooves 602 can be formed and configured such that each individual fiber is aligned

[0053] and positioned within the groove 602 with an accuracy of + / -1um. In some embodiments, each fiber can be placed together with a lid that presses the fiber into the groove at the bottom of each V-shaped groove 602. In some embodiments, two connectors 600 can be combined in a male-female connection to enable proper etc.), or can be formed from a polymer material by an etching process. The connector 600 can ultimately enhance the alignment and positioning of the fibers and improve the accuracy of the optics within the catheter and the optical system.

[0054] Figures 7A-7C illustrate exemplary diagrams of a multi-fiber push-on (MPO ) connector design according to embodiments of the present disclosure. The MPO connector design shown in Figures 7A-7C can be utilized to facilitate manufacturing and connectivity to the console and to replace a single connector. Figure 7A illustrates the bonding process for the MPO connector, while Figure 7B illustrates the connector assembled with the glass ferrule. As shown in Figure 7C, the MPO connector design can include a custom component with a previously smaller hole (e.g., 54um). In some embodiments, the custom component can be compatible with both the catheter side and the console side, and this design can further facilitate the fiber passing process and the bonding process. In some embodiments, an additional connector design can include using the MPO connector and adding a custom section with a smaller hole on the front panel of the connector ferrule. In some embodiments, this method can improve the coupling efficiency of using non-standard fiber diameters, but it is also possible to benefit from the use of existing multi-fiber connector options.

[0055] ​​​​​​​​​​​Exemplary Embodiments of Optical Analysis and Lesion Prediction In some embodiments, an optical signal can be acquired by a catheter, and an optical system within a console can perform analysis of the optical signal and generate models for predicting lesion depth and ablation time, as described herein. In some embodiments, the predicted lesion depth can represent the height and width of a lesion formed by energy applied to a portion of tissue by a catheter ..

[0056] Exemplary studies were performed to develop a lesion depth prediction algorithm using optical property measurements from ablated tissue. In those studies, tissue samples were excised from porcine hearts and the distal end of a catheter was positioned perpendicular to the endocardial surface of the tissue using a micro-positioner . The tissue samples included the right atrial free wall, superior vena cava, left atrial crown, mitral annulus, and left atrial appendage, and the catheter was suspended above the tissue from a spring to maintain a constant contact force and to reduce the influence of external mechanical vibrations on the recording of the contact force . The micro-positioner was adjusted to achieve a desired contact force value, and the force was measured using a weighing scale .

[0057] In some embodiments, the contact between the catheter and the tissue can be analyzed by direct visualization (e.g., using optical system 401) and by changes in weight on a scale . In some embodiments, a contact force of 0 g, 2 g, or 10 g, or more can represent no contact, soft contact, or strong contact between the catheter and the tissue . ​​Each can be shown. In some embodiments, the micro - positioner The positive distance measured by can indicate that the tissue is not in contact with the catheter tip, while on the other hand, the negative distance measured by the micro - positioner can indicate that the catheter tip has been introduced into the tissue. .

[0058] In some embodiments, the RF energy from the distal end of the catheter is applied to the tissue sample by power at levels between 20W and 40W and RF ablation time in the range between 5 seconds and 45 seconds. In some embodiments, focal RF ablation is performed in both the right atrium and the left atrium under various parameters (including, for example, various power values, times, irrigation flow rates, and catheter contact force values). To identify optical parameters of interest for predicting lesion depth, optical measurements of the tissue were obtained using interferometry, OCT, and / or OCR techniques. In some embodiments, the optical measurements can be obtained by using the optical system 401 of FIG. 4 as described herein.

[0059] FIGS. 8A and 8B illustrate graphs showing exemplary results from optical measurements of tissue according to embodiments of the present disclosure. In particular, FIG. 8A illustrates a graph of an exemplary structural image calculated as the average of an AM scan in a 5 - second time window according to embodiments of the present disclosure. In some embodiments, the optical power as a function of tissue depth is analyzed from the optical measurements and the catheter irrigation flow rate and incident angle values (e.g., the catheter ​​​​​​​​​​​​ Exiting from one or more of the optical viewports in the distal section of the catheter Based on the beam direction of the beam), the catheter tip (e.g., the end of the distal section of the catheter) and the tissue distance and the optical signal quality at different locations in the tissue can be further evaluated, for example, at the end of the distal section of the catheter) and the tissue distance and the optical signal quality evaluated.

[0060] In some embodiments, the tissue surface is detected and the lens and tissue interface distance can be evaluated based on the distance between two peaks as shown by the two vertical dashed lines in FIG. 8A. In some embodiments, the maximum image depth (e.g., optical penetration in the tissue) can be calculated as a function of the distance between the first tissue interface when the optical power exceeds the noise background by 5 dB as shown by the third vertical line shown in FIG. 8A. In some embodiments, a linear regression model (e.g., locally estimated scatterplot smoothing (LOESS: locally estimated scatterplot smoothing) curve fitting regression, etc.) can be applied to the data. as shown by the two vertical dashed lines in FIG. 8A. In some embodiments, the maximum image depth (e.g., optical penetration in the tissue) can be calculated as a function of the distance between the first tissue interface when the optical power exceeds the noise background by 5 dB as shown by the third vertical line shown in FIG. 8A. In some embodiments, a linear regression model (e.g., locally estimated scatterplot smoothing (LOESS: locally estimated scatterplot smoothing) curve fitting regression, etc.) can be applied to the data. evaluated based on the distance between two peaks as shown by the two vertical dashed lines in FIG. 8A. In some embodiments, the maximum image depth (e.g., optical penetration in the tissue) can be calculated as a function of the distance between the first tissue interface when the optical power exceeds the noise background by 5 dB as shown by the third vertical line shown in FIG. 8A. In some embodiments, a linear regression model (e.g., locally estimated scatterplot smoothing (LOESS: locally estimated scatterplot smoothing) curve fitting regression, etc.) can be applied to the data. For example, optical penetration in the tissue) is related to the depth when the optical power exceeds the noise background by 5 dB as shown by the third vertical line shown in FIG. 8A. For example, optical penetration in the tissue) is related to the depth when the optical power exceeds the noise background by 5 dB as shown by the third vertical line shown in FIG. 8A. evaluated based on the distance between the first tissue interface when the optical power exceeds the noise background by 5 dB as shown by the third vertical line shown in FIG. 8A. In some embodiments, a linear regression model (e.g., locally estimated scatterplot smoothing (LOESS: locally estimated scatterplot smoothing) curve fitting regression, etc.) can be applied to the data. For example, locally estimated scatterplot smoothing (LOESS: locally estimated scatterplot smoothing) curve fitting regression, etc.) can be applied to the data. For example, locally estimated scatterplot smoothing (LOESS: locally estimated scatterplot smoothing) curve fitting regression, etc.) can be applied to the data. For example, locally estimated scatterplot smoothing (LOESS: locally estimated scatterplot smoothing) curve fitting regression, etc.) can be applied to the data.

[0061] FIG. 8B illustrates an exemplary average phase delay graph calculated as the average of the A-scans of the structural image according to an embodiment of the present disclosure. In some embodiments, the phase delay slope can correspond to the slope measured from the tissue interface having the maximum phase delay (as shown by the two vertical lines shown in FIG. 8B). evaluated based on the distance between the first tissue interface when the optical power exceeds the noise background by 5 dB as shown by the third vertical line shown in FIG. 8A. In some embodiments, a linear regression model (e.g., locally estimated scatterplot smoothing (LOESS: locally estimated scatterplot smoothing) curve fitting regression, etc.) can be applied to the data. evaluated based on the distance between the first tissue interface when the optical power exceeds the noise background by 5 dB as shown by the third vertical line shown in FIG. 8A. In some embodiments, a linear regression model (e.g., locally estimated scatterplot smoothing (LOESS: locally estimated scatterplot smoothing) curve fitting regression, etc.) can be applied to the data. evaluated based on the distance between the first tissue interface when the optical power exceeds the noise background by 5 dB as shown by the third vertical line shown in FIG. 8A. In some embodiments, a linear regression model (e.g., locally estimated scatterplot smoothing (LOESS: locally estimated scatterplot smoothing) curve fitting regression, etc.) can be applied to the data. evaluated based on the distance between the first tissue interface when the optical power exceeds the noise background by 5 dB as shown by the third vertical line shown in FIG. 8A. In some embodiments, a linear regression model (e.g., locally estimated scatterplot smoothing (LOESS: locally estimated scatterplot smoothing) curve fitting regression, etc.) can be applied to the data.

[0062] In some embodiments, a system (e.g., catheter system 300 and optical system 401) can measure tissue strength and polarization and extract phase delay data and tissue characteristics (e.g., birefringence, etc.) therefrom. In some embodiments, structural changes in tissue can be correlated with A-scans and / or intensity measurements. Phase delay data can provide information about the tissue, including information about lesion depth and structural changes in the tissue (e.g., necrosis and tissue degeneration, etc.). Notably, the heart wall includes three layers (outer epicardium, middle myocardium, and inner endocardium), wherein the myocardium is the muscle tissue of the heart and is composed of cardiac muscle cells (cardiomyocytes). Cardiac muscle cells have a highly organized cellular structure with branched myofibrils and sarcomeres. Microscopically, the arrangement of sarcomeres and myofibrils in cardiac muscle results in a striated appearance. In some embodiments, untreated myocardial tissue that has not been ablated can have a high level of cellular organization, which exhibits a significant phase retardation (PR) between anti-parallel polarization states. High levels of cellular organization can lead to reflecting polarized light that wraps in phase around π on top of the cumulative phase retardation. In some embodiments, as light travels deeper through myocardial tissue at a rate proportional to the magnitude of birefringence, the phase delay can accumulate. Thus, less organization in the muscle structure of cardiac muscle tissue can potentially have a direct impact on the birefringence characteristics of the tissue.

[0063] FIG. 8B shows, at each depth relative to the tissue surface between 0 and π (phase wrapping), shows the accumulated phase delay. In some embodiments, the average phase delay can be calculated as the average of the A-scans in a 5 second time window. The information obtained in the average PR can then be related to the amount and arrangement of collagen and cells in the heart tissue .

[0064] In some embodiments, an inflection point in the slope of the phase delay data can be identified several hundred microns after the tissue surface. In some embodiments, this depth can correspond to the transition between the endocardium (collagen) and myocardium (mainly cardiomyocytes) in the tissue . In some embodiments, the average PR slope, R value, root mean square error (RMSE ) value, and the ratio between the maximum PR and minimum PR calculated from the end of the endocardial wall estimate to the maximum value can be related to the arrangement of cardiomyocytes in the myocardium. 2

[0065] In some embodiments, histological analysis of the tissue (e.g., using staining techniques) can be performed to correlate polarized sensitive optical coherence reflectometry (PS-OCR) with the arrangement of muscle fibers in the tissue, e.g., identifying collagen and cardiomyocytes in the PS-OCR image, and excluding any abnormal microanatomy from the measurements used in the linear regression model

[0066] In some embodiments, the R 2 value and root mean square error (RMSE) associated with the linear regression model can be related to the histology of the tissue, and thus a small R 2 value (e.g., <0.8) or a high RMSE value (e.g., >0.025) indicates fine​​​​​​​ It is possible to indicate excessive collagen in the extracellular matrix or the thick wall portion of the endocardium, which may reduce tissue.

[0067] Figures 9A, 9B, and 9C illustrate graphs showing exemplary results and analysis of optical signals obtained by polarization-sensitive optical coherence reflectometry (PS-OCR) from tissue according to embodiments of the present disclosure. In particular, Figure 9A shows the time progression of the PS-OCR optical signal obtained during an in vitro RF ablation

[0068] procedure. In some embodiments, after the first instance of heating, when there is a large dynamic range of periodic variation in the PR between orthogonal polarization states, and thus when reducing the dynamic range to the background noise level, a sudden change can be observed in Figure 9A. This PR change is likely to be approximately monotonic under optimal contact conditions and is designed such that a threshold can be estimated when fiber denaturation occurs. For this phase delay measurement, A-scan lines can be grouped together and filtered as a 2D signal, taking advantage of depth and time coherence. First, the signal can be convolved by a Gaussian kernel with a standard deviation of 30 samples. Next, the resulting smoothed signal can be processed by a median filter with a smaller support (e.g., 3x3) to remove local inhomogeneities. Finally, the signal is fixed equal to 80% of the maximum phase delay within the time frame considered.

[0069] ​​may be binarized (e.g., converted to binary) according to a predetermined threshold value determined by the In some embodiments, a loss of about 20% of the protein denaturation fraction is indicative of a loss of protein denaturation. A pre-determined threshold may be selected since it may result in reduced activity and cell viability. The resulting signal is data for most tissues from the tissue surface to a depth of ~1 mm. Clusters are illustrated in FIG. 9B as a function of time and depth. 1 illustrates an exemplary diagram showing the binarized phase delay of an optical signal as In some embodiments, the denaturation time (t D ) is equal to 80% of the maximum phase delay. This may be assumed to be the moment when the birefringence becomes smaller than a certain predetermined threshold. In the embodiment, the acquisition system (e.g., optical system 401) and the RF optical signal are It is possible to synchronize to the clock and guarantee the time base.

[0070] Once the signal has been successfully binarized, the total number of points for each scan can be projected onto the x-axis and an Arrhenius fit can be applied to the result. FIG. 9C shows an example graph of an Arrhenius fit curve of the result of FIG. 9B, in accordance with an embodiment of the present disclosure. In some embodiments, the denaturation time (t D ) and the rate at which the tissue is degenerated can be calculated according to the slope of the Arrhenius equation according to the following formula:

[0071]

number

[0072] In some embodiments, C and C T are the initial number of viable cells, and and the number of surviving cells at temperature T after heating at a constant heating rate B. In some embodiments, A and Ea are, respectively, a frequency factor and an activation energy value related to the cell death process. As a result, the denaturation time (t ) can be inferred from the transition between two clusters of data over time. In some embodiments, fiber denaturation can occur at the minimum time when the Arrhenius curve reaches the y-offset in a 0.01 second time window. In some embodiments, the vertical dashed line in FIG. 9C can be used to indicate the estimated t D , and the slope of t can be the rate at which tissue denaturation is reached. In some embodiments, statistical analysis can be performed on the acquired optical measurement data (e.g., FIGS. 8A-9C) (including applying power analysis, T-tests, and linear regression for analysis of variance (ANOVA) of the data to model the relationships between variables). In some embodiments, optical measurement data showing loss in birefringence corresponding to tissue denaturation and necrosis can be included in the development of a regression model for predicting lesion depth, as described herein. In some embodiments, the predicted lesion depth model may be useful for understanding lesion progression in tissue during or after performing RF ablation. In some embodiments, hyperthermia can potentially destroy tissue in a temperature range of 50°C to 90°C. At temperatures near 43°C to 45°C, irreversible cell damage (e.g., D D

[0073]

[0074] then, membrane disruption, protein denaturation, and mitochondrial dysfunction, etc.) may destroy cells after a longer exposure time (e.g., 30 - 60 minutes). At higher temperatures (e.g., temperatures above 60°C), rapid protein denaturation and cell death may often occur within seconds. To characterize the shape of the lesion and to correlate biophysical parameters measured in real time with optical measurements obtained by an optical system, the tissue can be further stained (e.g., with tetrazolium chloride (TTC)) after RF ablation and analyzed via visual inspection and imaging. FIGS. 10A and 10B illustrate exemplary diagrams showing a lesion formed in tissue at the catheter tip and measurements of the lesion, respectively, according to embodiments of the present disclosure. In some embodiments, the lesion size can be measured by obtaining one or more of the measurements represented by labels A - G in FIG. 10B. In some embodiments, the lesion size can be the maximum lesion depth (A), the maximum lesion width (B), the depth at the maximum lesion width (C), the cross-sectional diameter or lesion diameter at the surface (D), the tissue depth or thickness ( (E), the catheter indentation depth of the lesion, or the depth of tissue deformation after ablation (F), the lesion depth at - 45° from the axis (G), and the lesion depth at 45° from the axis

[0075] (H), and can be represented by at least one of them. In some embodiments, there may be a high correlation between the lesion depth and the lesion width, which may enable the prediction of the lesion width value. In some embodiments, the lesion size measurement value is obtained by an optical system. After RF ablation, the tissue can be further stained (e.g., with tetrazolium chloride (TTC)) and analyzed via visual inspection and imaging. FIGS. 10A and 10B illustrate exemplary diagrams showing a lesion formed in tissue at the catheter tip and measurements of the lesion, respectively, according to embodiments of the present disclosure. In some embodiments, the lesion size can be measured by obtaining one or more of the measurements represented by labels A - G in FIG. 10B. In some embodiments, the lesion size can be the maximum lesion depth (A), the maximum lesion width (B), the depth at the maximum lesion width (C), the cross-sectional diameter or lesion diameter at the surface (D), the tissue depth or thickness ( E), the catheter indentation depth of the lesion, or the depth of tissue deformation after ablation (F), the lesion depth at - 45° from the axis (G), and the lesion depth at 45° from the axis (H), and can be represented by at least one of them. In some embodiments, there may be a high correlation between the lesion depth and the lesion width, which may enable the prediction of the lesion width value. In some embodiments, the lesion size measurement value is obtained by an optical system. In some embodiments, the lesion size can be the maximum lesion depth (A), the maximum lesion width (B), the depth at the maximum lesion width (C), the cross-sectional diameter or lesion diameter at the surface (D), the tissue depth or thickness ( (E), the catheter indentation depth of the lesion, or the depth of tissue deformation after ablation (F), the lesion depth at - 45° from the axis (G), and the lesion depth at 45° from the axis (H), and can be represented by at least one of them. In some embodiments, the lesion size measurement value is It can be used when generating a lesion depth model, and the image processing can be performed to evaluate optical parameters and optical tissue characteristics as functions of the depth-resolved tissue structure.

[0076] In some embodiments, the predicted lesion model can be generated from the analysis of optical measurement data obtained by performing a plurality of RF ablations using a catheter having various parameters. By way of example, the RF ablation can be performed by the following parameters: power at a level between 20 W and 60 W, ablation time between 10 seconds and 50 seconds, irrigation flow rate fixed at 8 mL / min, and catheter contact force fixed at 20 g. In some embodiments, the optical measurement data is obtained from the RF ablation and can be analyzed (e.g., using optical system 401) to detect loss of birefringence, which can be correlated with necrosis and myofibrillar degeneration. In some embodiments, the loss of birefringence can be detected in at least one of the beams exiting the catheter (e.g., one of the beams exiting one or more of the optical viewports in the distal section 104 of catheter 100). In some embodiments, one or more optical viewports of the catheter can be in contact with the tissue, and one or more beams can be output at once for optical interrogation of the tissue.

[0077] In some embodiments, the catheter is in a vertical orientation (where the catheter tip portion is perpendicular to the tissue), a 45° angle (where the catheter tip portion is at an angle to the tissue), at an angle of 45° to the weave), a parallel orientation (where the catheter tip is parallel to the tissue), or other orientations, and can be positioned in the tissue in a variety of configurations. Exemplary different orientations of the catheter tip are shown in FIG. 14 and will be described in more detail below. Based on positioning the catheter in the tissue, one or more beams from the optical viewport can be switched (e.g., using the optical switch 409 in the optical system 401) on or off to obtain optical measurements from the tissue. and can be positioned in the tissue in a variety of configurations, including at an angle of 45° to the weave, a parallel orientation (where the catheter tip is parallel to the tissue), or other orientations. Exemplary different orientations of the catheter tip are shown in FIG. 14 and will be described in more detail below. Based on positioning the catheter in the tissue, one or more beams from the optical viewport can be switched (e.g., using the optical switch 409 in the optical system 401) on or off to obtain optical measurements from the tissue. Exemplary different orientations of the catheter tip are shown in FIG. 14 and will be described in more detail below. Based on positioning the catheter in the tissue, one or more beams from the optical viewport can be switched (e.g., using the optical switch 409 in the optical system 401) on or off to obtain optical measurements from the tissue. Exemplary different orientations of the catheter tip are shown in FIG. 14 and will be described in more detail below. Based on positioning the catheter in the tissue, one or more beams from the optical viewport can be switched (e.g., using the optical switch 409 in the optical system 401) on or off to obtain optical measurements from the tissue. Exemplary different orientations of the catheter tip are shown in FIG. 14 and will be described in more detail below. Based on positioning the catheter in the tissue, one or more beams from the optical viewport can be switched (e.g., using the optical switch 409 in the optical system 401) on or off to obtain optical measurements from the tissue. Exemplary different orientations of the catheter tip are shown in FIG. 14 and will be described in more detail below. Based on positioning the catheter in the tissue, one or more beams from the optical viewport can be switched (e.g., using the optical switch 409 in the optical system 401) on or off to obtain optical measurements from the tissue. Exemplary different orientations of the catheter tip are shown in FIG. 14 and will be described in more detail below. Based on positioning the catheter in the tissue, one or more beams from the optical viewport can be switched (e.g., using the optical switch 409 in the optical system 401) on or off to obtain optical measurements from the tissue.

[0078] In some embodiments, the lesion depth as a function of the ratio (t / t A / t D ) of ablation time to transit time at different incident angles of the beam can be calculated and represented as a logarithmic regression model. In some embodiments, the incident angle of the beam can indicate the various beam directions in which one or more beams exit the optical viewport of the catheter tip. In an example, RF ablation performed by a catheter positioned in a perpendicular configuration in tissue having an incident angle of 45° can result in a deeper lesion than other orientations. In some embodiments, the incident angle of the beam can indicate the various beam directions in which one or more beams exit the optical viewport of the catheter tip. In an example, RF ablation performed by a catheter positioned in a perpendicular configuration in tissue having an incident angle of 45° can result in a deeper lesion than other orientations. In some embodiments, the incident angle of the beam can indicate the various beam directions in which one or more beams exit the optical viewport of the catheter tip. In an example, RF ablation performed by a catheter positioned in a perpendicular configuration in tissue having an incident angle of 45° can result in a deeper lesion than other orientations. In some embodiments, the incident angle of the beam can indicate the various beam directions in which one or more beams exit the optical viewport of the catheter tip. In an example, RF ablation performed by a catheter positioned in a perpendicular configuration in tissue having an incident angle of 45° can result in a deeper lesion than other orientations. In some embodiments, the incident angle of the beam can indicate the various beam directions in which one or more beams exit the optical viewport of the catheter tip. In an example, RF ablation performed by a catheter positioned in a perpendicular configuration in tissue having an incident angle of 45° can result in a deeper lesion than other orientations. In some embodiments, the incident angle of the beam can indicate the various beam directions in which one or more beams exit the optical viewport of the catheter tip. In an example, RF ablation performed by a catheter positioned in a perpendicular configuration in tissue having an incident angle of 45° can result in a deeper lesion than other orientations.

[0079] In some embodiments, additional factors for the regression model can be included, such as the initial impedance associated with the surface of the tip in contact with the tissue (e.g., prior to RF ablation), and the drop in impedance value during RF ablation. In some embodiments, a machine learning algorithm (e.g., support vector In some embodiments, additional factors for the regression model can be included, such as the initial impedance associated with the surface of the tip in contact with the tissue (e.g., prior to RF ablation), and the drop in impedance value during RF ablation. In some embodiments, a machine learning algorithm (e.g., support vector In some embodiments, additional factors for the regression model can be included, such as the initial impedance associated with the surface of the tip in contact with the tissue (e.g., prior to RF ablation), and the drop in impedance value during RF ablation. In some embodiments, a machine learning algorithm (e.g., support vector In some embodiments, additional factors for the regression model can be included, such as the initial impedance associated with the surface of the tip in contact with the tissue (e.g., prior to RF ablation), and the drop in impedance value during RF ablation. In some embodiments, a machine learning algorithm (e.g., support vector A kurt machine and / or a neural network, etc.) can be applied to construct a regression model. For this purpose.

[0080] FIG. 11 illustrates a diagram showing an exemplary regression model for predicting the maximum lesion depth according to an embodiment of the present disclosure. In some embodiments, the regression model is based on the correlation between ablation time and time to degeneration, initial impedance, and the input of a beam for detecting fiber degeneration, and can be calculated from a neural network with 10 hidden layers. FIG. 12 illustrates a diagram showing an exemplary model for lesion depth analysis according to an embodiment of the present disclosure. In particular, FIG. 12 shows different in vitro measurements of a lesion depth model for catheter ablation with different temperatures. In some embodiments, the optical system of the catheter may have a physical limitation of 1.5 mm with respect to depth due to light scattering, and the catheter system may not be able to evaluate depths deeper than 1.5 mm. However, the methods, devices, and systems described herein can monitor changes in optical properties over time and enable measurement of optical properties (such as tissue birefringence, polarization, and phase delay, etc.) to predict lesion depths greater than 1.5 mm. In some embodiments, a portion of the tissue at a specific tissue site may be thicker than 1.5 mm, which may require obtaining optical information from a depth of 2 - 5 mm into the tissue. Therefore, an in vitro model (shown in FIG. 12) A kurt machine and / or a neural network, etc.) can be applied to construct a regression model. For this purpose.

[0081] FIG. 12 illustrates a diagram showing an exemplary model for lesion depth analysis according to an embodiment of the present disclosure. In particular, FIG. 12 shows different in vitro measurements of a lesion depth model for catheter ablation with different temperatures. In some embodiments, the optical system of the catheter may have a physical limitation of 1.5 mm with respect to depth due to light scattering, and the catheter system may not be able to evaluate depths deeper than 1.5 mm. However, the methods, devices, and systems described herein can monitor changes in optical properties over time and enable measurement of optical properties (such as tissue birefringence, polarization, and phase delay, etc.) to predict lesion depths greater than 1.5 mm. In some embodiments, a portion of the tissue at a specific tissue site may be thicker than 1.5 mm, which may require obtaining optical information from a depth of 2 - 5 mm into the tissue. Therefore, an in vitro model (shown in FIG. 12) A kurt machine and / or a neural network, etc.) can be applied to construct a regression model. For this purpose. In some embodiments, a portion of the tissue at a specific tissue site may be thicker than 1.5 mm, which may require obtaining optical information from a depth of 2 - 5 mm into the tissue. Therefore, an in vitro model (shown in FIG. 12) In some embodiments, a portion of the tissue at a specific tissue site may be thicker than 1.5 mm, which may require obtaining optical information from a depth of 2 - 5 mm into the tissue. Therefore, an in vitro model (shown in FIG. 12) In some embodiments, a portion of the tissue at a specific tissue site may be thicker than 1.5 mm, which may require obtaining optical information from a depth of 2 - 5 mm into the tissue. Therefore, an in vitro model (shown in FIG. 12) In some embodiments, a portion of the tissue at a specific tissue site may be thicker than 1.5 mm, which may require obtaining optical information from a depth of 2 - 5 mm into the tissue. Therefore, an in vitro model (shown in FIG. 12) In some embodiments, a portion of the tissue at a specific tissue site may be thicker than 1.5 mm, which may require obtaining optical information from a depth of 2 - 5 mm into the tissue. Therefore, an in vitro model (shown in FIG. 12) In some embodiments, a portion of the tissue at a specific tissue site may be thicker than 1.5 mm, which may require obtaining optical information from a depth of 2 - 5 mm into the tissue. Therefore, an in vitro model (shown in FIG. 12) In some embodiments, a portion of the tissue at a specific tissue site may be thicker than 1.5 mm, which may require obtaining optical information from a depth of 2 - 5 mm into the tissue. Therefore, an in vitro model (shown in FIG. 12) In some embodiments, a portion of the tissue at a specific tissue site may be thicker than 1.5 mm, which may require obtaining optical information from a depth of 2 - 5 mm into the tissue. Therefore, an in vitro model (shown in FIG. 12) As shown, it reaches 1.5 mm of the tissue modified after ablation Taking into account the estimated time required (e.g., denaturation time), how the energy is applied to the tissue at greater lesion depths is further evaluated

[0082] By correlating lesion depth to ablation time and by evaluating lesion progression to different sizes, an in vitro model can be constructed using optical measurement data and correlations In some embodiments, the optical signal providing information at a depth of 1.5 mm can be extrapolated to predict lesion depth data at deeper tissue levels

[0083] Figures 13A and 13B illustrate diagrams showing exemplary lesion depth and lesion width, respectively, as a function of ablation time, according to embodiments of the present disclosure In some embodiments, Figures 13A and 13B show lesion depth and lesion width, respectively, for ablations performed at temperatures of 50°C and 70°C In some embodiments, lesion depth and lesion width can be obtained by analyzing optical measurement data and by using a regression model to predict lesion depth, as discussed with reference to Figures 8A - 12

[0084] Figure 14 illustrates an exemplary diagram of catheter tip geometry and orifice position for contact with tissue, according to embodiments of the present disclosure In some embodiments, Figure 14 shows various incident angles (0°, 29°, 45°, 62°, and 90° ​​​​​​​​​shows the orientation of the catheter tip in (including). The upper panel in FIG. 14 shows the location of a plurality of orifices or optical viewports in the catheter tip, where three orifices can be positioned to contact the tissue. The bottom panel in FIG. 14 shows the orifice locations of the upper panel displaced by 50 um at the catheter tip. In some embodiments, the number of orifices in contact with the tissue can be determined based on the signals detected from the corresponding light beams. Based on the determination, the contact force can be calculated by direct mathematical relationships or statistical extrapolations. In some embodiments, the orifices at the catheter tip are for acquiring optical signals and for determining the progression of lesions in the tissue from multiple different angles with respect to the positioning of the catheter tip in the tissue.

[0085] FIG. 15 illustrates an exemplary diagram of the contact between a catheter and tissue, and the beam direction of the catheter tip, according to an embodiment of the present disclosure. The diagrams in the upper row of FIG. 15 illustrate exemplary diameters and exemplary values of the distance from the catheter tip with different levels of contact to the tissue. For example, catheter-tissue distances of about 0.32 mm, 0.73 mm, and 1.15 mm can represent soft contact, intermediate contact, and strong contact between the catheter and the tissue, respectively. In some embodiments, the middle row in FIG. 15 illustrates a lateral view at the catheter tip, where one to three beams from the optical viewport at the catheter tip are in contact with the tissue and can be used to optically evaluate the tissue. In some embodiments, showing that one to three beams from the optical viewport at the catheter tip are in contact with the tissue and can be used to optically evaluate the tissue. ​ In one configuration, the bottom row of FIG. 15 shows a front view of the catheter tip, where one to three beams from the optical viewports are in contact with tissue and can be used to optically evaluate the tissue. In some embodiments, it is possible for there to be 15 optical ports at the catheter tip, and any number of optical ports can be selected to provide one or more beams to the tissue. In some embodiments four or more beams can be used for optical analysis, and using one or more beams from multiple optical viewports provides a more accurate model for predicting lesion depth and understanding the progression of lesion shape and size within the tissue

[0086] FIG. 16 illustrates an exemplary graphical user interface (GUI) 1600 showing predicted lesion depth according to an embodiment of the present disclosure. In some embodiments the GUI 1600 can be presented on a display 325 coupled to a console 310, and in the console 310 optical measurement data can be obtained by an optical system 401 The GUI 1600 provides optical measurement data in real time or near real time (e.g., as processed by the console 310) for the ablation process In some embodiments, the GUI 1600 includes a front view 1602 of the catheter tip showing different sections 16 04 - 1606 corresponding to different optical viewports at the catheter tip.

[0087] ​​​​​​​​In some embodiments, the front view 1602 of the GUI 1600 shows which optical viewports of the catheter tip are in contact with tissue and which beams from the different optical viewports are active. For example, the dark gray section 1604 of the front view 1602 can indicate strong contact between the catheter and the tissue, the light gray section 1605 can indicate minimal or intermediate contact between the catheter and the tissue, and the white section 1606 can indicate no contact. In some embodiments, the different sections 1604 - 1606 can also indicate which beams are switched on or off for acquiring optical measurements from the tissue. In some embodiments, the dark gray section 1604 and the light gray section 1605 can indicate that the beams from the corresponding optical viewports are turned on, while the white section 1606 can indicate that the corresponding optical viewport is turned off. In some embodiments, the GUI 1600 can further include a plurality of tiles 1608 that show optical readings for each optical viewport section in the catheter. In some embodiments, the plurality of tiles 1608 can correspond to the different sections 1604 - 1606 in the front view 1602. Each tile 1608 represents an optical viewport section in the catheter. and which beams from the different optical viewports are operating. For example, the dark gray section 1604 of the front view 1602 can indicate strong contact between the catheter and the tissue, and the light gray section 1605 can indicate minimal or intermediate contact between the catheter and the tissue, while the white section 1606 can indicate no contact. In some embodiments, the different sections 1604 - 1606 can also indicate which beams are switched on or off to obtain optical measurements from the tissue. In some embodiments, the dark gray section 1604 and the light gray section 16 05 can indicate that the beams from the corresponding optical viewports are turned on, while on the other hand, the white section 1606 can indicate that the corresponding optical viewport is turned off. In some embodiments, the GUI 1600 can further include a plurality of tiles 1608 that show optical readings for each optical viewport section in the catheter. In some embodiments, the plurality of tiles 1608 can correspond to the different sections 1604 - 1606 in the front view 1602. Each tile 1608 represents an optical viewport section in the catheter. contact between the catheter and the tissue, while the white section 1606 can indicate no contact.

[0088] In some embodiments, the GUI 1600 can further include a plurality of tiles 1608 that show optical readings for each optical viewport section in the catheter. In some embodiments, the plurality of tiles 1608 can correspond to the different sections 1604 - 1606 in the front view 1602. Each tile 1608 represents an optical viewport section in the catheter. include a plurality of tiles 1608 that show optical readings for each optical viewport section in the catheter. In some embodiments, the plurality of tiles 1608 can correspond to the different sections 1604 - 1606 in the front view 1602. Each tile 1608 represents an optical viewport section in the catheter. In some embodiments, the GUI 1600 can further include a plurality of tiles 1608 that show optical readings for each optical viewport section in the catheter. In some embodiments, the plurality of tiles 1608 can correspond to the different sections 1604 - 1606 in the front view 1602. Each tile 1608 represents an optical viewport section in the catheter. In some embodiments, the plurality of tiles 1608 can correspond to the different sections 1604 - 1606 in the front view 1602. Each tile 1608 represents an optical viewport section in the catheter. In some embodiments, the plurality of tiles 1608 can correspond to the different sections 1604 - 1606 in the front view 1602. Each tile 1608 represents an optical viewport section in the catheter. The optical signals and / or optical measurements obtained from the yaw can be processed by the console to represent the resulting image. In some embodiments , the individual tiles 1608 can be switched on or off (or may appear or disappear) based on a particular optical viewport section being active at a given time. In some embodiments, the GUI1 600 can include one or more graphs 161 0 indicating ablation energy data (e.g., RF power), birefringence data, phase data, and predicted lesion depth data. In some embodiments, the GUI1600 can include one or more panels or indicators 1612 indicating the occurrence of stable contact between the catheter tip and the tissue, loss of birefringence, status of ablation energy (e.g., on / off), and predicted lesion depth. In some embodiments, the GUI1600 can include one or more buttons or text boxes enabling user selection and / or customization of parameters selected for ablation or for operating the catheter during ablation.

[0089] Exemplary embodiments of a method of operation The catheters, consoles, and systems described herein can be used to perform optical analysis of tissue and prediction of lesion depth. By utilizing the optical analysis and lesion prediction methods described herein, the catheters disclosed herein - A catheter and an optical system (e.g., catheter system 300 and optical system 4 01) can enable the evaluation of lesion formation in tissue in real time or near real time with values of accuracy, sensitivity, and specificity of 93.5%, 92.9%, and 9 6.6% respectively. It is possible to evaluate.

[0090] The various methods and other embodiments of the catheter and system described so far can be implemented using, for example, catheter 100 shown in FIG. 1, system 3 00 (including catheter 302 and console 310) shown in FIG. 3, optical system 4 01 shown in FIG. 4, and the embodiments shown in FIGS. 5 - 16. It can be implemented using the embodiments shown in FIGS. 5 - 16.

[0091] FIG. 17 illustrates an exemplary method 1700 for predicting lesion depth for ablation according to an embodiment of the present disclosure. In some embodiments, method 1700 can be performed by console 310, catheter 302, and / or optical system 401 of FIG. 3 as described herein. In block 1702, ablation can be performed by applying energy from the catheter to a portion of the tissue over a predetermined period of time. In some embodiments, the catheter can include a proximal section, a distal section including a plurality of optical ports, and a sheath connected between the proximal section and the distal section. In some embodiments, the energy applied by the catheter can be pulsed electric field, radio frequency (RF) energy, laser energy, cryogenic energy

[0092] In block 1702, ablation can be performed by applying energy from the catheter to a portion of the tissue over a predetermined period of time. In some embodiments, the catheter can include a proximal section, a distal section including a plurality of optical ports, and a sheath connected between the proximal section and the distal section. In some embodiments, the energy applied by the catheter can be pulsed electric field, radio frequency (RF) energy, laser energy, cryogenic energy In some embodiments, the catheter can include a proximal section, a distal section including a plurality of optical ports, and a sheath connected between the proximal section and the distal section. In some embodiments, the energy applied by the catheter can be pulsed electric field, radio frequency (RF) energy, laser energy, cryogenic energy pulsed electric field, radio frequency (RF) energy, laser energy, cryogenic energy pulsed electric field, radio frequency (RF) energy, laser energy, cryogenic energy or at least one of ultrasonic energy.

[0093] In block 1704, optical measurement data can be obtained from a portion of tissue using at least one of the optical ports in the catheter. In some embodiments the optical measurement data can include one or more optical coherence tomography (OCT) signals and / or optical coherence reflectometry (OCR) signals obtained from a portion of tissue . In some embodiments, the optical measurement data can be obtained by the components shown in the block diagram of FIG. 5, by the optical system 410, and / or by the console 310.

[0094] In block 1706, one or more optical properties of a portion of tissue can be identified by analyzing optical measurement data using a processing device coupled to the catheter . In some embodiments, the one or more optical properties can include at least one of polarization or spectral information (e.g., spectroscopic or imaging information from the tissue).

[0095] In block 1708, the time of tissue degeneration of a portion of tissue can be determined based on one or more optical properties of the portion of tissue. In some embodiments, the time of tissue degeneration can be associated with phase delay measurements and loss of birefringence in tissue below a predetermined threshold .

[0096] In block 1710, a model representing the correlation between lesion depth and ablation time Dell can use the time of denaturation, one or more optical properties, and a period of a predetermined time to generate. In some embodiments, the model can be a linear regression model and can be generated using machine learning algorithms (e.g., support vector machines and / or neural networks, etc.).

[0097] In block 1712, the predicted lesion depth can be generated over a period of a predetermined time using the model. In some embodiments, the predicted lesion depth can represent at least one of the depth and width of a lesion formed by the energy applied to a portion of the tissue by the catheter. In some embodiments, the predicted lesion depth can be a function of the ratio of the period of a predetermined time to the time of denaturation. In some embodiments, the lesion progression of a lesion can be determined by obtaining optical measurement data at a plurality of different angles with respect to a portion of the tissue using a plurality of optical ports in the distal section of the catheter, where each optical port can be positioned at a different location corresponding to each angle in the distal section of the catheter.

[0098] Exemplary computing embodiments FIG. 18 is a block diagram of exemplary components of a computer system 1800. One or more computer systems 1800 can be used, for example, to implement any of the embodiments discussed herein, as well as combinations and sub - combinations thereof. In some embodiments, one or more compu ters can be used to implement any of the embodiments discussed herein, The computer system 1800 can be used to implement the method 1700 shown in FIG. 17 and / or the console 310, signal generator 320, and display 325 as described in this specification. The computer system 1800 can include one or more processors (also referred to as central processing units or CPUs) (e.g., processor 1804, etc.). The processor 1804 can be connected to a communication infrastructure or bus 1806. Also, the computer system 1800 can include a user input / output interface 1802 (e.g., monitor, keyboard, pointing device, etc.), which can communicate with the communication infrastructure 1806 through the user input / output interface 1803. One or more of the processors 1804 can be a graphics processing unit (GPU). In certain embodiments, the GPU can be a processor that is a specialized electronic circuit designed to process mathematically intensive applications. The GPU can have a parallel structure that is efficient for parallel processing of large blocks of data (e.g., mathematically intensive data, images, videos, etc. common to computer graphics applications). Further, the computer system 1800 can include a main memory or primary memory 1808 (e.g., random access memory (RAM), etc.). The processor 1804 can be connected to the communication infrastructure or bus 1806. Also, the computer system 1800 can include a user input / output interface 1802 (e.g., monitor, keyboard, pointing device, etc.), which can communicate with the communication infrastructure 1806 through the user input / output interface 1803.

[0099] One or more of the processors 1804 can be a graphics processing unit (GPU). In certain embodiments, the GPU can be a processor that is a specialized electronic circuit designed to process mathematically intensive applications. The GPU can have a parallel structure that is efficient for parallel processing of large blocks of data (e.g., mathematically intensive data, images, videos, etc. common to computer graphics applications). Also, the computer system 1800 can include a main memory or primary memory 1808 (e.g., random access memory (RAM), etc.). The processor 1804 can be connected to the communication infrastructure or bus 1806. Also, the computer system 1800 can include a user input / output interface 1802 (e.g., monitor, keyboard, pointing device, etc.), which can communicate with the communication infrastructure 1806 through the user input / output interface 1803.

[0100] One or more of the processors 1804 can be a graphics processing unit (GPU). In certain embodiments, the GPU can be a processor that is a specialized electronic circuit designed to process mathematically intensive applications. The GPU can have a parallel structure that is efficient for parallel processing of large blocks of data (e.g., mathematically intensive data, images, videos, etc. common to computer graphics applications). Also, the computer system 1800 can include a main memory or primary memory 1808 (e.g., random access memory (RAM), etc.). The processor 1804 can be connected to the communication infrastructure or bus 1806. Also, the computer system 1800 can include a user input / output interface 1802 (e.g., monitor, keyboard, pointing device, etc.), which can communicate with the communication infrastructure 1806 through the user input / output interface 1803. One or more of the processors 1804 can be a graphics processing unit (GPU). In certain embodiments, the GPU can be a processor that is a specialized electronic circuit designed to process mathematically intensive applications. The GPU can have a parallel structure that is efficient for parallel processing of large blocks of data (e.g., mathematically intensive data, images, videos, etc. common to computer graphics applications). Also, the computer system 1800 can include a main memory or primary memory 1808 (e.g., random access memory (RAM), etc.).

[0101] The processor 1804 can be connected to the communication infrastructure or bus 1806. Also, the computer system 1800 can include a user input / output interface 1802 (e.g., monitor, keyboard, pointing device, etc.), which can communicate with the communication infrastructure 1806 through the user input / output interface 1803. The in-memory 1808 can include one or more levels of cache . The main memory 1808 can have control logic (i.e., computer software) and / or data stored therein. In some embodiments , the main memory 1808 can include optical logic configured to perform analysis of optical measurements obtained from tissue by a catheter and to determine lesion prediction .

[0102] Also, the computer system 1800 can include one or more secondary storage devices or memories 1810. The secondary memory 1810 can include, for example a hard disk drive 1812 and / or a removable storage drive 181 4.

[0103] The removable storage drive 1814 can interact with a removable storage unit 181 8. The removable storage unit 1818 can include a computer-usable or readable storage device , and the storage device can have computer software (control logic ) and / or data stored therein. The removable storage unit 1818 can include a program cartridge and cartridge interface (such as those found in video game devices), a removable memory chip (such as an EPROM or PROM, etc.) and associated socket, a memory stick and USB port , a memory card and associated memory card slot, and / or any other ​ It is possible to be a removable storage unit and a related interface . The removable storage drive 1814 can read from, and / or write to, the removable storage unit 181 8. It is possible to do so.

[0104] The secondary memory 1810 can include other means, devices, components, conveniences, or other approaches to enable computer programs and / or other instructions and / or data to be accessed by the computer system 1800. Such means, devices, components, conveniences, or other approaches can include, for example, the removable storage unit 1822 and the interface 1820. Examples of the removable storage unit 18 22 and the interface 1820 include a program cartridge and a cartridge interface (such as those found in video game devices, etc.), a removable memory chip (such as an EPROM or PROM, etc.) and its associated socket, a memory stick and a USB port, a memory card and its associated memory card slot, and / or any other removable storage unit and its associated interface. The computer system 1800 can further include a communication or network interface 182 4. The communication interface 1824 can (individually and collectively ... ... ... ... and the like).

[0105] ... ... collectively (as referenced by reference numeral 1828)) with external devices, external networks and can enable the computer system 1800 to communicate and interact with any combination such as external entities. For example, communication interface 1 824 can enable the computer system 1800 to communicate with an external or remote device 1828 via a communication path 1826, and the communication path 1826 can be wired and / or wireless (or a combination thereof), which can include any combination such as LAN, WAN, the Internet, etc. Control logic and / or data can be transmitted to and from the computer system 1800 via the communication path 1826. In some embodiments, the computer system 1800 can be connected to a catheter via connectors and optical and electrical connections (including optical fibers and electrical wires, pins, and / or components) at the communication interface 1824. In some embodiments, the computer system 1800 can be connected to a catheter via connectors and optical and electrical connections (including optical fibers and electrical wires, pins, and / or components) at the communication interface 1824. In some embodiments, the computer system 1800 can be connected to a catheter via connectors and optical and electrical connections (including optical fibers and electrical wires, pins, and / or components) at the communication interface 1824. In some embodiments, the computer system 1800 can be connected to a catheter via connectors and optical and electrical connections (including optical fibers and electrical wires, pins, and / or components) at the communication interface 1824.

[0106] Also, the computer system 1800 can be, by way of some non-limiting examples, a personal digital assistant (PDA), a desktop workstation, a laptop computer or notebook computer, a netbook, a tablet, a smart phone, a smartwatch or other wearable, a household appliance, a part of the Internet of Things, and / or an embedded system, or any combination thereof. Also, the computer system 1800 can be, by way of some non-limiting examples, a personal digital assistant (PDA), a desktop workstation, a laptop

[0107] The computer system 1800 can be a client or a server and, without limitation, can be a remote or distributed cloud computing solution, a local or on-premises software (an "on-premises" cloud-based solution), a "as-a-service" model (e.g., Content as a Service (CaaS), Digital Content as a Service (DCaaS), Software as a Service (SaaS), Managed Software as a Service (MSaaS), Platform as a Service (PaaS), Desktop as a Service (DaaS), Framework as a Service (FaaS), Backend as a Service (BaaS), Mobile Backend as a Service (MBaaS), Infrastructure as a Service (IaaS), etc.), and / or a hybrid model including any combination of the foregoing examples or other services or delivery paradigms, and can access or host any application and / or data through any delivery paradigm. Any applicable data structures, file formats, and schemas in the computer system 1800 include, without limitation, JavaScript Object Notation (JSON), Extensible Markup Language (XML), Yet Another Markup Language (YAML), Extensible Hypertext Markup Language (XHTML), Wireless Markup Language (WML), M

[0108] ​​​​​​​​​​​​​​​​​ MessagePack, XML User Interface Language (X UL), or any other functionally similar representation, either alone or in combination, may be derived from a standard and may alternatively, exclusively, or in combination with known or open standards, use a proprietary data structure, format, or scheme obtained.

[0109] In some embodiments, a tangible non - transitory computer - usable or readable medium having control logic (software) stored thereon is a tangible non - transitory device or article of manufacture, which may also be referred to herein as a computer program product or a program storage device. This includes, but is not limited to, a tangible article of manufacture embodying the computer system 18 00, main memory 1808, secondary memory 1810, and removable storage units 1818 and 1822, and any combination of the foregoing. Such control logic, when executed by one or more data processing devices (such as computer system 1800, etc.), can cause such data processing devices to operate as described herein

[0110] It should be recognized that the detailed description section (and not the abstract and summary sections of the invention) is intended to be used to construe the claims ​​​​​​​​One or more (but not all) exemplary embodiments of the present disclosure may be described, and thus are not intended to limit the present disclosure and the appended claims in any way. The embodiments of the present disclosure have been described above with the aid of functional building blocks that illustrate the implementation of its particular functions and relationships. The boundaries of these functional building blocks have been arbitrarily defined herein for the sake of convenience of explanation. Alternative boundaries may be defined as long as the particular functions and relationships are properly implemented. The foregoing description of specific embodiments fully reveals the general nature of the present disclosure, so that others can, by applying the knowledge within the skills of the art, readily modify and / or adapt such specific embodiments for various applications without undue experimentation, without departing from the general concept of the present disclosure. Accordingly, such adaptations and modifications are intended to be within the meaning and scope of the disclosed embodiments, based on the teachings and guidance presented herein. It should be understood that the terminology or jargon herein is for the purpose of explanation and not of limitation, and that such terminology or jargon should be interpreted by those skilled in the art in accordance with the teachings and guidance.

[0111] The embodiments of the present disclosure have been described above with the aid of functional building blocks that illustrate the implementation of its particular functions and relationships. The boundaries of these functional building blocks have been arbitrarily defined herein for the sake of convenience of explanation. Alternative boundaries may be defined as long as the particular functions and relationships are properly implemented. The foregoing description of specific embodiments fully reveals the general nature of the present disclosure, so that others can, by applying the knowledge within the skills of the art, readily modify and / or adapt such specific embodiments for various applications without undue experimentation, without departing from the general concept of the present disclosure. Accordingly, such adaptations and modifications are intended to be within the meaning and scope of the disclosed embodiments, based on the teachings and guidance presented herein. It should be understood that the terminology or jargon herein is for the purpose of explanation and not of limitation, and that such terminology or jargon should be interpreted by those skilled in the art in accordance with the teachings and guidance. The foregoing description of specific embodiments fully reveals the general nature of the present disclosure, so that others can, by applying the knowledge within the skills of the art, readily modify and / or adapt such specific embodiments for various applications without undue experimentation, without departing from the general concept of the present disclosure. Accordingly, such adaptations and modifications are intended to be within the meaning and scope of the disclosed embodiments, based on the teachings and guidance presented herein. It should be understood that the terminology or jargon herein is for the purpose of explanation and not of limitation, and that such terminology or jargon should be interpreted by those skilled in the art in accordance with the teachings and guidance. The foregoing description of specific embodiments fully reveals the general nature of the present disclosure, so that others can, by applying the knowledge within the skills of the art, readily modify and / or adapt such specific embodiments for various applications without undue experimentation, without departing from the general concept of the present disclosure. Accordingly, such adaptations and modifications are intended to be within the meaning and scope of the disclosed embodiments, based on the teachings and guidance presented herein. It should be understood that the terminology or jargon herein is for the purpose of explanation and not of limitation, and that such terminology or jargon should be interpreted by those skilled in the art in accordance with the teachings and guidance.

[0112] The foregoing description of specific embodiments fully reveals the general nature of the present disclosure, so that others can, by applying the knowledge within the skills of the art, readily modify and / or adapt such specific embodiments for various applications without undue experimentation, without departing from the general concept of the present disclosure. Accordingly, such adaptations and modifications are intended to be within the meaning and scope of the disclosed embodiments, based on the teachings and guidance presented herein. It should be understood that the terminology or jargon herein is for the purpose of explanation and not of limitation, and that such terminology or jargon should be interpreted by those skilled in the art in accordance with the teachings and guidance. The foregoing description of specific embodiments fully reveals the general nature of the present disclosure, so that others can, by applying the knowledge within the skills of the art, readily modify and / or adapt such specific embodiments for various applications without undue experimentation, without departing from the general concept of the present disclosure. Accordingly, such adaptations and modifications are intended to be within the meaning and scope of the disclosed embodiments, based on the teachings and guidance presented herein. It should be understood that the terminology or jargon herein is for the purpose of explanation and not of limitation, and that such terminology or jargon should be interpreted by those skilled in the art in accordance with the teachings and guidance. The foregoing description of specific embodiments fully reveals the general nature of the present disclosure, so that others can, by applying the knowledge within the skills of the art, readily modify and / or adapt such specific embodiments for various applications without undue experimentation, without departing from the general concept of the present disclosure. Accordingly, such adaptations and modifications are intended to be within the meaning and scope of the disclosed embodiments, based on the teachings and guidance presented herein. It should be understood that the terminology or jargon herein is for the purpose of explanation and not of limitation, and that such terminology or jargon should be interpreted by those skilled in the art in accordance with the teachings and guidance. The foregoing description of specific embodiments fully reveals the general nature of the present disclosure, so that others can, by applying the knowledge within the skills of the art, readily modify and / or adapt such specific embodiments for various applications without undue experimentation, without departing from the general concept of the present disclosure. Accordingly, such adaptations and modifications are intended to be within the meaning and scope of the disclosed embodiments, based on the teachings and guidance presented herein. It should be understood that the terminology or jargon herein is for the purpose of explanation and not of limitation, and that such terminology or jargon should be interpreted by those skilled in the art in accordance with the teachings and guidance. The foregoing description of specific embodiments fully reveals the general nature of the present disclosure, so that others can, by applying the knowledge within the skills of the art, readily modify and / or adapt such specific embodiments for various applications without undue experimentation, without departing from the general concept of the present disclosure. Accordingly, such adaptations and modifications are intended to be within the meaning and scope of the disclosed embodiments, based on the teachings and guidance presented herein. It should be understood that the terminology or jargon herein is for the purpose of explanation and not of limitation, and that such terminology or jargon should be interpreted by those skilled in the art in accordance with the teachings and guidance. The foregoing description of specific embodiments fully reveals the general nature of the present disclosure, so that others can, by applying the knowledge within the skills of the art, readily modify and / or adapt such specific embodiments for various applications without undue experimentation, without departing from the general concept of the present disclosure. Accordingly, such adaptations and modifications are intended to be within the meaning and scope of the disclosed embodiments, based on the teachings and guidance presented herein. It should be understood that the terminology or jargon herein is for the purpose of explanation and not of limitation, and that such terminology or jargon should be interpreted by those skilled in the art in accordance with the teachings and guidance. The foregoing description of specific embodiments fully reveals the general nature of the present disclosure, so that others can, by applying the knowledge within the skills of the art, readily modify and / or adapt such specific embodiments for various applications without undue experimentation, without departing from the general concept of the present disclosure. Accordingly, such adaptations and modifications are intended to be within the meaning and scope of the disclosed embodiments, based on the teachings and guidance presented herein. It should be understood that the terminology or jargon herein is for the purpose of explanation and not of limitation, and that such terminology or jargon should be interpreted by those skilled in the art in accordance with the teachings and guidance. The foregoing description of specific embodiments fully reveals the general nature of the present disclosure, so that others can, by applying the knowledge within the skills of the art, readily modify and / or adapt such specific embodiments for various applications without undue experimentation, without departing from the general concept of the present disclosure. Accordingly, such adaptations and modifications are intended to be within the meaning and scope of the disclosed embodiments, based on the teachings and guidance presented herein. It should be understood that the terminology or jargon herein is for the purpose of explanation and not of limitation, and that such terminology or jargon should be interpreted by those skilled in the art in accordance with the teachings and guidance. The foregoing description of specific embodiments fully reveals the general nature of the present disclosure, so that others can, by applying the knowledge within the skills of the art, readily modify and / or adapt such specific embodiments for various applications without undue experimentation, without departing from the general concept of the present disclosure. Accordingly, such adaptations and modifications are intended to be within the meaning and scope of the disclosed embodiments, based on the teachings and guidance presented herein. It should be understood that the terminology or jargon herein is for the purpose of explanation and not of limitation, and that such terminology or jargon should be interpreted by those skilled in the art in accordance with the teachings and guidance. The scope and range of the present disclosure should not be limited by any of the exemplary embodiments described above, but should be defined only by the following claims and their equivalents.

[0113] The scope and range of the present disclosure should not be limited by any of the exemplary embodiments described above, but should be defined only by the following claims and their equivalents. The scope and range of the present disclosure should not be limited by any of the exemplary embodiments described above, but should be defined only by the following claims and their equivalents. should be defined.

[0114] Moreover, the following aspects are explicitly disclosed:

[0115] 1. A step of performing ablation by applying energy from a catheter to a part of the tissue over a predetermined period of time, wherein the catheter includes a proximal section, a distal section including a plurality of optical ports, and a sheath connected between the proximal section and the distal section, the step of using at least one optical port in the catheter to obtain optical measurement data from a part of the tissue, the step of analyzing the optical measurement data using a processing device connected to the catheter to identify one or more optical properties of a part of the tissue, and the step of determining the time of denaturation of a part of the tissue based on one or more optical properties of a part of the tissue, and the step of including a sheath connected between the proximal section and the distal section, the step of using at least one optical port in the catheter to obtain optical measurement data from a part of the tissue, the step of analyzing the optical measurement data using a processing device connected to the catheter to identify one or more optical properties of a part of the tissue, and the step of determining the time of denaturation of a part of the tissue based on one or more optical properties of a part of the tissue, and a method including. Using at least one optical port in the catheter to obtain optical measurement data from a part of the tissue, the step of using a processing device connected to the catheter to analyze the optical measurement data to identify one or more optical properties of a part of the tissue, and the step of determining the time of denaturation of a part of the tissue based on one or more optical properties of a part of the tissue, and a method including. A method including.

[0116] 2. The energy applied by the catheter includes at least one of pulsed electric field, radio frequency (RF) energy, laser energy, or cryogenic energy, the method according to aspect 1. The energy applied by the catheter includes at least one of pulsed electric field, radio frequency (RF) energy, laser energy, or cryogenic energy, the method according to aspect 1. The method according to aspect 1, wherein the energy applied by the catheter includes at least one of pulsed electric field, radio frequency (RF) energy, laser energy, or cryogenic energy.

[0117] 3. The optical measurement data includes optical coherence tomography (OCT) signals or optical coherence reflectometry (OCR) signals obtained from a part of the tissue, and one or more optical properties include at least one of polarization or spectral information, the method according to aspect 1 or aspect 2. The optical measurement data includes optical coherence tomography (OCT) signals or optical coherence reflectometry (OCR) signals obtained from a part of the tissue, and one or more optical properties include at least one of polarization or spectral information, the method according to aspect 1 or aspect 2. The method according to aspect 1 or aspect 2, wherein the optical measurement data includes optical coherence tomography (OCT) signals or optical coherence reflectometry (OCR) signals obtained from a part of the tissue, and one or more optical properties include at least one of polarization or spectral information. The method according to aspect 1 or aspect 2, wherein the optical measurement data includes optical coherence tomography (OCT) signals or optical coherence reflectometry (OCR) signals obtained from a part of the tissue, and one or more optical properties include at least one of polarization or spectral information.

[0118] 4. Using the denaturation time, one or more optical properties, and a period of a predetermined time to generate a model representing the correlation between the lesion depth and the ablation time and the step of using the model to generate a predicted lesion depth over a period of a predetermined time and The method according to any one of aspects 1 to 3, further comprising

[0119] 5. The predicted lesion depth represents at least one of the depth and width of the lesion formed by the energy applied to a portion of the tissue by the catheter, according to aspect 4 The method described in

[0120] 6. The predicted lesion depth is a function of the ratio of the period of a predetermined time to the denaturation time, according to aspect 5 The method described

[0121] 7. Determining the lesion progression of the lesion by obtaining optical measurement data at a plurality of different angles with respect to a portion of the tissue using a plurality of optical ports, wherein each optical port is positioned at a different angle in the distal section of the catheter and the step of The method according to aspect 5, further comprising

[0122] 8. The method according to aspect 4, further comprising the step of selecting at least one optical port in the catheter for obtaining optical measurement data

[0123] 9. The plurality of optical ports includes 15 optical ports, and at least one optical port includes three or more optical ports, according to aspect 8

[0124] The method described ​​10. Based on identifying optical signals received from three or more optical ports, a step of determining a portion of the distal section of the catheter that is in contact with a portion of the tissue during ablation, and based on the determining step, a step of estimating a contact force between the portion of the distal section of the catheter and the portion of the tissue, and based on the contact force, a step of further determining a time of denaturation of the portion of the tissue, The method according to aspect 9, further comprising.

[0125] 11. A system, a catheter including a proximal section, a distal section, and a sheath connected between the proximal section and the distal section, a plurality of optical fibers positioned within the catheter, and a computing device connected to the plurality of optical fibers through a connector, the computing device including a memory and a processor, the computing device, wherein the processor is configured to receive optical measurement data of a portion of the tissue from the optical fibers during or after ablation, configured to identify one or more optical characteristics of a portion of the tissue by analyzing the optical measurement data, configured to determine a time of denaturation of a portion of the tissue based on one or more optical characteristics of the portion of the tissue, configured to generate a model representing a correlation between lesion depth and ablation time using the time of denaturation, one or more optical characteristics, and a predetermined time period, and configured to use the time of denaturation, one or more optical characteristics, and a predetermined time period to generate a model representing a correlation between lesion depth and ablation time, wherein configured to generate a predicted lesion depth over a predetermined ablation time using a model, a system.

[0126] 12. The optical measurement data includes an optical coherence tomography (OCT) signal or an optical coherence reflectometry (OCR) signal obtained from a portion of tissue, and one or more optical properties include at least one of polarization or spectral information, an aspect of the system according to 11.

[0127] 13. The predicted lesion depth represents at least one of the depth and width of a lesion formed by energy applied to a portion of tissue by a catheter, and the predicted lesion depth is a function of a ratio of a predetermined time period to the time of denaturation, an aspect 11 or the system according to aspect 12.

[0128] 14. The distal section of the catheter includes a plurality of optical ports, and a processor of a computing device is further configured to determine the lesion progression of a lesion by obtaining optical measurement data at a plurality of different angles with respect to a portion of tissue using the plurality of optical ports, and each optical port is positioned at a different angle in the distal section of the catheter, the system according to aspect 13.

[0129] 15. The connector includes a plurality of V-shaped grooves for alignment of respective optical fibers for connection between the catheter and the computing device, an aspect of the system according to any one of 11 to 14.

[0130] 16. A computing device,​​​​​​​ a memory, and a processor coupled to the memory, wherein the processor is configured to: apply energy to a portion of tissue over a predetermined period of time during ablation, and after that, receive optical measurement data of the portion of tissue from a catheter, identify one or more optical properties of the portion of tissue by analyzing the optical measurement data, determine a denaturation time of the portion of tissue based on the one or more optical properties of the portion of tissue, generate a model representing a correlation between lesion depth and ablation time using the denaturation time, the one or more optical properties, and the predetermined period of time, and use the model to generate a predicted lesion depth over the predetermined period of time. 17. The computing device according to aspect 16, wherein the optical measurement data includes an optical coherence tomography (OCT) signal or an optical coherence reflectometry (OCR) signal obtained from a portion of tissue, and the one or more optical properties include at least one of polarization or spectral information. 18. The computing device according to aspect 16, wherein the predicted lesion depth represents at least one of a depth and a width of a lesion formed by the energy applied to the portion of tissue by the catheter, and the predicted lesion depth is a function of a ratio of the predetermined period of time to the denaturation time. 19. The computing device according to aspect 16, wherein the predicted lesion depth represents at least one of a depth and a width of a lesion formed by the energy applied to the portion of tissue by the catheter, and the predicted lesion depth is a function of a ratio of the predetermined period of time to the denaturation time. 20. The computing device according to aspect 16, wherein the predicted lesion depth represents at least one of a depth and a width of a lesion formed by the energy applied to the portion of tissue by the catheter, and the predicted lesion depth is a function of a ratio of the predetermined period of time to the denaturation time. 21. The computing device according to aspect 16, wherein the predicted lesion depth represents at least one of a depth and a width of a lesion formed by the energy applied to the portion of tissue by the catheter, and the predicted lesion depth is a function of a ratio of the predetermined period of time to the denaturation time. 22. The computing device according to aspect 16, wherein the predicted lesion depth represents at least one of a depth and a width of a lesion formed by the energy applied to the portion of tissue by the catheter, and the predicted lesion depth is a function of a ratio of the predetermined period of time to the denaturation time. 23. The computing device according to aspect 16, wherein the predicted lesion depth represents at least one of a depth and a width of a lesion formed by the energy applied to the portion of tissue by the catheter, and the predicted lesion depth is a function of a ratio of the predetermined period of time to the denaturation time.

[0131]

[0132] ​​​​​​​Or the computing device according to aspect 17.

[0133] 19. The catheter includes a plurality of optical ports in the distal section of the catheter , and the processor is further configured to determine the lesion progression of the lesion by acquiring optical measurement data at a plurality of different angles with respect to a portion of the tissue using the plurality of optical ports , and each optical port is positioned at a different angle in the distal section of the catheter, the computing device according to aspect 18.

[0134] 20. The processor is further configured to determine a portion of the distal section of the catheter in contact with a portion of the tissue during ablation based on identifying an optical signal received from at least one of the plurality of optical ports , and is further configured to estimate a contact force between the portion of the distal section of the catheter and the portion of the tissue based on the determination , and is further configured to further determine a time of denaturation of a portion of the tissue based on the contact force, the computing device according to aspect 19.

Explanation of reference numerals

[0135] 100 Catheter 102 Proximal section 104 Distal section 106 Sheath 106a Sheath 106b Sheath 108 Processing device 110 Communication interface 202 Irrigation channel 206 Deflection mechanism 208 Electrical connection 210 Optical transmission medium 212 Protective cover 300 System 302 Catheter 304 Patient 310 Console 312 Optical connection 314 Electrical connection 316 Communication interface 320 Signal generator 325 Display 330 Irrigation pump 401 Optical system 402 Optical source 403 Polarization splitter 404 Coupling / splitting element 406 Sample arm 407 Polarization switch 408 Reference arm 409 Optical switch 410 Output fiber 412 Delay unit 414 Detector 420 Sample 600 Connector 602 V-shaped groove 1600 Graphical user interface (GUI) 1602 Front view 1604 Dark gray section 1605 Light gray section 1606 White section 1608 Tile 1610 Graph 1612 Panel, indicator 1800 Computer system 1802 User input / output interface 1803 User input / output device 1804 Processor 1806 Communication infrastructure 1808 Main memory 1810 Secondary Memory 1812 Hard Disk Drive 1814 Removable Storage Drive 1818 Removable Storage Unit 1820 Interface 1822 Removable Storage Unit 1824 Communication Interface 1826 Communication Path 1828 Remote Device, Network, Entity

Claims

1. A system comprising: a catheter including a proximal section, a distal section, and a sheath connected between the proximal section and the distal section; a plurality of optical fibers positioned within the catheter; a computing device connected to the plurality of optical fibers through a connector, the computing device including a memory and a processor; and the processor is configured to: receive optical measurement data of a portion of the tissue from the optical fibers after applying energy to the portion of the tissue over a predetermined period of time during ablation; identify one or more optical properties of the portion of the tissue by analyzing the optical measurement data; determine a denaturation time of the portion of the tissue based on the one or more optical properties of the portion of the tissue; generate a model representing a correlation between lesion depth and ablation time using the denaturation time, the one or more optical properties, and the predetermined period of time; and use the model to generate a predicted lesion depth over the predetermined period of time.

2. The system of claim 1, wherein the optical measurement data includes an optical coherence tomography (OCT) signal or an optical coherence reflectometry (OCR) signal obtained from a portion of the tissue, and the one or more optical properties include at least one of polarization or spectral information.

3. The system of claim 1, wherein the predicted lesion depth represents at least one of a depth and a width of a lesion formed by the energy applied to the portion of the tissue by the catheter, and the predicted lesion depth is a function of a ratio of the predetermined period of time to the denaturation time.

4. The distal section of the catheter includes a plurality of optical ports, and the processor of the computing device is further configured to determine the lesion progression of the lesion by using the plurality of optical ports to obtain the optical measurement data at a plurality of different angles with respect to a portion of the tissue, wherein each optical port is positioned at a different angle in the distal section of the catheter. The system according to claim 3.

5. The connector includes a plurality of V-shaped grooves for alignment of respective optical fibers for connection between the catheter and the computing device. The system according to claim 1.

6. A computing device, a memory, a processor coupled to the memory and includes The processor receives optical measurement data of a portion of the tissue from the catheter after applying energy to the portion of the tissue over a predetermined period of time during ablation, identifies one or more optical properties of the portion of the tissue by analyzing the optical measurement data, determines the time of degeneration of the portion of the tissue based on the one or more optical properties of the portion of the tissue, uses the time of degeneration, the one or more optical properties, and the predetermined period of time to generate a model representing the correlation between lesion depth and ablation time, A computing device configured to generate a predicted lesion depth over the predetermined period of time using the model.

7. The optical measurement data includes an optical coherence tomography (OCT) signal or an optical coherence reflectometry (OCR) signal obtained from a portion of the tissue, and the one or more optical properties include at least one of polarization or spectral information. The computing device according to claim 6.

8. The predicted lesion depth represents at least one of the depth and width of the lesion formed by the energy applied to the portion of the tissue by the catheter, and the predicted lesion depth is a function of the ratio of the predetermined period of time to the time of degeneration. The computing device according to claim 6.

9. The catheter includes a plurality of optical ports in the distal section of the catheter, and the processor is further configured to determine the lesion progression of the lesion by using the plurality of optical ports to obtain the optical measurement data at a plurality of different angles with respect to a portion of the tissue, and each optical port is positioned at a different angle in the distal section of the catheter. The computing device according to claim 8.

10. The processor is configured to determine a portion of the distal section of the catheter in contact with a portion of the tissue during the ablation based on identifying an optical signal received from at least one of the plurality of optical ports, estimate a contact force between the portion of the distal section of the catheter and a portion of the tissue based on the determining, and further configured to further determine a time of denaturation of a portion of the tissue based on the contact force. The computing device according to claim 6.

11. A method of operating a system according to any one of claims 1 to 5, comprising: obtaining optical measurement data from a portion of the tissue using at least one optical port in the catheter by the processor; identifying one or more optical properties of a portion of the tissue by the processor analyzing the optical measurement data using a processing device coupled to the catheter; determining a time of denaturation of a portion of the tissue by the processor based on the one or more optical properties of the portion of the tissue The method includes.

12. The energy applied by the catheter includes at least one of pulsed electric field, radio frequency (RF) energy, laser energy, and cryogenic energy. The method according to claim 11.

13. The optical measurement data includes an optical coherence tomography (OCT) signal or an optical coherence reflectometry (OCR) signal obtained from a portion of the tissue, and the one or more optical properties include at least one of polarization or spectral information. The method according to claim 11.

14. The processor generating a model representing a correlation between lesion depth and ablation time using the time of the denaturation, the one or more optical properties, and the period of the predetermined time; The processor using the model to generate a predicted lesion depth over the period of the predetermined time; The method of claim 11, further comprising. **Claim 15** The method of claim 14, wherein the predicted lesion depth represents at least one of a depth and a width of a lesion formed by the energy applied to a portion of the tissue by the catheter. **Claim 16** The method of claim 15, wherein the predicted lesion depth is a function of a ratio of the period of the predetermined time to the time of the denaturation. **Claim 17** The processor determining a lesion progression of the lesion by obtaining the optical measurement data at a plurality of different angles with respect to a portion of the tissue using the plurality of optical ports, wherein each optical port is positioned at a different angle in the distal section of the catheter; the method of claim 15, further comprising the step. **Claim 18** The method of claim 14, wherein at least one optical port in the catheter is selected to obtain the optical measurement data. **Claim 19** The method of claim 18, wherein the plurality of optical ports includes 15 optical ports, and the at least one optical port includes three or more optical ports. **Claim 20** The processor determining a portion of the distal section of the catheter in contact with a portion of the tissue during the ablation based on identifying optical signals received from the three or more optical ports; The processor estimating a contact force between the portion of the distal section of the catheter and a portion of the tissue based on the determining step; The processor further determining the time of denaturation of the portion of the tissue based on the contact force; The method of claim 19, further comprising.

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