Catheter-based birefringence mapping for ablation procedures

Abstract

Systems, methods, and computer readable media for catheter-based birefringence mapping for ablation procedures are described herein. A system includes a catheter including an optical fiber coupled with a computing device including a processor that can use optical measurements, in particular birefringence measurements, to create a three-dimensional map showing optical properties of tissue, and a mapping system.

Description

Technical Field

[0001] Aspects of the present disclosure relate to assemblies, systems, and methods for collecting tissue birefringence measurements using a catheter and console device and mapping the birefringence measurements on a three-dimensional map of the tissue. Background Art

[0002] Ablation is a medical technique used to produce tissue necrosis. It is used to help treat different pathologies including cancer, Barret's esophagus or cardiac arrhythmias, among others. The application of ablative energy denatures large biomolecules including proteins such as collagen, myosin or elastin. Ablation is traditionally performed by applying an alternating potential to the tip of a catheter in contact with the tissue to be treated within the patient's body.

[0003] The effectiveness of ablation depends on several factors, including the applied power, the quality of the electrical contact, local tissue properties, the presence of blood flow near the tissue surface, and the effectiveness of irrigation. Due to the variability of these parameters, it can be difficult to obtain consistent results and understand the effectiveness of ablation in tissue using current systems and methods for ablation.

[0004] Thus, such systems and methods may be limited due to difficulties and challenges in evaluating the results of ablation in tissue, such as identifying lesions formed in tissue and determining various properties of the lesions through a catheter. Summary of the invention

[0005] In addition, the following aspects are explicitly disclosed:

[0006] Aspect 1: A method comprising: receiving, by one or more processors, a three-dimensional map of an organ of an animal, wherein the three-dimensional map comprises coordinates; receiving, by the one or more processors, optical measurements of tissue in the organ and the location of the optical measurements in the organ from a catheter comprising an optical fiber; determining, by the one or more processors, coordinates in the three-dimensional map corresponding to the location of the optical measurements; extracting, by the one or more processors, birefringence measurements from the optical measurements; generating, by the one or more processors, a visual representation of the birefringence measurements; and modifying, by the one or more processors, the three-dimensional map at the coordinates to show the visual representation of the birefringence measurements at the coordinates, the modification creating a modified three-dimensional map.

[0007] Aspect 2: The method according to aspect 1, further comprising: displaying the modified three-dimensional map on a computing device by the one or more processors.

[0008] Aspect 3: The method according to aspect 1 further comprises: adjusting the birefringence measurement results by the one or more processors to correct for any movement of the catheter; and adjusting the birefringence measurement results by the one or more processors to correct for any movement of the organ.

[0009] Aspect 4: The method of aspect 1, wherein the visual representation of the birefringence measurement comprises a color gradient and a chromaticity gradient applied to the three-dimensional map.

[0010] Aspect 5: A method according to Aspect 1, wherein the optical measurement result is a first optical measurement result, and the method further includes: receiving, by the one or more processors, a second optical measurement result and a second position of tissue in the organ from the catheter, the second position being the position of the second optical measurement in the organ; determining, by the one or more processors, a second coordinate corresponding to the second position in the three-dimensional map; extracting, by the one or more processors, a second birefringence measurement result from the second optical measurement result; generating, by the one or more processors, a second visual representation, the second visual representation having the second birefringence measurement result; and modifying, by the one or more processors, the modified three-dimensional map at the second coordinate to show the second visual representation at the second coordinate.

[0011] Aspect 6: The method of aspect 1, wherein the visual representation represents birefringence measurements at multiple depths in the tissue at the location.

[0012] Aspect 7: A system comprising: a catheter, wherein the catheter collects optical measurements of a portion of tissue in an organ of an animal and the location of the optical measurements in the organ; a plurality of optical fibers, the plurality of optical fibers being positioned within the catheter; a positioning sensor, the positioning sensor being positioned within the catheter; and a computing device, the computing device being coupled to the plurality of optical fibers via a connector, the computing device comprising a processor and a memory, the memory having instructions stored thereon, the instructions, when executed by the processor, causing the processor to: receive, by the processor, a three-dimensional map of the organ, wherein the three-dimensional map comprises coordinates; receive, from the optical fibers, the optical measurements collected from the catheter; receive, from the positioning sensor, the location of the optical measurements collected from the catheter; determine, by the processor, coordinates in the three-dimensional map corresponding to the location of the optical measurements; extract, by the processor, birefringence measurements from the optical measurements; generate, by the processor, a visual representation of the birefringence measurements; and modify, by the processor, the three-dimensional map at the coordinates to show the visual representation of the birefringence measurements at the coordinates, the modification creating a modified three-dimensional map.

[0013] Aspect 8: The system of aspect 7, wherein the instructions further cause the processor to: display, by the processor, the modified three-dimensional map on the computing device.

[0014] Aspect 9: The system of aspect 7, the instructions further causing the processor to: adjust, by the processor, the birefringence measurements to correct for any movement of the catheter; and adjust, by the processor, the birefringence measurements to correct for any movement of the organ.

[0015] Aspect 10: The system of aspect 7, wherein the visual representation of the birefringence measurement comprises a color gradient and a chromaticity gradient applied to the three-dimensional map.

[0016] Aspect 11: A system according to Aspect 7, wherein the optical measurement result is a first optical measurement result, and the instructions further cause the processor to: receive, by the processor, a second optical measurement result and a second position of tissue in the organ from the catheter, the second position being the position of the second optical measurement result in the organ; determine, by the processor, a second coordinate corresponding to the second position in the three-dimensional map; extract, by the processor, a second birefringence measurement result from the second optical measurement result; generate, by the processor, a second visual representation, the second visual representation having the second birefringence measurement result; and modify, by the processor, the modified three-dimensional map at the second coordinate to show the second visual representation at the second coordinate.

[0017] Aspect 12: The system of aspect 7, wherein the visual representation represents birefringence measurements at multiple depths in the tissue at the location.

[0018] Aspect 13: A system according to Aspect 7, wherein the catheter includes a distal segment, a proximal segment, and a sheath coupled between the proximal segment and the distal segment, wherein the distal segment includes a tip having a plurality of optical ports and a positioning sensor, wherein the optical ports collect the optical measurements and the positioning sensor collects the positioning.

[0019] Aspect 14: A non-transitory computer-readable device having instructions stored thereon, which, when executed by at least one computing device, cause the at least one computing device to perform operations including: receiving a three-dimensional map of an organ of an animal, wherein the three-dimensional map includes coordinates; receiving optical measurements of tissue in the organ and the location of the optical measurements in the organ from a catheter including an optical fiber; determining coordinates in the three-dimensional map corresponding to the location of the optical measurements; extracting birefringence measurements from the optical measurements; generating a visual representation of the birefringence measurements; and modifying the three-dimensional map at the coordinates to show the visual representation of the birefringence measurements at the coordinates, the modification creating a modified three-dimensional map.

[0020] Aspect 15: The non-transitory computer-readable device of aspect 14, the operations further comprising: displaying the modified three-dimensional map on a computing device.

[0021] Aspect 16: The non-transitory computer readable device of aspect 14, the operations further comprising: adjusting the birefringence measurements to correct for any movement of the catheter; and adjusting the birefringence measurements to correct for any movement of the organ.

[0022] Aspect 17: The non-transitory computer readable device of aspect 14, wherein the visual representation of the birefringence measurement comprises a color gradient and a chromaticity gradient applied to the three-dimensional map.

[0023] Aspect 18: A non-transitory computer-readable device according to Aspect 14, wherein the optical measurement result is a first optical measurement result, and the operation further includes: receiving a second optical measurement result and a second position of the tissue in the organ from the catheter, the second position being the position of the second optical measurement result in the organ; determining a second coordinate in the three-dimensional map corresponding to the second position; extracting a second birefringence measurement result from the second optical measurement result; generating a second visual representation, the second visual representation having the second birefringence measurement result; and modifying the modified three-dimensional map at the second coordinate to show the second visual representation at the second coordinate.

[0024] Aspect 19: The non-transitory computer readable device of aspect 14, wherein the visual representation represents birefringence measurements at multiple depths in the tissue at the location.

[0025] Aspect 20: A non-transitory computer-readable device according to Aspect 14, wherein the catheter includes a distal segment, a proximal segment, and a sheath coupled between the proximal segment and the distal segment, wherein the distal segment includes a tip having a plurality of optical ports and a positioning sensor, wherein the optical ports collect the optical measurements and the positioning sensor collects the positioning. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The accompanying drawings, which are incorporated herein and form a part of this specification, illustrate the present invention and, together with the description, further explain the principles of the invention and enable those skilled in the relevant art to make and use the invention.

[0027] Figure 1 An example diagram of a system for ablation and lesion prediction in accordance with aspects of the present disclosure is presented.

[0028] Figure 2A An example diagram of a catheter according to aspects of the present disclosure is shown.

[0029] Figure 2B A diagram of an example distal section of a monopolar catheter according to aspects of the present disclosure is shown.

[0030] Figure 2C A diagram of an example distal section of a bipolar catheter according to aspects of the present disclosure is shown.

[0031] Figure 3A and 3B A cross-section of a catheter according to an embodiment of the present disclosure is shown.

[0032] Figure 4A A diagram of an example OCT and / or OCR system having multiple optical components according to an embodiment of the present disclosure is shown.

[0033] Figure 4B An example block diagram illustrating a complete chain of data acquisition integration of optical signals in accordance with aspects of the present disclosure is presented.

[0034] Figure 5 Example methods for mapping optical measurements on a three-dimensional map according to aspects of the present disclosure are presented.

[0035] Figure 6 Example methods for mapping birefringence measurements on a three-dimensional map according to aspects of the present disclosure are presented.

[0036] Figure 7 Examples of three-dimensional graphs showing birefringence measurements according to aspects of the present disclosure are presented.

[0037] Figure 8A block diagram illustrating example components of a computer system according to aspects of the present disclosure is presented.

[0038] Fig. 9 Examples of placement of orthogonal skin patches in accordance with aspects of the present disclosure are shown.

[0039] Aspects of the present invention will be described with reference to the accompanying drawings.The drawing in which an element first appears is generally indicated by the leftmost digit(s) in the corresponding reference number. DETAILED DESCRIPTION

[0040] During an ablation (e.g., radiofrequency ablation (RFA), pulsed field ablation (PFA), laser ablation, ultrasonic ablation, microwave ablation, etc.) procedure, an electrophysiologist (EP) uses a catheter to ablate specific locations of an organ or blood vessel (such as the heart) to create transmural ablation lines that electrically isolate different parts, segments, or regions of the organ. To guide the ablation, the EP can use an anatomical and voltage mapping system to locate the tip of the catheter in the cavity of the organ and perform the ablation. At the beginning of the ablation procedure, the EP uses a catheter and uses the tip of the catheter to scan the cavity of the organ. The tip of the catheter is used as a reference for structural mapping of the organ, and electrical sensors are used to create an electrophysiological map of the organ. The EP uses structural and voltage mapping to determine the location of the ablation point where it should be performed and to evaluate the success of the ablation.

[0041] However, the use of electrophysiological signals gives an incomplete representation of ablation success as it focuses on electrophysiological signals propagating at the surface of organ tissue and does not assess the effect of ablation at depth in the tissue. For example, RFA is often used for cardiac ablation, but its incompleteness results in high levels of atrial fibrillation recurrence, with recurrence rates ranging from 25% to over 60% depending on patient characteristics. In PFA, electrophysiological signals cannot be used to assess ablation success as even subtherapeutic ablations result in long periods of elimination of electrical activity, meaning that no direct measure of ablation success can be provided to the EP. For these reasons, a system for mapping the effect of ablation at depth in tissue using optical measurements could improve the outcomes of ablation of an organ.

[0042] An improved system for mapping the effects of ablation on tissue depth can be achieved by mapping the birefringence of the tissue. Birefringence is a physical property of anisotropic media (e.g., ordered tissue). Areas of low birefringence are associated with disordered tissue (isotropic media), where such tissues have a lower probability of propagating electrical signals. EP may be able to use the location of low birefringence areas to guide ablation strategies during ablation procedures because isotropic tissue is associated with physical specificity (such as ablated tissue, fibrosis and / or scars, and tissue with venous capillaries). In addition, surrounding structures that modify the shape of ablation lesions due to uneven propagation of electromagnetic fields can also be characterized by EP by mapping birefringence. Birefringence maps can be used to guide the location of ablation during surgery. Birefringence maps can also track the decrease in anisotropy of tissue caused by ablation over time during surgery (such as throughout the surgical time). Birefringence maps can be used to replace or supplement electrophysiological information.

[0043] Although specific configurations and arrangements are discussed, it should be understood that this is done for illustrative purposes only. Those skilled in the relevant art will recognize that other configurations and arrangements may be used without departing from the spirit and scope of the present disclosure. It will be apparent to those skilled in the relevant art that the present disclosure may also be used in various other applications.

[0044] It should be noted that the phrases "one aspect", "an aspect", "an exemplary aspect", etc. mentioned in this specification indicate that the described aspects may include specific features, structures, or characteristics, but each aspect may not necessarily include the specific features, structures, or characteristics. In addition, such phrases do not necessarily refer to the same aspect. Further, when a specific feature, structure, or characteristic is described in conjunction with an aspect, whether or not explicitly described, it is within the knowledge of a person skilled in the art to use such feature, structure, or characteristic in conjunction with other aspects.

[0045] It should be noted that while the present application may specifically refer to cardiac ablation, the various aspects described herein may also be directed to other pathologies and additional energy sources for ablation, including but not limited to cryogenics, radiofrequency (RF), microwaves, lasers, ultrasound, and pulsed electric fields. The principles of using energy to treat other pathologies are similar, and therefore the techniques for applying energy are also similar.

[0046] Throughout this document, the terms "electromagnetic radiation," "light," and "radiation beam" are all used to describe the same electromagnetic signal that propagates through the various described components and systems.

[0047] Example catheters and optical analysis systems that may be used with aspects of the present invention are described in U.S. Patent No. 11,523,740, which is incorporated herein by reference in its entirety.

[0048] Example mapping system and console aspects

[0049] In some aspects, the electroanatomical mapping system can be used to anatomically reconstruct an organ of an animal into a virtual three-dimensional (3D) image. In some aspects, the mapping system can be a stand-alone catheter, console, and / or system that collects positioning information to generate a 3D image. In some aspects, the mapping system can be integrated into a catheter system (e.g., Figure 1 The catheter system 100 and Figure 4A Such a mapping system may be, for example, a commercial system such as EnSite TM Precision, EnSite TM Automap module, Biosense CARTO TM Systems, etc. Mapping systems can be invasive or non-invasive systems.

[0050] To generate a 3D map, an electric and / or magnetic field can be created around the patient. For example, a mapping system can use orthogonal skin patches on a patient's body that generate an electric field centered on the patient's chest (e.g., three electrode pairs form three orthogonal axes (xyz) with the organ of interest at the center). Fig. 9 Shown is the example of the placement of this type of orthogonal skin patch 902. In some respects, the skin patch can be placed on the patient's back, chest and legs. In some respects, 3, 4, 5, 6, 7 or more skin patches can be positioned on the patient's body.

[0051] In another example, a mapping system generates a magnetic field using at least three coils positioned around the patient.In some aspects, both electric and magnetic fields can be generated around the patient.

[0052] A catheter capable of collecting electrophysiological (EP) information can be inserted into an organ of interest. The catheter can have a sensor at its tip that detects the electric and / or magnetic fields generated by an external field generator. The position of the catheter can be determined based on the strength of the field detected by the catheter sensor. If there are multiple sensors in the catheter, or if the catheter sensor is a directional sensor, the orientation of the catheter tip can also be determined. In some aspects, the catheter tip does not contain a sensor, but contains a transmitter whose signal is detected by an external sensor such as an electromagnetic sensor, an acoustic sensor, etc. The position of the catheter tip can then be determined by triangulating the signal received by the external sensor.

[0053] When the catheter is positioned at or swept over various points on the surface of an organ (such as the heart), the position of the catheter tip can be tracked, and the collected positions are used to generate a virtual 3D model of the organ. In some aspects, the mapping system collects position data (e.g., coordinates) of hundreds or thousands of points within and / or across the surface of the organ. In general, the greater the number of positions collected, the more accurate the virtual 3D model. If the catheter collects EP measurements while being tracked, these EP measurements can be superimposed on the 3D model to create an EP map. For example, according to various aspects described herein, the 3D model can be used to display specific measurements of the organ on the 3D model of the organ, including one or more of impedance / voltage, temperature, birefringence, etc.

[0054] The 3D model can be generated in real time or near real time so that the electrophysiologist can perform analysis during surgery. Alternatively, the 3D model can be generated prior to surgery so that measurements collected during surgery are mapped against a pre-existing 3D model. The 3D model can be displayed on any computing system that includes a display. In some aspects, a single catheter tip contains one or more sensors that give the single catheter both mapping and analysis capabilities. In some aspects, the catheter is an ablation catheter that also has ablation capabilities. In some aspects, the mapping catheter is separated from the ablation and / or analysis catheter, wherein the ablation and / or analysis catheter contains a sensor or transmitter that can still be used to locate the catheter tip within the same coordinate system, just as used with the mapping catheter.

[0055] Example catheter system and console aspects

[0056] Figure 1 An example diagram of a system 100 for performing ablation and generating a birefringence map according to aspects of the present disclosure is shown. The system 100 includes a catheter 102, a console 110, a signal generator 120, a display 125, and an irrigation pump 130. The catheter 102, the console 110, the signal generator 120, the display 125, and the irrigation pump 130 can be communicatively coupled together via wired and / or wireless connections. In some aspects, the console 110 can receive signals from multiple field generators or sensors ( Fig. 9 The illustrated patch 902) receives electric and / or magnetic field information, as described above. In some aspects, the catheter 102 can represent exemplary aspects of the catheter 200 as described below. In some aspects, the distal section of the catheter 102 is positioned at a portion of the tissue of the patient 104. It should be understood that the various aspects described herein can be used in vivo and / or in vitro.

[0057] In some aspects, the catheter 102 can be positioned at a portion of tissue that is subjected to ablation using energy generated by the signal generator 120. In some aspects, the signal generator 120 can be an electronic device configured to generate a radio frequency (RF), cryogenic or electroporation (e.g., pulsed electric field (PFA)) signal for ablation. The signal generator 120 can be coupled to the catheter 102 directly or through the console 110, and can send energy to the catheter 102 to ablate a portion of the tissue at the selected tissue site. In some aspects, the portion of the tissue can include myocardial tissue, cardiac muscle tissue, bone tissue, etc. Energy can be applied to a portion of the tissue through an optical viewport in the distal section of the catheter 102. After applying energy, structural changes in the tissue can be observed by acquiring an optical signal through one or more optical viewports of the catheter 102.

[0058] The console 110 may include a computing device configured to obtain an optical signal from the catheter 102 and analyze the optical signal to detect changes in the optical properties of the tissue. In some aspects, the console 110 may include hardware (e.g., circuit), firmware, software, or any combination thereof, to perform the analysis of the optical signal and produce a birefringence diagram as described herein. In some aspects, the console 110 may send light through the optical circuit and catheter 102 within itself and allow the light to enter the tissue to monitor the contact between scar progression, tissue and catheter 102, and other characteristics of the tissue. In some aspects, the console 110 may be referred to as a console (control console), a processing device, and / or a controller in this article. The console 110 may be coupled to a display 125, which may present the results from the optical signal analysis and damage prediction and allow the user to select / view, modify, and / or control parameters related to the operation of the catheter 102, the console 110, the signal generator 120, and / or the flushing pump 130.

[0059] In some aspects, an irrigation pump 130 can be coupled to the catheter 102 via tubing. In some aspects, the irrigation pump 130 can allow fluid to be pumped through the tubing and released at the tissue site through the catheter 102 (e.g., through an optical viewport or through a separate irrigation slit at a distal section of the catheter 102). Fluid from the irrigation pump 130 can cool the distal section of the catheter 102 and surrounding tissue during ablation, and can also flush away any debris during and / or after ablation.

[0060] In some aspects, the catheter 102 can be coupled to the console 110 via one or more optical connections 112 and one or more electrical connections 114. The optical connections 112 can include single-mode optical fibers and / or multi-mode optical fibers that allow for the collection and / or transmission of optical signals from and to the catheter 102 and the console 110 for further analysis. The electrical connections 114 can include wiring, pins, and / or components for supplying power and energy from the signal generator 120 to the catheter 102 for ablation.

[0061] In some aspects, the optical connection 112 and the electrical connection 114 can be connected to the console 110 through a communication interface 116. The communication interface 116 can allow for the transmission of various signals (e.g., optical signals and electrical signals) between the catheter 102 and the console 110. In some aspects, the communication interface 116 can include a connector that facilitates proper alignment of optical fibers between the catheter 102 and the console 110. In some aspects, the connector design can include electrical extension cords and optical extension cords.

[0062] Exemplary Catheter Aspects

[0063] Figure 2A A catheter 200 according to various aspects of the present disclosure is shown. The catheter 200 includes a proximal section 202, a distal section 204, and a shaft 206 coupled between the proximal section 202 and the distal section 204. In one aspect, the shaft 206 includes one or more radiopaque markers for navigation purposes. In one aspect, the catheter 200 includes a communication interface 210 between the catheter 200 and a processing device 208. The communication interface 210 may include one or more optical fibers and connectors between the processing device 208 and the catheter 200. In other examples, the communication interface 210 may include an interface component that allows wireless communication, such as Bluetooth, Wi-Fi, cellular, etc., to communicate with the catheter 200 or other processing components in the catheter system.

[0064] The proximal section 202 can house various electrical and optical components used in the operation of the catheter 200. In some embodiments, a light source can be included in the proximal section 202 to produce a radiation beam source for performing optical evaluation. In some embodiments, the light source can be a Figure 1The optical connection 112 in the proximal section is coupled to an external light source. The light source may include one or more lasers, laser diodes, light emitting diodes (LEDs) or other types of optical coherent sources. The radiation beam generated by the light source may have a wavelength in the infrared range. In one example, the central wavelength of the radiation beam is between about 1000nm and 1600nm. The light source may be designed to output a radiation beam with only a single wavelength, or it may be a swept frequency source and designed to output a series of different wavelengths. The generated radiation beam may be directed toward the distal section 204 through an optical transmission medium connected between the proximal section 202 and the distal section 204 within the shaft 206. Some examples of optical transmission media include single-mode optical fibers and / or multimode optical fibers. In one embodiment, the electrical transmission medium and the optical transmission medium are provided by the same mixed medium that allows electrical and optical signals to propagate.

[0065] In some aspects, the proximal segment 202 may include a second light source (e.g., a laser energy source) to generate laser energy applied to the distal segment 204 for tissue ablation. In some aspects, the proximal segment 202 may include a non-optical energy source for generating non-optical energy (e.g., RF energy) to be applied to the distal segment 204 for tissue ablation. In some aspects, the proximal segment 202 may include a second optical and non-optical energy source for selecting energy to be applied to the distal segment 204. In some aspects, the processing device 208 may include one or more components, such as detectors, electronic devices, and / or other components of the optical circuit / system as described herein. In other aspects, one or more components, such as detectors, electronic devices, and / or other components of the optical circuit / system may be included in the proximal segment 202.

[0066] In one embodiment, the proximal section 202 includes one or more components of an interferometer to perform coherent interferometry using light generated by a light source. Due to the nature of interferometric data analysis, in one embodiment, the optical transmission medium used to guide light directed to or from the distal section 204 does not affect the state and degree of polarization of the light. In another embodiment, the optical transmission medium can affect polarization in a constant and reversible manner. In some embodiments, the catheter 200 can include an optical circuit having one or more elements configured to perform optical spectroscopy. In such embodiments, at least a portion of the optical path can be composed of a multimode optical transmission medium (e.g., a multimode optical fiber).

[0067] The proximal section 202 may include additional interface elements with which a user of the catheter 200 can control the operation of the catheter 200. For example, the proximal section 202 may include a deflection control mechanism that controls the deflection angle of the distal section 204. The deflection control mechanism may include mechanical movement of an element on the proximal section 202, or the deflection control mechanism may use electrical and / or mechanical connections to control the movement of the distal section 204. The proximal section 202 may include various buttons or switches that allow a user to control when a radiation beam is emitted from the distal section 204, thereby allowing the acquisition of optical data. In some embodiments, the proximal section 202 may include a deflection control mechanism for controlling one or more pull wires coupled to the distal section 204. In some embodiments, the deflection control mechanism and the one or more pull wires allow the distal section of the catheter 200 to be guided so as to be manipulated within and targeted to a specific tissue region for ablation.

[0068] The distal section 204 includes a plurality of optical viewports. In some embodiments, the plurality of optical viewports may be referred to herein as orifices in the catheter tip. In one embodiment, one or more of the optical viewports are machined into the outer body of the distal section 204. The optical viewports are distributed outside the distal section 104, thereby producing a plurality of different viewing directions. In some embodiments, the optical viewports may emit and collect light (e.g., optical signals) at various angles relative to the distal section 204. In one embodiment, each viewing direction in the plurality of viewing directions is substantially non-coplanar. The optical viewport may also be designed to have a flushing function to cool the distal section 204 and surrounding tissue during ablation.

[0069] On the one hand, the distal section 204 may include one or more positioning sensors representing the location and / or orientation of the distal section 204. For example, the distal section 204 may include an electromagnetic positioning sensor for generating an electromagnetic signal, which can be mapped to a coordinate system when received by an external receiver to determine the location of the catheter tip in the body. As another example, an impedance-based 3-D mapping system (such as an electroanatomical monitoring (EAM) system) and / or a magnetic resonance imaging (MRI) system can be used to generate an electrophysiological map of the organ so that the location of the catheter can be identified with reference to the electrophysiological map. Example methods for generating electrophysiological maps can be found in U.S. Patents Nos. 6,226,542 and 6,892,091, the disclosures of which are incorporated herein by reference.

[0070] In some embodiments, a monopolar catheter may include a distal section having a monopolar electrode. Figure 2B 2 shows a diagram of an example distal section of a monopolar catheter 204a according to an embodiment of the present disclosure. In some embodiments, Figure 2BThe distal section of the catheter 204a in FIG. Figure 2A 200 . The distal section of the catheter 204a includes a plurality of electrodes 212, an ablation cap 213, a plurality of optical ports 215, one or more pull wire assemblies 218, and an irrigation conduit 210. In some embodiments, the distal section of the catheter 204 may have a single electrode for delivering ablation energy or a plurality of electrodes 212 with the same polarization. In some embodiments, the electrode 212 may be positioned at the very tip of the distal section 204. In some embodiments, PFA energy may be used, and the electrode 212 configuration may be configured to deliver a monophasic or biphasic pulse application. In some embodiments, the ablation cap 213 may also be an electrode and may be metallic. In some embodiments, the ablation cap 213 may be referred to as a distal cap. In some embodiments, the plurality of optical ports 215 may be referred to herein as a plurality of optical viewports. In some embodiments, the pull wire assembly 218 may include anchors and / or other components for allowing manipulation of the distal section of the catheter 204 so as to manipulate and target the specific tissue region for ablation in a specific tissue region. In some embodiments, irrigation conduit 210 may allow fluid to be directed along the catheter tip to cool tissue.

[0071] In some embodiments, the ablation cap 213 can include a plurality of optical ports 215 that can serve as orifices for optical ablation and can also serve as optical windows or viewports for light beams from a plurality of optical fibers in the catheter. In some embodiments, the optical ports 215 can be distributed in a non-planar manner on the dome-shaped surface of the ablation cap 213. In some embodiments, the optical fibers (e.g., Figure 3A and 3B The optical transmission medium 310 in the catheter can be guided to the lens on the distal section of the catheter through the catheter shaft. In some embodiments, the optical fiber can be connected to the lens through a wafer-based waveguide circuit that defines an optical component at the catheter tip. In other embodiments, the optical fiber in the catheter tip can be directly connected to the lens, which focuses light into the tissue through multiple optical ports 215. In some embodiments, the lens can be silicon or formed by another optically transparent material. In some embodiments, the lens can also be coated to reduce reflections at the interface or allow optical index differences with surrounding tissue, blood or fluid media.

[0072] In some embodiments, a bipolar catheter may include a distal section having bipolar electrodes. Figure 2C 204b according to an embodiment of the present disclosure. Figure 2C The distal section of the catheter 204b in FIG. Figure 2A204a. The distal section of the catheter 204b includes a plurality of optical ports 215, one or more of a plurality of electrodes 212a, and a tip 212b. In some embodiments, the electrodes 212a may have opposite polarities to one another. In some embodiments, the electrodes 212a may be positioned at a middle region of the distal section 204b. In some embodiments, the tip 212b may be positioned at the very tip of the distal section 204b. In some embodiments, PFA energy may be used, and the electrode 212a may be configured to deliver a monophasic or biphasic pulse application.

[0073] In some embodiments, the catheter tip can include passive and fixed number of optical components (e.g., 15 optical fibers with 15 lenses attached), without any mechanical switch or scanning device in the catheter itself. In some embodiments, the movement or rotation of optical elements can allow scanning in different directions in tissue. In some embodiments, multiple optical ports or viewports in the catheter can have various orientations in the catheter tip, wherein each output bundle guided from each viewport in the catheter can face different directions. For example, an output bundle can be guided forward, seven output bundles can be guided at 45 ° relative to organization, and seven output bundles can be guided at 90 ° relative to organization. In some embodiments, any number of bundles, viewports, and orientations of viewports can be present in the catheter tip.

[0074] Figure 3A and 3B A cross-sectional view of a shaft 206 according to an embodiment of the present disclosure is shown. The shaft 206 can include all elements that interconnect the proximal section 202 and the distal section 204. The shaft 206a shows an embodiment that accommodates multiple channels / lumens, including a flushing channel 302, a cable channel 312, and a channel 307 for a deflection mechanism. Through these channels 307, 312, 302, the deflection mechanism 306, electrical connections 308, and optical transmission medium 310, as well as cooling fluid, can be at least partially accommodated or transported. In some configurations, a protective cover can be used that surrounds the electrical connection 308 and the optical transmission medium 310. In other embodiments, the optical transmission medium 310 and components can be positioned within a protective cover that is separate from the protective cover that accommodates the electrical connection 308. In some embodiments, the electrical connection 308 can be used to provide a signal to an optical modulation component positioned in the distal section 204. In some embodiments, the electrical connection 308 can be connected to Figure 2BThe electrodes 212 are connected to the proximal segment 202 to deliver ablation energy. In some embodiments, the one or more optical transmission media 310 direct light generated by the light source (exposure light) toward the distal segment 204, while another subset of the optical transmission media 310 directs light (scattered light or reflected light) returned from the distal segment 204 back to the proximal segment 202. In another example, the same one or more optical transmission media 310 direct light in both directions. In some embodiments, the optical transmission medium 310 includes one or more single-mode optical fibers and / or multi-mode optical fibers.

[0075] The irrigation channel 302 may be a hollow tube for directing cooling fluid toward the distal segment 204. The irrigation channel 302 may contain heating and / or cooling elements disposed along the channel for affecting the temperature of the fluid. In another embodiment, the irrigation channel 302 may also be used as a way to draw fluid around the distal segment 204 back toward the proximal segment 302.

[0076] The deflection mechanism 306 may include electrical and / or mechanical elements designed to provide a signal to the distal section 204 to change the deflection angle of the distal section 204. According to one embodiment, the deflection system enables the distal section 204 to be guided by actuating a mechanical control placed in the proximal section 202. This system may be based on a series of aligned and evenly spaced cutouts in the shaft 206 that are intended to provide a unidirectional deflection of the distal section 204, combined with a line connecting the deflection mechanism control in the proximal section 202 to the catheter tip at the distal section 204. In this way, certain movement of the proximal section may be projected to the distal section. Other embodiments involving a combination of several control lines attached to the catheter tip may enable the catheter tip to deflect in different directions.

[0077] Figure 3B A cross section of axis 206b is shown. Axis 206b depicts a Figure 3A 206a in the embodiment of the present invention, except that there is no electrical connection 308. Shaft 206b may be used in the case where the generated radiation beam is modulated (eg, multiplexed) in the proximal section 202 or the distal section 204.

[0078] Return to reference Figure 2B and 2CWhen performing ablation therapy, ablative energy (e.g., PFA energy) can be delivered to the electrode 212 or 212a in the distal section 204 of the catheter 200 and applied to the target tissue to be treated. The pulsed electric field vector (PEF vector) of the PFA energy may be affected by various factors, such as the geometry of the electrodes and the relative positioning of the electrodes. In some embodiments, the effect of the ablation energy applied to the target tissue and the surrounding environment depends on various factors, and the parameters that determine the amount of ablation energy, such as the amplitude and duration of the pulsed electric field, need to be carefully selected in order to effectively treat the target tissue while minimizing damage to the surrounding tissue. Specifically, when performing ablation therapy, the fiber alignment of the target tissue relative to the PEF is an important factor to consider when determining the parameters of the PFA energy.

[0079] Specifically, in order to reach the irreversible barrier to electroporation, the strength of the applied electric field must be above a certain threshold. Since the applied electric field is a vector, its orientation relative to the cell membrane is important for cardiomyocytes, which have an elongated shape. Therefore, knowing the orientation of the muscle fibers relative to the applied field is useful for achieving the optimal electroporation threshold. Having the ability to directly assess the orientation of the muscle fibers relative to the applied field enables clinicians to perform safer, more reliable, and more durable ablation treatments.

[0080] Information about the orientation of the muscle fibers relative to the applied field is useful not only for the endocardial surface in contact with the electrode, but also for the depth of the tissue. The implementation of ablation requires consistent and accurate detection of the tissue to be treated and the surrounding environment. In some cases, optical coherence interferometry (such as OCT or OCR) can be used to measure various parameters of tissue samples, such as tomography and spectra of absorption, reflection and birefringence. In some cases, these parameters are related to the orientation of the muscle fibers of the tissue and change during the course of the ablation treatment, thereby requiring real-time detection and analysis to provide reliable information and guidance for the ablation treatment.

[0081] Example Optics and Console Aspects

[0082] FIG. 4 shows a diagram of an example system 400 with multiple optical components for performing OCT and / or OCR according to an embodiment of the present disclosure. A coherent light source 402 provides a coherent light beam. In some embodiments, the coherent light source 402 may be a non-dynamically swept source or a VCSEL with a tunable wavelength (e.g., via a MEMS tunable filter). In some embodiments, the coherent light source 402 may provide a coherent light beam (single path in air) with a coherent length. For example, the coherent length of the coherent light beam provided by the coherent light source 402 may be 0.1 mm to 1.0 mm, 1.0 mm to 1.0 cm, 1.0 cm to 10 cm, or greater than 10 cm. In some embodiments, the coherent light source 402 may be a swept source that generates a coherent light beam, the wavelength of which is periodically swept at a certain wavelength sweep frequency within a wavelength range around a central wavelength. In some embodiments, the central wavelength may be infrared. In some embodiments, the central wavelength may be between 1000 nm and 1600 nm. For example, the central wavelength of the coherent light beam may be about 1310 nm. In some embodiments, the wavelength range of the frequency sweep around the center wavelength can be between 30 nm and 70 nm. For example, the wavelength range of the frequency sweep around the center wavelength can be about 55 nm. In some embodiments, the wavelength sweep can be between 20 kHz and 100 kHz. For example, the wavelength sweep can be about 50 kHz. In some embodiments, the coherent light source 402 can be included in the console 110 (e.g., Figure 1 ) and coupled to the optical transmission medium 310 (as shown) of the catheter. Figure 3A and 3B shown).

[0083] The coherent light beam generated by the coherent light source 402 is coupled to the interferometer 410. The interferometer 410 includes a first optical coupler 404 that couples a first portion of the coherent light beam to the reference arm 408 and a second portion of the coherent light beam to the sample arm 406. In some embodiments, the sample arm 406 can be coupled to one or more optical components 4161-4162 that direct the second portion of the coherent light beam to the reference arm 408. N Optical multiplexer 412 in. Optical components 4161-416 N Each optical component in includes an optical path for directing a second portion of the coherent light beam to a location on a sample tissue 418 to be examined. The sample 418 may be healthy tissue, fibrotic tissue, scar, tissue undergoing an ablation procedure, or a test sample. N Each optical component in the catheter can be connected through one of the optical ports at the distal section of the catheter (e.g., Figure 2BAfter being illuminated by the coherent light, multiple optical signals can be returned from the sample 418, each of which is associated with the optical components 4161-416 N The plurality of optical signals depends on the condition of the sample 418 and is related to the coherent light beam. The plurality of optical signals is generated by the optical components 4161-416 N The first portion of the coherent light beam is collected and returned to the sample arm 406 through the optical multiplexer 412, and then combined with the first portion of the coherent light beam in the reference arm 408 through the second optical coupler 414. In some embodiments, the control unit 420 can be used to control the optical multiplexer 412 to select one or more optical components 4161-4162 to which the second portion of the coherent light beam is coupled. N The control unit 420 may be connected to a computer 428 to receive commands from the computer 428 and to transmit data to the computer.

[0084] In some embodiments, the optical multiplexer 412 and the optical components 4161-416 N Can be included in Figure 1 In some embodiments, the optical multiplexer 412 may be positioned within the catheter 102. Figure 1 The optical components 4161-416 within the console 110 and coupled to the catheter 102 via the optical connection 112 N In some embodiments, the first optical coupler 404 , the second optical coupler 414 , and the reference arm 408 may be included in the console 110 .

[0085] Interferometer 410 provides a plurality of optical output signals through second optical coupler 414, each optical output signal being coupled to optical components 4161-416 N Each of the optical output signals contains information about the reference arm and the optical components 4161-416 coupled to the reference arm. N The optical output signal is detected by optical detector 422. Optical detector 422 can convert the optical output signal into an electrical signal over time, and the electrical signal contains information about the interference between the reference arm and the sample arm coupled to the optical components 4161-416 N Information about the interference between the sample arms.

[0086] In some embodiments, interferometer 410 may include optical coupler 404, optical coupler 414, optical multiplexer 412, and optical components 4161-416 NIn some embodiments, the interferometer 410 can be connected to the coherent light source 402 and the optical detector 422 via an optical fiber. In some embodiments, the optical fiber can be a single-mode optical fiber, a multimode optical fiber, or a combination thereof. In some embodiments, some or all of the optical fibers can be polarization-maintaining (PM) optical fibers.

[0087] Since the wavelength of the coherent light beam is swept over a range of wavelengths at a certain sweep frequency, the wavelength also varies with time. Therefore, within each cycle of the wavelength sweep, each of the electrical signals provided by the optical detector 422 also varies with the changing wavelength. The Fourier transform of the electrical signal from the wavelength domain (or equivalently, the wave number domain) to the real space domain (or equivalently, the depth domain) can provide a signal related to the optical properties of the position of the sample 418 detected by the optical component (which varies with the scanning depth).

[0088] In some embodiments, optical detector 422 can process the optical output signal provided by interferometer 410 to perform effective measurements. For example, optical detector 422 can amplify the optical output signal, or filter the optical output signal to remove noise. In order to avoid signal distortion and provide a high-quality electrical signal containing information about sample 418, optical detector 422 should have sufficient bandwidth for processing and detecting the optical output signal. In some embodiments, optical detector 422 can have a bandwidth of about 100 MHz.

[0089] In some embodiments, the optical detector 422 may be positioned at Figure 1 The optical output signal may be transmitted to the optical detector 422 via the optical connection 112 and the interface 116. In some embodiments, the optical detector 422 may be positioned at Figure 1 The optical detector 422 is located inside the catheter 102 , and the electrical signal provided by the optical detector 422 can be transmitted to the console 110 via the electrical connection 114 and the interface 116 .

[0090] The electrical signal provided by the optical detector 422 can be further sampled into digital data by the data acquisition unit 424 at a certain data sampling rate. In some embodiments, the data acquisition unit 424 can be located at Figure 1In the console 110 in the apparatus. In order to avoid signal distortion or loss of information in the signal, the data sampling rate of the data acquisition unit 424 can be sufficiently higher than the bandwidth of the electrical signal provided by the optical detector 422. In some embodiments, the data sampling rate can be greater than the bandwidth of the optical detector. For example, the data sampling rate can be greater than 100 MHz. In some embodiments, the data sampling rate can be between 0 MHz and 175 MHz. In some embodiments, the data sampling rate can be between 0 MHz and 400 MHz. In some embodiments, the data sampling rate of the data acquisition unit 424 can be set by the k-clock of the coherent light source 402 (for example, the k-clock of the VCSEL swept laser), so that the entire image range can be automatically ensured and the swept nonlinearity can be compensated.

[0091] The data collected by the data collection unit 424 is further transmitted to the data processing unit 426. In some embodiments, the data processing unit 426 may be located at Figure 1 In some embodiments, the data processing unit 426 may be a processing unit of the computer 428. The data processing unit 426 may process the data and extract useful information from the data that may be helpful in analyzing the condition of the sample 418. For example, the data processing unit 426 may use a fast Fourier transform to convert the data that varies with the wavelength into a plurality of signals that vary with the scanning depth from the surface of the sample 418, wherein each of the plurality of signals is related to the scanning depth of the sample 418 through the optical components 4161-416 N In some embodiments, the data processing unit 426 may be connected to the coherent light source 402 to obtain the phase of the swept wavelength, so that the information of the wavelength is collected by the data processing unit 426 to apply a fast Fourier transform. In some embodiments, the plurality of signals may contain information about the refraction, birefringence, polarization and / or other optical properties of the sample 418. The plurality of signals that vary with the scanning depth may be further transmitted for display on the screen of the computer 428.

[0092] In some embodiments, the data processing unit 426 may also process multiple signals to extract information of interest therein. For example, the data processing unit 426 may detect one or more reference features in the multiple signals and crop the region of interest in the multiple signals based on the positions of the one or more reference features.

[0093] In some embodiments, the optical components 4161-416 NThe coherent light delivered to the sample 418 may be linearly polarized. In some embodiments, the polarization of the coherent light delivered to the sample 418 may be known by controlling the polarization of the coherent light or sampling the coherent light and measuring the polarization. In some embodiments, information about the polarization of the coherent light may be known. In some embodiments, using a PM optical fiber in the system 400, the polarization of the coherent light sent to the sample 418 may be fixed and therefore known. In some embodiments, using a single mode (SM) optical fiber in the system 400, the polarization of the coherent light sent to the sample 418 is not fixed, but may be calculated by normalizing it using a known polarization state measured in the system 400. In some embodiments, information about the relative polarization of the coherent light may be known. In some embodiments, by analyzing the output signal of the optical detector 422 using the data processing unit 426, information about the polarization or relative polarization of the coherent light helps to extract the fiber alignment information of the sample 418.

[0094] Figure 4B An example block diagram of a complete chain of data acquisition integration of optical signals according to various aspects of the present disclosure is shown. Data acquisition and processing of optical signals can be implemented by console 110. In some aspects, multiple single-ended signals can be digitized together with a reference interferometer for signal processing purposes and read in parallel or in a single processing stage by console 110. In some aspects, processing can be implemented in real time or near real time (e.g., about 50 milliseconds or similar values). In some aspects, any number of signals can be digitized. These signals can be combined and processed to measure the optical properties of tissues (such as birefringence, tissue stability, drag speed, etc.). The processed signals can be shown on a graphical user interface (GUI) presented on a display (e.g., display 125). In some aspects, the GUI can be refreshed so that multiple channels (e.g., 15 channels) of the detector can be represented simultaneously. In some aspects, the console 110 can cache optical data from all or multiple channels, and once the data is processed, the data can be refreshed and presented in the GUI.

[0095] In some aspects, data transfer and data processing can be optimized in different software abstraction layers so that data integrity is maintained while improving refresh times in the GUI. Once optical data (e.g., OCT structural / polarization data) is obtained, tissue detection algorithms using clustering methods or other methods can be implemented to separate tissue from other artifacts.

[0096] Furthermore, optimization algorithms can be applied to compensate for the nonlinearity and phase noise of the light source while switching using an external reference interferometer at different optical path delays. In some aspects, additional automatic calibration methods can be implemented to optimize the polarization state without manual interaction, and use motors and retroreflectors to automatically adjust the fiber lengths so that the coherence range of each fiber is optimized.

[0097] Example method for mapping optical measurements

[0098] The catheters, consoles, and systems described herein can be used to perform optical analysis and display the results of the optical analysis of tissue. By utilizing the optical analysis described herein, the catheters and optical systems disclosed herein (e.g., Figure 1 The catheter system 100 and Figure 4A The optical system 400 in can allow real-time or near real-time assessment of lesion formation in tissue using a three-dimensional model of the tissue.

[0099] For example, the catheter 200 shown in FIG. 2 may be used. Figure 1 The system 100 shown (including the catheter 102 and the console 110) and / or Figure 4A The illustrated optical system 400 implements the various methods described thus far, as well as other aspects of the catheters and systems.The methods described herein may be performed before, during, or after ablating tissue.

[0100] Figure 5 An example method 500 for mapping optical measurements on a three-dimensional map is presented in accordance with aspects of the present disclosure.

[0101] At box 502, a three-dimensional map of an animal organ (e.g., a human organ) is generated. In some aspects, the organ may be a heart. It should be understood that the methods described herein may be performed on any tissue having birefringence properties. A three-dimensional map may be generated by scanning the tip of a catheter (e.g., catheter 100) on all sides of the organ cavity to retrieve the coordinates of the organ. The collected organ data is then transmitted to a system (e.g., computer system 800) comprising hardware (e.g., circuit), firmware, software, or any combination thereof, wherein the system may generate a navigable three-dimensional map.

[0102] In some aspects, a three-dimensional map can be generated by system 100. In some aspects, the three-dimensional map can be generated by a separate or second system that generates a three-dimensional map of an organ. The three-dimensional map is generated so that a user can use the three-dimensional map as a reference to navigate a catheter through the organ. For example, by including anatomical plane coordinates, landmark-based coordinates, or any other nonlinear method of representing an organ by coordinates, the three-dimensional map can be navigable by a catheter. Example methods for generating electrophysiological maps can be found in U.S. Patents Nos. 6,226,542 and 6,892,091, the disclosures of which are incorporated herein by reference.

[0103] At box 504, optical measurements and the location of the optical measurements are collected by a catheter (e.g., catheter 102). Optical measurements can be acquired from a portion of the tissue using at least one optical port in the catheter. In some aspects, the optical measurements can include one or more optical coherence tomography (OCT) signals and / or optical coherence reflectance (OCR) signals acquired from a portion of the tissue. In some aspects, the optical measurements can be collected before ablation to allow an electrophysiologist to determine where and how ablation should be performed. In some aspects, the optical measurements can be collected during or after ablation. During ablation, the optical measurements can be collected and processed to guide the electrophysiologist and / or obtain real-time or near real-time information about the progress of the ablation. After ablation, the optical measurements can be collected to allow the electrophysiologist to determine the success of the ablation.

[0104] The location and / or orientation of the catheter tip can be determined by known methods such as MRI or based on impedance or using an electromagnetic positioning sensor in the catheter tip that generates an electrical signal when the optical measurement is taken. The optical measurement results and the location can be collected simultaneously through the catheter. In some aspects, the catheter tip can be used to determine the position and / or orientation of the catheter tip. Figure 4A Components shown in the block diagram, through the optical system 400 and / or through Figure 1 The console 110 in obtains optical measurement results and positioning.

[0105] At block 506, the optical measurements are mapped onto the three-dimensional map to create a modified three-dimensional map. Block 506 may be performed by the console 110 and the display 125 of the system 100. Figure 6 Block 506 is further described.

[0106] Figure 6An example method 600 for mapping optical measurements, such as birefringence measurements, on a three-dimensional map according to aspects of the present disclosure is shown. It should be understood that the methods described herein are described with reference to system 100, but any system including a processing unit that processes optical and electrical signals can be used to perform method 600. Method 600 can be performed in real time or near real time, so that an electrophysiologist or other user can view birefringence measurements while a procedure is ongoing.

[0107] At block 602, a three-dimensional map of an organ of an animal is received. The three-dimensional map may be the three-dimensional map generated in block 502. The three-dimensional map may be received by a computer system (e.g., computer system 800) coupled to system 100. The three-dimensional map may be stored in a local memory and / or a patient database. The three-dimensional map may be displayed on display 125 for viewing by a user (e.g., an electrophysiologist) during surgery.

[0108] At block 604, the processing unit may receive optical measurements of tissue in the organ and locations of the optical measurements in the organ from the catheter 102. In some aspects, the processing unit may be the console 110. It should be appreciated that multiple optical measurements and their corresponding locations may be received. Thus, block 604 and subsequent blocks of the method 600 may be repeatedly performed for multiple optical measurements. In some aspects, optical measurements may be received for each location in the organ.

[0109] At block 606, the processing unit may determine coordinates in the three-dimensional map corresponding to the locations of the optical measurements.

[0110] At block 608, birefringence measurements are extracted from the optical measurements. The birefringence measurements of the portion of the tissue may be extracted by analyzing the optical measurements using a processing device coupled to the catheter. In some aspects, the one or more optical properties include at least one of polarization or spectral information (e.g., spectral information or imaging information from the tissue).

[0111] At block 610, the processing unit may adjust the birefringence measurements to correct for movement of the catheter or organ when the measurements are taken. In some aspects, the adjustment may be to correct, modify, clean up, reduce noise in, or otherwise digitally process the birefringence measurements acquired with movement. For example, the processing unit may detect one or more reference features in the plurality of signals and crop a region of interest in the plurality of signals based on the location of the one or more reference features.

[0112] At block 612, the processing unit can generate a visual representation of the birefringence measurements. In some aspects, the visual representation can represent multiple birefringence measurements taken at coordinates to illustrate birefringence measurements taken at different depths of the tissue. In some aspects, the visual representation can include a color gradient and a chromaticity gradient representing the birefringence measurements. For example, purple can symbolize tissue with high birefringence at the coordinates, and red can symbolize tissue with low birefringence at the coordinates. When birefringence is reduced due to ablation, the color will fade to represent the reduced birefringence.

[0113] At block 614, the processing unit may modify the three-dimensional map at the coordinates to show a visual representation of the birefringence measurement at the coordinates. The modification may include any of: inserting a location, overlaying a location, or replacing a location with a visual representation in the three-dimensional map. The modification creates a modified three-dimensional map containing the structure and optical properties of the organ. The processing unit may modify the entire three-dimensional map immediately based on the received birefringence measurement at the coordinates throughout the map, and the processing unit may modify portions of the three-dimensional map in real time or approximately real time as updated birefringence measurements are received.

[0114] At block 616, the processing unit may transmit the modified three-dimensional map to a computer system, and the computer system may display the modified three-dimensional map. The modified three-dimensional map may be used to guide decisions about ablation locations during an ablation procedure, or to track the reduction in anisotropy of tissue caused by ablation throughout the duration of the procedure. Figure 7 Exemplary modified three-dimensional graphs are described.

[0115] Example 3D Plot

[0116] Figure 7 An example of a modified three-dimensional map showing birefringence measurements is shown. The example image shows birefringence measurements of a heart, but it should be understood that the methods described herein can be used on any tissue having birefringent properties.

[0117] Figure 702 shows a modified three-dimensional image of a heart before an ablation procedure. In this example, purple symbolizes tissue with high birefringence, and red symbolizes tissue with low birefringence.

[0118] Figure 704 shows a modified three-dimensional map of the heart after the ablation procedure. As conduction at a given location in the heart decreases, the color of the heart at that location in the three-dimensional map may fade or change until no birefringence is detected. In some aspects, optical measurements can be collected at the same location over a specific time period to allow a user (e.g., an electrophysiologist) to observe changes in birefringence as cells die after ablation. In some aspects, ablation is successful when birefringence is reduced by a certain amount (e.g., 20%, 30%, or 40%).

[0119] Exemplary Computational Aspects

[0120] Figure 8 800. For example, one or more computer systems 800 may be used to implement any of the aspects discussed herein, as well as combinations and sub-combinations thereof. In some aspects, as described herein, one or more computer systems 800 may be used to implement Figure 5 The method 500 shown, Figure 6 The method 600 and / or the console 110, the signal generator 120, and the display 125 are shown. The computer system 800 may include one or more processors (also referred to as central processing units or CPUs), such as a processor 804. The processor 804 may be connected to a communication infrastructure or bus 806.

[0121] The computer system 800 may further include a user input / output interface 802 , such as a display, a keyboard, a pointing device, etc. The computer system may communicate with a communication infrastructure 806 via a user input / output interface 803 .

[0122] One or more of the processors 804 may be a graphics processing unit (GPU). In one aspect, a GPU may be a processor that is a specialized electronic circuit designed to process mathematically intensive applications. A GPU may have a parallel structure that is very efficient for processing large blocks of data in parallel, such as mathematically intensive data common in computer graphics applications, images, videos, etc.

[0123] The computer system 800 may also include a main memory (primary memory) 808, such as a random access memory (RAM). The main memory 808 may include one or more levels of cache. The main memory 808 may store therein control logic (i.e., computer software) and / or data. In some aspects, the main memory 808 may include optical logic configured to analyze optical measurements obtained from tissue through the catheter and determine damage predictions.

[0124] The computer system 800 may also include one or more secondary storage devices or memories 810. The secondary storage 810 may include, for example, a hard drive 812 and / or a removable storage drive 814.

[0125] The removable storage drive 814 can interact with a removable storage unit 818. The removable storage unit 818 can include a computer-usable or readable storage device having computer software (control logic) and / or data stored thereon. The removable storage unit 818 can be a program cartridge and cartridge interface (such as the interface found in a video game device), a removable memory chip (such as an EPROM or PROM) and associated sockets, a memory stick and USB port, a memory card and associated memory card slot, and / or any other removable storage unit and associated interface. The removable storage drive 814 can read from and / or write to the removable storage unit 818.

[0126] Secondary storage 810 may include other means, devices, components, tools, or other methods for allowing computer system 800 to access computer programs and / or other instructions and / or data. Such means, devices, components, tools, or other methods may include, for example, a removable storage unit 822 and an interface 820. Examples of removable storage unit 822 and interface 820 may 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) and an associated socket, a memory stick and USB port, a memory card and an associated memory card slot, and / or any other removable storage unit and associated interface.

[0127] The computer system 800 may further include a communication or network interface 824. The communication interface 824 may enable the computer system 800 to communicate and interact with any combination of external devices, external networks, external entities, etc. (individually and collectively labeled by reference numeral 828). For example, the communication interface 824 may allow the computer system 800 to communicate with an external or remote device 828 via a communication path 826, which may be wired and / or wireless (or a combination thereof) and may include any combination of a LAN, a WAN, the Internet, etc. Control logic and / or data may be transmitted to and from the computer system 800 via the communication path 826. In some aspects, the computer system 800 may be coupled to the catheter via a connector and optical and electrical connections (including optical fiber and electrical wiring, pins, and / or components) at the communication interface 824.

[0128] The computer system 800 may also be any one or any combination of the following: a personal digital assistant (PDA), a desktop workstation, a laptop or notebook computer, a netbook, a tablet computer, a smart phone, a smart watch or other wearable device, an appliance, a part of the Internet of Things, and / or an embedded system, to name a few non-limiting examples.

[0129] The computer system 800 can be a client or server that accesses or hosts any application and / or data through any delivery paradigm, including but not limited to: remote or distributed cloud computing solutions; local or on-premises software ("on-premises" cloud-based solutions); "as a service" models (e.g., content as a service (CaaS), digital content as a service (DCaaS), software as a service (SaaS), hosted 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 that includes any combination of the foregoing examples or other services or delivery paradigms.

[0130] Any applicable data structures, file formats, and schemas in computer system 800 may be derived from standards including, but not limited to, JavaScript Object Notation (JSON), Extensible Markup Language (XML), YetAnother Markup Language (YAML), Extensible Hypertext Markup Language (XHTML), Wireless Markup Language (WML), MessagePack, XML User Interface Language (XUL), or any other functionally similar representations alone or in combination. Alternatively, proprietary data structures, formats, or schemas may be used alone or in combination with known or open standards.

[0131] In some aspects, a tangible non-transitory device or article of manufacture including a tangible non-transitory computer usable or readable medium having control logic (software) stored thereon may also be referred to herein as a computer program product or program storage device. This includes, but is not limited to, computer system 800, main memory 808, secondary memory 810, and removable storage units 818 and 822, and tangible articles of manufacture embodying any combination of the foregoing. When executed by one or more data processing devices (such as computer system 800), such control logic may cause such data processing devices to operate as described herein.

[0132] It should be understood that the Detailed Description section, rather than the Summary and Abstract sections, is intended to be used to interpret the claims. The Summary and Abstract sections may set forth one or more but not all exemplary aspects of the present disclosure as contemplated by the inventors, and therefore, are not intended to limit the present disclosure and the appended claims in any way.

[0133] Aspects of the present disclosure have been described above with the aid of functional building blocks, which illustrate implementations of specified functions and their relationships. For ease of description, the boundaries of these functional building blocks have been arbitrarily defined herein. Alternative boundaries may be defined as long as the specified functions and their relationships are properly performed.

[0134] The foregoing description of specific aspects will so completely reveal the general nature of the disclosure that others can easily modify and / or adapt various applications of such specific aspects by applying knowledge within the art without undue experimentation and without departing from the general concepts of the disclosure. Therefore, based on the teachings and guidance given herein, such adaptations and modifications are intended to be within the meaning and range of equivalents of the disclosed aspects. It should be understood that the words or terms in this article are for descriptive and not restrictive purposes, so that the terms or words of this specification will be interpreted by the skilled person in view of the teachings and guidance.

[0135] The breadth and scope of the present disclosure should not be limited by any of the above-described exemplary aspects, but should be defined only in accordance with the following claims and their equivalents.

Claims

1. A method comprising: receiving, by one or more processors, a three-dimensional map of an organ of an animal, wherein the three-dimensional map includes coordinates; receiving, by the one or more processors, optical measurements of tissue in the organ and locations of the optical measurements in the organ from a catheter including an optical fiber; determining, by the one or more processors, coordinates in the three-dimensional map corresponding to the locations of the optical measurements; extracting, by the one or more processors, birefringence measurements from the optical measurements; generating, by the one or more processors, a visual representation of the birefringence measurement; as well as The three-dimensional map is modified, by the one or more processors, at the coordinates to show the visual representation of the birefringence measurement at the coordinates, the modification creating a modified three-dimensional map.

2. The method according to claim 1, further comprising: The modified three-dimensional map is displayed on a computing device by the one or more processors.

3. The method according to claim 1, further comprising: adjusting, by the one or more processors, the birefringence measurements to correct for any movement of the catheter; as well as The birefringence measurements are adjusted by the one or more processors to correct for any movement of the organ.

4. The method of claim 1, wherein the visual representation of the birefringence measurement comprises a color gradient and a chromaticity gradient applied to the three-dimensional map.

5. The method according to claim 1, wherein the optical measurement result is a first optical measurement result, the method further comprising: receiving, by the one or more processors, from the catheter, a second optical measurement and a second location of tissue in the organ, the second location being a location of the second optical measurement in the organ; determining, by the one or more processors, a second coordinate in the three-dimensional map corresponding to the second location; extracting, by the one or more processors, a second birefringence measurement from the second optical measurement; generating, by the one or more processors, a second visual representation having the second birefringence measurement; as well as The modified three-dimensional map is modified, by the one or more processors, at the second coordinates to show the second visual representation at the second coordinates.

6. The method of claim 1, wherein the visual representation represents birefringence measurements at multiple depths in the tissue at the location.

7. A system comprising: a catheter, wherein the catheter collects optical measurements of a portion of tissue in an organ of an animal and localization of the optical measurements in the organ; a plurality of optical fibers positioned within the conduit; a positioning sensor, the positioning sensor being positioned within the catheter; as well as a computing device coupled to the plurality of optical fibers via a connector, the computing device comprising a processor and a memory, the memory having instructions stored thereon, the instructions, when executed by the processor, causing the processor to: receiving, by the processor, a three-dimensional map of the organ, wherein the three-dimensional map includes coordinates; receiving from the optical fiber the optical measurements collected from the catheter; receiving from the positioning sensor a location of the optical measurements collected from the catheter; determining, by the processor, coordinates in the three-dimensional map corresponding to the locations of the optical measurements; extracting, by the processor, a birefringence measurement from the optical measurement; generating, by the processor, a visual representation of the birefringence measurement; and The three-dimensional map is modified, by the processor, at the coordinates to show the visual representation of the birefringence measurement at the coordinates, the modification creating a modified three-dimensional map.

8. The system of claim 7, wherein the instructions further cause the processor to: The modified three-dimensional map is displayed, by the processor, on the computing device.

9. The system of claim 7, wherein the instructions further cause the processor to: adjusting, by the processor, the birefringence measurements to correct for any movement of the catheter; and The birefringence measurements are adjusted by the processor to correct for any movement of the organ.

10. The system of claim 7, wherein the visual representation of the birefringence measurement comprises a color gradient and a chromaticity gradient applied to the three-dimensional map.

11. The system of claim 7, wherein the optical measurement result is a first optical measurement result, the instructions further causing the processor to: receiving, by the processor from the catheter, a second optical measurement and a second location of tissue in the organ, the second location being a location of the second optical measurement in the organ; determining, by the processor, a second coordinate in the three-dimensional map corresponding to the second location; extracting, by the processor, a second birefringence measurement from the second optical measurement; generating, by the processor, a second visual representation having the second birefringence measurement; and The modified three-dimensional map is modified, by the processor, at the second coordinates to show the second visual representation at the second coordinates.

12. The system of claim 7, wherein the visual representation represents birefringence measurements at multiple depths in the tissue at the location.

13. A system according to claim 7, wherein the catheter includes a distal segment, a proximal segment, and a sheath coupled between the proximal segment and the distal segment, wherein the distal segment includes a tip having a plurality of optical ports and a positioning sensor, wherein the optical ports collect the optical measurements and the positioning sensor collects the positioning.

14. A non-transitory computer-readable device having stored thereon instructions that, when executed by at least one computing device, cause the at least one computing device to perform operations comprising: receiving a three-dimensional map of an organ of an animal, wherein the three-dimensional map includes coordinates; receiving optical measurements of tissue in the organ and the location of the optical measurements in the organ from a catheter including an optical fiber; determining coordinates in the three-dimensional map corresponding to the locations of the optical measurements; extracting a birefringence measurement from the optical measurement; generating a visual representation of the birefringence measurement; as well as The three-dimensional map is modified at the coordinates to show the visual representation of the birefringence measurement at the coordinates, the modification creating a modified three-dimensional map.

15. The non-transitory computer readable device of claim 14, the operations further comprising: The modified three-dimensional map is displayed on a computing device.

16. The non-transitory computer readable device of claim 14, the operations further comprising: adjusting the birefringence measurement to correct for any movement of the catheter; as well as The birefringence measurements are adjusted to correct for any movement of the organ.

17. The non-transitory computer readable device of claim 14, wherein the visual representation of the birefringence measurement comprises a color gradient and a chromaticity gradient applied to the three-dimensional map.

18. The non-transitory computer readable device of claim 14, wherein the optical measurement result is a first optical measurement result, the operations further comprising: receiving from the catheter a second optical measurement of tissue in the organ and a second location of the second optical measurement in the organ; determining a second coordinate in the three-dimensional map corresponding to the second location; extracting a second birefringence measurement from the second optical measurement; generating a second visual representation having the second birefringence measurement; as well as The modified three-dimensional graph is modified at the second coordinates to show the second visual representation at the second coordinates.

19. The non-transitory computer readable device of claim 14, wherein the visual representation represents birefringence measurements at multiple depths in the tissue at the location.

20. A non-transitory computer-readable device according to claim 14, wherein the catheter includes a distal segment, a proximal segment, and a sheath coupled between the proximal segment and the distal segment, wherein the distal segment includes a tip having a plurality of optical ports and a positioning sensor, wherein the optical ports collect the optical measurements and the positioning sensor collects the positioning.

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