Optically guided ablation system using pulsed field or other energy source

Abstract

A system includes a catheter, an optical circuit, a pulsed field ablation energy source, and a processing device. The catheter includes a proximal section, a distal section, and a shaft coupled between the proximal section and the distal section. The optical circuitry is configured to transmit light at least partially from the proximal section to the distal section and back. A pulsed field ablation energy source is coupled to the catheter and configured to transmit a pulsed electrical signal to the tissue sample. The processing device is configured to analyze the one or more light signals received from the optical circuit to determine a change in polarization or phase delay of light reflected or scattered by the tissue sample, and to determine a change in birefringence of the tissue sample based on the change in polarization or phase delay.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is a divisional application of the Chinese invention patent application entitled "Optically guided ablation system, catheter and ablation method using pulsed fields or other energy sources", filed on January 13, 2021, and application number 202180009067X. This application claims priority to European patent application No. 20382014.7 filed on January 13, 2020 and European patent application No. 20382774.6 filed on August 31, 2020. The disclosures thereof are incorporated herein by reference in their entirety. Technical Field

[0003] Embodiments of the present application relate to catheters, systems, and methods that utilize optical and photonic techniques to determine or predict structural changes in tissue associated with ablation-based lesions. Background Art

[0004] Several medical conditions are treated by ablating healthy tissue to produce lesions that affect local tissue or end-organ function. Major examples of this treatment include myocardial ablation for patients with abnormal heart rhythms, renal nerve ablation (e.g., renal denervation) for patients with hypertension, and neuroablation for patients with epilepsy. In such procedures, a catheter is used to deliver the energy required to ablate tissue locally via an intravascular route or a small incision. The energy used to produce the lesions may include traditional radiofrequency (RF)-based heating, cryogenic cooling, and pulsed field ablation.

[0005] Atrial fibrillation (AF) is a common type of cardiac arrhythmia, with an estimated 33.5 million people worldwide suffering from the disease in 2010. AF increases the risk of stroke by 5 times and is a major healthcare problem in developed countries. Common drug therapies used to control the heart rhythm of AF patients may have significant deficiencies in effectiveness and may cause serious side effects, thereby reducing the patient's quality of life. Cardiac catheter ablation therapy can be a minimally invasive procedure that uses a thin, steerable treatment catheter that uses energy to create lesions in cardiac tissue to treat abnormal heart rhythms. The success of the treatment depends on the clinician's ability to ablate tissue completely through the heart wall and not miss any gaps between ablation points that may cause AF to recur. Currently, clinicians cannot determine in real time the quality of catheter contact, contractile stability, energy delivered, or the quality of ablation. Conventional RF cardiac ablation may also result in serious complications related to perforation or accidental thermal damage to adjacent structures because such ablation uses thermal means to create lesions. In this regard, pulsed field ablation (PFA) uses electromagnetic pulses to create non-thermal lesions during the ablation process. PFA may cause irreversible electroporation of cells within the electrodes, ultimately leading to cell death. Although the technique reduces complications associated with thermal injury, there may be only limited or minimal necrosis in the electrode surface tissue due to thermal injury. Current technology is limited in showing clinicians whether lesions produced by PFA energy at selected parameters will result in irreversible electroporation and subsequent permanent injury. The lack of such information may contribute to the severity of recurrent fibrillation. Being able to directly assess the creation of lesions through the use of photonics will enable clinicians to create safer, more durable, and sustained lesions to treat AF and prevent its recurrence.

[0006] Epilepsy is the fourth most common neurological disorder and affects people of all ages. Treatment options to date include medications, neurostimulation, surgery, and ablation. Laser ablation using a catheter is one of the most recently used procedures because it is less invasive than surgery and is able to remove the focus of seizures by ablating the area causing the seizures. Limitations in the effectiveness and safety of the procedure are related to the inability to accurately measure the amount of energy (e.g., heat) delivered to the tissue, because too much energy can damage surrounding neurons, while too little energy will require re-ablation. Therefore, a catheter that can determine the amount of energy or local temperature of a tissue site would alleviate some of the shortcomings of current technology.

[0007] Several clinical studies have shown that renal nerve ablation can reduce blood pressure in patients with hypertension. This and other ablation procedures may be limited by the correct delivery of energy to produce the desired lesion geometry. Too little energy can result in lesions that do not adequately penetrate the tissue, leaving delivery gaps and subsequently requiring reintervention, while too much energy may cause complications such as renal artery stenosis or dissection. Therefore, renal denervation would benefit from the use of photonics-based catheters that can predict lesion geometry based on measurements of real-time tissue temperature at the ablation site.

[0008] Low coherence interferometry (LCI) is commonly used in the field of medical imaging to provide depth-resolved information of internal and external tissues. Exemplary LCI techniques include optical coherence reflectometry (OCR) and optical coherence tomography (OCT), both of which can provide depth-resolved information with high axial resolution through broadband light sources and interferometric detection systems. LCI techniques can be used to determine the structural characteristics of tissues and their changes when ablation damage occurs. Some optical variables that can be used to determine changes in tissue properties are frequency, flight time, polarization, and intensity.

[0009] Spectroscopic techniques based on elastic optical scattering, fluorescence, and Raman scattering are able to diagnose diseases by characterizing the cellular / subcellular structure, cellular metabolic state, and molecular signatures of normal and diseased tissues, respectively. Spectroscopic techniques have been used to determine the geometry of different anatomical structures within tissues and have the advantage of increased penetration depth compared to some LCI techniques.

[0010] As described above, cardiac ablation, renal denervation, and catheter-based neuroablation interventions suffer from significant limitations associated with a lack of real-time information during the clinical procedure to assess lesion progression after energy (eg, RF, cryotherapy, and / or pulsed fields) is delivered to a selected site. Summary of the invention

[0011] Accordingly, it may be desirable to provide new catheters, systems, and methods that use optical techniques (eg, LCI and spectroscopy) to assess lesion geometry during and after energy delivery to improve safety and ensure accuracy of ablation to reduce the need for re-intervention.

[0012] Thus, described herein are embodiments of a light-guided ablation system that includes a catheter, a light source, an optical circuit, an ablation energy source, and an ablation energy circuit. In various embodiments, the ablation system can be used with pulsed field ablation energy or RF ablation energy to treat cardiac fibrillation, epilepsy, or to perform renal denervation. Changes in polarization and phase delay of light used by the optical-based catheter systems described herein can be used to predict thermal lesion geometry during RF ablation or structural changes in tissue and cells associated with cell death during pulsed field ablation.

[0013] In one embodiment, an ablation system includes a catheter having an optical waveguide or optical fiber, a data processing device, a light source, an optical circuit, and an ablation energy source. The catheter includes a proximal segment, a distal segment, and a shaft connecting the proximal segment to the distal segment. In some embodiments, the proximal segment includes a handle as an interface with a clinical user. In some embodiments, the optical fiber and / or waveguide and the wire and / or cable are at least partially passed through the shaft of the catheter to transmit optical signals and ablation energy to / from the patient's body. In some embodiments, the optical fiber and / or waveguide is part of an optical circuit that allows transmission and control of optical signals sent by the light source. In one embodiment, the optical circuit includes a splitter and / or a switch to divide the optical signal from the light source into different paths of the optical circuit so that the optical signal is sent to different locations in or on the surface of the patient's body.

[0014] In some embodiments, the wire is used to send ablative energy from the ablative energy source to the ablation site inside or on the surface of the patient's body. In some embodiments, the ablative energy source is a pulsed field ablation (PFA) generator. In some embodiments, the PFA generator sends a pulsed electrical signal (monophase or biphasic) that generates a pulsed RF field to produce localized damage in the tissue at the ablation site. The electrical signal of the ablation energy source can be transmitted to the electrode located on the surface of the catheter shaft 202 through a wire or cable. Damage can be generated by electric field pulses from electrodes that contact or penetrate into the tissue at the ablation site. Depending on the amount of energy delivered to the tissue, the damage can be thermal or non-thermal. In some embodiments, the energy source can be adjusted to produce damage associated primarily with non-thermal damage to tissue structures. Non-thermal damage occurs when the ablation energy entering the tissue causes or increases the size of the pores in the tissue cell membrane to open or increase in size to the extent that causes cell edema. Such cell edema can alter cell function, and cells can respond to it by inducing apoptosis or other delayed cell death processes that cause cell death. Alterations in cell wall structure and subsequent cell death through apoptosis, pyroptosis, necroptosis, and / or necrotic processes may alter the birefringence properties of ablated tissues, as denaturation and / or fragmentation of cell membrane proteins, cytoskeletal proteins, or extracellular protein matrices alters how light interacts with these proteins. Consequently, the optical properties of light reflected or refracted from such denatured or fragmented structures, such as polarization, phase retardation, etc., can result in changes in tissue birefringence.

[0015] In some embodiments, an optical signal from a light source is propagated through an optical circuit to an ablation site in or on a patient's body surface simultaneously with or after ablative energy is delivered to the tissue. In some embodiments, light from the optical circuit penetrates the tissue and is reflected, refracted, or scattered back into the optical circuit. The reflected, refracted, or scattered light is returned at least partially through the optical circuit to an optical detector. The optical detector is used to collect optical data about the characteristics of the returned light, such as intensity, frequency, polarization state, flight time, phase delay, etc. In some embodiments, the optical data and characteristics are analyzed to determine changes in the birefringence of the treated tissue associated with ablation using pulsed field energy. In some embodiments, data from the returned optical signal, including changes in the birefringence of the tissue, can then be sent to a computer or processor unit coupled to the optical detector. The computer or processor unit can apply interpolation, extrapolation, artificial intelligence (e.g., machine learning), and / or other statistical algorithms to the data from the returned optical signal in order to correlate changes in the received signal with the durability and / or geometry of the ablation lesion, and with the possible recurrence of atrial fibrillation or other types of cardiac pacing abnormalities.

[0016] In one embodiment, an example system is described. The system includes a catheter, an optical circuit, a pulsed field ablation energy source, and a processing device. The catheter includes a proximal segment, a distal segment, and a shaft coupled between the proximal segment and the distal segment. The optical circuit is configured to transmit light at least partially from the proximal segment to the distal segment and back. The pulsed field ablation energy source is coupled to the catheter and configured to send pulsed electrical signals to a tissue sample. The processing device is configured to analyze one or more optical signals received from the optical circuit to determine a change in polarization or phase delay of light reflected or scattered by the tissue sample, and determine a change in birefringence of the tissue sample based on the change in polarization and phase delay and the change in the optical circuit.

[0017] In another embodiment, an example method for performing ablation in a patient is described. The method includes inserting a catheter into the vasculature of the patient, moving a distal end of the catheter to an ablation site in the vasculature of the patient, optically establishing tissue contact at the distal end of the catheter using light delivered to the ablation site through the distal end of the catheter, delivering energy from the distal end of the catheter from an energy source coupled to the catheter into the tissue, optically interrogating the ablated tissue site to determine a change in polarization or phase delay of light delivered to the ablated tissue site through the catheter, and removing the catheter from the vasculature.

[0018] In another embodiment, a catheter for ablating heart wall tissue is described. The catheter includes a proximal end, a distal end, a plurality of electrodes disposed at a distance from each other at the distal end, and at least one optical port located at a position on the distal end relative to the plurality of electrodes. The catheter is configured to be placed in an outer sheath so that the distal end is in a straight configuration compatible with vascular delivery, and the distal end presents a circular shape when pushed through the sheath. The plurality of electrodes are connected to an external power generating device by wires via an electrical connector on the proximal end of the catheter. The plurality of electrodes are configured to transmit electrical energy to the heart wall when energized by the external power generating device.

[0019] The further features and advantages of various embodiments, as well as the structure and operation, are described in detail below with reference to the accompanying drawings. It should be noted that the specific embodiments described in this disclosure are not intended to be limiting. These embodiments are presented in this disclosure for illustrative purposes only. Based on the teachings contained in this disclosure, other embodiments will be apparent to those skilled in the art of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 A diagram of an example ablation system with optical techniques for controlled tissue ablation is illustrated in accordance with an embodiment of the present disclosure.

[0021] Figure 2 A diagram illustrating example components of a catheter that may be used for controlled ablation according to an embodiment of the present disclosure is illustrated.

[0022] Figure 3A Illustrated is a diagram showing an exemplary axial cross-sectional view of a distal segment of a catheter according to an embodiment of the present disclosure.

[0023] Figure 3B Illustrated is a diagram showing an exemplary radial cross-sectional view of a distal segment of a catheter according to an embodiment of the present disclosure.

[0024] Figures 4A-4D Illustrations of exemplary 2D and 3D configurations of a distal segment of a catheter for accommodating ablation site geometry in accordance with embodiments of the present disclosure are illustrated.

[0025] Figure 5 A diagram of an example optical circuit is illustrated in accordance with an implementation of the present disclosure.

[0026] Figure 6 Illustrated are diagrams of exemplary experimental histological images of myocardial tissue of non-ablated and post-PFA ablated samples in accordance with an embodiment of the present disclosure.

[0027] Figure 7 An example method for clinical use of an optically guided pulsed field ablation system according to an embodiment of the present disclosure is illustrated.

[0028] Figure 8 Illustrated is a diagram of an exemplary distal end of a PFA-OCR catheter having a circular shape, according to an embodiment of the present disclosure.

[0029] Fig. 9 An exemplary cross-sectional view of a side view of a distal tip portion of a distal section of a PFA catheter with OCR diagnostic capabilities according to an embodiment of the present disclosure is illustrated.

[0030] Fig.10 An exemplary cross-sectional view of a side view of a distal segment of a PFA catheter with OCR diagnostic capabilities is illustrated, with an individually movable optical catheter inserted into its optical lumen, in accordance with an embodiment of the present disclosure.

[0031] Fig.11 An exemplary cross-sectional view of a distal segment of a PFA-OCR catheter according to an embodiment of the present disclosure is illustrated.

[0032] Fig.12 An exemplary cross-sectional view of a side view of a distal segment of a PFA catheter showing internal components according to an embodiment of the present disclosure is illustrated.

[0033] Fig.13 Another exemplary cross-sectional view of a side view of a distal segment of a PFA catheter according to an embodiment of the present disclosure is illustrated.

[0034] Fig.14 A diagram of an exemplary distal end of a PFA-OCR catheter system having two concentric catheters in accordance with an embodiment of the present disclosure is illustrated.

[0035] Fig.15 A diagram illustrating an example cross-section of the distal end of a PFA-OCR outer catheter according to an embodiment of the present disclosure is illustrated.

[0036] Fig.16 A diagram of an exemplary distal end of an inner catheter for translation within an outer catheter of a PFA-OCR catheter system is illustrated in accordance with an embodiment of the present disclosure.

[0037] Fig.17 An exemplary cross-sectional view of the distal end of an inner catheter for translation within an outer catheter of a PFA-OCR catheter system is illustrated in accordance with an embodiment of the present disclosure.

[0038] Figures 18A-18B An exemplary diagram of an exemplary distal segment of a PFA-OCR catheter system is illustrated, wherein the inner catheter is inserted into the outer catheter, according to an embodiment of the present disclosure. Fig.18A and 18BMisalignment and alignment of the electrodes and openings in the catheter are shown, respectively.

[0039] Fig.19 Illustrated are exemplary cross-sectional views of an inner catheter and an outer catheter in a dual catheter system for PFA-OCR according to an embodiment of the present disclosure.

[0040] Fig. 20 Illustrated are example cross-sectional views of an inner catheter and an outer catheter in a dual catheter system for PFA-OCR according to an embodiment of the present disclosure.

[0041] Fig.21 An example cross-sectional view of a side view of a distal segment of a PFA-OCR catheter system according to an embodiment of the present disclosure is illustrated, wherein a movable optical catheter is configured to rotate within a stationary outer catheter.

[0042] Fig. 22 An exemplary cross-sectional view of a dual catheter PFA-OCR system according to an embodiment of the present disclosure is illustrated, the system allowing selection of an active measurement position by rotation of one catheter relative to the other catheter.

[0043] Fig.23 A block diagram illustrating example components of a computer system according to an embodiment of the present disclosure is illustrated.

[0044] Embodiments of the present disclosure will be described with reference to the accompanying drawings. DETAILED DESCRIPTION

[0045] 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 is apparent to those skilled in the relevant art that the present disclosure may also be used for various other applications.

[0046] It should be noted that references in the specification to "one embodiment", "an embodiment", "an example embodiment", etc. indicate that the described embodiment may include specific features, structures, or characteristics, but each embodiment does not necessarily include the specific features, structures, or characteristics. In addition, these words do not necessarily refer to the same embodiment. In addition, when a specific feature, structure, or characteristic is described in conjunction with an embodiment, whether or not explicitly described, it is within the knowledge of those skilled in the art to implement such feature, structure, or characteristic in conjunction with other embodiments.

[0047] It should be noted that while the present application may be specifically directed to cardiac ablation, the embodiments described herein may also be directed to other pathologies, as well as additional energy sources for ablation, including but not limited to cryo, radio frequency (RF), microwave, laser, ultrasound, and pulsed electric fields.

[0048] Described herein are embodiments of medical systems that use optical signals to characterize changes in tissue during and after delivery of ablative energy to create lesions in the tissue.

[0049] In some embodiments, low coherence interferometry (LCI) and / or spectroscopy can be used with the optical signal to provide depth resolved information about the sample tissue being imaged. Although portions of this application may focus on catheters and the transmittance of optical signals through portions of the catheter, it should be understood that the embodiments discussed herein may be applicable to any medical device that uses optical signals.

[0050] Exemplary System Implementations

[0051] Figure 1 A schematic diagram of an exemplary ablation system is illustrated, which includes a catheter 100, a console 101, an ablation energy source 102, a cooling source 103, and a user interface 104. In some embodiments, the distal segment of the catheter 100 is positioned at a portion of the tissue of the patient 107. In some embodiments, the elements outside the catheter 100 (e.g., referred to herein as external elements) can be maintained in a single housing or multiple housings determined by the system design. In some embodiments, the elements in different housings can be connected by external data cables, optical fibers 105, and / or cables or wires 106. In some embodiments, the system may not include a cooling source 103. In some embodiments, the ablation system can use traditional radio frequency (RF) ablation means to produce thermal damage in the tissue, which may include a cooling source 103 in the form of an irrigation pump to prevent blood charring. In other embodiments, the ablation system can use pulsed field ablation energy or cryogenic energy, and the cooling source 103 may not be included in the ablation system.

[0052] Exemplary Catheter Embodiments

[0053] Figure 2A catheter 100 according to an embodiment of the present disclosure is illustrated. The catheter 100 includes a proximal segment 200, a distal segment 201, and a shaft 202 coupled between the proximal segment 200 and the distal segment 201. In some embodiments, the proximal segment 200 includes a handle for interfacing with a clinical user. The handle may include one or more buttons, sliders, levers, lights, dials, and other elements that allow mechanical and functional control of the catheter shaft 202 and the distal segment 201. In some embodiments, the proximal segment 200 of the catheter may also include wiring 204 and one or more connectors 205. The wiring 204 may include a harness or group of cables and optical fibers and / or waveguides. The one or more connectors 205 may serve as an interface for the catheter 100 and connect the catheter 100 directly or indirectly to other elements of the ablation system, including an ablation energy source 102, a light source, a console 101, and / or a user interface 104. In some embodiments, the proximal segment 200 of the catheter may also have a port connected to a cooling source 103. In some embodiments, the wiring 204, harness elements, and one or more connectors 205 may be detachable from the handle in the proximal section. In other embodiments, communication between the catheter 100 and other elements of the ablation system may be wireless, using technologies such as Bluetooth, WiFi, cellular, and the like.

[0054] The proximal segment 200 may include additional interface elements that a user of the catheter 100 may utilize to control the operation of the catheter 100. For example, the proximal segment 200 may include a deflection control mechanism that controls the deflection angle of the distal segment 201. The deflection control mechanism may use mechanical movement of elements of the proximal segment 200, or the deflection control mechanism may use an electrical connection to control the movement of the distal segment 201. The proximal segment 200 may include various buttons or switches that allow a user to control when RF energy is applied to the distal segment 201, or when radiation beams and / or light are sent from the distal segment 201, allowing optical data to be collected. In some embodiments, these buttons or switches are located at a separate user interface coupled to a processing device or the handle itself.

[0055] The deflection control mechanism may include electrical or mechanical elements designed to provide a signal to the distal segment 201 to change the deflection angle of the distal segment 201. According to one embodiment, the deflection system achieves the guidance of the distal segment 201 by actuating a mechanical control placed therein in the proximal segment 200. This deflection system may be based on a series of aligned and evenly spaced cutouts in the catheter shaft 202 intended to provide unidirectional or multi-directional deflection of the distal segment 201, combined with wires connecting the deflection mechanism control in the proximal segment 200 to the catheter tip 214 in the distal segment 201. In this way, a specific movement of the proximal segment 200 can be projected to the distal segment 201. In some embodiments, a combination of several control wires connected to the catheter tip can enable the catheter tip to deflect in different directions.

[0056] Figure 2 Elements of the distal segment 201 are further shown in an enlarged view showing the catheter tip 214. In one embodiment, the shaft 202 and distal segment of the catheter may include one or more radiopaque markers 215 for navigation purposes. According to some embodiments, the distal segment 201 may include one or more external electrodes 213 for ablation. The electrodes 213 may be distributed on the segments of the distal segment 201 of the catheter or directly on the catheter tip 214 at the distal end of the distal segment 201. In some embodiments where cooling is desired, the distal segment 201 of the catheter 100 may also include one or more irrigation holes 216. In some embodiments, a cooling fluid (e.g., compressible and / or incompressible) provided by the cooling source 103 travels through a channel at least partially through the shaft 202 of the catheter 100 and then externalizes through the irrigation holes 216. These irrigation holes 216 may be located in any segment of the catheter shaft 202, the electrodes 216, or the catheter tip 214.

[0057] Figure 3A and 3B Exemplary axial and radial cross-sectional views of a distal segment of a catheter according to an embodiment of the present disclosure are illustrated, respectively. Figure 3A and 3B Different configurations of electrodes, viewing ports, and lens fiber assemblies in the catheter tip are illustrated.

[0058] like Figure 3A-3B As shown, the distal segment 201 of the catheter and shaft 202 can have a single electrode or multiple electrodes 213 to deliver ablation energy. In some embodiments, PFA energy can be used, and the electrode 213 configuration can be configured to deliver monophasic or biphasic pulse application. In some embodiments where cooling is implemented, the central cooling channel 306 and the cooling communication path 307 can guide a cooling fluid through the shaft 202 to the distal segment 201, and then this fluid can be externalized through the irrigation holes 216 to cool the surrounding tissue or blood.

[0059] The distal segment 201 can also include a plurality of optical viewing ports 308 to send / collect light at various angles from the distal segment 201. In some embodiments, the optical viewing ports 308 can be distributed on the exterior of the distal segment 201, resulting in a plurality of different viewing directions, and in some embodiments, each of the plurality of viewing directions is substantially non-coplanar.

[0060] exist Figure 3A-3BIn some embodiments shown, light is transmitted by an optical fiber 105 through the shaft 202 and the distal segment 201. Such optical fibers 105 may be coated or uncoated. In some embodiments, the optical fibers 105 are coated with a polymer for protection, insulation, and structural integrity. In some embodiments, the optical fibers 105 are attached to a lens 300 to focus the light that will then enter the tissue. In some embodiments, the optical fibers can be mechanically or chemically attached by glue or adhesive 305. In some embodiments, the glue or adhesive 305 can be selected to provide mechanical strength as well as optical index matching. Figure 3B As shown, in some embodiments, the lens 300 and / or the optical fiber 105 can be supported by an internal support structure 304 to position and orient the lens 300 and the optical fiber 105 in an appropriate position. In other embodiments, the lens 300 can be positioned and / or oriented by the configuration of the shaft 202, the electrode 213, and the catheter tip 214. In some embodiments, the lens 300 may not be an external element of the optical fiber 105, but the curvature can be generated by manufacturing (e.g., etching, machining, laser cutting, or chemically forming) the curvature directly on the distal end of the optical fiber 105 and the optical fiber core. In some embodiments, the distal segment 201 can include a substrate with patterned waveguides and optical focusing or guiding elements (e.g., lenses, mirrors, etc.) for guiding light to / from each of the multiple optical observation ports 308. The substrate can be a flexible or partially flexible substrate made of a material such as polyimide, polyethylene glycol, polyparaxylene, or polydimethylsiloxane (PDMS).

[0061] In some embodiments, Figure 3A As shown, the lens 300 can be connected to the optical fiber and placed in a groove 303 of the catheter. In some embodiments, the lens can be flush 301 with the catheter surface (e.g., shaft, electrode or tip), or can extend beyond the surface 302 of the catheter shaft 202, electrode 213 or tip 214. In some embodiments, the lens that is flush 301 with the catheter surface or extends beyond the surface 302 can be the contact point with the external tissue. In some embodiments that implement cooling, the lens that is recessed into the catheter and uses a viewing port 308 to allow light to pass through can also use these same viewing ports 308 as irrigation holes 216. In some embodiments, the viewing port 308 and the irrigation holes 216 can be different and separate components.

[0062] Figures 4A-4D 2D and 3D geometries of a distal segment 201 of a catheter according to an embodiment of the present disclosure are illustrated. Figures 4A-4DAs shown, the distal segment 201 of the catheter can present different 2D and 3D geometries. In some embodiments, the 2D and 3D geometries of the distal segment can be the actual geometry of the catheter in its unloaded state. In some embodiments, the catheter geometry can be deflected and / or reshaped to be temporarily assembled within a delivery sheath so as to easily pass through the vasculature in the patient's body. In other embodiments, the 2D and 3D geometries of the distal segment can be generated from a relatively straight distal segment of the catheter by deformation associated with mechanical or electromagnetic forces controlled by the proximal segment 200, so that after passing through at least a portion of the vasculature and before ablative energy delivery, the distal segment forms such 2D and 3D geometries to improve the surface contact of the catheter with the local anatomical structure.

[0063] like Figures 4A-4D As shown, such 2D or 3D geometries may have electrodes 213 placed at different locations in the catheter to maximize electrode contact and optical proximity to anatomical structures (e.g., tissue ablation sites) that may require ablation. In some embodiments, the electrodes 213 and other components of the catheter may have a configuration similar to that of FIG. 3, where the lens / optical viewing port is arranged through the shaft 202, the distal segment 201, or the tip 214. In some geometries (e.g., Figure 4B The distal segment 201 of the catheter (shown in FIG. 1 ) can at least partially have a ring structure 401 during ablation. In some embodiments, the geometry having the ring structure 401 can be beneficial during peripheral ablation around arteries and veins in the vascular system. In some embodiments, Figure 4A The radial petal structure 400 shown in FIG. 4 can extend outward to better contact the surrounding tissue. In other embodiments, the 3D sphere structure 402 (such as Figure 4C In some embodiments, the distal segment 201 may be extended from the surface of the distal segment 201 to increase its overall diameter for better tissue engagement. In some embodiments, such extended geometry may be beneficial when ablating tissue having an inner diameter or vasculature or ablating tissue in a defined tissue cavity or chamber within or on the surface of the human body. Figure 4C The expanded 3D geometry shown in the figure can be produced by mechanical deflection by using a balloon, rod, wire or other mechanical element to change the geometry of the distal segment 201. In some embodiments, memory materials such as memory metal alloys (e.g., Nitinol, etc.) or memory polymers can be used to produce such geometry / configuration. Other embodiments of the 3D structure of the distal segment can include helical structures 403, 404, such as Figure 4DAs shown. In some embodiments, the helical structures 403, 404 can be used to ablate the lumen of the vasculature or cavity. In some embodiments, the geometry of the distal segment 201 of the catheter can be implemented during ablation using conventional RF, PFA or cryogenic energy. In some of the above-mentioned exemplary embodiments where the distal segment 201 changes geometry during the procedure, there may be a need to allow the optical fiber 105 (which tends to be axially rigid) relative to the distal segment 201 or shaft 202 to prevent undesirable binding or bending of the optical fiber 105 and possible mechanical failure.

[0064] In some embodiments, the catheter can include some or all of the following elements to interconnect the proximal segment 200 with the distal segment 201, including but not limited to a shaft, an irrigation channel, an RF conductive medium, a deflection mechanism, an electrical connection, and an optical transmission medium. In some embodiments, the electrical connection can be used to provide a signal to a light modulation component or an ablation element located in the distal segment 201. In some embodiments, one or more optical transmission media can guide light generated from a light source (e.g., exposure light) toward the distal segment 201, while another subset of optical transmission media guides light returned from the distal segment 201 (e.g., scattered or reflected light) back to the proximal segment 200. In some embodiments, the same one or more optical transmission media guide light in both directions. In some embodiments, the optical transmission medium includes a polarization-maintaining (PM) fiber or a single-mode fiber, a multimode fiber, or a waveguide (single-mode or multi-mode). In some embodiments, the same optical transmission medium is used to transmit the exposure light and the light returned from the (scattered or reflected) tissue through at least a portion of the length of the catheter, thereby forming a two-way communication path.

[0065] In some embodiments, the distal segment 201 of the catheter can include other elements, such as one or more thermal sensors, pressure sensors, force sensors, electrical sensors, beam splitters, optical mirrors, and multiplexers. In some embodiments, optical interferometers or RF energy source elements can also be contained within the proximal segment 200 / handle of the catheter. In some embodiments, the energy source 102 and most or all of the optical interferometry elements can be contained within an external element of the catheter, such as an external ablation energy source 102, console 101, or user interface 104. In some embodiments, the console 101, energy source 102, and user interface 104 can be contained within a single housing or multiple housings.

[0066] Exemplary Embodiments of Ablation Energy Circuits

[0067] In some embodiments, the ablation energy circuit can include an ablation energy source 102 and electrical transmission elements, such as wires and cables, insulating elements, switches, resistors, capacitors, transformers, modulation elements, connectors, and electrodes, as needed, so that the energy source can transfer the electrical energy transmitted in the catheter to the tissue through the electrodes to ablate and produce damage. In some embodiments, the ablation energy is transmitted by a pulsed field for a PFA system. In some embodiments, the frequency, amplitude, duration, and other characteristics of the electromagnetic pulse can be selected by a clinician before delivering the selected pulse treatment at the selected ablation site. In some embodiments, PFA can be delivered in a biphasic or monophasic manner. In some embodiments, the PFA energy pulses can be synchronized with the heart rhythm by sensing the heart electrical signals (e.g., QRS complex waves) using ECG / EKG or other sensing means, and then using the heart signals as a reference to deliver synchronized PFA energy pulses to the selected ablation site in the heart.

[0068] Exemplary Embodiments of Optical Circuits

[0069] Figure 5 A diagram of an example optical circuit 500 is illustrated according to an embodiment of the present disclosure. In some embodiments, Figure 5 The elements of the optical circuit 500 shown in FIG. 1 are present both within the catheter 100 and in external elements (e.g., external to the catheter 100). In some embodiments, the external elements of the optical circuit 500 can be housed in multiple or a single housing. In some embodiments, the external elements of the optical circuit 500 are housed within the console 101, which may or may not be housed in the same housing as the user interface 104 and the ablation energy source 102.

[0070] The optical circuit 500 has a light source 502 that can include one or more laser diodes or light emitting diodes (LEDs). For example, when performing time domain and / or spectral domain analysis, LEDs can be used, while tunable lasers can be used to scan the wavelength of light within a wavelength range. The radiation beam generated by the light source 502 can have a wavelength in the infrared range (e.g., 750nm to 1mm), while other light sources 502 can work in the visible light range (e.g., 400nm to 750nm) or the ultraviolet range (e.g., 400nm to 10nm). In one embodiment, the radiation beam has a central wavelength between 1000nm and 1600nm. The light source 502 can be designed to output only a single wavelength of the radiation beam, or it can be a swept source and is designed to output a range of different wavelengths. The wavelength range can include any wavelength found in the near infrared or mid-infrared spectral range. The generated radiation beam can be directed to the distal segment 201 via an optical transmission medium connected between the proximal segment 200 and the distal segment 201 in the shaft 202. Some examples of optical transmission media include single-mode and multi-mode optical fibers and integrated optical waveguides. In some embodiments, the electrical transmission medium and the optical transmission medium are provided by the same mixed medium that allows both electrical and optical signals to propagate.

[0071] In some embodiments, the optical circuit 500 includes one or more components of an interferometer to perform LCI using light generated from a light source. In some embodiments, when performing LCI, the optical circuit 500 can analyze interference data. Interference data analysis can be associated with understanding changes in polarization of light reflected or scattered by tissue, which can allow evaluation of changes in birefringence of the tissue. In some embodiments, the optical transmission medium used to guide light into and out of the distal segment 201 may not affect the state and degree of light polarization (e.g., single-mode fiber). In other embodiments, for such an LCI circuit, the optical transmission medium can affect polarization in a constant and reversible manner. In further embodiments of the optical circuit 500, optical analysis of light reflected or scattered back by the tissue can include methods related to tissue spectroscopy. For tissue spectroscopy, the optical transmission medium used to guide light into and out of the distal segment 201 can allow multi-mode light, such as multi-mode fiber. In further embodiments of the optical circuit 500, both single-mode fiber and multi-mode fiber can be used to determine different paths from one or more light sources to the distal segment 201 and back, so that the ablation process can be better controlled by the system using LCI methods and spectral methods.

[0072] Various embodiments of the present application include an LCI system integrated into a medical device such as a catheter 100 for optically interrogating a sample 510 (e.g., at a site of ablated tissue). In some embodiments, the LCI system can be implemented by an optical circuit 500, and the optical circuit 500 can be referred to herein as an LCI system. The optical circuit 500 can include a delay unit 512, which can include various light modulation elements. These modulation elements can perform phase and / or frequency modulation to offset undesirable optical effects in the light and select one or more depths of the sample to be imaged. 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.

[0073] The optical circuit further includes a beam splitting element 504, a sample arm 506, a reference arm 508, and a detector 514. In the illustrated embodiment, a delay unit 512 is located within the reference arm 508. However, it should be understood that the delay unit 512 may alternatively be located in the sample arm 506. Alternatively, various elements of the delay unit 512 may be present in both the sample arm 506 and the reference arm 508. For example, the elements of the delay unit 512 that introduce a variable delay to the light may be located in the sample arm 506, while the elements that modulate different polarization modes of the light may be located in the reference arm 508. In another embodiment, the elements of the delay unit 512 that modulate different polarization modes of the light may be located in the sample arm 506, while the elements that introduce a variable delay to the light may be located in the reference arm 508. In one embodiment, the sample arm 506 and the reference arm 508 are optical waveguides, such as patterned waveguides or optical fibers. In one embodiment, all components of the LCI system are integrated onto a planar lightwave circuit (PLC). In another embodiment, at least the components within the delay unit 512 are integrated on the same substrate of the PLC. Other implementations are also contemplated, such as fiber optic systems, free space optical systems, photonic crystal systems, etc.

[0074] It should be understood that the LCI system may include any number of other optical elements not shown for clarity. For example, the LCI system may include mirrors, lenses, gratings, separators, micromechanical elements, etc. along the path of the sample arm 506 or the reference arm 508.

[0075] The beam splitter element 504 is used to direct light received from the light source 502 to the sample arm 506 and the reference arm 508. The beam splitter element 504 can be, for example, a bidirectional coupler, a beam splitter, an adjustable split ratio coupler, an optical switch, or any other modulating optical device that converts a single beam of light into two or more beams of light. In some embodiments, the beam splitter element 504 splits the light into one or more reference arms and multiple sample arms, so that the light / radiation from the multiple sample arms can optically interrogate samples at different locations or directions at the distal segment 201. In some embodiments, the initial beam splitter element directs light into the reference arm 508 and the sample arm 506, and the second beam splitter element can further split the sample arm 506 into multiple beams. It should be understood that any combination of one or more beam splitter elements 504 in different parts of the radiation / optical circuit can be used to generate multiple reference beams and interrogate samples as needed for the optical analysis process.

[0076] The light propagating down the sample arm 506 eventually strikes the sample 510. The sample 510 can be any suitable sample to be imaged, such as tissue. The light is scattered and reflected back from different depths within the sample 510, and the scattered / reflected radiation is collected back into the sample arm 506. In another embodiment, the scattered / reflected radiation is collected back into a waveguide different from the transmitting waveguide. The scanning depth can be selected via the delay applied to the light in the delay unit 512.

[0077] The light within the sample arm 506 and the reference arm 508 is recombined before being received by the detector 514. In the illustrated embodiment, the light is recombined by the beam splitter element 504. In another embodiment, the light is recombined at an optical coupling element different from the beam splitter element 504. The detector 514 may include any number of photodiodes, charge coupled devices, and / or CMOS structures to convert the received light into electrical signals. The electrical signals contain depth-resolved optical data associated with the sample 510 and can be received by a processing module. The processing module has an interface to convert such electrical signals into digital data, which can then be processed and analyzed by a standard processing unit (e.g., a computer, a data processor, reprogrammable hardware, an ASIC, or any other type of digital data processing circuit or system).

[0078] As used herein, the term "depth resolved" defines data where one or more portions of the data associated with a particular depth of the imaged sample can be identified. According to one embodiment, the LCI system is shown as an interferometer design similar to a Michelson interferometer. However, other interferometer designs are possible, including Mach-Zehnder or Miller interferometer designs.

[0079] Exemplary Embodiments of External Elements of the System

[0080] like Figure 1 As shown, several elements of the system may be external to the catheter 100 and directly or indirectly connected to the catheter 100. These elements may be contained in multiple housings or a single housing. Figure 1 In the configuration shown, the console 101, the user interface 104, and the ablation energy source 102 are housed in separate housings. In some embodiments, a portion of the optical circuit 500 is encapsulated within the console 101 and a portion is encapsulated within the catheter 100. In further embodiments, the ablation energy source 102 may also be encapsulated within the console 101. Elements of the user interface 104 may be encapsulated within the console 101 and other elements within the display module. In some embodiments, the external elements of the system also include a processing module, which may be packaged in combination with any other external elements, such as within the console 101. The processing module may contain some elements of the optical circuit 500 or only receive signals from the optical circuit 500. The processing module may also include additional circuitry to measure the signal generated at the optical detector 514 and use it to generate data that can be further processed and analyzed. In some embodiments, the processing unit of the processing module, other elements of the processing module, the catheter 100, the ablation energy source 102, and the console 101 may be directly or indirectly connected to the user interface 104. User interface 104 can send auditory, visual, and / or tactile data to the user before, during, and / or after delivering ablative energy to inform him or her of the characteristics of sample 510 and the status of ablation system and treatment variables. Clinicians can use the data provided by user interface 104 to make more informed decisions about ablation treatments.

[0081] Exemplary Embodiments of Determining Birefringence of Tissue

[0082] Birefringence is an optical property of a material that is related to the polarization and propagation direction of light. Most viable human soft tissues are generally considered to be birefringent (e.g., myocardium, kidney, brain tissue, etc.). This birefringence arises from the organization and geometry of its internal components and structures. Most notably, the organization and geometry of proteins, and / or the organization and arrangement of cells within the tissue, are important determinants of tissue birefringence. When some of the internal proteins of a tissue are transformed from their normal state to a denatured state, the optical birefringence in the tissue changes because the geometry of the proteins themselves and their arrangement in the matrix changes. Collagen, elastin, and fibrin are extracellular matrix proteins that, when denatured, can affect the birefringence properties of the tissue because light reflected or scattered from this extracellular matrix may have a different polarization (e.g., polarization and phase delay) when compared to the light signal received when these proteins are in their normal state. Further, other proteins in the cell membrane and the cytoskeleton within the cell may also produce changes in the polarization state of light when denatured, or affect the anisotropy of the tissue when the geometry of the cell membrane or cytoskeleton changes.

[0083] Exemplary Embodiments of RF Ablation and Determining Birefringence of Tissue

[0084] By using an RF catheter or other medical delivery device, RF energy can be delivered to the tissue to cause heating. After the tissue reaches about 50°C, permanent thermal damage may occur due to necrosis. Protein denaturation may occur at about 70°C. Therefore, the catheter system as described herein uses polarization-sensitive LCI to query the optical state of the ablation sample and allows real-time direct visualization by analyzing the reflected and scattered light and its polarization and phase delay, as well as further information of the flight time, frequency and amplitude of the light signal in a depth-resolved manner when the tissue reaches 70°C. In other embodiments, a prediction algorithm using extrapolation, statistical fitting, interpolation or artificial intelligence (e.g., machine learning) can be applied to the lesion library to better predict the geometry of the lesion of permanent ablation (e.g., the width, length and / or depth of the lesion). In some embodiments, the algorithm can take into account the geometry of the lesion that has been directly visualized to reach 70°C and calculate the geometry of the tissue sample that has reached 50°C. The geometry of the lesion that has reached 50°C determines the tissue area of ​​permanent ablation, which will not have cardiac conductivity. Determining and visualizing this geometry allows the clinician to assess whether the lesion has fully penetrated the tissue wall or reached the desired structure at the ablation site, and whether gaps exist in the ablation line.

[0085] In some configurations of the optically guided ablation system, the penetration depth of the light available for direct visualization and its extrapolation to the lesion size at 50°C may not be sufficient to determine complete penetration into the tissue wall. In this case, when the ablation time in a particular lesion needs to exceed the time required to reach a change in birefringence at the maximum penetration depth of the light used for direct optical evaluation, a mathematical algorithm can be used to predict the lesion size in the tissue. Experiments using the system described herein have shown that the ratio of the total ablation time to the degeneration over a period of time can be a primary predictor of lesion size when used for statistical fitting algorithms (e.g., interpolation, extrapolation, regression, minimum residual, ANOVA, MANOVA, etc.) or artificial intelligence algorithms (e.g., machine learning). In some embodiments, the degeneration time can be defined as the time required to achieve degeneration at a known depth at 70°C. In some embodiments, the known depth used can be the maximum depth of the resolvable light signal used to analyze the polarization depth change, which can be approximately 1.5 mm for infrared / near infrared light. Therefore, the processing unit of the optically guided ablation system can be used in conjunction with such an algorithm to predict the depth of the lesion beyond the direct visualization depth in real time and send such information to the clinician through the user interface 104.

[0086] Exemplary embodiments of methods for PFA and determining tissue birefringence

[0087] Pulsed field ablation (PFA) uses electromagnetic pulses to produce lesions in tissue during the ablation process. Typically, PFA pulses are applied to two electrodes at a time, spaced relatively closely together on the tissue segment that needs to be damaged. A series of monophasic or biphasic high-voltage pulses are applied to the electrodes, briefly exposing the tissue between them to a high-intensity electric field. In some embodiments, a series of pulses may be referred to herein as a pulse train. In some embodiments, if the energy density, intensity, and overall intensity of the pulse train are sufficient to cause cell / tissue necrosis through thermal damage, the clinical applications and protocols of PFA may be intended to produce non-thermal damage through apoptosis or other types of non-necrotic delayed cell death.

[0088] During a clinical protocol for PFA, a pulse train of known frequency, amplitude, and duration is applied between two or more electrodes at the ablation site (e.g., in contact with or in close proximity to the tissue) to cause pores to open in the cell membranes of cells in the target tissue segment. The opening of these pores causes cellular edema, and if this edema is sufficient, apoptotic (or other delayed cell death) mechanisms are activated in the cells, leading to subsequent cell death. Therefore, when using PFA, polarization-sensitive LCI methods for determining changes in tissue birefringence due to protein denaturation at 70°C may not be sufficient. Because the tissue may not be able to reach this temperature, or only a minimal surface area of ​​the tissue in direct contact with the electrodes may undergo denaturation and necrosis. In some embodiments, all or the vast majority of the tissue samples being interrogated may experience delayed cell death without thermal injury.

[0089] Experiments using the polarization-sensitive LCI ablation system described herein showed that it is sensitive to changes in birefringence of tissue associated with application of PFA energy trains in the absence of thermal injury. Figure 6 FIG. 6 illustrates an exemplary experimental histological image of myocardial tissue 600 of a non-ablated sample and a sample after PFA ablation according to an embodiment of the present disclosure. In particular, Figure 6 Histological results comparing non-ablated tissue to PFA-ablated tissue are shown, which show birefringence changes in the polarization-sensitive LCI system. After applying the PFA ablation train, the pulses cause disruption of cell membranes and cell membrane proteins, such as Figure 6 As shown, loss of tissue integrity and architecture leads to cellular edema and subsequent apoptosis (delayed cell death).

[0090] The myocardial tissue sample 600 shows two adjacent areas with two very different structures. The non-ablated area 601 shows an organized and densely packed cell structure supported by cell membranes, intracellular cytoskeleton and extracellular matrix. The sample of PFA ablated tissue 602 shows completely destroyed cell membranes and intracellular cytoskeleton, cell nuclei 604 outside of such membranes, and enlarged gaps 603 in the cell structure and extracellular matrix.

[0091] Proteins and structures responsible for maintaining and organizing cellular structure and thus organizing anisotropy (e.g., birefringence) include: extracellular matrix (e.g., collagen, elastin), cytoskeleton / flagella or cilia (e.g., tubulin, actin or laminin), and cell membrane proteins (e.g., integral / transmembrane proteins). In some embodiments, PFA ablated tissue samples 602 show changes in birefringence in the LCI system after ablation. For different PFA ablation injuries during the experiment, birefringence changes were observed within a few seconds (e.g., less than 30 seconds) or minutes (e.g., up to 40 minutes) after the PFA energy (e.g., pulse train) was delivered to the tissue. The time to detect birefringence changes depends on the intensity (e.g., pulse amplitude), type (monophasic, biphasic), frequency (e.g., pulse frequency), and duration of the pulse train (e.g., the total time all pulses are delivered to the tissue).

[0092] In some embodiments, the delayed birefringence change may not be an immediate necrotic mechanism, but rather a delayed apoptosis / delayed cell death / remodeling response. The delayed change in birefringence may be associated with a delayed change (reduction) in tissue structural anisotropy. As seen in the histology of PFA ablated tissue 602, structural integrity as well as geometric and tissue changes can be seen at the tissue and cellular level. The tissue in the unablated sample 601 with the cellular structure of the tissue matrix determines the anisotropy of the tissue, which is lost after PFA ablation due to subsequent cell death and cellular edema (as shown in sample 602). Therefore, the loss of anisotropy in the tissue after PFA ablation and subsequent cytoskeletal failure, protein denaturation or fragmentation results in a loss of birefringence, which is detectable due to changes in polarization and phase delay of the LCI optically guided ablation system. The apoptotic process of cellular edema may directly affect the intracellular cytoskeleton and its structural proteins, such as tubulin (protein component of microtubules), actin (component of microfilaments) and lamins (component of intermediate filaments), as well as the connection to the extracellular matrix. Disruption of this connection between the cytoskeleton and the extracellular matrix may lead to a general loss of structure and organization of tissue fragments. Therefore, the loss of cytoskeletal integrity may be a major factor leading to the loss of anisotropy and birefringence on tissues, which can be detected by the LCI method described in this article.

[0093] Exemplary Embodiments of an Optically Guided PFA Procedure for Cardiac Ablation

[0094] In some embodiments, in order to use the optically guided PFA system for cardiac ablation, the catheter 100 is introduced into the human vascular system directly or through an access sheath. The distal segment 201 of the catheter is moved to the ablation site using a guidewire, an access sheath, a steerable sheath, or the deflection of the catheter 100 itself. At the ablation site (e.g., atrium, ventricle, artery, vein, etc.), at least one or more electrodes 213 on the surface of the distal segment 201 of the catheter are placed in direct contact with the tissue at the ablation site. Using light or other forms of radiation sent by a light source that travels at least partially through a PM optical transmission medium to the distal segment 201 of the catheter 100, contact or contact stability can be established between the distal segment 201 and the tissue ablation site. After contact or contact stability is established, a PFA pulse train can be sent to the tissue, wherein the characteristics of the pulse train (e.g., frequency, amplitude, intensity, or duration) are determined by the clinical user. During and / or after the transmission of the ablation pulse train, the birefringence changes of the interrogated tissue can be monitored by evaluating the changes in the polarization and phase delay of the reflected / scattered light signal sent into the tissue by the catheter 100. If no change or decrease in birefringence is detected within a predetermined time frame (eg, 1 second to 1 hour), the clinician can re-ablate the tissue using a pulse train having the same or different characteristics.

[0095] In some embodiments, a mathematical, statistical, or artificial intelligence prediction algorithm or equation can be used that uses a measure of the time-to-loss birefringence or the change / difference in the amount of birefringence in the ablated tissue to predict whether the PFA lesion is permanent and therefore may be related to the likelihood of recurrence of cardiac fibrillation. A clinician can use such an algorithm to determine the need to re-ablate tissue at a selected ablation site. In some embodiments, such a prediction algorithm can be programmed directly into the ablation system and the results communicated to the clinician via the user interface 104, or such an algorithm or equation can be provided to the clinician for their offline use.

[0096] In other embodiments of the ablation procedure, prior to establishing tissue contact at the ablation site, the distal segment 201 of the catheter 100 may undergo a geometric change to produce a change equivalent to, but not limited to, Figures 4A-4D to provide better contact or to adapt the catheter to the local anatomy.

[0097] In some embodiments of the PFA optically guided ablation procedure, the catheter can remain in place for a predetermined time after ablation, where a change in birefringence is expected to occur. In other embodiments of the procedure, after ablation, the catheter 100 is moved to another ablation site in the body. After the predetermined amount of time, the catheter 100 is moved back to the first ablation site to monitor whether the PFA pulses have produced a change in birefringence of the tissue. In further embodiments, the catheter can be removed from the body and the same catheter 100 or another similar catheter can be reused at a later re-intervention time to be moved again to the first ablation site to monitor whether the tissue has shown a change in birefringence as a result of the initial PFA pulse train.

[0098] Exemplary Embodiments of an Optically Guided Renal Denervation Procedure

[0099] In some embodiments, in order to use an optically guided ablation system for renal denervation, the catheter 100 is introduced into the human vasculature directly or through an access sheath. The distal segment 201 of the catheter is moved to the ablation site (e.g., the renal artery) using a guidewire, an access sheath, a steerable sheath, or a deflection of the catheter 100 itself. At the ablation site (e.g., the renal artery), at least one or more electrodes 213 on the surface of the distal segment 201 of the catheter are placed in direct contact with the tissue at the ablation site. Using light or other forms of radiation sent by a light source that travels at least partially through a PM optical transmission medium to the distal segment 201 of the catheter 100, contact or contact stability can be established between the distal segment 201 and the tissue ablation site. After contact or contact stability is established, RF energy can be sent to the tissue, wherein the characteristics of the RF energy (e.g., power, duration, etc.) are determined by the clinical user. During the transmission of the ablative RF energy, the birefringence changes of the queried tissue can be monitored by evaluating the changes in the polarization and phase delay of the reflected / scattered light signal sent into the tissue by the catheter 100. RF energy can be applied until the tissue is ablated to a desired depth predicted by an algorithm or equation in the system using the denaturation time or the ratio between the total ablation time and the denaturation time as a predictor variable. In some embodiments, the catheter can be moved as needed to complete ablation through the entire circumference of the renal artery.

[0100] In some embodiments of an optically guided ablation method for renal denervation, a user can move the catheter to the ablation site and re-interrogate the tissue using optical signals to determine birefringence loss through the circumference to ensure that no gaps exist.

[0101] In other embodiments of a renal denervation ablation procedure, prior to establishing tissue contact at the ablation site, the distal segment 201 of the catheter 100 may undergo a geometric change to produce an equivalent but not limited Figures 4A-4D2D and 3D structures such as those shown to provide better contact or to adapt the catheter to the local anatomy.

[0102] In some embodiments of the above-described renal denervation procedures, prior to delivering ablation energy, radiation / light that is at least partially propagated through a multimode optical transmission medium (multimode optical fiber or waveguide) can be used, wherein the light is processed and analyzed using optical spectroscopy to determine the depth of the location of the renal nerves relative to the renal artery wall. In some embodiments, the system can include independent single-mode optical circuits and multi-mode optical circuits to use LCI and spectroscopy in the same ablation catheter system. In some embodiments, ultrasound technology can also be added to the LCI catheter. In this exemplary ultrasound technology catheter, ultrasound signals can be used to determine the depth of the renal nerves prior to ablation.

[0103] Exemplary embodiments of optically guided ablation for treating epilepsy

[0104] In some embodiments, to treat epilepsy using an optically guided ablation system, a catheter 100 is introduced into the human vasculature directly or through an access sheath. The distal segment 201 of the catheter is moved to the ablation site using a guidewire, an access sheath, a steerable sheath, or a deflection of the catheter 100 itself. At the ablation site (e.g., a discrete epileptic focus), at least one or more electrodes 213 on the surface of the distal segment 201 of the catheter are placed in direct contact with the tissue at the ablation site. Using light or other forms of radiation sent by a light source that is at least partially propagated to the distal segment 201 of the catheter 100 through a PM optical transmission medium, contact or contact stability can be established between the distal segment 201 and the tissue ablation site. After contact or contact stability is established, RF energy can be sent to the tissue, wherein the characteristics of the RF energy (e.g., power, duration, etc.) are determined by the clinical user. During the transmission of ablative RF energy, changes in the birefringence of the interrogated tissue can be monitored by evaluating changes in the polarization and phase delay of the reflected / scattered light signal sent into the tissue by the catheter 100. RF energy can be applied until the tissue is ablated to a desired depth predicted by an algorithm or equation in the system, which uses the degeneration time or the ratio between the total ablation time and the degeneration time as a predictor variable. In some embodiments, the catheter can be moved to other epileptic foci as needed to repeat the ablation procedure.

[0105] Figure 7An example method for clinical use of an optically guided pulsed field ablation (PFA) system according to an embodiment of the present disclosure is illustrated. In some embodiments, the method may include inserting a catheter into a patient and navigating to a tissue ablation site and establishing contact with the tissue ablation site using an optical signal sent into the tissue through the catheter. The method further includes sending a PFA electromagnetic pulse train to the tissue through the catheter and monitoring changes in the tissue using an LCI optical system by monitoring changes in polarization and / or phase delay of the optical signal.

[0106] Exemplary Embodiments of a Pulsed Field Ablation Catheter with Integrated Optics

[0107] As described herein, a catheter device may be configured to deliver pulsed field ablation (PFA). Specific applications include delivering PFA to the left atrium of the heart in a non-invasive procedure to treat atrial fibrillation.

[0108] Typically, PFA pulses are applied to two electrodes at a time, relatively closely spaced on the tissue segment to be damaged. A series of monophasic or biphasic high-voltage pulses are applied to the electrodes, exposing the tissue between them briefly to a high-intensity electric field. The pulse train may be on the order of 500-1500 Vpp (peak-to-peak voltage), and may be centered on zero volts (biphasic), or single-ended from zero to peak voltage. In some cases, the pulses may be square waves or sine waves, each pulse typically having a duration of 10-100 microseconds, and 10 to 25 pulses are applied at intervals of 0.5 to 2 seconds. The electric field, and the resulting tissue damage, can extend from one electrode to the other. The lowest current density in the damaged area will be at the midpoint between the electrodes, and the current density increases as it approaches either electrode. The electric field is intended to cause irreversible electroporation of the cells therein, ultimately leading to delayed cell death. Depending on the location of the cells within the field, delayed cell death can be treated by apoptosis, pyroptosis, necroptosis, and the like.

[0109] When delivered correctly, PFA has been shown to effectively ablate tissue at selected locations, create permanent lesions, prevent spurious electrical signals from propagating through the atrial wall and further into the heart, and prevent further undesired fibrillation. However, if the PFA pulses are not delivered optimally, the lesions may be incomplete and the spurious signals may not be interrupted, resulting in remodeling that can lead to resumption of fibrillation at a later time (e.g., sometimes years after the procedure). Suboptimal PFA delivery can result from a variety of reasons, including improper electrode positioning, poor electrode contact, contact movement during delivery, or an improper combination of pulse train parameters, such as voltage, current, pulse width, number of pulses, pulse duration, decay time, monophasic versus biphasic mode, etc. If any of these parameters are insufficient resulting in resumption of fibrillation days or years after the procedure, a second procedure may be required, exposing the patient to additional risks and incurring additional costs.

[0110] Medical catheters may also include an optical system that uses optical coherence reflectometry (OCR) to sense parameters such as endocardial wall contact, tissue viability, lesion formation, and lesion depth and width. OCR methods may include measuring reflection amplitude, birefringence, polarization, etc. to determine contact quality, cell status, and lesion size. Some devices include micro-optics within the catheter for detecting target tissue, and extend through the catheter to connect to the proximal end to provide a light source and receiver, switches, reference arms, control electronics, data processing, and displays. However, current optical devices are generally directed to combined optical and electronic catheters that use radiofrequency ablation (RFA) rather than PFA.

[0111] Therefore, there is an unmet need for reliable devices and methods to increase the likelihood of creating permanent lesions with PFA during a single minimally invasive surgical procedure. Such means should allow the physician performing the procedure to assess in real time during the procedure: (i) the contact between the stimulation electrodes and the target anatomy, and (ii) the effectiveness of the ablation after the stimulation is applied, including the depth and area of ​​the lesion. If poor contact is detected, the physician can reposition the catheter before applying energy to the catheter electrode. If insufficient lesion depth or width is detected, the physician can apply additional PFA pulses to the problem area until a satisfactory lesion is observed. These assessments will enable the physician to create and verify uninterrupted, effective lesions during the procedure, thereby reducing the risk of fibrillation recurrence and repeat procedures.

[0112] Typically, PFA pulses are applied to two electrodes at a time, relatively closely spaced on the atrial wall segment that needs to be damaged. This is usually located in the atrial wall area around each of the four pulmonary vein orifices. A series of monophasic or biphasic high-voltage pulses are applied to the electrodes, briefly exposing the tissue between them to a high-intensity electric field. In an exemplary embodiment, the pulse train can be on the order of 500–1500 Vpp and can be centered at zero volts (biphasic) or single-ended from zero to peak voltage. The pulses can be square, each pulse typically having a duration of 10–100 microseconds, and 10 to 25 pulses are applied at intervals of 0.5 to 2 seconds. The electric field and the resulting damage will extend from one electrode to the other. The lowest current density in the damaged area will be located at the midpoint between the electrodes, and the current density increases as it approaches either electrode. The electric field is intended to cause irreversible electroporation of the cells therein, ultimately leading to apoptosis.

[0113] For optical assessment of the lesion, at least one optical viewing port can be placed at a precisely known point in the space between the electrodes: at the midpoint or some other point. In practice, such placement is difficult due to the precision limitations of position visualization systems such as fluoroscopic, ultrasound, RF-based or other mapping / navigation systems.

[0114] Depending on the specific optical measurement technique and electrical stimulation chosen, there may be a time lag between application of the voltage and the appearance of detectable changes in the ablated cells. This time lag may last from 30 seconds to 30 minutes. Once the electrical stimulation is applied, it may be necessary to hold the device in the same position during the time lag to observe the desired changes and confirm successful or unsuccessful ablation.

[0115] Figure 8 Illustrated is a diagram of an exemplary distal end of a PFA-OCR catheter having a circular shape in accordance with an embodiment of the present disclosure. Figure 8 The embodiment of the PFA-OCR catheter 800 shown in the figure can resemble a universal circular mapping catheter at its distal end outward. The circular shape is shown as an exemplary embodiment, but the distal segment of the catheter can be configured as a circle, an ellipse, or any polygon or combination of polygons. The shape can be configured to surround the pulmonary vein ostium and be deployed through a delivery catheter. Figure 8 A front view of the pulmonary vein ostium is provided, which extends into the plane of the page. In some embodiments, the delivery catheter can be sized 8 Fr or smaller (e.g., 2.66 mm or smaller). The body 801 of the rounded distal end of the catheter 800 can be made of a material such as polyvinyl chloride (PVC), polyamide, or The body 801 may have metal electrodes 802 spaced evenly along its length, made of a biocompatible material such as platinum, platinum-iridium, gold or stainless steel and other metals or metal coatings. Figure 8 The catheter 800 shown in FIG. 8 shows 8 electrodes, but the device can have between 24 and 32 electrodes 802. The electrodes 802 are located on the outside of the polymer body 801, exposed to allow contact with the endocardial wall. The electrodes 802 may partially or completely surround the body 801, but in view of surface irregularities, may have sufficient area to contact the vessel wall. Within the lumen of the body 801, each electrode 802 can be connected to a wire that can extend along the catheter shaft, which terminates in an electrical connector at the proximal end. The connector can be plugged into a dedicated console that provides electrical and optical energy to the catheter and senses the optical and electrical signals returned from the catheter.

[0116] Between each pair of adjacent electrodes 802 is an optical port 803, which may be configured as an opening on the side of the body 801 facing the endocardium. Figure 8 The back of the middle body 801. Although Figure 8Eight optical ports 803 are shown for illustration purposes, but any number of ports may be used. In some embodiments, any number of optical ports 803 and electrodes 802 may be placed in any configuration, as long as the ports 803 are not co-located with the electrodes 802, with a minimum of two electrodes 802 and one port 803. In some embodiments, the optical ports 803 may be referred to herein as orifices or openings formed in the catheter body 801 (e.g., Fig. 9 Openings 803A and 803B are shown).

[0117] Fig. 9 A close-up cross-sectional side view of the distal tip of the rounded distal end of catheter 800 is provided. For clarity, it is shown in a straight, uncurled position, as it would be contained in its delivery catheter (not shown). When deployed, the distal end of catheter 800 is positioned with the distal plane of its rounded shape in contact with the endocardial wall 901, as shown in FIG. Figure 8 and Fig. 9 The catheter body 801 is provided with electrodes 802A and 802B on the outside, and the additional electrode 802 is provided along the Figure 8 The bodies 801 are shown spaced apart but not in Fig. 9 802B are shown in cross-section but may completely or partially surround the outer surface of body 801. Electrodes 802 are positioned on body 801 such that at least a portion of each electrode 802 faces the distal plane of the circular shape of body 801 and contacts wall 901 when a slight force is applied to the catheter.

[0118] Inside the catheter body 801, at least one wire lumen 902 may extend down the length of the catheter. Holes, sheets, or slots spaced apart along the wire lumen 902 may allow wires to pass through to connect to each electrode 802. Electrode wires (not shown) may extend down the length of the wire lumen 902 and may terminate at an electrical connector (not shown) at the proximal end of the catheter. The wires may be attached to the electrodes 802 by solder, crimping, wedge bonding, ultrasonic welding, laser welding, conductive epoxy, or other means. In one embodiment, each electrode 802 is attached to a dedicated wire, allowing the control circuitry (not shown) in the console to similarly access each electrode 802. The console electronics may use the electrodes 802 for a variety of functions: (i) applying PFA stimulation; (ii) measuring electrographic signals; (iii) interacting with a navigation or mapping system, or; (iv) measuring tissue impedance. The electrodes 802 may be used multiple times across multiple of these functions, or may be dedicated to a single function. The electrode set 802 may include any combination of single-use or multiple-use electrodes.

[0119] In an alternative embodiment, multiple electrodes 802 may be connected together in parallel to form a single node. Figure 8When the electrodes 802 in the circle are connected, the user can move around the circle in a counterclockwise direction and connect every other electrode 802 together. Therefore, the 1st, 3rd, 5th and 7th electrodes 802 can form one node, and the 2nd, 4th, 6th and 8th electrodes 802 can form a second node. In this configuration, a PFA stimulation event can use the even electrodes 802 as one pole and the odd electrodes 802 as the other pole, thereby ablating the entire circular area at one time.

[0120] although Fig. 9 A single wire lumen 902 is shown in FIG. 9 , but other embodiments may provide multiple lumens, each containing a subset of the wires used in the system.

[0121] Return to Fig. 9 In the cross section in FIG. 8 , the catheter body 801 can further provide an internal optical lumen 903 that can extend downward along the length of the catheter 800. The optical lumen 903 can be located near or adjacent to the distal plane of the circular distal portion of 800 that contacts the endocardial wall surface 901. One or more openings 803 (e.g., openings 803A, 803B) can be provided in the optical lumen 903, exposing the optical lumen 903 to the outside of the catheter. The openings 803 can be used to project light out of the catheter and into the endocardial wall 901, and to receive reflected light into the catheter for measurement. The openings 803 can be holes, slots, or thin sheets formed in the catheter body 801. They can be open to the outside or can be covered by a suitable optically transparent covering, such as glass, polymers, or other ceramic materials. Fig. 9 Two openings 803A and 803B are depicted, but as Fig. 9 and Figure 8 As shown, any number of openings may be placed at any desired location around the circular distal segment of the catheter 800. In another embodiment, the distal segment body 801 of the catheter 800 may be made entirely of an optically transparent material. In some embodiments, the openings 803A, 803B may ensure optical transparency between the optical lumen 903 and the endocardial wall 901 at the wavelength used for optical analysis.

[0122] Fig.10 Shows Fig. 9, but the optical catheter 1001 is inserted into the optical lumen 903 from the proximal end on the left. The optical catheter 1001 can be moved independently of the distal end of the main catheter 800 system. The movement of the optical catheter 1001 can be accomplished by a control (not shown) at the proximal end of the system. The controller can be part of the proximal handle assembly, or can be located in one of the external devices connected to the catheter. The control can be a simple push / pull line. The control can be a knob, wheel, lever, slider, button, etc. The controller can be geared or geared to provide precise movement of the optical catheter 1001 through the optical lumen 903. The controller can provide a locking function to keep the optical catheter 1001 in a proper position relative to the optical lumen 903 and release it again to move to a new position. The control can be manual or electric, including a stepper motor or a linear displacement drive. It can provide a user interface to indicate the position of the optical catheter 1001 relative to the optical lumen 903 or other physical components of the system. The user interface can provide visual, auditory or tactile feedback to the catheter operator.

[0123] Near the distal end of the optical catheter 1001 is an optical opening 1003. When the console projects light energy 1002 through the optical catheter 1001, it can exit the catheter 1001 through the opening 1003. When the opening 1003 is aligned with one of the openings 803 on the exterior of the catheter body 801, the light energy 1002 can exit the catheter body 801 and enter the endocardium 901. In addition, at least some of the light energy 1002 can reflect back from tissue at or below the surface of the endocardium 901 and re-enter the optical catheter 1001.

[0124] The optical lumen opening 1003 may take any of the forms described above for the opening 803 in the outer catheter body 801. The form of the opening 1003 may be different from the opening 803. The optical lumen 903 and the optical catheter 1001 may provide the following features: ensure rotational alignment between the opening 1003 and the opening 803. The catheter operator may advance and retract the optical catheter 1001 along the optical lumen 903, stopping at any position where the opening 1003 of the optical catheter is aligned with the opening 803 on the outer catheter body 801. At these positions, the operator may assess the tissue parameters of interest by optical readings. The system may be configured with the optical catheter 1001 already partially or completely inserted into the optical lumen 903 when the catheter 800 is introduced into the target anatomical structure, which may be the heart. In an alternative embodiment, the catheter 800 may enter the target anatomical structure with the optical lumen 903 empty and the optical catheter 1001 subsequently introduced during the procedure.

[0125] In other embodiments, different types of catheters can be replaced with the optical catheter 1001. The optical lumen 903 can accommodate alternative catheters that can perform different functions when aligned with the opening 803 on the catheter body 801. Examples of replaceable alternative catheters include catheters for OCR, spectroscopy, including near-infrared spectroscopy, polarization uniformity, or other optical measurements; electrical stimulation or ablation with PFA or radiofrequency energy; electrical sensing, including electrograms or impedance measurements; mechanical position marking, including placement markers such as needle clips or sutures; other position markings, including dye injection or tissue staining for fluoroscopy, ultrasound viewing, or compatible electrophysiological navigation systems; biopsy; injection of drugs into tissues or elution into the bloodstream; photography or video recording; chemical property measurements; mechanical property measurements, including durometers; local ultrasound; laser suturing or ablation. For these and other exemplary catheter types, the external structure of the catheter 800 can allow for precise placement of the catheter and precise positioning of the location at the window (e.g., opening 803). Throughout the process, the operator can replace different catheter types as needed, including variations of the same catheter type.

[0126] Fig.11 A cross section of the distal end of catheter 800 looking from the proximal end toward the distal end at a location between or outside of electrodes 802 (not shown) is provided. The figure is oriented so that the endocardial wall 901 is on the right side of catheter 800. Within the body 801 of catheter 800 are a wire lumen 902, an optical lumen 903, and an optical conduit 1001, drawn to a different scale than the previous figures. The optical lumen 903 is adjacent to a side of the catheter body 801 that is configured to contact the endocardial wall 901. Openings 803 and 1003 are cut into the catheter body 801, optical lumen 903, and optical conduit 1001 midline, respectively, at locations indicated by two horizontal slashes, allowing light energy 1002 to exit and re-enter the optical conduit 1001. The optical lumen 903 is provided with a groove 1101 to receive a tongue 1102 on the optical conduit 1001. The tongue 1102 and groove 1101 extend down the length of the catheter 800 and ensure rotational alignment between the openings 803 and 1003. The optical catheter 1001 can be translated proximally or distally (into or out of the plane of the page in the figure) relative to the optical lumen 903 without causing the openings 803 and 1003 to become misaligned. Although the tongue and groove are shown as an alignment means in the present embodiment, other embodiments may use different alignment means, including but not limited to: oval, polygonal or other interlocking cross-sectional shapes for the optical catheter 1001 and the optical lumen 903; multiple polygonal tongue and groove shapes; a guide wire extending down to the optical lumen 903, which fits into a smaller lumen inside the optical catheter 1001.

[0127] Fig.12is a cross-sectional side view of the distal end of the optical catheter 1001 showing several internal structures. The catheter body 1201 may include a rotational locking feature ( Fig.12 Not shown), Fig.11 The tongue 1102 is exemplified in FIG. The body 1201 may include structures (not shown), such as metal coils, to facilitate distal and proximal movement between the openings 803 while remaining flexible to navigate tortuous anatomy and accommodate during introduction. Figure 8 1201. The focusing lens 1203 is rigidly fixed to the body 1201. The lens 1203 can be a microlens made of glass, fused quartz, silica, sapphire or other materials. The fiber optic cable 1202 can be connected to the lens 1203 by an adhesive such as a refractive index matching epoxy, laser welding or other means. In one embodiment, the distal end of the fiber optic cable 1202 can be directly polished to act as a lens. The fiber optic cable 1202 can extend downward along the length of the catheter 800 and can terminate at an optical connector (not shown) at the proximal end of the catheter 800. The optical connector can be connected to a console (not shown) to transfer light energy between the console and the catheter. The focused light energy 1002 can leave the lens 1203 from left to right in the figure and can be turned by an angled mirror 1204 to be projected through the opening 1003 and enter the endocardium 901 (not shown). The light energy 1002 can penetrate the tissue layers of the endocardium 901 and a portion of it can be reflected back into the optical catheter 1001 along the same path it entered. The steering mirror 1204 can also be rigidly fixed to the optical conduit body 1201 by eliminating the lens 1203, the mirror 1204, the opening 1003 and the rotational positioning tongue 1102 ( Fig.12 Relative movement between the optical elements (not shown) is used to maintain optical alignment.

[0128] Fig.13 The cross-sectional side view is provided to illustrate an alternative embodiment of the optical conduit 1001. In some embodiments, it may not be necessary to Fig.13 Mirror 1204 is shown. Instead, a highly flexible optical fiber 1202 is used, which can be turned 90 degrees at the attachment point of lens 1203, which is rigidly fixed directly to opening 1003 by adhesive, separate brackets, shaped structures for receiving the lens, or other means. Other concepts are used in optics for the internal arrangement of optical components.

[0129] Both the outer structure in catheter 800 and the inner movable optical catheter 1001 may be provided with coatings or materials at selected locations to facilitate visualization on fluoroscopic, navigational mapping, ultrasound, computed tomography, or other imaging systems.

[0130] In alternative embodiments, the electrode 802 and the opening 803 may be located as Fig.14 In this embodiment, the outer catheter 1401 can be similar to the rounded distal end of the catheter body 801. Figure 8 As shown, and may have electrodes 802 spaced thereon, each electrode 802 being connected to an inner wire, and the wire may extend proximally through the catheter 800, as shown. Figures 8 to 12 However, in Fig.14 In the embodiment of the present invention, the inner conduit 1402 can be attached to the outer conduit 1401 laterally so that the two form a concentric shape. The inner conduit 1402 can be provided with an opening 803 to allow light to enter and exit the inner conduit 1402. The inner conduit 1402 can be substantially Fig.10 The inner conduit 1402 is a hollow sheath that receives, orients and guides the optical conduit 1001 by means of the optical lumen 903 in the outer conduit 1401. Alternatively, the inner conduit 1402 can be a slot, wire frame, track or rail on the inside of the outer conduit 1401, which directly receives the optical conduit 1001 and arranges it around the inside of the inner conduit 1402 when the optical conduit 1001 is pushed. In these embodiments, the inner conduit 1402 will not have a housing, only rails or the like, and the outside of the conduit 1001 will be exposed to the outside. In the illustration and other illustrations, the openings 803 are shown as discrete windows, but in other embodiments, they can be slotted windows to allow for greater flexibility in viewing position. The inner conduit 1402 can also be made entirely of optically transparent material for maximum position flexibility.

[0131] In another embodiment, the positions of the inner catheter 1402 and the outer catheter 1401 can be reversed, such that the outer catheter 1401 provides the optical opening and the inner catheter 1402 provides the electrodes.

[0132] In another embodiment, a third catheter (not shown) similar to the inner catheter 1402 can be placed outside the outer catheter 1401. In this three-catheter embodiment, the middle catheter can have the opening 803 and the outer two catheter electrodes 802, or vice versa. Different embodiments may be advantageous in terms of creating larger lesions than having a larger viewing area to assess the lesion.

[0133] In another embodiment, both the inner catheter 1402 and the outer catheter 1401 can be Figure 8Here, the operator can choose between the two and insert a removable optical catheter 1001 through one or the other, or can insert an optical catheter 1001 in each simultaneously for multiple position observation. Alternatively, the shaft of catheter 800 can contain a single optical lumen 903, which can be turned to one or the other catheter 1401 or 1402 at a point near the distal segment, where catheters 1401 and 1402 can form a "Y" connection.

[0134] Figures 15 to 20 An alternative embodiment is shown. Fig.15 Shows Figure 8 and Fig. 9 A close-up of a simplified version of the outer catheter 1500 shown in FIG. 1501. In this version, the outer body 1501 may be provided with Figure 8 and Fig. 9 1502 and opening 1503 are provided in the same manner as described in . As in the previous embodiment, the conductive electrode 1502 can be exposed to the outside of the catheter body 1501 and can provide a connection to the wire from the inside of the body 1501. However, in the embodiment, the body of the outer catheter 1501 may not contain a wire or inner cavity for wiring.

[0135] Fig.16 is a side view of the distal end of the inner catheter 1504, which is configured to translate linearly within the outer catheter 1500. The catheter body 1505 is flexible enough to navigate tortuous anatomy and rigid enough to be pushed distally and pulled proximally by controls in the catheter 1500 handle (not shown) of the control type previously disclosed. The catheter body 1505 may include a metal braid (not shown) for pushability. At least two conductive electrodes 1506 may be arranged on the outer surface of the body 1505, spaced apart at a desired distance for application of PFA energy or for electrical sensing of impedance, cardiac signals, or catheter position. The electrodes 1506 can be connected to the interior of the catheter body 1505 for connection to wires and can be similar to those from Figure 8 and Fig. 9 At least one opening 1003 is disposed between the electrodes 1506 and is similar to Figure 8 and Fig. 9 An opening 803 in the body 1505 may be a fully open aperture, or it may be covered by an optically transparent material. Light energy 1002 may pass into and out of the opening 1003. It will be apparent to one skilled in the art that the size, arrangement, and number of openings 1003 and electrodes 1506 along the body 1505 may vary in different embodiments, allowing for a design tradeoff between functional robustness and assembly complexity.

[0136] Fig.17A cross-sectional side view of inner catheter 1504 is shown, showing the internal components. Body 1505 includes wire lumen 1508, which may extend partially or completely down the length of inner catheter 1504. Wire lumen 1508 contains wires 1509, at least one for each electrode 1506. Figure 8 and Fig. 9 In the example, the wires can be connected to the electrodes by various means described previously. Fig.17 The body 1505 may also include a set of optical components rigidly fixed to the body 1505. These components may include a lens 1203 and a turning mirror 1204, such as Fig.12 As shown. Rigidly fixed optical components can transfer light energy 1002 between the inner conduit 1504 and the exterior through the opening 1003, as previously described. The optical fiber 1202 can be connected to the lens 1203 as previously described and can guide light energy through the length of the inner conduit 1504 in two directions.

[0137] It will be apparent to those skilled in the art that other arrangements and types of optical components are possible, including Fig.13 and as described elsewhere in this specification. In addition, Fig.17 The separate wire lumen 1508 shown in FIG. 15A can be partially or completely omitted, and the entire volume within the body 1505 can be used to accommodate a partial or full length of wire 1509 and optical fiber 1202 for the inner catheter 1504 .

[0138] Fig.18A and 18B A diagram showing the translation of the inner catheter 1504 when placed within the outer catheter 1500 is illustrated. Fig.18A , the inner catheter 1504 is shown in a position where its two electrodes 1506 are not aligned with the electrodes 1502 of the outer catheter 1500, and therefore the inner catheter 1500 opening 1003 is also not aligned with the outer catheter opening 1503. Since there is no electrical connection between the inner and outer electrodes, electrical function (stimulation or sensing) is not possible. Likewise, due to the misalignment of the inner and outer openings, light energy 1002 cannot be transmitted between the catheter system and the endocardial tissue 901. Distally translating the inner catheter 1504 causes the inner electrode 1506 to align with the outer electrode 1502, as shown in FIG. Fig.18B As shown in , by completing the circuit of the optical circuit between tissue 901 and a console (not shown), the catheter system is allowed to have full electrical and optical functionality.

[0139] The PFA-OCR system can detect alignment or misalignment of the electrodes and the window and contact with the endocardial wall by measuring the electrical impedance between the internal electrodes 1506 using circuitry in the console or catheter. A misaligned catheter will register a high impedance. An aligned catheter with good endocardial contact will indicate the impedance of the endocardial wall, typically tens to hundreds of ohms. Similarly, the OCR system can be used to detect alignment between the inner opening 1003 and the outer opening 1503, because the light energy 1002 reflected from the inner wall of the outer catheter body 1501 will typically provide a significantly different reflection than the light energy 1002 reflected from the endocardial tissue 901.

[0140] As discussed with respect to other embodiments, a device for inserting the inner catheter 1504 into the outer catheter 1500 can be disposed at the proximal end of the handle, and the handle can provide various controls for precise translation of the inner catheter 1504 relative to the outer catheter 1500. The system can also provide a display to indicate relative catheter position, position, and alignment status. As with other embodiments, the inner catheter 1504 can be preloaded the full length of the outer catheter 1500. Alternatively, the inner catheter 1504 can be introduced into the outer catheter 1500 later in the process after the catheter 1500 is introduced into the target anatomical structure. Partial preloading is also possible.

[0141] Fig.19 is a cross-section of a catheter system embodiment including an outer catheter 1500 and an inner catheter 1504, and from Fig.11 Here, the outer body 1505 of the inner catheter 1504 is shown in cross section with its internal components not shown. The outer catheter 1500 body 1501 may provide an internal mechanical structure 1510 that provides a groove 1511 or similar guiding feature along the length of the catheter. The groove 1511 may engage with a tongue 1512 or similar feature on the inner catheter body 1505 to ensure rotational stability and ensure proper alignment between the inner catheter opening 1003 and the outer catheter opening 1503 (not shown), similar to Fig.11 As described in Fig.11 , the internal guide can also ensure that the inner catheter body 1505 is oriented to abut the surface of the outer catheter body 1501 on the side that will be closest to the endocardium 901, thereby bringing the optical component (not shown) into the inner catheter 1504, such as as close to the endocardium 901 as possible.

[0142] Fig.19 The cross section of is taken at a point where no electrodes 1506 or 1502 are provided on either the inner catheter 1504 or the outer catheter 1500. In contrast, Fig. 20The same cross section is presented, but at the position where both the inner catheter 1504 and the outer catheter 1500 are provided with one of their respective electrodes 1506 or 1502. The electrode 1502 of the outer catheter, shown in black and white dots, can surround the outer catheter 1500 on the outside and penetrate the catheter body 1501 to be disposed on the inner wall surface of the mechanical guide structure 1510, or be disposed in a groove of 1510. The interior of the electrode 1502 can be thicker in the area close to the guide structure 1510 shown on the left side of the figure. The electrode 1506 of the inner catheter 1504 can surround the outer surface of the inner catheter 1504, and can penetrate into the interior of the catheter 1504 to connect to its wire (the internal penetration and wire are not shown). Both the electrodes 1502 and 1506 can be arranged so that they will provide good electrical contact when aligned, but will also allow the inner catheter 1500 to fully translate proximally and distally through the electrodes. Those skilled in the art will recognize the various means to achieve this purpose, as well as the careful design of material selection, placement and thickness. The wall of the outer catheter 1500 can be designed to deform slightly when the electrodes make contact, providing elastic energy to press the metals together and ensure low resistance contact without placing pressure on non-contacting areas of the catheter and inhibiting further translation. A slightly tight fit between the contacting electrodes can also provide tactile feedback to the catheter system operator indicating when the electrodes are aligned.

[0143] In another embodiment, the outer catheter 1500 may not include Fig.15 The electrode 1502 is shown. Here the outer catheter body 1501 is a simple tube, but can be provided with holes along its length aligned with the optical opening 1503. The inner catheter 1504 ( Fig.16 ) can be sized to deform the flexible outer catheter 1500 when it is not aligned with the hole, but when the electrode 1506 is aligned with the hole, the electrode 1506 will protrude through the hole a sufficient distance to ensure low-ohmic contact with the endocardium 901. The inner electrode 1506 can be on one side of the inner catheter 1504 aligned with the hole ( Fig. 20 A thicker area or protruding cam is formed on the right side of center 1506 (the protruding cam is not shown in the figure).

[0144] In some embodiments, the openings or holes may take the form of discrete openings, or may be elongated slots that cover more area, thereby allowing for a design tradeoff between precise location and distance coverage.

[0145] In yet another embodiment, the outer catheter 1500 may not be a full tube, but may be a rigid rail structure that exhibits the same Figure 8 The inner catheter 1504 may have the same circular shape or different circular or polygonal shapes formed into parallel planes to the endocardial wall. Fig.16The electrodes and optics shown, but may be provided with a mechanical means for attaching to the rail structure. The rail structure may allow the electrode 1506 to contact the endocardial surface 901 and may position the opening 1003 close enough to the surface 901 to effectively optically detect it, typically at a distance of about less than 500 μm. The rail structure may be in the form of a wireframe with longitudinal wires connected at intervals by circular or semicircular support wires. The guardrail structure may also be a single rail with a tongue and groove or similar attachment feature, or a complete tube with a wide groove or grooves extending longitudinally downward along the side facing the endocardium 901. In another embodiment, the rail structure may be in the form of a single thick and rigid or semi-rigid wire that provides a suitable circular shape. The inner catheter 1504 may include a cavity outside or inside its main axis to connect to the large wire.

[0146] As previously described, the openings 1003 and 1503 in various embodiments can be completely open holes, or can be covered by a material that is optically transparent to the wavelength used by the system. If an open hole is used, it may be necessary to provide a means to prevent blood or other opaque materials from blocking the light energy path 1002. Flushing the catheter system with a biocompatible, optically transparent liquid (e.g., saline solution) can be used for thermal control and to prevent tissue accumulation on the tip of the RF ablation system. Previously disclosed catheter systems can include flushing ports at their proximal ends to allow forced flushing of the openings 1003 or 1503 to keep them optically clear, or to prevent blood from flowing back into the catheter system. The flushing fluid medium can be a medical grade saline solution, or any liquid that is biocompatible and optically transparent. It may be necessary to formulate a solution containing a refractive index matching liquid or other material to improve optical transmission or fluid properties, such as viscosity or lubricity. A viscous gel can be added to the space behind the opening instead of a liquid and kept there to keep the optical circuit unobstructed.

[0147] In another embodiment, a moving conduit is coupled to a relatively stationary conduit as in the previous embodiment, but in this case the relative motion may be rotational rather than translational. Fig.21A cross-sectional view of the distal segment of a PFA-OCR catheter 2100 is shown, with the longitudinal axis of the catheter extending from left to right on the page. This can be a dual catheter system, in which an inner optical catheter 2102 can be located within an outer catheter 2101. An optical opening 2103 can be provided along the outer catheter 2101 along the side (not shown, bottom of the figure) that contacts the endocardium, as in the previously described embodiments. Inside the inner optical catheter 2102 can be a plurality of optical tap assemblies 2104, and longitudinally through the optical tap assemblies 2104 can be optical fibers 2105. Throughout the figure, light energy is represented by a solid dark arrow on both sides. Each optical tap assembly 2104 can be configured to tap a portion of the light energy flowing into it from a laser source in a console (not shown) and through an optical fiber 2105, and can send the tapped portion to the microlens 1203 for focusing and sending through the inner catheter 2101 opening 2106. The unused portion of the incident light energy can continue through the optical fiber to the next optical assembly 2104. For example, light energy from a console laser source can propagate from left to right (from the proximal end to the distal end) along the optical fiber 2105. When the input light energy 2107B enters the optical assembly 2104B, it may encounter a semi-reflective steering mirror 1204B. The mirror can be manufactured with a partially reflective coating, causing a portion of the input energy 2108B to be reflected at a predetermined angle (90 degrees in the exemplary figure), and the remainder of the input energy 2109B can be sent through the mirror 1204B and further toward the distal end through the optical fiber 2105. The tapped light energy 2108B can be focused by the lens 1203B and can be projected through the inner catheter opening 2106B. The inner catheter 2102 can be configured to rotate around its longitudinal axis (from left to right in the figure), while the outer catheter 2102 can be configured to remain stationary. In the exemplary figure, the inner catheter 2102 is rotated relative to the outer catheter 2101 so that the openings 2106B and 2103B are aligned, allowing the light energy 2108B to leave the catheter and enter the endocardium (not shown). The projected light 2108B then reflects from the endocardium or other tissue and travels back along the same path it entered to be coupled back into the optical fiber 2105 and transmitted to the console for signal acquisition and measurement.

[0148] The optical components 2104 are oriented about the longitudinal axis of the inner catheter 2102, each at a unique angle, such as Fig.21 and Fig. 22 In the figure, the three optical components 2104 are oriented at 90 degrees relative to each other. Fig.21, an optical assembly 2104A including opening 2106A is shown with its lens and tapped light energy facing out of the page, an assembly 2104B including opening 2106B is oriented to send tapped light energy 2108B downward, and an optical assembly 2104C including opening 2106C is oriented to send its tapped light energy upward. Everything within the inner catheter 2102 can be fixed relative to the catheter and can rotate together when the operator rotates the inner catheter 2102 from a controller at the proximal end of the catheter. The optical assemblies 2104 and the inner catheter openings 2106 can be oriented so that at most only one optical assembly's opening 2106 is aligned with the outer catheter opening 2103 at any given time. Since all optical assemblies 2104 can be permanently fixed to the optical fiber 2105, they can all pass light energy 2108 simultaneously when the console applies energy. Optical assemblies 2104 whose openings 2106 are not aligned with the outer window 2103 can project light energy 2108 into the inner wall of the outer catheter 2101. The inner wall of the outer conduit 2101 can be made of or coated with a non-reflective material that absorbs light at the wavelength used by the system, ensuring that little or no light energy will be reflected back into the optical fiber 2105.

[0149] Fig. 22 A cross-sectional view of a dual catheter system 2100 is provided, looking toward Fig.21 The distal end of the catheter section is shown in FIG. 2104. The optical assembly 2104 is shown as 2104A being the darkest shade indicating that it is closest to the viewer, 2104B being the lighter shade indicating that it is further away than 2104A, and 2104C being the lightest shade indicating that it is the farthest away. This view illustrates the concept of user rotation to select the active optical measurement opening.

[0150] Despite Fig.21 and Fig. 22 A partially reflective steering mirror is shown in FIG, but the extraction of optical energy from the optical fiber 2105 and the recombination of the returned energy back into the optical fiber 2105 may also be achieved by other means. These include splitter / coupler devices, which can be designed to couple or split the desired portion of the total optical energy to / from the tap port. They may also include passive devices, such as gratings or prisms, for redirecting light of different wavelengths to different spatial directions, used in conjunction with multi-wavelength or broadband light.

[0151] Obviously, additional optical components 2104 can be positioned at different angles to allow for more viewports in the catheter system 2100 as desired. Fig.21 and Fig. 22 Electrodes are not shown, but it is apparent that electrodes and wires may be added in a manner similar or analogous to those in previously disclosed embodiments. For example, the Fig. 22 The cross section of the outer catheter 2101 is made larger in diameter so as to accommodate the electrode wire in a dedicated lumen or in the main lumen of 2101 as in the previous embodiment. Fig.21 and Fig. 22 The rotary electrode selection switch of the optical switch depicted in FIG21 can be easily seen, where a cam or other protruding internal electrode is disposed in the inner catheter 2102, which protrudes through an opening or otherwise contacts the outer fixed electrode only when a certain rotation angle is selected so that the inner and outer electrodes are aligned. The rotationally aligned electrodes and optical components can be combined together within the catheter 2101 so that both are engaged simultaneously when desired, similar to their previously described translational analogs. Any combination of multiple and single optical fiber or line combinations can be designed to meet specific user needs and manufacturing constraints.

[0152] The rotatable, selectively dual catheter system can be locked so that the inner catheter 2102 cannot translate within the outer catheter 2101. The rotatable inner catheter 2102 can be permanently secured to the distal end of 2101 by any of a variety of mechanical means. However, it will be apparent from this disclosure that combination embodiments of the system that allow both translational and rotational movement of one catheter relative to the other are possible and can be used in certain designs.

[0153] In other embodiments, the distal end of the PFA-OCR catheter may have multiple separate branches that do not form a continuous loop. The general principles of the present disclosure are compatible with such a multi-loop architecture. A separate parallel system may simply be provided for each branch within the same overall catheter system. Alternatively, parallel branches of the stationary portion of the system may be generated, for example corresponding to Fig. 9 The fixed outer catheter body 800 or Fig.15 1500 in. The parallel branches can be joined at the intersection of the nearest opening or electrode. Fig.10 A single movable inner catheter 1001 or Fig.16 1504 is inserted into the intersection. Mechanical guidance features can help to steer the movable inner catheter to the desired branch.

[0154] In other embodiments, the PFA-OCR catheter system of the present disclosure can be used with a distal end in the form of a three-dimensional basket, possibly shaped by a balloon device. In some embodiments, the basket can take the form of loops or branches as described above.

[0155] The exemplary embodiments depicted in the figures show a single optical assembly (fiber, lens, etc.) in a translatable inner catheter. In other embodiments, multiple fiber lens assemblies may comprise the optical portion of the system and may be fixed and secured to the body of a movable or fixed catheter. Fig.12 or Fig.13Multiple instances of optical components of the type illustrated in can be provided in a single catheter. In one embodiment, multiple optical fibers can extend down the length of the catheter to at least one proximal optical connector. In another embodiment, a single optical fiber extends through most of the catheter length, but near the distal end, the single optical fiber fans out multiple optical fibers via an optical multiplexer, with each downstream optical fiber connecting at least one separate optical channel. Optical multiplexing / demultiplexing can be accomplished by the arrangement of many micro-optical components, including: (i) wavelength division multiplexing using diffraction gratings, prisms to spatially shift light; (ii) beam steering using movable micromirrors; (iii) polarization division multiplexing using polarization filters; (iv) tunable wavelength filters, including acousto-optic tunable filters; (v) liquid crystal switching devices. In some embodiments, optical multiplexing and switching can be performed by a single multiplexing device near the optical opening 1003, 1503, which fan out from one optical fiber to multiple optical fibers. Other embodiments may take the form of a single optical fiber tapped at each desired optical sensing location; the tapped light energy 1002 may be routed to a short fiber / lens assembly via an optical switch. The tap may take the form of an optical coupler / splitter or a partial reflector arrangement. The individual light pass / block switches may be implemented as wavelength filters, polarization filters, liquid crystal switches, acousto-optic switches, or other devices. The electronic control lines for embodiments using such switches would be routed back to the electrical connector on the handle.

[0156] Just as light energy 1002 can be multiplexed to allow a small number of optical fibers to pass through most of the length of the catheter, electrical energy can be multiplexed to reduce the number of long wires required to pass through the catheter. In such an embodiment, the electronic multiplexer can be set at a point away from the proximal end of the catheter but close to the nearest electronic components (electrodes 802, 1502, 1506 or control electronics for the optical multiplexer). Switch control can be enhanced by any of a myriad of digital control methods and can include integrated circuits. The physical switch can be implemented as a micromechanical relay or a solid-state switch. The electrical switch can also be placed locally near each electrode. In one embodiment, a single wire can contact multiple electrodes, each electrode having its own local switch and control electronics, which only turns on its switch or signal when it detects a unique control signal on the single wire that is also used to carry stimulation power. In this embodiment, the unique control signal can be a sequence of bits or a unique frequency.

[0157] The electrodes may perform stimulation, measurement or monitoring functions as described above. The electrodes may be configured to perform multiple functions or be dedicated to a single function. In one embodiment, different electrodes are configured to stimulate and measure electrocardiographic functions simultaneously. The electrodes may also monitor the patient's electrocardiographic (ECG) function and may inhibit PFA stimulation during certain parts of the ECG cycle during which external electrical stimulation may cause fibrillation or other unwanted reactions. An embodiment of such a PFA stimulation inhibition system may include using one or more electrodes to monitor the ECG, processing the signal to determine when the "T" portion of the ECG cycle occurs, and inhibiting stimulation during the "T" portion of the cycle. The system may delay the application of stimulation until the next safe part of the ECG cycle occurs, such as after the end of the "T" wave. Signal processing may be performed in the console or by an electronic device within the catheter. It may include measuring well-defined events in the cardiac cycle, such as the fall of the "R" wave, and then inhibiting stimulation for a physiologically reasonable time after the "R" wave. The length of the inhibition period may be the same for all cardiac cycles, or it may automatically change based on the most recent heart rate measurement or other parameters.

[0158] In other embodiments of the present disclosure, the catheter system can be configured to perform RF ablation (RFA) as well as PFA. The system may have electrodes that are uniquely placed for the RFA function, and other electrodes for the PFA function. Alternatively, the same electrodes can be used for PFA and RFA at discrete times by switching different electrical stimulations (PFA or RFA) to the desired electrodes using circuits in the console. When used in RFA mode, a dispersion pad can be placed on the patient's back to disperse the RF current and provide a return path. In this case, only one electrode of the present disclosure can be energized with RF energy at a time. If necessary, RFA can also be applied to two electrodes of the system. Controls can be provided to the user on the catheter or console to switch the system between PFA and RFA modes. The optical system can measure and display the same optical parameters of the two modes, or can be configured to measure and display unique parameters of each mode. Irrigation holes and channels can be provided on or near the electrodes used for RFA.

[0159] In other embodiments, the present disclosure may be modified to achieve cryogenic ablation. In one embodiment, the catheter may have a balloon fixed to its distal end that is configured to be filled with a cryogenic liquid, such as liquid nitrogen provided by a console or other external device. The inner and outer catheters of the present disclosure may be configured to surround the balloon in a continuous series pattern, or as multiple parallel distal segments that may be selected as previously described.

[0160] In RF, cryo or PFA embodiments, the present disclosure features flexibility in placing optical observation locations relative to ablation stimulus (electrical or cryo) locations. That is, the designer can select observation locations around the created lesion that are of most interest for assessing lesion quality.

[0161] In some embodiments, a device may be provided to adjust the shape of the distal segment of the catheter of the present disclosure. This may include a pull wire or push rod controlled by the user. The adjustment device can be used to increase or decrease the diameter of the circle or the size of the polygon at the distal end of the catheter system.

[0162] Although Fig.11 , Fig.19 , Fig. 20 and Fig. 22 The cross-section of the present disclosure shown in depicts a circular cross-section, but other geometries of the distal segment may be advantageous. A semicircular shape with the flat side facing the endocardium 901 may have the advantage of covering more area of ​​the endocardial wall with each electrode, thereby providing better electrical contact. It may also reduce the distance between the optical opening and the endocardium to allow light energy to penetrate deeper into the endocardial tissue.

[0163] In another embodiment, in various disclosed embodiments, the outer catheter may be rotated by a user to better position the outer catheter openings or electrodes for engagement with the endocardium.

[0164] In other embodiments, various features may be added to the present disclosure to improve contact between the outer catheter opening and the electrodes and the endocardial wall. They may include: a balloon or other mechanical structure that presses the distal segment of the catheter against the wall; a slightly rough or abrasive surface to reduce slippage.

[0165] The description of the present disclosure uses exemplary embodiments from cardiac pulsed fields and RF ablation, particularly ablation of endocardial tissue near the ostia of the pulmonary veins. However, the principles of the present disclosure can be applied to other anatomical structures where tissue ablation may be of clinical value. These include, but are not limited to: cancerous or precancerous tumors; skin cells; neural tissue for procedures such as renal denervation; other neural cells; brain cells; or mucus or other congestive material that may cause pulmonary edema.

[0166] Other example implementations:

[0167] Example Implementation Set #1

[0168] Embodiment 1: A system for ablating cardiac wall tissue, the system comprising:

[0169] a catheter configured to be placed in an outer sheath so that its distal end is in a straight configuration compatible with vascular delivery, and when advanced through the sheath, the distal end assumes a rounded shape in a plane parallel to the heart wall and configured to contact the heart wall;

[0170] A plurality of electrodes are disposed on the distal end at a distance from each other, the electrodes being connected to an external power generating device via an electrical connector on the proximal end of the catheter through wires, and the electrodes are configured to transmit electrical energy to the heart wall when energized by the power generating device;

[0171] at least one optical port, the port comprising an optical assembly connected to an external light energy generating device via an optical fiber via an optical connector on the proximal end of the catheter, the optical assembly being configured to project light energy into the heart wall, receive light energy reflected from the heart wall, and transmit the reflected light to an external optical sensing device via the optical fiber and the optical connector when powered by the light energy generating device;

[0172] The at least one optical port is located on the distal end of the catheter at a location relative to the electrode selected for optimal measurement of changes in optical parameters caused by tissue ablation resulting from the energization of the electrode.

[0173] Embodiment 2: The system according to embodiment 1, wherein the side of the catheter configured to contact the heart wall is flattened to produce a semicircular cross-section of the catheter, the flat side maximizing the contact area of ​​the side with the heart wall.

[0174] Embodiment 3: The system of embodiment 1, wherein the circular shape is an oval shape, a polygonal shape, or a combination of oval and polygonal shapes.

[0175] Embodiment 4: A system according to embodiment 1, wherein at least two of the multiple electrodes are connected to dedicated lines, and the multiple dedicated lines are connected to a multiplexer located near the electrodes, and the multiplexer is configured to selectively switch between the dedicated electrode lines, the dedicated electrode lines and at least one proximal line, and the proximal line extends from the multiplexer to a connector on the proximal end of the catheter.

[0176] Embodiment 5: The system of embodiment 1, wherein a subset of the plurality of electrodes are wired together to form a single electrical node.

[0177] Embodiment 6: According to the system of embodiment 1, it includes a plurality of the optical ports and further includes an optical multiplexer located near the optical ports, and the optical multiplexer is configured to selectively switch between multiple optical fibers, each of which is dedicated to one of the optical ports and at least one proximal optical fiber, and the proximal optical fiber extends from the multiplexer to the connector on the proximal end of the catheter.

[0178] Embodiment 7: The system of embodiment 1, wherein the optical component is selected from: a focusing lens, a turning mirror, a diffraction grating, a GRIN lens, an optical tap, an optical coupler, and an optical polarizer.

[0179] Embodiment 8: The system of embodiment 1, wherein the electrical energy delivered to the heart wall by the plurality of electrodes is configured to ablate tissue in the heart wall by at least one process selected from the group consisting of: radiofrequency ablation, thermal ablation, pulsed field ablation, or irreversible electroporation.

[0180] Embodiment 9: The system of Embodiment 8, wherein a system operator can select the type of power delivered through control of the external power device.

[0181] Embodiment 10: A system according to embodiment 1, wherein the external light energy generating device, the at least one optical port and the external optical sensing device are configured to perform the optical measurement of optical parameter changes by at least one process selected from the following: optical coherence tomography, optical coherence reflectometry, low coherence interferometry, polarization uniformity measurement, polarization-sensitive optical coherence tomography, reflection intensity, spectroscopy, Raman spectroscopy and near-infrared spectroscopy.

[0182] Embodiment 11: The system of embodiment 10, wherein the optical measurement can be processed and displayed by an external device to indicate at least one of: contact stability between the optical port and the heart wall, tissue viability, tissue type, tissue depth, tissue composition.

[0183] Embodiment 12: The system of embodiment 11, wherein the processed and displayed optical measurements provide data to a depth of at least 1 mm into the measured tissue.

[0184] Embodiment 13: The system of embodiment 11, wherein the external device comprises an algorithm for calculating and displaying the estimated lesion depth.

[0185] Embodiment 14: The system of embodiment 10, wherein the system measures birefringence of tissue in the heart wall.

[0186] Embodiment 15: The system of embodiment 1, wherein the location selected for optimal measurement of the change in the optical parameter is at a midpoint between two electrodes configured to serve as a positive node and a negative node for pulsed field ablation stimulation.

[0187] Embodiment 16: A system according to embodiment 1, wherein at least one of the electrodes is configured to perform multiple functions when connected to at least one external device via the electrical connector on the proximal end of the catheter, the functions being selected from the following: electrical stimulation, electrogram measurement, electrocardiogram measurement, tissue impedance measurement.

[0188] Embodiment 17: The system of Embodiment 1, wherein the measuring of the optical parameter is performed before, during, or after the delivery of the electrical energy in order to evaluate the effect of the delivery.

[0189] Embodiment 18: The system of embodiment 1, wherein the distal end comprises a plurality of distal ends, each distal end being provided with its own electrode and optical port and configured into a parallel shape comprising a plurality of lines, a circular shape, or a polygonal shape.

[0190] Embodiment 19: The system of embodiment 18, wherein the plurality of distal ends are configured into a three-dimensional spherical shape.

[0191] Example Implementation Set #2

[0192] Embodiment 20: A system for ablating cardiac wall tissue, the system comprising:

[0193] a first catheter configured to be placed within the outer sheath such that its distal end is in a straight configuration compatible with vascular delivery, the distal end assuming a rounded shape when advanced through the sheath, the rounded shape being in a plane parallel to the heart wall and configured to contact the heart wall;

[0194] a second catheter configured to be longitudinally connected to the first catheter and to translate distally or proximally along the first catheter;

[0195] The second catheter further comprises a plurality of electrodes, the plurality of electrodes being arranged on the distal end of the second catheter at a distance from each other, the electrodes being connected to an external power generating device by wires via an electrical connector on the proximal end of the second catheter, the electrodes being configured to transmit electrical energy to the heart wall when energized by the power generating device;

[0196] The second catheter further comprises at least one optical port, the port comprising an optical assembly, the optical assembly being connected to an external light energy generating device by an optical fiber via an optical connector on a proximal end of the second catheter, the optical assembly being configured to project light energy into the heart wall and receive light energy reflected from the heart wall when powered by the light energy generating device, and transmit the reflected energy to an external optical sensing device via the optical fiber and the optical connector;

[0197] The at least one optical port is located on the distal end of the second catheter at a location relative to the electrode selected for optimal measurement of changes in optical parameters caused by tissue ablation resulting from the energization of the electrode.

[0198] Embodiment 21: The system of embodiment 20, wherein the first catheter is configured to provide a fixed planar path against the heart wall and remain in place when the second catheter is translated distally or proximally about the path by an operator.

[0199] Embodiment 22: The system of embodiment 20, wherein the second catheter is connected to the first catheter by a device disposed in an inner cavity on the second catheter, and the first catheter is configured to fit within the inner cavity.

[0200] Embodiment 23: The system of embodiment 20, wherein the second catheter is connected to the first catheter by a device disposed in an inner cavity on the first catheter, and the second catheter is configured to fit within the inner cavity.

[0201] Embodiment 24: The system of Embodiment 20, wherein the first catheter further comprises at least one of the electrodes connected to the external electrical device or at least one of the optical ports connected to the external optical device.

[0202] Embodiment 25 A system according to embodiment 20, wherein at least a portion of the side of the first catheter facing the heart wall is provided with at least one optically transparent opening, and the at least one optical port of the second catheter is configured to align with the opening when translated to its position.

[0203] Embodiment 26: The system of embodiment 20, wherein the second catheter is rotatable about its longitudinal axis relative to the first catheter.

[0204] Embodiment 27: The system of embodiment 20, wherein the second catheter is rotatably aligned within the first catheter to ensure that its optical port is directed toward the heart wall, and wherein the second catheter includes a device to prevent rotation about its longitudinal axis relative to the first catheter.

[0205] Embodiment 28: A system according to embodiment 20, wherein the first catheter and the second catheter are each provided with at least one electrode, and when the second catheter is translated to a specific position, the electrode pair are in electrical contact with each other, and the electrical contact establishes a connection from an external electrical device to one of the electrode pair in contact with the heart wall.

[0206] Embodiment 29: The system of embodiment 20, wherein the longitudinal axes of the first and second conduits are concentric.

[0207] Embodiment 30: The system of Embodiment 20, wherein the longitudinal axes of the first and second conduits are separated and parallel.

[0208] Embodiment 31: The system of embodiment 20, wherein the side of the second catheter configured to contact the heart wall is flattened to produce a semicircular cross-section of the catheter, and the flattened side is configured to maximize the contact area of ​​the side with the heart wall.

[0209] Embodiment 32: The system of embodiment 20, wherein the circular shape is an oval shape, a polygonal shape, or a combination of oval and polygonal shapes.

[0210] Embodiment 33: A system according to embodiment 20, wherein the optical component is selected from: a focusing lens, a turning mirror, a diffraction grating, a GRIN lens, an optical tap, an optical coupler, and an optical polarizer.

[0211] Embodiment 34: The system of embodiment 20, wherein the electrical energy delivered to the heart wall by the plurality of electrodes is configured to ablate tissue in the heart wall by at least one method selected from the group consisting of: radiofrequency ablation, thermal ablation, pulsed field ablation, or irreversible electroporation.

[0212] Embodiment 35: The system of Embodiment 34, wherein a system operator can select the type of electrical energy delivered through control of the external electrical energy device.

[0213] Embodiment 36: A system according to embodiment 20, wherein the external light energy generating device, the at least one optical port and the external optical sensing device are configured to perform the optical measurement of the change in optical parameters by at least one process selected from the following: optical coherence tomography, optical coherence reflectance measurement, low coherence interferometry, polarization uniformity measurement, polarization-sensitive optical coherence tomography, reflection intensity, spectroscopy, Raman spectroscopy and near-infrared spectroscopy.

[0214] Embodiment 37: The system of embodiment 36, wherein the optical measurement can be processed and displayed by an external device to indicate at least one of: contact stability between the optical port and the heart wall, tissue viability, tissue type, tissue depth, tissue composition.

[0215] Embodiment 38: The system of embodiment 37, wherein the processed and displayed optical measurements provide data to a depth of at least 1 mm into the tissue being measured.

[0216] Embodiment 39: The system of embodiment 37, wherein the external device comprises an algorithm for calculating and displaying the estimated lesion depth.

[0217] Embodiment 40: The system of embodiment 36, wherein the system measures birefringence of tissue in the heart wall.

[0218] Embodiment 41: The system of embodiment 20, wherein the location selected for optimal measurement of the change in the optical parameter is located at a midpoint between two electrodes configured to serve as a positive node and a negative node for pulsed field ablation stimulation.

[0219] Embodiment 42: A system according to embodiment 20, wherein at least one of the electrodes is configured to perform multiple functions when connected to at least one external device via the electrical connector on the proximal end of the catheter, the functions being selected from the following: electrical stimulation, electrogram measurement, electrocardiogram measurement, tissue impedance measurement.

[0220] Embodiment 43: The system of Embodiment 20, wherein the measurement of the optical parameter is performed before, during, or after the transmission of the electrical energy in order to evaluate the effect of the transmission.

[0221] Embodiment 44: A system according to embodiment 20, wherein the distal end includes a plurality of distal ends, each distal end having its own electrode and optical port, and configured to include a plurality of parallel shapes such as lines, circular shapes, or polygons.

[0222] Embodiment 45: A system according to embodiment 44, wherein the plurality of distal ends are configured into a three-dimensional spherical shape.

[0223] Embodiment 46: The system of Embodiment 44, wherein the second catheter is steerable to select the distal end to which it will translate.

[0224] Embodiment 47: The system of Embodiment 20, wherein the second catheter is fully translated distally relative to the first catheter.

[0225] Embodiment 48: A system according to embodiment 20, wherein the first catheter is inserted into the outer sheath during the vascular delivery without the second catheter, and after the first catheter is pushed through the sheath, the second catheter is translated to the distal segment of the first catheter.

[0226] Embodiment 49: The system of Embodiment 20, wherein the second catheter is secured to prevent longitudinal translation relative to the first catheter.

[0227] Embodiment 50: A system according to embodiment 49, wherein the second catheter is configured to be selectively rotated relative to the first catheter, and further wherein the optical ports are arranged around the circumference of the second catheter so that for a given rotation angle no more than one port will directly face the heart wall.

[0228] Embodiment 51: The system of Embodiment 20, further comprising a user controller configured to facilitate precise movement of the second catheter relative to the first catheter.

[0229] Embodiment 52: The system of embodiment 51, wherein the user control is located in one of: a catheter handle of the system, an external device connected to the catheter.

[0230] Embodiment 53: A system according to embodiment 51, wherein the user control includes at least one of the following: a motor, a stepper motor, a gear system, a knob, a sliding switch, a computer screen and input device, and a display indicating the precise position.

[0231] Example Implementation Set #3

[0232] Embodiment 54: A method for ablating cardiac tissue, the method comprising the steps of:

[0233] inserting a sheath comprising a first catheter device into a cardiac chamber;

[0234] advancing said first catheter device through said sheath, said first catheter being configured to assume a planar shape, said plane of said shape being oriented parallel to a heart chamber wall;

[0235] longitudinally translating a second catheter along the first catheter, the second catheter configured to follow a path defined by the shape of the first catheter, the second catheter further provided with electrodes configured to sense electrical parameters and transmit electrical energy, the second catheter further provided with an optical port configured to transmit light energy to the heart wall and transmit reflected light energy back to an externally connected optical measurement device;

[0236] pausing translation of the second catheter at a desired location about the path of the planar shape to deliver electrical energy to selectively ablate heart wall tissue;

[0237] applying light energy and measuring reflected energy to assess optical parameters indicative of contact stability, tissue viability, and lesion size and depth;

[0238] Repeating the steps of distal or proximal translation of the second catheter while fixing the position of the first catheter, applying electrical stimulation as needed and taking optical measurements to ensure continuous lesioning at a desired location; and

[0239] The catheter system is removed.

[0240] Embodiment 55: The method of Embodiment 54, wherein the catheter system comprises any of the catheter systems from Embodiments 20-55.

[0241] Exemplary Computing Implementations

[0242] Fig.23 2300. For example, one or more computer systems 2300 may be used to implement any of the embodiments discussed herein and combinations and sub-combinations thereof. In some embodiments, one or more computer systems 2300 may be used to implement the methods, calculations, and processing devices described herein. Computer system 2300 may include one or more processors (also referred to as central processing units or CPUs), such as processor 2304. Processor 2304 may be connected to a communication infrastructure or bus 2306.

[0243] The computer system 2300 may also include a user input / output interface 2302 , such as a monitor, keyboard, pointing device, etc., which may communicate with a communication infrastructure 2306 via a user input / output interface 2303 .

[0244] One or more processors 2304 may be a graphics processing unit (GPU). In one embodiment, a GPU may be a processor that is a specialized electronic circuit designed to process math-intensive applications. A GPU may have a parallel architecture that can efficiently process large blocks of data in parallel, such as math-intensive data common in computer graphics applications, images, videos, etc.

[0245] The computer system 2300 may also include a main memory or primary storage 2308, such as a random access memory (RAM). The main memory 2308 may include one or more levels of cache. The main memory 2308 may store control logic (i.e., computer software) and / or data therein. In some embodiments, the main memory 2308 may include optical logic configured to perform processing and analysis of optical measurements obtained from tissue through the catheter and determine injury predictions.

[0246] The computer system 2300 may also include one or more secondary storage devices or memories 2310. The secondary memory 2310 may include, for example, a hard drive 2312 and / or a removable storage drive 2314.

[0247] Removable storage drive 2314 may interact with removable storage unit 2318. Removable storage unit 2318 may include a computer usable or readable storage device having computer software (control logic) and / or data stored thereon. Removable storage unit 2318 may be a program cartridge and cartridge interface (such as found in a video game device), a removable storage 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. Removable storage drive 2314 may read and / or write to removable storage unit 2318.

[0248] Secondary memory 2310 may include other devices, means, components, tools, or other methods for allowing computer programs and / or other instructions and / or data to be accessed by computer system 2300. These devices, means, components, tools, or other methods may include, for example, a removable storage unit 2322 and an interface 2320. Examples of removable storage unit 2322 and interface 2320 may include a program cartridge and cartridge interface (such as found in video game devices), a removable memory chip (such as an EPROM or PROM) and associated slot, a memory stick and USB port, a memory card and associated memory card slot, and / or any other removable storage unit and associated interface.

[0249] The computer system 2300 may further include a communication or network interface 2324. The communication interface 2324 may enable the computer system 2300 to communicate and interact with any combination of external devices, external networks, external entities, and the like (individually and collectively by reference number 2328). For example, the communication interface 2324 may allow the computer system 2300 to communicate with an external or remote device 2328 via a communication path 2326, which may be wired and / or wireless (or a combination thereof) and may include LANs, WANs, networks, and the like. Control logic and / or data may be sent to and from the computer system 2300 via the communication path 2326. In some embodiments, the computer system 2300 may be coupled to the catheter via optical and electrical connections at the connector and communication interface 2324, including optical fibers and wires, pins, and / or components.

[0250] Computer system 2300 may also be a personal digital assistant (PDA), a desktop workstation, a laptop or notebook computer, a netbook, a tablet computer, a smartphone, a smart watch or other wearable device, an appliance, part of the Internet of Things, and / or an embedded system, to name a few non-limiting examples, or any combination thereof.

[0251] Computer system 2300 can be a client or server, accessing or hosting any applications and / or data via 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 hybrid models including any combination of the foregoing examples or other services or delivery paradigms.

[0252] Any applicable data structures, file formats, and schemas in computer system 2300 may be represented by, including but not limited to, JavaScript Object Notation (JSON), Extensible Markup Language (XML), Yet Another Markup Language (YAML), Extensible Hypertext Markup Language (XHTML), Wireless Markup Language (WML), MessagePack, XML User Interface Language (XUL), or any other functionally similar representation, alone or in combination. Alternatively, proprietary data structures, formats, or schemas may be used alone or in combination with known or open standards.

[0253] In some embodiments, 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 2300, main memory 2308, auxiliary memory 2310, and removable storage units 2318 and 2322, and tangible articles of manufacture embodying any combination of the foregoing. Such control logic, when executed by one or more data processing devices (e.g., computer system 2300), may cause such data processing devices to operate as described herein.

[0254] in conclusion

[0255] It will be apparent to one skilled in the art that the clinical ablation procedure described above need not include all of the steps described, and that the steps need not be in the exact order that has been presented.

[0256] 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 embodiments of the present disclosure as contemplated by the inventors, and thus are not intended to limit the present disclosure and the appended claims in any way.

[0257] The embodiments of the present disclosure have been described above with the help of functional building blocks, which illustrate the implementation of specified functions and their relationships. For the convenience of description, the boundaries of these functional building blocks have been arbitrarily defined here. As long as the specified functions and their relationships are properly performed, alternative boundaries can be defined.

[0258] The above description of the specific embodiments will reveal the general nature of the present disclosure so fully that others can easily modify and / or adapt various applications, such as specific embodiments, by applying the knowledge within the art without undue experimentation, without departing from the general concepts of the present disclosure. Therefore, based on the teachings and guidance presented herein, such adjustments and modifications are intended to be within the meaning and range of equivalents of the disclosed embodiments. It should be understood that the words or terms in this article are for the purpose of description rather than limitation, so that the terms or words of this specification will be interpreted by those skilled in the art based on the teachings and guidance.

[0259] The breadth and scope of the present disclosure should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.

[0260] In addition, the following aspects are explicitly disclosed:

[0261] 1. A system comprising:

[0262] Catheter, including:

[0263] proximal segment;

[0264] distal segment;

[0265] a shaft coupled between the proximal segment and the distal segment; and

[0266] an optical circuit configured to transmit light at least partially from the proximal segment to the distal segment and back;

[0267] a pulsed field ablation energy source coupled to the catheter and configured to send pulsed electrical signals to the tissue sample; and

[0268] A processing device, which is configured as follows:

[0269] One or more optical signals received from the optical circuit are analyzed to determine changes in polarization or phase retardation of light reflected or scattered by the tissue sample; and changes in birefringence of the tissue sample are determined based on the changes in polarization or phase retardation.

[0270] 2. A system according to aspect 1, wherein the optical circuit is configured to transmit light at least partially from the proximal segment to the distal segment and back using at least a partial polarization maintaining transmission medium in the shaft.

[0271] 3. A system according to aspect 1 or aspect 2, wherein the pulsed electrical signal sent by the pulsed field ablation energy source is monophasic or biphasic.

[0272] 4. A system according to any of the preceding aspects, wherein the change in polarization or phase delay of light reflected or scattered by the tissue sample is in response to a pulsed electrical signal sent to the tissue sample.

[0273] 5. The system according to any of the preceding aspects, wherein the one or more optical signals include optical coherence tomography (OCT) signals or optical coherence reflectometry (OCR) signals acquired from a tissue sample.

[0274] 6. The system according to any of the preceding aspects, wherein the optical circuit is configured to send light from the distal segment to the tissue sample.

[0275] 7. The system according to any of the preceding aspects, wherein the distal section of the catheter comprises a plurality of optical ports configured to collect light reflected or scattered from the tissue sample.

[0276] 8. The system according to any of the preceding aspects, wherein the characteristics of the pulsed electrical signal are selected by a user of the catheter, wherein the characteristics include frequency, amplitude and duration of the pulsed electrical signal.

[0277] 9. A method for performing ablation in a patient, the method comprising:

[0278] inserting a catheter into a patient's vasculature;

[0279] moving the distal end of the catheter to an ablation site in the patient's vasculature;

[0280] optically establishing tissue contact at the distal end of the catheter using light delivered through the distal end of the catheter to the ablation site;

[0281] delivering energy from a distal end of the catheter from an energy source coupled to the catheter into the tissue;

[0282] optically interrogating the ablated tissue site to determine changes in polarization or phase delay of light delivered to the ablated tissue site through the catheter; and

[0283] Remove the catheter from the vasculature.

[0284] 10. The method of aspect 9, wherein the energy comprises a pulse train, the energy source comprises a pulsed field ablation energy source, and the pulse train comprises a monophasic or biphasic pulsed electrical signal.

[0285] 11. A method according to clause 10, wherein the change in polarization or phase delay of the light is in response to a pulsed electrical signal transmitted to the tissue.

[0286] 12. The method of aspect 11, wherein characteristics of the pulsed electrical signal are selected by a user of the catheter, wherein the characteristics include frequency, amplitude and duration of the pulsed electrical signal.

[0287] 13. The method of any one of clauses 9 to 12, wherein the energy comprises radio frequency (RF) and the energy source comprises an RF energy source.

[0288] 14. A method according to one of aspects 9 to 13, wherein the catheter includes a shaft having a multimode transmission medium disposed therein, wherein the multimode transmission medium is used to enable the use of tissue spectroscopy to determine the depth of an anatomical structure within the patient.

[0289] 15. A catheter for ablating cardiac wall tissue, the catheter comprising:

[0290] proximal;

[0291] remote;

[0292] A plurality of electrodes are disposed at a distance from each other at the distal end; and

[0293] at least one optical port is located on the distal end relative to the plurality of electrodes,

[0294] wherein the catheter is configured to be placed within the outer sheath such that the distal end is in a straight configuration compatible with vascular delivery and the distal end assumes a rounded shape when pushed through the sheath,

[0295] The plurality of electrodes are connected to an external power generating device via an electrical connector on the proximal end of the catheter.

[0296] wherein the plurality of electrodes are configured to transmit electrical energy to the heart wall when energized by an external electrical energy generating device,

[0297] Wherein, at least one optical port includes an optical component connected to an external light energy generating device via an optical fiber via an optical connector on the proximal end of the catheter, wherein the optical component is configured to: when powered by the light energy generating device, project light energy into the heart wall, receive light energy reflected from the heart wall, and transmit the reflected light energy to an external optical sensing device via the optical fiber and the optical connector.

[0298] 16. The catheter of aspect 15, wherein the rounded shape of the distal end is in a plane parallel to the heart wall and is configured to contact the heart wall.

[0299] 17. A catheter according to aspect 15 or aspect 16, wherein the position of at least one optical port is selected to optimally observe changes in optical parameters caused by tissue ablation caused by energization of the plurality of electrodes.

[0300] 18. The catheter of any one of aspects 15 to 17, wherein the electrical energy delivered by the external electrical energy generating device comprises a pulsed electrical signal.

[0301] 19. The catheter of aspect 18, wherein the pulsed electrical signal is monophasic or biphasic.

[0302] 20. The catheter of any one of aspects 15 to 19, wherein the electrical energy delivered by the external electrical energy generating device comprises radio frequency (RF) energy.

Claims

1. An optically guided ablation system, comprising: Catheters, including: proximal segment; distal segment; a shaft coupled between the proximal section and the distal section; and an optical circuit configured to transmit light at least partially from the proximal segment to the distal segment and back; a pulsed field ablation energy source coupled to the catheter and configured to send pulsed electrical signals to the tissue sample; and A processing device, which is configured as follows: analyzing one or more optical signals received from the optical circuit to determine changes in polarization or phase delay of light reflected or scattered by the tissue sample; determining a change in birefringence of the tissue sample based on the change in polarization or phase retardation; and A prediction algorithm is applied or machine learning is implemented to predict the geometry of permanent ablation lesions, and / or the likely recurrence of cardiac pacing abnormalities, particularly fibrillation, based on the determined changes in birefringence of the tissue sample.

2. The optically guided ablation system according to claim 1, characterized in that: The prediction algorithm is suitable for implementing one or more of interpolation, extrapolation, regression, minimum residual and / or statistical fitting.

3. The optically guided ablation system according to claim 1, characterized in that: The processing device is configured to apply the prediction algorithm or implement machine learning to a predefined lesion library to predict the geometry of permanent ablation lesions.

4. The optically guided ablation system according to claim 1, characterized in that: The geometry of the permanent ablation lesion includes one or more of the width, length and / or depth of the lesion.

5. The optically guided ablation system according to claim 1, characterized in that: The optical circuit is configured to transmit light at least partially from the proximal segment to the distal segment and back using at least a partial polarization maintaining transmission medium in the shaft.

6. The optically guided ablation system according to claim 1, characterized in that: The pulsed electrical signal sent by the pulsed field ablation energy source is monophasic or biphasic.

7. The optically guided ablation system according to claim 1, characterized in that: The change in polarization or phase delay of the light reflected or scattered by the tissue sample is responsive to the pulsed electrical signal sent to the tissue sample.

8. The optically guided ablation system according to claim 1, characterized in that: The one or more optical signals include an optical coherence tomography (OCT) signal or an optical coherence reflectometry (OCR) signal acquired from the tissue sample.

9. The optically guided ablation system according to claim 1, characterized in that: The optical circuit is configured to transmit the light from the distal segment to the tissue sample.

10. The optically guided ablation system according to claim 1, characterized in that: The distal section of the catheter includes a plurality of optical ports configured to collect the light reflected or scattered from the tissue sample.

11. The optically guided ablation system according to claim 1, characterized in that: Characteristics of the pulsed electrical signal are selected by a user of the catheter, wherein the characteristics include frequency, amplitude, and duration of the pulsed electrical signal.

12. The optically guided ablation system according to claim 1, characterized in that The pulsed electrical signal is adapted to cause irreversible electroporation of the tissue sample.

13. The optically guided ablation system according to claim 12, characterized in that: The processing device is configured to analyze one or more optical signals received from the optical circuit to determine a change in polarization or phase delay of light reflected or scattered by the tissue sample after a predetermined period of time, wherein the predetermined period of time includes the time required to begin forming non-thermal damage in the tissue sample, wherein the non-thermal damage is caused by the irreversible electroporation of the tissue sample.

14. The optically guided ablation system according to claim 1, characterized in that: The catheter is configured to ablate a heart wall, the catheter further comprising: a plurality of electrodes disposed at a distance from each other on the distal segment; and at least one optical port located on the distal segment relative to the plurality of electrodes, wherein the catheter is configured to be placed in an outer sheath such that the distal segment is in a straight configuration compatible with vascular delivery, the distal segment assuming a rounded shape when pushed through the sheath, wherein the plurality of electrodes are connected to the pulsed field ablation energy source by wires via an electrical connector on the proximal section of the catheter, wherein the plurality of electrodes are configured to deliver electrical energy to the heart wall when energized by the pulsed field ablation energy source, Wherein, the at least one optical port includes an optical component connected to an external light energy generating device via an optical fiber via an optical connector on the proximal section of the catheter, wherein the optical component is configured to: when powered by the light energy generating device, project light energy into the heart wall, receive light energy reflected from the heart wall, and transmit the reflected light energy to an external optical sensing device via the optical fiber and the optical connector.

15. The optically guided ablation system according to claim 14, characterized in that: The circular shape of the distal section of the catheter is in a plane parallel to the heart wall and is configured to contact the heart wall.

16. The optically guided ablation system according to claim 14, characterized in that The location of the at least one optical port is selected to optimally observe changes in optical parameters caused by tissue ablation resulting from energization of the plurality of electrodes.

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