Optically guided ablation system for use with pulse field energy supply source

Abstract

To provide a system including a catheter, an optical circuit, a pulse field ablation energy supply source, and a processing device.SOLUTION: A catheter 100 includes: a proximal section; a distal section; and a shaft connected between the proximal section and the distal section. An optical circuit is configured to transport light at least partially from the proximal section to the distal section and inversely. A pulse field ablation energy supply source 102 is configured to be connected to a catheter and to transmit a pulsed electric signal to a tissue sample. A processing device is configured to analyze one or more optical signals received from the optical circuit to determine changes in polarization or phase retardation of light reflected or scattered by the tissue sample, and determine changes in a birefringence of the tissue sample based on the changes in polarization or phase retardation.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of EP application no. 20382014.7 filed on 13 January 2020 and and claims priority to EP application No. 20382774.6 filed on August 31, 2020. No. 6,399,623, the disclosure of which is incorporated herein by reference in its entirety.

[0002] Embodiments of the present application relate to ablation-based lesions. Optical imaging to determine or predict structural changes in tissues associated with The present invention relates to catheters, systems, and methods that utilize novel photonic technologies. [Background technology]

[0003] Some pathologies affect the function of local tissues or end organs, thus altering healthy tissue. The primary example of such a treatment is , myocardial ablation for patients with cardiac rhythm abnormalities, and renal surgery for patients with hypertension. splanchnic nerve ablation (e.g., renal denervation) and the treatment of patients with epilepsy In such procedures, catheters are used to The energy required to ablate tissue through a catheter or small incision is delivered by a The energy used to create the lesions is Conventional radio frequency (RF) based thermal, cryogenic cooling, and pulsed field abrasives It is possible to include the following options:

[0004] Atrial fibrillation (AF) is a common type of heart It is an arrhythmia, and in 2010, an estimated 33.5 million people worldwide were suffering from this disease. AF increases the risk of stroke by fivefold and is a major medical problem in developed countries. The available drug therapies commonly used to control the heart rhythm in AF patients may have significant drawbacks from the perspective of effectiveness, cause serious side effects, and may result in a reduction in the quality of life of patients. Cardiac catheter ablation therapy can be a minimally invasive procedure, which uses a thin steerable therapeutic catheter that uses energy to create lesions in heart tissue to treat cardiac rhythm abnormalities. The success of the therapy depends on the clinician's ability to completely ablate the tissue through the heart wall without missing any gaps between ablation points that can cause AF recurrence. Currently, clinicians cannot determine in real time the quality of catheter contact, contraction stability, the energy delivered, or the quality of the ablation performed. Also, conventional RF cardiac ablation may result in serious complications associated with puncture of adjacent structures or unintended thermal damage. The reason is that such ablation uses thermal means to create lesions. In that regard, pulsed field ablation (PFA) uses electromagnetic pulses to generate non-thermal lesions during the ablation process. PFA uses electrodes and can cause irreversible electroporation of cells within them, ultimately leading to cell death. This technique reduces complications associated with thermal damage, but only to the extent There may be little or no necrosis in the tissue at the surface of the electrode. The current technique is based on the lesion generated by PFA energy at selected parameters. results in irreversible electroporation and subsequent permanent lesions The lack of such information is limited in its ability to inform clinicians of whether This may lead to significant levels of fibrillation recurrence. Having the ability to directly assess lesion formation through AF is valuable for treating AF and To prevent recurrence, clinicians need to create safer, more durable, and more continuous lesions. This will enable the achievement of

[0005] Epilepsy is the fourth most common neurological disorder and affects people of all ages. To date, treatment options include medications, neurostimulation, surgery, and abdominal surgery. Catheter-based laser ablation has recently become available. It is one of the procedures that can be used to treat strokes because it is less invasive than surgery and has fewer side effects than other procedures that can cause seizures. By ablating the area that causes the seizures, the focus of the seizures can be eliminated. The effectiveness and safety limits for this procedure depend on the amount of energy delivered into the tissue. It is associated with the inability to measure the amount of heat (for example) with precision. The reason is that too much energy can damage surrounding neurons, and too little The energy would then need to be reablated. Catheters capable of determining the amount of glycerin or the local temperature at a tissue site are currently This would alleviate some of the shortcomings of the technology.

[0006] Several clinical studies have shown that ablation of the renal nerves reduces blood pressure in hypertensive patients. This and other ablation procedures have been shown to be capable of It can be limited by the correct delivery of energy to generate the lesion geometry. Too much energy can result in lesions that may not penetrate sufficiently into the tissue. On the one hand, this leaves a transmission gap and the need for subsequent reintervention, on the other hand, it creates too much energy This can result in complications such as renal artery stenosis or dissection. Therefore, renal denervation may be beneficial for measuring real-time tissue temperature at the ablated site.

[0043] Use of photonic-based catheters that can predict lesion geometry based on will gain profits from

[0007] Low Coherence Interferometry (LCI) etry) is often used in medical imaging to study internal tissue and An exemplary LCI technique is optical coherence reflectance (LCI), which provides depth-resolved information of both the internal and external tissues. Optical Coherence Reflectrometry (OCR) y) and Optical Coherence Tomography (OCT) The NIRS Tomography (NIRS) includes a broadband optical source and an interferometric detection system. The high axial resolution provided by these methods can provide depth-resolved information, respectively. The LCI technique allows the structural characterization of tissues and their function when ablation lesions occur. Optical properties that can be used to determine changes in tissue properties Some of the variables are frequency, time of flight, polarization, and intensity.

[0008] Spectroscopic techniques based on elastic optical scattering, fluorescence, and Raman scattering can diagnose diseases by characterizing the cell structure / subcellular structure, cell metabolic state, and molecular signature of normal and diseased tissues, respectively. Optical spectroscopy techniques have been used to determine the geometric shape of different anatomical structures in tissues, and spectroscopy techniques have the benefit of increased penetration depth compared to some LCI techniques. As described above, interventions based on cardiac ablation, renal denervation, and nerve ablation catheters

[0009] are plagued by significant limitations associated with the lack of real-time information during clinical procedures to evaluate lesion progression after energy (e.g., RF, cryogenic, and / or pulsed field) has been delivered to the selected site. SUMMARY OF THE INVENTION

[0010] Therefore, there may be a need to provide new catheters, systems, and methods that use optical techniques such as LCI and spectroscopy during and after energy delivery to evaluate lesion geometry in order to reduce the need for reintervention and improve safety and ensure ablation accuracy.

[0011] Accordingly, embodiments of an optically guided ablation system that includes a catheter, an optical source, an optical circuit, an ablation energy source and an ablation energy circuit are described herein. In various embodiments, the ablation A ablation system is used with pulsed field ablation energy or RF ablation energy to treat atrial fibrillation, epilepsy, or to perform renal denervation. The changes in polarization and phase delay of light used by the optical-based catheter system described herein can be associated with the thermal lesion geometry during RF ablation or the structural changes in tissue and cells associated with cell death in a pulsed field

[0012] ablation procedure and can be used to predict such changes. In some embodiments, the ablation system includes a catheter having an optical waveguide or fiber, a data processing device, an optical source, an optical circuit, and an ablation energy source. The catheter includes a proximal section, a distal section, and a shaft connecting the proximal section to the distal section. In some embodiments, the proximal section includes a handle as an interface with a clinical user. In some embodiments, the optical fiber and / or waveguide, and the electrical wire and / or cable travel at least partially through the catheter shaft to transmit light 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 enables transmission and control of light signals emitted by an optical source. In some embodiments, the optical circuit

[0013] In some embodiments, the electrical wire is from an ablation energy source to transmit ablation energy to an ablation site inside or on the surface of a patient's body. In some embodiments, the ablation energy source is a pulsed field ablation (PFA) generator. In some embodiments, the PFA generator sends a pulsed electrical signal (monophasic or biphasic), and the pulsed electrical signal generates a pulsed RF field that creates a lesion localized within the tissue at the ablation site. The electrical signal of the ablation energy source can travel through a wire or cable to an electrode positioned on the surface of the catheter shaft 202. The lesion can be caused by an electric field pulse from an electrode that is in contact with or penetrates into the tissue at the ablation site. The lesion can be thermal or non-thermal depending on the amount of energy transmitted into the tissue. In some embodiments, the energy source can be modulated to produce lesions that are mostly associated with non-thermal damage to the tissue structure. When the ablation energy entering the tissue causes or increases the size of pores in the cell membrane of the tissue cells and opens or increases in size to the extent that cellular edema is caused, non-thermal damage occurs. Such cellular edema can alter the cellular functions that the cells can respond to it by initiating apoptosis or other delayed cellular death processes that lead to cell death. The cell wall structure Alternative examples, as well as apoptosis, pyroptosis, necrosis, and / or subsequent cell death through the necrosis process can change the birefringence characteristics of the ablated tissue because the denaturation and / or fragmentation of proteins in the cell membrane proteins, cellular cytoskeletal proteins, or extracellular matrix changes how light interacts with such proteins. Therefore, the optical properties (such as polarization and phase retardation) of light reflected or refracted from such denatured or fragmented structures lead to changes in tissue birefringence. In some embodiments, an optical signal from an optical source travels through an optical circuit to an ablation site within or on the surface of a patient's body either simultaneously or after ablation energy has been transmitted into the tissue. In some embodiments, light from the optical circuit can penetrate the tissue and be reflected, refracted, or backscattered into the optical circuit. The reflected, refracted, or scattered light travels at least partially back through the optical circuit to an optical detector. The optical detector is used to collect optical data about the properties of the returning light (such as intensity, frequency, polarization state, time of flight, and phase retardation). In some embodiments, the optical data and properties are analyzed to determine changes in the birefringence of the treated tissue associated with the use of pulsed field energy for ablation. In some embodiments, data from the returning optical signal (including changes in tissue birefringence) is then coupled to a computer connected to the optical detector.

[0014] In some embodiments, an optical signal from an optical source travels through an optical circuit to an ablation site within or on the surface of a patient's body either simultaneously or after ablation energy has been transmitted into the tissue. In some embodiments, light from the optical circuit can penetrate the tissue and be reflected, refracted, or backscattered into the optical circuit. The reflected, refracted, or scattered light travels at least partially back through the optical circuit to an optical detector. The optical detector is used to collect optical data about the properties of the returning light (such as intensity, frequency, polarization state, time of flight, and phase retardation). In some embodiments, the optical data and properties are analyzed to determine changes in the birefringence of the treated tissue associated with the use of pulsed field energy for ablation. In some embodiments, data from the returning optical signal (including changes in tissue birefringence) is then coupled to a computer connected to the optical detector. In some embodiments, the optical data and properties are analyzed to determine changes in the birefringence of the treated tissue associated with the use of pulsed field energy for ablation. In some embodiments, data from the returning optical signal (including changes in tissue birefringence) is then coupled to a computer connected to the optical detector. from the returning optical signal (including changes in tissue birefringence) is then coupled to a computer It can be sent to a computer or a processor unit. The computer or the processor unit can apply interpolation, extrapolation, artificial intelligence (e.g., machine learning), and / or other statistical algorithms to the data from the returning optical signal, and correlate the changes in the received signal to the durability and / or geometric shape of the ablated lesion, as well as to the recurrence that can occur of ventricular fibrillation or other types of cardiac pacing abnormalities. It is designed to do so.

[0015] In one embodiment, an exemplary 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 section, a distal section, and a shaft connected between the proximal section and the distal section. The optical circuit is configured to transport light at least partially from the proximal section to the distal section and vice versa. The pulsed-field ablation energy source is connected to the catheter and is configured to transmit a pulsed electrical signal to the tissue sample. The processing device is configured to analyze one or more optical signals received from the optical circuit and determine changes in the polarization or phase delay of the light reflected or scattered by the tissue sample, and based on the changes in polarization and phase delay, determine changes in the birefringence of the tissue sample. It is configured to do so. It is configured to do so.

[0016] In another embodiment, an exemplary method for performing ablation in a patient is described. The method includes inserting a catheter into the patient's vascular system and the patient's blood vessel Moving the distal end of the catheter to the ablation site within the system, and establishing tissue contact at the distal end of the catheter through optical means using light delivered to the ablation site through the distal end of the catheter, and delivering energy from an energy source coupled to the catheter from the distal end of the catheter into the tissue, and optically interrogating the ablation tissue site and determining a change in polarization or phase delay of light delivered through the catheter to the ablation tissue site, and removing the catheter from the vasculature. determining a change in polarization or phase delay of light delivered through the catheter to the ablation tissue site, and removing the catheter from the vasculature.

[0017] In another embodiment, a catheter for ablating tissue of the heart wall is described. The catheter includes a proximal end, a distal end, a plurality of electrodes disposed on the distal end at a predetermined distance from each other, and at least one optical port positioned on the distal end at a predetermined location with respect to the plurality of electrodes. The catheter is configured to be disposed within an outer sheath, and the distal end is configured to be straight and adapted for vascular delivery, and the distal end assumes a circular shape when pushed through the sheath. The plurality of electrodes are connected by wires to an external electrical energy generating device via an electrical connector on the proximal end of the catheter. The plurality of electrodes are configured to deliver electrical energy to the heart wall when excited by an external electrical energy generating device. In another embodiment, a catheter for ablating tissue of the heart wall is described. The catheter includes a proximal end, a distal end, a plurality of electrodes disposed on the distal end at a predetermined distance from each other, and at least one optical port positioned on the distal end at a predetermined location with respect to the plurality of electrodes. The catheter is configured to be disposed within an outer sheath, and the distal end is configured to be straight and adapted for vascular delivery, and the distal end assumes a circular shape when pushed through the sheath. The plurality of electrodes are connected by wires to an external electrical energy generating device via an electrical connector on the proximal end of the catheter. The plurality of electrodes are configured to deliver electrical energy to the heart wall when excited by an external electrical energy generating device. In another embodiment, a catheter for ablating tissue of the heart wall is described. The catheter includes a proximal end, a distal end, a plurality of electrodes disposed on the distal end at a predetermined distance from each other, and at least one optical port positioned on the distal end at a predetermined location with respect to the plurality of electrodes. The catheter is configured to be disposed within an outer sheath, and the distal end is configured to be straight and adapted for vascular delivery, and the distal end assumes a circular shape when pushed through the sheath. The plurality of electrodes are connected by wires to an external electrical energy generating device via an electrical connector on the proximal end of the catheter. The plurality of electrodes are configured to deliver electrical energy to the heart wall when excited by an external electrical energy generating device. In another embodiment, a catheter for ablating tissue of the heart wall is described. The catheter includes a proximal end, a distal end, a plurality of electrodes disposed on the distal end at a predetermined distance from each other, and at least one optical port positioned on the distal end at a predetermined location with respect to the plurality of electrodes. The catheter is configured to be disposed within an outer sheath, and the distal end is configured to be straight and adapted for vascular delivery, and the distal end assumes a circular shape when pushed through the sheath. The plurality of electrodes are connected by wires to an external electrical energy generating device via an electrical connector on the proximal end of the catheter. The plurality of electrodes are configured to deliver electrical energy to the heart wall when excited by an external electrical energy generating device. In another embodiment, a catheter for ablating tissue of the heart wall is described. The catheter includes a proximal end, a distal end, a plurality of electrodes disposed on the distal end at a predetermined distance from each other, and at least one optical port positioned on the distal end at a predetermined location with respect to the plurality of electrodes. The catheter is configured to be disposed within an outer sheath, and the distal end is configured to be straight and adapted for vascular delivery, and the distal end assumes a circular shape when pushed through the sheath. The plurality of electrodes are connected by wires to an external electrical energy generating device via an electrical connector on the proximal end of the catheter. The plurality of electrodes are configured to deliver electrical energy to the heart wall when excited by an external electrical energy generating device. In another embodiment, a catheter for ablating tissue of the heart wall is described. The catheter includes a proximal end, a distal end, a plurality of electrodes disposed on the distal end at a predetermined distance from each other, and at least one optical port positioned on the distal end at a predetermined location with respect to the plurality of electrodes. The catheter is configured to be disposed within an outer sheath, and the distal end is configured to be straight and adapted for vascular delivery, and the distal end assumes a circular shape when pushed through the sheath. The plurality of electrodes are connected by wires to an external electrical energy generating device via an electrical connector on the proximal end of the catheter. The plurality of electrodes are configured to deliver electrical energy to the heart wall when excited by an external electrical energy generating device. In another embodiment, a catheter for ablating tissue of the heart wall is described. The catheter includes a proximal end, a distal end, a plurality of electrodes disposed on the distal end at a predetermined distance from each other, and at least one optical port positioned on the distal end at a predetermined location with respect to the plurality of electrodes. The catheter is configured to be disposed within an outer sheath, and the distal end is configured to be straight and adapted for vascular delivery, and the distal end assumes a circular shape when pushed through the sheath. The plurality of electrodes are connected by wires to an external electrical energy generating device via an electrical connector on the proximal end of the catheter. The plurality of electrodes are configured to deliver electrical energy to the heart wall when excited by an external electrical energy generating device. In another embodiment, a catheter for ablating tissue of the heart wall is described. The catheter includes a proximal end, a distal end, a plurality of electrodes disposed on the distal end at a predetermined distance from each other, and at least one optical port positioned on the distal end at a predetermined location with respect to the plurality of electrodes. The catheter is configured to be disposed within an outer sheath, and the distal end is configured to be straight and adapted for vascular delivery, and the distal end assumes a circular shape when pushed through the sheath. The plurality of electrodes are connected by wires to an external electrical energy generating device via an electrical connector on the proximal end of the catheter. The plurality of electrodes are configured to deliver electrical energy to the heart wall when excited by an external electrical energy generating device. In another embodiment, a catheter for ablating tissue of the heart wall is described. The catheter includes a proximal end, a distal end, a plurality of electrodes disposed on the distal end at a predetermined distance from each other, and at least one optical port positioned on the distal end at a predetermined location with respect to the plurality of electrodes. The catheter is configured to be disposed within an outer sheath, and the distal end is configured to be straight and adapted for vascular delivery, and the distal end assumes a circular shape when pushed through the sheath. The plurality of electrodes are connected by wires to an external electrical energy generating device via an electrical connector on the proximal end of the catheter. The plurality of electrodes are configured to deliver electrical energy to the heart wall when excited by an external electrical energy generating device. In another embodiment, a catheter for ablating tissue of the heart wall is described. The catheter includes a proximal end, a distal end, a plurality of electrodes disposed on the distal end at a predetermined distance from each other, and at least one optical port positioned on the distal end at a predetermined location with respect to the plurality of electrodes. The catheter is configured to be disposed within an outer sheath, and the distal end is configured to be straight and adapted for vascular delivery, and the distal end assumes a circular shape when pushed through the sheath. The plurality of electrodes are connected by wires to an external electrical energy generating device via an electrical connector on the proximal end of the catheter. The plurality of electrodes are configured to deliver electrical energy to the heart wall when excited by an external electrical energy generating device.

[0018] Further features and advantages, as well as the structure and operation of various embodiments, are described in detail below with reference to the accompanying drawings. The specific embodiments described herein are not intended to be limiting. It should be noted that the state is not intended to be limiting. Such embodiments are presented herein for illustrative purposes only. Additional embodiments will become apparent to those skilled in the art based on the teachings contained herein.

Brief Description of the Drawings

[0019]

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DETAILED DESCRIPTION OF THE INVENTION

[0020] Embodiments of the present disclosure will be described with reference to the accompanying drawings.

[0021] While specific configurations and arrangements are discussed, this is done for illustrative purposes only. It should be understood that other configurations and arrangements are within the spirit and scope of the present disclosure. It will be appreciated that the present disclosure may be used in a variety of ways without departing from its scope. It will be apparent to those skilled in the art that the present invention may also be used in a variety of other applications. .

[0022] In this specification, the terms "one embodiment," "an embodiment," "exemplary embodiment," etc. References to may indicate that the described embodiments include a particular feature, structure, or characteristic. Although various embodiments may be used, all embodiments do not necessarily include that particular feature, structure, or characteristic. It is noted that the phrase "is not necessarily" means that "is not necessarily" Moreover, references to specific features, structures, or characteristics may not necessarily refer to the same embodiment. However, when described in connection with an embodiment, it is understood that Regardless, it is not intended that such features, structures, or characteristics be implemented in conjunction with other embodiments. , will be within the knowledge of one skilled in the art.

[0023] Although this application may refer specifically to cardiac ablation, the present invention is not limited to the disclosed subject matter. The disclosed embodiment also provides an additional energy source for ablation ( These include cryogenic, radio frequency (RF), microwave, laser, ultrasonic, and pulsed electric fields. It is possible that these drugs may be used to treat a range of conditions, including but not limited to: It should be noted that

[0024] Described herein are embodiments of a medical system that includes a catheter, a catheter-based catheter, and a catheter-based catheter. During and after ablation energy is delivered to create a lesion, an optical signal is used to characterize tissue changes.

[0025] In some embodiments, low coherence interferometry (LCI) and / or spectroscopy is used with the optical signal to provide depth-resolved information about the tissue sample being imaged. The portion of the application can be focused on the transmission of the optical signal through the catheter and a portion of the catheter, although it should be understood that the embodiments discussed herein can be applied to any medical device that utilizes an optical signal.

[0026] Exemplary System Embodiments FIG. 1 illustrates a diagram of an exemplary ablation system, the ablation system including catheter 100, console 101, ablation energy supply source 102, cooling supply source 103, and user interface 104. In some embodiments, the distal section of catheter 100 is positioned in a portion of the tissue within patient 107. In some embodiments, the outer elements of catheter 100 (e.g., referred to herein as external elements) can be held within a single enclosure or within multiple enclosures as determined by the system design. In some embodiments, elements within different enclosures can be connected through an external data cable, optical fiber 105, and / or electrical cable wiring or wires 106. In some embodiments ​​​​​​​, the system may not include a cooling source 103. In some embodiments , the ablation system uses conventional radio frequency (RF) ablation means and is capable of generating a thermal lesion in tissue, which includes a cooling source 103 in the form of an irrigation pump and is capable of preventing carbonization of blood. 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.

[0027] Exemplary catheter embodiments FIG. 2 illustrates a catheter 100 according to an embodiment of the present disclosure. The catheter 100 includes a proximal section 200, a distal section 201, and a shaft 202 connected between the proximal section 200 and the distal section 201. In some embodiments , the proximal section 200 includes a handle for interfacing with a clinical user. The handle can include one or more buttons, sliders, levers, latches, dials, and other elements that enable mechanical and functional control of the catheter shaft 202 and the distal section 201. In some embodiments the proximal section 200 of the catheter can also include wiring 204 and one or more connectors 205. The wiring 204 can include a wire harness or a grouped cable and optical fibers and / or waveguides and one or more connectors 205 provide an interface for the catheter 100 is capable of fulfilling the role thereof and is capable of connecting the catheter 100 directly or indirectly to other elements of the ablation system (including the ablation energy source 102, the optical source, the console 101, and / or the user interface 104). In some embodiments, the proximal section 200 of the catheter can also have a port for connection to a cooling source 103. In some embodiments, the wiring 204, the wiring harness element, and one or more connectors 205 can be removable from the handle in the proximal section. In other embodiments, the communication between the catheter 100 and other elements of the ablation system can be wireless, using technologies such as Bluetooth, WiFi, cellular, etc. The proximal section 200 can further include additional interface elements, and the user of the catheter 100 can control the operation of the catheter 100 by means of the additional interface elements. For example, the proximal section 200 can include a deflection control mechanism for controlling the deflection angle of the distal section 201. The deflection control mechanism can utilize the mechanical movement of elements on the proximal section 200, or the deflection control mechanism can use an electrical connection to control the movement of the distal section 201. The proximal section 200 can include various buttons or switches, and the various buttons or switches can be used to control the timing when RF energy is applied in the distal section 201, or when radiation and the ablation energy source 102, the optical source, the console 101, and / or the user interface 104). In some embodiments, the proximal section of the catheter 200 can also have a port for connection to a cooling source 103. In some embodiments, the wiring 204, the wiring harness element, and one or more connectors 205 can be removable from the handle in the proximal section obtainable. In other embodiments, the communication between the catheter 100 and other elements of the ablation system can be wireless, using technologies such as Bluetooth, WiFi, cellular, etc. is possible.

[0028] The proximal section 200 can further include additional interface elements, and the user of the catheter 100 can control the operation of the catheter 100 by means of the additional interface elements. For example, the proximal section 200 can include a deflection control mechanism for controlling the deflection angle of the distal section 201. is possible. The deflection control mechanism can utilize the mechanical movement of elements on the proximal section 200, or the deflection control mechanism can use an electrical connection to control the movement of the distal section 201. The proximal section 200 can include various buttons or switches, and the various buttons or switches can be used to control the timing when RF energy is applied in the distal section 201, or when radiation and the like are applied. Enable the user to control when a beam of light is transmitted from the distal section 201 and enable the acquisition of optical data. In some embodiments, these buttons or switches are located on a separate user interface or the handle itself that is connected to the processing device.

[0029] The deflection control mechanism includes electrical or mechanical elements designed to provide a signal to the distal section 201 to vary the deflection angle of the distal section 201. According to an embodiment, the deflection system enables the guidance of the distal section 201 by actuating a mechanical control installed in the proximal section 200. This deflection system is a combination of a wire that connects the deflection mechanism control in the proximal section 200 to the catheter tip 214 in the distal section 201, and is intended to provide one - direction or multi - direction deflection of the distal section 201 based on a series of aligned and evenly spaced cut - outs in the catheter shaft 202. In this way, a specific movement of the proximal section 200 can be projected onto the distal section 201. In some embodiments, a combination of several control wires attached to the catheter tip can enable the deflection of the catheter tip along different directions.

[0030] FIG. 2 further illustrates the elements of the distal section 201 in an enlarged view showing the catheter tip 214. In one embodiment, the catheter shaft 202 and and the distal segment may include one or more radiopaque markers for navigation purposes. The distal section 201 may include the ablation catheter 215 in some embodiments. In some embodiments, the distal section 201 may include one or more external electrodes 213 for ablation. The electrodes 213 may be distributed across segments of the distal section 201 of the catheter, or may be directly disposed on the catheter tip 214 at the distal end of the distal section 201. In some embodiments, if cooling is required, the distal section 201 of the catheter 100 may also include one or more irrigation orifices 216. In some embodiments, the cooling fluid (e.g., compressible and / or non-compressible cooling fluid) provided by the cooling source 103 travels through a channel that at least partially passes through the shaft 202 of the catheter 100, and then exits externally through the irrigation orifices 216. These irrigation orifices 216 may be positioned in any segment of the catheter shaft 202, the electrodes 213, or the catheter tip 214.

[0031] Figures 3A and 3B respectively illustrate exemplary axial cross-sectional and radial cross-sectional diagrams of the distal segment of a catheter according to embodiments of the present disclosure. Figures 3A and 3B illustrate different configurations of electrodes, viewports, and lens-fiber assemblies at the catheter tip. As shown in FIGS. 3A - 3B, the distal section 201 and the shaft 202 of the catheter include a single electrode or multiple electrodes for delivering ablation energy.

[0032] ​ It is possible to have 213. In some embodiments, PFA energy can be used, and the electrode 213 configuration can be configured to deliver a 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 the cooling fluid through the shaft 202 to the distal section 201, and such fluid can then be discharged externally through the irrigation orifice 216 to cool the surrounding tissue or blood. Also, the distal section 201 includes a plurality of optical viewports 308 and can transmit / collect light from various angles from the distal section

[0033] 201. In some embodiments, the optical viewports 308 can be distributed across the outside of the distal section 201, resulting in a plurality of individual viewing directions, and in some embodiments, each of the plurality of viewing directions is not in a substantially the same plane. In some embodiments illustrated in FIGS. 3A - 3B, light is transported by the optical fiber 1 05 through the shaft 202 and the distal section 201. Such an optical fiber 105 may or may not be coated. In some embodiments, the optical fiber 105 is coated with a polymer for protection, insulation, and structural integrity. In some embodiments, the optical fiber 105 is attached to the lens 300 to focus the light, and the light will then enter the tissue. In some embodiments, the fiber

[0034] FIGS. 3A - 3B. 05 through the shaft 202 and the distal section 201. Such an optical fiber 105 may or may not be coated. In some embodiments, the optical fiber 105 is coated with a polymer for protection, insulation, and structural integrity. In some embodiments, the optical fiber 105 is attached to the lens 300 to focus the light, and the light will then enter the tissue. In some embodiments, the fiber 05 through the shaft 202 and the distal section 201. Such an optical fiber 105 may or may not be coated. In some embodiments, the optical fiber 105 is coated with a polymer for protection, insulation, and structural integrity. In some embodiments, the optical fiber 105 is attached to the lens 300 to focus the light, and the light will then enter the tissue. In some embodiments, the fiber 05 through the shaft 202 and the distal section 201. Such an optical fiber 105 may or may not be coated. In some embodiments, the optical fiber 105 is attached to the lens 300 to focus the light, and the light will then enter the tissue. In some embodiments, the fiber 05 through the shaft 202 and the distal section 201. Such an optical fiber 105 may or may not be coated. In some embodiments, the optical fiber 105 is attached to the lens 300 to focus the light, and the light will then enter the tissue. In some embodiments, the fiber The fiber can be mechanically or chemically attached through glue or an adhesive 305. In some embodiments, the glue or adhesive 305 can be selected to provide mechanical strength and also to provide optical index matching. As shown in FIG. 3B, in some embodiments, the lens 300 and / or the fiber 105 can be supported by an internal support structure 304 to localize and orient the lens 300 and the fiber 105 in appropriate positions. In other embodiments, the lens 300 can be localized 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 with respect to the fiber 105 and can be generated by a curvature directly fabricated (e.g., etched, machined, laser cut, or chemically formed) on the distal end of the fiber 105 and the fiber core. In some embodiments, the distal section 201 can include a substrate with patterned waveguides and optical focusing or directing elements such as lenses and mirrors, etc.) for guiding light to / from each of the plurality of optical viewports 308. The substrate can be a flexible or partially flexible substrate made of a material such as polyimide, polyethylene glycol, parylene, or polydimethylsiloxane (PDMS). In some embodiments, as shown in FIG. 3A, the lens 300 is connected to the optical fiber and can be placed in the recess 303 in the catheter. In some embodiments, the glue or adhesive 305 can be selected to provide mechanical strength and also to provide optical index matching.

[0035] In some embodiments, as shown in FIG. 3A, the lens 300 is connected to the optical fiber and can be placed in the recess 303 in the catheter. Some In an embodiment, the lens can be on the same plane 301 as the catheter surface (e.g., the shaft, electrode, or tip), or can extend beyond the surface 302 of the catheter shaft 202, the electrode 213, or the tip 214. In some embodiments, the lens that is on the same plane 301 as the catheter surface or extends beyond the surface 302 can be a point of contact with the external tissue. In some embodiments, when cooling is implemented, the lens that is embedded in the catheter and uses the viewport 308 to allow light passage can also use these same viewports 308 as irrigation orifices 216. In some embodiments, the viewport 308 and the irrigation orifice 216 can be separate and distinct elements. Figures 4A - 4D illustrate exemplary two - dimensional (2D) and three - dimensional (3D) geometric shape diagrams of the distal section 201 of a catheter according to embodiments of the present disclosure. As shown in Figures 4A - 4D, the distal section 201 of the catheter can take on different 2D and 3D geometric shapes. In some embodiments, the 2D and 3D geometric shapes of the distal section can be the actual geometric shape of the catheter in its unloaded state. In some embodiments, the catheter geometry can be deflected and / or reformed to temporarily fit within a delivery sheath to easily pass through the vasculature in a patient. In other embodiments, the distal section In some embodiments, the lens that is on the same plane 301 as the catheter surface or extends beyond the surface 302 can be a point of contact with the external tissue. In some embodiments, when cooling is implemented, the lens that is embedded in the catheter and uses the viewport 308 to allow light passage can also use these same viewports 308 as irrigation orifices 216. In some embodiments, the viewport 308 and the irrigation orifice 216 can be separate and distinct elements. In some embodiments, the lens that is on the same plane 301 as the catheter surface or extends beyond the surface 302 can be a point of contact with the external tissue. In some embodiments, when cooling is implemented, the lens that is embedded in the catheter and uses the viewport 308 to allow light passage can also use these same viewports 308 as irrigation orifices 216. In some embodiments, the viewport 308 and the irrigation orifice 216 can be separate and distinct elements. In some embodiments, when cooling is implemented, the lens that is embedded in the catheter and uses the viewport 308 to allow light passage can also use these same viewports 308 as irrigation orifices 216. In some embodiments, the viewport 308 and the irrigation orifice 216 can be separate and distinct elements. In some embodiments, when cooling is implemented, the lens that is embedded in the catheter and uses the viewport 308 to allow light passage can also use these same viewports 308 as irrigation orifices 216. In some embodiments, the viewport 308 and the irrigation orifice 216 can be separate and distinct elements. In some embodiments, the lens that is embedded in the catheter and uses the viewport 308 to allow light passage can also use these same viewports 308 as irrigation orifices 216. In some embodiments, the viewport 308 and the irrigation orifice 216 can be separate and distinct elements. In some embodiments, the viewport 308 and the irrigation orifice 216 can be separate and distinct elements. In some embodiments, the viewport 308 and the irrigation orifice 216 can be separate and distinct elements.

[0036] Figures 4A - 4D illustrate exemplary two - dimensional (2D) and three - dimensional (3D) geometric shape diagrams of the distal section 201 of a catheter according to embodiments of the present disclosure. As shown in Figures 4A - 4D, the distal section 201 of the catheter can take on different 2D and 3D geometric shapes. As shown in Figures 4A - 4D, the distal section 201 of the catheter can take on different 2D and 3D geometric shapes. In some embodiments, the distal section can take on different 2D and 3D geometric shapes. In some embodiments, the 2D and 3D geometric shapes of the distal section can be the actual geometric shape of the catheter in its unloaded state. In some embodiments, the 2D and 3D geometric shapes of the distal section can be the actual geometric shape of the catheter in its unloaded state. In some embodiments, the catheter geometry can be deflected and / or reformed to temporarily fit within a delivery sheath to easily pass through the vasculature in a patient. In some embodiments, the catheter geometry can be deflected and / or reformed to temporarily fit within a delivery sheath to easily pass through the vasculature in a patient. The 2D and 3D geometric shapes are controlled from the proximal section 200 through mechanical forces or deformations associated with electromagnetic forces to form a relatively straight catheter distal section or can be generated, and after passing through at least a section of the vasculature and before ablation energy delivery, the distal section is adapted to form such 2D and 3D geometric shapes to improve surface contact between the catheter and the local anatomical structure.

[0037] As shown in FIGS. 4A-4D, such 2D or 3D geometric shapes can have electrodes 213, which are placed at different locations within the catheter and are adapted to maximize electrode contact and optical access to anatomical structures (e.g., tissue ablation sites) where ablation may be required. In some embodiments, the electrodes 213 and other components of the catheter can have a configuration similar to that of FIG. 3 with a lens / optical view port disposed through the shaft 202, distal segment 201, or tip 214. In some geometries the distal section 201 of the catheter 201 (as shown in FIG. 4B) can at least partially have a loop configuration 401 during ablation . In some embodiments, geometries with a loop configuration 401 may be beneficial during ablation of the periphery around arteries and veins in the vasculature . In some embodiments, the radial petal-like configuration 400 shown in FIG. 4A can extend outwardly for better contact with the surrounding tissue. In other embodiments it is possible to have a configuration similar to that of FIG. 3 with a lens / optical view port disposed through the shaft 202, distal segment 201, or tip 214. In some geometries the distal section 201 of the catheter 201 (as shown in FIG. 4B) can at least partially have a loop configuration 401 during ablation . In some embodiments, geometries with a loop configuration 401 may be beneficial during ablation of the periphery around arteries and veins in the vasculature . In some embodiments, the radial petal-like configuration 400 shown in FIG. 4A can extend outwardly for better contact with the surrounding tissue. In other embodiments the radial petal-like configuration 400 shown in FIG. 4A can extend outwardly for better contact with the surrounding tissue. In other embodiments it can extend outwardly for better contact with the surrounding tissue. and a 3D spherical configuration 402 (such as that shown in FIG. 4C), a cone, a cylinder, or other irregular shaped configurations extend from the surface of the distal section 201 and can increase their overall diameter for better tissue engagement. In some embodiments, such extended geometries may be useful when ablating internal diameters or tissue of the vasculature, or when ablating tissue within or on the surface of a defined tissue cavity or chamber of the body. In some embodiments, the extended 3D geometric shaped configuration shown in FIG. 4C can be generated through mechanical deflection by using a balloon, rod, wire, or other mechanical element to change the geometry of the distal section 201. In some embodiments, a shape memory material (e.g., a shape memory metal alloy (e.g., nitinol, etc.) or a shape memory polymer, etc.) can be used to generate such geometries / configurations. Other embodiments of the 3D structure of the distal section can include helical structures 403, 404 as shown in FIG. 4D. In some embodiments, the helical structures 403, 404 can be used to ablate the inner lumen or cavity of the vasculature. In some embodiments, the geometry of the distal section 201 of the catheter can be implemented during ablation using conventional RF, PFA, or cryogenic energy. In some of the exemplary embodiments described above where the distal section 201 changes geometry during the procedure, the distal section 201 or the shaft 202 with respect to the optical fiber 105 (which is axially rigid through mechanical deflection by using a balloon, rod, wire, or other mechanical element to change the geometry of the distal section 201. In some embodiments, a shape memory material (e.g., a shape memory metal alloy (e.g., nitinol, etc.) or a shape memory polymer, etc.) can be used to generate such geometries / configurations. Other embodiments of the 3D structure of the distal section can include helical structures 403, 404 as shown in FIG. 4D. In some embodiments, the helical structures 403, 404 can be used to ablate the inner lumen or cavity of the vasculature. In some embodiments, the geometry of the distal section 201 of the catheter can be implemented during ablation using conventional RF, PFA, or cryogenic energy. In some of the exemplary embodiments described above where the distal section 201 changes geometry during the procedure, the distal section 201 or the shaft 202 with respect to the optical fiber 105 (which is axially rigid through mechanical deflection by using a balloon, rod, wire, or other mechanical element to change the geometry of the distal section 201. In some embodiments, a shape memory material (e.g., a shape memory metal alloy (e.g., nitinol, etc.) or a shape memory polymer, etc.) can be used to generate such geometries / configurations. Other embodiments of the 3D structure of the distal section can include helical structures 403, 404 as shown in FIG. 4D. In some embodiments, the helical structures 403, 404 can be used to ablate the inner lumen or cavity of the vasculature. In some embodiments, the geometry of the distal section 201 of the catheter can be implemented during ablation using conventional RF, PFA, or cryogenic energy. In some of the exemplary embodiments described above where the distal section 201 changes geometry during the procedure, the distal section 201 or the shaft 202 with respect to the optical fiber 105 (which is axially rigid through mechanical deflection by using a balloon, rod, wire, or other mechanical it is possible that there exists a mechanism that enables relative movement (which tends to be) to prevent unwanted tethering or bending of the optical fiber 105 and possible mechanical failures.

[0038] In some embodiments, the catheter can include some or all of the following elements that interconnect the proximal section 200 with the distal section 201, which includes, but is 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 signals to an optical modulation component or to an ablating element positioned in the distal section 201. In some embodiments, one or more optical transmission media can guide light generated from an optical source (e.g., exposure light) towards the distal section 201, while another subset of the optical transmission media guides light returning from the distal section 201 (e.g., scattered or reflected light) back to the proximal section 200. In some embodiments, the same one or more optical transmission media guide light in both directions. In some embodiments, the optical transmission media include polarization maintaining (PM) fibers or single mode fibers, multimode fibers, or waveguides (single mode or multimode). In some embodiments, the same optical transmission media guide exposure light and (scattered light) through at least a section of the length of the catheter. used to transport both the light returning from the (or reflected) tissue, creating a bidirectional communication path resulting in

[0039] In some embodiments, the distal section 201 of the catheter can include one or more other elements such as thermal sensors, pressure sensors, force sensors, electrical sensors, optical splitters, optical mirrors, and multiplexers. In some embodiments, an optical interferometer or RF energy source element can also be included within the proximal section 200 / handle of the catheter. In some embodiments, most or all of the energy source 102 and the optical interferometry elements can be included within an external element for the catheter, such as an external ablation energy source 102, a console 101, or a user interface 104. In some embodiments, the console 101, the energy source 10 2, and the user interface 104 can be included within a single enclosure or multiple enclosures. Exemplary embodiments of ablation energy circuits In some embodiments, the ablation energy circuit can include an ablation energy source 102 and electrical transport elements (e.g., wires and cables, insulating elements, switches, resistors, capacitors, transformers, modulation elements, connectors, and electrodes, as needed), such that the energy source is capable of delivering electrical energy, and the electrical energy is applied to the electrodes

[0040] ​​​​​​​is transported through the catheter into the tissue to ablate and create lesions and is. In some embodiments, the ablation energy is delivered through a pulsed field for a PFA system . In some embodiments, the frequency, amplitude, duration, and other characteristics of the electromagnetic pulses are selected by the clinician before delivering the selected pulsed therapy at the selected ablation site . In some embodiments, the PFA can be delivered in a biphasic or monophasic manner . In some embodiments, the PFA energy pulses are sensed by using an ECG / EKG or other sensing means to sense the cardiac electrical signal (e.g., QRS complex), and then synchronized with the cardiac rhythm by using the cardiac signal as a reference . In some embodiments, the synchronized PFA energy pulses can be delivered to the selected ablation site in the heart . In some embodiments, the PFA energy pulses are sensed by using an ECG / EKG or other sensing means to sense the cardiac electrical signal (e.g., QRS complex), and then synchronized with the cardiac rhythm by using the cardiac signal as a reference . In some embodiments, the PFA energy pulses are sensed by using an ECG / EKG or other sensing means to sense the cardiac electrical signal (e.g., QRS complex), and then synchronized with the cardiac rhythm by using the cardiac signal as a reference . In some embodiments, the PFA energy pulses are sensed by using an ECG / EKG or other sensing means to sense the cardiac electrical signal (e.g., QRS complex), and then synchronized with the cardiac rhythm by using the cardiac signal as a reference . In some embodiments, the PFA energy pulses are sensed by using an ECG / EKG or other sensing means to sense the cardiac electrical signal (e.g., QRS complex), and then synchronized with the cardiac rhythm by using the cardiac signal as a reference . In some embodiments, the PFA energy pulses are sensed by using an ECG / EKG or other sensing means to sense the cardiac electrical signal (e.g., QRS complex), and then synchronized with the cardiac rhythm by using the cardiac signal as a reference

[0041] Exemplary embodiments of the optical circuit FIG. 5 illustrates a diagram of an exemplary optical circuit 500 according to an embodiment of the present disclosure . In some embodiments, the elements of the optical circuit 500 illustrated in FIG. 5 are present in the catheter 100 and also exist as external elements (e.g., outside the catheter 100) . In some embodiments, the external elements of the optical circuit 500 can be housed in a plurality of or a single enclosure . In some embodiments, the external elements of the optical circuit 500 are housed in the console 101, which includes a user interface 104 and ablation energy . In some embodiments, the external elements of the optical circuit 500 can be housed in a plurality of or a single enclosure . In some embodiments, the external elements of the optical circuit 500 are housed in the console 101, which includes a user interface 104 and ablation energy . In some embodiments, the external elements of the optical circuit 500 are housed in the console 101, which includes a user interface 104 and ablation energy It may be housed within the same enclosure as the supply source 102, or it may not be housed. It is not necessary.

[0042] The optical circuit 500 has an optical supply source 502, and the optical supply source 502 can include one or more laser diodes or light-emitting diodes (LEDs). For example, an LED can be used when performing time-domain and / or spectral-domain analysis, while a tunable laser can be used to sweep the wavelength of light over a predetermined range of wavelengths. The radiation beam generated by the optical supply source 502 can have wavelengths within the infrared range (e.g., from 750 nm to 1 mm), while other optical supply sources 502 can operate within the visible range (e.g., from 400 nm to 750 nm) or the ultraviolet range (e.g., from 400 nm to 10 nm). In an example, the radiation beam has a central wavelength between 1000 nm and 1600 nm. The optical supply source 502 can be designed to output a radiation beam at only a single wavelength, or it can be a sweeping supply source and be designed to output a predetermined range of different wavelengths. The range of wavelengths can include any wavelength found within the near-infrared spectral range or the mid-infrared spectral range. The generated radiation beam can be guided towards the distal section 201 via an optical transmission medium connected between the proximal section 200 and the distal section 201 within the shaft 202. Some examples of optical transmission media include single-mode optical fibers and multimode optical fibers, as well as integrated optical waveguides. In some embodiments For example, an LED can be used when performing time-domain and / or spectral-domain analysis, while a tunable laser can be used to sweep the wavelength of light over a predetermined range of wavelengths. On the one hand, an LED can be used when performing time-domain and / or spectral-domain analysis, while a tunable laser can be used to sweep the wavelength of light over a predetermined range of wavelengths. The radiation beam generated by the optical supply source 502 can have wavelengths within the infrared range (e.g., from 750 nm to 1 mm), while other optical supply sources 502 can operate within the visible range (e.g., from 400 nm to 750 nm) or the ultraviolet range (e.g., from 400 nm to 10 nm). The radiation beam generated by the optical supply source 502 can have wavelengths within the infrared range (e.g., from 750 nm to 1 mm), while other optical supply sources 502 can operate within the visible range (e.g., from 400 nm to 750 nm) or the ultraviolet range (e.g., from 400 nm to 10 nm). On the one hand, the radiation beam generated by the optical supply source 502 can have wavelengths within the infrared range (e.g., from 750 nm to 1 mm), while other optical supply sources 502 can operate within the visible range (e.g., from 400 nm to 750 nm) or the ultraviolet range (e.g., from 400 nm to 10 nm). On the one hand, the radiation beam generated by the optical supply source 502 can have wavelengths within the infrared range (e.g., from 750 nm to 1 mm), while other optical supply sources 502 can operate within the visible range (e.g., from 400 nm to 750 nm) or the ultraviolet range (e.g., from 400 nm to 10 nm). The radiation beam generated by the optical supply source 502 can have wavelengths within the infrared range (e.g., from 750 nm to 1 mm), while other optical supply sources 502 can operate within the visible range (e.g., from 400 nm to 750 nm) or the ultraviolet range (e.g., from 400 nm to 10 nm). In an example, the radiation beam has a central wavelength between 1000 nm and 1600 nm. The optical supply source 502 can be designed to output a radiation beam at only a single wavelength, or it can be a sweeping supply source and be designed to output a predetermined range of different wavelengths. The range of wavelengths can include any wavelength found within the near-infrared spectral range or the mid-infrared spectral range. The range of wavelengths can include any wavelength found within the near-infrared spectral range or the mid-infrared spectral range. The generated radiation beam can be guided towards the distal section 201 via an optical transmission medium connected between the proximal section 200 and the distal section 201 within the shaft 202. The generated radiation beam can be guided towards the distal section 201 via an optical transmission medium connected between the proximal section 200 and the distal section 201 within the shaft 202. The generated radiation beam can be guided towards the distal section 201 via an optical transmission medium connected between the proximal section 200 and the distal section 201 within the shaft 202. Some examples of optical transmission media include single-mode optical fibers and multimode optical fibers, as well as integrated optical waveguides. Here, the electrical transmission medium and the optical transmission medium are provided by the same hybrid medium that enables the propagation of both electrical signals and optical signals.

[0043] In some embodiments, the optical circuit 500 includes one or more components of an interferometer to perform LCI using light generated from an optical source. In some embodiments, when performing LCI, the optical circuit 500 is capable of analyzing the data of the interferometer. The data analysis of the interferometer can be associated with understanding the change in the polarization state of the light reflected or scattered by the tissue, which can enable the evaluation of the change in birefringence of the tissue. In some embodiments, the optical transmission medium used to guide light to and from the distal section 201 may not affect the state and degree of polarization of the light (e.g., single-mode optical fiber). In other embodiments, for such an LCI circuit, the optical transmission medium can affect polarization in a certain and reversible manner. In a further embodiment of the optical circuit 500, the optical analysis of the light reflected or scattered back by the tissue can include methods associated with tissue spectroscopy. By tissue spectroscopy, the optical transmission medium used to guide light to and from the distal section 201 can enable multiple modes of light (e.g., multimode optical fiber, etc.). In a further embodiment of the optical circuit 500, both single-mode fibers and multimode fibers are one or more optical Can be used to determine different paths to and from the distal section 201 from the source, and both the LCI method and the spectroscopic method are used by the system to better control the ablation procedure.

[0044] Various embodiments of the present application include medical devices such as catheter 100 for optical interrogation of sample 510 (e.g., at the ablation tissue site). In some embodiments, the LCI system can be implemented by optical circuit 500, which may be referred to herein as the LCI system. Optical circuit 500 can include a delay unit 512, and the delay unit 512 can include various optical modulation elements. These modulation elements perform phase and / or frequency modulation to cancel unwanted optical effects in the light and to 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.

[0045] The optical circuit further includes a splitting element 504, a sample arm 506, a reference arm 508, and a detector 514. In the illustrated embodiment, the delay unit 512 is positioned within the reference arm 508. However, it should be noted that the delay unit 5 12 could instead be positioned within the sample arm 506. It should be understood that alternatively, various elements of the delay unit 512 may be present in both the sample arm 506 and the reference arm 508. For example, an element of the delay unit 512 that introduces a variable delay to light may be positioned within the sample arm 506, while an element that modulates different polarization modes of light may be positioned within the reference arm 508. In another example, an element of the delay unit 512 that modulates different polarization modes of light may be positioned within the sample arm 506, while an element that introduces a variable delay to light may be positioned within the reference arm 508. In one example, the sample arm 506 and the reference arm 508 are optical waveguides (such as patterned waveguides or optical fibers, etc.). In certain embodiments, all components of the LCI system are integrated on 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 implementation forms such as, for example, an optical fiber system, a free space optical system, a photonic crystal system, etc. can be similarly considered. It may be present in both the sample arm 506 and the reference arm 508. For example, an element of the delay unit 512 that introduces a variable delay to light may be positioned within the sample arm 506, while on the other hand, an element that modulates different polarization modes of light may be positioned within the reference arm 508. In another example, an element that modulates different polarization modes of light in the delay unit 512 may be positioned within the sample arm 506 while, on the other hand, an element that introduces a variable delay to light may be positioned within the reference arm 508 In one example, the sample arm 506 and the reference arm 508 are optical waveguides (such as, for example, patterned waveguides or optical fibers). In certain embodiments, all components of the LCI system are integrated on a planar lightwave circuit (P LC). In another embodiment, at least the components within the delay unit 512 are integrated on the same substrate of the PLC. For example, other implementation forms such as an optical fiber system, a free space optical system, a photonic crystal system, etc. can also be considered. 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, splitters, micro - mechanical elements, etc. along the path of the sample arm 506 or the reference arm 508.

[0046] 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, splitters, micro - mechanical elements, etc. along the path of the sample arm 506 or the reference arm 508. 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, splitters, micro - mechanical elements, etc. along the path of the sample arm 506 or the reference arm 508.

[0047] The splitting element 504 is used to direct the light received from the optical source 502 towards both the sampling arm 506 and the reference arm 508. The splitting element 304 can be, for example, a bi - directional coupler, an optical splitter, a coupler with an adjustable splitting ratio, an optical switch, or any other modulating optical device that can convert a single light beam into two or more light beams. In some embodiments, the splitting element 504 splits the light into one or more reference arms and a plurality of sample arms, and the light / radiation from the plurality of sample arms can optically interrogate the sample at different locations or in different directions in the distal section 201. In some embodiments, the first splitter element directs the light into the reference arm 508 and the sample arm 506, and the second splitter element can further split the sample arm 506 into a plurality of beams. Any combination of one or more splitting elements 504 in different parts of the radiation / light path can be used to generate a plurality of beams for reference and to interrogate the sample as required by the optical analysis procedure. The light traveling through the sample arm 506 ultimately impinges on the sample 510. The sample 510 can be any suitable sample to be imaged (e.g., a fabric, etc.). The light is scattered from various depths within the sample 510. The splitting element 504 can be, for example, a bi - directional coupler, an optical splitter, a coupler with an adjustable splitting ratio, an optical switch, or any other modulating optical device that can convert a single light beam into two or more light beams. In some embodiments, the splitting element 504 splits the light into one or more reference arms and a plurality of sample arms, and the light / radiation from the plurality of sample arms can optically interrogate the sample at different locations or in different directions in the distal section 201. In some embodiments, the first splitter element directs the light into the reference arm 508 and the sample arm 506, and the second splitter element can further split the sample arm 506 into a plurality of beams. Any combination of one or more splitting elements 504 in different parts of the radiation / light path can be used to generate a plurality of beams for reference and to interrogate the sample as required by the optical analysis procedure. The light traveling through the sample arm 506 ultimately impinges on the sample 510. The sample 510 can be any suitable sample to be imaged (e.g., a fabric, etc.). The light is scattered from various depths within the sample 510. In some embodiments, the first splitter element directs the light into the reference arm 508 and the sample arm 506, and the second splitter element can further split the sample arm 506 into a plurality of beams. Any combination of one or more splitting elements 504 in different parts of the radiation / light path can be used to generate a plurality of beams for reference and to interrogate the sample as required by the optical analysis procedure. The light traveling through the sample arm 506 ultimately impinges on the sample 510. The sample 510 can be any suitable sample to be imaged (e.g., a fabric, etc.). The light is scattered from various depths within the sample 510. It is understood that any combination of one or more splitting elements 504 in different parts of the radiation / light path can be used to generate a plurality of beams for reference and to interrogate the sample as required by the optical analysis procedure.

[0048] The light traveling through the sample arm 506 ultimately impinges on the sample 510. The sample 510 can be any suitable sample to be imaged (e.g., a fabric, etc.). The light is scattered from various depths within the sample 510. ​and reflected back, and the scattered / reflected radiation returns into the sample arm 506 and is collected. In another embodiment, the scattered / reflected radiation is returned into and collected in a different waveguide than the transmission waveguide. The scan depth can be selected via the delay imposed on the light in the delay unit 512.

[0049] The light in the sample arm 506 and the reference arm 508 is recombined again before being received at the detector 514. In the illustrated embodiment, the light is recombined by the splitting element 504. In another embodiment, the light is recombined at an optical coupling element different from the splitting element 504. The detector 514 can include any number of photodiodes, charge-coupled devices, and / or CMOS structures and is capable of converting the received light into an electrical signal. The electrical signal contains depth-resolved optical data associated with the sample 510 and can be received by a processing module. The processing module has an interface, and the interface converts such an electrical signal into digital data, and the digital data can then be processed and analyzed by a standard processing unit (e.g., a computer, a data processor, a reprogrammable hardware, an ASIC, or any other type of digital data processing circuit or system, etc.).

[0050] As used herein, the term "depth-resolved" means that one or more portions of the data associated with a particular depth of the imaged sample can be identified. ​​​​​​​​​​​​​Define the tag. The LCI system, according to an embodiment, is illustrated as an interferometer design similar to a Michelson interferometer. However, other interferometer designs, including Mach-Zehnder interferometer designs or Mireau interferometer designs, are equally possible.

[0051] Exemplary embodiments of external elements of the system As shown in FIG. 1, some elements of the system can be external to the catheter 100 and can be connected directly or indirectly to the catheter 100. Such elements can be included within multiple enclosures or a single enclosure. In the configuration shown in FIG. 1, the console 101, the user interface 104, and the ablation energy source 102 are housed within separate enclosures. 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 can also be encapsulated within the console 101. Elements of the user interface 104 can be enclosed within the console 101, and other elements can be enclosed within the display module. In some embodiments, the external elements of the system also include a processing module, which can be encapsulated in combination with any of the other external elements (e.g., within the console 101). The processing module can include some of the elements of the optical circuit 500 or can simply receive signals from the optical circuit 500. The processing module also includes additional circuitry and an optical detector 5 The signal generated at 14 can be measured and used for further processing. In some embodiments, the method may generate data that can be processed and analyzed. , 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 are configured to provide a user interface. The user interface 104 may be connected directly or indirectly to the user interface 104. 04 transmits audio, visual, and / or tactile data to the user and generates ablation energy. Characterization of the sample 510 before, during, and / or after the drug is delivered and inform the user of the ablation system status and treatment variables. The data provided by the user interface 104 may be used by a clinician to This can be used to make better-informed decisions about ablation treatments. It is possible.

[0052] Exemplary embodiments of determining tissue birefringence 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, and brain tissue). This birefringence is due to the The key to the success of this study is the organization and geometry of the proteins and structures. The geometry and / or organization and alignment of cells within the tissue may be used to determine the structure and geometry of the tissue. This is an important determinant of birefringence. The optical birefringence changes in tissues when they pass from the denatured state to the denatured state. This is because the geometric shape of the substance itself and their arrangement in the matrix change. Collagen, elastin, and fibrin are extracellular matrix proteins, which, when denatured, can affect the birefringence properties of tissues. The reason is that light reflected or scattered from such extracellular matrices can have different polarization states (e.g., polarization and phase delay) compared to the optical signals received when these proteins are in their normal state. Furthermore, other proteins in the cell membrane and the intracellular cytoskeleton when denatured, or when the geometry of the cell membrane or cytoskeleton changes, can cause changes in the polarization state of light and affect the anisotropy of tissues. Collagen, elastin, and fibrin are extracellular matrix proteins, which, when denatured, can affect the birefringence properties of tissues. The reason is that light reflected or scattered from such extracellular matrices can have different polarization states (e.g., polarization and phase delay) compared to the optical signals received when these proteins are in their normal state. Furthermore, other proteins in the cell membrane and the intracellular cytoskeleton when denatured, or when the geometry of the cell membrane or cytoskeleton changes, can cause changes in the polarization state of light and affect the anisotropy of tissues. Furthermore, other proteins in the cell membrane and the intracellular cytoskeleton when denatured, or when the geometry of the cell membrane or cytoskeleton changes, can cause changes in the polarization state of light and affect the anisotropy of tissues. Furthermore, other proteins in the cell membrane and the intracellular cytoskeleton when denatured, or when the geometry of the cell membrane or cytoskeleton changes, can cause changes in the polarization state of light and affect the anisotropy of tissues. Furthermore, other proteins in the cell membrane and the intracellular cytoskeleton when denatured, or when the geometry of the cell membrane or cytoskeleton changes, can cause changes in the polarization state of light and affect the anisotropy of tissues. Furthermore, other proteins in the cell membrane and the intracellular cytoskeleton when denatured, or when the geometry of the cell membrane or cytoskeleton changes, can cause changes in the polarization state of light and affect the anisotropy of tissues.

[0053] Exemplary embodiments of determining RF ablation and tissue birefringence By using an RF catheter or other medical delivery device, RF energy can be delivered into the tissue and cause heating. After the tissue reaches approximately 50°C, permanent thermal lesions may occur through necrosis. Protein denaturation may occur at approximately 70°C. Therefore, a catheter system as described herein uses polarization-sensitive LCI to interrogate the optical state of the ablated sample and, when the tissue reaches 70°C in a depth-resolved manner, analyzes the reflected and scattered light signals, as well as their polarization state and phase delay, along with additional information on the time-of-flight, frequency, and amplitude of the light signal, enabling real-time direct visualization. In additional embodiments, extrapolation, statistical fitting, interpolation By using an RF catheter or other medical delivery device, RF energy can be delivered into the tissue and cause heating. After the tissue reaches approximately 50°C, permanent thermal lesions may occur through necrosis. Protein denaturation may occur at approximately 70°C. Therefore, a catheter system as described herein uses polarization-sensitive LCI to interrogate the optical state of the ablated sample and, when the tissue reaches 70°C in a depth-resolved manner, analyzes the reflected and scattered light signals, as well as their polarization state and phase delay, along with additional information on the time-of-flight, frequency, and amplitude of the light signal, enabling real-time direct visualization. Therefore, a catheter system as described herein uses polarization-sensitive LCI to interrogate the optical state of the ablated sample and, when the tissue reaches 70°C in a depth-resolved manner, analyzes the reflected and scattered light signals, as well as their polarization state and phase delay, along with additional information on the time-of-flight, frequency, and amplitude of the light signal, enabling real-time direct visualization. Therefore, a catheter system as described herein uses polarization-sensitive LCI to interrogate the optical state of the ablated sample and, when the tissue reaches 70°C in a depth-resolved manner, analyzes the reflected and scattered light signals, as well as their polarization state and phase delay, along with additional information on the time-of-flight, frequency, and amplitude of the light signal, enabling real-time direct visualization. Therefore, a catheter system as described herein uses polarization-sensitive LCI to interrogate the optical state of the ablated sample and, when the tissue reaches 70°C in a depth-resolved manner, analyzes the reflected and scattered light signals, as well as their polarization state and phase delay, along with additional information on the time-of-flight, frequency, and amplitude of the light signal, enabling real-time direct visualization. Therefore, a catheter system as described herein uses polarization-sensitive LCI to interrogate the optical state of the ablated sample and, when the tissue reaches 70°C in a depth-resolved manner, analyzes the reflected and scattered light signals, as well as their polarization state and phase delay, along with additional information on the time-of-flight, frequency, and amplitude of the light signal, enabling real-time direct visualization. In additional embodiments, extrapolation, statistical fitting, interpolation 、 or a predictive algorithm using artificial intelligence (e.g., machine learning) is applied to the lesion library and can better predict the geometric shape of the permanently ablated lesion (e.g., the width, length and / or depth) of the lesion. In some embodiments the algorithm can take into account the geometric shape of the lesion directly visualized to reach 70° C. and calculate the geometric shape of the tissue sample that has reached 50° C. The geometric shape of the lesion that has reached 50° C. determines the area of the permanently ablated tissue that will not have cardiac rhythm electrical conductivity. Determining and visualizing such geometric shapes allows the clinician to evaluate whether the lesion has completely penetrated the tissue wall or reached the desired structure at the ablation site and whether there are gaps in the ablation line. In some configurations of optically guided ablation systems, the penetration depth of light (which can be used for direct visualization) and the extrapolation of the lesion size at 50° C. may not be sufficient to determine complete penetration into the tissue wall. In such a case, when the ablation time for that particular lesion needs to exceed the time it takes to reach a change in birefringence at the maximum depth of light penetration used for direct optical evaluation in the tissue

[0054] a mathematical algorithm can be used to predict the lesion size. Experiments using the systems described herein show that the ratio of the total ablation time to the time to denaturation and the extrapolation of the lesion size at 50° C. may not be sufficient to determine complete penetration into the tissue wall. In such a case, when the ablation time for that particular lesion needs to exceed the time it takes to reach a change in birefringence at the maximum depth of light penetration used for direct optical evaluation in the tissue a mathematical algorithm can be used to predict the lesion size. Experiments using the systems described herein show that the ratio of the total ablation time to the time to denaturation for the light penetration used for direct optical evaluation in the tissue to reach a change in birefringence at the maximum depth of light penetration a mathematical algorithm can be used to predict the lesion size. Experiments using the systems described herein show that the ratio of the total ablation time to the time to denaturation for the light penetration used for direct optical evaluation in the tissue to reach a change in birefringence at the maximum depth of light penetration for the light penetration used for direct optical evaluation in the tissue to reach a change in birefringence at the maximum depth of light penetration Insertion, extrapolation, regression, least squares, ANOVA, MANOVA, etc.) or artificial intelligence algorithms When used in a lesion size, it has been shown to be a major predictor. In some embodiments, the time to denaturation can be defined as the time required to reach denaturation at 70 °C at a known depth. In some embodiments, the known depth used can be the maximum depth for a resolvable optical signal to be analyzed with respect to changes in polarization depth, which can be approximately 1.5 mm with respect to infrared / near-infrared. Thus, the processing unit of an optically guided ablation system is used in combination with such algorithms to predict in real time the lesion depth beyond the depth for direct visualization and transmit such information to the clinician through the user interface 104.

[0055] Exemplary embodiments of methods for determining PFA and tissue birefringence Pulse field ablation (PFA) uses electromagnetic pulses to create lesions in tissue during the ablation process. Generally, PFA pulses are applied across two electrodes at a time, and the two electrodes are placed relatively closely spaced over the segment of tissue where the lesion is desired. A series of high- voltage pulses (either monophasic or biphasic) are imposed across the electrodes, exposing the tissue therebetween to a high-intensity electric field for a short period of time. In some embodiments, the series of pulses can be referred to herein as a pulse train. In some embodiments, the energy density, intensity, and overall If the intensity is sufficient to cause cell / tissue necrosis through thermal damage, PFA clinical applications and protocols for may be directed at generating non-thermal lesions through cell apoptosis or other types of non-nec rotic delayed cell death. It is possible.

[0056] During the clinical protocol for PFA, pulses of known frequency, amplitude, and duration are applied between two or more electrodes (e.g., in contact with or very close to the tissue) at the ablation site, causing pores to open in the cell membranes of the cells within the targeted tissue segment. The opening of such pores causes cell swelling, and if such swelling is sufficient, apoptosis (or other delayed cell death) mechanisms are activated within the cells, leading to subsequent cell death. Thus, polarization-sensitive LCI methods directed at determining changes in tissue birefringence due to protein denaturation at 70 °C may not be sufficient when using PFA. This is because that temperature may not be reached in the tissue, or only the minimum surface area of the tissue in direct contact with the electrodes may be subject to denaturation and necrosis. In some embodiments, all or most of the interrogated tissue sample may be subject to delayed cell death by non-thermal damage. . Therefore, the polarization-sensitive LCI method directed at determining changes in tissue birefringence due to protein denaturation at 70 °C may not be sufficient when using PFA. This is because that temperature may not be reached in the tissue, or only the minimum surface area of the tissue in direct contact with the electrodes may be subject to denaturation and necrosis. This is because that temperature may not be reached in the tissue, or only the minimum surface area of the tissue in direct contact with the electrodes may be subject to denaturation and necrosis. This is because that temperature may not be reached in the tissue, or only the minimum surface area of the tissue in direct contact with the electrodes may be subject to denaturation and necrosis. In some embodiments, all or most of the interrogated tissue sample may be subject to delayed cell death by non-thermal damage.

[0057] Experiments using the polarization-sensitive LCI ablation system described herein have shown that they are sensitive to changes in tissue birefringence associated with the application of PFA energy trains in the absence of thermal damage. FIG. 6 shows, according to an embodiment of the present disclosure, the ab lation... For non-rated samples and samples after PFA ablation, myocardial Diagrams of exemplary experimental histological images of tissue 600 are illustrated. For example, FIG. 6 shows histological results comparing non-ablated tissue with PFA-ablated tissue (which showed changes in birefringence in the polarized susceptibility LCI system). After the PFA ablation train was applied, the pulse caused disruptions in the cell membrane and cell membrane proteins, leading to cell swelling and subsequent apoptosis (delayed cell death) due to loss of tissue integrity and structure, as shown in FIG. 6.

[0058] The myocardial tissue sample 600 shows two adjacent areas with two very different structures. The non-ablated area 601 shows an organized, densely packed cell structure supported by the cell membrane, intracellular cytoskeleton, and extracellular matrix. The sample of PFA-ablated tissue 602 shows a completely disrupted cell membrane and intracellular cytoskeleton, a cell nucleus 604 outside such a membrane, and an enlarged gap 603 in the cell structure and extracellular matrix.

[0059] Proteins and structures responsible for maintaining and organizing in the cell structure, and thus for the anisotropy (e.g., birefringence) of the tissue, include the extracellular matrix (e.g., collagen, elastin), the cytoskeleton / cilia or flagella (e.g., tubulin, actin, or lamin), and cell membrane proteins (e.g., intrinsic / membrane-spanning proteins). In some embodiments, the PFA ablated tissue sample 602 showed a change in birefringence in the LCI system after ablation. For different PFA ablation lesions during the experiment, the change in birefringence was observed within seconds (e.g., less than 30 seconds) or within minutes (e.g., up to 40 minutes) after delivery of the PFA energy (e.g., pulse train) to the tissue. The time for detection of the change in birefringence depends on the intensity (e.g., amplitude of the pulse), type (monophasic, biphasic), frequency (e.g., frequency of the pulse), and duration of the pulse train (e.g., total time for all pulses to be delivered to the tissue). For different PFA ablation lesions during the experiment, the change in birefringence was observed within seconds (e.g., less than 30 seconds) or within minutes (e.g., up to 40 minutes) after delivery of the PFA energy (e.g., pulse train) to the tissue. For different PFA ablation lesions during the experiment, the change in birefringence was observed within seconds (e.g., less than 30 seconds) or within minutes (e.g., up to 40 minutes) after delivery of the PFA energy (e.g., pulse train) to the tissue. For different PFA ablation lesions during the experiment, the change in birefringence was observed within seconds (e.g., less than 30 seconds) or within minutes (e.g., up to 40 minutes) after delivery of the PFA energy (e.g., pulse train) to the tissue. For different PFA ablation lesions during the experiment, the change in birefringence was observed within seconds (e.g., less than 30 seconds) or within minutes (e.g., up to 40 minutes) after delivery of the PFA energy (e.g., pulse train) to the tissue. For different PFA ablation lesions during the experiment, the change in birefringence was observed within seconds (e.g., less than 30 seconds) or within minutes (e.g., up to 40 minutes) after delivery of the PFA energy (e.g., pulse train) to the tissue. For different PFA ablation lesions during the experiment, the change in birefringence was observed within seconds (e.g., less than 30 seconds) or within minutes (e.g., up to 40 minutes) after delivery of the PFA energy (e.g., pulse train) to the tissue. For different PFA ablation lesions during the experiment, the change in birefringence was observed within seconds (e.g., less than 30 seconds) or within minutes (e.g., up to 40 minutes) after delivery of the PFA energy (e.g., pulse train) to the tissue.

[0060] In some embodiments, the delayed change in birefringence may be a delayed apoptosis / delayed cell death / remodeling response rather than an immediate necrosis mechanism. The delayed change in birefringence may be associated with a delayed change (reduction) in the anisotropy of the tissue structure. As seen in the histology of the PFA ablated tissue 602, structural integrity as well as geometric and tissue changes are seen at the tissue and cellular levels. The organization in the non-ablated sample 601 of cell structures with organized microtubules determines the anisotropy of the tissue, which is lost after PFA ablation (as shown in sample 602) due to subsequent cell death resulting from apoptosis and cell swelling. Thus, the loss of anisotropy of the tissue after PFA ablation, and subsequent cytoskeletal failure, protein denaturation, or fragmentation leads to a loss of birefringence, which results in changes in polarization and phase delay by the LCI optically guided ablation system. In some embodiments, the delayed change in birefringence may be a delayed apoptosis / delayed cell death / remodeling response rather than an immediate necrosis mechanism. In some embodiments, the delayed change in birefringence may be a delayed apoptosis / delayed cell death / remodeling response rather than an immediate necrosis mechanism. In some embodiments, the delayed change in birefringence may be a delayed apoptosis / delayed cell death / remodeling response rather than an immediate necrosis mechanism. In some embodiments, the delayed change in birefringence may be a delayed apoptosis / delayed cell death / remodeling response rather than an immediate necrosis mechanism. In some embodiments, the delayed change in birefringence may be a delayed apoptosis / delayed cell death / remodeling response rather than an immediate necrosis mechanism. In some embodiments, the delayed change in birefringence may be a delayed apoptosis / delayed cell death / remodeling response rather than an immediate necrosis mechanism. In some embodiments, the delayed change in birefringence may be a delayed apoptosis / delayed cell death / remodeling response rather than an immediate necrosis mechanism. In some embodiments, the delayed change in birefringence may be a delayed apoptosis / delayed cell death / remodeling response rather than an immediate necrosis mechanism. In some embodiments, the delayed change in birefringence may be a delayed apoptosis / delayed cell death / remodeling response rather than an immediate necrosis mechanism. In some embodiments, the delayed change in birefringence may be a delayed apoptosis / delayed cell death / remodeling response rather than an immediate necrosis mechanism. Thus, it may be detectable. The apoptosis process from cellular swelling affects directly the intracellular cytoskeleton, its structural proteins, such as tubulin (the protein component of microtubules), actin (the component of microfilaments), and lamin (the component of intermediate filaments), etc., and may directly affect the connection to the extracellular matrix. Such disruption of the connection between the cytoskeleton and the extracellular matrix may lead to the overall loss of the structure and organization of tissue segments. Therefore, loss of cytoskeletal integrity may be a major factor leading to the loss of anisotropy and birefringence in the tissue that can be detected by the LCI methodology described herein.

[0061] Exemplary embodiments of optically guided PFA procedures for cardiac ablation In some embodiments, for use of an optically guided PFA system for cardiac ablation, the catheter 100 is introduced into the human vasculature, either directly or through an access sheath. The distal section 201 of the catheter is moved to the ablation site using a guide wire, an access sheath, a steerable sheath, or deflection of the catheter 100 itself. At the ablation site (e.g., atria, ventricles, arteries, veins, etc.), at least one or a plurality of electrodes 213 on the surface of the catheter distal section 201 are placed in direct contact with the tissue at the ablation site. Using light or other forms of radiation emitted by an optical source, which passes at least partially through a PM optical transmission medium to the distal section of the catheter 100, travel to 201, and between the distal section 201 and the tissue ablation site , contact or contact stability can be established. After contact or contact stability is established, PF A pulse train can be transmitted to the tissue, where the characteristics of the pulse train (e.g., frequency, amplitude, strength , or duration) are determined by the clinical user. During and / or after delivery of the ablation pulse train, changes in the birefringence of the interrogated tissue can be monitored through evaluation of changes in the polarization state and phase delay of the reflected / scattered optical signal sent into the tissue through the catheter 100. If no change or reduction in birefringence is detected within a predetermined time frame (e.g., from 1 second to 1 hour, etc.), the clinician may be able to re-ablate the tissue using a pulse train with the same or different characteristics.

[0062] In some embodiments, mathematical, statistical, or artificial intelligence prediction algorithms or equations (which use a measure of the time to loss of birefringence, or the change / difference in the amount of birefringence in the ablated tissue) can be used to predict whether the PFA lesion is permanent, and thus can be associated with the probability of recurrence of atrial fibrillation. Such an algorithm can be used by the clinician to determine the necessity of re-ablation of the tissue at the selected ablation site. In some embodiments, such prediction algorithms can be directly programmed into the ablation system, the results can be communicated to the clinician through the user interface 104, or such algorithms or equations can be provided to the clinician for their offline use. ​

[0063] In other embodiments of the ablation procedure, prior to establishing tissue contact at the ablation site, the distal section 201 of the catheter 100 undergoes a geometric change to generate 2D and 3D structures equal to those shown in FIGS. 4A-4D, among others, to provide better contact or to adapt the catheter to the local anatomical structure. to generate 2D and 3D structures equal to those shown in FIGS. 4A-4D, among others, to provide better contact or to adapt the catheter to the local anatomical structure. to generate 2D and 3D structures equal to those shown in FIGS. 4A-4D, among others, to provide better contact or to adapt the catheter to the local anatomical structure. to generate 2D and 3D structures equal to those shown in FIGS. 4A-4D, among others, to provide better contact or to adapt the catheter to the local anatomical structure. to generate 2D and 3D structures equal to those shown in FIGS. 4A-4D, among others, to provide better contact or to adapt the catheter to the local anatomical structure.

[0064] In some embodiments of the optically guided ablation procedure using PFA, the catheter can be held in place for a predetermined amount of 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 within the body. After a predetermined amount of time, the catheter 100 is moved back to the first ablation site to monitor whether the PFA pulse generated a change in the 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 during a later re-intervention and moved back to the first ablation site to monitor whether the tissue exhibited a change in birefringence due to the initial PFA pulse train. In some embodiments of the optically guided ablation procedure using PFA, the catheter can be held in place for a predetermined amount of 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 within the body. After a predetermined amount of time, the catheter 100 is moved back to the first ablation site to monitor whether the PFA pulse generated a change in the 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 during a later re-intervention and moved back to the first ablation site to monitor whether the tissue exhibited a change in birefringence due to the initial PFA pulse train. In some embodiments of the optically guided ablation procedure using PFA, the catheter can be held in place for a predetermined amount of 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 within the body. After a predetermined amount of time, the catheter 100 is moved back to the first ablation site to monitor whether the PFA pulse generated a change in the 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 during a later re-intervention and moved back to the first ablation site to monitor whether the tissue exhibited a change in birefringence due to the initial PFA pulse train. In some embodiments of the optically guided ablation procedure using PFA, the catheter can be held in place for a predetermined amount of 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 within the body. After a predetermined amount of time, the catheter 100 is moved back to the first ablation site to monitor whether the PFA pulse generated a change in the 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 during a later re-intervention and moved back to the first ablation site to monitor whether the tissue exhibited a change in birefringence due to the initial PFA pulse train. In some embodiments of the optically guided ablation procedure using PFA, the catheter can be held in place for a predetermined amount of 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 within the body. After a predetermined amount of time, the catheter 100 is moved back to the first ablation site to monitor whether the PFA pulse generated a change in the 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 during a later re-intervention and moved back to the first ablation site to monitor whether the tissue exhibited a change in birefringence due to the initial PFA pulse train. In some embodiments of the optically guided ablation procedure using PFA, the catheter can be held in place for a predetermined amount of 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 within the body. After a predetermined amount of time, the catheter 100 is moved back to the first ablation site to monitor whether the PFA pulse generated a change in the 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 during a later re-intervention and moved back to the first ablation site to monitor whether the tissue exhibited a change in birefringence due to the initial PFA pulse train. In some embodiments of the optically guided ablation procedure using PFA, the catheter can be held in place for a predetermined amount of 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 within the body. After a predetermined amount of time, the catheter 100 is moved back to the first ablation site to monitor whether the PFA pulse generated a change in the 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 during a later re-intervention and moved back to the first ablation site to monitor whether the tissue exhibited a change in birefringence due to the initial PFA pulse train. In some embodiments of the optically guided ablation procedure using PFA, the catheter can be held in place for a predetermined amount of 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 within the body. After a predetermined amount of time, the catheter 100 is moved back to the first ablation site to monitor whether the PFA pulse generated a change in the 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 during a later re-intervention and moved back to the first ablation site to monitor whether the tissue exhibited a change in birefringence due to the initial PFA pulse train. In some embodiments of the optically guided ablation procedure using PFA, the catheter can be held in place for a predetermined amount of 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 within the body. After a predetermined amount of time, the catheter 100 is moved back to the first ablation site to monitor whether the PFA pulse generated a change in the 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 during a later re-intervention and moved back to the first ablation site to monitor whether the tissue exhibited a change in birefringence due to the initial PFA pulse train. In some embodiments of the optically guided ablation procedure using PFA, the catheter can be held in place for a predetermined amount of 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 within the body. After a predetermined amount of time, the catheter 100 is moved back to the first ablation site to monitor whether the PFA pulse generated a change in the 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 during a later re-intervention and moved back to the first ablation site to monitor whether the tissue exhibited a change in birefringence due to the initial PFA pulse train.

[0065] Exemplary embodiments of the optically guided renal denervation procedure In some embodiments regarding the use of an optically guided ablation system for renal denervation, the catheter 100 is inserted directly or through an access sheath In some embodiments regarding the use of an optically guided ablation system for renal denervation, the catheter 100 is inserted directly or through an access sheath and introduced into the human vascular system. The distal section 201 of the catheter uses a guide wire - an access sheath, a steerable sheath, or the deflection of the catheter 100 itself to be moved to the ablation site (e.g., the renal artery). At the ablation site (e.g., the renal artery), at least one or a plurality of electrodes 213 on the surface of the distal section 201 of the catheter are placed in direct contact with the tissue at the ablation site . Using light or other forms of radiation emitted by an optical source ( which travels through at least a partially PM optical transmission medium to the distal section 201 of the catheter 100), contact or contact stability can be established between the distal section 201 and the tissue ablation site . After contact or contact stability is established, RF energy can be transmitted to the tissue, where the characteristics of the RF energy (e.g., power, duration, etc.) are determined by the clinical user . During the delivery of the ablation RF energy, changes in the birefringence of the interrogated tissue can be monitored through the evaluation of changes in the polarization state and phase delay of the reflected / scattered optical signals sent into the tissue through the catheter 100 . The RF energy can be applied until the tissue is ablated to the desired depth as predicted by an algorithm or equation in the system (which uses, as predictors, the time to denaturation or the ratio between the total ablation time and the time to denaturation) . In some embodiments, the catheter can be moved as needed to complete ablation through the entire circumference of the renal artery .

[0066] ​​​​​​​In some embodiments of an optically guided ablation method for renal denervation the user moves a catheter to the ablation site and uses an optical signal to re-interrogate the tissue and determine the loss of birefringence through the surrounding tissue to ensure that there are no gaps which is possible.

[0067] In other embodiments of the ablation procedure for renal denervation, prior to establishing tissue contact at the ablation site, the distal section 201 of the catheter 100 undergoes geometric changes and generates 2D and 3D structures equal to, but not limited to, those shown in FIGS. 4A - 4D to provide better contact or to adapt the catheter to the local anatomical structure which is possible.

[0068] In some embodiments of the renal denervation procedure described above, prior to delivery of ablation energy, radiation / light that travels at least in part through a multimode optical transmission medium (multimode fiber or waveguide) can be used and the light is processed and analyzed using optical spectroscopy methods to determine the depth at which the renal nerves are positioned relative to the renal artery wall. In some embodiments, the system includes both an independent single mode optical path and a multimode optical path and it is possible to use both LCI and spectroscopy in the same ablation catheter system. In some embodiments, ultrasonic technology can also be added to the LCI catheter. In such exemplary ultrasonic technology catheters, ultrasonic signals can be used to determine the depth of the renal nerves prior to ablation which is possible.

[0069] Exemplary embodiments of optically guided ablation for the treatment of epilepsy In some embodiments, with respect to the use of an optically guided ablation system for the treatment of epilepsy, a catheter 100 is introduced into the human vasculature, either directly or through an access sheath The distal section 201 of the catheter is moved to the ablation site using a guidewire, an access sheath, a steerable sheath, or deflection of the catheter 100 itself At the ablation site (e.g., discrete epileptic foci), at least one or a plurality of electrodes 213 on the surface of the distal section 201 of the catheter are placed in direct contact with the tissue at the ablation site Using light or other forms of radiation emitted by an optical source (which travels at least in part through a PM optical transmission medium to the distal section 201 of the catheter 100), contact or contact stability can be established between the distal section 201 and the tissue ablation site After contact or contact stability is established, RF energy can be transmitted to the tissue, where the characteristics of the RF energy (e.g., power, duration, etc.) are determined by the clinical user During the delivery of the ablation RF energy, changes in the birefringence of the interrogated tissue can be monitored through an assessment of changes in the polarization state and phase delay of the reflected / scattered optical signal sent into the tissue through the catheter 100 The RF energy is predicted by an algorithm or equation in the system (which uses, as predictors, time to denaturation, or total (using the ratio between the ablation time and the time to modification), the tissue can be applied until ablated to the desired depth until it is ablated to the desired depth. In some embodiments, the catheter can be moved to other seizure foci as desired and the ablation step can be repeated.

[0070] FIG. 7 illustrates an exemplary method for the clinical use of an optically guided pulsed field ablation (PFA) system according to an embodiment of the present disclosure. In some embodiments, the method can include inserting a catheter into a patient's body, navigating to a tissue ablation site, and establishing contact with the tissue ablation site using an optical signal transmitted through the catheter. The method can further include sending a PFA electromagnetic pulse train through the catheter to the tissue and monitoring for changes in the tissue with respect to changes in polarization and / or phase delay of the optical signal using an LCI optical system.

[0071] Exemplary embodiments of a pulsed field ablation catheter with integrated optics As described herein, a catheter device can be configured to deliver pulsed field ablation (PFA). Certain applications include PFA delivered to the left atrium of the heart in a non-invasive procedure to treat atrial fibrillation.

[0072] Generally, PFA pulses are applied across two electrodes at a time, and the two electrodes are the diseased ​​​​​​​​​​​It is placed relatively closely spaced above the segment of the tissue where a change is desired. One series of high voltage pulses (either monophasic or biphasic) is applied across the electrodes, exposing the tissue between them to a high-intensity electric field for a short period of time. The pulse train can be on the order of 500 - 1500 Vpp (voltage peak-to-peak), and can be centered at zero volts (biphasic), or single-ended from zero to peak voltage. In some cases, the pulses can be rectangular or sinusoidal, and each pulse typically has a duration of 10 - 100 microseconds, and 10 to 25 pulses are applied at intervals between 0.5 seconds and 2 seconds. The electric field (and thus the resulting lesion in the tissue) can extend from one electrode to the other. The lowest current density in the lesion zone is 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 within it, which ultimately causes delayed cell death. Depending on the location of the cells within the field, that delayed cell death can be processed through apoptosis, pyroptosis, and necrosis, etc. When correctly delivered, PFA has been shown to effectively ablate the tissue at the selected location, create a permanent lesion that prevents false electrical signals from propagating further into the heart across the atrial wall, and prevent further unwanted fibrillation. However, if the PFA pulses are not optimally delivered, the lesion may be incomplete and false

[0073] electrical signals may still propagate further into the heart. This can prevent the generation of permanent lesions that would otherwise prevent further unwanted fibrillation. However, if the PFA pulses are not optimally delivered, the lesion may be incomplete and false ​The signal cannot be interrupted, which may result in remodeling, leading to the resumption of fine movements (for example, sometimes after several years of the procedure such a long time). Sub-optimal PFA delivery can result from a number of causes, which include improper positioning of the electrodes, insufficient electrode contact, contact movement during delivery, or an improper combination of pulse train parameters (e.g., voltage, current, pulse width, number of pulses, pulse duration, decay time, monophasic vs. biphasic modality, etc.). A defect in any of these parameters that leads to the resumption of fine movements days or years after the procedure may require a second procedure, exposing the patient to additional risks and generating additional costs.

[0074] Also, a medical catheter can include an optical system that uses optical coherence reflectometry (OCR) to sense parameters (e.g., among others, in contact with the endocardial wall, tissue viability, lesion formation, and lesion depth and width, etc.). The OCR method can include measuring reflection amplitude, birefringence, degree of polarization, etc. to determine contact quality, cell status, and lesion dimensions. Some devices incorporate micro-optics within the catheter for exploring the target tissue and an optical fiber cable that extends through the catheter and is proximally connected to an external console, which provides an optical source and receiver, switch, reference arm, control electronics, data processing, and display. However, current optical devices generally use radio frequency instead of PFA. Directed to a combined optical and electrical catheter using radiofrequency ablation (RFA) There is a need for reliable devices and methods that increase the probability of creating permanent lesions by PFA during a single minimally invasive surgical procedure.

[0075] Thus, there is an unmet need for reliable devices and methods that increase the probability of creating permanent lesions by PFA during a single minimally invasive surgical procedure. The means should enable the physician performing the procedure to evaluate in real time during the procedure, (i) the contact between the stimulating electrode and the target anatomical structure, and (ii) the effectiveness of the ablation (including lesion depth and area) after the stimulation is applied. If insufficient contact is detected, the physician should be able to reposition the catheter before applying energy to the catheter's electrodes. If insufficient lesion depth or width is detected, the physician should be able to apply additional PFA pulses to the area in question until a satisfactory lesion is observed. These evaluations will enable the physician to create and verify effective lesions without interruption during the surgery, thus reducing the risk of fibrillation recurrence and reducing the need to repeat the procedure. There is an unmet need for reliable devices and methods that increase the probability of creating permanent lesions by PFA during a single minimally invasive surgical procedure. The means should enable the physician performing the procedure to evaluate in real time during the procedure, (i) the contact between the stimulating electrode and the target anatomical structure, and (ii) the effectiveness of the ablation (including lesion depth and area) after the stimulation is applied. If insufficient contact is detected, the physician should be able to reposition the catheter before applying energy to the catheter's electrodes. If insufficient lesion depth or width is detected, the physician should be able to apply additional PFA pulses to the area in question until a satisfactory lesion is observed. These evaluations will enable the physician to create and verify effective lesions without interruption during the surgery, thus reducing the risk of fibrillation recurrence and reducing the need to repeat the procedure. There is an unmet need for reliable devices and methods that increase the probability of creating permanent lesions by PFA during a single minimally invasive surgical procedure. The means should enable the physician performing the procedure to evaluate in real time during the procedure, (i) the contact between the stimulating electrode and the target anatomical structure, and (ii) the effectiveness of the ablation (including lesion depth and area) after the stimulation is applied. If insufficient contact is detected, the physician should be able to reposition the catheter before applying energy to the catheter's electrodes. If insufficient lesion depth or width is detected, the physician should be able to apply additional PFA pulses to the area in question until a satisfactory lesion is observed. These evaluations will enable the physician to create and verify effective lesions without interruption during the surgery, thus reducing the risk of fibrillation recurrence and reducing the need to repeat the procedure. i) the contact between the stimulating electrode and the target anatomical structure, and (ii) the effectiveness of the ablation (including lesion depth and area) after the stimulation is applied should be possible. If insufficient contact is detected, the physician should be able to reposition the catheter before applying energy to the catheter's electrodes. If insufficient lesion depth or width is detected, the physician should be able to apply additional PFA pulses to the area in question until a satisfactory lesion is observed. These evaluations will enable the physician to create and verify effective lesions without interruption during the surgery, thus reducing the risk of fibrillation recurrence and reducing the need to repeat the procedure. If insufficient contact is detected, the physician should be able to reposition the catheter before applying energy to the catheter's electrodes. If insufficient lesion depth or width is detected, the physician should be able to apply additional PFA pulses to the area in question until a satisfactory lesion is observed. These evaluations will enable the physician to create and verify effective lesions without interruption during the surgery, thus reducing the risk of fibrillation recurrence and reducing the need to repeat the procedure. If insufficient contact is detected, the physician should be able to reposition the catheter before applying energy to the catheter's electrodes. If insufficient lesion depth or width is detected, the physician should be able to apply additional PFA pulses to the area in question until a satisfactory lesion is observed. These evaluations will enable the physician to create and verify effective lesions without interruption during the surgery, thus reducing the risk of fibrillation recurrence and reducing the need to repeat the procedure. If insufficient lesion depth or width is detected, the physician should be able to apply additional PFA pulses to the area in question until a satisfactory lesion is observed. These evaluations will enable the physician to create and verify effective lesions without interruption during the surgery, thus reducing the risk of fibrillation recurrence and reducing the need to repeat the procedure. These evaluations will enable the physician to create and verify effective lesions without interruption during the surgery, thus reducing the risk of fibrillation recurrence and reducing the need to repeat the procedure. These evaluations will enable the physician to create and verify effective lesions without interruption during the surgery, thus reducing the risk of fibrillation recurrence and reducing the need to repeat the procedure. These evaluations will enable the physician to create and verify effective lesions without interruption during the surgery, thus reducing the risk of fibrillation recurrence and reducing the need to repeat the procedure.

[0076] Generally, PFA pulses are applied across two electrodes, and the two electrodes are placed relatively closely spaced over the segment of the atrial wall where the lesion is desired. Generally, PFA pulses are applied across two electrodes, and the two electrodes are placed relatively closely spaced over the segment of the atrial wall where the lesion is desired. This is typically in the atrial wall area surrounding each of the four pulmonary vein ostia. A series of high voltage pulses (either monophasic or biphasic) are imposed across the electrodes, exposing the tissue between them to a high intensity electric field for a short period of time. In an exemplary embodiment, the pulse A series of high voltage pulses (either monophasic or biphasic) are imposed across the electrodes, exposing the tissue between them to a high intensity electric field for a short period of time. In an exemplary embodiment, the pulse The columns can be on the order of 500 to 1500 Vpp and can be centered about zero volts (biphasic), or can be single-ended from zero to peak voltage. The pulses can be rectangular, each pulse typically having a duration of 10 to 100 microseconds, and pulses between 10 and 25 being applied at intervals between 0.5 seconds and 2 seconds. The electric field (and thus the resulting lesion) will extend from one electrode to the other. The lowest current density in the lesion zone will be at the midpoint between the electrodes and will increase as either electrode is approached. The electric field is intended to cause irreversible electroporation of the cells therein, which ultimately causes apoptosis. To optically evaluate the lesion, at least one optical viewport can be placed at a precisely known point (either the midpoint or some other point) in the space between the electrodes. In practice, such placement is difficult due to the precision limitations of the location visualization system (e.g., x-ray fluoroscopy, ultrasound, RF-based, or other mapping / navigation systems). Depending on the particular optical measurement technique and electrical stimulation selected, there can be a time lag between the application of the voltage and the appearance of a detectable change in the ablated cells. This time lag can last in the range of 30 seconds to 30 minutes. When the electrical stimulation is applied, in order to observe the desired changes and to determine whether the ablation was successful or not

[0077]

[0078] To confirm ablation, it may be necessary to hold the device in the same location during the time lag. This may be necessary.

[0079] FIG. 8 illustrates an exemplary distal end of a PFA-OCR catheter having a circular shape according to an embodiment of the present disclosure. The embodiment of the PFA-OCR catheter 800 (shown in FIG. 8) may appear similar to a general circular mapping catheter at its distal end. The circular shape is shown as an exemplary embodiment, but the catheter distal section may be configured as circular, oval, or any polygon, or a combination of polygons. Its shape may be configured to surround the pulmonary vein ostium and deployed through a delivery catheter. FIG. 8 provides a front view looking into the pulmonary vein ostium, and the pulmonary vein extends into the plane of the page. In some embodiments, the delivery catheter can be size 8Fr or smaller (e.g., 2.66 mm or smaller). The body portion 801 of the circular distal end of the catheter 800 may be formed from a non-conductive polymer (e.g., polyvinyl chloride (PVC), polyamide, or PeBax®). The body portion 801 can have metal electrodes 802, which are evenly spaced along its length and made of a biocompatible material (e.g., platinum, platinum iridium, gold, or stainless steel, as well as other metals or metal plating). The catheter 800 shown in FIG. 8 illustrates 8 electrodes, but the device can have between 24 and 32 electrodes 802. The electrodes 802 are polymer Although a circular shape is shown as an exemplary embodiment, the catheter distal section can be configured as circular, oval, or any polygon, or a combination of polygons. Its shape can be configured to surround the pulmonary vein ostium and deployed through a delivery catheter. FIG. 8 provides a front view looking into the pulmonary vein ostium, and the pulmonary vein extends into the plane of the page. In some embodiments, the delivery catheter can be size 8Fr or smaller (e.g., 2.66 mm or smaller). Although a circular shape is shown as an exemplary embodiment, the catheter distal section can be configured as circular, oval, or any polygon, or a combination of polygons. Its shape can be configured to surround the pulmonary vein ostium and deployed through a delivery catheter. FIG. 8 provides a front view looking into the pulmonary vein ostium, and the pulmonary vein extends into the plane of the page. In some embodiments, the delivery catheter can be size 8Fr or smaller (e.g., 2.66 mm or smaller). Although a circular shape is shown as an exemplary embodiment, the catheter distal section can be configured as circular, oval, or any polygon, or a combination of polygons. Its shape can be configured to surround the pulmonary vein ostium and deployed through a delivery catheter. FIG. 8 provides a front view looking into the pulmonary vein ostium, and the pulmonary vein extends into the plane of the page. In some embodiments, the delivery catheter can be size 8Fr or smaller (e.g., 2.66 mm or smaller). Although a circular shape is shown as an exemplary embodiment, the catheter distal section can be configured as circular, oval, or any polygon, or a combination of polygons. Its shape can be configured to surround the pulmonary vein ostium and deployed through a delivery catheter. FIG. 8 provides a front view looking into the pulmonary vein ostium, and the pulmonary vein extends into the plane of the page. In some embodiments, the delivery catheter can be size 8Fr or smaller (e.g., 2.66 mm or smaller). Although a circular shape is shown as an exemplary embodiment, the catheter distal section can be configured as circular, oval, or any polygon, or a combination of polygons. Its shape can be configured to surround the pulmonary vein ostium and deployed through a delivery catheter. FIG. 8 provides a front view looking into the pulmonary vein ostium, and the pulmonary vein extends into the plane of the page. In some embodiments, the delivery catheter can be size 8Fr or smaller (e.g., 2.66 mm or smaller). Although a circular shape is shown as an exemplary embodiment, the catheter distal section can be configured as circular, oval, or any polygon, or a combination of polygons. Its shape can be configured to surround the pulmonary vein ostium and deployed through a delivery catheter. FIG. 8 provides a front view looking into the pulmonary vein ostium, and the pulmonary vein extends into the plane of the page. In some embodiments, the delivery catheter can be size 8Fr or smaller (e.g., 2.66 mm or smaller). Although a circular shape is shown as an exemplary embodiment, the catheter distal section can be configured as circular, oval, or any polygon, or a combination of polygons. Its shape can be configured to surround the pulmonary vein ostium and deployed through a delivery catheter. FIG. 8 provides a front view looking into the pulmonary vein ostium, and the pulmonary vein extends into the plane of the page. In some embodiments, the delivery catheter can be size 8Fr or smaller (e.g., 2.66 mm or smaller). Although a circular shape is shown as an exemplary embodiment, the catheter distal section can be configured as circular, oval, or any polygon, or a combination of polygons. Its shape can be configured to surround the pulmonary vein ostium and deployed through a delivery catheter. FIG. 8 provides a front view looking into the pulmonary vein ostium, and the pulmonary vein extends into the plane of the page. In some embodiments, the delivery catheter can be size 8Fr or smaller (e.g., 2.66 mm or smaller). Although a circular shape is shown as an exemplary embodiment, the catheter distal section can be configured as circular, oval, or any polygon, or a combination of polygons. Its shape can be configured to surround the pulmonary vein ostium and deployed through a delivery catheter. FIG. 8 provides a front view looking into the pulmonary vein ostium, and the pulmonary vein extends into the plane of the page. In some embodiments, the delivery catheter can be size 8Fr or smaller (e.g., 2.66 mm or smaller). Although a circular shape is shown as an exemplary embodiment, the catheter distal section can be configured as circular, oval, or any polygon, or a combination of polygons. Its shape can be configured to surround the pulmonary vein ostium and deployed through a delivery catheter. FIG. 8 provides a front view looking into the pulmonary vein ostium, and the pulmonary vein extends into the plane of the page. In some embodiments, the delivery catheter can be size 8Fr or smaller (e.g., 2.66 mm or smaller). Although a circular shape is shown as an exemplary embodiment, the catheter distal section can be configured as circular, oval, or any polygon, or a combination of polygons. Its shape can be configured to surround the pulmonary vein ostium and deployed through a delivery catheter. FIG. 8 provides a front view looking into the pulmonary vein ostium, and the pulmonary vein extends into the plane of the page. In some embodiments, the delivery catheter can be size 8Fr or smaller (e.g., 2.66 mm or smaller). Although a circular shape is shown as an exemplary embodiment, the catheter distal section can be configured as circular, oval, or any polygon, or a combination of polygons. Its shape can be configured to surround the pulmonary vein ostium and deployed through a delivery catheter. FIG. 8 provides a front view looking into the pulmonary vein ostium, and the pulmonary vein extends into the plane of the page. In some embodiments, the delivery catheter can be size 8Fr or smaller (e.g., 2.66 mm or smaller). Although a circular shape is shown as an exemplary embodiment, the catheter distal section can be configured as circular, oval, or any polygon, or a combination of polygons. Its shape can be configured to surround the pulmonary vein ostium and deployed through a delivery catheter. FIG. 8 provides a front view looking into the pulmonary vein ostium, and the pulmonary vein extends into the plane of the page. In some embodiments, the delivery catheter can be size 8Fr or smaller (e.g., 2.66 mm or smaller). Although a circular shape is shown as an exemplary embodiment, the catheter distal section can be configured as circular, oval, or any polygon, or a combination of polygons. Its shape can be configured to surround the pulmonary vein ostium and deployed through a delivery catheter. FIG. 8 provides a front view looking into the pulmonary vein ostium, and the pulmonary vein extends into the plane of the page. In some embodiments, the delivery catheter can be size 8Fr or smaller (e.g., 2.66 mm or smaller). - It is located outside the main body 801 and is exposed to enable contact with the endocardial wall. The electrode 802 can partially or completely surround the main body 801, but considering the surface irregularities, it can have a sufficient area to contact the blood vessel wall. Inside the lumen in the main body 801, each electrode 802 can be attached to a wire that can extend under the shaft of the catheter, and the wire terminates at an electrical connector at the proximal end. The connector can be inserted into a dedicated console, and the dedicated console provides electrical energy and optical energy to the catheter and senses optical and electrical signals returning from the catheter.

[0080] There is an optical port 803 between each pair of adjacent electrodes 802, and the optical port 80 3 can be configured as an opening on the side of the main body 801 facing the endocardium (the back side of the main body 801 in FIG. 8). FIG. 8 shows eight optical ports 803 for illustrative purposes but any number of port counts can be used. In some embodiments, any number of optical ports 803 and electrodes 802 can be installed in any configuration as long as the port 803 is not in the same location as the electrode 802, and it includes at least two electrodes 802 and one port 803 In some embodiments, the optical port 803 can be referred to herein as an orifice or opening (e.g., openings 803A and 803B shown in FIG. 9) formed in the main body 801 of the catheter.

[0081] FIG. 9 provides an enlarged side cross-sectional view of the distal tip of the circular distal end of the catheter 800. For clarity, when it is contained within its delivery catheter (not shown), it is shown in a straight, uncurled position. When deployed, the distal end of the catheter 800 is positioned such that its circular distal plane contacts the endocardial wall 901, as shown in FIGS. 8 and 9. The outside of the catheter body 801 is provided with electrodes 802A and 802B, with additional electrodes 802 spaced along the body 801 (shown in FIG. 8 but not in FIG. 9). Electrode 802B is shown with a cutaway portion, but can completely or partially surround the outside surface of the body 801. The electrodes 802 are positioned on the body 801 such that at least a portion of each electrode 802 faces the circular distal plane of the body 801 and contacts the wall

[0082] 901 when a gentle force is applied to the catheter. Inside the catheter body 801, at least one wire lumen 902 can extend the length of the catheter. Holes, skives, or slots provided at intervals along the wire lumen 902 can allow passage of electrical wires to continue to each of the electrodes 802. Electrode wires (not shown) can extend the length of the wire lumen 902 and terminate at an electrical connector at the proximal end of the catheter (not shown). The wires can be attached to the electrodes 802 by Each electrode 802 is attached to a dedicated wire, enabling each electrode 802 to be similarly accessed by a control circuit within a console (not shown). The console electronics can use the electrodes 802 for several functions: (i) to apply PFA stimulation, (ii) to measure electrogram signals, (iii) to interface with a navigation or mapping system, or (iv) to measure tissue impedance. The electrodes 802 can be used multiplexedly across some of these functions or can be specialized for a single function. The set of electrodes 802 can include any combination of single-use or multi-use electrodes. 。 。 。 。 。 。 。

[0083] In an alternative embodiment, multiple electrodes 802 can be connected together in parallel to form a single node. For example, referring to the electrodes 802 in FIG. 8, the user can move sequentially around a circular perimeter in a counterclockwise direction, connecting every other electrode 802 together. Thus, the first, third, fifth, and seventh electrodes 802 can form one node, and the second, fourth, sixth, and eighth electrodes 802 can form a second node. In this configuration, PFA stimulation events can use the even-numbered electrodes 802 as one pole and the odd-numbered electrodes 802 as the other pole, and thus it is possible to ablate the entire circular area at once. 。 。 。 。 。 。 。 。

[0084] A single wire lumen 902 is shown in FIG. 9, but other embodiments can have multiple lumens It is possible to provide members, each of which includes a subset of the electrical wires used in the system.

[0085] Returning to the cross-section of FIG. 9, the catheter body 801 can further provide an internal optical lumen 903 that can extend along the length of the catheter 800. The optical lumen 903 can be positioned near or in contact with the distal plane of the circular distal portion of 800 that is in contact with the endocardial wall surface 901. One or more openings 803 (e.g., openings 803A, 803B) are provided in the optical lumen 903 and can expose 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 can also be used to receive light reflected back into the catheter for measurement. The openings 803 can be holes, slots, or skives formed in the catheter body 801. They can be open to the outside or can be covered by a suitable optically transparent coating (e.g., glass, polymer, or other ceramic material, etc.). FIG. 9 shows two openings 803A and 803B, but any number of openings can be placed at any desired location around the circular distal section of the catheter 800 as shown in FIGS. 9 and 8. In another embodiment, the distal section body 801 of the catheter 800 can be entirely made of an optically transparent material. In some embodiments ​​​​​​​​​​​​​​​​, the openings 803A and 803B can ensure the optical transparency between the optical lumen 903 and the endocardial wall at the wavelengths used for optical analysis. It is possible to ensure the optical transparency between the optical lumen 903 and the endocardial wall 901.

[0086] FIG. 10 illustrates the device shown in FIG. 9, with the optical catheter 1001 inserted into the optical lumen 903 from the proximal end on the left side. The optical catheter 1001 can be moved independently from the distal end of the main catheter 800 system. The movement of the optical catheter 1001 can be achieved by a control device at the proximal end of the system (not shown). The control device can be part of the proximal handle assembly or can be present in one of the external devices to which the catheter is connected. The control device can be a simple push / pull wire. The control device can be a rotary knob, wheel, lever, slider, or push button, etc. The control device can be gear-type or pinion-type to provide precise movement of the optical catheter 1001 through the optical lumen 903. The control device can provide a locking function to hold the optical catheter 1001 in place with respect to the optical lumen 903 and release it for movement to a new location. The control device can be manual or electric (including a stepper motor or a linear displacement drive). It provides a user interface and can indicate the location of the optical catheter 1001 with respect to the optical lumen 903 or other physical components of the system. The user interface can be visual, auditory. catheter 1001 can be moved independently from the distal end of the main catheter 800 system. The movement of the optical catheter 1001 can be achieved by a control device at the proximal end of the system (not shown). The control device can be part of the proximal handle assembly or can be present in one of the external devices to which the catheter is connected. The control device can be part of the proximal handle assembly or can be present in one of the external devices to which the catheter is connected. The control device can be a simple push / pull wire. The control device can be a rotary knob, wheel, lever, slider, or push button, etc. The control device can be a rotary knob, wheel, lever, slider, or push button, etc. The control device can be gear-type or pinion-type to provide precise movement of the optical catheter 1001 through the optical lumen 903. The control device can provide a locking function to hold the optical catheter 1001 in place with respect to the optical lumen 903 and release it for movement to a new location. The control device can provide a locking function to hold the optical catheter 1001 in place with respect to the optical lumen 903 and release it for movement to a new location. The control device can be manual or electric (including a stepper motor or a linear displacement drive). It provides a user interface and can indicate the location of the optical catheter 1001 with respect to the optical lumen 903 or other physical components of the system. The control device can be manual or electric (including a stepper motor or a linear displacement drive). It provides a user interface and can indicate the location of the optical catheter 1001 with respect to the optical lumen 903 or other physical components of the system. The user interface can be visual, auditory. or provide tactile feedback to the catheter operator. is possible.

[0087] The optical aperture 1003 is near the distal end of the optical catheter 1001. When the console projects optical energy 1002 through the optical catheter 1001, it is possible for it to exit the catheter 1001 through the aperture 1003. When the aperture 1003 is aligned with one of the apertures 803 in the outer catheter body 801, the optical energy 1002 can exit the catheter body 801 and enter the endocardium 901. Further, at least some of the optical energy 1002 can reflect back from the tissue on the surface of the endocardium 901 or the tissue below it and re-enter the optical catheter 1001.

[0088] The optical lumen aperture 1003 can take any of the forms previously described with respect to the aperture 803 in the outer catheter body 801. The form of the aperture 1003 can be different from that of the aperture 803. The optical lumen 903 and the optical catheter 1001 can provide features for ensuring rotational alignment between the aperture 1003 and the aperture 803. The catheter operator can advance and retract the optical catheter 1001 along the optical lumen 903 and stop it at any location where the aperture 1003 of the optical catheter is aligned with the aperture 803 on the outer catheter body 801. At these locations, the operator can perform optical readings and evaluate tissue parameters of interest. is possible.​​​​​​​ When the catheter 800 is introduced into a target anatomical structure (which may be the heart), the optical catheter 1001 can be configured to be partially or fully inserted into the optical lumen 903 already. In an alternative embodiment, the catheter 800 can enter the target anatomical structure with the optical lumen 903 empty, and the optical catheter 1001 is introduced later in the procedure. In other embodiments, different types of catheters can be exchanged 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 exchangeable alternative catheters include OCR, spectroscopy including near-infrared spectroscopy, degree of polarization uniformity, or other optical measurements, electrical stimulation or ablation by PFA or radio frequency energy, electrical sensing including electrogram or impedance measurement, mechanical site marking including placement of markers such as pincers or suture wires, other site marking including dye injection or tissue staining for fluoroscopy, for ultrasound observation, or for a compatible electrophysiology navigation system, biopsy, drug injection into tissue, or elution into the blood stream,

[0089] photography or videography, chemical property measurement, mechanical property measurement including durometer, local ultrasound, catheters for laser suture or ablation. The outer structure of the catheter 800 is a window for these and other exemplary catheter types (e.g., then, precise placement of the catheter at the opening 803) and precise targeting of the location can be enabled. The operator can, as desired throughout the procedure, exchange different catheter types (including variations of the same catheter type).

[0090] Figure 11 provides a cross-section of the distal end of catheter 800, viewed from the proximal end towards the distal end, at a location between or outside of electrodes 802 (not shown). The figure is oriented such that the endocardial wall portion 901 is on the right side of catheter 800. Inside the body portion 801 of catheter 800, there are a wire lumen 902, an optical lumen 903, and an optical catheter 1001, which is depicted at a different scale than the previous figures. The optical lumen 903 abuts against a side portion of the catheter body portion 801 configured to contact the endocardial wall portion 901. Openings 803 and 1003 are cut into the catheter body portion 801, the optical lumen 903, and the optical catheter 1001, respectively, at the locations indicated by two horizontal hashed lines, enabling optical energy 1002 to exit and re-enter the optical catheter 1001. The optical lumen 903 provides a groove portion 1101 that receives a tongue portion 1102 on the optical catheter 1001. The tongue portion 1102 and the groove portion 1101 extend along the length of catheter 800, ensuring rotational alignment between openings 803 and 1003. The optical catheter 1001 can move proximally or distally (into or out of the plane of the page of the figure) with respect to the optical lumen 903 without misaligning openings 803 and 1003. out of) without misaligning openings 803 and 1003 with respect to the optical lumen 903.​​​​​​​​​​​​​ can be translated. In this embodiment, a tongue-and-groove alignment ment is shown, although other embodiments may use different alignment means, which may include, but are not limited to, an oval, polygonal, or other interlocking cross-sectional shape for the optical catheter 1001 and the optical lumen 903, a plurality of polygonal tongue-and-groove shapes, and a guide wire extending into the smaller lumen inside the optical catheter 1001 that fits into the optical lumen 903.

[0091] FIG. 12 is a side cross-sectional view of the distal end of the optical catheter 1001 showing some internal structures. The catheter body 1201 can include a rotational locking feature (not shown in FIG. 12) exemplified as the tongue 1102 in FIG. 11. The body 120 1 includes a structure (not shown), such as a metal coil, that can navigate tortuous anatomical structures during introduction and facilitate distal and proximal movement between the openings 803 while maintaining flexibility to accommodate the circular or other shapes shown in FIG. 8. Inside the body 1201, the focusing lens 1 203 is rigidly fixed to the body 1201. The lens 1203 can be a glass, fused silica, silicon dioxide, sapphire, or other material micro-lens. The optical fiber cable 1202 can be connected to the lens 1203 by an adhesive, such as index matching epoxy, laser welding, or other means. In certain embodiments, the distal end of the optical fiber cable 1202 is made as a lens. can be directly polished for use. The optical fiber cable 1202 can extend to the length of the catheter 80 0 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) and can transfer optical energy between the console and the catheter. The focused optical energy 1002 can exit the lens 12 03 from left to right in the figure, be turned by the angled mirror 1204, and be projected through the aperture 1003 into the endocardium 901 (not shown). The optical energy 1002 can penetrate the tissue layer of the endocardium 901, and a portion of it can be retroreflected back into the optical catheter 1001 along the same path it entered. Also, the turning mirror 1204 can be rigidly fixed to the optical catheter body 1201 at a latch, and by excluding relative movement between the lens 1203, the mirror 1204, the aperture 1003, and the rotational positioning tongue 1102 (not shown in FIG. 12), the optical alignment is preserved.

[0092] FIG. 13 provides a side cross-sectional view for illustrating an alternative embodiment of the optical catheter 1001. In some embodiments, the mirror 1204 may not be necessary as shown in FIG. 13. Instead, a highly flexible optical fiber 1202 is used, which can turn 90 degrees at the attachment point to the lens 1203, and the lens 1203 is rigidly attached directly to the aperture 1003 by an adhesive, a separate holder, a shaped structure for receiving the lens, or other means. ​ There are other concepts of the internal arrangement of optical components among optical things

[0093] Both the external structure within the catheter 800 and the optically movable optical catheter 1001 within it can be provided with coatings or materials at selected locations that facilitate visualization on X-ray fluoroscopy, navigation mapping, ultrasound, computed tomography, or other imaging systems.

[0094] In an alternative embodiment, the electrodes 802 and the openings 803 can be positioned on a separate catheter attached to the side as shown in FIG. 14. In this example the outer catheter 1401 can resemble the circular distal end portion of the catheter body 801 shown in FIG. 8 and can have electrodes 802 positioned at intervals thereon, each electrode 802 being connected to an internal wire, the wire being able to extend proximally through the catheter 800 as in the embodiments of FIGS. 8 to 12. However, in the embodiment of FIG. 14, the inner catheter 1402 can be attached laterally to the outer catheter 1401 such that the two form a concentric shape. The inner catheter 1402 can be provided with openings 803 to allow light to be transferred both within and outside the inner catheter 1402. The inner catheter 1402 can essentially be a hollow sheath, and the hollow sheath can receive, orient, and guide the optical catheter 1001 in the manner of the optical lumen 903 of FIG. 10. Alternatively, the inner catheter 1402 can be the outer catheter 1402 A slot, wireframe, track, or rail inside the outer catheter 1401 is possible, which directly receives the optical catheter 1001 and routes it around the inside of the inner catheter 1402 when the optical catheter 1001 is pushed. In these embodiments, the inner catheter 1402 will not have an outer covering and will only have a guide track or the like, and the outside of the catheter 1001 will be exposed to the outside. In this explanatory diagram and other explanatory diagrams, the openings 803 are shown as discrete windows, but in other embodiments, they can be slot-shaped windows, allowing for more flexibility at the viewing location. Also, the inner catheter 1402 can be made entirely of an optically transparent material for maximum local flexibility. When the optical catheter 1001 is pushed, it is routed around the inside of the inner catheter 1402. In these embodiments, the inner catheter 1402 will not have an outer covering and will only have a guide track or the like, and the outside of the catheter 1001 will be exposed to the outside. In this explanatory diagram and other explanatory diagrams, the openings 803 are shown as discrete windows, but in other embodiments, they can be slot-shaped windows, allowing for more flexibility at the viewing location. Also, the inner catheter 1402 can be made entirely of an optically transparent material for maximum local flexibility. In these embodiments, the inner catheter 1402 will not have an outer covering and will only have a guide track or the like, and the outside of the catheter 1001 will be exposed to the outside. In this explanatory diagram and other explanatory diagrams, the openings 803 are shown as discrete windows, but in other embodiments, they can be slot-shaped windows, allowing for more flexibility at the viewing location. Also, the inner catheter 1402 can be made entirely of an optically transparent material for maximum local flexibility. In these embodiments, the inner catheter 1402 will not have an outer covering and will only have a guide track or the like, and the outside of the catheter 1001 will be exposed to the outside. In this explanatory diagram and other explanatory diagrams, the openings 803 are shown as discrete windows, but in other embodiments, they can be slot-shaped windows, allowing for more flexibility at the viewing location. Also, the inner catheter 1402 can be made entirely of an optically transparent material for maximum local flexibility. In this explanatory diagram and other explanatory diagrams, the openings 803 are shown as discrete windows, but in other embodiments, they can be slot-shaped windows, allowing for more flexibility at the viewing location. Also, the inner catheter 1402 can be made entirely of an optically transparent material for maximum local flexibility. In this explanatory diagram and other explanatory diagrams, the openings 803 are shown as discrete windows, but in other embodiments, they can be slot-shaped windows, allowing for more flexibility at the viewing location. Also, the inner catheter 1402 can be made entirely of an optically transparent material for maximum local flexibility. In other embodiments, they can be slot-shaped windows, allowing for more flexibility at the viewing location. Also, the inner catheter 1402 can be made entirely of an optically transparent material for maximum local flexibility. In other embodiments, they can be slot-shaped windows, allowing for more flexibility at the viewing location. Also, the inner catheter 1402 can be made entirely of an optically transparent material for maximum local flexibility. In other embodiments, they can be slot-shaped windows, allowing for more flexibility at the viewing location. Also, the inner catheter 1402 can be made entirely of an optically transparent material for maximum local flexibility.

[0095] 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. 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. 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.

[0096] In another embodiment, a third catheter (not shown) similar to the inner catheter 1402 can be installed outside the outer catheter 1401. In this three - catheter embodiment, the middle catheter can have the openings 803, and the two outer catheters can have the electrodes 802, or vice versa. Different embodiments can be advantageous for generating larger lesions when evaluating larger lesions due to having a larger observation area. In another embodiment, a third catheter (not shown) similar to the inner catheter 1402 can be installed outside the outer catheter 1401. In this three - catheter embodiment, the middle catheter can have the openings 803, and the two outer catheters can have the electrodes 802, or vice versa. Different embodiments can be advantageous for generating larger lesions when evaluating larger lesions due to having a larger observation area. In this three - catheter embodiment, the middle catheter can have the openings 803, and the two outer catheters can have the electrodes 802, or vice versa. Different embodiments can be advantageous for generating larger lesions when evaluating larger lesions due to having a larger observation area. In this three - catheter embodiment, the middle catheter can have the openings 803, and the two outer catheters can have the electrodes 802, or vice versa. Different embodiments can be advantageous for generating larger lesions when evaluating larger lesions due to having a larger observation area. Different embodiments can be advantageous for generating larger lesions when evaluating larger lesions due to having a larger observation area. Different embodiments can be advantageous for generating larger lesions when evaluating larger lesions due to having a larger observation area.

[0097] In another embodiment, both the inner catheter 1402 and the outer catheter 1401 are As in FIG. 8, both electrodes 802 and openings 803 may be provided. Here, the operator The user can select between the two and insert a movable optical catheter 1001 through one or the other. Or you can view multiple locations with the same optical Alternatively, the shaft of the catheter 800 can be inserted into the catheter 1001. The light source may include a single optical lumen 903, which may be , at a point near the distal portion of one or the other catheter 1401 or 14 02, where catheters 1401 and 1402 are in a "Y" connection. It is possible to form

[0098] Figures 15 to 20 illustrate an alternative embodiment. Figure 15 is a cross-sectional view of Figures 8 and 9. 15 shows an enlarged cross-section of a simplified version of the outer catheter 1500 shown. In this version, the outer body portion 1501 has the same structure as described in FIGS. In this manner, electrodes 1502 and openings 1503 can be provided. The conductive electrodes 1502 may be exposed on the outside of the catheter body 1501. It is possible to provide a connection to the wires from the inside. However, in this embodiment, The body of the side catheter 1501 is an internal catheter for routing a wire or wires. It may not include a side lumen.

[0099] FIG. 16 illustrates an inner catheter 1500 configured to translate linearly within an outer catheter 1500. It is a side view of the distal end of the catheter 1504. The catheter body 1505 is formed from a material flexible enough to navigate tortuous anatomical structures and is stiff enough to be pushed distally and pulled proximally by a control device within a control type catheter 1500 handle (not shown) as previously shown. The catheter body 150 5 can include a metal blade (not shown) for pushability. At least two conductive electrodes 1506 can be disposed on the outer surface of the body 1505, which are spaced apart at a desired distance for the application of PFA energy or for the electrical sensing of impedance, heart signals, or catheter location. The electrodes 1506 can be connected to the inner portion of the catheter body 1505 for connection to wires and can be similar to the electrodes 802 from FIGS. 8 and 9. At least one opening 1003 is disposed between the electrodes 1506 and can be similar to the opening 803 from FIGS. 8 and 9. It can be a fully open aperture or can be covered by an optically transparent material. Optical energy 1002 can pass into and out of the opening 1003. The size, number, and placement of the opening 1003 and electrodes 1506 along the body 1505 can vary in different embodiments, allowing a design tradeoff between the complexity of assembly and the robustness of functionality, which will be apparent to those skilled in the art.

[0100] FIG. 17 illustrates a cross-sectional side view of the inner catheter 1504 showing the internal components. It exists. The main body 1505 includes a wire lumen 1508, and the wire lumen 1 508 can partially or completely extend along the length of the inner catheter 1504 and is possible. The wire lumen 1508 includes a wire 1509, and there is at least one for each electrode 15 06. Similar to FIGS. 8 and 9, the wire can be connected to the electrode by various means described above, and in FIG. 17, it is shown as a black circle at the end of each wire 1509. Also, the main body 1505 can include a set of optical components rigidly fixed to the main body 1 505. These components can include a lens 1203 and a turning mirror 1204 as shown in FIG. 12 . The rigidly fixed optical components can transmit optical energy 1002 between the inner catheter 1504 and the outside through the opening 1003 as described above . The optical fiber 120 2 can be connected to the lens 1203 as described above and can guide optical energy in both directions through the length of the inner catheter 1504 . It will be apparent to those skilled in the art that other arrangements and types of optical components, including those shown in FIG. 13 and elsewhere in this specification, are also possible . Additionally, the separate wire lumen 1508 shown in FIG. 17 can be partially or completely omitted, and the entire volume within the main body 1505 can be filled with wires 1509 and optical fibers or filaments over some or all of the length of the inner catheter 1504 .

[0101] It will be apparent to those skilled in the art that other arrangements and types of optical components, including those shown in FIG. 13 and elsewhere in this specification, are also possible . Additionally, the separate wire lumen 1508 shown in FIG. 17 can be partially or completely omitted, and the entire volume within the main body 1505 can be filled with wires 1509 and optical fibers or filaments over some or all of the length of the inner catheter 1504 and filaments It can be used to include the fiber 1202.

[0102] Figures 18A and 18B illustrate diagrams showing the translation of the inner catheter 1504 when it is installed inside the outer catheter 1500. In Figure 18A, the inner cat heter 1504 is shown at a location where its two electrodes 1506 are not aligned with the electrodes 1502 of the outer catheter 1500. As a result, the opening 1003 of the inner catheter 1500 is also not aligned with the outer catheter opening 1503. Since there is no electrical connection between the inner electrode and the outer electrode, electrical functionality (stimulation or sensing) is not possible. Similarly, since the inner and outer openings are not aligned, optical energy 1002 cannot be transferred between the catheter system and the endocardial tissue 901. Translating the inner catheter 1504 distally causes the inner electrodes 1506 to align with the outer electrodes 1502, as shown in Figure 18B, completing the electrical circuit and optical path between the tissue 901 and the console (not shown), enabling full electrical and optical functionality for the catheter system. for the catheter system. Alignment or misalignment of the electrodes and windows, as well as contact with the endocardial wall can be detected by the PFA - OCR system by measuring the electrical impedance between the inner electrodes 1506 using a circuit in the console or catheter. A misaligned catheter will register a high impedance. An aligned catheter with good endocardial contact will have an impedance of the endocardial wall

[0103] and the console or catheter. can be detected by the PFA - OCR system by measuring the electrical impedance between the inner electrodes 1506 using a circuit in the console or catheter. A misaligned catheter will register a high impedance. An aligned catheter with good endocardial contact will have an impedance of the endocardial wall and the console or catheter.​ which will indicate (typically, from several tens to several hundreds of ohms). Similarly, the OCR system can be used to detect the alignment between the inner opening 1003 and the outer opening 1503. The reason is that the optical energy 1002 reflected from the inner wall of the outer catheter body 1501 will typically provide a measurably different reflection from the optical energy 1002 reflected from the endocardial tissue 901.

[0104] As discussed in connection with other embodiments, means for inserting the inner catheter 1504 into the outer catheter 1500 can be provided at the proximal end in the handle, and the handle can provide various controls for precise translation of the inner catheter 1504 relative to the outer catheter 1500. Also, the system can provide a display for indicating the relative catheter location, position, and alignment status. As in other embodiments, the inner catheter 1504 can be pre-loaded over the entire length of the outer catheter 1500. Alternatively, the inner catheter 1504 can be introduced into the outer catheter 1500 in the latter part of the procedure after the catheter 1500 has been introduced into the target anatomical structure. Partial pre-loading is also possible.

[0105] FIG. 19 is a cross-section of a catheter stem embodiment including the outer catheter 1500 and the inner catheter 1504, looking down the length of the catheter as in 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 has an internal It is possible to provide a mechanical structure 1510, and the internal mechanical structure 1510 provides a groove portion 1511 or a similar guiding feature under the length of the catheter. The groove portion 1511 interfaces with a tongue portion 1512 or a similar feature on the inner catheter body portion 1505, and it is possible to guarantee rotational stability. Similar to the system described in FIG. 11, it guarantees proper alignment between the inner catheter opening 1003 and the outer catheter opening 1503 (not shown). Similar to FIG. 11, the internal guide also guarantees that the inner catheter body portion 1505 is oriented to abut against the surface of the outer catheter body portion 1501 on the side that will be closest to the endocardium 901, and brings the optical component (not shown) in the inner catheter 1504 as close as possible to the endocardium 901.

[0106] The cross-section of FIG. 19 is taken at points on both the inner catheter 1504 and the outer catheter 1500, where the electrodes 1506 or 1502 are not disposed. In contrast, FIG. 20 presents the same cross-section, but it is at the location 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 with a white dot) surrounds the outer catheter 1500 from the outside, penetrates into the catheter body portion 1501, and is disposed internally on the surface of the inner wall portion on the mechanical guiding structure body 1510 or in the groove portion of 1510. The internal portion of the electrode 1502 is shown on the left side of the figure as the guiding structure ​​​​​​​​​​​​​In the area near the prosthesis 1510, it is possible to be thicker. The inner catheter electrode 1506 of the inner catheter 1504 can surround the outer surface of the inner catheter 1504 and penetrate into the interior of the catheter 1504 and be connectable to its wire (internal penetration and wire are not shown). Both electrodes 1502 and 1506 will provide good electrical contact when they are aligned, but can be arranged so as to allow complete translational movement of the inner catheter 1500 proximally and distally through the electrodes. Those skilled in the art will recognize various means to achieve this by carefully designing the material selection, installation, and thickness. The wall of the outer catheter 1500 can be designed to deform slightly when the electrodes are in contact, providing elastic energy to press the metals together, ensuring low - resistance contact without applying stress to the non - contact area of the catheter and without suppressing further translation. The slightly tight fit between the contacting electrodes can provide tactile feedback to the catheter system operator and indicate when the electrodes are aligned.

[0107] In another embodiment, the outer catheter 1500 may not include the electrode 1502 as shown in FIG. 15. Here, the outer catheter body 1501 is a simple tube, but can be provided with apertures arranged along its length alongside the optical aperture 1503. The electrode 1506 on the inner catheter 1504 (FIG. 16) deforms the flexible outer catheter 1500 when not aligned with the aperture ​​​​​​​​​​​​​​ can be sized, but when the electrode 1506 is aligned with the aperture, the electrode 1506 will project through the aperture by a sufficient distance to ensure low-ohmic contact with the endocardium 9 01. The inner electrode 1506 can be formed with a thicker region (or a protruding cam ) on the side of the inner catheter 1504 that is aligned with the aperture (to the right of 1506 in FIG. 20, the protruding cam is not shown in the figure ). )

[0108] In some embodiments, the opening or aperture can take the form of discrete openings, or can be an elongated slot that covers more area, allowing for a design trade-off between precise location and coverage ratio of distance.

[0109] In yet another embodiment, the outer catheter 1500 can be, rather than a complete tube, well, a rigid guide rail structure, and the guide rail structure can take the same circular shape as FIG. 8, or a different circular or polygonal shape formed in a plane parallel to the endocardial wall. The inner catheter 1504 can, as shown in FIG. 16 be provided with both electrodes and optics, but mechanical means for attachment to the guide rail structure can be provided. The guide rail structure allows the electrode 1506 to contact the endocardial surface 901 and positions the opening 100 3 sufficiently close to the surface 901 such that it can typically optically and effectively probe it at a distance of less than about 500 μm. The guide rail structure can take the form of a wireframe is possible, and the longitudinal wire is spaced and connected by circular or semi-circular support wires. Also, the guardrail structure can be a single rail with tongue-and-groove or similar attachment features, or a complete tube with wide slots or slots running longitudinally on the side facing the intima 901. In another embodiment, the guide rail structure can be in the form of a single thick and rigid or semi-rigid wire providing a suitably rounded shape. The inner catheter 1504 can include a lumen either externally or internally on its main shaft and can be connected to a large wire. As discussed earlier, the openings 1003 and 150 3 in various embodiments can be fully open apertures or can be covered by a material optically transparent to the wavelengths used by the system. When an open aperture is used, it may be necessary to provide means to prevent blood or other optically opaque materials from blocking the optical energy path 1 002. Irrigation of the catheter stem with a biocompatible optically transparent liquid (e.g., saline solution, etc.) can be used for thermal control and to prevent tissue buildup at the tip of the RF ablation system. The previously disclosed catheter systems

[0110] can include irrigation ports at their proximal ends, allowing forced irrigation of the openings 1003 or 1503 to keep them optically clear, or the cathe ter When an open aperture is used, it may be necessary to provide means to prevent blood or other optically opaque materials from blocking the optical energy path 1002. is used, it may be necessary to provide means to prevent blood or other optically opaque materials from blocking the optical energy path 1002. Irrigation of the catheter stem with a biocompatible optically transparent liquid (e.g., saline solution, etc.) can be used for thermal control and to prevent tissue buildup at the tip of the RF ablation system. The previously disclosed catheter systems can include irrigation ports at their proximal ends, allowing forced irrigation of the openings 1003 or 1503 to keep them optically clear, or the cathe ter 1503 to keep them optically clear, or the cathe It enables preventing the backflow of blood into the -ter system. The irrigation fluid medium is medical grade saline aqueous solution, or any liquid that is biocompatible and optically transparent is possible. To improve optical transmission or fluid properties (such as viscosity or lubricity, etc.) it may be desirable to formulate a solution containing an index-matching liquid or other materials Possibility exists. Instead of a liquid, a viscous gel can be added to the space behind the opening and can stay there to keep the optical path clear.

[0111] In another embodiment, the moving catheter is connected to a relatively stationary catheter as in the previous embodiment, but in this case, the relative movement can be rotational rather than translational is possible. FIG. 21 shows a cross-sectional view of the distal portion of the PFA-OCR catheter 2100 where the longitudinal axis of the catheter runs from left to right above the page. This can be a two-catheter system where the inner optical catheter 21 02 can be present within the outer catheter 2101. The optical opening 21 03 can be disposed along the outer catheter 2101 along the side that contacts the endocardium (not shown, at the bottom of the figure) as in the previously described embodiments. Inside the inner optical catheter 21 02, there can be a plurality of optical tap assemblies 2104, and the optical fiber 2105 can run longitudinally through the optical tap assembly 2104 is possible. Throughout the figure, the optical energy is symbolized by solid black arrows in both directions Each optical tap assembly 2104 is connected to a console (shown A portion of the optical energy flowing from the laser source in (not shown) through the fiber 2105 into it can be configured to tap, and the tapped portion can be transmitted to the micro-lens 1203 for focusing and transmission through the inner catheter 2101 opening 2106. The untapped portion of the incoming optical energy can continue through the fiber to the next optical assembly 2104. For example, the optical energy from a console laser source can travel from left to right (from proximal to distal) along the fiber 2105. When the input optical energy 2107B enters the optical assembly 2104B, it can encounter the semi-reflective turning mirror 1204B. This 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 remaining portion of the input energy 2109B can be transmitted through the mirror 1204B further distally through the fiber 2105. The tapped optical energy 2108B can be focused by the lens 1203B and projected through the inner catheter opening 2106B. The inner catheter 2102 can be configured to rotate about its longitudinal axis (from left to right in the figure), while on the other hand, the outer catheter 2101 can be configured to remain stationary. In the exemplary figure, the inner catheter 2102 is rotated relative to the outer catheter 2101 such that the openings 2106B and 2103B are aligned, allowing the optical energy 2108B to leave the catheter and enter the endocardium (not shown). It can be configured to tap a portion of the optical energy, and transmit the tapped portion to the micro-lens 1203 for focusing and transmission through the inner catheter 2101 opening 2106. The untapped portion of the incoming optical energy can continue through the fiber to the next optical assembly 2104. For example, the optical energy from a console laser source can travel from left to right (from proximal to distal) along the fiber 2105. When the input optical energy 2107B enters the optical assembly 2104B, it can encounter the semi-reflective turning mirror 1204B. This 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 remaining portion of the input energy 2109B can be transmitted through the mirror 1204B further distally through the fiber 2105. The tapped optical energy 2108B can be focused by the lens 1203B and projected through the inner catheter opening 2106B. The inner catheter 2102 can be configured to rotate about its longitudinal axis (from left to right in the figure), while on the other hand, the outer catheter 2101 can be configured to remain stationary. In the exemplary figure, the inner catheter 2102 is rotated relative to the outer catheter 2101 such that the openings 2106B and 2103B are aligned, allowing the optical energy 2108B to leave the catheter and enter the endocardium (not shown). The tapped optical energy 2108B can be focused by the lens 1203B and projected through the inner catheter opening 2106B. The inner catheter 2102 can be configured to rotate about its longitudinal axis (from left to right in the figure), while on the other hand, the outer catheter 2101 can be configured to remain stationary. In the exemplary figure, the inner catheter 2102 is rotated relative to the outer catheter 2101 such that the openings 2106B and 2103B are aligned, allowing the optical energy 2108B to leave the catheter and enter the endocardium (not shown). The tapped optical energy 2108B can be focused by the lens 1203B and projected through the inner catheter opening 2106B. The inner catheter 2102 can be configured to rotate about its longitudinal axis (from left to right in the figure), while on the other hand, the outer catheter 2101 can be configured to remain stationary. In the exemplary figure, the inner catheter 2102 is rotated relative to the outer catheter 2101 such that the openings 2106B and 2103B are aligned, allowing the optical energy 2108B to leave the catheter and enter the endocardium (not shown). This is done. The projected light 2108B then reflects from the endocardium or other tissue and travels back in the reverse direction along the same path it entered, connecting back to the fiber 2105 and being carried to the console for signal acquisition and measurement.

[0112] The optical assemblies 2104 are oriented around the longitudinal axis of the inner catheter 2102 at their respective unique angles, as shown in FIGS. 21 and 22. In the figure, three optical assemblies 2104 are oriented 90 degrees to each other. In FIG. 21, the optical assembly 2104A (including the opening 2106A) is shown with its lens and tapped optical energy facing out of the page, the assembly 2104B including the opening 2106B is oriented to send the tapped optical energy 2108B downward, and the optical assembly 2104C including the opening 2106C is oriented to send its tapped optical energy upward. All items 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 the control device at the proximal end of the catheter. The optical assemblies 2104 and the inner catheter openings 2 106 can be oriented such that at any given time, only the opening 210 6 of at most one optical assembly aligns with the outer catheter opening 2103. All optical assemblies 2104 can be permanently fixed to the fiber 2105 so that when energy is applied by the console, they transmit the optical energy 2108 in the same way. 106, and way. It is possible to pass all at times. The optical assembly 2104 (the opening 2106 of which is not aligned with the outer window 2103) can project optical energy 2108 into the inner wall portion of the outer catheter 2101. The inner wall portion of the outer catheter 210 1 can be made of a non-reflective material or coated with a non-reflective material, and the non-reflective material absorbs light at the wavelengths used by the system and ensures that little or no optical energy is reflected back into the fiber 2105.

[0113] FIG. 22 provides a cross-sectional view of the two-catheter system 2100 looking towards the distal end of the catheter section shown in FIG. 21. The optical assembly 2104 is shown with 2104A most darkly shaded, indicating that it is closest to the viewer, 2104B is shown shaded lighter than that, indicating that it is more distal than 2104A, and 2104C is shown shaded the lightest of all, indicating that it is the most distal. This figure clarifies the concept of rotational selection of the active optical measurement opening by the user.

[0114] Partially reflective turning mirrors are shown in FIGS. 21 and 22, but the tapping of optical energy from the fiber 2105 and the recombination of the returning energy back into the fiber 2105 can also be achieved by other means. These are ​​​​​Includes an optical splitter / coupler device that splits the total number of inputs to and from the tap port. The optical energy of the fluorophores can be designed to couple or split a desired portion of the optical energy of the fluorophores. , which include passive devices (e.g., gratings or prisms, etc.) , it is possible to redirect light at different wavelengths into different spatial directions, which , in combination with multi-wavelength or broadband light.

[0115] Obviously, additional optical assemblies 2104 can be disposed at different angles to accommodate different beam positions as desired. This allows for more viewports in the catheter system 2100. Although Figures 21 and 22 do not show electrodes, electrodes and wires may be used as described above. It is apparent that the present invention may be modified in a similar or similar manner to that of the embodiment described above. For example, the cross section of FIG. 22 shows that the 2101 is in a dedicated lumen or Either in the main lumen to accommodate the electrode wires in the previous embodiment. , the outer catheter 2101 may be modified to be larger in diameter. 21 and 22. The catheter 210 may be easily visualized and a cam or other protruding inner electrode may be inserted into the catheter 210. 2, which causes the inner electrode and the outer electrode to align. The protrusion or projection through the opening only occurs when a particular angle of rotation is selected. Otherwise, it will contact the stationary outer electrode. The assemblies can be assembled together in a catheter 2101, both of which have their Similar to the translational analogs described previously, they are adapted to be engaged simultaneously when desired. Any combination of multi-fiber and single-fiber, or yarn combinations can be designed to meet the needs of a particular user and manufacturing limitations. .

[0116] The selectable two-catheter system in the described rotational direction can lock the inner catheter 2102 so that it cannot translate within the outer catheter 2101. The rotatable inner catheter 2102 can be permanently fixed to the distal end of 2101 by any of a plurality of mechanical means. However, it will become apparent from the present disclosure that a combined embodiment of a system that allows both translational and rotational movement of one catheter relative to the other is possible and can be used for a particular design.

[0117] In other embodiments, the distal end of the PFA - OCR catheter can have a plurality of distinct branches that do not form a continuous loop. The general principles of the present disclosure are compatible with such a multi-loop architecture. For each branch within the same overall catheter system, it is simply possible to provide a separate parallel system. Alternatively, it is possible to create parallel branches of the stationary part of the system, which corresponds, for example, to the fixed outer catheter body 800 of FIG. 9 or 1500 of FIG. 15. The parallel branches can come together at the intersection point immediately proximal to the most proximal opening or electrode. The single movable inner catheter 1001 of FIG. 10 Alternatively, the 1504 of FIG. 16 can then be inserted to the intersection point. Mechanical guiding features can be capable of facilitating steering a movable inner catheter to a desired branch.

[0118] 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, which is shaped by a balloon device in some cases. In some embodiments, the basket can use loops or branches as described above. The exemplary embodiment shown in the figures shows a single optical assembly (such as a fiber, lens, etc.) in a translatable inner catheter. In other embodiments, multiple fiber - lens assemblies can include the optical part of the system and can be stationary and fixed to the body of either a movable catheter or a stationary catheter.

[0119] Multiple instances of the optical assembly of the type illustrated in FIG. 12 or FIG. 13 can be disposed within a single catheter. In one embodiment, multiple fibers can extend to at least one proximal optical connector along the length of the catheter. In another embodiment, a single optical fiber extends through most of the catheter length, but near the distal end, the single fiber fans out into multiple fibers through an optical multiplexer, and each downstream fiber is connected to at least one separate optical channel. Optical multiplexing / demultiplexing can be (i) wavelength - division multiplexing using a diffraction grating (a prism for spatially redirecting light), (ii) ​​​​​​​​​​​​ ) Beam steering using a movable micromirror, (iii) polarization division multiplexing using a polarization filter, (iv) a tunable wavelength filter (including an acousto-optic tunable filter), (v) including a liquid crystal switch device, can be achieved by the arrangement of many micro-optical components. In some embodiments, optical multiplexing and switching can be implemented by a single multiplexing device proximal to the optical apertures 1003, 1503 that fan out from one optical fiber to multiple fibers. Other embodiments can take the form of a single fiber tapped at each desired optical sensing location. The tapped optical energy 1002 can be routed through an optical switch to a short fiber / lens assembly. The tap can take the form of an optical coupler / splitter or a partially reflective mirror arrangement. Individual optical path / block switches can be implemented as wavelength filters, polarization filters, liquid crystal switches, acousto-optic switches, or other devices. The electronic device control lines for embodiments using such switches will be routed back to the electrical connectors on the handle. To allow a small number of fibers to pass through most of the length of the catheter, the optical energy 1002 can be multiplexed so that the electrical energy can be multiplexed to reduce the number of long wires required to cross the catheter. In such embodiments, the electronic multiplexer is located much farther distally from the proximal end of the catheter. can take the form of an optical coupler / splitter or a partially reflective mirror arrangement. Individual optical path / block switches can be implemented as wavelength filters, polarization filters, liquid crystal switches, acousto-optic switches, or other devices. The electronic device control lines for embodiments using such switches will be routed back to the electrical connectors on the handle. can be implemented as wavelength filters, polarization filters, liquid crystal switches, acousto-optic switches, or other devices. The electronic device control lines for embodiments using such switches will be routed back to the electrical connectors on the handle. For embodiments using such switches, the electronic device control lines will be routed back to the electrical connectors on the handle. For embodiments using such switches, the electronic device control lines will be routed back to the electrical connectors on the handle.

[0120] To allow a small number of fibers to pass through most of the length of the catheter, the optical energy 1002 can be multiplexed so that the electrical energy can be multiplexed to reduce the number of long wires required to cross the catheter. In such embodiments, the electronic multiplexer is located much farther distally from the proximal end of the catheter. can be multiplexed to reduce the number of long wires required to cross the catheter. In such embodiments, the electronic multiplexer is located much farther distally from the proximal end of the catheter. In such embodiments, the electronic multiplexer is located much farther distally from the proximal end of the catheter. It can be provided at a point, but at a point proximal to the nearest electronic component (electrodes 802, 1502, 1506 for an optical multiplexer or the control electronics). It can be provided at a point proximal to the nearest electronic component (electrodes 802, 1502, 1506 for an optical multiplexer or the control electronics). The switching control can be increased by any of numerous digital control methods and can include an integrated circuit. The physical switch can be implemented as a micro - mechanical relay or a solid - state switch. The electrical switch can also be installed locally near each respective electrode. In one embodiment, a single wire can contact multiple electrodes, and each electrode has its own localized switch and control electronics, and the control electronics opens the switch only when it detects its own control signal on the single wire that is also used to carry the stimulation power or signal. In this embodiment, the unique control signal can be a bit sequence or a unique frequency. In this embodiment, the unique control signal can be a bit sequence or a unique frequency.

[0121] As previously described, the electrodes can perform stimulation, measurement, or monitoring functions. The electrodes can be configured to perform multiple functions or can be specialized for a single function. In one embodiment, different electrodes are configured to simultaneously stimulate and measure electrogram functionality. Also, the electrodes can monitor the electrocardiogram (ECG) function of a patient and suppress PFA stimulation during portions of the ECG cycle (during which external electrical stimulation can cause fibrillation or other unwanted responses). An example of such a PFA stimulation suppression system is using one or more electrodes to monitor the ECG and, when the "T" portion of the ECG cycle occurs (during which external electrical stimulation can cause fibrillation or other unwanted responses), suppressing PFA stimulation​​ The signal is processed to determine when the stimulus occurs during the "T" portion of the cycle. The system may include, for example, suppressing the "T" wave after the "T" wave has ended. Alternatively, stimulation can be delayed until the next safe portion of the ECG cycle occurs. The signal processing can occur in the console or on the catheter. This can be done by electronic devices inside the heart. Measuring the physiology (e.g., the decline of the "R" wave) and then measuring the physiology after the "R" wave. and inhibiting the stimulation for a reasonably reasonable period of time. The length may be the same for every cardiac cycle or it may vary depending on the heart rate. The temperature may be varied automatically based on recent measurements of the temperature or other parameters.

[0122] In another embodiment of the present disclosure, the catheter system includes an RF ablative as well as a PFA. The system may be configured to perform RF A / F functionality. It is possible to have the electrode installed on its own and to connect other electrodes for PFA functionality. Alternatively, the same electrodes can be connected to different By switching the electrical stimulation (PFA or RFA) between the desired electrodes, It can be used for both PFA and RFA at the same time. When used in a pediatric cardiology setting, a dispersive pad is placed on the patient's back to disperse the RF current and It is possible to provide a return path. In this case, only one of the electrodes of the present disclosure can be excited by RF energy at once. If desired, the RFA can be It can be applied across two of the electrodes. The user is provided with control at the catheter or at the console and is able to toggle the system between the PFA mode and the RFA mode. The optical system can measure and display the same optical parameters for both modes, or can be configured to measure and display unique parameters for each mode. The irrigation holes and channels can be provided on or near the electrodes intended for RFA. In other embodiments, the present disclosure can be modified to achieve cryoablation. In one embodiment, the catheter can have a balloon attached to its distal end, which is configured to be filled with cryogenic liquid (e.g., liquid nitrogen, etc.) provided by the console or other external device. The inner and outer catheters of the present disclosure can be configured to surround the balloon in a continuous series pattern, or can be configured as a plurality of parallel distal sections that can be selected as described above. In RF, cryo, or PFA embodiments, the present disclosure features flexibility in placing the optical observation location relative to the ablation stimulation (electrical or cryogenic) site. That is, the designer can select the observation location around the generated lesion that will be of most interest when evaluating lesion quality. In some embodiments, for adjusting the shape of the distal portion of the catheter of the present disclosure

[0123]

[0124]

[0125] A means may be provided. This can include a pull wire or push rod that is controlled by the user. The adjustment means can be used to increase or decrease the diameter of a circular shape or the size of

[0126] a polygonal shape at the distal end of the catheter system. Although the cross-sections of the present disclosure shown in FIGS. 11, 19, 20, and 22 show a circular cross-section, other geometries for the distal section may also be advantageous. A semi-circular shape with a flat side facing the endocardium 901 has the advantage of covering more areas of the endocardial wall by each electrode and

[0127] may provide better electrical contact. It can also reduce the distance between the optical opening and the endocardium and enable deeper penetration of optical energy into the endocardial tissue.

[0128] In another embodiment, the outer catheter in various disclosed embodiments is rotatable by the user and can better position the outer catheter opening or electrode to interface with the endocardium.

[0129] The description of the present disclosure relates to cardiac Exemplary embodiments from ablation of endocardial tissue near the pulse point are used. However, the principles of the present disclosure are applicable to other anatomical structures where tissue ablation may have clinical value. These include cancerous or precancerous tumors, skin cells, nerve tissue for procedures such as renal denervation, other nerve cells, brain cells, or, for example, but not limited to, mucus or other congestive materials that may cause pulmonary edema.

[0130] Additional Exemplary Embodiments Exemplary Embodiment Set #1 Embodiment 1: A system for ablating tissue in the heart wall, the system comprising: A catheter configured to be disposed within an outer sheath, the distal end portion of which is straight and adapted for vascular delivery, the distal end portion assuming a circular shape when pushed through the sheath, the circular shape being in a plane parallel to the heart wall and configured to contact the heart wall, the catheter; A plurality of electrodes disposed on the distal end portion at a predetermined distance from each other, the electrodes being connected by wires to an external electrical energy generating device via an electrical connector on the proximal end portion of the catheter, the electrodes being configured to deliver electrical energy to the heart wall when excited by the electrical energy generating device; A plurality of electrodes; At least one optical port, the port including an optical component, the optical component being connected to an external light source via an optical connector on the proximal end portion of the catheter, the optical component; The learning energy generation device is connected by an optical fiber, and the optical component is configured to project optical energy into the heart wall when excited by the optical energy generation device, and is configured to receive and return the optical energy reflected from the heart wall, and transfer the reflected energy to an external optical sensing device through the optical fiber and the optical connector configured as such, at least one optical port, including, The at least one optical port is positioned on the distal end of the catheter at a predetermined location relative to the electrode, and the location is selected for optimal measurement of optical parameter changes caused by tissue ablation due to the excitation of the electrode system. including, The at least one optical port is positioned on the distal end of the catheter at a predetermined location relative to the electrode, and the location is selected for optimal measurement of optical parameter changes caused by tissue ablation due to the excitation of the electrode system. system. system.

[0131] Embodiment 2: The side of the catheter configured to contact the heart wall is flattened to produce a semi-circular cross-section of the catheter, and the flattened side maximizes the contact area between the side and the heart wall, the system according to Embodiment 1. system.

[0132] Embodiment 3: The circular shape is an oval shape, a polygonal shape, or a combination of an oval shape and a polygonal shape, the system according to Embodiment 1. system.

[0133] Embodiment 4: At least two of the plurality of electrodes are connected to dedicated wires, and the plurality of dedicated wires are connected to a multiplexer positioned proximal to the electrodes, and the multiplexer is connected to at least the dedicated electrode wires system. system. configured to selectively switch between one proximal wire, said proximal wire extending from said multiplexer to a connector on said proximal end of said catheter The system according to Embodiment 1.

[0134] Embodiment 5: A subset of said plurality of electrodes are wired together to form a single electrical node, the system according to Embodiment 1. The system according to Embodiment 1.

[0135] Embodiment 6: The system further includes a plurality of said optical ports and an optical multiplexer disposed proximal to said optical ports, said optical multiplexer configured to selectively switch between a plurality of optical fibers and at least one proximal fiber, each of said fibers being dedicated to one of said optical ports, said proximal fiber extending from said multiplexer to a connector on said proximal end of said catheter, the system according to Embodiment 1. The system according to Embodiment 1. configured to selectively switch between a plurality of optical fibers and at least one proximal fiber, each of said fibers being dedicated to one of said optical ports, said proximal fiber extending from said multiplexer to a connector on said proximal end of said catheter, the system according to Embodiment 1. The system according to Embodiment 1. configured to selectively switch between a plurality of optical fibers and at least one proximal fiber, each of said fibers being dedicated to one of said optical ports, said proximal fiber extending from said multiplexer to a connector on said proximal end of said catheter, the system according to Embodiment 1. The system according to Embodiment 1.

[0136] Embodiment 7: said optical component is selected from a focusing lens, a turning mirror, a diffraction grating, a GRIN lens, an optical tap, an optical coupler, an optical polarizer, the system according to Embodiment 1. The system according to Embodiment 1. The system according to Embodiment 1.

[0137] Embodiment 8: The electrical energy delivered to the heart wall by said plurality of electrodes is configured to ablate tissue of the heart wall by at least one process selected from radiofrequency ablation, thermal ablation, pulsed field ablation, or irreversible electroporation, the system according to Embodiment 1. The system according to Embodiment 1. The system according to Embodiment 1. The system according to Embodiment 1. The system according to Embodiment 1.

[0138] Embodiment 9: The system operator can select the type of electrical energy delivered by the control device over the external electrical energy device, the system according to Embodiment 8.

[0139] Embodiment 10: The external optical energy generating device, the at least one optical port, and the external optical sensing device are configured to perform the optical measurement of the optical parameter change by at least one process selected from 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, the system according to Embodiment 1.

[0140] Embodiment 11: The optical measurement can be processed and displayed by an external device, and can show at least one of the contact stability, tissue survival rate, tissue type, tissue depth, and tissue composition between the optical port and the heart wall, the system according to Embodiment 10.

[0141] Embodiment 12: The processed and displayed optical measurement provides data regarding at least 1 millimeter depth into the measured tissue, the system according to Embodiment 11.

[0142] Embodiment 13: The external device includes an algorithm for calculating and displaying the estimated depth of the lesion, the system according to Embodiment 11.

[0143] ​​​​​​​​​​​​​Embodiment 14: The system measures the birefringence of the tissue of the heart wall, as described in Embodiment 10 of the system described.

[0144] Embodiment 15: The location selected for optimal measurement of optical parameter changes is at the midpoint between two electrodes configured to serve as the positive node and the negative node for pulsed field ablation stimulation, as described in Embodiment 1 of the system described. of the system described.

[0145] Embodiment 16: When at least one of the electrodes is connected to at least one external device via the electrical connector above the proximal end of the catheter, it is configured to perform a plurality of functions, the functions being selected from electrical stimulation, electrogram measurement, electrocardiogram measurement, and tissue impedance measurement, as described in Embodiment 1 of the system described. of the system described.

[0146] Embodiment 17: The measurement 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, as described in Embodiment 1 of the system described. of the system described.

[0147] Embodiment 18: The distal end includes a plurality of some distal ends, each distal end providing its own electrode and optical port, and is configured in a parallel shape including a plurality of lines, circular shapes, or polygons, as described in Embodiment 1 of the system described.

[0148] Embodiment 19: The plurality of distal ends are configured in a three-dimensional rotational ellipsoid shape, as described in Embodiment 18 of the system described.

[0149] Exemplary Set of Embodiments #2 Embodiment 20: A system for ablating tissue of a heart wall, the system comprises a first catheter configured to be disposed within an outer sheath, the distal end thereof being configured to be straight and adapted for vascular delivery, the distal end assuming a circular shape when pushed through the sheath, the circular shape being in a plane parallel to the heart wall and configured to contact the heart wall, the first catheter; a second catheter configured to be longitudinally connected to the first catheter and configured to translate distally or proximally along the first catheter, the second catheter; comprising the second catheter further comprising a plurality of electrodes disposed on the distal end of the second catheter at a predetermined distance from each other, the electrodes being connected by wires to an external electrical energy generating device via an electrical connector on the proximal end of the second catheter, the electrodes being configured to deliver electrical energy to the heart wall when excited by the electrical energy generating device; the second catheter further comprising at least one optical port, the port comprising an optical component, the optical component being connected by an optical fiber to an external optical energy generating device via an optical connector on the proximal end of the second catheter, the optical component being configured configured to project optical energy into the heart wall when excited by and configured to receive and return optical energy reflected from the heart wall. and directing the reflected energy out through the fiber and the optical connector. a sensing device configured to receive the signal from the sensor and transmit the signal to the sensor; The at least one optical port is connected to the second optical port at a predetermined location relative to the electrode. a catheter having a distal end, the location being located on the distal end of the catheter; Optimal measurement of optical parameter changes caused by tissue ablation with The system of choice.

[0150] Embodiment 21: The first catheter is a planar catheter fixed against the heart wall. a catheter configured to provide a passageway for the second catheter to be advanced by an operator; The device is configured to remain in place while being translated distally or proximally about the tract. 21. The system of embodiment 20,

[0151] Embodiment 22: The second catheter is disposed over the second catheter. a first catheter connected to the first catheter by a lumen having a 21. The system of embodiment 20, wherein the system is configured to fit within the lumen. .

[0152] Embodiment 23: The second catheter is disposed over the first catheter. The second catheter is connected to the first catheter by a lumen having a 21. The system of embodiment 20, configured to fit within the lumen.

[0153] Embodiment 24: The first catheter is connected to the external electrical device and includes at least one of the electrodes or at least one of the optical ports connected to the external optical device, the system according to Embodiment 20.

[0154] Embodiment 25: At least a part of the side portion of the first catheter facing the heart wall portion is provided with at least one optically transparent opening, and the at least one optical port of the second catheter is configured to be aligned with the opening when translated to that location, the system according to Embodiment 20.

[0155] Embodiment 26: The second catheter can be rotated around the longitudinal axis thereof with respect to the first catheter, the system according to Embodiment 20.

[0156] Embodiment 27: The second catheter is rotationally aligned within the first catheter to ensure that the optical port is directed towards the heart wall portion, and further, the second catheter includes means for prohibiting rotation around the longitudinal axis thereof with respect to the first catheter, the system according to Embodiment 20.

[0157] Embodiment 28: The first and second catheters are each provided with at least one electrode, and the pair of electrodes are in electrical contact with each other when the second catheter is translated to a specific location, and the electrical contact establishes a connection to one of the pair of electrodes in contact with the heart wall portion from an external electrical device, the system according to Embodiment 20. ​

[0158] Embodiment 29: The longitudinal axes of the first and second catheters are concentric. The system according to Embodiment 20.

[0159] Embodiment 30: The longitudinal axes of the first and second catheters are separate and parallel. The system according to Embodiment 20.

[0160] Embodiment 31: The side portion of the second catheter configured to contact the heart wall is flattened to produce a semi-circular cross-section of the catheter, and the flattened side portion is configured to maximize the contact area between the side portion and the heart wall. The system according to Embodiment 20. The system according to Embodiment 20. The system according to Embodiment 20.

[0161] Embodiment 32: The circular shape is an oval shape, a polygonal shape, or a combination of an oval shape and a polygonal shape. The system according to Embodiment 20.

[0162] Embodiment 33: The optical component is selected from a focusing lens, a turning mirror, a diffraction grating, a GRIN lens, an optical tap, an optical coupler, an optical polarizer. The system according to Embodiment 20. The system according to Embodiment 20.

[0163] Embodiment 34: The electrical energy delivered to the heart wall by the plurality of electrodes is configured to ablate the tissue of the heart wall by at least one process selected from radiofrequency ablation, thermal ablation, pulsed field ablation, or irreversible electroporation. The system according to Embodiment 20. The system according to Embodiment 20. The system according to Embodiment 20. The system according to Embodiment 20.

[0164] Embodiment 35: The system operator can select the type of electrical energy delivered by the control device over the external electrical energy device , the system according to embodiment 34.

[0165] Embodiment 36: The external optical energy generating device, the at least one optical port, and the external optical sensing device are configured to perform the optical measurement of the optical parameter change by at least one process selected from optical coherence tomography, optical co herence reflectometry, low coherence interferometry, polarization uniformity measurement, polarization sensitive optical co herence tomography, reflection intensity, spectroscopy, Raman spectroscopy, and near-infrared spectroscopy , the system according to embodiment 20.

[0166] Embodiment 37: The optical measurement can be processed and displayed by an external device, and can show at least one of the contact stability, tissue survival rate, tissue type, tissue depth, tissue composition between the optical port and the heart wall portion, the system according to embodiment 36.

[0167]

[0168] Embodiment 38: The processed and displayed optical measurement provides data regarding at least 1 millimeter depth into the tissue being measured, the system according to embodiment 37.

[0169] ​​​​​​​​Embodiment 40: The system measures the birefringence of the tissue of the heart wall, as described in Embodiment 36 of the system described.

[0170] Embodiment 41: The location selected for optimal measurement of optical parameter changes is at the midpoint between two electrodes configured to serve as the positive and negative nodes for pulsed field ablation stimulation, as described in Embodiment 20 of the system described.

[0171] Embodiment 42: When at least one of the electrodes is connected to at least one external device via the electrical connector on the proximal end of the catheter, it is configured to perform a plurality of functions, the functions being selected from electrical stimulation, electrogram measurement, electrocardiogram measurement, tissue impedance measurement, as described in Embodiment 20 of the sys tem described. tem.

[0172] Embodiment 43: The measurement 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, as described in Embodiment 20 of the system described. of the system described.

[0173] Embodiment 44: The distal end includes a plurality of some distal ends, each distal end providing its own electrode and optical port, and is configured in a parallel shape including a plurality of lines, circular shapes, or polygons, as described in Embodiment 20 of the system described.

[0174] Embodiment 45: The plurality of distal ends are configured in a three-dimensional rotational ellipsoid shape, as described in Embodiment 44 of the system described.

[0175] Embodiment 46: The system according to embodiment 44, wherein the second catheter is steerable to select a distal end portion into which it will translate.

[0176] Embodiment 47: The system according to embodiment 20, wherein the second catheter is translated completely distally relative to the first catheter.

[0177] Embodiment 48: The system according to embodiment 20, wherein the first catheter is inserted into the outer sheath between the vascular deliveries without the second catheter, and the second catheter is translated to the distal portion of the first catheter after the first catheter is pushed through the sheath.

[0178] Embodiment 49: The system according to embodiment 20, wherein the second catheter is fixed to prevent longitudinal translation relative to the first catheter.

[0179] Embodiment 50: The system according to embodiment 49, wherein the second catheter is configured to selectively rotate relative to the first catheter, and further, the optical port is disposed around the circumference of the second catheter, and only one port is adapted to directly face the heart wall portion over a given rotational angle.

[0180] Embodiment 51: The system according to embodiment 20, further comprising user controls configured to facilitate precise movement of the second catheter relative to the first catheter.

[0181] Embodiment 52: The user control is positioned on one of the catheter handle of the system and an external device connected to the catheter, the system according to Embodiment 51.

[0182] Embodiment 53: The user control includes at least one of a motor, a stepper motor, a gearing system, a rotary knob, a slider switch, a computer screen and an input device, and a display indicating a precise location, the system according to Embodiment 51.

[0183] Exemplary Embodiment Set #3 Embodiment 54: A method for ablating heart tissue, the method comprising: inserting a sheath including a first catheter device into a heart cavity; pushing the first catheter device through the sheath, the first catheter being configured to have a planar shape, the plane of the shape being oriented parallel to the heart cavity wall; translating a second catheter longitudinally along the first catheter, the second catheter being configured to follow a path defined by the shape of the first catheter, the second catheter further having electrodes configured to sense electrical parameters and deliver electrical energy, the second catheter further having an optical port configured to deliver optical energy to the heart wall and transfer and return the reflected optical energy to an externally connected optical measurement device. ​​​​​​​​​​​​​​​​a step that has been performed, and translating the second catheter at a desired location around the path of the planar shape temporarily stopping and delivering electrical energy to selectively ablate heart wall tissue a step of; applying optical energy, measuring the reflected energy, and evaluating optical parameters indicating contact stability, tissue viability as well as lesion size and depth; while fixing the position of the first catheter, repeating the step of distal or proximal translation of the second catheter, applying electrical stimulation, and performing optical measurements as necessary to ensure that a continuous lesion is at the desired location; removing the catheter system; and a method comprising.

[0184] Embodiment 55: The catheter system is the method according to Embodiment 54, comprising any of the catheter systems from Embodiments 20 to 55.

[0185] Exemplary computing embodiments FIG. 23 is a block diagram of exemplary components of a computer system 2300. One or more computer systems 2300 can be used, for example, to implement any of the embodiments discussed herein, as well as combinations and sub - combinations thereof. In some embodiments, one or more computer systems 2300 can be used to implement methods, computing, and processing devices as described herein. The computer system 23 00 includes one or more processors (also referred to as central processing units or CPUs) (for example), and as described herein, the computer system 23 00 can be used to implement methods, computing, and processing devices. The computer system 23 00 includes one or more processors (also called central processing units or CPUs) (for For example, it can include a processor 2304, etc.). The processor 2304 is capable of being connected to a communication infrastructure or bus 2306.

[0186] Also, the computer system 2300 can include a user input / output interface 23 02 (such as a monitor, keyboard, pointing device, etc.), and it is capable of communicating with the communication infrastructure 2306 through the user input / output interface 2303.

[0187] One or more of the processors 2304 can be a graphics processing unit (GPU). In certain embodiments, the GPU can be a processor that is a specialized electronic circuit designed to process mathematically intensive applications. The GPU can have a parallel structure that is efficient for parallel processing of large blocks of data (such as mathematically intensive data, images, videos, etc. common to computer graphics applications).

[0188] Also, the computer system 2300 can include a main memory or primary memory 230 8 (such as random access memory (RAM), etc.). The main memory 2308 can include one or more levels of cache. The main memory 2308 can have control logic (i.e., computer software) and / or data stored therein. In some embodiments, the main memory 2308 is optical obtained from tissue by a catheter. configured to perform processing and analysis of measurement values and to determine lesion prediction and can include optical logic.

[0189] Also, computer system 2300 can include one or more secondary storage devices or memories 2310. Secondary memory 2310 can include, for example, hard disk drive 2312 and / or removable storage drive 231 4.

[0190] Removable storage drive 2314 can interact with removable storage unit 231 8. Removable storage unit 2318 can include a computer-usable or readable storage device and the storage device can have computer software (control logic and / or data stored therein. Removable storage unit 2318 can be a program cartridge and cartridge interface (such as those found in video game devices), a removable memory chip (such as an EPROM or PROM, etc.) and associated socket, a memory stick and USB port , a memory card and associated memory card slot, and / or any other removable storage unit and associated interface. Removable storage drive 2314 can read from and / or write to removable storage unit 231 8. Removable storage drive 2314 can read from and / or write to removable storage unit 231 8.

[0191] The secondary memory 2310 enables a computer program and / or other instructions and / or data to be accessed by the computer system 2300, and may include other means, devices, components, expedients, or other approaches for this purpose. Such means, devices, components, expedients, or other approaches may include, for example, a removable storage unit 2322 and an interface 2320. Examples of the removable storage unit 2322 and the interface 2320 include a program cartridge and a cartridge interface (such as those found in video game devices), a removable memory chip (such as an EPROM or PROM), and associated socket, a memory stick and a USB port, a memory card and an associated memory card slot, and / or any other removable storage unit and associated interface. The computer system 2300 may further include a communication or network interface 2324. The communication interface 2324 enables the computer system

[0192] 2300 to communicate and interact with any combination of external devices, external networks, external entities, etc. (individually and collectively (as referenced by reference numeral 2328)). For example, the communication interface 2324 enables the computer system 2300 to communicate with an external or remote device via a communication path 2326. ​It can be made possible to communicate with the autodevice 2328, and the communication path 2326 can be wired and / or wireless (or a combination thereof), which can include any combination such as LAN, WAN, the Internet, etc. Control logic and / or data can be transmitted to and from the computer system 2300 via the communication path 2326. In some embodiments, the computer system 2300 can be connected to the catheter via connectors and optical and electrical connections at the communication interface 2324 (including optical fibers and electrical wires, pins, and / or components). It can be wired and / or wireless (or a combination thereof), which can include any combination such as LAN, WAN, the Internet, etc. Control logic and / or data can be transmitted to and from the computer system 2300 via the communication path 2326. In some embodiments, the computer system 2300 can be connected to the catheter via connectors and optical and electrical connections at the communication interface 2324 (including optical fibers and electrical wires, pins, and / or components). In some embodiments, the computer system 2300 can be connected to the catheter via connectors and optical and electrical connections at the communication interface 2324 (including optical fibers and electrical wires, pins, and / or components). In some embodiments, the computer system 2300 can be connected to the catheter via connectors and optical and electrical connections at the communication interface 2324 (including optical fibers and electrical wires, pins, and / or components). In some embodiments, the computer system 2300 can be connected to the catheter via connectors and optical and electrical connections at the communication interface 2324 (including optical fibers and electrical wires, pins, and / or components). In some embodiments, the computer system 2300 can be connected to the catheter via connectors and optical and electrical connections at the communication interface 2324 (including optical fibers and electrical wires, pins, and / or components).

[0193] Also, the computer system 2300 can be, by way of some non-limiting examples, a personal digital assistant (PDA), a desktop workstation, a laptop computer or notebook computer, a netbook, a tablet, a smartphone, a smartwatch or other wearable, a household appliance, a part of the Internet of Things, and / or an embedded system, or any combination thereof. Also, the computer system 2300 can be, by way of some non-limiting examples, a personal digital assistant (PDA), a desktop workstation, a laptop computer or notebook computer, a netbook, a tablet, a smartphone, a smartwatch or other wearable, a household appliance, a part of the Internet of Things, and / or an embedded system, or any combination thereof. Also, the computer system 2300 can be, by way of some non-limiting examples, a personal digital assistant (PDA), a desktop workstation, a laptop computer or notebook computer, a netbook, a tablet, a smartphone, a smartwatch or other wearable, a household appliance, a part of the Internet of Things, and / or an embedded system, or any combination thereof. Also, the computer system 2300 can be, by way of some non-limiting examples, a personal digital assistant (PDA), a desktop workstation, a laptop computer or notebook computer, a netbook, a tablet, a smartphone, a smartwatch or other wearable, a household appliance, a part of the Internet of Things, and / or an embedded system, or any combination thereof. Also, the computer system 2300 can be, by way of some non-limiting examples, a personal digital assistant (PDA), a desktop workstation, a laptop computer or notebook computer, a netbook, a tablet, a smartphone, a smartwatch or other wearable, a household appliance, a part of the Internet of Things, and / or an embedded system, or any combination thereof. Also, the computer system 2300 can be, by way of some non-limiting examples, a personal digital assistant (PDA), a desktop workstation, a laptop computer or notebook computer, a netbook, a tablet, a smartphone, a smartwatch or other wearable, a household appliance, a part of the Internet of Things, and / or an embedded system, or any combination thereof.

[0194] The computer system 2300 can be a client or a server, including, but not limited to, remote or distributed cloud computing solutions, local or on-premises software (an "on-premises" cloud-based solution), an "as-a-service" model (e.g., content as a service). The computer system 2300 can be a client or a server, including, but not limited to, remote or distributed cloud computing solutions, local or on-premises software (an "on-premises" cloud-based solution), an "as-a-service" model (e.g., content as a service). The computer system 2300 can be a client or a server, including, but not limited to, remote or distributed cloud computing solutions, local or on-premises software (an "on-premises" cloud-based solution), an "as-a-service" model (e.g., content as a service). The computer system 2300 can be a client or a server, including, but not limited to, remote or distributed cloud computing solutions, local or on-premises software (an "on-premises" cloud-based solution), an "as-a-service" model (e.g., content as a service). S(CaaS), Digital Content as a Service (DCaaS), Software as a Service (SaaS), Managed Software as a Service (MSaaS), Pla tform as a Service (PaaS), Desktop as a Service (DaaS), Framework as a Service (FaaS), Backend as a Service (BaaS) , Mobile Backend as a Service (MBaaS), Infrastructure as a Service (IaaS), etc.), and / or a hybrid model including any combination of the aforementioned examples or other services or delivery paradigms, through any delivery paradigm, it is possible to access and / or host any application and / or data.

[0195] Any applicable data structures, file formats, and schemes in computer system 2300 include, but are not limited to, JavaScript Obj ect Notation (JSON), Extensible Markup Lan guage (XML), Yet Another Markup Language (Y AML), Extensible Hypertext Markup Languag e (XHTML), Wireless Markup Language (WML), M essagePack, XML User Interface Language (X UL), or any other functionally similar representation, either alone or in combination, can be derived from standards. Alternatively, exclusively, or in any combination with known or open standards, a proprietary data structure, format, or scheme can be used. ​ obtained

[0196] In some embodiments, it includes a tangible non-transitory computer-usable or readable medium having control logic (software) stored thereon A tangible non-transitory device or article of manufacture including such a tangible non-transitory medium is herein also referred to as a computer program product or a program storage device. This includes, but is not limited to, a tangible article of manufacture embodying the computer system 23 00, main memory 2308, secondary memory 2310, and removable storage units 2318 and 2322, and any combination of the foregoing. Such control logic can cause such data processing devices to operate as described herein when executed by one or more data processing devices (such as computer system 2300, etc.).

[0197] Conclusion The clinical ablation procedures described above need not include all of the steps as described, and it will be apparent to those skilled in the art that such steps need not be in the exact order presented

[0198] It should be recognized that the detailed description section (and not the summary and abstract sections of the invention) is intended to be used in interpreting the claims The summary and abstract sections of the invention describe one or more (but not all) exemplary embodiments of the disclosure as contemplated by the inventor ​​​​​​​​may be, and thus, the present disclosure and the appended claims are not intended to be limited thereby intentionally.

[0199] Embodiments of the present disclosure have been described above with the aid of functional building blocks that illustrate the implementation of its specific functions and relationships. The boundaries of these functional building blocks are arbitrarily defined herein for the sake of convenience of description. Alternative boundaries may be defined as long as the specific functions and relationships are appropriately implemented.

[0200] The foregoing description of specific embodiments fully and completely discloses the general nature of the present disclosure so that others, by applying the knowledge within the skills of the art, can, without undue experimentation, modify and / or adapt such specific embodiments for various applications without departing from the general concept of the present disclosure. Accordingly, such adaptations and modifications are intended to be within the meaning and scope of the disclosed embodiments and their equivalents based on the teachings and guidance presented herein. It should be understood that the terminology or jargon herein is for the purpose of description and not of limitation, and that such terminology or jargon should be interpreted by those skilled in the art as would be consistent with the teachings and guidance.

[0201] The breadth and scope of the present disclosure should not be limited by any of the exemplary embodiments described above, but should be defined only in accordance with the following claims and their equivalents.

[0202] ​​​​​​​​​​​​​​ In addition, the following aspects are explicitly disclosed:

[0203] 1. A system comprising: A catheter comprising: A proximal section, A distal section, A shaft connected between the proximal section and the distal section, and An optical circuit configured to transport light at least partially from the proximal section to the distal section and vice versa; A pulsed-field ablation energy source connected to the catheter and configured to transmit a pulsed electrical signal to a tissue sample; And a processing device The processing device is configured to analyze one or more optical signals received from the optical circuit and 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 or phase delay. System. Including, The processing device is configured to analyze one or more optical signals received from the optical circuit and 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 or phase delay. And, Based on the change in polarization or phase delay, determine a change in birefringence of the tissue sample. System configured as such.

[0204] 2. The system according to aspect 1, wherein the optical circuit is configured to transport light at least partially from the proximal section to the distal section and vice versa by using at least partially a polarization-maintaining transmission medium within the shaft. The optical circuit is configured to transport light at least partially from the proximal section to the distal section and vice versa by using at least partially a polarization-maintaining transmission medium within the shaft. System according to aspect 1.

[0205] 3. The system according to aspect 1 or aspect 2, wherein the pulsed electrical signal transmitted by the pulsed-field ablation energy source is monophasic or biphasic. System according to aspect 1 or aspect 2.

[0206] 4. The polarization or phase retardation change of light reflected or scattered by the tissue sample responds to the pulsed electrical signal transmitted to the tissue sample, and is the system according to any one of Aspects 1 to 3. 5. The one or more optical signals include the optical coherence tomography (OCT) signal or the optical coherence reflectometry (OCR) signal acquired by the tissue sample, and is the system according to any one of Aspects 1 to 4. 6. The optical circuit is configured to transmit light from the distal section to the tissue sample, and is the system according to any one of Aspects 1 to 5.

[0207] 7. The distal section of the catheter includes a plurality of optical ports configured to collect light reflected or scattered from the tissue sample, and is the system according to any one of Aspects 1 to 6. 8. The characteristics of the pulsed electrical signal are selected by the user of the catheter, and the characteristics include the frequency, amplitude, and duration of the pulsed electrical signal, and is the system according to any one of Aspects 1 to 7. 9. A method for performing ablation in a patient, the method comprising: inserting a catheter into the patient's vasculature; moving the distal end of the catheter to an ablation site in the patient's vasculature; and establishing tissue contact at the distal end of the catheter through an optical means using light delivered to the ablation site through the distal end of the catheter.

[0208] 10. The method further includes: generating a pulsed electrical signal at the proximal end of the catheter; transmitting the pulsed electrical signal to the distal end of the catheter; and changing the polarization or phase retardation of light reflected or scattered by the tissue sample in response to the pulsed electrical signal transmitted to the tissue sample. 11. The one or more optical signals include the optical coherence tomography (OCT) signal or the optical coherence reflectometry (OCR) signal acquired by the tissue sample, and the method further includes: analyzing the OCT signal or the OCR signal to obtain information about the tissue sample; and adjusting the pulsed electrical signal based on the information about the tissue sample.

[0209] 12. The optical circuit is configured to transmit light from the distal section to the tissue sample, and the method further includes: adjusting the intensity and / or wavelength of the light transmitted to the tissue sample based on the information about the tissue sample. 13. The distal section of the catheter includes a plurality of optical ports configured to collect light reflected or scattered from the tissue sample, and the method further includes: analyzing the light collected by the optical ports to obtain information about the tissue sample; and adjusting the pulsed electrical signal based on the information about the tissue sample. 14. The characteristics of the pulsed electrical signal are selected by the user of the catheter, and the method further includes: adjusting the characteristics of the pulsed electrical signal based on the information about the tissue sample.

[0210] 15. The method further includes: monitoring the tissue contact established at the distal end of the catheter; and adjusting the pulsed electrical signal based on the monitoring result to maintain the tissue contact. 16. The method further includes: monitoring the ablation process; and adjusting the pulsed electrical signal based on the monitoring result to control the ablation effect. 17. The method further includes: removing the catheter from the patient's vasculature after the ablation is completed.

[0211] 18. A system for performing ablation in a patient, the system including: a catheter having a proximal end and a distal end, the distal end including an optical means for delivering light to an ablation site in the patient's vasculature and a plurality of optical ports for collecting light reflected or scattered from the tissue sample; a light source for generating light; an optical circuit for transmitting the light from the light source to the distal end of the catheter; a signal generator for generating a pulsed electrical signal at the proximal end of the catheter; and a controller for controlling the signal generator and analyzing the light collected by the optical ports. 19. The optical means includes a fiber optic cable, and the system further includes: a polarization controller for changing the polarization of the light transmitted through the fiber optic cable; and a phase retardation controller for changing the phase retardation of the light transmitted through the fiber optic cable. 20. The one or more optical signals include the optical coherence tomography (OCT) signal or the optical coherence reflectometry (OCR) signal acquired by the tissue sample, and the system further includes: an OCT analyzer for analyzing the OCT signal; and an OCR analyzer for analyzing the OCR signal. 21. The optical circuit is configured to transmit light from the distal section to the tissue sample, and the system further includes: a light intensity adjuster for adjusting the intensity of the light transmitted to the tissue sample; and a light wavelength adjuster for adjusting the wavelength of the light transmitted to the tissue sample. 22. The distal section of the catheter includes a plurality of optical ports configured to collect light reflected or scattered from the tissue sample, and the system further includes: a light collector for collecting the light collected by the optical ports; and a signal processor for analyzing the light collected by the light collector. 23. The characteristics of the pulsed electrical signal are selected by the user of the catheter, and the system further includes: a signal adjuster for adjusting the characteristics of the pulsed electrical signal. Delivering energy from an energy source coupled to a catheter into tissue from a distal end portion of the catheter and, optically interrogating an ablation tissue site and determining a change in polarization or phase delay of light delivered to the ablation tissue site through the catheter and, removing the catheter from the vasculature A method comprising:

[0212] 10. The energy comprises a pulse train, the energy source comprises a pulsed field ablation energy source, the pulse train comprises a pulsed electrical signal, and the pulsed electrical signal is monophasic or biphasic, the method of aspect 9 wherein 11. The method of aspect 10, wherein the change in polarization or phase delay of the light is in response to a pulsed electrical signal delivered to the tissue

[0213] 12. The characteristics of the pulsed electrical signal are selected by a user of the catheter, and the characteristics include the frequency, amplitude, and duration of the pulsed electrical signal, the method of aspect 11 wherein

[0214] 13. The energy comprises radio frequency (RF), and the energy source comprises an RF energy source, the method according to any one of aspects 9 to 12 wherein 14. The catheter includes a shaft having a multimode transmission medium disposed therein, and the multimode transmission medium enables the use of tissue spectrometry to determine the depth of an anatomical structure in a patient

[0215] 15. The method according to any one of aspects 9 to 14, wherein the energy is delivered to the tissue at a power level of about 10 W to about 30 W

[0216] 16. The method according to any one of aspects 9 to 15, wherein the catheter is removed from the vasculature after the ablation tissue site has been interrogated wherein 17. The method according to any one of aspects 9 to 16, wherein the multimode transmission medium is configured to transmit light having a wavelength in the range of about 700 nm to about 1100 nm The method according to any one of aspects 9 to 13, used to enable.

[0217] 15. A catheter for ablating tissue of the heart wall, the catheter comprising: a proximal end, a distal end, a plurality of electrodes disposed on the distal end at a predetermined distance from each other, at least one optical port positioned on the distal end at a predetermined location with respect to the plurality of electrodes and the catheter is configured to be installed within an outer sheath, and the distal end is straight and configured to be suitable for vascular delivery, and the distal end takes a circular shape when pushed through the sheath, the plurality of electrodes are connected by wires to an external electrical energy generating device via an electrical connector on the proximal end of the catheter, the plurality of electrodes are configured to deliver electrical energy to the heart wall when excited by an external electrical energy generating device, at least one optical port includes an optical component, and the optical component is connected by an optical fiber to an external optical energy generating device via an optical connector on the proximal end of the catheter, and the optical component is configured to project optical energy into the heart wall when excited by an optical energy generating device, and is configured to receive and return the optical energy reflected from the heart wall, and is configured to transfer the reflected optical energy through the optical fiber and the optical connector to an external optical sensing device. A catheter.

[0218] ​​ 16. The circular shape of the distal end is in a plane parallel to the heart wall and is configured to contact the heart wall, the catheter according to aspect 15.

[0219] 17. The location of at least one optical port is selected for optimal observation of optical parameter changes caused by tissue ablation due to excitation of a plurality of electrodes, the catheter according to aspect 15 or aspect 16.

[0220] 18. The electrical energy delivered by the external electrical energy generating device includes a pulsed electrical signal, the catheter according to any one of aspects 15 to 17.

[0221] 19. The pulsed electrical signal is monophasic or biphasic, the catheter according to aspect 18.

[0222] 20. The electrical energy delivered by the external electrical energy generating device includes radio frequency (RF) energy, the catheter according to any one of aspects 15 to 19.

Description of Signs

[0223] 100 Catheter 101 Console 102 Ablation energy source 103 Cooling source 104 User interface 105 Optical fiber 106 Electrical cable wiring, wire 107 Patient 200 Proximal section 201 Distal section 202 Shaft 204 Wiring 205 Connector 213 External electrode 214 Catheter tip 215 Radiopaque marker 216 Irrigation orifice 300 Lens 301 Coplanar 302 Surface 303 Recess 304 Splitting element 305 Glue, adhesive 306 Central cooling channel 307 Cooling communication path 308 Optical viewport 400 Petal-like configuration 401 Loop configuration 402 3D spherical configuration 403 Spiral structure 404 Spiral structure 500 Optical circuit 502 Optical supply source 504 Splitting element 506 Sample arm 508 Reference arm 510 Sample 512 Delay unit 514 Detector 600 Myocardial tissue 601 Non-ablated area 602 PFA-ablated tissue 603 Gap 604 Cell nucleus 800 PFA-OCR catheter 801 Body part 802 Electrode 802A Electrode 802B Electrode 803 Optical port, opening 803A Opening 803B Opening 901 Endocardial wall part 902 Wire lumen 903 Optical lumen 1001 Optical catheter 1002 Optical energy 1003 Opening 1101 Groove portion 1102 Tongue portion 1201 Catheter body portion 1202 Optical fiber cable 1203 Lens 1203B Lens 1204 Mirror 1401 Outer catheter 1402 Inner catheter 1500 Outer catheter 1501 Body portion 1502 Electrode 1503 Opening 1504 Inner catheter 1505 Catheter body portion 1506 Electrode 1508 Wire lumen 1509 Wire 1510 Internal mechanical structure 1511 Groove portion 1512 Tongue portion 2100 PFA - OCR catheter 2101 Outer catheter 2102 Inner optical catheter 2103 Opening 2103B Opening 2104 Optical assembly 2104A Optical assembly 2104B Optical assembly 2104C Optical assembly 2105 Optical fiber 2106 Opening 2106A Opening 2106B Opening 2106C Opening 2107B Input optical energy 2108B Optical energy 2300 Computer system 2302 User input / output interface 2303 User Input / Output Device 2304 Processor 2306 Communication Infrastructure 2308 Main Memory 2310 Secondary Memory 2312 Hard Disk Drive 2314 Removable Storage Drive 2318 Removable Storage Unit 2320 Interface 2322 Removable Storage Unit 2324 Communication Interface 2326 Communication Path 2328 Remote Device, Network, Entity

Claims

1. 1. A system comprising: A catheter comprising: Proximal section, Distal section, a shaft coupled between the proximal section and the distal section; and a catheter including an optical circuit configured to at least partially transport light from the proximal section to the distal section and vice versa; a pulsed field ablation energy source coupled to the catheter and configured to deliver a pulsed electrical signal to the tissue sample; Processing device and Including, The processing device comprises: analyzing 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; configured to determine a change in birefringence of the tissue sample based on the change in polarization or phase retardation; The change in polarization or phase delay of the light reflected or scattered by the tissue sample is responsive to the pulsed electrical signal transmitted to the tissue sample.

2. 2. The system of claim 1, wherein the optical circuit is configured to transport light at least partially from the proximal section to the distal section and vice versa, at least partially using a polarization-maintaining transmission medium in the shaft.

3. The system of claim 1 , wherein the pulsed electrical signal delivered by the pulsed field ablation energy source is monophasic or biphasic.

4. The system of claim 1 , wherein the one or more optical signals include an optical coherence tomography (OCT) signal or an optical coherence reflectometry (OCR) signal acquired by the tissue sample.

5. The system of claim 1 , wherein the optical circuit is configured to transmit the light from the distal section to the tissue sample.

6. The system of claim 1 , wherein the distal section of the catheter includes a plurality of optical ports configured to collect the light reflected or scattered from the tissue sample.

7. The system of claim 1 , wherein characteristics of the pulsed electrical signal are selected by a user of the catheter, the characteristics including a frequency, an amplitude, and a duration of the pulsed electrical signal.

8. The catheter comprises: a plurality of electrodes disposed on the distal section at predetermined distances from one another; at least one optical port positioned on the distal section at a predetermined location relative to the plurality of electrodes; Further comprising: the catheter is configured to be placed within an outer sheath such that the distal section assumes a straight configuration compatible with vascular delivery, the distal section assuming a circular shape when pushed through the outer sheath; the plurality of electrodes are configured to be connected by wires to the pulsed field ablation energy source via an electrical connector on the proximal section of the catheter; the plurality of electrodes are configured to deliver electrical energy to a tissue sample when excited by the pulsed field ablation energy source; the at least one optical port includes an optical component, the optical component being connected by an optical fiber to the optical circuit via an optical connector on the proximal section of the catheter; The optical component comprises: projecting optical energy into the tissue sample when excited by the optical circuit; receiving optical energy reflected from the tissue sample; The system of claim 1 , configured to transport the reflected optical energy through the optical fiber and the optical connector to the processing device.

9. The system of claim 8 , wherein the circular shape of the distal section lies in a plane parallel to the tissue sample and is configured to contact the tissue sample.

10. The system of claim 8 , wherein a location of the at least one optical port is selected for optimal observation of optical parameter changes caused by tissue ablation by excitation of the multiple electrodes.

11. The system of claim 8 , wherein the pulsed electrical signal is monophasic or biphasic.

12. The system of claim 8 , wherein the tissue sample is a cardiac wall.

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