Medical probe comprising a substantially hemispherical or semi-conical membrane

Abstract

The disclosed technology includes a distal end of a medical probe. The distal end includes: a ridge extending radially outward from a longitudinal axis of an end effector in an expanded configuration; a membrane connected to the ridge; a first flexible circuit disposed on a first surface of the membrane, adjacent to each of a plurality of ridges; a second flexible circuit disposed on a second surface of the membrane, adjacent to each of the plurality of ridges; a plurality of first pairs of electrodes disposed on the first flexible circuit, adjacent to each other and adjacent to the ridges of the plurality of ridges; and a plurality of second pairs of electrodes disposed on a second flexible circuit, adjacent to each other and adjacent to the ridges of the plurality of ridges, such that the first pairs of electrodes and the second pairs of electrodes define a mirror configuration.

Description

Technical Field

[0001] This technology relates generally to medical devices, and more specifically to medical probes with electrodes, and further but not exclusively to medical probes suitable for mapping or ablation of tissues. Background Technology

[0002] Arrhythmias, such as atrial fibrillation (AF), occur when a region of heart tissue abnormally transmits electrical signals to adjacent tissues. This disrupts the normal cardiac cycle and leads to irregular heartbeats. Certain procedures are used to treat arrhythmias, including surgically disrupting the signal source causing the arrhythmia and interfering with the conduction pathways used for such signals. By selectively ablating heart tissue through the application of energy via a catheter, it can sometimes be possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another.

[0003] Many current ablation methods in this field utilize radio frequency (RF) electrical energy to heat tissue. RF ablation may have certain heating-related risks, such as tissue charring, burns, steam bursts, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistula.

[0004] Cryoablation is an alternative to radiofrequency ablation (RF) ablation, which generally reduces the thermal risks associated with RF ablation. However, manipulating the cryoablation device and selectively applying cryoablation are often more challenging than with RF ablation; therefore, cryoablation is not feasible in certain anatomical geometries that can be reached by electroablation devices.

[0005] Some ablation methods use irreversible electroporation (IRE) to ablate cardiac tissue using non-thermal ablation methods. IRE delivers short pulses of high voltage to the tissue, generating irreversible cell membrane permeability. The delivery of IRE energy to tissue using multi-electrode probes has been previously disclosed in patent literature. Examples of systems and apparatus configured for IRE ablation are disclosed in U.S. Patent Publications 2021 / 0169550A1, 2021 / 0169567A1, 2021 / 0169568A1, 2021 / 0196372A1, 2021 / 0177503A1, and 2021 / 0186604A1, as well as U.S. Patent No. 11,540,877, the entire contents of each of which are incorporated herein by reference and are appended to this document.

[0006] Regions of cardiac tissue can be mapped via catheter to identify abnormal electrical signals. Some catheter ablation procedures, particularly those for persistent atrial fibrillation, can be performed using electrophysiological (EP) mapping of target areas of abnormal electrical signals. Such EP mapping may include the use of diagnostic electrodes configured to monitor electrical signals within the cardiovascular system to precisely pinpoint the location of arrhythmogenic, abnormally conductive tissue sites. An example of an EP mapping system is described in U.S. Patent No. 5,738,096, the entire contents of which are incorporated herein by reference. Examples of EP mapping catheters are described in U.S. Patent Nos. 9,907,480, 2018 / 0036078, and 2018 / 0056038, the entire contents of each of which are incorporated herein by reference.

[0007] In addition to EP mapping, some catheter ablation procedures can be performed using image-guided surgery (IGS) systems. IGS systems allow physicians to visually track the catheter's position within the patient's body in real time, relative to images of the patient's anatomy. Some systems offer a combination of EP mapping and IGS functionality, including Biosense Webster, Inc. of Irvine, Calif's CARTO 3. ® system.

[0008] In current practice, the effectiveness of IRE energy delivery depends on the physician's skill, meaning patients may suffer from incomplete isolation of the target area. To effectively deliver IRE energy for ablation, the ablation catheter typically needs to be reoriented multiple times during the procedure, increasing procedure time and complicating the ablation process. Furthermore, existing catheters often require rigid internal structural members to ensure the maintenance of a predetermined configuration. However, this rigidity is disadvantageous when operating within human organs, as it hinders electrode contact with tissue. Other catheters may include flexible end effectors designed to overcome this drawback. These catheters may include time-consuming, complex, and expensive layered components that are difficult to manufacture and assemble. Therefore, there is a need for an improved end effector for a medical probe that addresses these issues and is capable of both ablation and mapping. Summary of the Invention

[0009] According to the disclosed technology, an end effector for a medical probe is provided, the end effector comprising: a plurality of ridges extending radially outward from a longitudinal axis of the end effector in an expanded configuration; a membrane connected to the plurality of ridges, the membrane including a distal end around the longitudinal axis and defining a volume having an open end, the membrane including a first surface and a second surface opposite the first surface; a first flexible circuit disposed on the first surface of the membrane, adjacent to each of the plurality of ridges and extending around the longitudinal axis; a second flexible circuit disposed on the second surface of the membrane, adjacent to each of the plurality of ridges and extending around the longitudinal axis; a plurality of first pairs of electrodes disposed on the first flexible circuit, adjacent to each other and adjacent to the ridges of the plurality of ridges; and a plurality of second pairs of electrodes disposed on the second flexible circuit, adjacent to each other and adjacent to the ridges of the plurality of ridges, such that the first pairs of electrodes and the second pairs of electrodes define a mirror configuration, wherein the membrane is located between the first pairs of electrodes and the second pairs of electrodes.

[0010] According to the disclosed technology, a medical system is also provided, comprising: a medical probe including an elongated probe body and an end effector connected to a distal end of the elongated probe body, the elongated probe body and the end effector extending along a longitudinal axis, the end effector including: a plurality of ridges connected to the elongated probe body and extending radially outward from the longitudinal axis of the end effector in an expanded configuration; a membrane connected to the plurality of ridges, the membrane including a distal end surrounding the longitudinal axis and defining a volume having an open end, the membrane including a first surface and a second surface opposite to the first surface; and a first flexible circuit disposed on the first surface of the membrane, near the plurality of ridges. Each of the plurality of ridges extends about a longitudinal axis; a second flexible circuit is disposed on a second surface of the membrane, close to each of the plurality of ridges and extending about a longitudinal axis; a plurality of first pairs of ablation electrodes are disposed on the first flexible circuit and close to each other and close to the ridges of the plurality of ridges; and a plurality of second pairs of electrodes are disposed on the second flexible circuit, close to each other and close to the ridges of the plurality of ridges, such that the first pairs of electrodes and the second pairs of electrodes define a mirror configuration, wherein the membrane is located between the first pairs of electrodes and the second pairs of electrodes; and an ablation generator is configured to provide ablation pulses to the plurality of first pairs of electrodes and the plurality of second pairs of electrodes.

[0011] According to the disclosed technology, a method for manufacturing an end effector for a medical probe is also provided, the method comprising: forming a plurality of ridges extending away from a longitudinal axis; disposing a first flexible circuit on a first side of the plurality of ridges, the first flexible circuit including a first flexible substrate and a first pair of electrodes; disposing a second flexible circuit on a second side of the plurality of ridges, the second flexible circuit including a second flexible substrate and a second pair of electrodes; placing a first sheet of insulating material in contact with the first flexible circuit, the first sheet surrounding the longitudinal axis; placing a second sheet of insulating material in contact with the second flexible circuit, the second sheet surrounding the longitudinal axis and defining a volume having an open end; and molding the first sheet and the second sheet to encapsulate the first flexible circuit and the second flexible circuit. Attached Figure Description

[0012] Figure 1 This is a schematic diagram of a medical system based on the disclosed technology, the medical device including a medical probe having a distal end with electrodes.

[0013] Figure 2A It is a schematic illustration showing a perspective view of the distal side of the distal end of a medical probe in an expanded configuration according to the disclosed technology.

[0014] Figure 2B It is a schematic illustration of a perspective view of the distal side of an alternative configuration of the distal end of a medical probe in an expanded configuration according to the disclosed technology.

[0015] Figure 3 This illustrates an expanded configuration based on the disclosed technology. Figure 2A A schematic diagram of the perspective view of the proximal side of the distal end of a medical probe;

[0016] Figure 4A It is shown that along the distal end according to the disclosed technology Figure 2A A schematic diagram of the cross-sectional view taken by line 4A-4A in the diagram;

[0017] Figure 4B This demonstrates the technology disclosed. Figure 2B A schematic illustration of a cross-sectional view of an alternative configuration of the distal end, which is similar to... Figure 4A A sectional view;

[0018] Figure 5A This demonstrates the technology disclosed. Figure 4A A schematic illustration of detail A in the diagram shows an exemplary ablation configuration of the electrodes;

[0019] Figure 5B This demonstrates the relationship between the disclosed technology and... Figure 5ASimilar detailed diagrams illustrate alternative ablation configurations of the electrodes;

[0020] Figure 5C This demonstrates the relationship between the disclosed technology and... Figure 5A Similar detailed diagrams illustrate alternative ablation configurations of the electrodes;

[0021] Figure 6 This demonstrates the technology disclosed. Figure 5A A schematic diagram with similar detail to the diagram shows an alternative configuration of the electrodes;

[0022] Figure 7 This demonstrates the technology disclosed. Figure 5A A schematic diagram with similar detail to the image shows an alternative configuration of the membrane;

[0023] Figure 8 This demonstrates the technology disclosed. Figure 5A A schematic diagram with similar detail to the image shows an alternative configuration of the membrane;

[0024] Figure 9 It is a schematic illustration showing a perspective view of the distal side of the other distal end of the expanded configuration according to the disclosed technology;

[0025] Figure 10 It is shown that, according to the disclosed technology, along the other distal end... Figure 9 A schematic diagram of the cross-sectional view taken by line 10-10 in the figure;

[0026] Figure 11 It is a schematic illustration of a perspective view of the distal side of another exemplary distal end in an expanded configuration according to the disclosed technology;

[0027] Figure 12 This illustrates the arrangement of the device within the sheath according to the disclosed technology. Figure 11 A schematic diagram of the side view of the distal end;

[0028] Figure 13 It is a flowchart depicting a method for manufacturing the distal end of a medical probe according to the disclosed technology;

[0029] Figure 14 This is a schematic diagram illustrating a first example electrode configuration for an example end effector according to the disclosed technology, the first example electrode configuration including an elongated ablation electrode and a diagnostic electrode positioned next to the ablation electrode;

[0030] Figure 15This is a schematic diagram illustrating a second example electrode configuration for an example end effector according to the disclosed technology, the second example electrode configuration including elongated ablation electrodes that are respectively segmented into parallel strips and diagnostic electrodes positioned next to the ablation electrodes;

[0031] Figure 16 This is a schematic diagram illustrating a third example electrode configuration for an example end effector according to the disclosed technology, the third example electrode configuration including a rectangular elongated ablation electrode and no diagnostic electrode; and

[0032] Figure 17 This is a schematic diagram illustrating a fourth example electrode configuration for an example end effector according to the disclosed technology, the fourth example electrode configuration including a rectangular elongated ablation electrode for diagnosing electrode interruption. Detailed Implementation

[0033] The following detailed description should be read in conjunction with the accompanying drawings, in which the same elements are labeled identically across the various figures. The drawings (not necessarily drawn to scale) depict selected examples and are not intended to limit the scope of this disclosure. The detailed description illustrates the principles of the disclosed technology by way of example, not limitation. This description will clearly enable those skilled in the art to prepare and use the disclosed technology, and describes several embodiments, adaptations, variations, alternatives, and uses of the disclosed technology, including what is currently believed to be the best mode for implementing the disclosed technology.

[0034] As used herein, the terms “about,” “approximately,” or “roughly” for any numerical value or range indicate suitable dimensional tolerances that allow a collection of parts or components to achieve the intended purpose as described herein. More specifically, “about” or “approximately” may refer to a range of ±20% of the enumerated value; for example, “about 90%” may refer to a range of 71% to 110% of the value. Furthermore, as used herein, the terms “patient,” “recipient,” “user,” and “examinee” refer to any human or animal examinee and are not intended to limit the system or method to human use, but the use of the subject matter in human patients represents a preferred embodiment. Similarly, the term “proximal” refers to a position closer to the operator or physician, while “distal” refers to a position further away from the operator or physician.

[0035] As discussed herein, the vascular system of the “patient,” “recipient,” “user,” and “subject” can be that of a human or any animal. It should be understood that the animal can be any applicable type, including but not limited to mammals, veterinary animals, livestock, or pets. For example, the animal can be a laboratory animal specifically selected to possess certain characteristics similar to humans (e.g., rats, dogs, pigs, monkeys, etc.). It should be understood that the subject can be, for example, any applicable human patient.

[0036] As discussed herein, “operator” may include physicians, surgeons, technicians, scientists, or any other individual or delivery device associated with the delivery of a multi-electrode catheter for the treatment of drug-resistant atrial fibrillation to a patient.

[0037] As discussed herein, when referring to the apparatus and corresponding systems of this disclosure, the term "ablation" refers to a component and structural feature configured to reduce or prevent the generation of unstable cardiac signals in cells by utilizing non-thermal energy, such as irreversible electroporation (IRE), and is interchangeably referred to herein as pulsed electric field (PEF) and pulsed field ablation (PFA). Throughout this disclosure, "ablation," when referring to the apparatus and corresponding systems of this disclosure, means non-thermal ablation of cardiac tissue for certain conditions, including but not limited to ablation for arrhythmias, atrial flutter, pulmonary vein isolation, supraventricular tachycardia, and ventricular tachycardia. The term "ablation" also includes known methods, apparatus, and systems for achieving various forms of body tissue ablation as understood by those skilled in the art.

[0038] As discussed herein, the terms "bipolar" and "monopolar," when used to refer to ablation protocols, describe different ablation protocols in terms of current path and electric field distribution. "Bipolar" refers to an ablation protocol utilizing a current path between two electrodes, both positioned at the treatment site; the current density and flux density at each of these electrodes are typically approximately equal. "Monopolar" refers to an ablation protocol utilizing a current path between two electrodes, wherein one electrode with high current density and high flux density is positioned at the treatment site, and a second electrode with relatively low current density and lower flux density is positioned away from the treatment site.

[0039] As discussed herein, the terms "biphase pulse" and "single-phase pulse" refer to the corresponding electrical signals. A "biphase pulse" is an electrical signal having a positive voltage phase pulse (referred to herein as "positive phase") and a negative voltage phase pulse (referred to herein as "negative phase"). A "single-phase pulse" is an electrical signal having only a positive phase or only a negative phase. Preferably, the system providing the biphase pulse is configured to prevent the application of a direct current (DC) voltage to the patient. For example, the average voltage of the biphase pulse may be zero volts relative to ground or other common reference voltage. Each phase of the biphase and single-phase pulses preferably has a square shape and a substantially constant voltage amplitude for most of the phase duration. The phases of the biphase pulse may be temporally separated by an interphase delay.

[0040] As discussed herein, the terms “tubular,” “tube,” and “shaft” should be interpreted broadly and are not limited to structures that are perfectly cylindrical or have a perfectly circular cross-section or a uniform cross-section over their entire length. For example, tubular / shaft structures are generally exemplified as substantially cylindrical structures. However, without departing from the scope of this disclosure, tubular / shaft structures may have tapered or curved outer surfaces.

[0041] This disclosure relates to systems, methods, uses, and devices for mapping and ablating cardiac tissue to treat arrhythmias. Ablation energy is typically delivered to the cardiac tissue via a distal portion of a catheter that delivers the energy along the tissue to be ablated. Some example catheters include a three-dimensional structure at their distal portion and are configured to apply ablation energy from various electrodes positioned on the three-dimensional structure. Fluoroscopy can be used to visualize ablation procedures incorporating such example catheters.

[0042] The use of thermal techniques such as radiofrequency (RF) energy and cryoablation to correct faulty heart tissue ablation is a well-known procedure. Typically, for successful ablation using thermal techniques, cardiac electrode potentials need to be measured at various locations within the myocardium. Furthermore, temperature measurements during ablation provide data enabling the ablation to be effective. Generally, for ablation procedures using thermal techniques, electrode potentials and temperatures are measured before, during, and after the actual ablation. RF methods can be risky, potentially leading to tissue charring, burns, vapor bursts, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas. Cryoablation is an alternative to RF ablation, reducing some of the thermal risks associated with it. However, manipulating cryoablation devices and selectively applying cryoablation is generally more challenging than with RF ablation; therefore, cryoablation is not feasible in certain anatomical geometries accessible by electroablation devices.

[0043] This disclosure may include electrodes configured for RF ablation, cryoablation, or irreversible electroporation (IRE). Throughout this disclosure, IRE is interchangeably referred to as pulsed electric field (PEF) ablation and pulsed field ablation (PFA). IRE, as discussed in this disclosure, is a non-thermal cell death technique that can be used for ablation of atrial arrhythmias. To perform ablation using IRE / PEF, a biphasic voltage pulse is applied to disrupt the cellular structures of the myocardium. The biphasic pulse is non-sinusoidal and can be tuned to target cells based on the electrophysiology of the cells. In contrast, to perform ablation using RF, a sinusoidal voltage waveform is applied to generate heat at the treatment area, thereby indiscriminately heating all cells in the treatment area. Therefore, IRE has the ability to avoid adjacent heat-sensitive structures or tissues, which is beneficial in reducing potential complications known to be affected by ablation or separation modes. In addition to or alternatively, monophasic pulses may be used.

[0044] refer to Figure 1This document illustrates an example catheter-based electrophysiological mapping and ablation system 10. System 10 includes multiple catheters inserted by a physician 24 through the skin into the chambers or vascular structures of the heart 12 via the patient's vascular system 23. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location within the heart 12. Multiple catheters can then be inserted into the delivery sheath catheter to reach that desired location. The multiple catheters may include catheters specifically for sensing intracardiac electrogram (IEGM) signals, catheters specifically for ablation, or catheters specifically for both sensing and ablation. An example catheter / medical probe 14 configured for sensing IEMM is illustrated herein. The physician 24 contacts the catheter shaft, having the distal end 28 of catheter 14 (e.g., a multilayer end effector 100), against the heart wall for sensing a target site within the heart 12. For ablation, the physician 24 similarly guides the distal end of the ablation catheter to the target site for ablation.

[0045] The catheter 14 includes multiple electrodes 160 (see...) Figure 2A and Figure 2B An exemplary catheter is provided, comprising multiple electrodes including an ablation electrode 161 and a diagnostic electrode 165. The diagnostic electrode 165 is positioned close to or surrounded by the ablation electrode 161 and is configured to sense an IEGGM signal and aid in confirming contact with tissue. In the example described herein, electrode 160 may be configured to deliver ablation energy (IRE or RF) to tissue within the heart 12. In addition to delivering ablation energy using electrode 160, electrode 160 may also be used to determine the location of end effector 100 or to measure physiological characteristics, such as local surface potential at a corresponding location on the tissue within the heart 12. Electrode 160 may be biased such that a larger portion of electrode 160 faces outward from end effector 100, such that electrode 160 delivers a larger amount of electrical energy outward away from end effector 100 (i.e., toward the tissue of heart 12) rather than inward toward end effector 100.

[0046] Examples of materials ideally suited for forming electrode 160 (which includes electrodes 161 and 165) include gold, platinum, and palladium (and their corresponding alloys). These materials also possess high thermal conductivity, which allows minimal heat generated on the tissue (i.e., by the ablation energy delivered to the tissue) to be conducted through the electrode to the back side of the electrode (i.e., the portion of electrode 160 on the inner side of the ridge), and then to the blood pool in the heart 12. Additionally, a silver epoxy resin / ink can be used to increase the surface area to reduce impedance and improve flexibility. In some examples, impedance-reducing coatings such as iridium oxide (IrOx) or platinum-iridium (PtIr) alloys can be employed.

[0047] The conduit 14 may additionally include a position sensor embedded in or near the distal end 28 for tracking the position and orientation of the distal end 28. Optionally and preferably, the position sensor is a magnetic position sensor comprising three magnetic coils for sensing three-dimensional (3D) position and orientation.

[0048] A magnetic-based position sensor operates in conjunction with a positioning pad 25, which includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predefined workspace. The real-time position of the distal end 28 of the conduit 14 can be tracked based on the magnetic field generated by the positioning pad 25 and sensed by the magnetic-based position sensor. Details of the magnetic-based position sensing technology are described in U.S. Patents 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091, each of which is incorporated herein by reference. The end effector 100 may also include one or more induction coils configured to provide electrical signals to a magneto-based position sensing system to determine the position or orientation of the end effector. For example, the end effector 100 may include designs similar to those described in U.S. Patent Publication No. 2024 / 0215894. Figure 5A and Figure 5B The induction loop or coil shown is incorporated herein by reference in its entirety and is appended to this document. In some examples, one or more induction coils in the end effector 100 may be used in conjunction with a position sensor to determine the position or orientation of the end effector 100.

[0049] System 10 includes one or more electrode patches 38 positioned to contact the skin of patient 23 to establish a position reference for impedance-based tracking of positioning pad 25 and electrodes 160. For impedance-based tracking, current is directed toward electrodes 160 and sensed at the electrode skin patch 38, allowing triangulation of the position of each electrode via the electrode patch 38. Details of the impedance-based position tracking technique are described in U.S. Patents 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference.

[0050] Recorder 11 displays an electrocardiogram 21 captured using surface ECG electrodes 18 and an intracardiac electrocardiogram (IEGM) captured using electrodes 160 of catheter 14. Recorder 11 may include pacing capability for pacing rhythms or may be electrically connected to a separate pacemaker.

[0051] System 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes of electrodes 160 configured for ablation at the distal end of a catheter. The energy generated by the ablation energy generator 50 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high-voltage DC or AC pulses, such as those used to achieve irreversible electroporation (IRE), or combinations thereof. The ablation energy generator 50 is preferably configured to provide biphasic bipolar pulses to induce IRE while maintaining tissue temperature below the thermal ablation temperature. Alternatively, the ablation energy generator 50 may be configured to provide monophasic IRE pulses, monopolar IRE pulses, thermal ablation electrical signals, or combinations thereof. For example, the ablation energy generator 50 may be configured to provide pulses similar to those described in U.S. Patent Publications 2021 / 0169550A1, 2021 / 0177503A1, 2021 / 0186604A1, and 2023 / 0009191A1, as well as U.S. Patent No. 11,540,877B2, the entire contents of which are incorporated herein by reference and are appended to this document. U.S. Patent No. 11,540,877B2 corresponds to U.S. Patent Publication 2021 / 0161592A1, the entire contents of which are incorporated herein by reference.

[0052] For example, as described in U.S. Patent No. 11,540,877B2, generator 50 may be configured to apply a bipolar pulse having an amplitude sufficient to induce an IRE in tissue contacted by the electrode, and RF energy having power sufficient to thermally ablate the tissue contacted by the electrode. In some embodiments, the bipolar pulse sequence comprises pulses having an amplitude of at least 200V, and each bipolar pulse has a duration of less than 20µs. Additionally, or alternatively, the RF signal has a frequency between 350kHz and 500kHz and an amplitude between 10V and 200V. The end effector may also include a temperature sensor, and the electrical signal generator may be configured to apply a signal in response to a temperature measured by the temperature sensor. In some embodiments, the IRE signal may have parameters as indicated in Table 1 of U.S. Patent No. 11,540,877B2. Note that the “bipolar pulse” described in U.S. Patent No. 11,540,877B2 is referred to herein as a “biphase pulse” and relates to the shape of an electrical signal; while the “bipolar pulse” as described herein relates to the arrangement of electrodes for receiving the pulse as defined above.

[0053] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between catheters, electrophysiological equipment, a power supply, and a workstation 55 for operating the system 10. The electrophysiological equipment of the system 10 may include, for example, multiple catheters, positioning pads 25, surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, the PIU 30 additionally has processing capabilities for real-time calculation of catheter position and for performing ECG calculations. The PIU 30 can control the generator 50 to supply electrical energy to the ablation electrodes of the end effector 100 according to the ablation protocol described above and in the references incorporated herein by reference. PIU 30, workstation 55, and generator 50 can be collectively considered as an ablation system console having one or more output ports configured to provide ablation energy to ablation electrodes, one or more processors, and a non-transitory computer-readable medium communicating with the processor to enable the ablation system console to provide ablation energy, as described above and in the examples below.

[0054] Workstation 55 includes a memory, a processor unit with a memory or storage device loaded with appropriate operating software, and user interaction capabilities. Workstation 55 may provide several functions, optionally including: (1) three-dimensional (3D) modeling of the endocardial anatomy and rendering the model or anatomical mapping 20 for display on display device 27; (2) displaying on display device 27, in the form of representative visual markers or images superimposed on the rendered anatomical mapping 20, an activation sequence (or other data) compiled from the recorded electrorecord 21; (3) displaying the real-time position and orientation of multiple catheters within the cardiac chambers; and (5) displaying on display device 27 sites of interest, such as those where ablation energy has been applied. A commercial product embodying the elements of system 10 could be CARTO. ™ 3 System was purchased from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0055] In some examples, system 10 also includes a flushing system configured to flush during IRE. In some embodiments, PIU 30 is configured to control the flushing system to provide flushing to the catheter end actuator, similar to that described in U.S. Patent Publication No. 2021 / 0196372A1, the entire contents of which are incorporated herein by reference and appended to this appendix. Flushing fluid may exit the distal end of catheter 14 through a port at the distal end of shaft 80 or through a hole in the body of end actuator 100.

[0056] Figure 2A This is a schematic illustration showing a perspective view of the distal side of the distal end 28 of the catheter 14. Figure 3 This is a schematic diagram showing a perspective view of the proximal side of the distal end 28 of the catheter 14. Figure 4A This is a schematic diagram of a cross-sectional view of a portion of the distal end 28.

[0057] It should be noted that Figure 4A Other cross-sectional views in this application are depicted as showing a flat / planar portion of the end effector 100. However, those skilled in the art will understand that these illustrations are intended only to convey to the reader the potential configuration of the electrodes 160 or layers of the end effector 100. In use, the end effector has an umbrella-like shape (discussed in more detail below); therefore, a more technically accurate depiction of the cross-sectional view of the end effector 100 would be a generally arched form, or an angled redirection at the ridge 122 of the end effector 100 (discussed in more detail below).

[0058] Now for reference Figure 2A and Figure 3 The distal end 28 of the catheter / medical probe 14 Figure 1 The device includes an end effector 100 extending from an elongated probe shaft 80 and along a longitudinal axis 60. In some examples, the probe shaft 80 carries the aforementioned flushing system. The end effector 100 includes a ridge frame 120 extending along the longitudinal axis 60.

[0059] The frame 120 includes an attachment segment 121 connected to the probe shaft 80 and a plurality of ridges 122 extending radially outward from the attachment segment 121 and the longitudinal axis 60. Figure 2A and Figure 3 In this example, each ridge has a fixed end (at the attachment segment 121) and a free distal end 122-1. In this example, eight ridges 122 are used, which are arranged at an angle / radial about the longitudinal axis 60. However, any suitable number of ridges (i.e., at least three) may be used without departing from the spirit and scope of this disclosure, provided that they are capable of supporting the three-dimensional structural membrane 130 (discussed in more detail below).

[0060] In some examples, frame 120 is integral (i.e., a monolithic structure). In such examples, frame 120 can be formed from planar or cylindrical tubular material using any suitable method. For example, frame 120 can be formed by cutting, laser cutting, stamping, or a combination thereof, such that the frame is separated to form ridges 122 and define attachment segments 121. In other examples, ridges 122 can be discrete components converging at attachment segments 121.

[0061] Frame 120 may include a flexible, elastic material (e.g., a shape memory alloy, such as nickel-titanium, also known as nitinol or stainless steel), whose shape is set to be biased to bend outwards into an expansion configuration, as shown in Figure 2 and Figure 3 As shown. The ridge 122 may be curved or extend generally linearly in the outward direction to the corresponding distal end 122-1. In the expanded configuration, the frame 120 resembles the ribs of an umbrella. Due to the flexible and elastic properties of the material, the ridge 122 can also move to a collapsed configuration (examples of the collapsed configuration can be found in...). Figure 12 (as seen in the image), in which the ridge 122 extends approximately along the longitudinal axis 60.

[0062] The end effector also includes a flexible diaphragm 130 connected to the frame 120 and extending to the distal end 130-1. Specifically, the diaphragm 130 is connected to each ridge 122 such that the distal end 130-1 surrounds / encloses the longitudinal axis 60, wherein the ridge 122 biases the diaphragm 130 into an expanded configuration and is also movable to a collapsed configuration. (See Figures 2 to...) Figure 3As seen, the distal end 130-1 of the membrane extends beyond the distal end 122-1 of the ridge 122. This membrane 130 serves to enhance the non-invasiveness of the end effector 100 and protect the subject from injury by sharp edges. The membrane 130 may comprise a flexible biocompatible material, such as a polymer. Further uses, advantages, and materials of the membrane 130 will be described in detail later herein. It should be noted that... Figures 4A to 7 and Figure 10 The flexible membrane 130 in the figure is depicted without cross-sectional shading to make it easier to distinguish the components shown in the corresponding figure.

[0063] The membrane 130 may include one or more sheets / layers fused together near the frame 120 to form a single, continuous, generally planar insulating block 130. For example, the membrane 130 may include: a first layer 132 forming a distally facing outer surface of the end effector 100; a second layer 134 forming a proximally facing outer surface of the end effector 100; and a third layer 136 disposed between the first layer 132 and the second layer 134. Figure 3 As is best seen, due to the overall shape of the end effector 100 in the expanded configuration, the second layer 134 defines a volume V with an open end (i.e., the proximal side of the volume V).

[0064] In some examples, one or more layers of membrane 130 (e.g., a third layer 136) comprise a dielectric material. For example, it may comprise a high-dielectric sheet / tile, or it may be formed using high-dielectric TPU doping. The various configurations shown in the figure provide different levels of electrical insulation between electrodes on opposite sides of membrane 130. The electrical insulation can be tailored to guide electric field lines between the bipolar ablation electrode pairs on opposite sides of membrane 130 during PFA application, and thus guide electroporation of cells within the target tissue.

[0065] The membrane 130 may surround the first flexible circuit 110 ( Figure 4A (Discussed in more detail below), the second flexible circuit 150 ( Figure 4AThe thermoforming of at least a portion of the frame 120 (discussed in more detail below) and the end effector 100 makes it easier to manufacture compared to other labor-intensive processes. The polymer may comprise TPU, silicone, or other thermoformable or molded materials that are inherently suitable for the thermoforming process. In the expanded configuration, the membrane 130 forms a generally hemispherical or semi-conical shape due to its connection with the ridges 122, similar to the shape of an umbrella canopy. Additionally, it should be noted that, depending on the tension of the membrane 130 wrapped around the ridges 122, the shape may resemble a polygonal pyramid (e.g., an octagonal pyramid in the presence of eight ridges 122). When the end effector 100 is pulled in the proximal direction, the umbrella shape can be collapsed from the expanded configuration by means of the engagement between the ridges 122 and the delivery sheath. In some examples, the ridges 122 may be inverted such that their distal ends 122-1 point in the distal direction upon collapse. In other examples, the actuator may be attached to the frame to cause the ridge 122 to move uniformly to either a collapsed or expanded configuration. The umbrella shape, in its solid / continuous film form, helps to keep the electrodes 160 at a known distance from each other, which is important for the formation and selection of ablation foci for ablation parameters.

[0066] refer to Figure 2A and Figure 4A The end effector 100 also includes a first flexible circuit 110 and a second flexible circuit 150, which extend radially about a longitudinal axis 60, for example, in a sunray pattern. Each flexible circuit 110, 150 includes flexible substrates 111, 151 (i.e., a first flexible substrate layer 111 and a second flexible substrate layer 151), which may be a continuous flexible circuit member extending completely or substantially completely about the longitudinal axis 60, or each flexible circuit 110, 150 / flexible substrate 111, 151 may be subdivided into a plurality of flexible circuit segments that extend together about the longitudinal axis 60 and are circumferentially spaced from each other. The first flexible circuit 110 and the second flexible circuit 150 each include a plurality of electrodes 160 electrically connected to the PIU 30 via electrical interconnects (e.g., traces). In the case where the flexible circuits 110, 150 are subdivided into a plurality of segments, these segments are each located near the ridge 122, and each corresponding flexible substrate 111, 151 may include the electrodes 160 thereon. Although not explicitly shown, it should be noted that the end effector 100 may also include other layers, such as a position sensing ring layer for sensing the position or shape of the end effector 100.

[0067] Each respective flexible substrate layer 111, 151 includes a biocompatible material. In some examples, each flexible substrate layer 111, 151 is formed entirely or almost entirely of a biocompatible material. In some examples, the flexible substrate layer is formed of a polyimide, copper, LCP, nitinol substrate, thermoplastic polyurethane (TPU), silicone, thermosetting resin, or other polymer substrate. In some examples, each flexible substrate layer 111, 151 described herein may be made primarily of polyimide. In other examples, it may be made alone or in combination of any one of biocompatible polyimide, glass-reinforced epoxy laminate, copper, or graphene.

[0068] As described above, flexible circuits 110 and 150 are disposed on a membrane 130 extending around a longitudinal axis 60. More specifically, a first flexible circuit 110 is disposed on a first surface 136A of the membrane 130 (which faces away from the longitudinal axis 60), and a second flexible circuit 151 is disposed on a second surface 136B of the membrane 130 opposite to the first surface 136A (relative to the ridge 122) (which faces the longitudinal axis 60).

[0069] Furthermore, the membrane 130 may abut the contact surfaces of the electrodes 160 such that only at least a portion of the contact surfaces of the plurality of electrodes 160 are exposed to the surrounding environment. The contact surfaces of the electrodes 160 may be flush with, recessed relative to, or protrude from the outer surface of the membrane 130. As used herein, “surrounding environment” refers to the external environment, such as an organ in which the end effector 100 is deployed or the operating room in which the end effector is located before deployment in a biological organ. The membrane 130 at least partially encapsulates or spaces the different layers of the end effector 100 (e.g., flexible circuits 110, 150 (including substrate layers 111, 151) and frame 120) along a vertical axis 62. See, for example... Figure 4A It shows flexible circuits 110 and 150 spaced apart from ridge 122 via a third layer 136 of membrane 130, the third layer being disposed between the flexible circuits 110 and 150 and ridge 122.

[0070] It should be noted that not all electrodes 160 on the flexible circuits 110, 150 described herein need to be exposed through the insulating material 130, as these unexposed electrodes can be used to sense far-field signals for noise reduction of proximity-tissue contact electrodes. Similarly, for an end effector with a reference electrode that contacts only blood and not tissue, far-field signals including noise or artifacts can be reduced or eliminated.

[0071] Continue to refer to Figure 2A , Figures 3 to 4AElectrode 160 includes multiple ablation (or treatment) electrode groups 161, each ablation electrode group 161 being positioned proximal to a corresponding ridge 122. These associated ridges 122 and electrodes 160 are referred to as electrode / ridge regions (or electrode and ridge regions). Figure 4A As is best observed, in some examples, not every ridge 122 has an associated set of electrodes. Figure 2A and Figures 3 to 4A The example presents an end effector 100 employing an alternating pattern of ablation electrodes 161 adjacent to ridges 122 and ablation electrodes 161 not adjacent to ridges 122. In other words, in this example, there are more ridges 122 than ablation electrode group 161 (e.g., the number of ridges 122 is doubled compared to electrode group 161). Figure 2A In the example, there are four electrode / ridge regions 102A-102D (i.e., the first electrode / ridge region 102A, the second electrode / ridge region 102B, the third electrode / ridge region 102C, and the fourth electrode / ridge region 102D).

[0072] Figure 2B and Figure 4B Depicting respectively similar to Figure 2A and Figure 4A A variant view, in which each ridge 122 has an associated electrode set. In other words, in Figure 2B and Figure 4B In the example, there are equal numbers of ridges 122 and ablation electrode groups 161. Figure 2B In the example, there are eight electrode / ridge regions 102A-102H (i.e., the first electrode / ridge region 102A, the second electrode / ridge region 102B, the third electrode / ridge region 102C, the fourth electrode / ridge region 102D, the fifth electrode / ridge region 102E, the sixth electrode / ridge region 102F, the seventh electrode / ridge region 102G, and the eighth electrode / ridge region 102H), but in other respects are structurally configured to be similar to... Figure 2A and Figures 3 to 4A The examples are the same. Therefore, those skilled in the art will understand that, unless specifically indicated otherwise, regarding, for example... Figure 4A The description of the electrode configuration also applies to Figure 4B Electrode configuration.

[0073] Each electrode of the corresponding ablation electrode assembly 161 is vertically spaced from its associated / adjacent ridge 122 (along the vertical axis 62). For example, in Figure 2A and Figures 3 to 4AAs can be seen, each ablation electrode 161 is disposed on the lateral side of its associated / adjacent ridge 122 in its electrode / ridge region and extends along its predetermined length.

[0074] Figure 4A On the left is an example electrode configuration on both sides (upper and lower) of an example end effector 100 including an elongated ablation electrode 161, each ablation electrode defining a treatment area. Although not shown in this figure, a diagnostic electrode 165 may be positioned in both ablation electrode areas (see, for example, discussed below). Figure 14 Outside the treatment area, the tissue contact electrode (discussed in more detail below) is positioned between the two upper ablation electrode areas, and the reference electrode (discussed in more detail below) is positioned in the non-tissue contact area of ​​the end effector 100.

[0075] The axis of each ridge 122 can be used as a line of symmetry for its corresponding associated electrode 160 (i.e., the electrode 160 disposed proximal to it). As shown, the electrode configuration is symmetrical about the ridge 122. Preferably, at least the ablation electrode 161 is symmetrical about each other with respect to the ridge 122. In an alternative example, the electrode configuration may not be symmetrical about the line of symmetry.

[0076] like Figure 4A As shown, in some examples, each ablation electrode group 161 may include four electrodes 161A-161D (also referred to herein as treatment or ablation electrodes), including a first ablation electrode 161A, a second ablation electrode 161B, a third ablation electrode 161C, and a fourth ablation electrode 161D. The first pair of ablation electrodes 161A, 161B are disposed on the first flexible circuit 110, close to each other and adjacent to their associated ridge 122. Similarly, the second pair of ablation electrodes 161C, 161D are disposed on the second flexible circuit 150, close to each other and adjacent to their associated ridge 122, with a membrane 130 located between them, thus defining a mirror configuration. The first pair of ablation electrodes 161 are configured to be positioned against tissue during treatment. When the upper side of the end effector 100 contacts tissue, the corresponding electrodes 161C, 161D on the opposite side contact bodily fluids (e.g., blood) and may serve as corresponding reference electrodes for those electrodes 161A, 161B that are in contact with tissue.

[0077] Figure 4AThe shown segment of membrane 130 (proximal to ridge 122) has a left half (which is to the left of the line of symmetry) and a right half (which is to the right of the line of symmetry). A first ablation electrode 161A defines a first electrode region that is entirely located to the left of its associated ridge 122. A second ablation electrode 161B defines a second electrode region that is entirely located to the right of its associated ridge 122. Similarly, a third ablation electrode 161C and a fourth ablation electrode 161D define third and fourth electrode regions, respectively, entirely located to the left and right of ridge 122.

[0078] The ablation electrodes 161A-161B can be in various shapes / designs, such as serpentine shapes, strips, rods, or articulated rods. Figures 14 to 17 Exemplary configurations are depicted, which are described in more detail below. Generally, ablation electrodes 161C, 161D are shown located on a second (lower) side opposite to ablation electrodes 161A, 161B on the first (upper) side. The opposing ablation electrodes 161C, 161D overlap with the ablation electrodes 161A, 161B on the first side, preferably overlap with most of the ablation electrodes 161A, 161B on the first side 101a, and may be symmetrical with respect to the plane defined by the membrane 130 when laid flat with respect to the ablation electrodes 161C, 161D on the first side (e.g., as shown in the image). Figure 4A (As shown, for illustrative purposes). For the sake of illustration, the cross-section of the end effector 100 is simplified to omit certain features, such as, but not limited to, electrical traces. The ablation electrodes 161A-161D are shown recessed into the membrane 130, but may alternatively protrude from the membrane on each respective side. The ablation electrodes 161A-161D may have approximately equal surface areas to each other.

[0079] In some examples, the length of the ablation electrodes 161A-161D is at least half the total radius of the end effector 100, as measured from the distal end 130-1 of the flexible membrane 130 to the attachment segment 121. In some examples, the ablation electrodes 161A-161D extend to approximately the distal end 130-1 of the flexible membrane 130-1.

[0080] Each set of ablation electrodes 161A-161D is connected to the ablation energy generator 50. Various ablation configurations can be employed using the configuration detailed herein. In some examples, and as described above, when the first side is in contact with tissue, the ablation electrodes 161C, 161D on the second side can serve as corresponding reference electrodes for the corresponding opposing electrodes 161A, 161B on the first side of the membrane 130. Alternatively, the ablation electrodes 161 on opposing sides can be paired to provide a bipolar PFA electrical signal between the paired ablation electrodes 161. Alternatively, the electrodes 161 on the same side can be paired to provide a bipolar PFA electrical signal between the paired electrodes. The bipolar PFA electrical signal can be monophasic or biphasic. It should be noted that although each pair of first electrodes (161A, 161B) is described as discrete electrodes, the electrical connection of two electrodes in each of the first pair (e.g., 161A, 161B) or the second pair (e.g., 161C, 161D) to form a single ablation electrode is also within the scope of the claimed technology. Specifically, the first pair of electrodes 161A, 161B may be electrically connected together via ridge 122 between these electrodes or directly at the generator 50 to define a single first electrode among a plurality of first electrodes disposed on the first surface of the membrane. Similarly, the second pair of electrodes 161C and 161D may be electrically connected together via ridge 122 between them or directly at the generator 50 to define a single second electrode among a plurality of second electrodes disposed on the second surface of the membrane. It should also be noted that each of electrodes 161A, 161B, 161C, 161D may be configured as a diagnostic electrode (which receives electrical signals from tissue rather than transmitting electrical signals from the generator for ablation).

[0081] The illustrated end effector 100 includes an optional diagnostic electrode 165 located on a first side of the membrane 130, electrically isolated from the ablation electrode 161. The diagnostic electrode 165 is configured to receive electrical signals from tissue to map cardiac tissue and detect arrhythmias. As shown, the diagnostic electrodes 165 are arranged in a pair, with a first diagnostic electrode 165 located on the left side of each ridge 122 and a second diagnostic electrode 165 located on the right side of each ridge 122.

[0082] The end effector 100 may include optional tissue contact mass electrodes positioned in pairs with close spacing, such that the impedance measured across the respective tissue contact mass electrode pair indicates that the electrodes in the pair are in contact with the tissue.

[0083] The end effector 100 includes an optional reference electrode disposed on a first side of the membrane 130 (it should be noted that although primarily described as a diagnostic electrode, reference numeral 165 may also be considered to denote an exemplary reference electrode or any other electrode discussed herein). Alternatively, the end effector 100 may include a reference electrode similarly disposed on a second side of the membrane. The reference electrode may be used for either monopolar or bipolar (separation or closure pair) ECG collection, or may be a reference. The number may be as few as four per side, but may be increased as needed (and may comply with trace limitations). Signals from the reference electrode may also be used for contact information to determine which portion of the blade is in contact with or near tissue. The end effector 100 includes one or more segments lacking any ablation electrode. The reference electrode may be disposed in this segment. As discussed herein, an ablation electrode, diagnostic electrode, or tissue contact electrode may be used as a reference electrode for a corresponding tissue-contact electrode on the opposite side. Each of these electrodes is positioned in a distal portion of the end effector 100 such that they can be positioned in contact with tissue if desired by the physician 24. Preferably, the reference electrode is positioned such that the physician 24 cannot, or at least is unlikely to, position the reference electrode in contact with the tissue, but is still relatively close to the electrode configured to contact the tissue.

[0084] In some examples, at least the ablation electrode, diagnostic electrode, and tissue contact electrode are flush with the outer surface of the membrane 130 to provide the end effector 100 with a first flush surface corresponding to a first side of the membrane 130, and a second flush surface corresponding to a second side of the membrane 130. Any combination of the ablation electrode 161 and other electrodes 165 (and other electrodes discussed herein) may include an exposed conductive layer in a flexible printed circuit board, which may include silver epoxy resin or conductive ink.

[0085] Further details regarding exemplary electrode configurations can be found in [reference needed]. Figures 14 to 17 The description was found.

[0086] As described above, the membrane 130 may include a third layer 136 located between a first / upper side and a second / lower side of the end effector 100. The third layer may include a polymer body region extending the width of a corresponding region associated with each ablation electrode assembly 161 and ridge 122. In some examples, such as those where the flexible circuits 110, 150 are embodied as discrete, discontinuous circuits, the third layer 136 may be provided as a corresponding thinned polymer-filled region connecting adjacent flexible circuits 110, 150 and lacking a frame or any circuitry. With this configuration, the membrane 130 may provide additional electrical insulation between the electrodes on opposite sides of the end effector 100 (compared to examples including openings, such as...). Figures 9 to 10(As seen in the image), while maintaining sufficient maneuverability to resist tissue positioning and transfer through the sheath. As described above, the third layer 136 may also be embodied as a high-dielectric layer extending between each side and around the end effector 100. The dielectric layer 134 overlaps and runs parallel to each of the ablation electrodes 161A-161D. The high-dielectric layer may comprise a ceramic-doped polymer to provide additional electrical insulation between the electrodes on opposite sides of the membrane 130 compared to a single polymer, while still providing sufficient flexibility. Some portions of the end effector 100 may be the high-dielectric layer 134, lacking a frame and circuitry. In some examples, the third layer 134 may be embodied as a high-dielectric tile between each side and configured to overlap to collapse into the delivery sheath together with the end effector 100. The high-dielectric tile may comprise a ceramic plate extending longitudinally through each segment of the body and overlapping between the segments. The high-dielectric tiles or longitudinally extending ceramic plates may be angled relative to the plane defined by the membrane 130 when laid flat, such that the tiles / plates are configured to overlap (with longitudinal sides on the longitudinal side) when the end actuator retracts into the sheath.

[0087] Figures 5A to 5C An exemplary ablation configuration for applying bipolar PFA electrical pulses is depicted in an example where the end effector includes four ablation electrodes 161A-161D. In these figures, the first ablation electrode 161A and the second ablation electrode 161B face outward toward the tissue, while the third ablation electrode 161C and the fourth ablation electrode 161D (which are disposed in volume V) face away from the tissue. In use, the first ablation electrode 161A and the second ablation electrode 161B may contact (or be disposed adjacent to) the tissue, and the ablation energy generator 50 selectively activates the paired ablation electrodes to apply pulsed field ablation pulses. In some examples, the pulses have a voltage of approximately 600 volts (V) to approximately 1,200 V. In other examples, the pulses have a voltage of 600 V to 2,600 V. In some examples, the bipolar PFA electrical signal comprises 60 pulses with a magnitude of approximately 1,200 V and a total duration of approximately 4 seconds. In some examples, the bipolar pulses may include an inter-pulse delay of approximately 2 microseconds. As will be understood by those skilled in the art as informed by the disclosure herein, the pattern of ablation electrode pairings can be adjusted based on the total number of ablation electrodes in the end effector 100, as discussed in more detail.

[0088] Figure 5AAn exemplary ablation configuration of this type is depicted. In this example, ablation electrodes 161A-161B are activated diagonally / crosswise and sequentially. Generator 50 can alternately excite the first pair of ablation electrodes 161 to apply a pulse between the first ablation electrode 161A (+) and the fourth ablation electrode 161D (-), and then excite the second pair of ablation electrodes 161 to apply a pulse between the second ablation electrode 161B (+) and the third ablation electrode 161C (-), such that only one pair of ablation electrodes 161 from each group is activated at a time.

[0089] In this example, ablation electrode 161 of a pair of ablation electrodes is symmetrical with respect to ridge 122 and located on opposite sides of membrane 130. A voltage is applied across the electrodes in the paired electrode regions, wherein for each pair of electrode regions, the ablation electrode in the first electrode region is in contact with tissue, and the other electrode region is located on opposite sides of the end effector and across ridge 122 opposite to the first electrode region. Figure 5A An ablation electrode 161A with a positive charge is shown, while a paired ablation electrode 161D has a negative charge. This illustrates a positive voltage pulse configured to induce electroporation in tissue in contact with the upper side of the membrane 130. Biphasic pulses can be applied, wherein the polarity is as follows: Figure 5A The polarity shown can be switched or alternated between the polarity of the ablation electrode 161D (which is not in contact with tissue) and the polarity of the ablation electrode 161A (which is in contact with tissue). This can be achieved as follows: Figure 5A A bipolar pulse train (which may include biphasic or monophasic pulses) is applied between the bipolar ablation electrode pairs 161A and 161D, as shown above. Then, a bipolar pulse train can be applied between another bipolar ablation electrode pair 161B and 161C in the same manner as described above.

[0090] In other words, Figure 5A An end effector 100 is depicted, configured to provide electrical pulses with amplitudes from 600V to 1200V between a bipolar pair comprising an ablation electrode (e.g., a first ablation electrode 161A) located on the upper side of a membrane 130 and in contact with tissue, and an ablation electrode (e.g., a fourth ablation electrode 161D) located on the lower side of the membrane 130 and not in contact with tissue. Similarly, ablation electrodes 161B and 161C may be paired.

[0091] In some examples, cardiac electrical signals can be measured from one or more diagnostic electrodes disposed on the tissue-contact side of the membrane 130. In some embodiments, tissue contact can be measured from a pair of tissue-contact electrodes disposed on the tissue-contact side of the membrane 130. In some examples, reference electrical signals can be measured from a reference electrode disposed on the tissue-contact side of the membrane 130, wherein the reference electrode itself does not contact the tissue.

[0092] Figure 5B Another exemplary ablation configuration is depicted. In this example, instead of applying the pulse diagonally, it is applied vertically (relative to...). Figure 5B The generator 50 applies pulses to the ablation electrodes 161 (or their orientation), such that the ablation electrodes in each pair overlap and are located on opposite sides of the membrane 130. The generator 50 can simultaneously or alternately excite the first pair of ablation electrodes 161 to apply pulses between the first ablation electrode 161A (+) and the third ablation electrode 161C (-), and excite the second pair of ablation electrodes 161 to apply pulses between the second ablation electrode 161B (+) and the fourth ablation electrode 161D (-). A voltage is applied across the tissue-contacting ablation electrodes 161A, 161B to the ablation electrodes 161C, 161D located on opposite sides of the membrane 130 and not in contact with tissue. Biphasic pulses can be applied, wherein the polarity is as follows: Figure 5B The polarity shown can be switched or alternated between the polarity of the ablation electrodes 161C and 161D that are not in contact with tissue and the polarity of the ablation electrodes 161A and 161B that are in contact with tissue. A bipolar pulse train can be applied between the bipolar ablation electrode pairs. As shown, the two ablation electrodes 161A and 161B that are in contact with tissue can be activated simultaneously. Alternatively, a bipolar pulse train can be applied to the first pair of ablation electrodes (161A and 161C) while de-energizing the second pair of ablation electrodes (161B and 161D), and subsequently, a bipolar pulse train can be applied to the second pair of ablation electrodes while de-energizing the first pair of ablation electrodes.

[0093] Figure 5C Another exemplary ablation configuration is depicted. In this example, instead of applying pulses diagonally or vertically, they are applied horizontally (relative to) the upper electrode pair. Figure 5B The orientation of the ablation electrodes 161 is used to apply pulses. In other words, the ablation electrodes 161 in each pair are symmetrical with respect to the ridge 122 and located on the same side of the membrane 130. Specifically, the generator 50 can excite the upper ablation electrode pair 161 to apply pulses between the first ablation electrode 161A (+) and the second ablation electrode 161B (-), while the third ablation electrode 161C and the fourth ablation electrode 161D are not activated. As shown, a voltage is applied to the ablation electrodes 161A, 161B on the tissue-contact side of the membrane 130. The ablation electrodes 161C, 161D that are not in tissue contact can be used as reference electrodes. Biphasic pulses can be applied, wherein the polarity is as follows: Figure 5C The polarity shown can be switched or alternated between the polarity where positive charge is on the right ablation electrode 161B and negative charge is on the left ablation electrode 161A. A bipolar pulse train can be applied between the bipolar ablation electrode pairs 161A and 161B.

[0094] It should be noted that, without departing from the spirit and scope of this disclosure, alternative methods relating to [the disclosure] may be adopted. Figure 5A and Figure 5C The described pattern is a cross-regional ablation pulse similar to the pattern shown. This is illustrated by example and referenced. Figure 2A An example having four electrode / ridge regions 102A-102D may employ a bipolar pulse train (which may include biphasic or monophasic pulses, as described above) between one or more ablation electrodes 161 in the first electrode / ridge region 102A and one or more ablation electrodes 161 in the second electrode / ridge region 102B, followed by a bipolar pulse train between one or more ablation electrodes 161 in the second electrode / ridge region 102B and one or more ablation electrodes 161 in the third electrode / ridge region 102C, followed by a bipolar pulse train between one or more ablation electrodes 161 in the third electrode / ridge region 102C and one or more ablation electrodes 161 in the fourth electrode / ridge region 102D, and finally a bipolar pulse train between one or more ablation electrodes 161 in the fourth electrode / ridge region 102G and one or more ablation electrodes 161 in the first electrode / ridge region 102H. In another example, and referring to... Figure 2B An example having eight electrode / ridge regions 102A-102H may include a bipolar pulse train (which may include biphasic or monophasic pulses as described above) applied between one or more ablation electrodes 161 in the first electrode / ridge region 102A and one or more ablation electrodes 161 in the second electrode / ridge region 102B, followed by a bipolar pulse train applied between one or more ablation electrodes 161 in the third electrode / ridge region 102C and one or more ablation electrodes 161 in the fourth electrode / ridge region 102D, followed by a bipolar pulse train applied between one or more ablation electrodes 161 in the fifth electrode / ridge region 102E and one or more ablation electrodes 161 in the sixth electrode / ridge region 102F, and then a bipolar pulse train applied between one or more ablation electrodes 161 in the seventh electrode / ridge region 102G and one or more ablation electrodes 161 in the eighth electrode / ridge region 102H.

[0095] Of course, other cross-regional ablation patterns can be used. For example, and continue to refer to... Figure 2BA bipolar pulse train (which may include biphasic or monophasic pulses) can be applied between one or more ablation electrodes 161 in the first electrode / ridge region 102A and one or more ablation electrodes 161 in the fifth electrode / ridge region 102E, followed by a bipolar pulse train between one or more ablation electrodes 161 in the second electrode / ridge region 102B and one or more ablation electrodes 161 in the sixth electrode / ridge region 102F, followed by a bipolar pulse train between one or more ablation electrodes 161 in the third electrode / ridge region 102C and one or more ablation electrodes 161 in the seventh electrode / ridge region 102G, and subsequently a bipolar pulse train between one or more ablation electrodes 161 in the fourth electrode / ridge region 102D and one or more ablation electrodes 161 in the eighth electrode / ridge region 102H. Similar techniques can be used... Figure 2A Examples.

[0096] In a further example, the cross-regional ablation pulse can have a more advanced bipolar pattern, employing two or more electrode / ridge regions as the positive electrode in the bipolar structure. This is illustrated by way of example, and with reference to... Figure 2A For example, a bipolar pulse train may be applied between the ablation electrode 161 (used as the positive electrode in the bipolar) in the first electrode / ridge region 102A and the second electrode / ridge region 102B and one or more ablation electrodes 161 (used as the negative electrode in the bipolar) in the third electrode / ridge region 102C, and subsequently between the ablation electrode 161 (used as the positive electrode in the bipolar) in the second electrode / ridge region 102B and the third electrode / ridge region 102C and one or more ablation electrodes 161 (used as the negative electrode in the bipolar) in the fourth electrode / ridge region 102D. A bipolar pulse train is then applied between the ablation electrodes 161 (used as positive electrodes in the bipolar system) in the third electrode / ridge region 102C and the fourth electrode / ridge region 102D and one or more ablation electrodes 161 (used as negative electrodes in the bipolar system) in the first electrode / ridge region 102A.

[0097] For example, and with reference Figure 2BFor example, a bipolar pulse train can be applied between the ablation electrode 161 (used as the positive electrode in the bipolar region) in the first electrode / ridge region 102A and the second electrode / ridge region 102B and the ablation electrode 161 (used as the negative electrode in the bipolar region) in the fifth electrode / ridge region 102E and the sixth electrode / ridge region 102F, and then a bipolar pulse can be applied between the ablation electrode 161 (used as the positive electrode in the bipolar region) in the second electrode / ridge region 102B and the third electrode / ridge region 102C and the ablation electrode 161 (used as the negative electrode in the bipolar region) in the sixth electrode / ridge region 102F and the seventh electrode / ridge region 102G. A bipolar pulse train is then applied between the ablation electrodes 161 (used as positive electrodes in the bipolar region) in the third electrode / ridge region 102C and the fourth electrode / ridge region 102D and the ablation electrodes 161 (used as negative electrodes in the bipolar region) in the seventh electrode / ridge region 102G and the eighth electrode / ridge region 102H. Subsequently, a bipolar pulse train is applied between the ablation electrodes 161 (used as positive electrodes in the bipolar region) in the fourth electrode / ridge region 102D and the fifth electrode / ridge region 102E and the ablation electrodes 161 (used as negative electrodes in the bipolar region) in the eighth electrode / ridge region 102G and the first electrode / ridge region 102A.

[0098] The ablation configuration examples described above are non-limiting and are intended only to illustrate certain ways in which the techniques described herein can be implemented. In all the examples above, the goal of the configuration of ablation bipolar and sequential ablation is to achieve circumferential ablation of the foci without requiring repositioning of the end effector 100.

[0099] Having described various exemplary ablation patterns that can be employed, this disclosure now turns to exemplary alternative physical forms that can be employed by electrode 160 or the entire end effector 100. Unless explicitly stated otherwise, it should be understood that the ablation configurations previously described can also be applied to any of the following exemplary end effectors.

[0100] Figure 6 A variant 100.1 of the aforementioned end effector 100 is depicted. This example is the same as the previously described example, except that instead of providing a set of four ablation electrodes 161 proximal to the ridge 122, a single pair of ablation electrodes is provided. Specifically, a first ablation electrode 161A.1 is disposed on a first flexible substrate 111 and a second ablation electrode 161B.1 is disposed on a second flexible substrate 151, in a mirror configuration. This example can be used relative to... Figure 5BThe ablation configuration discussed or the exemplary cross-regional ablation pattern described in the preceding paragraphs. It should also be noted that in some examples, a single ablation electrode 161A.1 may be provided on the upper side of each electrode / ridge region 102A-102H, where the aforementioned cross-regional ablation pulse is used to achieve IRE.

[0101] Figure 7 Another variant 100.2 of the end effector 100 described above is depicted. This variant 100.2 can be configured in the same way as the variant of the end effector 100, wherein the third layer 136 of the membrane is omitted, so that the two flexible substrates 111, 151 can be directly disposed on the ridge 122 or in contact with each other.

[0102] Figure 8 Another variant 100.3 of the aforementioned end effector 100 is depicted. In this example, the membrane 130 is used as a flexible circuit, wherein the first ablation electrode 161A and the second ablation electrode 161B, as well as the second ablation electrode 161C and the third ablation electrode 161D, are disposed on opposite surfaces of the membrane.

[0103] Now for reference Figures 9 to 10 These figures depict another variant 100.4 of the aforementioned end effector 100. In this example, the membrane 130.4 is configured with a cavity 114.4 defined therethrough, each cavity 114.4 having a closed periphery defined by the membrane 130.4. The distal end 130-1.4 of the membrane 130.4 forms an annular bridge 131A.4, with the ridge 122 and the electrode 160 connected to the annular bridge 131A.4 via a connecting segment 131B.4. The cavity 114.4 allows for easier collapse through the sheath and also allows for greater blood flow. The volume of material removed (compared to a solid umbrella form) is omitted, thus less material needs to be fitted in a given collapse cross section. The size and shape of the cavity 114.4 can be set or otherwise configured to allow the end effector 100 to flex through the sheath catheter. The size and shape of the gap 114.4 can be set or otherwise configured to collapse or expand when the end effector 100 presses against the nonplanar tissue surface to provide conformal contact with the nonplanar tissue surface. It should be recognized that consistent contact between the ablation electrode 161 and the nonplanar tissue produces an improved ablation focus compared to less conformal electrode contact. The distal end 130-1.4 of the membrane helps maintain the relative positioning between the electrodes 160. The annular bridge 131A.4 (or an additional bridge) can also be positioned along the membrane 130.4 at different distances from the longitudinal axis 60.

[0104] Now for reference Figures 11 to 12These figures depict another variant 100.5 of the aforementioned end effector 100. In this example, the ridge 122.4 is configured in the form of a basket conduit, wherein a first end of the ridge 122.4 is connected to a first probe shaft 80, and a second end of the ridge 122.4 is connected to a second probe shaft 82 (e.g., a push rod tube or push rod line), which can be used to inflate and collapse the basket (see...). Figure 12 The collapsed configuration in which the end effector 100.5 is disposed in the sheath 90.

[0105] Figure 13 This is a flowchart depicting a method 1000 for manufacturing an end effector 100 according to the present disclosure. Method 1000 includes forming a plurality of ridges extending 1002 away from a longitudinal axis. Method 1000 includes disposing a first flexible circuit 1004 on a first side of the plurality of ridges, the first flexible circuit including a first flexible substrate and a first ablation electrode. Method 1000 includes disposing a second flexible circuit 1006 on a second side of the plurality of ridges, the second flexible circuit including a second flexible substrate and a second ablation electrode. Method 1000 includes placing a first sheet of insulating material 1008 in contact with the first flexible circuit, the first sheet surrounding the longitudinal axis. Method 1000 includes placing a second sheet of insulating material 1010 in contact with a second flexible circuit, the second sheet surrounding the longitudinal axis and defining a volume having an open end. The method includes molding the first and second sheets 1012 to encapsulate the first and second flexible circuits such that a first pair of ablation electrodes, a second pair of ablation electrodes, and one of the ridges are positioned close to each other.

[0106] In some examples, prior to molding the first and second sheets 1012, method 1000 further includes placing a third sheet of insulating material between the first and second flexible circuits and in contact with the ridges; and molding the third sheet such that the first and second flexible circuits are spaced apart from the plurality of ridges.

[0107] Now go to Figures 14 to 17This describes alternative / exemplary electrode configurations. In some examples, the electrodes may have a herringbone configuration. An example of an electrode with a herringbone configuration is disclosed in U.S. Patent No. 11,642,165B2, the entire contents of which are incorporated herein by reference. Other advantageous designs are described in detail below. Generally, each ablation electrode may be designed with a shape based on a trade-off between the total edge area, the total contact area, and the open space of the non-ablation electrode. It should be recognized that a larger surface area to perimeter ratio can effectively deliver ablation energy while reducing the chance of arcing. It is also recognized that avoiding arcing is desirable. Instead, serpentine electrodes increase the mechanical flexibility of the blades. It should be recognized that the flexibility of the electrode can improve tissue contact and catheter life, but the geometry of serpentine electrodes has a lower area to perimeter ratio compared to solid electrodes.

[0108] Figure 14 This is an illustration of a first electrode configuration for an example end effector 100, which includes an example configuration of a treatment / ablation electrode 161 and a diagnostic electrode 165. In the illustrated example, each ablation electrode 161 is divided into two longitudinally elongated segments extending along its associated ridge 122. In this example, the longitudinally elongated segment on the left side of the ridge 122 forms the first ablation electrode 161, and the longitudinally elongated segment on the right side of the ridge 122 forms the second ablation electrode 161. By way of example, using this configuration, Figure 4A The example will have a total of eight elongated segments (one for each associated ridge 122), four on the upper side of the membrane 130 and four on the lower side. Of course, it should be understood that in some examples, the aforementioned four electrodes 161A-161D each have a single elongated segment, such that a total of four elongated segments (one for each associated ridge 122) may exist. In some examples, the total area of ​​each ablation electrode 161 or ablation electrode segment within the corresponding electrode region (as described above relative to...) Figure 4A (As discussed) is approximately 7.5mm 2 In some examples, such as... Figure 4A or Figure 4B The configuration, its implementation Figure 11The paired segments of the corresponding electrode / ridge region 102 can be connected together by the generator 50 with the same charge (e.g., positive charge), while another pair of electrode segments of the same electrode / ridge region 102 can be connected together by the generator 50 and have the same charge (e.g., negative charge), thereby providing a biphasic pulsed field between the two pairs of ablation electrode segments. In an alternative example, these adjacent elongated segments of each ablation electrode 161 (when in contact with tissue) can be disconnected from each other and individually connected to the generator 50, thereby providing a biphasic pulsed field between the two tissue-contacting ablation electrode segments in a bipolar configuration to allow electrons to flow between the ablation electrode segments.

[0109] Generally speaking, the ablation electrode 161 may include one or more serpentine longitudinally extending segments with a total width of W1 and a path width of W2 (in Figure 14 In the example shown, as mentioned above, there are two. Figure 14 The example includes six diagnostic electrodes 165 for each ablation electrode 161. The end effector 100 may include one, two, three, four, five, or six diagnostic electrodes 165 for each ablation electrode 161. Each diagnostic electrode is sized to be similar to a width W3, which is approximately 1.5 times the path width W2 of the ablation electrode 161 and approximately half the total width W1 of the elongated segment of the ablation electrode 161. The diagnostic electrodes 165 are surrounded on two or three sides by corresponding elongated segments of the ablation electrode 161.

[0110] Figure 15 This is an illustration of a second electrode configuration for an example end effector 100, which includes an ablation electrode 161 and a diagnostic electrode 165. The ablation electrode has elongated segments, each segment being divided into parallel strips. The diagnostic electrode is positioned adjacent to the elongated ablation electrode segments. Each elongated segment has multiple conductive strips extending parallel to each other to form a configuration similar to... Figure 14 The overall shape of the corresponding elongated segments is shown. Other ablation electrode shapes shown herein, and their alternative forms understood by those skilled in the art, can also be divided into similar forms. Figure 15 The diagram shows multiple conductive strips extending parallel to each other. This configuration increases the total edge length of the ablation electrode to provide the tissue with an ablation electrode of a similar shape to a solid during PFA (e.g., as shown in the diagram). Figure 14 (As shown) different electric field distributions.

[0111] Figure 16This is an illustration of a third example electrode configuration for an example end effector 100, which includes a rectangular elongated segment of an ablation electrode 161 without a diagnostic electrode 165. The entire width W1 of the electrode segment is used for the ablation electrode 161 to maximize its surface area. The diagnostic electrode may be disposed elsewhere on the flexible membrane 130.

[0112] Figure 17 This is an illustration of a fourth example electrode configuration for an example end effector 100, which includes a rectangular elongated segment of an ablation electrode 161 interrupted by a diagnostic electrode 165. Figure 16 Compared to the continuous rectangular electrode segments shown, the segmented, elongated ablation electrode segments can have greater flexibility to allow the membrane 130 to flex, but at the cost of the total ablation electrode area.

[0113] According to all the examples above, the end effector 100 preferably includes a total of two to eight ablation electrodes 161 for each associated ridge 122. The end effector 100 preferably includes exactly two, three, or four ablation electrodes (or electrode segments) on each side of the membrane 130. Each ablation electrode 161 preferably overlaps with a corresponding ablation electrode 161 on the opposite side of the membrane 130, such that the ablation electrodes are symmetrical with respect to the plane defined by the membrane 130 when laid flat (e.g., pre-assembled into its umbrella configuration). Fewer ablation electrodes can be achieved by electrically connecting combinations of ablation electrodes elsewhere within the end effector 100 or within the conduit 14. Increasing the number of ablation electrodes 161 can be achieved by dividing the ablation electrodes 161 into two portions that are electrically insulated from each other in the conduit 14 and configured to be activated independently by the generator 50. For example, Figure 2A The cross-section line 4A-4A in the example where the ablation electrode 161A is segmented into the following two electrodes can be used as a boundary line: the distal ablation electrode ( Figure 2A The portion of line 4A-4A to the left of 161A) and the proximal ablation electrode ( Figure 2A (The portion of 161A to the right of line 4A-4A in the diagram). Similarly, ablation electrodes 161B, 161C, and 161D can be divided in a similar manner.

[0114] In summary, ablation electrodes 161 can be paired in various combinations to provide a bipolar PFA electrical signal between the therapeutic electrodes in a pair of electrodes. As will be understood by those skilled in the art as informed by this disclosure, the individual pairs can be activated simultaneously or sequentially in various combinations to achieve PFA in the target tissue. The example therapeutic electrode configurations shown and described herein are non-limiting, and many other therapeutic electrode configurations are possible. In each therapeutic electrode configuration, the therapeutic electrodes can be paired according to the same concept outlined in the foregoing disclosure.

[0115] The disclosed technology described herein can be further understood in accordance with the following terms:

[0116] Clause 1. An end effector for a medical probe, the end effector comprising: a plurality of ridges extending radially outward from a longitudinal axis of the end effector in an expanded configuration; a membrane connected to the plurality of ridges, the membrane including a distal end surrounding the longitudinal axis and defining a volume having an open end, the membrane including a first surface and a second surface opposite to the first surface; a first flexible circuit disposed on the first surface of the membrane, adjacent to each of the plurality of ridges and extending about the longitudinal axis; a second flexible circuit disposed on a second surface of the membrane, adjacent to each of the plurality of ridges and extending about the longitudinal axis; a plurality of first pairs of electrodes disposed on the first flexible circuit, adjacent to each other and adjacent to the ridges of the plurality of ridges; and a plurality of second pairs of electrodes disposed on the second flexible circuit, adjacent to each other and adjacent to the ridges of the plurality of ridges, such that the first pairs of electrodes and the second pairs of electrodes define a mirror configuration, wherein the membrane is located between the first pairs of electrodes and the second pairs of electrodes.

[0117] Clause 2. The end effector according to Clause 1, wherein the plurality of ridges are arranged radially around the longitudinal axis.

[0118] Clause 3. The end effector according to any one of Clauses 1 to 2, each ridge including a proximal end fixed to the probe shaft and a free distal end, the distal end of the membrane extending beyond the free distal end of each ridge.

[0119] Clause 4. The end effector according to any one of Clauses 1 to 2, each ridge includes a proximal end fixed to a first probe shaft and a distal end fixed to a second probe shaft.

[0120] Clause 5. The end effector according to any one of Clauses 1 to 4, wherein the membrane is biased to the expansion configuration by the plurality of ridges.

[0121] Clause 6. The end effector according to any one of Clauses 1 to 5, wherein the membrane in the expansion configuration comprises a generally hemispherical, semi-conical, or polygonal pyramidal shape defining the volume, and further comprises a polymeric material.

[0122] Clause 7. An end effector according to any one of Clauses 1 to 6, the end effector being movable between a collapsed configuration and the expanded configuration, in which the plurality of ridges and the membrane are arranged generally along the longitudinal axis.

[0123] Clause 8. The end effector according to any one of Clauses 1 to 7, wherein the first surface is opposite to the longitudinal axis and the second surface faces the longitudinal axis.

[0124] Clause 9. An end effector according to any one of Clauses 1 to 8, wherein the first flexible circuit and the second flexible circuit are spaced apart from the plurality of ridges along a vertical axis, each first pair of electrodes is electrically connected together to define a single first electrode among a plurality of first electrodes on the first surface, and each second pair of electrodes is electrically connected together to define a single second electrode among a plurality of second electrodes on the second surface.

[0125] Clause 10. The end effector according to Clause 9, wherein a portion of the membrane is disposed between the plurality of ridges and the first flexible circuit and between the plurality of ridges and the second flexible circuit.

[0126] Clause 11. The end effector according to any one of Clauses 1 to 10 further includes a plurality of gaps defined to pass through the membrane, the first flexible circuit and the second flexible circuit between adjacent ridges of the plurality of ridges.

[0127] Clause 12. The end effector as described in Clause 11, each gap includes a closed periphery defined by the membrane.

[0128] Clause 13. The end effector according to any one of Clauses 1 to 12, wherein the membrane comprises a flexible biocompatible polymer material.

[0129] Clause 14. The end effector according to any one of Clauses 1 to 13, wherein the membrane comprises a plurality of layers, each layer surrounding the longitudinal axis, wherein at least one of the layers comprises an insulating material.

[0130] Clause 15. The end effector according to Clause 14, wherein each blade comprises at least one layer comprising a dielectric material.

[0131] Clause 16. The end effector according to any one of Clauses 1 to 15, wherein the first flexible circuit includes a plurality of first flexible substrates circumferentially spaced around the longitudinal axis, and each first electrode is disposed on a corresponding first flexible substrate.

[0132] Clause 17. The end effector according to any one of Clauses 1 to 16, wherein the number of ridges in the plurality of ridges is greater than the number of the first pair of electrodes.

[0133] Clause 18. The end effector according to any one of Clauses 1 to 17, wherein each first pair of electrodes is flush with the outer surface of the membrane.

[0134] Clause 19. The end effector according to any one of Clauses 1 to 17, wherein each first pair of electrodes protrudes from the outer surface of the membrane.

[0135] Clause 20. The end effector according to any one of Clauses 1 to 19, wherein the plurality of first pairs of electrodes and the plurality of second pairs of electrodes are ablation electrodes, and further comprises one or more diagnostic electrodes.

[0136] Clause 21. The end effector according to any one of Clauses 1 to 20, each of the first pair of electrodes and the second pair of electrodes includes an elongated segment comprising a plurality of conductive strips extending parallel to each other to form the overall shape of the elongated segment.

[0137] Clause 22. A medical system comprising: a medical probe including an elongated probe body and an end effector connected to a distal end of the elongated probe body, the elongated probe body and the end effector extending along a longitudinal axis, the end effector including: a plurality of ridges connected to the elongated probe body and extending radially outward from the longitudinal axis of the end effector in an expanded configuration; a membrane connected to the plurality of ridges, the membrane including a distal end surrounding the longitudinal axis and defining a volume having an open end, the membrane including a first surface and a second surface opposite to the first surface; a first flexible circuit disposed on the first surface of the membrane, adjacent to each of the plurality of ridges and surrounding the... The membrane extends along a longitudinal axis; a second flexible circuit disposed on a second surface of the membrane, close to each of the plurality of ridges and extending about the longitudinal axis; a plurality of first pairs of ablation electrodes disposed on the first flexible circuit and close to each other and close to the ridges of the plurality of ridges; and a plurality of second pairs of electrodes disposed on the second flexible circuit, close to each other and close to the ridges of the plurality of ridges, such that the first pairs of electrodes and the second pairs of electrodes define a mirror configuration, wherein the membrane is located between the first pairs of electrodes and the second pairs of electrodes; and an ablation generator configured to provide ablation pulses to the plurality of first pairs of electrodes and the plurality of second pairs of electrodes.

[0138] Clause 23. The medical system according to Clause 22, wherein the plurality of first pairs of ablation electrodes includes a first ablation electrode and a second ablation electrode, the first ablation electrode and the second ablation electrode being arranged close to each other, and the plurality of second pairs of ablation electrodes includes a third ablation electrode and a fourth ablation electrode, the third ablation electrode and the fourth ablation electrode being arranged close to each other and close to one of the ablation electrodes in the first pair of ablation electrodes.

[0139] Clause 24. The medical system according to Clause 23, wherein the first ablation electrode and the second ablation electrode in each first pair are disposed on opposite lateral sides relative to the respective ridge, and the third ablation electrode and the fourth ablation electrode in each second pair are disposed on opposite lateral sides relative to the respective ridge.

[0140] Clause 25. In any one of Clauses 23 to 24, the ablation generator is configured to provide an ablation pulse between the first ablation electrode and the fourth ablation electrode in each respective first pair of electrodes and second pair of electrodes.

[0141] Clause 26. In any one of Clauses 23 to 24, the ablation generator is configured to provide an ablation pulse between the first ablation electrode and the third ablation electrode in each respective first pair of electrodes and second pair of electrodes.

[0142] Clause 27. In any one of Clauses 23 to 24, the ablation generator is configured to provide an ablation pulse between the first ablation electrode and the second ablation electrode in each respective first pair of electrodes.

[0143] Clause 28. The medical system according to Clause 23, wherein each group of proximal first ablation electrodes, second ablation electrodes, third ablation electrodes and fourth ablation electrodes defines a corresponding electrode and ridge region, the ablation generator being configured to provide ablation pulses between different electrode and ridge regions.

[0144] Clause 28. A method of manufacturing an end effector for a medical probe, the method comprising: forming a plurality of ridges extending away from a longitudinal axis; disposing a first flexible circuit on a first side of the plurality of ridges, the first flexible circuit including a first flexible substrate and a first pair of electrodes; disposing a second flexible circuit on a second side of the plurality of ridges, the second flexible circuit including a second flexible substrate and a second pair of electrodes; placing a first sheet of insulating material in contact with the first flexible circuit, the first sheet surrounding the longitudinal axis; placing a second sheet of insulating material in contact with the second flexible circuit, the second sheet surrounding the longitudinal axis and defining a volume having an open end; and molding the first sheet and the second sheet to encapsulate the first flexible circuit and the second flexible circuit.

[0145] Clause 29. The method according to Clause 28 further comprises: placing a third sheet of insulating material between the first flexible circuit and the second flexible circuit and in contact with the plurality of ridges before molding the first sheet and the second sheet; and molding the third sheet such that the first flexible circuit and the second flexible circuit are spaced apart from the plurality of ridges.

[0146] The above embodiments are cited by way of example, and the disclosed technology is not limited to the content specifically shown and described above. Rather, the scope of the disclosed technology includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereof, which will occur to those skilled in the art upon reading the above description and are not disclosed in the prior art.

[0147] Where any material incorporated herein by reference contains similar terms but differs in definition or description, it should be understood that the definitions or descriptions provided herein will be used to understand the techniques disclosed herein.

Claims

1. An end effector for a medical probe, the end effector comprising: Multiple ridges, which extend radially outward from the longitudinal axis of the end effector in an expanded configuration; A membrane connected to the plurality of ridges, the membrane including a distal end surrounding the longitudinal axis and defining a volume having an open end, the membrane including a first surface and a second surface opposite to the first surface; A first flexible circuit is disposed on the first surface of the membrane, close to each of the plurality of ridges and extending about the longitudinal axis. A second flexible circuit is disposed on the second surface of the membrane, close to each of the plurality of ridges and extending about the longitudinal axis; A plurality of first pairs of electrodes are disposed on the first flexible circuit, close to each other and close to the ridges of the plurality of ridges; as well as A plurality of second pairs of electrodes are disposed on the second flexible circuit, close to each other and close to the ridges of the plurality of ridges, such that the first pair of electrodes and the second pair of electrodes define a mirror configuration, wherein the membrane is located between the first pair of electrodes and the second pair of electrodes.

2. The end effector according to claim 1, wherein the plurality of ridges are arranged radially around the longitudinal axis.

3. The end effector of claim 1, wherein each ridge includes a proximal end fixed to the probe shaft and a free distal end, the distal end of the membrane extending beyond the free distal end of each ridge.

4. The end effector of claim 1, wherein each ridge includes a proximal end fixed to the first probe shaft and a distal end fixed to the second probe shaft.

5. The end effector of claim 1, wherein the membrane is biased to the expansion configuration by the plurality of ridges.

6. The end effector of claim 1, wherein the membrane in the expansion configuration comprises a generally hemispherical, semi-conical, or polygonal pyramidal shape defining the volume, and further comprises a polymeric material.

7. The end effector of claim 1, wherein the end effector is movable between a collapsed configuration and an expanded configuration, wherein the plurality of ridges and the membrane are arranged substantially along the longitudinal axis in the collapsed configuration.

8. The end effector of claim 1, wherein the first surface is away from the longitudinal axis and the second surface faces the longitudinal axis.

9. The end effector of claim 1, wherein the first flexible circuit and the second flexible circuit are spaced apart from the plurality of ridges along a vertical axis, each first pair of electrodes is electrically connected together to define a single first electrode among a plurality of first electrodes on the first surface, and each second pair of electrodes is electrically connected together to define a single second electrode among a plurality of second electrodes on the second surface.

10. The end effector of claim 9, wherein a portion of the membrane is disposed between the plurality of ridges and the first flexible circuit and between the plurality of ridges and the second flexible circuit.

11. The end effector of claim 1, further comprising a plurality of gaps defined to pass through the membrane, the first flexible circuit and the second flexible circuit between adjacent ridges of the plurality of ridges.

12. The end effector of claim 1, wherein the membrane comprises a plurality of layers, each layer surrounding the longitudinal axis, wherein at least one of the layers comprises an insulating material.

13. The end effector of claim 12, wherein the plurality of layers of each blade comprises at least one layer comprising a dielectric material.

14. The end effector according to claim 1, wherein the first flexible circuit includes a plurality of first flexible substrates, the plurality of first flexible substrates being circumferentially spaced around the longitudinal axis, and each first electrode being disposed on a corresponding first flexible substrate.

15. The end effector of claim 1, wherein the number of ridges in the plurality of ridges is greater than the number of the first pair of electrodes.

16. The end effector of claim 1, wherein each first pair of electrodes is flush with the outer surface of the membrane.

17. The end effector of claim 1, wherein each first pair of electrodes protrudes from the outer surface of the membrane.

18. The end effector of claim 1, wherein each of the first pair of electrodes and the second pair of electrodes comprises an elongated segment, the elongated segment comprising a plurality of conductive strips extending parallel to each other to form the overall shape of the elongated segment.

19. A medical system comprising: A medical probe, the medical probe including an elongated probe body and an end effector connected to a distal end of the elongated probe body, the elongated probe body and the end effector extending along a longitudinal axis, the end effector including: Multiple ridges are connected to the elongated probe body and extend radially outward from the longitudinal axis of the end effector in an expanded configuration; A membrane connected to the plurality of ridges, the membrane including a distal end surrounding the longitudinal axis and defining a volume having an open end, the membrane including a first surface and a second surface opposite to the first surface; A first flexible circuit is disposed on the first surface of the membrane, close to each of the plurality of ridges and extending about the longitudinal axis. A second flexible circuit is disposed on the second surface of the membrane, close to each of the plurality of ridges and extending about the longitudinal axis; A plurality of first pairs of ablation electrodes are disposed on the first flexible circuit and are close to each other and to the ridges of the plurality of ridges; and A plurality of second pairs of electrodes are disposed on the second flexible circuit, close to each other and close to a ridge among the plurality of ridges, such that the first pair of electrodes and the second pair of electrodes define a mirror configuration, wherein the film is located between the first pair of electrodes and the second pair of electrodes; and An ablation generator configured to provide ablation pulses to the plurality of first pairs of electrodes and the plurality of second pairs of electrodes.

20. A method of manufacturing an end effector for a medical probe, the method comprising: Multiple ridges extending away from the longitudinal axis are formed; A first flexible circuit is disposed on a first side of the plurality of ridges, the first flexible circuit including a first flexible substrate and a first pair of electrodes; A second flexible circuit is disposed on the second side of the plurality of ridges, the second flexible circuit including a second flexible substrate and a second pair of electrodes; A first sheet of insulating material is placed in contact with the first flexible circuit, the first sheet being positioned around the longitudinal axis; A second sheet of insulating material is placed in contact with the second flexible circuit, the second sheet surrounding the longitudinal axis and defining a volume having an open end; as well as The first sheet and the second sheet are molded to encapsulate the first flexible circuit and the second flexible circuit.

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