Mapping and ablation catheter

Abstract

The disclosed techniques include a medical probe configured for mapping and ablation of tissue. The medical probe includes an inner catheter shaft extending along a longitudinal axis and an ablation electrode disposed at a distal end of the inner catheter shaft. The ablation electrode may be configured to deliver ablation energy to tissue. The medical probe further includes an outer cannula disposed at least partially around the inner catheter shaft and extending along the longitudinal axis; and a plurality of spines disposed at the distal end of the outer cannula. Each of the plurality of spines may include a mapping electrode configured to detect an electrophysiological signal. The outer cannula may be configured to move axially along the inner catheter shaft to move the plurality of spines axially relative to the ablation electrode.

Description

Technical Field

[0001] The present invention generally relates to medical devices configured for mapping and ablation of tissue. Background Art

[0002] When regions of cardiac tissue abnormally conduct electrical signals to adjacent tissue, cardiac arrhythmias, such as atrial fibrillation (AF), can occur. This disrupts the normal cardiac cycle and results in an irregular heartbeat. Certain procedures are used to treat cardiac arrhythmias, including surgically disturbing the source of the arrhythmia-causing signals and disturbing the conduction pathways for such signals. Selectively ablating cardiac tissue by applying energy via a catheter can sometimes stop or alter the propagation of unwanted electrical signals from one part of the heart to another.

[0003] To perform ablation of cardiac tissue, a physician typically inserts a sheath catheter through a blood vessel near the groin and navigates the sheath catheter to the patient's heart. Once inside the heart, the physician can perform a transseptal puncture, if necessary, to access the opposite side of the heart. The physician then typically inserts a mapping catheter and navigates the mapping catheter to the region of interest in the heart to collect electrophysiological signals from the tissue, thereby generating an electrophysiological map of the tissue. Some example probes include a plurality of ridges having electrodes disposed thereon. The electrodes are typically attached to the ridges, and the ridges are configured to extend outwardly when deployed from the sheath. The electrodes are then brought into contact with the tissue for mapping the electrophysiological signals propagating through the tissue.

[0004] Once a cardiac region is identified as propagating abnormal electrical signals, the physician typically must remove the mapping catheter and then insert an ablation catheter to perform the ablation. As previously described, the physician navigates the ablation catheter to the region of interest. Once the ablation catheter is properly positioned at the region of interest, ablation energy can be delivered to the tissue to interrupt the propagation of the abnormal electrical signals. However, it can be appreciated that inserting more than one catheter lengthens the procedure time, which is difficult for both the physician and the patient.

[0005] To shorten the procedure time, some physicians insert more than one catheter at a time, which may require multiple entry points and transseptal punctures. The long procedure time and multiple entry points or transseptal punctures can lengthen the patient's recovery time. Accordingly, there is a need for a device and method for reducing the complexity and time required to perform mapping and ablation of cardiac tissue. These and other problems can be solved by the techniques disclosed herein. Summary of the Invention

[0006] According to the disclosed technology, a medical probe configured for mapping and ablation of tissue is provided. The medical probe includes an inner catheter shaft extending along a longitudinal axis and an ablation electrode disposed at a distal end of the inner catheter shaft. The ablation electrode can be configured to deliver ablation energy to tissue. The medical probe further includes: an outer sheath disposed at least partially around the inner catheter shaft and extending along the longitudinal axis; and a plurality of ridges disposed at a distal end of the outer sheath. Each of the plurality of ridges may include a mapping electrode configured to detect electrophysiological signals. The outer sheath can be configured to move axially along the inner catheter shaft to axially move the plurality of ridges relative to the ablation electrode.

[0007] The disclosed technology also includes a method for performing mapping and ablation of tissue. The method may include inserting a medical probe into a lumen of a body. The medical probe may include an inner catheter shaft extending along a longitudinal axis and an ablation electrode disposed at a distal end of the inner catheter shaft. The ablation electrode can be configured to deliver ablation energy to tissue. The medical probe may further include: an outer sheath disposed at least partially around the inner catheter shaft and extending along the longitudinal axis; and a plurality of ridges disposed at a distal end of the outer sheath. Each of the plurality of ridges may include a mapping electrode configured to detect electrophysiological signals.

[0008] The method may further include sliding the outer sheath along the inner catheter shaft to extend the plurality of ridges beyond a distal end of the ablation electrode and receiving one or more electrophysiological signals from at least one mapping electrode disposed on the plurality of ridges. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The present invention will be more fully understood from the following detailed description of embodiments of the disclosure in conjunction with the accompanying drawings, in which:

[0010] Figure 1 is a schematic illustration of a medical system including a medical probe according to the disclosed technology;

[0011] Figure 2A is a schematic illustration of a medical probe having an end effector and a handle in a first configuration according to the disclosed technology;

[0012] Figure 2B is a schematic illustration of a medical probe having an end effector and a handle in a second configuration according to the disclosed technology;

[0013] Figure 3A is a side view of an end effector according to the disclosed technology;

[0014] Figure 3BIs a side view of an end effector having a mapping assembly that is pushed distally according to the disclosed technology;

[0015] Figure 3C Is a side view of an end effector having a mapping assembly that is pulled proximally according to the disclosed technology;

[0016] Figure 4 Is a detailed view of an end effector according to the disclosed technology;

[0017] Figure 5A Is a top perspective view of a mapping assembly according to the disclosed technology;

[0018] Figure 5B Is a top view of a mapping assembly according to the disclosed technology;

[0019] Figure 5C Is a side view of a mapping assembly according to the disclosed technology;

[0020] Figure 6 Is a side view of a mapping assembly and an outer cannula according to the disclosed technology;

[0021] Figure 7A Is a perspective view of an ablation assembly and an inner catheter shaft according to the disclosed technology;

[0022] Figure 7B Is a side view of an ablation assembly and an inner catheter shaft according to the disclosed technology; and

[0023] Figure 8 Is a flow chart of a method for performing mapping and ablation of tissue according to the disclosed technology. DETAILED DESCRIPTION

[0024] The disclosed technology relates to a medical probe that is configured to perform mapping of electrophysiological signals and ablation of tissue. The disclosed medical probe can simplify the procedures required to map and ablate tissue by eliminating the need to use more than one catheter. For illustration, the disclosed technology includes an end effector having a mapping assembly that is at least partially disposed around an ablation assembly. The mapping assembly can be moved distally beyond the distal end of the ablation assembly such that a physician can access tissue and obtain electrophysiological signals from the tissue. The mapping assembly can also be moved proximally such that the ablation assembly is away from the distal end of the mapping assembly, whereby the ablation assembly can deliver ablation energy to the tissue. In other words, a physician can slide the mapping assembly distally to perform a mapping protocol and then slide the mapping assembly proximally to expose the ablation catheter and perform an ablation protocol. The mapping protocol and the ablation protocol can be accomplished with a single medical probe, thereby simplifying the surgical workflow and reducing the total surgical time. Reducing the surgical time can also help reduce the patient's recovery time.

[0025] The following detailed description should be read in conjunction with the accompanying drawings, in which like reference numerals refer to like elements in the different drawings. The drawings (not necessarily to scale) depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example and not by way of limitation. This description will clearly enable one skilled in the art to make and use the invention and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.

[0026] As used herein, the term "about" or "approximately" in reference to any numerical value or range indicates a suitable dimensional tolerance that allows for a component or collection of components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" can refer to a range of values of plus or minus 20% of the recited value, e.g., "about 90%" can refer to a range of values from 71% to 110%.

[0027] In addition, as used herein, the terms "patient", "recipient", "user" and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, but the use of the subject invention 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.

[0028] As discussed herein, the vasculature of a "patient", "recipient", "user" and "subject" can be that of a human or any animal. It should be understood that the animal can be of any suitable type, including but not limited to mammals, veterinary animals, domestic animals or pet animals, etc. For example, the animal can be an experimental animal (e.g., rats, dogs, pigs, monkeys, etc.) specifically selected to have certain characteristics similar to humans. It should be understood that the subject can be, for example, any suitable human patient.

[0029] As discussed herein, a "physician" can include a doctor, surgeon, technician, scientist, operator, or any other individual or delivery instrument associated with delivering a multi-electrode catheter for treating drug-refractory atrial fibrillation to a subject.

[0030] As discussed herein, when referring to the devices and corresponding systems of the present disclosure, the term "ablation" refers to components and structural features configured to reduce or prevent the generation of unstable cardiac signals in cells by utilizing non-thermal energy, such as irreversible electroporation (IRE), which may be interchangeably referred to as pulsed electric field (PEF) and pulsed field ablation (PFA) in the present disclosure. "Ablation", as used throughout the present disclosure, when referring to the devices and corresponding systems of the present disclosure, refers to non-thermal ablation of cardiac tissue for certain conditions, including but not limited to arrhythmia, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablation" also includes known methods, devices, and systems for achieving various forms of ablation of bodily tissue as understood by those skilled in the relevant art.

[0031] As discussed herein, the terms "bipolar" and "unipolar", when used to refer to ablation protocols, describe ablation protocols that differ in terms of current path and electric field distribution. "Bipolar" refers to an ablation protocol that utilizes a current path between two electrodes, both of which are positioned at the treatment site, as described below; the current density and electric flux density at each of the two electrodes are typically approximately equal. "Unipolar" refers to an ablation protocol that utilizes a current path between two electrodes, where one electrode with a high current density and high electric flux density is positioned at the treatment site, and a second electrode with a relatively low current density and low electric flux density is positioned away from the treatment site.

[0032] As discussed herein, the terms "biphasic pulse" and "monophasic pulse" refer to corresponding electrical signals. A "biphasic pulse" refers to an electrical signal having a positive voltage phase pulse (referred to herein as the "positive phase") and a negative voltage phase pulse (referred to herein as the "negative phase"). A "monophasic pulse" refers to an electrical signal having only a positive phase or only a negative phase. Preferably, a system configured to provide a biphasic pulse is configured to prevent the application of a direct current (DC) voltage to the patient. For example, the average voltage of the biphasic pulse may be zero volts relative to ground or other common reference voltage. Additionally or alternatively, the system may include a capacitor or other protective component. The voltage amplitudes of the biphasic and / or monophasic pulses are described herein, and it should be understood that the expressed voltage amplitudes are the absolute values of the approximate peak amplitudes of each of the positive voltage phase and / or negative voltage phase. Each phase of the biphasic pulse and the monophasic pulse preferably has a square shape, having a substantially constant voltage amplitude during most of the phase duration. The phases of the biphasic pulse are separated in time by an interphase delay. The interphase delay duration is preferably less than or approximately equal to the duration of the phases of the biphasic pulse. The interphase delay duration is more preferably approximately 25% of the duration of the phases of the biphasic pulse.

[0033] As discussed herein, the terms "tubular" and "tube" should be understood broadly and are not limited to structures that are right circular cylinders or have a completely circular cross-section or a uniform cross-section along their entire length. For example, a tubular structure is typically illustrated as a structure that is substantially a right circular cylinder. However, without departing from the scope of the present disclosure, a tubular structure may have a conical or curved outer surface.

[0034] The present disclosure relates to systems, methods or uses, and devices that can be used to perform IRE ablation of cardiac tissue to treat arrhythmias. Ablation energy is typically provided to cardiac tissue by a distal portion of a catheter, which can deliver ablation energy along the tissue to be ablated. Some example catheters include a three-dimensional structure at the 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.

[0035] The application of thermal techniques such as radiofrequency (RF) energy and cryoablation for cardiac tissue ablation of a malfunctioning heart is a well-known procedure. Generally, in order to successfully ablate using a thermal technique, it is necessary to measure cardiac electrode potentials at various locations in the myocardium. In addition, temperature measurements during ablation provide data that can enable ablation efficacy. Generally, for ablation procedures using thermal ablation, electrode potentials and temperatures are measured before, during, and after actual ablation. RF methods can have risks that may lead to tissue charring, burns, steam pops, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas. Cryoablation is an alternative to RF ablation, which can reduce some of the thermal risks associated with RF ablation. However, compared to RF ablation, it is generally more challenging to manipulate a cryoablation device and selectively apply cryoablation; thus, cryoablation is not feasible in certain anatomical geometries that can be reached by an electroablation device.

[0036] The present disclosure may include electrodes configured for RF ablation, cryoablation, and / or irreversible electroporation (IRE). Throughout the present disclosure, IRE may be interchangeably referred to as pulsed electric field (PEF) ablation and pulsed field ablation (PFA). As discussed in the present disclosure, IRE is a non-thermal cell death technique that can be used for atrial arrhythmia ablation. To perform ablation using IRE / PEF, biphasic voltage pulses are applied to disrupt the cellular structure of the myocardium. The biphasic pulses are non-sinusoidal and can be tuned based on the electrophysiology of the cells to target the cells. In contrast, to perform ablation using RF, a sinusoidal voltage waveform is applied to generate heat at the treatment area, heating all cells indiscriminately in the treatment area. Thus, IRE has the ability to avoid adjacent thermosensitive structures or tissues, which will be beneficial in reducing possible complications known to be affected by ablation or isolation modalities. In addition or alternatively, monophasic pulses can be used.

[0037] Electroporation can be induced by applying a pulsed electric field across a biological cell, resulting in the reversible (temporary) or irreversible (permanent) formation of pores in the cell membrane. When a pulsed electric field is applied, the cell has a transmembrane electrostatic potential that rises above the static potential. When the transmembrane electrostatic potential remains below the threshold potential, the electroporation is reversible, meaning that the pores can close when the applied pulsed electric field is removed, and the cell can repair itself and survive. If the transmembrane electrostatic potential rises above the threshold potential, the electroporation is irreversible, and the cell becomes permanently permeable. Consequently, the cell dies due to the loss of homeostasis and typically dies by apoptosis. Generally, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of approximately 500 V / cm, while for bone, the threshold potential is 3000 V / cm. These differences in threshold potential allow IRE to selectively target tissues based on the threshold potential.

[0038] The solutions of the present disclosure include systems and methods for applying an electrical signal from a catheter electrode positioned near myocardial tissue to generate ablation energy to ablate myocardial tissue. In some examples, the systems and methods can effectively ablate the target tissue by inducing irreversible electroporation. In some examples, the systems and methods can effectively induce reversible electroporation as part of a diagnostic procedure. Reversible electroporation occurs when the electricity applied using the electrode is below the electric field threshold of the target tissue that allows the cell to repair. Reversible electroporation does not kill the cell but allows the physician to view the effect of reversible electroporation on the electrical activation signals near the target location. Exemplary systems and methods for reversible electroporation are disclosed in U.S. Patent Publication 2021 / 0162210, the entire content of which is incorporated herein by reference.

[0039] The pulsed electric field and its efficacy in inducing reversible electroporation and / or irreversible electroporation can be affected by the physical parameters of the system and the biphasic pulse parameters of the electrical signal. The physical parameters can include electrode contact area, electrode spacing, electrode geometry, etc. The examples presented herein generally include physical parameters suitable for effectively inducing reversible electroporation and / or irreversible electroporation. The biphasic pulse parameters of the electrical signal can include voltage amplitude, pulse duration, pulse interphase delay, interpulse delay, total application time, delivered energy, etc. In some examples, the parameters of the electrical signal can be adjusted to induce both reversible and irreversible electroporation given the same physical parameters. Examples of various ablation systems and methods including IRE are presented in U.S. Patent Publications 2021 / 0169550A1, 2021 / 0169567A1, 2021 / 0169568A1, 2021 / 0161592A1, 2021 / 0196372A1, 2021 / 0177503A1, and 2021 / 0186604A1, the entire content of each of these patent publications being incorporated herein by reference.

[0040] ReferenceFigure 1 which shows an example catheter-based electrophysiological mapping and ablation system 10. The system 10 includes a plurality of catheters that are inserted by a physician 24 through the vasculature of a patient 23 via the skin into a chamber or vascular structure of the heart 12. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location within the heart 12. Thereafter, a catheter having an end effector at its distal end 28 is inserted into the delivery sheath catheter to reach the desired location. Exemplary catheters 14 configured for sensing and ablation are further illustrated and described herein. The physician 24 contacts the distal end 28 of the catheter 14 (sometimes referred to herein as the end effector 28) with the heart wall to sense a target site within the heart 12 using a mapping assembly (to be further described herein). For ablation, the physician 24 may move the mapping assembly proximally to expose an ablation assembly for ablating tissue (as will be further described herein).

[0041] The catheter 14 is an exemplary catheter that includes one and preferably a plurality of electrodes 212 optionally distributed on a plurality of ridges 214 at the distal end 28 (as Figure 4 shown) and configured to sense IEGM signals and / or ablate tissue. The catheter 14 may additionally include a position sensor 118 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 118 is a magnetic-based position sensor that includes three magnetic coils for sensing three-dimensional (3D) position and orientation.

[0042] The magnetic-based position sensor 118 may operate in conjunction with a positioning pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined workspace. The real-time position of the distal end 28 of the catheter 14 may be tracked based on the magnetic field generated by the positioning pad 25 and sensed by the magnetic-based position sensor 118. Details of magnetic-based position sensing techniques are described in U.S. Patent Nos. 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, 6,892,091, the entire contents of each of which are incorporated herein by reference.

[0043] System 10 includes one or more electrode patches 38 that are positioned to contact the skin of patient 23 to establish a position reference for impedance-based tracking of positioning pad 25 and electrodes 26. For impedance-based tracking, current is directed toward electrodes 26 and sensed at the electrode skin patches 38 such that the position of each electrode can be triangulated via the electrode patches 38. Details of impedance-based position tracking techniques are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, the entire contents of each of which are incorporated herein by reference.

[0044] Recorder 11 displays electrocardiogram 21 captured using body surface ECG electrodes 18 and intracardiac electrogram (IEGM) captured using electrodes 26 of catheter 14. Recorder 11 may include pacing capabilities for pacing the heart rhythm and / or may be electrically connected to an independent pacemaker.

[0045] System 10 may include an ablation energy generator 50 that is adapted to conduct ablation energy to one or more electrodes at the distal tip of a catheter configured for ablation. The energy generated by ablation energy generator 50 may include, but is not limited to, radiofrequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that may be used to effect irreversible electroporation (IRE)), or combinations thereof.

[0046] Patient interface unit (PIU) 30 is an interface configured to establish electrical connectivity between the catheter, electrophysiology equipment, power source, and workstation 55 for controlling the operation of System 10. The electrophysiology equipment of System 10 may include, for example, catheter 14, positioning pad 25, body surface ECG electrodes 18, electrode patches 38, ablation energy generator 50, and recorder 11. Optionally and preferably, PIU 30 further includes processing capabilities for performing real-time calculations of the position of the catheter and for performing ECG calculations.

[0047] Workstation 55 includes a memory, a processor unit with a memory or storage device loaded with appropriate operating software, and user interface capabilities. Workstation 55 may provide a plurality of functions, optionally including: (1) performing three-dimensional (3D) modeling of endocardial anatomy and rendering a model or anatomical map 20 for display on display device 27; (2) displaying an activation sequence (or other data) compiled from the recorded electrocardiogram 21 as a representative visual marker or image superimposed on the rendered anatomical map 20 on display device 27; (3) displaying the real-time position and orientation of multiple catheters within the heart chambers; and (4) displaying sites of interest, such as where ablation energy has been applied, on display device 27. A commercial product embodying the elements of System 10 may be CARTOTM The 3System was purchased from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0048] Figure 2A and Figure 2B More particularly, catheter 14 is shown. Catheter 14 (sometimes referred to herein as a medical probe) can be configured to be inserted into heart 12 of patient 23 for mapping and ablating tissue in heart 12. As shown, catheter 14 can include an end effector 28, a first handle 120, and a second handle 220. End effector 28 can be attached to first handle 120 by an inner catheter shaft 122 and to second handle 220 by an outer sheath 222. Sheath 222 can be disposed around inner catheter shaft 122 such that sheath 222 can slide along the outer side of inner catheter shaft 122.

[0049] End effector 28 can also include an ablation assembly 110 and a mapping assembly 210. Ablation assembly 110 is attached to the distal end of inner catheter shaft 122, while mapping assembly 210 is attached to the distal end of sheath 222. In this way, when physician 24 slides first handle 120 and second handle 220 towards each other (as Figure 2A shown), ablation assembly 110 can extend beyond the distal end of mapping assembly 210 such that end effector 28 is configured to deliver ablation energy to tissue. Alternatively, when the physician moves first handle 120 and second handle 220 away from each other (as Figure 2B shown), mapping assembly 210 will slide beyond the distal end of ablation assembly 110 such that mapping assembly 210 is configured to contact tissue and collect electrophysiological signals from the tissue. In other words, physician 24 can slide second handle 220 distally to move mapping assembly 210 into contact with tissue to perform mapping of electrophysiological signals, and physician 24 can slide second handle 220 proximally to expose ablation assembly 110 to perform an ablation procedure.

[0050] The first handle 120 may include an actuator 124 that can be configured to deflect the end effector 28 radially outward from the longitudinal axis LA. For example, the actuator 124 can be attached to a pull wire that is attached to the distal end of the inner catheter shaft 122 or to the ablation assembly 110. When the physician 24 actuates the actuator 124, the pull wire will be pulled to deflect the end effector 28 outward from the longitudinal axis LA. It will be understood that when the inner catheter shaft 122 deflects outward, the inner catheter shaft 122 will also deflect the sleeve 222 (which is disposed around the inner catheter shaft 122) outward. In this way, when the actuator 124 is actuated, both the ablation assembly 110 and the mapping assembly 210 will be deflected outward from the longitudinal axis LA.

[0051] The first handle 120 may also include a first irrigation coupler 126 and a first electrical coupler 128. The first irrigation coupler 126 may be configured to connect to an irrigation supply and deliver irrigation to the ablation assembly 110 through the first handle 120. Figure 4 As shown, the ablation assembly 110 may include irrigation holes 114 configured to deliver irrigation fluid to tissue near the end effector 28. The first electrical coupler 128 may be configured to connect to a corresponding electrical coupler to connect the catheter 14 to the PIU 30 so that ablation energy supplied by the ablation energy generator 50 can be delivered to the ablation assembly 110.

[0052] The second handle 220 may include a second irrigation coupler 226 and a second electrical coupler 228. The second irrigation coupler 226 may be configured to connect to an irrigation supply and deliver irrigation to the mapping assembly 210 through the second handle 220. Figure 6 As shown, the mapping assembly 210 can include irrigation holes 215 configured to deliver irrigation fluid to tissue near the mapping assembly 210. The second electrical coupler 228 can be configured to connect to a corresponding electrical coupler to connect the catheter 14 to the PIU 30 so that electrical signals detected by the mapping assembly 210 can be analyzed and output for display.

[0053] Figure 3A , Figure 3B and Figure 3C Additional views of the end effector 28 are shown. As shown, the mapping assembly 210 can be disposed generally around the ablation assembly 110 and configured to slide distally and proximally on the ablation assembly 110 along the longitudinal axis. Figure 3BAs shown, when the mapping assembly 210 is moved distally, most of the movement of the mapping assembly 210 exceeds the distal end of the ablation assembly 110. In this way, the mapping assembly 210 can be configured to contact tissue and detect electrophysiological signals propagating through the tissue to perform a mapping procedure without being obstructed by the ablation assembly 110. Conversely, when the mapping assembly 210 is pulled proximally, the ablation assembly 110 will extend beyond the distal end of the mapping assembly 210 such that the ablation assembly 110 is configured to deliver ablation energy to the tissue without being obstructed by the mapping assembly 210. In this way, the end effector 28 can be configured to perform both a mapping procedure and an ablation procedure using only a single catheter 14.

[0054] As Figure 4 shown, the ablation assembly 110 can be disposed at the distal end of the inner catheter shaft 122 and includes an ablation electrode 112. In this example, the ablation electrode 112 is a single electrode disposed at the distal end of the inner catheter shaft 122, but it should be understood that more than one electrode can be disposed at the distal end of the inner catheter shaft 122 depending on the particular configuration. The ablation assembly 110 can be configured to perform RF ablation, IRE ablation, and / or cryoablation. In the case where the ablation assembly 110 is configured to perform IRE ablation, the ablation electrode 112 (or electrodes, depending on the configuration) can be configured to deliver a monopolar or bipolar ablation protocol. Additionally, the ablation electrode 112 can be configured to deliver a single-phase or biphasic ablation pulse.

[0055] As briefly described above, the ablation assembly 110 can also include irrigation holes 114 that are configured to deliver irrigation fluid to the ablation assembly 110, the mapping assembly 210, and / or the tissue. The irrigation holes 114 can be circumferentially disposed around the ablation electrode 112 and are configured to direct irrigation fluid outward from the ablation electrode 112.

[0056] The ablation assembly 110 can also include a force sensor 116 that is configured to detect a force applied to the ablation assembly 110. The force sensor 116 can be configured to detect a force such as the force applied to the distal end of the ablation assembly 110 when the ablation assembly 110 contacts tissue. In this way, the force sensor 116 can assist the physician 24 in knowing when the ablation assembly 110 is in sufficient contact with the tissue to deliver ablation energy to the tissue. Examples of contact force sensor assemblies are disclosed in U.S. Patent No. 8,357,152 and U.S. Patent No. 10,688,278 and U.S. Patent Publication No. 2021 / 0187254A1, each of which is incorporated herein by reference and appended to the appendix included herein.

[0057] As Figure 4As shown, the mapping assembly 210 can be disposed at the distal end of the cannula 222. The cannula 222 includes a braided structure 224 that prevents the cannula 222 from bending and / or being squeezed during operation. The braided structure 224 can also include wires that can be connected to the mapping electrodes 212 and / or the ablation electrodes 112. It will be understood that by incorporating the wires into the braided structure 224, the overall profile of the catheter 14 can be reduced. The mapping assembly 210 can also include one or more position sensors 118 disposed near the mapping assembly 210. The position sensors 118 can be configured to detect the position and orientation of the end effector 28, and this information can be output to the display device 27 for display to the physician 24. The position sensors 118 can be any suitable type of position sensor. For example but not limited to, the position sensors 118 can be one or more electromagnetic coils that are configured to output a signal when subjected to a generated electromagnetic field. In some examples, the position sensors 118 can be three position sensors spaced apart from each other circumferentially around the cannula 222 by approximately 120 degrees. Although the position sensors 118 are shown as being disposed on the cannula 222, it should be understood that the position sensors 118 can alternatively or additionally be disposed on the inner catheter shaft 122.

[0058] As Figure 5A , Figure 5B and Figure 5C Further shown, the mapping assembly 210 can include a ridge hub 216 and a plurality of ridges 214 extending radially outward from the ridge hub 216. Each of the ridges 214 can include one or more mapping electrodes 212 that are configured to detect electrophysiological signals propagating through tissue. The ridges 214 can be configured to extend generally in the distal direction such that when the mapping assembly 210 contacts tissue, the ridges 214 and the electrodes 212 contact the tissue.

[0059] It should be understood that the mapping assembly 210 can include various different numbers of ridges 214. For example, the mapping assembly 210 can include three ridges, four ridges, five ridges, six ridges, seven ridges, eight ridges, nine ridges, ten ridges, fifteen ridges, twenty ridges, or any other suitable number of ridges for a particular configuration. As Figures 5A to 5C shown, as a specific example, the mapping assembly 210 can include eight ridges.

[0060] The ridge hub 216 can include a lumen 230 extending through the ridge hub 216 along the longitudinal axis LA. The size of the lumen 230 can be set to fit around the ablation assembly 110 such that the ablation assembly 110 can slide through the ridge hub 216.

[0061] In some examples, the ridge hub 216 may include one or more connectors 217 that may be configured to electrically connect one or more mapping electrodes 212 to the ablation electrode 112. When the ablation electrode 112 is in electrical communication with the connector 217, electrical energy delivered to the ablation electrode 112 may be distributed to one or more mapping electrodes 212 to deliver ablation energy through the one or more electrodes 212. For example, when the ablation electrode 112 is in electrical communication with the connector 217, all of the mapping electrodes 212, only one mapping electrode 212, each distally positioned mapping electrode 212, every other mapping electrode 212, or any other configuration of mapping electrodes 212 may be configured to deliver ablation energy. It will be appreciated that delivering ablation energy through multiple mapping electrodes 212 may ablate a larger area of tissue.

[0062] Figure 6 An alternative example of the mapping assembly 210 having irrigation holes 215 disposed along the ridge 214 is shown. For example, the ridge 214 may include a tube or cannula that is disposed along or around the ridge 214 to deliver irrigation fluid to the irrigation holes 215. Alternatively, the ridge 214 itself may be made of a hollow tube blank and configured to deliver irrigation fluid to the irrigation holes 215. The irrigation holes 215 may be configured to deliver irrigation fluid from an irrigation supply source as previously described. In some examples, the irrigation holes 215 may be oriented such that the irrigation fluid is delivered to tissue near the distal end of the ridge 214. Additionally, although only one irrigation hole 215 is shown on each ridge 214, it should be understood that more than one irrigation hole 215 may be provided on each ridge 214 and the irrigation holes are configured to direct the irrigation fluid to a desired location (e.g., towards tissue, towards the ablation assembly 110, towards the ridge hub 216).

[0063] As Figure 7A and Figure 7B shown, the ablation assembly 110 may be disposed at the distal end of the inner catheter shaft 122 and may include an ablation electrode 112, irrigation holes 114 (radially around the circumference and on the distal tip) disposed on the ablation electrode 112, a force sensor 116, a position sensor 118, and a marker band 119. As previously described, the force sensor 116 may be configured to detect the force applied to the ablation electrode 112 such that feedback may be provided to the physician 24 to indicate when the ablation electrode 112 is in sufficient contact with tissue. The position sensor 118 may be the same as or similar to the aforementioned position sensor 218. For example, the position sensor 118 may be electromagnetic coils spaced apart from each other around the circumference of the inner catheter shaft 122 by approximately 120 degrees. The marker band 119 may be a radiopaque marker configured to be used in conjunction with fluoroscopy to determine the position of the end effector 28.

[0064] Figure 8 FIG. 800 is a flow chart of a method for performing mapping and ablation of an organization according to the disclosed technology. Method 800 may include inserting 802 a medical probe into a lumen of a body, sliding 804 an outer cannula along an inner catheter shaft to extend a plurality of ridges beyond a distal end of the ablation catheter, and receiving 806 one or more electrophysiological signals from at least one mapping electrode. As just described, method 800 can be used to complete a mapping procedure to determine the location and direction of electrophysiological signals propagating through tissue. The collection of electrophysiological signals can be used to identify the location and direction of abnormal signals propagating through tissue.

[0065] Method 800 may further include retracting 810 the outer cannula to extend the ablation electrode beyond a distal end of the plurality of ridges and delivering 812 ablation energy to the tissue. In other words, method 800 may include completing an ablation procedure. The ablation procedure may include ablating tissue at a determined location to prevent abnormal signals from propagating through the tissue.

[0066] As will be appreciated, method 800 as just described is not intended to be limited to the specific steps described or to the specific order of the steps described. That is, method 800 may include other intermediate steps not explicitly described herein and / or may be performed in various orders. Thus, although method 800 is described as having specific steps and presented in a specific order, method 800 is not limited thereto.

[0067] The disclosed technology described herein can be further understood in accordance with the following clauses:

[0068] Clause 1: A medical probe, comprising: an inner catheter shaft extending along a longitudinal axis; an ablation electrode disposed at a distal end of the inner catheter shaft, the ablation electrode being configured to deliver ablation energy to tissue; an outer cannula disposed at least partially around the inner catheter shaft and extending along the longitudinal axis; and a plurality of ridges disposed at a distal end of the outer cannula, each of the plurality of ridges including a mapping electrode configured to detect an electrophysiological signal, the outer cannula being configured to move axially along the inner catheter shaft to move the plurality of ridges axially relative to the ablation electrode.

[0069] Clause 2: The medical probe according to Clause 1, wherein the outer cannula is configured to move the plurality of ridges beyond a distal end of the ablation electrode.

[0070] Clause 3: The medical probe according to Clause 2, wherein the plurality of ridges are configured to extend radially outward from the longitudinal axis.

[0071] Clause 4: The medical probe according to Clause 3, wherein the plurality of ridges are configured to be positioned radially around the ablation electrode.

[0072] Clause 5: The medical probe according to Clause 1, further comprising a first handle disposed at a proximal end of the inner catheter shaft and a second handle disposed at a proximal end of the outer cannula.

[0073] Clause 6: The medical probe according to Clause 5, wherein the second handle is configured to move axially along the longitudinal axis relative to the first handle, thereby moving the outer cannula axially along the inner catheter shaft.

[0074] Clause 7: The medical probe according to Clause 5, further comprising a pull wire configured to deflect the inner catheter shaft radially outward from the longitudinal axis.

[0075] Clause 8: The medical probe according to Clause 7, wherein the first handle includes an actuator configured to pull the pull wire to deflect the inner catheter shaft radially outward from the longitudinal axis.

[0076] Clause 9: The medical probe according to Clause 7, wherein the outer cannula is configured to deflect radially outward when the inner catheter shaft is deflected radially outward from the longitudinal axis.

[0077] Clause 10: The medical probe according to Clause 5, wherein the first handle includes a flush coupler configured to receive flush fluid from a flush supply source, and the ablation electrode includes a plurality of openings, each opening being configured to allow the flush fluid to pass through the opening.

[0078] Clause 11: The medical probe according to Clause 5, wherein the second handle includes a flush coupler configured to receive flush fluid from a flush supply source, and the outer cannula is configured to deliver the flush fluid to the plurality of ridges.

[0079] Clause 12: The medical probe according to Clause 11, wherein each of the plurality of ridges includes an opening configured to allow the flush fluid to pass through the opening.

[0080] Clause 13: The medical probe according to Clause 1, further comprising an electromagnetic sensor disposed near the distal end of the inner catheter shaft, the electromagnetic sensor being configured to generate a current when subjected to an electromagnetic field.

[0081] Clause 14: The medical probe according to Clause 1, further comprising a force sensor disposed proximal to the ablation electrode, the force sensor being configured to detect a force applied to the ablation electrode.

[0082] Clause 15: The medical probe according to Clause 1, wherein the plurality of ridges includes at least five ridges, and each of the at least five ridges includes a plurality of mapping electrodes.

[0083] Clause 16: A method, comprising: inserting a medical probe into a lumen of a body, the medical probe including: an inner catheter shaft extending along a longitudinal axis; an ablation electrode disposed at a distal end of the inner catheter shaft, the ablation electrode configured to deliver ablation energy to tissue; an outer sheath disposed at least partially around the inner catheter shaft and extending along the longitudinal axis; and a plurality of ridges disposed at a distal end of the outer sheath, each of the plurality of ridges including a mapping electrode configured to detect an electrophysiological signal; sliding the outer sheath along the inner catheter shaft to extend the plurality of ridges beyond a distal end of the ablation electrode; and receiving one or more electrophysiological signals from at least one mapping electrode disposed on the plurality of ridges.

[0084] Clause 17: The method according to Clause 16, further comprising generating an electrophysiological map based at least in part on the one or more electrophysiological signals.

[0085] Clause 18: The method according to Clause 16, further comprising actuating a pull wire to deflect the inner catheter shaft, the ablation electrode, the outer sheath, and the plurality of ridges radially outwardly away from the longitudinal axis.

[0086] Clause 19: The method according to Clause 16, further comprising retracting the outer sheath along the inner catheter shaft to extend the ablation electrode beyond a distal end of the plurality of ridges.

[0087] Clause 20: The method according to Clause 19, further comprising delivering ablation energy to tissue via the ablation electrode.

[0088] The above embodiments are cited by way of example, and the present invention is not limited to what is specifically shown and described above. On the contrary, the scope of the present invention includes combinations and sub - combinations of the various features described above, as well as their variations and modifications, which will occur to those skilled in the art upon reading the above description and which are not disclosed in the prior art.

Claims

1. A medical probe, comprising: an inner catheter shaft extending along a longitudinal axis; an ablation electrode disposed at a distal end of the inner catheter shaft, the ablation electrode being configured to deliver ablation energy to tissue; an outer sheath disposed at least partially around the inner catheter shaft and extending along the longitudinal axis; and A plurality of ridges are disposed at the distal end of the outer sheath, each of the plurality of ridges comprising a mapping electrode configured to detect an electrophysiological signal, and the outer sheath is configured to move axially along the inner catheter shaft so that the plurality of ridges move axially relative to the ablation electrode. 2 . The medical probe of claim 1 , the outer sleeve being configured to move the plurality of ridges beyond a distal end of the ablation electrode. 3 . The medical probe of claim 2 , the plurality of ridges being configured to extend radially outward from the longitudinal axis. The medical probe of claim 3 , wherein the plurality of ridges are configured to be positioned radially around the ablation electrode. 5 . The medical probe of claim 1 , further comprising a first handle disposed at a proximal end of the inner catheter shaft and a second handle disposed at a proximal end of the outer sheath. 6 . The medical probe of claim 5 , the second handle being configured to move axially along the longitudinal axis relative to the first handle to thereby move the outer sheath axially along the inner catheter shaft. 7 . The medical probe of claim 5 , further comprising a pull wire configured to deflect the inner catheter shaft radially outward from the longitudinal axis. 8 . The medical probe of claim 7 , the first handle comprising an actuator configured to pull the pull wire to deflect the inner catheter shaft radially outward from the longitudinal axis.

9. The medical probe of claim 7, the outer sheath being configured to deflect radially outward when the inner catheter shaft is deflected radially outward from the longitudinal axis.

10. The medical probe of claim 5, the first handle comprising an irrigation coupler configured to receive irrigation fluid from an irrigation supply, and the ablation electrode comprising a plurality of openings, each opening configured to allow the irrigation fluid to pass through the opening.

11. The medical probe of claim 5, the second handle comprising an irrigation coupler configured to receive irrigation fluid from an irrigation supply, the outer cannula configured to deliver irrigation fluid to the plurality of ridges.

12. The medical probe of claim 11, each of the plurality of ridges comprising an opening configured to allow the irrigation fluid to pass through the opening.

13. The medical probe of claim 1, further comprising an electromagnetic sensor disposed proximate the distal end of the inner catheter shaft, the electromagnetic sensor configured to generate an electrical current when subjected to an electromagnetic field. 14 . The medical probe of claim 1 , further comprising a force sensor disposed proximal to the ablation electrode, the force sensor being configured to detect a force applied to the ablation electrode.

15. The medical probe according to claim 1, wherein: The plurality of ridges includes at least five ridges, and each of the at least five ridges includes a plurality of mapping electrodes.

16. A method comprising: A medical probe is inserted into a lumen of a body, the medical probe comprising: an inner catheter shaft extending along a longitudinal axis; an ablation electrode disposed at a distal end of the inner catheter shaft, the ablation electrode being configured to deliver ablation energy to tissue; an outer sheath disposed at least partially around the inner catheter shaft and extending along the longitudinal axis; and a plurality of ridges disposed at a distal end of the outer sheath, each of the plurality of ridges comprising a mapping electrode configured to detect an electrophysiological signal; sliding the outer sheath along the inner catheter shaft so that the plurality of ridges extend beyond the distal end of the ablation electrode; and One or more electrophysiological signals are received from at least one mapping electrode disposed on the plurality of ridges.

17. The method of claim 16, further comprising generating an electrophysiological map based at least in part on the one or more electrophysiological signals.

18. The method of claim 16, further comprising actuating a pull wire to deflect the inner catheter shaft, the ablation electrode, the outer sheath, and the plurality of ridges radially outwardly away from the longitudinal axis.

19. The method of claim 16, further comprising retracting the outer sheath along the inner catheter shaft to extend the ablation electrode beyond the distal ends of the plurality of ridges.

20. The method of claim 19, further comprising delivering ablation energy to tissue via the ablation electrode.

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