Mapping and ablation catheter

Abstract

To provide a medical device configured for tissue mapping and ablation.SOLUTION: A disclosed technology includes a medical probe configured for tissue mapping and ablation. The medical probe includes an inside catheter shaft extending along a longitudinal axis and an ablation electrode disposed at the distal end of the inside catheter shaft. The ablation electrode can be configured so as to deliver ablation energy to a tissue. The medical probe further includes an outside sleeve arranged around the inside catheter shaft at least partially, and extending along the longitudinal axis, which includes a plurality of spines arranged at the distal end of the outside sleeve. Each spine of the plurality of spines can include a mapping electrode configured so as to detect an electrophysiological signal. The outside sleeve can be configured so as to move in the axial direction along the inside catheter shaft, and cause the plurality of spines to move in the axial direction with respect to the ablation electrode.SELECTED DRAWING: Figure 4

Description

Technical Field

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

Background Art

[0002] Cardiac arrhythmias such as atrial fibrillation (AF) occur when regions of heart tissue conduct electrical signals abnormally to adjacent tissue. This disrupts the normal cardiac cycle and causes an asynchronous rhythm. Some of the specific procedures that exist for treating arrhythmias include surgically destroying the source of the signals that cause the arrhythmia and destroying the conduction pathways of such signals. By applying energy via a catheter to selectively ablate heart tissue, it is sometimes possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another.

[0003] To perform ablation of heart tissue, a physician generally inserts a sheath catheter through a blood vessel accessed near the groin and guides the sheath catheter to the patient's heart. Once in the heart, the physician can perform a transeptal puncture to access the opposite side of the heart if necessary. The physician then generally inserts a mapping catheter and guides the mapping catheter to the area of interest in the heart to collect electrophysiological signals from the tissue and generate an electrophysiological map of the tissue. Some exemplary probes include a number of spines with electrodes positioned thereon. The electrodes are generally attached to the spines, and the spines are configured to extend outwardly when deployed from the sheath. The electrodes are then brought into contact with the tissue for mapping electrophysiological signals propagating through the tissue.

[0004] When the cardiac region is identified as propagating abnormal electrical signals, a physician generally must remove the mapping catheter and then insert an ablation catheter to perform ablation. As described above, the physician guides the ablation catheter to the area of interest. Once the ablation catheter is properly positioned in the area of interest, ablation energy can be delivered to the tissue to disrupt the propagation of abnormal electrical signals. However, as is understood, inserting two or more catheters at once prolongs the surgical time, which can be similarly difficult for both the physician and the patient.

Summary of the Invention

Problems to be Solved by the Invention

[0005] To shorten the surgical time, some physicians insert two or more catheters at once, which may require multiple access points and septal punctures. The long surgical time and multiple access points or septal punctures can potentially prolong the patient's recovery time. Accordingly, there is a need for devices and methods to reduce the complexity and time required to perform cardiac tissue mapping and ablation. These and other problems can be addressed by the techniques disclosed herein.

Means for Solving the Problems

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

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

[0008] The method may further include sliding the outer sleeve along the inner catheter shaft to extend the plurality of spines 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 spines.

Brief Description of the Drawings

[0009] The present disclosure will be more fully understood by reading the following detailed description of embodiments of the present disclosure in conjunction with the drawings.

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BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The disclosed technology relates to a medical probe configured to perform mapping of electrophysiological signals and ablation of tissue. The disclosed medical probe can simplify the processes required for tissue mapping and ablation by eliminating the need to use two or more catheters. By way of example, the disclosed technology includes an end effector having a mapping assembly at least partially disposed around an ablation assembly. The mapping assembly can be moved distally beyond the distal end of the ablation assembly so that a physician can contact the tissue and obtain electrophysiological signals from the tissue. The mapping assembly can also be moved proximally so that the ablation assembly is distal to the distal end of the mapping assembly so that the ablation assembly can deliver ablation energy to the tissue. Stated another way, a physician can slide the mapping assembly distally to perform a mapping procedure and then slide the mapping assembly proximally to expose the ablation catheter and perform an ablation procedure. The mapping and ablation procedures can be performed with a single medical probe, thereby simplifying the surgical workflow and reducing the overall surgical time. The reduction in surgical time can also help reduce the patient's recovery time.

[0011] The following detailed description is to be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings are not necessarily to scale, depict selected embodiments, and are not intended to limit the scope of the invention. The detailed description is by way of example and not limitation, illustrating the principles of the invention. This description enables those skilled in the art to make and use the invention and describes some embodiments, adaptations, variations, alternatives, and uses of the invention, including what is presently considered to be the best mode of carrying out the invention.

[0012] As used herein, the term "about" or "substantially" with respect to any numerical value or range indicates a suitable dimensional tolerance that allows a component or collection to function for the intended purpose described herein. More specifically, "about" or "substantially" can refer to a range of values that are ±20% of the recited value. For example, "about 90%" can refer to a range of values from 71% to 110%.

[0013] In addition, as used herein, the terms "patient", "host", "user", and "subject" refer to any human or animal subject, and the use of the present invention in human patients represents a preferred embodiment, but is not intended to limit the system or method to human use. Similarly, the term "proximal" indicates the position closer to the operator or physician, while "distal" indicates the position farther from the operator or physician.

[0014] As contemplated herein, the vasculature of "patient", "host", "user", and "subject" can be that of a human or any animal. It should be understood that the animal can be of various any applicable types, including but not limited to mammals, veterinary animals, domestic animals, or pet animals. As an example, the animal can be an experimental animal (e.g., rat, dog, pig, monkey, etc.) specifically selected to have certain properties similar to humans. It should be understood that the subject can be, for example, any applicable human patient.

[0015] As contemplated herein, "physician" can include a doctor, surgeon, technician, scientist, operator, or any other individual or delivery device associated with the delivery of a multi-electrode catheter for the treatment of drug-refractory atrial fibrillation to a subject.

[0016] As discussed herein, the term "ablating" or "ablation," when referring to the devices and corresponding systems of the present disclosure, refers throughout the present disclosure to components and structural features configured to reduce or prevent the generation of irregular cardiac signals within cells by utilizing non-thermal energy such as irreversible electroporation (IRE), which is interchangeably referred to as pulsed electric field (PEF) and pulsed field ablation (PFA) throughout the present disclosure. When referring to the devices and corresponding systems of the present disclosure, ablating or ablation is used throughout the present disclosure with reference to non-thermal ablation of cardiac tissue in certain conditions, including but not limited to arrhythmias, atrial fibrillation ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablating" or "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation, as would be understood by one of ordinary skill in the art.

[0017] As discussed herein, the terms "bipolar" and "unipolar," when used to refer to ablation schemes, describe different ablation schemes with respect to current paths and electric field distributions. "Bipolar" refers to an ablation scheme that utilizes the current path between two electrodes both positioned at the treatment site, where the current density and electric flux density are typically approximately equal at each of the two electrodes. "Unipolar" refers to an ablation scheme that utilizes the current path between two electrodes, where one electrode having a high current density and high electric flux density is positioned at the treatment site and a second electrode having a relatively low current density and lower electric flux density is positioned remotely from the treatment site.

[0018] As contemplated herein, the terms "biphasic pulse" and "monophasic pulse" refer to respective 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 the positive phase or only the negative phase. Preferably, a system that provides a biphasic pulse is configured to prevent the application of direct current (DC) voltage to a patient. For example, the average voltage of a biphasic pulse can be zero volts relative to ground or another common reference voltage. Additionally or alternatively, the system can include a capacitor or other protective component. When the voltage amplitude of a biphasic pulse and / or a monophasic pulse is described herein, it is understood that the expressed voltage amplitude is the absolute value of the approximate peak amplitude of each of the positive voltage phase and / or the negative voltage phase. Each phase of a biphasic pulse and a monophasic pulse preferably has a square shape with an essentially constant voltage amplitude during most of the phase duration. The phases of a biphasic pulse are temporally separated by an interphase delay. The interphase delay duration is preferably less than or approximately equal to the duration of the phase of the biphasic pulse. The interphase delay duration is more preferably approximately 25% of the duration of the phase of the biphasic pulse.

[0019] As contemplated herein, the terms "tubular" and "tube" are to be construed broadly and are not limited to a straight cylindrical structure, or a structure having a cross-section that is strictly circular, or a structure having a uniform cross-section throughout its length. For example, a tubular structure is generally illustrated as a substantially straight cylindrical structure. However, a tubular structure can have a tapered or curved outer surface without departing from the scope of the present disclosure.

[0020] The present disclosure relates to systems, methods, or uses and devices that can be used for IRE ablation of cardiac tissue for treating cardiac arrhythmias. Ablation energy is typically delivered to cardiac tissue by a distal portion of a catheter that can deliver ablation energy along tissue to be ablated. Some exemplary catheters include a three-dimensional structure at the distal portion and are configured to manage ablation energy from various electrodes positioned on the three-dimensional structure. Ablation procedures incorporating such exemplary catheters can be visualized using fluoroscopy.

[0021] To improve a failing heart, ablation of cardiac tissue using the application of thermal techniques such as radio frequency (RF) energy and cryoablation is a well-known procedure. Typically, to successfully ablate using thermal techniques, it is necessary to measure cardiac potentials at various locations in the myocardium. In addition, temperature measurements during ablation provide data that enables the effectiveness of ablation. Typically, in ablation procedures using thermal techniques, potentials and temperatures are measured before, during, and after actual ablation. The RF approach can have risks leading to tissue charring, burning, steam popping, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistula. Cryoablation is an alternative approach to RF ablation that can reduce some of the thermal risks associated with RF ablation. However, maneuvering a cryoablation device and selectively applying cryoablation is generally more difficult compared to RF ablation, and thus cryoablation may not be feasible in certain anatomical shapes that can be reached by an electrical ablation device.

[0022] The present disclosure may include electrodes configured for RF ablation, cryoablation, and / or irreversible electroporation (IRE). IRE may be referred to interchangeably throughout the present disclosure as pulsed electric field (PEF) ablation and pulsed field ablation (PFA). The IRE contemplated in the present disclosure is a non-thermal cell death technique that may be used for ablation of atrial arrhythmias. To ablate using IRE / PEF, a biphasic voltage pulse is applied to disrupt the cellular structure of the myocardium. The biphasic pulse is a non-sinusoidal waveform and can be tailored to target cells based on the electrophysiology of the cells. In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to generate heat in the treatment area and indiscriminately heat all cells within the treatment area. Thus, IRE has the ability to spare adjacent heat-sensitive structures or tissues, which would be beneficial in reducing possible complications known in ablation modalities or isolation modalities. Additionally or alternatively, monophasic pulses can be utilized.

[0023] Electroporation can be induced by applying a pulsed electric field to biological cells to cause reversible (temporary) or irreversible (permanent) formation of pores within the cell membrane. Cells have a transmembrane electrostatic potential that increases beyond the resting potential upon application of the pulsed electric field. The transmembrane electrostatic potential remains below the threshold potential, but electroporation is reversible, meaning that the pores can close and the cells can self-repair and survive when the applied pulsed electric field is removed. When the transmembrane electrostatic potential increases beyond the threshold potential, electroporation is irreversible and the cells become permanently permeable. As a result, the cells die due to loss of homeostasis and typically die by apoptosis. Generally, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of about 500 V / cm, while bone has a threshold potential of 3000 V / cm. These differences in threshold potential allow IRE to selectively target tissues based on the threshold potential.

[0024] 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 for ablating the myocardial tissue. In some examples, the systems and methods can be effective for ablating target tissue by inducing irreversible electroporation. In some examples, the systems and methods can be effective for inducing reversible electroporation as part of a diagnostic procedure. Reversible electroporation occurs when the electricity applied by the electrodes is below the electric field threshold of the target tissue, which allows the cells to repair. Reversible electroporation does not kill the cells but allows the physician to see the effect of reversible electroporation on the electrical activation signal in the vicinity of the target location. Exemplary systems and methods for reversible electroporation are disclosed in U.S. Patent Application Publication No. 2021 / 0162210, which is incorporated herein by reference in its entirety.

[0025] The effectiveness of a pulsed electric field, and of a pulsed electric field that induces 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 the electrode contact area, the electrode spacing, the electrode shape, and the like. The examples presented herein generally include physical parameters adapted to effectively induce reversible and / or irreversible electroporation. The biphasic pulse parameters of the electrical signal can include the voltage amplitude, the pulse duration, the pulse phase delay, the interpulse delay, the total application time, the delivered energy, and the like. In some examples, the parameters of the electrical signal can be adjusted to induce both reversible electroporation and irreversible electroporation when the same physical parameters are provided. Examples of various systems and methods of ablation that include IRE are presented in U.S. Patent Application Publication Nos. 2021 / 0169550(A1), 2021 / 0169567(A1), 2021 / 0169568(A1), 2021 / 0161592(A1), 2021 / 0196372(A1), 2021 / 0177503(A1), and 2021 / 0186604(A1), the entireties of each of which are incorporated herein by reference.

[0026] Refer to FIG. 1, which shows an exemplary catheter-based electrophysiological mapping and ablation system 10. The system 10 includes a plurality of catheters that are percutaneously inserted by a physician 24 through the vasculature of a patient 23 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 in the heart 12. Thereafter, a catheter having an end effector at its distal tip 28 is inserted into the delivery sheath catheter to reach the desired location. An exemplary catheter 14 configured for sensing and ablation is illustrated and further described herein. The physician 24 contacts the distal tip 28 of the catheter 14 (which may also be referred to herein as the end effector 28) with the heart wall and senses a target site within the heart 12 using a mapping assembly (further described herein). For ablation, the physician 24 can move the mapping assembly proximally to expose an ablation assembly (as further described herein) for ablating tissue.

[0027] The catheter 14 includes one and preferably a plurality of electrodes 212 that are optionally distributed (as shown in FIG. 4) across a plurality of spines 214 at the distal tip 28 and that are configured to sense IEGM signals and / or ablate tissue. The catheter 14 may additionally include a position sensor 118 embedded within or near the distal tip 28 to track the position and orientation of the distal tip 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.

[0028] The magnetic - based position sensor 118 can operate in conjunction with a position pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working volume. The real - time position of the distal tip 28 of the catheter 14 can be tracked based on the magnetic field generated by the position pad 25 and sensed by the magnetic - based position sensor 118. Details of magnetic - based position sensing techniques are described in U.S. Pat. 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 entireties of each of which are incorporated herein by reference.

[0029] The system 10 includes one or more electrode patches 38 positioned for skin contact on the patient 23 to establish position referencing of the position pad 25 and impedance - based tracking of the electrodes 26. For impedance - based tracking, current is directed to the electrodes 26 such that the position of each electrode can be triangulated via the electrode patches 38 and sensed at the electrode - skin patches 38. Details of impedance - based position - tracking techniques are described in U.S. Pat. Nos. 7,536,218; 7,756,576; 7,848,787; 7,869,865; and 8,456,182, the entireties of each of which are incorporated herein by reference.

[0030] The recorder 11 displays an electrogram 21 captured by the body - surface ECG electrodes 18 and an intracardiac electrogram (IEGM) captured by the electrodes 26 of the catheter 14. The recorder 11 can include pacing capabilities for pacing the heart rhythm and / or can be electrically connected to an independent pacer.

[0031] System 10 may include an ablation energy generator 50 that is adapted to conduct ablation energy to one or more of the electrodes at the distal tip of a catheter configured to ablate. The energy generated by ablation energy generator 50 may include high frequency (RF) energy or pulsed field ablation (PFA) energy, or a combination thereof, including unipolar or bipolar high voltage DC pulses that may be used to effect irreversible electroporation (IRE), but is not limited thereto.

[0032] A patient interface unit (PIU) 30 is an interface configured to establish electrical communication between a catheter, an electrophysiology device, a power source, and a workstation 55 that controls the operation of system 10. The electrophysiology devices of system 10 may include, for example, catheter 14, position pad 25, body surface ECG electrodes 18, electrode patch 38, ablation energy generator 50, and recorder 11. Optionally and preferably, PIU 30 additionally includes processing capabilities for implementing real-time calculation of the position of the catheter and performing ECG calculations.

[0033] The workstation 55 includes a memory, a processor unit having a memory or storage device loaded with appropriate operating software, and user interface capabilities. The workstation 55 optionally provides a plurality of functions including: (1) modeling the endocardial anatomical structure in three dimensions (3D) and rendering it for display on a display device 27 as a model or anatomical map 20; (2) displaying on the display device 27, in a representative visual display or image superimposed on the rendered anatomical map 20, an activation sequence (or other data) compiled from the recorded electrogram 21; (3) displaying the real-time position and orientation of a plurality of catheters within the heart chamber; and (4) displaying on the display device 27 a site of interest such as a location where ablation energy is being applied. One commercially available product embodying the elements of the system 10 is available as the CARTO (trademark) 3 system, commercially available from Biosense Webster, Inc. (31 Technology Drive, Suite 200, Irvine, CA 92618, USA).

[0034] Figures 2A and 2B show the catheter 14 in more detail. The catheter 14 (which may also be referred to herein as a medical probe) may be configured to be inserted into the patient 23's heart 12 for mapping and ablation of tissue within the heart 12. As shown, the catheter 14 may include an end effector 28, a first handle 120, and a second handle 220. The end effector 28 may be attached to the first handle 120 by an inner catheter shaft 122 and to the second handle 220 by an outer sleeve 222. The sleeve 222 may be disposed around the inner catheter shaft 122 such that the sleeve 222 can slide along the outside of the inner catheter shaft 122.

[0035] The end effector 28 may further include an ablation assembly 110 and a mapping assembly 210. The ablation assembly 110 is attached to the distal end of the inner catheter shaft 122, and the mapping assembly 210 is attached to the distal end of the sleeve 222. In this way, when the physician 24 slides the first handle 120 and the second handle 220 towards each other (as shown in FIG. 2A), the ablation assembly 110 can extend beyond the distal end of the mapping assembly 210, and the end effector 28 is configured to deliver ablation energy to the tissue. Alternatively, when the physician moves the first handle 120 and the second handle 220 away from each other (as shown in FIG. 2B), the mapping assembly 210 slides beyond the distal end of the ablation assembly 110 such that the mapping assembly 210 is configured to contact the tissue and collect electrophysiological signals from the tissue. In other words, the physician 24 can slide the second handle 220 distally to move the mapping assembly 210 into contact with the tissue and perform mapping of the electrophysiological signals, and the physician 24 can slide the second handle 220 proximally to expose the ablation assembly 110 and perform an ablation procedure.

[0036] The first handle 120 may include an actuator 124 configured to deflect the end effector 28 radially outward from the longitudinal axis LA. The actuator 124 may be attached, for example, to a pull wire that is attached to the distal end of the inner catheter shaft 122 or the ablation assembly 110. When the physician 24 activates the actuator 124, the pull wire is pulled, deflecting the end effector 28 outward from the longitudinal axis LA. As will be appreciated, when the inner catheter shaft 122 is deflected outward, the inner catheter shaft 122 also deflects the sleeve 222 (disposed around the inner catheter shaft 122) outward. In this way, both the ablation assembly 110 and the mapping assembly 210 are deflected outward from the longitudinal axis LA when the actuator 124 is activated.

[0037] The first handle 120 may further include a first perfusion coupler 126 and a first electrical coupler 128. The first perfusion coupler 126 may be configured to connect to a perfusion supply and deliver perfusion through the first handle 120 and to the ablation assembly 110. As shown in FIG. 4, the ablation assembly 110 may include a perfusion hole 114 configured to deliver perfusion 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.

[0038] The second handle 220 may include a second perfusion coupler 226 and a second electrical coupler 228. The second perfusion coupler 226 may be configured to connect to a perfusion supply and deliver perfusion through the second handle 220 and to the mapping assembly 210. As shown in FIG. 6, the mapping assembly 210 may include perfusion holes 215 configured to deliver perfusion fluid to tissue near the mapping assembly 210. The second electrical coupler 228 may be configured to connect the catheter 14 to a corresponding electrical coupler so that electrical signals detected by the mapping assembly 210 can be analyzed and output for display.

[0039] FIGS. 3A, 3B, and 3C show additional views of the end effector 28. As shown, the mapping assembly 210 may generally be disposed around the ablation assembly 110 and configured to slide distally and proximally along the longitudinal axis over the ablation assembly 110. As illustrated in FIG. 3B, when the mapping assembly 210 is moved distally, most of the mapping assembly 210 is moved beyond the distal end of the ablation assembly 110. In this way, the mapping assembly 210 may 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. In contrast, when the mapping assembly 210 is pulled proximally, the ablation assembly 110 extends beyond the distal end of the mapping assembly 210 and is configured to deliver ablation energy to tissue without being obstructed by the mapping assembly 210. In this way, the end effector 28 may be configured to perform both a mapping procedure and an ablation procedure with only a single catheter 14.

[0040] As shown in FIG. 4, ablation assembly 110 may be disposed at the distal end of inner catheter shaft 122 and may include ablation electrode 112. In this example, ablation electrode 112 is a single electrode disposed at the distal end of inner catheter shaft 122, but it will be understood that two or more electrodes may be disposed at the distal end of inner catheter shaft 122 depending on the particular configuration. Ablation assembly 110 may be configured to perform RF ablation, IRE ablation, and / or cryoablation. When ablation assembly 110 is configured to perform IRE ablation, ablation electrode 112 (or multiple electrodes depending on the configuration) may be configured to deliver a monopolar or bipolar ablation scheme. Further, ablation electrode 112 may be configured to deliver a monophasic or biphasic ablation pulse.

[0041] As briefly described above, ablation assembly 110 may further include perfusion holes 114 configured to deliver perfusion fluid to ablation assembly 110, mapping assembly 210, and / or tissue. Perfusion holes 114 may be circumferentially disposed around ablation electrode 112 and may be configured to direct perfusion fluid outwardly from ablation electrode 112.

[0042] The ablation assembly 110 may further include a force sensor 116 configured to detect a force applied to the ablation assembly 110. The force sensor 116 may be configured to detect a force applied to the distal end of the ablation assembly 110, such as when the ablation assembly 110 is in contact with tissue. In this way, the force sensor 116 may 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 Nos. 8,357,152 and 10,688,278, and U.S. Patent Application Publication No. 2021 / 0187254(A1), each of which is incorporated herein by reference and appended to the appendix included herein.

[0043] As shown in FIG. 4, the mapping assembly 210 can be disposed at the distal end of the sleeve 222. The sleeve 222 includes a braided structure 224 to prevent the sleeve 222 from buckling and / or being pinched during operation. The braided structure 224 can further include electrical wires that can be connected to the mapping electrode 212 and / or the ablation electrode 112. As will be appreciated, by incorporating electrical wires into the braided structure 224, the overall outer profile of the catheter 14 can be reduced. The mapping assembly 210 can further include one or more position sensors 118 disposed near the mapping assembly 210. The position sensor 118 can be configured to detect the position and orientation of the end effector 28, and that information can be output to the display device 27 for display to the physician 24. The position sensor 118 can be any suitable type of position sensor. For example, without limitation, the position sensor 118 can be one or more electromagnetic coils configured to output a signal when exposed to a generated electromagnetic field. In some examples, the position sensor 118 can be three position sensors disposed approximately 120 degrees apart from each other around the circumference of the sleeve 222. Although the position sensor 118 is shown as being disposed on the sleeve 222, it will be understood that the position sensor 118 can alternatively or additionally be disposed on the inner catheter shaft 122.

[0044] As further shown in FIGS. 5A, 5B, and 5C, the mapping assembly 210 can include a spine hub 216 and a plurality of spines 214 extending radially outward from the spine hub 216. Each of the spines 214 can include one or more mapping electrodes 212 configured to detect electrophysiological signals propagating through the tissue. The spines 214 can be configured to generally extend distally such that the spines 214 and the electrodes 212 contact the tissue when the mapping assembly 210 contacts the tissue.

[0045] It will be understood that the mapping assembly 210 may include a variety of different numbers of spines 214. For example, the mapping assembly 210 may include 3 spines, 4 spines, 5 spines, 6 spines, 7 spines, 8 spines, 9 spines, 10 spines, 15 spines, 20 spines, or any other suitable number of spines for a particular configuration. As shown in FIGS. 5A-5C, the mapping assembly 210 may include 8 spines as an example.

[0046] The spine hub 216 may include a lumen 230 that extends through the spine hub 216 along the longitudinal axis LA. The lumen 230 may be sized to fit around the ablation assembly 110 such that the ablation assembly 110 can slide through the spine hub 216.

[0047] In some examples, the spine hub 216 may include one or more connectors 217 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 can 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 the mapping electrodes 212 can be configured to deliver ablation energy. As will be understood, by delivering ablation energy through a plurality of mapping electrodes 212, a larger area of tissue can be ablated.

[0048] FIG. 6 illustrates an alternative example of a mapping assembly 210 having irrigation holes 215 disposed along a spine 214. The spine 214 can include, for example, a tube or sleeve disposed along or around the spine 214 to deliver irrigation fluid to the irrigation holes 215. Alternatively, the spine 214 itself can be made of a hollow tube material and configured to deliver irrigation fluid to the irrigation holes 215. The irrigation holes 215 can be configured to deliver irrigation fluid from an irrigation supply as described above. In some examples, the irrigation holes 215 can be oriented such that irrigation fluid is delivered to tissue near the distal end of the spine 214. Further, although only one irrigation hole 215 is shown on each spine 214, it will be understood that two or more irrigation holes 215 can be disposed on each spine 214 and configured to direct irrigation fluid to a desired location (e.g., toward tissue, toward the ablation assembly 110, toward the spine hub 216).

[0049] As shown in FIGS. 7A and 7B, the ablation assembly 110 can be disposed at the distal end of an inner catheter shaft 122 and can include an ablation electrode 112, irrigation holes 114 disposed on the ablation electrode 112 (radially around the circumference and on the distal tip), a force sensor 116, a position sensor 118, and a marker band 119. As described above, the force sensor 116 can be configured to detect the force applied to the ablation electrode 112 such that it can provide feedback to the physician 24 indicating when the ablation electrode 112 is in sufficient contact with the tissue. The position sensor 118 can be the same as or similar to the position sensor 218 described above. For example, the position sensor 118 can be electromagnetic coils disposed about 120 degrees apart from each other around the circumference of the inner catheter shaft 122. The marker band 119 can be a radiopaque marker configured to be used with fluoroscopy to determine the position of the end effector 28.

[0050] FIG. 8 is a flowchart of a method 800 for performing tissue mapping and ablation according to the disclosed technique. Method 800 can include inserting a medical probe into a body lumen 802, sliding an outer sleeve along an inner catheter shaft to extend a plurality of spines beyond a distal end of an ablation catheter 804, and receiving one or more electrophysiological signals from at least one mapping electrode 806. As described above, method 800 can be used to complete a mapping procedure to determine the location and direction of electrophysiological signals propagated through tissue. The collection of electrophysiological signals can be used to identify the location and direction of abnormal signals propagated through tissue.

[0051] Method 800 can further include retracting the outer sleeve to extend an ablation electrode beyond a distal end of the plurality of spines 810 and delivering ablation energy to the tissue 812. In other words, method 800 can include completing an ablation procedure. The ablation procedure can include ablating tissue at an identified location to stop the propagation of abnormal signals through the tissue.

[0052] As will be appreciated, the method 800 described herein is not intended to be limited to the specific steps described or to the specific order of the described steps. That is, method 800 can include other intervening steps not explicitly described herein and / or can be performed in various orders. Thus, method 800 is described as having certain steps and presented in a certain order, but method 800 is not so limited.

[0053] The disclosed technique described herein can be further understood in accordance with the following clauses.

[0054] 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 sleeve at least partially disposed around the inner catheter shaft and extending along the longitudinal axis; and a plurality of spines disposed at a distal end of the outer sleeve, each spine of the plurality of spines including a mapping electrode configured to detect an electrophysiological signal, the outer sleeve being configured to move axially along the inner catheter shaft to move the plurality of spines axially relative to the ablation electrode.

[0055] Clause 2: The medical probe according to Clause 1, wherein the outer sleeve is configured to move the plurality of spines beyond a distal end of the ablation electrode.

[0056] Clause 3: The medical probe according to Clause 2, wherein the plurality of spines are configured to extend radially outward from the longitudinal axis.

[0057] Clause 4: The medical probe according to Clause 3, wherein the plurality of spines are configured to be positioned radially around the ablation electrode.

[0058] 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 sleeve.

[0059] Clause 6: The medical probe according to Clause 5, wherein the second handle is configured to be moved axially along the longitudinal axis relative to the first handle, thereby moving the outer sleeve axially along the inner catheter shaft.

[0060] 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.

[0061] 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.

[0062] Clause 9: The medical probe according to clause 7, wherein the outer sleeve is configured to deflect radially outward when the inner catheter shaft is deflected radially outward from the longitudinal axis.

[0063] Clause 10: The medical probe according to clause 5, wherein the first handle includes an irrigation coupler configured to receive irrigation fluid from an irrigation supply unit, and the ablation electrode includes a plurality of openings each configured to allow the irrigation fluid to pass therethrough.

[0064] Clause 11: The medical probe according to clause 5, wherein the second handle includes an irrigation coupler configured to receive irrigation fluid from an irrigation supply unit, and the outer sleeve is configured to deliver the irrigation fluid to a plurality of spines.

[0065] Clause 12: The medical probe according to clause 11, wherein each of the plurality of spines includes an opening configured to allow the irrigation fluid to pass therethrough.

[0066] 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 exposed to an electromagnetic field.

[0067] 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.

[0068] Clause 15: The medical probe according to Clause 1, wherein the plurality of spines includes at least five spines, and each of the at least five spines includes a plurality of mapping electrodes.

[0069] Clause 16: A method, comprising inserting a medical probe into a body lumen, 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 sleeve at least partially disposed around the inner catheter shaft and extending along the longitudinal axis, and a plurality of spines disposed at a distal end of the outer sleeve, each of the plurality of spines including a mapping electrode configured to detect an electrophysiological signal; sliding the outer sleeve along the inner catheter shaft to extend the plurality of spines beyond the distal end of the ablation electrode; and receiving one or more electrophysiological signals from at least one mapping electrode disposed on the plurality of spines.

[0070] 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.

[0071] 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 sleeve, and the plurality of spines radially outwardly away from the longitudinal axis.

[0072] Clause 19: The method according to Clause 16, further comprising retracting the outer sleeve along the inner catheter shaft to extend the ablation electrode beyond the distal end of the plurality of spines.

[0073] The method according to clause 19, further comprising delivering ablation energy to the tissue via an ablation electrode.

[0074] The above embodiments are cited as examples, and the present invention is not limited to those specifically illustrated and described herein. Rather, the scope of the present invention includes both combinations of various features and partial combinations thereof described herein, as well as those variations and modifications not disclosed in the prior art that would be contemplated by those skilled in the art upon reading the above description.

[0075] 〔Embodiment〕 (1) A medical probe, 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 sleeve at least partially disposed around the inner catheter shaft and extending along the longitudinal axis, a plurality of spines disposed at a distal end of the outer sleeve, each of the plurality of spines including a mapping electrode configured to detect an electrophysiological signal, the outer sleeve being configured to move axially along the inner catheter shaft to move the plurality of spines axially relative to the ablation electrode, a medical probe comprising a plurality of spines. (2) The medical probe according to embodiment 1, wherein the outer sleeve is configured to move the plurality of spines beyond a distal end of the ablation electrode. (3) The medical probe according to embodiment 2, wherein the plurality of spines are configured to extend radially outward from the longitudinal axis. (4) The medical probe according to embodiment 3, wherein the plurality of spines are configured to be positioned radially around the ablation electrode. (5) The medical probe according to embodiment 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 sleeve.

[0076] (6) The medical probe according to embodiment 5, wherein the second handle is configured to be axially moved along the longitudinal axis relative to the first handle, thereby axially moving the outer sleeve along the inner catheter shaft. (7) The medical probe according to embodiment 5, further comprising a pull wire configured to deflect the inner catheter shaft radially outward from the longitudinal axis. (8) The medical probe according to embodiment 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. (9) The medical probe according to embodiment 7, wherein the outer sleeve is configured to deflect radially outward when the inner catheter shaft is deflected radially outward from the longitudinal axis. (10) The medical probe according to embodiment 5, wherein the first handle includes a perfusion coupler configured to receive perfusion fluid from a perfusion supply unit, and the ablation electrodes each include a plurality of openings configured to allow the perfusion fluid to pass therethrough.

[0077] (11) The medical probe according to embodiment 5, wherein the second handle includes a perfusion coupler configured to receive perfusion fluid from a perfusion supply unit, and the outer sleeve is configured to deliver the perfusion fluid to the plurality of spines. (12) The medical probe according to embodiment 11, wherein each of the plurality of spines includes an opening configured to allow the perfusion fluid to pass therethrough. (13) The medical probe according to embodiment 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 exposed to an electromagnetic field. (14) The medical probe according to embodiment 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 embodiment 1, wherein the plurality of spines includes at least five spines, and each of the at least five spines includes a plurality of mapping electrodes.

[0078] (16) A method comprising: inserting a medical probe into a body lumen, 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 sleeve at least partially disposed around the inner catheter shaft and extending along the longitudinal axis; a plurality of spines disposed at a distal end of the outer sleeve, each of the plurality of spines including a mapping electrode configured to detect an electrophysiological signal; sliding the outer sleeve along the inner catheter shaft to extend the plurality of spines beyond a distal end of the ablation electrode; receiving one or more electrophysiological signals from at least one mapping electrode disposed on the plurality of spines. (17) The method according to embodiment 16, further comprising generating an electrophysiological map based at least in part on the one or more electrophysiological signals. (18) The method according to embodiment 16, further comprising actuating a pull wire to deflect the inner catheter shaft, the ablation electrode, the outer sleeve, and the plurality of spines radially outwardly away from the longitudinal axis. (19) The method according to embodiment 16, further comprising retracting the outer sleeve along the inner catheter shaft to extend the ablation electrode beyond the distal ends of the plurality of spines. (20) The method according to embodiment 19, further comprising delivering ablation energy to tissue via the ablation electrode.

Claims

1. 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 configured to deliver ablation energy to tissue; an outer sleeve disposed at least partially about the inner catheter shaft and extending along the longitudinal axis; a plurality of spines disposed at a distal end of the outer sleeve, each of the plurality of spines including a mapping electrode configured to detect electrophysiological signals, the outer sleeve configured to move axially along the inner catheter shaft to move the plurality of spines axially relative to the ablation electrodes.

2. The medical probe of claim 1 , wherein the outer sleeve is configured to move the plurality of spines beyond a distal end of the ablation electrode.

3. The medical probe of claim 2 , wherein the plurality of spines are configured to extend radially outward from the longitudinal axis.

4. The medical probe of claim 3 , wherein the plurality of spines 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 sleeve.

6. 6. The medical probe of claim 5, wherein the second handle is configured to be moved axially along the longitudinal axis relative to the first handle, thereby moving the outer sleeve 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 , 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.

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

10. 6. The medical probe of claim 5, wherein the first handle includes an irrigation coupler configured to receive irrigation fluid from an irrigation supply, and the ablation electrodes include a plurality of openings each configured to pass the irrigation fluid therethrough.

11. 6. The medical probe of claim 5, wherein the second handle includes an irrigation coupler configured to receive irrigation fluid from an irrigation supply, and the outer sleeve is configured to deliver irrigation fluid to the plurality of spines.

12. The medical probe of claim 11 , wherein each spine of the plurality of spines includes an opening configured to pass the irrigation fluid therethrough.

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

15. The medical probe of claim 1 , wherein the plurality of spines comprises at least five spines, and each spine of the at least five spines comprises a plurality of mapping electrodes.

16. 1. A method comprising:

1. Inserting a medical probe into a body lumen, 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 configured to deliver ablation energy to tissue; an outer sleeve disposed at least partially about the inner catheter shaft and extending along the longitudinal axis; a plurality of spines disposed at a distal end of the outer sleeve, each spine of the plurality of spines including a mapping electrode configured to detect electrophysiological signals; sliding the outer sleeve along the inner catheter shaft to extend the plurality of spines beyond the distal end of the ablation electrode; and receiving one or more electrophysiological signals from at least one mapping electrode positioned on the plurality of spines.

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

19. 17. The method of claim 16, further comprising retracting the outer sleeve along the inner catheter shaft to extend the ablation electrodes beyond the distal ends of the plurality of spines.

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

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