Expandable electrode assembly comprising extended distal end for medical catheter

Abstract

To provide an end effector of a medical probe.SOLUTION: The technology disclosed herein includes an end effector for a medical probe. The end effector can comprise an expandable distal end assembly extending along a longitudinal axis. The expandable distal end assembly can extend radially outward from the longitudinal axis and define an outer diameter. The end effector can further comprise a distal tip extending distally from the expandable distal end assembly along the longitudinal axis over a tip length greater than the outer diameter. The distal tip can be fixed longitudinally in relation to the expandable distal end assembly and be deflectable with respect to the longitudinal axis. The tip can comprise an electrode configured to deliver ablative energy to tissue or receive signals from tissue.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority under 35 U.S.C. § 119(e) to and the benefit of U.S. Provisional Application No. 63 / 581,475, filed September 8, 2023 (Attorney Docket No. BIO6884USPSP1-253757.000427), the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THEINVENTION The present invention relates generally to medical devices, and more particularly to expandable catheters configured to deliver ablation energy to or receive signals from tissue. [Background technology]

[0003] Cardiac arrhythmias, such as atrial fibrillation (AF), occur when an area of ​​cardiac tissue abnormally conducts electrical signals to adjacent tissue. This disrupts the normal cardiac cycle and causes asynchronous rhythms. Certain procedures that exist to treat arrhythmias include surgically destroying the source of the signals that cause the arrhythmia and destroying the conduction pathways of such signals. By selectively ablating cardiac tissue with the application of energy via a catheter, it is sometimes possible to stop or change the propagation of undesired electrical signals from one part of the heart to another. Medical probes may utilize radio frequency (RF) electrical energy to heat tissue. Some ablation approaches use irreversible electroporation (IRE) to ablate cardiac tissue using non-thermal ablation methods.

[0004] Pulmonary vein isolation is a procedure commonly used to treat AF. Physicians typically use at least two catheters to complete a pulmonary vein isolation procedure, one catheter with an expandable array of electrodes, such as a balloon or basket catheter, and a second catheter with a focal tip electrode. The catheters are used in combination to deliver ablation energy to a specified area of ​​the heart, particularly around the pulmonary veins, to block irregular electrical signals. As will be appreciated, typically only one catheter can be inserted into the heart chamber at a time. The removal and insertion of each catheter extends the total procedure time, which can be difficult for physicians and patients alike, making recovery more difficult for patients. Summary of the Invention [Problem to be solved by the invention]

[0005] Thus, there is a need for a device configured to reduce the overall procedure time by completing multiple elements of a pulmonary vein isolation procedure with a single device. These and other problems may be addressed by the techniques disclosed herein. [Means for solving the problem]

[0006] The disclosed technology includes an end effector for a medical probe. The end effector can include an expandable distal tip assembly extending along a longitudinal axis. The expandable distal tip assembly can extend radially outward from the longitudinal axis and define an outer diameter. The end effector can further include a distal tip extending distally from the expandable distal tip assembly along the longitudinal axis over a tip length greater than the outer diameter. The distal tip can be longitudinally fixed relative to the expandable distal tip assembly and deflectable relative to the longitudinal axis. The tip can include an electrode configured to deliver ablation energy to tissue or receive signals from tissue.

[0007] The disclosed technology may include a medical probe comprising an insertion tube having a proximal end and a distal end. The insertion tube may extend along a longitudinal axis. The medical probe may further comprise an expandable distal tip assembly disposed at a distal end of the insertion tube. The expandable distal tip assembly may extend radially outward from the longitudinal axis. The medical probe may further comprise a distal tip extending distally from the expandable distal tip assembly along the longitudinal axis. The distal tip may be longitudinally fixed relative to the expandable distal tip assembly and may comprise an electrode configured to deliver ablation energy to or receive signals from tissue.

[0008] The disclosed technology may further include an end effector for a medical probe comprising a balloon extending along a longitudinal axis and configured to extend radially outward from the longitudinal axis when inflated. The balloon may comprise a stretchable circuit material and a plurality of electrodes disposed on an outer surface of the balloon. The plurality of electrodes may comprise conductive ink. These and other advantages of the disclosed technology will become more apparent throughout this disclosure in conjunction with the drawings. [Brief description of the drawings]

[0009] [Figure 1] 1 is a schematic, pictorial illustration of a medical system including a medical probe having an end effector with electrodes, in accordance with some embodiments of the disclosed technology; [Diagram 2] FIG. 1 is a perspective view of a medical probe and handle in accordance with the disclosed technology; [Diagram 3] FIG. 13 is a side view of an end effector in accordance with the disclosed technology; [Figure 4A] FIG. 13 is a perspective view of an end effector in accordance with the disclosed technology; [Figure 4B] FIG. 13 is another perspective view of an end effector in accordance with the disclosed technology; [Diagram 5]FIG. 13 is a top perspective view of an end effector with a distal electrode removed in accordance with the disclosed technology; [Figure 6] FIG. 4 is a cross-sectional view of the end effector taken along line AA of FIG. 3 in accordance with the technology of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The disclosed technology can help reduce the time required to complete cardiac tissue ablation, including pulmonary vein isolation procedures, by including an expandable distal end assembly having multiple electrodes and a distal tip extending from the expandable assembly and comprising the electrodes. The electrodes on the expandable assembly as well as the electrodes on the distal tip can each be configured to deliver ablation energy to or receive signals from tissue. In this manner, the disclosed technology combines the functionality of a typical balloon or basket ablation catheter with that of a focal ablation catheter, thereby eliminating the need to use multiple catheters to complete pulmonary vein isolation. Stated another way, the disclosed technology can perform ablation of both large and small areas of tissue with a single catheter.

[0011] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates, by way of example and not by way of limitation, the principles of the invention. The description clearly enables 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 currently contemplated to be the best mode for carrying out the invention.

[0012] As used herein, the term "about" or "approximately" in relation to any numerical value or range indicates a suitable dimensional tolerance that enables a portion or collection of components to function for the intended purpose described herein. More specifically, "about" or "approximately" may refer to a range of values ​​of ±20% of the recited value, for example, "about 90%" may refer to a range of values ​​of 71% to 110%.

[0013] As used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and are not intended to limit the use of the system or method to humans, although the use of the present invention in subjects in human patients represents a preferred embodiment. In addition, the vasculature of the "patient," "host," "user," and "subject" may be that of a human or any animal. It should be understood that the animal may be of any of a variety of applicable types, including, but not limited to, mammals, veterinary animals, livestock animals, or pet animals, and the like. As an example, the animal may be a laboratory animal (e.g., rats, dogs, pigs, monkeys, and the like) that has been specifically selected to have certain characteristics similar to humans. It should be understood that the subject may be, for example, any applicable human patient. Similarly, the term "proximal" refers to a location closer to the operator or physician, while "distal" refers to a location farther from the operator or physician.

[0014] As discussed herein, a "physician" or "operator" may include a physician, surgeon, engineer, scientist, or any other individual or delivery instrument associated with the delivery of a multi-electrode catheter for the treatment of drug refractory atrial fibrillation to a subject.

[0015] As discussed herein, the term "ablate" or "ablation", in the context of the devices and corresponding systems of the present disclosure, refers to components and structural features that are configured to reduce or prevent the generation of irregular cardiac signals within cells by utilizing non-thermal energy, such as irreversible electroporation (IRE), interchangeably referred to as pulsed electric field (PEF) and pulsed field ablation (PFA), throughout this disclosure. In the context of the devices and corresponding systems of the present disclosure, ablation or ablation is used throughout this disclosure in reference to non-thermal ablation of cardiac tissue in certain conditions, including, but not limited to, arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablate" or "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation, as will be understood by those skilled in the art.

[0016] As discussed herein, the terms "bipolar" and "monopolar", when used to refer to ablation schemes, describe different ablation schemes with respect to current paths and electric field distribution. "Bipolar" refers to an ablation scheme that utilizes a current path between two electrodes, both placed at the treatment site. The current density and electric flux density are typically approximately equal at each of the two electrodes. "Monopolar" refers to an ablation scheme that utilizes a current path between two electrodes, where one electrode containing a high current density and high electric flux density is placed at the treatment site, and a second electrode containing a relatively low current density and lower electric flux density is placed remotely from the treatment site.

[0017] As discussed herein, the terms "tubular" and "tube" are to be interpreted broadly and are not limited to right cylindrical structures, or structures that are strictly circular in cross section, or structures that are uniform in cross section throughout their length. For example, a tubular structure may generally be illustrated as a substantially right cylindrical structure, although the tubular structure may have a tapered or curved outer surface without departing from the scope of the present disclosure.

[0018] The techniques of the present disclosure can be configured to deliver monophasic or biphasic pulses to ablate tissue. For example, the electrodes described herein configured to deliver ablation energy to tissue or receive signals from tissue can be configured to deliver monophasic pulses, biphasic pulses, or some combination thereof. The terms "biphasic pulse" and "monophasic pulse" refer to the respective electrical signals. "Biphasic pulse" refers to an electrical signal that includes a positive voltage phase pulse (referred to herein as "positive phase") and a negative voltage phase pulse (referred to herein as "negative phase"). "Monophasic pulse" refers to an electrical signal that includes only a positive phase or only a negative phase.

[0019] Ablation of cardiac tissue, applying radio frequency (RF) energy and thermal techniques such as cryoablation, to improve a failing heart, is a well-known procedure. Typically, to successfully ablate using thermal techniques, cardiac potentials must be measured at various locations in the myocardium. In addition, temperature measurements during ablation provide data that allows for the effectiveness of the ablation. Typically, in ablation procedures using thermal techniques, electrode potentials and temperatures are measured before, during, and after the actual ablation.

[0020] Exemplary systems, methods, and devices of the present disclosure may be particularly suited for IRE ablation of cardiac tissue to treat cardiac arrhythmias. Ablation energy is typically delivered to the cardiac tissue by electrodes capable of delivering the ablation energy along the tissue to be ablated. Ablation procedures incorporating such exemplary catheters may be visualized using fluoroscopy, magnetic-based position sensing, and / or active current localization techniques.

[0021] IRE, as discussed in this disclosure, is a non-thermal cell death technique that can be used to ablate atrial arrhythmias. To ablate using IRE / PEF, biphasic voltage pulses are applied to destroy cellular structures in the myocardium. The biphasic pulses are non-sinusoidal waveforms 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, indiscriminately heating 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 with ablation or isolation modalities. Additionally or alternatively, monophasic pulses can be utilized.

[0022] Electroporation can be induced by applying a pulsed electric field to biological cells to cause the reversible (temporary) or irreversible (permanent) generation of pores in the cell membrane. Cells have a transmembrane electrostatic potential that increases above the resting potential upon application of the pulsed electric field. While the transmembrane electrostatic potential remains below a threshold potential, electroporation is reversible, meaning that the pores can close when the applied pulsed electric field is removed and the cell can self-repair and survive. If the transmembrane electrostatic potential increases above a threshold potential, electroporation is irreversible and the cell becomes permanently permeable. As a result, the cell dies due to loss of homeostasis, typically by programmed cell death or apoptosis, which is believed to leave less scar tissue compared to other ablation modalities. In general, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of approximately 500 V / cm, while bone has a threshold potential of 3000 V / cm. These differences in threshold potentials allow IRE to selectively target tissues based on threshold potential.

[0023] Please refer to FIG. 1, which shows an exemplary catheter-based electrophysiological mapping and ablation system 10. The system 10 includes one or more catheters that are percutaneously inserted by a physician 24 through the vascular system of a patient 23 and into a cardiac chamber or vasculature of a heart 12. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location of the heart 12. Multiple catheters can then be inserted into the delivery sheath catheter to reach the desired location. The one or more catheters may include catheters dedicated to sensing Intracardiac Electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. An exemplary catheter 14 configured to sense IEGMs is illustrated herein. For ablation, the physician 24 similarly delivers an end effector 28, including an ablation electrode, to a target site for ablation. If the end effector 28 is alternatively or additionally configured for mapping electrophysiological signals, the physician 24 similarly contacts the end effector 28 with the heart wall to sense a target site within the heart 12.

[0024] The catheter 14 is an exemplary catheter that includes an end effector 28 comprising an expandable assembly and one, and preferably multiple, electrodes optionally distributed across the distal tip of the end effector 28 and configured to deliver ablation energy to or receive signals from tissue. The catheter 14 may additionally include a magnetic-based position sensor 29 embedded in or near the end effector 28 for tracking the position and orientation of the end effector 28. The end effector 28 may further include one or more impedance-based electrodes 26 disposed in or near the end effector 28 for tracking the position and orientation of the end effector 28.

[0025] The magnetic-based position sensor 29 may operate in conjunction with a location 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 end effector 28 of the catheter 14 may be tracked based on the magnetic fields generated by the location pad 25 and sensed by the magnetic-based position sensor 29. The magnetic-based position sensor 29 may be a single-axis sensor, a dual-axis sensor, or a three-axis sensor, depending on the particular configuration. 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, and 6,892,091, each of which is incorporated by reference herein as if fully set forth herein.

[0026] The system 10 includes one or more electrode patches 38 positioned for skin contact on the patient 23 to establish a position reference for the location pads 25 and impedance-based tracking of the electrodes 26. For impedance-based tracking, a current is directed to the impedance-based electrodes 26 and sensed at the electrode skin patch 38, so that the location of each electrode can be triangulated via the electrode patch 38. Details of impedance-based position tracking technology are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated by reference herein as if fully set forth herein.

[0027] Recorder 11 displays electrograms 21 captured by the body surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured by electrodes on catheter 14. Recorder 11 may include pacing capability for pacing the cardiac rhythm and / or may be electrically connected to a stand-alone pacer.

[0028] The system 10 may include an ablation energy generator 50 disposed on the end effector and adapted to conduct ablation energy to one or more electrodes configured to deliver ablation energy to tissue. The energy generated by the 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, such as may be used to effect irreversible electroporation (IRE), or combinations thereof.

[0029] Patient interface unit (PIU) 30 is an interface configured to establish electrical communication between the catheters, electrophysiological equipment, a power source, and a workstation 55 that controls the operation of system 10. The electrophysiological equipment of system 10 may include, for example, multiple catheters, location pads 25, body surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, PIU 30 additionally includes processing capabilities to implement real-time calculations of catheter positions and perform ECG calculations.

[0030] The workstation 55 includes a processor unit having a memory, a memory or storage device loaded with suitable operating software, and a user interface function. The workstation 55 may optionally provide multiple functions, including: (1) modeling the endocardial anatomical structures in three dimensions (3D) and rendering a model or anatomical map 20 for display on the display device 27; (2) displaying activation sequences (or other data) compiled from recorded electrograms 21 in a representative visual display or image superimposed on the rendered anatomical map 20 on the display device 27; (3) displaying real-time positions and orientations of multiple catheters within the cardiac chambers; and (4) displaying sites of interest, such as where ablation energy has been applied, on the display device 27. One commercially available product embodying elements of the system 10 is available as the CARTO™ 3 system, available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0031] 2, the disclosed technology includes an end effector 28 comprising an expandable distal end assembly 100 and a distal tip 112. The end effector 28 can be attached to a handle 120 by an insertion tube 122 configured for insertion through a delivery sheath and / or into the vasculature of the patient 23. The handle 120 can include an actuator 124 configured to deflect the end effector 28 radially outward from the longitudinal axis LA. The actuator 124 can be attached to one or more pull wires 140 (shown in FIG. 6) attached to anchor points 142 disposed near the distal end of the end effector 28. As can be appreciated, the actuator 124 can pull the pull wires 140, which can deflect the end effector 28 radially outward from the longitudinal axis LA.

[0032] The handle 120 may further include one or more irrigation supply connectors 126 and one or more electrical connectors 128. The irrigation supply connectors 126 may be configured to attach to an irrigation supply capable of delivering irrigation to and through the end effector 28. The electrical connectors 128 may be configured to electrically connect electrodes disposed on the end effector 28 to the PIU 30.

[0033] As shown more clearly in FIG. 3, the end effector 28 can include an expandable distal end assembly 100 and a distal tip 112. FIGS. 4A and 4B show alternative perspective views of the end effector 28. The expandable distal end assembly 100 can include a plurality of electrodes 102 (only one electrode 102 is labeled for simplicity) disposed about the circumference of the expandable distal end assembly 100 and a plurality of electrical traces 104 disposed along the expandable distal end assembly 100, each electrical trace 104 being electrically connected to one or more electrodes 102. Each of the electrodes 102 can be disposed in a distal half of the expandable distal end assembly 100. In other words, each of the electrodes 102 can be disposed distal to the equator line EL (top of FIG. 3) of the expandable distal end assembly 100. In this manner, the electrodes 102 can be positioned to deliver ablation energy to, or receive signals from, tissue on or around the pulmonary vein when the expandable distal tip assembly 100 is at least partially inserted into the pulmonary vein. The proximal coupler 106 can couple the expandable distal tip assembly 100 to the insertion tube 122, and the distal coupler 108 can couple the expandable distal tip assembly 100 to the distal tip 112.

[0034] The electrodes 102 can be any type of electrode, including but not limited to electrodes suitable for sensing electrophysiological signals, delivering ablation energy to tissue, position sensing, reference electrodes, etc. The electrodes 102 can be of any shape and made of a conductive material such as gold, silver, platinum, iridium, etc. The electrodes 102 can be configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).

[0035] The expandable distal end assembly 100 can be configured to transition between an expanded configuration (as shown in FIG. 2 ) and a folded configuration (not shown) in which the expandable distal end assembly 100 is configured to fold and be pulled or pushed through an insertion sheath and / or vasculature of the patient 23. The expandable distal end assembly 100 can be, for example, an inflatable balloon configured to be inflated to transition to the expanded configuration. The balloon can be inflated by irrigation fluid received through the irrigation supply connector 126. In some examples, the expandable distal end assembly 100 can include one or more openings (not shown) configured to allow irrigation fluid to exit the expandable distal end assembly 100. Alternatively, the expandable distal end assembly 100 can be configured to be inflated by irrigation fluid but sealed or at least partially sealed to prevent irrigation fluid from leaking through the walls of the expandable distal end assembly 100. In this configuration, irrigation fluid can be delivered to and / or through the distal tip 112. Alternatively, the expandable distal end assembly 100 and the distal tip 112 can each be configured to have an opening to allow irrigation fluid to flow therethrough.

[0036] The expandable distal end assembly 100 can be made from a stretchable circuit material, and the electrodes 102 and / or electrical traces 104 can be printed directly onto the expandable distal end assembly 100 using conductive inks, without the need for a polyimide substrate material. The expandable distal end assembly 100 can be made from, for example, Beyolex™ manufactured by Panasonic™, or other stretchable circuit materials. In other examples, the electrodes 102 and / or electrical traces 104 can be printed onto a stretchable circuit material to form a flexible circuit, and the flexible circuit can be disposed along the outer surface of the expandable distal end assembly 100.

[0037] Although not shown, it will be appreciated that the expandable distal end assembly 100 can alternatively comprise a plurality of spines configured to bend radially outward from the longitudinal axis LA to form a basket assembly. The electrodes 102 can be disposed along the spines, and the basket assembly can be configured to transition between an expanded configuration when pushed out of a delivery sheath and a collapsed configuration when placed within the delivery sheath.

[0038] The distal tip 112 can extend distally from the expandable distal end assembly 100 along the longitudinal axis LA. The distal tip 112 can extend distally from the expandable distal end assembly 100 over a tip length that is greater than the outer diameter of the expandable distal end assembly 100. For example, the expandable distal end assembly 100 can have a diameter measured at its equator line EL, or at a location where the diameter of the expandable distal end assembly 100 is greatest, and the tip length of the distal tip 112 can be greater than the length of the diameter. In some examples, the length of the distal tip 112 can be 1.5, 2, 3, 4, or at least 5 times the diameter of the expandable distal end assembly 100. By having an elongated distal tip 112 as shown, the distal tip 112 can be configured to deflect radially outward from the longitudinal axis LA when the pull wire 140 is pulled by the actuator 124, as described above. The distal tip 112 can be longitudinally fixed relative to the expandable distal end assembly 100 .

[0039] The distal tip 112 may include a distal electrode 110 disposed at a distal end of the distal tip 112. The distal electrode 110 may be configured to deliver ablation energy to tissue or receive signals from tissue. By including a distal electrode 110 disposed at a distal end of the distal tip 112, the distal electrode 110 may be configured to be used as a focal electrode for delivering ablation energy to small or hard-to-reach areas of the heart 12. Thus, the end effector 28 may combine the advantages of having multiple electrodes 102 disposed on an expandable distal tip assembly 100 that may be configured to deliver ablation energy to a relatively large area of ​​tissue (e.g., around a pulmonary vein) with the advantages of having a focal electrode (the distal electrode 110) configured to deliver ablation energy to a small area of ​​tissue. In this manner, the techniques of the present disclosure may help reduce or completely eliminate the need for using multiple catheters during a procedure, thereby reducing the total procedure time. The distal electrode 110 can be configured to deliver an electrical pulse for irreversible electroporation, the pulse having a peak voltage of at least 900 volts (V).

[0040] To aid in determining the position and orientation of the distal tip 112, the distal tip 112 may have one or more magnetic-based position sensors 29 disposed near the distal end of the distal tip 112. As previously described, the magnetic-based position sensors 29 may be configured to generate an electrical current when exposed to a magnetic field generated by the magnetic coil 32. Alternatively or additionally, the distal tip 112 may have one or more impedance-based electrodes 26 disposed thereon and configured to detect the position and orientation of the distal tip 112 using an active current position, as previously described. Thus, the end effector 28 may have one or more position sensors configured to detect the position and orientation of the end effector 28, which may be used to render a representation of the location and orientation of the end effector 28 on a display.

[0041] FIG. 5 illustrates a perspective view of the end effector 28 with the distal electrode 110 removed to show the large and small lumens 130, 132 extending through the distal tip 112. As can be appreciated, the large and small lumens 130, 132 can extend all the way through the insertion tube 122 to the handle 120. The large lumen 130 can be configured to receive irrigation fluid and / or a pull wire 140 can be disposed through at least one of the large lumens 130. In this manner, irrigation fluid can be delivered to the distal electrode 110. Although not shown, the distal electrode 110 can have one or more openings formed therethrough and configured to deliver irrigation fluid therethrough. Alternatively or additionally, the distal tip 112 can have one or more openings formed therethrough and configured to deliver irrigation fluid therethrough. Referring back to FIG. 5, it can be seen that the position of each electrode, and therefore the overall shape of the basket, can be determined through the use of a magnetic field sensor 300 in the form of a flat loop of a single wire with two leads that run along the balloon (inside or outside) and back to the handle. Each electrode has a wire loop in the form of a spiral so that the position of each electrode can be visualized. The support of the magnetic position sensor 300 and the shape determination of this sensor can be understood from US Patent Application Publication Nos. 20180344202(A1), 20220265194(A1), or 10687761(B2), each of which is incorporated by reference with a copy provided in the appendix of the priority application US Provisional Patent Application No. 63 / 581,475.

[0042] The small lumen 132 can be configured to accommodate one or more electrical wires that can extend from the handle 120 to the distal electrode 110, the magnetic-based position sensor 29, or the impedance-based electrode 26. As will be appreciated, the number of large and small lumens 130, 132 may be greater or less than that shown, depending on the particular configuration. Additionally, while the large lumen 130 has been described as being configured to receive irrigation fluid or to accommodate a pull wire 140, and the small lumen 132 has been described as being configured to accommodate electrical wires, it will be appreciated that one or more of the small lumens 132 can similarly be configured to receive irrigation fluid and / or to accommodate a pull wire 140, and one or more of the large lumens 130 can be configured to accommodate electrical wires, depending on the particular configuration.

[0043] As shown in Figure 6, which is a cross-sectional view of the end effector 28 taken along line AA in Figure 3, a pull wire 140 can extend through at least one of the large lumens 130 and attach to an anchor point 142 located near the distal electrode 110. As previously described, when the actuator 124 is actuated, the pull wire can pull on the distal tip 112, deflecting it radially outward from the longitudinal axis LA. Although not shown, it will be appreciated that the end effector can include more than one pull wire 140 and the anchor points 142 can be located in various locations to affect the radius of articulation of the distal tip 112 and / or the end effector 28 as a whole.

[0044] The techniques of the present disclosure described herein can be further understood in accordance with the following clauses.

[0045] Clause 1: 1. An end effector for a medical probe comprising: an expandable distal end assembly extending along a longitudinal axis, the expandable distal end assembly extending radially outward from the longitudinal axis and defining an outer diameter; and a distal tip extending distally from the expandable distal end assembly along the longitudinal axis over a tip length greater than the outer diameter, the distal tip comprising an electrode longitudinally fixed relative to the expandable distal end assembly and deflectable relative to the longitudinal axis, the distal tip comprising an electrode configured to deliver ablation energy to or receive signals from tissue.

[0046] Clause 2: The end effector described in Clause 1, wherein the expandable distal end assembly further comprises a plurality of electrodes disposed on the expandable distal end assembly and configured to deliver ablation energy to tissue or receive signals from tissue.

[0047] Clause 3: An end effector as described in clause 2, wherein the plurality of electrodes are radially arranged along a circumference of the expandable distal end assembly distal to an equator line of the expandable distal end assembly.

[0048] Clause 4: An end effector described in any one of the preceding clauses, wherein the distal tip is further configured to deflect radially outward from the longitudinal axis.

[0049] Clause 5: The end effector of clause 4, further comprising a pull wire configured to deflect the distal tip radially outward from the longitudinal axis.

[0050] Clause 6: An end effector described in any one of the preceding clauses, wherein the distal tip extends distally from the expandable distal end assembly a distance at least 1.5 times the length of the outer diameter of the expandable distal end assembly.

[0051] Clause 7: The end effector of clause 6, wherein the distance comprises twice the length of an outer diameter of the expandable distal end assembly.

[0052] Clause 8: An end effector described in any one of the preceding clauses, wherein the distal tip further comprises an impedance-based position sensor.

[0053] Clause 9: An end effector described in any one of the preceding clauses, wherein the distal tip further comprises an electromagnetic position sensor configured to output a current when exposed to a magnetic field generated by the magnetic field generator.

[0054] Clause 10: An end effector as described in clause 9, wherein the electromagnetic position sensor includes a three-axis sensor.

[0055] Clause 11: An end effector described in any one of the preceding clauses, wherein the end effector is further configured to allow irrigation fluid to flow through at least the distal tip.

[0056] Clause 12: An end effector described in any one of the preceding clauses, wherein the expandable distal end assembly is configured to transition between an expanded configuration and a collapsed configuration.

[0057] Clause 13: An end effector as described in clause 12, wherein the expandable distal end assembly comprises a balloon configured to be inflated and deflated to transition the expandable distal end assembly between an expanded configuration and a collapsed configuration.

[0058] Clause 14: An end effector as described in clause 13, wherein the expandable distal end assembly is configured to be inflated by receiving irrigation fluid, and the expandable distal end assembly is sealed to prevent irrigation fluid from exiting the expandable distal end assembly.

[0059] Clause 15: An end effector as described in clause 13 or clause 14, wherein the balloon comprises a stretchable circuit material.

[0060] Clause 16: An end effector as described in clause 15, wherein the plurality of electrodes are printed directly onto the stretchable circuit material.

[0061] Clause 17: An end effector as described in clause 16, wherein the plurality of electrodes comprises conductive ink.

[0062] Clause 18: An end effector as described in clause 13, wherein the balloon comprises a flexible circuit disposed on an outer surface of the balloon, the flexible circuit being electrically connected to at least some of the plurality of electrodes.

[0063] Clause 19: An end effector as described in Clause 12, wherein the expandable distal end assembly comprises a plurality of spines configured to bend radially outward from the longitudinal axis to transition the distal end assembly between an expanded configuration and a collapsed configuration.

[0064] Clause 20: A medical probe comprising: an insertion tube having a proximal end and a distal end, the insertion tube extending along a longitudinal axis; an expandable distal end assembly disposed at a distal end of the insertion tube, the expandable distal end assembly extending radially outward from the longitudinal axis; and a distal tip extending distally along the longitudinal axis from the expandable distal end assembly, the distal tip including an electrode longitudinally fixed to the expandable distal end assembly and configured to deliver ablation energy to or receive signals from tissue.

[0065] Clause 21: The medical probe of clause 20, wherein the distal tip is further configured to deflect radially outward from the longitudinal axis.

[0066] Clause 22: The medical probe of clause 21, further comprising a pull wire configured to deflect the distal tip radially outward from the longitudinal axis.

[0067] Clause 23: The medical probe of clause 22, further comprising a handle disposed at a proximal end of the insertion tube, the handle comprising an actuator configured to pull the pull wire to deflect the distal tip radially outward from the longitudinal axis.

[0068] Clause 24: A medical probe described in any one of clauses 20 to 23, wherein the distal tip extends distally from the expandable distal end assembly a distance at least 1.5 times the length of the diameter of the expandable distal end assembly.

[0069] Clause 25: The medical probe described in clause 24, wherein the distance comprises twice the length of the diameter of the expandable distal end assembly.

[0070] Clause 26: A medical probe described in any one of clauses 20 to 25, wherein the distal tip further comprises an impedance-based position sensor.

[0071] Clause 27: A medical probe described in any one of clauses 20 to 26, further comprising an electromagnetic position sensor, the distal tip of which is configured to output a current when exposed to a magnetic field generated by the magnetic field generator.

[0072] Clause 28: The medical probe of clause 27, wherein the electromagnetic position sensor includes a three-axis sensor.

[0073] Clause 29: A medical probe described in any one of clauses 20 to 28, further configured to allow irrigation fluid to flow through at least the distal tip.

[0074] Clause 30: A medical probe described in any one of clauses 20 to 29, wherein the expandable distal end assembly further comprises a plurality of electrodes disposed on the expandable distal end assembly and configured to deliver ablation energy to tissue or receive signals from tissue.

[0075] Clause 31: A medical probe as described in clause 30, wherein the plurality of electrodes are radially arranged along the circumference of the expandable distal end assembly.

[0076] Clause 32: A medical probe described in any one of clauses 20 to 31, wherein the expandable distal end assembly is configured to transition between an expanded configuration and a collapsed configuration.

[0077] Clause 33: The medical probe described in Clause 32, wherein the expandable distal end assembly comprises a balloon configured to be inflated and deflated to transition the expandable distal end assembly between an expanded configuration and a collapsed configuration.

[0078] Clause 34: The medical probe of clause 33, wherein the balloon comprises a stretchable circuit material.

[0079] Clause 35: The medical probe of clause 34, wherein the plurality of electrodes are printed directly onto the stretchable circuit material.

[0080] Clause 36: A medical probe as described in clause 35, wherein the plurality of electrodes comprises conductive ink.

[0081] Clause 37: The medical probe described in Clause 33, wherein the balloon comprises a flexible circuit disposed on an outer surface of the balloon, the flexible circuit being electrically connected to at least some of the plurality of electrodes.

[0082] Clause 38: The medical probe described in Clause 32, wherein the expandable distal end assembly comprises a plurality of spines configured to bend radially outward from the longitudinal axis to transition the distal end assembly between an expanded configuration and a collapsed configuration.

[0083] Clause 39: An end effector for a medical probe comprising: a balloon extending along a longitudinal axis and configured to extend radially outward from the longitudinal axis when inflated, the balloon comprising a stretchable circuit material; and a plurality of electrodes disposed on an outer surface of the balloon, the plurality of electrodes comprising conductive ink.

[0084] Clause 40: An end effector as described in clause 39, further comprising a plurality of flexible traces printed on an outer surface of the balloon using conductive ink, the plurality of flexible traces being electrically connected to a plurality of electrodes.

[0085] Clause 41: An end effector described in Clause 39 or Clause 40, further comprising a distal tip extending from a distal end of the balloon, the distal tip comprising an electrode configured to deliver ablation energy to tissue or receive signals from tissue.

[0086] Clause 42: An end effector described in any one of clauses 39 to 41, wherein the distal tip is further configured to deflect radially outward from the longitudinal axis.

[0087] Clause 43: The end effector described in Clause 42, further comprising a pull wire configured to deflect the distal tip radially outward from the longitudinal axis.

[0088] Clause 44: An end effector described in any one of clauses 39 to 43, wherein the distal tip extends distally from the balloon a distance at least 1.5 times the length of the diameter of the balloon.

[0089] Clause 45: The end effector of clause 44, wherein the distance comprises twice the length of the diameter of the balloon.

[0090] Clause 46: An end effector described in any one of clauses 39 to 45, wherein the distal tip further comprises an impedance-based position sensor.

[0091] Clause 47: An end effector described in any one of clauses 39 to 46, further comprising an electromagnetic position sensor, the distal tip of which is configured to output a current when subjected to a magnetic field generated by the magnetic field generator.

[0092] Clause 48: An end effector as described in clause 47, wherein the electromagnetic position sensor includes a three-axis sensor.

[0093] Clause 49: An end effector described in any one of clauses 39 to 48, wherein the end effector is further configured to allow irrigation fluid to flow through at least the distal tip.

[0094] Clause 50: An end effector described in any one of clauses 39 to 49, wherein a plurality of electrodes are radially arranged around the circumference of the balloon.

[0095] Clause 51: An end effector described in any one of clauses 39 to 50, wherein the balloon is configured to transition between an expanded configuration and a folded configuration.

[0096] The above embodiments are cited by way of example, and the invention is not limited to what has been specifically shown and described hereinabove. Rather, the scope of the invention includes both combinations and subcombinations of the various features described and illustrated above, as well as variations and modifications thereof not disclosed in the prior art that will occur to those skilled in the art upon reading the foregoing description.

[0097] [Embodiment] (1) An end effector for a medical probe, comprising: an expandable distal end assembly extending along a longitudinal axis, the expandable distal end assembly extending radially outward from the longitudinal axis and defining an outer diameter; a distal tip extending distally from the expandable distal end assembly along the longitudinal axis a tip length greater than the outer diameter, the distal tip comprising an electrode longitudinally fixed to the expandable distal end assembly and deflectable relative to the longitudinal axis, the electrode configured to deliver ablation energy to tissue or receive electrophysiological signals from tissue. (2) An end effector as described in embodiment 1, wherein the expandable distal end assembly further comprises a plurality of electrodes disposed on the expandable distal end assembly and configured to deliver ablation energy to tissue or receive signals from tissue. (3) The end effector of embodiment 2, wherein the plurality of electrodes are radially arranged along a circumference of the expandable distal end assembly distal to an equator of the expandable distal end assembly. (4) The end effector of embodiment 1, wherein the distal tip is further configured to deflect radially outward from the longitudinal axis. (5) The end effector of embodiment 1, wherein the distal tip extends distally from the expandable distal end assembly a distance at least 1.5 times the length of the outer diameter of the expandable distal end assembly.

[0098] (6) An end effector as described in embodiment 1, wherein the distal tip further comprises an impedance-based position sensor. (7) An end effector as described in embodiment 1, wherein the distal tip further comprises an electromagnetic position sensor configured to output a current when exposed to a magnetic field generated by a magnetic field generator. (8) An end effector as described in embodiment 7, wherein the electromagnetic position sensor includes a three-axis sensor. (9) The end effector of embodiment 1, wherein the end effector is further configured to allow irrigation fluid to flow through at least the distal tip. (10) An end effector as described in embodiment 1, wherein the expandable distal end assembly comprises a balloon configured to be inflated and deflated to transition the expandable distal end assembly between an expanded configuration and a collapsed configuration.

[0099] (11) The end effector of claim 10, wherein the balloon comprises a stretchable circuit material. (12) The end effector of claim 11, wherein the balloon comprises a plurality of electrodes printed directly onto the stretchable circuit material. (13) An end effector as described in claim 12, wherein the plurality of electrodes comprises conductive ink. (14) The end effector of claim 13, wherein the balloon comprises a flexible circuit disposed on an outer surface of the balloon, the flexible circuit being electrically connected to at least some of the plurality of electrodes. (15) A medical probe comprising: an insertion tube having a proximal end and a distal end, the insertion tube extending along a longitudinal axis; an expandable distal tip assembly disposed at the distal end of the insertion tube, the expandable distal tip assembly extending radially outward from the longitudinal axis; a distal tip extending distally from the expandable distal end assembly along the longitudinal axis, the distal tip comprising an electrode longitudinally fixed to the expandable distal end assembly and configured to deliver ablation energy to or receive signals from tissue.

[0100] (16) The medical probe of claim 15, wherein the distal tip is further configured to deflect radially outward from the longitudinal axis. (17) The medical probe of claim 15, wherein the distal tip extends distally from the expandable distal end assembly a distance at least 1.5 times the length of a diameter of the expandable distal end assembly. (18) The medical probe of claim 15, wherein the expandable distal tip assembly further comprises a stretchable circuit material and a plurality of electrodes, the plurality of electrodes being printed directly onto the stretchable circuit material. (19) An end effector for a medical probe, comprising: a balloon extending along a longitudinal axis and configured to extend radially outward from the longitudinal axis upon inflation, the balloon comprising a stretchable circuit material; a plurality of electrodes disposed on an outer surface of the balloon, the plurality of electrodes comprising a conductive ink. (20) The end effector of embodiment 19, further comprising a plurality of flexible traces printed on the outer surface of the balloon using conductive ink, the plurality of flexible traces being electrically connected to the plurality of electrodes.

Claims

1. 1. An end effector for a medical probe, comprising: an expandable distal end assembly extending along a longitudinal axis, the expandable distal end assembly extending radially outward from the longitudinal axis and defining an outer diameter; a distal tip extending distally from the expandable distal end assembly along the longitudinal axis a tip length greater than the outer diameter, the distal tip comprising an electrode longitudinally fixed to the expandable distal end assembly and deflectable relative to the longitudinal axis, the electrode configured to deliver ablation energy to tissue or receive electrophysiological signals from tissue.

2. 10. The end effector of claim 1, wherein the expandable distal end assembly further comprises a plurality of electrodes disposed on the expandable distal end assembly and configured to deliver ablation energy to or receive signals from tissue.

3. The end effector of claim 2 , wherein the plurality of electrodes are arranged radially along a circumference of the expandable distal end assembly distal to an equator of the expandable distal end assembly.

4. The end effector of claim 1 , wherein the distal tip is further configured to deflect radially outward from the longitudinal axis.

5. The end effector of claim 1 , wherein the distal tip extends distally from the expandable distal end assembly a distance at least 1.5 times the length of the outer diameter of the expandable distal end assembly.

6. The end effector of claim 1 , wherein the distal tip further comprises an impedance-based position sensor.

7. The end effector of claim 1 , further comprising an electromagnetic position sensor configured to output a current when exposed to a magnetic field generated by a magnetic field generator, the distal tip further comprising: an electromagnetic position sensor configured to output a current when exposed to a magnetic field generated by a magnetic field generator.

8. The end effector of claim 7 , wherein the electromagnetic position sensor comprises a three-axis sensor.

9. The end effector of claim 1 , further configured to allow irrigation fluid to flow through at least the distal tip.

10. The end effector of claim 1 , wherein the expandable distal end assembly comprises a balloon configured to be inflated and deflated to transition the expandable distal end assembly between an expanded configuration and a collapsed configuration.

11. The end effector of claim 10 , wherein the balloon comprises a stretchable circuit material.

12. The end effector of claim 11 , wherein the balloon comprises a plurality of electrodes printed directly onto the stretchable circuit material.

13. The end effector of claim 12 , wherein the plurality of electrodes comprises conductive ink.

14. The end effector of claim 13 , wherein the balloon comprises a flexible circuit disposed on an outer surface of the balloon, the flexible circuit being electrically connected to at least some of the plurality of electrodes.

15. 1. A medical probe, comprising: an insertion tube having a proximal end and a distal end, the insertion tube extending along a longitudinal axis; an expandable distal tip assembly disposed at the distal end of the insertion tube, the expandable distal tip assembly extending radially outward from the longitudinal axis; a distal tip extending distally from the expandable distal end assembly along the longitudinal axis, the distal tip comprising an electrode longitudinally fixed to the expandable distal end assembly and configured to deliver ablation energy to or receive signals from tissue.

16. The medical probe of claim 15 , wherein the distal tip is further configured to deflect radially outward from the longitudinal axis.

17. The medical probe of claim 15 , wherein the distal tip extends distally from the expandable distal tip assembly a distance at least 1.5 times the length of a diameter of the expandable distal tip assembly.

18. The medical probe of claim 15 , wherein the expandable distal tip assembly further comprises a stretchable circuit material and a plurality of electrodes, the plurality of electrodes being printed directly onto the stretchable circuit material.

19. 1. An end effector for a medical probe, comprising: a balloon extending along a longitudinal axis and configured to extend radially outward from the longitudinal axis upon inflation, the balloon comprising a stretchable circuit material; a plurality of electrodes disposed on an outer surface of the balloon, the plurality of electrodes comprising a conductive ink.

20. 20. The end effector of claim 19, further comprising a plurality of flexible traces printed on the outer surface of the balloon using conductive ink, the plurality of flexible traces electrically connected to the plurality of electrodes.

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