Expandable electrode assembly for medical catheter comprising extended distal end

Abstract

The disclosed technology includes an end effector for a medical probe. The end effector may include an expandable distal end assembly that extends along a longitudinal axis. The expandable distal end assembly may extend radially outward from the longitudinal axis and define an outer diameter. The end effector may also include a distal tip extending distally from the expandable distal end assembly along the longitudinal axis beyond a tip length greater than the outer diameter. The distal tip may be longitudinally fixed relative to the expandable distal end assembly and deflectable relative to the longitudinal axis. The tip may include an electrode configured to deliver ablation energy to or receive a signal from tissue.

Description

[0001] Cross-references to related patent applications

[0002] This application claims priority to and the benefits of U.S. Provisional Patent Application No. 63 / 581,475 (Agent File No.: BIO6884USPSP1-253757.000427), filed on September 8, 2023, under 35 U.S.C. §119(e), the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates generally to medical devices, and in particular to expandable catheters configured to deliver ablative energy to tissue or receive signals from tissue. Background Art

[0004] 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 an irregular heartbeat. Certain procedures are used to treat arrhythmias, including surgically disrupting the source of the signal that causes the arrhythmia and disrupting the conduction pathways for such signals. By selectively ablating cardiac tissue by applying energy via a catheter, it is sometimes possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another. Medical probes can use radio frequency (RF) electrical energy to heat tissue. Some ablation methods use irreversible electroporation (IRE) to ablate cardiac tissue using non-thermal ablation methods.

[0005] 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 has an expandable electrode array, such as a balloon or basket catheter, and a second catheter has a focal tip electrode. These catheters are used in combination to deliver ablation energy to identified areas 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 a heart chamber at a time. The removal and insertion of each catheter extends the total procedure time, which can be difficult for both the physician and the patient, and makes it more difficult for the patient to recover. Therefore, there is a need in the art for a device that is configured to reduce the total procedure time by completing multiple elements of a pulmonary vein isolation procedure with a single device. This and other problems can be addressed by the technology disclosed herein. Summary of the invention

[0006] The disclosed technology includes an end effector for a medical probe. The end effector may include an expandable distal end assembly extending along a longitudinal axis. The expandable distal end assembly may extend radially outward from the longitudinal axis and define an outer diameter. The end effector may also include a distal tip extending distally from the expandable distal end assembly along the longitudinal axis beyond a tip length greater than the outer diameter. The distal tip may be longitudinally fixed relative to the expandable distal end assembly and capable of deflecting relative to the longitudinal axis. The tip may include an electrode configured to deliver ablation energy to tissue or receive a signal 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 also include an expandable distal end assembly disposed at the distal end of the insertion tube. The expandable distal end assembly may extend radially outward from the longitudinal axis. The medical probe may also include a distal tip extending distally from the expandable distal end assembly along the longitudinal axis. The distal tip may be longitudinally fixed relative to the expandable distal end assembly and include an electrode configured to deliver ablation energy to tissue or receive signals from tissue.

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

[0009] Figure 1 is a schematic illustration of a medical system including a medical probe having an end effector with electrodes according to an embodiment of the disclosed technology;

[0010] Figure 2 is a perspective view of a medical probe and handle according to the disclosed technology;

[0011] Figure 3 is a side view of an end effector according to the disclosed technology;

[0012] Figure 4A is a perspective view of an end effector according to the disclosed technology;

[0013] Figure 4B is another perspective view of an end effector according to the disclosed technology;

[0014] Figure 5 is a top perspective view of an end effector according to the disclosed technology with the distal electrode removed; and

[0015] Figure 6 The end effector according to the disclosed technology is along Figure 3 A cross-sectional view taken along line AA. DETAILED DESCRIPTION

[0016] 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 including electrodes. The electrodes on the expandable assembly and the electrodes on the distal tip can each be configured to deliver ablation energy to the tissue or receive signals from the tissue. In this way, the disclosed technology combines the functions of a typical balloon or basket ablation catheter with the functions of a focal ablation catheter, thereby eliminating the need to use multiple catheters to complete pulmonary vein isolation. In other words, the disclosed technology is able to utilize a single catheter to ablate both large and small tissue areas.

[0017] The following detailed description should be read in conjunction with the accompanying drawings, in which the same elements are labeled the same in different drawings. The accompanying drawings (not necessarily drawn to scale) depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example and not by way of limitation. This description will clearly enable those skilled in the art to prepare and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including the best modes currently believed to be implemented in the invention.

[0018] As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a part or assembly of components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of ±20% of the value of the recited value, for example, "about 90%" may refer to a range of values ​​from 71% to 110%.

[0019] As used herein, the terms "patient," "receptor," "user," and "subject" refer to any human or animal subject, and are not intended to limit the systems or methods to human use, but the use of the subject invention in human patients represents a preferred embodiment. In addition, the vascular system of the "patient," "receptor," "user," and "subject" can be the vascular system of a human or any animal. It should be understood that the animal can be of any suitable type, including but not limited to mammals, veterinary animals, livestock animals, or pet animals, etc. For example, the animal can be an experimental animal (e.g., rats, dogs, pigs, monkeys, etc.) specifically selected to have certain characteristics similar to humans. It should be understood that the subject can be, for example, any suitable human patient. Similarly, the term "proximal" refers to a position closer to an operator or physician, while "distal" refers to a position farther away from an operator or physician.

[0020] As discussed herein, a "physician" or "operator" may include a physician, surgeon, technician, scientist, or any other individual or delivery instrumentation associated with delivering a multi-electrode catheter for treating drug-refractory atrial fibrillation to a subject.

[0021] As discussed herein, when referring to the devices and corresponding systems of the present disclosure, the term "ablation" refers to components and structural features configured to reduce or prevent the generation of unstable cardiac signals in cells by utilizing non-thermal energy (such as irreversible electroporation (IRE)), which are interchangeably referred to as pulsed electric fields (PEF) and pulsed field ablation (PFA) in the present disclosure. "Ablation" as used throughout the present disclosure, when referring to the devices and corresponding systems of the present disclosure, refers to non-thermal ablation of cardiac tissue for certain conditions, including but not limited to arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation as understood by those skilled in the relevant art.

[0022] As discussed herein, the terms "bipolar" and "monopolar" when used to refer to ablation regimens describe ablation regimens that differ in terms of current paths and electric field distribution. "Bipolar" refers to an ablation regimen that utilizes a current path between two electrodes as described below, both electrodes being positioned at a treatment site; the current density and electric flux density at each of the two electrodes are generally approximately equal. "Monopolar" refers to an ablation regimen that utilizes a current path between two electrodes as described below, wherein one electrode including a high current density and a high electric flux density is positioned at the treatment site, and a second electrode including a relatively lower current density and a lower electric flux density is positioned away from the treatment site.

[0023] As discussed herein, the terms "tubular" and "tube" should be interpreted broadly and are not limited to structures that are perfect cylinders or have a completely circular cross-section or a uniform cross-section throughout their length. For example, while tubular structures may generally be illustrated as substantially perfect cylindrical structures, tubular structures may have tapered or curved outer surfaces without departing from the scope of the present disclosure.

[0024] The disclosed technology can be configured to deliver monophasic or biphasic pulses to ablate tissue. For example, the electrodes described herein that are 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 corresponding electrical signals. "Biphasic pulse" refers to an electrical signal that includes a positive voltage phase pulse (referred to herein as a "positive phase") and a negative voltage phase pulse (referred to herein as a "negative phase"). "Monophasic pulse" refers to an electrical signal that includes only a positive phase or a negative phase.

[0025] Ablation of cardiac tissue using the application of thermal techniques such as radiofrequency (RF) energy and cryoablation to correct a malfunctioning heart is a well-known procedure. Typically, in order to successfully ablate using thermal techniques, cardiac electrode potentials need to be measured at various locations in the myocardium. In addition, temperature measurements during ablation provide data that can be used to achieve ablation efficacy. Typically, for ablation procedures using thermal ablation, electrode potentials and temperatures are measured before, during, and after the actual ablation.

[0026] The example systems, methods, and devices of the present invention may be particularly suitable for IRE ablation of cardiac tissue to treat arrhythmias. Ablation energy is typically provided to cardiac tissue by electrodes that can deliver ablation energy along the tissue to be ablated. Fluoroscopy, magnetic-based position sensing, and / or active current localization techniques may be used to visualize ablation procedures involving such example catheters.

[0027] IRE as discussed in the present disclosure is a non-thermal cell death technique that can be used for ablation of atrial arrhythmias. To ablate using IRE / PEF, biphasic voltage pulses are applied to destroy the cellular structure of the myocardium. The biphasic pulses are non-sinusoidal and can be tuned 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 at the treatment area, heating all cells indiscriminately in the treatment area. Therefore, IRE has the ability to avoid adjacent heat-sensitive structures or tissues, which will have benefits in reducing possible complications known to be affected by ablation or separation modalities. In addition or alternatively, monophasic pulses can be used.

[0028] Electroporation can be induced by applying a pulsed electric field across biological cells to cause holes to be reversibly (temporarily) or irreversibly (permanently) produced in the cell membrane. When a pulsed electric field is applied, the cell has a transmembrane electrostatic potential that is elevated above the static potential. When the transmembrane electrostatic potential remains below the threshold potential, electroporation is reversible, which means that the hole can be closed when the applied pulsed electric field is removed, and the cell can self-repair and survive. If the transmembrane electrostatic potential is elevated above the threshold potential, electroporation is irreversible and the cell becomes permanently permeable. Therefore, the cell dies due to loss of homeostasis, usually by programmed cell death or apoptosis, which is believed to leave less scar tissue than other ablation methods. Typically, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of approximately 500V / cm, while for bones, the threshold potential is 3000V / cm. These differences in threshold potentials allow IRE to selectively target tissues based on threshold potentials.

[0029] refer to Figure 1 , which shows an example catheter-based electrophysiological mapping and ablation system 10. The system 10 includes one or more catheters that are inserted into a chamber or vascular structure of the heart 12 by a physician 24 through the vascular system of a patient 23 via the skin. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 12. Multiple catheters may then be inserted into the delivery sheath catheter to reach the desired location. The one or more catheters may include a catheter dedicated to sensing intracardiac electrogram (IEGM) signals, a catheter dedicated to ablation, and / or a catheter dedicated to both sensing and ablation. An example catheter 14 configured for sensing IEGM is illustrated herein. For ablation, the physician 24 brings 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 the target site in the heart 12.

[0030] The catheter 14 is an exemplary catheter that includes an end effector 28 that includes one and preferably a plurality of electrodes that are optionally distributed on the expandable assembly and the distal end of the end effector 28 and are configured to deliver ablation energy to the tissue or receive signals from the tissue. The catheter 14 may further include a magnetically based position sensor 29 that is embedded in or near the end effector 28 for tracking the position and orientation of the end effector 28. The end effector 28 may also include one or more impedance-based electrodes 26 that are disposed in or near the end effector 28 for tracking the position and orientation of the end effector 28.

[0031] The magnetic-based position sensor 29 can operate with the positioning mat 25, which includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predefined workspace. The real-time position of the end effector 28 of the catheter 14 can be tracked based on the magnetic field generated by the positioning mat 25 and sensed by the magnetic-based position sensor 29. The magnetic-based position sensor 29 can be a single-axis sensor, a dual-axis sensor, or a three-axis sensor, depending on the specific configuration. Details of magnetic-based position sensing technology are described in U.S. Patents 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091, each of which is incorporated herein by reference as if fully set forth herein.

[0032] The system 10 includes one or more electrode patches 38 positioned in contact with the skin of the patient 23 to establish a position reference for the positioning pad 25 and the impedance-based tracking of the electrodes 26. For impedance-based tracking, current is directed toward the impedance-based electrodes 26 and sensed at the electrode skin patches 38 so that the position of each electrode can be triangulated via the electrode patches 38. Details of impedance-based position tracking techniques are described in U.S. Patents 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference as if fully set forth herein.

[0033] Recorder 11 displays electrograms 21 captured using body surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured using electrodes of catheter 14. Recorder 11 may include pacing capabilities for pacing the cardiac rhythm and / or may be electrically connected to a separate pacemaker.

[0034] The system 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes disposed on an end effector and configured to deliver ablation energy to tissue. The energy generated by the ablation energy generator 50 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that may be used to achieve irreversible electroporation (IRE)), or a combination thereof.

[0035] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between catheters, electrophysiology equipment, a power source, and a workstation 55 for controlling the operation of the system 10. The electrophysiology equipment of the system 10 may include, for example, multiple catheters, positioning pads 25, surface ECG electrodes 18, electrode patches 38, ablation energy generator 50, and recorder 11. Optionally and preferably, the PIU 30 additionally includes processing capabilities for enabling real-time calculation of the position of the catheter and for performing ECG calculations.

[0036] Workstation 55 includes memory, a processor unit with memory or storage loaded with appropriate operating software, and user interface capabilities. Workstation 55 can provide multiple functions, optionally including: (1) three-dimensional (3D) modeling of endocardial anatomy and rendering of the model or anatomical map 20 for display on display device 27; (2) displaying on display device 27 an activation sequence (or other data) compiled from recorded electrograms 21 as representative visual markers or images superimposed on the rendered anatomical map 20; (3) displaying the real-time position and orientation of multiple catheters within the heart chamber; and (4) displaying on display device 27 sites of interest, such as where ablation energy has been applied. A commercial product embodying elements of system 10 may be CARTO TM 3 System was purchased from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0037] Now go to Figure 2 , the disclosed technology includes an end effector 28, which includes an expandable distal tip assembly 100 and a distal tip 112. The end effector 28 can be attached to a handle 120 via an insertion tube 122, which is configured for insertion through a delivery sheath and / or into the vasculature of a patient 23. The 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 to one or more pull wires 140 (such as Figure 6 ), the one or more pull wires are attached to an anchor point 142 disposed near the distal end of the end effector 28. As will be appreciated, the actuator 124 can pull the pull wire 140, and by pulling the pull wire 140, the end effector 28 can be deflected radially outward from the longitudinal axis LA.

[0038] The handle 120 may also include one or more irrigation supply connectors 126 and one or more electrical connectors 128. The irrigation supply connector 126 may be configured to attach to an irrigation supply that can deliver irrigation fluid to and through the end effector 28. The electrical connector 128 may be configured to electrically connect electrodes disposed on the end effector 28 to the PIU 30.

[0039] like Figure 3 As more clearly shown in FIG. 1 , the end effector 28 may include an expandable distal tip assembly 100 and a distal tip 112 . Figure 4A and Figure 4B An alternative perspective view of the end effector 28 is illustrated. The expandable distal tip assembly 100 may include a plurality of electrodes 102 (only one electrode 102 is labeled for simplicity) disposed around the circumference of the expandable distal tip assembly 100 and a plurality of electrical traces 104 disposed along the expandable distal tip assembly 100, wherein each electrical trace 104 is electrically connected to one or more electrodes 102. The electrodes 102 may each be disposed on the distal half of the expandable distal tip assembly 100. In other words, the electrodes 102 may each be disposed on the distal side of the equator EL of the expandable distal tip assembly 100 ( Figure 3 122). In this manner, when the expandable distal tip assembly 100 is at least partially inserted into the pulmonary vein, the electrode 102 can be positioned to deliver ablation energy to the tissue or receive signals from the tissue on or around 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.

[0040] Electrode 102 may 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. Electrode 102 may be of any shape and formed of a conductive material such as gold, silver, platinum, iridium, etc. Electrode 102 may be configured to deliver an electrical pulse for irreversible electroporation having a peak voltage of at least 900 volts (V).

[0041] The expandable distal tip assembly 100 can be configured to be in an expanded configuration (e.g. Figure 2The expandable distal tip assembly 100 may be configured to be inflated and / or at least partially inflated to transition between an expanded configuration (not shown) and a collapsed configuration (not shown), in which the expandable distal tip assembly 100 is collapsed and configured to be pulled or pushed through the insertion sheath and / or the vasculature of the patient 23. The expandable distal tip assembly 100 may be, for example, an inflatable balloon configured to be inflated to transition to an expanded configuration. The balloon may be inflated by an irrigation fluid received through the irrigation supply connector 126. In some examples, the expandable distal tip assembly 100 may include one or more orifices (not shown) configured to allow irrigation fluid to exit the expandable distal tip assembly 100. Alternatively, the expandable distal tip assembly 100 may be configured to be inflated by irrigation fluid, but be sealed or at least partially sealed so that no irrigation fluid escapes through the wall of the expandable distal tip assembly 100. In this configuration, irrigation fluid may be delivered to and / or through the distal tip 112. Alternatively, the expandable distal tip assembly 100 and the distal tip 112 may each have an orifice and be configured to allow irrigation fluid to flow therethrough.

[0042] The expandable distal tip assembly 100 can be made of a stretchable circuit material, and the electrodes 102 and / or electrical traces 104 can be printed directly onto the expandable distal tip assembly 100 using conductive ink without the need for a polyimide substrate material. The expandable distal tip assembly 100 can be manufactured, for example, by Panasonic TM Made by Beyolex TM Or other similar stretchable circuit materials. In other examples, the electrodes 102 and / or the electrical traces 104 can be printed onto the stretchable circuit material to form a flexible circuit, and the flexible circuit can be disposed along the outer surface of the expandable distal tip assembly 100 .

[0043] Although not shown, it should be understood that the expandable distal tip assembly 100 may alternatively include a plurality of ridges configured to bend radially outward from the longitudinal axis LA to form a basket assembly. The electrodes 102 may be disposed along the ridges, and the basket assembly may be configured to transition between an expanded configuration when pushed out of a delivery sheath and a collapsed configuration when disposed in the delivery sheath.

[0044] The distal end 112 may extend distally from the expandable distal end assembly 100 along the longitudinal axis LA. The distal end 112 may extend distally from the expandable distal end assembly 100 beyond a terminal length that is greater than the outer diameter of the expandable distal end assembly 100. For example, the expandable distal end assembly 100 may have a diameter measured at its equator EL or at a position where the diameter of the expandable distal end assembly 100 is the largest, and the terminal length of the distal end 112 may be greater than the length of the diameter. In some examples, the length of the distal end 112 may be 1.5 times, 2 times, 3 times, 4 times, or even at least 5 times the diameter of the expandable distal end assembly 100. By having an elongated distal end 112 as shown, the distal end 112 may 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 end 112 may be longitudinally fixed relative to the expandable distal end assembly 100.

[0045] The distal tip 112 may include a distal electrode 110 disposed on 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 on a distal end of the distal tip 112, the distal electrode 110 may be configured to be used as a focusing electrode for delivering ablation energy to small areas or hard-to-reach areas of the heart 12. Thus, the end effector 28 may combine the following benefits: a plurality of electrodes 102 disposed on an expandable distal tip assembly 100, the plurality of electrodes being configured to deliver ablation energy to relatively large tissue areas (e.g., around a pulmonary vein); having a focusing electrode (distal electrode 110) configured to deliver ablation energy to small tissue areas. In this way, the disclosed technology reduces or completely eliminates the need to use multiple catheters during a procedure, thereby helping to reduce the overall procedure time. The distal electrode 110 can be configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).

[0046] To assist 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 electric current when subjected to a magnetic field generated by the magnetic coil 32. Alternatively or in addition, 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 active current positioning 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 then be used to render a representation of the position and orientation of the end effector 28 on a display.

[0047] Figure 5 A perspective view of the end effector 28 is illustrated with the distal electrode 110 removed to show the large lumen 130 and the small lumen 132 extending through the distal tip 112. As will be appreciated, the large lumen 130 and the small lumen 132 may extend all the way through the insertion tube 122 and to the handle 120. The large lumen 130 may be configured to receive an irrigation fluid, and / or the pull wire 140 may be configured to pass through at least one of the large lumens 130. In this manner, an irrigation fluid may be delivered to the distal electrode 110. Although not shown, the distal electrode 110 may have one or more orifices formed therethrough that are configured to deliver an irrigation fluid therethrough. Alternatively or in addition, the distal tip 112 may have one or more orifices formed therethrough that are configured to deliver an irrigation fluid therethrough. Return to Reference Figure 5 , the position of each electrode can be seen, and therefore the overall shape of the basket can be determined by using a magnetic field sensor 300 in the form of a flat ring through a single wire with two leads extending along the balloon (inside or outside) back to the handle. Each electrode will have a wire loop in the form of a spiral so that the position of each electrode can be visualized. Support for the magnetic position sensor 300 and the shape determination of the sensor can be understood from the following patents: U.S. Patent Publication No. US20180344202A1, US20220265194A1 or U.S. Patent No. US10687761B2, each of which is incorporated by reference, with a copy provided in the appendix to the priority application, i.e., U.S. Provisional Patent Application No. 63 / 581,475.

[0048] The small lumen 132 can be configured to accommodate one or more wires (which can extend from the handle 120 to the distal electrode 110), a magnetic-based position sensor 29, or an impedance-based electrode 26. As will be appreciated, the number of large lumens 130 and small lumens 132 can be greater or less than the number shown, depending on the particular configuration. In addition, although the large lumen 130 is described as being configured to receive an irrigation fluid or to accommodate a pull wire 140, and the small lumen 132 is described as being configured to accommodate a wire, it should be understood that one or more small lumens 132 can be similarly configured to receive an irrigation fluid and / or accommodate a pull wire 140, and one or more large lumens 130 can be configured to accommodate a wire, depending on the particular configuration.

[0049] like Figure 6 As shown, the figure is along Figure 3 In the cross-sectional view of the end effector 28 taken along line AA of FIG. 1 , the pull wire 140 can extend through at least one of the large lumens 130 and be attached to an anchor point 142 disposed near the distal electrode 110. As previously described, when the actuator 124 is actuated, the pull wire can pull the distal tip 112, thereby deflecting the distal tip 112 radially outward from the longitudinal axis LA. Although not shown, it should be understood that the end effector can include more than one pull wire 140, and the anchor point 142 can be disposed in a variety of locations to affect the articulation radius of the distal tip 112 and / or the entire end effector 28.

[0050] The disclosed technology described herein can be further understood according to the following terms:

[0051] Clause 1:

[0052] An end effector for a medical probe, the end effector 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 beyond a tip length greater than the outer diameter, the distal tip being longitudinally fixed relative to the expandable distal end assembly and capable of deflecting relative to the longitudinal axis, the tip comprising an electrode configured to deliver ablation energy to tissue or receive signals from tissue.

[0053] Clause 2: According to the end effector of Clause 1, the expandable distal tip assembly further comprises a plurality of electrodes disposed on the expandable distal tip assembly and configured to deliver ablation energy to tissue or receive signals from tissue.

[0054] Clause 3: According to the end effector of Clause 2, the plurality of electrodes are radially arranged along the circumference of the expandable distal tip assembly distal to the equator of the expandable distal tip assembly.

[0055] Clause 4: The end effector of any preceding clause, the distal tip further configured to deflect radially outward from the longitudinal axis.

[0056] 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.

[0057] Clause 6: The end effector according to any of the preceding clauses, wherein the distal tip extends distally from the expandable distal tip assembly a distance that is at least 1.5 times the length of the outer diameter of the expandable distal tip assembly.

[0058] Clause 7: The end effector of clause 6, wherein said distance comprises 2 times said length of said outer diameter of said expandable distal tip assembly.

[0059] Clause 8: The end effector of any preceding clause, the distal tip further comprising an impedance-based position sensor.

[0060] Clause 9: The end effector of any of the preceding clauses, the distal tip further comprising an electromagnetic position sensor configured to output a current when subjected to a magnetic field generated by a magnetic field generator.

[0061] Clause 10: The end effector of clause 9, wherein the electromagnetic position sensor comprises a three-axis sensor.

[0062] Clause 11: The end effector of any of the preceding clauses, further configured to allow irrigation fluid to flow through at least the distal tip.

[0063] Clause 12: The end effector of any of the preceding clauses, the expandable distal tip assembly being configured to transition between an expanded configuration and a collapsed configuration.

[0064] Clause 13: The end effector of clause 12, wherein the expandable distal tip assembly comprises a balloon configured to inflate and deflate to transition the expandable distal tip assembly between the expanded configuration and the collapsed configuration.

[0065] Clause 14: The end effector of clause 13, wherein the expandable distal tip assembly is configured to be inflated by receiving an irrigation fluid, the expandable distal tip assembly being sealed to prevent the irrigation fluid from exiting the expandable distal tip assembly.

[0066] Clause 15: The end effector of clause 13 or clause 14, wherein the balloon comprises a stretchable circuit material.

[0067] Clause 16: The end effector of clause 15, wherein the plurality of electrodes are printed directly onto the stretchable circuit material.

[0068] Clause 17: The end effector of clause 16, wherein the plurality of electrodes comprise conductive ink.

[0069] Clause 18: The end effector of 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.

[0070] Clause 19: The end effector of clause 12, wherein the expandable distal end assembly comprises a plurality of ridges configured to bend radially outward from the longitudinal axis to transition the distal end assembly between the expanded configuration and the collapsed configuration.

[0071] Item 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, the expandable distal end assembly being disposed at the distal end of the insertion tube, the expandable distal end assembly extending radially outward from the longitudinal axis; and a distal tip extending distally from the expandable distal end assembly along the longitudinal axis, the distal tip being longitudinally fixed relative to the expandable distal end assembly and comprising an electrode configured to deliver ablation energy to tissue or receive signals from tissue.

[0072] Clause 21: The medical probe of clause 20, the distal tip further configured to deflect radially outward from the longitudinal axis.

[0073] 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.

[0074] Clause 23: The medical probe according to Clause 22, further comprising a handle disposed at the 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.

[0075] Clause 24: The medical probe of any one of clauses 20 to 23, wherein the distal tip extends distally from the expandable distal tip assembly a distance that is at least 1.5 times the length of a diameter of the expandable distal tip assembly.

[0076] Clause 25: The medical probe of clause 24, wherein the distance comprises 2 times the length of the diameter of the expandable distal tip assembly.

[0077] Clause 26: The medical probe of any of clauses 20 to 25, the distal tip further comprising an impedance-based position sensor.

[0078] Clause 27: The medical probe of any of clauses 20 to 26, the distal tip further comprising an electromagnetic position sensor configured to output a current when subjected to a magnetic field generated by a magnetic field generator.

[0079] Clause 28: The medical probe of clause 27, wherein the electromagnetic position sensor comprises a three-axis sensor.

[0080] Clause 29: The medical probe of any of clauses 20 to 28, further configured to allow irrigation fluid to flow through at least the distal tip.

[0081] Clause 30: The medical probe according to any one of clauses 20 to 29, wherein the expandable distal tip assembly further comprises a plurality of electrodes disposed on the expandable distal tip assembly and configured to deliver ablation energy to tissue or receive signals from tissue.

[0082] Clause 31: The medical probe of clause 30, wherein the plurality of electrodes are radially disposed along a circumference of the expandable distal tip assembly.

[0083] Clause 32: The medical probe of any of clauses 20 to 31, the expandable distal tip assembly configured to transition between an expanded configuration and a collapsed configuration.

[0084] Clause 33: The medical probe of clause 32, wherein the expandable distal tip assembly comprises a balloon configured to inflate and deflate to transition the expandable distal tip assembly between the expanded configuration and the collapsed configuration.

[0085] Clause 34: The medical probe of clause 33, wherein the balloon comprises a stretchable circuit material.

[0086] Item 35: The medical probe according to Item 34, wherein the plurality of electrodes are directly printed on the stretchable circuit material.

[0087] Clause 36: The medical probe of clause 35, wherein the plurality of electrodes comprise conductive ink.

[0088] Clause 37: The medical probe of 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.

[0089] Clause 38: The medical probe of clause 32, wherein the expandable distal tip assembly comprises a plurality of ridges configured to bend radially outward from the longitudinal axis to transition the distal tip assembly between the expanded configuration and the collapsed configuration.

[0090] Item 39: An end effector for a medical probe, the end effector 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 a conductive ink.

[0091] Clause 40: The end effector of clause 39, 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.

[0092] Clause 41: The end effector of clause 39 or clause 40, further comprising a distal tip extending from the distal end of the balloon, the distal tip comprising an electrode configured to deliver ablation energy to tissue or receive signals from tissue.

[0093] Clause 42: The end effector of any of clauses 39 to 41, said distal tip further configured to deflect radially outward from said longitudinal axis.

[0094] Clause 43: The end effector of clause 42, further comprising a pull wire configured to deflect the distal tip radially outward from the longitudinal axis.

[0095] Clause 44: The end effector of any one of Clauses 39 to 43, wherein the distal tip extends distally from the balloon a distance that is at least 1.5 times the length of the diameter of the balloon.

[0096] Clause 45: The end effector of clause 44, wherein said distance comprises 2 times said length of said diameter of said balloon.

[0097] Clause 46: The end effector of any of clauses 39 to 45, said distal tip further comprising an impedance-based position sensor.

[0098] Clause 47: The end effector of any of clauses 39 to 46, the distal tip further comprising an electromagnetic position sensor configured to output a current when subjected to a magnetic field generated by a magnetic field generator.

[0099] Clause 48: The end effector of clause 47, wherein the electromagnetic position sensor comprises a three-axis sensor.

[0100] Clause 49: The end effector of any of clauses 39 to 48, further configured to allow irrigation fluid to flow through at least the distal tip.

[0101] Clause 50: The end effector of any one of clauses 39 to 49, wherein the plurality of electrodes are radially disposed along the circumference of the balloon.

[0102] Clause 51: The end effector of any of clauses 39 to 50, wherein the balloon is configured to transition between an expanded configuration and a collapsed configuration.

[0103] The above embodiments are cited by way of example, and the present invention is not limited by what is specifically shown and described above. On the contrary, the scope of the present invention includes combinations and sub-combinations of the various features described and shown above, as well as variations and modifications thereof, which will occur to those skilled in the art upon reading the above description and which are not disclosed in the prior art.

Claims

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

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

3. According to the end actuator of claim 2, the plurality of electrodes are radially arranged along the circumference of the expandable distal end assembly distal to the 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 according to claim 1, wherein the distance that the distal tip extends distally from the expandable distal end assembly is at least 1.5 times the length of the outer diameter of the expandable distal end assembly.

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

7. The end effector of claim 1, the distal tip further comprising an electromagnetic position sensor configured to output a current when subjected 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 tip assembly comprises a balloon configured to inflate and deflate to transition the expandable distal tip 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 on the stretchable circuit material.

13. The end effector of claim 12, the plurality of electrodes comprising 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; and A distal tip extends distally from the expandable distal tip assembly along the longitudinal axis, the distal tip being longitudinally fixed relative to the expandable distal tip assembly and comprising an electrode configured to deliver ablation energy to tissue or receive signals from tissue.

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

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

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

19. An end effector for a medical probe, the end effector 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 are disposed on an outer surface of the balloon, the plurality of electrodes comprising conductive ink.

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 being electrically connected to the plurality of electrodes.

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