Electrodes with retention features for use with medical probes

Abstract

The disclosed technology includes an electrode including a body extending along a longitudinal axis from a proximal end to a distal end. The body defines: a tissue-facing surface; a lumen extending through the body along a longitudinal axis from a proximal end to a distal end; and one or more recesses extending through the body, transverse to the longitudinal axis of the body. One or more recesses are disposed between the tissue-facing surface and the lumen and define a first portion extending into the body a first depth and a second portion extending from the first portion into the body a second depth. The first portion includes a first gap distance and the second portion includes a second gap distance. The second gap distance may be greater than the first gap distance.

Description

Technical Field

[0001] The present invention relates generally to medical devices, and more particularly to medical probes having electrodes, and further but not exclusively to medical probes suitable for mapping and ablation of cardiac tissue. Background Technology

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

[0003] Areas of cardiac tissue can be mapped using medical probes to identify abnormal electrical signals. Ablation can be performed using the same or different medical probes. Some example probes include multiple ridges with electrodes mounted thereon. The electrodes are typically attached to the ridges, and the ridges are configured to bend radially outward as they unfold from the sheath. The electrodes are then brought into contact with the tissue to map or ablate it.

[0004] Some example conduits include multiple ridges on which electrodes are mounted. The electrodes are typically attached to the ridges and secured in place by brazing, welding, or using adhesives. However, due to the small size of the electrodes, brazing or welding them to the ridges can be difficult, and adhesives often do not adhere well to metallic materials or brazing or welding materials. If the adhesive does not adhere sufficiently to the electrode or delaminates from the electrode, the electrode may loosen on the ridge and slide out of place along it. However, attaching the electrode to the ridge using adhesives is generally a simpler and more cost-effective process. Therefore, a system and method are needed for attaching electrodes to the ridges of basket assemblies using adhesives that ensure adequate adhesion to both the electrode and the ridge. These and other problems can be addressed by the techniques disclosed herein. Summary of the Invention

[0005] According to the disclosed technology, an electrode for a medical probe is provided. The electrode includes a body extending along a longitudinal axis from a proximal end to a distal end. The body defines: a tissue-facing surface; a lumen extending through the body along the longitudinal axis from the proximal end to the distal end; and one or more recesses extending through the body transverse to the longitudinal axis of the body. The one or more recesses are disposed between the tissue-facing surface and the lumen, and define a first portion and a second portion, the first portion extending to a first depth in the body, and the second portion extending from the first portion to a second depth in the body. The first portion includes a first gap distance, and the second portion includes a second gap distance. The second gap distance may be greater than the first gap distance.

[0006] The disclosed technology also includes a medical probe comprising a tubular shaft including a proximal end and a distal end, wherein the tubular shaft extends along a longitudinal axis. The medical probe further includes an expandable basket assembly coupled to the distal end of the tubular shaft. The expandable basket assembly may include a plurality of ridges and a plurality of electrodes, the plurality of ridges being coupled to the tubular shaft and configured to bend radially outward from the longitudinal axis of the tubular shaft, the plurality of electrodes being disposed on the plurality of ridges. Each of the plurality of electrodes may include a body extending from a proximal end to a distal end of the body along a longitudinal axis. The body may define: a tissue-facing surface; a lumen extending through the body from the proximal end to the distal end; and one or more recesses disposed between the tissue-facing surface and the lumen, transverse to the longitudinal axis of the body. The one or more recesses may define a first portion extending to a first depth in the body, the second portion extending from the first portion to a second depth in the body. The first part may include a first gap distance, and the second part may include a second gap distance. The second gap distance may be greater than the first gap distance.

[0007] The disclosed technology also includes a method of manufacturing an electrode for a medical probe. The method may include: forming a lumen through a body of the electrode, wherein the lumen extends along a longitudinal axis from a proximal end to a distal end; and forming one or more recesses extending along the body transverse to the longitudinal axis. The one or more recesses may define a first portion and a second portion, the first portion extending to a first depth in the body, and the second portion extending from the first portion to a second depth in the body. The first portion may include a first gap distance, and the second portion may include a second gap distance. The second gap distance may be greater than the first gap distance. Attached Figure Description

[0008] This disclosure will be more fully understood through the following detailed description of embodiments thereof, taken in conjunction with the accompanying drawings, in which:

[0009] Figure 1 It is a schematic diagram of a medical system including a medical probe according to the disclosed technology, the medical probe having a distal end including electrodes;

[0010] Figure 2 It is a schematic diagram of a basket-type conduit including electrodes based on the disclosed technology;

[0011] Figure 3 It is a perspective view of the electrodes according to the disclosed technology;

[0012] Figure 4A It is a side view of the electrodes according to the disclosed technology;

[0013] Figure 4B It is based on the disclosed technology. Figure 4A Detailed view of the electrodes;

[0014] Figure 5 It is an end view of the electrode according to the disclosed technology;

[0015] Figure 6 It is based on the disclosed technology. Figure 5 The cross-sectional view of the electrode taken along line AA; and

[0016] Figure 7 This is a flowchart illustrating a method for manufacturing a medical probe based on the disclosed technology. Detailed Implementation

[0017] The electrode described herein provides a solution to ensure that the electrode is adequately secured in place on a ridge when held in place using an adhesive. The electrode includes recesses within its body that are formed to receive the adhesive and prevent removal of the adhesive from the recesses once the adhesive has hardened. For example, the recess includes a first portion extending into the electrode body, and a second portion extending from the first portion and having a gap distance greater than that of the first portion. In this way, the adhesive, in liquid form, can enter the recess, but is prevented from being removed from the recess when in a cured solid form, thereby securing the electrode in place on the ridge.

[0018] The following detailed description should be read in conjunction with the accompanying drawings, in which the same elements are labeled the same in different figures. The drawings (not necessarily drawn to scale) depict selected embodiments and are not intended to limit the scope of the invention. The principles of the invention are illustrated by way of example rather than limitation. This description will clearly enable those skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including those currently believed to be the best mode for carrying out the invention.

[0019] As used herein, the term “about” or “approximately” for any numerical value or range indicates appropriate dimensional tolerances that allow a collection of parts or components to achieve the intended purpose as described herein. More specifically, “about” or “approximately” can refer to a range of ±20% of the enumerated value, for example, “about 90%” can refer to a range of 70% to 110% of the value.

[0020] In addition, as used herein, the terms “patient,” “recipient,” “user,” and “subject” refer to any human or animal subject and are not intended to limit the system or method to human use, but the use of the subject matter invention in human patients represents a preferred embodiment. Similarly, the term “proximal” refers to a position closer to the operator or physician, while “distal” refers to a position further away from the operator or physician.

[0021] As discussed herein, the vascular system of the “patient,” “recipient,” “user,” and “subject” can be that of a human or any animal. It should be understood that the animal can be any applicable type, including but not limited to mammals, veterinary animals, livestock, or pets. For example, the animal can be a laboratory animal specifically selected to possess certain characteristics similar to humans (e.g., rats, dogs, pigs, monkeys, etc.). It should be understood that the subject can be, for example, any applicable human patient.

[0022] As discussed in this article, “physician” may include doctors, surgeons, technicians, scientists, operators, or any other individual or delivery device associated with the delivery of a multi-electrode catheter for the treatment of drug-resistant atrial fibrillation to a patient.

[0023] As discussed herein, when referring to the apparatus and corresponding systems of this disclosure, the term "ablation" refers to a component and structural feature configured to reduce or prevent the generation of unstable cardiac signals in cells by utilizing non-thermal energy (such as irreversible electroporation (IRE)), which are interchangeably referred to in this disclosure as pulsed electric field (PEF) and pulsed field ablation (PFA). Throughout this disclosure, "ablation," when referring to the apparatus and corresponding systems of this disclosure, means non-thermal ablation of cardiac tissue for certain conditions, including but not limited to ablation for arrhythmias, atrial flutter, pulmonary vein isolation, supraventricular tachycardia, and ventricular tachycardia. The term "ablation" also includes known methods, apparatus, and systems for achieving various forms of body tissue ablation as understood by those skilled in the art.

[0024] The medical probes described herein may include electrodes configured to map electrophysiological signals propagating through tissue and / or deliver ablation energy to tissue. For example, the electrodes may be configured to deliver ablation energy to tissue using techniques such as bipolar or monopolar ablation employing biphasic or monophasic signals, as well as thermal ablation techniques. As discussed herein, the terms “bipolar” and “monopolar” describe different ablation schemes in terms of current path and electric field distribution when used to refer to ablation schemes. “Bipolar” refers to an ablation scheme utilizing a current path between two electrodes, both positioned at the treatment site; the current density and flux density at each of the two electrodes are generally approximately equal. “Monopolar” refers to an ablation scheme utilizing a current path between two electrodes, wherein one electrode with a high current density and high flux density is positioned at the treatment site, and a second electrode with a relatively low current density and lower flux density is positioned away from the treatment site.

[0025] As discussed herein, the terms "biphase pulse" and "single-phase pulse" refer to the corresponding electrical signals. A "biphase pulse" refers to an electrical signal having a positive voltage phase pulse (referred to herein as "positive phase") and a negative voltage phase pulse (referred to herein as "negative phase"). A "single-phase pulse" refers to an electrical signal having only a positive phase or only a negative phase. Preferably, the system providing the biphase pulse is configured to prevent the application of a direct current (DC) voltage to the patient. For example, the average voltage of the biphase pulse may be zero volts relative to ground or other common reference voltage. Additionally or alternatively, the system may include capacitors or other protective components. The voltage amplitudes of the biphase and / or single-phase pulses are described herein; it should be understood that the expressed voltage amplitudes are the absolute values ​​of the approximate peak amplitudes of each of the positive and / or negative voltage phases. Each phase of the biphase and single-phase pulses preferably has a square shape and a substantially constant voltage amplitude for most of the phase duration. The phases of the biphase pulse are temporally separated by an interphase delay. The duration of the interphase delay is preferably less than or approximately equal to the duration of a phase of the biphase pulse. The interphase delay duration is more preferably about 25% of the phase duration of the biphase pulse.

[0026] As discussed herein, the terms “tubular” and “tube” should be interpreted broadly and are not limited to structures that are perfectly cylindrical or have a perfectly circular cross-section or a uniform cross-section over their entire length. For example, tubular structures are generally exemplified as structures that are substantially cylindrical. However, without departing from the scope of this disclosure, tubular structures may have tapered or curved outer surfaces.

[0027] This disclosure relates to systems, methods, or uses, and devices that can be used to perform IRE ablation of cardiac tissue to treat arrhythmias. Ablation energy is typically delivered to the cardiac tissue by electrodes on an end effector of a catheter that can deliver ablation energy along the tissue to be ablated. Some example catheters include a three-dimensional structure at their distal portion and are configured to apply ablation energy from various electrodes positioned on the three-dimensional structure. Fluoroscopy can be used to visualize ablation procedures incorporating such example catheters.

[0028] The use of thermal techniques such as radiofrequency (RF) energy and cryoablation to correct faulty heart tissue ablation is a well-known procedure. Typically, for successful ablation using thermal techniques, cardiac electrode potentials need to be measured at various locations in the myocardium. Furthermore, temperature measurements during ablation provide data that enable the ablation to be effective. Generally, for ablation procedures using thermal ablation, electrode potentials and temperatures are measured before, during, and after the actual ablation. RF methods can carry risks that may include tissue charring, burns, vapor bursts, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistula. Cryoablation is an alternative to RF ablation, reducing some of the thermal risks associated with it. However, manipulating cryoablation devices and selectively applying cryoablation is generally more challenging than with RF ablation; therefore, cryoablation is not feasible in certain anatomical geometries that can be reached by electroablation devices.

[0029] This disclosure may include electrodes configured for RF ablation, cryoablation, and / or irreversible electroporation (IRE). Throughout this disclosure, IRE is interchangeably referred to as pulsed electric field (PEF) ablation and pulsed field ablation (PFA). IRE, as discussed in this disclosure, is a non-thermal cell death technique that can be used for ablation of atrial arrhythmias. To perform ablation using IRE / PEF, a biphasic voltage pulse is applied to disrupt the cellular structures of the myocardium. The biphasic pulse is non-sinusoidal and can be tuned to target cells based on the electrophysiology of the cells. In contrast, to perform ablation using RF, a sinusoidal voltage waveform is applied to generate heat at the treatment area, indiscriminately heating all cells in the treatment area. Therefore, IRE has the ability to avoid adjacent heat-sensitive structures or tissues, which will be beneficial in reducing potential complications known to be affected by ablation or dissociation modes. In addition to or alternatively, monophasic pulses may be used.

[0030] Electroporation can be induced by applying a pulsed electric field across biological cells, resulting in either reversible (temporary) or irreversible (permanent) pores in the cell membrane. When a pulsed electric field is applied, the cell possesses a transmembrane electrostatic potential that rises above its resting potential. Electroporation is reversible when the transmembrane electrostatic potential remains below a threshold potential, meaning the pore closes when the applied pulsed electric field is removed, and the cell can repair itself and survive. If the transmembrane electrostatic potential rises above the threshold potential, electroporation is irreversible, and the cell becomes permanently permeable. Therefore, the cell dies due to the loss of homeostasis, typically via apoptosis. Generally, different cell types have different threshold potentials. For example, heart cells have a threshold potential of approximately 500 V / cm, while bone cells have a threshold potential of 3000 V / cm. These differences in threshold potentials allow IREs to selectively target tissues based on the threshold potential.

[0031] This disclosure includes systems and methods for applying electrical signals from catheter electrodes positioned near myocardial tissue to generate ablation energy to ablate the myocardial tissue. In some examples, the system and method can effectively ablate target tissue by inducing irreversible electroporation. In some examples, the system and method can effectively induce reversible electroporation as part of a diagnostic procedure. Reversible electroporation occurs when the electricity applied using the electrodes is below the electric field threshold of the target tissue that allows for cell repair. Reversible electroporation does not kill cells but allows physicians to observe the effect of reversible electroporation on electrical activation signals near the target site. Example systems and methods for reversible electroporation are disclosed in U.S. Patent Publication 2021 / 0162210, the entire contents of which are incorporated herein by reference.

[0032] The effectiveness of pulsed electric fields in inducing reversible and / or irreversible electroporation can be influenced by the system's physical parameters and the biphasic pulse parameters of the electrical signal. Physical parameters may include electrode contact area, electrode spacing, electrode geometry, etc. The examples presented herein generally include physical parameters suitable for effectively inducing reversible and / or irreversible electroporation. The biphasic pulse parameters of the electrical signal may include voltage amplitude, pulse duration, pulse-to-phase delay, pulse-to-pulse delay, total application time, delivered energy, etc. In some examples, the parameters of the electrical signal can be adjusted to induce both reversible and irreversible electroporation given the same physical parameters. Examples of various ablation systems and methods, including IRE, are presented in U.S. Patent Publications 2021 / 0169550A1, 2021 / 0169567A1, 2021 / 0169568A1, 2021 / 0161592A1, 2021 / 0196372A1, 2021 / 0177503A1, and 2021 / 0186604A1, the entire contents of each of which are incorporated herein by reference.

[0033] refer to Figure 1 This document illustrates an example catheter-based electrophysiological mapping and ablation system 10. System 10 includes multiple catheters inserted by a physician 24 through the skin into the chambers or vascular structures of the heart 12 via the patient's vascular system 23. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location within the heart 12. Multiple catheters can then be inserted into the delivery sheath catheter to reach that desired location. These multiple 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 example catheter 14 configured for sensing and ablation is illustrated herein. The physician 24 contacts the distal end 28 of catheter 14 (sometimes referred to herein as a basket catheter, basket assembly, expandable basket assembly, and / or end effector) against the heart wall for sensing a target site within the heart 12.

[0034] The catheter 14 is an exemplary catheter that includes one, and preferably multiple, electrodes 100 optionally distributed above multiple ridges 22 at the distal end 28 and configured to sense IEGM signals and / or deliver ablation energy to tissue. The catheter 14 may additionally include a position sensor 29 embedded in or near the distal end 28 for tracking the position and orientation of the distal end 28. Optionally and preferably, the position sensor 29 is a magnetically based position sensor comprising three magnetic coils for sensing three-dimensional (3D) position and orientation.

[0035] The magnetic-based position sensor 29 operates in conjunction with a positioning pad 25, which includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predetermined workspace. The real-time position of the distal end 28 of the conduit 14 can be tracked based on the magnetic field generated by the positioning pad 25 and sensed by the magnetic-based position sensor 29. Details of the magnetic-based position sensing technology are described in U.S. Patents 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, the entire contents of each of which are incorporated herein by reference.

[0036] System 10 includes one or more electrode patches 38 positioned to contact the skin of patient 23 to establish a position reference for impedance-based tracking of positioning pad 25 and electrode 100. For impedance-based tracking, current is directed toward electrode 100 and sensed at the electrode skin patch 38, allowing triangulation of the position of each electrode via the electrode patch 38. Details of the impedance-based position tracking technique are described in U.S. Patents 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, the entire contents of each of which are incorporated herein by reference.

[0037] Recorder 11 displays an electrogram 21 captured using surface ECG electrodes 18 and an intracardiac electrogram (IEGM) captured using electrodes 100 of catheter 14. Recorder 11 may include pacing capability for pacing rhythms and / or may be electrically connected to a separate pacemaker.

[0038] System 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes at the distal end of a catheter configured for ablation. 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 can be used to achieve irreversible electroporation (IRE), or combinations thereof.

[0039] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between catheters, electrophysiological equipment, a power supply, and a workstation 55 for operating the system 10. The electrophysiological equipment of the system 10 may include, for example, multiple catheters, positioning pads 25, surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, the PIU 30 further includes processing capabilities for real-time calculation of catheter position and for performing ECG calculations.

[0040] Workstation 55 includes a memory, a processor unit with a memory or storage device loaded with appropriate operating software, and user interaction capabilities. Workstation 55 may provide several functions, optionally including: (1) three-dimensional (3D) modeling of the endocardial anatomy and rendering the model or anatomical mapping 20 for display on display device 27; (2) displaying on display device 27 a representative visual marker or image superimposed on the rendered anatomical mapping 20 to show activation sequences (or other data) compiled from the recorded electrogram 21; (3) displaying the real-time position and orientation of multiple catheters within the cardiac chambers; and (4) displaying on display device 27 sites of interest, such as where ablation energy has been applied. An example of an element embodying system 10 could be CARTO. TM The system was purchased from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0041] Figure 2 This is a schematic diagram showing a perspective view of a basket catheter 28, in which the ridge 22 and electrode 100 are positioned in an expanded form, such as by being pushed out of a sheath (not shown). Figure 2 As shown, the basket catheter 28 may include a plurality of ridges 22 that are radially outwardly curved from the longitudinal axis 86 when in an expanded form. The ridges 22 may be formed of a biocompatible elastic material (such as nitinol) such that the ridges 22 are naturally biased to expand outward into an expanded form.

[0042] Each ridge 22 may include one or more electrodes 100 attached thereto. Electrodes 100 may be configured such that they can be aligned with or misaligned with electrodes 100 on adjacent ridges 22. Electrodes 100 may be configured such that they fold together in a tight configuration when retracted into a sheath. The electrodes 100 described herein may be configured for mapping electrophysiological signals through tissue and / or ablating tissue.

[0043] The ridge 22 may have an elliptical (e.g., circular) or rectangular (may be flat) cross-section and comprises a flexible, elastic material forming the ridge 22 (e.g., a shape memory alloy, such as nitinol, also known as nickel-titanium alloy, or other materials such as cobalt-chromium, stainless steel, titanium, or even polymer materials). The disclosed technique can be applied to a basket conduit 28 formed by a single ridge 22 or multiple ridges 22, wherein each ridge 22 is attached at both ends.

[0044] The ridge 22 may be formed from a single sheet of planar material. In some examples, the ridge 22 may be formed from a single sheet of planar material such that the ridge 22 converges toward a central intersection. In other examples, the ridge 22 may be formed separately and then attached at both ends, as shown and just described.

[0045] As will be understood, the ridge 22 may be electrically isolated from the electrode 100 to prevent arcing from the electrode 100 to the ridge 22. For example, an insulating sheath (not shown) may be provided between the ridge 22 and the electrode 100, but those skilled in the art will understand that other insulating coverings are also conceivable. For example, an insulating coating may be applied to the ridge 22, the electrode 100, or both. The insulating sheath may be made of biocompatible, electrically insulating materials such as polyamide-polyether (Pebax) copolymers, polyethylene terephthalate (PET), polyurethane, polyimide, parylene, silicone, etc. In some examples, the insulating material may include biocompatible polymers, including but not limited to: polyetheretherketone (PEEK), polyglycolic acid (PGA), poly(lactic-co-glycolic acid) copolymer (PLGA), polycaprolactone (PCL), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), poly-L-lactide, polydioxanone, polycarbonate, and polyanhydride, wherein the proportions of certain polymers are selected to control the degree of inflammatory response. The insulating sheath may also include one or more additives or fillers, such as, for example, polytetrafluoroethylene (PTFE), boron nitride, silicon nitride, silicon carbide, alumina, aluminum nitride, zinc oxide, etc.

[0046] Figure 3This is a perspective view of electrode 100 according to the disclosed technology. Electrode 100 may include a body 102 extending along a longitudinal axis 104 from a proximal end 106 to a distal end 106. Electrode 100 may be formed in various shapes, sizes, and configurations depending on the specific application. As shown, electrode 100 may define a lumen 110 extending along the longitudinal axis 104 through body 102. Lumen 110 may be configured to receive a ridge 22 of basket conduit 28, such that electrode 100 can slide along and be secured to ridge 22.

[0047] Electrode 100 may include an inward-facing surface 112 and a tissue-facing surface 114. For example, electrode 100 may be configured such that when electrode 100 is attached to ridge 22, the inward-facing surface 112 may be the surface of electrode 100 facing inward toward the central portion of basket assembly 28, while the tissue-facing surface 114 may be the surface of electrode 100 facing outward from basket assembly 28, such that the tissue-facing surface 114 is configured to contact tissue when deployed in patient 23. To help ensure that basket assembly 28 is non-invasive, electrode 100 may include rounded edges 116 (non-invasive edges) at least on the surfaces that may contact tissue. As will be described in more detail herein, rounded edges 116 may be formed, for example, by tumbling, sanding, filing, deburring, sandblasting, or other methods of rounding the edges of electrode 100.

[0048] All or some of the electrodes in electrode 100 may comprise conductive materials. For example, all electrodes 100 may be made entirely of gold, silver, platinum, palladium, stainless steel (and their respective alloys). Alternatively, only a portion of electrode 100 (e.g., tissue-facing surface 114) may be made of the materials just listed. These materials also have high thermal conductivity, which allows minimal heat generated on the tissue (i.e., by the ablation energy delivered to the tissue) to be conducted through electrode 100 to the back surface of electrode 100 (i.e., the inward-facing surface 112), and then to the blood pool in heart 12. The electrodes may be configured to deliver electrical pulses having a peak voltage of at least 900 volts (V).

[0049] Electrode 100 may include one or more end recesses 118, one end recess being located near a proximal end 106 and another end recess being located near a distal end 108. The end recesses 118 may be positioned along a longitudinal axis 104 and aligned with a lumen 110 extending through the body 102. The end recesses 118 may be configured to receive at least a portion (relative to) an adhesive 200 positioned above the electrode 100 and the ridge 22. Figure 6(Described in more detail). The end recess 118 can help provide more surface area for the adhesive to adhere to the electrode 100. The end recess 118 can help prevent the electrode 100 from rotating about the longitudinal axis 104, thereby helping to ensure that the tissue-facing surface 114 is properly positioned to contact the tissue. In other words, the end recess 118 can be configured to receive at least a portion of the adhesive 200 and partially interlock with the adhesive 200, thereby acting as a mechanical lock to prevent the electrode 100 from rotating about the longitudinal axis 104. Additionally or alternatively, the end recess 118 can also be configured to receive one or more wires, such that the wires can be adhered or soldered in place.

[0050] Electrode 100 may also include one or more recesses 120 located at a proximal end 106 and a distal end 108, at least partially on electrode 100 between tissue-facing surface 114 and lumen 110. Figure 4A It is a side view of electrode 100 based on the disclosed technology, and Figure 4B yes Figure 4A A detailed view of electrode 100 is shown. As illustrated, recess 120 may include a first gap distance 122 and a second gap distance 124, the first gap distance being closest to the outer portion of recess 120 and the second gap distance being located at the inner portion of recess 120. The second gap distance 124 may be greater than the first gap distance 122. That is, a first portion of recess 120 may extend into the body 102 of electrode 100 to a first depth having the first gap distance 122, and a second portion of recess 120 may extend from the end of the first portion into the body 102 to a second depth having a second gap distance 124 greater than the first gap distance 122. In this way, recess 120 may be configured to receive adhesive 200 when adhesive 200 is in a fluid (or semi-fluid) state, and then prevent adhesive 200 from being removed from recess 120 once cured. That is, once adhesive 200 becomes a solid material, adhesive 200 in the second portion having the second gap distance 124 will not be pulled back through the first portion having the smaller first gap distance 122. In other words, the adhesive 200 can form a bayonet connection with the electrode 100 via the recess 120 to help ensure that the electrode 100 is fixed to the ridge 22.

[0051] Figure 5 It is an end view of electrode 100 based on the disclosed technology, and Figure 6 yes Figure 5 A cross-sectional view of electrode 100 taken along line AA. (See diagram below.) Figure 5As shown, electrode 100 may include a circular profile, which further facilitates the formation of a non-invasive shape. In some examples, the tissue-facing surface 114 may have a smaller surface area than the inward-facing surface 112, while in other examples, the tissue-facing surface 114 may have a larger surface area or an equal surface area compared to the inward-facing surface 112.

[0052] like Figure 6 As shown more clearly, adhesive 200 may be at least partially disposed above electrode 100 and ridge 22 to secure electrode 100 to ridge 22. Recess 120 may be configured to receive at least a portion of adhesive 200, thereby preventing adhesive 200 from delaminating from electrode 100. As shown, adhesive 200 may be present on top, bottom, and sides (…). Figure 6 (Not visible in the middle) Extends around the ridge 22 and the electrode 100 to help secure the electrode 100 to the ridge 22. In this way, the adhesive 200 can be at least partially disposed in the recess 120 and the end recess 118.

[0053] The adhesive 200 may be a non-conductive material, initially in liquid or non-solid form, and then curing into a solid or semi-solid form to secure the electrode 100 to the ridge 22. In this way, the adhesive 200 can flow into the recess 120 during installation and then be allowed to cure, preventing the adhesive 200 from delaminating from the electrode 100 or otherwise becoming unattached to the electrode 100. The adhesive 200 may be a polymeric material or other biocompatible adhesive, and may be a natural curing adhesive, a light-curing adhesive, a thermosetting adhesive (including thermosetting silicone adhesives), a UV-curing adhesive, a cyanoacrylate adhesive, acrylic, epoxy resin, polymethyl methacrylate (PMMA), fibroin, polyurethane adhesive, reflow polymers (such as polyurethane, polyetheretherketone (PEEK), or polyethylene terephthalate (PET)), or other suitable types of adhesives.

[0054] Figure 7 This is a flowchart illustrating a method 700 for manufacturing a medical probe according to the disclosed technology. Method 700 may include forming a lumen 702 extending through the body of the electrode from a proximal end to a distal end. Method 700 may include forming a first recess 704 on the proximal end of the electrode and a second recess 706 on the distal end of the electrode. The first and second recesses may include a first portion and a second portion of a recess 120 as described in more detail herein.

[0055] Method 700 may further include tumbling the electrode 708 to form a non-traumatic edge along the body of the electrode, and then inserting a ridge 710 through a lumen of the electrode. Method 700 may include disposing a non-conductive material (e.g., an adhesive as described more fully herein) at least partially above the ridge 712 and at least partially above the electrode. The non-conductive material may extend into the first and second recesses, and is described more fully herein. In this way, the electrode 100 can be secured to the ridge and prevent slippage along the length of the ridge.

[0056] The disclosed technology described herein can be further understood in accordance with the following terms:

[0057] Clause 1: An electrode for a medical probe, the electrode comprising: a body extending along a longitudinal axis from a proximal end to a distal end, the body defining: a tissue-facing surface; a lumen extending along the longitudinal axis from the proximal end to the distal end through the body; and one or more recesses extending through the body, transverse to the longitudinal axis of the body, the one or more recesses disposed between the tissue-facing surface and the lumen, and defining: a first portion extending to a first depth in the body, the first portion including a first gap distance; and a second portion extending from the first portion to a second depth in the body, the second portion including a second gap distance greater than the first gap distance.

[0058] Clause 2: The lumen is configured to receive the ridge of the medical probe according to the electrode described in Clause 1.

[0059] Clause 3: The electrode according to any one of the preceding clauses, wherein the one or more recesses are configured to receive non-conductive material disposed at least partially above the ridge and the electrode.

[0060] Clause 4: For the electrode according to any one of the preceding clauses, the body further defines an inward-facing surface, and the one or more recesses are positioned closer to the tissue-facing surface rather than the inward-facing surface.

[0061] Clause 5: The electrode according to Clause 4, wherein the one or more recesses include a first recess and a second recess, the first recess being configured to be closest to the distal end of the body, and the second recess being configured to be closest to the proximal end of the body.

[0062] Clause 6: For the electrodes pursuant to any of the preceding clauses, the body further defines one or more non-traumatic edges.

[0063] Clause 7: The electrode according to any one of the preceding clauses, wherein the tissue-facing surface is configured to deliver ablation energy to the tissue.

[0064] Clause 8: The medical probe according to Clause 7, wherein the tissue-facing surface is configured to deliver an electrical pulse for irreversible electroporation, the pulse having a peak voltage of at least 900 volts (V).

[0065] Clause 9: A medical probe comprising: a tubular shaft including a proximal end and a distal end, the tubular shaft extending along a longitudinal axis of the tubular shaft; and an expandable basket assembly coupled to the distal end of the tubular shaft, the expandable basket assembly including: a plurality of ridges coupled to the tubular shaft and configured to bend radially outward from the longitudinal axis of the tubular shaft; and a plurality of electrodes disposed on the plurality of ridges, each of the plurality of electrodes including: a body extending along a longitudinal axis of the body from the proximal end of the body to the distal end of the tubular shaft. At a lateral end, the body defines: a tissue-facing surface; a lumen extending through the body from the proximal end to the distal end; and one or more recesses disposed between the tissue-facing surface and the lumen, transverse to the longitudinal axis of the body, the one or more recesses defining: a first portion extending to a first depth in the body, the first portion including a first gap distance; and a second portion extending from the first portion to a second depth in the body, the second portion including a second gap distance greater than the first gap distance.

[0066] Clause 10: The medical probe according to Clause 9, wherein the lumen is configured to receive a corresponding ridge among the plurality of ridges.

[0067] Clause 11: A medical probe according to any one of Clauses 9 or 10, wherein the one or more recesses are configured to receive non-conductive material disposed at least partially above a respective ridge of the electrodes and the plurality of ridges to secure the electrodes to the respective ridges.

[0068] Clause 12: In any one of Clauses 9 to 11, the body of each of the plurality of electrodes further defines an inward-facing surface, wherein the one or more recesses are positioned closer to the tissue-facing surface than the inward-facing surface.

[0069] Clause 13: The medical probe according to Clause 12, wherein the inward-facing surface is configured to face the inner portion of the expandable basket assembly when the plurality of electrodes are disposed on the plurality of ridges.

[0070] Clause 14: The medical probe according to Clause 13, wherein the tissue-facing surface is configured to face outward from the inner portion of the expandable basket assembly to contact the tissue.

[0071] Clause 15: The medical probe according to any one of Clauses 9 to 14, wherein the one or more recesses include a first recess and a second recess, the first recess being configured to be closest to the distal end of the body, and the second recess being configured to be closest to the proximal end of the body.

[0072] Clause 16: For any medical probe according to any one of Clauses 9 to 15, the body of each of the plurality of electrodes further defines one or more non-invasive edges.

[0073] Clause 17: A medical probe according to any one of Clauses 9 to 16, wherein each of the plurality of electrodes is configured to deliver ablation energy to tissue.

[0074] Clause 18: A medical probe according to any one of Clauses 9 to 17, wherein the plurality of electrodes are configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).

[0075] Clause 19: A method of manufacturing an electrode for a medical probe, the method comprising: forming a lumen through a body of the electrode, the lumen extending along a longitudinal axis from a proximal end to a distal end; and forming one or more recesses extending along the body transverse to the longitudinal axis, the one or more recesses defining: a first portion extending to a first depth in the body, the first portion including a first gap distance; and a second portion extending from the first portion to a second depth in the body, the second portion including a second gap distance greater than the first gap distance.

[0076] Clause 20: The method according to Clause 19 further includes: rolling the electrode to form a non-traumatic edge.

[0077] The above embodiments are cited by way of example, and the invention is not limited to the specific examples shown and described above. Rather, the scope of the invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereof, which will occur to those skilled in the art upon reading the above description and are not disclosed in the prior art.

Claims

1. An electrode for a medical probe, the electrode comprising: The body, extending along a longitudinal axis from the proximal end to the distal end, defines: The surface facing the organization; A lumen extending through the body along the longitudinal axis from the proximal end to the distal end; and One or more recesses extending through the body, transverse to the longitudinal axis of the body, the one or more recesses being disposed between the tissue-facing surface and the lumen, and defining: A first portion extends into the body to a first depth, the first portion including a first gap distance; and The second part extends from the first part to a second depth in the body, and the second part includes a second gap distance that is greater than the first gap distance.

2. The electrode of claim 1, wherein the lumen is configured to receive the ridge of the medical probe.

3. The electrode of claim 2, wherein the one or more recesses are configured to receive non-conductive material at least partially disposed above the ridge and the electrode.

4. The electrode of claim 1, wherein the body further defines an inward-facing surface, and the one or more recesses are positioned closer to the tissue-facing surface than the inward-facing surface.

5. The electrode according to claim 4, wherein the one or more recesses include a first recess and a second recess, the first recess being configured to be closest to the distal end of the body, and the second recess being configured to be closest to the proximal end of the body.

6. The electrode of claim 1, wherein the body further defines one or more non-traumatic edges.

7. The electrode of claim 1, wherein the tissue-facing surface is configured to deliver ablation energy to the tissue.

8. The medical probe of claim 7, wherein the tissue-facing surface is configured to deliver an electrical pulse for irreversible electroporation, the pulse having a peak voltage of at least 900 volts (V).

9. A medical probe, comprising: A tubular shaft, the tubular shaft including a proximal end and a distal end, the tubular shaft extending along the longitudinal axis of the tubular shaft; and An expandable basket assembly, the expandable basket assembly being coupled to the distal end of the tubular shaft, the expandable basket assembly comprising: A plurality of ridges, the plurality of ridges being coupled to the tubular shaft and configured to bend radially outward from the longitudinal axis of the tubular shaft; and Multiple electrodes are disposed on the multiple ridges, each of the multiple electrodes comprising: A body extending from a proximal end to a distal end along a longitudinal axis of the body, the body defining: a tissue-facing surface; a lumen extending through the body from the proximal end to the distal end; and one or more recesses disposed between the tissue-facing surface and the lumen, transverse to the longitudinal axis of the body, the one or more recesses defining: A first portion, extending to a first depth within the body, the first portion including a first gap distance; and The second part extends from the first part to a second depth in the body, and the second part includes a second gap distance that is greater than the first gap distance.

10. The medical probe of claim 9, wherein the lumen is configured to receive a corresponding ridge among the plurality of ridges.

11. The medical probe of claim 9, wherein the one or more recesses are configured to receive non-conductive material at least partially disposed above a respective ridge of the electrode and the plurality of ridges to secure the electrode to the respective ridge.

12. The medical probe of claim 9, wherein the body of each of the plurality of electrodes further defines an inward-facing surface, and the one or more recesses are positioned closer to the tissue-facing surface than to the inward-facing surface.

13. The medical probe of claim 12, wherein the inward-facing surface is configured to face the inner portion of the expandable basket assembly when the plurality of electrodes are disposed on the plurality of ridges.

14. The medical probe of claim 13, wherein the tissue-facing surface is configured to face outward from the inner portion of the expandable basket assembly to contact the tissue.

15. The medical probe of claim 9, wherein the one or more recesses include a first recess and a second recess, the first recess being configured to be closest to the distal end of the body, and the second recess being configured to be closest to the proximal end of the body.

16. The medical probe of claim 9, wherein the body of each of the plurality of electrodes further defines one or more non-invasive edges.

17. The medical probe of claim 9, wherein each of the plurality of electrodes is configured to deliver ablation energy to tissue.

18. The medical probe of claim 9, wherein the plurality of electrodes are configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).

19. A method of manufacturing an electrode for a medical probe, the method comprising: A lumen is formed through the body of the electrode, the lumen extending along a longitudinal axis from the proximal end to the distal end; as well as One or more recesses are formed, the one or more recesses extending along the body and transverse to the longitudinal axis, the one or more recesses defining: The first part extends into the body at a first depth, the... The first part includes the first gap distance; and The second part extends from the first part to a second depth in the body, and the second part includes a second gap distance that is greater than the first gap distance.

20. The method of claim 19, further comprising: The electrode is rolled to form a non-traumatic edge.

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