Flexible circuit electrodes for lasso catheter

Abstract

To provide an electrode assembly for a medical device.SOLUTION: An electrode assembly for a medical device can include a flexible substrate extending along a plane with a plurality of electrical leads extending along at least a portion of the flexible substrate. The electrode assembly can further include a plurality of electrodes disposed on the flexible substrate. Each electrode of the plurality of electrodes can be electrically connected to at least one electrical lead of the plurality of electrical leads. The plurality of electrodes can be positioned on the flexible substrate so that when the electrode assembly is wrapped around an end effector member wrapped about a longitudinal axis to define a lasso catheter, at least some of the electrodes of the plurality of electrodes are positioned on a side of a lasso catheter facing away from the longitudinal axis extending through a lasso catheter.SELECTED DRAWING: Figure 2A

Description

[Technical field]

[0001] The present invention relates generally to medical devices, and more particularly to a lasso catheter having improved flexibility and electrode placement. [Background technology]

[0002] Cardiac arrhythmias, such as atrial fibrillation (AF), occur when an area of ​​cardiac tissue abnormally conducts electrical signals to adjacent tissue. This disrupts the normal cardiac cycle and causes asynchronous rhythms. Certain procedures that exist to treat arrhythmias include surgically destroying the source of the signals that cause the arrhythmia and destroying the conduction pathways of such signals. Electrical signals propagating through the heart can be mapped using a mapping catheter, and then only selected areas of tissue can be ablated to treat AF. By selectively ablating cardiac tissue with the application of energy through a catheter, it is sometimes possible to stop or change the propagation of undesired electrical signals from one part of the heart to another. Medical probes may utilize radiofrequency (RF) electrical energy to heat tissue. Some ablation approaches use irreversible electroporation (IRE) to ablate cardiac tissue using non-thermal ablation methods.

[0003] Pulmonary vein isolation is a commonly used procedure to treat AF. Physicians typically use lasso catheters with multiple ring electrodes clamped or otherwise attached to the spine of the lasso catheter. However, these ring electrodes are not configured to simultaneously measure the electroanatomical signals of the tissue and the electrical signals propagated through the surrounding blood, which can reduce the effectiveness of the mapping operation and lead to an unnecessary increase in the total procedure time. Furthermore, assembling the ring electrodes on the lasso catheter can be a difficult and time-consuming process, thereby increasing the overall cost of the lasso catheter. Thus, there is a need in the art for a device that can perform multiple functions simultaneously and is configured to reduce the total procedure time by completing multiple elements of the mapping procedure with a single device that is applicable to a range of sizes. These and other problems can be addressed by the techniques disclosed herein. Summary of the Invention [Means for solving the problem]

[0004] The disclosed technology includes an electrode assembly for a medical device. The electrode assembly can include a flexible substrate extending along a plane. The electrode assembly can further include a plurality of electrical leads extending along at least a portion of the flexible substrate. The electrode assembly can further include a plurality of electrodes disposed on the flexible substrate. Each electrode of the plurality of electrodes can be electrically connected to at least one electrical lead of the plurality of electrical leads. The plurality of electrodes can be disposed on the flexible substrate such that when the electrode assembly is wrapped around an end effector member wrapped about a longitudinal axis to define a lasso catheter, at least some of the electrodes of the plurality of electrodes are disposed on a side of the lasso catheter facing away from a longitudinal axis extending through the lasso catheter.

[0005] The disclosed techniques may include a medical probe including an insertion tube extending along a longitudinal axis. The medical probe may further include an end effector disposed at a distal end of the insertion tube. The end effector may be configured to bend radially outward from the longitudinal axis generally perpendicular to the longitudinal axis. The end effector may include a spine member and an electrode assembly disposed along at least a portion of the spine member. The electrode assembly may include a flexible substrate and a plurality of electrical leads extending along at least a portion of the flexible substrate. The electrode assembly may further include a plurality of electrodes disposed on the flexible substrate. Each electrode of the plurality of electrodes may be electrically connected to at least one electrical lead of the plurality of electrical leads. The plurality of electrodes may be wrapped around the spine member. At least some of the electrodes of the plurality of electrodes may be positioned facing away from the longitudinal axis.

[0006] The disclosed technology may further include a method of manufacturing a medical probe. The method may include forming a spine into a generally circular shape. The method may further include helically winding an electrode assembly around the spine. The electrode assembly may include a flexible substrate and a plurality of electrical leads extending along at least a portion of the flexible substrate. The electrode assembly may further include a plurality of electrodes disposed on the flexible substrate. Each electrode of the plurality of electrodes may be electrically connected to at least one electrical lead of the plurality of electrical leads. The plurality of electrodes may be disposed on the flexible substrate such that when the electrode assembly is helically wound around the spine, at least some of the electrodes of the plurality of electrodes may be positioned facing away from an axis of the generally circular shape. These and other advantages of the disclosed technology will become more apparent throughout this disclosure in conjunction with the drawings. [Brief description of the drawings]

[0007] [Figure 1]1 is a schematic, pictorial illustration of a medical system including a medical probe having an end effector with electrodes, in accordance with some embodiments of the disclosed technology; [Figure 2A] FIG. 13 is a bottom perspective view of an end effector for a medical probe in accordance with the disclosed technology; [Figure 2B] FIG. 1 is a top perspective view of an end effector for a medical probe in accordance with the disclosed technology; [Figure 2C] FIG. 1 is a side view of an end effector for a medical probe in accordance with the disclosed technology. [Figure 2D] FIG. 1 is a top view of an end effector for a medical probe in accordance with the disclosed technology; [Diagram 3] FIG. 13 is a side view of a spine member encased within a flexible substrate in accordance with the techniques of the present disclosure. [Figure 4] 4 is a cross-sectional view of a spine member of a medical probe according to the disclosed technology taken along line XX of FIG. 3. [Figure 5A] FIG. 2 is a top view of a flexible substrate having multiple electrodes in accordance with the techniques of the present disclosure. [Figure 5B] FIG. 5B is a side view of a spine member encased in a flexible substrate as illustrated in FIG. 5A in accordance with the techniques of the present disclosure. [Figure 6A] FIG. 13 is a top view of an additional embodiment of a flexible substrate having multiple electrodes in accordance with the techniques of the present disclosure. [Figure 6B] FIG. 6B is a side view of a spine member encased within a flexible substrate as illustrated in FIG. 6A in accordance with the techniques of the present disclosure. [Figure 7A] FIG. 13 is a detailed view of a spine member encased within an insulating sleeve in accordance with the techniques of the present disclosure. [Figure 7B] FIG. 13 is a detailed view of a spine member encased within an insulating sleeve in accordance with the techniques of the present disclosure. [Figure 8] 1 is a flow chart of a method for manufacturing a medical probe in accordance with the techniques of this disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] The disclosed technology includes electrodes disposed on a flexible substrate that can replace the conventional ring electrodes employed in lasso catheters. The disclosed technology can help ensure that contact is maintained between at least one electrode disposed on a medical probe and a target tissue during mapping of electroanatomical signals in the pulmonary veins. Furthermore, the disclosed technology can help ensure that at least one electrode does not contact tissue but is in electrical communication with the surrounding blood to obtain a reference signal that can be used to eliminate noise that may be detected during the mapping procedure. As a result, the accuracy of the mapping procedure can be increased and the overall time required to complete a pulmonary vein isolation procedure can be reduced. Furthermore, the disclosed technology can help simplify the process of manufacturing a lasso catheter, thereby reducing the overall cost of the lasso catheter.

[0009] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates, by way of example, but not by way of limitation, the principles of the invention. The description clearly enables one skilled in the art to make and use the invention and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is currently contemplated to be the best mode for carrying out the invention.

[0010] As used herein, the term "about" or "approximately" in relation to any numerical value or range indicates a suitable dimensional tolerance that enables a portion or collection of components to function for the intended purpose described herein. More specifically, "about" or "approximately" may refer to a range of values ​​of ±20% of the recited value. For example, "about 90%" may refer to a range of values ​​of 71% to 110%.

[0011] As used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject and are not intended to limit the use of the system or method to humans, although the use of the present invention in a human patient represents a preferred embodiment. In addition, the vasculature of the "patient," "host," "user," and "subject" may be that of any human or animal. It should be understood that the animal may be of any of a variety of applicable types, including, but not limited to, mammals, veterinary animals, livestock animals, or pet animals, and the like. As an example, the animal may be a laboratory animal (e.g., rats, dogs, pigs, monkeys, and the like) that has been specifically selected to have certain characteristics similar to humans. It should be understood that the subject may be, for example, any applicable human patient. Similarly, the term "proximal" refers to a location closer to the operator or physician, while "distal" refers to a location farther from the operator or physician.

[0012] As discussed herein, a "physician" or "operator" may include a physician, surgeon, engineer, scientist, or any other individual or delivery instrument associated with the delivery of a multi-electrode catheter for the treatment of drug refractory atrial fibrillation to a subject.

[0013] As discussed herein, the term "ablate" or "ablation," in the context of the devices and corresponding systems of the present disclosure, refers to components and structural features that are configured to reduce or prevent the generation of irregular cardiac signals within cells by utilizing non-thermal energy, such as irreversible electroporation (IRE), which is interchangeably referred to as pulsed electric field (PEF) and pulsed field ablation (PFA) throughout this disclosure. In the context of the devices and corresponding systems of the present disclosure, ablation or ablation is used throughout this disclosure in reference to non-thermal ablation of cardiac tissue in certain conditions, including, but not limited to, arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablate" or "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation, as will be appreciated by those skilled in the art.

[0014] As discussed herein, the terms "bipolar" and "monopolar", when used to refer to ablation schemes, describe different ablation schemes with respect to current paths and electric field distribution. "Bipolar" refers to an ablation scheme that utilizes a current path between two electrodes, both placed at the treatment site. The current density and electric flux density are typically approximately equal at each of the two electrodes. "Monopolar" refers to an ablation scheme that utilizes a current path between two electrodes, where one electrode containing a high current density and high electric flux density is placed at the treatment site, and a second electrode containing a relatively low current density and lower electric flux density is placed remotely from the treatment site.

[0015] The techniques of the present disclosure can be configured to deliver monophasic or biphasic pulses to ablate tissue. For example, the electrodes described herein configured to deliver ablation energy to tissue can be configured to deliver monophasic pulses, biphasic pulses, or some combination thereof. The terms "biphasic pulse" and "monophasic pulse" refer to the respective electrical signals. "Biphasic pulse" refers to an electrical signal that includes a positive voltage phase pulse (referred to herein as 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 only a negative phase.

[0016] Ablation of cardiac tissue, applying radio frequency (RF) energy and thermal techniques such as cryoablation, to improve a failing heart, is a well-known procedure. Typically, to successfully ablate using thermal techniques, cardiac potentials must be measured at various locations in the myocardium. In addition, temperature measurements during ablation provide data that allows for the effectiveness of the ablation. Typically, in ablation procedures using thermal techniques, electrode potentials and temperatures are measured before, during, and after the actual ablation.

[0017] Exemplary systems, methods, and devices of the present disclosure may be particularly suited for IRE ablation of cardiac tissue to treat cardiac arrhythmias. Ablation energy is typically delivered to the cardiac tissue by electrodes capable of delivering the ablation energy along the tissue to be ablated. Ablation procedures incorporating such exemplary catheters may be visualized using fluoroscopy, magnetic-based position sensing, and / or active current localization techniques.

[0018] IRE, as discussed in this disclosure, is a non-thermal cell death technique that can be used to ablate atrial arrhythmias. To ablate using IRE / PEF, biphasic voltage pulses are applied to destroy cellular structures in the myocardium. The biphasic pulses are non-sinusoidal waveforms and can be tailored to target cells based on the electrophysiology of the cells. In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to generate heat in the treatment area, indiscriminately heating all cells within the treatment area. Thus, IRE has the ability to spare adjacent heat-sensitive structures or tissues, which would be beneficial in reducing possible complications known with ablation or isolation modalities. Additionally or alternatively, monophasic pulses can be utilized.

[0019] Electroporation can be induced by applying a pulsed electric field to biological cells to cause reversible (temporary) or irreversible (permanent) generation of pores in the cell membrane. Cells have a transmembrane electrostatic potential that increases above the resting potential upon application of the pulsed electric field. While the transmembrane electrostatic potential remains below a threshold potential, electroporation is reversible, meaning that the pores can close when the applied pulsed electric field is removed and the cell can self-repair and survive. If the transmembrane electrostatic potential increases above a threshold potential, electroporation is irreversible and the cell becomes permanently permeabilized. As a result, the cell dies due to loss of homeostasis, typically by programmed cell death or apoptosis, which is believed to leave less scar tissue compared to other ablation modalities. In general, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of about 500 V / cm, while bone has a threshold potential of 3000 V / cm. These differences in threshold potentials allow IRE to selectively target tissues based on threshold potential.

[0020] Please refer to FIG. 1, which illustrates an exemplary catheter-based electrophysiological mapping and ablation system 10. The system 10 includes one or more catheters that are percutaneously inserted by a physician 24 through the vascular system of a patient 23 and into a cardiac chamber or vascular structure of a heart 12. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location of the heart 12. Multiple catheters can then be inserted into the delivery sheath catheter to reach the desired location. The one or more catheters may include catheters dedicated to sensing Intracardiac Electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. An exemplary catheter 14 configured to sense IEGMs is illustrated herein. For ablation, the physician 24 similarly delivers an end effector 28, including an ablation electrode, to a target site for ablation. If the end effector 28 is alternatively or additionally configured for mapping electrophysiological signals (e.g., IEGM signals), the physician 24 similarly contacts the end effector 28 with the heart wall to sense a target site within the heart 12.

[0021] The catheter 14 is an exemplary catheter that includes an end effector 28 comprising one and preferably multiple electrodes 26 optionally distributed across the expandable assembly and the distal tip of the end effector 28 and configured to detect electrophysiological signals and / or deliver ablation energy to tissue. The catheter 14 may additionally include a magnetic-based position sensor embedded in or near the end effector 28 for tracking the position and orientation of the end effector 28. The end effector 28 may further include one or more impedance-based electrodes disposed in or near the end effector 28 for tracking the position and orientation of the end effector 28.

[0022] The magnetic-based position sensor may operate in conjunction with a location pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working volume. The real-time position of the end effector 28 of the catheter 14 may be tracked based on the magnetic fields generated by the location pad 25 and sensed by the magnetic-based position sensor 29. The magnetic-based position sensor may be a single-axis sensor, a dual-axis sensor, or a three-axis sensor, depending on the particular configuration. Details of magnetic-based position sensing techniques are described in U.S. Pat. Nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091, each of which is incorporated by reference herein as if fully set forth herein.

[0023] The system 10 includes one or more electrode patches 38 positioned for skin contact on the patient 23 to establish a position reference for the location pads 25 and impedance-based electrode tracking. For impedance-based tracking, a current is directed to the impedance-based electrodes and sensed at the electrode skin patch 38, so that the location of each electrode can be triangulated via the electrode patch 38. Details of impedance-based position tracking technology are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated by reference herein as if fully set forth herein.

[0024] Recorder 11 displays electrograms 21 captured by the body surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured by electrodes on catheter 14. Recorder 11 may include pacing capability for pacing the cardiac rhythm and / or may be electrically connected to a stand-alone pacer.

[0025] The system 10 may include an ablation energy generator 50 disposed on the end effector and adapted to conduct ablation energy to one or more electrodes configured to deliver ablation energy to tissue. The energy generated by the ablation energy generator 50 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy, including unipolar or bipolar high voltage DC pulses, such as may be used to effect irreversible electroporation (IRE), or a combination thereof.

[0026] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between the catheters, the electrophysiological equipment, a power source, and a workstation 55 that controls the operation of the system 10. The electrophysiological equipment of the system 10 may include, for example, multiple catheters, location pads 25, body surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, the PIU 30 additionally includes processing capabilities to implement real-time calculations of the catheter positions and perform ECG calculations.

[0027] The workstation 55 includes a processor unit having a memory, a memory or storage device loaded with appropriate operating software, and a user interface function. The workstation 55 may optionally provide multiple functions, including: (1) modeling the endocardial anatomical structures in three dimensions (3D) and rendering a model or anatomical map 20 for display on the display device 27; (2) displaying activation sequences (or other data) compiled from recorded electrograms 21 in a representative visual display or image superimposed on the rendered anatomical map 20 on the display device 27; (3) displaying real-time positions and orientations of multiple catheters within the cardiac chambers; and (4) displaying sites of interest, such as where ablation energy is being applied, on the display device 27. One commercially available product embodying elements of the system 10 is available as the CARTO™ 3 system, available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0028] 2A-2D, various views of the end effector 28 are illustrated and described. The end effector 28 may form the distal end of a medical probe. FIG. 2A is a top perspective view of the medical probe, FIG. 2B is a bottom perspective view, FIG. 2C is a side view, and FIG. 2D is a top view. As illustrated, the end effector 28 may be attached to a distal end of an insertion tube 102 that extends along a longitudinal axis LA. The end effector 28 may be configured to bend radially outward from the longitudinal axis LA in a direction generally perpendicular to the longitudinal axis LA in a generally circular configuration. The end effector 28 may be attached to the insertion tube 102 at a proximal end 112, extend generally along the longitudinal axis LA for a predetermined distance, and then bend approximately perpendicular to the longitudinal axis LA to form a circular configuration with the remainder of the end effector 28 to a distal end 114.

[0029] The end effector 28 can include a spine member 104 and an electrode assembly 150 disposed along at least a portion of the spine member 104. The spine member 104 can be made of a resilient material, but can be configured to form the generally circular shape of the end effector 28. The shape memory material can be, for example, Nitinol or other biocompatible material that can be biased to form the generally circular shape when deployed from an insertion sheath. The electrode assembly 150 can include a flexible substrate 120 with a plurality of electrical leads 122 extending along at least a portion thereof. The electrode assembly 150 can further include a plurality of electrodes 26 disposed on the flexible substrate 120, each electrode 26 being electrically connected to at least one of the plurality of electrical leads 122 and configured to detect electroanatomical signals. The flexible substrate 120 can be wrapped around the spine member 104 of the end effector 28 such that at least some of the electrodes 26 are positioned facing away from the longitudinal axis LA. In this manner, the end effector 28 can include at least some of the electrodes 26 configured to contact tissue when inserted into the pulmonary vein.

[0030] Although the techniques of the present disclosure are described throughout this disclosure primarily for mapping electroanatomical signals, it will be understood that alternatively or additionally, the techniques of the present disclosure may be configured for delivering ablative energy to tissue. For example, the electrodes 26 described herein may be configured to detect electroanatomical signals for a mapping procedure, for delivering ablative energy to tissue, or both. When the electrodes 26 are configured to deliver ablative energy to tissue, the electrodes 26 may be configured for RF or IRE ablation. Additionally, the electrodes 26 may be configured to deliver unipolar or bipolar signals having monophasic or biphasic pulses.

[0031] FIG. 3 illustrates the spine member 104 encased within a flexible substrate 120. As previously described, the flexible substrate 120 may include a plurality of electrical leads 122 extending along at least a portion of the flexible substrate 120 and a plurality of electrodes 26 disposed on the flexible substrate 120. The flexible substrate 120, the electrical leads 122, and the electrodes 26 may define an electrode assembly 150. Each electrode 26 of the plurality of electrodes 26 may be electrically connected to at least one electrical lead 122 of the plurality of electrical leads 122. When the electrode assembly 150 is wrapped around the spine member 104, the plurality of electrodes 26 may be positioned along the flexible substrate such that each electrode 26 of the plurality of electrodes 26 is spaced apart from an adjacent electrode 26 of the plurality of electrodes 26 by a distance D. In some examples, the distance D may be between about 1 mm and 20 mm, between about 5 mm and 15 mm, or between about 8 mm and 12 mm. In another example, the distance D may be about 9 mm.

[0032] The multiple electrodes 26 may be disposed on the flexible substrate 120 such that the multiple electrodes 26 are aligned around the circumference of the spine member 104. For example, at least two electrodes 26 may be aligned around the circumference of the spine member 104. In other examples, three, four, five, or more electrodes 26 may be aligned around the circumference of the spine member 104.

[0033] 5A and 6A, it will be appreciated that the flexible substrate 120 can include a group of multiple electrodes 26 disposed thereon, distributed along the flexible substrate 120 such that at least one electrode 26 faces the tissue and at least one electrode 26 faces the blood when the flexible substrate 120 is wrapped around the spine member 104 of the medical probe. Furthermore, an insulating sleeve 130 can be disposed over the electrode assembly 150 of the flexible substrate 120 once the flexible substrate 120 is spirally wrapped around the spine member 104.

[0034] FIG. 4 illustrates a cross-section of the spine member 104 taken along line XX in FIG. 3. As depicted and described above, the flexible substrate 120 wrapped around the spine member 104 can include a plurality of electrodes 26 arranged such that a plurality of the electrodes 26 can be generally aligned around the circumference of the spine member 104. Additionally, the electrodes 26 can be spaced apart from one another at an angle θ° from one another around the circumference of the spine member 104. In some examples, θ can be about 120°. In other examples, θ can be about 180°, about 90°, about 60°, about 30°, or other angles, depending on the number of electrodes and the particular configuration. In some examples, the electrodes 26 can be equally spaced along the circumference of the spine member 106, or the electrodes can be unequally spaced (e.g., a greater number of the electrodes 26 can be configured to face generally away from the longitudinal axis, or vice versa). As will be appreciated, at least one electrode 26 of the multiple electrodes 26 may be configured to face tissue, while another electrode 26 may be configured to face blood when the medical device is inserted into a body lumen.

[0035] 5A-5B, FIG. 5A illustrates a top view of an electrode assembly 150. The electrode assembly 150 may include a flexible substrate 120 and a plurality of electrical leads 122 disposed along a portion of the flexible substrate 120. The electrode assembly 150 may further include a plurality of electrodes 26 disposed on the flexible substrate 120, and each electrode 26 of the plurality of electrodes 26 may be electrically connected to at least one electrical lead 122 of the plurality of electrical leads 122. FIG. 5B illustrates a side view of the flexible substrate 120 spirally wrapped around the spine member 104. The flexible substrate 120 may be wrapped around the spine member 104 such that at least some of the electrodes 26 of the plurality of electrodes 26 face away from the longitudinal axis LA of the spine member 104. 5A-5B, the plurality of electrodes 26 may be disposed on the flexible substrate 120 such that at least three electrodes 26 are aligned around the circumference of the spine member 104 at each location where an electrode 26 is positioned facing away from the longitudinal axis LA. The electrodes 26 of the plurality of electrodes 26 may be spaced about 120° apart around the circumference of the spine member 104 as depicted in FIG. 4. Additionally, the electrodes 26 may be spaced apart a distance D along the longitudinal axis LA of the spine member 104 as previously discussed. As will be appreciated, the distance D may be a range of distances corresponding to the number of electrodes 26 disposed along the flexible substrate 120 and a particular configuration.

[0036] 6A-6B illustrate a flexible substrate 120 that may include a plurality of electrodes 26 disposed thereon, with at least four electrodes 26 aligned around the circumference of the spine member 104 at each location where the electrodes 26 are positioned facing away from the longitudinal axis LA of the spine member 104. For example, the electrodes 26 may be configured to be spaced apart from one another by approximately 90° when the electrode assembly 150 is wrapped around the spine member 104. It will be understood that the plurality of electrodes 26 may include any number of electrodes 26, and that the angle θ may be a range of angles, provided that this number of electrodes 26 are spaced apart from one another around the circumference of the spine member 104. For example, as will be understood by one of ordinary skill in the art, two electrodes 26 of the plurality of electrodes 26 may be spaced apart by approximately 180°, five electrodes may be spaced apart by approximately 72°, etc.

[0037] 7A-7B, FIG. 7A illustrates an insulating sleeve 130 that may be disposed over an electrode assembly 150 of the spine member 104, the electrode assembly 150 including a plurality of electrodes 26. The insulating sleeve 130 may include a plurality of openings 132 extending therethrough, each opening 132 of the insulating sleeve 130 adapted to align with a respective electrode 26 of the plurality of electrodes 26. In other words, the openings 132 may be configured to at least partially expose the electrodes 26. In the example illustrated in FIG. 7A, the openings 132 of the insulating sleeve 130 may partially expose a portion of the spine member 104.

[0038] The openings 132 can be formed in the insulating sleeve 130 prior to placing the insulating sleeve 130 over the electrode assembly 150 and spine member 104. Alternatively, the openings 132 can be cut into the insulating sleeve 130 after placing the insulating sleeve 130 over the electrode assembly 150 and spine member 104 to expose the electrodes 26.

[0039] FIG. 7B illustrates an insulating sleeve 130 that may be disposed over the electrode assembly 150 and the spine member 104. As previously described, the insulating sleeve 130 may include multiple openings 132 extending therethrough to at least partially expose the electrodes 26. However, in this example, the openings 132 may include multiple openings 132 extending through the insulating sleeve 130 at the location of each electrode 26, rather than one large opening 132 as shown in FIG. 7A. In this manner, the insulating sleeve 130 may be configured to provide mechanical protection to the electrodes 26 in addition to providing electrical insulation to the unexposed areas of the electrode assembly 150. The multiple openings 132 may be sized and spaced to ensure that the electrodes 26 can conduct sufficient electricity to or from the tissue and / or blood. In some examples, not shown, the insulating sleeve 130 may include multiple irrigation holes extending therethrough, each configured to allow irrigation fluid to flow therethrough.

[0040] 8 shows a flow chart disclosing a method 800 of manufacturing a medical probe. The method 800 may include forming 802 the spine member 104 into a generally circular shape and helically winding 804 an electrode assembly 150 around the spine member, the electrode assembly 150 comprising a flexible substrate 120, a plurality of electrical leads 122 extending along at least a portion of the flexible substrate 120, and a plurality of electrodes 26 disposed on the flexible substrate. The method 800 may include disposing 806 an insulating sleeve 130 over the electrode assembly 150 and forming 808 a plurality of openings 132 through the insulating sleeve 130, the plurality of openings configured to align with the plurality of electrodes 26.

[0041] In some examples, the plurality of electrical leads 122 of the method 800 can be electrically connected to at least one electrical lead 122 of the plurality of electrical leads 122. Additionally, the plurality of electrodes 26 can be disposed on the flexible substrate 120 such that when the electrode assembly 150 is spirally wrapped around the spine member 104, at least some of the electrodes 26 can be positioned facing away from the axis of the generally circular shape of the spine member 104. As discussed above, the electrode assembly 150 can include any number of the electrodes 26. In some examples, the medical probe can further include a position sensor (not shown) configured to generate a current when exposed to an electromagnetic field.

[0042] With regard to the above examples, in certain embodiments, the end effector 28 has a delivery configuration and a deployed configuration. In the delivery configuration, the end effector 28 is typically generally straight, i.e., may be in a straight configuration as it is advanced through the catheter 14 and delivered to the heart through the catheter 14. Once inside the heart and deployed from the catheter, the end effector 28 may assume a lasso shape as illustrated herein. Positioning of the electrodes 26 by both distance D and angular displacement angle θ is typically performed when the end effector is in the deployed configuration. Distance D and angle θ may be different when in the straight delivery configuration. Additionally, as illustrated, the flexible substrate 120 may space the distance between the electrodes 26 when straight, allowing distance D and angle θ to be met when wrapped around the spine 104 and deployed.

[0043] The techniques of the present disclosure described herein can be further understood in accordance with the following clauses.

[0044] Clause 1: An electrode assembly comprising: a flexible substrate extending along a plane; a plurality of electrical leads extending along at least a portion of the flexible substrate; and a plurality of electrodes disposed on the flexible substrate, each electrode of the plurality of electrodes being electrically connected to at least one electrical lead of the plurality of electrical leads, the plurality of electrodes being positioned on the flexible substrate such that, when the electrode assembly is wrapped around an end effector member wrapped about a longitudinal axis to define a lasso catheter, at least some of the electrodes of the plurality of electrodes are positioned on a side of the lasso catheter facing away from a longitudinal axis extending through the lasso catheter.

[0045] Clause 2: An electrode assembly as described in clause 1, wherein each of the electrodes of the plurality of electrodes is configured to detect an electroanatomical signal.

[0046] Clause 3: An electrode assembly as described in clauses 1 and 2, wherein the plurality of electrodes are arranged in a spiral shape along the flexible substrate such that each electrode of the plurality of electrodes is spaced approximately 9 millimeters from an adjacent electrode of the plurality of electrodes.

[0047] Clause 4: An electrode assembly as described in clause 1, wherein the multiple electrodes are arranged on the flexible substrate such that at least three electrodes are generally aligned around the circumference of the lasso catheter, with each location where the electrodes are positioned facing away from the longitudinal axis.

[0048] Clause 5: An electrode assembly as described in clause 4, wherein the at least three electrodes are spaced approximately 120° apart from each other around the circumference of the lasso catheter.

[0049] Clause 6: An electrode assembly as described in clause 5, wherein at least one electrode of the at least three electrodes is configured to face tissue and at least another electrode of the at least three electrodes is configured to face blood when the lasso catheter is inserted into a body lumen.

[0050] Clause 7: A medical probe comprising: an insertion tube extending along a longitudinal axis; and an end effector disposed at a distal end of the insertion tube, the end effector configured to bend radially outward from the longitudinal axis generally perpendicular to the longitudinal axis, the end effector comprising a spine member and an electrode assembly disposed along at least a portion of the spine member, the electrode assembly comprising: a flexible substrate; a plurality of electrical leads extending along at least a portion of the flexible substrate; and a plurality of electrodes disposed on the flexible substrate, each electrode of the plurality of electrodes being electrically connected to at least one electrical lead of the plurality of electrical leads, the plurality of electrodes being wrapped around the spine member, and at least some of the electrodes of the plurality of electrodes being positioned facing away from the longitudinal axis.

[0051] Clause 8: A medical probe as described in clause 7, wherein each of the electrodes of the plurality of electrodes is configured to detect an electroanatomical signal.

[0052] Clause 9: A medical probe as described in Clause 7, wherein the multiple electrodes are arranged on the flexible substrate such that at each location where the electrodes are positioned facing away from the longitudinal axis, at least three electrodes are aligned around the circumference of the spine member.

[0053] Clause 10: The medical probe of clause 9, wherein the at least three electrodes are spaced approximately 120° apart from each other around the circumference of the spine member.

[0054] Clause 11: A medical probe as described in clauses 9 and 10, wherein at least one electrode of the at least three electrodes is configured to face tissue and at least another electrode of the at least three electrodes is configured to face blood when the medical probe is inserted into a body cavity.

[0055] Clause 12: A medical probe as described in clauses 7 to 11, wherein the plurality of electrodes are arranged along the flexible substrate such that when the electrode assembly is spirally wrapped around the spine member, each electrode of the plurality of electrodes is spaced approximately 9 millimeters from an adjacent electrode of the plurality of electrodes.

[0056] Clause 13: The medical probe of any one of clauses 7 to 12, further comprising an insulating sleeve disposed over the electrode assembly.

[0057] Clause 14: The medical probe described in clause 13, wherein the insulating sleeve has a plurality of openings extending therethrough, the plurality of openings being configured to align with the plurality of electrodes.

[0058] Clause 15: A medical probe as described in clauses 13 and 14, wherein the plurality of openings includes a plurality of openings extending through the insulating sleeve at each electrode of the plurality of electrodes.

[0059] Clause 16: A medical probe as described in clauses 13 to 15, wherein the insulating sleeve has a plurality of irrigation holes extending through the insulating sleeve, the plurality of irrigation holes being configured to allow irrigation fluid to flow therethrough.

[0060] Clause 17: The medical probe of clauses 7-16, further comprising a position sensor configured to generate a current when subjected to an electromagnetic field.

[0061] Clause 18: A method comprising forming a spine member into a generally circular shape; and spirally wrapping an electrode assembly around the spine member, the electrode assembly comprising a flexible substrate, a plurality of electrical leads extending along at least a portion of the flexible substrate, and a plurality of electrodes disposed on the flexible substrate, each electrode of the plurality of electrodes being electrically connected to at least one electrical lead of the plurality of electrical leads, the plurality of electrodes being positioned on the flexible substrate such that when the electrode assembly is spirally wrapped around the spine member, at least some of the electrodes of the plurality of electrodes are positioned facing away from an axis of the generally circular shape of the spine member.

[0062] Clause 19: The method of clause 18, further comprising disposing an insulating sleeve over the electrode assembly.

[0063] Clause 20: The method of clause 19, further comprising forming a plurality of openings through the insulating sleeve, the plurality of openings configured to align with the plurality of electrodes.

[0064] The above embodiments are cited by way of example, and the invention is not limited to what has been specifically shown and described hereinabove. Rather, the scope of the invention includes both combinations and subcombinations of the various features described and illustrated above, as well as variations and modifications thereof not disclosed in the prior art that will occur to those skilled in the art upon reading the foregoing description.

[0065] [Embodiment] (1) An electrode assembly for a medical device, comprising: a flexible substrate extending along a plane; a plurality of electrical leads extending along at least a portion of the flexible substrate; a plurality of electrodes disposed on the flexible substrate, each electrode of the plurality of electrodes being electrically connected to at least one electrical lead of the plurality of electrical leads, the plurality of electrodes being positioned on the flexible substrate such that when the electrode assembly is wrapped around an end effector member wrapped about a longitudinal axis to define a lasso catheter, at least some of the electrodes of the plurality of electrodes are positioned on a side of the lasso catheter facing away from the longitudinal axis extending through the lasso catheter; An electrode assembly comprising: (2) An electrode assembly as described in embodiment 1, wherein each of the electrodes of the plurality of electrodes is configured to detect an electroanatomical signal. (3) The electrode assembly of claim 1, wherein the plurality of electrodes are arranged in a spiral along the flexible substrate such that each electrode in the plurality of electrodes is spaced about 9 millimeters from an adjacent electrode in the plurality of electrodes. (4) The electrode assembly of embodiment 1, wherein the plurality of electrodes are arranged on the flexible substrate such that at each location where an electrode is positioned facing away from the longitudinal axis, at least three electrodes are generally aligned around the circumference of the lasso catheter. (5) The electrode assembly of claim 4, wherein the at least three electrodes are spaced approximately 120° apart from one another around the circumference of the lasso catheter.

[0066] (6) The electrode assembly of embodiment 5, wherein at least one electrode of the at least three electrodes is configured to face tissue and at least another electrode of the at least three electrodes is configured to face blood when the lasso catheter is inserted into a body lumen. (7) A medical probe, comprising: an insertion tube extending along a longitudinal axis; an end effector disposed at a distal end of the insertion tube, the end effector configured to bend radially outward from the longitudinal axis generally perpendicular to the longitudinal axis, the end effector comprising: A spine member; an electrode assembly disposed along at least a portion of the spine member, the electrode assembly comprising: A flexible substrate; a plurality of electrical leads extending along at least a portion of the flexible substrate; a plurality of electrodes disposed on the flexible substrate, each electrode of the plurality of electrodes electrically connected to at least one electrical lead of the plurality of electrical leads, the plurality of electrodes wrapped around the spine member, and at least some of the electrodes of the plurality of electrodes positioned facing away from the longitudinal axis; A medical probe comprising: (8) A medical probe as described in embodiment 7, wherein each of the electrodes of the plurality of electrodes is configured to detect an electroanatomical signal. (9) A medical probe as described in embodiment 7, wherein the plurality of electrodes are arranged on the flexible substrate such that at each location where an electrode is positioned facing away from the longitudinal axis, at least three electrodes are aligned around the circumference of the spine member. (10) The medical probe of claim 9, wherein the at least three electrodes are spaced approximately 120 degrees apart from each other around the circumference of the spine member.

[0067] (11) The medical probe of embodiment 10, wherein at least one electrode of the at least three electrodes is configured to face tissue and at least another electrode of the at least three electrodes is configured to face blood when the medical probe is inserted into a body lumen. (12) The medical probe of claim 7, wherein the plurality of electrodes are arranged along the flexible substrate such that, when the electrode assembly is spirally wrapped around the spine member, each electrode of the plurality of electrodes is spaced approximately 9 millimeters from an adjacent electrode of the plurality of electrodes. (13) The medical probe of claim 12, further comprising an insulating sleeve disposed over the electrode assembly. (14) The medical probe of claim 13, wherein the insulating sleeve has a plurality of openings extending therethrough, the plurality of openings configured to align with the plurality of electrodes. (15) The medical probe of claim 14, wherein the plurality of openings includes a plurality of openings extending through the insulating sleeve at each electrode of the plurality of electrodes.

[0068] (16) The medical probe of claim 13, wherein the insulating sleeve includes a plurality of irrigation holes extending therethrough, the plurality of irrigation holes being configured to allow irrigation fluid to flow therethrough. (17) The medical probe of embodiment 7, further comprising a position sensor configured to generate a current when subjected to an electromagnetic field. (18) A method comprising the steps of: forming the spine member into a generally circular shape; and spirally wrapping the spine member with an electrode assembly, the electrode assembly comprising: A flexible substrate; a plurality of electrical leads extending along at least a portion of the flexible substrate; a plurality of electrodes disposed on the flexible substrate, each electrode of the plurality of electrodes being electrically connected to at least one electrical lead of the plurality of electrical leads, the plurality of electrodes being positioned on the flexible substrate such that when the electrode assembly is spirally wrapped around the spine member, at least some of the electrodes of the plurality of electrodes are positioned to face away from an axis of the generally circular shape of the spine member; A method comprising: 19. The method of claim 18, further comprising disposing an insulating sleeve over the electrode assembly. 20. The method of claim 19, further comprising forming a plurality of openings through the insulating sleeve, the plurality of openings configured to align with the plurality of electrodes.

Claims

1. 1. An electrode assembly for a medical device, comprising: a flexible substrate extending along a plane; a plurality of electrical leads extending along at least a portion of the flexible substrate; a plurality of electrodes disposed on the flexible substrate, each electrode of the plurality of electrodes being electrically connected to at least one electrical lead of the plurality of electrical leads, the plurality of electrodes being positioned on the flexible substrate such that when the electrode assembly is wrapped around an end effector member wrapped about a longitudinal axis to define a lasso catheter, at least some of the electrodes of the plurality of electrodes are positioned on a side of the lasso catheter facing away from the longitudinal axis extending through the lasso catheter; An electrode assembly comprising:

2. The electrode assembly of claim 1 , wherein each of the electrodes of the plurality of electrodes is configured to detect an electroanatomical signal.

3. 2. The electrode assembly of claim 1, wherein the plurality of electrodes are arranged in a spiral along the flexible substrate such that each electrode in the plurality of electrodes is spaced approximately 9 millimeters from an adjacent electrode in the plurality of electrodes.

4. 2. The electrode assembly of claim 1, wherein the plurality of electrodes are arranged on the flexible substrate such that at each location where an electrode is positioned facing away from the longitudinal axis, at least three electrodes are generally aligned around a circumference of the lasso catheter.

5. The electrode assembly of claim 4 , wherein the at least three electrodes are spaced approximately 120° apart from one another around the circumference of the lasso catheter.

6. 6. The electrode assembly of claim 5, wherein at least one electrode of the at least three electrodes is configured to face tissue and at least another electrode of the at least three electrodes is configured to face blood when the lasso catheter is inserted into a body lumen.

7. 1. A medical probe, comprising: an insertion tube extending along a longitudinal axis; an end effector disposed at a distal end of the insertion tube, the end effector configured to bend radially outward from the longitudinal axis generally perpendicular to the longitudinal axis, the end effector comprising: A spine member; an electrode assembly disposed along at least a portion of the spine member, the electrode assembly comprising: A flexible substrate; a plurality of electrical leads extending along at least a portion of the flexible substrate; a plurality of electrodes disposed on the flexible substrate, each electrode of the plurality of electrodes electrically connected to at least one electrical lead of the plurality of electrical leads, the plurality of electrodes wrapped around the spine member, and at least some of the electrodes of the plurality of electrodes positioned facing away from the longitudinal axis; A medical probe comprising:

8. The medical probe of claim 7 , wherein each of the electrodes of the plurality of electrodes is configured to detect an electroanatomical signal.

9. 8. The medical probe of claim 7, wherein the plurality of electrodes are arranged on the flexible substrate such that at each location an electrode is positioned facing away from the longitudinal axis, at least three electrodes are aligned around a circumference of the spine member.

10. The medical probe of claim 9 , wherein the at least three electrodes are spaced approximately 120° apart from one another around the circumference of the spine member.

11. 11. The medical probe of claim 10, wherein at least one electrode of the at least three electrodes is configured to face tissue and at least another electrode of the at least three electrodes is configured to face blood when the medical probe is inserted into a body lumen.

12. 8. The medical probe of claim 7, wherein the plurality of electrodes are arranged along the flexible substrate such that when the electrode assembly is spirally wrapped around the spine member, each electrode of the plurality of electrodes is spaced approximately 9 millimeters from an adjacent electrode of the plurality of electrodes.

13. The medical probe of claim 12 , further comprising an insulating sleeve disposed over the electrode assembly.

14. The medical probe of claim 13 , wherein the insulating sleeve includes a plurality of apertures extending therethrough, the plurality of apertures configured to align with the plurality of electrodes.

15. The medical probe of claim 14 , wherein the plurality of apertures includes a plurality of apertures extending through the insulating sleeve at each electrode of the plurality of electrodes.

16. 14. The medical probe of claim 13, wherein the insulating sleeve includes a plurality of irrigation holes extending therethrough, the plurality of irrigation holes configured to allow irrigation fluid to flow therethrough.

17. The medical probe of claim 7 , further comprising a position sensor configured to generate a current when subjected to an electromagnetic field.

18. 1. A method comprising: forming the spine member into a generally circular shape; and spirally wrapping the spine member with an electrode assembly, the electrode assembly comprising: A flexible substrate; a plurality of electrical leads extending along at least a portion of the flexible substrate; a plurality of electrodes disposed on the flexible substrate, each electrode of the plurality of electrodes being electrically connected to at least one electrical lead of the plurality of electrical leads, the plurality of electrodes being positioned on the flexible substrate such that when the electrode assembly is spirally wrapped around the spine member, at least some of the electrodes of the plurality of electrodes are positioned to face away from an axis of the generally circular shape of the spine member; A method comprising:

19. The method of claim 18 , further comprising disposing an insulating sleeve over the electrode assembly.

20. 20. The method of claim 19, further comprising forming a plurality of openings through the insulating sleeve, the plurality of openings configured to align with the plurality of electrodes.

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